RxAmerica Prior Authorization Criteria:

RxAmerica 

Prior Authorization Criteria: 

5HT-3 ANTAGONISTS 

FDA-APPROVED INDICATIONS 

Ondansetron is indicated: 

A. For the prevention or treatment of nausea/vomiting. 

COVERAGE POLICY 

Ondansetron is covered for members who meet the following criteria: 

A. Verification of B vs D criteria as per CMS regulations 

B. This must NOT be a full therapeutic replacement for IV therapy for a patient 

receiving cancer treatment 

C. AND the patient must be receiving highly emetogenic chemotherapy, radiation 

therapy, or post-operative treatment. 

D. OR the patient is not being treated for chemotherapy, radiation therapy, or postoperative 

treatment. 

E. AND the patient has previous trial or contraindication to BOTH Promethazine 

AND Prochlorperazine 

F. AND the failure on Promethazine and Prochlorperazine is verified through chart 

notes submitted by the prescribing physician 

G. Brand name will only be approved with failure on ALL available generic 

formulations 

NON COVERAGE 

Ondansetron is NOT covered for members who meet the following criteria: 

A. The patient is receiving Ondansetron as a full therapeutic replacement for IV 

therapy for a patient receiving cancer treatment. 

B. The patient has NOT tried and failed BOTH Promethazine and Prochlorperazine. 

C. Chart notes documenting failure on Promethazine and Prochlorperazine are not 

submitted for review. 

REQUIRED MEDICAL 

INFORMATION 

Chart notes as indicated in Covered Uses 

AUTHORIZATION PERIOD 

2 Weeks Per treatment 

1


Actimmune® is indicated: 

A. Chronic Granulomatous Disease 

B. Severe Malignant Osteopetrosis 



ACTIMMUNE 


Actimmune® is covered for members who meet the following criteria: 

A. Documented Chronic Granulomatous Disease or Severe Malignant Osteopetrosis 

B. AND have had CBC, differential, and platelet counts to illustrate Hepatic levels 

WNL. Tests need to be administered in three month intervals to avoid hepatic 

toxicity 

C. AND no history of myelosuppression. 

NON COVERAGE 

Actimmune® is NOT covered for members with the following criteria: 

A. Hypersensitivity to E.Coli derived products and/or interferon gamma. 


INFORMATION 



3 months 

2

FDA APPROVED INDICATIONS 

A. Osteoporosis 

B. Osteoporosis Prophylaxis 

C. Paget’s Disease: 



ACTONEL 


A. Patient has failure to generic alendronate or contraindication 

B. AND has diagnosis of Osteoporosis indicated by a T-Score of 2.5 or more 

standard deviations below the young-adult mean BMD or X-ray illustrating 

fracture in the spine and/or hip. 

C. For Paget’s Disease the member must have documented failure to alendronate 

therapy for 6 months or contraindication to alendronate 

NON COVERAGE 

Actonel is not covered for members who meet the following criteria: 

A. No documentation to failure to alendronate therapy, 

B. Or T-Score value that does not indicate osteoporosis 


INFORMATION 

Chart Notes. T-score or X-ray 

illustrating fracture 


Plan Year 

3



ADAGEN 


Adagen® is indicated: 

A. Adenosine Deaminase (ADA) deficiency 


Adagen® is covered for members who meet the following criteria: 

A. Documented diagnosis of Adenosine Deaminase (ADA) deficiency 

B. AND patient has failed bone marrow transplantation or is not a suitable 

candidate for bone marrow transplantation 

C. AND is being used for direct replacement for deficient enzyme (no benefit 

achieved in patients with immunodeficiency due to other causes) 

NON COVERAGE 

Adagen® is NOT covered for members with the following criteria: 

A. Immunodeficencies that do not have an association with adenosine deaminase 

B. Patient has diagnosis of severe thrombocytopenia 

C. Use for preparatory or support therapy for bone marrow transplantation 

REQUIRED MEDICAL INFORMATION 


PRESCRIBER RESTRICTIONS 

Endocrinologist 


Plan Year 

4



AFINITOR 


A. All FDA approved indications not otherwise excluded from Part D. 


Afinitor is covered for patient that meet the following criteria: 

A. Patient must have previous trial and failure with one of the following: 

a. Sutent 

b. Nexavar 


The following copies of chart notes/laboratory reports are required: 

A. Documentation of previous trial/failure of Sutent or Nexavar 

AGE RESTRICTIONS 

Patient must be 18 years of age or older 


Oncologist 


Plan Year 

5


Agrylin® is indicated: 

A. Chronic Myelogenous Leukemia 

B. Polycythemia Vera 

C. Thrombocytosis 



AGRYLIN 


Agrylin® is covered for members who meet the following criteria: 

A. Agrylin® is not covered unless contraindication to the all commercially 

available generic anagrelide products. Therefore only generic anagrelide will 

be covered. 

B. AND is being used for Chronic Myelogenous Leukemia, Polycythemia Vera, 

Thrombocytosis 

a. Chronic Myelogenous Leukemia diagnosis: 

i. Persistent granulocyte count Greater than or equal to 

50,000/mcL w/o infection 

ii. Absoulte basophil count Greater than or equal to 100/mcL 

iii. Evidence for hyperplasia of the granulocytic line in the bone 

marrow 

iv. Philadelphia chromosome is present 

v. Luekocyte alkaline phosphatase Less than or equal to lower 

limit of the lab range 

b. Polycythemia Vera diagnosis: 

i. Increased red cell mass 

ii. Normal arterial oxygen saturation 

iii. Splenomegaly 

iv. Platelet Count Greater than or equal to 400,000/mcL w/o iron 

deficiency or bleeding 

v. Leukocytosis Greater than or equal to 12,000/mcL w/o 

infection 

vi. Elevated leukocyte alkaline phosphatase 

vii. Elevated serum B12 

c. Thrombosytosis diagnosis: 

i. Platelet Count Greater than or equal to900,000/mcL 

ii. Profound megakaryocytic hyperplasia in bone marrow 

iii. Absence of Philadelphia chromosome 

iv. Normal red cell mass 

v. Normal serum iron and ferritin and normal marrow iron stores 

C. AND patient does not have severe hepatic impairment 

D. AND patient does not have known or suspected heart disease a pre-treatment 

cardiovascular examination is required to ensure safety. 

6



AGRYLIN 

(Continued) 

NON COVERAGE 

Agrylin® is NOT covered for members with the following criteria: 

A. Severe hepatic impairment 

B. Women who are or may become pregnant 

C. Known heart disease 




Oncologist or Hematologist 


2 months 

7



ALDURAZYME 


Aldurazyme® is indicated: 

A. For patients with Hurler and Hurler-Scheie forms of Mucopolysaccharidosis I 

(MPS) and for patients with the Scheie form who have moderate-to-severe 

symptoms. 


Aldurazyme® is covered for members who meet the following criteria: 

A. Diagnosis is documented as Hurler syndrome (MPS 1H) or Hurler-Scheie 

syndrome (MPS IS). 

B. OR the diagnosis is documented as Scheie syndrome (MPS IS). 

C. AND the patient has at least two of the listed moderate-to-severe symptoms. 

Impaired vision Recurrent otitis media Recurrent 

sinopulmonary 

infections 

Impaired hearing Upper airway obstruction Malaise and reduced 

endurance 

Corneal clouding Macrocephaly Reduced joint range 

of motion 

Progressively 

coarse facial 

features 

Carpal tunnel 

syndrome 

Cardiac 

abnormalities and 

valvular disease 

Coarse facial features 

Delayed or regressed 

mental development 

Communicating 

hydrocephalus 

Umbilical and 

inguinal hermias 

Hepatosplenomegaly 

Spinal cord 

compression 

Sleep apnea Short stature Reduced pulmonary 

function 

Bone deformities 

D. AND diagnosis has been confirmed by diagnostic method (measurement of alphaiduronidase 

activity) or antenatal diagnosis (enzymatic assay). 

E. AND if the patient has previously received at least 26 weeks of Aldurazyme® 

therapy, they must show an improvement in lung function (forced vital capacity 

[FVC] from when therapy was started. 

8



ALDURAZYME 

(Continued) 

NON COVERAGE 

Aldurazyme® is NOT covered for members with the following criteria: 

A. The diagnosis is NOT documented as Hurler syndrome, Hurler-Scheie syndrome 

or Scheie syndrome. 

B. If the diagnosis is Scheie syndrome and they do not have at least two mild-tomoderate 

severe symptoms. 

C. If the diagnosis has NOT been confirmed by diagnostic method or antenatal 

diagnosis. 

D. If the patient has previously received at least 26 weeks of Aldurazyme® therapy 

and they have not shown an Improvement in lung function [FVC]. 






Plan Year 

9



ALFERON N 


Alferon N® is indicated: 

A. For intralesional treatment of refractory or recurring external condylomata 

acuminate in patients 18 years or age or older. 


Alferon N® is covered for members who meet the following criteria: 

A. Patient has NO allergy to egg protein, immunoglobulin (IgG) or neomycin. 

B. AND the patient must have a diagnosis for Condylomata Acuminata. 

C. AND the patient is 18 years of age or older. 

D. AND the prescribing physician is a board certified dermatologist or obtained a 

consult from the listed specialty. 

E. AND the patient has tried, failed or intolerant to a 16 week course of Aldara® 

treatment. 

F. AND approval can be allowed for up to 8 weeks. 

G. AND if the patient has received previous therapy, the patient must not initiate 

therapy until 3 months after the initial course of therapy unless the warts enlarge 

or new warts appear. 

H. AND the initial therapy must have shown a clinical benefit that shows resolution 

or decrease in wart size. And approval can be allowed for up to 8 weeks. 

NON COVERAGE 

Alferon N® is NOT covered for members with the following criteria: 

A. Patient has an allergy to egg protein, immunoglobulin or neomycin. 

B. The diagnosis is NOT Condylomata Acuminata. 

C. If the diagnosis is for Condylomata Acuminata and the patient meets one or more 

of the following criteria: 

D. AND the patient is under the age of 18 years old 

E. AND/OR the prescribing physician is NOT a dermatologist or has NOT obtained 

a consult. 

F. AND/OR the patient has NOT tried, failed or is intolerant to a 16 week course of 

Aldara®. 

G. AND/OR the patient has received previous therapy and the request is NOT 

beyond 3 months from the initial request AND/OR NO new warts have appeared 

or enlarged 

H. AND/OR the initial therapy has NOT shown a clinical benefit. 


INFORMATION 



8 weeks 

10



AMITIZA 


Amitiza® is indicated: 

A. For the treatment of chronic idiopathic constipation in adults. 

B. For the treatment of irritable bowel syndrome-constipation predominant 

C. All other FDA approved indications not otherwise excluded from Part D 


Amitiza® is covered for members who meet the following criteria: 

A. Diagnosis is documented as chronic idiopathic constipation OR irritable bowel 

syndrome-constipation predominant. 

B. AND patient is 18 years of age or older. 

C. AND the patient has NO history of mechanical gastrointestional obstruction. 

D. AND the patient is not pregnant if female. 

E. AND the patient meets 2 (two) or more of the following ROME criteria for the 

diagnosis of chronic constipation for at least 12 weeks in the preceding 12 

months: 

a. Straining during Greater than 25% of bowel movement. 

b. Lumpy or hard stools for Greater than 25% of bowel movement. 

c. Less than 3 (three) stools per week. 

d. Sensation of incomplete evacuation for Greater than 25% of bowel 

movement. 

e. Sensation of anorectal blockage for Greater than 25% of bowel movement. 

f. Loose stools not present. 

g. Manual maneuvers are needed to facilitate Greater than 25% of bowel 

movement. 

F. AND the patient has tried and failed a drug regimen of lactulose for greater than 3 

(three) months. (Please verify that the patient has received polyethylene glycol 

therapy for three months by reviewing the patient’s drug history or the patient’s 

chart notes). 

G. AND if the patient has received previous Amitiza® therapy, the physician must 

show a documented Improvement in the patient’s stool frequency, stool 

consistency and/or abdominal distention from the beginning of Amitiza® 

treatment. 

H. AND evidence of ROME criteria, failure to drug regimens and improvement in 

symptoms are documented in patient’s chart notes provided by prescribing 

provider. 

NON COVERAGE 

Amitiza® is NOT covered for members with the following criteria: 

A. Diagnosis is NOT documented as chronic constipation OR irritable bowel 

syndrome-constipation predominant. 

B. Patient is 17 years of age or younger. 

11



AMITIZA 

(Cotninued) 

C. Patient does NOT meet 2 of the ROME criteria for chronic constipation. 

D. Patient has NOT failed a 3 month trial of polyethylene glycol. 

E. Patient has NOT failed a 3 month trial of lactulose. 

F. If the patient has had previous Amitiza® and has NOT shown an improvement in 

symptoms. 

G. Provider has NOT provided the patient’s chart notes for documentation. 


INFORMATION 



Plan Year 

12


Agrylin® is indicated: 

A. Chronic Myelogenous Leukemia 

B. Polycythemia Vera 

C. Thrombocytosis 



ANAGRELIDE 


Agrylin® is covered for members who meet the following criteria: 

A. Agrylin® is not covered unless contraindication to the all commercially available 

generic anagrelide products. Therefore only generic anagrelide will be covered. 

B. AND is being used for Chronic Myelogenous Leukemia, Polycythemia Vera, 

Thrombocytosis 

a. Chronic Myelogenous Leukemia diagnosis: 

i. Persistent granulocyte count Greater than or equal to 50,000/mcL w/o 

infection 

ii. Absoulte basophil count Greater than or equal to 100/mcL 

iii. Evidence for hyperplasia of the granulocytic line in the bone marrow 

iv. Philadelphia chromosome is present 

v. Luekocyte alkaline phosphatase Less than or equal to lower limit of 

the lab range 

b. Polycythemia Vera diagnosis: 

i. Increased red cell mass 

ii. Normal arterial oxygen saturation 

iii. Splenomegaly 

iv. Platelet Count Greater than or equal to 400,000/mcL w/o iron 

deficiency or bleeding 

v. Leukocytosis Greater than or equal to 12,000/mcL w/o infection 

vi. Elevated leukocyte alkaline phosphatase 

vii. Elevated serum B12 

c. Thrombosytosis diagnosis: 

i. Platelet Count Greater than or equal to900,000/mcL 

ii. Profound megakaryocytic hyperplasia in bone marrow 

iii. Absence of Philadelphia chromosome 

iv. Normal red cell mass 

v. Normal serum iron and ferritin and normal marrow iron stores 

vi. AND patient does not have severe hepatic impairment 

vii. AND patient does not have known or suspected heart disease a pretreatment 

cardiovascular examination is required to ensure safety. 

13



ANAGRELIDE 

(Continued) 

NON COVERAGE 

Agrylin® is NOT covered for members with the following criteria: 


B. Women who are or may become pregnant 

C. Known heart disease 




Oncologist or Hematologist 


2 months 

14


Antizol® is indicated: 

A. Ethylene Glycol Poisoning 

B. Methanol Poisoning 



ANTIZOL 


Antizol® is covered for members who meet the following criteria: 

A. Patient is suffering from acute methanol or ethylene glycol poisoning 

B. AND verification of all B vs. D criteria indicate coverage by Part D 

NON COVERAGE 

Antizol® is NOT covered for members with the following criteria: 

A. Known hypersensitivity to fomepizole or other pyrazoles 


INFORMATION 



3 days 

15



ATGAM 


Atgam® is indicated: 

A. Aplastic Anemia 

B. Kidney Transplant Rejection or prophylaxis 


Atgam® is covered for members who meet the following criteria: 

A. Patient is receiving concomitant immunosuppressive therapy 

B. AND verification of all B vs. D criteria indicate coverage by Part D 

NON COVERAGE 

Atgam® is NOT covered for members with the following criteria: 

A. Patients not receiving concomitant immunosuppressive therapy 

B. Medication should be administered through Medicare Part B 


INFORMATION 



Initial authorization: 14 days 

16



AVONEX 


Avonex® is indicated: 

A. For the treatment of patients with relapsing forms of multiple sclerosis to slow the 

accumulation of physicial disability and decrease the frequency of clinical 

exacerbations. Safety and efficacy in patients with chronic progressive multiple 

sclerosis have not been established. 


Avonex® is covered for members who meet the following criteria: 

A. The prescribing provider is a neurologist or has obtained a consult from the listed 

specialty. 

B. AND the diagnosis is documented as Relapsing-Remitting Multiple Sclerosis. 

(Avonex® does not have the indication for primary progressive, secondary 

progressive or progressive relapsing multiple sclerosis). 

C. AND the patient has a history of at least two focal neurological deficits (e.g., loss 

of vision, double vision, localized numbness, localized weakness, walking gait 

abnormalities, slurred speech, tingling) in which the second deficit followed after 

the resolution of the first deficit. 

D. AND an MRI has been performed and is suggestive of multiple sclerosis 

(evidence of lesion). 

E. AND the patient will NOT be receiving Avonex® therapy in combination with 

interferon-beta therapy (e.g., Rebif®, or Betaseron®), Copaxone® or 

mitoxantrone. (Please verify that the patient is not on duplicate therapy by 

reviewing the patient’s drug history or chart). 

F. AND if the patient has received previous Avonex® therapy, the provider can 

document a decrease in the frequency of clinical relapses OR slowing in the 

progression of the disease OR the patient has remained stable OR lesions on MRI 

have diminished after initiation of therapy. 

NON COVERAGE 

Avonex® is NOT covered for members with the following criteria: 

A. The prescribing provider is NOT a neurologist or the prescribing provider has 

NOT obtained a consult from the listed specialty. 

B. The diagnosis is NOT documented as Relapsing-Remitting Multiple Sclerosis. 

C. The diagnosis is documented as primary progressive, secondary progressive or 

progressive relapsing multiple sclerosis. 

D. The patient has NO history of at least two focal neurological deficits. 

E. The patient has a history of at least two focal neurological deficits but the initial 

deficit did not resolve before the start of the second deficit. 

F. An MRI has NOT been performed. 

G. An MRI has been performed but is NOT suggestive of multiple sclerosis (no 

evidence of lesion). 

17



AVONEX 

(Continued) 

H. The patient will be receiving Avonex® therapy in combination with interferonbeta 

therapy (e.g., Rebif® or Betaseron®), Copaxone® or mitoxantrone. 

I. If the patient has received previous Avonex® therapy and he/she cannot show a 

decrease in the frequency of clinical relapses or slowing in the progression of the 

disease or a decrease in the lesions on MRI or stability of the disease. 




Neurologist 


Plan Year 

18


Azathioprine is indicated: 

A. Kidney rejection prophylaxis 

B. Rheumatoid arthritis 



AZATHIOPRINE 


Azathioprine is covered for members who meet the following criteria: 

A. Patient is diagnosed with Rheumatoid Arthritis 

a. Failure to 3 months therapy of NSAIDs 

B. Kidney Transplant Prophylaxis 

a. Coverage of Kidney transplant is not covered or was not covered by 

Medicare Part B 

NON COVERAGE 

Azathioprine is NOT covered for members with the following criteria: 

A. Kidney transplantation or other form of transplant surgery was covered by 

Medicare Part B. 


INFORMATION 



Plan Year 

19



BANZEL 


Banzel® is indicated: 

A. For treatment of Lennox-Gastaut syndrome 


Banzel® is covered for members who meet the following criteria: 

A. Patient must be diagnosed with Lennox-Gastaut Syndrome 

B. Patient must be 4 years old or greater. 

NON COVERAGE 

Banzel® is NOT covered for members with the following criteria: 

A. Diagnosis is NOT Lennox-Gastaut Syndrome 

B. Patient is less than 4 years old 

C. Patient is diagnosed with Familial Short QT Syndrome 


INFORMATION 



Plan Year 

20



BETASERON 


Betaseron® is indicated: 

A. For the treatment of relapsing forms of multiple sclerosis to reduce the frequency 

of clinical exacerbations. Patients with multiple sclerosis in whom efficacy has 

been demonstrated include patients who have experienced a first clinical episode 

and have MRI features consistent with multiple sclerosis. 


Betaseron® is covered for members who meet the following criteria: 


specialty. 


(Betaseron® does not have the indication for primary progressive, secondary 





the resolution of the first deficit. AND an MRI has been performed and is 

suggestive of multiple sclerosis (evidence of lesion). 

D. AND the patient will NOT be receiving Betaseron® therapy in combination with 

interferon-beta therapy (e.g., Rebif®, or Avonex®), Copaxone® or mitoxantrone. 

(Please verify that the patient is not on duplicate therapy by reviewing the 

patient’s drug history or chart). 

E. AND if the patient has received previous Betaseron® therapy, the provider can 



have diminished after initiation of therapy. 

NON COVERAGE 

Betaseron® is NOT covered for members with the following criteria: 

A. A.The prescribing provider is NOT a neurologist or the prescribing provider has 


B. B.The diagnosis is NOT documented as Relapsing-Remitting Multiple Sclerosis. 









21



BETASERON 

(Continued) 

H. The patient will be receiving Betaseron® therapy in combination with interferonbeta 

therapy (e.g., Rebif® or Avonex®), Copaxone® or mitoxantrone. 

I. If the patient has received previous Betaseron® therapy and he/she cannot show a 






Neurologist 


Plan Year 

22



BUPHENYL 


Buphenyl® is indicated: 

A. Argininosuccinic acid synthease deficiency 

B. Carbamoyl Phosphate synthetase deficiency 

C. Ornithine Transcarbamoylase deficiency 


Buphenyl® is covered for members who meet the following criteria: 

A. Buphenyl® is used to treat urea cycle disorders diagnosed by FDA approved 

indications as stated above 

NON COVERAGE 

Buphenyl® is NOT covered for members with the following criteria: 

A. To treat hyperammonemia 






Plan Year 

23



BYETTA 


Byetta® is indicated: 

A. For adjunctive therapy to improve glycemic control in patients with type-2 

diabetes mellitus who are taking metformin, a sulfonylurea, a thiazolidinedione, a 

combination of metformin and a sulfonylurea, or a combination of metformin and 

a thiazolidinedione, but have not achieved adequate glycemic control. 


Byetta® is covered for members who meet the following criteria: 

A. The patient is diagnosed as having type-2 diabetes. 

B. AND the patient has an HbA1c level greater than 7. 

C. AND the patient’s current drug therapy includes metformin (eg. Metformin, 

Avandiamet®, or ActoPlus Met®) and therapy has been escalated to the highest 

tolerated dose, (Please verify that the patient has received metformin therapy by 

reviewing the patient’s drug history). OR if the patient is unable to take 

metformin due to clinical contraindications they can substitute the metformin 

requirement with a maximum tolerated dose of a sulfonylurea (chorpropramide, 

tolazamide, glipizide, glimepiride, or glyburide). 

D. AND the patient’s current drug therapy includes a thiazolidnedione (eg. 

Avandia®, Avandiamet®, Actos® or ActoPlus Met®) and therapy has been 

escalated to the highest tolerated dose. (Please verify that the patient has received 

thiazolidnedione therapy by reviewing the patient’s drug history). 

E. AND the patient has a creatinine clearance of greater than 30 ml/minute or normal 

kidney function. 

F. AND the patient does NOT have severe GI disease. 

G. AND the patient does NOT have gastroparesis. 

H. AND evidence of diagnosis and HbA1c is documented in the patient’s chart notes 

provided by the prescribing provider. 

I. AND if the patient has received previous Byetta® therapy, the physician must 

show a documented reduction in the patient’s HbA1c since initiating Byetta® 

therapy. 

24



BYETTA 

(Continued) 

NON COVERAGE 

Byetta® is NOT covered for members who meet the following criteria: 

A. The patient has NOT been diagnosed as having type-2 diabetes. 

B. The patient has an HbA1c level less than 7. 

C. The patient’s current drug therapy does NOT include metformin (eg. Metformin, 

Avandiamet®, or ActoPlus Met®) and therapy has NOT been escalated to the 

highest tolerated dose, (Please verify that the patient has received metformin 

therapy by reviewing the patient’s drug history). OR if the patient is unable to 

take metformin due to clinical contraindications they have NOT substituted the 

metformin requirement with a maximum tolerated dose of a sulfonylurea 

(chorpropramide, tolazamide, glipizide, glimepiride, or glyburide). 

D. The patient’s current drug therapy does NOT include a thiazolidnedione (eg. 

Avandia®, Avandiamet®, Actos® or ActoPlus Met®) and therapy has NOT been 

escalated to the highest tolerated dose. (Please verify that the patient has 

received thiazolidnedione therapy by reviewing the patient’s drug history). 

E. The patient has a creatinine clearance of less than 30 ml/minute. 

F. The patient has severe GI disease. 

G. The patient has gastroparesis. 

H. No evidence of diagnosis or HbA1c is documented in the patient’s chart notes 

provided by the prescribing provider. 

I. If the patient has received previous Byetta® therapy, and the physician has NOT 

shown a documented reduction in the patient’s HbA1c since initiating Byetta® 

therapy. 

J. Diagnosis is documented as weight loss. 

K. Diagnosis is documented as type-1 diabetes. 

L. Diagnosis is documented as ketoacidosis. 


INFORMATION 



Plan Year 

25


Campath® is indicated: 

A. Chronic Lymphocytic Leukemia 



CAMPATH 


Campath® is covered for members who meet the following criteria: 

A. Campath® is approved for the diagnosis of Chronic Lymphocytic Leukemia 

B. AND if the medication meets B vs. D determination that the medication should be 

covered by Medicare Part D 

NON COVERAGE 

Campath® is NOT covered for members with the following criteria: 

A. To treat non-FDA indications 




Oncologist 


Plan Year 

26



CAMPRAL DELAYED-RELEASE TABLETS 


Campral® delayed-release tablets are indicated for maintenance of abstinence from 

alcohol in patients with alcohol dependence that are abstinent at treatment initiation. 


Campral® delayed-release tablets are covered for members who meet the following 

criteria: 

A. Clinical diagnosis for alcohol dependence 

B. AND clinical evidence indicated that the consumer will be abstinent at least 5 

days prior treatment initiation. 

C. AND a trial of naltrexone (oral/injectable) has been attempted, at clinically 

significant dosage and duration. Or therapy is documented to be clinically 

inappropriate (hepatic insufficiency, chronic pain medication use). 

D. AND medication administration should be part of a comprehensive psychosocial 

treatment program. 

NON COVERAGE 

Campral® delayed-release tablets are NOT covered for members with the following 

criteria: 

A. For patients who cannot reach abstinence prior to therapy initiation 


INFORMATION 



6 months 

27


Camptosar® is indicated: 

A. Colorectal Cancer 



CAMPTOSAR 


Camptosar® is covered for members who meet the following criteria: 

A. Camptosar® is approved for the diagnosis of Colorectal Cancer 

B. AND if the medication meets B vs. D determination that the medication should be 


NON COVERAGE 

Camptosar® is NOT covered for members with the following criteria: 

A. To treat non-FDA indications 




Oncologist 


Plan Year 

28



CARIMUNE 


Immune Globulin is indicated: 

A. For the treatment of primary immunodeficiency 

B. For the treatment of idiopathic thrombocytopenic purpura 

C. For the treatment of Kawasaki disease 


Immune Globulin is covered for members who meet the following criteria: 

A. Verify B vs. D criteria per CMS guidelines 

a. Treatment of hypergammaglobulinemia 

B. AND the patient is diagnosed with primary immunodeficiency 

C. OR the patient is diagnosed with idiopathic thrombocytopenic purpura 

D. OR the patient is diagnosed with Kawasaki disease 

NON COVERAGE 

Immune globulin is NOT covered for members who meet the following criteria: 

A. Medication is covered by Part B per CMS guidelines 

B. The diagnosis is NOT hypergammaglobulinemia, primary immunodeficiency, OR 

Kawasaki disease 


INFORMATION 



6 months 

29



CELLCEPT 


Cellcept® is indicated: 

A. Heart Transplant Rejection Prophylaxis 

B. Kidney Transplant Rejection Prophylaxis 

C. Liver Transplant Rejection Prophylaxis 


Cellcept® is covered for members who meet the following criteria: 

A. If the patient is female and of childbearing years, she is NOT pregnant, has NO 

plans for pregnancy and has been educated on the potential dangers of Cellcept® 

therapy. 

B. AND diagnosis is documented as the prophylaxis of organ rejection in a patient 

receiving or received an organ transplant. 

C. AND the transplant was NOT covered by Medicare Part A/B. (Please verify the 

payer of the transplant. If Medicare paid for the transplant, Cellcept® is covered 

by Medicare Part A/B). 

D. AND approval can be allowed for up to one year. 

NON COVERAGE 

Cellcept® is NOT covered for members with the following criteria: 

A. Hypersensitivity to Mycophenolate 

B. The patient is female and of childbearing years and is pregnant or has plans for 

pregnancy. 

C. The diagnosis is NOT documented as prophylaxis of organ rejection after 

receiving an organ transplant or a compendia listed indication. 

D. The transplant was paid for by Medicare Part A/B 


INFORMATION 



Plan Year 

30


Ceredase® is indicated: 

A. Gaucher’s disease 



CEREDASE 


Ceredase® is covered for members who meet the following criteria: 

A. Patient has documented diagnosis of Gaucher’s disease 

B. AND can not tolerate Imiglucerase therapy 

C. AND B vs. D criteria is determined that this medication should be paid for by 

Medicare Part D 

NON COVERAGE 

Ceredase® is NOT covered for members with the following criteria: 

A. Patients who can tolerate Imiglucerase therapy 

B. When therapy is covered by Medicare Part B 


INFORMATION 



Plan Year 

31



CEREZYME 


Cerezyme® is indicated: 

A. For long-term enzyme replacement therapy for pediatric and adult patients with a 

confirmed diagnosis of type-1 Gaucher disease that results in one or more of the 

following conditions: Anemia, thrombocytopenia, bone disease, hepatomegaly or 

splenomegaly. 


Cerezyme® is covered for members who meet the following criteria: 

A. Diagnosis is documented as mild-to-moderate type-1 Gaucher disease. 

B. AND diagnosis has been confirmed by bone marrow histology, DNA testing or 

measurement of b-glucocerebrosidase enzyme activity less than 30%. 

C. AND the patient has at least one of the following conditions: Anemia, 

thrombocytopenia, bone disease, hepatomegaly or splenomegaly. 

D. AND if the patient has previously received 24 months of Cerezyme® therapy, 

they must show a decrease in liver and spleen volume and/or increases in platelet 

count and/or increases in hemoglobin concentration since starting therapy. 

NON COVERAGE 

Cerezyme® is NOT covered for members with the following criteria: 

A. The diagnosis is NOT documented as mild-to moderate type-1 Gaucher disease. 

B. Diagnosis has NOT been confirmed by bone marrow histology, DNA testing or 

measurement of enzyme activity. 

C. The patient does not have at least one of the following conditions: Anemia, 

thrombocytopenia, bone disease, hepatomegaly or splenomegaly. 

D. If the patient has previously received 24 months of Cerezyme® therapy and they 

have NOT shown a decrease in liver and spleen volume and/or increases in 

platelet count and/or increases in hemoglobin concentration since starting therapy. 






Plan Year 

32



CIMZIA 


Cimzia® is indicated: 

A. For treatment of moderately to severely active Crohn’s disease to reduce signs 

and symptoms and to maintain clinical response in patient who have an 

inadequate response to conventional therapy. 


Cimzia® is covered for members who meet the following criteria: 

A. Verification of B vs D criteria per CMS guidelines 

B. Patient has NO history of auto immune disease, recurring infections, heart failure, 

immuno suppression or malignancies. 

C. AND the diagnosis is documented as Crohn’s Disease 

D. AND the patient has tried, failed and/or had an inadequate response to a 60-day 

trial of at least two Crohn’s disease conventional therapies that may include the 

following: Sulfazalazine, Azulfidine®, balsalazide, Colazal®, mesalamine, 

Asacol®, Canasa®, Lialda®, Pentasa®, Rowasa®, azathioprine, Imuran®, 

cyclosporine, Neoral®, Sandimmune®, Gengraf®, methotrexate, mercaptopurine, 

or Purinethol®. 

E. OR if the patient has received previous Cimzia® therapy, the patient must see an 

improvement in clinical symptoms that can include reduced abdominal pain, 

diarrhea, cramps, and/or fistulas. 

F. AND the patient will NOT receive combination therapy with other biologic 

and/or retinoid therapy. (Eg. Enbrel®, Humira®, Remicade®, Kineret®, 

Orencia®, Soriatane® Tysabri®, Raptiva® and Rituxan®. (Please verify that the 

patient is not on duplicate therapy by reviewing the patient’s drug history or 

chart). 

G. AND evidence of diagnosis, previous failed therapy, or clinical improvement is 

documented in patient’s chart notes provided by prescribing provider. 

NON COVERAGE 

Cimzia® is NOT covered for members with the following criteria: 

A. Medication is paid for by Part B 

B. Patient has a history of auto immune disease, recurring infections, heart failure, 


C. The prescribing provider is NOT a gastroenterologist or obtained a consult from 

the listed specialty. 

D. The diagnosis is NOT documented as severe Crohn’s disease 

E. The diagnosis is listed as ulcerative colitis. 

F. The patient has NOT failed at least two 60-day conventional drug regimens. 

G. If the patient is receiving combination therapy that includes any one of the 

following medications: Enbrel®, Humira®, Remicade®, Tysabri®, Kineret®, 

Orencia®, Soriatane® or Rituxan®. 

33



CIMZIA 

(Continued) 

H. If the patient has received previous Cimzia® therapy and the provider has NOT 

shown an improvement in clinical symptoms. 

I. Evidence of diagnosis, previous failed therapy and symptoms are NOT 

documented in patient’s chart notes provided by the prescribing provider. 


Chart notes documenting previous trial failure of at least TWO of the following: 

Sulfazalazine, Azulfidine®, balsalazide, Colazal®, mesalamine, Asacol®, Canasa®, 

Lialda®, Pentasa®, Rowasa®, azathioprine, Imuran®, cyclosporine, Neoral®, 

Sandimmune®, Gengraf®, methotrexate, mercaptopurine, or Purinethol®. 


Patient must be 18 years of age or greater 


Gastroenterologist 


Plan Year 

34


Cladribine is indicated: 

A. Hairy Cell Leukemia 



CLADRIBINE 


Cladribine is covered for members who meet the following criteria: 

A. Patient is diagnosed with Hairy Cell Leukemia 

B. AND is being diagnosed by an Oncologist 

C. AND the medication meets B vs. D determination criteria that authorized 

coverage to Medicare Part D 

NON COVERAGE 

Cladribine is NOT covered for members with the following criteria: 

A. Non FDA approved indications 

REQUIREDMEDICAL INFORMATION 



Oncologist 


7 days 

35


Amnesteem® is indicated: 

A. Acne Vulgaris 

B. Cystic Acne 



CLARAVIS 


Amnesteem® is covered for members who meet the following criteria: 

A. For the treatment of Acne Vulgaris and Cystic Acne 

B. AND Prescribed by a dermatologist 

C. AND documentation of failure oral antibiotics for 3 months 

D. AND documentation of failure of topical acne preparations for 3 months (benzoyl 

peroxide, topical tretinoin cream, topical antibiotics) 

E. AND in female patients a negative pregnancy test, mother is not breast feeding, or 

intentions of pregnancy 

F. AND No history of depression 

NON COVERAGE 

Amnestem® is NOT covered for members with the following criteria: 


B. Women who are or may become pregnant, or breast feeding 

C. History of depression 

D. Hypersensitivity to retenoids 




Dermatologist 


20 months 

36



COLONY STIMULATING FACTOR 


Colony Stimulating Factor is indicated: 

A. Chemotherapy Induced Neutropenia 

B. Febrile Neutropenia 

C. Neutropenia 

D. Peripheral Blood Stem Cell Mobilization 


Colony Stimulating Factor is covered for members who meet the following criteria: 

A. Patient is diagnosed with approved indication as stated above 

B. AND lab values indicate necessity for therapy (Chart Notes required to 

substantiate need) 

C. AND B vs. D criteria indicates that coverage should be through Medicare Part D 

NON COVERAGE 

Colony Stimulating Factor is NOT covered for members with the following criteria: 

A. Inadequate chart notes to substantiate need for Colony Stimulating Factor 




Oncologist 


3 months 

37



COPAXONE 


Copaxone® is indicated: 

A. For reduction of the frequency of relapses in patients with Relapsing-Remitting 

Multiple Sclerosis. 

B. All other FDA approved indications not otherwise excluded from Part D. 


Copaxone® is covered for members who meet the following criteria: 


specialty. 


(Copaxone® does not have the indication for primary progressive, secondary 





the resolution of the first deficit. 

D. AND the patient will NOT be receiving Copaxone® therapy in combination with 

interferon-beta therapy (e.g., Rebif®, Avonex®, or Betaseron®) or mitoxantrone. 

(Please verify that the patient is not on duplicate therapy by reviewing the 


E. AND if the patient has received previous Copaxone® therapy, the provider can 



have diminished after initiating therapy. 

NON COVERAGE 

Copaxone® is NOT covered for members with the following criteria: 

A. The prescribing provider is NOT a neurologist or the prescribing provider has 


B. The diagnosis is NOT documented as Relapsing-Remitting Multiple Sclerosis. 









H. The patient will be receiving Copaxone® therapy in combination with interferonbeta 

therapy (e.g., Rebif®, Avonex®, or Betaseron®) or mitoxantrone. 

38



COPAXONE 

(Continued) 

I. If the patient has received previous Copaxone® therapy and he/she cannot show a 




Chart Notes 


Neurologist 


Plan Year 

39



CYCLOPHOSPHAMIDE 


Cyclophosphamide is indicated: 

A. Acute Lymphocytic Leukemia 

B. Acute Myelogenous Leukemia 

C. Breast Cancer 

D. Burkitt’s Lymphoma 

E. Chronic Lymphocytic Leukemia 

F. Chronic Myelogenous Leukemia 

G. Cutaneous T-Cell Lymphoma 

H. Hodgkin’s Disease 

I. Multiple Myeloma 

J. Mycosis Fungoides 

K. Nephrotic Syndrome 

L. Neuroblastoma 

M. Non-Hodkin’s Lymphoma 

N. Ovarian Cancer 

O. Retinoblastoma 

P. Malignant histiocytosis 

Q. All other FDA approved 

indications not otherwise 

excluded from Part D 


Cyclophosphamide is covered for members who meet the following criteria: 

A. Patient is diagnosed with FDA indicated diagnosis as described above 

B. AND the medication meets B vs. D determination criteria that authorized 


NON COVERAGE 

Cyclophosphamide is NOT covered for members with the following criteria: 





Oncologist 


Initial authorization: 1 month 

40



CYCLOSPORINE 


Cyclosporine is indicated: 

A. Heart Transplant Prophylaxis 

B. Kidney Transplant Prophylaxis 

C. Liver Transplant Prophylaxis 

D. Psoriasis 

E. Rheumatoid Arthiritis 

F. All other FDA approved indications not otherwise excluded from Part D 


Cyclosporine is covered for members who meet the following criteria: 

A. Approved for all prophylaxis diagnoses as described above (Heart, Kidney, Liver) 

B. AND prescribed by Transplant Surgeon 

C. AND B vs. D determination has been established that medication should be 


D. If diagnosis of Psoriasis must be diagnosed by a Dermatologist 

E. AND documented failure to at least two different topical steroids 

NON COVERAGE 

Cyclosporine is NOT covered for members with the following criteria: 





Oncologist 


Plan Year 

41


Cyklokapron® is indicated: 

A. Bleeding Prophylaxis 

B. Dysfunctional Uterine Bleeding 

C. Hemophilia A/B 

D. Hemorrhage 



CYKLOKAPRON 


Cyklokapron® is covered for members who meet the following criteria: 

A. Patient is diagnosed with FDA approved indications as stated above 

B. AND the patient meets B vs. D determination that requires Medicare Part D 

payment 

NON COVERAGE 

Cyklokapron® is NOT covered for members with the following criteria: 

B. Non-FDA approved indications 


INFORMATION 



1 month 

42



CYTARABINE 


Cytarabine is indicated: 

A. Acute Lymphocytic Leukemia 

B. Acute Myelogenous Leukemia 

C. Carcinomatous meningitis 

D. Chronic Myelogernous Leukemia 

E. All other FDA approved indications not otherwise excluded from Part D 


Cytarabine is covered for members who meet the following criteria: 

A. Patient is diagnosed with FDA approved indications as stated above 

B. AND medication is being prescribed by an Oncologist 

C. AND patient does not have an active infection 

D. AND the patient meets B vs. D determination that requires Medicare Part D 

payment 

NON COVERAGE 

Cytarabine® is NOT covered for members with the following criteria: 

A. Non-FDA approved indications 




Oncologist 


Plan Year 

43


Dacogen® is indicated for: 

A. Myelodysplastic Syndrome 



DACOGEN 


Dacogen® is covered for members who meet the following criteria: 

A. Patient is diagnosed with Myelodysplastic Syndrome 

B. AND medication is prescribed by an Oncologist 

C. AND B vs. D criteria is met to ensure coverage should be through Medicare Part 

D. 

NON COVERAGE 

Dacogen® is NOT covered for members with the following criteria: 


B. Patient is pregnant 

C. Children 




Oncologist 


24 weeks 

44



DUREZOL 


Durezol® is indicated: 

A. For treatment of postoperative ocular pain 

B. For treatment of postoperative ocular inflammation 


Durezol® is covered for members who meet the following criteria: 

A. Prescribed by Ophthalmologist 

B. Must be used for postoperative ocular pain OR postoperative ocular inflammation 

NON COVERAGE 

Durezol® is NOT covered for members with the following criteria: 

A. Prescribed by non-ophthalmologist 

B. Used for non-postoperative treatment 


Opthalmologist 


INFORMATION 

Chart notes per Covered Uses 


4 weeks 

45


Elaprase® is indicated: 

A. Hunter Syndrome 



ELAPRASE 


Elaprase is covered for members who meet the following criteria: 

A. Approve only for patients diagnosed with mucopolysaccharidosis II (Hunter 

Syndrome) 

NON COVERAGE 

Elaprase® is NOT covered for members with the following criteria: 







Plan Year 

46


Elidel® is indicated: 

A. Atopic dermatitis (eczema) 



ELIDEL 


Elidel® is covered for members who meet the following criteria: 

A. Diagnosis is documented as atopic dermatitis or eczema 

B. The prescribing physician is a dermatologist 

C. The patient is age 2 or older 

D. Patients greater than 12 years of age have completed a documented trial and 

failure of first-line agents including high potency topical steroids or have 

documented intolerance or unresponsiveness to high potency topical steroids. 

E. The patient is not immunocompromised 

NON COVERAGE 

Elidel® is NOT covered for members who meet the following criteria: 

A. The documented diagnosis is NOT atopic dermatitis or eczema 

B. The prescribing physician is NOT a dermatologist 

C. The patient is less than 2 years old 

D. Patients greater than 12 years of age who have NOT completed a documented 

trial and failure of first-line agents including high potency steroids 

E. The patient is immunocompromised 

F. The patient has used Elidel® for 6 weeks or more without improvement 




Dermatologist 


Plan Year 

47



ELIGARD 

FDA APPROVED FOR 

Eligard® is indicated: 

A. For the palliative treatment of advanced prostate cancer, particularly when 

orchiectomy or estrogen therapy are not indicated or are unacceptable 

B. For the management of endometriosis including pain relief and reduction of 

endometriotic lesions 

C. For the treatment of central precocious puberty (idiopathic or neurogenic) in 

children less than 8 or 9 years old 

D. For the preoperative treatment of anemia due to uterine leiomyomata (fibroids) in 

combination with iron supplementation when iron therapy alone fails to correct 

the anemia 


Eligard® is covered for members who meet the following criteria: 

A. The documented diagnosis is one of the FDA approved indications listed above. 

B. If the diagnosis is advanced prostate cancer, orchiectomy or estrogen therapy are 

documented as unacceptable. 

C. If the diagnosis is endometriosis the patient has completed documented trial and 

failures of oral contraceptives, medroxyprogesterone, and Danazol 

D. If the diagnosis is precocious puberty, patient must be less than 9 years old 

E. AND verification of all B vs. D criteria indicate coverage by Part D 

NON COVERAGE 

Eligard® is NOT covered for members with the following criteria: 

A. If there is not a documented diagnosis as listed under the FDA-approved 

indications above. 


not indicated for are unacceptable. 

C. If the diagnosis is endometriosis, the patient has completed a documented trial 

and failure of oral contraceptives, medroxyprogesterone, and Danazol. 

D. If the diagnosis is precocious puberty, the patient must be less than 9 years old at 

beginning of treatment. Treatment should be discontinued before age 11 for 

females and age 12 for males. 

E. If the patient is female and she is pregnant, has plans for pregnancy or has NOT 

been educated on the potential dangers of Lupron® therapy in pregnancy. 




Oncologist 


6 months 

48



ELITEK 


Elitek® is indicated: 

A. For the prevention of hyperuricemia in patients with leukemia, lymphoma, or 

solid tumor malignancies who are receiving anti-cancer therapy expected to result 

in tumor lysis 


Elitek® is covered for members who meet the following criteria: 

A. The prescribing physician is a board certified oncologist. 

B. AND the use is documented as prevention of hyperuricemia 

C. AND the patient has leukemia, lymphoma or a solid tumor malignancy 

D. AND the patient is receiving chemotherapy expected to result in tumor lysis 


NON COVERAGE 

Elitek® is NOT covered for members who meet the following criteria: 

A. The prescribing physician is NOT a board certified oncologist 

B. The use is NOT documented as prevention of hyperuricemia 

C. The patient does NOT have leukemia, lymphoma or a solid tumor malignancy 

D. The patient is NOT receiving chemotherapy expected to result in tumor lysis 




Oncologist 


Plan Year 

49



ELOXATIN 


Eloxatin® is indicated: 

A. For the treatment of stage III colon cancer patients who have undergone complete 

resection of the primary tumor 

B. For the treatment of advanced colorectal cancer 


Eloxatin® is covered for members who meet the following criteria: 


B. AND if the patient is female and of childbearing years, she is NOT pregnant, has 

NO plans for pregnancy and has been educated on the potential dangers of 

Eloxatin® therapy in pregnancy. 

C. AND the diagnosis is documented as treatment for stage III colon cancer and the 

patient has undergone complete resection of the primary tumor, or advanced 

colorectal cancer. 

D. AND Eloxatin® is to be administered with infusional 5-fluorouracil and 

leucovorin. 

NON COVERAGE 

Eloxatin® is NOT covered for members who meet the following criteria: 

A. The prescribing physician is NOT a board certified oncologist or nephrologist. 

B. If the patient is female and she is pregnant, has plans for pregnancy or has NOT 

been educated on the potential dangers of Eloxatin ® therapy in pregnancy. 

C. The diagnosis is NOT documented as treatment for stage III colon cancer and the 

patient has undergone complete resection of the primary tumor, or advanced 

colorectal cancer. 

D. Eloxatin® is NOT administered with infusional 5-fluorouracil and leucovorin. 




Oncologist 


Plan Year 

50


Emend® is indicated: 

A. Nausea/Vomitting 



EMEND 


Emend® is covered for members who meet the following criteria: 

A. Documented trial and failure to Ondansetron 

B. Part B will be billed if the medication is being used for cancer treatment and as a 

“full replacement” of intravenous administration within 48 hours of cancer 

treatment and 

C. The physical prescription written by the prescriber states: “As a full therapeutic 

replacement for an intravenous anti-emetic drug as part of a cancer 

chemotherapeutic regiment.” 

D. If the requirements in Step A and B are verified then 48 hours of therapy will be 

billed to Part B. 

E. If the requirements in Step 1 and 2 are not met, 48 hours past the administration 

of chemotherapy, or the initial 48 hours supply has been dispensed then the 

medication will be billed to Part D. 

Emend must also meet the above criteria and the following to be covered under Part B: 

A. Administered in combination with a 5HT 3 Antagonist (Zofran, Kytril, Anzemet) 

and dexamethasone. 

B. Beneficiary has received one or more of the following chemotherapeutic agents: 

a. Carmustine (BiCNU) 

b. Cisplatin (Platinol) 

c. Cyclophosphamide 

(Cytoxan) 

d. Dacarbazine (DTIC- 

Dome) 

NON COVERAGE 

Emend® is NOT covered for members with the following criteria: 


B. Nausea from non-oncologic related conditions or medications 

C. Has not had trial and failure to Ondansetron 



e. Mechlorethamine 

(Mustargen) 

f. Streptozocin (Zanosar) 

g. Doxorubicin 

(Adriamycin) 

h. Epirubicin (Ellence) 

i. Lomustine (CeeNu) 


Oncologist 


6 months 

51



EMSAM 


EMSAM® is indicated for: 

A. The treatment of major depressive disorder. 

B. All other FDA approved indications not otherwise excluded from Part D 


EMSAM® is covered for members who meet the following criteria: 

A. Clinical diagnosis of major depressive disorder not responsive other 

antidepressants 

B. At least 2 documented trials (clinically sufficient dose and duration) of the 

following: Selective Serotonin Reuptake Inhibitors (SSRI), 

Serotonin/Norepinephrine Reuptake Inhibitors (SNRI), bupropion, mirtazapine, or 

tricyclic/tetracyclic antidepressants 

C. Clinical diagnosis of major depressive disorder for those patients who cannot take 

any oral preparations (including commercially available liquid antidepressants). 

D. For requests over 6mg/24 hours, patient must agree to adhere to a tyramine 

restrictive diet. 

NON COVERAGE 

EMSAM® is NOT covered for members with the following criteria: 

A. Recent pharmacy claims of the following, unless provider can document an 

appropriate medication discontinuation date. 

a. At least 4-5 half-lives (approximately 1 week) for the following 

medication and their active metabolites: SSRIs, SNRIs, TCAs, MAOIs, 

meperidine, other analgesics (tramadol, methadone, and propoxyphene), 

dextromethorphan, St.John’s wort, mirtazapine, bupropion, or buspirone. 

b. Claims within 5 weeks for fluoxetine. 

B. Concurrent selegiline treatment. 




Psychiatrist 


Plan Year 

52



ENBREL 


Enbrel® is indicated: 

A. For reducing signs and symptoms in patients with active ankylosing spondylitis. 

B. For the treatment of adult patients (18 years or older) with chronic moderate to 

severe plaque psoriasis who are candidates for systemic therapy or phototherapy. 

C. For reducing signs and symptoms of moderately to severely active polyarticularcourse 

juvenile rheumatoid arthritis (JRA) in patients who have had an inadequate 

response to 1 (one) or more disease-modifying antirheumatic drugs (DMARD). 

D. For reducing signs and symptoms, inducing major clinical response, inhibiting the 

progression of structural damage, and improving physical function in patients 

with moderately to severely active rheumatoid arthritis. Enbrel® can be initiated 

in combination with methotrexate (MTX) or used alone. 

E. For reducing signs and symptoms, inhibiting the progression of structural damage 

of active arthritis, and improving physical function in patients with psoriatic 

arthritis. Enbrel® can be used in combination with methotrexate in patients who 

do not respond adequately to methotrexate alone. 


Enbrel® is covered for members who meet the following criteria: 

A. Patient has NO history of auto immune disease, recurring infections, heart failure, 


B. AND the prescribing provider is a rheumatologist, dermatologist, orthopedist or 

has obtained a consult from the listed specialties. 

C. AND diagnosis is documented as moderate to severe active rheumatoid arthritis. 

a. AND the patient has at least four (4) of the following symptoms: 

i. Morning stiffness. 

ii. Arthritis of three (3) or more joint areas. 

iii. Arthritis of hand joints. 

iv. Symmetric arthritis. 

v. Rheumatoid nodules. 

vi. Serum rheumatoid factor. 

vii. Radiographic changes. 

b. AND the patient has had at least an 8-week maximum tolerated dose trial 

and failure to at least two 2 of the following DMARDS listed: 

Methotrexate, cyclosporine, Neoral®, Samdimmune®, Gengraf®, 

azathioprine, Imuran®, penicillamine, Cuprimine®, Depen®, 

sulfasalazine, Azulfidine®, leflunomide, Arava®, gold sodium thiomalate, 

Aurolate®, aurothioglucose, Solganal®, auranofin, Ridaura®, 

hydroxychoroquine, Plaquenil®. (Verification can be made by reviewing 

the patient’s drug history or patient’s chart). 

53



ENBREL 

(Continued) 

c. AND if the patient has received previous Enbrel® therapy, the provider 

must show an improvement in clinical symptoms that may include 

improvement in tender and swollen joint count, mobility, stiffness or delay 

in progression of disease. 

D. OR the diagnosis is juvenile rheumatoid arthritis. 

a. AND the age of the patient is 17 years old or less. 

b. AND the patient has had at least a 6-week duration of persistent arthritis in 

one or more joints. 

c. AND the patient has had at least an 8-week maximum tolerated dose trial 

and failure to at least two(2) of the following DMARDS listed: 

Methotrexate, cyclosporine, Neoral®, Samdimmune®, Gengraf®, 






d. AND if the patient has received previous Enbrel® therapy, the provider 




E. OR the diagnosis is documented as psoriatic arthritis. 

a. AND the patient has at least one of the following symptoms: 

i. Three (3) or more swollen joints. 

ii. Three (3) or more tender joints. 


and failure to at least two (2) of the following DMARDS listed: 

(methorexate, cyclosporine, Neoral®, Sandimmune®, Gengraf®, 




hydroxychoroquine, Plaquenil®) if methotrexate is contraindicated. 

(Verification can be made by reviewing the patient’s drug history or 

patient’s chart). 

c. AND if the patient has received previous Enbrel® therapy, the provider 




54



ENBREL 

(Continued) 

F. OR the diagnosis is documented as active ankylosing spondylitis. 

a. AND the patient has tried and failed at least a 60-day trial of at least two 

non-steroidal anti-inflammatory (NSAID) drugs that can include any two 

of the following medications: Diclofenac, etodolac, fenoprofen, 

flurbiprofen, ibuprofen, indomethacin, celecoxib, Celebrex®, ketoprofen, 

meclofenamate, nabumetone, naproxen, oxaprozin, piroxicam, sulinidac, 

or tolmetin. (Please verify that the patient has received NSAID therapy by 

reviewing the patient’s drug history). 

b. AND if the patient has received previous Enbrel® therapy, the provider 




G. OR the diagnosis is documented as chronic moderate to severe plaque psoriasis. 

a. AND the patient has had the disease for 1 year or greater. 

b. AND the patient’s age is 18 years old or older. 

c. AND the involvement of plaque psoriasis is 10% or greater of the patient’s 

total body surface area (BSA) OR if the BSA is less than 10%, the plaque 

psoriasis must involve areas that will prevent the patient from performing 

crucial daily functions such as walking (eg. feet). 

d. AND the patient has tried and failed at least a 60-day trial of three (3) 

conventional therapies that may include any of the following: 

i. High potency topical steroid treatment. 

ii. Calcipotriene (Dovenex®) 

iii. Phototherapy. 

iv. Retinoids (Soriatane®) 

v. Methotrexate. 

vi. Cyclosporine. 

e. AND If this is the initial plaque psoriasis request for Enbrel®, 50 mg 

twice a week therapy is ONLY approved for 3 months. OR if the patient 

has received Enbrel® therapy for greater than three(3) months, the patient 

must see a significant reduction in plaque thickness, erythemia, 

desquamation and affected body surface area. AND therapy is only 

allowed 50 mg once a week. (Please verify patient’s chart notes to verify 

clinical improvement). 

f. AND the patient will NOT receive combination therapy with other 

biologic and retinoid therapy. (Eg. Humira®, Remicade®, Kineret®, 

Orencia®, Soriatane®, Raptiva® and Rituxan®. (Please verify that the 

patient is not on duplicate therapy by reviewing the patient’s drug history 

or chart). 

g. AND evidence of diagnosis, previous failed therapy or clinical 

improvement is documented in patient’s chart notes provided by 

prescribing provider. 

55



ENBREL 

(Continued) 

NON COVERAGE 

Enbrel® is NOT covered for members with the following criteria: 

A. The diagnosis is NOT documented as severe active rheumatoid arthritis, juvenile 

rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or chronic 

moderate to severe plaque psoriasis. 

B. The diagnosis is listed as Crohn’s Disease or ulcerative colitis. 

C. If the diagnosis is listed as severe active rheumatoid arthritis, the patient does 

NOT have four of the listed symptoms. 

D. If the diagnosis is listed as severe active rheumatoid arthritis, the patient has NOT 

failed two 8-week maximum tolerated DMARD trials. 

E. If the diagnosis is juvenile rheumatoid arthritis and the patient is over the age of 

17 years old. 

F. If the diagnosis is juvenile rheumatoid arthritis and the patient has NOT had at 

least a 6-week duration of persistent arthritis on one or more joints. 

G. If the diagnosis is juvenile rheumatoid arthritis and the patient has NOT failed a 

two 8-week maximum tolerated DMARD trials. 

H. If the diagnosis is psoriatic arthritis and the patient does NOT have three swollen 

joints or three tender joints. 

I. If the diagnosis is psoriatic arthritis and the patient has NOT failed two 8-week 

maximum tolerated DMARD trials. 

J. If the diagnosis is ankylosing spondylitis and the patient has NOT failed two 60- 

day NSAID drug regimens. 

K. If the diagnosis is chronic moderate to severe plaque psoriasis and the patient has 

NOT had the disease for 1 year or greater. 

L. If the diagnosis is chronic moderate to severe plaque psoriasis and the 

involvement is less than 10% of body surface area or does NOT involve an area 

that will affect a critical daily function. 

M. If the diagnosis is chronic moderate to severe plaque psoriasis and the patient has 

NOT failed a 60-day trial to two conventional therapies. 

N. If the diagnosis is chronic moderate to severe plaque psoriases and the patient has 

received Enbrel® therapy greater than 3 months and the provider is requesting 50 

mg twice a week. 

O. If the diagnosis is chronic moderate to severe plaque psoriases and the patient has 

received Enbrel® therapy greater than 3 months and the patient has NOT shown a 

significant reduction in plaque thickness, erythemia, desquamation and affected 

BSA. 

P. If the patient is receiving combination therapy that includes any one of the 

following medications: Humira®, 

Q. Remicade®, Kineret®, Orencia®, Soriatane®or Rituxan®. 

56



ENBREL 

(Continued) 

R. If the patient has received previous Enbrel® therapy and the provide has NOT 


S. Evidence of diagnosis, previous failed therapy and symptoms are NOT 





Rheumatologist and Dermatologist 


Plan Year 

57



ERAXIS 


Eraxis® is indicated: 

A. For the treatment of candidemia and other Candida infections. 


Eraxis® is covered for members who meet the following criteria: 

A. The prescribing physician is an infectious disease specialist. 

B. AND the patient is 2 years of age or older. 

C. AND the diagnosis is documented as candidemia or another Candida infection 

D. AND the patient has completed a documented trial and failure of Fluconazole 


NON COVERAGE 

Eraxis® is NOT covered for members who meet the following criteria: 

A. The prescribing physician is NOT an infectious disease specialist 

B. The patient is under the age of 2 years old. 

C. The diagnosis is NOT documented as candidemia or another Candid infection 

D. The patient has NOT completed a documented trial and failure of Fluconazole 




Infectious Disease 


6 Months 

58



ERYTHROPOIESIS STIMULATING AGENTS 


erythropoietin is indicated: 

A. For the treatment of anemia associated with chronic renal failure (CRF), including 

patients on dialysis and patients not on dialysis. Erythropoietin is indicated to 

elevate or maintain the red blood cell level (as manifested by the hematocrit or 

hemoglobin determinations) and to decrease the need for transfusions in these 

patients. 

B. Non-dialysis patients with symptomatic anemia considered for therapy should 

have a hemoglobin less than 10 g/dL. 

C. For the treatment of anemia related to therapy with zidovudine in HIV-infected 

patients. 

D. For the treatment of anemia in patients with non-myeloid malignancies where 

anemia is due to the effect of concomitantly administered chemotherapy. 

E. For the treatment of anemic patients (hemoglobin Greater than 10 to Less than or 

equal to 13 g/dL) who are at high risk for perioperative blood loss from elective, 

noncardiac, nonvascular surgery to reduce the need for allogenic blood 

transfusions. 


Erythropoietin is covered for members who meet the following criteria: 

A. Lab values have been completed within 30 days of the request. 

B. AND the diagnosis is documented as treatment for a surgery patient who is at 

high risk for perioperative blood loss. 

a. AND the patient’s hemoglobin is Greater than 10 to Less than or equal to 

12 g/dL OR hematocrit Less than or equal to 33%. 

b. AND the patient is receiving iron supplementation. (Please verify in the 

patient’s drug history or chart that the patient is receiving iron therapy). 

c. AND surgery is within 30 days of request. 

d. AND therapy is NOT being used to prevent a patient from receiving a 

transfusion for religious reasons. 

e. AND the patient is presenting to a retail pharmacy with a prescription for 

erythropoietin (Medicare Part B only pays for erythropoietin when a 

physician or facility dispenses the medication from their own supply). 

f. AND authorization can be allowed for up to one month. (Treatment can 

include 4 weekly doses). 

C. OR the diagnosis is documented as the treatment of anemia associated with 

chronic renal failure. 

a. AND the patient is NOT on dialysis. (Please verify if the patient is on 

dialysis. Medicare Part B pays for erythropoietin when the patient is 

receiving dialysis). 


59



(Continued) 

b. AND it is the initial request for erythropoietin (Patient has not received 

erythropoietin therapy for at least 12 weeks): 

c. AND the patient’s transferrin saturation is at least 20%. (Please verify the 

lab value in the patient’s chart). 

d. AND the patient’s ferritin level is at least 100 ng/mL. (Please verify the 

lab value in the patient’s chart.) 

e. AND the patient’s hemoglobin is Less than or equal to 11 g/dL OR 

hematocrit Less than or equal to 33%. 

f. AND the patient is presenting to a retail pharmacy with a prescription for 



g. AND authorization can be allowed for up to 12 weeks. 

h. AND/OR the patient has received previous erythropoietin therapy within 

the last 12 weeks. 

i. AND the patient’s hemoglobin is Less than 12 g/dL OR hematocrit Less 

than 36%. 

j. AND the patient’s transferrin saturation is at least 20%. 

k. AND the patient’s ferritin level is at least 100 ng/mL. 

l. AND the patient has experienced an increase in hemoglobin or hematocrit 

since the initial erythropoietin treatment and therapy is needed to maintain 

the patient’s current hemoglobin or hematocrit level. 

m. AND the patient is presenting to a retail pharmacy with a prescription for 



n. AND authorization can be allowed for up to 24 weeks. 

D. OR the diagnosis is documented as treatment of anemia in an HIV-infected 

patient. 

a. AND it is the initial request for erythropoietin (Patient has not received 


b. AND the patient is on anti-retroviral therapy. (e.g. Epivir, lamivudine, 

Zerit, stavudine, Hivid, Retrovir, zidovudine, Ziagen, Entriva, Combivir, 

Trizivir, Truvada, Epzicom, Viramune, Rescriptor, Sustiva, Atripla, 

Fuzeon). (Please verify the use of anti-retroviral by reviewing the 

patient’s chart or drug history). 

c. AND the patient’s transferrin saturation is at least 20%. (Please verify in 

the patient’s chart) 

d. AND the patient’s hemoglobin is Less than or equal to 11 g/dL OR 

hematocrit Less than or equal to 33%. (Please verify in the patient’s chart.) 


60



(Continued) 




f. AND authorization can be allowed for up to 12 weeks. 

g. AND/OR the patient has received previous erythropoietin therapy within 


h. AND the patient is on anti-retroviral therapy. (e.g. Epivir, lamivudine, 

Zerit, stavudine, Hivid, Retrovir, zidovudine, Ziagen, Entriva, Combivir, 

Trizivir, Truvada, Epzicom, Viramune, Rescriptor, Sustiva, Atripla, 

Fuzeon). (Please verify the use of anti-retroviral by reviewing the 

patient’s chart or drug history). 

i. AND the patient’s serum erythropoietin level was Less than or equal to 

500 mUnits/mL at the time therapy was initiated. (Please verify in the 


j. AND the patient’s transferrin saturation is at least 20%. (Please verify in 


k. AND the patient’s hemoglobin is Less than or equal to 12 g/dL OR 

hematocrit Less than or equal to 36%. (Please verify in the patient’s 

chart.) 

l. AND the patient has experienced an increase in hemoglobin or hematocrit 



m. AND the patient is presenting to a retail pharmacy with a prescription for 



n. AND authorization can be allowed for up to 24 weeks. 

E. OR the diagnosis is documented as treatment of anemia in cancer patients on 

chemotherapy. 



b. AND the patient has a non-myeloid malignancy. 

c. AND the patient is receiving a chemotherapy regimen to treat the nonmyeloid 

malignancy. 

d. AND the patient’s transferrin saturation is at least 20%. (Please verify in 


e. AND the patient’s serum erythropoietin level is Less than or equal to 200 

mUnits/mL. (Please verify in the patient’s chart. Levels above 

200mUnits/mL is not recommended). 

f. AND the patient’s hemoglobin is Less than or equal to 11 g/dL OR 

hematocrit Less than or equal to 33%. (Please verify in the patient’s 

Chart). 


61



(Continued) 

g. AND the patient is presenting to a retail pharmacy with a prescription for 



h. AND authorization can be allowed for up to 12 weeks. 

i. AND/OR the patient has received previous erythropoietin therapy within 


j. AND the patient has a non-myeloid malignancy. 

k. AND the patient is receiving a chemotherapy regimen to treat the nonmyeloid 

malignancy. 

l. AND the patient’s transferrin saturation is at least 20%. 

m. AND the patient’s serum erythropoietin level was Less than or equal to 

200 mUnits/mL at the time therapy was initiated. (Please verify in the 

patient’s chart. Levels above 200mUnits/mL is not recommended). 

n. AND the patient’s hemoglobin is Less than or equal to 12 g/dL OR 


o. AND the patient has experienced an increase in hemoglobin or hematocrit 



p. AND the patient is presenting to a retail pharmacy with a prescription for 



q. AND authorization can be allowed for up to 24 weeks. 

F. OR the diagnosis is documented as anemia secondary to myelodysplasia. 



b. AND the patient’s serum erythropoietin level is Less than or equal to 500 

mUnits/mL. (Please verify in the patient’s chart). 

c. AND the patient’s transferrin saturation is at least 20%. (Please verify in 


d. AND the patient’s hemoglobin is Less than or equal to 11 g/dL OR 





f. AND authorization can be allowed for up to 12 weeks. 

g. AND/OR the patient has received previous erythropoietin therapy within 


h. AND the patient’s serum erythropoietin level was less than or equal to 500 

mUnits/mL at the time therapy was initiated. (Please verify in the patient’s 

chart). 


62



(Continued) 

i. AND the patient’s transferrin saturation is at least 20%. (Please verify in 


j. AND the patient’s hemoglobin is Less than or equal to 12 g/dL OR 


k. AND the patient has experienced an increase in hemoglobin or hematocrit 



l. AND the patient is presenting to a retail pharmacy with a prescription for 



m. AND authorization can be allowed for up to 24 weeks. 

NON COVERAGE 

Erythropoietin is NOT covered for members who meet the following criteria: 

A. The patient’s transferrin saturation is NOT at least 20%. (Please verify the lab 

value in the patients chart). 

B. OR the patient’s ferritin level is NOT at least 100 ng/mL. (Please verify the lab 

value in the patients chart.) 

C. OR the patient’s hemoglobin is greater than 10 g/dL OR hematocrit greater than 

33%. 


INFORMATION 



12 weeks 

63


Amifostine is indicated: 

A. Nephrotoxicity Prophylaxis 

B. Xerostomia Prophylaxis 



ETHYOL 


Amifostine is covered for members who meet the following criteria: 

A. Patient is being treated for FDA indications as stated above 

B. AND being prescribed by an Oncologist 

C. AND B vs. D criteria indicates coverage should be through Medicare Part D 

NON COVERAGE 

Amifostine is NOT covered for members with the following criteria: 


B. Known hypotension with dehydration 

C. Hypersensitivity to aminothiol or mannitol 


INFORMATION 



6 months 

64



EXELON 


A. Alzheimers 

B. Parkinson’s Dementia 



Exelon is covered for members who meet the following criteria: 

A. For treatment of Alzheimer’s Disease: 

a. Failure to at least a three month trial with Aricept 

B. For treatment of Parkinson’s Disease: 

a. Trial with at least TWO of the following: 

i. Amantadine 

ii. Bromocriptine 

iii. Carbidopa/Levodopa 

iv. Comtan 

v. Mirapex 

vi. Ropinirole 

vii. Selegiline 

NON COVERAGE 

Exelon is not covered for members who meet the following criteria: 

A. No documented trial and failure to Aricept and Namenda therapy 


INFORMATION 

Chart Notes 


Plan Year 

65



EXJADE 


Exjade® is indicated: 

A. For the treatment of chronic iron toxicity secondary to transfusional iron 

overload (e.g. due to transfusional hemosiderosis in patients with chronic 

anemias such as thalassemia and sickle cell anemia) 



Exjade® is covered for members who meet the following criteria: 

A. Patient has a diagnosis of transfusion-dependent anemia (β-thalassemia, sickle 

cell disease, Diamond-Blackfan anemia, or myelodysplastic syndrome) and 

chronic iron overload due to blood transfusions, evidenced by serum ferritin 

1,000-8,000ng/mL. 

B. Patient failed Desferal therapy due to compliance or is unable to use it 

(documentation of noncompliance, adverse effects, and/or contraindications). 

C. Exjade is being prescribed by a hematologist or other specialist. 

Recommended monitoring includes monthly serum ferritin, baseline and monthly serum 

creatinine, monthly urine protein, monthly LFTs, baseline and yearly auditory and 

ophthalmic testing, including slit-lamp examination and dilated funduscopy. 

NON COVERAGE 

Exjade® is NOT covered for members with the following criteria 

A. The diagnosis is not documented as chronic iron toxicity secondary to 

transfusional iron overload. 




Hematologist 


3 months 

66



FABRAZYME 


Fabrazyme® is indicated: 

A. For use in patients with Fabry disease. 


Fabrazyme® is covered for members who meet the following criteria: 

A. Diagnosis is documented as a patient with Fabry disease. 

B. AND the diagnosis has been confirmed with an enzyme assay measuring a 

deficient activity of alpha-galactosidase enzyme. 

NON COVERAGE 

Fabrazyme® is NOT covered for members with the following criteria: 

A. The diagnosis is NOT documented as Fabry disease. 

B. The diagnosis has not been confirmed with an enzyme assay measuring the 

deficient activity of alpha-glactosidase enzyme. 


INFORMATION 



Plan Year 

67



FLEBOGAMMA 









B. Treatment of hypergammaglobulinemia 

C. AND the patient is diagnosed with primary immunodeficiency 

D. OR the patient is diagnosed with idiopathic thrombocytopenic purpura 

E. OR the patient is diagnosed with Kawasaki disease 

NON COVERAGE 


C. Medication is covered by Part B per CMS guidelines 

D. The diagnosis is NOT hypergammaglobulinemia, primary immunodeficiency, OR 



INFORMATION 



Plan Year 

68



FORTEO 


Forteo® is indicated: 

A. For the treatment of postmenopausal women with osteoporosis who are at high 

risk for fracture. These include women with a history of osteoporotic fracture, or 

who have multiple risk factors for fracture, or who have failed or are intolerant of 

previous osteoporosis therapy. 

B. For the treatment to increase bone mass in men with primary or hypogonadal 

osteoporosis who are at high risk for fracture. 


Forteo® is covered for members who meet the following criteria: 

A. Patient has NOT been diagnosed with Paget’s disease nor has high levels of 

alkaline phosphatase. 

B. AND the patient does NOT have pre-existing hypercalcemia, skeletal 

malignancies, or prior radiation therapy involving the skeleton. 

C. AND if the patient is female, is she age 50 years old or older (postmenopausal). 

D. AND diagnosis is documented as postmenopausal women with osteoporosis or a 

man with primary or hypgonadal osteoporosis. 

E. AND the patient has at least two of the following fracture risk fractures: 

a. T score Less than or equal to - 2.5. 

b. Prior fragility fracture (Counts as two risk fractures). 

c. Age Greater than or equal to 70 years old. 

d. Family history (1 st degree relative). 

F. AND the patient has failed to have an adequate response to treatment with a 

bisphosphonate therapy (Fosamax®, alendronate, Actonel®, risedronate, 

Boniva® and/or Reclast®) for at least 1 year. (Please verify that the patient has 

received bisphosphonate therapy by reviewing the patient’s drug history or 


G. AND patient has NOT had accumulative Forteo® therapy for more than 24 

months (Lifetime therapy). 

H. AND evidence of diagnosis, risk fractures, and tried bisphosphonate therapy is 

documented in patient’s chart notes provided by prescribing provider. 

NON COVERAGE 

Forteo® is NOT covered for members with the following criteria: 

A. Patient has been diagnosed with Paget’s disease and/or has high levels of alkaline 

phosphatase and/or has hypercalcemia and/or skeletal malignancies and/or prior 

radiation therapy involving the skeleton. 

B. If the patient is female and is under the age of 50 and has not experienced 

menopause. 

C. Diagnosis is NOT documented as osteoporosis. 

D. The patient does NOT have at least TWO risk factors. 

69



FORTEO 

(Continued) 

E. The patient has NOT had an adequate response to bisphosphonate treatment. 

F. The patient has had more than 24 months of Forteo® therapy. 


INFORMATION 



Plan Year 

70



GAMASTAN 






D. All other FDA approved indications not otherwise excluded from Part D 




a. Treatment of hypogammaglobulinemia 

B. OR the patient is diagnosed as per FDA-Approved indications above 

NON COVERAGE 




INFORMATION 



Plan Year 

71



GAMMAGARD 













NON COVERAGE 






INFORMATION 



Plan Year 

72



GAMUNEX 













NON COVERAGE 




INFORMATION 



6 months 

73



GLEEVEC 


Gleevec® is indicated: 

A. For newly diagnosed adult patients with Philadelphia chromosome positive 

chronic myeloid leukemia (Ph+CML) in chronic phase. 

B. For patients with Ph+CML in blast crisis, accelerated phase, or in chronic phase 

after failure of interferon-alpha therapy. 

C. For pediatric patients with Ph+CML in chronic phase who are newly diagnosed or 

whose disease has recurred after stem cell transplant or who are resistant to 

interferon-alpha therapy. 

D. For adult patients with relapsed or refractory Philadelphia chromosome positive 

acute lymphoblastic leukemia (Ph+ ALL). 

E. For adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) 

associated with PDGFR (platelet-derived growth factor receptor) gene rearrangements. 

F. For adult patients with aggressive systemic mastocytosis (ASM) without the 

D816V c-Kit Mutation or with C-Kit mutation status unknown. 

G. For adult patients with hypereosinophilic syndrome (HES) and/or chronic 

eosinophilic Leukemia (CEL) who have the FIP1L1-PDGFR alpha fusion kinase, 

FIP1l1-PDGFR alpha fusion kinase negative or unkown. 

H. For adult patients with unresectable, recurrent and/or metastatic 

dermatofibrosarcoma protuberans (DFSP). 

I. For patients with Kit (CD117) positive unresectable and/or metastatic malignant 

gastrointestinal stromal tumors (GIST). 


Gleevec® is covered for members who meet the following criteria: 

A. The prescribing physician is board certified as an oncologist, hemaatologist or has 

obtained a consult from any of the listed specialties. 

B. AND if the patient is female, she is NOT pregnant AND has no plans to conceive. 

C. AND diagnosis is documented as KIT (CD117) positive unresectable and/or 

metastatic malignant gastrointestinal stromal tumors (GIST). 

D. OR diagnosis is documented as an adult patient with Philadelphia chromosome 

positive chronic myeloid leukemia (Ph+CML) in chronic phase, in blast crisis or 

in accelerated phase. 

E. OR an adult patient with relapsed or refractory Philadelphia chromosome positive 

acute lymphoblastic leukemia (Ph+ ALL). 

F. OR a pediatric patient with Ph+CML. 

a. And the pediatric patient is in a chronic phase. 

G. OR an adult patient with myelodysplastic/ myeloproliferative disease 

(MDS/MPD). 

a. AND the MDS/MPD is associated with PDGFR (platelet-derived growth 

factor receptor) gene re-arrangements. 

74



GLEEVEC 

(Continued) 

H. OR an adult patient with aggressive systemic mastocytosis (ASM). 

a. And the patient does not have a D816V C-Kit mutation or the c-Kit 

mutation status is unknown. 

I. OR an adult patient with hypereosinophilic syndrome (HES) and/or chronic 

eosinophilic leukemia (CEL). 

J. OR an adult patient with unresectable, recurrent and/or metastatic 

dermatofibrosarcoma protuberans (DFSP). 

K. AND if the patient has received previous Gleevec® therapy, the provider must 

show a documented hematologic or cytogenic response to imatinib. 

L. Patient is on duplicate therapy that can include interferon alpha therapy (eg. 

Intron-A®, Roferon A®, Pegasys®, and or Infergen®). (Please verify that the 

patient has received interferon alpha therapy by reviewing the patient’s drug 

history). 

M. AND evidence of diagnosis and hematologic or cytogenic response (for retreatment) 

documented in patient’s chart notes provided by the prescribing 

provider. 

NON COVERAGE 

Gleevec® is NOT covered for members with the following criteria: 

A. Patient is female is pregnant or plans to conceive. 

B. Patient’s diagnosis is NOT documented in the patient’s chart notes as KIT 

(CD117) positive unresectable and/or metastatic malignant GIST, or an adult with 

Ph+CML in chronic phase, blast crisis or in accelerated phase, or an adult patient 

with relapsed or refractory PH+ALL, or an adult patient with MDS/MPD that is 

NOT associated with PDGFR gene re-arrangements, or an adult diagnosed patient 

with HES and/or CEL or an adult patient diagnosed with unresectable, recurrent 

and/or metastatic DFSP. 

C. OR the diagnosis is a pediatric patient with Ph+CML not the in chronic phase. 

D. OR the diagnosis is an adult patient with MDS/MPD and is NOT associated with 

PDGFR gene re-arrangements. 

E. OR the patient has received previous Gleevec® therapy and has not shown a 

hematologic or cytogenic response. 




Oncologist 


6 months 

75



HUMAN CHORIONIC GONADOTROPIN, HCG 


Gonadotropin is indicated for: 

A. Cryptorchidism 

B. Hypogonadotropic hypogonadism, In male patients 


Gonadotropin is covered for members who meet either of the following criteria: 

A. In a Male patient 

a. If the patient has a diagnosis of prepubertal cryptochidism not due to 

anatomic obstruction or hypogonadism secondary to a pituitary deficiency. 

b. AND If the patient does not have any signs of the following diagnoses: 

i. Precocious puberty, or 

ii. Prostatic carcinoma or other androgen dependent neoplasm 

c. And is not being used in the treatment of obesity. 

B. Not covered for female patients 

NON COVERAGE 

Gonadotropin is NOT covered for members of the following criteria: 

A. In a Male patient: 

a. If the patient does NOT have a diagnosis of prepubertal cryptochidism not 

due to anatomic obstruction or hypogonadism secondary to a pituitary 

deficiency. 

b. If the patient does have any signs of the following diagnoses: 



c. If it is being used in the treatment of obesity. 

B. If patient is female 

REQUIRED MEDCIAL INFORMATION 





Plan Year 

76



HEPATITIS C 

Indications / Required Criteria: 

Treatment will be approved when any of the following indication(s) exists: 

A. Chronic Hepatitis C Virus (HCV), Genotype 1 or 4 

a. Recent lab reports documenting elevated HCV RNA are required, along 

with genotype. 

b. Request is initiated by a GI or infectious disease specialist. 

c. Initial authorization will be given for 12 weeks. At 12 weeks, an early 

viral response (EVR) must be documented via repeat HCV RNA assay. 

(EVR during the first 12 weeks is predictive of the patients viral 

response3). 

d. For patients with a greater than2log reduction in viral load, therapy may 

be continued up to a total of 48 weeks treatment. 

e. For patients who fail to achieve a 2log reduction, treatment should be 

discontinued. These patients have a less then 2% chance of achieving an 

SVR with continued therapy3,4. 

B. Chronic Hepatitis C Virus (HCV), Genotype 2, 3, 5, or 6 

a. Recent lab reports documenting elevated HCV RNA are required, along 

with genotype. 

b. Request is initiated by a GI or infectious disease specialist. 12. Initial 

authorization will be given for 12 weeks. At 12 weeks, an early viral 

response (EVR) must be documented via repeat HCV RNA assay. (EVR 

during the first 12 weeks is predictive of the patient’s viral response3). 

c. For patients with a greater than2log reduction in viral load, therapy may 

be continued up to a total of 24 weeks treatment. 

d. For patients who fail to achieve a 2log reduction, treatment should be 

discontinued. These patients have a less then 2% chance of achieving an 

SVR with continued therapy3,4. 

C. Retreatment (not approvable) 

a. Re-treatment of non-responders to standard interferon-ribavirin 

combinations is not generally indicated, and therefore will not be 

approved. Only 15-20% of nonresponders achieve an SVR upon retreatment. 

Response rates are even poorer for those with Genotype 1. 

b. For patients who have relapsed after combination treatment, re-treatment 

is generally not indicated and is currently being studied. Upon retreatment, 

most of these patients relapse as well 

D. OR the indication is documented as chronic hepatitis B 

a. AND the patient has evidence of a positive HBsAg (+ or -) serological 

marker for greater than 6 months OR evidence by a liver biopsy showing 

chronic hepatitis 

b. AND the patient has a Hepatitis B viral load greater than 100,000 copies 

per ml 

77



HEPSERA 


Hepsera® is indicated: 

A. For the treatment of chronic hepatitis B in patients Greater than or equal to 12 

years of age. 


Hepsera® is covered for members who meet the following criteria: 

A. Patient is age 12 years or older. 

B. AND the patient has been diagnosed with chronic hepatitis B. 

C. AND the patient has evidence of a positive HBsAg (+ or -) serological marker for 

greater than 6 months OR evidence by a liver biopsy showing chronic hepatitis. 

(Please verify that the patient has a HBsAg serological marker for greater than 6 

months or a positive liver biopsy by reviewing the patient’s drug history or chart). 

D. AND the patient has a Hepatitis B viral load greater than 100,000 copies per ml. 

E. AND the patient has elevations in liver aminotransferases (ALT or AST) that are 

two (2) times greater than normal. 

F. AND the patient has been tested for HIV. (Hepsera® therapy can cause HIV 

resistance in untreated HIV infection). AND if the patient has received previous 

Hepsera® treatment, there is documented clinical improvement shown by a drop 

in viral load or reduction in the patient’s liver aminotransferases. (Please verify 

patient’s chart notes to verify drop in viral load or reduction in liver 

aminotransferases from their starting level). 

G. AND the patient is not receiving duplicate therapy that includes Baraclude®, 

Tyzeka®, Epivir®, Intron A® and/or Infergen®. (Please verify that the patient 

does not have duplicate therapy by reviewing the patient’s drug history or chart). 

H. AND evidence of diagnosis, serological markers, liver biopsy, viral load, and 

liver aminotransferases is documented in patient’s chart. 

NON COVERAGE 

Hepsera® is NOT covered for members with the following criteria: 

A. Patient is under the age of 12 years old. 

B. Patient has NOT been diagnosed with chronic hepatitis B. 

C. Patient has NO evidence of a Hepatitis B serological marker for greater than 6 

months OR evidence by a positive liver biopsy. 

D. Patient does NOT have a Hepatitis B viral load greater than 100,000 copies per 

ml. 

E. Patient does NOT have liver aminotransferases (ALT or AST) that are two (2) 

times greater than normal. 

F. Patient has NOT been tested for HIV. 

G. Patient is on duplicate therapy that can include one of the following: Baraclude®, 

Tyzeka®, Epivir®, Intron-A®, and or Infergen®. 

79



HEPSERA 

(Continued) 

H. Prescriber has provided no evidence of diagnosis, serological markers, viral load, 

duplicate therapy or liver Aminotransferases. 


INFORMATION 



Plan Year 

80



HUMIRA 


Humira® is indicated: 

B. For reducing signs and symptoms in patients with active ankylosing spondylitis. 

C. For the treatment of adult patients (18 years or older) with moderate to severe 

chronic plaque psoriasis who are candidates for systemic therapy or phototherapy. 

D. For reducing signs and symptoms, inducing major clinical response, inhibiting the 

progression of structural damage, and improving physical function in patients 

with moderately to severely active rheumatoid arthritis. Humira® can be used 

alone or in combination with methotrexate or other disease-modifying antirheumatic 

drugs (DMARDS). 

E. For reducing signs and symptoms, inhibiting the progression of structural damage, 

and improving physical function in patients with psoriatic arthritis. Humira® can 

be used in alone or in combination with DMARDS. 

F. For reducing signs and symptoms and inducing and maintaining clinical remission 

in adult patients with moderately to severely active Crohn’s disease who have had 

an inadequate response to conventional therapy. Humira® is indicated for 

reducing signs and symptoms and inducing clinical remission in patients who 

have lost response to or are intolerant to infliximab. 

G. All other FDA approved indications not otherwise excluded from Part D 


Humira® is covered for members who meet the following criteria: 

H. Patient has NO history of auto immune disease, recurring infections, heart failure, 


I. AND the prescribing provider is a gastroenterologist, rheumatologist, 

dermatologist, orthopedist or has obtained a consult from the listed specialties. 

J. AND diagnosis is documented as moderate to severe active rheumatoid arthritis. 

a. AND the patient has at least four (4) of the following symptoms: 

i. Morning stiffness. 

ii. Arthritis of three (3) or more joint areas. 

iii. Arthritis of hand joints. 

iv. Symmetric arthritis. 

v. Rheumatoid nodules. 

vi. Serum rheumatoid factor. 

vii. Radiographic changes. 

81



HUMIRA 

(Continued) 



Methotrexate, cyclosporine, Neoral®, Sandimmune®, Gengraf®, 






c. AND if the patient has received previous Humira® therapy, the provider 


improvement in tender and swollen joint count, mobility, stiffness or 

progression of disease. 

K. OR the diagnosis is documented as psoriatic arthritis. 

a. AND the patient has at least one of the following symptoms: 

i. Three (3) or more swollen joints. 

ii. Three (3) or more tender joints. 



(cyclosporine, Neoral®, Sandimmune®, Gengraf®, azathioprine, 

Imuran®, penicillamine, Cuprimine®, Depen®, sulfasalazine, 

Azulfidine®, leflunomide, Arava®, gold sodium thiomalate, Aurolate®, 

aurothioglucose, Solganal®, auranofin, Ridaura®, hydroxychoroquine, 

Plaquenil®) if methotrexate is contraindicated. (Verification can be made 

by reviewing the patient’s drug history or patient’s chart). 

c. AND if the patient has received previous Humira® therapy, the provider 




L. OR the diagnosis is documented as active ankylosing spondylitis. 

a. AND the patient has tried and failed at least a 60-day trial of at least two 

non-steroidal anti-inflammatory (NSAID) drugs that can include any two 

of the following medications: Diclofenac, etodolac, fenoprofen, 

flurbiprofen, ibuprofen, indomethacin, celecoxib, Celebrex®, ketoprofen, 

meclofenamate, nabumetone, naproxen, oxaprozin, piroxicam, sulinidac, 

or tolmetin. (Please verify that the patient has received NSAID therapy by 

reviewing the patient’s drug history). 

b. AND if the patient has received previous Humira® therapy, the provider 



in the progression of disease. 

M. OR the diagnosis is documented as chronic moderate to severe plaque psoriasis. 

82



HUMIRA 

(Continued) 

a. AND the patient has had the disease for 1 year or greater. 

b. AND the patient’s age is 18 years old or older. 

c. AND the involvement of plaque psoriasis is 10% or greater of the patient’s 

total body surface area (BSA) OR if the BSA is less than 10%, the plaque 

psoriasis must involve areas that will prevent the patient from performing 

crucial daily functions such as walking (eg. feet). 

d. AND the patient has tried and failed at least a 60-day trial of two (2) 

conventional therapies that may include any of the following: 

i. High potency topical steroid treatment. 

ii. Calcipotriene (Dovonex®) 

iii. Phototherapy. 

iv. Retinoids (Soriatane®) 

v. Methotrexate. 

vi. Cyclosporine. 

e. If the patient has received Humira® therapy for greater than three (3) 

months, the patient must see a significant reduction in plaque thickness, 

erythemia, desquamation and affected body surface area.(Please verify 

patient’s chart notes to verify clinical improvement). 

N. OR the diagnosis is documented as Crohn’s Disease: 

a. AND the patient has tried, failed and/or had an inadequate response to a 

60-day trial of at least two Crohn’s disease conventional therapies that 

may include the following: Sulfazalazine, Azulfidine®, balsalazide, 

Colazal®, mesalamine, Asacol®, Canasa®, Lialda®, Pentasa®, 

Rowasa®, azathioprine, Imuran®, cyclosporine, Neoral®, Sandimmune®, 

Gengraf®, methotrexate, mercaptopurine, or Purinethol®. 

b. AND if the patient has received previous Humira® therapy, the patient 

must see an improvement in clinical symptoms that can include reduced 

abdominal pain, diarrhea, cramps, and/or fistulas. 

c. AND the patient will NOT receive combination therapy with other 

biologic and/or retinoid therapy. (Eg. Enbrel®, Remicade®, Kineret®, 

Orencia®, Soriatane® Tysabri®, Raptiva® and Rituxan®. (Please verify 

that the patient is not on duplicate therapy by reviewing the patient’s drug 

history or chart). 

d. AND evidence of diagnosis, previous failed therapy, or clinical 

improvement is documented in patient’s chart notes provided by 

prescribing provider. 

NON COVERAGE 

Humira® is NOT covered for members with the following criteria: 

J. Patient has a history of auto immune disease, recurring infections, heart failure, 


83



HUMIRA 

(Continued) 

K. The prescribing provider is NOT a rheumatologist, gastroenterologist, 

dermatologist, orthopedist or obtained a consult from the listed specialties. 

L. The diagnosis is NOT documented as severe active rheumatoid arthritis, Crohn’s 

disease, psoriatic arthritis, ankylosing spondylitis or chronic moderate to severe 

plaque psoriasis. 

M. The diagnosis is listed as ulcerative colitis. 

N. If the diagnosis is listed as severe active rheumatoid arthritis, the patient does 

NOT have four of the listed symptoms. 

O. If the diagnosis is listed as severe active rheumatoid arthritis, the patient has NOT 

failed a 8-week maximum tolerated trial to at least two DMARDs. 

P. If the diagnosis is psoriatic arthritis and the patient does NOT have three swollen 

joints or three tender joints. 

Q. If the diagnosis is psoriatic arthritis and the patient has NOT failed a 8-week 

maximum tolerated trial to at least two DMARDs. 

R. If the diagnosis is ankylosing spondylitis and the patient has NOT failed two 60- 

day NSAID drug regimens. 

S. If the diagnosis is chronic moderate to severe plaque psoriasis and the patient has 

not had the disease for 1 year or greater. 

T. If the diagnosis is chronic moderate to severe plaque psoriasis and the 

involvement is less than 10% of body surface area or does NOT involve an area 

that will affect a critical daily function. 

U. If the diagnosis is chronic moderate to severe plaque psoriasis and the patient has 

NOT failed a 60-day trial to two conventional therapies. 

V. If the diagnosis is documented as Crohn’s disease and the patient has NOT failed 

at least two 60-day conventional drug regimens. 

W. If the patient is receiving combination therapy that includes any one of the 

following medications: Enbrel®, Remicade®, Tysabri®, Kineret®, Orencia®, 

Soriatane® or Rituxan®. 

X. If the patient has received previous Humira® therapy and the provider has NOT 


Y. Evidence of diagnosis, previous failed therapy and symptoms are NOT 





Rheumatologist, Dermatologist and 

Gastroenterology 


Plan Year 

84



IMITREX 


Imitrex® is indicated: 

A. For the treatment of migraine headache attacks with or without aura and cluster 

headache 



Imitrex® is covered for members who meet the following criteria: 

A. The patient is 18 years of age or older. 

B. AND the diagnosis is documented as migraine headache or cluster headache 

C. AND the the patient has completed a documented trial and failure of an abortive 

medication such as Fioricet, Fiorinal, Tylenol and NSAIDs 

NON COVERAGE 

Imitrex® is NOT covered for members who meet the following criteria: 

A. A. The patient is under the age of 18 years old. . 

B. The diagnosis is NOT migraine headache or cluster headache 

C. The patient has not completed a documented trial and failure of an abortive 

medication such as Fioricet, Fiorinal, Tylenol and NSAIDS 


INFORMATION 

Chart Notes 


Plan Year 

85



INCRELEX 


Increlex® is indicated: 

A. For the long-term treatment of growth failure in children with severe primary 

IGF-1 deficiency (Primary IGFD) or with growth hormone (GH) gene deletion 

who have developed neutralizing antibodies to growth Hormone. 


Increlex® is covered for members who meet the following criteria: 

A. The prescribing physician is a board certified endocrinologist. 

B. AND the patient is between the age of 2 years old and 20 years old. 

C. AND the patient has no evidence of a closed epiphyses. 

D. AND the patient does NOT have any evidence of active malignancy. 

E. AND the patient is not being treated with chronic anti-inflammatory steroids. 

F. AND the diagnosis is documented as the treatment of growth failure in a child 

with severe primary IGF-1 deficiency or with growth hormone gene deletion who 

have developed neutralizing antibodies to growth hormone. 

G. AND the patient has a basal IGF-1 standard deviation score Less than or equal to 

-3 based on lab reference for age and sex. (Please verify the IGF-1 level in the 

patient’s chart notes and ensure the test was performed within 3 months of the 

initial request). 

H. AND the patient has a normal or elevated growth hormone level that has been 

confirmed with at least one growth hormone stimulation test. (Please verify the 

stimulation test result in the patient’s chart notes). 

I. AND the patient has severe growth retardation with a height standard deviation 

(SDS) score more than 3 SDS below the mean for chronological age and sex and 

their target height based on mid-parental height calculation. (Please verify the 

SDS score in the patient’s chart notes). 

J. AND all indications of secondary IGF-1 have been ruled out such as growth 

hormone deficiency, hypothyroidism and malnutrition. 

K. AND the patient is not taking or has no plans to receive growth hormone therapy 

in combination with Increlex® therapy. (Please review the patient’s drug history 

or drug chart to verify that the patient will not be receiving growth hormone 

therapy (e.g. Humatrope®, Genotropin®, Norditropin®, Serostim®, Nutropin®, 

Saizen®, Tev-Tropin®, Zorbtive®). 

L. AND if the patient has received previous mescasermin therapy, the patient must 

meet all of the following criteria: 

M. There has been an increase in height velocity Greater than 2.5 cm total growth in 

one year of therapy. 

N. There is no evidence of epiphyseal closure. 

O. The patient has NOT met their expected final adult height or targeted height based 

on mid-parental height calculation or their current absolute height is Less than or 

equal to 25 th percentile (defined as 68 inches in males and 63 inches in females. 

86



INCRELEX 

(Continued) 

NON COVERAGE 

Increlex® is NOT covered for members with the following criteria: 

A. The prescribing physician is NOT a board certified endocrinologist. 

B. The patient is NOT between the age of 2 years old and 20 years old. 

C. The patient has evidence of a closed epiphyses. 

D. The patient has evidence of active malignancy. 

E. The patient is being treated with chronic anti-inflammatory steroids. 

F. The diagnosis is NOT documented as the treatment of growth failure in a 

child with severe primary IGF-1 deficiency or with growth hormone gene 

deletion who have developed neutralizing antibodies to growth hormone. 

G. If the diagnosis is documented as the treatment of growth failure in a child 

with severe primary IGF-1 deficiency or with growth hormone gene deletion 

who have developed neutralizing antibodies to growth hormone and the 

patient meets any of the following criteria: 

H. The patient has a basal IGF-1 standard deviation score Greater than -2.9 based 

on lab reference for age and sex. 

I. AND the patient has a low growth hormone level ([Max peak Less thanLess 

than 5ng/mL by RIA or Less than 2.5 ng/mL by IRMA]) that has been 

confirmed with at least one growth hormone stimulation test. 

J. The patient’s normal growth hormone level has not been confirmed by at least 

one growth hormone stimulation test. 

K. The patient does NOT have severe growth retardation. 

L. Indications of secondary IGF-1 have NOT been ruled out such as growth 

hormone deficiency, hypothyroidism and malnutrition. 

M. The patient is taking or has plans to receive growth hormone therapy in 

combination with Increlex® therapy. 

N. If the patient has received previous mescasermin therapy and the patient meets 

any of the following criteria: 

1. There has been an increase in height velocity Less than 2.5 cm total 

growth in one year of therapy. 

2. There is evidence of epiphyseal closure. 

3. The patient has met their expected final adult height or targeted height 

based on mid-parental 

height calculation or their current absolute height is Less than 25 th 

percentile (defined as 68 inches in males and 63 inches in females). 






Plan Year 

87



INSPRA 


Inspra® is indicated: 

A. Improving survival of stable patients with left ventricular systolic dysfunction 

(LVEF Less than 40%) and CHF after an acute myocardial infarction. 

B. Hypertension, alone or combined with other agents. 


Inspra® is covered for members who meet the following criteria: 

A. The patient has had a serum potassium level taken within 10 days of initiation of 

therapy and the level is Less than 5.5 mEq/L. 

B. AND the patient is NOT receiving any potent CYP3A inhibitors that will affect 

the metabolism of Inspra®. (e.g. diltiazem, Cardizem®, Cartia XT®, Diltia 

XT®, Tiazac®, ketoconazole, verapamil, Calan®, Covera®, Verelan®, Isoptin®, 

vinblastine, doxorubicin, isoniazid, ritonavir, Norvir®, Kaletra®, cyclosporine, 

Viracept®, Crixivan®, Fortovase®, Invirase®, ciprofloxacin, Cipro®, 

itraconazole, Sporonax®, norfloxacin, voriconazole, Vfend®, rifampin, rifabutin). 

(Please verify that the patient is not receiving any of these medications by 


C. AND the diagnosis is documented as hypertension. 

D. AND the patient has tried and failed maximum tolerated doses of a 60-day trial or 

had unacceptable toxicity to spironolactone (Aldactone®, Spirono®). (Please 

review the patient’s drug history or chart to verify a trial to spironolactone). 

E. AND the patient does NOT have type-2 diabetes with microalbuminuria. 

F. AND the patient does NOT have a serum creatinine Greater than 2 mg/dL in 

males or Greater than 1.8 mg/dL in females. 

G. AND the patient does NOT have a creatinine clearance Less than or equal to 50 

mL/min. 

H. AND the patient is NOT or will be taking Inspra® in combination with potassium 

supplements or potassium sparing diuretics (e.g. amiloride, spironolactone or 

triamterene). (Please review the patient’s drug history or chart to verify no 

concomitant use with potassium supplements or potassium sparing diuretics). 

I. AND if the patient has had previous Inspra® therapy, he/she must show a 

decrease in systolic and diastolic blood pressure since initiating Inspra® therapy. 

J. AND/OR the diagnosis is documented as a patient with left ventricular systolic 

dysfunction and/or congestive heart failure after an acute myocardial infarction. 

K. AND the patient has tried and failed maximum tolerated doses of a 60-day trial or 

had unacceptable toxicity to spironolactone (e.g. Aldactone®, Spirono®). (Please 

review the patient’s drug history or chart to verify a trial to spironolactone). 

L. AND the patient does NOT have a creatinine clearance Less than or equal to 30 

mL/ min. 

M. AND if the patient has had previous Inspra® therapy, he/she must show an 

improvement in left ventricular systolic dysfunction and/or congestive heart 

failure symptoms (e.g. fatigue, edema, shortness of breath) since initiating 

Inspra® therapy. 

88



INSPRA 

(Continued) 

NON COVERAGE 

Inspra® is NOT covered for members who meet the following criteria: 

A. The patient has NOT had a serum potassium level taken within 10 days of 

initiation of therapy. 

B. The patient has had a serum potassium level taken within 10 days of initiation of 

therapy and the level is Greater than 5.5 mEq/L. 

C. The patient is receiving a potent CYP3A inhibitors that will affect the metabolism 

of Inspra®. 

D. The diagnosis is NOT documented as hypertension, heart failure or left 

ventricular systolic dysfunction. 

E. The diagnosis is documented as hypertension and the patient meets any of the 

following criteria: 

F. The patient has NOT tried and failed maximum tolerated doses of at least a 60- 

day trial or had unacceptable toxicity to spironolactone (Aldactone®, Spirono®). 

G. The patient has type-2 diabetes with microalbuminuria. 

H. The patient has a serum creatinine Greater than 2 mg/dL in males or Greater than 

1.8 mg/dL in females. 

I. The patient has a creatinine clearance Less than or equal to 50 mL/min. 

J. The patient is or will be taking Inspra® in combination with potassium 

supplements or potassium sparing diuretics. 

K. If the patient has had previous Inspra® therapy and he/she has NOT shown a 

decrease in systolic and diastolic blood pressure since initiating Inspra® therapy. 

L. The diagnosis is documented as a patient with left ventricular systolic dysfunction 

and/or congestive heart failure after an acute myocardial infarction and the patient 

meets any of the following criteria: 

M. The patient has NOT tried and failed maximum tolerated doses of at least a 60- 

day trial or had unacceptable toxicity to spironolactone (e.g. Aldactone®, 

Spirono®). 

N. The patient has a creatinine clearance Less than or equal to 30 mL/ min. 

O. If the patient has had previous Inspra® therapy and he/she has NOT shown an 

improvement in left ventricular systolic dysfunction and/or congestive heart 

failure symptoms (e.g. fatigue, edema, shortness of breath) since initiating 

Inspra® therapy. 




Cardiologist 


Plan Year 

89



INTRON A 


Intron® A is indicated: 

A. For the treatment of patients 18 years of age or older with hairy cell leukemia. 

B. For an adjuvant to surgical treatment in patients 18 years of age or older with 

malignant melanoma who are free of disease but at high risk for system 

recurrence, within 56 days of surgery. 

C. For the initial treatment of clinically aggressive follicular Non-Hodgkin’s 

Lymphoma in conjunction with anthracycline-containing combination 

chemotherapy in patients 18 years of age or older. (Efficacy in patients with lowgrade, 

low-tumor burden follicular Non-Hodgkin’s Lymphoma has not been 

demonstrated.) 

D. For intralesional treatment of selected patients 18 years of age or older with 

condylomata acuminate involving external surfaces of the genital and perianal 

areas. 

E. For the treatment of selected patients 18 years of age or older with AIDS-Related 

Kaposi’s Sarcoma. 

F. For the treatment of chronic hepatitis C in patients 18 years of age or older with 

compensated liver disease who have a history of blood or blood-product exposure 

and/or are HCV antibody positive. 

G. For the treatment of chronic hepatitis B in patients 1 years of age or older with 

compensated liver disease. 


Intron® A is covered for members who meet the following criteria: 

A. Patient has NO history of decompensated liver disease, autoimmune hepatitis or is 

an immunosuppressed transplant recipient. 

B. AND the patient does NOT have a history of a serious psychiatric condition or 

clinical depression. 

C. AND the patient has received an eye exam to screen and has NO evidence of an 

ophthalmologic disorder. 

D. AND the patient has a normal thyroid status or is maintained in the normal lab 

value range by medication. 

E. AND the patient has NO history of an autoimmune disease such as vasculitis, 

Raynaud’s phenomenon, rheumatoid arthritis, lupus erythematosus or 

rhabdomyolsis. 

F. AND the patient could NOT have undergone a liver transplant and therapy is 

being uses as a prophylaxis or treatment of established heptatis C to reduce 

allograft failure. 

G. AND the indication is documented as Hairy Cell Leukemia. 

a. AND the patient is 18 years of age or older. 

b. AND the prescribing physician is a board certified oncologist. 

c. AND approval can be allowed for up to 6 months. 

90



INTRON A 

(Continued) 

d. AND if the patient has received previous therapy, the patient must meet 

previous criteria and experience a positive response to therapy that 

includes a delayed or no progression of disease. 

H. OR the indication is documented as Malignant Melonoma. 



c. AND the patient has received surgical treatment within 56 weeks of 

request. 

d. AND the patient is free of disease but at high risk for recurrence. 

e. AND approval can be allowed for up to 52 weeks. 

f. AND if the patient has received previous therapy, the patient must have 

had a recurrence of disease and surgical treatment within 56 weeks of 

request. 

I. OR the indication is documented as Follicular Non-Hodgkin’s Lymphoma. 



c. AND Intron® A therapy will be used in combination with an 

anthracycline-containing combination chemotherapy agent (eg. 

daunorubicin, doxorubicin, epirubicin, idarubicin, Cerubidine®, 

DaunoXome®, Adriamycin®, Rubex®, Doxil®, Evacet®, Ellence®, 

Idamycin®). (Please verify that the patient will be receiving 

anthracycline® therapy by reviewing the patient’s drug history or chart). 

d. AND the patient does not does not have low-grade, low-tumor burden 

disease (Efficacy has not been demonstrated). 

e. AND approval can be allowed for up to 1 year. 

f. AND if the patient has received previous therapy, the patient must have 

had treatment with an anthracycline-containing agent and meet the above 

criteria. Approval can be allowed for up to 1 year. 

J. OR the indication is documented as Condylomata Acuminata. 


b. AND the prescribing physician is a board certified dermatologist or 

obtained a consult from the listed specialty. 

c. AND the area of involvement includes external surfaces of the genital 

and/or perianal area. 

d. AND the patient has tried, failed or intolerant to a 16 week course of 

Aldara® treatment. 

e. AND approval can be allowed for up to 3 weeks. 

f. AND if the patient has received previous therapy, the patient must initiate 

therapy on week 12 through 16 for an additional course of 3 weeks. The 

patient must also meet the same initial requirements and shown a positive 

benefit with the initial therapy defined as resolution or decrease in wart 

size. 

91



INTRON A 

(Continued) 

K. OR the indication is documented as AIDS-Related Kaposi’s Sarcoma. 


b. AND the prescribing physician is an infectious disease specialist or has 


c. AND approval can be allowed for up to one year. 

d. AND if the patient has received previous therapy, the patient must meet 

previous criteria and experience a positive response to therapy that 

includes a delay or NO disease progression. Approval can be allowed for 

up to one year. 

L. OR the indication is documented as Chronic Hepatitis C. 

a. AND the prescribing physician is a gastroenterologist or trained in 

infectious disease or has obtained a consult from the listed specialties. 

b. AND the diagnosis has been confirmed by a positive enzyme immunoassay 

(eg. EIA, ELISA). 

c. AND a HCV RNA quantitative assay has been performed to confirm 

active HCV replication. 

d. AND a biopsy has been performed showing that the patient has a fibrosis 

level of 1 through 4. 

e. AND the patient has had at least a 3 month trial and failure to Pegasys® or 

Peg-Intron®. 

f. AND the patient has had at least a 3 month trial and failure to ribavirin. 

g. AND therapy will be given in conjunction with ribivarin therapy. 

h. AND approval can be allowed for up to 16 weeks. 

i. AND if the patient has received previous 16 week therapy, the patient 

must meet previous criteria AND show a two-log drop in their HCV RNA 

level and a drop in AST and ALT lab values. If patient meets criteria, 

approval can be allowed up to a year with a lifetime maximum treatment 

of 24 months. 

M. OR the indication is documented as Chronic Hepatitis B. 

a. AND the prescribing physician is a gastroenterologist or trained in 

infectious disease or has obtained a consult from the listed specialties. 

b. AND the patient has evidence of a positive HBsAg (+ or -) serological 

marker for greater than 6 months OR evidence by a liver biopsy showing 

chronic hepatitis. (Please verify that the patient has an HBsAg serological 

marker for greater than 6 months or a positive liver biopsy by reviewing 

the patient’s drug history or chart). 

c. AND the patient has a Hepatitis B viral load greater than 100,000 copies 

per ml. 

d. AND the patient has elevations in liver aminotransferases (ALT or AST) 

that are two (2) times greater than normal. 

92



INTRON A 

(Continued) 

e. AND if the patient is 12 years of age or older, they must have tried or 

failed at least a 6 month trial of Hepsera®, Baraclude® or Tyzeka®. 

Patients age 11 years or younger do not require a trial and failure. 

(Therapy can be verified by reviewing the patient’s chart as well as 

reviewing to see that there was no drop in viral load or reduction in liver 

aminotransferases. 

f. AND the patient is not receiving duplicate therapy that includes 

Baraclude®, Tyzeka®, Epivir®, Intron A® and/or Infergen®. (Please 

verify that the patient does not have duplicate therapy by reviewing the 


g. AND approval can be allowed for up to one year. 

h. AND if the patient has received previous Intron® A treatment, there must 

be documented clinical improvement shown by a drop in viral load or 

reduction in the patient’s liver aminotransferases AND still the presence of 

a viral load for continued therapy. (Please verify patient’s chart notes to 

verify drop in viral load or reduction in liver aminotransferases from their 

starting level). 

N. OR the indication is documented as an indication listed in compendia. 

a. The prior authorization request should be reviewed by a prior 

authorization pharmacist. Pharmacist should review the drug study for: 

b. A study can be found. 

c. The study shows clinical improvement with treatment. 

d. If there are first line treatments, the patient has tried and failed. 

e. The patient meets the criteria of the study. 

f. The study has clinical validity (eg. blinded, substantial population). 

g. The study’s population meets the patient’s demographics. 

h. The patient’s disease status is not terminal and therapy will provide 

benefit. 

i. The patient will not receive duplicate therapy. 

j. Authorization period or re-treatment is within timeframe of study. 

NON COVERAGE 

Intron® A is NOT covered for members with the following criteria: 

A. Patient has a history of decompensated liver disease, autoimmune hepatitis or is 

an immunosuppressed transplant recipient. 

B. Patient has a history of a serious psychiatric condition or clinical depression. 

C. The patient has NOT received an eye exam and/or has evidence of an 

ophthalmologic disorder. 

D. The patient has an abnormal thyroid status that cannot be maintained by 

medication. 

E. The patient has a history of an autoimmune disease. 

93



INTRON A 

(Continued) 

F. The patient has undergone a liver transplant and is using therapy as a prophylaxis 

or treatment to reduce allograft failure. 

G. The indication is Hairy Cell Leukemia and the patient is under the age of 18 

and/or 

a. The physician is NOT a board certified oncologist. 

b. If the patient has received a previous therapy and he/she shows 

progression of disease while on previous therapy. 

H. The indication is Malignant Melonoma and the patient is under the age of 18 

and/or: 

a. The physician is NOT a board certified oncologist. 

b. The patient has NOT received surgical treatment within 56 weeks of the 

request. 

c. The patient has evidence of disease. 

d. If the patient has received previous therapy and he/she shows NO positive 

response with previous treatment or has had NO surgical treatment within 

56 weeks of the request. 

I. The indication is Follicular Non-Hodgkin’s Lymphoma and the patient is under 

the age of 18 and/or: The physician is NOT a board certified oncologist. 

a. Therapy will NOT be used in combination with an anthracycline 

containing medication. 

b. The patient has low-grade, low-tumor burden. 

J. The indication is Condylomata Acuminata and the patient is under the age 18 

and/or: 

a. The physician is NOT a board certified dermatologist or obtained a 

consult. 

b. The area of involvement does NOT involve external surfaces of the genital 

and/or perianal area. 

c. The patient has NOT failed a 16 week course of Aldara® treatment. 

d. If the patient has received previous therapy and the request is not on week 

12 through 16 of treatment and/or has NOT shown a positive benefit. 

K. The indication is AIDS-Related Kaposi’s Sarcoma and the patient is under the age 

of 18 and/or: 

a. The physician is not an infectious disease specialist or obtained a consult. 

b. If the patient has had previous therapy and he/she does NOT show a delay 

in disease progression. 

L. The indication is Chronic Hepatitis C and the prescribing physician is NOT a 

gastroenterologist or trained in infectious disease or obtained a consult and/or: 

a. The diagnosis has NOT been confirmed by a positive enzyme immunoassay. 

b. No assay has been done to confirm active HCV replication. 

c. A biopsy has NOT been performed or does NOT show fibrosis. 

d. The patient has NOT had a trial and failure to Pegasys® or Peg-Intron®. 

94



INTRON A 

(Continued) 

e. The patient has NOT had a trial and failure to ribivarin. 

f. If the patient has had previous therapy and he/she has NOT shown a twolog 

drop in their HCV RNA level and a drop in their AST and ALT lab 

values. 

g. The patient has had a lifetime therapy of 24 months. 

M. The indication is Chronic Hepatitis B and the prescribing physician is NOT a 

gastroenterologist or a trained Infectious disease specialist or obtained a consult 

and/or: 

a. The patient has NO evidence of an HBsAg serological marker for greater 

than 6 months or evidence of chronic hepatitis by liver biopsy. 

b. The patient does NOT have a viral load greater than 100,000 copies per 

ml. 

c. The patient does NOT have two times greater than normal liver 

aminotransferases. 

d. The patient is 12 years of age or older and has NOT had a 6 month trial 

and failure of Hepsera®, Baraclude® or Tyzeka®. 

e. The patient is receiving duplicate therapy with Hepsera®, Baraclude®, 

Epivir®, Infergen® or Tyzeka®. 

f. If the patient has had previous therapy and he/she has NOT shown a drop 

in viral load or reduction in their liver aminotransferases or NO presence 

of a viral load. 

N. The indication is listed as acute chronic hepatitis C. (Many individuals will clear 

their viral load with their own immune system). 

O. The indication is listed as a Compendia indication and no studies are found to 

validate efficacy and/or: 

a. The study shows NO clinical improvement with treatment. 

b. Patient has NOT tried first line therapy. 

c. The patient does NOT meet the criteria of the study. 

d. The study has NO clinical validity (eg. un-blinded, one patient). 

e. The study’s population does NOT meet the patient’s demographics. 

f. The patient’s disease status is terminal and therapy will provide no benefit. 

g. The patient is receiving duplicate therapy. 




Dermatologist, Oncologist, Infectious 

Disease 


Plan Year 

95



INVEGA 


Invega® is indicated: 

A. For the acute and maintenance treatment of schizophrenia. 


Invega® is covered for members who meet the following criteria: 

A. The prescribing physician is a psychiatrist or has obtained a consult from the 

listed specialty. 


C. AND the diagnosis is NOT documented as dementia-related psychosis. 

D. AND the patient does NOT have congenital long QT syndrome or NO history of 

cardiac arrhythmias. 

E. AND the diagnosis is documented as schizophrenia. 

F. AND the patient has tried and failed (schizophrenia is unmanaged) a 30-day trial 

or had unacceptable toxicity to risperidone (Risperdal®) AND at least ONE of the 

following medications: Seroquel®, Zyprexa®, Geodon®, or Abilify®. (Please 

review the patient’s drug history or chart to verify a trial to risperidone and one 

other antipsychotic medication). 

G. AND Invega® therapy will NOT be used in combination with risperidone 

therapy. (Please review the patient’s drug history or chart to verify no 

combination use with risperidone (Risperdal®). 

H. AND if the patient has received previous Invega® therapy, the provider has seen 

clinical evidence demonstrating improvement in schizophrenia symptoms. 

NON COVERAGE 

Invega® is NOT covered for members who meet the following criteria: 

A. The prescribing physician is NOT a psychiatrist or the prescriber has NOT 



C. The diagnosis is documented as dementia-related psychosis. 

D. The patient does have congenital long QT syndrome or has a history of cardiac 

arrhythmias. 

E. The diagnosis is NOT documented as schizophrenia. 

F. The patient has NOT tried and failed a 30-day trial or had unacceptable toxicity to 

risperidone (Risperdal®). 

G. The patient has NOT tried and failed a 30-day trial or had an unacceptable 

toxicity to at least ONE of the following medications: Seroquel®, Zyprexa®, 

Geodon®, or Abilify®. 

H. Invega® therapy will be used in combination with risperidone therapy. 

I. If the patient has received previous Invega® therapy and the provider has NOT 

seen any clinical evidence demonstrating improvement in schizophrenia 

symptoms. 

96



INVEGA 

(Continued) 




Psychiatrist 


Plan Year 

97



ITRACONAZOLE 


Itraconazole is indicated: 

A. For Aspergillosis, histoplasmosis, blastomycosis, candidiasis, onychomycosis. 


Itraconazole is covered for members who meet the following criteria: 

A. Diagnosis is documented as one of the above diagnoses. 

B. AND if diagnosis is aspergilosis the patient is intolerant of or refractory to 

amphotericin B therapy 

C. AND if the diagnosis is oropharyngeal candidiasis the patient is unresponsive or 

refractory to fluconazole therapy. 

D. AND if the patient is female and of childbearing years, she is NOT pregnant, has 

NO plans for pregnancy, is on a form of contraception or has NO ability to 

conceive and has been educated on the potential dangers of Itraconazole therapy. 

NON COVERAGE 

Itraconazole is NOT covered for members with the following criteria: 

A. The diagnosis is NOT documented as Aspergillosis, histoplasmosis, 

blastomycosis, candidiasis, onychomycosis. 

B. If the diagnosis is aspergillosis and the patient has NOT failed or is refractory to 

Amphotercin B therapy. 

C. If the diagnosis is onychomycosis due to dermatophytes (tinea unguium) and the 

patient IS NOT immunocompromised 

D. If the diagnosis is oropharyngeal and/or oral candidiasis and any formulation 

other than Itraconazole oral solution is requested. 

E. If the diagnosis is oropharyngeal candidiasis and the patient had NOT failed or is 

not refractory to fluconazole therapy. 


INFORMATION 



12 weeks 

98



IVEEGAM 













NON COVERAGE 






INFORMATION 



Plan Year 

99



IXEMPRA 


Ixempra® is indicated: 

A. For the treatment of breast cancer in patients with metastatic or locally advanced 

breast cancer that is resistant or refractory to anthracyclines, taxanes, and 

capecitabine OR refractory to anthracyclines and taxanes when capecitabine is 

being used in combination. 


Ixempra® is covered for members who meet the following criteria: 


B. Incident to a physician’s service 

C. AND the patient is diagnosed with metastatic or locally advanced breast cancer 

D. AND the patient has previous trial and failure on a taxane 

E. AND chart notes documenting previous failure to a taxane are received 

F. AND the patient has previous failure to anthracyclines or further therapy is 

contraindicated 

G. AND chart notes documenting failure or contraindication to anthracycline therapy 

are received 

H. AND treatment with Ixempra® follows 1 (ONE) of the following: 

I. Patient has previous trial and failure using capecitabine with chart notes 

documenting this failure are provided 

J. Patient will be using capecitabine in combination with Ixempra® and written 

medical summary is provided that shows dosing strategy 

NON COVERAGE 

Ixempra® is NOT covered for members who meet the following criteria: 


B. The diagnosis is NOT metastatic or locally advanced breast cancer 

C. The patient has NO previous treatment with anthracycline AND taxane 

D. Patient will NOT be receiving capecitabine in combination with Ixempra® 

treatment OR has not had previous failure on treatment with capecitabine 

E. Chart notes documenting previous failure or contraindication to anthracycline 

treatment, taxane trial and failure, and capecitabine failure or dosing strategy 

along with Ixempra® treatment are not received or do not address the needed 

information 



PRESCIBER RESTRICTIONS 

Oncologist 


Plan Year 

100



KEPPRA XR 


Keppra XR® is indicated: 

A. For treatment of myoclonic seizures 

B. For treatment of partial seizures 

C. For treatment of tonic-clonic seizures 


Keppra XR® is covered for members who meet the following criteria: 

A. Patient must have previous trial/failure of generic Levetiracetam 

NON COVERAGE 

Keppra XR® is NOT covered for members with the following criteria: 

A. Diagnosis is NOT myoclonic, partial, or tonic-clonic seizures 

B. Patient has no previous trial/failure of generic Levetiracetam. 


INFORMATION 



Plan Year 

101



KETEK 


Ketek® is indicated: 

A. For the treatment of community-acquired pneumonia*Ketek is no longer 

indicated for the treatment of sinusitis or bronchitis per FDA warning letter issued 

2/12/2007 


Ketek® is covered for members who meet the following criteria: 

A. The patient is diagnosed with community-acquired pneumonia 

B. AND the patient has had previous failed therapy on BOTH of the following: 

C. Azithromycin 

D. A fluoroquinolone 

E. AND chart notes are submitted that document failure on BOTH azithromycin 

AND a fluoroquinolone (including length of therapy of both agents) 

NON COVERAGE 

Ketek® is NOT covered for members who meet the following criteria: 

A. The diagnosis is NOT community-acquired pneumonia 

B. The patient has NO previous treatment with azithromycin AND a fluoroquinolone 

C. Chart notes documenting previous failure or contraindication to azithromycin 

AND a fluoroquinolone are not received or do not address the needed information 

D. The patient has previously shown macrolide hypersensitivity 

E. The patient has pre-existing QT prolongation or torsades de pointes 


INFORMATION 



10 days 

102



KINERET 


Kineret® is indicated: 

A. For reducing the signs and symptoms and slowing the progression of structural 

damage of moderately to severely active rheumatoid arthritis in patients who have 

failed other therapies. 



Kineret® is covered for members who meet the following criteria: 

A. Verification of B vs. D coverage per CMS guidelines 

a. Incident to a physician’s service 

B. AND the patient must have a minimum of 4 of the following symptoms in 

accordance with American College of Rheumatology: 

a. Morning stiffness 

b. Arthritis of 3 or more joint areas 

c. Arthritis of hand joints 

d. Symmetric arthritis 

e. Rheumatoid nodules 

f. Serum rheumatoid factor 

g. Radiographic changes 

C. AND the patient must have previous trial and failure or contraindication on ALL 

of the following: 

a. 1 DMARD (Sulfasalazine, Hydroxychloroquine, Cyclosporine, 

oral/injectable Gold, Penicillamine, Azathioprine, Leflunomide, 

Methotrexate) 

b. Humira® 

D. AND chart notes documenting previous trial/failure of 1 DMARD AND Humira® 

NON COVERAGE 

Kineret® is NOT covered for members who meet the following criteria: 

A. Medication is paid for by Part B per CMS guidelines 

B. The diagnosis is NOT rheumatoid arthritis 

C. The patient has NO previous treatment with The patient has no previous 

trial/failure of at least 1 DMARD AND Humira® 

D. Chart notes documenting patient’s previous trials and failures are not provided or 

do not address the needed information. 

i. Route of administration is IM or IV 

ii. Patient is currently immunosuppressed or has current infection 


Chart notes as per Covered Uses 


Rheumatologist and Neurologist 


Plan Year 

103



LAMISIL AT TOPICAL SPRAY 1% 


Lamisil AT Topical Spray 1%® is indicated: 

A. For the treatment of tinea infections due to susceptible organisms Interdigital 

tinea pedis (athlete’s foot), tinea cruris (jock itch), or tinea corporis (ringworm). 


Lamisil AT Topical Spray 1%® is covered for members who meet the following criteria: 

A. Diagnosis is documented as interdigital tinea pedis (athlete’s foot), tinea cruris 

(jock itch), or tinea corporis (ringworm). 

B. Patient has completed a documented 4 week trail and failure of generic terbinafine 

cream. 

NON COVERAGE 

Lamisil AT Topical Spray 1%® is NOT covered for members with the following criteria: 

A. The diagnosis is NOT documented as interdigital tinea pedis (athlete’s 

foot), tinea cruris (jock itch), or tinea corporis (ringworm). 

B. The patient has not completed a documented 4 week trial and error of 

generic terbinafine cream. 


INFORMATION 



Plan Year 

104



LETAIRIS 


Letairis® is indicated: 

A. For the treatment of pulmonary hypertension in patients with WHO Class II or III 

symptoms, to improve exercise capacity and to delay clinical worsening. 


Letairis® is covered for members who meet the following criteria: 

A. The providing prescriber is a board certified pulmonologist or cardiologist. 

B. Diagnosis is documented as pulmonary hypertension in patients with WHO Class 

II or III symptoms. 

C. AND if the patient is female and of childbearing years, she is NOT pregnant, has 


conceive and has been educated on the potential dangers of Letairis® therapy. 

D. PAH is not associated with portal hypertension, sickle cell disease, or 

thromboembolic disease. 

E. Baseline liver aminotranferases are less than 3X ULN. 

F. Mean PAP is greater than or equal to 25mm Hg at rest. 

G. Documented trial and failure of treatment with a calcium channel blocker. 

NON COVERAGE 

Letairis® is NOT covered for members with the following criteria: 

A. The diagnosis is NOT documented as pulmonary hypertension in patients with 

WHO Class II or III symptoms 

B. Diagnosis has NOT been confirmed by a board certified pulmonologist or 

cardiologist. 

C. The patient is female and of childbearing years, she is pregnant, has plans for 

pregnancy, is not on a form of contraception or has the ability to conceive. 

D. The patient has PAH associated with portal hypertension, sickle cell disease, or 

thromboembolic disease. 

E. Baseline liver aminotranferases are greater than 3X ULN. 

F. Mean PAP is less than 25mm Hg at rest. 

G. No documented trial and failure of treatment with a calcium channel blocker. 




Pulmonologist and Cardiologist 


Plan Year 

105



LEUCOVORIN 


Leucovorin is indicated: 

A. For the treatment of florouracil therapy, macrocytic anemia, megaloblastic 

anemia, MTX toxicity prophylaxis, pyrimethamine toxicity/prophylaxis, 

trimethoprim toxicity/prophylaxis, trimetrexate toxicity/prophylaxis 


Leucovorin is covered for members who meet the following criteria: 

A. Patient is prescribed Leucovorin for an indicated diagnosis as illustrated above 

B. AND patient does not suffer from pernicious anemia 

C. AND B vs. D criteria determines that the medications should be covered by 


NON COVERAGE 

Leucovorin is NOT covered for members who meet the following criteria: 

A. Non approved indications 

B. Patients that have pernicious anemia 


INFORMATION 



Plan Year 

106


Cladribine is indicated: 

A. Hairy Cell Leukemia 



LEUSTATIN 


Cladribine is covered for members who meet the following criteria: 

A. Patient is diagnosed with Hairy Cell Leukemia 

B. AND is being diagnosed by an Oncologist 

C. AND the medication meets B vs. D determination criteria that authorized 


NON COVERAGE 

Cladribine is NOT covered for members with the following criteria: 





Oncologist 


Plan Year 

107



LIDODERM 


Lidoderm® is indicated: 

A. For treatment of postherpetic neuralgia 



Lidoderm® is covered for members who meet the following criteria: 

A. Diagnosis is documented as postherpetic neuralgia 

B. Patient has completed a documented 1 month trial and failure of two of the 

following: 

a. Opiate analgesics 

b. Gabapentin 

c. Tricyclic antidepressants (amitriptyline, nortriptyline or desipramine) 

d. Topical capsaicin 

NON COVERAGE 

Lidoderm® is NOT covered for members who meet the following criteria: 

A. Diagnosis is NOT documented as postherpetic neuralgia 

B. Patient has NOT completed a documented 1 month trial and failure of two of the 

following: 

a. Opiate analgesics 

b. Gabapentin 

c. Tricyclic antidepressants (amitriptyline, nortriptyline or desipramine) 

d. Topical capsaicin. 


INFORMATION 



3 months 

108



LOVAZA 


Lovaza® is indicated: 

A. As an adjunct to diet to reduce triglyceride levels in adult patients with very 

high (Greater than or equal to 500 mg/dL) triglyceride levels. 


Lovaza® is covered for members who meet the following criteria: 

A. The patient is 18 years of age or older. 

B. AND the patient has a triglyceride level of 500 mg/dL or greater. (Please review 

the patient’s chart to verify their triglyceride level). 

C. AND the patient has tried and failed or is intolerant to at least a 60-day drug 

regimen to two of the following drug classes (Please review the patient’s drug 

history or chart to verify the use of each drug class): 

a. Niacin (e.g. Niaspan®, Niacor®, niacin). 

b. Fenofibrate (e.g. Tricor®, Triglide®, Lofibra®, Antara®, fenofibrate). 

c. Gemfibrozil (e.g. gemfibrozil, Lopid®). does NOT have gastroparesis. 

D. AND if the patient has had previous Lovaza® therapy, he/she must show a 

reduction in their triglyceride level since initiating Lovaza® therapy. 

NON COVERAGE 

Lovaza® is NOT covered for members who meet the following criteria: 

A. The patient is under the age of 18 years old. 

B. The patient has a triglyceride level less than 500 mg/dL. 

C. The patient has NOT tried and failed or is intolerable to at least a 60-day drug 

regimen to two of the following drug classes: 

a. Niacin (e.g. Niaspan®, Niacor®, niacin). 

b. Fenofibrate (e.g. Tricor®, Triglide®, Lofibra®, Antara®, fenofibrate). 

c. Gemfibrozil (e.g. gemfibrozil, Lopid). 

D. If the patient has had previous Lovaza® therapy and he/she has not shown a 

reduction in their triglyceride level since initiating Lovaza® therapy. 


INFORMATION 



Plan Year 

109



LUPRON DEPOT 


Lupron® is indicated: 

A. For the palliative treatment of advanced prostate cancer, particularly when 

orchiectomy or estrogen therapy are not indicated or are unacceptable 

B. For the management of endometriosis including pain relief and reduction of 

endometriotic lesions 

C. For the treatment of central precocious puberty (idiopathic or neurogenic) in 

children less than 8 or 9 years old 

D. For the preoperative treatment of anemia due to uterine leiomyomata (fibroids) in 

combination with iron supplementation when iron therapy alone fails to correct 

the anemia 


Lupron® is covered for members who meet the following criteria: 

A. The documented diagnosis is one of the FDA approved indications listed above. 


documented as unacceptable. 

C. If the diagnosis is endometriosis the patient has completed documented trial and 

failures of at least two of the following: oral contraceptives, 

medroxyprogesterone, and Danazol 

D. If the diagnosis is precocious puberty, patient must be less than 9 years old 


NON COVERAGE 

Lupron® is NOT covered for members with the following criteria: 

A. If there is not a documented diagnosis as listed under the FDA-approved 

indications above. 


not indicated for are unacceptable. 

C. If the diagnosis is endometriosis, the patient has NOT completed a documented 

trial and failure of at least two of the following: oral contraceptives, 

medroxyprogesterone, and Danazol. 

D. If the diagnosis is precocious puberty, the patient is NOT less than 9 years old at 

beginning of treatment. Treatment should be discontinued before age 11 for 

females and age 12 for males. 

E. If the patient is female and she is pregnant, has plans for pregnancy or has NOT 

been educated on the potential dangers of Lupron® therapy in pregnancy. 




OBGYN and Oncologist and 



3 months 

110



MARINOL 


Marinol® is indicated: 

A. For the treatment of anorexia associated with weight loss in patients with AIDS. 

B. For the treatment of nausea and vomiting associated with cancer chemotherapy in 

patients who have failed to respond adequately to conventional antiemetic 

treatments. 

C. All other FDA approved indications not otherwise excluded from Part D. 


Marinol® is covered for members who meet the following criteria: 

A. The diagnosis is documented as anorexia associated with weight loss in a patient 

with AIDS. 

a. AND the patient has had an involuntary weight loss of Greater than 10% 

of pre-illness baseline body weight or body mass index (BMI) Less than 

20 kg/m 2 in the absence of a concurrent illness or medical condition other 

than HIV infection that may cause weight loss. 

b. AND the patient has failed to respond to a 30-day drug regimen of 

megestrol (Megace®) AND an anabolic steroid (e.g. Testim®, 

Androgel®, testosterone enanthate, testosterone cypionate, Testoderm®, 

Androderm®, methyltestosterone, or fluoxymesterone). (Please verify the 

use of megestrol and an anabolic steroid by reviewing the patient’s drug 


c. AND if the patient has received previous Marinol® therapy, he/she must 

show a positive response to treatment by maintaining or increasing their 

initial weight and/or muscle mass before initiating Marinol® therapy. 

B. The diagnosis is documented as nausea and vomiting associated with cancer 

chemotherapy in a cancer patient. 

a. AND the patient is receiving a chemotherapy or radiation regimen. 

(Please verify in the patient’s chart notes). 

b. AND if Marinol® therapy is NOT being used as a full therapeutic 

replacement for an intravenous anti-emetic drug (e.g., Aloxi®, Zofran®). 

If Marinol® is used as a full replacement of IV antiemetic administration 

and the treatment is or will be within 48 hours of cancer treatment, 

Medicare Part B will pay for the therapy. Please verify with the provider). 

c. AND if Marinol® therapy is being used as a full therapeutic replacement 

for an intravenous anti-emetic drug (e.g., Aloxi®, Zofran® BUT 

Marinol® treatment will NOT be within 48 hours of cancer treatment. (If 

Marinol® is used as a full replacement of IV antiemetic administration 

and the treatment is or will be within 48 hours of cancer treatment, 

Medicare Part B will pay for the therapy. (Please verify with the provider). 

111



MARINOL 

(Continued) 

d. AND the patient has had a full trial and failure through at least one cycle 

of chemotherapy with IV Zofran® AND at least two of the following oral 

anti-emetic agents: 

i. metoclopramide. 

ii. promethazine. 

iii. prochlorperazine. 

iv. dimenhydrinate. 

v. meclizine. 

vi. trimethobenzamide. 

vii. Oral 5-HT3 receptor Antagonist (e.g., Anzemet®, Zofran®, 

Kytril®, Zomig®). 

e. AND if the patient has received previous Marinol® therapy, he/she must 

show a positive response by showing a reduced incidence of emesis and/or 

nausea. 

NON COVERAGE 

Marinol® is NOT covered for members with the following criteria: 

A. The diagnosis is not documented as anorexia associated with weight loss in a 

patient with AIDS or nausea and vomiting associated with cancer chemotherapy 

in a cancer patient. 

B. The diagnosis is documented as anorexia associated with weight loss in a patient 

with AIDS and the patient meets any of the following criteria. 

a. The patient has NOT had an involuntary weight loss of Greater than 10% 




b. The patient has NOT failed to respond to a 30-day drug regimen of 



Androderm®, methyltestosterone, or fluoxymesterone). 

c. If the patient has received previous Marinol® therapy and he/she has NOT 

shown a positive response to treatment by maintaining or increasing their 

initial weight and/or muscle mass before initiating Marinol® therapy. 

C. The diagnosis is documented as nausea and vomiting associated with cancer 

chemotherapy in a cancer patient. 

a. The patient is NOT receiving a chemotherapy or radiation regimen. 

b. Marinol® therapy is being used as a full therapeutic replacement for an 

intravenous anti-emetic drug (e.g., Aloxi®, Zofran®) and treatment is or 

will be within 48 hours of cancer treatment. 

112



MARINOL 

(Continued) 

c. The patient has NOT had a full trial and failure through at least one cycle 

of chemotherapy with IV Zofran® AND at least two of the following oral 

anti-emetic agents: 

i. metoclopramide. 

ii. promethazine. 

iii. prochlorperazine. 

iv. dimenhydrinate. 

v. meclizine. 

vi. trimethobenzamide. 

vii. Oral 5-HT3 receptor Antagonist (e.g., Anzemet®, Zofran®, 

Kytril®, Zomig®). 

d. If the patient has received previous Marinol® therapy and he/she has not 

shown a positive response by showing a reduced incidence of emesis 

and/or nausea. 


INFORMATION 



6 months 

113


Mesnex® is indicated: 

A. Hemorrhagic Cystitis 



MESNEX 


Mesnex® is covered for members who meet the following criteria: 


B. AND patient is being administered with ifosfamide or cyclophosphamide 

C. AND B vs. D criteria indicates that coverage should be through Medicare Part D 

NON COVERAGE 

Mesnex® is NOT covered for members with the following criteria: 

A. Receiving medications other than ifosfamide or cyclophosphamide. 




Oncologist 


3 months 

114



MIACALCIN This PA criteria is for the injection only 


Miacalcin® is indicated: 

A. Hypercalcemia 

B. Osteoporosis 

C. Paget’s Disease 


Miacalcin® is covered for members who meet the following criteria: 

A. Injection for Hypercalcemia and Paget’s Disease: 

a. Patient is diagnosed with approved indication as stated above 

b. AND B vs. D criteria indicates that coverage should be through Medicare 

Part D 

B. Injection for Osteoporosis: 

a. Patient can not use Nasal Miacalcin 

b. AND has diagnosis of Osteoporosis indicated by a T-Score of 2.5 or more 

standard deviations below the young-adult mean BMD. 

NON COVERAGE 

Miacalcin® is NOT covered for members with the following criteria: 



INFORMATION 



Plan Year 

115



MYFORTIC 


Myfortic® is indicated: 

A. For the prophylaxis of organ rejection in patients receiving allogeneic renal 

transplants, administered in combination with cyclosporine and corticosteroids. 


Myfortic® is covered for members who meet the following criteria: 

A. If the patient is female and of childbearing years, she is NOT pregnant, has NO 

plans for pregnancy and has been educated on the potential dangers of Myfortic® 

therapy. 

B. AND diagnosis is documented as the prophylaxis of organ rejection in a patient 


C. AND the transplant was NOT covered by Medicare Part A. (Please verify the 

payer of the transplant. If Medicare paid for the transplant, Myfortic® is covered 

by Medicare Part B). 

D. AND approval can be allowed for up to one year. 

NON COVERAGE 

Myfortic® is NOT covered for members with the following criteria: 

A. The patient is female and of childbearing years and is pregnant or has plans for 

pregnancy. 

B. The diagnosis is NOT documented as prophylaxis of organ rejection after 


C. The transplant was paid for by Medicare Part A. 


INFORMATION 



Plan Year 

116



MYOZYME 


Myozyme® is indicated: 

A. For use in patients with Pompe disease (alpha glucosidase deficiency). 

Myozyme® has been shown to improve ventilator-free survival in patients with 

infantile-onset Pompe disease. Use of Myozyme® in patients with other forms of 

Pompe disease has not been adequately studied to assure safety and efficacy. 


Myozyme® is covered for members who meet the following criteria: 

A. Diagnosis is documented as infantile-onset Pompe disease (glycogen storage 

disease type II, GSD II, glycogenosis type II, acid maltase deficiency disease). 

B. AND diagnosis has been confirmed by an enzymatic assay showing a deficiency 

in acid alpha glucosidase. 

C. AND the patient is NOT receiving treatment at home. (Myozyme® therapy 

would be paid by Medicare Part B). 

D. AND/OR if the patient is in a hospital or long term care facility (LTC) or skilled 

nursing facility (SNF) and the payer of the stay is NOT Medicare Part A. 

(Medicare Part A can pay for the first 110 days and Myozyme® therapy would be 

paid by Medicare Part B. (Please verify payer). 

E. AND the medication is NOT being administered using an IMPLANTABLE 

F. PUMP. (Please verify the delivery method of the medication. Administration 

through an implantable pump is covered under Medicare Part B.) 

G. AND approval can be allowed for up to one year. 

NON COVERAGE 

Myozyme® is NOT covered for members who meet the following criteria: 

A. Diagnosis is NOT documented as infantile-onset Pompe disease (glycogen 

storage disease type II, GSD II, glycogenosis type II, acid maltase deficiency 

disease). 

B. Diagnosis is documented as late-onset Pompe disease. 

C. Diagnosis has NOT been confirmed by an enzymatic assay showing a deficiency 

in acid alpha glucosidase. 

D. The patient is receiving treatment at home. (Myozyme® therapy would be paid 


E. The patient is in a hospital or long term care facility (LTC) or skilled nursing 

facility (SNF) and the payer of the stay is Medicare Part A. (Medicare Part B 

would pay for Myozyme® therapy). 

F. The patient is in a hospital or LTC or SNF and the medication is being 

administered using an IMPLANTABLE PUMP. (Administration through an 

implantable pump is covered under Medicare Part B.) 

REQUIRED MEDCIAL INFORMATION 



Endocrinology 


Plan Year 

117



NAGALZYME 


Naglazyme® is indicated: 

A. For patients with Mucopolysaccharidosis VI (MPS VI). 


Naglazyme® is covered for members who meet the following criteria: 

A. Diagnosis is documented as mucopolysaccharidosis VI (MPS VI). 

B. AND diagnosis has been confirmed by an enzymatic assay showing a deficiency 

in N-acetylgalactosamine activity. 

C. AND the patient has at least one of the listed MPS VI symptoms. 

Impaired vision Recurrent otitis media. Recurrent 

sinopulmonary 

infections 

Impaired hearing Upper airway obstruction Malaise and reduced 

endurance 

Corneal clouding Macrocephaly Reduced joint range 

of motion 

Progressively 

coarse facial 

features 

Carpal tunnel 

syndrome 

Cardiac 

abnormalities and 

valvular disease 

Reduced 

pulmonary 

function 

Short stature 

Communicating 

hydrocephalus 

Spinal cord compression 

Hepatospenomegaly 

Umbilical and 

inguinal hernias 

Hepatosplenomegaly 

Sleep apnea 

Dysostosis mutiplex 

D. AND if the patient has previously received Naglazyme® therapy, they must show 

an improvement in walking and/or stair-climbing capacity since initiating therapy. 

NON COVERAGE 

E. Naglazyme® is NOT covered for members with the following criteria: 

F. The diagnosis is NOT documented as mucopolysaccharidosis VI (MPS VI). 

G. Diagnosis has NOT been confirmed by enzymatic assay that shows a deficiency 

in N-acetylgalactosamine activity. 

H. The patient does NOT have at least one of the listed symptoms of MPS VI. 

I. If the patient has previously received Naglazyme® therapy and they have not 

shown an improvement in walking or stair-climbing capacity. 






Plan Year 

118



NEURONTIN SOLUTION 


Neurontin® is indicated: 

A. For the symptomatic treatment of neuropathic pain associated with post-herpetic 

neuralgia and diabetic peripheral neuropathy 

B. For the adjunctive treatment of partial seizures with or without secondary 

generalized tonic-clonic seizures 

DOSE 

The recommended dose of Neurontin® is: 

A. Initially 300 mg PO three times per day. Can increase up to 3600 mg/day. 


Neurontin® is covered for members who meet the following criteria: 

A. The patient is diagnosed with either neuropathic pain OR partial seizures 

B. AND the patient has previous trial/failure with maximum doses of oral gabapentin 

capsules/tablets 

C. AND chart notes are received documenting trial of gabapentin capsules/tablets 

NON COVERAGE 

Neurontin® is NOT covered for members who meet the following criteria: 

A. The diagnosis is NOT neuropathic pain OR partial seizures 

B. The patient has NO previous treatment with maximum doses of gabapentin 

capsules/tablets 

C. Chart notes documenting previous failure or contraindication to gabapentin 

capsules/tablets are not received or do not address the needed information 


INFORMATION 



Plan Year 

119



NEUTREXIN 


Neutrexin® is indicated: 

A. For the treatment of moderate-to-severe pneumocystis pneumonia (PCP) in 

immunocompromised patients 


Neutrexin® is covered for members who meet the following criteria: 

A. Verification of B vs. D criteria per CMS guidelines 

B. Incident to a physician’s service 

C. AND the patient is diagnosed with moderate to severe pneumocystis pneumonia 

(PCP) 

D. AND the patient is immunocompromised (including HIV and oncology patients) 

E. AND the patient has previous trial/failure or contraindication to 

sulfamethoxazole/trimethoprim AND pentamidine 

F. AND the patient is concurrently taking leucovorin with treatment 

G. AND chart notes are received that document patient’s immune status as well as 

previous trial and failure or contraindication to sulfamethoxazole/trimethoprim 

AND pentamidine 

NON COVERAGE 

Neutrexin® is NOT covered for members who meet the following criteria: 

A. Medication is paid for by Part B 

B. The diagnosis is NOT pneumocystis pneumonia 

C. The patient is NOT immunocompromised 

D. The patient has NO previous trials with sulfamethoxazole/trimethoprim AND 

pentamidine 

E. The patient is NOT taking leucovorin with treatment 

F. Chart notes documenting previous failure or contraindication to 

sulfamethoxazole/trimethoprim AND pentamidine are not received or do not 

address the needed information 






21 days 

120



NEXAVAR 


Nexavar® is indicated: 

A. For the treatment of unresectable hepatocellular carcinoma. 

B. For the treatment of advanced renal cell carcinoma. 


Nexavar® is covered for members who meet the following criteria: 

A. The prescribing physician is a board certified oncologist or nephrologist. 



Nexavar® therapy in pregnancy. 

C. AND the patient will NOT be treated with interferon alfa (Roferon-A®, 

Pegasys®, Intron-A®, Peg-Intron®) or interleukin-2 (Proleukin®) therapy in 

combination with Nexavar® treatment. (Please verify the patient’s drug history or 

patient chart to verify that the patient is not on interferon alfa or interleukin-2 

therapy). 

D. AND the diagnosis is documented as treatment for hepatocellular carcinoma. 

a. AND the carcinoma is surgically unresectable. 

b. AND if the patient has received previous Nexavar® therapy, he/she has 

evidence of clinical improvement from the pretreatment report and or the 

patient has stable disease (tumor size within 25% of baseline). 

E. AND/OR the diagnosis is documented as metastatic (advanced) renal cell 

carcinoma. 


b. AND if the patient has had previous Nexavar® therapy, he/she has 

evidence of clinical improvement from the pretreatment report and or the 

patient has stable disease (tumor size within 25% of baseline). 

NON COVERAGE 

Nexavar® is NOT covered for members who meet the following criteria: 



been educated on the potential dangers of Nexavar® therapy in pregnancy. 

C. The patient will be receiving interferon alfa or Proleukin® therapy in combination 

with Nexavar® treatment. 

D. The diagnosis is NOT documented as treatment for hepatocellular or renal cell 

carcinoma. 

E. The diagnosis is documented as treatment for hepatocellular carcinoma and they 

meet any of the following criteria. 

a. The carcinoma is resectable. 

b. If the patient has received previous Nexavar® therapy and he/she has 

evidence of tumor growth greater than 25% of the baseline tumor size. 

121



NEXAVAR 

(Continued) 

F. The diagnosis is documented as renal cell carcinoma and they meet any of the 


a. The carcinoma is not metastatic. 

b. The carcinoma can be surgically resectable. 

c. If the patient has had previous Nexavar® therapy and he/she has evidence 

of tumor growth greater than 25% of the baseline tumor size. 


INFORMATION 



Plan Year 

122



NICOTROL 


Nicotrol® is indicated: 

A. For use as an aid in the treatment of nicotine withdrawal following cessation of 

smoking 

DOSE 

The recommended dose of Nicotrol® is: 

A. Nasal spray: 1 spray into each nostril 1-2 times each hour as needed whenever the 

patient feels the need to smoke. Recommended duration is three months. 

B. Inhaler: 24 to 64 mg (6 to 16 cartridges) per day for up to 12 weeks. 


Nicotrol® is covered for members who meet the following criteria: 

A. The patient is diagnosed with nicotine addiction or withdrawal following 

cessation of smoking 

B. AND the patient has stopped smoking previous to receiving medication 

C. AND the patient is enrolled in a smoking cessation program 

D. AND documentation verifying enrollment in a smoking cessation program is 

provided 

E. AND the request is for 3 months or less 

NON COVERAGE 

Nicotrol® is NOT covered for members who meet the following criteria: 

A. The diagnosis is NOT withdrawal due to smoking cessation 

B. The patient has NOT stopped smoking 

C. The patient is NOT enrolled in a smoking cessation program 

D. The request is for more than 3 months 

E. Documentation of enrollment in a smoking cessation program is received or does 

not address the needed information 


INFORMATION 



3 months 

123



NOVANTRONE 

\FDA-APPROVED INDICATIONS 

Mitoxantrone is indicated: 

A. For the treatment of acute myelogenous leukemia (AML) 

B. For the treatment of secondary (chronic) progressive, progressive relapsing, or 

worsening relapsing-remitting multiple sclerosis to reduce neurologic disability 

and/or frequency of clinical relapses 

C. For the palliative treatment of severe pain related to advanced hormone-refractory 

prostate cancer in combination with corticosteroids 


Mitoxantrone® is covered for members who meet the following criteria: 

A. For Acute myelogenous leukemia: 

a. The documented diagnosis is acute myelogenous leukemia 

B. For Multiple Sclerosis: 

a. The diagnosis is documented as secondary (chronic) progressive, 

progressive relapsing, or worsening relapsing-remitting multiple sclerosis 

C. For Prostate Cancer: 

a. Tthe diagnosis is documented as prostate cancer 

NON COVERAGE 

Mitoxantrone is NOT covered for members who meet the following criteria: 

A. The diagnosis is NOT acute myelogenous leukemia, prostate cancer or secondary 

(chronic) progressive, progressive relapsing, or worsening relapsing-remitting 

multiple sclerosis 

B. The diagnosis is documented as primary progressive multiple sclerosis 


INFORMATION 



Plan Year 

124



NOVAREL| OVIDREL | PREGNYL 



Novarel is indicated for: 



C. Ovulation induction 


Novarel is covered for members who meet either of the following criteria: 








NON COVERAGE 

Novarel is NOT covered for members of the following criteria: 

A. In a Male patient: 

a. If the patient does NOT have a diagnosis of prepubertal cryptochidism not 


deficiency. 

b. If the patient does have any signs of the following diagnoses: 



c. If it is being used in the treatment of obesity. 

B. If patient is female 






Plan Year 

125



OCTAGAM 













NON COVERAGE 






INFORMATION 



Plan Year 

126



OCTREOTIDE | SANDOSTATIN LAR® | SANDOSTATIN 


Octreotide is indicated for: 

A. Acromegaly, Inadequate response to or ineligible for surgery, radiation, or 

bromocriptine mesylate 

B. Carcinoid syndrome, Metastatic; symptomatic treatment 

C. Vasoactive intestinal peptide-secreting tumor, Associated diarrhea 

Safety and efficacy in children not established 


Octreotide is covered for members who meet either of the following criteria: 

A. AND If the patient has ONE of the following diagnoses 

a. Acromegaly 

b. Vasoactive intestinal peptide-secreting tumor 

c. Carcinoid syndrome 

B. AND If the prescriber has documentation of the diagnosis with corresponding 

chemical markers of the above. 

NON COVERAGE 

Octreotide is NOT covered for members who meet either of the following criteria: 

A. If the patient does NOT have ONE of the following diagnoses? 

a. Acromegaly 

b. Vasoactive intestinal peptide-secreting tumor, or 

c. Carcinoid syndrome, or 

B. If the prescriber does NOT have documentation of the diagnosis with 

corresponding chemical markers of the above. 




Endocrinologist, Gastroenterologist and 

Oncologist 


6 months 

127



ORENCIA 


Orencia® is indicated: 

A. For the treatment of moderate to severe rheumatoid arthritis AND juvenile 

idiopathic arthritis to reduce signs and symptoms of the disease, to induce major 

clinical response, to slow the progression of structural damage, and to improve 

physical function in patients with an inadequate response to one or more disease 

modifying anti-rheumatic drugs (DMARDs) such as methotrexate or TNF 

antagonists. 



Orencia® is covered for members who meet the following criteria: 

A. Patient must be diagnosed with rheumatoid arthritis OR juvenile idiopathic 

arthritis 

B. AND the patient must have a minimum of 4 of the following symptoms in 

accordance with American College of Rheumatology: 

a. Morning stiffness 

b. Arthritis of 3 or more joint areas 

c. Arthritis of hand joints 

d. Symmetric arthritis 

e. Rheumatoid nodules 

f. Serum rheumatoid factor 

g. Radiographic changes 

C. AND the patient must have previous trial and failure or contraindication on ALL 

of the following: 

a. 1 DMARD (Sulfasalazine, Hydroxychloroquine, Cyclosporine, 

oral/injectable Gold, Penicillamine, Azathioprine, Leflunomide, 

Methotrexate) 

b. Humira® 

D. AND chart notes documenting previous trial/failure of 1 DMARD AND Humira® 

NON COVERAGE 

Orencia® is NOT covered for members who meet the following criteria: 

A. The patient is NOT diagnosed with rheumatoid arthritis OR juvenile idiopathic 

arthritis 

B. The patient has Less than 4 of symptoms in accordance with American College of 

Rheumatology 

C. The patient has no previous trial/failure of at least 1 DMARDs AND Humira® 




INFORMATION 



Plan Year 

128



ORFADIN 


Orfadin® is indicated: 

A. For the treatment of heredity tyrosinemia type I. 



Orfadin® is covered for members who meet the following criteria: 

A. Patient must be diagnosed with hereditary tyrosinemia type I. 

B. AND the patient must have documented treatment protocol of protein-restricted 

diet that is low in phenylalanine. 

C. AND the patient’s baseline liver function tests (LFTs) must be within normal 

limits. 

D. AND the patient’s baseline LFTs must be submitted via the prescribing physician 

for evaluation. 

NON COVERAGE 

Orfadin® is NOT covered for members who meet the following criteria: 

A. The patient is NOT diagnosed with hereditary tyrosinemia type I 

B. The patient does NOT have documented treatment protocol of protein-restricted 

diet 

C. The patient’s baseline LFTs are not within normal limits 

D. Chart notes documenting patient’s baseline LFTs are not provided or do not 

address the needed information. 






Plan Year 

129


Orthoclone® is indicated: 

A. Heart Transplant Rejection 

B. Kidney Transplant Rejection 

C. Liver Transplant Rejection 



ORTHOCLONE 


Orthoclone® is covered for members who meet the following criteria: 

A. Patients being treated for Heart, Lung, or Kidney transplant 

B. AND has been unresponsive to high dose steroids 

C. AND is suffering Acute rejection 

D. AND patient is free of hypervolemia 

E. AND B vs. D criteria is determined that coverage should be through Medicare 

Part D 

NON COVERAGE 

Orthoclone® is NOT covered for members who meet the following criteria: 

A. Not being used for Acute rejection 

B. Patient suffers hypervolemia 

C. If Medication should be covered by Medicare B 


INFORMATION 



Plan Year 

130



OXANDROLONE 


All FDA-approved indications not otherwise excluded from Part D 


Plan Year 

131



OXSORALEN 


Oxsoralen® is indicated: 

A. For the treatment of cutaneous T-cell lymphoma 

B. For the treatment of psoriasis 

C. For the treatment of vitiligo 



Oxsoralen® is covered for members who meet the following criteria: 

A. Patient must be diagnosed with T-cell lymphoma OR psoriasis OR vitiligo. 

B. AND the patient must have previous trial/failure or contraindication to ALL of the 

following: 

a. At least 1 topical steroid 

b. Dovonex®. 

C. AND chart notes must be submitted documenting previous trials on topical steroid 

and Dovonex®. 

NON COVERAGE 

Orxsoralen® is NOT covered for members who meet the following criteria: 

A. The patient is NOT diagnosed with T-Cell lymphoma, psoriasis, or vitiligo 

B. The patient has NO previous trial on at least 1 topical steroid and Dovonex® 

C. Chart notes documenting patient’s previous trials on topical steroids and 

Dovonex® are not submitted or do not address the needed information. 




Dermatologist and Oncologist 


Plan Year 

132



PAMIDRONATE 


pamidronate is indicated: 

A. For the treatment of hypercalcemia 

B. For the treatment of osteolytic metastases 

C. For the treatment of Paget’s disease 

D. Osteoporosis 


pamidronate is covered for members who meet the following criteria: 

A. Patient must be diagnosed with hypercalcemia 

B. AND the patient’s hypercalcemia must be associated with malignancy 

C. AND lab reports showing patient’s high calcium are submitted 

D. OR patient is diagnosed with osteolytic metastases 

E. AND the patient is also diagnosed with multiple myeloma 

F. AND the patient is currently receiving antineoplastic therapy 

G. OR the patient is diagnosed with Paget’s disease 

H. AND disease is moderate to severe 

I. AND patient has documented high alkaline phosphatasse and normal calcium 

levels 

J. AND osteomalacia has been ruled out 

K. OR diagnosis of osteoporosis 

L. AND the patient has previously failed at least 2 (TWO) of the following: Actonel, 

Fosamax, Boniva, Miacalcin 

M. AND Chart notes documenting failure on two of the above agents are received 

NON COVERAGE 

pamidronate is NOT covered for members who meet the following criteria: 

A. The patient is NOT diagnosed with hypercalcemia, osteolytic metastases, Paget’s 

disease, or osteoporosis 

B. The patient does NOT have the appropriate comorbidities (i.e. cancer) if 

diagnosed with hypercalcemia or 

osteolytic metastases. 

C. The patient has no previous trial/failure of Actonel, Fosamax, Boniva, or 

Miacalcin if diagnosed with 

Osteoporosis 



E. Osteomalacia has not been ruled out if patient has diagnosis of Paget’s disease 


INFORMATION 



Plan Year 

133



PANGLOBULIN 













NON COVERAGE 






INFORMATION 



Plan Year 

134



POLYGAM 













NON COVERAGE 




INFORMATION 



Plan Year 

135



PREGNYL 



Pregnyl is indicated for: 




Pregnyl is covered for members who meet either of the following criteria: 








NON COVERAGE 

Pregnyl is NOT covered for members of the following criteria: 

C. In a Male patient: 

d. If the patient does NOT have a diagnosis of prepubertal cryptochidism not 


deficiency. 

e. If the patient does have any signs of the following diagnoses: 



f. If it is being used in the treatment of obesity. 

D. If patient is female 






Plan Year 

136



PROGRAF 


Prograf® is indicated: 

A. For the prophylaxis of organ rejection in patients receiving allogeneic liver, 

kidney or heart transplants. 


Prograf® is covered for members who meet the following criteria: 

A. Diagnosis is documented as the prophylaxis of organ rejection in a patient 


B. AND the transplant was NOT covered by Medicare Part A. (Please verify the 

payer of the transplant. If Medicare paid for the transplant, Prograf® is covered 


C. AND the transplant was paid by Medicaid or other sources 

D. OR is an approved compendia indication. 

E. AND the Prograf® formulation is the oral tablet. 

F. AND approval can be allowed for up to one year. 

G. OR the Prograf® formulation is the IV vial. 

H. AND the patient is in a hospital or long term care facility (LTC) or skilled nursing 

facility (SNF) and the payer of the stay is NOT Medicare Part A. (Medicare Part 

A can pay for the first 110 days and Prograf® therapy would be paid by Medicare 

Part B. Please verify payer). 

I. AND the medication is NOT being administered using an IMPLANTABLE 

PUMP. (Please verify the delivery method of the medication. Administration 

through an implantable pump is covered under Medicare Part B.) 

J. AND approval can be allowed for up to one year. 

K. AND/OR the patient is receiving treatment at home. 

L. AND the medication is NOT being administered using an IMPLANTABLE or 

EXTERNAL PUMP. 

M. AND approval can be allowed for up to one year. 

NON COVERAGE 

Prograf® is NOT covered for members with the following criteria: 

A. The diagnosis is NOT documented as prophylaxis of organ rejection after 


B. The transplant was paid for by Medicare Part A. 

C. The request is for Prograf® IV formulation in a patient in a hospital or LTC or 

SNF that has Medicare Part A coverage. 

D. The request is for Prograf® IV formulation and the medication is being 

administered using an implantable pump. 

E. The request is for Prograf® IV formulation in a patient at home and the 

medication is being administered using an implantable or external pump. 


INFORMATION 



Plan Year 

137



PROMACTA 


Promacta® is indicated: 

A. For the treatment of idiopathic thrombocytic purpura 

B. For the treatment of thrombocytopenia 


Promacta® is covered for members who meet the following criteria: 

A. Patient must be diagnosed with idiopathic thrombocytic purpura OR 

thrombocytopenia 

B. AND Patient must have previous trial/failure to a corticosteroid 

C. OR Patient must have previous trial/failure to immune globulin 

D. OR Patient must have had splenectomy 

NON COVERAGE 

Promacta® is NOT covered for members with the following criteria: 

A. Patient is NOT diagnosed with idiopathic thrombocytic purpura OR 

thrombocytopenia 

B. Patient has not had previous trial/failure with corticosteroid OR immune globulin 

OR splenectomy 

C. Patient must not have pre-existing chronic hepatic disease 


Chart notes documenting previous trial/failure of corticosteroid OR immune globulin OR 

chart notes documenting splenectomy. 


Plan Year 

138



PROVIGIL 


Provigil® is indicated: 

A. For improved wakefulness in adult patients with excessive sleepiness associated 

with narcolepsy, obstructive sleep apnea/hypopnea syndrome (OSAHS) and shift 

work sleep disorder (SWSD). 



Provigil® is covered for members who meet the following criteria: 

A. The prescribing physician is board certified as a sleep specialist, ear, nose and 

throat specialist, neurologist or pulmonologist or has obtained a consult from any 

of the listed specialties. 

B. Diagnosis is documented as excessive daytime sleepiness associated with 

narcolepsy. 

C. OR diagnosis is documented as shift work sleep disorder when the patient meets 

the following criteria 

D. OR diagnosis is documented as treatment of excessive daytime sleepiness 

associated with OSAHS when the patient meets the following criteria: 

a. The patient is receiving nasal continuous positive airway pressure (CPAP) 

or bi-level positive airway pressure (BIPAP) for at least 1 month, 

b. AND CPAP or BIPAP therapy must be continued on a routine basis in 

combination with Provigil® therapy, 

c. AND the daytime fatigue is significantly impacting, impairing, or 

compromising the patient’s ability to function normally, 

d. AND the patient is compliant with CPAP or BIPAP therapy. 

E. OR diagnosis is documented as fatigue associated with Multiple Sclerosis when 

the patient meets the following criteria: 

a. Patient has had an adequate trial of amantadine and fatigue is still 

unmanageable. 

b. AND Provigil® therapy will NOT be prescribed in combination with any 

of the following long acting medications used for insomnia: flurazepam, 

Dalmane®, eszopiclone, Lunesta®) estazolam, Prosom® temazepam, 

Restoril®. 

c. AND documentation that the patient is not on Xyrem® therapy. 

d. AND evidence of diagnosis documented in patient’s chart notes provided 

by prescribing provider. 

139



PROVIGIL 

(Continued) 

NON COVERAGE 

Provigil® is NOT covered for members with the following criteria: 

A. The prescribing physician is NOT board certified as a sleep specialist, ear, nose 

and throat specialist, neurologist or pulmonologist or has NOT obtained a consult 

from any of the listed specialties. 

B. If the diagnosis is OSAHS and NO NPSG diagnostic has been performed. 

C. If the diagnosis is OSAHS and the patient has not received CPAP or BIPAP 

therapy for at least 1 month. 

D. If the diagnosis is OSAHS and the daytime fatigue is NOT significantly 

impacting, impairing, or compromising the patient’s ability to function normally. 

E. If the diagnosis is OSAHS and CPAP or BIPAP therapy is NOT being continued 

with Provigil® therapy. 

F. If the diagnosis is fatigue associated with Multiple Sclerosis and the patient has 

NOT had an adequate trial of amantadine. 

G. Patient is receiving a long acting medication for insomnia. 

H. Patient is currently receiving Xyrem® therapy. 

I. Provider does not provide patient chart notes for documentation. 

J. If the diagnosis is listed as depression, Parkinsons’ disease, or fatigue not 

associated with narcolepsy, OSAHS or shift work. 


INFORMATION 



Plan Year 

140



PULMOZYME 


Pulmozyme® solution is indicated: 

A. For the management of cystic fibrosis patients to improve pulmonary function. 


Pulmozyme® is covered for members who meet the following criteria: 

A. The patient is a cystic fibrosis patient and medication is being used to improve 

pulmonary function and/or reduce the frequency of respiratory infections. 

B. AND the patient will be using one of the following nebulizers: Hudston T UPdraft 

II®, Marquest Acorn II®, PARI LC Jet+, Pari BABY®, Durable 

Sidestream®. (Safety and efficacy have only been shown with these nebulizers). 

C. AND the patient will be using one of the following compressors: Pulmo-Aide®, 

PARI PRONEB®, Mobilaire®, Porta-Neb®. (Safety and efficacy have only been 

shown with these compressors). 

D. AND the patient is being treated in a hospital or long-term care facility (LTC) or a 

skilled-nursing facility (SNF). 

E. AND the payer of the stay is NOT Medicare Part A. ((Medicare Part A can pay 

for the first 110 days and Pulmozyme® would be paid by Medicare Part B. 

Please verify payer). 

F. AND approval can be allowed for up to one year. 

G. AND/OR the patient is being treated at home. 

H. THEN Pulmozyme® is NOT covered. (Patients using a medication with a 

nebulizer are covered under Medicare Part B). 

I. AND if the patient has previously received Pulmozyme®, he/she must show an 

improvement in pulmonary function and/or reduction in the frequency of 

respiratory infections since initiating therapy. 

NON COVERAGE 

Pulmozyme® is NOT covered for members with the following criteria: 

A. Patient is NOT a cystic fibrosis patient. 

B. The medication is NOT being used to improve pulmonary function and/or reduce 

the frequency of respiratory infections. 

C. If the patient is being treated in a hospital or long-term facility (LTC) or a skillednursing 

facility (SNF) and the payer of the stay is Medicare Part A. 

D. The patient is being treated at home. (Patients using medication with a nebulizer 

are covered under Medicare Part B). 

E. If the patient has previously received Pulmozyme® and he/she has NOT shown 

an improvement in pulmonary function and/or reduction in the frequency of 

respiratory infections since initiating therapy. 




Pulmonologist 


Plan Year 

141



RANEXA 


Ranexa® is indicated: 

B. For the treatment of chronic angina. Because Ranexa® prolongs the QT interval, 

it should be reserved for patients who have not achieved an adequate response 

with other antianginal drugs. Ranexa® should be used in combination with 

amlodipine, beta-blockers or nitrates. 


Ranexa® is covered for members who meet the following criteria: 

A. The diagnosis documented as chronic angina with symptoms limiting daily 

activities. 

B. AND the prescribing physician is a board certified cardiologist or has obtained a 

consult from the listed specialty. 

C. AND the patient has NO pre-existing QT prolongation (eg. ventricular 

tachycardia, congenital long QT syndrome, uncorrected hypokalemia). 

D. AND the patient has NO hepatic impairment (Child-Pugh Classes A [mild], B 

[moderate], or C [severe]. 

E. AND the patient is NOT receiving a medication that prolongs the QT interval (eg. 

amiodarone, Cordarone®, Pacerone®, droperidol, chlorpromazine, erythromycin, 

Biaxin®, clarithromycin, sotalol, Betapace®, thioridazine, Mellaril®, flecainide, 

Tambocor®, haloperidol, Haldol®, quinine, procainamide, quinidine, Geodon®, 

Effexor XR®, Propulsid®, Risperdal®, Serevent®, Imitrex®, tamoxifen, 

tizanidine, Zanaflex®, Zomig®, Seroquel®, Tikosyn®, Anzemet®, 

dysopyramide, Norpace®, Orap®, fluoxetine, Prozac®, Foscavir®, Dynacirc®, 

isradipine, Avelox®, Amerge®, Cardene®, Sandostatin®, paroxetine, Paxil®, 

mesoridazine, or Serentil®). (Please verify that the patient is not receiving any 

of these medications by reviewing the patient’s drug history or chart). 

F. AND the patient is NOT receiving any potent CYP3A inhibitors that will affect 

the metabolism of Ranexa®. (eg. diltiazem, Cardizem®, Cartia XT®, Diltia 

XT®, Tiazac®, ketoconazole, verapamil, Calan®, Covera®, Verelan®, Isoptin®, 

vinblastine, doxorubicin, isoniazid, ritonavir, Norvir®, Kaletra®, cyclosporine, 

Viracept®, Crixivan®, Fortovase®, Invirase®, ciprofloxacin, Cipro®, 

itraconazole, Sporonax®, norfloxacin, voriconazole, Vfend®, rifampin, rifabutin). 

(Please verify that the patient is not receiving any of these medications by 


G. AND the patient has tried, failed and/or been intolerant (continues to have angina 

that limits daily activities) to a 30-day trial of at least one agent two of the 

following three classes: (Please verify that the patient has tried, failed or is 

intolerant to at least one agent in each class for at least 30 days by reviewing the 


a. Betablockers: (eg. Toprol XL®, atenolol, Coreg®, propranolol, bisprolol, 

metoprolol, timolol, acebutolol, nadolol, propranolol). 

142



RANEXA 

(Continued) 

b. Calcium Channel Blocker: (eg. amlodipine, nifedipine, nosoldipine, 

isradipine, diltiazem, nicardipine, felodipine, verapamil, Norvasc®, 

Exforge®, Caduet®, Lotrel®, Azor®). 

c. Nitrate: (eg. isosorbide, Isordil®, Dilatrate SR®, Monoket®, Ismo®, 

Imdur®, nitroglycerin, Nitro-Time®). 

H. AND therapy will be given in combination with amlodipine, a beta blocker and/or 

a nitrate. (eg. amlodipine, Norvasc®, Exforge®, Caduet®, Lotrel®, Azor®, 

Toprol XL®, metoprolol, atenolol, bisprolol, timolol, acebutolol, nadolol, 

propranolol, Coreg®, isosorbide, Isordil®, Dilatrate SR®, Monoket®, Ismo®, 

Imdur®, nitroglycerin, Nitro-Time®) (Please verify that the patient is or will be 

receiving one of these medications to be taken in combination with Ranexa® by 


I. AND if the patient has received prior treatment with Ranexa®. 

J. The patient must experience a decrease in angina frequency since initiating 

treatment. 

K. AND approval can be allowed for up to 3 months for the initial request (To ensure 

efficacy of the medication) and up to one year for extended authorization. 

NON COVERAGE 

Ranexa® is NOT covered for members with the following criteria: 

A. The diagnosis is NOT documented as chronic angina. 

B. The prescribing physician is NOT a board certified cardiologist or has NOT 


C. The patient has a pre-existing QT prolongation (eg. ventricular tachycardia, 

congenital long QT syndrome, uncorrected hypokalemia). 

D. The patient has hepatic impairment (Child-Pugh Classes A [mild], B [moderate], 

or C [severe]. 

E. The patient is receiving a medication that prolongs the QT interval. 

F. The patient is receiving a potent CYP3A inhibitors that will affect the metabolism 

of Ranexa®. 

G. The patient has NOT tried, failed and/or been intolerant (continues to have 

angina) to a 30-day trial of at least one agent in two ot the three medication 

classes of beta blockers, calcium channel blockers and nitrates. 

H. Therapy will NOT be given in combination with amlodipine, a beta blocker 

and/or a nitrate. 

I. If the patient has received prior treatment with Ranexa® and has NOT 

experienced a decrease in angina frequency since initiating treatment. 




Cardiologist 


Plan Year 

143



RAPAMUNE 


Rapamune® is indicated: 

A. For the prophylaxis of organ rejection in patients aged 13 years or older receiving 

renal transplants. 


Rapamune® is covered for members who meet the following criteria: 

A. Diagnosis is documented as the prophylaxis of organ rejection in a patient 


B. AND the transplant was NOT covered by Medicare Part A. (Please verify the 

payer of the transplant. If Medicare paid for the transplant, Rapamune® is 

covered by Medicare Part B). 

C. AND approval can be allowed for up to one year. 

D. OR the indication is documented as an indication listed in compendia. 

E. The prior authorization request should be reviewed by a prior authorization 

pharmacist. Pharmacist should review the drug study for: 

F. A study can be found. 

G. The study shows clinical improvement with treatment. 

H. If there are first line treatments, the patient must have tried and failed. (e.g. 

Psoriasis patients should have tried and failed methotrexate). 

I. The patient meets the criteria of the study. 

J. The study has clinical validity (e.g. blinded, substantial population). 

K. The study’s population meets the patient’s demographics. 

L. The patient’s disease status is not terminal and therapy will provide benefit. 

M. The patient will not receive duplicate therapy. 

N. Authorization period or re-treatment is within timeframe of study. 

NON COVERAGE 

Rapamune® is NOT covered for members with the following criteria: 

F. The diagnosis is NOT documented as prophylaxis of organ rejection after 


G. The transplant was paid for by Medicare Part A. 

H. The indication is listed in compendia and the patient has not tried and failed first 

line therapy. 

I. The indication is listed in compendia and there is no study or the study has no 

clinical validity. 

J. The patient is receiving duplicate therapy. 


INFORMATION 



Plan Year 

144



REGRANEX 


Regranex® is indicated: 

A. For the treatment of diabetic foot ulcer 

B. For the treatment of wound management 


Regranex® is covered for members who meet the following criteria: 

A. Must be used for treatment of lower-extremity diabetic ulcers 

B. AND the ulcer must extend into subcutaneous tissue 

C. AND the tissue must have an adequate blood supply 

D. AND the patient must have concurrent good ulcer treatment practices including 

ALL of the following: 

a. Debridgement 

b. Pressure relief 

c. Infection relief 

E. AND the above good ulcer treatment practices must be documented through chart 

notes 

F. AND the ulcer must be less than 10 cm 2 in size 

G. AND the patient must have somewhat controlled diabetes (A1c less than 10.0%) 

H. AND the patient’s A1c is verified though lab report submitted 

I. Initial authorization for 10 weeks. If additional authorization is needed chart 

notes showing at least a 30% reduction in ulcer size are required for additional 

approval of another 10 weeks. Total of 20 weeks of treatment. 

NON COVERAGE 

Regranex® is NOT covered for members who meet the following criteria: 

A. The patient is not diagnosed with diabetes 

B. The ulcer is greater than 10 cm 2 in size 

C. Good ulcer treatment practices are NOT being utilized 

D. Patient’s A1c is greater than 10.0% 

E. Chart notes documenting patient’s A1c are not received or do not address the 

needed information. 


INFORMATION 



10 weeks 

145



RELISTOR 


Reslistor® is indicated: 

A. For treatment of opiate-induced constipation in patients with advanced illness 

who are receiving palliative care when response to laxative therapy has been 

insufficient. 


Relistor® is covered for members who meet the following criteria: 

A. B vs D determination per CMS guidelines 

B. Patient must have previous trial/failure on BOTH of the following: 

a. Polyethylene Glycol 

b. Amitiza 

NON COVERAGE 

Relistor® is NOT covered for members with the following criteria: 

A. Diagnosis is NOT opiate-induced constipation 

B. Patient has no previous trial/failure of BOTH Polyethylene Glycol AND Amitiza 


INFORMATION 



4 Months 

146



REVATIO 


Revatio® is indicated: 

A. For the treatment of pulmonary arterial hypertension (WHO Group 1) to improve 

exercise ability. 


Revatio® is covered for members who meet the following criteria: 


B. AND the prescribing provider is a pulmonologist, and/or cardiologist or has 

obtained a consult from the listed specialties. 

C. AND the diagnosis is documented as pulmonary arterial hypertension. 

D. AND the patient is NOT on any nitrate therapy (eg. isosorbide, Isordil®, Diltrate- 

SR®, Ismo®, Monoket®, Imdur®, nitroglycerin, NitroQuick®, Nitrostat®, 

Nitrotab®, Nitro-Time®, Nitro-Bid®, Minitran®, Nitro-Dur®, Nitrek®). 

(Verification can be made by reviewing the patient’s drug history or patient’s 

chart). 

E. AND the patient does NOT have pulmonary veno-occlusive disease (PVOD), 

(contraindicated). 

F. AND the patient has NOT suffered a myocardial infarction (MI), stroke or lifethreatening 

arrhythmia with the last 6 months. (Contraindicated). 

G. AND the patient does NOT have coronary artery disease causing unstable angina. 

(Contraindicated). 

H. AND the patient does NOT have blood pressure Greater than 170/110. 

(Contraindicated). 

I. AND the patient does NOT have retinitis pigmentosa. (contraindicated). 

J. AND the patient has had an adequate trial and failure (4 weeks or more) or is not 

a candidate for calcium channel blocker therapy. (eg. nifedipine, Adalat CC®, 

Nifedical XL®, Procardia®, Procardia XL®, amlodipine, Norvasc®, diltiazem, 

Cardizem®, Cartia XT®, Dilacor XR®, Diltia XT®, Tiazac®, Cardizem CD®). 

(Verification can be made by reviewing the patient’s drug history or patient’s 

chart). 

K. AND the patient will NOT receive combination therapy with a prostacyclin 

(Flolan®, Ventavis®, Remodulin®) or an endothelin antagonist (Tracleer®) or a 

phosphodiesterase type-5 inhibitor (Viagra®) agent. Combination therapy has not 

been approved by the FDA. (Please verify that the patient is not on duplicate 

therapy by reviewing the patient’s drug history or chart). 

L. AND the diagnosis is documented as pulmonary arterial hypertension class 1 

defined by the World Health Organization (WHO). 

M. AND the diagnosis is NOT documented as pulmonary arterial hypertension class 

2, 3, or 4 defined by the WHO. 

N. AND therapy is being prescribed to improve exercise ability. 

O. AND the dose does not exceed 20 mg three times a day. 

147



REVATIO 

(Continued) 

P. AND if the patient has received previous Revatio® therapy, the patient must see 

an improvement in their exercise ability (walking distance), dyspnea fatigue 

and/or an improvement in functional status (New York Heart Association (NYHA 

functional class). 

NON COVERAGE 

Revatio® is NOT covered for members with the following criteria: 


B. The prescribing provider is NOT a pulmonologist, and/or cardiologist or obtained 

a consult from the listed specialties. 

C. The diagnosis is NOT listed as pulmonary hypertension. 

D. The diagnosis is listed as impotence. 

E. The patient is receiving nitrate therapy. 

F. The patient has pulmonary veno-occlusive disease (PVOD). 

G. The patient has suffered a MI, stroke or life-threatening arrhythmia within the last 

6 months. 

H. The patient has coronary artery disease causing unstable angina. 

I. The patient has a blood pressure Greater than 170/110. 

J. The patient has retinitis pigmentosa. 

K. The patient has NOT had an adequate 4-week trial and failure to a calcium 

channel blocker therapy. 

L. The patient will receive Tracleer®, Flolan®, Ventavis®, Viagra®, or 

Remodulin® therapy while receiving a Revatio® drug regimen. (Please verify 

that the patient does not have duplicate therapy by reviewing the patient’s drug 


M. The patient’s pulmonary arterial hypertension has NOT been classified as class 1 

defined by the WHO. 

N. The patient’s pulmonary arterial hypertension has been classified as class 2, 3, or 

4 by the WHO. 

O. Revatio® is NOT being prescribed to improve exercise ability. 

P. The dose exceeds 20 mg three times a day. 

Q. If the patient has received previous Revatio® therapy and they have NOT seen an 

improvement in their exercise ability (walking distance) and/or an improvement 

in their NYHA functional classification. 

R. Evidence of diagnosis, WHO classification, and exercise ability and/or dyspnea 

fatigue is NOT documented in the patient’s chart notes provided by prescribing 

provider. 




Pulmonologist and Cardiologist 


Plan Year 

148



REVLIMID 


Revlimid® is indicated: 

A. For the treatment of multiple myeloma when used in combination with 

dexamethasone in patients who have received at least one prior therapy. 

B. For the treatment of patients with transfusion-dependent anemia due to low or 

intermediate-1 risk myelodysplastic syndromes [MDS] associated with a deletion 

5q cytogenetic abnormality with or without additional cytogenetic abnormalities. 



Revlimid® is covered for members who meet the following criteria: 

A. If the patient is female and is of childbearing age, she is NOT pregnant, does 

NOT have plans for pregnancy, is using a reliable method of contraception and is 

participating in the RxAssist program. 

B. AND if the patient is male, he has received both oral and written warnings of the 

potential risks of taking lenalidomide and exposing a fetus to the drug. 

C. AND diagnosis is documented as multiple myeloma. 

D. AND the patient has tried and failed to respond to at least one therapy listed 

below: (Please verify that the patient has failed previous therapy by reviewing the 


a. Melphalan. 

b. Carmustine. 

c. Cyclophosphamide. 

d. Doxorubicin 

e. Doxorubicin liposomal. 

f. Bortezomib. 

g. Zoledronic Acid. 

E. AND the patient has tried and failed to respond to a thalidomide regimen. (Please 

verify that the patient has failed previous thalidomide therapy by reviewing the 

patient’s drug history and/or chart). 

F. AND lenalidomide therapy will and/or currently is being used in combination 

with dexamethasone. (Please verify by reviewing the patients drug history or 

chart). 

G. AND if the patient has received previous Revlimid® therapy, he/she has shown a 

delay or experienced no disease progression. 

H. AND/OR diagnosis is documented as transfusion-dependent anemia in a low or 

intermediate-1 risk myelodysplastic syndrome associated with a deletion 5q 

cytogenetic abnormality. 

I. AND the patient has received 2 or more units of red blood cells [RBC] within 8 

weeks of the reported anemia. 

J. AND if the patient has received previous Revlimid® therapy, he/she can show 

stabilization of anemia by having experienced one of the following: 

a. 50% reduction in blood transfusions. 

b. An increase in hemoglobin of at least 1g/dL over baseline. 

149



REVLIMID 

(Continued) 

c. The absence of the pretreatment cytogenetic abnormality or a reduction in 

the number of abnormal cells of at least 50%. 

NON COVERAGE 

Revlimid® is NOT covered for members with the following criteria: 

A. The patient is a female patient of child bearing age that is pregnant or has plans 

for pregnancy, is NOT using a reliable form of contraception or is NOT 

participating in the RxAssist program. 

B. The patient is a male and has NOT received both oral and written warnings on the 

potential risk of taking lenalidomide and exposing a fetus to the drug. 

C. The diagnosis is NOT documented as multiple myeloma or transfusion-dependent 

anemia in a low or intermediate-1 risk myelodysplastic syndrome associated with 

a deletion 5q cytogenetic abnormality. 

D. The diagnosis is documented as multiple myeloma and the patient has NOT tried 

and failed at least one of the following listed therapies: Melphalan, carmustine, 

cyclophosphamide, doxorubicin, bortezomib, or zoledronic acid. 

E. The diagnosis is documented as multiple myeloma and the patient has NOT tried 

and failed thalidomide therapy. 

F. The diagnosis is documented as multiple myeloma and the patient is NOT taking 

lenalidomide therapy in combination with dexamethasone. 

G. The diagnosis is documented as multiple myeloma in a patient previously 

receiving Revlimid® therapy and he/she has shown disease progression. 

H. The diagnosis is transfusion-dependent anemia in a low or intermediate-1 risk 

myelodysplastic syndrome associated with a deletion 5q cytogenetic abnormality 

and the patient has NOT received 2 or more units of red blood cells within 8 

weeks of the reported anemia. 

I. If the diagnosis is transfusion-dependent anemia in a low or intermediate-1 risk 

myelodysplastic syndrome associated with a deletion 5q cytogenetic abnormality 

in a patient that has received previous Revlimid® therapy and he/she has not 

shown stabilization of the anemia. 




Hematologist and Oncologist 


6 months 

150



RISPERDAL 


Risperdal® is indicated: 

A. For the acute and maintenance treatment of schizophrenia 

B. For the short-term treatment of acute mania or mixed episodes associated with 

bipolar disorder (bipolar I disorder) 

C. Irritability related to autism 


Risperdal® is covered for members who meet the following criteria: 

A. The prescribing physician is a psychiatrist or has obtained a consult from the 

listed specialty. 


C. AND the diagnosis is NOT documented as dementia-related psychosis. 

D. AND the patient does NOT have congenital long QT syndrome or NO history of 

cardiac arrhythmias. 

E. AND the diagnosis is documented as schizophrenia, acute mania or autism 

F. AND Risperdal® will NOT be used in combination with another atypical 

antipsychotic drug. (Please reviewthe patient’s drug history or chart to verify no 

combination use with another atypical antipsychotic drug) 

G. AND if the patient has received previous Risperdal® therapy, the provider has 

seen clinical evidence demonstrating improvement in schizophrenia symptoms. 

NON COVERAGE 

Risperdal® is NOT covered for members who meet the following criteria: 

A. The prescribing physician is NOT a psychiatrist or the prescriber has NOT 



C. The diagnosis is documented as dementia-related psychosis. 

D. The patient does have congenital long QT syndrome or has a history of cardiac 

arrhythmias. 

E. Risperdal® therapy will be used in combination with another atypical 

antipsychotic drug 

F. If the patient has received previous Risperdal® therapy and the provider has NOT 

seen any clinical evidence demonstrating improvement in schizophrenia 

symptoms. 


INFORMATION 

Chart Notes 


Plan Year 

151



ROTATEQ 


RotaTeq®® is indicated: 

A. For the prophylaxis of gastroenteritis caused by rotavirus infection 


RotaTeq® is covered for members who meet the following criteria: 

A. Must be used for prophylaxis against rotavirus infection 

B. AND the patient must be between 6-12 weeks old upon first dose 

C. AND the patient will receive all three doses before 32 weeks of age 

D. AND request is for 3 doses (or less if patient has already received 1-2 doses) 

NON COVERAGE 

RotaTeq® is NOT covered for members who meet the following criteria: 

A. RotaTeq® is not being used for ANY other diagnosis than prophylaxis against 

rotavirus infection 

B. The patient is less than 6 weeks old or greater than 12 weeks old 

C. Patient will not receive all three doses before 32 weeks of age 

D. Request is for more than 3 doses 


INFORMATION 



Plan Year 

152



SAIZEN 


A. Somatropin is indicated (Not all branded medications have each indication listed 

below. Please refer to reference symbol for actual indication): 

A. For the long-term treatment of pediatric patients who have growth failure due to 

an inadequate secretion of endogenous growth hormone. 

B. For the long-term treatment of pediatric patients who have growth failure due to 

Prader-Willi syndrome.* 

C. For long-term replacement therapy in adults with growth hormone deficiency of 

either childhood or adult-onset etiology.* 

D. For the treatment of short stature associated with Turner syndrome in patients 

whose epiphyses are not closed. 

E. For the long-term treatment of idiopathic short stature, also called non-growth 

hormone deficient short stature, defined by height SDS less than or equal to -2.25 

and associated with growth rates unlikely to permit attainment of adult height in 

the normal range, in pediatric patients whose epiphyses are not closed and for 

whom diagnostic evaluation excludes other causes associated with short stature 

that should be observed or treated by other means. 

F. For replacement of endogenous growth hormone in adults with growth hormone 

deficiency who meet both of the following 2 criteria: 

a. Adult onset: Patients who have growth hormone deficiency either alone, 

or with multiple disease, hypothalamic disease, surgery, radiation therapy, 

or trauma. 

b. Child onset: Patients who were growth-hormone-deficient during 

childhood who have growth hormone deficiency confirmed as an adult. 

G. For the long-term treatment of children with growth failure due to inadequate 

secretion of endogenous growth hormone. 

H. For the treatment of growth failure associated with chronic renal insufficiency up 

to the time of renal transplantation. 

I. For the long-term treatment of growth failure associated with Turner syndrome. 

J. For the replacement of endogenous growth hormone in patients with adult growth 

hormone deficiency who 

K. meet both of the following 2 criteria: 

a. Adult onset: Patients who have adult growth hormone deficiency either 

alone or with multiple hormone deficiencies (hypopituitarism) as a result 

of pituitary disease, hypothalamic disease, surgery, radiation therapy, or 

trauma. 

b. Child onset: Patients who were growth hormone deficient during 

childhood, confirmed as an adult. 

L. For the treatment of HIV patients with wasting or cachexia to increase lean body 

mass and body weight, and improve physical endurance. Concomitant 

antiretroviral therapy is necessary. 

153



SAIZEN 

(Continued) 

M. For the treatment of short bowel syndrome in patients receiving specialized 

nutritional support. = 

N. All other FDA approved indications not otherwise excluded from Part D 


Somatropin® is covered for members who meet the following criteria: 

A. The prescribing physician is a board certified endocrinologist or infectious disease 

specialist. 

B. The request for somatropin is the formulary covered agent. (Please review drug 

formulary to ensure prior authorization is for the formulary covered medication). 

C. The patient is 20 years of age or older. 


E. AND the diagnosis is documented as growth hormone deficiency in an adult 

needing replacement with endogenous growth hormone. 

a. AND the patient has a biochemical diagnosis of growth hormone 

deficiency, means of a negative response to 2) standard growth hormone 

stimulation tests [Max peak less than 5ng/mL by RIA or Less than 2.5 

ng/mL by IRMA] OR an IGF-1 level that is two standard deviations below 

normal for the patient’s age group. (Please verify the growth hormone or 

IGF-1 level in the patient’s chart notes and ensure the tests were 

preformed within 3 months of the initial request). 

b. AND the growth hormone deficiency is due to at least one of the 

following etiologies: 

i. Pituitary or hypothalamus surgery 

ii. Pituitary or hypothalamus disease. 

iii. Pituitary or hypothalamus injury. 

iv. Radiation therapy. 

v. Growth-hormone deficiency during childhood. (Requires an 

additional stimulation test during adulthood). 

c. AND the patient has symptoms of growth hormone deficiency that 

includes one of the following: 

i. Reduced bone density of more than (1) standard deviation below 

the age and gender-specific mean. 

ii. Evidence of cardiac decompensation defined as reduced ejection 

fracture of Less than 50%. 

d. AND if the patient has received previous somatropin therapy, he/she has 

shown an improvement in quality of life and/or symptoms (bone mass, 

muscle mass, strength, body fat and/or cholesterol). 

F. AND/OR the diagnosis is documented as AIDS wasting or AIDS cachexia. 

154



SAIZEN 

(Continued) 











c. AND if the patient has received previous somatropin therapy, he/she must 


initial weight and/or muscle mass before initiating somatropin therapy. 

G. AND/OR the diagnosis is documented as a patient with short bowel syndrome. 

a. AND the patient is receiving specialized nutritional therapy and parental 

nutrition stable. 

b. AND the small intenstine is Less than 200 cm in length and at least 2 

months post resection. 

c. AND the patient has 30% or greater functioning colon with at least 15 cm 

of intact jejunum or at least 90 cm of intact jejunum and/or ileum. 

d. AND the patient has an intach stomach and duodenum. 

e. AND the patient has stable hepatic and renal status (billirubin Less than 3 

X ULN and Creatinine Less than 3mL/dL). 

f. AND if the patient has received previous somatropin therapy, he/she must 

show a positive response by showing a reduction on their dependence on 

total parenteral nutrition. 

NON COVERAGE 

Somatropin® is NOT covered for members with the following criteria: 

A. The prescribing physician is NOT a board certified endocrinologist or infectious 

disease specialist. 

B. The request for somatropin is NOT the formulary covered agent. 

C. The patient has evidence of active malignancy. 

D. The patient is NOT 20 years of age or older. 

E. The diagnosis is NOT documented as growth hormone deficiency in an adult 

needing replacement with endogenous growth hormone, AIDS wasting or AIDS 

cachexia or short bowel syndrome. 

F. If the diagnosis is documented as growth hormone deficiency in adult and they 

meet any of the following criteria: 

155



SAIZEN 

(Continued) 

a. The patient does NOT have a biochemical diagnosis of growth hormone 

deficiency to 2 standard growth hormone stimulation tests or an IGF-1 

level that is NOT two standard deviations below normal for the patient’s 

age group. 

b. The growth hormone deficiency is NOT due to at least one of the 






v. Growth-hormone deficiency during childhood. 

c. The patient does NOT have symptoms of growth hormone deficiency that 






d. If the patient has received previous somatropin therapy and he/she does 

not show an improvement In quality of life and/or symptoms (bone mass, 


G. If the diagnosis is documented as AIDS wasting or AIDS cachexia and they meet 


a. 

The patient has NOT had an involuntary weight loss of Greater than 10% 


20 kg/m 2 . 

b. The patient has had an involuntary weight loss of Greater than 10% of preillness 

baseline body weight or body mass index (BMI) Less than 20 

kg/m2 but the weight loss happened with a concurrent illness or medical 

condition other than HIV infection. 

c. The patient has NOT failed a 30 day drug regimen of megestrol 

(Megace®) AND an anabolic steroid. 

d. If the patient has received previous somatropin therapy and he/she has 

NOT shown a positive response to treatment by maintaining or increasing 

their initial weight before initiating somatropin therapy. 

H. If the diagnosis is documented as a patient with short bowel syndrome and they 


a. The patient is NOT receiving specialized nutritional therapy or NOT 

parental nutrition stable. 

b. The small intenstine is Greater than 200 cm in length and NOT at least 2 


c. The patient has Less than 30% or functioning colon with Less than 15 cm 

of intact jejunum or Less than 90 cm of intact jejunum and/or ileum. 

156



SAIZEN 

(Continued) 

d. The patient does not have an intact stomach and duodenum. 

e. The patient does NOT have stable hepatic and renal status (billirubin 

Greater than 3 X ULN and Creatinine Greater than 3mL/dL). 

f. If the patient has received previous somatropin therapyand he/she has 

NOT shown a positive response by showing a reduction on their 

dependence on total parenteral nutrition. 

I. The diagnosis is for cystic fibrosis, Down syndrome, fibromyalgia, infertility, 

obesity, delayed growth and development, familial or idiopathatic short stature in 

an adult, dwarfism, skeletal dysplasia, osteogenesis imperfecta, Bloom syndrome, 

respiratory failure, inflammatory bowel disease, burn injuries, muscular 

dystrophy, Noonan syndrome, Spina Bifida, juvenile rheumatoid arthritis, 

osteoporosis, post-traumatic stress disorder, depression, hypertension, 

hypophosphatemic rickets or adult short stature. 


INFORMATION 



Plan Year 

157



SANCUSO 


Sancuso® is indicated: 

A. For prophylaxis of chemotherapy-induced nausea/vomiting in patients receiving 

moderately and/or highly emetogenic chemotherapy for up to 5 consecutive days 


Sancuso® is covered for members who meet the following criteria: 

A. Patient must have previous trial/failure on oral Ondansetron OR Granisetron. 

NON COVERAGE 

Sancuso® is NOT covered for members with the following criteria: 

A. Used for non-chemotherapy-induced nausea/vomiting 

B. Patient has no previous trial/failure of oral Ondansetron OR Granisetron. 


INFORMATION 



Plan Year 

158



SIMULECT 


Simulect® is indicated: 

A. Kidney Transplant Rejection Prophylaxis 


Simulect® is covered for members who meet the following criteria: 

A. Patient is undergoing Kidney Transplant 

B. AND the surgery is not paid for be Medicare Part B 

C. AND B vs. D criteria determines that the medication should be covered through 


NON COVERAGE 

Simulect® is NOT covered for members who meet the following criteria: 

A. Transplant other than kidney 

B. Service is covered by Medicare Part A/B 


INFORMATION 



Plan Year 

159



SOMAVERT 


Somavert® is indicated: 

A. For the treatment of acromegaly in patients who have an inadequate response to 

surgery and/or radiation therapy and/or other medical therapies, or for whom 

these therapies are not appropriate. 


Somavert® is covered for members who meet the following criteria: 

A. Diagnosis is documented as acromegaly. 

B. AND the diagnosis has been verified with an elevated IGF-1 level or growth 

hormone levels with a glucose tolerance test. (Please review the patient’s chart 

notes for documentation). 

C. AND the patient has received and failed surgery or radiation therapy. (Please 

review the patient’s chart notes for documentation of attempt to remove tumor by 

surgery or radiation). 

D. AND the patient has tried and failed at least a 3 month trial of Sandostatin® or 

octreotide or Somatuline® (lanveotide). 

E. AND liver tests (ALT, AST) have been performed and the upper limit of normal 

(ULN) is within a range of normal to 3 times ULN. 

F. AND the patient will not receive combination therapy that can include 

Sandostatin®, octreotide or Somatuline®. 

G. AND if the patient has previously received Somavert® therapy, they must have a 

reduction in their serum IGF-1 concentration level since starting therapy. 

NON COVERAGE 

Somavert® is NOT covered for members with the following criteria: 

A. The diagnosis is NOT documented as acromegaly. 

B. The patient chart notes do not show an elevated IGF-1 level or growth hormone 

levels with a glucose tolerance test. 

C. The patient has NOT failed surgery or radiation therapy. 

D. The patient has NOT tried and failed a 3 month trial of Sandostatin® or octreotide 

or Somatuline®. 

E. The patient has liver tests higher than three times the ULN. 

F. The patient is receiving Sandostatin®, octreotide or Somatuline® therapy. 

G. If the patient has received previous Somavert® therapy and he/she has NOT 

shown a reduction in their initial IGF-1 concentration since starting therapy. 






Plan Year 

160



SPORANOX 


Sporanox® is indicated: 

A. For the treatment of infection with aspergillosis, blastomycosis, candidiasis, 

histoplasmosis, and onychomychosis 


Sporanox® is covered for members who meet the following criteria: 

A. Must be used for treatment of aspergillosis infection 

a. AND the patient must have previous trial/failure of amphotericin B 

b. AND chart notes documenting positive culture of aspergillosis as well as 

previous failure on amphotericin B must be received 

B. OR the patient must be diagnosed with blastomycosis (pulmonary or 

extrapulmonary) 

a. AND Dose is no more than 400 mg once daily PO. 

C. OR the patient must be diagnosed with candidiasis 

a. AND the patient has previous tried and failed or had contraindication to 

fluconazole 

b. AND the trial of fluconazole is documented in chart notes and submitted 

D. OR the patient is diagnosed with histoplasmosis 

a. AND the dose is no more than 400 mg/day*Note: if diagnosis is 

disseminated histoplasmosis treatment should be for 6-12 months 

E. OR the patient must be diagnosed with onychomycosis 

a. AND the patient must have previous trial and failure or contraindication to 

terbinafine 

b. AND chart notes are submitted that document trial and failure on 

terbinafine 

F. Brand name for 100 mg capsule will only be approved with failure on ALL 

available generic formulations 

NON COVERAGE 

Sporanox® is NOT covered for members who meet the following criteria: 

A. The patient is not diagnosed with an FDA-approved use (aspergillosis, 

blastomycosis, candidiasis, histoplasmosis, onychomycosis) 

B. The dosage is greater than 400 mg/day 

C. The patient is not properly tried on preceding first-line therapies for aspergillosis, 

candidiasis, and onychomycosis as outlined in Sanford Guide 

D. Chart notes documenting patient’s previous medication trials as indicated above 

are not received or do not address the needed information. 


INFORMATION 



12 Weeks 

161



SUCRAID 


Sucraid® is indicated: 

A. For oral replacement therapy of the genetically determined sucrase deficiency, 

which is part of congenital sucrase-isomaltase deficiency (CSID) 


Sucraid® is covered for members who meet the following criteria: 

A. The patient must be diagnosed with congenital sucrase-isomaltase deficiency 

B. AND the diagnosis must be verified with chart notes showing specific genetic 

testing showing sucrase deficiency 

NON COVERAGE 

Sucraid® is NOT covered for members who meet the following criteria: 

A. The patient is NOT diagnosed with congenital sucrase-isomaltase deficiency 

B. The dosage is greater than 2 mL/day 

C. Patient has either yeast or glycerin hypersensitivity 

D. No genetic testing to specifically show sucrase deficiency has been performed 

E. Chart notes documenting genetic testing are not received or do not address the 

needed information. 






Plan Year 

162



SUTENT 


Sutent® is indicated: 

A. For the treatment of gastrointestinal stromal tumor after disease progression on or 

intolerance to imatinib mesylate. 

B. For the treatment of advanced renal cell carcinoma. 


Sutent® is covered for members who meet the following criteria: 

A. The prescribing physician is a board certified oncologist, gastroenterologist or 

nephrologist. 



Sutent® therapy in pregnancy. 

C. AND the patient will NOT be treated with interferon alfa (Roferon-A®, 

Pegasys®, Intron-A®, Peg-Intron®) or interleukin-2 (Proleukin®) therapy in 

combination with Sutent® treatment. (Please verify the patient’s drug history or 

patient chart to verify that the patient is not on interferon alfa or interleukin-2 

therapy). 

D. AND the diagnosis is documented as treatment for gastrointestinal stromal tumor 

(GIST). 

a. AND GIST is unresectable and/or metastatic malignant. 

b. AND the patient has experienced disease progression while trying or 

intolerant to at least a 30-day Gleevec® drug regimen. (Please verify the 

patient’s drug history or chart to verify a trial of Gleevec®). 

c. AND if the patient has received previous Sutent® therapy, he/she has no 

evidence of disease progression (tumor growth) since initiating Sutent® 

therapy. 

E. AND/OR the diagnosis is documented as metastatic (advanced) renal cell 

carcinoma. 


b. AND if the patient has had previous Sutent® therapy, he/she has no 

evidence of disease progression since initiating Sutent® therapy. 

NON COVERAGE 

Sutent® is NOT covered for members who meet the following criteria: 

A. The prescribing physician is NOT a board certified oncologist, gastroenterologist 

or nephrologist. 


been educated on the potential dangers of Sutent® therapy in pregnancy. 

C. The patient will be receiving interferon alfa or Proleukin® therapy in combination 

with Sutent® treatment. 

163



SUTENT 

(Continued) 

D. The diagnosis is NOT documented as treatment for gastrointestinal stromal tumor 

(GIST) or renal cell carcinoma. 

E. The diagnosis is documented as treatment for gastrointestinal stromal tumor 

(GIST) and they meet any of the following criteria. 

a. GIST is resectable. 

b. The patient has NOT had a 30-day Gleevec® drug trial. 

c. The patient has tried Gleevec® therapy and is NOT intolerant and has 

NOT experienced disease progression while receiving a 90-day Gleevec® 

drug regimen. 

d. If the patient has received previous Sutent® therapy and he/she has 

evidence of disease progression (tumor growth) since initiating Sutent® 

therapy. 

F. The diagnosis is documented as renal cell carcinoma and they meet any of the 


a. The carcinoma is not metastatic. 

b. The carcinoma can be surgically resectable. 

c. If the patient has had previous Sutent® therapy and he/she has evidence of 

disease progression since initiating Sutent® therapy. 




Oncologist 


Plan Year 

164



SYMLIN 


Symlin® is indicated: 

A. For type-1 diabetes: As an adjunct treatment in patients who use mealtime insulin 

therapy and who have failed to achieve desired glucose control despite optimal 

insulin therapy. 

B. For type-2 diabetes: As an adjunct treatment in patients who use mealtime insulin 

therapy and who have failed to achieve desired glucose control despite optimal 

insulin therapy, with or without a concurrent sulfonylurea agent and/or 

metformin. 


Symlin® is covered for members who meet the following criteria: 

A. The patient does NOT have gastroparesis. 

B. AND the patient’s HbA1c is greater than 7% but lower than 9%. (Please verify 

the patient’s HbA1c by reviewing the patient’s chart notes). 

C. AND the patient has NOT had recurrent severe hypoglycemia during the past 6 

months. 

D. AND the patient will NOT be taken Symlin® in combination with any of the 

following medications that may alter gastrointestinal motility: metoclopramide, 

Reglan®, dexpanthenol, Zelnorm®, erythromycin, cisapride, Propulsid®, 

clarithromycin, Biaxin®, ranitidine, Zantac®, nizatidine, Axid®, neostigmine, 

lidocaine or Amitiza®. (Please verify the use of medications that can increase GI 

motility by reviewing the patient’s drug history or chart). 

E. AND the patient is over the age of 2 years old. 

F. AND the patient is NOT currently receiving a Byetta® drug regimen. (Please 

verify if the patient is receiving Byetta® by reviewing their drug history or chart). 

G. AND the diagnosis is documented as diabetes type-1. 

H. AND the patient has tried and failed at least a three-month optimization of insulin 

therapy that includes a trial and failure to short acting insulin. (e.g. Humulin® R, 

Novolin® R, Humulin® 70/30, Humulin® 50/50, Humalog®, Novolog®, 

Apidra® and Exubra®). (Please verify the use of short-acting insulin by 


I. AND the patient will continue the use of short-acting insulin during treatment 

with Symlin®. 

J. AND if the patient has had previous Symlin® therapy, he/she must show a 

reduction in their HbA1c since initiating Symlin® therapy. 

K. AND/OR the diagnosis is documented as diabetes type-2. 

L. AND the patient has tried and failed at least a three-month optimization of insulin 

therapy that includes a trial and failure to BOTH short and long-acting insulin. 

M. Short acting insulin: (e.g. Humulin® R, Novolin® R, Humulin® 70/30, 

Humulin® 50/50, Humalog®, Novolog®, Apidra® and Exubra®). (Please verify 

the use of a short-acting insulin by reviewing the patient’s drug history or chart). 

165



SYMLIN 

(Continued) 

N. Long acting insulin: (e.g. NPH, Humulin® N, Novolin® N, Humulin® 70/30, 

Humulin® 50/50, Lente, Humulin® L, Humulin® U, Humalog® 75/30, Lantus®, 

Levenir®). (Please verify the use of a long-acting insulin by reviewing the 


O. AND the patient will continue the use of short-acting insulin during treatment 

with Symlin®. 

P. AND if the patient has had previous Symlin® therapy, he/she must show a 

reduction in their HbA1c since initiating Symlin® therapy. (Please verify the 

HbA1c in the patient’s chart). 

NON COVERAGE 

Symlin® is NOT covered for members who meet the following criteria: 

A. The patient has gastroparesis. 

B. The patient’s HbA1c is less than 7% or greater than 9%. 

C. The patient has had recurrent severe hypoglycemia during the past 6 months. 

D. The patient will be taken Symlin® in combination with any of the following 

medications that may alter gastrointestinal motility: metoclopramide, Reglan®, 

dexpanthenol, Zelnorm®, erythromycin, cisapride, Propulsid®, clarithromycin, 

Biaxin®, ranitidine, Zantac®, nizatidine, Axid®, neostigmine, lidocaine or 

Amitiza®. 

E. The patient is under the age of 2 years old. 

F. The patient is currently receiving a Byetta® drug regimen. 

G. The diagnosis is NOT documented as diabetes type-1 or type-2. 

H. The patient has NOT tried and failed at least a three-month optimization of insulin 

therapy that includes a trial and failure to short acting insulin. (e.g. Humulin® R, 

Novolin® R, Humulin® 70/30, Humulin® 50/50, Humalog®, Novolog®, 

Apidra® and Exubra®). 

I. The patient will NOT continue to use short-acting insulin during treatment with 

Symlin®. 

J. The diagnosis is documented as diabetes type-2 and they have not tried and failed 

a three-month optimization of insulin therapy that includes a trial and failure to 

long-acting insulin. 

K. If the patient has had previous Symlin® therapy, he/she must show a reduction in 

their HbA1c since initiating Symlin® therapy. 






Plan Year 

166



SYNAREL 


Synarel® is indicated: 

A. For treatment of endometriosis 

B. For treatment of precocious puberty 



Synarel® is covered for members who meet the following criteria: 

A. The patient must be diagnosed with endometriosis 

a. AND the patient has previous trial and failure on ALL of the following: 

i. 1 form of oral contraceptive pills 

ii. Leuprolide 

b. AND treatment duration is no longer than 6 months 

B. OR the patient must be diagnosed with precocious puberty 

a. AND the patient is determined to have significant advancement of bone 

age due to significant early maturation 

b. AND the patient must be younger than 10 years old 

NON COVERAGE 

Synarel® is NOT covered for members who meet the following criteria: 

F. The patient is NOT diagnosed with endometriosis or precocious puberty 

G. The dosage is greater than 800 mcg/day is diagnosed with endometriosis OR 1800 

mcg/day if diagnosed with precocious puberty 

H. The patient is pregnant (category X) 

I. If diagnosed with endometriosis, no previous trial and failure on 1 form of oral 

contraceptive pills AND leuprolide 

J. Chart notes documenting trials on oral contraceptives pills and leuprolide are not 

received or do not address the needed information 

K. If diagnosed with precocious puberty, patient is 10 years old or older 




OBGYN and Endocrinologist 


6 months 

167



TAMIFLU 


Tamiflu® is indicated: 

A. For prophylaxis for infections due to influenza A or B following close contact 

with an infected individual or during a community outbreak 

B. For treatment of uncomplicated influenza type A or type B infection in patients 

who have been symptomatic for no more than 2 days 



Tamiflu® is covered for members who meet the following criteria: 

A. The patient must be diagnosed with influenza A or B infection 

B. AND the patient must have been symptomatic for no more than 2 days 

C. AND treatment is for no more than 5 days 

D. OR The patient is receiving prophylaxis 

E. AND treatment is for no more than 6 weeks 

F. AND if treatment is greater than 10 days a written medical summary documenting 

need for more than 10 days must be submitted with request 

NON COVERAGE 

Tamiflu® is NOT covered for members who meet the following criteria: 

A. The patient is NOT diagnosed with influenza A or B infection or prophylaxis for 

influenza A or B infection after contact with infected individual 

B. The request is for more than 10 capsules (for prophylaxis, patient may fill up to 6 

weeks if initial 10 days is not effective) 

C. more than 10 days of therapy, a written medical summary illustrating need for 

additional treatment due to inefficacy of initial therapy is not received 


INFORMATION 



Up to 6 weeks 

168



TARCEVA 


Tarceva® is indicated: 

A. For the monotherapy treatment of patients with locally advanced or metastatic 

non-small cell lung cancer after failure of at least one prior chemotherapy 

regimen. 

B. For the first-line treatment of patients with locally advanced, unresectable or 

metastatic pancreatic cancer when used in combination with gemcitabine. 


Tarceva® is covered for members who meet the following criteria: 

A. The prescribing physician is a board certified oncologist or nephrologist. 



Tarceva® therapy in pregnancy. 

C. AND the diagnosis is documented as treatment for non-small cell lung cancer. 

a. AND the cancer is locally advanced or metastatic (Stage 3 or Stage 4). 

b. AND the patient’s disease has progressed after completing or had 

unacceptable toxicity to at least one of the following chemotherapy 

regimens: 

i. Platinum-based regimen: (e.g. carboplatin, Paroplatin®, cisplatin, 

Platinol®, oxaliplatin, or Eloxatin®) 

ii. axoid-based regimen: (e.g. paclitaxel, Taxol®, Onxol®, 

Abraxane®, docetaxel, or Taxotere®). 

c. AND Tarceva® therapy will NOT be used in combination with any other 

chemotherapy agent. (Please verify that the patient is not receiving 

additional chemotherapy by reviewing the patient’s drug history or chart.) 

d. AND if the patient has received previous Tarceva® therapy, the provider 

has evidence of clinical improvement from the pretreatment report by 

showing no increase in tumor size and/or progression of disease. 

D. AND/OR the diagnosis is documented as pancreatic cancer. 

a. AND the cancer is surgically unresectable. 

b. AND the cancer is locally advanced or metastatic (Stage 3 or Stage 4). 

c. AND the patient will and/or has received Tarceva® therapy in 

combination with gemcitabine (Gemzar®) on a 4 and/or 8 week cycle. 

d. AND if the patient has had previous Tarceva® therapy, the provider has 

evidence of clinical improvement from the pretreatment report by showing 

no increase in tumor size and/or progression of disease. 

169



TARCEVA 

(Continued) 

NON COVERAGE 

Tarceva® is NOT covered for members who meet the following criteria: 


B. If the patient is female and of childbearing years and she is pregnant, has plans for 

pregnancy or has NOT been educated on the potential dangers of Tarceva® 

therapy in pregnancy. 

C. The diagnosis is NOT documented as non-small cell lung cancer or pancreatic 

cancer. 

D. AND the diagnosis is documented as treatment for non-small cell lung cancer and 

the patient meets any of the following criteria: 

a. The cancer is NOT locally advanced or metastatic (Stage 3 or Stage 4). 

b. The patient’s disease has NOT progressed after completing a platinumbased 

or taxoid-based chemotherapy regimen. 

c. The patient did NOT complete or had NO unacceptable toxicity to a 

platinum-based or taxoid based chemotherapy regimen. 

i. Tarveca® therapy will or has been used in combination with 

another chemotherapy agent. 

ii. If the patient has received previous Tarceva® therapy and the 

provider has NO evidence of clinical improvement from the 

pretreatment report or shows an increase in tumor size and/or 

progression of disease. 

E. AND/OR the diagnosis is documented as pancreatic cancer and the patient meets 


a. The cancer is surgically resectable. 

b. The cancer is NOT locally advanced or metastatic (Stage 3 or Stage 4). 

c. The patient will NOT or has NOT received Tarceva® therapy in 

combination with gemcitabine (Gemzar®) on a 4 and/or 8 week cycle. 

d. If the patient has had previous Tarceva® therapy and the provider has NO 

evidence of clinical improvement from the pretreatment report or shows 

an increase in tumor size and/or progression of disease. 




Oncologist 


6 months 

170



TARGRETIN 


Targretin® is indicated: 

A. Oral: For the treatment of cutaneous manifestations of cutaneous T-cell 

lymphoma (CTCL) 

B. Topical: For treatment of stage 1A or 1B cutaneous T-cell lymphoma who have 

refractory or persistent disease after other therapies or who have not tolerated 

other therapies 


Targretin® is covered for members who meet the following criteria: 

A. The patient must be diagnosed with cutaneous manifestations of cutaneous T-cell 

lymphoma (CTCL) 

B. AND the patient must have advanced disease (if oral is used) 

C. OR the patient must be diagnosed with stage 1A or 1B cutaneous T-cell 

lymphoma with cutaneous manifestations 

D. AND the patient has previously failed treatment with at least 1 (ONE) topical 

steroid OR phototherapy 

NON COVERAGE 

Targretin® is NOT covered for members who meet the following criteria: 

A. The patient is NOT diagnosed with cutaneous manifestations of cutaneous T-cell 

lymphoma 

B. If requesting oral, the patient does NOT have advanced disease 

C. If requesting topical, the patient does NOT have stage 1A or 1B 

D. If requesting topical, the patient has NOT previously attempted treatment with at 

least 1 (ONE) topical steroid OR phototherapy 

E. Chart notes documenting previous trial on topical steroid(s) or phototherapy are 

not received or do not address the needed information 




Dermatologist and Oncologist 


Plan Year 

171



TASIGNA 


Tasigna® is indicated: 

A. For the treatment of chronic phase and accelerated phase Philadelphia 

chromosome positive (Ph+) chronic myelogenous leukemia (CML) in patients 

resistant to or intolerant to prior therapy that included imatinib. 


Tasigna® is covered for members who meet the following criteria: 

A. The patient must be diagnosed with Philadelphia chromosome positive chronic 

myelogenous leukemia 

B. AND the dosing must be 400 mg twice daily 

C. AND the patient must have previous trial and failure or intolerance to prior 

therapy that included imatinib 

D. AND chart notes documenting previous trial/failure or intolerance to imatinib 

therapy must be received 

NON COVERAGE 

Tasigna® is NOT covered for members who meet the following criteria: 

A. The patient is NOT diagnosed with Philadelphia chromosome positive chronic 

myelogenous leukemia 

B. The request is for more than 400 mg twice daily 

C. The patient has NOT previously attempted treatment with imatinib 

D. Chart notes documenting previous trial on imitinib are not received or do not 

address the needed information 


INFORMATION 



Plan Year 

172



TEV-TROPIN 


Somatropin is indicated (Not all branded medications have each indication listed below. 

Please refer to reference symbol for actual indication): 

A. For the long-term treatment of pediatric patients who have growth failure due to 

an inadequate secretion of endogenous growth hormone. 

B. For the long-term treatment of pediatric patients who have growth failure due to 

Prader-Willi syndrome.* 

C. For long-term replacement therapy in adults with growth hormone deficiency of 

either childhood or adult-onset etiology.* 

D. For the treatment of short stature associated with Turner syndrome in patients 

whose epiphyses are not closed. 

E. For the long-term treatment of idiopathic short stature, also called non-growth 

hormone deficient short stature, defined by height SDS less than or equal to -2.25 

and associated with growth rates unlikely to permit attainment of adult height in 

the normal range, in pediatric patients whose epiphyses are not closed and for 

whom diagnostic evaluation excludes other causes associated with short stature 

that should be observed or treated by other means. 

F. For replacement of endogenous growth hormone in adults with growth hormone 

deficiency who meet both of the following 2 criteria: 

a. Adult onset: Patients who have growth hormone deficiency either alone, 

or with multiple disease, hypothalamic disease, surgery, radiation therapy, 

or trauma. 

b. Child onset: Patients who were growth-hormone-deficient during 

childhood who have growth hormone deficiency confirmed as an adult. 

G. For the long-term treatment of children with growth failure due to inadequate 

secretion of endogenous growth hormone. 

H. For the treatment of growth failure associated with chronic renal insufficiency up 

to the time of renal transplantation. 

I. For the long-term treatment of growth failure associated with Turner syndrome. 

J. For the replacement of endogenous growth hormone in patients with adult growth 

hormone deficiency who meet both of the following 2 criteria: 

a. Adult onset: Patients who have adult growth hormone deficiency either 

alone or with multiple hormone deficiencies (hypopituitarism) as a result 

of pituitary disease, hypothalamic disease, surgery, radiation therapy, or 

trauma. 

b. Child onset: Patients who were growth hormone deficient during 

childhood, confirmed as an adult. 

K. For the treatment of HIV patients with wasting or cachexia to increase lean body 

mass and body weight, and improve physical endurance. Concomitant 

antiretroviral therapy is necessary. 

L. For the treatment of short bowel syndrome in patients receiving specialized 

nutritional support. 

173



TEV-TROPIN 

(Continued) 


Somatropin® is covered for members who meet the following criteria: 

A. The prescribing physician is a board certified endocrinologist or infectious disease 

specialist. 

B. The request for somatropin is the formulary covered agent. (Please review drug 

formulary to ensure prior authorization is for the formulary covered medication). 

C. The patient is 20 years of age or older. 


E. AND the diagnosis is documented as growth hormone deficiency in an adult 

needing replacement with endogenous growth hormone. 

a. AND the patient has a biochemical diagnosis of growth hormone 

deficiency, means of a negative response to 2) standard growth hormone 

stimulation tests [Max peak less than 5ng/mL by RIA or Less than 2.5 

ng/mL by IRMA] OR an IGF-1 level that is two standard deviations below 

normal for the patient’s age group. (Please verify the growth hormone or 

IGF-1 level in the patient’s chart notes and ensure the tests were 

preformed within 3 months of the initial request). 

b. AND the growth hormone deficiency is due to at least one of the 






v. Growth-hormone deficiency during childhood. (Requires an 

additional stimulation test during adulthood). 

c. AND the patient has symptoms of growth hormone deficiency that 






d. AND if the patient has received previous somatropin therapy, he/she has 

shown an improvement in quality of life and/or symptoms (bone mass, 


F. AND/OR the diagnosis is documented as AIDS wasting or AIDS cachexia. 





174



TEV-TROPIN 

(Continued) 







c. AND if the patient has received previous somatropin therapy, he/she must 


initial weight and/or muscle mass before initiating somatropin therapy. 

G. AND/OR the diagnosis is documented as a patient with short bowel syndrome. 

a. AND the patient is receiving specialized nutritional therapy and parental 

nutrition stable. 

b. AND the small intenstine is Less than 200 cm in length and at least 2 


c. AND the patient has 30% or greater functioning colon with at least 15 cm 

of intact jejunum or at least 90 cm of intact jejunum and/or ileum. 

d. AND the patient has an intach stomach and duodenum. 

e. AND the patient has stable hepatic and renal status (billirubin Less than 3 

X ULN and Creatinine Less than 3mL/dL). 

f. AND if the patient has received previous somatropin therapy, he/she must 

show a positive response by showing a reduction on their dependence on 

total parenteral nutrition. 

NON COVERAGE 

Somatropin® is NOT covered for members with the following criteria: 

A. The prescribing physician is NOT a board certified endocrinologist or infectious 

disease specialist. 

B. The request for somatropin is NOT the formulary covered agent. 

C. The patient has evidence of active malignancy. 

D. The patient is NOT 20 years of age or older. 

E. The diagnosis is NOT documented as growth hormone deficiency in an adult 

needing replacement with endogenous growth hormone, AIDS wasting or AIDS 

cachexia or short bowel syndrome. 

F. If the diagnosis is documented as growth hormone deficiency in adult and they 


a. The patient does NOT have a biochemical diagnosis of growth hormone 

deficiency to 2 standard growth hormone stimulation tests or an IGF-1 

level that is NOT two standard deviations below normal for the patient’s 

age group. 

b. The growth hormone deficiency is NOT due to at least one of the 



175



TEV-TROPIN 

(Continued) 




v. Growth-hormone deficiency during childhood. 

c. The patient does NOT have symptoms of growth hormone deficiency that 






d. If the patient has received previous somatropin therapy and he/she does 

not show an improvement In quality of life and/or symptoms (bone mass, 


G. If the diagnosis is documented as AIDS wasting or AIDS cachexia and they meet 


a. The patient has NOT had an involuntary weight loss of Greater than 10% 


20 kg/m 2 . 

b. The patient has had an involuntary weight loss of Greater than 10% of preillness 

baseline body weight or body mass index (BMI) Less than 20 

kg/m2 but the weight loss happened with a concurrent illness or medical 

condition other than HIV infection. 

c. The patient has NOT failed a 30 day drug regimen of megestrol 

(Megace®) AND an anabolic steroid. 

d. If the patient has received previous somatropin therapy and he/she has 

NOT shown a positive response to treatment by maintaining or increasing 

their initial weight before initiating somatropin therapy. 

H. If the diagnosis is documented as a patient with short bowel syndrome and they 


a. The patient is NOT receiving specialized nutritional therapy or NOT 

parental nutrition stable. 

b. The small intenstine is Greater than 200 cm in length and NOT at least 2 


c. The patient has Less than 30% or functioning colon with Less than 15 cm 

of intact jejunum or Less than 90 cm of intact jejunum and/or ileum. 

d. The patient does not have an intact stomach and duodenum. 

e. The patient does NOT have stable hepatic and renal status (billirubin 

Greater than 3 X ULN and Creatinine Greater than 3mL/dL). 

f. If the patient has received previous somatropin therapyand he/she has 

NOT shown a positive response by showing a reduction on their 

dependence on total parenteral nutrition. 

176



TEV-TROPIN 

(Continued) 

I. The diagnosis is for cystic fibrosis, Down syndrome, fibromyalgia, infertility, 

obesity, delayed growth and development, familial or idiopathatic short stature in 

an adult, dwarfism, skeletal dysplasia, osteogenesis imperfecta, Bloom syndrome, 

respiratory failure, inflammatory bowel disease, burn injuries, muscular 

dystrophy, Noonan syndrome, Spina Bifida, juvenile rheumatoid arthritis, 

osteoporosis, post-traumatic stress disorder, depression, hypertension, 

hypophosphatemic rickets or adult short stature. 


INFORMATION 



Plan Year 

177



TORISEL 


Torisel® is indicated: 

A. For the treatment of advanced renal cell carcinoma 


Torisel® is covered for members who meet the following criteria: 

A. Verification of B vs. D criteria as per CMS regulations 


B. AND the patient must be diagnosed with renal cell carcinoma 

C. AND the patient must have advanced disease as indicated by 1 (ONE) of the 

following 

a. Patients with metastatic disease 

b. Patients with locally advanced disease not curable with resection 

D. AND must be prescribed by oncologist or nephrologist 

NON COVERAGE 

Torisel® is NOT covered for members who meet the following criteria: 

A. The medication is a Part B medication per CMS guidelines 

B. The diagnosis is NOT renal cell carcinoma 

C. The patient does NOT have advanced disease 

D. Prescribing physician is NOT an oncologist or nephrologist 




Oncologist 


Plan Year 

178



TRACLEER 


Tracleer® is indicated: 

A. For the treatment of pulmonary arterial hypertension in patients with World 

Health Organization Class III or IV symptoms, to improve exercise ability and 

decrease the rate of clinical worsening. 


Tracleer® is covered for members who meet the following criteria: 

A. If the patient is female and is of childbearing age, she is NOT pregnant, does 

NOT have plans for pregnancy and is using a reliable method of contraception. 


B. AND the patient is not on a drug regimen for cyclosporine (eg. Gengraf®, 

Neoral®, Sandimmune®) and/or glyburide (eg. Diabeta®, Micronase®, 

Glynase®). (contraindicated). (Verification can be made by reviewing the 

patient’s drug history or patient’s chart). 

C. AND the patient does not have elevated aminotransferases (eg. AST, ALT) 

greater than three (3) times the upper limit of normal and/or bilirubin greater than 

two (2) times the upper limit of normal. (Verification can be made by reviewing 


D. AND the prescribing provider is a pulmonologist, and/or cardiologist or has 

obtained a consult from the listed specialties. 

E. AND the diagnosis is documented as pulmonary arterial hypertension. 

F. AND the patient does NOT have pulmonary veno-occlusive disease (PVOD), 


G. AND the patient has had an adequate trial and failure (4 weeks or more) or is not 

a candidate for calcium channel blocker therapy. (eg. amlodipine, Norvasc®, 

nifedipine, Adalat CC®, Nifedical XL®, Procardia®, Procardia XL®, diltiazem, 

Cardizem®, Cartia XT®, Dilacor XR®, Diltia XT®, Tiazac®, Norvasc®, 

amlodipine, or Cardizem CD®). (Verification can be made by reviewing the 

patient’s drug history or patient’s chart). 

H. AND the patient will NOT receive combination therapy with a prostacyclin 

(Flolan®, Ventavis®, Remodulin®) or a phosphodiesterase type-5 inhibitor 

(Viagra®, Revatio®) agent. Combination therapy has not been approved by the 

FDA. (Please verify that the patient is not on duplicate therapy by reviewing the 


I. AND the diagnosis is documented as pulmonary arterial hypertension class III or 

IV defined by the World Health Organization (WHO). 

J. AND the diagnosis is NOT documented as pulmonary arterial hypertension class I 

or II defined by the WHO. 

K. AND therapy is being prescribed to improve exercise ability. 

179



TRACLEER 

(Continued) 

L. AND if the patient has received previous Tracleer® therapy, the patient must see 

an improvement in their exercise ability (walking distance), dyspnea fatigue, an 

improvement in functional status (New York Heart Association (NYHA 

functional class) and/or NO clinical worsening of pulmonary hypertension. 

NON COVERAGE 

Tracleer® is NOT covered for members with the following criteria: 

A. A female patient of child bearing age that is pregnant or has plans for pregnancy 

or is NOT using a reliable form of contraception. 

B. The patient will be taking cyclosporine and/or glyburide therapy concurrently 

with Tracleer® therapy. 

C. The patient has elevated aminotransferase levels greater than three (3) times the 

upper limit of normal and/or bilirubin greater than two (2) times the upper limit of 

normal. 

D. The prescribing provider is NOT a pulmonologist, and/or cardiologist or obtained 


E. The diagnosis is NOT listed as pulmonary hypertension. 

F. The patient has pulmonary veno-occlusive disease (PVOD). 

G. The patient is a candidate for calcium channel blocker therapy (CCB) and has 

NOT had an adequate 4-week trial and failure to a CCB drug regimen. 

H. The patient will receive Revatio®, Flolan®, Ventavis®, or Remodulin® therapy 

while receiving a Tracleer® drug regimen. (Please verify that the patient does not 

have duplicate therapy by reviewing the patient’s drug history or chart). 

I. The patient’s pulmonary arterial hypertension has NOT been classified as class III 

or IV defined by the WHO. 

J. The patient’s pulmonary arterial hypertension has been classified as class I or II 

by the WHO. 

K. Tracleer® is NOT being prescribed to improve exercise ability. 

L. If the patient has received previous Tracleer® therapy and they have NOT seen an 

improvement in their exercise ability (walking distance), dyspnea fatigue and/or 

an improvement in their NYHA functional classification. 

M. Evidence of diagnosis, WHO classification, lab values and exercise ability is 

NOT documented in the patient’s chart notes provided by prescribing provider. 




Pulmonologist 


6 months 

180


Tretinoin is indicated: 

A. Acne Vulgaris 

B. Cystic Acne 



TRETINOIN PRODUCTS 


Avita® is covered for members who meet the following criteria: 

A. Patient is diagnosed with Acne Vulgaris or Cystic Acne 

B. AND failure to topical benzoyl peroxide products and topical antibiotics 

NON COVERAGE 

Tretinoin is NOT covered for members with the following criteria: 

A. Using for facial wrinkles or other cosmetic indications 


INFORMATION 



3 months 

181


A. Hyperlipopoteinemia 

B. Hypertriglyceridemia 



TRICOR 


Tricor is covered for members who meet the following criteria: 

A. Failure or contraindications to generic Fenofibrate 

NON COVERAGE 

Tricor is not covered for members who meet the following criteria: 

A. No failure or contraindications to Fenofibrate 


INFORMATION 

Chart Notes 


Plan Year 

182



TYKERB 


Tykerb® is indicated: 

A. In combination with capecitabine, for the treatment of patients with advanced or 

metastatic breast cancer whose tumors over express HER2 and who have received 

prior therapy including an anthracycline, a taxane, and trastuzumab. 


Tykerb® is covered for members who meet the following criteria: 




Tarceva® therapy in pregnancy. 

C. AND the diagnosis is documented as treatment for breast cancer. 

D. AND the cancer is advanced or metastatic (Stage 3 or Stage 4). 

E. AND a fluorescence in situ hybridization (FISH) or immunohistochemistry (IHC) 

test has been preformed to confirm HER2 protein over expression with a score of 

+2 or better. 

F. AND patient’s disease has progressed after completing or had unacceptable 

toxicity to all three of the following chemotherapy regimens: 

a. Anthracycline regimen: (e.g. daunorubicin, DaunoXome®, doxorubicin, 

Adriamycin®, Doxil®, epirubicin, Ellence®, idarubicin, Idamycin®). 

b. Taxane regimen: (e.g. paclitaxel, Taxol®, Onxol®, Abraxane®, 

docetaxel, or Taxotere®). 

c. trastuzumab (Herceptin®). 

G. AND Tykerb® therapy will be or is being used in combination with capecitabine 

(Xeloda®). (Please verify that the patient is receiving Xeloda® therapy by 

reviewing the patient’s drug history or chart.) 

H. AND Tykerb® therapy will NOT be used in combination with an anthracycline 

regimen, Herceptin® or a Taxane regimen. 

I. AND if the patient has received previous Tykerb® therapy, the provider has 

evidence of clinical improvement from the pretreatment report by showing no 

increase in tumor size and/or progression of disease. 

NON COVERAGE 

Tykerb® is NOT covered for members who meet the following criteria: 

A. The prescribing physician is NOT a board certified oncologist. 

B. If the patient is female and of childbearing years and is pregnant, has plans for 

pregnancy or has NOT been educated on the potential dangers of Tarceva® 

therapy in pregnancy. 

C. The diagnosis is NOT documented as treatment for breast cancer. 

D. The diagnosis is documented as treatment for breast cancer and the patient meets 


183



TYKERB 

(Continued) 

E. The cancer is NOT advanced or NOT metastatic (Stage 3 or Stage 4). 

F. A fluorescence in situ hybridization (FISH) or immunohistochemistry (IHC) test 

has NOT been preformed to confirm HER2 protein over expression. 

G. A FISH or IHC test has been performed but the score was less than +2. 

H. The patient has NOT completed and NOT failed an anthracycline, taxane and 

Herceptin® drug regimen.The patient’s disease has NOT progressed after 

completing an anthracycline, taxane and Herceptin® drug regimen. 

I. Tykerb® therapy will NOT be or is NOT being used in combination with 

capecitabine (Xeloda®). 

J. Tykerb® therapy will be used in combination with an anthracycline regimen, 

Herceptin® or a Taxane regimen. 

K. If the patient has received previous Tykerb® therapy and the provider has NO 

evidence of clinical improvement from the pretreatment report or shows an 

increase in tumor size and/or progression of disease. 




Oncologist 


Plan Year 

184



TYZEKA 


Tyzeka® is indicated: 

A. For the treatment of chronic hepatitis B in adults with evidence of active viral 

replication and either evidence of persistent elevations in serum aminotransferases 

(ALT or AST) or histologically active disease. 


Tyzeka® is covered for members who meet the following criteria: 


B. AND the prescribing provider is a gastroenterologist or trained in infectious 

disease or has obtained a consult from the listed specialties. 

C. AND the patient has been diagnosed with chronic hepatitis B. 

D. AND the patient has evidence of a positive HBsAg (+ or -) serological marker for 

greater than 6 months OR evidence by a liver biopsy showing chronic hepatitis. 

(Please verify that the patient has a HBsAg serological marker for greater than 6 

months or a positive liver biopsy by reviewing the patient’s drug history or chart). 

E. AND the patient has a Hepatitis B viral load greater than 100,000 copies per ml. 

F. AND the patient has elevations in liver aminotransferases (ALT or AST) that are 

two (2) times greater than normal. 

G. AND the patient has been tested for HIV. (Tyzeka® therapy can cause HIV 

resistance in untreated HIV infection). 

H. AND if the patient has received previous Tyzeka® treatment, there is documented 

clinical improvement shown by a drop in viral load or reduction in the patient’s 

liver aminotransferases. (Please verify patient’s chart notes to verify drop in viral 

load or reduction in liver aminotransferases from their starting level). 

I. AND the patient is not receiving duplicate therapy that includes Hepsera®, 

Baraclude®, Epivir®, Intron A® and/or Infergen®. (Please verify that the patient 

does not have duplicate therapy by reviewing the patient’s drug history or chart). 

J. AND evidence of diagnosis, serological markers, liver biopsy, viral load, and 

liver aminotransferases is documented in patient’s chart. 

NON COVERAGE 

Tyzeka® is NOT covered for members with the following criteria: 


B. The provider is NOT a gastroenterologist, trained in infectious disease or obtained 


C. Patient has NOT been diagnosed with chronic hepatitis B. 

D. Patient has NO evidence of a Hepatitis B serological marker for greater than 6 

months OR evidence by a positive liver biopsy. 

E. Patient does NOT have a Hepatitis B viral load greater than 100,000 copies per 

ml. 

185



TYZEKA 

(Continued) 

F. Patient does NOT have liver aminotransferases (ALT or AST) that are two (2) 

times greater than normal. 

G. Patient has NOT been tested for HIV. 

H. Patient is on duplicate therapy that can include one of the following: Hepsera®, 

Baraclude®, Epivir®, Intron-A®, and or Infergen®. 

I. Prescriber has provided no evidence of diagnosis, serological markers, viral load, 

duplicate therapy or liver aminotransferases. 

REQUIRED MEDICAL INFORMATIONS 





Plan Year 

186



VESANOID 


Vesanoid® is indicated: 

A. For the treatment of remission induction in acute promyelocytic leukemia 


Vesanoid® is covered for members who meet the following criteria: 

A. The patient is diagnosed with acute promyelocytic leukemia 

B. AND the medication is being used for induction of remission 

C. AND the patient has no previous history of trial on Vesanoid® 

D. AND the request is for no more than 90 days 

E. AND the request comes from an oncologist 

NON COVERAGE 

Vesanoid® is NOT covered for members who meet the following criteria: 

A. The diagnosis is NOT acute promyelocytic leukemia 

B. The medication is being used for maintenance therapy 

C. The patient has previous history of trial of Vesanoid® 

D. The request is for more than 90 days 

E. The request does not come from an oncologist 




Oncologist 


90 days 

187



VFEND 


Vfend® is indicated: 

A. For the treatment of infection with invasive aspergillosis, candidiasis, furariosis, 

Scedosporium apiospermum 


Vfend® is covered for members who meet the following criteria: 

A. The patient is diagnosed with invasive aspergillosis 

a. AND the patient has had previous trial and failure or contraindication to 

itraconazole*If aspergillosis infection is extrapulmonary no previous trial 

is required 

b. AND chart notes documenting trial and failure or contraindication to 

itraconazole are received 

B. OR the patient is diagnosed with candidiasis 

a. AND the patient has previous trial and failure or contraindication to 

BOTH fluconazole and itraconazole 

b. AND chart notes documenting trial and failure or contraindication to 

itraconazole are received 

C. OR the patient is diagnosed with furariosis or Scedosporium sp. 

a. AND Vfend® is being used as salvage therapy due to failure of other 

therapies 

b. AND chart notes documenting previous treatment failures is received 

NON COVERAGE 

Vfend® is NOT covered for members who meet the following criteria: 

A. The diagnosis is NOT invasive aspergillosis, candidiasis, furariosis, or 

Scedosporium sp. infection 

B. If being used for aspergillosis or candidiasis, previous medication regimens as 

noted have not been utilized 

C. If being used for furariosis or Scedosporium sp., NOT being used for salvage 

therapy 

D. Chart notes documenting previous regimens is not received or do not address 

needed information 






1 month 

188



VIDAZA 


Vidaza® is indicated: 

A. For the treatment of myelodysplastic syndrome. 


Vidaza® is covered for members who meet the following criteria: 



B. AND the patient is diagnosed with myelodysplastic syndrome 

C. AND the patient has low probability to respond to immunosuppressive therapy 

(IST) 

D. AND chart notes documenting low serum epopoietin as well as documentation 

showing reasoning for patient’s low probability to respond to IST 

E. AND for extended authorization, patient is showing benefit from treatment 

NON COVERAGE 

Vidaza® is NOT covered for members who meet the following criteria: 


B. The diagnosis is NOT myelodysplastic syndrome 

C. Patient has HIGH probability to respond to IST 

D. Chart notes documenting epopoietin levels and low probability for benefit from 

IST are not received or do not address the needed information 




Oncologist 


4 months 

189



VIMPAT 


All FDA approved indications not otherwise excluded from Part D 


Vimpat® is covered for members who meet the following criteria: 

A. A.Patient will receive Vimpat as an adjunctive anticonvulsant. 

B. Patient has a documented trial/failure/contraindication to two or more of the 

following: 

a. Carbamazepine 

b. Divalproex 

c. Gabapentin 

d. Lamotrigine 

e. Levetiracetam 

f. Oxcarbazepine 

g. Phenytoin 

h. Pregabalin 

i. Tiagabine 

j. Topiramate 

k. Valproic acid 

l. Zonisamide 


The following copies of chart notes/laboratory reports are required: 

A. Documentation showing that Vimpat will be given as an adjunctive 

anticonvulsant 

B. Documentation showing that the patient has had a previous 

trial/failure/contraindication to two or more of the following: 

a. Carbamazepine 

b. Divalproex 

c. Gabapentin 

d. Lamotrigine 

e. Levetiracetam 

f. Oxcarbazepine 

g. Phenytoin 

h. Pregabalin 

i. Tiagabine 

j. Topiramate 

k. Valproic acid 

l. Zonisamide 


Covered for 17 years and older 


Plan Year 

190



VISTIDE 


Vistide® is indicated: 

A. Cytomegalovirus 

B. Cytomegalovirus retinitis 

C. Cytomegalovirus retinitis prophylaxis 



Vistide® is covered for members who meet the following criteria: 


B. AND patient has AIDS 

C. AND patient is NOT taking one of the following medications: 

a. Aminoglycosides 

b. Amphotericin B 

c. Foscarnet 

d. NSAIDs 

e. Pentamidine 

f. Tacrolimus 

g. Vancomycin 

D. AND (in prophylaxis patients) CD4+ count is Less than 100-150 cells/ mm 3 

E. AND B vs. D criteria indicates that coverage should be through Medicare Part D 

NON COVERAGE 

Vistide® is NOT covered for members with the following criteria: 


B. Patients without AIDS 

C. If patient is taking 

a. Aminoglycosides 

b. Amphotericin B 

c. Foscarnet 

d. NSAIDs 

e. Pentamidine 

f. Tacrolimus 

g. Vancomycin 






3 months 

191



VIVAGLOBIN 













NON COVERAGE 



B. The diagnosis is NOT hypergammaglobulinemia, primary immunodeficiency, 

Idiopathic Thrombocytopenia Purpura OR Kawasaki disease 


INFORMATION 



Plan Year 

192



XENAZINE 


Xenazine® is indicated: 

A. For treatment of chorea associated with Huntington’s Disease 


Xenazine® is covered for members who meet the following criteria: 

A. Patient must be diagnosed with Huntington’s chorea 

B. Patient must have previous trial/failure of Haloperidol 

NON COVERAGE 

Xenazine® is NOT covered for members with the following criteria: 

A. Diagnosis is NOT Huntington’s chorea 

B. Patient has no previous trial/failure on Haolperidol 

C. Patient has significant hepatic disease 

D. Patient is taking concurrent MAOI therapy 

E. Patients diagnosed with torsade de pointes 


INFORMATION 



Plan Year 

193



XOLAIR 


Xolair® is indicated: 

A. For adults and adolescents (12 years of age and above) with moderate to severe 

persistent asthma who have a positive skin test to a perennial aeroallergen and 

whose symptoms are inadequately controlled with inhaled corticosteroids. Safety 

and efficacy have not been established in other allergic conditions. 



Xolair® is covered for members who meet the following criteria: 

A. The patient must be 12 years of age or older. 

B. AND the prescribing provider is a board certified pulmonologist, allergist or 

immunologist. 

C. AND the patient is NOT a current smoker. 

D. AND the diagnosis is documented as moderate-to-severe persistent asthma and 

there is evidence of reversible disease (20% or greater improvement in peak 

expiratory flow [PEF] with a short acting bronchodilator challenge). (Please 

verify the patient’s chart notes for diagnosis). 

E. AND the patient has tested positive to a perennial aeroallergen skin test. (Please 

verify the patient’s chart notes for a positive aeroallergen skin test). 

F. AND the patient’s baseline IgE is between 30 and 700 IU/ mL. (Please verify IgE 

level in the patient’s chart notes). 

G. AND the patient has been compliant and maintained on standard inhaled 

corticosteroid therapy for at least 6-months and still remains inadequately 

controlled. (Please verify the patient’s chart notes or drug history to verify their 

use of an inhaled corticosteroid [e.g. QVAR®, Pulmicort®, AeroBid®, Flovent®, 

Azmacort®, Asmanex®). 

H. AND the patient has had a 3-month trial and failure or intolerant to a long acting 

beta agonist agent that can Include Symbicort®, Foradil®, Serevent®, or 

Advair®. 

I. AND if the patient has received prior treatment with Xolair®, 

J. The patient must experience a reduction in symptoms and improvement in their 

FEV1 or PEF before initiation of re-treatment. 

NON COVERAGE 

Xolair® is NOT covered for members with the following criteria: 

A. The patient is under the age of 12 year old. 

B. The prescribing provider is NOT a board certified pulmonologist, allergist or 

immunologist. 

C. The patient is a current smoker. 

D. The diagnosis is NOT documented as moderate-to-severe persistent asthma OR 

there is NO evidence of reversible disease. 

194



XOLAIR 

(Continued) 

E. The diagnosis is documented as a food (e.g. peanut) or latex allergy. 

F. The diagnosis is documented as allergic rhinitis. 

G. The patient has NOT tested positive to a perennial aeroallergen skin test. 

H. The patient’s baseline IgE is NOT between 30 and 700 IU/ mL. 

I. The patient has NOT been compliant and maintained on standard inhaled 

corticosteroid therapy for at least 6-months. 

J. The patient has NOT had a 3-month trial and failure or intolerant to a long acting 

beta agonist agent. 

K. If the patient has received prior treatment with Xolair® and NOT experienced a 

reduction in symptoms and improvement in their FEV1 or PEF. 

REQUIRED MEDICAL INFORMAITON 



Pulmonologist, allergist, or 

immunologist 


Plan Year 

195



XYREM 


Xyrem® is indicated: 

A. For the treatment of excessive daytime sleepiness and cataplexy in patients with 

narcolepsy. 

Xyrem® is only available through the Xyrem® Success Program. Physicians may contact 

the centralized pharmacy at 1-866-977-3688. The Xyrem® success program ensures that 

the patient reads and understands the risks associated with Xyrem® use. 


Xyrem® is covered for members who meet the following criteria: 

A. The prescribing provider is a board certified sleep specialist, pulmonologist, 

neurologist or psychiatrist. 

B. AND the diagnosis is documented as excessive daytime sleepiness with 

symptoms that limits their ability to perform normal daily activities. 

C. OR the diagnosis is documented as cataplexy (a condition characterized by weak 

or paralyzed muscles) in patients with narcolepsy. (Please verify cataplexy 

diagnosis in patient’s chart notes). 

D. AND the patient has tried and failed (continues to have symptoms) to at least a 4- 

week therapy of the highest tolerated dose of Provigil®. (Please verify the use of 

Provigil® by reviewing the patient’s drug history or chart notes). 

E. AND the patient is NOT being treated with a sedative hypnotic agent (e.g. 

flurazepam, Dalmane®, zolpidem, Ambien®, eszopiclone, Lunesta® estazolam, 

Prosom®, temazepam, Restoril®, chloral hydrate).(Please verify the use of a 

sedative hypnotic® by reviewing the patient’s drug history or chart notes). 

F. AND the patient will NOT be receiving combination therapy with Provigil®. 

(Please verify the potential Of combination use by reviewing the patient’s drug 

history or chart notes). 

G. AND if the patient has received prior treatment with Xyrem®. 

H. The patient must experience a decrease in daytime sleepiness and/or cataplexy in 

a narcoleptic patient. 

I. AND approval can be allowed for 3 months for the initial authorization or up to 1 

year for an additional request. 

NON COVERAGE 

Xyrem® is NOT covered for members with the following criteria: 

A. The prescribing provider is NOT a board certified sleep specialist, 

pulmonologist, neurologist or psychiatrist. 

B. The patient has NOT tried and failed at least a 4-week therapy of the highest 

tolerated dose of Provigil®. 

C. The patient is being treated with a sedative hypnotic agent. 

D. The patient is receiving combination Xyrem® therapy with Provigil®. 

196



XYREM 

(Continued) 






3 months 

197



ZAVESCA 


Zavesca® is indicated: 

A. For the treatment of adult patients with mild-to-moderate type-1 Gaucher disease 

for whom enzyme replacement therapy is not a therapeutic option. 


Zavesca® is covered for members who meet the following criteria: 

A. Diagnosis is documented as mild-to-moderate type-1 Gaucher disease. 


C. AND diagnosis has been confirmed by bone marrow histology, DNA testing or 

measurement of b-glucocerebrosidase enzyme activity less than 30%. 

D. AND the patient has a hemoglobin concentration above 9 g/dL or a platelet count 

above 50 x10 9 /L or active bone disease. (Zavesca® has not been evaluated in 

patients with severe disease). 

E. AND the patient has tried and failed enzyme replacement therapy (e.g. 

Ceredase®, Cerezyme®) or is not a therapeutic option (e.g. allergy, 

hypersensitivity). (Please verify trial in the patient’s drug history or chart). 

F. AND if the patient is female and of childbearing years, she is NOT pregnant, has 


conceive and has been educated on the potential dangers of Zavesca® therapy. 

G. AND if the patient has previously received 24 months of Zavesca® therapy, they 

must show a decrease in liver and spleen volume and/or increases in platelet count 

and/or increases in hemoglobin concentration. 

NON COVERAGE 

Zavesca® is NOT covered for members with the following criteria: 

A. The diagnosis is NOT documented as mild-to moderate type-1 Gaucher disease. 


C. Diagnosis has NOT been confirmed by bone marrow histology, DNA testing or 

measurement of enzyme activity. 

D. The patient has a hemoglobin concentration below 9 g/dL or a platelet count 

below 50 x10 9 /L or active bone disease. 

E. The patient has not tried, failed or intolerant to enzyme replacement therapy. 

F. If the patient is female and of childbearing years, she cannot be pregnant, have 

plans for pregnancy, and not educated on the potential risk of pregnancy with 

Zavesca® therapy. 

G. If the patient has previously received 24 months of Zavesca® therapy and has 

NOT shown a decrease in liver and spleen volume and/or increases in platelet 

count and/or increases in hemoglobin concentration since starting Zavesca® 

therapy. 

198



ZAVESCA 

(Continued) 






Plan Year 

199


Zemplar® is indicated: 

A. Secondary Hyperparathyroidism 



ZEMPLAR 


Zemplar® is covered for members who meet the following criteria: 

A. Zemplar is being prescribed for Secondary Hyperparathyroidism 

B. AND Intact Parathyroid Hormone (iPTH) Greater than240 pg/mL (or Greater 

than4 times theupper limit of normal) 

C. AND Corrected serum calcium Less than 10.5 mg/dL 

D. AND Corrected Ca XP Less than 70 

E. OR Failure (or contraindication) of Rocaltrol/Calcijex/Hectorol oral or injection 

therapy by demonstrating iPTH level Greater than180 pg/mL (or Greater than 3 

times the upper limit of normal) despite adequate therapy 

F. OR Development of hypercalcemia (serum calcium Greater than 11.5 mg/dL) 

despite adequate therapy and discontinuance of calcium based phosphate binders 

For Renewal Authorization: 

A. iPTH Greater than 120 pg/mL (or 2 times the upper limit of normal) 

B. AND Corrected serum calcium Less than 11.5 mg/dL 

C. AND Corrected Ca XP Less than 75 

NON COVERAGE 

Zemplar® is NOT covered for members with the following criteria: 

D. Hypercalcemia 

E. Vitamin D toxicity 

F. Concurrent use with Vitamin D analogs 






Plan Year 

200



ZENAPAX 


Zenapax® is indicated: 

A. Kidney Transplant Rejection Prophylaxis 


Zenapax® is covered for members who meet the following criteria: 

A. Zenapax is being prescribed for Kidney transplantation prophylaxis 

B. AND the patient is greater than 11 months old 

C. AND B vs. D criteria is determined that coverage should be through Medicare 

Part D. 

NON COVERAGE 

Zenapax® is NOT covered for members with the following criteria: 

A. Zenapax is NOT being prescribed for Kidney transplantation prophylaxis 

B. The patient is less than 11 months old 

C. B vs. D criteria is determined that coverage should be through Medicare Part B 


INFORMATION 



10 weeks 

201



ZYPREXA ZYDIS 


A. Acute Psychosis 

B. Agitation 

C. Bipolar Disorder 

D. Mania 

E. Schizophrenia. 

F. All other FDA approved indications not otherwise excluded from Part D 


Zyprexa-Zydis is covered for members who meet the following criteria: 

A. Patients that have an FDA approved indication that are NPO (Nothing By Mouth). 

B. Chart notes required indicating that patient can not take tablets or capsules. 

NON COVERAGE 

Zypresxa-Zydis is not covered for members who meet the following criteria: 

A. Patient has other tablets or capsules in their medication profile indicating that they can 

take Zyprexa tablets 


INFORMATION 

Chart Notes 


Plan Year 

202



ZYVOX 


Zyvox® is indicated For the following aerobic and facultative Gram-positive 

microorganisms. 

A. Vancomycin-Resistant Enterococcus faecium, including cases with concurrent 

bacteremia. 

B. Nosocomial pneumonia caused by Staphylococcus aureus (methicillin-susceptible 

and methicillin-resistant strains), or Streptococcus pneumoniae (including multidrug 

resistant strains [MDRSP]). 

C. Complicated skin and skin structure infections, including diabetic foot infections, 

without concomitant osteomyelitis, caused by Staphylococcus aureus (methicillinsusceptible 

and methicillin-resistant strains), Streptococcus pyogenes, or 

Streptococcus agalactiae. (Zyvox® has not been studied in the treatment of 

decubitus ulcers). 

D. Uncomplicated skin and skin structure infections caused by Staphylococcus 

aureus (methicillin-susceptible only) or Streptococcus pyogenes. 

E. Community-acquired pneumonia caused by Streptococcus pneumoniae (including 

multi-drug resistant strains [MDRS]), including cases with concurrent bacteremia 

or Staphylococcus aureus (methicillin-susceptible strains only). 


Zyvox® is covered for members who meet the following criteria: 

A. Therapy is NOT being used for prophylaxis therapy. 

B. The infection is NOT a decubitus ulcer. (Zyvox® has not been studied in the 

treatment of decubitus ulcers). 

C. The prescriber has provided chart notes, lab values and susceptibility results that 

document that the pathogen is susceptible to Zyvox®, other medications that the 

organism is susceptible to have been tried, the infection is a covered indication 

listed below, and the organism is a covered pathogen also listed below: 

D. A first time Zyvox® request to treat an infection caused by Vancomycin- 

Resistant Enterococcus faecium. 

a. AND approval can be allowed for 14 to 28 days. 

b. OR a request to extend Zyvox® treatment beyond the initial 14 to 28 day 

approved treatment for an infection caused by Vancomycin-Resistant 

Enterococcus faecium. 

c. AND an in-vitro susceptibility test (within 5-days of the request) that 

shows a continued presence of the pathogen and the organism’s continued 

susceptibility to Zyvox®. 

d. AND approval can be allowed for an additional 14 to 28 days. 

E. OR a first time Zyvox® request to treat a nosocomial pneumonia infection caused 

by Staphylococcus aureus (methicillin-susceptible and methicillin-resistant 

strains) or Streptococcus pneumoniae (including multi-drug resistant strains 

[MDRSP]). 

203



ZYVOX 

(Continued) 

a. AND the susceptibility report shows that the pathogen is not susceptible to 

any other antibiotic OR the provider can show a documented trial and 

failure or intolerance to the listed susceptible antibiotic. 

b. AND approval can be allowed for up to 14 days. 

c. OR a request to extend Zyvox® treatment beyond the initial 10-14 day 

approved treatment for a nosocomial pneumonia infection caused by 

Staphylococcus aureus or Streptococcus pneumoniae. 

d. AND an in-vitro susceptibility test (within 5-days of the request) that 

shows a continued presence of the pathogen and the organism’s continued 


e. AND approval can be allowed for up to 14 days. 

F. OR a first time Zyvox® request to treat complicated skin and skin structure 

infections, including diabetic foot infections, without concomitant osteomyelitis, 

caused by Staphylococcus aureus (methicillin-susceptible and methicillin-resistant 

strains) OR Streptococcus pyogenes OR Streptococcus agalactiae. 




b. AND the patient does NOT have osteomyelitis. 

c. AND approval can be allowed for up to 14 days. 

G. OR a request to extend Zyvox® treatment beyond the initial 10-14 day approved 

treatment for a complicated skin and skin structure infections, including diabetic 

foot infections, without concomitant osteomyelitis, caused by Staphylococcus 

aureus (methicillin-susceptible and methicillin-resistant strains) OR Streptococcus 

pyogenes OR Streptococcus agalactiae.. 

a. AND in-vitro susceptibility test (within 5-days of the request) that shows a 

continued presence of the pathogen and the organism’s continued 


b. AND the patient does NOT have osteomyelitis. 


H. OR a first time Zyvox® request to treat uncomplicated skin and skin structure 

infections caused by methicillin-susceptible only -Staphylococcus aureus. 

a. AND the pathogen is methicillin-susceptible only. 

b. AND the susceptibility report shows that the pathogen is not susceptible to 




d. OR a request to extend Zyvox® treatment beyond the initial 10-14 day 

approved treatment for an uncomplicated skin and skin structure infections 

caused by methicillin-susceptible only -Staphylococcus aureus. 

e. AND the pathogen is methicillin-susceptible only. 

204



ZYVOX 

(Continued) 

f. AND in-vitro susceptibility test (within 5-days of the request) that shows a 



g. AND approval can be allowed for up to 14 days. 

I. OR a first time Zyvox® request to treat uncomplicated skin and skin structure 

infections caused by Streptococcus pyogenes. 






approved treatment for an uncomplicated skin and skin structure infections 

caused by Streptococcus pyogenes. 

d. AND in-vitro susceptibility test (within 5-days of the request) that shows a 




J. OR a first time Zyvox® request to treat community-acquired pneumonia caused 

by Streptococcus pneumoniae (including multi-drug resistant strains [MDRS]), 

including cases with concurrent bacteremia. 






approved treatment for a community-acquired pneumonia caused by 

Streptococcus pneumoniae. 

d. AND in-vitro susceptibility test (within 5-days of the request) that shows a 




K. OR a first time Zyvox® request to treat community-acquired pneumonia caused 

by Staphylococcus aureus (methicillin-susceptible strains only). 

a. AND the pathogen is methicillin-susceptible. 

b. AND the susceptibility report shows that the pathogen is NOT susceptible 

to any other antibiotic OR the provider can show a documented trial and 



d. OR a request to extend Zyvox® treatment beyond the initial 10-14 day 

approved treatment for a community-acquired pneumonia caused by 

Staphylococcus aureus (methicillin-susceptible strains only). 

e. AND the pathogen is methicillin-susceptible. 

205



ZYVOX 

(Continued) 

f. AND in-vitro susceptibility test (within 5-days of the request) that shows a 



g. AND approval can be allowed for up to 14 days. 

NON COVERAGE 

A. Therapy is being used for prophylaxis. 

B. The infection is a decubitus ulcer. 

C. The diagnosis is neutropenia. 

D. The prescriber has not provided chart notes to document diagnosis, organism, 

susceptibility results and failure to other medications. 

E. The infection is caused by Enterococcus faecium but is NOT Vancomycin- 

Resistant. 

F. Susceptibility test shows the pathogen susceptible to another antibiotic and no 

drug regimen and been tried and failed. 

G. The patient has received previous Zyvox® therapy and an in-vitro susceptibility 

test has NOT been provided OR is NOT within 5 days of the request OR the 

pathogen is no longer susceptible to Zyvox®. 

H. The diagnosis is nosocomial pneumonia but the infection is NOT caused by 

Staphylococcus aureus or Streptococcus pneumoniae. 

I. The diagnosis is complicated skin and skin structure infections and the patient has 

osteomyelitis. 

J. The diagnosis is complicated skin and skin structure infections and NOT caused 

by Staphylococcus aureus or Streptococcus pyogenes or Streptococcus agalactiae. 

K. The diagnosis is uncomplicated skin and skin structure infections and the 

infection is caused by methicillin resistant Staphylococcus aureus. 

L. The diagnosis is uncomplicated skin and skin structure infections and the 

infection is NOT caused by methicillin susceptible Staphylococcus aureus or 

Streptococcus pyogenes. 

M. The diagnosis is community-acquired pneumonia and the infection is NOT caused 

by Streptococcus pneumoniae OR methicillin-susceptible Staphylococcus aureus. 

N. The diagnosis is community-acquired pneumonia and the infection is caused by 

methicillin-resistant Staphylcoccus aureus. 


INFORMAITON 



Plan Year 

206



INDEX 

5 

5HT-3 ANTAGONISTS ....................................1 

A 

ACTIMMUNE ...................................................2 

ACTONEL .........................................................3 

ADAGEN ...........................................................4 

AFINITOR .........................................................5 

AGRYLIN..........................................................6 

ALDURAZYME ................................................8 

ALFERON N....................................................10 

AMITIZA .........................................................11 

ANAGRELIDE ................................................13 

ANTIZOL.........................................................15 

ATGAM ...........................................................16 

AVONEX .........................................................17 

AZATHIOPRINE.............................................19 

B 

BANZEL ..........................................................20 

BETASERON ..................................................21 

BUPHENYL.....................................................23 

BYETTA ..........................................................24 

C 

CAMPATH ......................................................26 

CAMPRAL DELAYED-RELEASE TABLETS 

.....................................................................27 

CAMPTOSAR..................................................28 

CARIMUNE.....................................................29 

CELLCEPT ......................................................30 

CEREDASE .....................................................31 

CEREZYME ....................................................32 

CHORIONIC GONADOTROPIN ...................76 

CIMZIA............................................................33 

CLADRIBINE..................................................35 

CLARAVIS......................................................36 

COLONY STIMULATING FACTOR.............37 

COPAXONE ....................................................38 

CYCLOPHOSPHAMIDE ................................40 

CYCLOSPORINE............................................41 

CYKLOKAPRON............................................42 

CYTARABINE ................................................43 

D 

DACOGEN ......................................................44 

DUREZOL .......................................................45 

E 

ELAPRASE......................................................46 

ELIDEL ........................................................... 47 

ELIGARD........................................................ 48 

ELITEK ........................................................... 49 

ELOXATIN..................................................... 50 

EMEND........................................................... 51 

EMSAM .......................................................... 52 

ENBREL.......................................................... 53 

ERAXIS........................................................... 58 


.................................................................... 59 

ETHYOL ......................................................... 64 

EXELON ......................................................... 65 

EXJADE .......................................................... 66 

F 

FABRAZYME ................................................ 67 

FLEBOGAMMA............................................. 68 

FORTEO.......................................................... 69 

G 

GAMASTAN .................................................. 71 

GAMMAGARD .............................................. 72 

GAMUNEX..................................................... 73 

GLEEVEC....................................................... 74 

H 

HEPATITIS C ................................................. 77 

HEPSERA ....................................................... 79 

HUMIRA......................................................... 81 

I 

IMITREX ........................................................ 85 

INCRELEX ..................................................... 86 

INSPRA........................................................... 88 

INTRON A ...................................................... 90 

INVEGA.......................................................... 96 

ITRACONAZOLE .......................................... 98 

IVEEGAM....................................................... 99 

IXEMPRA ..................................................... 100 

K 

KEPPRA XR ................................................. 101 

KETEK.......................................................... 102 

KINERET ...................................................... 103 

L 

LAMISIL AT TOPICAL SPRAY 1%........... 104 

LETAIRIS ..................................................... 105 

LEUCOVORIN ............................................. 106 

LEUSTATIN ................................................. 107 

LIDODERM .................................................. 108 

207

LOVAZA .......................................................109 

LUPRON DEPOT ..........................................110 

M 

MARINOL .....................................................111 

MESNEX .......................................................114 

MIACALCIN .................................................115 

MYFORTIC ...................................................116 

MYOZYME ...................................................117 

N 

NAGALZYME...............................................118 

NEURONTIN SOLUTION............................119 

NEUTREXIN .................................................120 

NEXAVAR ....................................................121 

NICOTROL....................................................123 

NOVANTRONE ............................................124 

NOVAREL.....................................................125 

O 

OCTAGAM....................................................126 

OCTREOTIDE...............................................127 

ORENCIA ......................................................128 

ORFADIN ......................................................129 

ORTHOCLONE.............................................130 

OXANDROLONE .........................................131 

OXSORALEN................................................132 

P 

PAMIDRONATE...........................................133 

PANGLOBULIN............................................134 

POLYGAM ....................................................135 

PREGNYL......................................................136 

PROGRAF......................................................137 

PROMACTA..................................................138 

PROVIGIL .....................................................139 

PULMOZYME...............................................141 

R 

RANEXA .......................................................142 

RAPAMUNE..................................................144 

REGRANEX ..................................................145 

RELISTOR.....................................................146 

REVATIO ......................................................147 

REVLIMID ....................................................149 

RISPERDAL ..................................................151 



ROTATEQ .................................................... 152 

S 

SAIZEN......................................................... 153 

SANCUSO .................................................... 158 

SIMULECT ................................................... 159 

SOMAVERT ................................................. 160 

SPORANOX.................................................. 161 

SUCRAID...................................................... 162 

SUTENT........................................................ 163 

SYMLIN........................................................ 165 

SYNAREL..................................................... 167 

T 

TAMIFLU ..................................................... 168 

TARCEVA .................................................... 169 

TARGRETIN ................................................ 171 

TASIGNA...................................................... 172 

TEV-TROPIN................................................ 173 

TORISEL....................................................... 178 

TRACLEER .................................................. 179 

TRETINOIN PRODUCTS ............................ 181 

TRICOR ........................................................ 182 

TYKERB ....................................................... 183 

TYZEKA ....................................................... 185 

V 

VESANOID................................................... 187 

VFEND.......................................................... 188 

VIDAZA........................................................ 189 

VIMPAT........................................................ 190 

VISTIDE........................................................ 191 

VIVAGLOBIN .............................................. 192 

X 

XENAZINE................................................... 193 

XOLAIR........................................................ 194 

XYREM......................................................... 196 

Z 

ZAVESCA..................................................... 198 

ZEMPLAR .................................................... 200 

ZENAPAX .................................................... 201 

ZYPREXA ZYDIS........................................ 202 

ZYVOX ......................................................... 203 

208

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