Therapy Class Review - Express Scripts

Therapy Class Review 

Express Scripts 2007 Drug Trend Report


In this section of the Drug Trend Report, we evaluate trends for nine nonspecialty classes and seven 

specialty classes. For each featured class, we detail components of trend, key facts about the class, 

market-share trend over the past five years, important points to note, and pipeline and patent 

expiration information. 

NONSPECIALTY 

This year, we added shorter discussions for six nonspecialty classes that deserve notice due to unusual 

activity. While some of these classes to watch may have little impact on total spend, they all include one 

or more drugs that influence utilization or cost, or both. 

The top 20 nonspecialty therapy classes accounted for 75% of nonspecialty drug spend for 2007. 

Exhibit 22 

PMPY Cost and Cost per Prescription for Selected Nonspecialty Therapy Classes 2006 to 2007 

Ranked by 2007 PMPY Cost 

PMPY Cost 

Cost per Prescription 

2006 2007 % Change 2006 2007 % Change 

Antihyperlipidemics $ 91.53 $ 83.32 -9.0% $ 79.48 $ 67.32 -15.3% 

Gastrointestinals $ 62.50 $ 63.09 1.0% $100.38 $ 99.19 -1.2% 

Antidepressants $ 58.88 $ 56.91 -3.3% $ 62.08 $ 58.17 -6.3% 

Antidiabetics $ 42.67 $ 49.50 16.0% $ 65.23 $ 73.55 12.8% 

Antiasthmatics $ 40.65 $ 45.82 12.7% $ 83.65 $ 92.17 10.2% 

Antihypertensives $ 41.20 $ 45.19 9.7% $ 33.70 $ 35.73 6.0% 

Anticonvulsants $ 27.36 $ 31.88 16.6% $ 96.98 $105.82 9.1% 

Antivirals $ 18.56 $ 21.27 14.6% $214.50 $234.76 9.4% 

Hypnotics $ 12.62 $ 11.64 -7.7% $ 74.50 $ 61.81 -17.0% 

Others $366.79 $390.13 6.4% $ 42.16 $ 44.18 4.8% 

Total $762.76 $798.76 4.7% $ 53.25 $ 54.34 2.0% 


express scripts 2007 drug trend report 21

Antihyperlipidemics NONSPECIALTY RANK 1 

COMPONENTS OF TREND 2006 TO 2007 KEY FACTS 2007 

Cost per Prescription -15.3% Cost PMPY: $83.32 

Price -2.0% # Rx PMPY: 1.24 

Units per Prescription -0.2% Prevalence of Use: 11.5% 

Brand/Generic Mix -9.1% Average Cost/Rx: $67.32 

Therapeutic Mix -4.7% # Rx/User/Year: 9.78 

Utilization 7.5% 

Prevalence 4.8% 

Intensity 2.5% 

New Drugs 0 

TOTAL -9.0% 

Antihyperlipidemics Market-Share Trend 

60% 

50% 

Generics $34.80 


Percent of Prescriptions 

40% 

30% 

20% 

10% 

0 

2003 

2004 2005 2006 

2007 

Lipitor ® $90.07 

Vytorin ® $82.36 

Crestor ® $82.64 

Zetia ® $78.80 

TriCor ® $88.01 

• Generic market share for antihyperlipidemics rose from 9% in 2005 to nearly 40% in 2007. 

• Although utilization of antihyperlipidemics continues to increase, a full year’s use of multisource 

generics for Zocor ® decreased cost per prescription and drove overall trend into negative numbers. 

• Statins will remain the mainstay of treatment for high cholesterol. 

• The next statin scheduled to lose patent protection is Lipitor ® in 2010 (2011 if the patent 

is reinstated). 

• Niacin remains the only product to raise HDL cholesterol. Cordaptive , the combination 

of extended-release niacin and a flushing inhibitor, will compete with Niaspan ® in this market. 

• The antihyperlipidemics pipeline consists mainly of products that combine a statin with other therapies 

to target several types of high cholesterol with a single pill. 

Brand Generic Pipeline or Patent Expiration Anticipated Availability 

Cordaptive 

niacin, extended release/ 

laropiprant (MK-0524A) 

Pipeline 6/29/2008 

ABT-335 next-generation fenofibrate Pipeline 2008 

mipomersen Pipeline 2009 

MK-0524B Cordaptive /simvastatin Pipeline 2009 

22 express scripts 2007 drug trend report

Gastrointestinals NONSPECIALTY RANK 2 



Price 2.2% # Rx PMPY: 0.64 

Units per Prescription 0.7% Prevalence of Use: 8.5% 






New Drugs 0 

TOTAL 1.0% 

Gastrointestinals Market-Share Trend 

45% 


40% 

35% 

30% 

25% 

20% 

15% 

10% 

5% 

0 

2003 

2004 2005 2006 

2007 


Nexium ® $145.36 

Prevacid ® $146.00 

Protonix ® $117.54 

AcipHex ® $150.39 

• Overall trend in the gastrointestinals class was relatively flat; increased use was offset by decreased 

cost per prescription. 

• Proton pump inhibitors (PPIs) will continue to dominate treatment for gastroesophageal reflux disease 

(GERD) into the next decade. 

• Generic Prilosec OTC ® became available during Q1 2008. 

• Although the Protonix ® patent is not due to expire until early 2011, generics for it were launched 

at risk (before litigation was resolved) in late December 2007. A trial date has yet to be scheduled. 



TAK-390MR dexlansoprazole Pipeline 10/28/2008 

Prevacid ® OTC lansoprazole Pipeline Q4 2009 

Prilosec OTC ® omeprazole Patent Expiration Q1 2008 

Prevacid ® lansoprazole Patent Expiration 11/10/2009 


Antidepressants NONSPECIALTY RANK 3 






Therapeutic Mix 2.0% # Rx/User/Year: 8.49 




New Drugs 0 

TOTAL -3.3% 

Antidepressants Market-Share Trend 

70% 



60% 

50% 

40% 

30% 

20% 

10% 

0 

2003 

2004 2005 2006 

2007 


Lexapro ® $77.02 

Effexor XR ® $131.63 

Cymbalta ® $129.91 

Wellbutrin XL ® $149.41 

• Overall trend for antidepressants was negative because more patients used generic antidepressants. 

Generics now dominate market share at more than 65%. 

• As serotonin-norepinephrine reuptake inhibitors (SNRIs) continue to get unique additional indications, 

they will take market share from generically available selective serotonin reuptake inhibitors (SSRIs). 

• Non-AB-rated generic tablets to Effexor XR ® could launch after the venlafaxine patent expires 

on June 13, 2008. 


BVF-033 bupropion salt Pipeline 4/23/2008 

amibegron Pipeline 2009 

saredutant Pipeline 2009 

Valdoxan ® agomelatine Pipeline 2009 

Paxil CR ® paroxetine, extended release Patent Expiration 10/1/2008 

Wellbutrin XL ® 

150mg 

bupropion, extended release Patent Expiration 2008 


Antidiabetics NONSPECIALTY RANK 4 


Cost per Prescription 12.8% Cost PMPY: $49.50 







Intensity -1.9% 

New Drugs 0.7% 

TOTAL 16.0% 

Antidiabetics Market-Share Trend 

60% 

50% 



40% 

30% 

20% 

10% 

0 

2003 

2004 2005 2006 

2007 

Actos ® $154.66 

Lantus ® $116.30 

Avandia ® $135.51 

Humalog ® $154.74 

Januvia ® $148.16 

Byetta ® $191.69 

• Overall trend for antidiabetics was up 16.5%, largely due to higher cost per prescription. 

• After reports of potential safety issues, utilization of Avandia ® dropped in late 2007. 

• Significant new generic opportunities are limited until early next decade. 

• Manufacturers developing inhaled insulins are re-evaluating market potential of their products after 

Exubera ® was withdrawn from the market due to disappointing sales. 



alogliptin Pipeline 11/4/2008 

Byetta ® LAR exenatide, long-acting Pipeline 2009 

liraglutide Pipeline 2009 

saxagliptin Pipeline 2009 

Precose ® acarbose Patent Expiration 2008 

Prandin ® repaglinide Patent Expiration 3/14/2009 

Glyset ® miglitol Patent Expiration 7/27/2009 


Antiasthmatics NONSPECIALTY RANK 5 











TOTAL 12.7% 

Antiasthmatics Market-Share Trend 

40% 



35% 

30% 

25% 

20% 

15% 

10% 

5% 

0 

2003 

2004 2005 2006 

2007 

Singulair ® $92.32 


Advair Diskus ® $167.92 

ProAir ® HFA $34.12 

Spiriva ® $120.55 

Flovent ® HFA $106.65 

• With an 8% increase, inflation is the driver of overall trend for antiasthmatics. Generic albuterol 

metered-dose inhalers (MDIs) are being replaced by brand-name MDIs containing nondamaging 

hydrofluoroalkane propellants. Limited supplies of CFC-containing inhalers may still be available, 

but they cannot be sold in the U.S. after Dec. 31, 2008. 

• Advair Diskus ® and Singulair ® represent the majority of spend in the antiasthmatics class. 

• Complex inhaler devices and difficulty in determining equivalence of topically acting products 

will delay FDA approval of other generic asthma inhalers. 

• Moving into the next decade, once-daily long-acting beta agonists (LABA) and corticosteroid/LABA 

combinations may replace the current twice-daily products. 


ProAir ® 

Breathmatic albuterol HFA MDI Pipeline 2008 

Flutiform fluticasone/formoterol Pipeline 2009 

indacaterol Pipeline 2009 

Serevent ® salmeterol Patent Expiration 8/12/2008 

Advair Diskus ® fluticasone/salmeterol Patent Expiration 2008/2010 


Antihypertensives NONSPECIALTY RANK 6 






Therapeutic Mix 0 # Rx/User/Year: 9.99 





TOTAL 9.7% 

Antihypertensives Market-Share Trend 

70% 


60% 

50% 

40% 

30% 

20% 

10% 

0 

2003 

2004 2005 2006 

2007 


Diovan ® /Diovan HCT ® $63.49 

Cozaar ® /Hyzaar ® $61.01 

Benicar ® /Benicar HCT ® $54.55 

Altace ® $56.05 

Lotrel ® $87.51 

Avapro ® $53.87 

• Roughly two-thirds of trend for antihypertensives resulted from cost per prescription — primarily 

driven by inflation. 

• The first generics for lower strengths of Lotrel ® were launched at risk in May 2007. Litigation 

is delaying generics from additional manufacturers, as well as generics for higher strengths of Lotrel. 

• Generics to Altace ® capsules (but not Altace tablets) became available in late December 2007. 

• The patent for the last brand-only angiotensin-converting enzyme inhibitor, Aceon ® , expires in 2009, 

although challenges are pending. 

• Exforge ® and Azor are two new brand-name amlodipine/angiotensin receptor blocker combinations 

that entered the market in 2007. The availability of generic amlodipine likely will result in other 

combination products. 



Aceon ® perindopril Patent Expiration 11/10/2009 


Anticonvulsants NONSPECIALTY RANK 7 










New Drugs 0 

TOTAL 16.6% 

Anticonvulsants Market-Share Trend 

60% 

50% 




40% 

30% 

20% 

10% 

0 

2003 

2004 2005 2006 

2007 

• At 16.6%, the anticonvulsants class had the largest increase in trend for 2007. 

• Cost per prescription increased due to both inflation and therapeutic mix. 

Topamax ® $221.80 

Lamictal ® $233.24 

Lyrica ® $127.24 

Depakote ® ER $135.05 

Depakote ® $147.37 

Keppra ® $247.06 

• Utilization also increased because anticonvulsants continue to be used off-label for a wide variety 

of conditions, including pain and migraines. 

• The significant generic opportunities in this class for 2008 include possible first-time generics to 

Lamictal ® , Keppra ® and Depakote ® /Depakote ® ER. 


lacosamide Pipeline 9/29/2008 

Keppra XR levetiracetam, extended release Pipeline 2008 

Lamictal XR lamotrigine, extended release Pipeline 2008 

Depakote ® / 

Depakote ® ER 

divalproex Patent Expiration 7/29/2008 

Keppra ® levetiracetam Patent Expiration 11/1/2008 

Lamictal ® lamotrigine Patent Expiration 2008 

Topamax ® topiramate Patent Expiration 3/26/2009 


Antivirals NONSPECIALTY RANK 10 











TOTAL 14.6% 

Antivirals Market-Share Trend 


50% 

45% 

40% 

35% 

30% 

25% 

20% 

15% 

10% 

5% 

0 

2003 

2004 2005 2006 

2007 

Valtrex ® $167.36 


Tamiflu ® $69.05 

Famvir ® $190.36 

Truvada ® $784.24 

Atripla ® $1,233.19 

• The two drugs that drove 2007 trend in the antivirals category were Valtrex ® , for treating herpes, 

and Atripla ® , a once-daily triple therapy for treating HIV. 

• Following a patent-litigation settlement, generics to Valtrex are expected to become available 

in December 2009. 

• Because the recent influenza seasons have been relatively mild, the use of Tamiflu ® and Relenza ® 

has not been as significant as in previous years. 

• In 2007, the market saw the introduction of two HIV drugs with novel mechanisms: Selzentry ® blocks 

HIV from entering healthy cells; Isentress ® blocks an important step in viral replication. Both are used 

in combination with other antivirals. 



vicriviroc Pipeline 2009 

Zerit ® stavudine Patent Expiration 12/24/2008 

Valtrex ® valacyclovir Patent Expiration 12/23/2009 


Hypnotics NONSPECIALTY RANK 21 



Price 19.2% # Rx PMPY: 0.19 







New Drugs 0 

TOTAL -7.7% 

Hypnotics Market-Share Trend 

80% 



70% 

60% 

50% 

40% 

30% 

20% 

10% 

0 

2003 

2004 2005 2006 

2007 


Ambien CR ® $95.82 

Ambien ® $107.15 

Lunesta ® $106.01 

Rozerem TM $82.58 

Sonata ® $98.23 

• Overall trend for hypnotics was negative due to the April 2007 launch of generics for Ambien ® . 

However, continued increase in utilization and double-digit growth in inflation dampened 

the full impact of the generics. 

• The receipt of a second approvable letter requesting further studies for indiplon could mark the 

end of its development. 

• Silenor (low-dose doxepin) is continuing in development for insomnia. Doxepin is already used 

for anxiety and depression. 

• The hypnotics class remains the leading class in direct-to-consumer spending. 


indiplon Pipeline 2008 

Silenor doxepin Pipeline 2008 

eplivanserin Pipeline 2009 

Sonata ® zaleplon Patent Expiration 6/6/2008 

Ambien CR ® zolpidem, extended release Patent Expiration (exclusivity) 3/2/2009 


Classes to Watch 

Narcotic Analgesics NONSPECIALTY RANK 8 



Utilization 4.5% # Rx PMPY: 0.63 

New Drugs 0 Prevalence of Use: 16.7% 

TOTAL 14.7% Average Cost/Rx: $43.03 

# Rx/User/Year: 3.43 

• Even though generics control the narcotic analgesics, inflation increased class trend. 

• Patent settlements are forcing a phaseout of generics for OxyContin ® , re-establishing brand-name 

OxyContin in the market, and contributing to inflation for both generics and brands. 

• Patients using narcotic analgesics are particularly susceptible to dose creep (increases in dosage 

to maintain response), which drives up utilization. 

Stimulants/Antiobesity Agents NONSPECIALTY RANK 11 




New Drugs 0.9% Prevalence of Use: 2.1% 



• Trend in this category is driven by drugs, such as Adderall XR ® and Concerta ® , that are used for 

the treatment of attention deficit hyperactivity disorder. 

• Generic Adderall XR (mixed amphetamine salts) is expected to reach the market in April 2009, 

following a patent settlement. 

• FDA approval of the prescription antiobesity drug rimonabant (Acomplia ® in Europe; proposed name 

Zimulti ® in the U.S.) was delayed due to safety concerns. 


Miscellaneous Endocrines NONSPECIALTY RANK 12 



Utilization -3.4% # Rx PMPY: 0.23 




• Bisphosphonates — used to treat osteoporosis — dominate trend for the class. 

• Although utilization was down due to potential side effects publicized in 2007, three brand-name 

bisphosphonates made up nearly 75% of market share in the class. 

• The leading bisphosphonate, Fosamax ® , which has more than 40% of utilization, lost patent protection 

in February 2008. Its generic will impact trend for 2008. 

• Evista ® , a selective estrogen receptor modulator (SERM), which treats osteoporosis and breast cancer, may 

face competition in 2008 from Viviant and Fablyn ® , both under FDA review for treating osteoporosis. 


Antipsychotics NONSPECIALTY RANK 13 







• Inflation is the main driver of trend for antipsychotics, but both utilization and new drugs contribute. 

• Although generics made up more than 26% of antipsychotics spend, the brand-name drugs Seroquel ® , 

Risperdal ® and Abilify ® represented nearly 60% of 2007 market share. 

• On June 29, 2008, the main drug patent for Risperdal will expire — opening the potential for 

considerable savings in this class. 

• Asenapine and iloperidone, two new drugs for treating schizophrenia and bipolar disorder, are currently 

under FDA review. 

• New brands will continue to enter the market, providing treatment options for those not adequately 

controlled on current therapies. 

Miscellaneous Genitourinary NONSPECIALTY RANK 24 








• The majority of spend in the miscellaneous genitourinary class is from the use of Flomax ® . 

Following a settlement, generics to Flomax are expected in March 2010. 

• Extensive direct-to-consumer advertising will continue to drive utilization for the class. 

Antiparkinson Agents NONSPECIALTY RANK 41 







• Growth among the antiparkinson agents is driven largely by Requip ® and Mirapex ® . Although both 

are approved for treating Parkinson’s disease, their newer indications for treating restless legs 

syndrome have been publicized heavily in direct-to-consumer advertising. 

• The patent on Requip will expire May 19, 2008. As a follow-on, the manufacturer is developing 

once-daily Requip XL ® , which could be approved in 2008. 


SPECIALTY 

Utilization and cost have also been analyzed for leading specialty therapy classes. Components of 

trend and pipelines for potential products are reviewed for each of the classes listed below. In addition, 

information on orphan drugs has been included. 

Exhibit 23 

PMPY Cost and Cost per Prescription for Selected Specialty Therapy Classes 2006 to 2007 

Ranked by 2007 PMPY Cost 

Inflammatory 

Conditions 

Multiple 

Sclerosis 

PMPY Cost 

Cost per Prescription 

2006 2007 % Change 2006 2007 % Change 

$19.44 $22.96 18.1% $1,480.57 $1,547.97 4.6% 

$13.85 $16.02 15.7% $1,469.75 $1,647.00 12.1% 

Cancer $10.82 $12.96 19.7% $1,568.00 $1,816.38 15.8% 

Blood Cell $ 5.38 $ 4.86 -9.7% $1,581.82 $1,724.51 9.0% 

Deficiency 

Growth 

$ 4.35 $ 4.62 6.3% $2,524.33 $2,569.10 1.8% 

Hormone 

Deficiency 

Anticoagulants $ 3.57 $ 4.18 17.3% $ 848.81 $ 887.11 4.5% 

Hepatitis C $ 3.32 $ 3.34 0.6% $1,113.54 $1,174.31 5.5% 

Others $13.60 $15.78 16.1% $1,216.87 $1,340.40 10.2% 

Total $74.30 $84.73 14.0% $1,404.01 $1,519.15 8.2% 


Orphan Drugs 

Increasingly, specialty-drug spend includes orphan drugs, a designation that may be unfamiliar to many 

plan sponsors. In short, orphan drugs treat conditions that affect relatively few patients. 

To meet the need for research on treatments for rare diseases, the Orphan Drug Act was passed in 1983. 

Generally, this legislation supports pharmaceutical companies that develop products to treat conditions 

affecting fewer than 200,000 Americans. Benefits for the manufacturers of orphan drugs include: 

• Tax incentives for clinical research 

• Grant funding to subsidize costs of clinical trials 

• Seven years of marketing exclusivity after approval 

Since the act was passed, nearly 300 1 orphan drugs and biologics have been approved. Many of them 

treat conditions that previously had no medications available. Information on how orphan drugs affected 

Express Scripts’ specialty-drug trend in 2007 is included at the end of this section. 

1 

Haffner ME. Adopting orphan drugs — two dozen years of treating rare diseases. N Engl J Med. 2006;354(5):445-447. 


Inflammatory Conditions SPECIALTY RANK 1 



Price 5.2% # Rx PMPY: 0.0148 


Brand/Generic Mix 0 Average Cost/Rx: $1,547.97 





New Drugs 0 

TOTAL 18.1% 

Inflammatory Conditions Market-Share Trend 

90% 



80% 

70% 

60% 

50% 

40% 

30% 

20% 

10% 

0 

2003 

2004 2005 2006 

2007 

Enbrel ® $1,515.31 

Humira ® $1,585.81 

Raptiva ® $1,614.23 

Remicade ® $2,603.30 

• Expanded indications and earlier use of tumor necrosis factor (TNF) inhibitors such as Enbrel ® , 

Humira ® and Remicade ® to treat rheumatoid arthritis (RA) continue to drive trend growth for this class. 

• Actemra ® , LymphoStat-B ® and ustekinumab are biologic drugs with novel mechanisms that may be 

approved in 2008 for RA, lupus and psoriasis, respectively. 

• Cimzia ® and golimumab are long-acting TNF inhibitors given monthly by subcutaneous (SQ) injection, 

as compared to more frequent dosing for current TNF inhibitors. 

• LymphoStat-B is among several drugs expected to enter the lupus market by the end of the decade. 

Rituxan ® , currently approved for non-Hodgkin’s lymphoma and RA, is also likely to receive an expanded 

indication for lupus. 

Inflammatory Conditions Pipeline 

Brand Generic Route of Administration Proposed Use Anticipated Availability 

Actemra ® tocilizumab IV infusion RA 2008 

Cimzia ® certolizumab SQ Crohn’s disease, RA 2008 

LymphoStat-B ® belimumab IV infusion Lupus, RA 2008 

ustekinumab SQ Psoriasis 2008 


Multiple Sclerosis SPECIALTY RANK 2 



Price 12.4% # Rx PMPY: 0.0097 







New Drugs 0 

TOTAL 15.7% 

Multiple Sclerosis Market-Share Trend 


50% 

45% 

40% 

35% 

30% 

25% 

20% 

15% 

10% 

5% 

0 

2003 

2004 2005 2006 

2007 

Avonex ® $1,567.28 

Copaxone ® $1,647.12 

Rebif ® $1,711.54 

Betaseron ® $1,717.05 

Tysabri ® $2,262.59 

H.P. Acthar ® $11,040.59 

• With the cost per prescription increasing 12.1% in 2007, inflation continues to be the key driver 

of trend for drugs to treat multiple sclerosis (MS). 

• H.P. Acthar ® Gel, an intramuscular medication sometimes used to treat acute exacerbations 

of MS, experienced a significant price increase in 2007. 

• Current MS therapies are injected, but several oral drugs, including Fampridine-SR, fingolimod, 

Mylinax and Panaclar , may reach the market in the next few years. 

• Rituxan ® and Zenapax ® , which are already on the market for other indications, are being evaluated 

for use in the treatment of MS. Both require IV infusion. 


Multiple Sclerosis Pipeline 


Mylinax cladribine Oral MS 2008 

Panaclar 

Fampridine-SR 

BG-12 

(dimethyl fumarate) 

fampridine 

(4-aminopyridine) 

sustained-release 

Oral MS 2008 

Oral MS 2009 

fingolimod Oral MS 2009 


Cancer SPECIALTY RANK 3 



Price 14.1% # Rx PMPY: 0.0071 


Brand/Generic Mix -0.1% Average Cost/Rx: $1,816.38 






TOTAL 19.7% 

Cancer Market-Share Trend 

30% 

25% 

Lupron Depot ® $792.48 



20% 

15% 

10% 

5% 

0 

2003 

2004 2005 2006 

2007 

Xeloda ® $1,200.66 

Gleevec ® $3,109.45 

Temodar ® $2,070.55 

leuprolide $235.76 

Tarceva ® $2,975.65 

Thalomid ® $4,742.66 

• Although the introduction of new drugs did not affect trend in most therapy classes, it represented 

2.8% of trend for the cancer therapy class. Tykerb ® , an oral breast cancer drug approved in 

March 2007, had the biggest impact. 

• Targeted therapies, such as the oral tyrosine kinase inhibitor vatalanib and the monoclonal antibodies 

galiximab and ofatumumab, are expected to play an increasingly important role in the treatment of 

various cancer types. 

• While many of the cancer drugs in the pipeline require IV infusion, approximately 25% of cancer 

therapies in development are oral. Infused cancer therapies are typically billed under the medical 

benefit since they are administered in a physician’s office; however, these oral cancer medications, 

which can frequently be taken in a patient’s home, are expected to have an increasingly important 

impact on the prescription-drug benefit. 

Cancer Pipeline 


HuMax-CD20 ® ofatumumab IV infusion Chronic lymphocytic 

leukemia (CLL) 

Onconase ® ranpirnase IV infusion Mesothelioma 2008 

2008 

phenoxodiol Oral Prostate cancer 2008 

Treanda ® bendamustine IV infusion CLL 2008 


Blood Cell Deficiency SPECIALTY RANK 4 



Price 1.4% # Rx PMPY: 0.0028 




Utilization -17.1% 

Prevalence -13.2% 


New Drugs 0 

TOTAL -9.7% 

Blood Cell Deficiency Market-Share Trend 

60% 

50% 

Procrit ® $1,131.10 


40% 

30% 

20% 

10% 

0 

2003 

2004 2005 2006 

2007 

Aranesp ® $1,405.73 

Neupogen ® $2,347.92 

Neulasta ® $3,817.31 

Epogen ® $1,075.90 

Leukine ® $3,172.38 

• Safety concerns associated with the use of erythropoiesis-stimulating agents — Aranesp ® , Epogen ® 

and Procrit ® — caused a decrease in utilization of these anemia medications. 

• In early 2008, the liquid form of Leukine ® was withdrawn from the market due to reports of adverse 

reactions. The lyophilized (freeze-dried) formulation is still available, and market share should not 

be impacted significantly. 

• Two novel therapies, Nplate and Promacta ® , may be approved in 2008 for idiopathic thrombocytopenic 

purpura (ITP), a bleeding disorder related to low platelet counts. 


Blood Cell Deficiency Pipeline 


ferumoxytol IV infusion Anemia 2008 

Mozobil plerixafor SQ Stem cell 

mobilization 

Nplate romiplostim IV infusion and SQ ITP 2008 

Promacta ® eltrombopag Oral ITP 2008 

2008 


Growth Hormone Deficiency SPECIALTY RANK 5 



Price 7.0% # Rx PMPY: 0.0018 







New Drugs 0 

TOTAL 6.3% 

Growth Hormone Deficiency Market-Share Trend 

35% 



30% 

25% 

20% 

15% 

10% 

5% 

0 

2003 

2004 2005 2006 

2007 

Humatrope ® $2,287.87 

Nutropin AQ ® $2,766.52 

Genotropin ® $2,314.26 

Norditropin ® /NordiFlex ® $2,493.48 

Saizen ® $2,436.36 

Nutropin ® $3,245.12 

• Omnitrope growth hormone was launched in the U.S. in early 2007. The FDA has been careful to point 

out that Omnitrope is not a generic biologic, but rather a follow-on protein product. Even at an average 

cost of less than $500 per prescription, Omnitrope has not gained appreciable market share in the U.S. 

An easier-to-use pen form approved in February 2008 may increase its acceptance. 

• Accretropin is a recombinant human growth hormone being developed for treating short stature in 

children with growth hormone deficiency and girls with Turner’s syndrome. 

• Tesamorelin is an analog of the growth hormone-releasing factor that induces growth hormone. 

It is being studied for the treatment of HIV-related lipodystrophy. 

Growth Hormone Deficiency Pipeline 


Accretropin 

recombinant 

human growth 

hormone 

tesamorelin 

(TH-9507) 

SQ 

SQ 

Growth hormone 

deficiency 

HIV-related 

lipodystrophy 

ALTU-238 SQ Growth hormone 

deficiency 

2008 

2008 

2009 


Anticoagulants SPECIALTY RANK 6 



Price 5.9% # Rx PMPY: 0.0047 


Brand/Generic Mix 0 Average Cost/Rx: $887.11 





New Drugs 0 

TOTAL 17.3% 

Anticoagulants Market-Share Trend 


100% 

90% 

80% 

70% 

60% 

50% 

40% 

30% 

20% 

10% 

0 

2003 

2004 2005 2006 

2007 

Lovenox ® $874.71 

Arixtra ® $1,296.39 

Fragmin ® $805.79 

Innohep ® $1,147.85 

• Anticoagulants had the greatest trend increase in specialty-drug use — primarily due to shifts in 

payment from the medical benefit to the prescription-drug benefit. 

• ATryn ® is an infused anticoagulant that will be administered during major surgical procedures to 

patients with hereditary antithrombin deficiency. 

• Recent data showing increased bleeding in patients taking idraparinux may delay its approval. 

Idraparinux is an SQ anticoagulant in development for treating blood clots in the legs and lungs. 

Its once-weekly dosing differentiates it from current products that need more frequent dosing. 

• Generic alternatives to Lovenox ® may enter the market in 2009, pending approval and resolution 

of patent litigation. 


Anticoagulants Pipeline 

ATryn ® 


antithrombin III, 

recombinant 

Anticoagulants Patent Expiration 

IV infusion Anticoagulant 2008 

idraparinux SQ Anticoagulant 2008 

Drug Generic Indication Anticipated Generic Availability 

Lovenox ® enoxaparin Anticoagulant 2009 


Hepatitis C SPECIALTY RANK 7 



Price 2.4% # Rx PMPY: 0.0028 


Brand/Generic Mix -0.6% Average Cost/Rx: $1,174.31 


Utilization -4.6% 

Prevalence -8.6% 


New Drugs 0 

TOTAL 0.6% 

Hepatitis C Market-Share Trend 



45% 

40% 

35% 

30% 

25% 

20% 

15% 

10% 

5% 

0 

2003 

2004 2005 2006 

2007 

ribavirin $558.51 

Pegasys ® $1,651.60 

PegIntron TM $1,614.85 

RibaPak ® $851.02 

Infergen ® $1,985.02 

Ribasphere ® $528.82 

Copegus ® $1,106.96 

Rebetol ® $1,214.99 

• New treatment options in development for hepatitis C include several oral products. At least initially, 

many of the oral drugs will be used in combination with ribavirin, or with ribavirin and pegylated 

interferon together. 

• Albuferon ® is a long-acting interferon that may be dosed once every two weeks or possibly once 

monthly, as compared to weekly dosing with the currently available interferons. 

• The next big class of drugs that shows promise for hepatitis C is the oral protease inhibitors, including 

boceprevir and telaprevir. 

Hepatitis C Pipeline 


Albuferon ® 

albumininterferon 

alpha 2b 

SQ Hepatitis C 2010 

boceprevir Oral Hepatitis C 2010 

celgosivir Oral Hepatitis C 2010 

telaprevir Oral Hepatitis C 2011 


Orphan Drugs 

By definition, rare (orphan) conditions affect small groups of patients. Diseases with names as familiar 

as cystic fibrosis and sickle-cell anemia, and as unfamiliar as acromegaly, are all considered rare. 

Collectively, an estimated 25 million Americans have one of the more than 6,000 rare conditions that 

have been identified by the National Institutes of Health 2 . Many of them are long-term, serious and at 

least partially genetic. 

New rare diseases are being discovered, advances in genetics are making rare conditions more likely to 

be diagnosed, and the number of orphan medications available to treat them is growing. Therefore, rare 

diseases and orphan drugs will continue to receive an increasing amount of attention in the coming years. 

Orphan designations are granted to specific indications for drugs. Many medications with orphan 

indications for chronic conditions may cost hundreds of thousands of dollars per year. According to 

Express Scripts data, annual costs for Cerezyme ® , for example, can exceed $200,000 per year. Cerezyme 

is indicated for Gaucher’s disease, an inherited enzyme deficiency that must be treated for life. 

A single prescription drug may have both non-orphan and orphan approvals. One example is H.P. Acthar ® , 

which is used to treat several rare conditions, including acute flare-ups of MS. It also has an off-label 

orphan designation for the treatment of infantile spasms. In August 2007, the manufacturer of this drug 

increased its wholesale price from $2,062 per vial to more than $29,000 per vial, increasing the average 

cost per prescription to $11,041. 

According to an analysis of Express Scripts data, drugs with orphan indications make up slightly more 

than one-third of specialty drugs, but contribute a disproportionate part (71.3%) to specialty-drug 

spend. Additionally, as shown in Exhibit 24, orphan drugs cost more than twice as much as non-orphan 

medications on a PMPY basis. 

Exhibit 24 

Specialty-Drug Trend by Orphan Status 

$70 


PMPY 

$60 

$50 

$40 

$30 

$20 

$60.43 

$10 

$24.29 

$ 0 

Non-Orphan Drugs 

Orphan Drugs 

Source: 2008 Express Scripts analysis 

2 

National Organization for Rare Disorders. What is a rare disorder? Last modified August 28, 2007. 

Available at: www.rarediseases.org/info/about.html. Accessed March 24, 2008. 


In the U.S., rare diseases generally have patient populations of fewer than 200,000. Although the diseases 

they treat may be obscure, orphan drugs are often well-known. One example is Gleevec ® , approved as an 

orphan for relatively rare cancers and blood diseases. 

Treatments for conditions affecting more than 200,000 U.S. citizens may also be orphan drugs if their 

sales are not anticipated to offset the costs involved in making them. For instance, even though MS 

affects an estimated 400,000 Americans, some MS medications, such as Avonex ® and Betaseron ® , 

have orphan-drug status because of their high development and manufacturing costs. 

The use of orphan drugs is expected to grow over the next few years. Some of the orphan drugs being 

developed are listed in Exhibit 25. 

Exhibit 25 

Selected Orphan Drugs in Development 


Brand (Generic) Condition Description Risk Factors Prevalence 

Cinryze 

(C1-inhibitor) 

Firazyr ® (icatibant) 

Rhucin ® (ecallantide/ 

DX-88 rhC1INH) 

Hereditary 

angioedema 

(HAE) 

Attacks of swelling in the 

face, feet, gastrointestinal 

tract, hands, throat or 

other parts of the body 

Genetics 6,000 to 10,000 3 

Kiacta (eprodisate) 

Xiaflex (clostridial 

collagenase for 

injection) 

Amyloid A 

amyloidosis 

(AA amyloidosis, 

Secondary 

amyloidosis) 

Dupuytren’s 

contracture 

Deposits of amyloid 

proteins in body tissues 

and organs disrupt 

normal functioning 

Thickening and shortening 

of the skin on the hand 

pulls the fingers 

towards the palm 

Male, 

age over 40 years, 

chronic inflammatory, 

infectious or 

malignant conditions 

Male, 

age over 65 years, 

Caucasian ancestry 

1,275 to 3,000 

new cases 

per year 4 

Up to 30% of 

high-risk groups 5 

3 

HAE overview. United States Hereditary Angioedema Association. No date given. Available at: 

http://www.haea.org/hae_overview_for_physicians.php. Accessed Jan. 31, 2008. 

4 

Falk RH, Comenzo RL, Skinner M. The systemic amyloidoses. N Engl J Med. 1997;337(13):898-909. 

5 

Brown AN, Gilkeson GS. Fibrosing diseases: Diabetic stiff hand syndrome, Dupuytren’s contracture, palmar and plantar 

fasciitis, retroperitoneal fibrosis, and Peyronie’s disease. In: Koopman WJ, Moreland LW, eds., Arthritis and Allied Conditions: 

A Textbook of Rheumatology, 15th ed., vol. 2. Philadelphia: Lippincott Williams & Wilkins; 2005:2093-2108.

Therapy Class Review - Express Scripts

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