IgG Therapy for the Home-Based Patient: Administration and ... - NHIA

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IgG Market Overview and Uses The IgG market has grown steadily over the past several years. In 2010, sales of intravenous IgG (IVIG) and subcutaneous IgG (SCIG) combined exceeded $2.8 billion. Approximately 42.3 million grams of product was sold in 2010—an 8% increase over the previous year. 1 Although IgG is by no means a major therapeutic class in terms of payer drug spend, like chemotherapy or rheumatology therapies, it is gradually becoming a notable category. For a health plan with 1 million covered lives, approximately $16 million or about 6% of all claims will be for IVIG. 2 Of the IgG that is used for FDAapproved indications, 36% is for the treatment of primary immunodeficiencies, 26% in hematology and oncology, 25% for neurological disorders, and 13% for miscellaneous indications. 1 However, it’s difficult to ascertain the true breakdown of the IgG market because a great deal of immune globulin is used for offlabel indications. In 2009 the offlabel usages for IVIG represented approximately 55% of prescribed product. 1 It’s important to note that although these indications are not yet approved by the U.S. Food and Drug Administration (FDA), many indications are supported by peerreviewed literature and are generally accepted for reimbursement by payers. See Exhibit 1 for a list of FDAapproved indications and offlabel uses. With more than 150 specific disease states falling under the umbrella of primary deficiency disorders, clinicians and payers alike encounter challenges determining when and for which patients IgG is most appropriate. A history of product shortages and growing demand only serve to increase the pressures surrounding these decisions. In 2006, the American Academy of Allergy, Asthma, and Immunology (AAAAI) conducted a literature review and issued evidencebased recommendations for efficient use of IgG, categorizing them by the degree to which the therapy was beneficial and the strength of the recommendation based on the available evidence. 3 This paper and other resources for clinicians are available in an online toolkit available at: http://www.aaaai.org/practiceresources/managementtoolsandtechnology/ivigtoolkit.aspx. The Emergence of SCIG The subcutaneous method of IgG (SCIG) administration has been an accepted practice in Scandinavia and the United Kingdom for some time. Literature dating back 60 years, including the research of pioneering American physician Ogden Bruton, a pediatrician at Walter Reed Army Hospital, documents the safe and effective use of SCIG in a case of primary immune deficiency (PID) in an eight year old boy with Xlined agammaglobulinemia which is also known as “Bruton’s syndrome.” 4 In 1980, Berger and colleagues at the National Institutes of Health reported using a portable syringe driver to administer IgG to three adult patients, concluding that the slow subcutaneous infusions were well Exhibit 1 Uses for IgG FDAApproved Indications (as of November 2012) • Primary immunodeficiencies • Allogenic bone marrow/stem cell transplant • Chronic lymphocytic leukemia • Idiopathic thrombocytopenic purpura • Pediatric HIV • Kawasaki disease • Chronic inflammatory demyelinating polyneuropathy (CIDP)* • Kidney transplant, with a highantibody recipient or an ABOincompatible donor OffLabel Uses—Neurological • GuillainBarre syndrome • Multifocal Motor Neuropathy • Multiple Sclerosis • Myasthenia Gravis (w/exacerbation) • Neuromyelitis Optica (Devic’s disease) • Stiff Person’s syndrome OffLabel Uses—Other • Dermatomyositis • Infertility • Pediatric autoimmune neuropsychiatric disorders associated with Streptococcal infections (PANDAS) • Pemphigus • Polymyositis • Renal transplant • Scleroderma • Sjogren’s syndrome • Susac’s syndrome * Only GamunexC® and GammaKed® are approved at this time Source: Huber, A. Advanced Considerations for Home Administration of Immunoglobulin Therapy. NHIA Annual Conference & Exposition, April 2011, Orlando, Florida. 2 IgG Therapy for the HomeBased Patient: Administration and Delivery Method Considerations
tolerated and noticeably free of adverse reactions. 5 This study paved the way for additional research in both adult and pediatric patients—largely with positive results. By 1981, the safe and effective home administration of SCIG was first reported. 6 Subsequent studies reported similar success with varying rates of administration. 7,8,9 Despite these innovations, the subcutaneous (SC) method of IgG administration did not take hold in the U.S., largely due to the availability of IVIG and the fact that there was no commercial product specifically formulated for SC delivery. That changed in 2006, when the FDA approved the first IgG formulation designed exclusively for subcutaneous administration. 10 Since then, three additional SCIG formulations have been FDA approved for primary immunodeficiency—with others currently in clinical trials. The subcutaneous administration of IVIG formulations has also become more widespread. To date, few studies have been conducted to directly compare IVIG and SCIG. However, sufficient available research has shown that, due to its relatively stable bioavailability, SCIG is associated with fewer systemic adverse events. 11 In addition, this administration route offers a variety of advantages to patients who are willing to commit to selfadministration. SCIG Patient Selection SCIG offers several advantages over intravenous administration. Chief among them is a viable treatment alternative for patients with limited vascular access or those who cannot tolerate the side effects commonly associated with IV administration. The slower administration and gradual absorption of SCIG eliminates rapid, large variances in serum IgG levels, which reduces adverse affects, such as migraines, and the need to premedicate prior to infusion. In addition, consistent serum levels achieved through this therapy modality eliminate low trough levels, thereby reducing associated symptoms, such as extreme fatigue, joint pain, swelling, and malaise. 11 SCIG also offers greater flexibility and patient autonomy. Although the fractionated doses require weekly—or more frequent—infusions, patients often enjoy the flexibility of being SCIG at a Glance Advantages • No IV access necessary • Fewer systemic side effects, no need to premedicate • Fewer systemic effects resulting from peak and trough variability • Patient flexibility/autonomy Disadvantages of SCIG • Requires commitment and compliance • Not appropriate for large volume therapies or very lean patients • Requires more frequent infusions • Local infusion reactions can occur IgG Therapy for the HomeBased Patient: Administration and Delivery Method Considerations 3
Page 1 and 2: IgG Therapy for the Home-Based Pati
Page 3: Author Bios: Hetty Lima, R.Ph., FAS
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IgG Therapy for the Home-Based Patient: Administration and ... - NHIA

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