Insights into the immune globulin (IG) specialty drug market.
Self-injectable and oral specialty drugs have dominated the FDA approval list in 2010, but intravenous immune globulin, an infused specialty drug used since the early 1980s, still captures the attention of specialty pharmacy stakeholders.
In 2006, CSL Behring introduced subcutaneous immune globulin to the market. For the purposes of this discussion, “IG” will refer to both intravenous and subcutaneous immune globulin products. Specialty drugs are expensive, and IG is no exception, yet IG is unique in specialty pharmacy for 4 reasons: supply, clinical use, reimbursement, and coordination of care.
IG is derived and manufactured from plasma drawn directly from thousands of plasma donors, and is produced as either a lyophilized powder for reconstitution or a ready-to-use liquid. During the manufacturing process, each product is fractionated, stabilized, and purified. In fact, product differences resulting from the manufacturing process are the primary physical differentiators among the various IG products. Due in part to the complex manufacturing process and the sensitive nature of the products, most manufacturers typically partner with 3 to 5 “Authorized Distributors of Record (ADR)” to ensure safe and appropriate delivery of product into the market.
Products distributed to a provider by a manufacturer’s ADR are provided with a paper or electronic pedigree confirming the distribution history of specific products. It is important for specialty pharmacies, as well as any provider, to have relationships with one or more ADRs for IG products to ensure product integrity and for assistance during product lot-specific product recalls.
Stability of IG
Because IG supply is dependent upon plasma availability, the stability of IG attainability has been variable during the last 10 years. Notably, product supply tightened dramatically several times throughout the late 1990s and mid- 2000s, prices skyrocketed, and “secondary distributors” gained prominence as providers scrambled to find IG products. Secondary distributors purchase IG products from ADRs as seen in the normal chain of distribution or attempt to purchase excess supply directly from providers, and then resell the products to other providers with high product demand.
Because these distributors do not purchase product directly from the manufacturer, it is important for providers to ensure that a paper or electronic pedigree is available with each product purchase. As of this writing, the IG market is relatively stable, with plentiful product availability from most manufacturers. Specialty and infusion pharmacies typically obtain pricing for IG by directly contracting with a manufacturer or by participating in a group purchasing organization (GPO). GPOs allow small to midsize pharmacies aggregate purchasing power to obtain the best possible price for products.
Most IG products are indicated for the treatment of primary immunodeficiency (PID) and/or chronic immune thrombocytopenic purpura, and one IG product, Gamunex, has earned an additional neurologic indication for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP).1 IG has been effective not only for its indicated uses, but also as an “off-label” treatment option for a myriad of conditions ranging from the areas of neurology to rheumatology to infectious disease.
Reports have shown that 50% to 80% of IG use is for off-label indications supported by medical evidence, primarily in the fields of neurology and immunodeficiency.2 As manufacturers progressively investigate the many offlabel uses of IG, additional indications are expected. A search of www.clinicaltrials. gov for immune globulin shows 576 open phase II and phase III clinical trials investigating the use of IG for Alzheimer’s, multifocal motor neuropathy, neuropathic pain, and CIDP, among other conditions.
Reimbursement and Managed Care
Reimbursement by insurance companies for IG is a key factor driving the site of care for patients needing IG therapy. In years past, IG was largely administered in physicians’ offices and outpatient clinics, but the Medicare reimbursement rate to these providers changed dramatically with the passage of the Medicare Prescription Drug Improvement and Modernization Act of 2003 (MMA). Under this law, the Medicare reimbursement to providers for IG and on average wholesale price (AWP) to a lower rate based on average sales price (ASP). Due in part to lower reimbursement and product shortages, many physicians triaged care from the office and clinic setting to the hospital.
Many hospitals treated these patients, but the diagnosis related group (DRG) reimbursement structure used by Medicare and many commercial payers squeezed their margins, since most DRGs do not provide additional reimbursement for expensive medications. The reimbursement changes by Medicare, along with reduced reimbursement to traditional providers by commercial payers, have driven the site of care for many IG patients to the home setting.
Medicare coverage in the home setting varies, with the drug being reimbursed under either Part B or Part D. Part B coverage in the home is limited to patients with a diagnosis of PID, and Part D coverage varies with each prescription drug plan. Aside from Medicare, commercial payers vary greatly in their coverage of IG in the home setting, with coverage of the drug under the medical benefit, pharmacy benefit, or both. Payers covering the drug under the pharmacy benefit often utilize pharmacy benefit managers (PBMs) to manage drug coverage.
Approximately 68% of payers have classified IG as a specialty drug3, and many contracted PBMs utilize an exclusive specialty pharmacy or a small network of pharmacies to ship the medication directly to the patient. Conversely, payers who cover IG under the medical benefit often utilize contracted home infusion pharmacies and specialty infusion pharmacies to service their members. Most commercial payers reimburse these providers for both the drug, based on either an AWP discount or factor of wholesale acquisition cost, and for professional pharmacy services and care coordination in the form of a “per diem.” These providers typically handle the care coordination process from product procurement to drug administration and home nursing services.
Management of IG usage is a difficult issue for managed care organizations. Because of the complex nature of the drug and the many off-label uses, traditional managed care strategies, such as prior authorizations, step therapy, and quantity limits, are often difficult to perform. However, managed care organizations ranked the management of IG as one of their highest priority drug categories in a recent survey.3 It is critical for specialty pharmacy, home infusion, and specialty infusion providers to develop relationships with managed care organizations to ensure proper and appropriate use of IG.
Coordination of Care
Coordination of care is a significant issue for any specialty pharmacy drug, but the factors mentioned throughout this article related to supply, clinical use, and reimbursement make coordination of care an even more important concern for IG. IG may be administered in the home setting safely for many patients, but the specialty pharmacies, home infusion pharmacies, and home health nurses involved in the provision and administration of the drug must recognize the complexity of IG therapy and the importance of following up with the prescriber after each infusion.
It is possible—and many payers require—that specialty pharmacies ship IG directly to the patient and utilize local home nursing for administration. While payers may be able to obtain deeper discounts using an exclusive or preferred network of specialty pharmacies, a distant specialty pharmacy provider for a drug like IG creates opportunities for blunders in care coordination.
For many patients, an ideal solution would be to utilize a local or regional specialty infusion pharmacy with expertise in infused specialty drugs. These local providers would be better positioned to coordinate care with the patient, prescriber, and home health nurse involved in the care of the patient.
1. Huff C. Special report: maximizing efficiencies and economic benefits of IG. Pharmacy Practice News. December 2009:1-8.
2. Analysis of supply, demand, and access issues associated with immune globulin intravenous (IG). US Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation. Washington, DC; 2007.
3. EMD Serono specialty digest: managed care strategies for specialty pharmaceuticals. EMD Serono, Inc. 6th ed. 2010:16,18.
About the Author
Dr. Davis is Director of Clinical Services at Vital Care Rx, an integrated specialty and infusion pharmacy provider. He graduated from Samford University and is currently working on an MBA at the College of Business and Industry, Mississippi State University. Vital Care Rx, located in Meridian, Mississippi, is an integrated home infusion and specialty pharmacy provider and the founding pharmacy of Vital Care, Inc, which offers a network of approximately 100 affiliated infusion pharmacies across 18 states.