Status of Immune Globulin Intravenous (IGIV) Products

In the last few months, the Department of Health and Human Services (HHS) and its agencies, the Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS), have received several reports that some health care providers have had difficulty obtaining Immune Globulin Intravenous (IGIV), a.k.a. IVIG, products. HHS is actively working with manufacturers, health care providers, patient groups, and other government entities to better understand the present situation and to assess potential actions. Although there are reports from some health care providers of difficulties with IGIV product distribution and pricing, we do not find evidence of an overall shortage of IGIV at present, or indicators of an impending shortage.

Reports from providers indicate that they have encountered problems obtaining specific brands of IGIV for some patients, including privately insured patients and those covered by Medicare. In some cases treatment locations have reportedly shifted from physician offices to hospital settings. Some hospitals have reportedly experienced difficulty in obtaining the physicians� IGIV product of choice for the patient. At the same time, prices for IGIV have been on an upward trend, most notably in the secondary (or resale) market. From discussions with stakeholders, it is clear that a number of changes have been occurring in the marketplace; however, their relationship to the issues reported by some providers is not fully understood, but will be monitored;

• Providers vary in the scope of indications for which they prescribe IGIV. Some providers have reported that the majority of their IGIV use is for off-label indications. Off-label use may have increased, contributing to rising demand. (Current label indications include: Primary Humoral Immunodeficiency, acute and chronic Idiopathic Thrombocytopenia Purpura, B cell Chronic Lymphocytic Leukemia, Kawasaki Syndrome, Pediatric HIV, and Bone Marrow Transplantation.)
• Industry consolidations and other business practice changes that apparently have been intended to improve efficiencies may have reduced historic inventory levels. For example, some manufacturers have been allocating products to a smaller number of distributors combined with a reduction in the size of their inventories. Although fewer products were distributed in the last twelve months than in the previous twelve months, the smaller inventories may not reflect a shortage if manufacturers can supply additional inventories as needed. Manufacturers and distributors have reported that any supply chain issues should be resolved soon.
• The Medicare Modernization Act, effective January 2005, changed the Medicare payment for IGIV administered in physician offices and the home to be 106 percent of the manufacturer's average sales price. The Medicare payment rate is updated quarterly and has been increased nine percent for lyophilized IGIV as of July 2005.

We are working with stakeholders to further assess the evolving marketplace. At this time, we believe there is sufficient supply of IGIV for patients who need it. Under manufacturers' allocation processes, physicians might best serve their patients by communicating their supply needs directly to manufacturers and by ensuring that IGIV treatment is prioritized toward FDA labeled use and those diseases or clinical conditions that have been shown to benefit from IGIV based on evidence of safety and efficacy, and for which safe and effective alternative therapies are not available.

It is a HHS goal to work with partners in the marketplace to help prevent or alleviate shortages of medical products, including IGIV. We are seeking additional information on the current availability of IGIV products. We are asking health care providers and patients who experience difficulty obtaining IGIV to report their experiences (e.g. denial of treatment, delay of treatment, forced reduction in dosage, etc.) by sending an email to FDA at CBERProductshortages@cber.fda.gov. Those without email access may call (800) 835-4709. Reports related to Medicare-related coverage and access to care should call 1-800-MEDICARE.