MASAC Document #138
MASAC RESOLUTION ON REIMBURSEMENT FOR INDIVIDUALS RESUMING USE OF RECOMBINANT FACTOR VIII CONCENTRATE
The following resolution was approved by the Medical and Scientific Advisory Council (MASAC) of the National Hemophilia Foundation on November 2, 2002, and adopted by the NHF Board of Directors on November 3, 2002.
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During 2001-2002 many hemophilia A patients voluntarily and for altruistic reasons used plasma-derived factor VIII clotting factor concentrates (CFCs) during a world-wide shortage of recombinant factor VIII CFCs (rFVIII CFCs), thereby making rFVIII CFCs available to children with hemophilia A who may otherwise not have had access to these very high purity CFCs. The Medical and Scientific Advisory Council of the National Hemophilia Foundation, in a series of recommendations made in response to the rVIII CFC shortage, specifically asked for this voluntary switch among these individuals in order to reduce the likelihood that any hemophilia A patient in the United States would bleed because no CFC was available. This conservation strategy was effective, the shortage has been ameliorated, and MASAC has rescinded these temporary recommendations. Unfortunately, MASAC has received reports of scattered incidents in which third party payers have denied payment for higher-priced recombinant CFCs when the altruistic individual attempted to return to his/her physician's preferred, prescribed rFVIII CFC. This egregious practice of reimbursement denial is contrary to the recommended treatment guidelines of MASAC1 and is contrary to specific recommendations made by the Advisory Committee on Blood Safety and Availability to the United States Secretary of Health. Further, denial of reimbursement is inconsistent with published scientific data that ultra-high purity CFCs are indicated for individuals with hemophilia who have an underlying immune deficiency.2
1. National Hemophilia Foundation Medical and Scientific Advisory Council Recommendation #106: MASAC Recommendation Regarding the Use of Recombinant Clotting Factor Replacement Therapies. New York: 2000.
2. Seremetis S, et al. Three-year randomized study of high-purity or intermediate-purity factor VIII concentrates in symptom-free HIV-positive hemophiliacs: effects on immune status. Lancet 1993;342:700.