MASAC Document #159
MASAC RECOMMENDATION REGARDING FACTOR CONCENTRATE PRESCRIPTIONS AND FORMULARY DEVELOPMENT AND RESTRICTIONS
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The following recommendations were approved by the Medical and Scientific Advisory Council (MASAC) of the National Hemophilia Foundation on February 12, 2005, and adopted by the NHF Board of Directors on March 12, 2005.
Persons with bleeding disorders require treatment with clotting factor concentrates for prevention and treatment of bleeding.
Clotting factor therapies are neither pharmacologically nor therapeutically equivalent and vary based upon purity, half-life, recovery, method of manufacture, viral removal & inactivation processes, potential immunogenicity, and other attributes. The characteristics of each product and the resultant product choice for an individual patient require a complex decision making process with the ultimate product being agreed upon by the patient and their respective healthcare provider. It is critical that the bleeding disorder community has access to a diverse range of therapies and that prescriptions for specific clotting factor concentrates are respected and reimbursed.
MASAC supports continued availability and reimbursement of the full range of all prescribed replacement therapies for treatment of bleeding disorders. Prescriptions for clotting factor therapies should be written as non-generic to assure that the product prescribed is appropriately dispensed and reimbursed. Reimbursement for clotting factor replacement therapies should continue to be based upon methodologies appropriate to each specific product. The benefit of limiting products to one within a class, such as one recombinant factor VIII concentrate, solely for the purpose of cost containment is not supported by present clinical practice or by published data.