BioMarin closes reimbursement agreement with German insurance fund for Roctavian

BioMarin announced an agreement with the German National Association of Statutory Health Insurance Funds – GKV-SV – on the reimbursement amount for Roctavian for people with severe hemophilia A. This is the first gene therapy for hemophilia to receive an agreed federal price in Germany. Roctavian brings value to individuals and the healthcare system in Germany, as a one-time, single-dose therapy delivered as an intravenous infusion over 3-4 hours at a gross price of EUR28,933.53 per vial. This vial price equates to approximately $900K per patient in net revenue to BioMarin. BioMarin and GKV-SV have agreed on an outcome-based prospective cohort model for Roctavian. This agreement, with a minimum term of 3 years, ensures the supply and reimbursement for eligible patients in Germany with Roctavian by the GKV-SV. Final price negotiations with the Italian Medicines Agency are underway and expected to be formalized by year-end 2023. BioMarin continues to work with private and public payers in the U.S. to enable access. It is estimated that there are approximately 6,500 adults living with severe hemophilia A in the U.S. BioMarin expects approximately 2,500 of those adults to be eligible to receive ROCTAVIAN at this time.