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BioMarin Announces Agreement with German Health Insurance Fund on Reimbursement Amount for ROCTAVIAN® (valoctocogene roxaparvovec-rvox) for Severe Hemophilia A in Germany
ROCTAVIAN is First Gene Therapy for Hemophilia to Receive Approved Federal Price in Germany SAN RAFAEL, Calif., Nov. 28, 2023 /PRNewswire/ -- BioMarin
About this update from Biomarin Pharmaceutical Inc.
[{"type":"text","content":"ROCTAVIAN is First Gene Therapy for Hemophilia to Receive Approved Federal Price in Germany\nSAN RAFAEL, Calif., Nov. 28, 2023 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (Nasdaq: BMRN), a global biotechnology company dedicated to transforming lives through genetic discovery, today announced an agreement with the German National Association of Statutory Health Insurance Funds (GKV-SV) on the reimbursement amount for ROCTAVIAN® (valoctocogene roxaparvovec-rvox) 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 €28,933.53 per vial. This vial price equates to approximately $900,000 per patient in net revenue to BioMarin at the current exchange rate, accounting for average patient weight and number of vials required for the one-time treatment, estimated reductions for customary rebates and discounts.\n\n \n \n \n \n \n \n\n \n\"We are pleased to have reached an agreement on the reimbursement amount for ROCTAVIAN with the GKV-SV, which is responsible for health insurance that covers approximately 90% of the German population,\" said Jeff Ajer, executive vice president and chief commercial officer at BioMarin. \"This important progress will facilitate access to ROCTAVIAN for eligible individuals among the roughly 2,000 adults with severe hemophilia A in Germany and marks a key step forward for the hemophilia community.\"\nBioMarin and GKV-SV have agreed on an outcome-based prospective cohort model for ROCTAVIAN. This will allow future reimbursement to be increased or decreased, based on real-world data collected from the German Haemophilia Registry of patients treated with 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.\nTwo patients in Germany have now received ROCTAVIAN commercially, and 60 people are eligible for next steps based on companion diagnostic testing results for adeno-associated virus serotype 5 (AAV5) antibodies.\nAdditionally, final price negotiations with the Italian Medicines Agency are underway and expected to be formalized by year-end 2023.\nSigni...