ICER Hemophilia Gene Therapy Reviews Show Clear ‘Net Health Benefit’ But Caution On Patient, Payer Fronts Given Upfront Costs
Restrictive interpretations of FDA labels for BioMarin and CSL Behring products by payers could signal slow launch of gene therapies seeking to supplant existing treatments.
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Round Two: BioMarin Resubmits Hemophilia A Gene Therapy Roctavian In US
BioMarin maintains its lead in the race to win approval for a hemophilia A gene therapy in the US by resubmitting Roctavian two years after the FDA issued a CRL in response to the original BLA.
Roctavian’s Durability: For The Price, Payers Wanted Longer-Term Proof Anyway
FDA’s decision to seek two more years of data for BioMarin’s gene therapy for hemophilia A ‘makes perfect sense,’ Harvard Pilgrim Health Care’s Michael Sherman says.
Genentech Hemophilia Therapy Gets Solid Endorsement From ICER
Hemlibra could save health care system $1.85m per patient annually as it displaces current approaches to treatment, Institute for Clinical and Economic Review projects in draft report.