CMS announced a voluntary five‑year 'GENEROUS' model to negotiate Medicaid outpatient drug prices linked to international benchmarks, inviting manufacturers and states to participate beginning January. The program ties supplemental rebates to prices in select developed nations and aims to reduce Medicaid drug spending, which topped $100 billion in 2024. Separately, the FDA expanded its Commissioner’s National Priority Voucher pilot by adding six drugs for accelerated review, bringing the total to 15 therapies. The vouchers are meant to compress review timelines for treatments deemed in the national interest, reflecting administration priorities to speed access to certain medicines. Together, the moves signal intensified federal intervention in drug pricing and review pathways. Biotech executives warn of potential market distortions, while policymakers argue the measures will lower costs and speed access; companies face trade‑offs about participation and global pricing strategies.
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