Depending on who you ask, the Centers for Medicare and Medicaid Services’ (CMS) decision last week to restrict payment for amyloid-targeted Alzheimer’s drugs was either a show of strength from an agency once considered a rubber stamp following a new drug approval, or aggressive overreach by an agency ill-equipped to set clinical trial requirements for an already FDA-approved drug.
Rarely are two sides so defiantly split in their positions, even as biopharma industry observers try to parse what may be the biggest elephant in the room for accelerated approvals for a long time coming.
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