For Generics, A Victory Lap – And A Warning – On Drug Shortages
Avoiding disaster at the beginning of the pandemic and offering a pro-active supply chain blueprint should position the generics industry well for an onshoring debate in Congress, but a look back at March 2020 is a reminder that even small policy shifts can have a big impact.
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Reshoring Debate Continues As COVID-19 Drives New Wave Of US Drug Shortages
As the response to another wave of COVID-19 infections continues, fill rates of critical medicines such as methylprednisolone are dropping. But experts say the answer is not to concentrate manufacturing in US facilities, which could lead to further risks if US supply is disrupted.
Pink Sheet Podcast: Medicare Inflation Rebates And Negotiation, Leqembi Reimbursement, US FDA Gene Therapy Chief
Pink Sheet reporter and editors discuss the first round of mandated Medicare inflation rebates and new guidance on price negotiations, consider the VA’s decision to cover the Alzheimer’s drug Leqembi, and the US FDA continuing to search for a cell and gene therapy office leader.
Leqembi’s FSS Pricing Meets ICER’s Cost-Effectiveness Threshold; VA Requiring Coverage With Evidence
Eisai/Biogen Alzheimer’s treatment isn’t actually on the VA formulary, but Leqembi’s Federal Supply Schedule price, coming in at just over $20,000 annually, could address spending concerns.