Cell And Gene Therapy Outcomes-Based Contracts In Medicaid Need ‘National’ Support,' HHS Says
The demonstration project planned by the US Centers for Medicare and Medicaid Services is in keeping with past agency efforts to promote value-based contracts for cell and gene therapy.
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Medicaid ‘Price Verification’ Audit Proposal Aims To Promote Cell, Gene Therapy Rebate Concessions
CMS proposed rule impact may be ‘modest’ but is framed as ensuring patient access to cutting edge treatments by helping to control Medicaid spending. Biden administration initiative also aims to address misclassification of brand drugs, duplicative 340B discounts, and PBM spread pricing.
FDA’s Califf Speaks Of Tailoring Trials For CMS Evidence Amid Spotlight On Alzheimer’s Drugs
FDA Commissioner Robert Califf spoke of the need for a better hand-off to CMS, including tailoring trials to generate evidence relevant for Medicare coverage. He also weighed in on the possibility of accelerated approval for chronic disease drugs, among other topics.
Drug Pricing Reforms In US Congress: Legacy Systems vs. Cutting-Edge
A House hearing on bipartisan drug pricing reform bills continues the intense focus on the role of pharmacy benefit managers. But it also shows continued interest in finding ways to make payment systems work for cutting edge gene therapies.