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What Clinical and HEOR Evidence Does CMS Expect for IRA Drug Price Negotiations?

The Inflation Reduction Act (IRA) has fundamentally changed U.S. drug pricing, granting the Centers for Medicare & Medicaid Services (CMS) authority to negotiate prices for high-expenditure Part B and Part D drugs. This negotiation is rooted in evidence, requiring manufacturers to submit detailed, Medicare-centered clinical and economic information to ensure prices reflect real-world clinical value. For Health Economics and Outcomes Research (HE…
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National Health Council broke the news in on Wednesday, December 3, 2025.
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