US CMS Releases Guidance on Upcoming Drug Price Negotiations

March 16, 2023

The pharma and biotech industry has waited with bated breath for more information on impending drug price negotiations with the US Centers for Medicare and Medicaid Services (CMS) that begin in 2026. The agency released its guidance on the process, laying out the process in detail. CMS has also put out a call for feedback. Responses are due by April 14th.

According to Zachary Brennan, “How this mostly non-public, potentially year-long drug price negotiation process will work: Beginning Oct. 2, select drugmakers falling into this top 10 list (published Sept. 1) will have to sign an agreement with CMS and confidentially provide information on the non-federal average manufacturer price, R&D costs, and the extent to which those costs have been recouped (abandoned and failed drug costs will be considered), as well as unit costs of production and distribution, federal financial support for the drug’s discovery and development, data on pending and approved patent applications and exclusivities, and data on revenue and sales volume.”

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(Source: Endpoints News, March 16th, 2023)

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