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‘Small Biotech Exception’ From Medicare Price Negotiation Granted To Four Drugs For 2026

 
• By Cathy Kelly

CMS has not disclosed how many requests for the exception it received but will follow up with applicants regarding its decisions this month.

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CMS Criteria For Decisions On Applications Still To Come • Source: Shutterstock

The Centers for Medicare and Medicaid Services excused four drugs from being selected for Medicare price negotiation in the first round because they qualified for the small biotech exception, according to the agency.

“For initial price applicability year 2026, drug companies submitted requests and information to CMS for four drugs that were determined to be qualified for the small biotech exception,” CMS said in a fact sheet on the initial list. The list of 10 drugs that will be subject to negotiated prices beginning in 2026 was released by CMS on 29 August

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