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

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

lab research
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...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Market Access

With Thyroid Petition Win, AbbVie Snares Itself; US FDA Sets Up Another Compounding Fight

 
• By 

AbbVie didn’t get everything it sought from a citizen petition but may still have the upper hand over smaller rivals after FDA gives makers of animal-derived thyroid medications a year to seek approval. If the agency removes compounded products, it could face more pricing pushback.

Could Study Questioning GLP-1 Cost Savings Impact CMMI Demo Chances?

 
• By 

The findings are consistent with some other research and likely are due to obesity patients becoming more connected to needed health care services.

Why Chiesi’s Raxone Faced A Decade-Long Wait For English Funding

 

Chiesi’s orphan drug Raxone has secured an English funding recommendation for the treatment of Leber's hereditary optic neuropathy, a decade after the orphan drug was approved for marketing. Chiesi told the Pink Sheet about its “long, and often challenging” road to reimbursement.

US Pricing Reform: New Products Offer ‘On Ramp’ To Implementation, Lilly’s Ricks Says

 
• By 

Eli Lilly's CEO argued that pricing reforms aimed at existing drugs would be “hard to sustain or justify,” while other companies suggested a growing interest in direct-to-consumer sales programs.

More from Pink Sheet

New EU Filings

 

Ensitrelvir, Shionogi's treatment for COVID-19, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

With Thyroid Petition Win, AbbVie Snares Itself; US FDA Sets Up Another Compounding Fight

 
• By 

AbbVie didn’t get everything it sought from a citizen petition but may still have the upper hand over smaller rivals after FDA gives makers of animal-derived thyroid medications a year to seek approval. If the agency removes compounded products, it could face more pricing pushback.

Could Study Questioning GLP-1 Cost Savings Impact CMMI Demo Chances?

 
• By 

The findings are consistent with some other research and likely are due to obesity patients becoming more connected to needed health care services.