CAR-T Label Update Could Address Medicare Coverage Challenges, FDA’s Gottlieb Suggests

The $245 price agreed to by both firms may be in line with the maximum fair price that Medicare negotiated for Novo Nordisk’s semaglutide products.

The Trump Administration’s efforts to encourage more US-based pharmaceutical manufacturing have largely centered on FDA plans and Trump’s threats of tariffs and Most Favored Nation pricing, but Oz hinted Medicare and Medicaid soon may soon announce new incentives.

CMS official John Brooks said CMS cannot undo plans to publish MFPs and not average sales prices for physician-administered drugs in the Medicare price negotiation program. But he suggested the agency could modify its approach related to bona fide service fees and ASPs.

The exemption from Medicare price negotiation provides relief to drugs with orphan indications that represent significant levels of Medicare spending, the Congressional Budget Office said as it raised its spending forecast.