Industry seeking IRA carve-out for some small molecules

Speaking on an earnings call Wednesday, Novartis’ Vasant Narasimhan expressed optimism that Congress will, at some point, extend the threshold for some drugs approved under NDAs to be subject to the Medicare drug price negotiation program. The program, established in the Inflation Reduction Act, allows CMS to set the prices of drugs approved under NDAs nine years after approval; drugs approved under BLAs can be subject to price-setting 13 years after approval.

Narasimhan, the CEO of  Novartis AG (SIX:NOVN; NYSE:NVS), said there is bipartisan support in Congress for a bill extending the nine years to 13 years for “genetically targeted therapies.” He added that passing the bill will take time and that election-year politics make enactment this year unlikely. Narasimhan said that in addition to genetically targeted therapies, “over the coming years” the pharmaceutical industry hopes to convince Congress to shift the Medicare price-setting threshold to 13 years for all small molecule drugs...