Medicare
Although the legislation has little chance of passing, it offers some clues about the administration's goals for MFN agreements, which differ from the voluntary deals struck with large pharma companies.
The expansion of the US Medicare drug price negotiation to include Part B products for the first time should be a very big deal, but the impact is not going to be significant in the first year and maybe future years.
CMS also outlined eligibility criteria for patients with a body mass index of 27, 30 and 35 or more for the demonstration project planned in Medicare and Medicaid.
CMS is proposing enhanced payments for hospitals that commit to purchasing essential medicines from domestic sources, but wants ideas for defining a “domestic” medicine.
The agency may be prepared to discuss broader voluntary Most Favored Nation agreements with small and mid-size firms during April meetings about the GENEROUS model.
At BIO’s Investor and Growth Summit, panelists said Most Favored Nation pricing in the US is forcing biopharma companies to scrap plans to to out-license ex-US rights to their drugs, a previously common practice.
The CMS proposal to assign liability to manufacturers despite licensing arrangements reflects the agency’s concern that companies will try to game the models.
The move is aligned with a growing industry shift toward lowering list prices to current net pricing levels and eliminating rebates.
The first round of price caps imposed via Medicare negotiation have taken effect, but if the leading target is any indication, industry appears able to handle the consequences.
CMS’ explanation of the process for arriving at the maximum fair prices for 15 Medicare Part D drugs scheduled to be implemented in 2027 still was general and opaque with significantly redacted documents.
The sales opportunity in Medicare Part D and Medicaid arrives as Lilly and Novo Nordisk face a new competitive threat from compounded semaglutide for obesity.
The US Labor Department also added a proposed rule requiring PBMs to disclose additional compensation information to certain employer-plan sponsors.
The HHS OIG advisory pertains to manufacturer sales to patients. OIG will seek stakeholder input regarding possible additional guidance on manufacturer arrangements with pharmacies, pharmacy benefit managers, telemedicine vendors and marketers.
The process will pit breast cancer treatment competitors Kisqali and Verzenio against each other as CMS develops pricing offers.
Enactment of a law delinking PBM compensation from list prices would still be a long-sought victory for pharma.
Heavy hitters Keytruda and Opdivo got a pass in the third round of price negotiation because of the expanded orphan drug exemption in President Trump’s One Big Beautiful Bill.
BMS's Lenkowsky discussed the impact of the company's MFN deal in an interview at the J.P. Morgan Healthcare conference.
The plan does not include many details, but is intended to help Congress draft legislation ensuring Most Favored Nation drug pricing agreements can be made, as well as implement measures intended to lower insurance premiums.
The announced agreement means AbbVie and Regeneron are the only companies of the 17 notified by the White House in July yet to make a deal.
The agency is considering setting a payer participation ‘threshold’ to meet before the model goes into effect.