Pricing Debate
Jonathan Blum, who was principal deputy administrator during the Biden Administration, explained the agency’s approach to setting up the price negotiation program and said changes likely will be implemented by the Trump Administration.
Eli Lilly is seeking an injunction barring a weight loss clinic from dispensing modified versions of its GLP-1 products.
The UK government has listened to industry concerns about high clawback rates under the voluntary scheme and will review it in June in a bid to resolve the issue and “move on to bigger and more important things,” health secretary Wes Streeting says.
A Republican think tank suggested variations of the Most Favored Nation and international reference policies in Medicare and Medicaid, as well as tariffs and other trade levers to rebalance drug pricing disparities between US countries and abroad.
Democrats opposed the nomination because they believe Mehmet Oz will not defend Medicaid from spending cuts. His pledge to continue lowering drug costs in Medicare and Medicaid did not offset the concerns.
The UK branded drug industry is calling for adjustments to be made to the UK voluntary scheme framework for branded medicines, after the payment rate increased to 22.9% for 2025. Meanwhile, the generics industry says the scheme is functioning “as intended” and opposes any changes.
An initiative run by health technology appraisal (HTA) bodies in the US, Canada and England is looking at how non-traditional treatment benefits, such as the value of hope and scientific spillover, can inform appraisals and understanding of a product’s value.
An HHS legal brief argues company lawsuits seeking immediate clearance to use rebates in 340B are premature and that the department has merely used a ‘measured approach’ in weighing the possibility. Past experience suggests otherwise, a pricing expert said.
The government wants to raise the statutory scheme payment rate for newer branded medicines from 15.5% to 32.2%, after sales data for Q2 and Q3 2024 showed “higher than expected newer medicines sales growth.”
Physician and TV personality Mehmet Oz, who is President Trump's nominee for CMS administrator, said he was instructed by President Trump to explore “every single way” the agency could lower drug costs.
Former CMS official John Coster offered insights into why the agency has declined to directly engage in efforts to avoid duplication of Medicare negotiated prices and 340B discounts during an interview with the Pink Sheet.
Health technology assessment agencies are willing to pay more than usual for advanced therapies that treat rare or severe diseases, but an advanced therapy for a common condition would not qualify for such a modifier, a former senior figure at England’s NICE says.
Manufacturers still hope to advance legislation removing the “pill penalty” from the law, as well as changes they want included in the CMS guidance for the 2028 price implementation year.
US pharma leadership is painting its mission, particularly its goal to end Medicare price controls, as patriotic and essential to America’s global dominance over China, a move that seems designed to align with President Trump’s priorities.
A lower asking price from BMS and more insight into the benefits Breyanzi offers have convinced the health technology assessment institute, NICE, to reverse its rejection of the one-off treatment for large B-cell lymphoma.
Some changes to the contentious social security financing bill have been made, but industry and the government remain at odds over a €1.2bn drugs overspend.
The pharmaceutical industry has been quiet on Trump's early federal government overhauls that could harm the drug business, still betting he will help produce better results than Biden.
Congress may be empowered to change the Part D stabilization demo, but a health policy expert said CMS is more likely to repeal, adjust or replace the program.
Brazil’s drug regulator ANVISA has also published its first post-marketing authorization monitoring reports on advanced therapies Yescarta, Zolgenma, Kymriah, Carvykti and Luxturna.
President Trump’s 10% tariff on active pharmaceutical ingredients and finished dosage forms could push some generic drug makers to exit therapeutic categories if they cannot absorb the new costs, which could lead to shortages.