Pricing Debate
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.
Debate on how to manage drug spending continues in France despite an ongoing disagreement between industry and the government about whether there was €1.2bn overspend on medicines in 2024.
Manufacturers will address what constitutes appropriate therapeutic alternatives for the selected drugs as part of the negotiation process.
HHS Secretary nominee Robert F. Kennedy Jr. discussed the Trump Administration's support for Medicare price negotiation during his confirmation hearing.
While Japan looks set to further improve policies to support ventures and ease market entry this year, these will contrast with ongoing reimbursement price controls.
Boehringer Ingelheim “made it more difficult” for doctors to prescribe generic versions of its Spiriva (tiotropium) inhalers, Romania’s Competition Council has found, as it levied a fine of more than $25m on the German originator.
Chairman-designee Andrew Ferguson likely will continue the commission’s investigation of PBMs during the next administration.
Any Trump Administration policy involving international pricing should include foreign governments paying higher prices, as well as lowering US prices, CEOs say.
A TD Cowen survey explored expectations about the impact of the Inflation Reduction Act, access to 340B discounts and general price trends.
If all goes to plan, improvements the national health technology assessment agency wants to make to its drug review procedures – including the tailored, complex and accelerated access reviews – could become effective for applications received in the first half of 2025.
Major foreign pharma industry groups in Japan are threatening to pull out of a planned public-private council initiative over a proposed sales tax on certain drugs to fund drug discovery.
The policies for China’s biopharma industry in 2024 centered around innovative small molecules, biologics and cell and gene therapies. Regulation changes for the industry in 2025 could be a continuation of that.
Multiple industry groups in Japan warn that a decision to implement an "off-year" drug price revision in April will reverse other recent policy moves to support innovation.
The Danish procurement body for hospital medicines, AMGROS, wants to better understand how to make alternative pricing agreements work and is inviting companies to take part in “deep dive dialogue” to ensure industry proposals hit the mark.
Outcomes-based and price-volume agreements are the alternative pricing deals most frequently suggested by industry to AMGROS, Danish procurement body.
A shifting political power balance in Japan is leading to renewed debate on the pace of regular drug reimbursement price cuts.
The collapse of the French government brings more uncertainty for the pharmaceutical industry.