Pink Sheet reporter and editors discuss concerns that the incoming administration could try to influence the upcoming FDA user fee reauthorization, as well as the changes Dr. Mehmet Oz, President-elect Donald Trump’s controversial selection to run the US Centers for Medicare and Medicaid Services, could impose if confirmed.
NICE, England’s health technology assessment institute, says it was unable to reach a price agreement for AstraZeneca/Daiichi Sankyo’s HER2-low breast cancer drug Enhertu, breaking a line of 21 positive recommendations for breast cancer therapies.
The next round of the negotiation program is scheduled to begin in February unless the new administration delays the start of the process.
A new, international group of health technology assessment agencies will work together on topics related to health economic methods that could include dynamic pricing and non-traditional ways of evaluating value in cost-effectiveness analyses.
But the expected nominee brings little experience running a large government organization or with the policy and budget challenges confronting Medicare and Medicaid.
The health technology assessment institute said its “unique insights” could help companies effectively prepare for their appraisals, potentially streamlining their path through the process, and helping to get innovative technologies to patients faster.
Commission members say the standalone prescription drug plan market needs to be bolstered, given that more than 40% of Medicare beneficiaries in fee-for-service Medicare are enrolled in PDPs.
The FDA’s Peter Marks warned novel approvals will suffer if the agency is forced to spend its time relitigating vaccines. At the top HHS post Kennedy could impact pharma from basic research funding to drug pricing.
While many companies demonstrated an interest in the UK’s licensing and access pathway for innovative medicines, few made use of the various benefits the scheme had to offer, the MHRA said.
With Republicans winning a governing trifecta, prospects improve for 340B program reforms, PBM legislation, and Inflation Reduction Act drug pricing revisions. But immediate priorities for Congress and the new president will be elsewhere.
Company’s move against the US agency tasked with overseeing the 340B drug discount program is the latest in a series of manufacturer attempts to rein in ballooning 340B price concessions.
GSK’s Arexvy and Pfizer’s Abrysvo are FDA-approved for individuals younger than 60 years old, but CDC’s Advisory Committee on Immunization Practices wants more data on Guillain-Barré syndrome cases in older adults and efficacy in severely immune-compromised persons before making a recommendation.
Plan sponsors continue working to offset the risk from major policy shifts.
Some stakeholders say that the entry criteria for the licensing and access pathway have been too broad, leading to an overburdening of the scheme.
While election results are not complete, prospects improve under new regime for 340B program reforms, PBM legislation, and Inflation Reduction Act drug pricing revisions. But immediate priorities for Congress and the new president will be elsewhere.
An appeals court panel seemed skeptical of whether AstraZeneca has standing in its Administrative Procedure Act challenges against the IRA’s drug price negotiation program, but suggested a company with standing might be successful in their court.
PBM reform likely will remain a priority no matter which party controls Congress, but experts differ on the party that likely would be harder on the industry.
Two of three appeals court judges hearing Bristol Myers Squibb and Janssen’s appeal questioned whether Medicare’s drug price negotiation program was truly structured in a way that gives manufacturers a choice not to participate.
Medicines Australia has expressed skepticism over the Pharmaceutical Benefits Advisory Committee’s claim that in March 2025 it will only be able to assess 32 submissions from companies that want to get their drugs subsidized under the Pharmaceutical Benefits Scheme.
The move towards greater regulatory collaboration is a positive step for gene therapy developers, Astellas’ gene therapy strategy lead Richard Wilson says – adding, however, that pharma still needed to understand the Asian markets better.