Medicare

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.

The next round of the negotiation program is scheduled to begin in February unless the new administration delays the start of the process.

But the expected nominee brings little experience running a large government organization or with the policy and budget challenges confronting Medicare and Medicaid.

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.

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.

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.

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.

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.

Judges on the Third Circuit panel in the BMS and JNJ IRA cases seemed sympathetic to industry’s concerns about the government using the term “maximum fair price” in the IRA’s Medicare drug price negotiation program.

The leading supplier of repackaged off-label Avastin for ophthalmic uses is discontinuing the product. Is this the beginning of the end for a relatively cheap wet AMD treatment?

The landmark drug pricing reforms from the Inflation Reduction Act are starting to take full effect – and it turns out that the impact may not be as dramatic as originally projected based on updated analyses from the US Congressional Budget Office.

The US Congressional Budget Office acknowledged that weight loss drug coverage could drive long term savings from ancillary health issues, but not enough to offset the cost of the drugs. Expanding Medicare coverage would cost the US Treasury $35 billion over 10 years.

A manufacturer information campaign is increasing awareness about the Inflation Reduction Act provisions easing cost sharing obligations for high-cost drugs in Part D, the insurer said.

Pink Sheet reporter and editors discuss an emerging pharma strategy to avoid Medicare price negotiations, legal wrangling related to compounding GLP-1 drugs for obesity and diabetes, and the varying opinions of FDA officials on the acceptability of artificial intelligence models that are not fully explainable.

The US Medicaid agency will not require diagnostic codes on prescriptions any time soon after hearing “overwhelming” opposition from stakeholders.

Pharmacy benefit managers are not the only ones in the supply chain that may not feel incentivized to encourage patient access to Medicare negotiated drugs.

The US Centers for Medicare and Medicaid Services is counting on “good faith” between manufacturers and covered entities to ensure appropriate 340B pricing is offered on drugs subject to the new negotiation authority.

A growing number of future Part B candidates for Medicare price negotiation may avoid price controls in the program with injectable versions.