Medicare

Stelara, Xarelto, Januvia and Farxiga, which are expected to have biosimilar or generic competition before the end of 2026, could be the first negotiated drugs subject to the policy.

Anti-PBM sentiment continues to rise, but industry observers still question whether the reforms being discussed will be effective.

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.

Data illustrates the 2025 Medicare Part D plan landscape, including changes in premiums and plan options.

Despite GOP criticism of the Part D stabilization program and its budgetary impact, the Trump Administration may decide to keep it in part to avoid blame for a premium increase.

If successful, the new CMS cell and gene therapy access model eventually could expand to oncology or hemophilia products, an Avalere Health expert said.

The much-anticipated report from the US Centers for Medicare and Medicaid Services is heavily redacted and lacks a specific justification for the prices, but preserves agency flexibility to shape the program going forward.

In the proposed rule, CMS said it would begin reviewing Part D plan formularies and utilization practices to see if programs include incentives to reduce costs, as well as offered suggestions for implementing the new Medicare Prescription Payment Plan.

The new discount obligation will more than offset the increased sales expected to be driven by the redesign's $2,000 cap on beneficiary spending. The forecast is the first public discussion of the Part D redesign's impact on an individual company.

The potential for manufacturer liability may become a concern if problems providing rebates to pharmacies on negotiated drugs emerge because the system goes awry, a former CMS official suggested in an interview with the Pink Sheet.

Unusual CMS letter to Medicare Advantage plan sponsors disputes coverage exclusions of the ALS treatment on the basis of its accelerated approval status.

The US Medicare agency’s proposal to cover weight loss drugs hinges on defining obesity as a disease. While the characterization matches the growing medical consensus, the incoming Trump Administration may not agree.

The proposal states that Part D plans could define "obesity" for coverage determination, but CMS said overly restrictive criteria would be inconsistent with formulary review requirements and step-therapy would not be allowed.

Proposed rule on GLP-1s sets up an expensive benefit that would need to be implemented (or rejected) by the incoming Trump administration. Move suggests the next round of drugs subject to Medicare price-setting will include Novo’s semaglutide – and could be announced by the Biden team before they leave.

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.