Government Payers

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.

A Catalyst fix, a pediatric rare disease voucher reauthorization that should prevent future workload imbalances for FDA, and a boost for out-of-state coverage in Medicaid are among Congress’s year end commitments to pediatric and rare disease patients that now seem in doubt.

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.

China is advocating reforms to health insurance, particularly the wider use of commercial schemes, for reasons to support innovative drug development.

Outcomes-based and price-volume agreements are the alternative pricing deals most frequently suggested by industry to AMGROS, Danish procurement body.

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.

Pink Sheet reporter and editors discuss potential threats to the COVID-19 vaccines under the Trump Administration, the DOGE commission’s search for spending cuts and its impact on the FDA, as well as a new 340B rebate pricing model that some pharma companies are implementing to contain the program’s costs.

The majority of new drugs added to the latest revision of China's NRDL were developed by Chinese companies, although half of the global top 20 pharmas also have new entries. Bispecifics were included for the first time but no CAR-Ts made the cut.

Scant evidence has emerged proving that carving out retail pharmacy benefit management from Medicaid managed care organization contracts helps limit costs.

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.