Medicare
The US Centers for Medicare and Medicaid Services argued gender affirming care is not health care to help justify the new proposed rules. The argument could create a new opening for the federal government to go after other pharmaceuticals.
The FDA’s policies on analgesic labeling appear to be limiting the potential for novel non-opioid pain medicines to qualify for separate payments in Medicare after CMS said the indication must be for post-operative use.
Manufacturers are responding to a convergence of factors, but plans will miss the rebate dollars they have relied on in the current pricing model.
An IQVIA analysis is the first published investigation of the financial impact of 340B rebates on covered entity-owned pharmacies and supports the manufacturers’ position that the rebate model is workable for providers.
CMS backs off on a plan to put “guardrails” around manufacturer payments that are excluded from Average Sales Price calculations in Medicare, but is planning to revisit the issue.
CMS may have decided some of the IPAY 2027 drugs did not measure up to their IPAY 2026 therapeutic alternatives, but negotiation parameters also may have played a role in the lower prices negotiated in the latest round compared to the first cycle.
The final guidance for the upcoming third round of the Medicare drug price negotiation process is most notable for the amount left unchanged.
Because they are not heavily rebated already, the discounts on four cancer treatments and a trio of other specialty drugs may benefit patients and the government more than others in the IPAY 2027 class.
The Medicare negotiated price is slightly higher than the Most Favored Nation price recently announced by the Trump Administration.
The second cycle of IRA price negotiations could result in price cuts as high as 85% to the 2024 list prices, but the mean discount across the 15 negotiated drugs appears similar to the previous round.
The inclusion of Medicare Part B drugs in the program for the first time will sweep in several biologics, even though heavy hitters Keytruda and Opdivo will not be among them.
Is the $2,000 out-of-pocket spending limit in Part D too ‘aggressive’? Manufacturers could be targeted when policymakers seek a solution for the disarray in the standalone plan market caused in part by the cap.
The Trump Administration’s formula for ‘Most Favored Nation’ pharmaceutical pricing has evolved since the first Trump team proposed MFN pricing for Medicare in 2020. The ‘GENEROUS’ Medicaid model in 2025 is indeed more generous to manufacturers – though still not an attractive proposition.
The $245 price agreed to by both firms may be in line with the maximum fair price that Medicare negotiated for Novo Nordisk’s semaglutide products.
The Trump Administration’s efforts to encourage more US-based pharmaceutical manufacturing have largely centered on FDA plans and Trump’s threats of tariffs and Most Favored Nation pricing, but Oz hinted Medicare and Medicaid soon may soon announce new incentives.
CMS official John Brooks said CMS cannot undo plans to publish MFPs and not average sales prices for physician-administered drugs in the Medicare price negotiation program. But he suggested the agency could modify its approach related to bona fide service fees and ASPs.
The exemption from Medicare price negotiation provides relief to drugs with orphan indications that represent significant levels of Medicare spending, the Congressional Budget Office said as it raised its spending forecast.
Only Bausch Health’s Xifaxan may have had a lower initial offer among the 15 drugs in the current Medicare price negotiation round, researchers at the University of Washington and the University of California, San Diego, projected.
Pink Sheet reporter and editors discuss the FDA’s role in the Astra Zeneca Most Favored Nation drug pricing deal and the Justice Department interpreting the off-label promotion laws differently than the FDA.
The US government shutdown is challenging HRSA’s ability to advance the 340B pilot program on schedule.