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.
South Korea has laid out comprehensive drug pricing reforms that aim to enhance patient access to treatment, accelerate innovation and stabilize essential drug supplies, but the industry is concerned it could lead to weaker R&D and manufacturing and increased dependency on high-priced imports.
Postmarket optimization studies for cancer drugs can strengthen clinical trust in cancer medicines, which in turn results in therapies being used more often, a researcher says.
The Medicare negotiated price is slightly higher than the Most Favored Nation price recently announced by the Trump Administration.
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 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.
With UK chancellor Rachel Reeves set to deliver the country’s budget on Wednesday, Medicines UK has set out five “focus areas” where the off-patent industry believes that action is needed.
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.
Demonstration could bring unprecedented transparency into international net prices, at least to CMS.
Association for Accessible Medicines CEO John Murphy told the Pink Sheet that the FDA may need to consider phasing in the requirements for the new ANDA priority voucher incentive program if it wants sponsors to apply in the near-term.
Sam Roberts, chief executive of England’s NICE, has defended the health technology assessment institute’s cost-effectiveness thresholds and the country’s ranking against other nations when it comes to market access, while acknowledging that the UK’s pharma ecosystem is “really tough.”
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.
An early negotiation process for certain cancer drugs could cut pricing negotiation times by up to six months, while a targeted process for non-complex drug negotiations could lead to timelines that are 30–45% faster than standard negotiations.
HRSA releases finalized plans for the 340B rebate model pilot program, but does not change its position on when manufacturers may deny 340B rebates because of duplicate discounts.
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.