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.
The ‘day of reckoning’ for the outpatient drug discount program has arrived as annual spending continues its 20%-plus annual growth rate, Drug Channels’ Adam Fein said.
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.
A slash in rebate rates is only a first step towards restoring the competitiveness of the UK’s pharmaceutical industry, according to the ABPI.
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.
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.
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.