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.
International reliance mechanisms for approving drugs have an important place, but the UK regulator should increase focus on becoming a first approver of medicines, according to the British pharmaceutical industry.
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.
Under the newly-announced UK-US trade deal, the UK will increase the thresholds used to evaluate the cost-effectiveness of new medicines, which should allow higher prices for innovative therapies.
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.
Among products granted conditional approval in China over the 2020-22 period, the completion of confirmatory trials and conversion to traditional approval took up to a median of five years, according to a Pink Sheet analysis.
The UK’s autumn budget failed to introduce any widespread changes for pharma, but scale-ups and innovators could benefit from changes to enterprise and investment schemes. Some industry voices warn of underinvestment in the MHRA and innovative medicines.
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.
While Japan tries to balance its healthcare costs, the major US industry group is concerned reimbursement pricing practices in the country could influence US levels under Trump's MFN policy.
While there is a general shift towards alignment and collaboration in health technology assessments in the EU under the new HTA Regulation, member states still have “their own recipe” when it comes to making reimbursement decisions.
The pharmaceutical industry has been pushing back on a deeply unpopular rebate on products deemed to be “free combination” medicines in Germany.
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.
While the volume of questions that companies have received from the EU member states under the Health Technology Assessment Regulation has been lower than expected, some firms are struggling with the comparator analysis required to answer some questions, an expert says.
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.
England is set to become the first market outside of the US where Autolus’ CAR-T therapy Aucatzyl is reimbursed for acute lymphoblastic leukemia, after the country’s health technology assessment institution, NICE, recommended its use for certain patients.
Incentives are “probably the only solution” to encouraging companies to optimize cancer drugs, but this will require funding and systemic changes, the chair of the European Medicines Agency’s oncology working party says.
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.