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The Centers for Medicare & Medicaid Services (CMS) published finalized guidance providing details regarding the second cycle of negotiations under the Inflation Reduction Act’s (IRA) Medicare Drug Price Negotiation ProgramThe new guidance implements several changes from the first guidance, including additional engagement and price negotiation opportunities to manufacturers with drugs selected for negotiationCMS is set to announce the selection of up to 15 additional drugs covered by Part D for the next round of negotiations by February 1, 2025. This second cycle of negotiations with participating drug companies will occur during 2025, and any negotiated prices for this second set of drugs will be effective starting January 1, 2027
NHS England’s proposed rollout would initially offer Eli Lilly’s Mounjaro (tirzepatide) for managing overweight and obesity in individuals with a BMI over 40 kg/m² and at least three weight-related health conditions. The eligibility would then gradually expand to include those with fewer associated conditionsThe National Institute for Health and Care Excellence (NICE) has opened a consultation on the proposal, with final guidance to follow after reviewing stakeholder feedback. The phased rollout is considered necessary due to the large number of people who could benefitFrontier Economics estimates that obesity-related conditions cost the NHS £11.4 billion annually, highlighting the significant financial burden that these conditions place on the healthcare system
In draft guidance, the National Institute for Health and Care Excellence (NICE) has not recommended Menarini Stemline’s Korserdu (elacestrant) for the treatment of oestrogen receptor (ER) -positive, HER2-negative advanced breast cancer with an ESR1 mutation, following endocrine therapy.Despite considering Korserdu's impact on both quality and length of life, its most likely cost-effectiveness estimate is above what NICE considers an acceptable use of NHS resourcesNICE's document states that the proposed list price for Korserdu is confidential and cannot be disclosed until the final draft guidance is published
A campaign spokesperson told Politico that former President Donald Trump, if reelected in 2024, plans to revive his controversial “most favored nations” (MFN) pharmaceutical pricing modelIf it had gone into effect, the MFN rule would have established an international reference pricing system in the U.S., stipulating that the U.S. would pay the lowest price paid among other wealthy nations that are part of the Organization for Economic Co-operation and Development (OECD)The proposal has received fierce backlash from industry and a lukewarm reception from many of Trump’s fellow Republican lawmakers, who believe the scheme will harm innovation and threaten U.S. leadership in pharmaceutical research & development
The European Medicines Agency (EMA) and the European Medicines Regulatory Network have outlined that there is a need to improve the reliability of long-term planning for initial marketing authorization applications (MAAs)“This has been a recurrent problem for the network for many years, binding precious assessment resources and slowing down medicine approval times,” the group explainsTo address the issue, the EMA has already introduced stricter guidelines that require applicants to justify requests for extended clock-stops, which will no longer be granted for incomplete submissions. Additionally, the Agency has revamped its assessment report templates to improve clarity and eliminate redundancy, with further updates planned for 2025
The European Chamber of Commerce in Korea (ECCK) is calling for changes to South Korea's healthcare system, as the group is concerned that the current policies prevent innovative treatments from being properly valuedThe ECCK has submitted recommendations for reforms on a range of issues, suggesting a more flexible approach, particularly in determining cost-effectiveness of innovative medicines approved through fast-track programs like Korea's Global Innovative Products Fast Track (GIFT)The group also criticizes the current tax burden on companies due to the risk-sharing system for innovative drugs
The German Federal Council recently passed the Medical Research Act (MFG), which includes the introduction of confidential pricing in Germany and incentives to include German participants in clinical trials The Act faced amendments before its final greenlight, especially with the confidential pricing clause after much backlash. Manufacturers will now have the choice, after concluding negotiations, to select between secret or transparent reimbursement amounts. If they opt for the former, they will be required to offer an additional 9% discountAccording to Alan Crowther, EVERSANA's General Manager of Global Pricing, Access, and Digital Solutions, the Act likely burden small firms more heavily than large, similar to the European pharma legislation. Additionally, he calls the 9% discount “interesting,” in the sense that “Similar to France's indirect method (vs. this direct model), the Federal Ministry of Health legislation is saying "if you see value in confidential pricing, then we want a share in that value." Confidentiality as an option may be increasing somewhat in health systems around the world, but at a cost to manufacturers.”
During the National Institute for Health and Care Excellence (NICE) meeting on September 25, 2024, the board concluded that the new severity modifier is functioning as intendedAccording to NICE, the severity modifier has been applied more widely than the end-of-life modifier, resulting in a higher proportion of positive recommendationsNICE is committed to continuously monitoring technology appraisal decisions to ensure that appropriate weightings are applied
Spain’s Interministerial Commission on Drug Prices (CIPM) has approved funding for Enhertu (trastuzumab deruxtecan) and Trodelvy (sacituzumab govitecan), two therapies for metastatic breast cancerThe funding approval comes after a protracted debate involving the Ministry of Health, the Popular Party (PP), and patient advocacy groupsLast week, Secretary of State, Javier Padilla, shifted the blame to autonomous communities governed by the PP, suggesting they had previously opposed the funding in CIPM meetings, although he did not specify any voting details
The Inflation Reduction Act's (IRA) drug pricing provisions took center-stage at the Medicaid Drug Rebate Program (MDRP) Summit 2024, with several sessions devoted to discussing both the law's immediate and long-term impact, as well as what future negotiations might look likeSome key panels included insights from the selection and negotiation process, as well as how to prepare for the next round of negotiations; a discussion of the operational challenges of the IRA; and insights on the biggest potential consequences stemming from the IRA and how the upcoming presidential election could change the pharmaceutical policy landscapeAll panelists emphasized how important it will be for manufacturers to plan ahead for potential selection and to start gathering data and evidence supporting a product's value as early as possible
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