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We at NAVLIN Daily are thankful for all our customers and want to wish everyone a Happy Thanksgiving! Thank you for being patient while our news was limited on Thursday and Friday, we will now resume as usual from MondayLast week, in the eleventh hour before Thanksgiving, the Trump administration published its final prices for the 15 prescription drugs selected for the second round of negotiation under the Inflation Reduction Act (IRA), with discounts ranging from 38% to 85% compared to current list prices. Janumet, Breo Ellipta, and Tradjenta face the steepest discounts; meanwhile, Austedo landed the lowest discount of the groupMeanwhile in Europe, as the UK released its budget, local media reported that the government is in advanced negotiations with the White House on a deal that could see the NHS pay substantially more for U.S.-made medicines, and France’s draft Social Security Financing Bill (PLFSS) continues to cause disagreements
South Korea has released the full details of its hotly-anticipated Pharmaceutical Pricing System Improvement PlanThe reform focuses on three key areas: incentives for innovative R&D and new drugs; strengthened mechanisms for supply of essential medicines; and a revised, more aggressive price-reduction framework for genericsSpecifically, the document includes an expansion of the dual-pricing mechanism, a shorter reimbursement timeline for rare disease drugs, higher ICER thresholds, incentives to encourage domestic production of essential medicines, and a phased reduction of the long-standing “2012 half-price rule” baseline from 53.55% to 40%
While the French Senate adopted on first reading, with amendments, the draft financing of social security (PLFSS) for 2026, by 196 votes to 119, a subsequent joint committee meeting composed of seven deputies and seven senators did not manage to reach an agreement on this textDuring the Senate explanations of the vote, Senator for Meurthe-et-Moselle, Ms. Silvana Silvani warned that the 2026 Social Security Financing Bill presented on October 14 was “particularly regressive,” marked by “numerous setbacks in the scope of social security reimbursements” and by “the leap in austerity policy on spending health.” She added that the Senate majority had also “eliminated price transparency of the drug,” a change she linked to the broader dismantling of protections within the healthcare systemAs a result of the Senate’s significant modifications and the committee’s failure to find a compromise, the National Assembly will now take up the text for a second reading on December 2, with a formal vote expected by December 9
According to the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), EU Institutions are coming close to a final agreement on the revision of the General Pharmaceutical LegislationOne area where EUCOPE urges the negotiators to be cautious is the new access framework, particularly in combination with changes such as the U.S. Most Favored Nation (MFN). According to the group, it would create a “too stringent environment” for innovative companies, who may have to delay launching in the EU, causing “a terrible impact on patients.”EUCOPE calls for a more holistic approach that takes into account the realities of innovative companies, particularly small and mid-sized ones, and the specificities of different therapies and technologies
The Trump administration published its final prices for the 15 prescription drugs selected for the second round of negotiation under the Inflation Reduction Act (IRA), with discounts ranging from 38-85% compared to current list pricesCompared to current list prices, Janumet, Breo Ellipta, and Tradjenta face the steepest discounts; meanwhile, Austedo landed the lowest discount of the groupNotably, the negotiated prices for semaglutide (Wegovy, Ozempic, and Rybelsus), are more than the recently announced “MFN” price achieved in the White House's one-off deal with Novo Nordisk. The Trump administration has yet to address the discrepancy
The French Senate has adopted some amendments while withdrawing others from Article 34 of the draft 2026 Social Security Financing Bill (PLFSS), which reforms France’s early access (accès précoce) and direct access (accès direct) schemes for innovative medicinesAlthough senators supported renewing the direct access experiment for two additional years, they rejected several key components of the reform. Senate discussions highlighted concerns that the proposed overhaul of early access risked restricting patient access to innovative therapies, especially for those with rare or serious illnessesAccording to the Senate’s explanatory notes, the reform could “delay access to care” and cause “a real loss of therapeutic opportunity”
The Observer has reported that the UK government is in advanced discussions with the White House on a deal that could see the National Health Service (NHS) pay substantially more for U.S.-made medicines under a raised QALY thresholdThe deal would include a commitment from the UK to raise the cost-effectiveness thresholds used by the National Institute for Health and Care Excellence (NICE). Specifically, it would increase the maximum cost per QALY from today’s £20,000–£30,000 to £25,000–£35,000 or above, as previously rumoredThe report specifies that this would be calculated in real terms, protecting additional drug revenues from being offset by higher taxation (the Voluntary Scheme for Branded Medicines Pricing, Access, and Growth (VPAG)), and would only apply to future drug launches
Last week saw a wide range in HTA decisions in Europe, with France’s High Authority for Health (HAS) declining Eisai and Biogen’s Leqembi (lecanemab) for early Alzheimer’s, giving it an “Insufficient” SMR rating and no ASMR improvement. NICE ended its review of AstraZeneca’s Enhertu (trastuzumab deruxtecan) for HER2-low breast cancer, however, in Germany, G-BA gave Eli Lilly’s Retsevmo (selpercatinib) a "significant" added benefit, which reflects the highest possible rating and a major, previously unachieved therapeutic improvementIn wider Europe, EU pharma reform talks hit a deadlock, the UK’s VPAG deadline was extended again until December 2025, and France dropped an amendment on price transparency from its PLFSS for 2026Meanwhile, NAVLIN Daily attended Advanced Therapies USA 2025, where experts discussed U.S. payer trends for cell and gene therapies, and experts advocated for a more flexible FDA review process. Read on to find out more
Welcome to NAVLIN Daily’s new global weekly policy roundup, where we will hand-select the most important changes in market access around the world and deliver them straight to your inbox every FridayThis is a complimentary preview of our new service. If you would like to continue receiving these updates, please contact connect@navlin.com for a subscriptionThis newsletter provides highlights region by region: United States, Europe, Asia & South Pacific, Middle East, Sub-Saharan Africa and Latin America. At the bottom, we also provide our “On the Horizon” scan to help you stay on top of key expected upcoming events, including policy updates and implementation milestones on reforms. Please reach out if you have any suggestions or comments regarding this new service, as your feedback is important to us
A parliamentary Committee has warned that the UK’s life sciences sector is losing faith in the government’s ability to deliver stable and credible policies on medicine pricing and uptake, urging the Health Secretary to take “urgent” corrective actionOn September 17, a meeting convened after a string of announcements from AstraZeneca, GSK and MSD signalling that the UK’s life sciences environment has become “challenging” and “unfriendly.” At that session, industry representatives pointed to voluntary scheme for branded medicines pricing, access and growth's (VPAG) 23.5% payment rates, outdated NICE cost-effectiveness thresholds, and barriers to NHS uptake as key factors driving decisions to withdraw investmentAs a result, in a letter sent to Health Secretary Wes Streeting, Dame Chi Onwurah, Chair of the Science, Innovation and Technology Committee, emphasized: "To many, it looks like the UK lacks sovereignty over key NHS pricing decisions, and I urge the Health Secretary to make clear how he will ensure [U.S.] trade negotiations don’t take precedence over domestic policy priorities”
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