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The European Union’s joint clinical assessment (JCA) of Innovent Biologics’ Tyvyt (sintilimab), co-developed with Eli Lilly, has been discontinued after the company’s updated dossier was found to contain substantial gaps in study information, evidence retrieval, and the methods underpinning its indirect treatment comparisons“In the dossier, insufficient information and data are provided on the characterization of the included studies and interventions, the course of included studies, and other characteristics. In addition, detailed information on outcomes (e.g., definition of outcomes, planned and actual follow-up times, imaging intervals) is missing,” the European Commission noted. “This information, in principle, is mostly contained in the Clinical Study Report (CSR) of the study ORIENT-11 and in publications of the studies on comparators”Sintilimab is the fourth JCA to be discontinued, with Sasanlimab, following withdrawal of its EMA marketing authorization application, and catequentinib and Tacquell, which were both discontinued after their JCA dossiers failed to satisfy the requirements under Article 9(2), (3) and (4)
The EU’s overhaul of pharmaceutical legislation has entered the final stages of the legislative process, with the Council setting out detailed first-reading texts covering regulatory protection, medicine launches, orphan-drug incentives, antimicrobial resistance, shortages, environmental requirements, and a major restructuring of the European Medicines Agency (EMA). The Council’s formal adoption of its position at first reading and statement of reasons is scheduled for September 28Council documents 7105/26 and 7106/26 set out, respectively, the new Regulation governing centralized medicines procedures and the EMA, and a new Directive establishing the Union code for medicines for human useThe final framework keeps eight years of regulatory data protection, followed by one year of market protection, with extra protection available in certain circumstances. Meanwhile, under Article 59, a Member State can request that a marketing authorization holder place a protected medicine on its market and supply enough product to meet patient needs
Newly released but heavily redacted copies of the U.S. administration’s Most Favored Nation (MFN) agreements with Eli Lilly and Pfizer have been obtained and published by Public Citizen, offering glimpses of information related to previously undisclosed pricing, reporting, and implementation provisionsLilly’s agreement appears to exempt GLP-1 products such as Mounjaro and Zepbound (tirzepatide) from the GENEROUS model, and allows for the omission of patient assistance programs, free drug programs, and similar offerings from manufacturer-reported net pricesMeanwhile, Pfizer’s agreement appears to confirm that GENEROUS prices are excluded from Medicaid Best Price and do not impact 340B ceiling prices. The text also indicates that the company will share with the U.S. government a portion of revenue associated with increases in net prices for ex-U.S. products covered by the agreement
Last week, NAVLIN Daily brought you key market access developments from across the globe In Europe, a Lancet study found that drugmakers may raise prices or delay launches abroad to offset losses from the U.S. MFN policy, while Germany explored a potential pharmaceutical pricing deal with Washington to avert the threat of additional tariffs Spain also pushed for greater EU coordination on access to innovative medicines while China wrapped up negotiations for its NRDL, with 124 drugs currently absent from the catalog potentially gaining access
Japan's medical insurance system has incorporated Amchepry, the first commercialized iPSC-based treatment for Parkinson’s in the worldWhile the drug is priced at ¥55.3 million (~$354,566), its costs will be capped for patients based on income and other factorsAmchepry received conditional approval and must validate its efficacy with seven years of real-world data
The National Institute for Health and Care Excellence (NICE) has reversed its previous rejection of AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan), recommending the targeted therapy for routine NHS use in England for around 1,000 people with HER2-low advanced breast cancer each yearNICE said a commercial solution has now been agreed with the companies, alongside changes to its assessment methods following the UK-U.S. Pharmaceutical Pricing Agreement. These include higher cost-effectiveness thresholds, which came into effect in April 2026, as well as a new method for assessing quality of life published on August 27The recommendation was made through NICE's review process, which allows guidance to be reconsidered when new evidence or commercial arrangements become available
South Korea’s fast-track rare disease drug listing project received 14 applications from pharma companies, including major players like Novartis and AstraZenecaDespite financial risks, many companies seem to be banking on early market entry. The numerous applications signal potential success for the pilotOne company said participating allows them to voice opinions during system revisions and potentially secure favorable agreements down the line
A study published in The Lancet found that pharmaceutical companies may raise prices in foreign markets or delay launches to offset losses from the U.S. MFN policyFor 101 products, Medicare savings would exceed sales in the binding reference country, according to the researchHowever, the European Commission (EC) recently concluded that it was too early to predict outcomes. Regardless, global leaders are strategizing to mitigate the influence of the MFN policy on drug prices
Last week, NAVLIN Daily brought you key market access developments from across the globe NAVLIN Daily is an official media partner for three upcoming industry events: World Vaccine Congress Europe (October 19–21, Amsterdam), MDRP Summit 2026 (October 5–7, Chicago), and Pricing & Contracting West Coast 2026 (December 7–8, La Jolla, California) In Germany, the Health Ministry proposed a major overhaul of the AMNOG benefit assessment system, while Spain pushed for an EU mechanism to enable earlier procurement of innovative medicines. In South Korea, the government began phased price reassessments covering more than 14,000 reimbursed drugs
China just wrapped up negotiations for its National Reimbursement Drug List (NRDL), with 124 drugs currently absent from the catalog potentially gaining access. Successful additions will be unveiled in NovemberA separate Commercial Insurance Innovative Drug List also saw key negotiations regarding CAR-T therapies, radiopharmaceuticals, and treatments for rare diseasesTalks for the commercial catalog were described as efficient as a result of preliminary meetings that helped companies assess general price expectations
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