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Last week, NAVLIN Daily brought you key market access developments from across the globe In the U.S., new details emerged on MFN drug pricing deals with Pfizer and Eli Lilly, while all 50 states, the District of Columbia, and Puerto Rico applied to join the GENEROUS drug pricing modelIn Japan, the medical insurance system has incorporated Amchepry, the first commercialized iPSC-based treatment for Parkinson’s in the world, while China released its 15th Five-Year Plan for its pharmaceutical industry, which sets ambitious goals, including 20% annual growth for innovative drugs and at least five global blockbusters surpassing $1 billion in sales
Germany’s Federal Joint Committee (G-BA) has raised significant concerns over proposals from the Federal Ministry of Health (BMG) to reform the AMNOG benefit assessment process, warning that the planned special pathway could apply to more than 60% of assessments for medicines with new active substancesG-BA Chair Dr. Sonja Optendrenk said mandatory reassessments after three to four years could substantially increase the number of AMNOG procedures and administrative work for both pharmaceutical companies and G-BA, while potentially increasing statutory health insurance (GKV) pharmaceutical expenditureOptendrenk proposed maintaining the existing data-based benefit assessment for all medicines with new active substances, while allowing G-BA to carry out an additional qualitative assessment in specific treatment situations with increased medical need and, where appropriate, determine that a medicine has potential for a therapeutically relevant additional benefit
Novartis and Eli Lilly face a petition in India's Kerala High Court asking for lower prices on breast cancer drugs ribociclib and abemaciclibNovartis made $12.7B globally from ribociclib between 2020-25, with just $55.7M from India. Lilly earned $19.6B from abemaciclib globally in the same span, compared to $31.5M in India. Both companies argue high development costs but didn’t share exact numbers with the courtThe petition has also brought the manufacturing cost of ribociclib into focus. Producing a 200 mg ribociclib tablet costs about ₹81 ($0.84) when the active pharmaceutical ingredient (API) is manufactured in-house and roughly ₹123 ($1.28) when the API is imported
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
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