NAVLIN Daily NewsCheckout Today’s News
The Centers for Medicare & Medicaid Services (CMS) released its list of the 15 prescription drugs that will be subject to the third cycle of the Inflation Reduction Act’s (IRA) Medicare Drug Price Negotiation ProgramFor the first time, the list includes drugs payable under Medicare Part B, as well as products covered under Medicare Part D. CMS also selected one drug for renegotiation: Boehringer Ingelheim and Eli Lilly’s Tradjenta (linagliptin). Tradjenta was originally selected for the second round of price negotiations According to CMS, between November 2024 and October 2025, the 15 selected medicines accounted for approximately $27 billion in total prescription drug spending under Medicare Part B and Part D
India and the EU signed a Free Trade Agreement (FTA) that removes up to 11% tariffs on most pharmaceuticals and medical devices. This will lower costs for Europe-made medicines like cancer therapies, biologics, and weight-loss drugs, making them more affordable in IndiaHailing the FTA, Union Minister for Chemicals and Fertilisers Shri J P Nadda said, “India–EU FTA opens new doors for pharmaceuticals and medical devices. Access to the $572.3 billion Pharma and MedTech market in the EU"Sudarshan Jain, Secretary General of the Indian Pharmaceutical Alliance (IPA), welcomed the conclusion of the agreement, adding, "Indian companies play a critical role in supplying affordable, quality-assured medicines to Europe, and noted that the expected removal of EU tariffs of up to 11% on pharmaceuticals would enhance trade and support greater access to innovative drugs for Indian patients"
The South Korean government's reform plan, including 40% cut in generic drug prices, has met backlash from the industry, which fears it will harm revenues, small companies, and new drug development. Officials argue that the plan will ensure health system sustainability and will positively restructure the industryAt a National Assembly meeting on Monday, critics cited past reforms that destabilized the market and offered suggestions such as gradual cuts, exemptions for companies investing in R&D, and support for domestic API productionThe government remains firm on the plan but is open to tweaking implementation timelines to mitigate uncertainty for the industry. Officials stressed that the system overhaul isn't just about saving funds but supporting innovation and stabilizing drug supply channels
France’s 2026 Social Security Financing Bill (PLFSS) includes a measure aimed at expanding the range of countries used to benchmark medicine and medical device prices in FranceAs reported, Article 34, reinstated by the National Assembly after having been deleted by the Senate, was carried under Article 88, page 91 of the Bill. It allows the Economic Committee for Health Products (CEPS) to take into account non-European countries with comparable market characteristicsIn an explanatory note during the PLFSS readings last year, Thibault Bazin, Member of the Republican Right group, pointed to the rapid rise in spending on medicines and medical devices since 2021, an average increase of 7.4% annually, compared to 3% GDP growth over the same period. As such, the amendment argues that looking at countries with lower prices but strong access to therapeutic innovation could help restore balance to France’s social security accounts
Last week, to kick off the new year, NAVLIN Daily published its 2025 trends round-up, offering an in-depth review of the policy, pricing and access developments that shaped the global pharmaceutical landscape over the past year. Check it out now! In the U.S., AbbVie and J&J announced the 15th & 16th voluntary MFN drug pricing agreements with the Trump administration Elsewhere, Brazil majorly restructured its drug pricing regulation and in France, pharmaceutical industry trade body Leem faced a crisis as around 30 major members exited the organization, including Sanofi, Ipsen, and Pierre Fabre. If you’re interested in the implications of these recent changes, you can register for our new Global Policy Watch newsletter here
Spain’s draft Royal Decree regulating the assessment of health technologies (HTAs) has entered its decisive stage after being sent to the Council of State under an urgent procedure, which limits its review period to 15 days, reports to DiariofarmaThese details were confirmed by Sonia García Pérez, advisory member of the General Directorate of the Common Portfolio of the National Health System and Pharmacy, during a conference organized by EUPATI Spain to mark the first year of application of the European HTA RegulationAccording to Diariofarma the version currently under consultation is not identical to the draft previously submitted for public comments, as it incorporates a series of technical and structural adjustments aimed at clarifying how the future national HTA system will function and how it will align with the European framework
AbbVie announced a voluntary Most Favored Nation (MFN) drug pricing deal with the Trump administration, becoming the 16th drugmaker to enter such an agreementOther manufacturers who have struck MFN deals so far include Amgen, Bristol Myers Squibb, Boehringer Ingelheim, Genentech, Gilead Sciences, GSK, Merck, Novartis, Sanofi, Pfizer, AstraZeneca, EMD Serono, Eli Lilly, Johnson & Johnson, and Novo NordiskAbbVie’s deal appears similar to previous agreements and the company notes that its expanded DTP offerings will include Alphagan (brimonidine tartrate), Combigan (brimonidine/timolol), Humira (adalimumab), and Synthroid (levothyroxine). The company is also pledging $100 billion in U.S.-based research and development (R&D) and capital investments, including manufacturing, over the next decade
Brazil’s Resolution No. 3/2025 restructures drug pricing by expanding categories from six to eight, formally recognizing incremental innovation and updating criteria for therapeutic gain, including removing patent requirements for premium pricingThe rule strengthens the role of the Price Information Document (DIP), sets clear review timelines, allows provisional pricing when data is pending, and increases the risk of ex officio price setting if requirements are not metImportantly, the number of reference countries used for price comparisons has increased from nine to 14. Germany, Japan, the United Kingdom, Norway, Mexico, and South Africa were added, and New Zealand was removed. The new framework will apply not only to new applications but also to ongoing and provisional pricing cases from April 29, 2026
Happy New Year to our readers!NAVLIN Daily has published its 2025 end-of-year trends round-up, offering an in-depth review of the policy, pricing and access developments that shaped the global pharmaceutical landscape over the past yearWe take a look back at 2025 developments in MFN, price transparency, global M&A, access to GLP-1 therapies, NICE policy trends and HTA decisions; the full newsletter is available below, via NAVLIN Daily
China’s updated National Reimbursement Drug List (NRDL) prioritizes innovative and ultra-long-acting medicines. Nearly half of new additions are Category 1 drugs, emphasizing clinical value. Oncology, anti-infectives, and rare disease therapies led the new listingsThe NHSA favored ultra-long-acting drugs like Innogen’s GLP-1RA, Novartis’ Leqvio, and Hengrui’s PCSK9-targeted mA for their value and lower annual costs. Domestic drugmakers are pushing these products over short-acting alternativesHCV treatments in China have been subject to a shake-up as older drugs like Merck's Zepatier and Ascletis' offerings exit due to limited genotype coverage. New local therapies now dominate with broader coverage across genotypes offered by Kawin’s coblopasvir and HEC Pharma’s imitasvir
650+
+99%
<24
4,000+
24x7
99.5%
