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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
In a latest announcement, the European Commission opened the first 2026 submission window for joint scientific consultations under the EU HTA Regulation, running from 7 January to 4 February 2026, and open to developers of medicines and medical devicesDevelopers can request JSCs in parallel with EMA scientific advice, enabling joint meetings with EMA coordinators, EMA and HTA experts to support coordinated early regulatory and HTA planningApplications must be submitted via the HTA IT Platform by 4 February 2026, with briefing document deadlines in April, May, or June 2026; early platform registration is advised, and no fee applies
The Indian state of Rajasthan has introduced a portability provision under its publicly subsidised health insurance program, allowing eligible patients from other states to access cashless treatment at hospitals in RajasthanThe reform was implemented by the Rajasthan State Health Assurance Agency (RSHAA) with technical support from the World Health Organization (WHO) through the Universal Health Coverage (UHC) PartnershipSumeer Singh Meena, Executive Director (IT) at the RSHAA, said, “The mapping of health benefit packages across states and integrating them into the live IT system was one of the toughest milestones. Once completed, it opened doors for true portability. Now, patients can easily access services in Rajasthan, irrespective of their home state”
The UK’s Chair of the House of Commons Science, Innovation and Technology Committee has written to two senior ministers demanding urgent clarification over a controversial pharmaceutical trade deal with the U.S. and wider life sciences investment policy which was announced last DecemberAt the time Dame Chi Onwurah, Chair of the Science, Innovation and Technology Committee had written to ministers Zubir Ahmed and Lord Vallance, in which they responded that they could not comment in detail on negotiations, stating: “Given the nature of these discussions and the commercial sensitivities, we cannot provide a running commentary on the specifics.” They added that the government would “always act in the interests of UK patients and uphold our domestic health policy objectives, particularly around affordability and access to medicinesHowever, Dame Onwurah later said she was “surprised to see leaked details of the UK-U.S. pharma deal in the Financial Times the same day, with an official press release quoting both ministers released an hour later.” As a result, Dame Onwurah, has given Health Secretary Wes Streeting and Science and Technology Secretary Liz Kendall until January 9, to adequately address her original questions
The Trump administration announced Most Favored Nation (MFN) drug pricing deals with nine additional pharmaceutical companies, including Amgen, Bristol Myers Squibb, Boehringer Ingelheim, Genentech, Gilead Sciences, GSK, Merck, Novartis, and SanofiThe companies will join Pfizer, AstraZeneca, EMD Serono, Eli Lilly, and Novo Nordisk, who have already struck deals with the administration over the past few monthsThe new agreements appear to mirror the previous five, with a focus on: offering products at MFN pricing through Medicaid; commitments to set prices on new drugs launched in the U.S. at no more than prices in other wealthy countries; offering certain medications at a significant discount through direct-to-patient (DTP) models; and promises to invest billions in U.S. manufacturing and research
From everyone at EVERSANA and NAVLIN Daily, we wish you happy holidays & warm wishes for a healthy new year! Due to the holidays, from Monday our news will be taking a break until the new year. We will resume posting as normal on Friday, January 2.
More pharmaceutical companies are expected to announce Most Favored Nation (MFN) drug pricing deals with the Trump administration on Friday, December 19According to reports from Reuters, around five companies—including AbbVie, Novartis, and Roche—are set to enter into these agreementsReuters notes that the administration is also expected to reveal further details about the new GENEROUS Model, which allows manufacturers to voluntarily offer MFN prices through Medicaid
The European Commission’s recently announced Biotech Act I has received mixed reactions from industry, as groups warn that extending supplementary protection certificates would delay competition, increase healthcare costs and fail to boost EU R&D, while urging stronger competition rules, harmonized Bolar exemptions and legal certainty for day-one market entry after patent expiryAs reported earlier, the European Commission announced an omnibus combining the Biotech Act I, reforms to medical device regulations, and a first-ever EU cardiovascular health strategy. During the announcement, Health Commissioner Olivér Várhelyi announced the introduction of an additional year of patent protection, via an extension of supplementary protection certificates, for biotechnological products that are invented, tested and manufactured in Europe. The Commission argues that the incentive is designed to anchor innovation and production within the EU, ensuring European patients benefit first from breakthrough therapiesHowever, Biosimilar Medicines Group underlined the financial implications of delayed competition by pointing to blockbuster oncology medicines. “A simulation shows that for just three cancer blockbuster drugs (Keytruda (pembrolizumab) / Darzalex (daratumumab) / Opdivo (nivolumab)) each year of delayed competition would cost healthcare systems EUR 7.7 billion,” it stated
Dolors Montserrat MEP, the rapporteur for the Pharmaceutical Directive, has shared that the new EU drug launch obligation under the pharma package will take effect in January 2027Assuming the Plenary Session of the European Parliament will approve the pharmaceutical package in January 2026, other aspects of the EU pharmaceutical package will likely not become operational until January 2028 to allow time for implementationAccording to reports from a meeting with specialist media, she explained: “When a medicine is approved, any country can request it from the company. If, after one year, it has not been made available, there are two possible mechanisms: the Commission asks the company to make it available on that market through an agreement. If it does not, the industry will lose market protection in that country, and generics and biosimilars can be marketed.”
The European Parliament’s public health committee has approved its proposals on the Critical Medicines Act (CMA), advancing legislation intended to strengthen Europe’s security of supply for essential medicines. Parliament’s position is expected to be adopted during the January 2026 plenary session, after which negotiations with EU governments can beginEarlier this month, the EU Council adopted its position, which introduced measures such as; a requirement for the Commission to issue guidance, including to help Member States determine whether a critical medicine or active ingredient has been produced in the EU, and an obligation to use criteria relating to resilience in the public procurement of critical medicinesHowever, both the Council and Parliament’s proposals have been met with criticism, as EUCOPE underscores that “the proposed measures will not solve the fundamental barriers to patient access, mostly related to national competence”
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