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The long-awaited trilogue negotiations on the European Union's pharmaceutical legislative package officially got underway on June 17 in Strasbourg, but ended early with no substantial progress being madeThe EU Council's agreed position made on June 4 faced opposition from some member states due to concerns over the retention of the Regulatory Data Protection (RDP) period. Meanwhile, Estonia and Cyprus raised concerns over perceived overreach by the pharmaceutical industry, while Portugal and Czechia voiced frustration at the lack of strong guarantees for improved access to medicines across member statesDespite the rocky start, some remain hopeful. Tomislav Sokol, shadow rapporteur for the Regulation, expressed optimism, citing broad alignment between Parliament and the Council on the Commission's original proposal. Yet others, including MEPs Nicolás González Casares and Tilly Metz, cautioned that significant disagreements, especially over modulated RDP, still threaten to derail the process
In its final draft guidance, the National Institute for Health and Care Excellence (NICE) has decided not to recommend Biogen/Eisai’s Leqembi and Eli Lilly’s Kisunla for treating early Alzheimer’s, citing modest clinical benefits and high costsNICE cited significant uncertainty in economic modelling and deemed both treatments not cost-effective for NHS use, including under managed access schemesHelen Knight, director of medicines evaluation at NICE, stated, “We have done everything we possibly can to try and achieve a positive outcome in our assessments of these treatments, including providing an additional opportunity for evidence to be submitted." In separate statements, Lilly and Eisai have both said they plan to appeal the decisions
The Indian government has added 116 new drugs, including the Human Papillomavirus (HPV) vaccine, to its network of Pradhan Mantri Jan Aushadhi Kendras (PMBJKs, generic stores)The nationwide HPV vaccination drive for girls aged 9-14 is delayed due to limited stock from Serum Institute of India (SII), the sole licensed manufacturer. To address the gap, the government has now included the recombinant HPV quadrivalent vaccine on the JAKs drug listThe newly added medicines will be available across 16,500 Jan Aushadhi Kendras in India by September
The Department of Health and Social Care (DHSC) has announced that it will increase the statutory scheme headline payment percentage for 2025 to 23.4%As this amendment will not be in force until 1 July 2025, companies that made statutory scheme payments in the first half of 2025 at the lower rate of 15.5% will instead pay an uplifted rate of 31.3% from 1 July 2025. The new rate brings the annual average in the statutory scheme to 23.4% over the whole of 2025The record 31.3% is double the current rate that pharmaceutical companies must repay on the sales of newer products under the statutory scheme. Richard Torbett, Chief Executive, the ABPI, said: “The UK’s sky-high and unpredictable payment rates send a terrible message to international investors at a time when the UK is trying to position life sciences research and development as an engine for health and growth
Last week, NAVLIN held its fourth Pharma Pricing & Access Innovation Conference (PPIC) at the Mövenpick in Basel, where more than 150 industry experts came together to network and share their insights Members of the NAVLIN team, industry, and payers shared their expertise with the crowd: The final day saw detailed discussions on early asset evaluation, navigating loss of exclusivity, and a forecast for U.S. and global policy and reimbursement trends, among many others Key sessions covered topics including horizon scanning and the future of gene therapy pricing (with a very special guest!). This year’s conference also introduced several new successful features, including Payer Speed Networking and dedicated Product Focus Groups, which participants widely praised for facilitating more meaningful discussions
Last week, NAVLIN held its fourth Pharma Pricing & Access Innovation Conference (PPIC) in Basel, where more than 100 industry experts came together to network and share their insightsFollowing the European Parliament's Health Committee green light to enter into interinstitutional negotiations on the reform of the EU pharmaceutical legislation, with 29 in favor, one against, and two abstentions, the EU Council announced several amendments to the proposed legislation. However, the European Federation of Pharmaceutical Industries and Associations (EFPIA) has called these amendments a "missed opportunity for European innovation" The European Commission has opened the second request period for joint scientific consultations (JSC) under the EU HTA Regulation, which will run from June 2 to June 30, 2025
The Japanese government has unveiled a draft version of this year’s Basic Policy on Economic and Fiscal Management and Reform (honebuto)The draft was presented to the Council on Economic and Fiscal Policy (CEFP) on June 6. The final paper will likely be passed through Cabinet approval this week following further discussions between lawmakers of various partiesFollowing on from recent discussions about broadening the use of cost-effectiveness evaluation (CEA), the honebuto proposes strengthening the drug pricing system by formally using CEA in price setting
Glenmark is set to launch Brukinsa (zanubrutinib) in India, a cancer drug approved by the Drugs Controller General of India (DCGI)Brukinsa is a new treatment option for Indian patients with hematological (blood) cancers. It is the first and only Bruton’s tyrosine kinase (BTK) inhibitor in India approved to treat five types of B-cell malignancies“We look forward to bringing Brukinsa to India in the coming months,” said Alok Malik, President and Business Head – India Formulations at Glenmark
EVERSANA clients are invited to an exclusive opportunity to attend the Capital for Cures Summit Frankfurt on Wednesday, 17 June at 4:00 pm CESTThe event is a private gathering for investors, startups, and industry leaders across biotech, healthcare, and venture capitalSpeakers include Adina Krausz, Founding Partner and CEO of InnoSource Ventures AG, Sebastian Gensior, Founder of Slate Mountains Capital and Roland Petrenko, Head of Pharma & Healthcare – EMEA at SS&C Intralinks
Welcome to Day Two of NAVLIN’s Pharma Pricing & Access Innovation Conference (PPIC) at the Mövenpick Hotel in Basel!Yesterday, attendees explored the ever-evolving policy environment, best practices in early access planning, and operational excellence in pricing and market monitoring. The day also featured NAVLIN’s product vision, providing a clear view of where the industry is heading and how we’re enabling smarter, faster decisions for access professionalsWe’re looking forward to more hands-on learning today, before our closing ceremony and cocktails!
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