NAVLIN Daily NewsCheckout Today’s News
Speaking at the World Evidence, Pricing, and Access (EPA) Congress in Amsterdam, Helen Knight, Director of Medicines Evaluation at NICE, suggested that 12 years is “not an acceptable timeframe" for the roll-out of Mounjaro (tirzepatide) in the UK NICE’s standard guidance requires the NHS to fund approved treatments within three months. However, given the scale of change required for such a popular product, the NHS requested a 12-year Funding Variation, which was a “challenge for NICE, as it was for a product that we knew was good for patients and value for money for the taxpayer,” according to KnightKnight suggested that increasing affordability challenges in the future may increase the NHS’ requirement to trigger Funding Variation requests more frequently. She also noted that NICE is updating the process for evaluating and approving Funding Variation requests, working with system partners and industry
Despite ongoing reforms, the European pharmaceutical industry remains attractive to U.S. firms, according to EUCOPE Secretary General Alexander NatzHe revealed several U.S. companies recently confirmed plans to establish operations in Europe, even in the face of potential E.U. tariffs on pharma products from the U.S, and uncertainty around the EU HTA regulation and pharma legislation review He emphasized the stability of Germany's pharma market, but expressed concerns about access in smaller and lower-income markets such as Greece and Cyprus - in part, due to international reference pricing (IRP)
We’re on the ground for day one of the World EPA Congress at the RAI Center in Amsterdam. Industry leaders kicked off the conference by addressing the need for better collaboration across healthcare stakeholders, among other topics in a wide-ranging first morning Senior VP of U.S. Market Access at AstraZeneca, Chris Mancill, discussed the U.S's healthcare payer dynamics, noting the rising prominence of GLP-1 drugs for weight loss and diabetes. He stressed the reality of operating within limited healthcare budgets and the challenges of implementing value-based agreements in the U.S. healthcare marketThe adoption of AI in healthcare decision-making was another topic of discussion, as well as the growing demand for preventative healthcare products in LMICs - find out more below.
Speaking at the World Evidence, Pricing and Access (EPA) Congress in Amsterdam, Wim Goettsch, Special Advisor for HTA at the Dutch National Health Care Institute (Zorginstituut Nederland, ZIN) and Professor at Utrecht University, provided insights into SUSTAIN-HTA, an initiative aimed at reinforcing HTA methodologies to align with the European Regulation on Health Technology Assessment (EU HTAR)He stressed that HTA does not operate in isolation. "We are not living in a silo—this project is really linked to the outside world." He also highlighted ongoing work in real-world data (RWD) and evidence synthesis, emphasizing the importance of determining the appropriate methodologies for integrating RWD into HTA practice"Our mission is to provide a fair and well-balanced filter for all the new HTA methods developed by academic groups, research initiatives, etc.," Goettsch concluded. In time, the project hopes to establish a platform that all EU HTA bodies can join to support the future of HTA methodology
Speaking at the World Evidence, Pricing and Access (EPA) Congress in Amsterdam, Martina Garau, Director, Office of Health Economics (OHE) discussed the importance of understanding HTA reforms over timeGarau stressed the value of international collaborations among HTA agencies. These alliances bring about consistency in HTA guidelines and enable international leadership in methodological changes. However, the implementation of any possible reforms is influenced by the existing legislative and political factors in each countryLooking ahead, Garau believes in the need for stronger international collaboration to align HTA methodologies, ultimately enhancing decision-making. She stressed the need for early stakeholder involvement, and suggested that there is potential for greater alignment across borders in the future
From 2026, upon expiration of patents, India will begin manufacturing drugs like Glucagon-like peptide-1 receptor agonists (GLP-1RA). The move is a part of India's Production-Linked Incentive (PLI) scheme Arunish Chawla, Secretary of the Department of Pharmaceuticals (DoP), stated that around 300 drugs, including 24 leading ones, are set to lose their patent rights worldwide within the next five years. India aims to use the PLI scheme to take advantage of this situation, with preparations to produce these drugs already underwayThe Indian government has allotted USD 574.5 million over five years for this initiative
U.S. President Donald Trump has surprised the global industry with a plan to impose a new 25% tariff on pharmaceutical importsThe announcement follows the recent implementation of a 10% additional duty on all imports from China and a 25% additional levy on imports from Mexico and CanadaThe president did not mention whether or not the latest tariff applies to all countries, but said the levy would increase over time
It's now just two weeks until the World Evidence, Pricing, and Access (EPA) Congress, taking place March 5 to 6, 2025, at the RAI Congress Centre in AmsterdamThe congress promises valuable insights from industry experts, including value-based pricing, real-world evidence, digital health, patient engagement, and biosimilarsAs a media partner, NAVLIN Daily's dedicated team will be on-site and reporting on the event, bringing you invaluable insights from speakers and experts. As a valued NAVLIN customer, you can use our NAVLIN50 registration discount code for a 50% discount
The French Senate has adopted the Social Security Financing Bill (PLFSS) for 2025, however, it still needs to promulgated and published in the Official GazetteeAccording to the adopted bill, the safeguard clause threshold (M amount) has been set at EUR 27.25 billion, rather than the previously expected EUR 27.89 billion. This threshold represents the maximum reimbursed drug expenditure before triggering contributions from pharmaceutical companies. A key provision of the safeguard clause is that no company’s contribution will exceed 10% of its turnover from reimbursed drugs in FranceThe bill also raises the rebate cap for generics and certain non-generic drugs from 40% to 50%, expands this allowance to biosimilars, and shortens the biosimilar substitution waiting period to one year
Generic Aadhaar, an India-based pharmaceutical firm providing affordable generic medicines, has announced an ambition to reach all 1.4 billion Indians with high-quality, affordable medicines by the end of 2025 by expanding its network to 5,000+ storesThe firm offers all its formulations at an 80% discount across various therapeutic segments, including cardiology, diabetology, oncology, pediatrics, gastroenterology, dermatology, and neurology, with medicines for epilepsy, Parkinson's, and Alzheimer's “This relentless focus on accessibility and affordability is a direct challenge to the barriers that have long hindered equitable healthcare in India,” Arjun Deshpande, Founder of Generic Aadhaar, told NAVLIN Daily
650+
+99%
<24
4,000+
24x7
99.5%
