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Cathrin Schäfer, Head of Market Access Europe at BeiGene, spoke about the recent amendments to the EU pharma legislation at Reuters Pharma EuropeSchäfer praised the Commission's recent recognition that simultaneous product launch across all EU member states poses significant challenges due to varying systems and requirements. Still, she stressed the need to support innovation and avoid making the environment in Europe more challenging for pharmaceutical companies Despite the recent revisions to the proposals in the legislation review, there is still concern that the reforms might stifle innovation and investment in Europe - the European Federation of Pharmaceutical Industries and Associations (EFPIA) previously warned that if the legislation review goes ahead, Europe could lose 8% of its pharmaceutical innovation in the next 15 years
Speaking at Reuters Pharma 2024, Stefan Oelrich, a board member of Bayer AG, emphasized the need for the sector to work together to cope with future challenges such as legislation changes, increased innovation, and ageing populations. He stressed that only by working in unison, much like a rowing team, can the pharmaceutical industry fully leverage the potential of innovationImportantly, Oelrich noted a shift in attitudes among European Union policymakers towards the pharmaceutical sector, particularly since COVID-19. He specifically welcomed the recognition of pharma’s feedback by the EU Commission in the most recent review of pharma legislation, but expressed concern that the final policy change still does not sufficiently foster innovationHe also touched on room for collaboration to ensure pharma can be efficient enough to make the most of the innovation coming through the pipeline
Monica Shaw, SVP of European Markets at Bristol Myers Squibb, has emphasized the importance of collaboration across the pharmaceutical sector, governments, and health bodies to ensure patient access to medicines at Reuters Pharma EuropeShe believes that the recent changes to the EU pharmaceutical legislation and the incoming Health Technology Assessment (HTA) regulation bring both opportunities and challenges - the legislation review offers a chance to improve the regulatory environment in favor of innovation. However, it is critical that healthcare is seen as an investment by policy holdersCollaboration, she notes, could be the key to overcoming these hurdles, but the "devil is in the detail" as it requires pragmatic implementation
The European Parliament has adopted the revisions to EU pharmaceutical legislation, cementing the biggest policy reform in this area in two decadesThe terms for Regulatory Data Protection have been altered from the original proposal, as have the nuances around launch conditionality and transferrable exclusivity vouchers granted for antimicrobials. Though the amendments to the reform have been generally well-received, industry associations like EUCOPE and EFPIA still have areas of particular concernThe legislation is not expected to be negotiated until 2026 and will likely not be in effect until 2028. The main concern for policymakers now is aligning these changes with the goal of enhancing Europe's competitiveness and resilience
The Pharmaceutical Research and Manufacturers of America (PhRMA) has embraced Japan's FY2024 drug pricing reform. The reform passed in late 2021 is set to roll out from April 2024, and is considered a positive step towards balancing new drug pricing, the cost of innovation, and healthcare spendingJiuyuan Gene’s product could become China’s first biosimilar referencing Novo Nordisk’s diabetes and weight-loss drug Ozempic (semaglutide).The European Access Academy (EAA), as part of the European Commission's HTA Stakeholder Network, has issued a commentary paper on the first Implementation Acts (IA) draft regarding the European Regulation on Health Technology Assessment (EU HTAR)
The German federal government's cabinet has approved the Medical Research Act draft with a few minor changes. Notably, the controversial move to enable confidential payment amounts for new medicines was retained in the final draftThe move on confidential prices has raised concerns. Critics from industry and insurers believe it could potentially lead to billions in extra costs every year without any added value for care. There are also fears that this could significantly increase drug prices in other European countries and add to the bureaucratic burden for insurance companiesThe AOK Federal Association has suggested having an "interim price" for medicines from the day after approval. This would replace the free list price and be retroactively set against a fixed reimbursement amount after nine months. The focus, they believe, should be on maintaining high-quality drug supply at affordable prices and not on jeopardizing proven pricing mechanisms
We are pleased to announce that NAVLIN Daily is an official media partner with the World Orphan Drug Congress (WODC) USA, taking place April 23-25, 2024, at the Boston Convention and Exhibition Center in Boston, MassachusettsThe event convenes leading pharmaceutical and biotech companies, government and regulatory authorities, patient advocacy groups, payers, investors and solution providers to meet and brainstorm ways to advance orphan drug development and improve access to life-saving therapiesAs a valued NAVLIN customer, you can use our NAVLIN50 registration discount code for an exlusive 50% discount
At Pharma USA 2024, Lukasz Jarzyna, of Alexion, worried about small U.S. payers in the cell & gene therapy space: “Maybe they have zero patients one year, maybe they have a whole family under the plan that's diagnosed,” adding that a stop loss arrangement could help Meanwhile, Medicaid Best Price complicates value-based agreements (VBAs), but the executive said work is underway to define how such agreements will functionPayers are also developing tracking systems for patients who keep switching plans since U.S. patients switch often, noted Jarzyna
In the cell and gene therapy (CGT) space, access to treatments is limited, and companies need to work harder to reach out to patient populations and gain insights while seeking ways to raise the quality of point of contact data, panelists saidIt was noted that small molecules and CGT need to be studied differently, as new and unexpected metrics are often needed for CGTFive or ten years out, long-term follow-up opportunities could look very different from existing data registries, said Jason Lott, from Bayer, who worries about duplication and a lack of economies of scale
Today, just two in ten patients have access to these therapies, lamented Cindy Perettie of Kite, Gilead, at Pharma USA 2024On the advancement of CAR T therapies, Jeff Patton of One Oncology noted, “You really need to educate payers and health systems. Tell them this is coming and this is big. I don't think they know how big it's going to be” Patton predicts that community clinics will become more proficient than academic centers at delivering CAR T care because they will see more patients
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