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The French Association of Generic Medicines (GEMME) has criticized a proposal in France's 2025 Social Security Financing Bill (PLFSS) that triples the safeguard clause targeting the generics industry, which could exacerbate already challenging financial conditionsGEMME worries that the proposed increases could threaten the viability of hundreds of medications, lead to production stoppages, and fuel market instability. Additional concerns stem from stricter penalties for non-compliance with stock security requirements, especially for older, low-cost drugs that have a high therapeutic valueTo address the potential issues for the generics industry, GEMME proposes boosting the generics market by 10%, using more biosimilar medicines, expanding hybrid medications, and accelerating approval timelines
Korea’s Health Insurance Review & Assessment Service (HIRA) Cancer Review Committee decided to establish a new method for reviewing combinations of new and already-listed therapies Speaking at EPP’s Life Science Pricing Forum in Berlin, Natalie Mochova, Strategic Partner Manager at Zentiva, discussed the challenges generic products face when undergoing international reference pricing (IRP) in the digital era The UK's Department for Science, Innovation and Technology has launched the Regulatory Innovation Office (RIO) as part of the Labour government's promise to modernize regulations and speed up approvals
The French government has proposed EUR 1 billion in drug price cuts and maintained a clawback cap at EUR 1.6 billion in its draft Social Security Finance Bill (PLFSS) for 2025A revised method for calculating clawback to increase transparency has also been proposed. This mechanism, known as the “safeguard clause (Contribution M)," will now be based on the amount reimbursed by the public health insurance system (Assurance Maladie) rather than total sales figures. Additionally, the clause will be set at a trigger level of EUR 23.3 billionDespite these cost containment measures, the French Pharmaceutical Association (LEEM) has expressed concern that the lowered drug prices combined with financial stress on manufacturers could lead to a shortage of drugs. They believe this could undermine the entire pharmaceutical value chain, from R&D to production, and limit access to treatments and innovations
Japan's Central Social Insurance Medical Council (Chuikyo) has agreed on a general policy for the pricing and post-launch adjustments of Eli Lilly’s Kisunla (donanemab)The Ministry of Health, Labor and Welfare (MHLW) presented the proposal, suggesting that Kisunla shares many similarities with Leqembi in terms of action, structure, and administration - under the plan, Kisunla will follow existing pricing methods, such as the comparator or cost-based method, and the same post-launch re-pricing system applied to Leqembi will be usedThe cost-effectiveness assessment (CEA) rules for Kisunla will also mirror those for Leqembi. Three pricing scenarios were considered, depending on whether Kisunla receives a usefulness premium and the chosen pricing method
The Centers for Medicare & Medicaid Services (CMS) released a sample list of prescription generic drugs that the agency preliminarily intends to include under the proposed Medicare $2 Drug List Model, which is intended to allow Medicare Part D enrollees access listed drugs for a fixed copayment of no more than $2 for a month’s supply per drugThe sample list published by CMS includes 101 drugs covering therapeutic uses across 15 clinical categories, with a focus on drugs that represent a large proportion of Part D generic drug utilization The agency also issued a Request for Information (RFI) to gather stakeholder feedback on the preliminary list. Responses are due December 9, 2024
Speaking at EPP’s Life Science Pricing Forum in Berlin, Germany, Sandro Cesaro, Head of Market Access & Innovative Value Strategies, Oncology Europe & Canada, AstraZeneca, explored uses of machine learning in market accessHe highlighted two specific uses for AI in oncology, the first of which is using AI to predict which lung cancer patients will most benefit from immunotherapy. The second is for predicting the risk of severe COVID-19 infection in immunocompromised cancer patients, to enable targeted prevention strategiesCesaro sees great potential in using AI in these areas, but echoing the wider consensus across the conference, he adds that while AI can process large amounts of data quickly, human curation is still necessary to achieve high levels of accuracy, especially in tasks like meta-analysis and processing HTA documents
Germany's Federal Ministry of Health (BMG) has issued guidance on discounts for combination drugs that contain new compounds, nearly two years after the original law was passed The GKV Financial Stabilization Act requests a flat 20% rebate, unless the combination provides significant added medical benefit. The regulations come into force on October 10, 2024.The German Association of Research-Based Pharmaceutical Companies (vfa) has criticized the new discount, calling it a "flawed design." The group claims its implementation will cause issues for diseases that need combination therapy, such as cancer or HIV. However, GKV-SV supports it, stating that only a few combinations offer significant added benefit
GSK Pharma plans to enter the oncology market in India by launching two high-value therapies, moving beyond its traditional offerings in general medicine, according to Managing Director Bhushan Akshikar in an exclusive interview with Time of India (TOI)The company also plans to broaden its focus on preventive healthcare by introducing more vaccines for adults. They have emphasized on innovation at scale, with cores therapies continuing to provide benefits to millions of IndiansAkshikar, talking about pricing, told TOI, "We’ve always implemented tiered pricing in India and will continue to pursue locally relevant pricing models." He pointed out that while they operate in commoditized categories, such as paracetamol, they maintain high-quality standards comparable to global benchmarks
The Scottish Medicines Consortium (SMC) has approved five new medicines for use in Scotland, following its latest meetingThis month saw the approval of Nexpovio (selinexor), Keytruda (pembrolizumab), Orgovyx (relugolix), Rezzayo (rezafungin acetate) and Vabysmo (faricimab)Following the meeting, SMC Chair Dr Scott Muir said the committee is "pleased to be able to accept these new medicines for use by NHSScotland," adding “Selinexor offers an additional treatment option for patients with multiple myeloma, allowing more personalised treatment. Pembrolizumab will provide a treatment for people who have had surgery to remove lung cancer but are at a high risk of the cancer coming back.”
Frontiers Health 2024, powered by EVERSANA, lands in Berlin at the bcc Berlin Congress Center on October 17-18! Jim Lang, CEO, Alan Crowther, NAVLIN General Manager, and Mike Ryan, General Manager in Europe, will be among EVERSANA's speakers at the eventThe event is a great platform for attendees to connect and discuss the latest innovations and trends in healthcare, with a promise of potential collaborations and investment opportunities. A primary focus of Frontiers Health is the significance of AI and other technologies in revolutionizing healthcare, from wearable devices to remote diagnosticsRegister now, using the code FHEVS20 to save 20%!
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