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Eli Lilly and other pharmaceutical manufacturers intend to ask the Trump Administration to halt Medicare drug price negotiationsLilly CEO Dave Ricks told Bloomberg that the government must fix the program before negotiating the price of additional drugs.The announcement comes as the Centers for Medicare & Medicaid Services (CMS) prepares to publish its second list of prescription medications subject to negotiation under the Inflation Reduction Act (IRA) by February 1, 2025
The German Federal Ministry of Health has presented a draft amendment to the Drug Benefit Assessment Ordinance (AM-NutzenV) to integrate the EU Joint Clinical Assessment (JCA) into Germany’s AMNOG process Canada's Drug Agency (CDA) announced plans to implement additional improvements to its drug reimbursement review process - Canada’s Patented Medicine Prices Review Board (PMPRB) also published its new Draft Guidelines for public review and comment Under Japan's FY2025 off-year drug price revision, deferred price cuts will be implemented for the price maintenance premium (PMP) - this move could negatively impact some pharma companies, but MHLW official Koshin Kiyohara calls it "reasonable" and "unavoidable”
The new Health Technology Assessment Regulation (HTAR) officially came into effect on January 12, 2025, aiming to accelerate and broaden access to innovative medicines across EU countriesLast Friday, the European Medicines Agency (EMA) welcomed the regulation and expressed its readiness to support the European Commission and Member States in ensuring its successful implementationEMA will assist in three key areas: Joint Clinical Assessments (JCAs), Joint Scientific Consultations (JSCs), and information exchange on future health technologies to improve regulatory and HTA alignment
Eli Lilly's GLP-1 receptor agonist, Zepbound (tirzepatide), will be covered by Medicare for obstructive sleep apnea, according to reports from CNBCThe Centers for Medicare & Medicaid Services (CMS) made the decision after the treatment won U.S. Food and Drug Administration (FDA) approval as the first and only prescription medicine for moderate-to-severe obstructive sleep apnea in adults with obesity. Until now, the blockbuster drug has not been covered by Medicare because the federal program is prohibited from covering anti-obesity treatments, which are classified as “lifestyle drugs”However, the Biden Administration recently proposed expanding Medicare coverage of GLP-1 drugs to include the treatment of obesity. Access to these products could increase significantly if the proposal is allowed to take effect by the incoming Trump Administration
The German Federal Ministry of Health has presented a draft amendment to the Drug Benefit Assessment Ordinance (AM-NutzenV) to integrate the EU Joint Clinical Assessment (JCA) into Germany’s AMNOG processThe Federal Joint Committee of Germany (G-BA) will have the authority to suspend national benefit assessments for up to three months if JCA reports are delayed, ensuring alignment with EU-level findings while maintaining efficiency and timely market availabilityEffective from January 12, 2025, the EU HTA regulation will initially apply to new marketing authorization applications for medicinal products containing new active ingredients used in cancer therapy or Advanced Therapy Medicinal Products (ATMPs). By 2028, this will extend to orphan drugs, with full implementation for all new medicines by 2030
We are pleased to announce that NAVLIN Daily is an official media partner with 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 biosimilarsNAVLIN 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
Weeks after the preliminary results were determined for China’s 10th national volume-based procurement (VBP) round, the winning contracts have been finalized Through the end of 2027, the 10th VBP has tasked nearly two hundred companies with distributing products worth a combined value of USD 178 millionThe companies that scored the highest number of bids were CSPC and Brilliant Pharma which both won 15 bids, and Hebei Tiancheng Pharmaceutical Co., Ltd won the most funds, totaling RMB 80 million
Sweden’s Dental and Pharmaceutical Benefits Agency (TLV) is rolling out strategies to expand access to medicines for patients with rare and severe health conditionsMeasures include accepting higher costs for medicines, and implementing a "staircase model" to progressively determine acceptable incremental cost-effectiveness ratios (ICER) based on the rarity of the condition“It may be reasonable to accept a higher cost,” says Agneta Karlsson, Director General of TLV. “It is therefore also reasonable that we accept a lower cost of medicines for many patients, who sell for large amounts"
From January 2025, pharmaceutical companies in Germany can request confidential reimbursement amounts for their products, under the Medical Research Act (MFG)Only four groups can request details about these confidential reimbursements: hospitals and their overseers, legal entities that buy the medicinal product, pharmaceutical importers, and companies applying for approval of a generic drug. These claimants can access the information after registering and completing a specific processAccess to these confidential reimbursement amounts varies per claimant group, with full access granted to groups 1 and 3, while groups 2 and 4 have access under certain conditions - full details have been published by GKV-Spitzenverband
The UK Department of Health and Social Care (DHSC) has announced that in 2025, pharmaceutical companies will face a 22.9% payment on eligible sales of new medicines under the 2024 Voluntary Scheme for Branded Medicines Pricing, Access, and Growth (VPAG) - a substantial increase from the 2024 rateAccording to the DHSC, the increase is due to growth in sales, a calculated underpayment of £373 million from 2024, and policy adjustments. The higher payment payment percentage for 2025 could potentially discourage investment in the UK market, but companies have yet to react to the newsThe DHSC has published a document detailing how the new level was calculated
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