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Germany's newly passed Medical Research Act (MFG) has removed a requirement for pharmaceutical companies to disclose actual sales prices in other European countries – essentially ending the practice of International Reference Pricing (IRP) in GermanyA passage in the MFG states, "Due to the elimination of the obligation to transmit the actual sales prices in other European countries as part of the negotiation of the reimbursement amount for a medicinal product, pharmaceutical companies are slightly relieved of their administrative burden"Germany used IRP as a complementary tool, rather than a primary determinant for setting prices. While Germany did not directly set prices based on IRP, the actual sales prices of medicines in other European countries were considered during reimbursement negotiations
Roche's Alecensa (alectinib) has received a "major" rating from the Federal Joint Committee (G-BA) for the treatment of a subgroup of patients with ALK-positive non-small cell lung cancer (NSCLC) at high risk of recurrence, making it the first drug of the year to earn this ratingFor patients who had already received or were ineligible for platinum-based chemotherapy, the G-BA found no evidence to demonstrate Alecensa's additional benefit, concluding it as "not proven" In its appraisal document, G-BA noted the list price of Alecensa (150 mg) is priced at EUR 5,636.86, following statutory discounts.
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"
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