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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
Spain is planning to overhaul its current pharmaceutical regulation with a brand new Law on Medicines and Health Products (LMPS) - driven by a need to bring its system up to date, reflect on the lessons from the pandemic, and address modern healthcare challenges, the LMPS includes a very wide range of measures that have the potential to overhaul the system in a dramatic way The 160 document governs everything from research to marketing, as well as decisions for financing medicines with public funds and the new system of reference prices. Overall, it introduces 146 articles and 21 additional provisions, compared to 126 articles and 16 provisions in the previous decree - Royal Legislative Decree 1/2015 on Guarantees and Rational Use of Medicines and Health Products - which it aims to replaceThe money saved by these measures is planned to be put back into the health system, contributing to aspects such as digital health and more advanced pricing systems
The EMA's Committee for Medicinal Products for Human Use (CHMP) has recommended approval for 17 new medicines, including several for rare diseases and COVID-19 prevention - this brings the total medicines approved in 2024 to 114, up from 77 in the previous yearAmong the standout treatments, Welireg became the first approved treatment for von Hippel-Lindau disease, a rare genetic disorder. Kavigale, a monoclonal antibody, was recommended for the prevention of COVID-19 in immunocompromised adults and teenagers, while Nemluvio and Kostaive were endorsed for treatment of chronic skin conditionsAdditionally, the CHMP determined that Eli Lilly’s Mounjaro (tirzepatide) will not be reclassified as a sleep apnea treatment in Europe, noting that use in this group is “already covered by the approved indication for weight management and that a separate indication for the treatment of moderate to severe OSA in adults with obesity is not needed"
The Institute for Clinical and Economic Review's (ICER) annual Unsupported Prices Increases (UPI) report found that unsupported price hikes among just five therapies resulted in a total of $815 million incremental added costs to U.S. payers in 2023These five therapies include Biktarvy (bictegravir, emtricitabine & tenofovir alafenamide), Darzalex (daratumumab), Entresto (sacubitril/valsartan), Cabometyx (cabozantinib), and Xeljanz (tofacitinib)The 2023 report represents a decrease from last year's findings. For 2022, ICER identified eight drugs with unsupported price increases lacking new clinical evidence. These unsupported net price increases collectively resulted in an additional cost of $1.27 billion to U.S. payers in 2022
The recent 11th HTA Coordination Group (HTACG) meeting, chaired by Roisín Adams and co-chaired by Marco Marchetti and Niklas Hedberg, resulted in the adoption of nine guidance documentsThe group finalized and approved the "Annual Work Programme for 2025," defining key strategic priorities for the upcoming yearNew guidance documents include procedural instructions for Joint Clinical Assessment (JCA) and Joint Scientific Consultation (JSC) on medicinal products, as well as templates for briefing documents and scoping processes
The European Commission has issued “Procedural Guidance for Joint Clinical Assessments (JCA) of Medicinal Products”, outlining the steps for producing JCAs as per the EU Health Technology Assessment Regulation (EU HTAR)In the standard procedure, the Population/Intervention/Comparator/Outcomes (PICO) scoping phase is allocated 87 days, with 21 days specifically designated for the PICO surveyThe document states that there are no clock stops in the JCA procedure, even in cases where the indication changes
Industry stakeholders are raising urgent concerns over the limited capacity for advice meetings available to pharmaceutical companies planning their clinical trials in 2025With the implementation of the EU Regulation on Health Technology Assessment (HTA) set for January 2025, the first Joint Clinical Assessments (JCA) will be conducted, primarily focusing on new cancer treatments, cell and gene therapiesDespite supporting the goals of the EU regulation, industry leaders point out a significant shortfall. Only five to seven Joint Scientific Consultations are scheduled for 2025, which is far less than the predicted need. With an increasing influx of innovative therapies, more than 50 products are forecasted to require advice
During a webinar hosted by the Office of Healthcare Economics (OHE), experts discussed the challenges posed by current pricing models for combination therapies, particularly in cancer treatmentAstellas' Stan Jackson stressed that the industry needs to support bodies like OHE in presenting credible solutions to policymakers. Carole Longson, with experience at NICE & the ABPI, suggested the creation of a "sandbox" to explore possible solutions together and test-drive methodologiesOHE’s report, published in June, proposes a framework for pricing combination therapies using a Combination-Based Differential Pricing (CBDP) model. The framework involves scenario-based classification, flexible pricing models, and value alignment, emphasizing the importance of each component's clinical benefits and cost-effectiveness
In its final draft guidance, the National Institute for Health and Care Excellence (NICE) has recommended Eli Lilly’s Mounjaro (tirzepatide) for adults with a BMI of ≥35 kg/m² and at least one weight-related comorbidity, to manage overweight and obesity alongside diet and exercise, highlighting its clinical benefits and cost-effectiveness for this populationMounjaro, priced at £122 for four Kwikpens, is not recommended for individuals with a BMI ≥30 kg/m² due to exceeding NICE’s cost-effectiveness thresholdOver the initial three years, around 220,000 people are expected to benefit, and evidence collected during this period will guide the broader rollout to eligible patients
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