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A new report by the Office of Health Economics (OHE) has found that decisions made by the UK's National Institute for Health and Care Excellence (NICE) play a significant role in international health technology assessment (HTA) decision-making, but its impact varies by countryThe report, titled "Do NICE's Decision Outcomes Impact International HTA Decision-making?", analyzed the potential impact of NICE's decisions on HTA bodies in 12 countries, Australia, Brazil, Canada, France, Italy, Israel, Japan, South Korea, Poland, Saudi Arabia, Sweden, and the United Arab EmiratesOne key finding from the study is that negative decisions from NICE carry significant weight, as they can trigger heightened scrutiny of submissions to other HTA agencies. Additionally, they often exert downward pressure on prices during negotiations, even if they don't directly shape the final HTA decision
Novartis has removed Tabrecta (capmatinib) from the market in Germany due to "issues" with the AMNOG system. In February, the Federal Joint Committee (G-BA) voted that the added benefit of Tabrecta was "not proven" for treating advanced non-small cell lung cancer with specific genetic mutationsNovartis was then unable to reach an agreement with the GKV-Spitzenverband for a rebated price for Tabrecta, leading to its withdrawal from the German market. This could impact international reference pricing (IRP) practices for other countriesCurrent stocks of Tabrecta will last until around March 2024, allowing existing patients to continue their treatment. After that, the drug will be available only through named-patient schemes, requiring approval for reimbursement by health insurance funds
The Dutch Ministry of Finance is assessing the potential cost savings of broadening its international reference pricing (IRP) reference basket to encompass ten countries, and applying a rule based on the average of the three lowest-priced countries to determine the maximum drug priceCurrently, the maximum price is calculated based on the average prices in Belgium, the UK, Norway, and France. However, the change would include France, the UK, Denmark, Finland, Ireland, Norway, Austria, Sweden, Belgium, and GermanyThe potential changes are dependent on discussions following the election scheduled for November, 2023. While the proposals could save an estimated EUR 95 million per year, concerns have been raised by the Dutch Association for Innovative Medicines (VIG) about the impact on drug availability
The European Commission has approved the transfer of Strimvelis' marketing authorization from Orchard Therapeutics to the Telethon Foundation, ensuring that eligible patients with adenosine deaminase severe combined immunodeficiency (ADA-SCID) in the European Union will continue to receive the gene therapyOrchard Therapeutics had previously announced its intention to move away from gene therapy for primary immunodeficiencies, which put ADA-SCID patients at risk of losing access to treatment. The Telethon Foundation has stepped in to take on the responsibility of providing Strimvelis, despite it being a loss-making productFondazione Telethon will make Strimvelis available to eligible patients through the San Raffaele Hospital in Milan, Italy. The gene therapy, which was the first approved in the world for ex vivo gene therapy, is only approved in Europe and cannot be frozen or preserved, requiring the production site to be in close proximity to the administration site
The Dutch Association for Innovative Medicines (VIG) has strongly criticized the Ministry of Finance's latest proposals for cost-containment measures in the pharmaceutical sector, calling them a "disastrous menu of options for drug cuts”The measures, if implemented, could save the government up to EUR 1.1 billion annually, however, VIG raises concerns about patient access and the sustainability of the healthcare system“The measures lead to medicines disappearing from the market in the Netherlands and the serious risk that new medicines will no longer be offered in our country at all,” commented Wim de Haart, Health Economics and reimbursement Manager at VIG. “That's why I think political parties should scratch their heads before they consider introducing one or more of these measures”
Following a recent court ruling that annulled the 2020 Plan for the Consolidation of Therapeutic Positioning Reports (IPT), the Spanish Ministry of Health has chosen to exclude economic evaluations from its latest drug approvals, opting to comply with the court's decision while simultaneously studying ways to reintegrate the economic analysis componentThe National Court's ruling, issued in late July, came in response to an appeal by the association of the innovative pharmaceutical industry (Farmaindustria), in which the group argued that the Plan went beyond the scope of the law by regulating the procedure for the inclusion of a drug in public financing and pricing, imposing obligations that extended beyond the realm of the AdministrationFollowing the court's decision, the Ministry of Health announced that it was evaluating its response to the ruling, with the option to appeal still on the table. However, due to time constraints and the necessity of proceeding with drug approvals, certain actions couldn't be delayed
The Alliance for Regenerative Medicine (ARM) explores practical steps to improve patient access to Advanced Therapy Medicinal Products (ATMPs) in Europe through innovative contracting methods in its latest report: "Innovative Contracting for ATMPs in Europe: Recent Learning from the Manufacturer Experiences"ARM notes a rise in innovative contracting for ATMPs in Europe over the past five years and conducted interviews and workshops with industry representatives, including seven out of the ten manufacturers that obtained marketing authorization for ATMPs in Europe since 2018Challenges in health technology assessment (HTA), pricing fluctuations, and the need for early dialogues between stakeholders are key issues in the adoption of innovative contracts for ATMPs, emphasizing the importance of trust-building between payers and manufacturers for successful implementation
The new compulsory discounts in the GKV-FinStG do not consider the economic consequences and the cumulative effects of savings measures, according to the Federal Association of the Pharmaceutical Industry (BPI)The BPI argues that the GKV-FinStG also has negative effects on the security of supply for innovative medicines, especially for patients with rare diseases, and it has become a "price-setting process" dominated by statutory health insuranceThe BPI calls for subsequent adjustments to the GKV-FinStG, stating that it contradicts the goals of the federal government and has a negative impact on Germany as a location for innovation and research
Boehringer Ingelheim has withdrawn Spevigo (spesolimab) for the treatment of generalized pustular psoriasis in Germany, after the therapy's added benefit was deemed "Not Proven" by the Federal Joint Committee (G-BA)Boehringer plans to challenge the benefit assessment in court, expressing concerns that the German system could lead to a loss of competitiveness in the healthcare industry and impact patient careSpeaking to NAVLIN Daily, the company called G-BA’s decision “fundamentally flawed,” suggesting that it is “indicative of a rigid benefit assessment process that does not prioritize patient needs"
As the comment period on the effects of the GKV Financial Stabilization Act (GKV-FinStG) comes to a close, the German industry Association of Research-Based Drug Manufacturers (vfa) has once again floated concerns that the bill will lead to negative consequences for patient care and the pharmaceutical industry, with delays in introducing innovative medicines and potential job lossesThe group’s new research suggests that up to 30 products or approvals could be negatively affected by the measures in the next two yearsOverall, the vfa called the bill "alarming," adding, "It is already clear that patients in Germany will have to live with treatment restrictions in the future because medicines are withdrawn from the market or are not even brought onto the market."
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