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The draft law on the 2024 Social Security Finance Bill (PLFSS), which aims to strengthen France’s health system, has been presented to the Council of Ministers in France. It will now be forwarded at the latest by October 15 to the National Assembly, where the parliamentary vote on it will begin The Swiss Federal Council has approved revisions to the Health Insurance Ordinance (KVV), the Health Insurance Benefits Ordinance (KLV), and the Medicines Ordinance (DSO), to be implemented on January 1, 2024 Japan has become the second country to approve Eisai & Biogen's Leqembi (lecanemab) as a treatment for mild cognitive impairment and mild dementia due to Alzheimer's disease, based on positive Phase 3 trial results
The draft law on the 2024 Social Security Finance Bill (PLFSS), which aims to strengthen the country's health system, has been presented to the Council of Ministers in France. It will now be forwarded at the latest by October 15 to the National Assembly, where the parliamentary vote on it will beginThe PLFSS "simplifies and harmonizes" the method of calculating the safeguard clause, but to stabilize the sector's contribution to overall savings companies will be asked to accept price reductions totaling EUR 1 billion, with EUR 850 million for pharmaceuticalsAccording to the draft, the early access and compassionate access scheme will be adjusted to further improve patient access to innovative treatments, while respecting the “requirements of health and financial sustainability”
The Swiss Federal Council has approved revisions to the Health Insurance Ordinance (KVV), the Health Insurance Benefits Ordinance (KLV), and the Medicines Ordinance (DSO), to be implemented on January 1, 2024The revised ordinances encourage the use of generics and biosimilars and support “process optimization.” The amendments also focus on Article 71, through which products for rare disease outside the government’s positive reimbursement list may be individually reimbursed when no other equivalent is listedFurther, to accelerate listing on the positive reimbursement list with pharmaceutical prices, companies may now file for market authorization at Swissmedic and reimbursement and pricing at Federal Office of Public Health (BAG) simultaneously, if the product meets a high unmet medical need
Japan has become the second country to approve Eisai & Biogen's Leqembi (lecanemab) as a treatment for mild cognitive impairment and mild dementia due to Alzheimer's disease, based on positive Phase 3 trial resultsEisai will conduct a post-marketing study and work with physicians to manage amyloid-related imaging abnormality (ARIA) in patients who receive LeqembiLeqembi is the first approved anti-amyloid Alzheimer's disease treatment in Japan that reduces disease progression and slows cognitive impairment in the early and mild dementia stages. It is also under regulatory review in the EU, the UK, and other markets
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
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