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The Federal Joint Committee (G-BA) decided to temporarily suspend the benefit assessment for Janssen’s Carvykti (ciltacabtagene autoleucel) for its newly added indication for treating adult patients with relapsed and refractory multiple myeloma who have undergone at least one therapy and are refractory to lenalidomideThe suspension was prompted by the company's report on June 13, 2024, indicating that Carvykti sales exceeded EUR 30 million in the first quarter of 2024The temporary suspension will end no later than eight months after G-BA requests additional evidence of Carvykti's benefit compared to appropriate comparator therapies
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has authorized a new use of Novo Nordisk’s Wegovy (semaglutide): to mitigate the risk of serious heart conditions among obese adults with established heart disease, making it the first weight loss medication in the UK cleared for cardiovascular event preventionThe new approval allows for wider use of Wegovy to prevent cardiovascular incidents, including heart attacks and strokes, based on clinical data indicating a 20% fall in major adverse heart events compared to placeboWhile the National Institute for Health and Care Excellence (NICE) has yet to endorse this use of Wegovy for this inducation, NHS England's national medical director, Professor Sir Stephen Powis, has a positive outlook on the decision
The Netherlands National Health Care Institute (ZIN) has advised the Minister of Health, Welfare, and Sport (VWS) to include CSL Behring's Hemgenix (etranacogene dezaparvovec) in the basic health insurance package after price negotiations for the treatment of severe and moderate hemophilia B (congenital factor IX deficiency) in adult patients without a history of factor IX inhibitorsThe Phase 3 HOPE-B study indicated that Hemgenix significantly reduces annual bleeding events and improves quality of life compared to prophylactic treatment with coagulation factor IX concentratesThe company proposes a 10-year pay-for-performance agreement, with an annual price of EUR 280,000 per patient, 38% below the list price of coagulation factor IX concentrates. The Beneluxa assessment suggests the maximum price could be EUR 604,574 to EUR 757,302 based on negotiated prices
International interest in China, the globe’s second-largest pharma market, thrives, defying recent market setbacks like COVID-19, supply chain problems, nationally negotiated price cuts, and data security fearsWestern investors and drug companies are spurring a record tally of licensing agreements with Chinese firms, and several high-value foreign acquisitions of Chinese companies have already taken place this yearRegardless, the U.S. BIOSECURE Act, which would block Chinese biotech companies from American federal funding and U.S.-based partnerships to protect data security, is scheduled for a full house vote in the fall
During the week of July 15, 2024, over 15 treatments won regulatory approvals across the U.S., Europe, South Korea, China, Canada, and BrazilMeanwhile, just a couple companies received special designations for their products, including Sumitomo and and FutureChemNAVLIN Daily’s roundup of regulatory activity from the past week is below
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Pharmacoeconomic assessments are set to become mandatory in Saudi Arabia starting from July 2025. The Saudi Food and Drug Authority (SFDA) will require manufacturers to submit a budget-impact analysis or a type of cost analysis (-effectiveness, -minimization, -utility, or -benefit), as well as a market share and marketing plan alongside these assessmentsAdditionally, decisions made by other HTA bodies like the National Institute for Health and Care Excellence (NICE), Canada’s Drug Agency (CDA), and France’s High Health Authority (HAS) will play a significant role, as the SFDA now mandates companies to submit data from these HTA assessment bodies, with CDA being particularly influentialManufacturers must be meticulous in preparing and submitting relevant data according to these new requirements for a successful application. This is a change from the previous system, where omissions in price certificate forms could be negotiated during the appeals process to achieve a final price
Last week, the Health Committee (Bundestag) approved the Federal Government's Medical Research Act (MFG), with some amendments. The major point of contention—the proposal for confidential reimbursement amounts for new patent-protected drugs—was adjusted to clarify that only pharmaceutical companies with German research departments will qualify, drug makers have five days to choose between confidential or transparent pricing, and choosing confidentiality comes with a standardized 9% discount on the agreed priceAccording to Alan Crowther, EVERSANA's General Manager of Global Pricing, Access, and Digital Solutions, there are key implications that immediately surface, and the move signifies that "Confidentiality as an option may be increasing somewhat in health systems around the world, but at a cost to manufacturers"Read on to understand more about the consequences of this major change in Germany
The Federal Government's Medical Research Act (MFG) in Germany has been approved by the Health Committee (Bundestag), after endorsing 26 amendments proposed by the coalitionInterestingly, the contentious issue of confidential pricing for new patent-protected drugs has been revised and clarified: Only pharmaceutical companies with German research departments will qualify, drug makers have five days to choose between confidential or transparent pricing, and choosing confidentiality comes with a standardized 9% discount on the agreed priceThe final outcome of the MFG will depend on the upcoming plenary session vote
Hungary, which will hold the EU presidency from July to December 2024, will play a crucial role in implementing the European pharmaceutical legislation review and the joint EU health technology assessment (HTA) initiative. Technical discussions about the legislation resume on 3 and 4 July under the Hungarian Presidency, although some MEPs are worried about Hungary's credibility in fulfilling its role given its “lack of compliance with EU law and values and the principle of sincere cooperation"The changes, aimed for initiation in 2024, intend to reduce the protection duration from eight to six years. While countries such as Denmark, Italy, and Sweden criticized the unpredictability this creates, Spain and Portugal support a shorter duration of seven yearsThe European Commission also suggests a hybrid approach to ensure pharmaceutical companies supply the European market. The Parliament favors incentives without mandatory supply requirements, with countries like Austria supporting this model. However, Latvia supports the Commission's original proposal, arguing it considers the unique aspects of national healthcare systems, while others like Estonia and the Czech Republic express skepticism or call for a more company-led initiative
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