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AIFA’s new Scientific and Economic Committee (CSE) has cut the average pricing and reimbursement evaluation period to approximately four months, according to a new reportGeneric drugs are the fastest to process (two months), while orphan medicines take the longest (11.9 months). The four-month average is weighted heavily by the high number (56%) of generic applicationsThe report states that the full P&R pathway, from procedure start to Official Gazette publication, now averages 185 days (six to seven months). Including the pre-initiation phase, it climbs to 206 days
Bidding for China’s volume-based procurement program took place at the Nanjiao Hotel in Shanghai on Friday. After initial and revival bids were placed, officials announced that 521 products from 327 companies met the preliminary qualifications to be selectedBidding was highly competitive, with “mainstream” companies that could guarantee the supply and quality of highly regarded products preferred in this year’s selectionsJiang Changsong, assistant dean of the National Institute of Healthcare Security and director of the Price and Procurement Office, believed that the optimized price mechanism may yield only moderate overall price reductions this year compared to past batches
Spain has now enacted Law 3/2026, effective August 1, making drug pricing and reimbursement agreements formally confidentialUnder the revised legislation, financing agreements between the Ministry of Health and pharmaceutical companies, information generated through their implementation, and awarded prices in public medicine supply contracts are explicitly classified as confidentialNAVLIN Daily has been covering the ongoing legislative process extensively
In a recent interview, new G-BA Chair Dr. Sonja Optendren said that Germany could consider covering weight-loss drugs "under certain conditions"Statutory health insurance providers in Germany currently do not reimburse weight loss drugs, as they fall under lifestyle medicationsIf this policy does change, Germany would be following in the footsteps of France, which became the first country in the EU to start reimbursing modern weight-loss drugs such as Ozempic and Wegovy earlier this year
Eisai has launched Leqembi (lecanemab) in India for the treatment of early Alzheimer’s disease after receiving marketing authorization from the Central Drugs Standard Control Organization (CDSCO) Leqembi is indicated for patients with Mild Cognitive Impairment (MCI) and mild dementia due to early Alzheimer’s disease The launch comes as India faces a growing dementia burden driven by an ageing population, late diagnosis, and limited awareness
Last week, NAVLIN Daily brought you key market access developments from across the globe The U.S. administration continued advancing its multi-pronged MFN drug pricing strategy, while AstraZeneca said the evolving U.S. policy has already influenced its pricing approach France strengthened its HTA framework with the launch of a new strategic center of expertise to support evolving evaluation and market access activities
The Spanish government has removed specific price-cut percentages for generics in its draft Medicines Law, leaving the upcoming Royal Decree to finalize these detailsMeanwhile, Farmaindustria and Biosim are still calling for major changes to the proposed frameworkFarmaindustria further warned that the proposed model could trigger unsustainable price erosion if competitors substantially undercut prices without the pricing bands envisaged in the draft Medicines Law, while Biosimsaid the draft should clearly distinguish between maximum reimbursed prices, notified prices, and free market prices, arguing that medicines sold outside the National Health System should generally be subject to free pricing unless explicitly regulated
Brazil's delay from marketing authorization to reimbursement for innovative drugs was 41 months, nine months longer than the Latin American average, according to this year's W.A.I.T. Indicator surveyWhile oncology drugs were the most widely available in Brazil, this therapeutic category also faced the longest delays, averaging 57 monthsThe country's healthcare system is struggling to keep up with rapid pharmaceutical innovation due to underinvestment and regulatory hurdles. However, reforms, such as CMED pricing updates and the introduction of MEAs (managed entry agreements), aim to create a more value-based access system
France's High Health Authority (HAS) has created the Methods, Europe, Data Mission (MiMED), replacing the Real-Life Data Coordination Unit (CCDVR) as a strategic center of expertise within the Directorate for Evaluation and Access to Innovation (DEAI) to support evolving health technology assessment (HTA) activitiesMiMED will support the adoption of emerging assessment approaches, including adaptive trials, single-arm studies, indirect comparisons, and biomarker-based methods, while expanding the use of real-world data from registries, cohorts, and reimbursement databases to inform HTA evaluationsMiMED will reinforce HAS's contribution to the implementation of the EU HTA Regulation (HTAR) by supporting European collaboration, enhancing methodological expertise, and helping develop future HTA standards across France and Europe
The U.S. administration continues to push forward with its multi-pronged approach to Most Favored Nation (MFN) policy, with the voluntary GENEROUS model underway and the mandatory GLOBE and GUARD awaiting potential completion at the Office of Management and BudgetMeanwhile, overseas, ex-U.S. nations pursue their own measures to combat the potential effects of MFN, such as launch delays and product withdrawalsIn a long-form interview with NAVLIN Daily, public health expert Kent McKinney, MPH, noted that "the innovation cost of MFN, if it materializes, will be quiet, distributed, and hard to attribute," adding, "That's exactly why it deserves more thoughtful consideration and an end-to-end solution designed to reward, not penalize, innovation"
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