G-BA Assessment of Ojemda Highlights National…

Germany's Federal Joint Committee (G-BA) could not consider the final Joint Clinical Assessment (JCA) report for Ojemda because it had not been published when the German benefit assessment began, although the JCA dossier formed part of the evidence reviewedG-BA rejected Ipsen's matching-adjusted indirect comparison (MAIC) from the JCA dossier for the German benefit assessment and instead based its assessment primarily on the single-arm FIREFLY-1 study, using a newer three-year data cutAs an orphan drug, Ojemda underwent Germany's abbreviated assessment procedure; if annual sales exceed EUR 30 million, it will become subject to a standard benefit assessment

Japan CEA Review Backs Greater Manufacturer Access

A Japanese health ministry-funded research group has broadly approved its draft conclusions on technical reforms to the country’s cost-effectiveness assessment (CEA) systemThe group called for greater opportunities for manufacturers to attend CEA organization meetings and better use of an existing mechanism for considering important new evidenceA final report is expected to be submitted to the Central Social Insurance Medical Council (Chuikyo) in September, although industry representatives have called for further technical discussions

Tissue-Engineered Skin for Burns Enters JCA List

A tissue-engineered skin product for burns has entered the European Union’s joint clinical assessment (JCA) processThe product is the first tissue-engineered therapy to enter JCA and the fourth non-oncology advanced therapy medicinal product (ATMP)HAS will lead the JCA, with RIZIV-INAMI serving as co-assessor. This is the fourth JCA involving the French national HTA agency and the third involving the Belgian organization

LAST WEEK IN REVIEW

Last week, NAVLIN Daily brought you key market access developments from across the globe In the U.S., we saw scrutiny of TrumpRx’s early impact and a new bill targeting foreign drug pricing policies  Across the pond, NICE published an AI delivery plan, and France began to think about this year’s PLFSS, with CNAM suggesting €1.3 billion in savings from healthcare products

Drugmakers Already Skipping Swiss Launches Due to MFN:…

A new Interpharma survey found that drugmakers declined to seek Swiss reimbursement for seven of 22 innovative medicines and withheld three from Swissmedic approval between January 2025 and June 2026, citing U.S. MFN policyThe association said the 18-month average of 15 reimbursement submissions compares with 24 medicines submitted annually between 2019 and 2025, indicating reduced Swiss access to new therapiesInterpharma warned that proposed Health Insurance Ordinance revisions, which focus on cost containment, could further delay launches, increase price pressure and reduce clinical trials

Chinese Inter-provincial Procurement Alliance Releases…

Henan province has led an inter-provincial drug procurement round with 34 drug varieties up for bidding. A total of 130 pharmaceutical firms were selected across 269 drug specificationsThe variety groups were split into competitive high-quality drugs (Group A) and lower-priced options (Group B)The procurement batch involved 32 provinces, municipalities, and regions across China, including heavyweights like Beijing, Shanghai, and Guangdong

Outside of Weight Loss Drugs, TrumpRx Utilization…

The overall impact of TrumpRx appears limited based on the first few months of the program, according to new reporting from POLITICOAccording to a 10-Q filed by GoodRx and reviewed by POLITICO, the discount drug retailer has not noticed a material impact on its business from the programEarly demand has been concentrated in GLP-1 therapies, though GoodRx said the program’s longer-term impact remains uncertain as MFN pricing and direct-to-consumer drug access expand

LAST WEEK IN REVIEW

Last week, NAVLIN Daily brought you key market access developments from across the globeChina advanced its latest round of volume-based procurement, while Spain enacted Law 3/2026, making drug pricing and reimbursement agreements confidentialMeanwhile, South Korea introduced new drug pricing standards on August 1, lowering generic price reductions and adjusting multi-item listing rules

AIFA Says New P&R Model Cuts Average Evaluation Time…

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 12th VBP Batch Concludes, 327…

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