HTA

Law 3563 creates a Neuquén health technology assessment agency. Guadalupe Montero explains how it will weigh safety, benefit, equity and budget impact.

The Enzutrix patent dispute goes to South Africa's Constitutional Court on 23 November 2026. UC and Astellas are pursuing damages over the generic prostate cancer drug, while Eurolab argues the patent was never validly obtained. #SyenzaNews #MarketAccess

CMS finalizes the GLOBE Model drug pricing rule, benchmarking Medicare Part B drug rebates against international prices from April 2027. #SyenzaNews #MarketAccess

The final rule also covers a temporary price floor for small biotech drugs and Part D plan payments to dispensing entities. #SyenzaNews #DrugPricing #MarketAccess

INFARMED recommends public funding for Refixia nonacog beta pegol in children under 12 with haemophilia B, based on two single-arm trials. #SyenzaNews #MarketAccess

The G-BA has found no proven added benefit for dupilumab in chronic spontaneous urticaria, compared with omalizumab plus second-generation H1 antihistamines.

The EMA mid-year report 2026 records 485 scientific advice requests in the first half, the first joint clinical assessment under the HTA Regulation and progress on the new pharmaceutical law. #SyenzaNews #MarketAccess

The Dutch health institute Zorginstituut Nederland has concluded that a second cochlear implant for adults with severe hearing loss in both ears belongs in the basic health package. #SyenzaNews #MarketAccess

Dr. Reddy's has FDA tentative approval for generic lenacapavir HIV prevention, priced at US$40 per person per year across 120 countries. #SyenzaNews #HIVprevention #MarketAccess

Australia's PBS strategic agreements with the medicines industry expire on 30 June 2027. At a 23 October webinar, the health department, GBMA and Medicines Australia explained what the deals cover, how patients can feed in, and where industry says they have fallen short on access. #SyenzaNews #MarketAccess #HTA #PBS #Australia

The US Department of Labor has finalized its PBM fee disclosure rule. From plan years beginning on or after 1 July 2027, PBMs must disclose rebates, spread compensation, copay claw-backs and per-drug net prices to large self-insured ERISA plans, report twice a year, and accept an annual audit by an auditor the plan chooses. EBSA estimates $818.4 million a year in transfers from PBMs to plans and participants. #SyenzaNews #PBM #DrugPricing #MarketAccess

Four authors writing in The Lancet Regional Health - Europe say the Commission's MDR and IVDR simplification proposal keeps the core flaw: notified bodies still decide, one by one, whether innovative devices reach the market. They argue for an EU medical device agency with binding powers over strategy, guidance and advice. #SyenzaNews #MedTech #MedicalDevices #MarketAccess