HTA

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

Portugal's outpatient medicine bill rose 7.9% in January to August 2026. Antidiabetics drove nearly a third of the increase, and semaglutide spend rose 54.5%. #SyenzaNews #MarketAccess #HealthEconomics

The FDA's draft guidance lets sponsors add new patient-specific variants to one BLA without new trials, while CMS plans to broaden its gene therapy access model.

Novartis core operating income rose 10% at constant exchange rates in Q3 2026, and 2026 guidance for the measure was raised. #SyenzaNews #MarketAccess

Portaria n.º 464/2026/1 limits state reimbursement for obesity medicines to SNS patients in a hospital obesity pathway. Cover is 15% for 12 months. #SyenzaNews #MarketAccess