HTA

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The FDA's draft guidance lets sponsors add new patient-specific variants to one BLA without new trials, while CMS plans to broaden its gene therapy access model.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

A Pretoria court has declared invalid the antiretroviral tender awards for two items and ordered the health department to redo the split within 120 days. Cipla's review succeeded on all five grounds, while Hetero's challenge was dismissed with attorney-and-client costs. #SyenzaNews #SouthAfrica #HIV

Health economists in clinical trials are most useful when they join early, explain their methods in plain language and plan for the data they will need. That was the central message of a webinar brought together by University College London and the Global Health Network at the University of Oxford. A professor of health policy and systems management in Uganda moderated three panelists with trial experience across Africa and Asia. Why trials need economic questions The moderator framed the session […]