HTA

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The FDA's draft guidance lets sponsors add new patient-specific variants to one BLA without new trials, while CMS plans to broaden its gene therapy access model.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

New drug launch prices are still high. ICER's 2026 Launch Price and Access Report finds the median net price for 2025 approvals was about $257,000, and only about one in three new prescriptions was filled within 30 days. #SyenzaNews #MarketAccess #HEOR

The National Health Council says importing foreign price controls through most favored nation pricing will not serve American patients.

Insulin analogue cost-effectiveness studies for adults with type 1 diabetes mostly point the same way: the newer products usually come out ahead of human insulin. A new systematic review says that headline rests on thinner ground than it looks. The paper, by Shiwa Yaghoubi Bina, Steve Njokuocha and the T1D Economic Evidence Synthesis Group, has been accepted for Value in Health. The version available now is a pre-proof, so figures could still change at copyediting. The World Health Organization funded […]

Health security in Europe is being redefined from emergency response to national resilience, and the EFPIA View argues it starts with funded health systems.