Syenza News — health technology assessment, market access and health economics

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

EMA’s safety committee has opened a Deanxit safety review at Belgium’s request, after reports of movement disorders and memory problems with the flupentixol/melitracen combination. The Belgian agency also questioned the benefit of combining the two substances. #SyenzaNews #Pharmacovigilance #EMA #MentalHealth

The FDA has granted accelerated approval to Voceryq, the first plasmid DNA-based immunotherapy in the US, for adults with recurrent respiratory papillomatosis.

Infarmed’s first Deep Dive looks at migraine medicines in Portugal. In 2025, more than 73,000 people used SNS-reimbursed migraine therapies, 85% of them women. Patients paid about €6 million (61%) of the €9.9 million pharmacy bill, and atogepant, funded only at the end of 2024, already led spending. #SyenzaNews #Migraine #MarketAccess #Portugal

MIT’s William Bonvillian opens his innovation systems course with Solow and Romer: technology drives about two-thirds of US growth, and R&D only pays off with trained talent doing it. His prospector theory has a blunt corollary for anyone fencing off talent. #SyenzaNews #InnovationPolicy #HealthEconomics #RandD

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

The Santa Maria Local Health Unit and Medtronic have signed a memorandum to create a hybrid care model that pairs in-person care with remote monitoring. Four clinical areas come first. #SyenzaNews #HealthcareInnovation #DigitalHealth

Lilly’s TRANSCEND-T2D-2 trial found retatrutide lowered A1C more than Ozempic 2 mg and produced more than double the weight loss at 80 weeks. #SyenzaNews #clinicaltrials

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