Syenza News — health technology assessment, market access and health economics
Labor Department Finalizes PBM Fee Disclosure Rule for Large Self-Insured Plans
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
Recent Posts
Lancet Authors Make the Case for an EU Medical Device Agency
Oct 30
Hybrid healthcare hub in Portugal: ULSSM, Medtronic join forces
Oct 29
Retatrutide Head-to-Head Trial Shows Greater A1C Cut Than Ozempic
Oct 29
Portugal Outpatient Medicine Spend Rises 7.9%, Led by Diabetes Drugs
Oct 29
Orphan Medical Devices Pilot Closes With 13 Positive Status Opinions
Oct 28Syenza's Top Picks
Emvistegrast in ulcerative colitis hits Phase 2 primary endpoint
Oct 20, 2026
FDA Launches Neuroscience Medical Product Development Program
Oct 23, 2026
Clinical AI governance framework guides AI tool evaluation
Oct 23, 2026
Palbociclib Maintenance in HER2-Positive Breast Cancer: EMA Withdrawal
Oct 23, 2026
Health Economists in Clinical Trials: Why Early Engagement Matters
Oct 22, 2026
New Drug Launch Prices Stay High While Patients Wait for Access
Oct 21, 2026
Latest News
Europe Free account
EMA Expert Panel Advice Pilot Ends With a Streamlined 60-Day Procedure
EMA’s expert panel advice pilot for high-risk medical devices closed in February 2026 with 27 advice procedures finalised. Average advice time fell from 112 days in phase one to 86 in phase two, and a 60-day procedure followed. #SyenzaNews #MedicalDevices #HTA #MarketAccess
Diseases
Individualised gene therapies for rare diseases: FDA draft guidance
The FDA’s draft guidance lets sponsors add new patient-specific variants to one BLA without new trials, while CMS plans to broaden its gene therapy access model.
Clinical Practice
KRAS G12C inhibitor divarasib outperforms approved drugs
The KRAS G12C inhibitor divarasib improved survival versus sotorasib or adagrasib in the phase III Krascendo 1 trial. #SyenzaNews #oncology #NSCLC
Europe
Novartis core operating income rises, 2026 outlook raised
Novartis core operating income rose 10% at constant exchange rates in Q3 2026, and 2026 guidance for the measure was raised. #SyenzaNews #MarketAccess
Clinical Practice
Izalontamab brengitecan breast cancer: 59% lower risk of progression
Phase 3 PANKU-Breast01 data show izalontamab brengitecan cut the risk of disease progression or death by 59% versus chemotherapy in HR-positive, HER2-negative breast cancer. #SyenzaNews #breastcancer #oncology
Clinical Practice
Keytruda Monotherapy Endometrial Cancer: 43% Risk Reduction
Keytruda monotherapy cut the risk of progression or death by 43% against platinum chemotherapy in dMMR endometrial cancer, in the KEYNOTE-C93 Phase 3 trial. #SyenzaNews #oncology #precisionmedicine #endometrialcancer
Europe
Endometriosis and fibroid tablets in England: prescriptions soar
NHS use of NICE-recommended endometriosis and fibroid tablets in England more than tripled in a year, from 1.2 million to 3.7 million tablets. #SyenzaNews #MarketAccess
Clinical Practice
JNJ-6143 prostate cancer: 75% tumor response in Phase 1 trial
JNJ-6143, an investigational first-in-class oral molecule, produced a 75% tumor response rate among patients with measurable disease in a Phase 1 study. #SyenzaNews #prostatecancer #oncology
Clinical Practice
Claudin 18.2 antibody-drug conjugate prolongs survival in gastro-oesophageal cancer
Sone-Ve doubled median overall survival versus investigator’s choice in third-line and later gastro-oesophageal cancer; second-line PFS missed significance.
Diseases
Obesity drug reimbursement in Portugal: new SNS terms
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
Value Science Weekly
The week in health technology assessment, market access and health economics — what moved, and what it means.
