Germany found a small added benefit for Zynyz in first-line anal cancer. Here is what the final G-BA resolution means. https://www.mattheneus.com/editorial/g-ba-retifanlimab-anal-cancer-small-added-benefit-podium303-final-resolution-2026-10-01 #HTA #RegulatoryAffairs #Pharma

One fluoxetine outlier distorted two Lancet networks. A three-analysis reappraisal shows why trial influence matters. https://www.mattheneus.com/editorial/pubmed-fluoxetine-paediatric-depression-outlier-trial-nma-reappraisal-2026-10-02 #HTA #NMA #EvidenceSynthesis #Pharma

Disability equity claims need subgroup cost-effectiveness evidence. Five scenarios show why the details matter. https://www.mattheneus.com/editorial/qaly-disability-subgroup-cost-effectiveness-equity-file-2026-09-28 #HTA #HealthEconomics #EvidenceSynthesis

A regulatory sandbox application starts with a testable evidence plan and clear learning goals. #HTA #RegulatoryAffairs https://www.mattheneus.com/editorial/european-regulatory-sandbox-evidence-plan-entry-transition-2026-10-02

Germany’s Zynyz appraisal shows how uncertainty can leave added benefit unquantifiable. #HTA #Pharma https://www.mattheneus.com/editorial/g-ba-zynyz-merkel-cell-carcinoma-added-benefit-unquantifiable-2026-10-01

AI in lung cancer radiology is advancing faster than its comparative evidence base. #HTA #EvidenceSynthesis https://www.mattheneus.com/editorial/iqwig-lung-cancer-ai-radiology-final-report-evidence-gap-2026-10-01

#ETUDESANTEDUSOIR
Les boissons sucrées comme les sodas et les boissons sportives, dès l'enfance, augmentent fortement le risque de #HTA à l'âge adulte contrairement aux fruits frais qui réduisent ce risque
Par @hsph.harvard.edu & @utoronto.ca
buff.ly/e5eTTzx

Denmark issues new CTIS submission guidance for complex clinical trials and seasonal vaccine studies. #HTA #RegulatoryAffairs #Pharma https://www.mattheneus.com/editorial/danish-medicines-agency-complex-clinical-trial-seasonal-vaccine-ctis-guidance-2026-10-02

EMA sets 2026 year-end submission dates for Type I variations, helping regulatory teams plan upcoming filings. #HTA #RegulatoryAffairs #Pharma https://www.mattheneus.com/editorial/ema-type-i-variation-end-year-submission-dates-2026-10-01

Preregistration is moving to the centre of credible real-world evidence, with change histories making analytical decisions auditable. https://www.mattheneus.com/editorial/joint-rwe-transparency-statement-preregistration-change-history-2026-09-29 #HTA #RWE #RegulatoryAffairs

Sweden’s Alhemo decision shows how HTA can reconcile a difficult bleeding endpoint with cost evidence. https://www.mattheneus.com/editorial/tlv-alhemo-concizumab-haemophilia-b-explorer8-cost-comparison-2026-10-02 #HTA #HealthEconomics #Pharma

Germany’s G-BA found Lynkuet’s added benefit unproven in both menopause subgroups. Read the final resolution: https://www.mattheneus.com/editorial/g-ba-lynkuet-oasis3-final-resolution-2026-10-01 #HTA #RegulatoryAffairs #Pharma

Fourteen social-science approaches expand how HTA teams assess uncertainty and support implementation. https://www.mattheneus.com/editorial/social-science-uncertainty-method-selection-hta-policy-implementation-2026-10-02 #HTA #EvidenceSynthesis #HealthEconomics

AI in older-adult care needs measured technology costs before its value case can be trusted. #HTA #HealthEconomics #RWE https://www.mattheneus.com/editorial/ai-older-adult-care-economic-evaluation-cost-validation-gaps-2026-10-01

Global regulators are aligning on non-animal evidence and batch release, with practical implications for medicines development. #HTA #RegulatoryAffairs #Pharma https://www.mattheneus.com/editorial/mhra-icmra-non-animal-methods-batch-release-global-statement-2026-10-01

Sweden’s Jaypirca decision shows how unanchored MAIC and Bayesian network analysis can shape CLL access. #HTA #MAIC #NMA #EvidenceSynthesis https://www.mattheneus.com/editorial/tlv-jaypirca-pirtobrutinib-cll-unanchored-maic-bayesian-nma-cost-comparison-2026-09-30

UK approval extends Ocrevus access to children with relapsing-remitting multiple sclerosis. https://www.mattheneus.com/editorial/mhra-ocrevus-paediatric-rrms-access-work-sharing-operetta2-2026-09-21 #HTA #RegulatoryAffairs #Pharma

A new tutorial brings model-form uncertainty into observational cost-effectiveness analysis with nonparametric regression. https://www.mattheneus.com/editorial/nonparametric-regression-observational-cost-effectiveness-model-form-2026-10-01 #HTA #RWE #HealthEconomics

Sweden raised Rectogesic’s reimbursed price by 60.6% to protect supply continuity. https://www.mattheneus.com/editorial/tlv-rectogesic-price-increase-supply-continuity-gross-margin-2026-10-01 #HTA #Pharma #HealthEconomics

AOTMiT rejected Wegovy reimbursement despite cost-utility results below Poland's statutory threshold, citing a programme population mismatch. #HTA #HealthEconomics https://www.mattheneus.com/editorial/aotmit-wegovy-obesity-programme-population-mismatch-budget-rejection-2026-10-01