EMA's women's health workshop set out ten priority actions, with sex-disaggregated data reporting at the centre. https://www.mattheneus.com/editorial/ema-womens-health-workshop-ten-priority-actions-sex-disaggregated-data-2026-09-30 #HTA #RegulatoryAffairs

Regulators and payers endorsed hierarchical composite endpoints in infectious disease trials, then split on tiebreakers. https://www.mattheneus.com/editorial/hierarchical-composite-endpoint-infectious-disease-regulatory-reimbursement-acceptability-2026-09-30 #HTA #EvidenceSynthesis

TLV has added subcutaneous Phesgo to Sweden's benefits scheme for early and metastatic HER2+ breast cancer, leaning on APHINITY and CLEOPATRA. https://www.mattheneus.com/editorial/tlv-phesgo-subcutaneous-her2-breast-cancer-benefits-inclusion-aphinity-cleopatra-2026-09-30 #HTA #HealthEconomics

Sweden's TLV extends Kerendia (finerenone) reimbursement to heart failure with LVEF 40% or higher, broadening access beyond CKD. https://www.mattheneus.com/editorial/tlv-kerendia-finerenone-heart-failure-lvef-40-reimbursement-extension-2026-09-28 #HTA #HealthEconomics

Trajectories or transition probabilities? The engine choice decides what a therapy-sequence ICER can represent. https://www.mattheneus.com/editorial/ehr-microsimulation-trajectory-multistate-therapy-sequence-cost-effectiveness-2026-09-30 #HTA #HealthEconomics #RWE

A returning PBAC submission is priced against its own prior recommendation, a pattern consistent enough to plan for. https://www.mattheneus.com/editorial/pbac-repeat-submission-prior-recommendation-price-justification-pattern-2026-09-30 #HTA #RegulatoryAffairs

EU expert panel wants comparative studies on magnesium-alloy bioabsorbable bone screws: alloy equivalence cannot be assumed across devices. https://www.mattheneus.com/editorial/european-commission-expert-panel-magnesium-alloy-bioabsorbable-screws-alloy-equivalence-2026-09-29 #HTA #RegulatoryAffairs

Germany has cleared secondary use of cervical screening programme data to study why participation lags. Registry access as evidence infrastructure. https://www.mattheneus.com/editorial/g-ba-cervical-screening-secondary-data-use-approval-participation-2026-09-24 #HTA #RWE #EvidenceSynthesis

EU expert panel demands comparative studies on magnesium-alloy bioabsorbable bone screws before alloy equivalence claims. #HTA #RegulatoryAffairs https://www.mattheneus.com/editorial/european-commission-expert-panel-magnesium-alloy-bioabsorbable-screws-alloy-equivalence-2026-09-29

Germany's G-BA approves secondary use of cervical screening data for a participation study — a notable step for real-world data access policy. #HTA #RWE #HealthEconomics https://www.mattheneus.com/editorial/g-ba-cervical-screening-secondary-data-use-approval-participation-2026-09-24

Australia's reimbursement committee flags three cancer trials where overall survival data moved after listing. https://www.mattheneus.com/editorial/pbac-overall-survival-monitoring-system-cancer-medicines-red-alert-trials-2026-09-29 #HTA #RWE #HealthEconomics

Rozanolixizumab now sits beside efgartigimod and immunoglobulin in myasthenia gravis, but anchored and unanchored adjustments differ in weight. https://www.mattheneus.com/editorial/pubmed-rozanolixizumab-fcrn-anchored-unanchored-population-adjustment-evidence-2026-09-29 #HTA #MAIC #EvidenceSynthesis

Queensland DCEA: diabetes screening yields 8562 QALYs of inequality reduction; the leading treatment, 514. https://www.mattheneus.com/editorial/queensland-inequality-impact-calculator-aggregate-distributional-cost-effectiveness-2026-09-29 #HTA #HealthEconomics

EU proposes a Council Recommendation on cardiovascular health checks, putting screening yield and budget impact on the evidence agenda. https://www.mattheneus.com/editorial/european-commission-cardiovascular-health-checks-council-recommendation-2026-09-28 #HTA #HealthEconomics

GB would get enabling powers for its own device licensing route under Health Bill amendments. https://www.mattheneus.com/editorial/mhra-health-bill-amendments-device-licensing-information-sharing-2026-09-01 #HTA #RegulatoryAffairs

Australia's first COCOON carer value set ranks financial burden above physical health, reshaping carer QoL in economic evaluation. https://www.mattheneus.com/editorial/cocoon-carer-value-set-australia-financial-burden-economic-evaluation-2026-09-29 #HTA #HealthEconomics

Scientific innovation alone does not guarantee patient access.

HTA is where clinical evidence, patient value, economics, and healthcare-system priorities come together to inform access decisions.

#MedicalAffairs #HTA

Clone every patient into every strategy, then censor and weight: it is how treatment-timing comparisons keep index dates aligned and avoid immortal time. https://www.mattheneus.com/editorial/clone-censor-weight-treatment-timing-index-date-alignment-2026-09-28 #HTA #RWE #EvidenceSynthesis

FDA approves apitegromab as an add-on in nonambulatory spinal muscular atrophy: the SAPPHIRE evidence lineage now has to carry an add-on question through HTA. https://www.mattheneus.com/editorial/fda-apitegromab-isembyld-nonambulatory-sma-add-on-approval-sapphire-2026-09-28 #HTA #RegulatoryAffairs

Poland's AOTMiT opens a seven-day tariff consultation on robotic and laparoscopic radical prostatectomy. https://www.mattheneus.com/editorial/aotmit-robotic-surgery-laparoscopic-prostatectomy-device-cost-tariff-consultation-2026-09-28 #HTA #HealthEconomics #RegulatoryAffairs