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

G-BA divided belantamab mafodotin into four myeloma patient groups and found added benefit in only one. #HTA #EvidenceSynthesis https://www.mattheneus.com/editorial/g-ba-belantamab-mafodotin-bortezomib-dexamethasone-dreamm7-resolution-2026-10-01

Only complete pathologic response cleared the individual-level surrogacy threshold in pancreatic cancer.

https://www.mattheneus.com/editorial/pubmed-pancreatic-cancer-progression-free-survival-individual-level-surrogacy-threshold-2026-10-01

#HTA #EvidenceSynthesis

HAS rates zilucoplan prefilled pens ASMR V: no clinical added value over existing syringes.

https://www.mattheneus.com/editorial/has-zilbrysq-zilucoplan-prefilled-pen-asmr-v-restricted-reimbursement-2026-10-01

#HTA #RegulatoryAffairs #Pharma

FDA approves lirafugratinib on single-arm response-rate evidence, leaving HTA bodies to value a therapy with no comparative arm. https://www.mattheneus.com/editorial/fda-lyrfigtu-lirafugratinib-fgfr2-priority-review-approval-refocus-single-arm-2026-10-01 #HTA #RegulatoryAffairs

The #Beneluxa Initiative welcomes two new #JCA reports prepared by #NCPE, together with #IQWiG on tarlatamab (IMDYLLTRA) and #HAS on onasemnogene abeparvovec (ITVISMA). 📚 We invite respective companies to submit for national #HTA, as the reports will contribute to evidence-based decision-making.

Rwanda triaged 136 cancer interventions to decide which ones actually needed a new cost-effectiveness model. https://www.mattheneus.com/editorial/adaptive-health-technology-assessment-decision-risk-chart-benefits-package-2026-10-01 #HTA #HealthEconomics #RWE

A Brazilian expert panel split equity and acceptability into two separate evidence jobs.
https://www.mattheneus.com/editorial/brazil-hta-equity-acceptability-delphi-consensus-evidence-strategy-2026-09-30
#HTA #EvidenceSynthesis #HealthEconomics

SMC accepts perioperative pembrolizumab in head and neck cancer; the multistate extrapolation carries the uncertainty. https://www.mattheneus.com/editorial/smc-pembrolizumab-keytruda-resectable-head-neck-acceptance-multistate-extrapolation-2026-09-07 #HTA #HealthEconomics

What a health technology assessment system looks like before it has local utilities or a willingness-to-pay threshold: Jordan.
https://www.mattheneus.com/editorial/jordan-health-technology-assessment-barriers-local-utilities-willingness-to-pay-threshold-2026-09-30
#HTA #HealthEconomics

96 trials in one network, and only one digital sleep therapy clears the clinical threshold.
https://www.mattheneus.com/editorial/pubmed-digital-therapeutics-sleep-quality-network-meta-analysis-mcid-2026-09-30
#HTA #NMA #EvidenceSynthesis

MHRA opens its 14-day assessment route to more Phase 1 patient studies, reshaping early UK trial timelines. https://www.mattheneus.com/editorial/mhra-14-day-assessment-stepwise-implementation-phase-1-eligibility-expansion-2026-09-30 #HTA #RegulatoryAffairs

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