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

Poland's AOTMiT refuses reimbursement for oral edaravone imported for amyotrophic lateral sclerosis. https://www.mattheneus.com/editorial/aotmit-radicut-edaravone-oral-suspension-als-targeted-import-non-recommendation-2026-09-28 #HTA #RegulatoryAffairs #HealthEconomics

Fibromyalgia trials measure pain with too many different instruments to compare, so which one should a protocol pre-specify? https://www.mattheneus.com/editorial/fibromyalgia-patient-reported-instrument-fragmentation-trial-comparability-2026-09-28 #HTA #EvidenceSynthesis #RWE

Seventy-one trials, and activity interventions for older adults still have no stable quality-of-life ranking. https://www.mattheneus.com/editorial/pubmed-older-adults-activity-interventions-quality-of-life-bayesian-network-meta-analysis-2026-09-28 #HTA #NMA #EvidenceSynthesis

HeartX Announces 2026 Accelerator Participants - Five Innovative Startups Selected #USA #Fayetteville #HeartX #MedAxiom #HTA

Which registries can support evidence planning in non-muscle-invasive bladder cancer? A German review found two active studies. #HTA #RWE #EvidenceSynthesis https://www.mattheneus.com/editorial/iqwig-non-muscle-invasive-bladder-cancer-registry-search-2026-09-28

How much could withdrawing heart-failure therapy after AF remission change five-year costs? #HTA #HealthEconomics #Pharma https://www.mattheneus.com/editorial/withdraw-af-heart-failure-therapy-withdrawal-cost-minimisation-2026-09-27

Four coverage cases reveal what behavioural interventions need for reimbursement across cost, engagement and scalability. https://www.mattheneus.com/editorial/behavioural-intervention-coverage-cost-engagement-scalability-2026-09-28 #HTA #HealthEconomics

Denmark’s medicines agency sets a 28 September cutover for Europe’s new clinical-trial safety reporting module. https://www.mattheneus.com/editorial/danish-medicines-agency-ctis-annual-safety-report-module-cutover-2026-09-28 #HTA #RegulatoryAffairs #Pharma

PBAC recommends Clozaril orally disintegrating tablets across five strengths, expanding formulation choice. https://www.mattheneus.com/editorial/pbac-clozaril-orally-disintegrating-tablets-five-strengths-listing-2026-08-21 #HTA #Pharma #RegulatoryAffairs

Utility mapping can fail exactly where accuracy matters most for survivors in poor health. https://www.mattheneus.com/editorial/gynaecological-cancer-eq5d-mapping-low-utility-accuracy-2026-09-27 #HTA #HealthEconomics #EvidenceSynthesis

Health-state mapping can be least accurate where decisions are most sensitive: survivors in the poorest health. https://www.mattheneus.com/editorial/gynaecological-cancer-eq5d-mapping-low-utility-accuracy-2026-09-27 #HTA #HealthEconomics #EvidenceSynthesis

How much does a complication advantage drive value? Tubular lumbar decompression stayed cheaper even after that advantage disappeared. #HTA #HealthEconomics https://www.mattheneus.com/editorial/lumbar-decompression-cost-effectiveness-complication-threshold-model-2026-09-27

Zero eligible trials can still guide policy. Germany’s colorectal screening review maps a critical evidence gap. https://www.mattheneus.com/editorial/iqwig-colorectal-screening-age-interval-zero-trial-model-2026-04-15 #HTA #EvidenceSynthesis #HealthEconomics

Can bedtime dosing improve hypertension outcomes? A five-trial network meta-analysis offers an exploratory ranking. https://www.mattheneus.com/editorial/pubmed-antihypertensive-chronotherapy-star-network-ranking-2026-09-25 #HTA #NMA #EvidenceSynthesis #HealthEconomics

Germany opens a migraine-acupuncture consultation around a three-trial evidence base. https://www.mattheneus.com/editorial/g-ba-acupuncture-migraine-prevention-consultation-three-trial-evidence-2026-09-24 #HTA #EvidenceSynthesis #RegulatoryAffairs

Sixty-eight percent of occupational heat studies stayed in the lab, leaving a field-effectiveness evidence gap. https://www.mattheneus.com/editorial/occupational-heat-stress-laboratory-field-effectiveness-evidence-gap-2026-09-26 #HTA #EvidenceSynthesis #RWE

Sweden’s TLV estimates Kisunla at SEK 1.55m–4.54m per QALY, showing how durability assumptions drive value. https://www.mattheneus.com/editorial/tlv-kisunla-donanemab-cost-effectiveness-durability-scenarios-2026-09-22 #HTA #HealthEconomics #Pharma

Poland's HTA agency flags a comparator gap in Tevimbra's nasopharyngeal cancer submission. https://www.mattheneus.com/editorial/aotmit-tevimbra-nasopharyngeal-carcinoma-comparator-gap-assessment-2026-09-25 #HTA #Pharma #RegulatoryAffairs