{"entity":{"id":"hta","kind":"term","name":"Health technology assessment (HTA), reimbursement and QALYs","aka":["HTA","health technology assessment","reimbursement","reimbursed","reimbursement decision","coverage decision","payer","payers","cost-effectiveness","cost effectiveness","cost-effective","QALY","QALYs","quality-adjusted life year","incremental cost-effectiveness ratio","willingness-to-pay threshold","value-based pricing","managed access","Cancer Drugs Fund","technology appraisal","G-BA","AMNOG","HAS","PBAC","CADTH","value assessment","coverage decisions","technology appraisals"],"tldr":"Approval says a drug works; reimbursement says who will pay. Health technology assessment bodies (NICE, G-BA, PBAC) judge whether the benefit is worth the price, often per quality-adjusted life year, and can delay access for years after approval.","summary":"A QALY is one year of life in perfect health; NICE's threshold is £25,000-35,000 per QALY, raised from £20,000-30,000 on 2 April 2026, with a severity modifier that weights QALYs by 1.2 or 1.7, and drugs above it are rejected or admitted via managed access schemes such as the Cancer Drugs Fund with confidential discounts. Germany assesses added benefit and negotiates price after a year of free pricing; France's HAS grades clinical benefit; the US has no national HTA and Medicare must cover approved cancer drugs, though ICER publishes non-binding assessments and the IRA now permits Medicare negotiation. The gap between approval and reimbursement (often 1-2 years in Europe, longer in middle-income countries) is a major access bottleneck.","asOf":"2026-09-09","wikipedia":"https://en.wikipedia.org/wiki/Health_technology_assessment","links":[{"label":"Wikipedia","url":"https://en.wikipedia.org/wiki/Health_technology_assessment"}],"tags":[],"related":["qol-pro","financial-toxicity","regulatory-agencies","real-world-evidence","eu-hta-regulation","nice-methods","cancer-drugs-fund","innovative-medicines-fund","amnog","inflation-reduction-act","medicare-ced","france-early-access","china-vbp-nrdl","state-biomarker-testing-laws"],"cancers":[],"sections":["drug-discovery"],"technologies":["nice-guidance","icer-value-assessment","drug-price-transparency"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"category":"Regulation & policy"},"route":"/terms/hta/","neighbours":{"term":[{"id":"340b-program","kind":"term","name":"340B Drug Pricing Program","route":"/terms/340b-program/"},{"id":"amnog","kind":"term","name":"AMNOG (Germany, 2011)","route":"/terms/amnog/"},{"id":"cancer-drugs-fund","kind":"term","name":"Cancer Drugs Fund (England)","route":"/terms/cancer-drugs-fund/"},{"id":"china-vbp-nrdl","kind":"term","name":"China National Reimbursement Drug List negotiation and volume-based procurement","route":"/terms/china-vbp-nrdl/"},{"id":"eu-hta-regulation","kind":"term","name":"EU HTA Regulation (EU) 2021/2282: joint clinical assessments","route":"/terms/eu-hta-regulation/"},{"id":"financial-toxicity","kind":"term","name":"Financial toxicity","route":"/terms/financial-toxicity/"},{"id":"france-early-access","kind":"term","name":"France: early access (accès précoce), formerly ATU","route":"/terms/france-early-access/"},{"id":"icer-value-assessment","kind":"term","name":"ICER and health technology assessment","route":"/terms/icer-value-assessment/"},{"id":"ilap","kind":"term","name":"ILAP (Innovative Licensing and Access Pathway)","route":"/terms/ilap/"},{"id":"inflation-reduction-act","kind":"term","name":"Inflation Reduction Act 2022: Medicare drug price negotiation","route":"/terms/inflation-reduction-act/"},{"id":"innovative-medicines-fund","kind":"term","name":"Innovative Medicines Fund (England)","route":"/terms/innovative-medicines-fund/"},{"id":"medicare-ced","kind":"term","name":"Medicare coverage with evidence development","route":"/terms/medicare-ced/"},{"id":"nice-methods","kind":"term","name":"NICE technology appraisal methods (2022)","route":"/terms/nice-methods/"},{"id":"drug-price-transparency","kind":"term","name":"Oncology drug pricing and price transparency","route":"/terms/drug-price-transparency/"},{"id":"qol-pro","kind":"term","name":"Quality of life and patient-reported outcomes (QoL, PRO)","route":"/terms/qol-pro/"},{"id":"quality-adjusted-survival","kind":"term","name":"Quality-adjusted survival (QALYs and Q-TWiST)","route":"/terms/quality-adjusted-survival/"},{"id":"real-world-evidence","kind":"term","name":"Real-world evidence","route":"/terms/real-world-evidence/"},{"id":"regulatory-agencies","kind":"term","name":"Regulators beyond the FDA (EMA/CHMP, MHRA, PMDA, NMPA, TGA)","route":"/terms/regulatory-agencies/"},{"id":"state-biomarker-testing-laws","kind":"term","name":"State biomarker testing coverage laws","route":"/terms/state-biomarker-testing-laws/"}],"section":[{"id":"drug-discovery","kind":"section","name":"Drug Discovery Platforms","route":"/fronts/drug-discovery/"}],"collection":[{"id":"nice-guidance","kind":"collection","name":"NICE cancer guidance and technology appraisals (UK)","route":"/collections/nice-guidance/"}],"person":[{"id":"jonathan-benger","kind":"person","name":"Jonathan Benger","route":"/people/jonathan-benger/"},{"id":"lionel-collet","kind":"person","name":"Lionel Collet","route":"/people/lionel-collet/"},{"id":"robyn-ward","kind":"person","name":"Robyn Ward","route":"/people/robyn-ward/"}],"institution":[{"id":"bfarm","kind":"institution","name":"Bundesinstitut für Arzneimittel und Medizinprodukte","route":"/institutions/bfarm/"},{"id":"deutsche-krebsgesellschaft","kind":"institution","name":"Deutsche Krebsgesellschaft","route":"/institutions/deutsche-krebsgesellschaft/"},{"id":"nhsa","kind":"institution","name":"National Healthcare Security Administration","route":"/institutions/nhsa/"}],"roadmap":[{"id":"global-access-roadmap","kind":"roadmap","name":"Global access and affordability roadmap: essential medicines and generics → biosimilars and frugal trials → reliance, pooling and homegrown innovation","route":"/roadmaps/global-access-roadmap/"}]}}