{"entity":{"id":"nice-methods","kind":"term","name":"NICE technology appraisal methods (2022)","aka":["NICE methods","NICE methods review","NICE manual","PMG36","severity modifier","end-of-life criteria","cost per QALY threshold","NICE threshold","technology appraisal process"],"tldr":"The rulebook NICE uses to decide whether the NHS in England should pay for a medicine: a cost per quality-adjusted life year usually between 20,000 and 30,000 pounds, with extra weight since 2022 for severe diseases in place of the old bonus for end-of-life cancer drugs.","summary":"United Kingdom (England and Wales), methods guidance with statutory force through NHS funding directions. NICE's health technology evaluations manual (process and methods guide PMG36) took effect on 1 February 2022 after a methods review that began in 2019, replacing the 2013 methods guide. Primary text: the NICE manual page. The NHS is legally obliged to fund technologies NICE recommends, normally within three months.\n\nWhat the methods say: NICE compares the cost per quality-adjusted life year (QALY) gained with a range of 20,000 to 30,000 pounds, with a 3.5 percent discount rate. The 2022 manual introduced a severity modifier that weights health gains by 1.2 or 1.7 for conditions with large absolute and proportional shortfalls in quality-adjusted life expectancy, replacing the end-of-life criteria that since 2009 had allowed a weight of about 1.7 for treatments extending life by three months or more in patients with under two years to live, a rule that mainly benefited cancer drugs. The manual also accepted more uncertainty in rare diseases, formalised managed access through the Cancer Drugs Fund and the Innovative Medicines Fund, and allowed a broader view of real-world evidence. Highly specialised technologies for very rare diseases have a separate threshold of 100,000 pounds per QALY, rising with the size of the benefit.\n\nThe arguments: cancer charities fear that the severity modifier helps fewer cancer drugs than the end-of-life rule did, and NICE's own analysis anticipated a shift toward other diseases; economists argued the old rule was unfair to other patients. The threshold itself has not risen since 1999, which industry calls a real-terms cut and which the 2024 voluntary pricing scheme negotiation revisited without changing.","asOf":"2026-09-17","links":[{"label":"NICE: health technology evaluations, the manual (PMG36)","url":"https://www.nice.org.uk/process/pmg36"}],"tags":["law","uk"],"related":["hta","cancer-drugs-fund","innovative-medicines-fund","icer-value-assessment","qol-pro","eu-hta-regulation","amnog","ilap","financial-toxicity","nice-guidance"],"cancers":[],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":["nice","smc"],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":["b-drug-pricing"],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"category":"Regulation & policy"},"route":"/terms/nice-methods/","neighbours":{"term":[{"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":"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":"hta","kind":"term","name":"Health technology assessment (HTA), reimbursement and QALYs","route":"/terms/hta/"},{"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":"innovative-medicines-fund","kind":"term","name":"Innovative Medicines Fund (England)","route":"/terms/innovative-medicines-fund/"},{"id":"qol-pro","kind":"term","name":"Quality of life and patient-reported outcomes (QoL, PRO)","route":"/terms/qol-pro/"}],"collection":[{"id":"nice-guidance","kind":"collection","name":"NICE cancer guidance and technology appraisals (UK)","route":"/collections/nice-guidance/"}],"institution":[{"id":"nice","kind":"institution","name":"National Institute for Health and Care Excellence","route":"/institutions/nice/"},{"id":"smc","kind":"institution","name":"Scottish Medicines Consortium","route":"/institutions/smc/"}],"bottleneck":[{"id":"b-drug-pricing","kind":"bottleneck","name":"Prices and value","route":"/bottlenecks/b-drug-pricing/"}]}}