NICE technology appraisal methods (2022)

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.

What 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.

The 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.