Changes in NICE Guidance Following Surveillance Review: When, How and Why?

OBJECTIVES: NICE monitor, amend and update technology appraisal (TA) guidance via their ‘surveillance’ process to ensure it remains current and accurate. Unlike reviews following managed access (e.g. through the Cancer Drugs Fund [CDF]), surveillance reviews are more flexible in both timing and process. This research investigated triggers for surveillance reviews and the characteristics of re-appraisals.

METHODS: The NICE database was searched for TAs with changes in guidance between 1 January 2014 and 24 April 2024 (excluding CDF reviews). Supplementary manual searches of all published TAs since 24 April 2022 were conducted to identify re-appraisals not captured by database searches.

RESULTS: Database searches identified 610 TAs; 41 (6.7%) reported guidance changes, of which 5 were re-appraisals. Supplementary hand searches identified an additional 6 re-appraisals. TAs with guidance changes (n=41) spanned a wide range of disease areas and had a mean time between publication and latest update of 5.7 years (range: 0.2–17.1 years). Common triggers (not mutually exclusive) included changes in commercial arrangement (n=15), related NICE guidance (n=8), related guidelines (n=7) and marketing authorization (n=5).

Re-appraisals included partial (n=5), full (n=2) and rapid (n=4) reviews and could be requested by NICE or manufacturers. Rapid reviews had short timelines and typically a single committee meeting; larger variation was observed for partial/full reviews. Rapid reviews typically included amended economic models, and in some cases limited clinical evidence. Evidence informing partial/full reviews varied dramatically, including longer follow-up from existing trials, new clinical trials, real-world evidence, and updated indirect treatment comparisons to include additional comparators. Re-appraisals led to expansions in the recommended population or changes from negative to positive recommendations.

CONCLUSIONS: Changes in NICE guidance are rare but occur across wide-ranging disease areas and for varied reasons. Surveillance remains an important process to ensure guidance is up-to-date and maximize patient access to innovative health technologies conditional on new evidence.