Objectives: The National Institute of Health and Care Excellence (NICE) appraises the clinical- and cost-effectiveness of health technologies upon which they issue recommendations on whether they should be adopted by the National Health Service in England and Wales. NICE issues review dates with each appraisal where they will assess whether the guidance needs updating, but will consider a review ahead of this deadline if significant new evidence comes to light that could change the recommendation. Additionally, a rapid review facility is available to consider new patient access schemes (PASs) subsequent to guidance publication. This research aims to determine how frequently NICE Single Technology Appraisal (STA) recommendations have changed subsequent to it being issued. Methods: All STAs were screened up to 1st December 2015 for any guidance that had been superseded. The date, decision, drug, indication and key rationale from both original and subsequent submissions were extracted. Results: 216 STA appraisals were identified; only 6% (12/216) had been superseded. 5 of these 12 were replaced with MTA guidance. Another 5/12 were rapid reviews, 4 were 'optimised' recommendations for which the previous guidance was 'not recommended' and the other was 'recommended' that was previously 'optimised'. These rapid reviews were an average of 15 months after the initial appraisal (range: 10-20 months). For the other 2/12 superseded appraisals, alteplase was recommended in 2012, 5 years post-initial recommendation, following a revision to the licensed indications extending the time period within which the drug can be administered. Additionally, bevacizumab+taxane breast cancer was not recommended in 2011 after an initial non-submission in 2008. Conclusions: Companies wanting to attain NICE recommendations need to focus their efforts on any appeals in the draft guidance review consultation processes. Once final guidance is issued, it is very difficult to change this, unless the company is willing to offer a new/alternative PAS.
Macaulay, R. (2016). NOT NICE – NOW WHAT? Value in Health, 19(3), A263. https://doi.org/10.1016/j.jval.2016.03.809