When The Outcome of An Appraisal Is Not Nice: A Review Of Nice Appeals

OBJECTIVES: The National Institute for Health and Care Excellence (NICE) provides stakeholders to health technology appraisals the option to appeal the decision. We conducted an analysis of past appeals to review the appraisal appeal process by time, therapeutic area, number and type of appellants, grounds of the appeal, and success of the appeal. METHODS: Appeals starting from the year 2000 were identified on the NICE website. Appeal decision documents were reviewed to obtain date of appeal, therapeutic area, number of appellants, type of appellant, grounds of the appeal, and outcome of the appeal (ie, whether it was dismissed or upheld). Results were tabulated in an Excel spreadsheet and descriptive statistics were compiled. RESULTS: A total of 87 past appeals were identified and appeal decisions were available for 75 of the appeals. The annual number of appeals peaked between 2006 and 2008. The most common therapeutic areas of appeals were oncology (39%), rheumatology (16%), and endocrinology (12%).There were a mean of 2.4 appellants per appeal. Manufacturers were the most common appellant (47%), followed by professional group (22%), patient group (22%), clinical (5%), and other (3%).The most frequent ground for an appeal was unreasonable evidence (92%), followed by failure to be fair (64%), and exceeded powers (23%). Forty-two (56%) of the appeal decisions were dismissed on all grounds, while the remaining 33 (44%) were upheld on one or more grounds. Failure to be fair was the most common ground for upholding the appeal (38%), followed by unreasonable evidence (34%), and exceeded powers (7%). CONCLUSIONS: Manufacturers are the most common appellant in NICE appeals, with unreasonable evidence being the most common ground for the appeal. However, failure to be fair is the ground for appeal most likely to be upheld.