Analysis of NICE Fast Track Appraisals: What Are the Key Characteristics for Success?

OBJECTIVES: NICE Fast Track Appraisals (FTAs) aim to shorten appraisal times for submissions that show similar cost and efficacy to current standard of care. This research aimed to identify and characterise NICE FTAs and analyse how these characteristics relate to time from submission date to published recommendation.

METHODS: The analysis included successful NICE FTAs submitted between April 1, 2017, and Dec 31, 2021. Submissions were reviewed by two independent reviewers to identify the following key characteristics: certainty of clinical evidence, number of comparators, cost of medicines, size of the population, severity of the disease, previous FTAs in disease area, and other indications for the same medicine. Characteristics were quantitatively scored based on the NICE FTA criteria and other measures such as level of innovation (number of comparators as proxy) and establishment in clinical practice (other indications as proxy). The relationship between the eligibility scores and the difference between the submission date to published recommendation was analysed using a correlation coefficient.

RESULTS: Ten FTA appraisals were identified; the time from submission to published recommendations ranged from 25-68 weeks. We found that low-cost medicines with two or more comparators and previous FTAs in the therapy area were common characteristics across successful submissions. Additionally, therapy areas were usually chronic but not severe with a high prevalence population. A moderate negative correlation coefficient of –0.32 (95% CI -0.96, +0.31) was found between the eligibility score and the difference between submission date and published recommendation.

CONCLUSIONS: NICE submissions that show specific characteristics are more likely to be candidates for the FTA route and have shorter times to publication. NICE should provide clearer guidance and support to enable more companies to identify which medicines are suitable for the FTA route. This would help address the recent capacity challenges NICE has experienced.