OBJECTIVES: The National Institute for Health and Care Excellence (NICE) is responsible for determining the clinical and cost effectiveness of new technologies in England. One outcome of a NICE appraisal is termination. The objective of this study was to record termination trends over time, and determine if products with multiple indications were disproportionally impacted.

METHODS: NICE Technology and Highly Specialised Technology guidance were extracted from the NICE website (27.08.03 to 31.08.23). ‘Multi-indication’ products were counted if two or more indications were recorded. Combination therapy submissions were excluded to avoid duplication due to difficulties in categorising which of the products would be considered multi-indication. This study considered three groups; “Published: all” (n=582), “Published: post-July 2016” (n= 377) and “In Development” (n=199).

RESULTS:

79.2% (n=61/77) of all terminations happened post-July 2016. Post-July 2016, 16.2% (n=61/377) of submissions were terminated (average annual termination rate = 13.6% as a proportion of submissions). Terminations are generally increasing, with a steep rise since 2020 (2016 post-July: 0; 2017: 8; 2018: 2; 2019: 4, 2020: 5; 2021: 12; 2022: 21; 2023 [to date]: 9).

Post-July 2016, 57.0% (n=215/377) of all submissions were multi-indication (excluding combination therapies [n=108]). These accounted for 63.9% (n=39/61) of total terminations post-July 2016, despite being only 57.0% (n=215/377) of total submissions.

53.8% (n=107/199) of “In Development” entries were originator indications, 34.7% (n=69/199) were follow-on indications for a previously recommended/optimised product, and 11.6% (n=23/199) were for multiple submissions in development without a previously reimbursed indication. A significant proportion (46.2%) of appraisals currently in development are multi-indication.

CONCLUSIONS: The proportion of terminated submissions seems likely to increase in the future whilst disproportionately impacting products with multiple indications. With these products representing almost half of the appraisals currently in development at NICE, this raises serious questions regarding potential systemic barriers impacting patient access to innovative medicines.