What Is Driving the Increase in Terminated NICE Appraisals?
Author(s)
Helena Grant, BSc.
Petauri Evidence, Bicester, United Kingdom.
Petauri Evidence, Bicester, United Kingdom.
OBJECTIVES: The proportion of manufacturer-terminated National Institute for Health and Care Excellence (NICE) appraisals has been increasing over time. Previous research has highlighted the increase, and the fact that terminations are disproportionately higher for cancer and rare diseases, multi-indication products, and combination products. This research sought to explore the drivers behind the increase in terminated NICE appraisals by characterising the reason for all terminated appraisals and analysing trends by year and indication.
METHODS: A database of all terminated NICE appraisals between 2008-2025 was analysed in Excel in June 2025. The manufacturer’s reasons for terminating the appraisal were categorised into themes related to economic evidence, clinical evidence, National Health Service (NHS) implementation, and administrative factors. Descriptive statistics were used to assess general trends and infer how the year of submission and indication may relate to the reason behind termination.
RESULTS: The most common reasons for terminating appraisals overall were that the manufacturer did not think the technology would be a cost-effective use of NHS resources (33%), did not have sufficient clinical evidence (15%), or decided not to launch in the UK (14%). The reasons for termination varied widely across indications and disease categories. A time series analysis found that the percentage of appraisals terminated due to cost-effectiveness reasons rose from 0% in the period 2008/2009-2010/2011 to 46% in the period 2023/2024-2025/2026. The percentage of terminations due to clinical evidence and NHS implementation factors generally declined over time.
CONCLUSIONS: Given NICE’s role in enabling access to novel and innovative therapies for patients in England, the increasing rise in manufacturers deciding to terminate their appraisal is concerning. These results suggest positive progress over time in robust clinical evidence generation and integration of new technologies in the NHS, but that demonstrating the cost effectiveness of new technologies may be more challenging.
METHODS: A database of all terminated NICE appraisals between 2008-2025 was analysed in Excel in June 2025. The manufacturer’s reasons for terminating the appraisal were categorised into themes related to economic evidence, clinical evidence, National Health Service (NHS) implementation, and administrative factors. Descriptive statistics were used to assess general trends and infer how the year of submission and indication may relate to the reason behind termination.
RESULTS: The most common reasons for terminating appraisals overall were that the manufacturer did not think the technology would be a cost-effective use of NHS resources (33%), did not have sufficient clinical evidence (15%), or decided not to launch in the UK (14%). The reasons for termination varied widely across indications and disease categories. A time series analysis found that the percentage of appraisals terminated due to cost-effectiveness reasons rose from 0% in the period 2008/2009-2010/2011 to 46% in the period 2023/2024-2025/2026. The percentage of terminations due to clinical evidence and NHS implementation factors generally declined over time.
CONCLUSIONS: Given NICE’s role in enabling access to novel and innovative therapies for patients in England, the increasing rise in manufacturers deciding to terminate their appraisal is concerning. These results suggest positive progress over time in robust clinical evidence generation and integration of new technologies in the NHS, but that demonstrating the cost effectiveness of new technologies may be more challenging.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
HTA365
Topic
Economic Evaluation, Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes, Systems & Structure
Disease
No Additional Disease & Conditions/Specialized Treatment Areas