Impact of the 2022 NICE Methods Update on Patient Access to Advanced Cancer Treatments in England
Author(s)
Xingyao Liu, MSc1, Keyur Patel, MSc, PharmD2, Safa McLachlan, MSc2, Karin Butler, MSc2, Kumar Perampaladas, MSc2, Ben Whybrow, MSc2, James Hargrave, Msc2, Farhan Mughal, MSc2.
1Kintiga, Cambridge, United Kingdom, 2Daiichi Sankyo UK Ltd, Uxbridge, United Kingdom.
1Kintiga, Cambridge, United Kingdom, 2Daiichi Sankyo UK Ltd, Uxbridge, United Kingdom.
OBJECTIVES: This study investigated the impact of the National Institute for Health and Care Excellence (NICE) 2022 Methods update, specifically the introduction of the severity modifier replacing end-of-life criteria, on patient access to cancer and advanced cancer treatments using three indicators: divergence between European Medicines Agency (EMA) approvals and NICE technology appraisals (TAs), NICE TA termination rates, and positive recommendation rates.
METHODS: To differentiate the effect of the Methods update from the Cancer Drugs Fund (CDF) relaunch in July 2016, which influenced NICE positive recommendation rates for cancer treatments, retrospective analyses were conducted on NICE TAs before (July 2016-January 2022) and after (February 2022-December 2024) the Methods update. Termination and recommendation rates were calculated. EMA approvals of new active substances and indication extensions (2016-2024) were cross-referenced with NICE appraisal statuses and outcomes. Advanced cancer was defined as indications containing keywords ‘advanced’ or ‘metastatic’, excluding brain and haematological cancers due to different staging criteria.
RESULTS: For all cancer treatments, post-Methods, the proportion of EMA-approved treatments not appraised by NICE rose (7.4% [15/203] to 8.6% [12/139]), as did NICE’s termination rate (17.0% [40/235] to 21.3% [29/136]). NICE’s positive recommendation rate also increased (87.8% [181/206] to 90.2% [46/51). In advanced cancer, post-Methods, the proportion of EMA approvals not appraised by NICE (4.5% [5/111] to 9.2% [7/76]) and NICE’s termination rate (10.8% [13/120] to 17.2% [11/64]) increased, while NICE’s positive recommendation rate declined (86.5% [90/104] to 81.8% [18/22]).
CONCLUSIONS: The analysis showed that following the 2022 NICE Methods update, there has been greater divergence from EMA decisions, higher termination rates, and reduced positive recommendations for advanced cancer treatments. These trends may indicate emerging barriers to access for high-need populations. Continued monitoring and subsequent policy refinement may be warranted to ensure NICE Methods remain aligned with scientific advancement and patient need.
METHODS: To differentiate the effect of the Methods update from the Cancer Drugs Fund (CDF) relaunch in July 2016, which influenced NICE positive recommendation rates for cancer treatments, retrospective analyses were conducted on NICE TAs before (July 2016-January 2022) and after (February 2022-December 2024) the Methods update. Termination and recommendation rates were calculated. EMA approvals of new active substances and indication extensions (2016-2024) were cross-referenced with NICE appraisal statuses and outcomes. Advanced cancer was defined as indications containing keywords ‘advanced’ or ‘metastatic’, excluding brain and haematological cancers due to different staging criteria.
RESULTS: For all cancer treatments, post-Methods, the proportion of EMA-approved treatments not appraised by NICE rose (7.4% [15/203] to 8.6% [12/139]), as did NICE’s termination rate (17.0% [40/235] to 21.3% [29/136]). NICE’s positive recommendation rate also increased (87.8% [181/206] to 90.2% [46/51). In advanced cancer, post-Methods, the proportion of EMA approvals not appraised by NICE (4.5% [5/111] to 9.2% [7/76]) and NICE’s termination rate (10.8% [13/120] to 17.2% [11/64]) increased, while NICE’s positive recommendation rate declined (86.5% [90/104] to 81.8% [18/22]).
CONCLUSIONS: The analysis showed that following the 2022 NICE Methods update, there has been greater divergence from EMA decisions, higher termination rates, and reduced positive recommendations for advanced cancer treatments. These trends may indicate emerging barriers to access for high-need populations. Continued monitoring and subsequent policy refinement may be warranted to ensure NICE Methods remain aligned with scientific advancement and patient need.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
HTA193
Topic
Health Policy & Regulatory, Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes
Disease
Oncology