OBJECTIVES: Real-world evidence (RWE) is increasing in popularity due to its ability to optimize the design of randomized controlled trials (RCTs) and provide insights into the safety and usage of medicinal interventions. On June 23^rd 2022, England’s National Institute for Health and Care Excellence (NICE) introduced a framework to improve the quality of RWE used in decision-making and identify where RWE can reduce uncertainties. This study assessed the framework’s impact on RWE used to inform the clinical effectiveness of interventions assessed in the technology appraisal (TA) program, within 18 months of implementation.

METHODS: The NICE website was reviewed to identify TAs published pre-guidance (01.01.21 – 23.06.22) and post-guidance (24.06.22 – 01.01.24). TAs were excluded if they had been terminated or if they were treatment guideline updates from TAs published more than 5 years ago. For each TA that included RWE in the clinical effectiveness section, the following were recorded: NICE recommendation, disease area, study type, location, the contribution to the clinical evidence, and the reason for inclusion.

RESULTS: Of the 271 identified TAs, 60 were excluded (52 terminated, 8 updates). Of the remaining 211, 103 (49%) were published pre-framework and 108 (51%) post-framework. Pre-framework, 28/103 TAs (27%) used RWE to inform clinical effectiveness versus 33/108 (31%) post-framework. Oncology TAs included RWE more commonly than any other disease area both pre- (20/28 [71%]) and post-framework (18/33 [55%]). Post-framework the proportion of oncology TAs using the Cancer Drugs Fund (CDF) substantially decreased (60% [12/20]) versus (22% [4/18]).

CONCLUSIONS: The overall proportion of TAs using RWE did not significantly change post-framework, however, there were noticeable trends within the oncology and non-oncology disease areas (e.g., lower proportion of CDF). A reduction in the use of the CDF may be due to non-CDF RWE reducing uncertainties in the clinical effectiveness for some oncology interventions.