Presentation (CTI)

OBJECTIVES: Prostate cancer was the most diagnosed cancer in England in 2022, as such, many targeted treatments have recently undergone assessment by the National Institute of Health and Care Excellence (NICE). Real-world evidence (RWE) is increasingly used to support single technology appraisals (STAs) but it’s role in the assessment of prostate cancer STAs submitted to NICE is unclear. This review aimed to establish how RWE has been used in company evidence submissions for prostate cancer STAs to NICE between 2016-2026.
METHODS: A systematic review of the NICE Guidance database identified prostate cancer STAs with published guidance between 29th July 2016 and 17th June 2026. Appraisals were screened against pre-defined criteria. Cited RWE was extracted, categorised by data source and purpose, and mapped to submission, sections (Section B.1:background, B.2:clinical effectiveness or B.3:cost-effectiveness). Thematic analysis explored RWE patterns across STAs.
RESULTS: Of 21 STAs identified, 14 were included. 319 references to RWE were recorded across these STAs. All STAs included RWE, most frequently from registries (36%, n=114). RWE appeared most in B.1 (45%, n=145), followed by B.3 (35%, n=113) and B.2 (19%, n=61), indicating greater use in describing background disease epidemiology and economic inputs than clinical evidence, RWE most often described burden of disease/unmet need (23%, n=73) followed by real-world outcomes (18%, n=56) and disease epidemiology (17%, n=54). Almost three-quarters of STAs (71%, n=10) included RWE in the base-case cost-effectiveness analysis, most frequently to inform utility values or disutilities.
CONCLUSIONS: RWE is widely used in prostate cancer STAs and sourced primarily from secondary data sources complementing previous research and reflecting HTA preferences. Although encouraging to see RWE used in most base-case economic analyses, it is difficult to determine how this influenced decision-making. A formalised approach to reporting the consideration of RWE within NICE decision-making would promote transparency and the use of impactful RWE in HTA.