Comparison of the Use of Real-World Evidence for Clinical Effectiveness in HTA Pre- and Post- Introduction of the NICE Framework
Rebecca Mackley, Rhiannon Green, Medha Shrivastava, Steady Chasimpha, Rhiannon Teague
Poster Session: 5. 15 November 2023. Poster Session Time: 9:00-11:30. Discussion Period: 9:00-10:00.
Abstract
OBJECTIVES: Data insufficiency has led to payers becoming more receptive of real-world evidence (RWE) to inform clinical effectiveness in reimbursement decision-making. In June 2022, the National Institute for Health and Care Excellence (NICE) introduced a framework to improve the quality of RWE used to inform guidance and identify where RWE can reduce uncertainties. We aimed to assess the framework’s impact on the use of RWE to inform the clinical effectiveness of interventions assessed in the technology appraisal (TA) program.
METHODS: We identified TAs from the NICE website published up to one year pre- and post-introduction of the framework (23.06.21 – 23.06.22 vs 24.06.22 – 24.06.23). For each TA that included RWE for clinical effectiveness, the following were recorded: disease area, study type, location, notes regarding data quality, the contribution to the clinical evidence, and whether an SLR was used in study identification.
RESULTS: Of the 201 TAs identified, 47 were excluded (42 terminated, 5 updates). Of the remaining 154, 72 were published pre-framework and 82 post-framework. Pre-framework, 20 TAs (28%) used RWE to inform clinical effectiveness versus 24 (29%) post-framework. Overall, oncology was the disease area that most commonly used RWE (29/44 [66%]). Post-framework, a lower proportion of oncology TAs used RWE (58% versus 75%) and RWE from the Cancer Drugs Fund (CDF) (36% versus 67%). Conversely, the use of RWE in non-oncology TAs doubled post-framework (5 [14%] versus 10 [27%]). Where RWE was used, NICE regularly assessed its generalizability to the UK population, as well as whether it had been identified systematically.
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 longer timeframe may be needed to assess the true impact of the framework on the use of RWE.