The Use of Real-World Evidence in NICE Health Technology Appraisals: A Quantitative Review of Submissions to NICE Between 2022 and 2024
Speaker(s)
Aidarous A1, Tahir H2, Diribe O1, Allen R1
1Sanofi, Reading, RDG, UK, 2Sanofi, Reading, WBK, UK
Presentation Documents
OBJECTIVES: Use of Real-World Evidence (RWE) in technology appraisals is steadily increasing. With health technology assessment agencies developing frameworks to support generation of fit-for-purpose RWE by manufacturers, it is important to understand the contemporary use and landscape of RWE. Here we describe the use of RWE in NICE submissions between 2022 and 2024.
METHODS: A review of technology appraisals ([TA]; single TA [STA] and highly specialized technologies [HST]) published by NICE between January 2022 and April 2024 was conducted. Submissions that incorporated primary research based on real-world data were included (inclusion criterion). Data on therapeutic area, data provenance and rationale for use were captured.
RESULTS: In total, 180 submissions were identified, 58 (25%) met the inclusion criteria, 46/58 (79%) STAs and 12/58 (21%) HSTs. These covered 56 unique or unique combinations of technologies. 75 unique RWE projects informed the 58 appraisals, an average of 1.3 RWE projects per submission. Oncology was the most represented therapeutic area, 31/58 (53.4%).
Uses of RWE projects primarily included description of; clinical outcomes (n=43), patient and health condition characterization (n=16), resource utilization and disease burden (n=8), treatment and care pathway (n=6) and patient-reported outcomes (n=2). The underlying data source for the 75 projects geographically originated from: UK-only (46/75[61.3%]), multiple locations (15/75[20%]), USA-only (7/75[9.3%]), Australia-only (2/75[2.7%]) and 1/75(1.3%) for each of Belgium, Canada, France, Israel, and Taiwan.CONCLUSIONS: Given the nature of NICE, it is not surprising the majority of RWE was to support evidence on outcomes. Although the introduction of RWE Framework may not have led to a substantial quantitative change in TAs supported by RWE, it is likely its short-term impact will be qualitative, thereby improving its likelihood to impact decision making With almost 40% of the projects using RWD from outside the UK, there is an obvious need for frameworks to support consistent approaches to data transportability.
Code
HTA29
Topic
Health Technology Assessment
Topic Subcategory
Systems & Structure
Disease
No Additional Disease & Conditions/Specialized Treatment Areas