The Use of Real-World Evidence in Health Technology Assessment and the Application of the NICE RWE Framework: A Review of NICE Technology Appraisals
Author(s)
Zainab Abdali, MSc1, Kurt Taylor, PhD1, Nicholas Latimer, MSc, PhD2.
1Petauri Evidence Ltd, Nottingham, UK, Nottingham, United Kingdom, 2SCHARR, University of Sheffield, Sheffield, United Kingdom.
1Petauri Evidence Ltd, Nottingham, UK, Nottingham, United Kingdom, 2SCHARR, University of Sheffield, Sheffield, United Kingdom.
OBJECTIVES: Real-world evidence (RWE), generated from real-world data (RWD), is increasingly used to enhance health technology assessments (HTAs) and inform healthcare decisions. The NICE RWE framework has been developed to provide guidance on when RWD should be incorporated into the technology appraisal process, and to outline best practices for planning, conducting, and reporting RWE studies. However, the extent to which this framework has been applied in recent NICE appraisals remains unclear. A review of recent NICE appraisals was conducted to explore this.
METHODS: The NICE website was screened to identify technology appraisals completed since the NICE RWE framework was published (June 2022 to May 2025). Appraisal documents were reviewed to extract information on the technology, therapeutic/disease area, RWE categories, data sources, accessibility, and integration methods. Information on the NICE recommendation was also extracted. Findings were analysed using a narrative approach.
RESULTS: A total of 280 appraisals were identified, of which 226 were reviewed following exclusion of terminated appraisals. RWE was employed in 103 technology appraisals to inform a wide range of considerations, including effectiveness, safety, patient characteristics, and treatment pathways. RWE was used in submissions either as primary evidence in the base-case analysis, such as serving as an external control for indirect treatment comparisons, or to inform scenario analyses and validate data inputs. Data sources included national and international databases, registries, and observational studies. However, the NICE RWE framework was referenced in sixteen appraisals, and best practice tools for planning, conduct, and reporting were used in only five appraisals, showing limited uptake.
CONCLUSIONS: There is an increasing use of RWE in HTA submissions. However, best practices recommended by the NICE RWE framework are rarely utilised. Increased emphasis on methodological rigour and adherence to established reporting standards is essential to safeguard the quality, transparency, and accountability of evidence.
METHODS: The NICE website was screened to identify technology appraisals completed since the NICE RWE framework was published (June 2022 to May 2025). Appraisal documents were reviewed to extract information on the technology, therapeutic/disease area, RWE categories, data sources, accessibility, and integration methods. Information on the NICE recommendation was also extracted. Findings were analysed using a narrative approach.
RESULTS: A total of 280 appraisals were identified, of which 226 were reviewed following exclusion of terminated appraisals. RWE was employed in 103 technology appraisals to inform a wide range of considerations, including effectiveness, safety, patient characteristics, and treatment pathways. RWE was used in submissions either as primary evidence in the base-case analysis, such as serving as an external control for indirect treatment comparisons, or to inform scenario analyses and validate data inputs. Data sources included national and international databases, registries, and observational studies. However, the NICE RWE framework was referenced in sixteen appraisals, and best practice tools for planning, conduct, and reporting were used in only five appraisals, showing limited uptake.
CONCLUSIONS: There is an increasing use of RWE in HTA submissions. However, best practices recommended by the NICE RWE framework are rarely utilised. Increased emphasis on methodological rigour and adherence to established reporting standards is essential to safeguard the quality, transparency, and accountability of evidence.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
HTA335
Topic
Economic Evaluation, Health Technology Assessment, Real World Data & Information Systems
Topic Subcategory
Value Frameworks & Dossier Format
Disease
No Additional Disease & Conditions/Specialized Treatment Areas