Launch of NICE real-world evidence framework heralds a new era in health technology assessment in the UK

The eagerly anticipated NICE real-world evidence framework outlines how and when real-world-data can be used in submissions to NICE as well as clearly describing best-practices to improve the quality and transparency of real-world evidence studies.

Following a consultation process in 2021, in June 2022 the National Institute for Health and Care Excellence (NICE) have launched the NICE real-world evidence (RWE) framework. Part of NICE’s five-year strategic plan, the framework provides guidance on the use of real-world data (RWD) to inform health technology assessment (HTA). The framework follows in the footsteps of other guidance documents for the use of RWE in regulatory decision making released in the USA, EU and Asia in recent years.

The framework outlines core principles that aim to produce high-quality, trusted RWE and is structured to enable those conducting various RWE studies to implement these principles. The framework structure includes:

1. Introduction to RWE: outlining how NICE define RWD/RWE, the types and sources of RWD, current and potential uses of RWE in NICE submissions and the challenges that are common to many RWE studies.
2. How quantitative RWE studies should be conducted: providing in-depth guidance surrounding the planning, conduct, and reporting of RWE studies.
3. How the suitability of the data should be assessed: explaining that data should be of good, known provenance and fit-for-purpose exemplified by the data quality and relevance; to facilitate this NICE has provided a bespoke reporting checklist called the the Data Suitability Assessment Tool (DataSAT).
4. How real-world studies of comparative effects should be carried out: detailing recommendations for conducting non-randomised studies, including study design, analysis and reporting; a second reporting checklist ‘Reporting on methods used to minimise risk of bias’ is also provided.

Recognizing the evolving role of RWE in HTA, NICE also explain this is a ‘living framework’ that will be periodically revised to incorporate user feedback and experiences as well as to widen its scope.

Full details on the NICE real-world evidence framework can be found on the website here https://www.nice.org.uk/corporate/ecd9/chapter/overview

Read the the Editorial published in the Journal of Comparative Effectiveness Research here