NICE process and methods
1.1 Early value assessment is a new evidence-based approach designed to improve the care of people and effective use of NHS resources through quicker access to promising health technologies that address national unmet need. It champions stronger partnership working between regulatory, healthcare and research organisations to benefit people and better support innovators while ensuring value for money for the NHS.
1.2 There are 4 key aims of the early value assessment approach:
To focus on promising innovations that meet the needs and priorities of people, and the health and social care systems.
To enable earlier access to useful innovations through faster assessments and timely guidance production.
To better support adoption and evidence generation by embedding early value assessment in cross-partnership working.
To check the benefits of promising innovations are realised and ensure value for money for the health and social care systems.
1.3 To develop early value assessments, NICE is adopting a 'test and learn' approach and running at least 10 pilots of different use cases. Approaches being tested are outlined in appendix 1 table 3 and include assessments of varying length with a clinical gap analysis and various approaches to economic analysis such as reviewing economic literature or early conceptual modelling. Each early value assessment will include relevant technologies that are used for a specific purpose or indication. Early value assessment recommendations will refer to each technology individually.
1.4 This interim statement outlines:
the vision for the new topic intelligence function and how pilot topics have been identified
the process and methods that are being tested for assessing early value and producing sound and timely guidance
the approaches for evidence generation that are being tested to support further evidence generation for technologies that have been conditionally recommended through the early value assessment process.
1.5 The approaches outlined in this statement are iterative and may change to fit the needs of the project. Learnings from the tested approaches will inform the final design of early value assessment and will then be documented in a final manual.