BRINGING MOLECULAR DIAGNOSTIC TESTS INTO CLINICAL PRACTICE- MAPPING THE EVIDENCE PATHWAY
Author(s)
Thompson AJ1, Allen AJ2, Bouttell J3, Gavan S1, Graziado S4, Hall PS5, McMeekin PM6, Smith AF7, Uchegbu I8, Vale L2, Payne K1
1The University of Manchester, Manchester, UK, 2Newcastle University, Newcastle upon Tyne, UK, 3The University of Glasgow, Glasgow, UK, 4Newcastle upon Tyne Hospitals, Newcastle upon Tyne, UK, 5University of Edinburgh, Edinburgh, UK, 6The University of Northumbria, Newcastle upon Tyne, UK, 7The University of Leeds, Leeds, UK, 8Imperial College London, London, UK
Currently, there is a lack of clarity as to how new molecular diagnostics can navigate the development ‘pathway’ and go from discovery and research into routine clinical practice. Compared with therapeutics, the development pathway for diagnostics is more complex and fragmented, leading to low uptake. At the end of the current pathway, regulatory organisations such as NICE in the UK often have to assess diagnostic technologies without robust ‘end-to-end’ studies demonstrating the full impact on patient benefits and costs. Where significant evidence gaps exist, assessment by NICE can often prove a challenge with promising technologies failing to secure positive recommendations as a result. Unlike therapeutics, implementation within the NHS for NICE-approved diagnostics is not mandatory, leading to further uncertainty for developers as to whether there is a return on investment. A clear and explicit description of the diagnostic pathway and the role of economic evidence could help to (1) improve research efficiency by informing the identification and collection of appropriate data earlier in the development process; (2) identify methodological work needed to improve the rigor of such research; and (3) align evidence generation to the needs of local and national decision-makers. The objective of this conceptual study is to describe a ‘map’ of the current development pathway for new diagnostic technologies within England and Scotland and describe the type of economic evidence needed to support the development process at each defined stage of the pathway. Drawing upon the collective experience of health economists working within the UK diagnostics landscape, the pathway will differentiate between types of diagnostics (e.g. ‘companion’ versus ‘standalone’) and delineate the differences between evidence generation and assessment for diagnostics compared with therapeutics. The different types of economic evidence required by NICE and local funders will also be discussed and the implications for likely implementation highlighted.
Conference/Value in Health Info
2017-11, ISPOR Europe 2017, Glasgow, Scotland
Value in Health, Vol. 20, No. 9 (October 2017)
Code
PHP318
Topic
Health Policy & Regulatory
Disease
Multiple Diseases