A Delphi study on valuing DNA sequencing in oncology: a European stakeholder developed framework for assessing next generation sequencing and comprehensive genomic profiling diagnostics.

Background: Advanced genomic technologies like Next Generation Sequencing and Comprehensive Genomic Profiling are pivotal for the prevention, management and treatment of cancer by identifying crucial genetic markers. However, their adoption in Europe is inconsistent, partly due to the lack of a validated approach to assessing their value.

Methods: A multi-phase mixed-methods approach was implemented, integrating a systematic review and multi-stakeholder consensus-generating Delphi exercise to derive a comprehensive set of value criteria and arrive at a value assessment framework. This value assessment framework adapted an existing Latin American-focused diagnostic framework to the European context. The Delphi included representatives from the broader stakeholder community (patient advocacy, industry, decision-makers, health technology assessment, regulators, academia, and physicians). Over four rounds, participants refined and rated the significance of these criteria in the context of the assessment of the specified technologies in oncology, particularly for reimbursement decisions. Responses were analysed in terms of stability and level of consensus in order to generate a final value assessment framework.

Findings: 34 individuals participated in all rounds of the Delphi exercise. The final value assessment framework includes 8 distinct value criteria, including: clinical impact; test performance and quality; quality of scientific evidence; non-clinical impact; impact on health system integration, organisation and delivery of care; economic aspects; ethical and governance concerns; and health system priorities. Within these criteria, a total of 27 distinct sub-criteria were identified, 23 of which had consensus as 'important' or 'very important' in assessing value.

Interpretation: The resultant value assessment framework is validated by a wide range of key European stakeholders and enables systematic assessment of Next Generation Sequencing and Comprehensive Genomic Profiling technologies used in oncology diagnostics within the European setting. The framework includes aspects that are not adequately considered in current health technology assessment and goes beyond existing value assessment frameworks through the inclusion of newer criteria such as data governance concerns.

Funding: Funding was provided by the Precision Cancer Consortium with an unrestricted educational grant.