1754P - Towards a next-generation sequencing/comprehensive genomic profiling value framework: Systematic review for identifying new domains and adapting a diagnostic test value framework in Europe

Background

Next Generation Sequencing / Comprehensive Genomic Profiling (NGS/CGP) have recently expanded, mainly in oncology. To guide healthcare decision-making, it is key to have a value framework (VF), which allows a transparent assessment of value criteria. In 2020, IECS published a VF for diagnostic tests in Latin America (Augustovski et al, VIH 2021 ). This study aims to enrich, update, and adapt the previous VF to develop an NGS/CGP VF targeted to oncology in Europe. The aim of this study is to identify value criteria/sub criteria from published VFs, map them to the current VF, and report an updated and evidence-based list of non-overlapping criteria for subsequent assessment of their relevance for an NGS/CGP VF in Europe.

Methods

A systematic review (SR) of VFs aimed at any type of health technology. A mapping was then performed to determine similarities and differences with the IECS VF criteria.

Results

A total of 43 VFs were identified from 2067 unduplicated records and grey literature. The vast majority (n=38, 88%) were developed in high-income countries, 30% (n=13) were oriented towards genetic testing and only 16% (n=7) targeted oncology. A total of 223 criteria (C) and sub criteria (SC) were retrieved (93% of them fully or partially included in IECS VF). The two most common criteria related to clinical benefit and economic aspects. VFs oriented to oncology had higher overlap with the IECS VF, as well as those VFs oriented to genetic testing. A total of 18 criteria (C) and 35 non-overlapping sub-criteria (SC) were listed (15C and 21SC from IECS VF and 3C and 14SC from the SR). Some examples of new potential criteria included quality assurance/improvement; and public health/population benefit.

Conclusions

Our study provides an evidence-based, user-oriented update of criteria and sub criteria for healthcare decision-making tailored for NGS/CGP genetic testing in oncology, which may be a helpful list of criteria for health technologies in general. This list will serve as the basis to adapt the existing VF with the assistance of key European experts and stakeholders in order to co-create a European NGS/CGP VF in oncology.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

Institute for Clinical Effectiveness and Health Policy (IECS).

Funding

Precision Cancer Consortium (PCC).

Disclosure

All authors have declared no conflicts of interest.