OBJECTIVES: As personalized medicine becomes increasingly ubiquitous in oncology, there is a growing need to increase access to biomarker testing. One approach is greater use of Next-Generation Sequencing (NGS). There is an ongoing debate regarding whether NGS is cost-effectiveness today. This research aims to assess the current evidence base on the cost-effectiveness of NGS as a biomarker testing strategy in oncology and develop policy recommendations.

METHODS: A structured literature review focusing on the period from 2017-2022 was conducted. Eligibility criteria were developed based on the indication and type of cost-effectiveness analysis provided.

RESULTS: A total of 29 studies were selected and analyzed. Cost-effectiveness outcomes of NGS varied depending on the methodology used, type of NGS considered, number of genes tested, indication, and patient population. Overall, targeted panel testing (2-200 genes) demonstrated cost-effectiveness compared to single-gene testing when 4+ genes are tested. Larger NGS panels (200+ genes) were deemed less cost-effective. NGS was also shown to be less cost-effective as a first-line biomarker testing strategy in patient populations with 1 to 2 highly dominant mutations. In addition, when compared with single-gene testing, NGS provided reductions in turnaround time, personnel time, repeat hospital visits, and lower hospital costs. Finally, NGS demonstrated significant patient benefit by identifying additional mutations and increasing the number of patients receiving targeted therapies.

CONCLUSIONS: The existing literature supports the cost-effectiveness of NGS as a biomarker testing strategy in oncology under the right circumstances. Furthermore, as the costs of NGS inevitably decrease and the number of viable biomarkers increases, it will become more cost-effective. These findings underline the need to develop effective policies which support holistic assessment benefits, equitable reimbursement and access, as well as infrastructure expansion.