Incorporating diagnostic testing into economic evaluations of tumour-agnostic therapies

Tumor-agnostic treatments represent paradigm shift in oncology, targeting specific genetic mutations irrespective of the tumor’s anatomical origin. This personalized approach relies on companion diagnostic testing to identify patients likely to respond to treatment. However, incorporating molecular diagnostics poses challenges to healthcare systems, particularly regarding costs and accessibility. This must be addressed in economic evaluations to guide health technology assessment and reimbursement decisions. This study reviewed economic evaluations of tumor-agnostic therapies, focusing on the role of diagnostic testing. A literature search identified 13 compounds targeting nine molecular alterations, with eight relevant publications analyzed. The review revealed heterogeneity in how diagnostic testing is incorporated into cost-effectiveness models. While some studies excluded the costs and consequences of diagnostic tests entirely, others included them partially or fully. Key findings underscore the substantial impact of testing, particularly for low-prevalence biomarkers. Integrating diagnostic testing into economic evaluations is essential for accurately assessing the health economic value of tumor-agnostic therapies. Economic models must account for test-treatment combinations and consider shifts in treatment pathways compared to routine practice. As the field evolves, the development of robust frameworks and clear guidance on the requirements are crucial to support sustainable and equitable healthcare decision-making.