Challenges of Conducting Value Assessment for Comprehensive Genomic Profiling

Area of Science:

• Oncology
• Genomics
• Health Economics

Background:

• Precision medicine is transforming clinical practice, with comprehensive genomic profiling (CGP) showing promise as a universal companion diagnostic.
• CGP can potentially improve patient outcomes and healthcare efficiency, but assessing its value presents unique challenges.

Purpose of the Study:

• To evaluate the challenges in assessing the value of comprehensive genomic profiling (CGP) within current health technology assessment (HTA) frameworks.
• To propose policy reforms for value assessment and funding to enhance patient access to CGP.

Main Methods:

• Analysis of academic and policy literature in oncology.
• Stakeholder interviews with health economists, payers, clinicians, and public policy officials.
• Examination of health technology assessment (HTA) processes, including incremental cost-effectiveness ratios (ICER).

Main Results:

• Value assessment of CGP varies across healthcare systems and is often ill-suited to current HTA processes, especially for tests with multiple associated therapies.
• Existing HTA approaches struggle to account for the broader systemic benefits of CGP, such as enhanced clinical trial participation.
• Current HTA models limit the comprehensive value assessment of CGP.

Conclusions:

• Current health technology assessment (HTA) models are inadequate for evaluating the full value of comprehensive genomic profiling (CGP).
• Policy proposals include investing in genomic testing infrastructure, decoupling CGP assessment from specific therapies, tailoring evaluation methods, and collecting broader evidence of benefit.
• Reforms are necessary to improve patient access to CGP and realize its potential in precision medicine.