OBJECTIVES

To conduct an assessment of precision medicine diagnostics coverage between Medicare MolDx and leading US commercial payer plans

METHODS

To date, a comprehensive analysis of heterogeneity in plan coverage rationale and status for precision diagnostics has not been conducted. In response, the study authors performed a coverage profile assessment for a cohort of 58 precision diagnostics drawn from Medicare’s MolDx coverage policy database from January 2015 to November 2020. Coverage status and evidence-based gap analysis commentary for each diagnostic (or diagnostic class) was evaluated against corresponding coverage policies from the ten largest commercial insurers nationally.

RESULTS

Compared to Medicare's MolDx coverage positions, commercial plan coverage of precision diagnostics is more restrictive, with stakeholders most frequently citing a need for more compelling clinical utility and proxy health economic value demonstrations. Our study findings suggest a need for manufacturers to incorporate specific, robust clinical evidence frameworks to facilitate more expansive market access of these assays; in support, we also present a payer-validated (n=2) qualitative case study addressing how coverage could be improved for pharmacogenomic testing for psychiatric medications.

CONCLUSIONS

Currently, coverage of precision diagnostics, and by proxy broader utilization, is limited by sufficiently resonant clinical utility data. Expanded market access will be driven by improved addressable patient population framing and demonstration of positive impact of test use on patient outcomes and healthcare delivery efficiency.