OBJECTIVES

Testing for genomic tumor markers can potentially inform diagnosis, prognosis, and treatment choice. Its success, however, hinges on careful translation and integration into routine cancer care. This global payer landscape review assesses the barriers to and opportunities for genomic testing across key health systems.

METHODS

We reviewed payer coverage policies, national and local coverage determinations, and health technology assessments in North America, European Union Five (EU5), Japan, and Australia pertaining to the use of next generation sequencing (NGS) and various oncology biomarkers.

RESULTS

Our review demonstrated that many countries’ reimbursement policies require proven clinical utility for the diagnostic modality and specific biomarkers for coverage. However, there is widespread uncertainty as to how clinical utility is defined and evaluated. While the NGS reimbursement landscape is highly variable, the United States (US), EU5, and Japan lead the way in expanding access to this technology. In the US, the 2018 national coverage determination (NCD) covers NGS tests provided to Medicare beneficiaries with advanced cancer. The NCD offers a roadmap for coverage, however only 2 of the 5 major private payers have published policies outlining the evidentiary requirements to demonstrate the clinical utility of NGS use in routine care. In EU5, NGS funding is most clearly established in Germany and France, where fee schedule-based funding and fixed rate schemes are available. Similarly, Japan approved national coverage for NGS in 2019 based on a fixed rate scheme. Dedicated NGS funding does not exist in the rest of the EU5 and countries like Canada, because current systems hinder the introduction of new fee codes for novel medical technologies. Combined, reimbursement hurdles and lacking clinical guidelines have resulted in slow testing uptake.

CONCLUSIONS

While the advent of increasing affordability and availability of NGS will expand testing use, reimbursement hurdles remain a challenging barrier to clinical adoption of genomic testing.