OBJECTIVES : Genetic testing is critical to optimizing the outcomes of targeted therapies since testing identifies patients who are most likely to benefit from these treatments. Further, product labels may require genetic testing. Thus, it is important to understand current genetic testing reimbursement policies. This study characterized the global reimbursement landscape of genetic testing across thirteen markets.

METHODS : Secondary research through various sources (e.g., insurance policies, fee schedules, laboratory catalogues, government websites, etc.) was conducted to understand current reimbursement mechanisms for genetic testing. Thirteen markets across five continents were surveyed: US, Canada, EU4, UK, Switzerland, Sweden, Japan, China, Brazil, and Australia. Findings on current reimbursement policies and coding infrastructure were synthesized. The presence of manufacturer-sponsored genetic testing was also researched.

RESULTS : Several trends in genetic testing reimbursement were identified. While genetic testing is often reimbursed in the majority (10/13, 77%) of surveyed markets, 3/13 (23%) do not provide routine public reimbursement for genetic testing (Australia, Brazil, and China).

The coding infrastructure utilized for genetic testing reimbursement varies across the 10/13 (77%) markets with coverage. 6/13 (46%) of markets (USA, France, Germany, Switzerland, Sweden, and Japan) often utilize general genetic testing codes, which are independent of any gene or disease. Codes specific to genes or diseases were found in 3/13 (23%) of markets (UK, Spain, and Canada). In 1/13 (8%) markets (Italy), both general and specific codes were identified.

Manufacturer-sponsored genetic testing programs were identified in all markets across various diseases. These programs encompassed both direct patient sponsorship and more indirect avenues such as grants to research or patient advocacy organizations.

CONCLUSIONS : Reimbursement of genetic testing varies globally across markets. Since securing reimbursement can be a complex process which differs across markets, sponsors should carefully assess any reimbursement barriers and consider mitigation tactics in order to increase access and uptake for products that require genetic testing.