Insurer coverage of prostate cancer biomarkers.

INTRODUCTION: Several recently-developed prostate cancer (CaP) biomarkers are recommended per national guidelines, yet feasibility of obtaining these tests is unknown. We used a national database to assess insurance coverage of CaP biomarkers.

MATERIALS AND METHODS: Insurance policies regarding 4K Score, ExoDx, My Prostate Score, Prostate Cancer Antigen 3, Prostate Health Index, and SelectMDx as of January 1, 2022 were extracted from the policy reporter database. Coverage was defined as a biomarker being deemed medically necessary, conditionally covered, or covered with prior authorization. Overall rates of biomarker coverage were compared by insurance type and region using Chi-squared test. SelectMDx was not covered by any queried policies and was omitted from analysis.

RESULTS: A total of 186 insurance plans were identified among 131 payers. Of the 186 plans, 109 (59%) covered at least one biomarker, with prior authorization required for 38 (35%) of these plans. Prostate Cancer Antigen 3 and 4K Score had higher rates of coverage compared to ExoDx, Prostate Health Index, and My Prostate Score (52% and 43% vs. 26%, 26%, and 5%, respectively, P < 0.01). Medicare plans had higher rates of coverage compared to non-Medicare plans (80% Medicare vs. 17% commercial, 15% federal employer, and 13% Medicaid, P < 0.01), and nationwide plans had higher coverage rates compared to regional plans (43% nationwide vs. 32% midwest, 27% northeast, 25% south, 24% west, P < 0.01). Covered biomarkers under Medicare plans were less likely to require prior authorization compared to those covered by non-Medicare plans (12% Medicare vs. 63% commercial, 100% federal employer, 70% Medicaid, P < 0.01).

CONCLUSIONS: Coverage of novel CaP biomarkers are relatively robust for Medicare plans but sparse for non-Medicare plans, with the majority of non-Medicare plans requiring prior authorization. Non-Medicare eligible men may face significant barriers to obtaining these tests.