Department of Urology, New York-Presbyterian Hospital, Weill Cornell Medical College, New York, NY.
Department of Urology, University Hospitals Cleveland Medical Center, Case Western Reserve University School of Medicine, Cleveland, OH.
Urol Oncol. 2023 Jul;41(7):324.e9-324.e12. doi: 10.1016/j.urolonc.2023.04.020. Epub 2023 May 23.
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.
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.
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).
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.
国家指南建议使用几种新开发的前列腺癌（CaP）生物标志物，但获得这些检测的可行性尚不清楚。我们使用国家数据库评估 CaP 生物标志物的保险覆盖范围。
截至 2022 年 1 月 1 日，从政策报告数据库中提取了有关 4K Score、ExoDx、My Prostate Score、前列腺癌抗原 3、前列腺健康指数和 SelectMDx 的保险政策。将生物标志物被视为医学必需、有条件覆盖或有事先授权覆盖的情况定义为覆盖。使用卡方检验比较不同保险类型和地区的生物标志物覆盖总体率。由于 SelectMDx 未被任何查询的政策涵盖，因此未包含在分析中。
在 131 家支付方中，共确定了 186 份保险计划。在这 186 个计划中，有 109 个（59%）覆盖了至少一种生物标志物，其中 38 个（35%）计划需要事先授权。与 ExoDx、前列腺健康指数和 My Prostate Score 相比，前列腺癌抗原 3 和 4K Score 的覆盖率更高（分别为 52%和 43%，而分别为 26%、26%和 5%，P < 0.01）。与非医疗保险计划相比，医疗保险计划的覆盖率更高（医疗保险 80%，商业保险 17%，联邦雇主保险 15%，医疗补助保险 13%，P < 0.01），与区域计划相比，全国性计划的覆盖率更高（全国性计划 43%，中西部地区 32%，东北地区 27%，南部地区 25%，西部地区 24%，P < 0.01）。与非医疗保险计划相比，医疗保险计划下覆盖的生物标志物不太可能需要事先授权（医疗保险 12%，商业保险 63%，联邦雇主保险 100%，医疗补助保险 70%，P < 0.01）。
对于医疗保险计划，新型 CaP 生物标志物的覆盖范围相对广泛，但对于非医疗保险计划则很少，大多数非医疗保险计划都需要事先授权。非医疗保险合格男性可能在获得这些检测方面面临重大障碍。
