Trosman Julia R, Weldon Christine B, Kurian Allison W, Pasquinelli Mary M, Kircher Sheetal M, Martin Nikki, Douglas Michael P, Phillips Kathryn A
UCSF Center for Translational and Policy Research on Precision Medicine (TRANSPERS), San Francisco, CA 94143, United States.
Department of Clinical Pharmacy, University of California San Francisco, San Francisco, CA 94143, United States.
Health Aff Sch. 2023 Jun 20;1(1):qxad005. doi: 10.1093/haschl/qxad005. eCollection 2023 Jul.
Emerging blood-based multicancer early-detection (MCED) tests may redefine cancer screening, reduce mortality, and address health disparities if their benefit is demonstrated. U.S. payers' coverage policies will impact MCED test adoption and access; thus, their perspectives must be understood. We examined views, coverage barriers, and evidentiary needs for MCED from 19 private payers collectively covering 150 000 000 enrollees. Most saw an MCED test's potential merit for cancers without current screening (84%), but fewer saw its merit for cancers with existing screening (37%). The largest coverage barriers were inclusion of cancers without demonstrated benefits of early diagnosis (73%), a high false-negative rate (53%), and lack of care protocols for MCED-detected but unconfirmed cancers (53%). The majority (58%) would not require mortality evidence and would accept surrogate endpoints. Most payers (64%) would accept rigorous real-world evidence in the absence of a large randomized controlled trial. The majority (74%) did not expect MCED to reduce disparities due to potential harm from overtreatment resulting from an MCED and barriers to downstream care. Payers' perspectives and evidentiary needs may inform MCED test developers, researchers producing evidence, and health systems framing MCED screening programs. Private payers should be stakeholders of a national MCED policy and equity agenda.
新兴的基于血液的多癌早期检测（MCED）测试如果能证明其益处，可能会重新定义癌症筛查、降低死亡率并解决健康差异问题。美国医保支付方的覆盖政策将影响MCED测试的采用和可及性；因此，必须了解他们的观点。我们调查了19家私人医保支付方对MCED的看法、覆盖障碍和证据需求，这些支付方总共覆盖了1.5亿参保人。大多数人认为MCED测试对于目前尚无筛查手段的癌症具有潜在价值（84%），但认为其对已有筛查手段的癌症具有价值的人较少（37%）。最大的覆盖障碍包括纳入早期诊断无明显益处的癌症（73%）、高假阴性率（53%）以及缺乏针对MCED检测出但未经确认的癌症的护理方案（53%）。大多数人（58%）不需要死亡率证据，并会接受替代终点。在没有大型随机对照试验的情况下，大多数医保支付方（64%）会接受严格的真实世界证据。大多数人（74%）预计MCED不会减少差异，因为MCED可能导致过度治疗带来潜在危害以及下游护理存在障碍。医保支付方的观点和证据需求可能会为MCED测试开发者、提供证据的研究人员以及制定MCED筛查计划的卫生系统提供参考。私人医保支付方应成为国家MCED政策和公平议程的利益相关者。
