Perspectives of private payers on multicancer early-detection tests: informing research, implementation, and policy

Abstract

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.

Primary Care Patient Interest in Multi-Cancer Early Detection for Cancer Screening

“…Findings from the current study suggest that when patients are provided information about MCED testing that focuses on the describing the logistics of having a "simple" blood test for cancer screening, patient interest in having MCED testing is likely to be very high. Before making MCED testing widely available to primary care patients, however, health systems and health care providers should consider not only the results of clinical trials, but also how to address the need to provide patients with more complete information about the pros and cons of MCED testing, including details related to test use in concert with other types of recommended cancer screening tests, procedures required for following up abnormal MCED test findings, and insurance coverage and costs associated with testing and follow-up [29]. Attention should also be paid to addressing provider concerns related to the time required for patient education and decision support, along with the management of false positive and false negative findings.…”

Cancer screening with multicancer detection tests: A translational science review

“…Some health plans provide MCD tests as part of their screening programs; however, in a recent study of 19 major private payers, none reported covering MCD testing. 7 The usefulness of a cancer screening test to reduce cancer morbidity and mortality is interrelated with test performance measures, such as sensitivity (correctly detecting a cancer signal in those with cancer) and specificity (correctly identifying a cancer signal only in those with cancer), the acceptability and affordability of the test, the potential burden and costs of the diagnostic workup after a positive MCD screening result, and effective cancer care delivery that leads to improved patient outcomes, including survival. To date, cancer detection tests recommended for widespread population screening (breast, cervix, colon, and lung) have demonstrated improvements in cancer-specific mortality.…”

“…At this time, no MCD tests have received marketing authorization by the US Food and Drug Administration (FDA). Some health plans provide MCD tests as part of their screening programs; however, in a recent study of 19 major private payers, none reported covering MCD testing 7 …”