Multicancer Early detection Panels (MCEDs) in the Primary Care Setting

Ueberroth, Benjamin E.; Marks, Lisa; Borad, Mitesh J.; Agrwal, Neera

doi:10.1016/j.amjmed.2022.03.006

Cited by 9 publications

(8 citation statements)

References 14 publications

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“…Other coverage hurdles previously identified for presymptomatic tests, and expected for MCED tests, were a requirement for cost-effectiveness and payers’ unwillingness to cover tests for broad versus risk-defined populations. 20 , 37 , 50 , 51 In contrast, most payers in our study would not require cost-effectiveness data for MCED test coverage and nearly half would cover MCED tests for population screening, if proven. This also suggests that private payers’ coverage approaches are evolving over time.…”

Section: Discussionmentioning

confidence: 96%

“…Despite the lack of evidence and reimbursement, clinical implementation of MCED tests has begun. 20 , 25 , 26 , 54 It has been suggested that incorporating payer perspectives into clinical implementation of medical innovations can make implementation more appropriate 39 and we believe this is also true for MCED tests. Payers’ evidentiary needs and requirements may help health systems adopting MCED tests assess evolving evidence in the context of potential coverage, forecast when and for which tests coverage may occur, and integrate these forecasts into MCED programs.…”

Section: Discussionmentioning

confidence: 99%

“… 14 , 17–19 Despite assumptions that MCED tests will reduce cancer disparities, its impact on health equity is unknown. 20–22 …”

Section: Introductionmentioning

confidence: 99%

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

Trosman

Weldon²,

Kurian

et al. 2023

Health Affairs Scholar

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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.

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Section: Discussionmentioning

confidence: 96%

Section: Discussionmentioning

confidence: 99%

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

Trosman

Weldon²,

Kurian

et al. 2023

Health Affairs Scholar

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“…GRAIL's Galleri test 17,22 and Thrive's DETECT-A 20 (Detecting cancers Earlier Through Elective Mutation-based blood Collection and Testing) are of note. However, as many recent studies have shown, the issue of low PPV persists as a signi cant limitation of the newly developed multicancer tests (see Supplementary Table S1) 17,20,22,23 . Thus, a risk-strati ed approach is likely to be needed to enhance the risk-bene t balance of these tests.…”

Section: Introductionmentioning

confidence: 99%

Potential Utility of Risk Stratification for Multicancer Screening with Liquid Biopsy Tests

Chatterjee

Kim

Scharpf

et al. 2023

Preprint

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Our proof-of-concept study reveals the potential of risk stratification by the combined effects of age, polygenic risk scores (PRS), and non-genetic risk factors in increasing the risk-benefit balance of rapidly emerging non-invasive multicancer liquid biopsy tests for early cancer detection. We develop and validate sex-specific pan-cancer risk scores (PCRSs), defined by the combination of body mass index, smoking, family history of cancers, and cancer-specific polygenic risk scores (PRSs), to predict the absolute risk of developing at least one of the many common cancer types. We demonstrate the added value of PRSs in improving the predictive performance of the risk-factors-only model and project the positive predictive values for two promising multicancer screening tests across risk strata defined by age and PCRS.

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“…MCED has the promise to lower cancer mortality, especially through early detection of cancers for which there is currently no screening available. However, as many recent studies have shown, the issue of low PPV persists as a significant limitation of the newly developed multicancer tests (Supplementary Table 1 ) 21 , 24 , 26 , 29 . The values of PPV for tests are anticipated to be highly influenced by specificity, and for a constant specificity value, by the combination of sensitivity and prevalence.…”

mentioning

confidence: 99%

Potential utility of risk stratification for multicancer screening with liquid biopsy tests

et al. 2023

View full text Add to dashboard Cite

Our proof-of-concept study reveals the potential of risk stratification by the combined effects of age, polygenic risk scores (PRS), and non-genetic risk factors in increasing the risk-benefit balance of rapidly emerging non-invasive multicancer early detection (MCED) liquid biopsy tests. We develop and validate sex-specific pan-cancer risk scores (PCRSs), defined by the combination of body mass index, smoking, family history of cancers, and cancer-specific polygenic risk scores (PRSs), to predict the absolute risk of developing at least one of the many common cancer types. We demonstrate the added value of PRSs in improving the predictive performance of the risk factors only model and project the positive and negative predictive values for two promising multicancer screening tests across risk strata defined by age and PCRS.

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Multicancer Early detection Panels (MCEDs) in the Primary Care Setting

Cited by 9 publications

References 14 publications

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

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

Potential Utility of Risk Stratification for Multicancer Screening with Liquid Biopsy Tests

Potential utility of risk stratification for multicancer screening with liquid biopsy tests

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