The Potential Value-Based Price of a Multi-Cancer Early Detection Genomic Blood Test to Complement Current Single Cancer Screening in the USA

Abstract

Background: Multi-cancer early detection (MCED) testing could increase detection of cancer at early stages, when survival outcomes are better and treatment costs are lower, but is expected to increase screening costs. This study modeled an MCED test for 19 solid cancers in a US population and estimated the potential value-based price (the maximum price to meet a given willingness to pay) of the MCED test plus current single cancer screening (usual care) compared to usual care alone from a third-party payer perspective over a lifetime horizon.

Methods: A hybrid cohort-level state-transition and decision-tree model was developed to estimate the clinical and economic outcomes of annual MCED testing between age 50 and 79 years. The impact on time and stage of diagnosis was computed using an interception modeling approach, with the consequences of cancer modeled based on stage at diagnosis. The model parameters were mainly sourced from the literature, including a published case-control study to inform MCED test performance. All costs were inflated to 2021 US dollars.

Results: Multi-cancer early detection testing shifted cancer diagnoses to earlier stages, with a 53% reduction in stage IV cancer diagnoses, resulting in longer overall survival compared with usual care. Addition of MCED decreased per cancer treatment costs by $5421 and resulted in a gain of 0.13 and 0.38 quality-adjusted life-years across all individuals in the screening program and those diagnosed with cancer, respectively. At a willingness-to-pay threshold of $100,000 per quality-adjusted life-year gained, the potential value-based price of an MCED test was estimated at $1196. The projected survival of individuals diagnosed with cancer and the number of cancers detected at an earlier stage by MCED had the greatest impact on outcomes.

Conclusions: An MCED test with high specificity would potentially improve long-term health outcomes and reduce cancer treatment costs, resulting in a value-based price of $1196 at a $100,000/quality-adjusted life-year willingness-to-pay threshold.

Fig. 1

Overview of the model structure with an example of stage and time shifting of diagnosed cancers due to a multi-cancer early detection (MCED) test. a *False-positive patients (in asymptomatic/no cancer group) and those misdiagnosed because of a wrong cancer signal origin (in detected cancer group) accrued additional work-up costs and disutilities before being accurately assigned to having cancer or not. b An individual who will be diagnosed with cancer at stage III under usual care (left), may (i) have the same cancer diagnosis with MCED testing, (ii) the cancer detection shifted to stage II and an earlier age, or (iii) the cancer detection shifted to stage I and an even earlier stage. Note: Patients can die from background mortality during the pre-diagnosis phase

Fig. 2

Number of patients diagnosed with cancer (overall total and example cancers). Note: The total number of cancers diagnosed by multi-cancer early detection (MCED) plus usual care are higher than those diagnosed by the usual care arm alone as the base case considers overdiagnosis. Overall stage shift represents a combination of cancers that have a substantial stage shift due to MCED (e.g., esophageal) and those with a more modest stage shift (e.g., hormone receptor positive [HR+] breast cancer)

Fig. 3

Base-case cost outcomes (lifetime cost per person). MCED multi-cancer early detection. Note: All reported cost outcomes are discounted

Fig. 4

Tornado diagram of sensitivity analyses. MCED multi-cancer early detection. Note: Sorting based on the greatest to least variation in change from $100,000/quality-adjusted life-year incremental cost-effectiveness ratio

Fig. 5

Results from stepped inclusion scenario analyses (sensitivity and incidence). An anus, Bl bladder, Br- breast HR-, Br+ breast HR+, Ce cervix, CR colon and rectum, Es esophagus, HN head and neck, KR kidney and renal pelvis, LI liver and intrahepatic bile duct, LB lung and bronchus, LM lymphoma, Oth other, Ov ovarian, Pa pancreas, Pr prostate, QALY quality-adjusted life-year, St stomach, Ur urothelial, Ut uterus