Health economic impact of a biopsy-based cell cycle gene expression assay in localized prostate cancer.

Background: Prior studies have established that broader incorporation of active surveillance, guided by additional prognostic tools, may mitigate the growing economic burden of localized prostate cancer in the USA. This study sought to further explore the potential of a particular gene expression-based prognostic tool to address this unmet need. Materials & methods: A deterministic, decision-analytic model was developed to estimate the economic impact of the Prolaris® test on a US commercial health plan. Results & conclusion: When adopted in patients classified by the American Urological Association as low or intermediate risk, the assay was projected to reduce costs by $1894 and $2129 per patient over 3 and 10 years, respectively, largely through the increased use of active surveillance.

Economic burden of illness associated with localized prostate cancer in the United States.

Aim: Prior studies have established the economic burden of prostate cancer on society. However, changes to screening, novel therapies and increased use of active surveillance (AS) create a need for an updated analysis. Methods: A deterministic, decision-analytic model was developed to estimate medical costs associated with localized prostate cancer over 10 years. Results: 10-year costs averaged $45,957, $99,445 and $188,928 for low-, intermediate- and high-risk patients, respectively. For low-risk patients, AS 10-year costs averaged $33,912/patient, whereas definitive treatment averaged $49,667/patient. Despite higher failure rates in intermediate-risk patients, AS remained less costly than definitive treatment, with 10-year costs averaging $90,614/patient and $99,394/patient, respectively. Conclusion: Broader incorporation of AS, guided by additional prognostic tools, may mitigate this growing economic burden.

Budget impact analysis of a novel gene expression assay for the diagnosis of malignant melanoma.

BACKGROUND: Traditional pathology techniques alone can be insufficient to reliably distinguish between malignant melanoma, dysplastic nevi, and benign nevi in biopsies of suspicious pigmented lesions. Numerous studies have shown high rates of ambiguity when assessing such samples. A novel gene expression assay has been developed to objectively differentiate malignant melanoma from benign nevi. OBJECTIVE: The purpose of this study was to quantify the economic impact of the gene expression assay on a US commercial health plan. METHODS: The clinical paradigm of care was modeled for a hypothetical cohort of patients with suspicious pigmented lesions that are difficult-to-diagnose. Costs were assigned to each unit of care provided based on 2013 Medicare fee-for-service rates. Patients were followed for 10 years and were modeled to progress according to the natural history of their disease. The total cost of care was calculated for two scenarios: a Reference Scenario, representing current clinical practice, and a Test Scenario, in which each lesion was tested with the gene expression assay and diagnosed. Total cost of care was compared between the two scenarios to determine overall budget impact. Sensitivity analyses were performed to test the robustness of the model. RESULTS: The gene expression assay reduces costs by $1268 per patient tested over 10 years, a decrease of 8.3%, after accounting for the cost of the assay. For a health plan with 10 million members, this would translate to over $8 million in savings. The largest portion of this saving comes from reducing the number of missed melanomas, which would otherwise progress to advanced disease. In sensitivity analyses, no single model input changed within a reasonable range of values caused the model to show that the assay was not cost-saving. CONCLUSION: In addition to improving the diagnosis of melanoma, this gene expression assay would likely reduce costs for health plans that choose to cover it.