title: Budget impact analysis of a novel gene expression assay for the diagnosis of malignant melanoma.
abstract: 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.
  
  
  CONCLUSIONS
  In addition to improving the diagnosis of melanoma, this gene expression assay would likely reduce costs for health plans that choose to cover it.
authors.affiliation: Department of Pathology, Southern California Permanente Medical Group , Los Angeles, CA , USA.
authors.forename: David S
authors.initials: DS
authors.lastname: Cassarino
authors.forename: Nicolas
authors.initials: N
authors.lastname: Lewine
authors.forename: Doria
authors.initials: D
authors.lastname: Cole
authors.forename: Brandon
authors.initials: B
authors.lastname: Wade
authors.forename: Gary
authors.initials: G
authors.lastname: Gustavsen
mesh_terms: D003362:Cost-Benefit Analysis; D003365:Costs and Cost Analysis; D003661:Decision Support Techniques; D003937:Diagnosis, Differential; D018450:Disease Progression; D020869:Gene Expression Profiling / Q000191:economics*; D005102:Health Expenditures / Q000706:statistics & numerical data*; D006801:Humans; D006278:Medicare / Q000191:economics*; D008545:Melanoma / Q000175:diagnosis*; D017059:Models, Econometric; D014481:United States
keywords: Cost-effectiveness; Dermatology; Gene expression; Health economics; Melanoma; Myriad myPath Melanoma; Pathology