Cost Analysis of a Pigmented Lesion Assay for Pigmented Skin Lesions.

TAKE-HOME MESSAGE

• The pigmented lesion assay (PLA) is a gene expression test used to rule out melanoma in clinically atypical pigmented lesions. The test uses skin samples collected by adhesive patches and has a very high negative-predictive value (NPV; >99%). The authors of this study compared the costs of the PLA in ruling out melanoma with the costs of the current standard of care, which includes visual inspection of the lesion with subsequent biopsy and histopathologic assessment (VAH). The authors found that using PLA versus VAH resulted in a dramatic reduction in the proportion of individuals undergoing biopsy for suspicious lesions (13.3% vs 69.0%) as well as number of biopsies needed to diagnose melanoma (2.7 vs 15.7). The average cost of the PLA test is USD 500, compared with USD 947 for biopsy and subsequent histopathologic examination of a suspicious lesion.

• Using the PLA to rule out melanoma in a clinically suspicious lesion led to a 47% reduction in healthcare costs by avoiding biopsy and histopathologic evaluation. The PLA has further potential in reducing costs by avoiding unnecessary surgical procedures and missed melanoma diagnoses.

  IMPORTANCE

  A recently described noninvasive gene expression test (the pigmented lesion assay [PLA]) with adhesive patch-based sampling has the potential to rule out melanoma and the need for surgical biopsy of pigmented lesions suggestive of melanoma with a negative predictive value of 99% compared with 83% for the histopathologic standard of care. The cost implications of using this molecular test vs visual assessment followed by biopsy and histopathologic assessment (VAH) have not been evaluated.

  OBJECTIVE

  To determine potential cost savings of PLA use vs the VAH pathway.

  DESIGN, SETTING, AND PARTICIPANTS

  This health economic analysis performed from a US payer perspective was based on consensus treatment guidelines and fee schedules from the Centers for Medicare & Medicaid Services. Data for model input were derived from routine use of the test in US dermatology practices and literature. Participants included patients with primary cutaneous pigmented lesions suggestive of melanoma. Data were analyzed from February 8 to December 1, 2017.

  MAIN OUTCOMES AND MEASURES

  The primary analysis consisted of the relative reduction in costs of diagnostic surgical procedures for PLA vs VAH management. Additional analyses included stage-related treatment costs associated with delays in diagnosis.

  RESULTS

  In the cost analysis for this economic model, the relative reduction in surgical procedure costs (biopsy and subsequent excision), assuming $0 for the PLA to facilitate multiple comparison scenarios, was -$395 compared with VAH. The relative reduction in stage-related treatment costs associated with the PLA was -$433 compared with VAH, primarily associated with avoidance of delays due to false-negative diagnoses. Surveillance costs were reduced by -$119 with the PLA. The total cost of fully adjudicating a lesion suggestive of melanoma by VAH was $947. At a mean selling price reference point for PLA of $500, cost savings of $447 (47%) per lesion tested could be realized.

  CONCLUSIONS AND RELEVANCE

  The results of this analysis suggest that the PLA reduces cost and may improve the care of patients with primary pigmented skin lesions suggestive of melanoma.

  
  
  JAMA Dermatology

  Economic Analysis of a Noninvasive Molecular Pathologic Assay for Pigmented Skin Lesions

  JAMA Dermatol 2018 Jul 11;n/a(n/a)n/a, J Hornberger, DM Siegel