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Expert Rev Pharmacoecon Outcomes Res. 2013 Jun;13(3):371-80. doi: 10.1586/erp.13.22. Epub 2013 May 15.

Cost-effectiveness of a FISH assay for the diagnosis of melanoma in the USA.

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  • 1United BioSource Corp., Modeling and Simulation, Bethesda, MD, USA.



The authors evaluated the cost-effectiveness of a FISH assay in melanoma diagnosis in the USA.


A model was developed simulating the addition of FISH to the diagnosis of suspected melanoma. A decision analytic module simulated diagnosis using microscopic assessment alone versus addition of FISH (sensitivity: 92%; specificity: 94%). The authors simulated a clinical setting in which an initial excisional biopsy microscopic assessment (sensitivity: 73%; specificity: 78%) was followed by dermatopathologist assessment (sensitivity: 89%; specificity: 79%) for inconclusive results. Diagnostic strategies 1 and 2 added FISH to the initial and dermatopathologist assessments, respectively. A Markov outcomes module simulated patients' remaining lifetime, including treatment.


In diagnostic strategies 1 and 2, the cost per quality-adjusted life year gained was US$14,930 and 43,925, respectively, versus no FISH. Cost per misdiagnosis avoided was US$3292 and 3759, respectively. Sensitivity and specificity without FISH were both ≥88%; however, addition of FISH exceeded US$100,000/quality-adjusted life year.


In specific clinical settings, FISH could be cost effective for melanoma diagnosis.

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