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

Abstract

Objective: The authors evaluated the cost–effectiveness of a FISH assay in melanoma diagnosis in the USA. Method: 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. Results: 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. Conclusion: In specific clinical settings, FISH could be cost effective for melanoma diagnosis.

Keywords::

• diagnosis
• economic analysis
• FISH
• melanoma
• model

Acknowledgements

The authors gratefully acknowledge the contributions of Ekaterina Pestova and Gu Li to the initial model concept and approach, model review and interpretation of results. The authors also thank Susan Jewell for her helpful contributions to the model concept development.

Financial & competing interests disclosure

A Kansal, A Shaul and S Stern are employees of United BioSource Corp., which received funding from Abbott Diagnostics to conduct this study. K Busam received honorarium from Abbott Diagnostics. C Doucet and D Chalfin are employees of Abbott Diagnostics. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.