Physician Blog

An Interview with Dr. Dan Siegel, Co-Author of the Recent Publication in JAMA Dermatology, “Economic Analysis of a Noninvasive Molecular Pathologic Assay for Pigmented Skin Lesions”

August 3, 2018

What was the background for this Health Economic study?
The current standard of care pathway for assessing pigmented skin lesions suspicious of melanoma is visual assessment followed by surgical biopsy and histopathology. Unfortunately there is considerable overlap between histopathologic criteria of benign pigmented lesions and early melanomas leading to a negative predictive value of around 83% (or a 17% chance of missing melanoma) while biopsying about 90% of benign lesions that don’t need to be biopsied. There is growing evidence that gene expression risk factors tied to melanoma biology may matter more than what a lesion looks like. The background for this study was to determine if DermTech’s Pigmented Lesion Assay (PLA), a highly accurate and non-invasive melanoma rule-out gene expression test with a negative predictive value of over 99% (and a less than 1% chance of missing melanoma) that dramatically reduces avoidable biopsies while missing fewer melanomas can also reduce cost. People generally believe that the cost of such a molecular test will be higher than the current care standard. This study looked at the cost implications from a US payer prospective and was based on consensus treatment guidelines, published peer reviewed literature and fee schedules from Medicare.

What were the key findings?
The study found that the PLA reduces cost versus the VAH pathway. At an average price of $500, the PLA provides substantial cost savings of about $450 peradjudicated pigmented skin lesion. Savings are driven primarily by the reduction in surgical biopsies and excisions and reduced stage-related treatment costs impacted by not missing melanomas and detecting them earlier. The PLA reduces the number needed to biopsy to detect a melanoma from about 25 for dermatologists and 39 for physician assistants as most recently published by Laura Ferris and colleagues in JAMA Dermatology to 2.7.

What should readers take away from your study?
The take home message is that cutting edge technology can deliver better care at reduced cost.

Do you have any recommendations for future research as a result of this study?
It will be interesting to see if future Non-Invasive Molecular Pathology tests for other types of skin cancer, like basal cell or squamous cell carcinoma, that are based on the same non-invasive adhesive patch sample collection platform can similarly improve performance while reducing cost.

Is there anything else you would like to add?
Gene expression risk factors may matter more than what skin lesions suspicious of melanoma look like – it’s an honor to be part of a likely paradigm shift in dermatology that helps both our patients and the healthcare system. I enjoy being part of this journey and helping out on DermTech’s scientific advisory board.

Daniel Siegel, MD, is a Clinical Professor of Dermatology at SUNY Downstate and is a former President of the American Academy of Dermatology. He is also in private practice with Long Island Skin Cancer and Dermatologic Surgery in Smithtown, New York