Authors' objectives: This health technology assessment evaluates the diagnostic accuracy, clinical utility, and budget impact of publicly funding pigmented lesion assay for people with suspected melanoma skin lesions. It also evaluates the experiences, preferences, and values of people who have experience with skin biopsy for suspected melanoma.

Authors' results and conclusions: Results We included seven studies in the clinical evidence review. Pigmented lesion assay has a sensitivity of 79% (95% confidence interval [CI] 58%–93%) and a specificity of 80% (95% CI 73%–85%; GRADE: Low). We found one published cost-effectiveness study with potentially serious limitations. Therefore, the cost-effectiveness of pigmented lesion assay compared with the standard care pathway is currently uncertain. Assuming a very low uptake, we estimated that the budget impact of publicly funding pigmented lesion assay in Ontario over the next 5 years is about $3.44 million if the test is used exclusively by primary care providers, or about $2.56 million if it is used exclusively by specialists. The people with whom we spoke who had experienced biopsy for suspected melanoma responded positively to the potential benefits of pigmented lesion assay, emphasizing its ease-of-use, potential increase in early detection of melanoma, and reduction in physical and emotional burden of unnecessary biopsies. Participants also felt that the accuracy of this tool was essential to ensure minimal false negatives. Conclusions There is uncertainty because of the low-quality evidence for the diagnostic accuracy of pigmented lesion assay. The cost-effectiveness of pigmented lesion assay compared with standard care is also uncertain. We estimated that publicly funding pigmented lesion assay in Ontario over the next 5 years would result in additional costs of $3.44 million (if used exclusively by primary care providers) or $2.56 million (if used exclusively by specialists). For people who had experienced biopsy for suspected melanoma, it was felt that pigmented lesion assay could represent an effective tool to increase early detection and avoid unnecessary biopsies, if the tool was accurate.

Authors' recommendations: Ontario Health, based on guidance from the Ontario Health Technology Advisory Committee, recommends against publicly funding pigmented lesion assay for people with suspected melanoma lesions

Authors' methods: We performed a systematic literature search of the clinical evidence. We assessed the risk of bias of each included study using the Quality Assessment of Diagnostic Accuracy Studies–2 (QUADAS-2) and the Risk of Bias Assessment Tool for Non-randomized Studies (RoBANS). We assessed the quality of the body of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We performed a systematic literature search of the economic evidence. We also analyzed the budget impact of publicly funding pigmented lesion assay in adults with suspected melanoma in Ontario. To contextualize the potential value of pigmented lesion assay, we spoke with people who had undergone skin biopsy for melanoma. We also used the qualitative research synthesis from a report by the Canadian Agency for Drugs and Technologies in Health to provide context for the preferences and values of those with suspected melanoma.

Project Status: Completed

URL for project: https://www.hqontario.ca/evidence-to-improve-care/health-technology-assessment/reviews-and-recommendations/pigmented-lesion-assay-for-suspected-melanoma-lesions

Year Published: 2021

URL for published report: https://www.hqontario.ca/Portals/0/Documents/evidence/reports/hta-pigmented-lesion-assay-for-suspected-melanoma-lesions.pdf

Requestor: Ontario Health Technology Advisory Committee (OHTAC); Ontario Ministry of Health

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Canada

Province: Ontario

Organisation Name: Ontario Health

Contact Address: 525 University Ave, Toronto, ON M5G 2L3

Contact Name: Nancy Sikich, Director Health Technology Assessment

Contact Email: oh-hqo_hta@ontariohealth.ca

Copyright: © Queen’s Printer for Ontario, 2021 The copyright for all Ontario Health publications is owned by the Queen’s Printer for Ontario. Materials may be reproduced for commercial purposes only under a licence from the Queen’s Printer. For further information or to request a licence to reproduce content, please contact: Senior Copyright Advisor Publications Ontario 416-326-5153 copyright@ontario.ca