40-GEP Test Utilization Can Mitigate Financial Burden of Cutaneous Squamous Cell Carcinoma

Patients with cutaneous squamous cell carcinoma (cSCC) would save substantially on Medicare costs with the use of the 40-gene expression profile (40-GEP) to inform decisions regarding adjuvant radiation therapy (ART), according to a recent study published in Journal of Clinical and Aesthetic Dermatology.

Gene Expression Analysis Concept | image credit: Катерина Євтехова - stock.adobe.com

Prior research has demonstrated the efficacy of ART in reducing recurrence and metastasis in cSCC. While ART is a recommended treatment for patients with localized forms of high risk cSCC, these patients are vulnerable to over- or under-treatment due to the spectrum of metastatic risks they possess. Furthermore, ART is accompanied by various unpleasant side effects such as vomiting, nausea, hair loss, dermatitis, long-term events like dementia, lymphedema, or heightened risks for secondary cancers, and high costs. Identifying patients who can derive the most benefits from ART and maximizing the balance between treatment outcomes, complications, and associated costs has been an ongoing challenge for clinicians.

The 40-GEP test is used to assess patient risks for metastasis in cases of high-risk cSCC. In this method, patients are classified as at low risk (Class 1), moderate risk (Class 2A) or high risk (Class 2B) for metastatic potential. As the authors of the present study mention, prior studies have shown that results from the 40-GEP test can influence patient-care decisions such as surveillance imaging, follow-up care, and administration of ART. As research continues to be conducted on the safety and efficacy of ART, the current study sought to investigate whether the use of the 40-GEP test to inform ART decisions reduces health care costs for Medicare-eligible patients with cSCC.

From May 2021 to May 2022, eligible patients were identified through the IQVIA database and normalized medical claims data. The claims data included 4 primary current procedural terminology (CPT) code-defined radiation therapy modalities: radiation therapy (XRT), intensity-modulation radiation therapy (IMRT), image-guided proton therapy (IGPT), and intensity modulated proton therapy (IMPT). Due to a lack of standardized selection criteria for ART, researchers analyzed 3 separate scenarios for ART-eligible individuals. In the first scenario, study A assess prospective clinical orders with composite results from 40-GEP at rates of 70.4% in Class 1 patients, 27.1% in Class 2A, and 2.5% in Class 2B. Study B was a clinical validation study with composite 40-GEP result rates of 46.8% in Class 1, 47.5% in Class 2A, and 5.7% in Class 2B. Study C was an observed distribution of a high-risk cSCC population who underwent ART that had composite 40-GEP result rates of 24.4% for Class 1, 55.6% in Class 2A, and 20% in Class 2B. This last study was meant to evaluate the financial implications of going without ART.

A total of 22,917 Medicare-eligible patients with cSCC who received ART in the US were identified. Their average direct costs for ART, which included IGRT, IMRT, XRT, and IMPT, was $60,693 per patient. These costs added up to a projected $1.4 billion in annual ART costs. Through a sensitivity analysis, researchers observed that, dependent on the distribution of 40-GEP results, an additional $38 million to $66 million could be saved annually for each 10% of Class 2A tests that omitted ART. Overall, using the 40-GEP test to forego ART in Medicare-eligible patients with cSCC could save an estimated $972 million for this population.

These findings showcased the value the 40-GEP test possess to substantially reduce health care costs and unnecessary treatments in the management of cSCC throughout the Medicare system. If this study should be expanded further, researchers noted the need to more comprehensive information on ART-related complications and more complete patient information to investigate this impact.

Reference

Somani AK, Ibrahim SF, Tassavor M, Yoo J, Farberg AS. Use of the 40-gene expression profile (40-GEP) test in Medicare-eligible patients diagnosed with cutaneous squamous cell carcinoma (cSCC) to guide adjuvant radiation therapy (ART) decisions leads to a significant reduction in healthcare costs. J Clin Aesthet Dermatol. 2024;17(1):41-44. https://jcadonline.com/gene-expression-profile-squamous-cell-carcinoma/