Studying Off Label Insurance Coverage for Patients With Cutaneous Cancers a "Filter" Observational Study

This study evaluates the time spent on obtaining insurance approval and drugs, means of insurance coverage, out-of-pocket costs for patients, and the surgical outcomes after neoadjuvant treatment is completed in skin cancer patients receiving "off label" and "on label" neoadjuvant treatment. "Neoadjuvant therapy" means cancer treatment given before surgery. However, in many instances, neoadjuvant therapy is used as an "off-label" approach for several types of skin cancers. "Off-label" means that the FDA has not yet approved its use for that type of cancer. Therefore, insurance approval of these "off-label" treatments could be delayed compared to label use, and "off-label" treatments may require several weeks of pre-authorization. There is evidence that the delayed start of cancer treatment can lead to poorer outcomes.

NCT Number	NCT07215988
Lead Sponsor	Ohio State University Comprehensive Cancer Center
Conditions	Clinical Stage II Cutaneous Merkel Cell Carcinoma AJCC v8, Clinical Stage III Cutaneous Merkel Cell Carcinoma AJCC v8, Clinical Stage IV Cutaneous Merkel Cell Carcinoma AJCC v8, Locally Advanced Basal Cell Carcinoma, Locally Advanced Malignant Skin Neoplasm, Locally Advanced Merkel Cell Carcinoma, Locally Advanced Mucosal Melanoma, Locally Advanced Squamous Cell Carcinoma
Enrollment	70 participants
Start Date	2026-02-04
Primary Completion	2027-12-31 (estimated)
Study Completion	2027-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-06-25