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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorOhio State University Comprehensive Cancer Center

About this trial

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.

Eligibility criteria

Qualifiers

* MERKEL CELL CARCINOMA

Signed informed consent

Pathology report confirming Merkel at the time of screening

Stage II, III or IV resectable (criteria based on Merkel Cell carcinoma TNM pathologic staging AJCC UICC 8th edition) or unresectable cancers amenable to surgery if a response is elicited with neoadjuvant therapy

Disqualifiers

* MERKEL CELL CARCINOMA

Metastatic disease not amenable to complete resection

Prior immunotherapy, chemotherapy, or radiation therapy for treatment of MCC within the past year

Any clinically significant medical condition, which in the judgment of the attending physician would contraindicate immunotherapy

Trial design

Treatments tested in this trial

  • Non-Interventional Study

Treatment groups

70 Participants
are divided into 4 treatment groups