Studying Off Label Insurance Coverage for Patients With Cutaneous Cancers a "Filter" Observational Study
Ohio State University Comprehensive Cancer Center
Summary
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.
Description
PRIMARY OBJECTIVE: I. To assess in real-life clinical practice, the timing, cost, and surgical outcomes of patients who have resectable various skin cancers that are locally advanced or have a high risk of recurrence. OUTLINE: This is an observational study. Patients complete a survey and have their medical records reviewed on study.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * \* 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 * ≥ 18 years of age * Genomics of the cancer attempted * Description of planned surgical resection by surgeon * Planned treatment with immunotherapy. Possible Beacon plan entitled OP NIVOLUMAB IPILIMUMAB NEUROENDOCRINE (PRL 8149)…
Interventions
- OtherNon-Interventional Study
Non-interventional study
Location
- Ohio State University Comprehensive Cancer CenterColumbus, Ohio