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.
• \* 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)
∙ 2 cycles will be given prior to surgery (=12 weeks).
• MUCOSAL MELANOMA
⁃ Signed informed consent
⁃ Pathology report confirming mucosal melanoma at the time of screening
⁃ Stage III or IV resectable (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
⁃ SOC (standard of care) treatment planned with immunotherapy Possible Beacon plan entitled OP NIVOLUMAB IPILIMUMAB -\> NIVOLUMAB Q4 WEEK MAINTENANCE MELANOMA 4 cycles will be given prior to surgery (=12 weeks)
∙ BASAL CELL CARCINOMA
⁃ Signed informed consent
⁃ Pathology report confirming basal cell carcinoma with subtype at the time of screening
⁃ Resectable tumor of any stage, or unresectable tumor that could be amenable to surgery if there is a good response.
⁃ ≥ 18 years of age
⁃ Genomics of the cancer attempted
⁃ Description of planned surgical resection by surgeon
⁃ SOC treatment planned with possible Beacon plan entitled OP SONIDEGIB BASAL CELL CARCINOMA 3 months will be given prior to surgery (= 12 weeks) (Vismodegib may be substituted if current national shortage of sonidegib persists)
∙ RARE CUTANEOUS CANCERS
⁃ Signed informed consent
⁃ Pathology report confirming squamous cell carcinoma at the time of screening
⁃ Stage II, III, or IV resectable or (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 SOC treatment with possible Beacon plan entitled OP WEEKLY CARBOPLATIN PACLITAXEL + PEMBROLIZUMAB Q3 WEEKS HEAD AND NECK
∙ 4 cycles will be given prior to surgery (= 12 weeks)