Lonsurf (trifluridine/tipiracil) — United Healthcare

Initial criteria

• Patient is less than 19 years of age OR
• Diagnosis of advanced or metastatic colorectal cancer (colon, appendiceal, or rectal cancer) AND history of failure, contraindication, or intolerance to all of the following: fluoropyrimidine-based chemotherapy, oxaliplatin-based chemotherapy, irinotecan-based chemotherapy, anti-VEGF biological therapy AND (tumor is RAS mutant-type OR (tumor is RAS wild-type AND history of failure, contraindication, or intolerance to anti-EGFR therapy)) OR
• Diagnosis of unresectable locally advanced, recurrent, or metastatic gastric cancer OR unresectable locally advanced, recurrent, or metastatic gastroesophageal junction adenocarcinoma AND history of failure, contraindication, or intolerance to at least two prior lines of chemotherapy that consisted of the following agents: fluoropyrimidine (e.g., fluorouracil), platinum (e.g., carboplatin, cisplatin, oxaliplatin), taxane (e.g., docetaxel, paclitaxel) or irinotecan, and HER2/neu-targeted therapy (e.g., trastuzumab) if HER2 overexpression OR
• The drug has been recognized for treatment of the cancer indication by the NCCN Drugs and Biologics Compendium with a Category of Evidence and Consensus of 1, 2A, or 2B

Reauthorization criteria

• Patient does not show evidence of progressive disease while on Lonsurf therapy

Approval duration

12 months