Rozlytrek (entrectinib) — CareFirst (Caremark)

Initial criteria

• For solid tumors: patient has a NTRK gene fusion without a known acquired resistance mutation as demonstrated by laboratory testing (e.g., next-generation sequencing or fluorescence in situ hybridization)
• For solid tumors: tumor is metastatic or where surgical resection is likely to result in severe morbidity
• For solid tumors: disease has progressed following treatment or there is no satisfactory alternative therapy
• For NSCLC: recurrent, advanced, or metastatic NTRK gene fusion-positive or ROS1-rearrangement positive NSCLC as a single agent
• For cutaneous melanoma: metastatic or unresectable NTRK gene fusion-positive or ROS1 gene fusion-positive cutaneous melanoma as second-line or subsequent therapy as a single agent for disease progression, intolerance, and/or projected risk of progression with BRAF-targeted therapy

Reauthorization criteria

• For ROS1-rearrangement positive NSCLC: no evidence of unacceptable toxicity while on current regimen
• For all other indications: no evidence of unacceptable toxicity or disease progression while on current regimen

Approval duration

12 months