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Rozlytrek (entrectinib)United Healthcare

Solid tumors with NTRK gene fusion

Initial criteria

  • Presence of solid tumors (e.g., sarcoma, NSCLC, salivary, breast, thyroid, colorectal, neuroendocrine, pancreatic, gynecological, cholangiocarcinoma, etc.)
  • Disease is positive for neurotrophic receptor tyrosine kinase (NTRK) gene fusion (e.g., ETV6-NTRK3, TPM3-NTRK1, LMNA-NTRK1, etc.)
  • Disease is without a known acquired resistance mutation [e.g., TRKA G595R substitution, TRKA G667C substitution, or other recurrent kinase domain (solvent front and xDFG) mutations]
  • Disease is one of the following: Metastatic OR Unresectable

Reauthorization criteria

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

Approval duration

12 months