Larotrectinib and entrectinib are considered medically necessary when ALL of the following are met:
Individual has a confirmatory diagnosis of a solid tumor which is metastatic OR when surgical resection is likely to result in severe morbidity.
The tumor has an NTRK gene fusion without a known acquired resistance variant.
Individual has progressed following standard of care OR failed standard of care for the given solid tumor.
Must be prescribed by an oncologist/hematologist.
Individual does NOT have any U.S. Food and Drug Administration (FDA) labeled contraindications to the requested agent and is intended to be used consistently with the FDA approved label (see policy guidelines).
Larotrectinib and entrectinib are considered investigational in all other situations.