Cabometyx (cabozantinib) — CareFirst (Caremark)

Initial criteria

• Renal cell carcinoma: advanced, relapsed, or stage IV (including brain metastases) and used as a single agent or in combination with nivolumab
• Hepatocellular carcinoma: used as a single agent for subsequent treatment
• Non-small cell lung cancer: recurrent, advanced, or metastatic disease with RET gene rearrangement following progression on first-line pralsetinib (Gavreto) or selpercatinib (Retevmo); documentation of RET gene rearrangement required
• Ewing sarcoma: used as a single agent for subsequent therapy
• Osteosarcoma: used as a single agent for subsequent therapy
• Soft tissue sarcoma: alveolar soft part sarcoma, epithelioid hemangioendothelioma, or extraskeletal myxoid chondrosarcoma treated as a single agent
• Gastrointestinal stromal tumor: member has residual, unresectable, tumor rupture, or recurrent/metastatic disease AND has failed ≥ 4 FDA-approved therapies (e.g., imatinib, sunitinib, regorafenib, ripretinib) AND will use as a single agent
• Thyroid carcinoma: follicular, oncocytic/Hürthle cell, or papillary histology with locally advanced or metastatic disease AND disease progressed after VEGFR-targeted therapy (e.g., lenvatinib, sorafenib) AND not amenable to radioactive iodine therapy AND age ≥ 12 years
• Endometrial carcinoma: recurrent disease treated as a single agent for subsequent therapy
• Neuroendocrine and adrenal gland tumors: recurrent, locoregional advanced, unresectable, or metastatic disease treated as a single agent

Reauthorization criteria

• GIST: continued authorization if no evidence of unacceptable toxicity while on current regimen
• All other indications: continued authorization if no evidence of unacceptable toxicity or disease progression while on current regimen

Approval duration

12 months