vemurafenib — CareFirst (Caremark)

Preferred products

• dabrafenib (Tafinlar)
• trametinib (Mekinist)

Initial criteria

• Cutaneous melanoma: Authorization of 12 months may be granted for BRAF V600 mutation positive (e.g., BRAF V600E or V600K) disease when any of the following apply: (1) Unresectable or metastatic disease when used either as a single agent if BRAF/MEK inhibitor combination therapy is contraindicated, or in combination with cobimetinib (Cotellic) with or without atezolizumab (Tecentriq) or atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza); (2) Neoadjuvant therapy in combination with cobimetinib (Cotellic) if immunotherapy is contraindicated when the member has had an unacceptable toxicity to dabrafenib (Tafinlar) plus trametinib (Mekinist) or dabrafenib/trametinib are less desirable based on side-effect profiles; (3) Adjuvant treatment of resected stage III disease in combination with cobimetinib (Cotellic) when the member has had an unacceptable toxicity to dabrafenib (Tafinlar) in combination with trametinib (Mekinist) or these are less desirable based on side-effect profiles; (4) Limited resectable local satellite/in-transit recurrent disease in combination with cobimetinib (Cotellic) when the member has had an unacceptable toxicity to dabrafenib (Tafinlar) in combination with trametinib (Mekinist) or these are less desirable based on side-effect profiles.
• Central Nervous System Cancer: Authorization of 12 months may be granted for treatment of BRAF V600 mutation positive gliomas, meningiomas, or astrocytomas.
• Histiocytic Neoplasms: Authorization of 12 months may be granted for treatment of BRAF V600 mutation positive Erdheim-Chester disease or Langerhans cell histiocytosis as a single agent.
• Non-small Cell Lung Cancer (NSCLC): Authorization of 12 months may be granted for treatment of BRAF V600E mutation positive advanced, recurrent, or metastatic NSCLC as a single agent if the combination of dabrafenib (Tafinlar) plus trametinib (Mekinist) is not tolerated and the member has not experienced disease progression on BRAF-targeted therapy.
• Hairy Cell Leukemia: Authorization of 12 months may be granted when either (1) used as subsequent therapy as a single agent or in combination with rituximab, or (2) as initial therapy in combination with obinutuzumab or rituximab for members unable to tolerate purine analogs.
• Thyroid Carcinoma: Authorization of 12 months may be granted when recurrent or metastatic papillary thyroid carcinoma is refractory to radioactive iodine (RAI) therapy and tumor is positive for BRAF V600E.

Reauthorization criteria

• Authorization of 12 months may be granted for continued treatment when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.

Approval duration

12 months