COTELLIC (cobimetinib)

COTELLIC (cobimetinib)

ORAL ADMINISTRATION

Indications for Prior Authorization:

• Melanoma: Indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, in combination with vemurafenib
• Histiocytic Neoplasms: indicated for the treatment of adult patients with histiocytic neoplasms.

Coverage Criteria:

For diagnosis of melanoma:

• Patient has unresectable or metastatic melanoma; AND
• One of the following (A or B):
  • A) Patient has a BRAF V600E mutation as detected by a U.S. Food and Drug Administration (FDA)-approved test (e.g., cobas 4800 BRAF V600 Mutation Test) or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA), or 
  • B) Patient has a BRAF V600K mutation as detected by a U.S. Food and Drug Administration (FDA)-approved test (e.g., cobas 4800 BRAF V600 Mutation Test) or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA), AND
• Used in combination with Zelboraf (vemurafenib) *

*This product may require a prior authorization

For diagnosis of histiocytic neoplasms:

• Patient has histiocytic neoplasm; AND
• Used as monotherapy

Reauthorization Criteria:

For diagnosis all indications:

• Patient has not experienced disease progression while on therapy 

Coverage Duration: 

For diagnosis of melanoma melanoma or histiocytic neoplasms:

• Initial: 12 months

• Reauthorization: 12 months 

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Policy Updates:

• 7/25/2016 - Initial review
• 3/1/2024 (policy effective date)- Updated criteria for melanoma.  Created criteria for histiocytic neoplasms. (P&T 2/20/2024) (P&T meeting February)

References:

• Cotellic Prescribing Information. Genentech, Inc. South San Francisco, CA. October 2022. 
• Larkin J, Ascierto PA, Dréno B, et al. Combined vemurafenib and cobimetinib in BRAF-mutated melanoma. N Engl J Med. 2014;371(20):1867-76. 
• U.S. Food and Drug Administration. List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools). Available at: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/ucm301431.htm. Accessed May 30, 2023.