Zelboraf (vemurafenib)

ZELBORAF (vemurafenib)

Self-Administration – oral

Diagnosis considered for coverage:

• Melanoma - Indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test.
• Erdheim-Chester Disease - Indicated for the treatment of patients with Erdheim-Chester Disease (ECD) with BRAF V600 mutation.

Coverage Criteria:

For diagnosis of Melanoma:

• Patient has unresectable melanoma, or metastatic melanoma; AND
• Cancer is BRAF V600 mutant type as detected by an FDA-approved test (e.g., cobas 4600 BRAF V600 Mutation Test) or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)

For diagnosis of Erdheim-Chester Disease:

• Diagnosis of Erdheim-Chester disease (ECD) AND 
• Disease is BRAF V600 mutant type (MT) 

Reauthorization Criteria:

For diagnosis of all indications:

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

Coverage Duration: 

For diagnosis for all indications:

• 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:

• 3/1/2024 (policy effective date)- New Sohonos Criteria (P&T 2/20/2024) (P&T meeting February).

References:

1.    Zelboraf Prescribing Information. Genentech USA, Inc., May 2020. 

2.    National Comprehensive Cancer (NCCN) Drugs & Biologics Compendium [internet database]. Updated periodically. Available at: http://www.nccn.org/professionals/drug_compendium/content/contents.asp. Accessed February 14, 2023.