WHA
 

Zelboraf (vemurafenib)

Indications for Prior Authorization

Zelboraf (vemurafenib)
  • For diagnosis of Melanoma
    Indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test. Limitation of Use: ZELBORAF is not indicated for treatment of patients with wild-type BRAF melanoma.

  • For diagnosis of Erdheim-Chester Disease
    Indicated for the treatment of patients with Erdheim-Chester Disease with BRAF V600 mutation.

Criteria

Zelboraf

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month [A]
For diagnosis of Melanoma

  • One of the following diagnoses:
    • Unresectable melanoma
    • 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)
Zelboraf

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Erdheim-Chester Disease

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

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of All Indications

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

  • Guideline ID
    GL-511316

  • Formulary
    premium

  • Effective date
    May 1, 2026

  • P&T approval date
    Feb 21, 2012

P & T Revisions

2026-03-04, 2025-02-28, 2024-02-23, 2023-07-18, 2023-03-15, 2022-03-03, 2021-09-28, 2021-05-26, 2021-05-25, 2021-03-04, 2020-02-18

  1. Zelboraf Prescribing Information. Genentech USA, Inc., May 2020.
  • 2026-03-04: 2026 UM Annual Review. No criteria changes. Background updates.
  • 2025-02-28: 2025 Annual Review. Background updates.
  • 2024-02-23: Annual Review. Updated indication to match prescriber information. Removed background section. Updated references.
  • 2023-07-18: Removed Oncology specialist requirement
  • 2023-03-15: Annual review - updated references.
  • 2022-03-03: Annual review - updated references.
  • 2021-09-28: Addition of EHB formulary to guideline, no changes to criteria
  • 2021-05-26: Addition of EHB formulary to guideline, no changes to criteria
  • 2021-05-25: Addition of EHB formulary to guideline, no changes to criteria
  • 2021-03-04: Annual review - updated references.
  • 2020-02-18: Annual review - updated criterion to "test performed a facility approved by CLIA" to align with med D verbiage for clarity. Also removed drug name from reauth criteria. Updated background and references.