Pharmacy Prior Authorization Criteria

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.

Prior Authorization (Initial Authorization)

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

Prior Authorization (Initial Authorization)

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

AND

Prior Authorization (Reauthorization)

Length of Approval: 12 Month [A]
For diagnosis of All Indications

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

Zelboraf Prescribing Information. Genentech USA, Inc., May 2020.
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 28, 2025

In the pivotal trial (Trial 1) evaluating treatment naive patients who received Zelboraf (vemurafenib), the median follow-up was 6.2 months and the median progression free survival (PFS) was 5.3 months (95% CI, 4.9 - 6.6). In the pivotal trial (Trial 2) evaluating Zelboraf (vemurafenib) in patients who received prior systemic therapy, the best overall response rate was 52% (95% CI, 43 - 61%), the median time to response was 1.4 months, and the median duration of response was 6.5 months (95% CI, 5.6 - not reached). [1] According to the NCCN melanoma guidelines, Zelboraf (vemurafenib) is associated with a 40-50% response rate in patients with a V600 mutated BRAF gene; however, the median duration of response is only 5 - 6 months. [2]

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.