Medical Policy

Effective Date:12/07/2011 Title:Zelboraf (Vemurafenib)
Revision Date:06/01/2014 Document:BI328:00
CPT Code(s):81210
Public Statement

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Zelboraf (Vemurafenib) requires prior authorization.

2)    Zelboraf (Vemurafenib) is used to treat unresectable or metastatic malignant melanoma.

Medical Statement

Zelboraf is considered medically necessary for patients who meet the following criteria:

1)    Diagnosis of unresectable or metastatic malignant melanoma in patients with V600E mutation of the BRAF gene as detected by an FDA approved test (81210).  OR

2)    Diagnosis of non-small cell lung cancer (NSCLC) with BRAF mutations.

3)    Zelboraf is not covered for patients with wild-type BRAF melanoma.


Codes Used in this BI:

81210 – BRAF (v-raf murine sarcoma viral oncogene homolog B1), gene analysis, V600E variant

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  1. Zelboraf Product Information.  Genentech, Inc.  August 2011.
  2. Chapman PB, Hauschild A, Robert C, et al.  Improved Survival with Vemurafenib in Melanoma with BRAF V600E Mutation.  N Engl J Med 2011 June 30; 364(26):2507-16.
  3. NCCN Drugs & Biologics Compendium.  Accessed online May 2014.
Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.

Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.