CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Zelboraf (vemurafenib) coverage and prior authorization criteria

Defines covered indications, required BRAF mutation documentation, authorization durations, and continuation criteria for vemurafenib (Zelboraf) including FDA-approved and compendial uses. Specifies 12-month authorization periods and continuation requirements; excludes other indications as investigational.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyZelboraf (vemurafenib) coverage and prior authorization criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmission of BRAF mutation documentation is necessary to initiate the prior authorization review for applicable indications; authorization typically granted for 12 months when criteria met.

POLICY UPDATE CHANGES

No material clinical/coverage changes — policy remains current with previously established criteria and authorization durations.

12-monthTypical authorization length

BRAF V600E/V600KRequired mutation(s)

MultipleCovered indications (FDA + compendial)

Coverage Summary

Scope: Zelboraf (vemurafenib) is covered with criteria for FDA-approved indications and selected compendial uses when a BRAF V600 mutation (e.g., V600E or V600K) is documented. Coverage requires submission of BRAF mutation documentation and that the member has no exclusions to the prescribed therapy.

Initial Therapy Criteria

Covered Indications (FDA-approved and Compendial) - general lead-in

Covered when ALL of the following are met:

ALL of the following

Member has an indicated diagnosis listed in Section I (FDA-approved or compendial uses)
BRAF V600 mutation documented (e.g., V600E or V600K) as detected by an FDA-approved test or documented mutation evidence as required in Documentation section
Member has no exclusions to the prescribed therapy

FDA-Approved Indications - Cutaneous Melanoma

Authorization of 12 months may be granted when ALL of the following are met:

Covered melanoma settings (any of the following)

Unresectable or metastatic cutaneous melanoma with BRAF V600 mutation when used as a single agent if BRAF/MEK inhibitor combination therapy is contraindicated
Neoadjuvant therapy in combination with cobimetinib (Cotellic) if immunotherapy is contraindicated and member had unacceptable toxicity to dabrafenib plus trametinib or dabrafenib/trametinib are less desirable
Use in combination with cobimetinib with or without atezolizumab
Adjuvant treatment of resected stage III disease in combination with cobimetinib when member had unacceptable toxicity to dabrafenib plus trametinib or dabrafenib/trametinib are less desirable
Limited resectable local satellite/in-transit recurrent disease in combination with cobimetinib when member had unacceptable toxicity to dabrafenib plus trametinib or dabrafenib/trametinib are less desirable

Tumor is BRAF V600 mutation-positive (e.g., V600E or V600K)

FDA-Approved Indications - Erdheim-Chester Disease

Authorization of 12 months may be granted when ALL of the following are met:

Diagnosis of Erdheim-Chester Disease

Tumor harbors BRAF V600 mutation

Compendial Uses - listed cancers

Authorization of 12 months may be granted for the following BRAF V600 mutation-positive malignancies when criteria are met:

Prior Authorization & Documentation

Prior Authorization

Prior authorization required with BRAF documentation

Submission of BRAF mutation documentation is necessary to initiate the prior authorization review for applicable indications; authorization typically granted for 12 months when criteria met.

Authorization typically granted for 12 months when criteria met

Documentation Required

Document BRAF V600 mutation status

Provider must document tumor BRAF V600 mutation (e.g., V600E or V600K) detected by an FDA-approved test or equivalent documentation per policy.

e.g., FDA-approved test or equivalent documentation

Denial Risk

Claims for non-listed indications may be denied

Use for any indication not listed in the FDA-approved or compendial sections is considered investigational/not medically necessary and may be denied.

Background & Definitions

Zelboraf (vemurafenib) is a BRAF inhibitor indicated for treatment of malignancies that harbor an activating BRAF V600 mutation. The policy covers FDA-approved indications (including unresectable or metastatic melanoma and Erdheim‑Chester disease with BRAF V600 mutation) and several compendial uses (for example, NSCLC, papillary thyroid carcinoma, glioma, meningioma, astrocytoma, histiocytic neoplasms, and hairy cell leukemia) when the tumor is documented to be BRAF V600 mutation-positive.

All covered uses require submission of BRAF mutation documentation to initiate prior authorization review; any indication not listed in the FDA-approved or compendial sections is considered investigational and not medically necessary.

BRAF V600 mutation: An activating mutation in codon 600 of the BRAF gene (commonly V600E or V600K), which is required for coverage per this policy.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyZelboraf (vemurafenib) coverage and prior authorization criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

On This Page

OpenPayer

Zelboraf (vemurafenib) coverage and prior authorization criteria

Coverage Summary

Initial Therapy Criteria

Continuation Therapy Criteria

Unproven / Exclusions

Prior Authorization & Documentation

Applicable Codes

Clinical Evidence & References

Background & Definitions