CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Zelboraf (vemurafenib) coverage policy

Defines accepted indications, inclusion and exclusion criteria, and administrative requirements for coverage of Zelboraf (vemurafenib) for malignant melanoma (BRAF V600E positive) including continuation request rules and dosing limits. Specifies required sources of evidence and decision authority.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyZelboraf (vemurafenib) coverage policy

Policy CodePolicy N/A

Change TypeClarified exclusion of 3-drug regimen; revised approval/effective dates

Effective DateMay 31, 2024

Next Review Date

Key ActionSupport requests with FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature and seek Evolent authorization for medication requests.

POLICY UPDATE CHANGES

Policy position that cobimetinib + vemurafenib + atezolizumab (3-drug) is not supported based on IMspire150 overall survival results.

Approval and effective dates updated to Approval Date May 08, 2024 and Effective Date May 31, 2024.

1Covered Indication (malignant melanoma, BRAF V600E)

3Hard dosing limits (single/day/month)

1Unsupported 3-drug regimen (excluded)

Coverage Summary

Covered with criteria for Zelboraf (vemurafenib) for BRAF V600E mutation positive metastatic, recurrent, or unresectable malignant melanoma when used as combination therapy with cobimetinib or as a single agent if combination therapy is contraindicated; continuation requests exempt when met; dosing limits apply (single dose ≤ 960 mg, daily ≤ 1,920 mg, maximum 240 tablets/month). Evolent Utilization Management reviews and authorizes medication requests; medications not authorized by Evolent may not be reimbursed. Approval Date: May 08, 2024. Effective Date: May 31, 2024.

Initial Therapy Criteria

Indications - Malignant Melanoma

Zelboraf (vemurafenib) may be used when ALL of the following are met:

ALL of the following

Member has metastatic, recurrent, or unresectable malignant melanoma
Tumor is BRAF V600E mutation positive
Therapy line
- First line therapy
- Second-line or subsequent line therapy
Administration option
- Vemurafenib used in combination with cobimetinib (Cotellic)
- Vemurafenib used as a single agent if combination therapy is contraindicated

Continuation Therapy Criteria

Continuation Requests Exemption

Continuation requests for a not-approvable medication shall be exempt provided ALL of the following are met:

ALL of the following

The requested medication was used within the last year
The member has not experienced disease progression and/or no intolerance to the requested medication
Additional medication(s) are not being added to the continuation request

Unproven / Exclusions

Exclusion Criteria

Not covered when ANY of the following exclusion criteria apply:

ANY of the following

Disease progression on the same regimen or with another combination of a BRAF inhibitor (e.g., encorafenib or dabrafenib) and MEK inhibitor (e.g., binimetinib or trametinib)
Member has BRAF V600E negative (wild type) melanoma
Dosing exceeds the single dose limit of 960 mg960 mg
Dosing exceeds the daily dose limit of 1,920 mg per day1,920 mg per day
Treatment exceeds the maximum limit of 240 tablets (240 mg) per month240 tablets per month
Investigational use for an off-label indication that lacks sufficient evidence or is not generally accepted by the medical community (not supported by FDA label, CMS-recognized compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature)
Sufficient evidence defined by listed trial/design/outcome criteria in policy
Three-drug regimen of cobimetinib + vemurafenib + atezolizumab is not supported for metastatic/recurrent/unresectable BRAF V600E or V600K melanoma based on IMspire150 overall survival results

The policy explicitly excludes the three‑drug regimen of cobimetinib + vemurafenib + atezolizumab based on evidence from the IMspire150 trial (primary analysis and updated overall survival results). Investigational or off‑label uses require support from FDA labeling, CMS‑recognized compendia, NCCN or ASCO guidelines, or acceptable peer‑reviewed literature as defined in the policy.

Provider Actions & Authorization Requirements

Prior Authorization

Evolent authorization required

Evolent (Utilization Management) must review and authorize all medication requests for Zelboraf (vemurafenib). Medications that are not authorized by Evolent may be deemed not approvable and therefore not reimbursable.

Documentation Required

Support with recognized evidence sources

Requests must be supported by one of the following: FDA-approved product labeling, CMS-recognized compendia, National Comprehensive Cancer Network (NCCN) or American Society of Clinical Oncology (ASCO) clinical guidelines, or peer‑reviewed literature that meets the requirements of the CMS Medicare Benefit Policy Manual Chapter 15.

Denial Risk

Requests exceeding dosing or tablet limits

Claims may be excluded if dosing or tablet limits are exceeded.

Single dose limit: 960 mg
Daily dose limit: 1,920 mg per day
Monthly tablet limit: Maximum 240 tablets (240 mg strength) per month

Denial Risk

Use in BRAF V600E negative melanoma

Requests for use of Zelboraf in members with BRAF V600E negative (wild type) melanoma are excluded under this policy and may be denied.

Denial Risk

Investigational/off-label uses without sufficient evidence

Investigational or off‑label uses that lack sufficient evidence or are not generally accepted by the medical community (i.e., not supported by CMS‑recognized compendia or acceptable peer‑reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 criteria) are excluded and may be denied.

Revision History

2024-05-31effective_dateLatest

Policy effective date updated to May 31, 2024 (Approval Date May 08, 2024).

2024-05-08committee_review

Committee review/approval updated through May 08, 2024 (Approval Date May 08, 2024).

clinical_clarification

Policy clarifies that cobimetinib + vemurafenib + atezolizumab (three‑drug regimen) is not supported based on IMspire150 overall survival results; references updated IMspire150 survival results and directs to Evolent alternative regimens.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyZelboraf (vemurafenib) coverage policy

Policy CodePolicy N/A

Change TypeClarified exclusion of 3-drug regimen; revised approval/effective dates

Effective DateMay 31, 2024

Next Review Date

Key ActionSupport requests with FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature and seek Evolent authorization for medication requests.

On This Page

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Zelboraf (vemurafenib) coverage policy

Coverage Summary

Initial Therapy Criteria

Continuation Therapy Criteria

Unproven / Exclusions

Provider Actions & Authorization Requirements

Applicable Codes

Clinical Evidence

Background

Revision History