CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Cotellic (cobimetinib) — Coverage Criteria (combination with vemurafenib for BRAF V600 melanoma)

Defines medical necessity and coverage criteria for Cotellic (cobimetinib), primarily in combination with vemurafenib for BRAF V600E or V600K mutation‑positive metastatic, recurrent, or unresectable malignant melanoma; applies to UM reviewers and prescribing network providers.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyCotellic (cobimetinib) — Coverage Criteria (combination with vemurafenib for BRAF V600 melanoma)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateMay 31, 2024

Next Review Date

Key ActionObtain prior authorization for Cotellic used in combination with vemurafenib for BRAF V600E or V600K mutation‑positive metastatic, recurrent, or unresectable melanoma.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

BRAF V600E/V600Kmutation required for coverage

60 mgsingle dose maximum

63 tablets/monthmaximum monthly quantity

May 31, 2024effective date

Coverage Criteria for Cotellic (cobimetinib)

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Covered use — Cotellic + vemurafenib for BRAF V600 melanoma

Covered when ALL of the following are met

Indication and mutation: Member has metastatic, recurrent, or unresectable malignant melanoma AND tumor is BRAF V600E or V600K mutation positive

Coverage limited to combination with vemurafenib

Line of therapy: Used as first-line therapy for metastatic or unresectable disease OR used as second-line or subsequent therapy

Evidence support: Use is supported by FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature meeting CMS criteria

Continuation requests exempt if prior use within 1 year, no progression/intolerance, and no additional medications are being added

This policy excludes several uses of Cotellic (cobimetinib). Cotellic is not indicated for patients with wild‑type BRAF melanoma. The drug is also not covered as a single‑agent therapy for metastatic, recurrent, or unresectable disease. Combination use that includes a three‑drug regimen of Cotellic + vemurafenib (Zelboraf) + atezolizumab (Tecentriq) is specifically excluded by this policy. Other exclusion triggers include prior disease progression on Cotellic or another MEK inhibitor, dosing that exceeds the single‑dose limit of 60 mg, or total monthly dosing that exceeds 63 (20 mg) tablets per month.

Coverage is limited to use of Cotellic in combination with vemurafenib for members whose tumors are BRAF V600E or V600K mutation positive, and only for metastatic, recurrent, or unresectable malignant melanoma. The combination may be used as first‑line therapy for metastatic or unresectable disease or as second‑line or subsequent therapy. Use of the two‑drug Cotellic + vemurafenib regimen is supported by the policy; however, the three‑drug regimen with atezolizumab is not supported

Provider Actions and Documentation Requirements

Prior Authorization
Prior Authorization Required
Prior authorization is required for Cotellic (cobimetinib). Approvals are limited to use of Cotellic in combination with Zelboraf (vemurafenib) for treatment of metastatic, recurrent, or unresectable malignant melanoma with documented BRAF V600E or V600K mutations. Requests must specify the regimen and indication; approvals will not be granted for unapproved combinations or single-agent use.
Prior authorization required for Cotellic + vemurafenib only
Indication limited to BRAF V600E or V600K mutation–positive metastatic, recurrent, or unresectable malignant melanoma

Documentation Required
Required Supporting Evidence and Documentation
Provide documentation demonstrating mutation status and clinical context. Include pathology/genetic testing confirming BRAF V600E or V600K mutation, treatment intent (first-line vs subsequent), prior therapy history if applicable, and supporting evidence references (see acceptable sources). If requesting an off-label use, include detailed peer-reviewed evidence or CMS-recognized compendia support.
Attach BRAF mutation test report (V600E or V600K)
State line of therapy (first-line or subsequent) and prior systemic treatments
Cite FDA labeling, CMS compendia, NCCN/ASCO guidelines, or peer-reviewed literature

Note
Provider Action Items
Urgent provider actions: do not submit requests for single-agent Cotellic or for the Cotellic + vemurafenib + atezolizumab three-drug regimen. Verify dosing does not exceed the single-dose limit of 60 mg and monthly limit of 63 (20 mg) tablets. Disclose any prior MEK inhibitor exposure or progression on a MEK inhibitor.
Do not request Cotellic monotherapy
Do not request Cotellic + vemurafenib + atezolizumab
Confirm dosing: single dose ≤ 60 mg; monthly ≤ 63 tablets (20 mg)

Denial Risk
Key Denial Triggers
Therapy will be denied for the following conditions: wild-type BRAF melanoma; use of Cotellic as a single agent; requests for Cotellic + vemurafenib + atezolizumab; disease progression while on Cotellic or another MEK inhibitor; dosing above limits; treatment exceeding monthly tablet limits; investigational/off-label uses lacking sufficient CMS-compendia or peer-reviewed evidence.
Wild-type BRAF melanoma (no approval)
Cotellic used as a single agent (no approval)
Cotellic + vemurafenib + atezolizumab regimen (not supported)
Progression while on Cotellic or another MEK inhibitor
Single dose > 60 mg or > 63 (20 mg) tablets per month
Investigational/off-label uses without adequate CMS compendia or acceptable peer-reviewed evidence

Definitions and Investigational Use

Investigational / insufficient evidence — definition

DefinitionUse is considered investigational/insufficient evidence when the indication lacks support from FDA labeling, CMS‑recognized compendia, NCCN/ASCO guidelines, or acceptable peer‑reviewed literature

Insufficient evidence examplesReliance only on abstracts or case reports is inadequate

Evidence considerationsAssess whether patient/cancer characteristics, regimen representation, clinically meaningful outcomes, and study design appropriately address the question

Standards referencedCMS recognized compendia, NCCN/ASCO guidance, and peer‑reviewed literature meeting CMS criteria

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyCotellic (cobimetinib) — Coverage Criteria (combination with vemurafenib for BRAF V600 melanoma)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateMay 31, 2024

Next Review Date

Key ActionObtain prior authorization for Cotellic used in combination with vemurafenib for BRAF V600E or V600K mutation‑positive metastatic, recurrent, or unresectable melanoma.

SourceLink

On This Page

OpenPayer

Cotellic (cobimetinib) — Coverage Criteria (combination with vemurafenib for BRAF V600 melanoma)

Coverage Criteria for Cotellic (cobimetinib)

Initial Therapy — Medical Necessity Criteria

Continuation Therapy Criteria

Provider Actions and Documentation Requirements

Coding and Quantity Limits

Quantity Limit Summary

Definitions and Investigational Use

Background and Drug Information