CurrentCignaPolicy N/A

Cotellic (cobimetinib) prior authorization

Defines prior authorization requirements and medical necessity criteria for Cotellic (cobimetinib) prescription benefit coverage for adults, including FDA-approved and selected supportive-evidence oncology indications.

Policy Summary

PayerCigna

PolicyCotellic (cobimetinib) prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of age, diagnosis, and BRAF V600 mutation status when required.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2FDA indications

1 yearApproval duration

IncludedSupportive evidence uses

NCCNGuideline refs

Coverage Criteria for Cotellic (cobimetinib)

COVERAGE CRITERIA

Covered when ALL of the following are met for FDA-approved indications

Policy Summary

PayerCigna

PolicyCotellic (cobimetinib) prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of age, diagnosis, and BRAF V600 mutation status when required.

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Histiocytic Neoplasm (FDA)

A: Patient is >= 18 years of age>=18
B: Patient has one of the following diagnoses: Langerhans cell histiocytosis; Erdheim-Chester disease; Rosai-Dorfman disease

Melanoma (FDA)

A: Patient is >= 18 years of age>=18
B: Patient has unresectable, advanced, or metastatic melanoma
C: Patient has BRAF V600 mutation-positive diseaseBRAF V600 mutation-positive
D: Medication is prescribed in combination with Zelboraf (vemurafenib)

Cotellic (cobimetinib) is considered not medically necessary for any uses that are not specifically listed in this policy. The policy will be updated as new published data become available to reflect any changes in supported indications.

Any request for Cotellic that does not meet the specific coverage criteria set forth in this policy is considered not medically necessary. Providers should ensure the indication and required documentation align with the policy before submitting a prior authorization request.

Covered Regimens

Regimen	Indication	Coverage
Cotellic (cobimetinib) prescribed in combination with Zelboraf (vemurafenib)	Melanoma, unresectable or metastatic, BRAF V600E or V600K mutation-positive	Covered

Regimen	Indication	Coverage
Cotellic (cobimetinib) as single agent	Histiocytic neoplasms (e.g., Langerhans cell histiocytosis; Erdheim-Chester disease; Rosai-Dorfman disease) in adults	Covered

Coding and Age

Covered/Referenced Codesmixed

NDC/CPT/HCPCS not listed

No specific billing or NDC codes provided in document

inv-05: Age — >= 18 years

Age requirementPatient must be ≥ 18 years of age

Applies to FDA indicationsRequired for Histiocytic Neoplasm and Melanoma approvals (both list age ≥ 18 as criterion)

Applies to supportive-evidence CNS usesRequired for Central Nervous System cancer supportive-evidence approvals

Provider Actions and Prior Authorization

Prior Authorization

Prior Authorization Recommended

Prior authorization is recommended for Cotellic (cobimetinib) under the prescription benefit. Approvals are issued for 1 year when specified clinical criteria are met. Submit requests to the plan's prior authorization process and include all supporting clinical documentation to avoid delays.

Prior authorization recommended; approvals provided for 1 year when clinical criteria are met
Include documentation of age, diagnosis, and mutation status (when required) with the PA request
For melanoma and CNS indications where required, document BRAF V600 mutation-positive status and that Cotellic is prescribed in combination with Zelboraf (vemurafenib)

Note

Sequencing and Combination Preference

Cotellic is preferred as the MEK inhibitor choice per NCCN guidance for histiocytic neoplasms; combination BRAF/MEK inhibition (Cotellic plus a BRAF inhibitor such as Zelboraf) is preferred for BRAF V600–mutant unresectable or metastatic melanoma. If combination therapy is contraindicated, monotherapy with a BRAF inhibitor may be appropriate per guidelines. When requesting coverage, clearly state sequencing or combination rationale and reference guideline-based preference.

NCCN: Cotellic (preferred) or alternative MEK inhibitors recommended for histiocytic neoplasms
For BRAF V600–mutant melanoma, combination Cotellic + Zelboraf is required by policy for coverage
If combination therapy cannot be used, document contraindication and rationale for alternative sequencing (e.g., BRAF inhibitor monotherapy)

Denial Risk

Coverage / Code Mismatch or Non-covered Use

Requests that are billed with codes or for diagnoses not covered under this policy, or uses considered not medically necessary (including any use not listed as an FDA-approved indication or other uses with supportive evidence), will be denied. Ensure claims use the most appropriate current codes and that submitted diagnoses match covered indications.

Services billed for conditions or diagnoses not covered by this policy will be denied as not covered
Use the most appropriate diagnosis and procedure/drug codes as of the date of service
Cotellic is not medically necessary for any uses other than those listed in this policy

Background

Background: Cotellic (cobimetinib) is a mitogen‑activated extracellular signal‑regulated kinase (MEK) inhibitor. It is indicated as a single agent for certain histiocytic neoplasms in adults and, when combined with vemurafenib (Zelboraf), for treatment of BRAF V600 mutation‑positive unresectable or metastatic melanoma. NCCN guidance also supports BRAF/MEK inhibitor combinations across several tumor types, including selected central nervous system tumors and histiocytic neoplasms. Prior authorization is recommended for Cotellic, and approvals for covered indications are issued for 1 year.

Definitions

inv-11: BRAF V600 mutation-positive — BRAF V600 mutation-positive disease

DefinitionBRAF V600 mutation-positive disease

Relevance — MelanomaRequired criterion for FDA-approved melanoma indication (must be BRAF V600 mutation-positive)

Relevance — CNS indicationsRequired for supportive‑evidence CNS cancer uses when approved per policy

Line of Therapy

first-line

Line: NCCN recommends BRAF/MEK inhibitor combinations for first-line and subsequent therapy in metastatic or unresectable melanoma (categories as specified by NCCN)

See NCCN for category specifics

Biomarker Requirements

inv-13: BRAF V600 — mutation-positive

Biomarker thresholdBRAF V600 — mutation-positive

Indications requiring markerMelanoma (FDA) and CNS cancer (supportive evidence) require BRAF V600 mutation-positive status

Testing expectationDocumentation of BRAF V600 mutation status is required for authorization when indicated