CurrentUnitedHealthcarePolicy N/A

Cotellic (cobimetinib) prior authorization criteria

Defines UnitedHealthcare pharmacy prior authorization and reauthorization requirements for cobimetinib (Cotellic), including melanoma, CNS cancers, and histiocytic neoplasms; applies to insured members subject to pharmacy UM rules.

Policy Summary

PayerUnitedHealthcare

PolicyCotellic (cobimetinib) prior authorization criteria

Policy CodePolicy N/A

Change TypeCoverage criteria updated (NCCN alignment)

Effective DateFeb 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization; prescriptions for members under 19 will automatically process without coverage review.

SourceLink

POLICY UPDATE CHANGES

Updated coverage criteria for central nervous system cancers and histiocytic neoplasms based on NCCN recommendations.

Melanoma, CNS cancer, and histiocytic neoplasm criteria updated per NCCN guidelines in 11/2024 review.

Added explicit requirement that Cotellic be used in combination with Zelboraf (vemurafenib) for melanoma and CNS indications where specified.

12 monthsauthorization duration for approved requests

BRAF V600E/V600Krequired mutation for melanoma coverage

Age <19 auto-approvemembers under 19 process without coverage review

Combination

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Coverage and Clinical Criteria

Pediatric members (<19 years)

Coverage for patients less than 19 years of age

Age <19 automatic approval: Patient is less than 19 years of age

Authorization will be issued for 12 months

Initial Therapy — Melanoma

Initial authorization for melanoma

Melanoma initial authorization

Disease status or prior therapy: (2) One of the following: (a) Unacceptable toxicities to Tafinlar (dabrafenib) or Mekinist (trametinib) on the basis of agent side-effect profile OR (b) Disease that is relapsed >3 months after treatment discontinuation OR (c) Disease that is unresectable OR (d) Metastatic disease
Molecular requirement: (3) Disease is positive for BRAF V600E or BRAF V600K mutation
Combination therapy requirement: (4) Used in combination with Zelboraf (vemurafenib)
Authorization will be issued for 12 months

Continuation Therapy — Melanoma

Reauthorization for melanoma

Melanoma reauthorization

Combination therapy requirement: (2) Used in combination with Zelboraf (vemurafenib)
Authorization will be issued for 12 months

Initial Therapy — CNS Cancers

Initial authorization for CNS cancers

CNS initial authorization

Molecular requirement: (2) Disease is BRAF V600E positive
Combination therapy requirement: (3) Used in combination with Zelboraf (vemurafenib)
Authorization will be issued for 12 months

Continuation Therapy — CNS Cancers

Reauthorization for CNS cancers

CNS reauthorization

Combination therapy requirement: (2) Used in combination with Zelboraf (vemurafenib)
Authorization will be issued for 12 months

Initial Therapy — Histiocytic Neoplasms

Initial authorization for histiocytic neoplasms

Histiocytic initial authorization: Diagnosis of one of the following histiocytic neoplasms: Langerhans cell histiocytosis, Erdheim-Chester disease, or Rosai-Dorfman Disease

Authorization will be issued for 12 months

Continuation Therapy — Histiocytic Neoplasms

Reauthorization for histiocytic neoplasms

Histiocytic reauthorization: Patient does not show evidence of progressive disease while on Cotellic therapy

Authorization will be issued for 12 months

NCCN Recommended Regimens

NCCN recommended regimens

NCCN recognition: Drug recognized by the NCCN Drugs and Biologics Compendium with Category 1, 2A, or 2B

Authorization will be issued for 12 months; state mandates and member benefit plan may impact coverage

Some state laws require coverage of off-label medication use or mandate the use of specific compendia. Where such state mandates apply, they supersede the language in this policy or the notification criteria and may require coverage that would otherwise be outside the policy terms.

Requests that do not meet the stated coverage criteria are not consistent with medical necessity. Examples include use without a documented diagnosis specified in the criteria (for example, melanoma or the CNS tumor types listed), use when the required BRAF V600E or V600K mutation is not present where specified, or use as monotherapy when the criteria require use in combination with Zelboraf (vemurafenib). Such scenarios may result in denial of coverage.

Initial Therapy Requirements by Indication

Initial — Melanoma

Melanoma initial authorization requirements

Melanoma initial

Prior therapy or disease status: Either unacceptable toxicity to dabrafenib or trametinib OR disease that is relapsed >3 months after treatment discontinuation OR unresectable OR metastatic
Molecular requirement: BRAF V600E or BRAF V600K positive
Combination therapy: Used in combination with Zelboraf (vemurafenib)
12-month authorization

Initial — CNS Cancers

Reauthorization / Continuation Requirements

Reauthorization — General

Reauthorization rules across indications

No progression: Patient does not show evidence of progressive disease while on Cotellic therapy

Authorization will be issued for 12 months

Provider Responsibilities and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for Cotellic (cobimetinib). Submit clinical documentation supporting diagnosis, prior therapies, mutation status, and planned combination with vemurafenib. Authorization requests are typically for a 12-month period when criteria are met.

Affects requests for melanoma and specified histiocytic neoplasms
Authorization duration: 12 months when approved
Automated approval pathways may apply based on prior claim/medication history and ICD-10 diagnosis codes

Step Therapy

Step / Alternative Therapy Consideration

Step-therapy and alternative therapy considerations: confirm and document prior use or intolerance to indicated BRAF/MEK agents when applicable. For melanoma, if the patient has unacceptable toxicity to dabrafenib (Tafinlar) or trametinib (Mekinist), document the adverse events and rationale for switching to cobimetinib combined with vemurafenib. If using for histiocytic neoplasms, document diagnosis-specific indication.

Step Therapy and Alternative Pathways

Step	Requirement	Notes
1	Consider prior intolerance or unacceptable toxicity to Tafinlar (dabrafenib) or Mekinist (trametinib)	Allows alternative pathway for initial melanoma authorization when intolerance to dabrafenib or trametinib is documented

Key Definitions

BRAF mutation positive

DefinitionBRAF mutation positive refers to presence of a BRAF V600E or BRAF V600K somatic mutation.

Associated indicationsRequired for coverage of Cotellic in unresectable or metastatic melanoma when used in combination with vemurafenib.

Testing implicationDocumented molecular test demonstrating BRAF V600E or V600K positivity is required where the policy specifies this mutation for an indication.

CNS cancers relevanceNCCN recommends Cotellic with vemurafenib for certain CNS cancers that are BRAF V600E positive.

Drug-label contextCotellic’s FDA‑labeled melanoma indication specifies use in patients whose tumors harbor BRAF V600E or V600K mutations (used with vemurafenib).

Drug Background and Indications

Cotellic (cobimetinib) is a MEK kinase inhibitor used in oncology. The product is indicated in combination with vemurafenib for patients with unresectable or metastatic melanoma harboring BRAF V600E or V600K mutations, and it is recognized by NCCN for certain cancer indications. The agent is also identified for use in specific histiocytic neoplasms. Authorizations under this policy reference the product labeling and the NCCN Drugs & Biologics Compendium when defining covered indications and required diagnostic criteria.

Coding and Billing

Covered ICD-10 / Diagnosis CodesICD-10Covered

Langerhans cell histiocytosis	Langerhans cell histiocytosis
Erdheim-Chester disease	Erdheim-Chester disease
Rosai-Dorfman Disease	Rosai-Dorfman Disease

Coverage Status Notesmixed

AUTH_DURATION	Authorization will be issued for 12 months for initial and reauthorization approvals.
REAUTH_CRITERION	Reauthorization requires patient does not show evidence of progressive disease while on Cotellic therapy.

Policy Revision History

2025-11annual_reviewLatest

Updated coverage criteria for central nervous system cancers and histiocytic neoplasms to align with NCCN recommendations.

2024-11annual_review

Updated melanoma, central nervous system cancers, and histiocytic neoplasms criteria based on NCCN guidelines.

2019-11annual_review