CurrentUnitedHealthcarePolicy N/A

Cotellic (cobimetinib) prior authorization criteria

Prior authorization and notification requirements for coverage of Cotellic (cobimetinib) for UnitedHealthcare members, including melanoma, CNS cancers, and histiocytic neoplasms; applies to pharmacy benefit and specialty drug management.

Policy Summary

PayerUnitedHealthcare

PolicyCotellic (cobimetinib) prior authorization criteria

Policy CodePolicy N/A

Change TypeRevised coverage criteria based on NCCN

Effective DateFeb 1, 2026

Next Review DateN/A

Key ActionRequest prior authorization showing diagnosis, required BRAF mutation status where applicable, and combination use with vemurafenib when applicable; approvals issued for 12 months.

SourceLink

POLICY UPDATE CHANGES

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

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

12 monthsauthorization duration issued for approvals

BRAF V600E/V600Kmutations required for melanoma indication

With Zelborafcombination requirement

Age <19pediatric auto-process

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Coverage Criteria

Initial Therapy - Melanoma

Covered when ALL of the following are met for melanoma initial therapy

Melanoma initial: Diagnosis of melanoma

Disease status or prior therapy: Patient has unacceptable toxicities to Tafinlar (dabrafenib) or Mekinist (trametinib) OR disease is relapsed > 3 months after treatment discontinuation OR disease is unresectable OR disease is metastatic

Document unacceptable toxicity or disease status where applicable

Mutation: Disease is positive for BRAF V600E OR BRAF V600K

Combination requirement: Used in combination with Zelboraf (vemurafenib)

Authorization will be issued for 12 months

Reauthorization - Melanoma

Reauthorization criteria for melanoma

Melanoma reauthorization: Patient does not show evidence of progressive disease while on Cotellic therapy AND used in combination with Zelboraf (vemurafenib)

Authorization will be issued for 12 months

Initial Therapy - CNS Cancers

Covered when ALL of the following are met for CNS cancers initial therapy

CNS diagnosis: Diagnosis of circumscribed glioma OR glioblastoma

CNS mutation: Disease is BRAF V600E positive

Combination requirement: Used in combination with Zelboraf (vemurafenib)

Authorization will be issued for 12 months

Reauthorization - CNS Cancers

Reauthorization criteria for CNS cancers

CNS reauthorization: Patient does not show evidence of progressive disease while on Cotellic therapy AND used in combination with Zelboraf (vemurafenib)

Authorization will be issued for 12 months

Initial and Reauthorization - Histiocytic Neoplasms

Covered when ALL of the following are met for histiocytic neoplasms (initial and reauthorization)

Histiocytic diagnosis: Diagnosis of Langerhans cell histiocytosis OR Erdheim-Chester disease OR Rosai-Dorfman Disease

Authorization will be issued for 12 months

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-recognized regimens may be authorized

NCCN regimens: Regimen 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 plans may impact coverage

Pediatrics

Pediatric: Patient is less than 19 years of age

Authorization will be issued for 12 months; prescriptions automatically process without coverage review

Some states mandate coverage for off-label medication use or require use of specific compendia. Where applicable, these state mandates or required compendium references take precedence and supersede the language of this policy or the stated notification/coverage criteria.

Use of Cotellic that does not meet the specified diagnosis, required mutation status, required combination therapy, or an NCCN-recognized regimen (Category 1, 2A, or 2B) may be denied as not meeting coverage criteria.

Initial Therapy Criteria

Initial - Melanoma

Melanoma initial therapy requirements

Diagnosis of melanoma

Alternative pathway: Unacceptable toxicities to Tafinlar (dabrafenib) or Mekinist (trametinib) OR disease relapsed > 3 months after discontinuation OR disease is unresectable OR disease is metastatic

Mutation: BRAF V600E OR BRAF V600K positive

Combination: Used in combination with Zelboraf (vemurafenib)

Initial - CNS Cancers

CNS cancers initial therapy requirements

Diagnosis of circumscribed glioma OR glioblastoma

Mutation: BRAF V600E positive

Combination: Used in combination with Zelboraf (vemurafenib)

Initial - Histiocytic Neoplasms

Histiocytic neoplasms initial therapy requirements

Diagnosis of Langerhans cell histiocytosis OR Erdheim-Chester disease OR Rosai-Dorfman Disease

Continuation / Reauthorization Criteria

Continuation Therapy

Reauthorization/continuation requires demonstration of non-progression on therapy and continued use per indication-specific combination requirements.

Continuation - non-progression: Patient does not show evidence of progressive disease while on Cotellic therapy

Authorization will be issued for 12 months

Continuation - combination: Continued use in combination with Zelboraf (vemurafenib) where initial approval required combination

Reauthorization - CNS Cancers

Reauthorization criteria for CNS cancers

CNS reauth: Patient does not show evidence of progressive disease while on Cotellic therapy AND used in combination with Zelboraf (vemurafenib)

Authorization will be issued for 12 months

Reauthorization - Melanoma

Reauthorization criteria for melanoma

Melanoma reauth: Patient does not show evidence of progressive disease while on Cotellic therapy AND used in combination with Zelboraf (vemurafenib)

Authorization will be issued for 12 months

Provider Actions and Prior Authorization Instructions

Prior Authorization

Pediatric processing

For members less than 19 years of age, authorization will be issued for 12 months and the prescription will automatically process without a coverage review. Some states mandate coverage for off‑label uses or require other Compendium references; state mandates and the member's benefit plan may modify coverage.

Members <19: automatic 12-month authorization without coverage review
State mandates and member benefit plans may supersede criteria

Prior Authorization

Melanoma initial authorization

Initial authorization for melanoma requires a diagnosis of melanoma, BRAF V600E or V600K mutation positivity, and use of Cotellic in combination with Zelboraf (vemurafenib). Cotellic may be approved for melanoma if the patient has unacceptable toxicities to alternative BRAF/MEK agents (Tafinlar/dabrafenib or Mekinist/trametinib). Authorization will be issued for 12 months.

Diagnosis: melanoma
Mutation: BRAF V600E or V600K
Used in combination with Zelboraf (vemurafenib)
Allows use when patient has unacceptable toxicities to dabrafenib or trametinib

Prior Authorization

Melanoma reauthorization

Reauthorization for melanoma requires that the patient does not show evidence of progressive disease while on Cotellic therapy and that Cotellic continues to be used in combination with Zelboraf (vemurafenib). Authorization will be issued for 12 months.

No evidence of progressive disease on Cotellic
Continued combination with Zelboraf (vemurafenib)

Prior Authorization

CNS cancers initial authorization

Initial authorization for CNS cancers requires a diagnosis of circumscribed glioma or glioblastoma, tumor positivity for BRAF V600E, and use of Cotellic in combination with Zelboraf (vemurafenib). Authorization will be issued for 12 months.

Diagnosis: circumscribed glioma or glioblastoma
BRAF V600E positive disease
Used in combination with Zelboraf (vemurafenib)

Prior Authorization

CNS cancers reauthorization

Reauthorization for CNS cancers requires that the patient does not show evidence of progressive disease while on Cotellic therapy and that Cotellic continues to be used in combination with Zelboraf (vemurafenib). Authorization will be issued for 12 months.

No evidence of progressive disease on Cotellic
Continued combination with Zelboraf (vemurafenib)

Prior Authorization

Histiocytic neoplasms authorization

Initial authorization for histiocytic neoplasms requires a diagnosis of one of the following: Langerhans cell histiocytosis, Erdheim‑Chester disease, or Rosai‑Dorfman disease. Authorization will be issued for 12 months.

Diagnosis: Langerhans cell histiocytosis, Erdheim‑Chester disease, or Rosai‑Dorfman Disease

Prior Authorization

Histiocytic neoplasms reauthorization

Reauthorization for histiocytic neoplasms requires that the patient does not show evidence of progressive disease while on Cotellic therapy. Authorization will be issued for 12 months.

No evidence of progressive disease on Cotellic

Prior Authorization

NCCN recommended regimens

The drug is recognized by the NCCN Drugs and Biologics Compendium for the cancer indication with a Category of Evidence and Consensus of 1, 2A, or 2B. NCCN‑recommended regimens meeting those categories will be authorized for 12 months. State mandates, federal regulatory requirements, and the member's benefit plan may modify coverage.

NCCN Category 1, 2A, or 2B regimens: 12‑month authorization
State mandates and member benefit plans may alter coverage

Note

Administrative approvals

UnitedHealthcare may approve initial and reauthorization requests based solely on previous claim/medication history, diagnosis codes (ICD‑10), and/or prior authorization history using automated approval or re‑approval processes. Supply limits may apply.

Approvals may be issued based on claim/medication history and diagnosis codes without additional clinical review
Supply limits may be in place

Denial Risk

Denial conditions and pediatric auto‑process

Failure to meet the listed coverage criteria may result in denial of coverage. For members under 19 years of age, prescriptions automatically process without review; otherwise, denial conditions apply when criteria are not met.

Failure to meet criteria may result in denial of coverage
Members <19 automatically process without review

OpenPayer

Cotellic (cobimetinib) prior authorization criteria

Coverage Criteria

Initial Therapy Criteria

Continuation / Reauthorization Criteria

Provider Actions and Prior Authorization Instructions

Step Therapy and Alternatives

Background

Definitions

Coding

Revision History