CurrentUnitedHealthcarePolicy N/A

Gomekli (mirdametinib) prior authorization

Defines UnitedHealthcare pharmacy prior authorization and reauthorization requirements for Gomekli (mirdametinib) for treatment of neurofibromatosis type 1 with symptomatic plexiform neurofibromas; applies to members and providers using UnitedHealthcare pharmacy benefits.

Policy Summary

PayerUnitedHealthcare

PolicyGomekli (mirdametinib) prior authorization

Policy CodePolicy N/A

Change TypeNew program

Effective DateJul 1, 2025

Next Review DateN/A

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

SourceLink

POLICY UPDATE CHANGES

Gomekli (mirdametinib) prior authorization program created with approval criteria and 12-month authorization periods.

12 monthsauthorization period (initial and reauthorization)

≥2 yrsminimum patient age indicated in FDA label

age <19auto-process for pediatric

compendiumNCCN recognition

Coverage Criteria for Gomekli (mirdametinib)

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Initial Therapy

Covered when ALL of the following are met

Initial Authorization: Diagnosis of neurofibromatosis type 1

Initial Authorization: Patient has plexiform neurofibromas (PN) that are symptomatic

Initial Authorization: Plexiform neurofibromas are not amenable to complete resection

Authorization will be issued for 12 months

Pediatric Automatic Approval

Automatic approval condition

Pediatric automatic process: Patient is less than 19 years of age — prescription will automatically process without a coverage review

Authorization will be issued for 12 months per policy

Continuation Therapy / Reauthorization

Reauthorization covered when ALL of the following are met

Reauthorization: Patient does not show evidence of progressive disease while on Gomekli therapy

Authorization will be issued for 12 months

State or federal mandates may affect coverage determinations and supersede this policy where applicable. In addition, some jurisdictions have specific requirements that require coverage for certain off‑label medication uses; where those mandates apply they take precedence over the criteria in this document.

Reauthorization requests may be denied if there is evidence that the patient has progressive disease while on Gomekli. Continued coverage for Gomekli is contingent on documentation demonstrating the absence of disease progression during therapy.

Provider Actions, Documentation, and Billing Notes

Prior Authorization

Prior Authorization Required

Prior authorization required for initial therapy in members ≥19 years for Gomekli (mirdametinib). Initial authorization is granted when the member meets the documented clinical criteria (diagnosis of neurofibromatosis type 1 AND plexiform neurofibromas that are symptomatic and not amenable to complete resection). When criteria are met for members <19 years, authorization will be issued for 12 months.

Initial authorization: diagnosis of neurofibromatosis type 1 AND symptomatic plexiform neurofibromas not amenable to complete resection
Authorization duration for eligible members <19 years: 12 months

Denial Risk

Denial Triggers

Requests may be denied if the submitted documentation does not meet the required diagnosis or clinical criteria (e.g., lacking documentation of NF1 diagnosis, absence of symptomatic PN, or documentation that tumor is amenable to complete resection). Reauthorization may be denied if there is evidence of progressive disease while on Gomekli therapy or if required supporting documentation is not provided.

Denial triggers include: missing/insufficient documentation of NF1 diagnosis or PN characteristics
Progressive disease on therapy may trigger reauthorization denial

Documentation Required

Supporting Documentation

Approvals may be based on prior claim or medication history, submitted diagnosis codes (ICD-10), and claim logic; automated approval and re‑approval processes may be used. Submit clinical notes supporting NF1 diagnosis, documentation that PN are symptomatic and not surgically resectable, prior treatment history, and any relevant package insert information. Supply limits may apply.

Supporting documentation: clinical notes, imaging/surgical consults documenting PN not amenable to complete resection, prior medication/claim history, ICD-10 diagnosis codes
Program may use automated approval based on claims/medication history and claim logic
Supply limits may be enforced

Step Therapy

No step therapy requirements are specified for Gomekli in the source guidance.

Step therapy: none specified

Background

Gomekli (mirdametinib) is a kinase inhibitor indicated for the treatment of adult and pediatric patients aged 2 years and older with neurofibromatosis type 1 who have symptomatic plexiform neurofibromas that are not amenable to complete surgical resection. This policy applies to members and providers using UnitedHealthcare pharmacy benefits and outlines prior authorization and reauthorization requirements, including that prescriptions for members under 19 years will automatically process without coverage review while initial and continued approvals for others are issued per the criteria.

Policy Summary

PayerUnitedHealthcare

PolicyGomekli (mirdametinib) prior authorization

Policy CodePolicy N/A

Change TypeNew program

Effective DateJul 1, 2025

Next Review DateN/A

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

SourceLink

On This Page

OpenPayer

Gomekli (mirdametinib) prior authorization

Coverage Criteria for Gomekli (mirdametinib)

Initial Therapy Authorization Criteria

Continuation / Reauthorization Criteria

Provider Actions, Documentation, and Billing Notes

Key Definitions

Quantity Limits and Supply

Background