CurrentUnitedHealthcarePolicy N/A

Ojemda (tovorafenib) prior authorization

Defines prior authorization and coverage criteria for Ojemda (tovorafenib) for treatment of pediatric low-grade glioma, specifying initial and reauthorization requirements and age-based automatic processing for members under 19.

Policy Summary

PayerUnitedHealthcare

PolicyOjemda (tovorafenib) prior authorization

Policy CodePolicy N/A

Change TypeAdministrative — no material coverage changes

Effective DateSep 1, 2025

Next Review DateJun 1, 2025

Key ActionSubmit prior authorization documenting diagnosis of relapsed or refractory pediatric low-grade glioma and evidence of a qualifying BRAF alteration.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization period

>= 6 monthsminimum patient age

6/2024, 6/2025P&T review

2025-09-01policy effective

Coverage Criteria for Ojemda (tovorafenib)

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inv-02: Reauthorization — Covered when ALL of the following are met

Covered when ALL of the following are met

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

Authorization issued for 12 months

inv-03: Patients less than 19 years of age — Automatic processing for younger patients

Automatic processing for younger patients

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

Authorization issued for 12 months

Continuation / Reauthorization Criteria

inv-12: Continuation therapy / Reauthorization — Reauthorization requirement

Reauthorization requirement

Continued therapy: Patient must not show evidence of progressive disease while on Ojemda therapy

12-month authorization if criterion met

Provider Actions and Documentation Requirements

Prior Authorization

Prior authorization required for Ojemda (age-based exception)

Prior authorization is required for Ojemda except for prescriptions for members under 19 years of age, which will automatically process. For initial approval, documentation must show diagnosis of pediatric low-grade glioma that is relapsed or refractory and presence of a qualifying BRAF alteration. Authorization is issued for 12 months.

Initial approval requires: (1) diagnosis of pediatric low-grade glioma; (2) disease is relapsed or refractory; and (3) presence of BRAF fusion/rearrangement or BRAF V600 mutation.
Members <19 years: prescription will be approved automatically and authorization issued for 12 months.

Step Therapy

Automated approval/re-approval may be used

Automated approval and re-approval processes may be used based on prior claim/medication history, diagnosis codes (ICD-10), and claim logic; usage varies by program or therapeutic class.

UnitedHealthcare may approve initial and reauthorization solely on previous claim/medication history, diagnosis codes, and/or claim logic.
Use of automated approval/re-approval processes varies by program and therapeutic class.

Documentation Required

Document required BRAF genetic alteration

Documentation must demonstrate the presence of one of the specified genetic alterations: either a BRAF fusion or rearrangement OR a BRAF V600 mutation.

Required genetic alterations: BRAF fusion or rearrangement; or BRAF V600 mutation.

Denial Risk

Coverage prerequisites — risk of denial if criteria not documented

Requests that do not document a diagnosis of pediatric low-grade glioma, relapsed or refractory disease, and presence of a qualifying BRAF alteration risk denial.

Denial risk if any of these are missing: pediatric low-grade glioma diagnosis; relapsed or refractory disease status; documentation of BRAF fusion/rearrangement or BRAF V600 mutation.

Definitions

Pediatric LGG with BRAF alteration — Eligible tumor subtype for Ojemda

Tumor subtypePediatric low-grade glioma (LGG) harboring BRAF fusion or rearrangement, or BRAF V600 mutation

Indication age rangePatients 6 months of age and older

Regulatory statusIndication approved under accelerated approval based on response rate and duration of response

Requirement for confirmatory dataContinued approval may be contingent on verification of clinical benefit in confirmatory trial(s)

Therapy contextIndication applies to relapsed or refractory disease

Background

Ojemda (tovorafenib) is a kinase inhibitor indicated for treatment of patients aged 6 months and older with relapsed or refractory pediatric low-grade glioma harboring a BRAF fusion/rearrangement or BRAF V600 mutation. For members under the age of 19 years, prescriptions will automatically process without a coverage review. Approval for other ages and indications is subject to the coverage criteria in this policy and any applicable state mandates or compendium requirements.