CurrentCentenePolicy CP.PHAR.686

Clinical Policy: Tovorafenib (Ojemda)

Covers medical necessity and prior authorization criteria for Ojemda (tovorafenib) in pediatric patients with relapsed or refractory low-grade glioma harboring BRAF fusion/rearrangement or BRAF V600 mutation; applies to Centene-affiliated health plans and lines of business including Commercial, HIM, and Medicaid.

Policy Summary

PayerCentene

PolicyTovorafenib (Ojemda) coverage criteria

Policy CodePolicy CP.PHAR.686

Change TypeNo material changes

Effective DateSep 10, 2024

Next Review Date

Key ActionSubmit prior authorization demonstrating relapsed or refractory pediatric LGG with BRAF fusion/rearrangement or V600 mutation, age ≥6 months, oncologist involvement, prior systemic therapy failure, current BSA, and dosing within caps or supported by literature.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥6 monthsminimum approved patient age

≥1 priorrequired prior therapy

600 mg/weekmax weekly dose

12 monthsauth length

Pediatric LGG BRAF+covered indication

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Coverage Criteria for Ojemda (tovorafenib)

inv-01: Initial Therapy

Covered when ALL of the following are met:

Initial Pediatric LGG criteria: 1. Diagnosis of relapsed or refractory low-grade glioma (LGG); 2. Prescribed by or in consultation with an oncologist; 3. Age ≥ 6 months; 4. Disease is positive for one of the following: (a) BRAF fusion or rearrangement, or (b) BRAF V600 mutation; 5. Failure of at least one line of prior systemic therapy (see Appendix B for examples); 6. Documentation of the member's current body surface area (BSA) (m2); 7. Request meets one of the following: (a) Requested dose does not exceed both 380 mg per m2 of BSA and 600 mg once weekly; OR (b) Requested dose is supported by practice guidelines or peer‑reviewed literature for the relevant off‑label use (prescriber must submit supporting evidence). Note: Prescribed regimen must be FDA‑approved or recommended by NCCN. Approval duration: 12 months.

inv-02: Continuation Therapy

Covered when ALL of the following are met:

Continued Pediatric LGG criteria: 1. Member is currently receiving medication via Centene benefit, or documentation supports that the member has been receiving Ojemda for a covered indication and has received the medication for at least 30 days; 2. Member is responding positively to therapy; 3. If the request is for a dose increase, the request meets one of the following: (a) Both of the following: (i) Documentation of the member's current body surface area (BSA) (m2); and (ii) New dose does not exceed both 380 mg per m2 of BSA and 600 mg once weekly; OR (b) Dose is supported by practice guidelines or peer‑reviewed literature for the relevant off‑label use (prescriber must submit supporting evidence). Note: Prescribed regimen must be FDA‑approved or recommended by NCCN. Approval duration: 12 months.

Requests for use of tovorafenib (Ojemda) for indications that are not FDA-approved and are not specifically addressed in this policy are not authorized unless the provider submits sufficient documentation demonstrating efficacy and safety in accordance with the applicable off-label use policies referenced by Centene. Providers should follow the required off-label documentation pathways (see CP.CPA.09, HIM.PA.154, CP.PMN.53) when seeking coverage for such uses.

Uses of tovorafenib for non-FDA approved indications that are not described in this policy will be considered unauthorized unless the prescriber provides adequate off-label supporting evidence. Documentation must meet the criteria outlined in Centene's off-label use policies (commercial, HIM, or Medicaid as applicable) or be supported by evidence of coverage documents to be eligible for review.

Dose and Coding Limits

inv-05: Maximum weekly dose — 600 mg/week

Maximum weekly dose600 mg per week

inv-06: Dose by BSA — 380 mg per m2 (dose cap)

Dose by body surface area (BSA)380 mg per m2 of BSA (dose cap)

Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for initial therapy. Requests must include documentation of diagnosis, BRAF status, age, prior systemic therapy, prescriber specialty, and dosing information consistent with policy limits or supported by literature/guidelines.

Submit prior authorization before initiating therapy
Prescriber: oncologist or consultation with an oncologist documented
Age requirement: ≥ 6 months
Dose limits: ≤ 380 mg/m2 and ≤ 600 mg once weekly unless supported by guidelines/literature

Step Therapy

Therapeutic Alternatives / Prior Therapy

A trial and failure of at least one prior line of systemic therapy is required for approval of initial therapy for pediatric low-grade glioma. See Appendix B for examples of therapeutic alternatives (e.g., vincristine, carboplatin, vinblastine).

Required: failure of ≥ 1 line of prior systemic therapy

Background

Tovorafenib (Ojemda) is addressed in this policy for its FDA-approved pediatric indication; however, any request for non‑approved indications must include sufficient evidence of efficacy and safety per Centene's off-label policies to be considered for authorization. Absent that documentation, such requests will not be authorized under this policy.

Definitions and Regulatory Notes

inv-12: Definition — B-Raf proto-oncogene, serine/threonine kinase (BRAF)

TermB-Raf proto-oncogene, serine/threonine kinase (BRAF)

ContextReferenced as a biomarker for tumor testing to identify fusion, rearrangement, or V600 mutation in pediatric low-grade glioma.

Testing noteBRAF testing available from independent labs; rearrangements detected by FISH (see Appendix D).

inv-13: Definition — body surface area (BSA)

TermBody surface area (BSA)

Use in dosingDosing of Ojemda is specified per m2 of BSA (e.g., 380 mg/m2 recommended); current BSA must be documented for authorization.

Initial Therapy Requirements

inv-15: Initial Therapy — initial therapy coverage requirements for pediatric LGG

Covered when ALL of the following are met:

Initial Therapy Nodes - Pediatric LGG: 1. Diagnosis of relapsed or refractory low-grade glioma (LGG); 2. Prescribed by or in consultation with an oncologist; 3. Age ≥ 6 months; 4. Disease is positive for one of the following: (a) BRAF fusion or rearrangement; or (b) BRAF V600 mutation; 5. Failure of at least one line of prior systemic therapy; 6. Documentation of the member's current body surface area (BSA) (m2); 7. Requested dose meets one of the following: (a) Does not exceed both 380 mg per m2 of BSA and 600 mg once weekly; or (b) Is supported by practice guidelines or peer‑reviewed literature for the relevant off‑label use (prescriber must submit supporting evidence). Note: Prescribed regimen must be FDA‑approved or recommended by NCCN. Approval duration: 12 months.

Continued Therapy Requirements

inv-16: Continued Therapy — continued therapy requirements for pediatric LGG

Covered when ALL of the following are met:

Continued Therapy Nodes - Pediatric LGG: 1. Member is currently receiving medication via Centene benefit, or documentation supports that the member has been receiving Ojemda for a covered indication and has received the medication for at least 30 days; 2. Member is responding positively to therapy; 3. If the request is for a dose increase, the request meets one of the following: (a) Both: (i) Documentation of the member's current body surface area (BSA) (m2); and (ii) New dose does not exceed both 380 mg per m2 of BSA and 600 mg once weekly; or (b) Dose is supported by practice guidelines or peer‑reviewed literature (prescriber must submit supporting evidence). Note: Prescribed regimen must be FDA‑approved or recommended by NCCN. Approval duration: 12 months.

Step Therapy / Prior Systemic Therapy

Step	Requirement / Description
1	Prior systemic therapy required: Failure of at least one line of prior systemic therapy (see Appendix B for examples of therapeutic alternatives such as vincristine/carboplatin or vinblastine).

Quantity and Dispensing Limits

inv-18: Ojemda (tovorafenib) — quantity limit 600 mg

DrugOjemda (tovorafenib)

Quantity limit600 mg per week

FormulationsTablets: 100 mg; Oral suspension: 300 mg/12 mL