CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Ojemda (tovorafenib) — coverage and prior authorization criteria

Defines coverage and prior authorization requirements for Ojemda (tovorafenib) for treatment of relapsed or refractory pediatric low-grade glioma with BRAF alterations; applies to providers submitting medication requests to Evolent for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyOjemda (tovorafenib) — coverage and prior authorization criteria

Policy CodePolicy N/A

Change TypeMaterial content updates and template migration

Effective DateJun 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization and support the request with FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature.

SourceLink

POLICY UPDATE CHANGES

Converted to new Evolent guideline template and replaced UM ONC_1503 Ojemda (tovorafenib).

Added maximum dosage form quantities in exclusion criteria.

Updated exclusion criteria and references.

6 months+minimum patient age for covered indication

BRAF fusion/rearrangement or V600required tumor biomarker for covered glioma indication

J8999billing code listed for tovorafenib

600 mg

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Coverage criteria for Ojemda (tovorafenib)

Initial and continuation coverage

Covered when ALL of the following are met

Covered indication criteria: Patient is 6 months of age or older; diagnosis is relapsed or refractory pediatric low-grade glioma (LGG); tumor harbors a BRAF fusion or rearrangement OR BRAF V600 mutation; use is supported by FDA labeling, CMS‑recognized compendia, NCCN/ASCO guidelines, or acceptable peer‑reviewed literature per CMS standards.

Continuation requests may be exempt if there is no disease progression, prior use within the last year without >30‑day lapse, and no additional anticancer medications are being added (see continuation rules).

Exclusion criteria for Ojemda (tovorafenib) include patients with BRAF wild-type glioma, those with documented disease progression while taking tovorafenib, and those receiving concurrent use with other anticancer therapies. Dosing-related exclusions apply: a single dose that exceeds 600 mg is excluded, and treatment that would exceed 24 (100 mg) tablets per month is excluded. Additionally, investigational or off‑label uses lacking sufficient evidence per the policy’s evidentiary standards (e.g., not supported by CMS‑recognized compendia or acceptable peer‑reviewed literature) are excluded.

Use of Ojemda (tovorafenib) for indications that are not the covered pediatric low‑grade glioma population is considered off‑label and will be evaluated against the policy’s evidentiary standards. Off‑label or investigational uses that are not supported by CMS‑recognized compendia or acceptable peer‑reviewed literature — including when the published evidence does not adequately represent the patient population, regimen, or clinically meaningful outcomes — are considered insufficient and may be deemed not medically necessary.

Regimen / indication	Evidence source / notes	Coverage status
Tovorafenib (Ojemda) — relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation	Per FDA labeling and supported compendia; use must be supported by FDA approved product labeling, CMS‑recognized compendia, NCCN/ASCO guidelines, or acceptable peer‑reviewed literature (see references: Ojemda prescribing information; FIREFLY‑1 trial).	Covered
Dosing limits and exclusions	Requests exceeding single‑dose limit of 600 mg or treatment exceeding 24 (100 mg) tablets/month will be excluded; concurrent use with other anticancer therapies or disease progression on tovorafenib are exclusions. (See exclusion criteria.)	Not covered when exclusion criteria met

Billing and code limits

Drug HCPCS codeHCPCSCovered

J8999

tovorafenib

Single-dose limit — maximum single dose (exclusion if exceeded)

Maximum single dose600 mg (requests exceeding this single-dose limit are excluded)

Policy consequenceRequests will be excluded (and may be denied) if dosing exceeds the single-dose limit of 600 mg.

Relevant codeJ8999 - tovorafenib (see coding section)

Monthly tablet limit — maximum tablets per month (exclusion if exceeded)

Maximum monthly tablet limit24 (100 mg) tablets per month (treatment exceeding this limit is excluded)

Policy consequenceRequests will be excluded (and may be denied) if treatment exceeds 24 (100 mg) tablets/month.

What providers must do

Prior Authorization

Prior Authorization Required

Prior authorization is required for requests for Ojemda (tovorafenib). Providers must submit clinical documentation that supports the indication using one of the following sources: FDA-approved product labeling, CMS-recognized compendia, NCCN or ASCO clinical guidelines, or acceptable peer‑reviewed literature consistent with CMS Medicare Benefit Policy Manual Chapter 15.

Submit prior authorization with supporting documentation: FDA labeling, CMS compendia, NCCN/ASCO guidance, or acceptable peer-reviewed literature.
For continuation requests, the member must not have experienced disease progression on Ojemda, the drug must have been used within the last year without a lapse >30 days from prior authorization, and no additional medications are being added to the continuation request.
Evolent processes all medication requests; medications not authorized by Evolent may be considered not approvable and not reimbursable.

Note

Operational / Legacy Instructions

Providers should be aware of operational and legacy instructions: Evolent is responsible for processing medication requests and implementation/last revised dates are noted in the clinical guideline. Use the documented implementation and revision information for operational reference.

Key definitions and covered indication

Covered indication — relapsed or refractory pediatric low-grade glioma with BRAF fusion/rearrangement or V600 mutation

IndicationRelapsed or refractory pediatric low-grade glioma (LGG)

Age requirementMembers 6 months of age and older

Required tumor alterationsTumor must harbor a BRAF fusion or rearrangement OR BRAF V600 mutation

ConditionUse must align with FDA labeling or supported compendia/guidelines per policy criteria

Position in therapy

salvage

Line of therapy: Relapsed or refractory setting for pediatric low-grade glioma (salvage use).

Specific prior-line number (first-line vs later) is not specified in the document.

Required tumor biomarkers

BRAF fusion or rearrangement; BRAF V600 mutation — required biomarker(s) for coverage

Required biomarker(s)BRAF fusion or rearrangement; BRAF V600 mutation

PurposeBiomarker positivity is required for coverage of pediatric LGG indication

Evidence alignmentTesting results should be documented and consistent with FDA labeling or accepted compendia/guidelines

Background on tovorafenib (Ojemda)

Tovorafenib (Ojemda) is a type II RAF inhibitor indicated for certain pediatric low‑grade gliomas that harbor a BRAF fusion or rearrangement or a BRAF V600 mutation. The policy applies to members aged 6 months and older with relapsed or refractory pediatric low‑grade glioma and requires alignment of use with FDA labeling or recognized compendia/guidelines. Requests must also meet dosing limits and other criteria described in the policy.