ModifiedNeighborhood Health Plan of Rhode IslandPolicy N/A

Evolent Clinical Guideline 3129 for Ojemda TM (tovorafenib)

Defines accepted indications, contraindications, exclusion criteria, and coding for tovorafenib (Ojemda) use, focusing on relapsed/refractory pediatric low-grade glioma with BRAF alterations; includes continuation conditions and billing code. Applies across commercial, exchange, and Medicaid lines of business managed by Evolent.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyEvolent Clinical Guideline 3129 for Ojemda TM (tovorafenib)

Policy CodePolicy N/A

Change TypeModified (dosage/quantity limits and exclusion criteria updated)

Effective DateJun 1, 2025

Next Review Date

Key ActionProcess prior authorization through Evolent and ensure use is supported by FDA labeling, CMS compendia, NCCN/ASCO guidelines, or acceptable peer‑reviewed literature; document tumor BRAF fusion/rearrangement or BRAF V600 mutation status.

POLICY UPDATE CHANGES

Added maximum dosage form quantities in exclusion criteria

Updated exclusion criteria and references

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

New policy created in June 2024

1Covered Indications (oncologic)

24Monthly tablet limit

600Single dose max (mg)

FDA/Comp/NCCN/ASCO/Peer

Evidence source types required

Coverage Summary & Scope

This guideline covers Ojemda (tovorafenib) for the treatment of relapsed or refractory pediatric low-grade glioma (LGG) in patients ≥ 6 months of age whose tumors harbor a BRAF fusion or rearrangement, or BRAF V600 mutation. It applies to Commercial, Exchange/Marketplace, and Medicaid lines of business. Coverage stance: covered_with_criteria, with use requiring documentation and prior authorization per Evolent requirements.

Thresholds and Quick Facts

Single dose limit<= 600 mg

Monthly tablet limit<= 24 (100 mg) tablets per month

Age threshold>= 6 months

Evidence source types requiredFDA labeling, CMS-recognized compendia, NCCN, ASCO guidelines, or qualifying peer-reviewed literature

Medically Necessary and Exclusion Criteria

Medically Necessary / Initial and Continuation Therapy

Covered when ALL of the following are met:

ALL of the following

Diagnosis of relapsed or refractory pediatric low-grade glioma (LGG)
Age: Patient age 6 months of age or older>= 6 months
Tumor BRAF status: Tumor harbors a BRAF fusion or rearrangement, or BRAF V600 mutation
Evidence source requirement: Use is supported by FDA labeling, CMS-recognized compendia, NCCN, ASCO guidelines, or peer-reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 requirements

Billing Codes

Applicable Drug HCPCS/J-codeHCPCSCovered

J8999

tovorafenib

Billing and claims should use HCPCS code J8999 for tovorafenib. Do not exceed a single dose of 600 mg, and do not exceed a maximum of 24 (100 mg) tablets per month when submitting claims; exceeding these limits may result in denial.

Prior Authorization, Documentation & Billing Rules

Prior Authorization

Prior authorization required and evidence support

Medication requests must be processed by Evolent; use must be supported by FDA labeling, CMS compendia, NCCN, ASCO guidelines, or acceptable peer-reviewed literature per CMS Medicare Benefit Policy Manual Chapter 15; medications not authorized by Evolent may be deemed not approvable and not reimbursable.

Applicable code: J8999
Required evidence sources: FDA labeling; CMS-recognized compendia; NCCN guidelines; ASCO guidelines; peer-reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15

Documentation Required

Documentation of BRAF alteration required

Provider must document tumor BRAF fusion/rearrangement or BRAF V600 mutation status to meet coverage criteria.

Background & Evidence

Evolent Clinical Guideline defines utilization management requirements for tovorafenib (Ojemda), describing accepted FDA-approved and acceptable off-label uses when supported by CMS-recognized compendia, NCCN, ASCO guidelines, or acceptable peer-reviewed literature per CMS Medicare Benefit Policy Manual Chapter 15. The guideline was converted to a new template and supersedes the prior UM ONC_1503 policy. Continuation requests for a not-approvable medication may be exempt from the policy when the member has not progressed on therapy, the medication was used within the last year without a lapse of >30 days of active authorization, and no additional medications are being added.

Evidence Sources

Key trial citedFIREFLY-1 phase 2 trial (Kilburn et al., Nat Med 2024)

Manufacturer prescribing informationOjemda prescribing information, Day One Biopharmaceuticals, 2025

Continuation requests exempt: Continuation requests for a not-approvable medication are exempt if the member has no disease progression on the medication, the medication was used within the last year without a lapse of more than 30 days of active authorization, and no additional medications are being added to the request.

Sufficient evidence: Sufficient evidence is that which is supported by CMS compendia, NCCN, ASCO, or peer-reviewed literature meeting CMS standards; case reports and abstracts without full peer-reviewed articles are generally insufficient. Considerations include whether patient/cancer characteristics and the administered regimen are adequately represented, whether outcomes are clinically meaningful (ASCO definitions), and whether study design is appropriate.

Revision History & Material Changes

June 2024policy_created

New policy created in June 2024

June 2025material_changeLatest

Added maximum dosage form quantities in exclusion criteria (treatment exceeds the maximum limit of 24 (100 mg) tablets/month; dosing exceeds single dose limit of 600 mg)

June 2025material_changeLatest

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyEvolent Clinical Guideline 3129 for Ojemda TM (tovorafenib)

Policy CodePolicy N/A

Change TypeModified (dosage/quantity limits and exclusion criteria updated)

Effective DateJun 1, 2025

Next Review Date

On This Page

One of the listed evidence sources must support the requested use

Continuation Therapy (exemption when medication is not approvable)

Continuation requests exempt from this policy when ALL of the following are met:

ALL of the following

No progression: Member has not experienced disease progression on the requested medication
Recent prior use: Requested medication was used within the last year without a lapse of more than 30 days of having an active authorization<= 1 year; no lapse > 30 days
No added meds: Additional medication(s) are not being added to the continuation request

Required documentation: tumor BRAF fusion or rearrangement OR BRAF V600 mutation (report/result)

Denial Risk

Denial for excluded scenarios

Claims may be denied if the request meets any exclusion criteria, including scenarios where the clinical or evidence requirements are not met.

BRAF wild-type glioma
Disease progression while taking tovorafenib (Ojemda)
Concurrent use with other anticancer therapies
Dosing exceeds single dose limit of 600 mg
Monthly quantity exceeds 24 (100 mg) tablets
Off-label indications lacking sufficient evidence or not accepted by the medical community

Billing Rule

Dosage and quantity limits

Do not exceed single dose of 600 mg and maximum of 24 (100 mg) tablets per month when submitting claims for tovorafenib.

Single dose limit: <= 600 mg
Monthly tablet limit: <= 24 (100 mg) tablets per month
Affected code: J8999

Updated exclusion criteria and references (clarified investigational/off-label evidence sufficiency and updated reference list)

June 2025administrative_changeLatest

Converted to new Evolent guideline template and replaced prior UM ONC_1503 (administrative restructure)