CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Ojemda

Defines accepted indications, continuation and exclusion criteria, dosing limits, coding, applicable lines of business, and evidence sources for tovorafenib (Ojemda) for use in cancer, specifically relapsed/refractory pediatric low-grade glioma with BRAF alterations. Applies to medication requests processed by Evolent.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyOjemda

Policy CodePolicy N/A

Change TypeRevised / Added / Clarified

Effective Date2025-06

Next Review Date

Key ActionMedication requests for Ojemda must be processed and authorized by Evolent and supported by FDA labeling, CMS compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature meeting CMS requirements.

SourceLink

POLICY UPDATE CHANGES

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

Maximum dosage form quantities (24 x 100 mg tablets per month) added to exclusion criteria.

Updated exclusion criteria regarding investigational/off-label indications and evidence requirements.

1Covered Indications (pediatric LGG with BRAF alteration)

3Key exclusion reasons listed

24Maximum 100 mg tablets per month

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Coverage Summary

Coverage stance: covered_with_criteria. This guideline covers Ojemda (tovorafenib) for the specified indication when the policy's criteria are met, including required evidence sources (FDA labeling, CMS-recognized compendia, NCCN/ASCO guidance, or peer-reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 requirements).

Scope and covered indication: Applies to medication requests processed by Evolent for use in cancer, specifically relapsed or refractory pediatric low-grade glioma (LGG) in members ≥ 6 months of age whose tumors harbor a BRAF fusion or rearrangement or a BRAF V600 mutation. Drug coding: J8999 (tovorafenib).

Payer/process note: Evolent is responsible for processing medication requests and authorizations for network ordering providers; medications not authorized by Evolent may be deemed not approvable and therefore not reimbursable.

Quick facts and thresholds

Minimum age>= 6 months

Single dose limit<= 600 mg per single dose

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

Coverage stancecovered_with_criteria

Applicable lines of businessCommercial; Exchange/Marketplace; Medicaid; (Not CHIP, Not Medicare Advantage)

Initial Therapy Criteria

Initial Authorization - Indication

Covered when ALL of the following are met:

ALL of the following

Diagnosis of relapsed or refractory pediatric low-grade glioma (LGG)
BRAF alteration
- BRAF fusion or rearrangement
- BRAF V600 mutation
Minimum age: Member is at least 6 months of age>= 6 months

Continuation Therapy Criteria

Continuation Authorization

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 use: Requested medication was used within the last year without a lapse of more than 30 days of having an active authorization
No additions: No additional medication(s) are being added to the continuation request

Exclusion / Not Approvable Criteria

Treatment is NOT approvable when ANY of the following apply:

ANY of the following

BRAF wild-type: Member has BRAF wild-type glioma
Progression on Ojemda: Disease progression while taking Ojemda (tovorafenib)
Concurrent therapy: Concurrent use with other anticancer therapies
Single dose limit: Dosing exceeds single dose limit of 600 mg

Applicable Codes

Drug HCPCS/J-codeHCPCSCovered

J8999

tovorafenib

Provider Actions

Prior Authorization

Authorization required for Ojemda

Medication requests for Ojemda (tovorafenib) must be processed and authorized by Evolent. Requests must be supported by FDA-approved product labeling, CMS-recognized compendia, NCCN or ASCO clinical guidelines, or peer-reviewed literature that meets the requirements of the CMS Medicare Benefit Policy Manual Chapter 15.

Affected code: J8999

Documentation Required

Documentation of BRAF alteration required

Providers must document the tumor BRAF alteration to support approval. Documentation should indicate whether the tumor harbors a BRAF fusion or rearrangement, or a BRAF V600 mutation.

Acceptable documentation: pathology reports, genetic/molecular test reports

Clinical Evidence & References

Kilburn et al., Nat Med. 2024;30(1):207-217Phase 2 FIREFLY-1 trial (evidence source)

Day One Biopharmaceuticals, Inc., 2025Prescribing information (labeling source)

Evidence sources cited include the Phase 2 FIREFLY-1 trial (Kilburn et al., Nat Med. 2024) and the Ojemda prescribing information (Day One Biopharmaceuticals, Inc., 2025), along with recognized references and compendia (e.g., Clinical Pharmacology, Micromedex, NCCN Drugs and Biologics Compendium, AHFS).

Acceptable off-label uses require support from CMS-recognized compendia or peer-reviewed literature that meet the CMS Medicare Benefit Policy Manual Chapter 15 criteria (as described in the guideline: adequate representation of patient/cancer characteristics and regimen, clinically meaningful outcomes per ASCO guidance, appropriate study design, and exclusion of reliance on case reports or abstracts).

Background

Background: This Evolent Clinical Guideline defines accepted FDA-approved and acceptable off-label uses for Ojemda (tovorafenib) and is used by Evolent to process medication requests and authorizations for network providers. Medications not authorized by Evolent may be considered not approvable and therefore not reimbursable.

Scope: The guideline applies to medication requests processed by Evolent for treatment of cancer, specifically relapsed/refractory pediatric low-grade glioma with BRAF fusion/rearrangement or BRAF V600 mutation, and is intended for use in prior authorization and utilization management for applicable lines of business.

Revision History

June 2025revisedLatest

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

June 2025addedLatest

Maximum dosage form quantities (24 x 100 mg tablets per month) added to exclusion criteria; specifies dosing limit to prevent approvals exceeding 24 tablets/month.

June 2025

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyOjemda

Policy CodePolicy N/A

Change TypeRevised / Added / Clarified

Effective Date2025-06

Next Review Date

SourceLink

On This Page

Evidence support: Request is supported by FDA approved labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or peer-reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 requirements

<= 600 mg per single dose

Monthly tablet limit: Treatment exceeds the maximum limit of 24 (100 mg) tablets/month<= 24 x 100 mg tablets per month

Investigational/off-label evidence

Representation of patients: Insufficient representation of patient or cancer clinical characteristics in published evidence
Regimen representation: Regimen not adequately represented in published evidence
Clinically meaningful outcomes: Reported study outcomes do not represent clinically meaningful outcomes (ASCO guidance: Hazard Ratio < 0.80 or OS/PFS benefit ≥ 3 months)
Experimental design inappropriate to address question (e.g., unacceptable methodology)
Case reports/abstracts: Case reports or meeting abstracts without full peer-reviewed article are inadequate

The updated guideline adds explicit exclusion wording limiting maximum dosage form quantities to prevent approvals exceeding 24 x 100 mg tablets per month, and clarifies exclusion criteria and evidence requirements for investigational or off-label uses (e.g., insufficient representation of patient/cancer characteristics, inadequate regimen representation, lack of clinically meaningful outcomes, inappropriate experimental design, and that case reports or meeting abstracts without full peer-reviewed articles are inadequate).

Denial Risk

Denial conditions

Claims may be denied when any exclusion criteria are met, including: the member has BRAF wild-type glioma; disease progression while taking Ojemda; concurrent use with other anticancer therapies; dosing limits exceeded (single dose >600 mg or monthly tablet limit exceeded); or when an investigational/off-label use lacks sufficient evidence per CMS standards.

Affected code: J8999
Dosing thresholds: single dose limit <= 600 mg; maximum 24 (100 mg) tablets per month

Updated exclusion criteria regarding investigational/off-label indications and defined acceptable evidence sources and criteria for sufficiency per CMS standards (e.g., representation of patient/cancer characteristics, regimen representation, clinically meaningful outcomes per ASCO, study design considerations, and exclusion of case reports/abstracts without full peer-reviewed articles).