Pharmacy Prior Authorization Criteria

Ojemda (tovorafenib)

Indications for Prior Authorization

Ojemda (tovorafenib)

• For diagnosis of Pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation
  Indicated for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Criteria

Ojemda

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Pediatric low-grade glioma

• Diagnosis of pediatric low-grade glioma
AND
• Disease is relapsed or refractory
AND
• Presence of a BRAF fusion or rearrangement, or BRAF V600 mutation as detected by an FDA-approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)
AND
• Patient does not have known or suspected diagnosis of neurofibromatosis type 1 (NF-1)
AND
• Patient is 6 months of age or older
AND
• Disease has progressed on or after at least one line of prior systemic therapy (e.g., chemotherapy)

Ojemda

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Pediatric low-grade glioma

• Patient does not show evidence of progressive disease while on therapy

P & T Revisions

2026-06-16, 2025-08-07, 2024-07-03

References

1. Ojemda Prescribing Information. Day One Biopharmaceuticals, Inc. Brisbane CA 94005. June 2026.
2. Childhood Astrocytomas, Other Gliomas, and Glioneuronal/Neuronal Tumors Treatment (PDQ®)–Health Professional Version, NIH National Cancer Institute. Accessed June 2026.
3. Clinical Consult June 2024

---

Revision History

• 2026-06-16: 2026 Annual Review. No criteria updates. References updated.
• 2025-08-07: 2025 Annual Review. Updated genetic mutation language. Updated references.
• 2024-07-03: New program

---