WHA

OJEMDA (tovorafenib)

Self-Administration - oral suspension and oral tablet

Diagnosis considered for coverage:

  • 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 durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Coverage Criteria:

For diagnosis of pediatric low-grade glioma:

  • Diagnosis of pediatric low-grade glioma, AND

  • Disease is relapsed or refractory, AND

  • Disease has 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)

Reauthorization Criteria:

For diagnosis of pediatric low-grade glioma:

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

Coverage Duration: 

  • Initial: 12 months

  • Reauthorization: 12 months

Dosing: 

For diagnosis of pediatric low-grade glioma:

  • 380 mg/m2 orally once weekly (maximum of 600 mg orally once weekly) until disease progression or intolerable toxicity

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Policy Updates:

  • 10/01/2024 – New policy approved by WHA P&T Committee. (P&T, 11/20/2024) 

References:
  1. Ojemda Prescribing Information. Day One Biopharmaceuticals, Inc. Brisbane CA 94005. May 2024. 

 

Last review date: December 1, 2024