REZLIDHIA (olutasidenib)

Self-Administration – oral

Diagnosis considered for coverage:
  • Acute Myeloid Leukemia (AML): Indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test.

Coverage Criteria:

For diagnosis of acute myeloid leukemia (AML):

  • Dose does not exceed 150 mg orally twice daily, AND

  • Patient is 18 years of age or older, AND

  • Prescribed by or in consultation with an oncologist/hematologist, AND

  • Diagnosis of acute myeloid leukemia (AML), AND

  • Disease is one of the following:

    • Relapsed

    • Refractory, AND

  • Presence of a susceptible isocitrate dehydrogenase-1(IDH1) mutation as detected by a U.S. Food and Drug Administration (FDA)-approved test (e.g., Abbott RealTime IDH1 assay) or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)

Reauthorization Criteria:

For diagnosis of acute myeloid leukemia (AML):

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

Coverage Duration: 
  • Initial: 12 months

  • Reauthorization: 12 months

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.

Additional Information: 
  • Warnings

    • Hepatotoxicity: Monitor liver function tests during treatment with REZLIDHIA. If hepatotoxicity occurs, interrupt and reduce or discontinue REZLIDHIA.

  • Drug Interactions

    • Strong or moderate CYP3A Inducers: Avoid concomitant use.

    • Sensitive CYP3A Substrates: Avoid concomitant use. Monitor if unavoidable.

Policy Updates:  
  • 05/16/2023  – New policy approved by P&T.

References:
  • Rezlidhia Prescribing Information. Rigel Pharmaceuticals, Inc. South San Francisco, CA. December 2022. 

  • The NCCN Drugs and Biologics Compendium (NCCN Compendium). Available at http://www.nccn.org/professionals/drug_compendium/content/contents.asp. Accessed on January 3, 2023. 

Last review date: June 1, 2023

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