REZLIDHIA (olutasidenib)

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.