BRUKINSA (zanubrutinib)

SELF-ADMINISTRATION- ORAL 

Indications for Prior Authorization:
  • Indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have received ≥ 1 prior therapy
Coverage Criteria:
  • Dose does not exceed 320 mg orally (four 80 mg capsules) once daily; AND 

  • Prescribed by or in consultation with an oncologist; AND

  • Patient is 18 years of age or older; AND

  • Diagnosis of mantle cell lymphoma (relapsed or refractory); AND

  • Patient has failed to respond to at least 1 prior therapy

Coverage Duration:
  • 1 year
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:
  • Precautions:

    • Avoid co-administration with moderate/strong CYP3A inducers

    • Use in specific populations:

      • Breast-feeding considerations: not recommended by the manufacturer during therapy or for ≥ 2 weeks following the last Brukinsa dose

  • Dosage and administration:

    • Severe hepatic impairment: the recommended dose is 80 mg twice daily

Policy Updates:
  • 02/18/2020 - Initial review

  • 06/01/2023 - Updating policy to include dosing/prescriber requirements for MCL and formatting

References:
  • Brukinsa Prescribing Information.  BeiGene USA, Inc.  San Mateo, CA.  April 2023.  

Last review date: June 1, 2023