Product Details

Brukinsa

Zanubrutinib
80 mg
Capsule


DIN/PIN/NPN

02512963

Manufacturer

Innomar Strategies, Inc.

Formulary Listing Date

2023-03-09  

Unit Price

67.9833

Amount MOH Pays

67.9833

Coverage Status

Exceptional Access Program Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

L01EL03

Interchangeable Products

NO  

LU Clinical Criteria

NO  

EAP Criteria

Therapeutic Class Reimbursement Criteria
Oncology Drugs

Zanubrutinib

  • Brand(s): Brukinsa
  • Dosage Form/Strength: 80 mg capsule
  • Effective date: March 9, 2023

Initial Criteria:

For the treatment of Relapsed or Refractory Waldenstrom Macroglobulinemia (WM) in patients meeting ALL the following criteria:

  1. Confirmed diagnosis of WM from a prescriber with expertise in the management and diagnosis of WM; AND 

  1. At the time of initial diagnosis of WM, the patient met at least one criterion for treatment of active, symptomatic WM according to the International Workshops for Waldenström Macroglobulinaemia (IWWM) consensus panel; AND 

  1. Has relapsed or is refractory to at least one prior line of treatment for WM; AND 

  1. Has a good performance status of ECOG less than or equal to 2; AND 

  1. Zanubrutinib will be used as monotherapy.

Exclusion Criteria:

  • Patients who have experienced disease progression on another BTK inhibitor for WM. 

  • Patients who have experienced disease transformation to another form of cancer.

Notes: 

  1. Blood work should be performed monthly at the beginning of treatment and then can be performed less frequently at the discretion of the treating physician. 

  1. Baseline imaging should be completed. For patients with extramedullary disease, imaging should be at the discretion of the treating physician. 

Renewal Criteria:
Renewals will be considered in patients until disease progression or development of unacceptable toxicity.
Response to therapy should be evaluated in accordance with IWWM response criteria.

Approved dose:
320 mg orally daily or 160 mg twice a day.

Initial and renewal approval period: 1 year

EAP Drug Request Form:

Standard Form for EAP Drug Requests

Product Monograph

View Monograph