Product Details

Bosulif

Bosutinib
500 mg
Tablet


DIN/PIN/NPN

02419157

Manufacturer

Pfizer Canada Inc.

Formulary Listing Date

2017-04-27  

Unit Price

152.2403

Amount MOH Pays

152.2403

Coverage Status

Exceptional Access Program Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

L01EA04

Interchangeable Products

NO  

LU Clinical Criteria

NO  

EAP Criteria

Therapeutic Class Reimbursement Criteria
Oncology Drugs

Bosutinib

  • Brand(s): Bosulif
  • Dosage Form/Strength: 100 mg, 500 mg tablet
  • (Last Update: September 3, 2020)

For the treatment of patients with Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) in patients meeting the following criteria:

  1. 18 years of age or older; AND

  2. Diagnosis of (Ph+) chronic phase, accelerated phase, or blast phase CML; AND

  3. Bosutinib is used in one of the following clinical situations:
    i) As second line therapy after experiencing disease progression on imatinib, dasatinib, or nilotinib1 in first line;
    OR
    ii) As third line therapy after experiencing disease progression to imatinib, dasatinib, nilotinib1, or ponatinib in second line;
    OR
    iii) In patients who have not progressed on one or more prior TKIs but who have documented mutational drug resistance to imatinib, dasatinib, and/or nilotinib1 which make them clinically inappropriate treatment choices;
    OR
    iv) In patients who have not progressed on one or more TKIs but have experienced unacceptable intolerance or toxicity to one prior TKI (i.e., imatinib, dasatinib, or nilotinib1)

Exclusion Criteria:

  • Bosutinib will not be funded in combination with another oral TKI (e.g., imatinib, nilotinib, dasatinib, or ponatinib)
  • Bosutinib will not be funded as 4th line treatment for CML or beyond.

1Note that nilotinib is not funded in blast phase CML, therefore, considerations will only be applied for imatinib and dasatinib in patients with blast phase CML

Renewal criteria:
Renewal of funding will be considered upon confirmation from the patient’s clinician that the patient has experienced hematologic and/or cytogenic response and is expected to continue to do so

Recommended Dosing: 500mg per day

Approval period for initials & renewals: 1 year

EAP Drug Request Form:

Standard Form for EAP Drug Requests

Product Monograph

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