Product Details
Tasigna
Nilotinib150 mg
Capsule
DIN/PIN/NPN
02368250
Manufacturer
Novartis Pharma Canada Inc.
Formulary Listing Date
2023-04-28
Unit Price
31.2988
Amount MOH Pays
31.2988
Coverage Status
Exceptional Access Program Product
ODB Formulary Therapeutic Classification
Therapeutic Note
NO
ATC Code
L01EA03
Interchangeable Products
NOLU Clinical Criteria
NOEAP Criteria
Therapeutic Class | Reimbursement Criteria |
---|---|
Oncology Drugs | Nilotinib
For the treatment of patients with chronic phase Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia (CML). Note: Ministry will only fund any TWO of the oral Tyrosine Kinase inhibitors (TKIs)* used for chronic phase CML per patient in a lifetime. (*TKIs: imatinib, nilotinib, or dasatinib) Approved dose: 300 mg twice daily but not exceeding 800 mg/day Duration of Approval: 1 Year For the treatment of patients with accelerated phase Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia (CML) with documented intolerance1 or resistance2 to imatinib therapy. 1Intolerance to imatinib at any dose occurs where the Patient has experienced persistent grade 3 or grade 4 toxicity requiring discontinuation of imatinib therapy; or 2Imatinib resistance occurs where the Patient has primary or acquired resistance to imatinib at doses of at least 600mg/day or via a mutational analysis report. Exclusion Criteria – Patients with the following exclusion criteria will not be funded:
Approved dosage: Up to 800 mg/day but doses above 800 mg per day will not be considered Renewal Criteria: Duration of Approval: 1 Year EAP Drug Request Form: |