Product Details

Tasigna

Nilotinib
200 mg
Capsule


DIN/PIN/NPN

02315874

Manufacturer

Novartis Pharma Canada Inc.

Formulary Listing Date

2023-04-28  

Unit Price

43.5677

Amount MOH Pays

43.5677

Coverage Status

Exceptional Access Program Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

L01EA03

Interchangeable Products

NO  

LU Clinical Criteria

NO  

EAP Criteria

Therapeutic Class Reimbursement Criteria
Oncology Drugs

Nilotinib

  • Brand(s): Tasigna
  • Dosage Form/Strength: 150 mg, 200 mg capsule

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)
If the patient develops grade 3 or 4 toxicity on one of the above TKI’s within 3 months of initiating therapy, access to a 3rd oral TKI will be funded for that patient.

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:

  • blast phase CML;
  • for Ph+ acute lymphocytic leukemia (ALL);
  • combination treatment with any two or more oral TKIS’s (imatinib, nilotinib, or dasatinib) will not be funded
  • For accelerated phase CML, nilotinib is not funded as a sequential third line therapy in patients who experience primary or acquired resistance (not including mutational resistance) to dasatinib.

Approved dosage: Up to 800 mg/day but doses above 800 mg per day will not be considered

Renewal Criteria:
Renewals are considered for patients who experience hematologic and/or cytogenic response to therapy, is expected to continue to benefit from therapy with Tasigna.

Duration of Approval: 1 Year

EAP Drug Request Form:

Standard Form for EAP Drug Requests

Product Monograph

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