Product Details

Iclusig

Ponatinib
45 mg
Tablet


DIN/PIN/NPN

02437341

Manufacturer

Takeda Canada Inc.

Formulary Listing Date

2021-04-30  

Unit Price

351.0267

Amount MOH Pays

351.0267

Coverage Status

Exceptional Access Program Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

L01EA05

Interchangeable Products

NO  

LU Clinical Criteria

NO  

EAP Criteria

Therapeutic Class Reimbursement Criteria
Oncology Drugs

Ponatinib

  • Brand(s): Iclusig
  • Dosage Form/Strength: 15 mg, 45 mg tablets

Chronic Phase CML:

  1. For the treatment of patients with Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia (CML) in chronic phase and documented T315i mutation; OR

  1. For the treatment of patients with Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia (CML) in chronic phase with documented resistance/disease progression or intolerance to at least 2 prior oral TKIs (imatinib, dasatinib or nilotinib), where ponatinib would be the third or fourth line TKI. 

Duration of Approval: 1 year

Accelerated Phase CML:

  1. For the treatment of patients with Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia (CML) in accelerated phase and documented T315i mutation; OR 

  2. For the treatment of patients with Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia (CML) in accelerated phase with documented resistance/disease progression or intolerance to at least 2 prior oral TKIs (imatinib, dasatinib or nilotinib), where ponatinib would be the third or fourth line TKI.

Duration of Approval: 1 year

Blast Phase CML: 

  1. For the treatment of patients with Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia (CML) in blast phase and documented T315i mutation; OR 

  1. For the treatment of patients with Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia (CML) in blast phase with documented resistance/disease progression or intolerance to at least 2 prior oral TKIs (imatinib and dasatinib), where ponatinib would be the third or fourth line TKI.

For Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ALL): 

  1. For the treatment of patients with Philadelphia chromosome positive acute lymphoblastic leukemia (Ph +ALL) and documented T315i mutation; OR 

  1. For the treatment of patients with Philadelphia chromosome positive acute lymphoblastic leukemia (Ph +ALL) with documented resistance/disease progression or intolerance to imatinib and dasatinib, where ponatinib would be the third line TKI. 

Renewals will be considered upon confirmation from the clinician that the patient has experienced hematologic and/or cytogenic response and is expected to continue to do so. 

Duration of Approval: 1 year

EAP Drug Request Form:

Standard Form for EAP Drug Requests

Product Monograph

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