Product Details

Teva-Dasatinib

Dasatinib
70 mg
Tablet


DIN/PIN/NPN

02478323

Manufacturer

Teva Canada Limited

Formulary Listing Date

2021-04-30  

Unit Price

72.9336

Amount MOH Pays

72.9336

Coverage Status

Off-Formulary Interchangeable Exceptional Access Program Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

L01EA02

Interchangeable Products

DIN/ PIN/ NPN Brand name Unit Price Amount MOH pays
02478323 Teva-Dasatinib 72.9336 72.9336
02499312 Taro-Dasatinib 72.9337 72.9337
02293145 Sprycel 85.8042 72.9337
02514753 Reddy-Dasatinib 72.9336 72.9336
02481499 Apo-Dasatinib 72.9336 72.9336
 

LU Clinical Criteria

NO  

EAP Criteria

Therapeutic Class Reimbursement Criteria
Oncology Drugs

Dasatinib

  • Brand(s): Sprycel and generics (see formulary for list of funded generics)
  • Dosage Form/Strength: 20 mg, 50 mg, 70 mg, 100 mg tablet

For the treatment of Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia (CML) in the chronic phase.1

Dosing recommendation: 100 mg per day.

Renewals will be considered for patients who have experienced hematologic and/or cytogenic response and are expected to continue to do so.

Duration of Approval: 1 Year

Exclusion criteria:
Combination treatment with any two or more of the oral tyrosine-kinase inhibitors (TKI) (i.e., imatinib, nilotinib or dasatinib) will not be funded.

1Note: Funding is only considered for any two oral TKIs* per patient in a lifetime for chronic phase CML (*TKIs: imatinib, nilotinib, or dasatinib). If a patient develops grade 3 or grade 4 toxicity on one of the listed TKI’s within 3 months of initiating therapy, funding for a third oral TKI will be allowed.


For the treatment of patients with accelerated phase or blast phase Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia (CML) with documented resistance1 or intolerance2 (as defined below) to imatinib therapy

Dosing recommendation: 140 mg per day.

Definitions of resistance and intolerance:
1Imatinib resistance is defined as primary or acquired resistance to imatinib at doses of at least 600 mg/day or through a mutational analysis report.
2Intolerance to imatinib (at any dose) is defined as persistent grade 3 or grade 4 toxicity requiring discontinuation of therapy.

Renewals will be considered for patients who have experienced hematologic and/or cytogenic response and are expected to continue to do so.

Duration of Approval: 1 Year

Exclusion criteria:

  • Combination treatment with any 2 or more of the oral TKIs (i.e. imatinib, nilotinib or dasatinib) will not be funded.
  • Dasatinib is not funded as a sequential third line therapy in patients who experience primary or acquired resistance (not including mutational resistance) to nilotinib.

For the treatment of Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) in patients meeting the following criteria:

  1. An adult patient with Philadelphia chromosome positive acute lymphoblastic leukemia (Ph +ALL); AND

  2. Patient’s disease is resistant1 to imatinib-containing chemotherapy (patient must have tried 600 mg/day); OR

  3. Patient has experienced intolerance2 to imatinib therapy.

1Imatinib resistance is defined as primary or acquired resistance to imatinib at doses of at least 600 mg/day or through a mutational analysis report.

2Intolerance to imatinib (at any dose) is defined as the patient has experienced persistent grade 3 or grade 4 toxicity requiring discontinuation of therapy.

Renewals will be considered after confirmation from the patient’s physician that the patient has benefited or continues to benefit from therapy with Sprycel and is expected to continue to do so.

Duration of Approval: 1 Year

Reimbursement of dasatinib for children with acute lymphoblastic leukemia will be considered on a case-by-case basis.

EAP Drug Request Form:

Standard Form for EAP Drug Requests

Product Monograph

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