Product Details

Scemblix

Asciminib
40 mg
Tablet


DIN/PIN/NPN

02528339

Manufacturer

Novartis Pharma Canada Inc.

Formulary Listing Date

2023-05-19  

Unit Price

85.0000

Amount MOH Pays

85.0000

Coverage Status

Exceptional Access Program Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

L01EA06

Interchangeable Products

NO  

LU Clinical Criteria

NO  

EAP Criteria

Therapeutic Class Reimbursement Criteria
Oncology Drugs

Asciminib

  • Brand(s): Scemblix
  • Dosage Form/Strength: 20 mg, 40 mg tablets
  • Effective date: May 19, 2023

Initiation Criteria:

For the treatment of adult patients with chronic phase 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 CML; AND

3. Asciminib is used in one of the following clinical situations:
i) As third line therapy after experiencing disease progression or intolerance to two or more prior tyrosine kinase Inhibitor (TKI) therapies (imatinib, dasatinib, nilotinib, bosutinib or ponatinib);
OR
ii) As first or second line in patients who have a documented mutational drug resistance to imatinib, dasatinib, and nilotinib, which makes them clinically inappropriate treatment choices for first- or second-line therapy;
OR
iii) As second or subsequent line therapy in patients who progressed on bosutinib in first line and who have a documented mutational drug resistance to imatinib, dasatinib, and nilotinib, which makes them clinically inappropriate treatment choices.

Exclusion Criteria:

  • Asciminib is not funded for blast or accelerated phase CML.
  • Asciminib will not be funded for patients with V299L or T315I mutation.
  • Asciminib will not be funded in combination with another oral TKI for treatment of CML.
  • Asciminib will not be funded as 5th line treatment for CML or beyond. (Note 1)

Notes:

  1. For a time-limited period, patients who have used 4 lines of treatment that included bosutinib and ponatinib for (Ph+) chronic phase CML, prior to provincial reimbursement of asciminib, will be considered for asciminib on a case-by-case basis.

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: 40 mg twice daily or 80 mg once daily.

Approval period for initials & renewals: 1 year

EAP Drug Request Form:

Standard Form for EAP Drug Requests

Product Monograph

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