Scemblix

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