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:
- 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
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