The CML Society of Canada is responding to the March 17, 2026 recommendation from Canada’s Drug Agency (CDA-AMC) regarding asciminib (Scemblix), a targeted therapy for adults living with chronic myeloid leukemia (CML).
CDA-AMC did not recommend routine public reimbursement of asciminib for patients previously treated with one tyrosine kinase inhibitor (TKI). However, the recommendation acknowledges that access may be considered on a case-by-case basis for certain patients.
“This nuance matters. Not every CML patient fits a rigid treatment sequence, and treatment decisions must reflect that reality.”— Cheryl-Anne, Co-Founder & President, CML Society of Canada
At the same time, the Society notes that reliance on case-by-case access introduces additional complexity into an already strained healthcare system.
“When access depends on individual approvals, it can place added burden on clinicians and contribute to delays and inconsistency for patients.”— Cheryl-Anne, Co-Founder & President, CML Society of Canada
The decision also highlights variation in access across Canada. In Quebec, the Institut national d’excellence en santé et en services sociaux (INESSS) issued a positive recommendation in December 2025 for a broader use of asciminib, including for patients who have received prior therapy. However, a final ministerial decision regarding reimbursement has not yet been implemented.
As a result, patients with similar clinical profiles may experience different access outcomes depending on where they live.
“This reflects a broader issue in how therapies are evaluated across the treatment pathway. Value should be considered across the full patient journey—not only where a treatment sits in sequence.”— Cheryl-Anne, Co-Founder & President, CML Society of Canada
Chronic myeloid leukemia is a rare cancer in Canada, with approximately 600 new cases diagnosed annually. Clinical trials in this setting often involve relatively small patient populations. The evidence reviewed in this case included approximately 100 patients and was considered immature at the time of assessment.
“Evaluation frameworks must reflect the realities of rare diseases. If we require large, fully mature datasets in small populations, we risk delaying access to meaningful innovation.”— Cheryl-Anne, Co-Founder & President, CML Society of Canada
The Society also emphasizes that treatment success in CML extends beyond molecular response. Quality of life—including fatigue, tolerability, and the ability to maintain daily function—is critical for patients who often remain on therapy for many years.
“CML has become a chronic condition for many patients. How patients live on therapy matters just as much as how they respond to it.”— Cheryl-Anne, Co-Founder & President, CML Society of Canada
The CML Society of Canada is calling for a more value-based approach to drug evaluation—one that incorporates long-term outcomes, quality of life, and the potential for treatment-free remission (TFR).
“Achieving TFR depends on patients being able to remain on therapy long enough to reach deep molecular response. Supporting quality of life is not optional—it is part of achieving better outcomes.”— Cheryl-Anne, Co-Founder & President, CML Society of Canada
The Society is also working toward a partnership with Cancer Fatigue Services (CFS), a Canadian provider of structured fatigue and supportive care programs, to explore how targeted quality-of-life support can help patients better tolerate therapy and remain on treatment over time.
What Patients Should Know
- Routine public reimbursement for second-line use was not recommended by CDA-AMC
- Case-by-case access may be considered in certain circumstances by public drug plans
- In Quebec, a positive INESSS recommendation has been issued, but a final funding decision is pending
- Patients should speak with their hematologist about available treatment options and access pathways
Key Terms Explained
About The CML Society of Canada
The CML Society of Canada is a federally incorporated, patient-led organization dedicated to improving the lives of Canadians affected by chronic myeloid leukemia through education, advocacy, and support.