Scemblix® Receives Positive Funding Recommendations from INESSS for Newly Diagnosed and Previously Treated Adult Patients with Chronic Myeloid Leukemia

• Novartis Canada applauds the positive funding recommendations for Scemblix^® (asciminib) for both newly diagnosed and previously treated patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP) in Québec. ^1,2
• Scemblix^® has been funded in Québec since 2023 for patients previously treated with two or more tyrosine kinase inhibitors (TKIs).³
• These recommendations represent a significant step forward in broadening access to Scemblix^® for all eligible patients living with CML in Québec. 

MONTREAL, QC, December 19, 2025 – Novartis Canada is pleased to announce that the Institut national d’excellence en santé et en services sociaux (INESSS) has recommended Scemblix^® (asciminib) to be funded as both a first and second line therapy for eligible Chronic Myeloid Leukemia (CML) patients in Québec.^1,2

“INESSS’s decision to approve asciminib for use regardless of treatment line represents an important step toward more value-based decision-making in CML care in Quebec,” said Cheryl-Anne Simoneau, Founder and Board Member of The Chronic Myelogenous Leukemia Society of Canada. “From a Value-Based Healthcare perspective, access to therapies with demonstrated efficacy and safety supports care that is better aligned with patient needs and preferences. Enabling clinicians to consider the full range of appropriate treatment options from the outset, helps support more individualized care over time. We welcome this evidence-informed decision as a positive development for people living with CML.”

These positive recommendations follow a positive decision from Canada’s Drug Agency (CDA-AMC) in October 2025 to fund Scemblix^® as a first line therapy for newly diagnosed CML patients.⁴ CDA-AMC’s recommendation for patients previously treated with one tyrosine kinase inhibitor (TKI) is currently under review, and a decision is expected in early 2026.⁵

“Twenty-five years ago, the treatment of CML was revolutionized by the arrival of imatinib, transforming this deadly disease into a chronic condition. Unfortunately, in nearly 50 percent of our patients, the quality of this saved life is impaired by treatment-related side effects,” said Dr. Lambert Busque, hematologist and Chief, Molecular Diagnostics and Diagnostic Program of Medical Biology, Hôpital Maisonneuve-Rosemont. “The arrival of asciminib is the biggest step toward having access to a drug that combines efficacy and tolerability.”

In making their recommendations, INESSS considered the clinical benefits of Scemblix^®, particularly in achieving major molecular response (MMR) and deep molecular response (DMR), as well as its favourable safety profile compared to other TKIs.^1,2

“At Novartis Canada, we are committed to collaborating with government and healthcare partners to ensure novel therapies like Scemblix^® are accessible to the patients who need them,” said Dimitri Gitas, Country President, Novartis Pharmaceuticals Canada Inc. “With these positive recommendations from INESSS, we are one step closer to ensuring equitable access to Scemblix^® across Québec – and Canada – so that no patient is left behind.” 

Scemblix^® is also one of the first Project Orbis cancer treatments to be prioritized for public funding under Ontario’s new Funding Accelerated for Specific Treatments (FAST) program.⁶ Novartis Canada will work closely with the province of Québec to facilitate accelerated funding, supporting timely access for patients.

About Scemblix^® (asciminib)
Scemblix^® is the first CML treatment that works by specifically targeting the ABL Myristoyl Pocket (referred to as a STAMP inhibitor in scientific literature).^2,3 The current approved CML treatments are TKIs that target the adenosine triphosphate (ATP)-binding site (ATP-competitive).⁵

About Novartis 

Novartis is a focused innovative medicines company. Every day, we work to reimagine medicine to improve and extend people's lives so that patients, healthcare professionals and societies are empowered in the face of serious diseases. Our medicines reach more than 250 million people worldwide.

In Canada, Novartis Pharmaceuticals Canada Inc. employs approximately 500 people to serve the evolving needs of patients and the healthcare system and invests over $30 million in R&D yearly in the country. For more information visit www.novartis.ca.

Media Contact Information
Adam Miller, Communications and Patient Advocacy Lead 
+1 514-633-7873
[email protected]
Scemblix^® is a registered trademark.

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