• Quebec has the highest rate of breast cancer in Canada.¹ The Government of Quebec recently endorsed lowering the breast cancer screening age for women,^2,3 reflecting the province's commitment to earlier diagnosis and improving outcomes.
• Despite this commitment to improving breast cancer outcomes, and the comprehensive clinical evidence, INESSS has recommended limiting the patient population eligible for access to KISQALI^® (ribociclib tablets), a treatment that can significantly reduce the risk of breast cancer recurrence.⁴
• Approximately 90-95% of people diagnosed with advanced breast cancer have previously been diagnosed and treated for early breast cancer.⁵ Of these recurrences, 80% have spread and are incurable.⁶ 
• KISQALI is the only CDK4/6 inhibitor approved for early breast cancer patients with high-risk disease characteristics whose breast cancer has not yet spread to their lymph nodes.^7,8

MONTREAL, Dec. 3, 2025 /CNW/ - Novartis Canada is deeply disappointed by the recent Institut national d'excellence en santé et en services sociaux (INESSS) recommendation to limit the patient population with early breast cancer (eBC) that is eligible for access to KISQALI^® (ribociclib tablets).⁹ Without coverage by the public drug plan, patients who are screened and diagnosed with eBC and face a high risk of progression to advanced disease will not have access to a treatment that can significantly reduce the risk of breast cancer recurrence.¹⁰

Approved by Health Canada in June 2025 for adult patients with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) stage II-III eBC at high risk of recurrence, KISQALI is a treatment that is taken after a primary cancer treatment to lower the risk of cancer returning.⁷ In clinical trials, KISQALI demonstrated a significant 28% reduction in the risk of recurrence across a broad population of high-risk eBC patients, including a significant 40% reduction for patients whose cancer has not yet spread to lymph nodes but who have other high-risk characteristics.¹¹

INESSS has recommended KISQALI be reimbursed only for the limited patient population that already have access to another CDK4/6i treatment option. Of critical importance, the approach used to arrive at this recommendation is inconsistent with established standards in health technology assessment and ignores the clinical trial design evaluating KISQALI in eBC that supported regulatory approval in over 55 countries.^12,13

This decision creates a significant treatment gap, causing eligible patients to be left behind with no additional, publicly funded treatment option to reduce the risk of recurrence. As of September 2025, KISQALI in eBC is reimbursed in over 20 countries – including in the United Kingdom¹⁴ and Germany¹⁵ where KISQALI is reimbursed for all eligible patients at high risk of recurrence. Public reimbursement of KISQALI in Quebec must include all eligible eBC patients, aligned with Health Canada approval, to ensure equitable access to a treatment that can significantly reduce their risk of breast cancer recurrence and improve long-term outcomes for patients in Quebec. 

Health Canada's approval of KISQALI offered hope to a patient community in need of more effective tools to help improve their chances against this challenging disease. Novartis Canada stands firmly with all patients, families, and healthcare providers in the fight against breast cancer. We urge decision makers to align public reimbursement with the robust clinical evidence supporting KISQALI in eBC to ensure access to effective treatment options and enable shared decision-making between patients and their healthcare providers, ensuring that no patient is left behind.

About early breast cancer (eBC)
Breast cancer is the most commonly diagnosed cancer among Canadian women, with approximately 70% of cases diagnosed in the early stages of the disease.^16,17,18 However, despite existing treatment options, people with stage II and III HR+/HER2- eBC remain at significant risk of recurrence.^18,19

The risk of recurrence is influenced by factors such as lymph node involvement, tumor size, age at diagnosis, and biomarkers. While patients without lymph node involvement typically have a lower risk, nearly 25% of those with HR+/HER2- eBC may experience recurrence within 20 years,²⁰ peaking after the first five years.²¹ However, more than half of recurrences still happen after five years,²² with approximately 90-95% of people diagnosed with metastatic breast cancer previously diagnosed and treated for eBC.⁵ Of these recurrences, 80% have spread and are incurable.⁶ 

About KISQALI^® (ribociclib tablets)
KISQALI was previously approved by Health Canada on March 2, 2018, for the treatment of patients with HR+/HER2- advanced or metastatic breast cancer.²³

KISQALI is a selective cyclin-dependent kinase inhibitor, a class of drugs that help slow the progression of cancer by inhibiting two proteins called cyclin-dependent kinase 4 and 6 (CDK4/6). These proteins, when over-activated, can enable cancer cells to grow and divide too quickly. Targeting CDK4/6 with enhanced precision may play a role in ensuring that cancer cells do not continue to replicate uncontrollably.²⁴

In eBC, KISQALI is the only CDK4/6 inhibitor recommended for both all node-positive disease and patients with no nodal involvement with high-risk disease characteristics.^7,8 The National Comprehensive Cancer Network (NCCN) guidelines recommend ribociclib (KISQALI) as a Category 1 preferred CDK4/6 inhibitor for breast cancer patients.⁸ KISQALI, in combination with an aromatase inhibitor (AI), has the highest score (A) on the ESMO-Magnitude of Clinical Benefit Scale for the adjuvant treatment of adults with stage II and III HR+/HER2- eBC, at high risk of recurrence.²⁵

The most common Adverse Drug Reactions across the NATALEE study (>20% and exceeding the frequency for AI alone) were neutropenia (62.5% vs. 4.6%), infections (36.3% vs. 26.3%), nausea (23.3% vs.7.8%, headache (23.0% vs. 17.1%), fatigue (22.3% vs. 13.2%), leukopenia (22.3% vs. 3.6%), and abnormal liver function tests (22.3% vs. 7.6%).²⁴

Please see the Product Monograph for KISQALI, available at https://www.novartis.com/ca-en/kisqalimonograph.

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.

KISQALI^® is a registered trademark.

References

SOURCE Novartis Pharmaceuticals Canada Inc.