INESSS recommends reimbursement of KISQALI® for all eligible patients with early-stage breast cancer at high risk of recurrence

• Institut national d'excellence en santé et en services sociaux (INESSS) recommends reimbursement of KISQALI^®(ribociclib tablets) for patients with stage II or III HR+ (hormone receptor–positive)/ HER2− (human epidermal growth factor receptor 2–negative) breast cancer at high risk of recurrence.¹
• This recommendation supports equitable access across Canada to a treatment option that significantly reduces the risk of cancer recurrence, in line with clinical guidelines and the positive recommendation from Canada's Drug Agency (CDA-AMC).

MONTREAL, Oct. 23, 2026 /CNW/ -- Novartis Canada welcomes the recommendation from INESSS regarding reimbursement of KISQALI® for all eligible patients with early-stage breast cancer at high risk of recurrence.

This recommendation marks an important step forward for people living with breast cancer in Quebec and recognizes the clinical value of KISQALI^® in reducing the risk of recurrence in all eligible patients. In clinical trials, KISQALI^® significantly reduced the risk of recurrence by 28% across a broad population of high-risk patients.² In certain patients with high-risk pathological features despite no lymph node involvement, this reduction may reach up to 40%.²

"This INESSS reassessment recognizes the demonstrated clinical benefits of KISQALI^® for eligible patients with early-stage breast cancer," said Dimitri Gitas, President of Novartis Canada. "We welcome this important step forward for breast cancer care in Quebec," Dimitri Gitas, President, Novartis Canada

"This recommendation represents an important step forward for people living with early-stage breast cancer. Reducing the risk of recurrence is a significant scientific advancement and a priority for Quebec patients and their loved ones. Access to evidence-based treatment options helps improve long-term outcomes. We are thrilled to see this new treatment for breast cancer patients in Quebec," Kim Carson, President, Breast Cancer Canada

"Our collective ambition must be that no woman dies from breast cancer that can be treated or prevented. Every new option that reduces the risk of recurrence brings us closer to that goal. We are pleased that INESSS now recognizes this therapy as an important option in the clinician's arsenal, enabling more patients to benefit from scientific progress," Dr. Nathaniel Bouganim, Medical Oncologist, McGill University Health Centre (MUHC)

"Our ambition at the McPeak-Sirois Group is simple: to ensure that major advances in breast cancer research translate into tangible benefits for patients as quickly as possible," said Dr. Jamil Asselah of McPeak-Sirois Group. Medical.

"This positive recommendation from INESSS is much more than scientific recognition. It reflects the impact of Quebec's contribution to major international clinical trials and, above all, the importance of turning today's discoveries into accessible treatments for tomorrow. This is a hopeful step forward for patients, their loved ones, and our entire medical and scientific community," Dr. Jamil Asselah, Chair of the Scientific Committee, McPeak-Sirois Group, Medical Oncologist, MUHC.

This second INESSS assessment follows a resubmission filed by Novartis Canada after the initial recommendation restricted the eligible population, based on a methodology that Novartis Canada considered not aligned with recognized standards.⁴

Novartis Canada supports assessments that are based on the full body of clinical evidence and prespecified analytical methods to ensure consistent, evidence-based decisions and to support equitable access to innovative medicines.

The positive INESSS recommendation for Kisqali^® is an important step towards public reimbursement of this treatment in Quebec. Novartis Canada will continue to work with public payers to support timely and equitable access to KISQALI^® for all eligible patients across Canada.

About Kisqali^® (ribociclib tablets)

Approved by Health Canada in June 2025, KISQALI^®, in combination with an aromatase inhibitor, is indicated as adjuvant treatment for adult patients with stage II or III HR+/HER2- breast cancer at high risk of recurrence.³

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 aides the control of cancer cell replication.⁵

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

1. Institut national d'excellence en santé et en services sociaux (INESSS). Updated recommendation on Kisqali for early-stage breast cancer.https://www.inesss.qc.ca/fileadmin/doc/INESSS/Inscription_medicaments/Avis_au_ministre/Octobre_2026/Avis_20260923/Kisqali_EA_2026_09.pdf .

2.Crown J, et al. Adjuvant ribociclib plus nonsteroidal aromatase inhibitor therapy in patients with HR-positive/HER2-negative early breast cancer: 5-year follow-up of NATALEE efficacy outcomes and updated overall survival. ESMO Open. 2025;10(11):105858. https://www.sciencedirect.com/science/article/pii/S2059702925017272

3. Health Canada. Notice of Compliance information for KISQALI (ribociclib), new adjuvant indication. June 12, 2025. https://health-products.canada.ca/noc-ac/nocInfo?no=35510

4. Institut national d'excellence en santé et en services sociaux (INESSS). Kisqali MC: cancer du sein RH+ HER2− de stade précoce. Extrait d'avis au ministre. Avis transmis au ministre, novembre 2025. https://www.inesss.qc.ca/fileadmin/doc/INESSS/Inscription_medicaments/Avis_au_ministre/D%C3%A9cembre_2025/Kisqali_2025_11.pdf

5. Novartis. (2025). KISQALI Product Monograph. Available at: https://www.novartis.com/usen/sites/novartis_us/files/kisqali.pdf. Accessed October 2026.

SOURCE Novartis Pharmaceuticals Canada Inc.

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