High-risk Early Breast Cancer Patients in Quebec Left Behind by Recent INESSS Recommendation

• 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

¹ Canadian Cancer Society. Canadian Cancer Statistics 2025. Available at: https://cdn.cancer.ca/-/media/files/cancer-information/resources/publications/canadian-cancer-statistics-2025/2025_pdf_final_en.pdf?rev=15a29168f5b64626b017be0df4301110&hash=0438F5466FAB543ADC1B9818038D6A8D&_gl=1*1i6rdpw*_gcl_au*OTM4NTMwMjg2LjE3NjQwMjAzNzI. Accessed November 2025.

² Institut national d'excellence en santé et en services sociaux (INESSS). Enjeux, considérations et modalités de mise en œuvre entourant l'accès au dépistage du cancer du sein chez les femmes âgées entre 40 et 49 ans au Québec. September 2025. Available at: https://www.inesss.qc.ca/fileadmin/doc/INESSS/Rapports/Oncologie/Depistage_cancer_sein_40_49_ans_Avis_INESSS.pdf. Accessed November 2025.

³ Gouvernement du Québec. Programme québécois de dépistage du cancer du sein - Le ministère de la Santé et des Services sociaux accueille favorablement deux rapports sur la possibilité d'élargissement de l'accès au dépistage pour les femmes de 40 à 49 ans. September 29, 2025. Available at: https://www.quebec.ca/nouvelles/actualites/details/programme-quebecois-de-depistage-du-cancer-du-sein-le-ministere-de-la-sante-et-des-services-sociaux-accueille-favorablement-deux-rapports-sur-la-possibilite-delargissement-de-lacces-au-depistage-pour-les-femmes-de-40-a-49-ans-66092. Accessed November 2025.

⁴ Tarantino P, et al. Characteristics of real-world NATALEE- and monarchE-eligible populations with HR+/HER2- early breast cancer: a United States Electronic Health Records database analysis. ESMO Open. 2025 Jun;10(6):105304.

⁵ MD Anderson Cancer Center. Breast cancer recurrence: Which types of breast cancer are most likely to come back? Available at: Breast cancer recurrence: Which types of breast cancer are most likely to come back? | MD Anderson Cancer Center. Accessed November 2025.

⁶ Geurts YM, Witteveen A, Bretveld R, et al. Patterns and predictors of first and subsequent recurrence in women with early breast cancer. Breast Cancer Res Treat. Oct 2017;165(3):709-720. doi:10.1007/s10549-017-4340-3.

⁷ Novartis Canada. Health Canada approves Novartis' KISQALI® for HR+/HER2- early breast cancer patients at high risk of recurrence. Available at: Health Canada approves Novartis' KISQALI^® for HR+/HER2- early breast cancer patients at high risk of recurrence | Novartis Canada. Accessed November 2025.

⁸ NCCN Guidelines. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) - Breast Cancer. Available at: https://www.nccn.org. Accessed November 2025.

⁹ Institut national d'excellence en santé et en services sociaux (INESSS). Kisqali (cancer du sein stade II ou III). December 2025. Available at: https://www.inesss.qc.ca/thematiques/medicaments/medicaments-evaluation-aux-fins-dinscription/extrait-davis-au-ministre/kisqali-cancer-du-sein-stade-ii-ou-iii-7872.html. Accessed December 2025.

¹⁰ Jhaveri, K., et al. (2024). Real-world evidence on risk of recurrence in patients with node-negative and node-positive HR+/HER2− early breast cancer from US electronic health records (Poster 292P). Paper presented at the ESMO 2024 Congress.

¹¹ Crown, D. 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, 105858.

¹² Directorate-General for Health and Food Safety. (2024, November 28). Guidance on the scoping process for joint clinical assessments [Guide]. European Commission.

¹³ National Institute for Health and Care Excellence. (2022, September 30). Guide PMG36: Economic evaluation--Analysis of data for patient subgroups [Guide section]. NICE. Available at: https://www.nice.org.uk/process/pmg36/chapter/economic-evaluation-2#analysis-of-data-for-patient-subgroups. Accessed November 2025.

¹⁴ NICE Technology appraisal guidance for ribociclib with an aromatase inhibitor for adjuvant treatment of hormone receptor-positive HER2-negative early breast cancer at high risk of recurrence, Reference number:TA1086, available at: https://www.nice.org.uk/guidance/ta1086 

¹⁵ Gemeinsamer Bundesausschuss. Justification of the Resolution of the Federal Joint Committee (G-BA) on an Amendment of the Pharmaceuticals Directive: Annex XII – Benefit Assessment of Medicinal Products with New Active Ingredients according to Section 35a SGB V Ribociclib (new therapeutic indication: breast cancer, HR+, HER2-, early at high risk of recurrence, adjuvant treatment, combination with aromatase inhibitor). June 2025. Available at: https://www.g-ba.de/downloads/40-1465-11537/2025-06-05_AM-RL-XII_Ribociclib_D-1137_TrG_EN.pdf. Accessed November 2025. 

¹⁶ American Cancer Society. Breast Cancer Facts & Figures 2019-2020. 2019. Available at: https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/breast-cancer-facts-and-figures/breast-cancer-facts-and-figures-2019-2020.pdf. Accessed November 2025. 

¹⁷ Howlader N, Altekruse SF, Li CI, et al. US incidence of breast cancer subtypes defined by joint hormone receptor and HER2 status. J Natl Cancer Inst. 2014;106(5):dju055. doi:10.1093/jnci/dju055.

¹⁸ Breast Cancer Now. Breast cancer recurrence. May 2019. Available at: https://breastcancernow.org/about-breast-cancer/diagnosis/breast-cancer-recurrence/. Accessed November 2025. 

¹⁹ Novartis. FDA approves Novartis Kisqali® to reduce risk of recurrence in people with HR+/HER2- early breast cancer. Available at: https://www.novartis.com/news/media-releases/fda-approves-novartis-kisqali-reduce-risk-recurrence-people-hrher2-early-breast-cancer. Accessed November 2025.

²⁰ Pan H, Gray R, Braybrooke J, et al. 20-Year Risks of Breast-Cancer Recurrence after Stopping Endocrine Therapy at 5 Years (incl. supplementary appendix). N Engl J Med. 2017;377(19):1836-1846. doi:10.1056/NEJMoa1701830.

²¹ Bushnell GG, Deshmukh AP, den Hollander P, et al. Breast cancer dormancy: need for clinically relevant models to address current gaps in knowledge. NPJ Breast Cancer. 2021;7(1):66. Published 2021 May 28. doi:10.1038/s41523-021-00269-x.

²² Pedersen RN et al., The Incidence of Breast Cancer Recurrence 10-32 Years After Primary Diagnosis. JNCI: Journal of the National Cancer Institute, Volume 114, Issue 3, March 2022, Pages 391–399.

²³ Novartis Canada. Health Canada approves KISQALI™ for the treatment of HR-positive and HER2-negative metastatic breast cancer in postmenopausal women in combination with letrozole as an initial endocrine-based therapy. Available at: https://www.newswire.ca/news-releases/health-canada-approves-kisqali-for-the-treatment-of-hr-positive-and-her2-negative-metastatic-breast-cancer-in-postmenopausal-women-in-combination-with-letrozole-as-an-initial-endocrine-based-therapy-681481661.html. Accessed November 2025.

²⁴ Novartis. (2025). KISQALI Product Monograph. Available at: https://www.novartis.com/us-en/sites/novartis_us/files/kisqali.pdf. Accessed November 2025.

²⁵ European Society of Medical Oncology (ESMO). ESMO MCBS scorecards; NATALEE. Available at: https://www.esmo.org/guidelines/esmo-mcbs/esmo-mcbs-for-solid-tumours/esmo-mcbs-scorecards/scorecard-468-1. Accessed November 2025.

SOURCE Novartis Pharmaceuticals Canada Inc.

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