Leqvio® advances toward broader access with agreement between Novartis and the pan-Canadian Pharmaceutical Alliance

• Eligible Canadian patients with heterozygous familial hypercholesterolemia (HeFH) are one step closer to publicly funded access to cholesterol lowering treatment.

MONTRÉAL, Aug. 21, 2025 /CNW/ - Novartis Pharmaceuticals Canada Inc. is pleased to announce the successful conclusion of negotiations with the pan-Canadian Pharmaceutical Alliance (pCPA) for the public reimbursement of Leqvio^® (inclisiran) for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH), a genetic condition characterized by elevated levels of low-density lipoprotein cholesterol (LDL-C), significantly increasing the risk of early cardiovascular events such as heart attack and stroke.¹

"At HeartLife, we believe that people living with FH deserve timely access to the most effective therapies available," said Marc Bains, Co-Founder, HeartLife Foundation. "This agreement is an important step forward in closing long-standing gaps in care and expanding treatment options for patients who face a significantly higher risk of early heart disease. We are committed to working with partners across Canada to ensure these advances reach the people who need them most."

"Familial Hypercholesterolemia is underdiagnosed and undertreated, despite the significant cardiovascular risk it carries," said Dr. Liam Brunham, Canada Research Chair and Associate Professor at University of British Columbia and Co-Lead of FH Canada. "For many patients with FH, it is challenging to control LDL-C levels with standard therapies. Having access to advanced therapies is an important advance in the treatment of these patients. The conclusion of pCPA negotiations for this therapy is a positive sign towards expanded access to treatment options and closing an important gap in care."

"Concluding pCPA negotiations for Leqvio^® is a significant moment for Canadians living with HeFH," said Mark Vineis, Country President, Novartis Pharmaceuticals Canada Inc. "We're committed to working with provincial and territorial partners to help ensure timely and equitable access to this treatment option for patients with elevated cardiovascular risk."

Although this milestone represents meaningful progress, public reimbursement through provincial and territorial formularies has not yet been secured. As the next step, Novartis will collaborate with public drug programs towards timely access to treatment for eligible patients living with HeFH.

About Leqvio^® (inclisiran)

Leqvio^® is indicated as an adjunct to lifestyle changes, including diet, to further reduce LDL-C level in adults living with HeFH who are on maximally tolerated dose of a statin, with or without other LDL-C-lowering therapies. Leqvio^® was first approved by Health Canada in 2021 based on clinical trials that demonstrated its efficacy to safely lower LDL cholesterol^2,3,4 and received a positive funding recommendation from the Institut national d'excellence en santé et en services sociaux (INESSS) in 2021 for adults with HeFH. Since its commercialization in 2022, Leqvio^® has made a difference in the lives of more than 4,500 Canadians and 290,000 patients worldwide.⁵

About Cardiovascular Disease (CVD)

Cardiovascular diseases (CVD), including heart disease, stroke and vascular cognitive impairment, are responsible for the loss of one life every five minutes,⁶ and are the second leading cause of death in Canada after cancer.⁷ In Canada, heart disease is the leading cause of hospitalization among Canadian women, aside from giving birth,⁸ and within the Canadian healthcare system, CVD accounts for $22 billion annually.⁵ The five-year prevalence of ASCVD in Canada ranges between 6.91%-8.55% in adults.^6,7 HeFH has an estimated prevalence of 1 in 250 to 311 individuals.^9,10,11

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 disease. Our medicines reach more than 300 million people worldwide. Reimagine medicine with us.

In Canada, Novartis Pharmaceuticals Canada Inc. employs approximately 600 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.

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	^1 What Is Heterozygous Familial Hypercholesterolemia? Family Heart. Accessed on August 8, 2025. Available at: What Is Heterozygous FH? | Family Heart Foundation
	^2 ClinicalTrials.gov. ORION-9 (NCT NCT03397121). Accessed on August 8, 2025. Available at: https://classic.clinicaltrials.gov/ct2/show/NCT03397121
	^3 ClinicalTrials.gov. ORION-10 (NCT NCT03399370). Accessed on August 8, 2025. Available at: https://classic.clinicaltrials.gov/ct2/show/NCT03399370
	^4 ClinicalTrials.gov. ORION-11 (NCT NCT03400800). Accessed on August 8, 2025. Available at: https://classic.clinicaltrials.gov/ct2/show/NCT03400800
	^5 Novartis Data on file.
	^6 2019 Heart & Stroke Report. Accessed on August 8, 2025. Available at: https://www.heartandstroke.ca/articles/connected-by-the-numbers
	^7 Heart Disease in Canada. Canada. Accessed on August 8, 2025. Available at: https://www.canada.ca/content/dam/phac-aspc/documents/services/publications/diseases-conditions/heart-disease-fact-sheet/heart-disease-factsheet-eng.pdf
	^8 Jaffer S, Foulds HJA, Parry M, Gonsalves CA, Pacheco C, Clavel MA, Mullen KA, Yip CYY, Mulvagh SL, Norris CM. The Canadian Women's Heart Health Alliance ATLAS on the Epidemiology, Diagnosis, and Management of Cardiovascular Disease in Women-Chapter 2: Scope of the Problem. CJC Open. 2020 Oct 15;3(1):1-11. doi: 10.1016/j.cjco.2020.10.009. PMID: 33458627; PMCID: PMC7801195. Accessed on August 8, 2025.
	^9 Akioyamen LE, Genest J, Shan SD, Reel RL, Albaum JM et al. (2017) Estimating the prevalence of heterozygous familial hypercholesterolaemia: a systematic review and meta-analysis. BMJ Open 7 (9): e016461. Accessed on August 8, 2025.
	^10 Hu P, Dharmayat KI, Stevens CA, Sharabiani MT, Jones RS et al. (2020) Prevalence of familial hypercholesterolemia among the general population and patients with atherosclerotic cardiovascular disease: a systematic review and meta-analysis. Circulation 141 (22): 1742-1759. Accessed on August 8, 2025.
	^11 Beheshti SO, Madsen CM, Varbo A, Nordestgaard BG (2020) Worldwide prevalence of familial hypercholesterolemia: meta-analyses of 11 million subjects. J Am Coll Cardiol 75 (20): 2553-2566. Accessed on August 8, 2025.

SOURCE Novartis Pharmaceuticals Canada Inc.

Novartis Media Contact: Karla Fuentes Arellano, Communications and Patient Advocacy Lead, E-mail: [email protected], M [phone]