Novartis Pharmaceuticals Canada Inc. announced on August 21, 2025, the successful conclusion of negotiations with the pan-Canadian Pharmaceutical Alliance (pCPA) for public reimbursement of Leqvio (inclisiran) in treating adults with heterozygous familial hypercholesterolemia (HeFH). This genetic condition is characterized by elevated low-density lipoprotein cholesterol (LDL-C) levels, significantly increasing the risk of early cardiovascular events including heart attack and stroke.
Addressing Critical Treatment Gaps
The agreement addresses a significant unmet medical need in Canadian healthcare. "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."
Marc Bains, Co-Founder of HeartLife Foundation, emphasized the clinical significance: "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."
Clinical Impact and Current Usage
Leqvio is indicated as an adjunct to lifestyle changes, including diet, to further reduce LDL-C levels in adults living with HeFH who are on maximally tolerated doses of statins, with or without other LDL-C-lowering therapies. The drug received Health Canada approval in 2021 based on clinical trials demonstrating its efficacy to safely lower LDL cholesterol.
Since its commercialization in 2022, Leqvio has made a difference in the lives of more than 4,500 Canadians and 290,000 patients worldwide. The treatment received a positive funding recommendation from the Institut national d'excellence en santé et en services sociaux (INESSS) in 2021 for adults with HeFH.
Next Steps for Patient Access
While the pCPA agreement represents meaningful progress, public reimbursement through provincial and territorial formularies has not yet been secured. Mark Vineis, Country President of Novartis Pharmaceuticals Canada Inc., stated: "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."
Disease Burden Context
Cardiovascular diseases represent a substantial healthcare burden in Canada, responsible for one death every five minutes and serving as the second leading cause of death after cancer. Within the Canadian healthcare system, cardiovascular disease accounts for $22 billion annually. HeFH has an estimated prevalence of 1 in 250 to 311 individuals, with the five-year prevalence of atherosclerotic cardiovascular disease in Canada ranging between 6.91%-8.55% in adults.
