Canadians with inherited hyperlipidemia may soon see a new option
Canadian patients with a rare genetic condition that causes dangerously high cholesterol levels are one step closer to accessing publicly funded treatment following a breakthrough agreement between pharmaceutical giant Novartis and provincial drug negotiators.
Novartis Pharmaceuticals Canada announced Thursday that it has successfully concluded negotiations with the pan-Canadian Pharmaceutical Alliance (pCPA) for public reimbursement of Leqvio (inclisiran), a cholesterol-lowering medication specifically designed for adults with heterozygous familial hypercholesterolemia (HeFH).
HeFH is a genetic condition that affects approximately one in 250 to 311 Canadians, causing severely elevated levels of “bad” LDL cholesterol from birth. This dramatically increases patients’ risk of early heart attacks and strokes, often occurring decades earlier than in the general population.
“Familial hypercholesterolemia is underdiagnosed and undertreated, despite the significant cardiovascular risk it carries,” said Dr. Liam Brunham, Canada research chair and associate professor at the University of British Columbia. “For many patients with FH, it is challenging to control LDL-C levels with standard therapies.”
The agreement represents a significant milestone for patients who have struggled to manage their condition with conventional treatments. Marc Bains, co-founder of the HeartLife Foundation, called the development “an important step forward in closing long-standing gaps in care.”
However, patients will need to wait a bit longer for coverage. While the pCPA negotiations have concluded, individual provincial and territorial governments must still add the drug to their respective formularies before public reimbursement becomes available. Novartis says it will now work directly with these jurisdictions to secure timely access.
Leqvio, which received Health Canada approval in 2021, has already helped more than 4,500 Canadians since its commercial launch in 2022. The medication is administered as an injection twice yearly and works alongside lifestyle changes and maximum doses of statins.
The drug received a positive funding recommendation from Quebec’s health technology assessment agency in 2021, signalling early recognition of its potential benefit for HeFH patients.
Cardiovascular disease remains a leading health concern in Canada, claiming one life every five minutes and representing the second-leading cause of death after cancer. The condition costs the Canadian healthcare system $22 billion annually.
Mark Vineis, Novartis Canada’s country president, emphasized the company’s commitment to “working with provincial and territorial partners to help ensure timely and equitable access to this treatment option for patients with elevated cardiovascular risk.”
