Vol. 4 No. 5 (2024): May
Reimbursement Recommendations

Inclisiran (Leqvio)

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Published May 9, 2024

Key Messages

  • CADTH recommends that Leqvio not be reimbursed by public drug plans as an adjunct to lifestyle changes, including diet, to further reduce low-density lipoprotein cholesterol (LDL-C) levels in adults who are on a maximally tolerated dose (MTD) of a statin, with or without other LDL-C–lowering therapies, and who have nonfamilial hypercholesterolemia (nFH) with atherosclerotic cardiovascular disease (ASCVD).
  • Evidence from 2 clinical trials showed that treatment with Leqvio lowered bad cholesterol (LDL-C) in adults with nFH with ASCVD who were already being treated with the highest possible dose of statins and in those who cannot tolerate treatment with statins.
  • A post hoc pooled analysis of major adverse cardiovascular events (MACEs) from the ORION-10 and ORION-11 trials precluded the Canadian Drug Expert Committee (CDEC) from determining whether inclisiran reduces the risk of cardiovascular morbidity and death in adults with nFH with ASCVD.
  • Patients identified a need for treatments that are less burdensome, can reduce bad cholesterol (LDL-C) and cardiovascular morbidity and death, and improve health-related quality of life (HRQoL); however, there was not enough evidence to show that Leqvio would reduce cardiovascular morbidity and death or improve HRQoL.