Bempedoic Acid (Nilemdo)

Key Messages

• Canada’s Drug Agency (CDA-AMC) recommends that Nilemdo be reimbursed by public drug plans for primary hyperlipidemia and cardiovascular disease (CVD), if certain conditions are met.
• The Canadian Drug Expert Committee (CDEC) determined that Nilemdo demonstrated acceptable clinical value versus ezetimibe in patients with primary hyperlipidemia and CVD. However, it was uncertain whether Nilemdo demonstrates acceptable clinical value versus alirocumab, evolocumab, or inclisiran in patients with primary hyperlipidemia and CVD. This determination was enough for CDEC to recommend that Nilemdo be reimbursed. Given that Nilemdo is expected to be an alternative lipid-lowering therapy, acceptable clinical value refers to at least comparable value versus lipid-lowering therapies other than statins.
• Evidence from 1 clinical trial showed that Nilemdo, compared with placebo, reduced the risk of major cardiovascular events from happening (including death, heart attack that does not result in death, stroke that does not result in death, or surgical procedures that restore blood to parts of the heart) when given for a median follow-up of 3.4 years. This study included adults who had CVD and high levels of lipids in the blood, and who were unable to receive stable, recommended statin therapy. In those who were receiving the highest tolerated dose of statins, evidence from 2 clinical trials showed that 12 weeks of treatment with Nilemdo reduced low-density lipoprotein cholesterol (LDL-C) levels compared with placebo in the presence of CVD and high levels of lipids in the blood.
• Evidence from an indirect treatment comparison showed that there was no clear difference between Nilemdo and ezetimibe for reducing LDL-C levels after 24 weeks of treatment, but that injectable lipid-lowering therapies (e.g., alirocumab, evolocumab, and inclisiran) were more effective than Nilemdo or ezetimibe at reducing LDL-C levels. The indirect treatment comparison included adults who had high levels of lipids in the blood and who had CVD or were at high risk of CVD, despite receiving stable, recommended statin therapy or being unable to receive recommended statin therapy.
• Nilemdo may address an unmet need for treatment that reduces the risk of cardiovascular events in patients with high LDL-C levels who are at high risk of CVD, and who are either unable to receive stable, recommended statin therapy, or who are already receiving the highest tolerated dose of statins.
• Based on all of the preceding considerations, CDEC recommended that Nilemdo be reimbursed.
• Nilemdo should only be covered for adults with a history of CVD or at high risk of CVD and who have elevated LDL-C levels.
• Nilemdo should be initially covered for 3 months and may be continued if the patient shows a meaningful reduction in LDL-C of at least 10% from before treatment began with Nilemdo, and the cost of Nilemdo does not exceed the drug program cost of ezetimibe.
• Important budget impact considerations must be addressed for health systems to be able to adopt Nilemdo.