CADTH Reimbursement Recommendation

This disclaimer and any questions or matters of any nature arising from or relating to the content or use (or misuse) of this document will be governed by and interpreted in accordance with the laws of the Province of Ontario and the laws of Canada applicable therein, and all proceedings shall be subject to the exclusive jurisdiction of the courts of the Province of Ontario, Canada. [...] The clinical experts referenced the 2021 CCS Dyslipidemia Guidelines to identify the patient population most in need of an intervention for the management of primary hyperlipidemia in secondary prevention – the subset of patients with ASCVD (at high CV risk) who have been shown to derive the largest benefit from intensification of statin therapy with the addition of a PCSK9 inhibitor. [...] In consideration of the descriptive analyses used in the OLE studies and the ad-hoc subgroup analysis of patients with prior MI, the available evidence should only be considered suggestive of a potential treatment effect, subject to uncertainty associated with the exploratory nature of the analyses. [...] In the subset of patients with prior MI, the mean time from the most recent MI was 8.070 years (SD = 6.137 years) in patients who were randomized to evolocumab in the parent trial and 7.835 years (SD = 5.905 years) in patients who were randomized to placebo in the parent trial. [...] In terms of Index ACS events, 57% in the evolocumab group and 70% in the placebo group had NSTE-ACS, and 43% in the evolocumab group and 30% in the placebo group had STEMI.