Cost-Effectiveness Analysis of Evolocumab in Adult Patients with Atherosclerotic Cardiovascular Disease in Canada

Abstract

Introduction To evaluate the cost-effectiveness of evolocumab when added to standard of care lipid-lowering treatment (LLT) for patients with atherosclerotic cardiovascular disease (ASCVD) who cannot adequately control their low-density lipoprotein cholesterol (LDL-C) despite optimized LLT in Canada. Methods An incremental cost-utility analysis was conducted using a Markov cohort state transition model adapted to the Canadian setting. Analyses were conducted from a public health and societal perspective using a lifetime time horizon for Canada. Scenario analyses were conducted on the basis of recommendations from the 2021 Canadian Cardiovascular Society (CCS) dyslipidemia guidelines. Results In ASCVD patients with prior myocardial infarction (MI) and baseline LDL-C ≥ 1.8 mmol/L, adding evolocumab to optimized statin therapy with or without ezetimibe is associated with an incremental cost per quality-adjusted life year (QALY) gained of $66,453 CAD. Furthermore, for every 100 patients treated with evolocumab for lifetime, adding evolocumab to optimized LLT will prevent approximately 52 cardiovascular (CV) events, of which seven would be fatal. The results are generally robust using univariate and simultaneous variation in model input parameters. Scenario analyses for patient populations as per the CCS guidelines suggest that evolocumab added to optimized LLT may be considered cost-effective, given an incremental cost-effectiveness ratio (ICER) threshold of CAD$100,000 per QALY gained. Limitations associated with this analysis should be interpreted in the context of data and modeling assumptions used. Conclusion Overall, this analysis supports reimbursement of evolocumab by payers in patients with ASCVD who cannot reach LDL-C thresholds despite optimized LLT to reduce unnecessary fatal and non-fatal CV events. Supplementary Information The online version contains supplementary material available at 10.1007/s12325-022-02130-4.

Guideline LDL-C Threshold Achievement in Acute Myocardial Infarction Patients: A Real-World Evidence Study Demonstrating the Impact of Treatment Intensification with PCSK9i

“…Indeed, in patients with ACS whose LDL-C levels are not at threshold and have been treated with maximally tolerated statins and ezetimibe, ESC/EAS guidelines recommend intensification to PCSK9i in hospital if possible [7]. Some payer requirements (e.g., ezetimibe trial before prescription; LDL-C tests) may also contribute to the time delay between the AMI event and PCSK9i initiation [18][19][20]. The high number of ASCVD events observed before starting PCKS9i could reflect the study design, whereby pre-AMI events may be included if the LLT was initiated within 1 year of the AMI and events following LLT dispense were not captured.…”

Cost-effectiveness of adding ezetimibe and/or PCSK9 inhibitors to high-dose statins for secondary prevention of cardiovascular disease in Chinese adults

“…A study conducted in the United States found that the ICER for PCSK9 inhibitors compared to statins for preventing cardiovascular events is US$268,637 per QALY (in 2017), which is cost-effective (35). A similar conclusion reached Canada with the ICER being US$48,912 per QALY (in 2021) by adding PCSK9 inhibitors (36). However, with an ICER of US$133,613 per QALY (in 2019), PCSK9 inhibitors in China were far from costeffective when the decision threshold of three times of GDP (US $32,973 per QALY) (37).…”

Optimizing Post-Acute Coronary Syndrome Dyslipidemia Management: Insights from the North American Acute Coronary Syndrome Reflective III

“…The initiation of PCSK9i therapy can present a challenge to prescribing physicians, with more than 20% identifying cost/coverage issues as a barrier to starting this treatment. However, despite the cost of the drug, particularly in view of the significant benefits in reducing the need for coronary revascularization, MI, stroke, and death, PCSK9i therapy is cost-effective in high-risk secondary prevention settings, particularly in those with prior MI and persistent elevation of LDL-C despite optimal statin treatment [ 22 , 23 ]. Overall, these barriers to prescribing non-statin therapies shown in our study represented missed opportunities where additional lipid-lowering therapies were guideline-indicated.…”