Montreal Heart Institute, Université de Montréal, Montreal, QC, Canada.
Health Economics and Market Access, Value Access and Policy, Amgen Canada Inc., 6775 Financial Drive, Suite 100, Mississauga, ON, L5N 0A4, Canada.
Adv Ther. 2022 Jul;39(7):3262-3279. doi: 10.1007/s12325-022-02130-4. Epub 2022 May 23.
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.
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.
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.
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.
评估依洛尤单抗在加拿大不能充分控制低密度脂蛋白胆固醇(LDL-C)的动脉粥样硬化性心血管疾病(ASCVD)患者中添加到标准降脂治疗(LLT)之上的成本效益。
使用适应加拿大环境的 Markov 队列状态转移模型进行增量成本效用分析。使用加拿大的终生时间范围,从公共卫生和社会角度进行分析。基于 2021 年加拿大心血管学会(CCS)血脂异常指南的建议进行情景分析。
在基线 LDL-C≥1.8mmol/L 且既往发生心肌梗死(MI)的 ASCVD 患者中,与优化他汀类药物联合治疗或不联合依折麦布相比,添加依洛尤单抗可使每获得一个质量调整生命年(QALY)的增量成本增加 66,453 加元。此外,对于每 100 例接受依洛尤单抗终生治疗的患者,添加依洛尤单抗可预防大约 52 例心血管(CV)事件,其中 7 例为致命事件。使用单变量和模型输入参数的同时变化,结果通常是稳健的。根据 CCS 指南的患者人群进行的情景分析表明,鉴于增量成本效益比(ICER)达到 CAD$100,000 每获得一个 QALY,则依洛尤单抗添加到优化 LLT 可能被认为是具有成本效益的。应在使用数据和建模假设的上下文中解释该分析的局限性。
总体而言,该分析支持支付方对 ASCVD 患者进行依洛尤单抗报销,这些患者尽管接受了优化 LLT,但仍无法达到 LDL-C 阈值,以减少不必要的致命和非致命 CV 事件。