Cost-effectiveness analysis of PCSK9 inhibitors in cardiovascular diseases: a systematic review

Azari, Samad; Rezapour, Aziz; Omidi, Negar; Alipour, Vahid; Behzadifar, Masoud; Safari, Hossein; Tajdini, Masih; Bragazzi, Nicola Luigi

doi:10.1007/s10741-019-09874-2

Cited by 30 publications

(20 citation statements)

References 25 publications

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“…The reported ICERs were significantly higher when compared with ezetimibe plus statins. Similar results have been published in previous systematic reviews [58,60], although these reviews were not specific for secondary prevention. Drug cost was the main driver of costeffectiveness in five studies [12,43,44,47,48].…”

Section: Discussionsupporting

confidence: 89%

743 WITHDRAWN:Â Novel Treatment Strategies for Secondary Prevention of Cardiovascular Disease: A Systematic Review of Cost-Effectiveness

2020

Heart, Lung and Circulation

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Background New pharmacological therapies for the treatment of cardiovascular disease (CVD) have emerged in recent years. The high rates of CVD and the need for long-term treatment to decrease risk factors makes cost-effectiveness crucial for their successful long-term implementation. Objective This study assessed cost-effectiveness studies of novel pharmacological treatments (ezetimibe, proprotein convertase subtilisin/kexin type 9 [PCSK9] inhibitors, omega-3 polyunsaturated fatty acids [n-3 PUFAs], and the cardiovascular polypill) compared with standard care for the secondary prevention of CVD. Methods We searched seven databases and the reference list of selected literature reviews for eligible cost-effective analyses (CEA) published between January 2009 and January 2020 that evaluated the above novel treatments versus standard care. Two independent reviewers performed the screening and evaluation in accordance with the Consolidated Health Economic Evaluation Reporting Standards statement. Cost results were adapted to 2018 US dollars (US$) to facilitate comparisons between studies. Consideration of cost-effectiveness was based on the original study criteria. Results Thirty-two studies were included in this review, most of them adopting a healthcare perspective. Studies evaluating ezetimibe, PCSK9 inhibitors and n-3 PUFAs assessed their addition to standard care compared with standard care alone, while studies analysing the polypill evaluated the replacement of multiple monotherapies for a fixed-dose combination. Ten studies reported on ezetimibe, fifteen evaluated PCSK9 inhibitors, five focused on n-3 PUFAs and seven on the polypill. From a healthcare perspective, ezetimibe was cost effective in 62.5% of the studies (incremental cost-effectiveness ratios [ICERs]

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Section: Discussionsupporting

confidence: 89%

743 WITHDRAWN:Â Novel Treatment Strategies for Secondary Prevention of Cardiovascular Disease: A Systematic Review of Cost-Effectiveness

2020

Heart, Lung and Circulation

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“…GAUSS-1, GAUSS-2 and GAUSS-3 trials showed that PCSK9i could effectively reduce the risk of muscle adverse events in patients with statin intolerance compared with ezetimibe (Sullivan et al, 2012;Stroes et al, 2014;Nissen et al, 2016). Although the price of PCSK9i is presently higher than that of other drugs and less costeffectiveness in general patients, the beneficial effects of these inhibitors are well documented, especially in patients with statin intolerance and familial hypercholesterolemia (Azari et al, 2020). In the future, the price of PCSK9i should be adjusted within the acceptable range of patients, which will help to bring greater cost-effectiveness and more clinical benefits.…”

Section: Discussionmentioning

confidence: 99%

Efficacy and Safety of Lipid-Lowering Drugs of Different Intensity on Clinical Outcomes: A Systematic Review and Network Meta-Analysis

Pan

et al. 2021

Front. Pharmacol.

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There have been many meta-analyses for statins, ezetimibe and proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i) to evaluate clinical outcomes, but the efficacy and safety of different intensity of these three drugs on clinical outcomes was absent. PCSK9i, ezetimibe, and statins were divided into seven interventions as follows: including PCSK9i + high-intensity statins (P9i+HT), PCSK9i + moderate-intensity statins (P9i+MT), ezetimibe + high-intensity statins (Eze+HT), ezetimibe + moderate-intensity statins (Eze+MT), high-intensity statins (HT), moderate-intensity statins (MT), and low-intensity statins (LT). The risk ratios (RR) and 95% confidence intervals (CI) were calculated to evaluate the clinical outcomes in all randomized controlled trials included. In traditional meta-analysis, the more intensive treatment had a lower risk of all-cause mortality (RR 0.91, 95% CI 0.88–0.95), cardiovascular mortality (RR 0.89, 95% CI 0.86–0.92), myocardial infarction (RR 0.79, 95% CI 0.77–0.81), coronary revascularization (RR 0.80, 95% CI 0.76-0.84), and cerebrovascular events (RR 0.84, 95% CI 0.80–0.88) compared with the less intensive treatment. However, the more intensive treatment had a higher risk of new-onset diabetes (RR 1.08, 95% CI 1.04-1.12). The network meta-analysis demonstrated that P9i+HT, P9i+MT, HT, and MT were significantly associated with a risk reduction in coronary revascularization and cerebrovascular events compared with PLBO. LT could effectively reduce the risk of cardiovascular mortality (RR 0.71, 95% CI 0.54–0.92), MI (RR 0.67, 95% CI 0.54-0.82), and coronary revascularization (RR 0.77, 95% CI 0.65–0.91) compared with PLBO. P9i+HT was superior to HT in reducing the risk of MI (RR 0.78, 95% CI 0.68–0.90), coronary revascularization (RR 0.84, 95% CI 0.73–0.96), and cerebrovascular events (RR 0.78, 95% CI 0.64–0.95). However, compared with PLBO, P9i+HT, HT, and MT could increase the risk of new-onset diabetes (RR 1.23, 95% CI 1.11–1.37; RR 1.23, 95% CI 1.14–1.33; RR 1.09, 95% CI 1.02–1.15, respectively). In conclusion, PCSK9i added to background statins may be recommended as preferred lipid-lowering therapy, and did not increase the additional risk of new-onset diabetes. The safety and efficacy of ezetimibe was not superior to that of statins. LT can be recommended as the initial therapy.

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“…discontinuing IP), and the earliest of the end of study date or the last dose date + 30 days for those without events (i.e. not discontinuing IP); patients who discontinued IP because of death were censored [52] b Arithmetic mean of 18% coronary artery bypass graft (SAR 50,000) and 82% percutaneous coronary intervention (SAR 42,240) [17] c The utility value for 'other ASCVD' was assumed to be equal to the value attributed to subsequent years of MI (0.82) d The utility values for combined health states were calculated using the multiplicative utility approach for comorbidities. The product of individual health states was taken to calculate the combined health state utility value [42] In the clinically evident ASCVD population with baseline LDL-C ≥ 100 mg/dL (2.6 mmol/L), adding evolocumab to background LLT generated more costs (SAR91,134 [$US50,630]) than conventional background LLT alone but also generated more life-years (1.22) and QALYs (1.21).…”

Section: Base Casementioning

confidence: 99%

“…However, the perceived added value of evolocumab could vary from country to country, as the reported incremental cost-effectiveness ratio (ICER) for evolocumab ranged from $US51,687 to 1,336,221 in ASCVD and from $US35,225 to 503,000 in heterozygous familial hypercholesterolemia (HeFH), indicating that PCSK9 inhibitors may be cost effective in some countries but not in others [17][18][19]. Differences in cost effectiveness are mainly because of different population characteristics, CVD risk factors, efficacy assumptions, and drug prices [17]. There is a need to support healthcare decision makers with economic evaluations to ensure scarce healthcare resources are invested efficiently.…”

Section: Introductionmentioning

confidence: 99%

Cost-Effectiveness Analysis of Evolocumab for the Treatment of Dyslipidemia in the Kingdom of Saudi Arabia

Alghamdi

Balkhi

Altowaijri

et al. 2021

PharmacoEconomics Open

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Background Proprotein convertase subtilisin/kexin type 9 inhibitors, such as evolocumab, are cholesterol-lowering drugs effective in lowering lipid levels in high-risk patients with primary hypercholesterolemia or mixed dyslipidemia. Objective This study assessed the cost effectiveness of evolocumab in combination with lipid-lowering therapies (LLTs) compared with LLTs alone, from a public healthcare perspective in the Kingdom of Saudi Arabia (KSA). Methods A Markov cohort state transition model was used, incorporating efficacy estimates from the FOURIER clinical trial and baseline cardiovascular event rates observed in clinical practice. Other model inputs were extracted from the literature and Saudi sources. Results In patients with clinically evident atherosclerotic cardiovascular disease and baseline low-density lipoprotein cholesterol ≥ 70 or ≥ 100 mg/dL, adding evolocumab to a maximally tolerated statin, with or without ezetimibe, was associated with incremental cost-effectiveness ratios (ICERs) of Saudi Arabian riyal (SAR) 109,274 ($US60,708) per quality-adjusted lifeyear (QALY) gained and SAR75,163 ($US41,757) per QALY gained, respectively. The ICER was SAR22,391 ($US12,440) per QALY gained in patients with heterozygous familial hypercholesterolemia. Sensitivity analysis results were robust to changes in model parameters and fell below the willingness-to-pay threshold of up to three times gross domestic product per capita in 2019 (SAR264,813 [$US147,118]). Conclusion Evolocumab can be considered a cost-effective treatment option for patients with atherosclerotic cardiovascular disease or heterozygous familial hypercholesterolemia in the KSA.

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Cost-effectiveness analysis of PCSK9 inhibitors in cardiovascular diseases: a systematic review

Cited by 30 publications

References 25 publications

743 WITHDRAWN:Â Novel Treatment Strategies for Secondary Prevention of Cardiovascular Disease: A Systematic Review of Cost-Effectiveness

743 WITHDRAWN:Â Novel Treatment Strategies for Secondary Prevention of Cardiovascular Disease: A Systematic Review of Cost-Effectiveness

Efficacy and Safety of Lipid-Lowering Drugs of Different Intensity on Clinical Outcomes: A Systematic Review and Network Meta-Analysis

Cost-Effectiveness Analysis of Evolocumab for the Treatment of Dyslipidemia in the Kingdom of Saudi Arabia

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