Are PCSK9 Inhibitors Cost Effective?

Korman, Max Joseph; Retterstøl, Kjetil; Kristiansen, Ivar Sønbø; Wisløff, Torbjørn

doi:10.1007/s40273-018-0671-0

Cited by 27 publications

(20 citation statements)

References 27 publications

(33 reference statements)

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“…Generally, the transferability of health economic evaluations is limited. However, a recent review of economic evaluations of PCSK9 inhibitors found that differences between countries were much smaller than other differences between studies, such as those explored in the present analysis (34). That review found incremental health effects among FH patients of more than 2 QALYs in two studies and less than 1 QALY in three studies.…”

Section: Discussioncontrasting

confidence: 49%

“…Even though such reductions have yet not been shown for PCSK9 inhibitors, they are plausible from the LDL level reductions and make treatment cost-effective in wider groups. These model differences should be noticed when comparing our results to those published by others(34).A high number of genotyped FH patients and the complete follow-up in Norwegian registries provide a sound basis for the estimates of the present study. All AMI and CHD hospitalizations all FH patients genotyped in Norway are therefore included in the calculated incidence.Still, the study has several limitations.…”

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confidence: 65%

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Economic evaluation of lipid lowering with PCSK9 inhibitors in patients with familial hypercholesterolemia: Methodological aspects

et al. 2019

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Background and aims Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors have proved to reduce low density lipoprotein cholesterol levels in numerous clinical trials. In two large clinical trials PCSK9 inhibitor treatment reduced the risk of cardiovascular disease. Our aim was to explore the impact of varying assumptions about clinical effectiveness on health and economic outcomes for patients with familial hypercholesterolemia. Methods We used a previously published and validated Norwegian model for cardiovascular disease. The model was updated with recent data from the world's second largest registry of patients with genetically confirmed familial hypercholesterolemia. We performed analyses for 24 different subgroups of patients based on age, gender, statin tolerance and previous history of cardiovascular disease. Results In 1 out of 24 subgroups, PCSK9 inhibitors were cost-effective when effectiveness was modelled using direct relative efficacy as reported in the FOURIER trial. When using assumptions as suggested in a recent consensus statement from the European Atherosclerosis Society, 14 subgroups were cost-effective. Conclusion Cost-effectiveness of PCSK9 inhibitors depends highly on assumptions regarding effectiveness. Basing assumptions only on randomised controlled trials and not taking into account varying effect based on baseline cholesterol level results in much fewer groups being cost-effective.

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Section: Discussioncontrasting

confidence: 49%

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confidence: 65%

Economic evaluation of lipid lowering with PCSK9 inhibitors in patients with familial hypercholesterolemia: Methodological aspects

et al. 2019

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“…Moreover, due to the high prevalence of CVD and the high costs associated with its management, understanding of the cost-effectiveness of treatments is crucial to inform decision making about healthcare spending. randomised controlled trials (RCTs) [7], but their cost-effectiveness has been widely debated [8,9]. Ezetimibe reduces intestinal absorption of cholesterol by blocking the internalisation of the cholesterol transport protein Niemann-Pick C1-like 1 (NPC1L1) to the enterocytes [10].…”

Section: Introductionmentioning

confidence: 99%

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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“…In all analyses performed, ezetimibe was consistently a cost-saving strategy compared with evolocumab except for the case where evolocumab price is significantly reduced and the branded ezetimibe is used. In a review 135 of 10 health economic evaluations from United States of America (USA) and Europe, cost effectiveness of PCSK9 inhibitors remained uncertain and price reduction was recommended. Following the CV outcome trials, a study showed that relevant costs saved per CV event annually remained very small in Apulia, Italy 136 .…”

Section: Cost-effectiveness Of Pcsk9 Monoclonal Antibodiesmentioning

confidence: 99%

Efficacy and safety of PCSK9 monoclonal antibodies: an evidence-based review and update

Kaddoura

Orabi

Salam

2020

Journal of Drug Assessment

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Objective: Treatment of dyslipidemia lowers cardiovascular (CV) risk. Although statin use is a cornerstone therapy, many patients are not achieving their risk-specific low-density lipoprotein cholesterol (LDL-C) goals. The proprotein convertase subtilisin/kexin type 9 (PCSK9) monoclonal antibodies have been extensively studied as lipid-lowering therapy (LLT). Herein, we present an updated evidencebased review of the efficacy and safety of PCSK9 monoclonal antibodies in the treatment of familial and non-familial hypercholesterolemia. Methods: PubMed database was searched to review Phase III studies on PCSK9 monoclonal antibodies. Then, the US National Institutes of Health Registry and the WHO International Clinical Trial Registry Platform were searched to identify and present the ongoing research. Results: PCSK9 monoclonal antibodies were investigated for the treatment of dyslipidemia, as a single therapeutic agent or as an add-on therapy to the traditional LLT. They proved effective and safe in the treatment of familial and non-familial hypercholesterolemia, and in the prevention of adverse CV events. Conclusions: The use of PCSK9 monoclonal antibodies in the treatment of dyslipidemia is currently recommended to achieve risk-specific LDL-C goal to reduce adverse CV events. Future results of the ongoing research might expand their clinical generalizability to broader patient populations.

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Are PCSK9 Inhibitors Cost Effective?

Cited by 27 publications

References 27 publications

Economic evaluation of lipid lowering with PCSK9 inhibitors in patients with familial hypercholesterolemia: Methodological aspects

Economic evaluation of lipid lowering with PCSK9 inhibitors in patients with familial hypercholesterolemia: Methodological aspects

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

Efficacy and safety of PCSK9 monoclonal antibodies: an evidence-based review and update

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