Cost Effectiveness of Ezetimibe in Patients with Cardiovascular Disease and Statin Intolerance or Contraindications

Ara, Roberta; Pandor, Abdullah; Tumur, Indra; Paisley, Suzy; Duenas, Alejandra; Williams, Robert; Rees, A; Wilkinson, Anna; Durrington, Paul N.; Chilcott, Jim

doi:10.2165/0129784-200808060-00005

Cited by 18 publications

(23 citation statements)

References 27 publications

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“…Our analyses are also consistent with other analyses in that it finds ezetimibe to be a cost-effective treatment option—and at least one report has found ezetimibe is cost-effective for use specifically in Norway. 31 , 32 …”

Section: Discussionmentioning

confidence: 99%

Modelling the cost-effectiveness of PCSK9 inhibitors vs. ezetimibe through LDL-C reductions in a Norwegian setting

Korman

Wisløff

2017

European Heart Journal - Cardiovascular Pharmacotherapy

100

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AimsDespite the success of statins, there remains unmet clinical need in cardiovascular disease (CVD) prevention. New proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors reduce low-density lipoprotein cholesterol (LDL-C) by 55–65%. Two PCSK9 inhibitors, evolocumab, and alirocumab, were approved for use in Norway but not yet for reimbursement through public national insurance. We aim to explore the cost-effectiveness of these compared with available treatments in a Norwegian setting.Methods and resultsA state transition Markov model was developed to model the cost-effectiveness of PCSK9 inhibitors for prevention of coronary heart disease, ischaemic strokes, and death among high-risk patient subpopulations in Norway, in both primary and secondary settings. Evolocumab and alirocumab are compared against ezetimibe and standard treatment. Risk of CVD is based on population incidence rates and adjusted according to baseline risk factors. Preventative effect of treatment was modelled according to absolute reduction in LDL-C. PCSK9 inhibitors were never found to be cost-effective in primary prevention. In secondary prevention they were cost-effective only for older, high-risk patients. The lowest cost-effectiveness ratios were for heterozygous familial hypercholesterolaemia patients and high-risk diabetics, with €63 200 and €68 400 per quality-adjusted life-year, respectively.ConclusionHigh lifetime costs of PCSK9 inhibitors may not be offset by estimated health gains for most eligible patients. PCSK9 inhibitors are found in the model only to be cost-effective in secondary prevention for older patients with high absolute risk of CVD. This picture is likely to change as price decreases. Future research is needed to determine the long-term preventative effects of PCSK9 inhibitors.

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Section: Discussionmentioning

confidence: 99%

Modelling the cost-effectiveness of PCSK9 inhibitors vs. ezetimibe through LDL-C reductions in a Norwegian setting

Korman

Wisløff

2017

European Heart Journal - Cardiovascular Pharmacotherapy

100

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“…This must be weighed against the unknown long‐term efficacy and safety profile of ezetimibe and, with limited healthcare resources, its cost‐effectiveness should also be considered. Assuming that the ezetimibe‐induced decrease in LDL cholesterol translates into the same decrease in cardiovascular event rates as a similar statin induced decrease in LDL cholesterol, it has, however recently been reported that ezetimibe monotherapy could be a cost‐effective alternative for subgroups of patients with high baseline LDL cholesterol levels [14, 45].…”

Section: Discussionmentioning

confidence: 99%

Ezetimibe monotherapy for cholesterol lowering in 2,722 people: systematic review and meta‐analysis of randomized controlled trials

Pandor¹,

Ara²,

Tumur³

et al. 2009

Journal of Internal Medicine

193

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Abstract. Pandor A, Ara RM, Tumur I, Wilkinson AJ, Paisley S, Duenas A, Durrington PN, Chilcott J (University of Sheffield, Sheffield; and University of Manchester, Manchester; UK). Ezetimibe monotherapy for cholesterol lowering in 2,722 people: systematic review and meta-analysis of randomized controlled trials. J Intern Med 2009; 265: 568-580.Objectives. To study the evidence on the efficacy and safety of ezetimibe monotherapy for the treatment of primary (heterozygous familial and non-familial) hypercholesterolaemia. Design. Systematic review and meta-analysis of randomized controlled trials (RCTs).Methods. Eleven electronic bibliographic databases covering the biomedical, scientific and grey literature were searched from inception and supplemented by contact with experts in the field. Two reviewers independently determined the eligibility of RCTs, with a minimum treatment duration of 12 weeks, which compared ezetimibe monotherapy (10 mg per day) with placebo.Results. In the absence of data from clinical outcome trials, surrogate endpoints such as changes in lipid concentrations were used as indicators of clinical outcomes. A meta-analysis of eight randomized, doubleblind, placebo-controlled trials (all 12 weeks) showed that ezetimibe monotherapy was associated with a statistically significant mean reduction in LDL cholesterol (from baseline to endpoint) of )18.58%, (95% CI: )19.67 to )17.48, P < 0.00001) compared with placebo. Significant (P < 0.00001) changes were also found in total cholesterol ()13.46%, 95% CI: )14.22 to )12.70), HDL cholesterol (3.00%, 95% CI: 2.06-3.94) and triglyceride levels ()8.06%, 95% CI: )10.92 to )5.20). Ezetimibe monotherapy appeared to be well tolerated with a safety profile similar to placebo.Conclusions. In a meta-analysis restricted to short-term trials in hypercholesterolaemia, significant potentially favourable changes in lipid and lipoprotein levels relative to baseline occurred with ezetimibe monotherapy. Further long-term studies with cardiovascular and other clinical outcome data are needed to assess the efficacy and safety of ezetimibe more fully.

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“…The incidence of creatine phosphokinase (CK) > 10 times upper limit of normal (ULN) was 0.2% for ezetimibe versus 0.1% for placebo and 0.1% for ezetimibe coadministered with a statin versus 0.4% for statins alone [29,62]. Risk of skeletal muscle toxicity increases with higher doses of statin, advanced age (> 65 years), hypothyroidism, renal impairment and, depending on the statin used, concomitant use of other drugs [63].…”

Section: Ezetimibe Potential Adverse Effectsmentioning

confidence: 99%

Evaluating the safety of Liptruzet (ezetimibe and atorvastatin): what are the potential benefits beyond low-density lipoprotein cholesterol-lowering effect?

Husain

Hassan

Elmadhoun

et al. 2015

Expert Opinion on Drug Safety

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The combination of (eze/ator) is proven to be effective in lowering LDL-c. It is not only a safe and effective treatment of hyperlipidemia, but it also reduces inflammatory markers and atherosclerosis. It is not yet clear, however, whether the combination therapy can decrease the risk of diabetes associated with statin administration. Insulin sensitivity is improved by the single administration of ezetimibe, a finding that is documented by several clinical and animal studies. More specifically, ezetimibe has been shown to decrease insulin resistance associated with nonalcoholic fatty liver disease (NAFLD). The effects of combination therapy that have to be explored in future research and clinical trials include whether this combination can be used in the treatment of NAFLD, cholesterol gallstones and portal hypertension.

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Cost Effectiveness of Ezetimibe in Patients with Cardiovascular Disease and Statin Intolerance or Contraindications

Abstract: Ezetimibe monotherapy compared with no treatment is a cost-effective alternative for individuals with a history of CVD and high LDL-C levels, who do not tolerate statins or in whom they are contraindicated.

Cited by 18 publications

References 27 publications

Modelling the cost-effectiveness of PCSK9 inhibitors vs. ezetimibe through LDL-C reductions in a Norwegian setting

Modelling the cost-effectiveness of PCSK9 inhibitors vs. ezetimibe through LDL-C reductions in a Norwegian setting

Ezetimibe monotherapy for cholesterol lowering in 2,722 people: systematic review and meta‐analysis of randomized controlled trials

Evaluating the safety of Liptruzet (ezetimibe and atorvastatin): what are the potential benefits beyond low-density lipoprotein cholesterol-lowering effect?

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