Cost-effectiveness of Evolocumab in Patients With High Cardiovascular Risk in Spain

Villa, Guillermo; Löthgren, Mickael; Kutikova, Lucie; Lindgren, Peter; Gandra, Shravanthi R.; Fonarow, Gregg C.; Sorio, Francesc; Masana, Luís; Bayés‐Genís, Antoni; Hout, Ben van

doi:10.1016/j.clinthera.2017.02.011

Cited by 48 publications

(60 citation statements)

References 28 publications

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“…The three Amgen papers analysed evolocumab compared with standard of care (typically statins) from a Spanish perspective in one paper and a US perspective in two others (12)(13)(14). The main differences between the two US papers were that the one by Fonarow and colleagues from 2017 (12) had incorporated results from the recently published FOURIER trial, which reported effect on myocardial infarction and stroke.…”

Section: Resultsmentioning

confidence: 99%

“…The Spanish study concluded that evolocumab was cost-effective for a population of FH patients where the majority had established CVD with an ICER at EUR€30,893 per QALY. For secondary prevention of non-FH patients, it reported an ICER of EUR€45,340 per QALY, which would typically be considered not cost-effective according to cost-effectiveness thresholds in Spain (14).…”

Section: Resultsmentioning

confidence: 99%

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Are PCSK9 Inhibitors Cost Effective?

et al. 2018

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The objective of this study was to review available health economic evaluations of PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitors. These drugs reduce low-density lipid cholesterol levels and cardiovascular risk, but their cost effectiveness has been questioned. We searched Medline and Embase for economic evaluations in any language at any time. Studies were included if they analysed any PCSK9 inhibitor compared with either statin alone or in combination with ezetimibe or any other therapy considered standard prior to the introduction of PCSK9 inhibitors. We found ten full health economic evaluations of PCSK9 inhibitors, two from Europe and eight from the United States (US). Six of the eight from the US were from two different consortia that analysed PCSK9 inhibitors at different stages through the development of evidence. All studies generally reported incremental cost-effectiveness ratios above suggested thresholds for cost effectiveness, except one study from Spain. The results of this review indicate that PCSK9 inhibitors in general are not cost effective at the current prices, but lower prices may change the results.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Are PCSK9 Inhibitors Cost Effective?

et al. 2018

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“…102 A Spanish study modelled the effects of evolocumab when added to standard of care for patients with FH or a prior ACVD event. 116 It found substantially lower cost per QALY, of~$70 000 for patients with FH and $45 000 in secondary prevention. Notably, the modelled annual cost of intervention was about a third of that used in the studies from the USA.…”

Section: Neurocognitive Effectsmentioning

confidence: 96%

“…A Spanish study modelled the effects of evolocumab when added to standard of care for patients with FH or a prior ACVD event . It found substantially lower cost per QALY, of ~$70 000 for patients with FH and $45 000 in secondary prevention.…”

Section: Anti‐pcsk9 Monoclonal Antibodiesmentioning

confidence: 99%

PCSK9 in context: A contemporary review of an important biological target for the prevention and treatment of atherosclerotic cardiovascular disease

Page

Watts

2017

Diabetes Obesity Metabolism

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The identification of the critical role of proprotein convertase subtilisin/kexin type 9 (PCSK9) has rapidly led to the development of PCSK9 inhibition with monoclonal antibodies (mAbs). PCSK9 mAbs are already in limited clinical use and are the subject of major cardiovascular outcomes trials, which, if universally positive, could see much wider clinical application of these agents. Patients with familial hypercholesterolaemia are the most obvious candidates for these drugs, but other patients with elevated cardiovascular risk, statin intolerance or hyperlipoproteinaemia(a) may also benefit. PCSK9 mAbs, administered once or twice monthly, reduce LDL cholesterol levels by 50% to 70%, and appear to be safe and acceptable to patients over at least 2 years of treatment; however, treatment-emergent adverse effects are not always identified in clinical trials, as well-evidenced by statin myopathy. Inclisiran is a promising RNA-based therapy that promotes the degradation of PCSK9 mRNA transcripts and has similar efficacy to mAbs, but with a much longer duration of action. The cost-effectiveness and long-term safety of therapies targeted at inhibiting PCSK9 remain to be demonstrated if they are to be used widely in coronary prevention.

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“…Some have indicated that the incremental cost of adding a PCSK9 inhibitor is prohibitive without significant discounting, [27][28][29] whereas others claimed that incorporation of PCSK9 inhibitor treatment in patients with clinical ASCVD or with heterozygous FH would be below the benchmark or willingness to pay threshold for a quality-adjusted life-year (QALY) gained (typically $50,000 to $100,000/year). 30,31 These contrasting findings may be due to a number of factors, including the setting (US or a single country in Europe), drug costs, patient characteristics (clinical setting, baseline age, background therapy, and baseline LDL-C levels), the estimated LDL-C and event reductions (either modeled, or based on registry or trial data), the extent to which indirect costs (which are related to productivity losses due to cardiovascular events) were incorporated, and the time horizon and perspective of the health economic analysis. There are health systems around the world, in Australia for example, where the use of this class of drugs in non-FH is only available by private prescription at this stage.…”

Section: Clinical Challenges In Preventing Ascvd By Ldl-cholesterol Lmentioning

confidence: 99%

PCSK9 inhibition, atherosclerotic cardiovascular disease, and health economics: Challenges at the crossroads

Annemans

Stock²,

Chapman

2019

Journal of Clinical Lipidology

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BACKGROUND: Improved survival after a cardiovascular event has led to an expanding patient population at very high risk of recurrent events. Reduction in low-density lipoprotein cholesterol, and thus implicitly non-high-density lipoprotein cholesterol, to guideline-recommended goals is a key tenet of secondary prevention. Yet, standard-of-care treatment with statin (with or without ezetimibe) often leaves a high risk of preventable cardiovascular events. Inhibitors of proprotein convertase subtilisin/kexin type 9 (PCSK9), highly efficacious lipid-lowering treatments that confer reduction in cardiovascular events and death, clearly have a role in the personalized management of these very-high-risk patients. Given budget constraints, however, their integration into the health care pathway merits health economic considerations. Consequently, it is important to identify challenges at the crossroads of the clinical and economic dimensions.FINDINGS AND CONCLUSION: Health economic analyses involve application of modeling scenarios integrating multiple parameters to ultimately yield values for quality-adjusted life-years and cost-effectiveness ratios. To date, these analyses have led to widely variable estimates of these benchmarks for PCSK9 inhibitors, causing confusion among stakeholders in the health care pathway. Clearly, a consensual approach to the conduct and reporting of health economic analyses involving all players, including noneconomists such as clinicians and patient advocates, is essential to bridge the gap between the clinical needs of patients and financial access to PCSK9 inhibition.

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Cost-effectiveness of Evolocumab in Patients With High Cardiovascular Risk in Spain

Cited by 48 publications

References 28 publications

Are PCSK9 Inhibitors Cost Effective?

Are PCSK9 Inhibitors Cost Effective?

PCSK9 in context: A contemporary review of an important biological target for the prevention and treatment of atherosclerotic cardiovascular disease

PCSK9 inhibition, atherosclerotic cardiovascular disease, and health economics: Challenges at the crossroads

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