Cost‐Effectiveness of<scp>LDL</scp>‐C Lowering With Evolocumab in Patients With High Cardiovascular Risk in the United States

Gandra, Shravanthi R.; Villa, Guillermo; Fonarow, Gregg C.; Löthgren, Mickael; Lindgren, Peter; Somaratne, Ransi; Hout, Ben van

doi:10.1002/clc.22535

Cited by 77 publications

(84 citation statements)

References 32 publications

(61 reference statements)

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“…Such a preference could be a matter of concern [Au: for healthcare providers? ], especially given the currently excessive costs of these new agents [262][263][264] . The issue of safety also needs to be addressed.…”

Section: [H1] Implications For Health Economicsmentioning

confidence: 99%

Lipid management in patients with chronic kidney disease

Ferro¹,

Mark²,

Kanbay³

et al. 2018

Nat Rev Nephrol

171

142

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Glomerular filtration rate is inversely associated with cardiovascular disease independent of conventional risk factors. An increased risk of cardiovascular disease is present even at minor levels of renal impairment and the risk is highest in patients with endstage renal disease (ESRD) requiring dialysis. Renal dysfunction changes the level, composition, and quality of blood lipids in favour of a more atherogenic profile. Patients with advanced chronic kidney disease or ESRD have a characteristic lipid pattern of hypertriglyceridemia and low HDL-cholesterol levels but normal LDL-cholesterol levels. In the general population, a clear relationship exists between LDL-cholesterol, coronary heart disease and ischaemic stroke. However, in patients with ESRD, LDL-cholesterol seems to show a negative association [Au: with these outcomes?] at below average LDL-cholesterol levels and a flat or weakly positive association with mortality at higher LDL-cholesterol levels. Overall, the available data suggest that lowering of LDL-cholesterol is beneficial for prevention of major atherosclerotic events in patients with chronic kidney disease and in kidney transplant recipient but is not beneficial in patients requiring dialysis. [Au: I've moved the description of the content of your Review to the end of the introduction as per our journal style. To fully reflect the content of your article, please finish off the abstrace with a couple of sentences relating to novel lipid-lowering therapies and the need for reconsideration of the KDIGO guidelines in the light of new data. We have a limit of 200 words for this section.] [Au: I have highlighted suggestions for glossary terms throughout your manuscript with a [G]. Please provide succinct, one-sentence definitions for these specialist terms.] [H1] Introduction Guidelines regarding the management of lipids in patients with chronic kidney disease (CKD) and especially in those with end-stage renal disease (ESRD) are inconsistent in part owing to important deficiencies in the available data. [Au: Edit OK?] In 2013 KDIGO produced a comprehensive clinical practice guideline for lipid management in CKD 1. [Au: I suggest that we cite your original Table 1 (now Table 3) in the discussion of KDIGO recommendations at the end of the review so that the table is included next to this discussion in the final layout rather than in the introduction to the Review.

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Section: [H1] Implications For Health Economicsmentioning

confidence: 99%

Lipid management in patients with chronic kidney disease

Ferro¹,

Mark²,

Kanbay³

et al. 2018

Nat Rev Nephrol

171

142

View full text Add to dashboard Cite

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“…A previously published Markov cohort state transition model [19–21] was adapted, considering a Bulgarian payer perspective and a life-long treatment duration. The model employs annual cycles (with a half-cycle correction [22]) and was built using Microsoft Excel 2010 (Microsoft Corp., Redmond, WA).…”

Section: Methodsmentioning

confidence: 99%

Cost-effectiveness of evolocumab in treatment of heterozygous familial hypercholesterolaemia in Bulgaria: measuring health benefit by effectively treated patient-years*

Borissov¹,

Urbich

Georgieva³

et al. 2017

Journal of Market Access & Health Policy

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Background: An elevated level of low-density lipoprotein cholesterol (LDL-C) constitutes one of the most important modifiable risk factors for cardiovascular disease (CVD). Individuals with heterozygous familial hypercholesterolaemia (HeFH) are particularly vulnerable to CVD events. The addition of evolocumab to statins has shown marked reductions in LDL-C levels. The objective of this analysis is to demonstrate the clinical and economic value of LDL-C lowering with evolocumab from the Bulgarian public health care perspective. Methods: A disease-specific measure of health benefit was devised: Effectively treated patient-years (ETPYs) combine length of life with the likelihood of attaining best-practice recommendations on LDL-C lowering. “Effective treatment” was defined as a reduction in LDL-C levels of ≥50%. A Markov cohort state-transition model was adapted, considering a life-long treatment duration. Demographics, baseline characteristics and efficacy data were taken from the RUTHERFORD-2 trial. The model uses the relationship between LDL-C lowering and reduced CVD event rates observed in the meta-analyses conducted by the Cholesterol Treatment Trialists’ Collaboration. Outcomes and costs (from year 2015) were discounted at an annual rate of 5%. Sensitivity analyses were conducted to assess uncertainty surrounding the results. Results: The total incremental costs of evolocumab added to statins versus statins alone are BGN 120,329 while adding 9.30 ETPYs over lifetime. These results imply an incremental cost per ETPY of BGN 12,937 (US$ 7,215; € 6,604). The use of evolocumab is associated with a relative reduction in the CVD event rate by 38% (18% per 1 mmol/L). Conclusions: Adding evolocumab to statins may be considered cost-effective in light of an additional expense per patient-year gained in which individuals with HeFH receive effective treatment under the terms of international prevention guidelines. ETPYs are an intuitive and clinically meaningful measure of patient benefit that, in relation to costs, can support health care decision-making that considers quality of care.

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“…The high treatment costs and potential side effects, however, currently prohibit their prescription in the majority of individuals with diabetes [7, 10, 11]. Identification of high-risk individuals in whom the benefits of aggressive prevention outweigh the costs and side effects is therefore crucial.…”

Section: Introductionmentioning

confidence: 99%

Multiplex proteomics for prediction of major cardiovascular events in type 2 diabetes

et al. 2018

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Aims/hypothesisMultiplex proteomics could improve understanding and risk prediction of major adverse cardiovascular events (MACE) in type 2 diabetes. This study assessed 80 cardiovascular and inflammatory proteins for biomarker discovery and prediction of MACE in type 2 diabetes.MethodsWe combined data from six prospective epidemiological studies of 30–77-year-old individuals with type 2 diabetes in whom 80 circulating proteins were measured by proximity extension assay. Multivariable-adjusted Cox regression was used in a discovery/replication design to identify biomarkers for incident MACE. We used gradient-boosted machine learning and lasso regularised Cox regression in a random 75% training subsample to assess whether adding proteins to risk factors included in the Swedish National Diabetes Register risk model would improve the prediction of MACE in the separate 25% test subsample.ResultsOf 1211 adults with type 2 diabetes (32% women), 211 experienced a MACE over a mean (±SD) of 6.4 ± 2.3 years. We replicated associations (<5% false discovery rate) between risk of MACE and eight proteins: matrix metalloproteinase (MMP)-12, IL-27 subunit α (IL-27a), kidney injury molecule (KIM)-1, fibroblast growth factor (FGF)-23, protein S100-A12, TNF receptor (TNFR)-1, TNFR-2 and TNF-related apoptosis-inducing ligand receptor (TRAIL-R)2. Addition of the 80-protein assay to established risk factors improved discrimination in the separate test sample from 0.686 (95% CI 0.682, 0.689) to 0.748 (95% CI 0.746, 0.751). A sparse model of 20 added proteins achieved a C statistic of 0.747 (95% CI 0.653, 0.842) in the test sample.Conclusions/interpretationWe identified eight protein biomarkers, four of which are novel, for risk of MACE in community residents with type 2 diabetes, and found improved risk prediction by combining multiplex proteomics with an established risk model. Multiprotein arrays could be useful in identifying individuals with type 2 diabetes who are at highest risk of a cardiovascular event.Electronic supplementary materialThe online version of this article (10.1007/s00125-018-4641-z) contains peer-reviewed but unedited supplementary material, which is available to authorised users.

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Cost‐Effectiveness ofLDL‐C Lowering With Evolocumab in Patients With High Cardiovascular Risk in the United States

Cited by 77 publications

References 32 publications

Lipid management in patients with chronic kidney disease

Lipid management in patients with chronic kidney disease

Cost-effectiveness of evolocumab in treatment of heterozygous familial hypercholesterolaemia in Bulgaria: measuring health benefit by effectively treated patient-years*

Multiplex proteomics for prediction of major cardiovascular events in type 2 diabetes

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