Cost-effectiveness of cardiac resynchronization therapy in combination with an implantable cardioverter defibrillator (CRT-D) for the treatment of chronic heart failure from a German health care systemperspective

Aidelsburger, Pamela; Grabein, Kristin; Klauß, Volker; Wasem, Jürgen

doi:10.1007/s00392-007-0586-9

Cited by 29 publications

(29 citation statements)

References 24 publications

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“…Five studies used more than one trial, through meta-analysis, systematic review or different trial populations 155,194,195,197,200 and four studies used other sources of evidence to model the intervention effect. 64,130,193,199 The majority of the studies (n = 15) reported that CRT was cost-effective. 64,155,172,[187][188][189][190][191][192][193]195,196,[198][199][200] Two studies (conducted in the USA 197 and Canada 194 ) in patients in NYHA class III and with a prolonged QRS duration were uncertain whether or not CRT was cost-effective.…”

Section: Economic Evaluations Of Cardiac Resynchronisation Therapymentioning

confidence: 99%

“…200 The study type was mostly cost-utility analysis (n = 16) with one cost-effectiveness analysis. 172 Most studies used a Markov model (n = 11), 64,155,187,188,193,194,[196][197][198][199][200] with six studies using other methodology 172,[190][191][192]195 and one using trial-based analysis. 189 Twelve studies used a long-term time horizon of > 20 years 64,155,172,188,189,191,[194][195][196][197][198]200 and five studies had a short time horizon of < 8 years.…”

Section: Economic Evaluations Of Cardiac Resynchronisation Therapymentioning

confidence: 99%

“…Four studies were conducted in the UK 64,189,190,198 with six conducted elsewhere in Europe. 187,188,191,193,196,199 Two studies were carried out in Australia, 172,195 two in the USA, 192,197 and one each in Canada, 194 Brazil 155 and Argentina. 200 The study type was mostly cost-utility analysis (n = 16) with one cost-effectiveness analysis.…”

Section: Economic Evaluations Of Cardiac Resynchronisation Therapymentioning

confidence: 99%

“…189 Twelve studies used a long-term time horizon of > 20 years 64,155,172,188,189,191,[194][195][196][197][198]200 and five studies had a short time horizon of < 8 years. 187,190,192,193,199 Eight studies were based on a single trial, with the CARE-HF 109 (five studies [188][189][190][191]198 ) and COMPANION 116 (three studies 172,192,196 ) trials the most commonly used. Five studies used more than one trial, through meta-analysis, systematic review or different trial populations 155,194,195,197,200 and four studies used other sources of evidence to model the intervention effect.…”

Section: Economic Evaluations Of Cardiac Resynchronisation Therapymentioning

confidence: 99%

“…Thirty-six 63,149, of the included studies assessed ICDs and 17 64,155,172,[187][188][189][190][191][192][193][194][195][196][197][198][199][200] assessed CRT. Two 155,172 of these studies assessed both ICDs and CRT; details of these two studies have been included within both the ICD and the CRT sections.…”

Section: Quantity and Quality Of Research Availablementioning

confidence: 99%

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Implantable cardioverter defibrillators for the treatment of arrhythmias and cardiac resynchronisation therapy for the treatment of heart failure: systematic review and economic evaluation

Colquitt¹,

Mendes²,

Clegg³

et al. 2014

Health Technology Assessment

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BackgroundThis assessment updates and expands on two previous technology assessments that evaluated implantable cardioverter defibrillators (ICDs) for arrhythmias and cardiac resynchronisation therapy (CRT) for heart failure (HF).ObjectivesTo assess the clinical effectiveness and cost-effectiveness of ICDs in addition to optimal pharmacological therapy (OPT) for people at increased risk of sudden cardiac death (SCD) as a result of ventricular arrhythmias despite receiving OPT; to assess CRT with or without a defibrillator (CRT-D or CRT-P) in addition to OPT for people with HF as a result of left ventricular systolic dysfunction (LVSD) and cardiac dyssynchrony despite receiving OPT; and to assess CRT-D in addition to OPT for people with both conditions.Data sourcesElectronic resources including MEDLINE, EMBASE and The Cochrane Library were searched from inception to November 2012. Additional studies were sought from reference lists, clinical experts and manufacturers’ submissions to the National Institute for Health and Care Excellence.Review methodsInclusion criteria were applied by two reviewers independently. Data extraction and quality assessment were undertaken by one reviewer and checked by a second. Data were synthesised through narrative review and meta-analyses. For the three populations above, randomised controlled trials (RCTs) comparing (1) ICD with standard therapy, (2) CRT-P or CRT-D with each other or with OPT and (3) CRT-D with OPT, CRT-P or ICD were eligible. Outcomes included mortality, adverse events and quality of life. A previously developed Markov model was adapted to estimate the cost-effectiveness of OPT, ICDs, CRT-P and CRT-D in the three populations by simulating disease progression calculated at 4-weekly cycles over a lifetime horizon.ResultsA total of 4556 references were identified, of which 26 RCTs were included in the review: 13 compared ICD with medical therapy, four compared CRT-P/CRT-D with OPT and nine compared CRT-D with ICD. ICDs reduced all-cause mortality in people at increased risk of SCD, defined in trials as those with previous ventricular arrhythmias/cardiac arrest, myocardial infarction (MI) > 3 weeks previously, non-ischaemic cardiomyopathy (depending on data included) or ischaemic/non-ischaemic HF and left ventricular ejection fraction ≤ 35%. There was no benefit in people scheduled for coronary artery bypass graft. A reduction in SCD but not all-cause mortality was found in people with recent MI. Incremental cost-effectiveness ratios (ICERs) ranged from £14,231 per quality-adjusted life-year (QALY) to £29,756 per QALY for the scenarios modelled. CRT-P and CRT-D reduced mortality and HF hospitalisations, and improved other outcomes, in people with HF as a result of LVSD and cardiac dyssynchrony when compared with OPT. The rate of SCD was lower with CRT-D than with CRT-P but other outcomes were similar. CRT-P and CRT-D compared with OPT produced ICERs of £27,584 per QALY and £27,899 per QALY respectively. The ICER for CRT-D compared with CRT-P was £28,420 per QALY. In people with both conditions, CRT-D reduced the risk of all-cause mortality and HF hospitalisation, and improved other outcomes, compared with ICDs. Complications were more common with CRT-D. Initial management with OPT alone was most cost-effective (ICER £2824 per QALY compared with ICD) when health-related quality of life was kept constant over time. Costs and QALYs for CRT-D and CRT-P were similar. The ICER for CRT-D compared with ICD was £27,195 per QALY and that for CRT-D compared with OPT was £35,193 per QALY.LimitationsLimitations of the model include the structural assumptions made about disease progression and treatment provision, the extrapolation of trial survival estimates over time and the assumptions made around parameter values when evidence was not available for specific patient groups.ConclusionsIn people at risk of SCD as a result of ventricular arrhythmias and in those with HF as a result of LVSD and cardiac dyssynchrony, the interventions modelled produced ICERs of < £30,000 per QALY gained. In people with both conditions, the ICER for CRT-D compared with ICD, but not CRT-D compared with OPT, was < £30,000 per QALY, and the costs and QALYs for CRT-D and CRT-P were similar. A RCT comparing CRT-D and CRT-P in people with HF as a result of LVSD and cardiac dyssynchrony is required, for both those with and those without an ICD indication. A RCT is also needed into the benefits of ICD in non-ischaemic cardiomyopathy in the absence of dyssynchrony.Study registrationThis study is registered as PROSPERO number CRD42012002062.FundingThe National Institute for Health Research Health Technology Assessment programme.

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Section: Economic Evaluations Of Cardiac Resynchronisation Therapymentioning

confidence: 99%

Section: Economic Evaluations Of Cardiac Resynchronisation Therapymentioning

confidence: 99%

Section: Economic Evaluations Of Cardiac Resynchronisation Therapymentioning

confidence: 99%

Section: Economic Evaluations Of Cardiac Resynchronisation Therapymentioning

confidence: 99%

Section: Quantity and Quality Of Research Availablementioning

confidence: 99%

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Implantable cardioverter defibrillators for the treatment of arrhythmias and cardiac resynchronisation therapy for the treatment of heart failure: systematic review and economic evaluation

Colquitt¹,

Mendes²,

Clegg³

et al. 2014

Health Technology Assessment

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Implantable cardiac defibrillators for people with non-ischaemic cardiomyopathy

Moheb

Nicolas

Khamis

et al. 2018

Cochrane Database of Systematic Reviews

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Improving the Methods for the Economic Evaluation of Medical Devices

et al. 2017

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Medical devices (MDs) have distinctive features, such as incremental innovation, dynamic pricing, the learning curve and organisational impact, that need to be considered when they are evaluated. This paper investigates how MDs have been assessed in practice, in order to identify methodological gaps that need to be addressed to improve the decision-making process for their adoption.We used the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) checklist supplemented by some additional categories to assess the quality of reporting and consideration of the distinctive features of MDs. Two case studies were considered: transcatheter aortic valve implantation (TAVI) representing an emerging technology and implantable cardioverter defibrillators (ICDs) representing a mature technology. Economic evaluation studies published as journal articles or within Health Technology Assessment reports were identified through a systematic literature review. A total of 19 studies on TAVI and 41 studies on ICDs were analysed. Learning curve was considered in only 16% of studies on TAVI. Incremental innovation was more frequently mentioned in the studies of ICDs, but its impact was considered in only 34% of the cases. Dynamic pricing was the most recognised feature but was empirically tested in less than half of studies of TAVI and only 32% of studies on ICDs. Finally, organisational impact was considered in only one study of ICDs and in almost all studies on TAVI, but none of them estimated its impact.By their very nature, most of the distinctive features of MDs cannot be fully assessed at market entry. However, their potential impact could be modelled, based on the experience with previous MDs, in order to make a preliminary recommendation. Then, well-designed post-market studies could help in reducing uncertainties and make policymakers more confident to achieve conclusive recommendations.

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Cost-effectiveness of cardiac resynchronization therapy in combination with an implantable cardioverter defibrillator (CRT-D) for the treatment of chronic heart failure from a German health care systemperspective

Abstract: CRT-D plus OPT may be a cost-effective alternative for the treatment of patients with CHF in NYHA functional class III and IV depending on device longevity.

Cited by 29 publications

References 24 publications

Implantable cardioverter defibrillators for the treatment of arrhythmias and cardiac resynchronisation therapy for the treatment of heart failure: systematic review and economic evaluation

Implantable cardioverter defibrillators for the treatment of arrhythmias and cardiac resynchronisation therapy for the treatment of heart failure: systematic review and economic evaluation

Implantable cardiac defibrillators for people with non-ischaemic cardiomyopathy

Improving the Methods for the Economic Evaluation of Medical Devices

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