Is combined resynchronisation and implantable defibrillator therapy a cost-effective option for left ventricular dysfunction?
Introduction
Meta-analyses have shown the addition of cardiac resynchronisation (CRT) to medical therapy that reduces the risk of mortality and hospitalisation and results in clinically important improvement in exercise capacity and health related quality of life of NYHA class III and IV patients with left ventricular dysfunction and prolonged QRS interval receiving optimal medical therapy [1], [2], [3], [4], [5], [6]. Furthermore, CRT has consistently been shown to be cost-effective in this population [7], [8], [9], [10], [11], [12], [13].
In addition to their standalone application, CRT devices can be combined with an implantable cardioverter defibrillator (CRT–ICD). Although a recent network meta-analysis showed no significant overall survival benefit of CRT–ICD over CRT [6], in the one head-to-head trial to date, CRT–ICD treated patients experienced an additional reduction in the risk of sudden cardiac death compared to those treated by CRT alone [14]. That ICD is the best therapy for the prevention of sudden cardiac death has been established by numerous primary and secondary prevention trials [15].
Nevertheless as highlighted in a recent BMJ editorial, the question remains as to whether the additional clinical and health benefit of CRT–ICD in patients indicated for CRT therapy is sufficient to justify these more costly devices (£5074 for CRT versus £17,266 for CRT–ICD devices) [16], [17], [18], [19]. Using a decision analytic model independently commissioned for the National Institute for Health and Clinical Excellence (NICE) in the United Kingdom we examine this question and also explore whether there is a subgroup of ventricular dysfunction patients for whom CRT–ICD may be more cost-effective.
Section snippets
Methods
A Markov model with a Monte Carlo simulation developed in Microsoft Excel® (Microsoft Corporation, Redmond, WA, USA) was used to compare the outcomes and costs of CRT over the patient lifetime [20]. The model simulated a mixed age cohort of patients with NYHA class III and IV heart failure, evidence of left ventricular systolic dysfunction (left ventricular ejection fraction ≤ 35%) and evidence of electrical dysynchrony (QRS direction > 120 ms). The starting age of patients was drawn from a mixed
Clinical events
The predicted mean survival using our model was 4.7, 5.8 and 6.2 years for medical therapy, CRT and CRT–ICD respectively. The predicted rates of heart failure hospitalisation and sudden cardiac death during these periods of patient survival are also shown in Table 3. These predications are in accord with clinical trial data and clinical experience.
CRT versus medical therapy
CRT conferred an estimated additional 0.70 QALYs for an additional £11,630 per person, giving an incremental cost-effectiveness ratio of £16,735, 95%
Discussion
Although the incremental cost-effectiveness of CRT alone compared to medical therapy falls below a notional maximum willingness to pay threshold of £30,000 per QALY currently applied in UK, combined CRT–ICD devices are not a cost-effective option for left ventricular dysfunction patients indicated for resynchronisation therapy. Instead, our findings show that combined CRT–ICD devices should be restricted to younger patients (less than 60 years) and those with a high risk of sudden cardiac death
Conclusion
On the basis of synthesising current best evidence, combined resynchronisation and implantable defibrillator therapy is not cost-effective for patients with left ventricular dysfunction indicated for rsynchornisation therapy. Instead resynchronisation alone devices alone remain the most cost-effective policy option in this population. Combined devices may be cost-effective in the subgroups of younger patients or those with high risk of sudden cardiac death.
Role of funding source
This study was funded by the NIHR HTA programme and commissioned by the National Institute for Health and Clinical Excellence. Neither the funder nor the commissioner had any role in the collection, analysis or interpretation of the data or in the decision to submit the manuscript for publication.
Acknowledgements
We thank: the external advisory panel that provided advice to this project — Dr. RG Charles, Dr. M Gammage, Dr. D Hildick-Smith, Dr. F Leyva, Dr. FA McAlister, Dr. V Paul and Prof. M Sculpher; Alison Price, Wessex Institute for Health Research and Development, University of Southampton for her assistance in the literature searches and Dr. Martin Pitt in the development of the decision model.
The authors of this manuscript have certified that they comply with the Principles of Ethical Publishing
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