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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 system perspective |
| Aidelsburger P, Grabein K, Klauss V, Wasem J |
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Record Status This is a critical abstract of an economic evaluation that meets the criteria for inclusion on NHS EED. Each abstract contains a brief summary of the methods, the results and conclusions followed by a detailed critical assessment on the reliability of the study and the conclusions drawn. CRD summary This study assessed the cost-effectiveness of cardiac resynchronisation therapy with an implantable cardioverter defibrillator (CRT-D) in addition to optimal pharmacological therapy (OPT) in comparison with OPT alone in patients with moderate to severe chronic heart failure. CRT-D plus OPT might be cost-effective, depending on the lifetime of the device. The study was based on valid methodology, but some aspects of the analysis were not extensively described. In general, the authors’ conclusions appear to be appropriate, although dependent on the assumptions. Type of economic evaluation Cost-effectiveness analysis, cost-utility analysis Study objective The objective was to assess the cost-effectiveness of cardiac resynchronisation therapy using an implantable cardioverter defibrillator (CRT-D) in addition to optimal pharmacological therapy (OPT) in comparison with OPT alone, in patients with chronic heart failure (CHF) who were in the New York Heart Association (NYHA) functional classes III and IV. Interventions The two strategies were CRT-D plus OPT compared with OPT alone. OPT comprised a variety of medical options, which were angiotensin-converting enzyme inhibitors, diuretics, beta-adrenoceptor antagonists, aldosterone receptor antagonists, angiotensin receptor blockers, cardiac glycosides, vasodilator agents, positive inotropic agents, anti-coagulation, or anti-arrhythmic agents. Location/setting Germany/secondary and tertiary care. Methods Analytical approach:This economic evaluation was based on an adapted published model. This model included a 30-day standard decision tree followed by a Markov chain. The time horizon of the analysis was two years. The authors stated that the perspective of the German health care system was adopted.
Effectiveness data:A systematic review of the literature was conducted to identify the relevant sources for data for the model. Most of the clinical data came from the Comparison of Medical Therapy, Pacing, and Defibrillation in Chronic Heart Failure (COMPANION) study, a randomised controlled trial (RCT), which compared OPT with CRT-D. No other information on this trial was reported. Other data for the transition probabilities for the Markov model were taken from another RCT or were based on authors’ assumptions. The primary clinical outcome was the reduction in risk of death with CRT-D plus OPT compared with OPT alone.
Monetary benefit and utility valuations:The utility values were derived from a published study, the details of which were not given. However, the utility weights were reported for each health state.
Measure of benefit:Quality-adjusted life-years (QALYs) and life-years (LYs) were used as the summary benefit measures and were discounted at an annual rate of 3%.
Cost data:The health service costs were those of device implantation and revision, infection of the device, drugs, out-patient visits, in-patient stay and surgical procedures (radiofrequency ablation, heart transplantation, coronary artery bypass graft, and percutaneous transluminal coronary angioplasty). The resource use data were derived from the literature or national guidelines, while the costs reflected the prices charged by the German health care system taking into account the differences between federal states. The drug costs came from a German price list (Rote List), while the costs of hospitalisation came from German Diagnosis Related Groups. The price year was 2005 and all costs were in Euros (EUR). Future costs were discounted at an annual rate of 3%.
Analysis of uncertainty:One-way sensitivity analyses were carried out on the model inputs using published data ranges whenever possible. In an alternative scenario, a device lifetime of seven years (two years in the base case), was considered. Results Over two years, the total costs per patient were EUR 4,618 with OPT alone and EUR 31,292 with CRT-D plus OPT. The expected QALYs were 0.958, with OPT alone and 1.261, with CRT-D plus OPT. Thus, the incremental cost per QALY gained with CRT-D plus OPT over OPT alone was EUR 88,143 after two years and EUR 24,650 with a device lifetime of seven years.
The reduction in risk of death with CRT-D plus OPT compared with OPT alone was 13.8%. The incremental cost per LY gained was EUR 193,996.
The sensitivity analysis confirmed that these base-case findings were robust, but were sensitive to assumptions regarding the utility values and the time horizon. Authors' conclusions The authors concluded that CRT-D plus OPT might be a cost-effective alternative to OPT alone for the treatment of CHF from the perspective of the German health care system. However such a conclusion depended on the assumptions on the lifetime of the device. CRD commentary Interventions:The rationale for the selection of the comparators was clear. All the possible medical treatments included in OPT were reported and these medications were considered as a single group.
Effectiveness/benefits:The authors performed a systematic literature review to identify the relevant sources for the data. However, little information on the methods and conduct of this review was provided. Most of the evidence came from a published RCT, which is generally considered to be a valid source of data. Nevertheless, the main characteristics of this study (the sample size, patients’ characteristics, settings, etc) were not reported. Little information on the sources of the utility valuations used to calculate the QALYs was reported. For example, it was not stated whose preferences determined the estimates used, or which tool was used to elicit them. This information would have been useful given the important role of utility valuation in the findings. QALYs are a validated benefit measure and are particularly appropriate for this patient population.
Costs:The categories of costs were relevant to the perspective. The costs of some items were presented as macro-categories, which might reduce the transparency of the economic analysis, but this was due to the sources used (i.e., diagnosis related groups). Extensive information on the sources for the unit costs and the adjustments made for statutory health insurance or discounts was provided. The price year and the use of discounting were reported. Wide ranges of values for cost estimates were considered in the sensitivity analysis. The authors acknowledged that the German health care system did not differentiate between the costs for CRT-D implantation with or without complications, which could be a limitation of this analysis.
Analysis and results:The synthesis of the costs and benefits was appropriately performed using an incremental approach. The results of the base-case analysis were clearly presented. The decision model was presented graphically and was satisfactorily described. The issue of uncertainty was investigated by means of a deterministic analysis which focused only on the individual model inputs. The use of a multivariate approach would have been more appropriate. The authors acknowledged that a conservative approach, favouring OPT alone, was taken in some of the model assumptions.
Concluding remarks:The study was based on valid methodology, but some aspects of the analysis were not extensively described. In general, the authors’ conclusions appear to be appropriate, although they depended on the model assumptions. Funding Funded by a grant from Guidant Corp. Bibliographic details Aidelsburger P, Grabein K, Klauss V, Wasem J. 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 system perspective. Clinical Research in Cardiology 2008; 97(2): 89-97 Other publications of related interest Bristow M, Saxon L, Boehmer J, et al. Cardiac-resynchronization therapy with or without an implantable defibrillator in advanced chronic heart failure. N Eng J Med 2004;350:2140-50.
Feldman A, de Lissovoy G, Bristow M, et al. Cost effectiveness of cardiac resynchronization therapy in the Comparison of Medical Therapy Pacing, and Defibrillation in Heart Failure (COMPANION) trial. J Am Coll Cardiol 2005;46:2311-21.
Yao G, Freemantle N, Calvert M, et al. The long-term cost-effectiveness of cardiac resynchronization therapy with or without an implantable cardioverter-defibrillator. Eur Heart J 2007;28:42-51. Indexing Status Subject indexing assigned by NLM MeSH Aged; Cardiac Pacing, Artificial /economics /utilization; Cardiotonic Agents /adverse effects /therapeutic use; Chronic Disease; Combined Modality Therapy; Cost-Benefit Analysis; Defibrillators, Implantable /economics /utilization; Delivery of Health Care /economics; Female; Germany; Health Care Costs; Health Care Surveys; Heart Failure /diagnosis /economics /mortality /therapy; Humans; Male; Markov Chains; Middle Aged; Models, Economic; Quality-Adjusted Life Years; Risk Assessment; Survival Analysis AccessionNumber 22008000540 Date bibliographic record published 31/03/2009 Date abstract record published 24/06/2009 |
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