The economical challenge in the treatment of chronic heart failure: is primary prophylactic ICD therapy cost-effective in Europe? Reply
Year: 2009
Type: editorial
Abstract: We thank Cowie et al. for the critical discussion of our editorial 1 about their cost-effectiveness analysis of primary prophylactic ICD therapy in Europe . 2 By writing the editorial, we want to stimulate and open up the discussion about this complex issue that can be looked at from different perspectives. In this editorial, our assumptions were all based on the results of studies that were published in international journals. In a best case scenario with a patient (starting age of 61 years) who meets the inclusion and exclusion criteria of the multicentre randomized trials (stable conditions of the underlying heart disease, optimal pharmacological and interventional treatment), and a constant relative efficacy of the ICD over time with a device longevity of 6.3 years, Cowie et al.2 showed that primary prophylactic ICD therapy is cost-effective over the patient's lifetime at Belgium reimbursement costs. We agree that the cost-effectiveness analysis of Cowie et al. is comparable to the SCD-HeFT analysis 3 when they calculated the costs over a 12 year time horizon [€43 752 and €41 793 to gain one quality adjusted life year (QALY), respectively]. The reason why we have compared these analyses with the cost-effectiveness analysis of the MADIT II trial 4 was to clarify that other input variables such as device costs, longevity, etc. produced an economically less attractive cost-effectiveness despite of a higher efficacy of ICD therapy in the MADIT II trial (€56 143–€81 429 per QALY) than in the SCD-HeFT study. The results of the cost-effectiveness analyses about ICD therapy in patients with severe heart failure NYHA class III are still controversial. The SCD-HeFT trial included the most patients with NYHA class III ( N = 760, 30%) and the sub-analysis did not show any benefit of ICD therapy in these patients (hazard ratio 1.16). 5 Opposing, the DEFINITE trial which included fewer patients with heart failure NYHA class III ( N = 96, 21%) revealed a higher benefit of ICD therapy in this heart failure population. 6 The MADIT II trial that included 298 patients (24%) with heart failure NYHA class III showed no significant difference in the effect of ICD on survival according to the functional class of heart failure, but this conclusion was based on a sub-analysis that compared only two groups: NYHA class I and NYHA class ≥II. 4 , 7 Our assumption that primary prophylactic ICD therapy in patients with NYHA class III heart failure is economically unfavourable is supported by the deterministic sensitivity analysis of Cowie et al. They calculated a lower ICD cost-effectiveness as the ratio of heart failure death to sudden cardiac death increases 2 and it is already known that the proportion of sudden cardiac deaths generally decreased with increasing severity of heart failure according to NYHA functional class. Conversely, the proportion of patients who died from worsening heart failure increased with increasing severity of heart failure. 8 Regarding to the device longevity, we did not incorrectly assumed that the current cost-effective analysis was based on device longevity of 6.5 years. This assumption was written down both in the paper and in the online available supplementary material . 2 However, the corrected device longevity of 6.3 years is, in our opinion, also not representative for the whole ICD population in Europe . We supported this argument by a retrospective study in which 73% of the single-chamber ICD's were replaced during the first 5 years after implantation. 9 A European ICD cost-effectiveness analysis must not be based on only one type of ICD (Gem II VR) especially when its longevity was only high without pre-arrhythmia EGM storage. Furthermore, the high frequency of device and lead recalls in the last years may further decrease device longevity and as shown in the deterministic sensitivity analysis of Cowie et al. , the period of replacement was one of the variables which most affected the cost-effectiveness. Other variables for which the model of Cowie et al. was very sensitive were ICD efficacy and the age at the time of ICD implantation. 2 Our assumption that the starting age (61 years) was underestimated was based on the retrospective cohort study of Pellegrini et al.10 In clinical practice, 20% of the patients who underwent both primary and secondary prophylactic ICD implantation were older than 75 years. In summary, it still remains a difficult challenge to make a global cost-effectiveness analysis for all the European countries with different health care systems, reimbursement availability for ICD therapy, and their own national guidelines for ICD therapy as shown in the Table 1 . We must not overestimate the cost-effectiveness of primary prophylactic ICD therapy when we based the analysis only on a best case scenario. Reimbursement systems, guidelines, and numbers of ICD implantations in some ESC member countries in 2008 11 ICD, implantable cardioverter/defibrillator; NA, not available. Reimbursement systems, guidelines, and numbers of ICD implantations in some ESC member countries in 2008 11 ICD, implantable cardioverter/defibrillator; NA, not available. Conflict of interest: M.M. has received speaker's honoraria form Boston Scientific and St Jude Medical.
Source: EP Europace
Authors: M. Meine, T. Smith, R. N.W. Hauer
Institutions: University Medical Center Utrecht, Erasmus MC
Language: English
Subfield: Cardiology and Cardiovascular Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
OpenAlex ID: W4248677985