Original Title: Coste-efectividad del desfibrilador automático implantable en prevención primaria en Espańa

Authors' objectives: • To review the scientific literature about ICD effectiveness and cost-effectiveness for primary prevention of SCD. • To assess ICD cost-effectiveness and cost-utility compared to the best medical treatment for primary prevention of SCD from the Spanish National Health Service perspective using a decision analytic model.

Authors' results and conclusions: RESULTS: We did not identify any new randomized clinical trial in the systematic review update. We included 9 main studies with several articles related, summing up 16 articles included. We also include 4 articles focused on health related quality of life and 19 economic evaluations about primary prevention. Results from out meta-analysis show that ICD+BMT reduced in 33% and 25% the risk of death from any cause in patients with ischemic and non-ischemic cardiomyopathy respectively. Relative reduction of arrhythmic death is equal to 59%. Results from the economic evaluation conclude an incremental cost-effectiveness ratio equal to € 38,371 per quality adjusted life year inpatients with ischemic cardiomyopathy and € 52,694 per quality adjusted life year in patients with non-ischemic cardiomyopathy. These results suggest that ICD+BMT is not a cost-effectiveness strategy compared to BMT for a maximum willingness to pay of €30,000 per quality adjusted life year. However, incremental cost-effectiveness ratio for patients with similar profile to MADIT is equal to € 16,660 per quality adjusted life year, suggesting that ICD+BMT is a cost-effectiveness alternative for this kind of patients in Spain. CONCLUSIONS: • Prophylactic ICD also reduces mortality in patients with prior myocardial infarction, left ventricular ejection fraction ≤ 0.35; documented episode of asymptomatic unsustained ventricular tachycardia; and inducible, nonsuppressible ventricular tachyarrhythmia on electrophysiologic study; and in patients with prior myocardial infarction and left ventricular ejection fraction ≤ 0.30. • ICD do not reduce all cause mortality in patients that have suffered a recent myocardial infarction in the last 40 days. • ICD+BMT reduced in 33% and 25% the risk of death from any cause in patients with ischemic and non-ischemic cardiomyopathy respectively. Relative reduction of arrhythmic death is equal to 59%. • There are no differences between alternatives regarding quality of life. Health related quality of life studies suggest that increasing ICD shocks imply worst quality of life. • 19 economic evaluations were identified. Neither of them was focused on Spain. There was a wide variation between studies. Some studies agreed that ICD is a cost-effectiveness alternative in high risk patients. However, risk stratification is essential. • Results from our model suggest that ICD is a cost-effectiveness alternative for primary prevention of SCD in Spain from the National Health Service perspective only for patients with ischemic cardiomyopathy and a similar profile to those included in MADT. ICD would only be a cost-effectiveness strategy inpatients with ischemic cardiomyopathy with similar profile to those included in MADIT II and in patients with non-ischemic cardiomyopathy for willingness to pay higher than € 50,000 per quality adjusted life year.

Authors' methods: A previous systematic review was updated. Specifically, we reviewed ICD efficacy (based on randomized clinical trials) and effectiveness (based on economic evaluations) for primary prevention of SCD. We also review health related quality of life studies focused on patients with heart failure and an ICD implanted. Search strategies were applied in the main databases: MEDLINE and MEDLINE in process using PubMed, Cochrane Central Register of Controlled Trials and CRD (DARE, HTA, NHS EED). We performed metaanalysis of the main outcomes measures (all cause mortality and arrhythmic mortality) as data quantitative synthesis. We also distinguish between different groups of patients (ischemic and non-ischemic cardiomyopathy) trying to identify differences in effectiveness. Finally, we developed a complete economic evaluation to compare health benefits and costs between the two alternatives: ICD+BMT vs. BMT using a decision Markov model, and distinguishing between patients with ischemic and non-ischemic cardiomyopathy. We also investigate in depth the group of patients with ischemic cardiomyopathy distinguishing between patients with similar profile to MADIT and patients with similar profile to MADIT II. We also performed deterministic and probabilistic sensitivity analysis to assess the robustness of the model and uncertainty around the parameters and results.

Project Status: Completed

Year Published: 2011

URL for published report: https://sescs.es/coste-efectividad-del-desfibrilador-automatico-implantable-en-prevencion-primaria-en-espana/

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Spain

Organisation Name: Canary Health Service

Contact Address: Dirección del Servicio. Servicio Canario de la Salud, Camino Candelaria 44, 1ª planta, 38109 El Rosario, Santa Cruz de Tenerife

Contact Name: sescs@sescs.es

Contact Email: sescs@sescs.es