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Cost–utility of cardiac contractility modulation in patients with heart failure with reduced ejection fraction in Italy

Aims Cardiac contractility modulation (CCM) is a device therapy for heart failure, based on the delivery of high‐voltage biphasic impulses to the right ventricular septum during the myocardial absolute refractory period. This study evaluated the cost‐effectiveness of CCM therapy plus optimal medical...

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Published in:ESC Heart Failure 2024-02, Vol.11 (1), p.229-239
Main Authors: Narducci, Maria Lucia, Nurchis, Mario Cesare, Ballacci, Federico, Giordano, Federica, Calabrò, Giovanna Elisa, Massetti, Massimo, Crea, Filippo, Aspromonte, Nadia, Damiani, Gianfranco
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container_title ESC Heart Failure
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creator Narducci, Maria Lucia
Nurchis, Mario Cesare
Ballacci, Federico
Giordano, Federica
Calabrò, Giovanna Elisa
Massetti, Massimo
Crea, Filippo
Aspromonte, Nadia
Damiani, Gianfranco
description Aims Cardiac contractility modulation (CCM) is a device therapy for heart failure, based on the delivery of high‐voltage biphasic impulses to the right ventricular septum during the myocardial absolute refractory period. This study evaluated the cost‐effectiveness of CCM therapy plus optimal medical therapy (OMT) vs. OMT alone in patients with heart failure with reduced ejection fraction. Methods and results A Markov model with a lifespan time horizon was developed to assess the cost–utility using the FIX trials as main data sources. A deterministic sensitivity analysis and a probabilistic sensitivity analysis were run to analyse the decision uncertainty in the model through cost‐effectiveness acceptability curve (CEAC) and cost‐effectiveness acceptability frontier (CEAF). Value of information analysis was also conducted computing the expected value of perfect information (EVPI) and the expected value of partial perfect information. The base case results showed that the CCM plus OMT option was highly cost‐effective compared with OMT alone with an incremental cost–utility ratio of €7034/quality‐adjusted life year (QALY). The CEAC and CEAF illustrated that for all willingness to pay levels above €5600/QALY, tested up to €50 000/QALY, CCM plus OMT alternative had the highest probability of being cost‐effective. The EVPI per patient was estimated to be €124 412 on a willingness to pay threshold of €30 000/QALY. Conclusions For patients with heart failure with reduced ejection fraction, CCM therapy could be cost‐effective when taking a lifetime horizon. Further long‐term, post‐approval clinical studies are needed to verify these results in a real‐world context, particularly concerning the effect of CCM therapy on mortality.
doi_str_mv 10.1002/ehf2.14538
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This study evaluated the cost‐effectiveness of CCM therapy plus optimal medical therapy (OMT) vs. OMT alone in patients with heart failure with reduced ejection fraction. Methods and results A Markov model with a lifespan time horizon was developed to assess the cost–utility using the FIX trials as main data sources. A deterministic sensitivity analysis and a probabilistic sensitivity analysis were run to analyse the decision uncertainty in the model through cost‐effectiveness acceptability curve (CEAC) and cost‐effectiveness acceptability frontier (CEAF). Value of information analysis was also conducted computing the expected value of perfect information (EVPI) and the expected value of partial perfect information. The base case results showed that the CCM plus OMT option was highly cost‐effective compared with OMT alone with an incremental cost–utility ratio of €7034/quality‐adjusted life year (QALY). The CEAC and CEAF illustrated that for all willingness to pay levels above €5600/QALY, tested up to €50 000/QALY, CCM plus OMT alternative had the highest probability of being cost‐effective. The EVPI per patient was estimated to be €124 412 on a willingness to pay threshold of €30 000/QALY. Conclusions For patients with heart failure with reduced ejection fraction, CCM therapy could be cost‐effective when taking a lifetime horizon. Further long‐term, post‐approval clinical studies are needed to verify these results in a real‐world context, particularly concerning the effect of CCM therapy on mortality.</description><identifier>ISSN: 2055-5822</identifier><identifier>EISSN: 2055-5822</identifier><identifier>DOI: 10.1002/ehf2.14538</identifier><identifier>PMID: 37943287</identifier><language>eng</language><publisher>England: John Wiley &amp; Sons, Inc</publisher><subject>Adenosine triphosphatase ; Cardiac contractility modulation ; Cardiotonic Agents ; Clinical trials ; Cost analysis ; Costs ; Device therapy ; Economic evaluation ; Ejection fraction ; Health services ; Heart Failure ; Humans ; Italy - epidemiology ; Markov chains ; Original ; Patients ; Questionnaires ; Sensitivity analysis ; Stroke Volume</subject><ispartof>ESC Heart Failure, 2024-02, Vol.11 (1), p.229-239</ispartof><rights>2023 The Authors. 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This study evaluated the cost‐effectiveness of CCM therapy plus optimal medical therapy (OMT) vs. OMT alone in patients with heart failure with reduced ejection fraction. Methods and results A Markov model with a lifespan time horizon was developed to assess the cost–utility using the FIX trials as main data sources. A deterministic sensitivity analysis and a probabilistic sensitivity analysis were run to analyse the decision uncertainty in the model through cost‐effectiveness acceptability curve (CEAC) and cost‐effectiveness acceptability frontier (CEAF). Value of information analysis was also conducted computing the expected value of perfect information (EVPI) and the expected value of partial perfect information. The base case results showed that the CCM plus OMT option was highly cost‐effective compared with OMT alone with an incremental cost–utility ratio of €7034/quality‐adjusted life year (QALY). 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This study evaluated the cost‐effectiveness of CCM therapy plus optimal medical therapy (OMT) vs. OMT alone in patients with heart failure with reduced ejection fraction. Methods and results A Markov model with a lifespan time horizon was developed to assess the cost–utility using the FIX trials as main data sources. A deterministic sensitivity analysis and a probabilistic sensitivity analysis were run to analyse the decision uncertainty in the model through cost‐effectiveness acceptability curve (CEAC) and cost‐effectiveness acceptability frontier (CEAF). Value of information analysis was also conducted computing the expected value of perfect information (EVPI) and the expected value of partial perfect information. The base case results showed that the CCM plus OMT option was highly cost‐effective compared with OMT alone with an incremental cost–utility ratio of €7034/quality‐adjusted life year (QALY). The CEAC and CEAF illustrated that for all willingness to pay levels above €5600/QALY, tested up to €50 000/QALY, CCM plus OMT alternative had the highest probability of being cost‐effective. The EVPI per patient was estimated to be €124 412 on a willingness to pay threshold of €30 000/QALY. Conclusions For patients with heart failure with reduced ejection fraction, CCM therapy could be cost‐effective when taking a lifetime horizon. Further long‐term, post‐approval clinical studies are needed to verify these results in a real‐world context, particularly concerning the effect of CCM therapy on mortality.</abstract><cop>England</cop><pub>John Wiley &amp; Sons, Inc</pub><pmid>37943287</pmid><doi>10.1002/ehf2.14538</doi><tpages>11</tpages><orcidid>https://orcid.org/0000-0002-0341-1142</orcidid><oa>free_for_read</oa></addata></record>
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subjects Adenosine triphosphatase
Cardiac contractility modulation
Cardiotonic Agents
Clinical trials
Cost analysis
Costs
Device therapy
Economic evaluation
Ejection fraction
Health services
Heart Failure
Humans
Italy - epidemiology
Markov chains
Original
Patients
Questionnaires
Sensitivity analysis
Stroke Volume
title Cost–utility of cardiac contractility modulation in patients with heart failure with reduced ejection fraction in Italy
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