Abstract
Background
Dronedarone is a therapy for the treatment of patients with paroxysmal and persistent
atrial fibrillation or atrial flutter. According to results in the ATHENA trial, dronedarone
on top of standard of care (SOC) decreases the risk of cardiovascular hospitalizations
or death by 24% compared with SOC alone.
Objectives
A patient-level health economic model was developed to evaluate the cost-effectiveness
of dronedarone on top of SOC versus SOC alone.
Methods
The risk of experiencing stroke, congestive heart failure, acute coronary syndromes,
treatment discontinuation, and death was modeled by separate health states, whereas
adverse events were included as 1-time cost and utility decrements. State transition
probabilities were primarily deduced from the patient-level data from ATHENA using
survival analysis. Four sets of analyses were performed to reflect costs and treatment
effects in Canada, Italy, Sweden, and Switzerland. Cost-effectiveness analysis was
also conducted in a newly defined patient population identified by the European Medicines
Agency (EMA) to avoid the use of dronedarone in permanent AF patients resembling those
in the PALLAS study.
Results
The predicted survival time was, for the Canadian cohort, extended from 10.11 to 10.24
years when dronedarone was added to SOC. Similar results were found for the other
countries, resulting in incremental cost-effectiveness ratios (ICERs) of €5828, €5873,
€14,970, and €8554 per QALYs for Canada, Italy, Sweden, and, Switzerland, respectively.
These results are all well below current established cost-effectiveness thresholds.
In the EMA-restricted population, all patients were predicted to live longer, and
the ICER increased but remained within established thresholds, with an average cost
per QALY gained of €15,900.
Conclusions
Dronedarone on top of SOC appears to be a cost-effective treatment for atrial fibrillation
compared with SOC alone. Despite the differences in the local settings considered,
the results were consistent among all the countries included in the study. ClinicalTrials.gov identifier: NCT00174785.
Key words
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Article info
Publication history
Published online: July 09, 2012
Accepted:
June 4,
2012
Identification
Copyright
© 2012 Elsevier HS Journals, Inc. Published by Elsevier Inc. All rights reserved.
