Incremental cost–effectiveness of percutaneous versus surgical closure of atrial septal defects in children under a public health system perspective in Brazil

Abstract

Introduction: Cost–effectiveness (CE) studies of percutaneous (PC) versus surgical (SC) atrial septal defect closure are lacking. Methods: A systematic literature review in children and a CE analysis based on a model of long-term outcomes were performed. Direct costs of PC and SC were US$8700 (defined arbitrarily) and US$5700 (actually paid), respectively. Three-times the Brazilian GDI (US$28,700) per year of life saved (with a discount rate of 5%) was used as a limit for willingness-to-pay. Discussion: PC had a high (US$104,500) incremental CE ratio despite lower complication rates, shorter hospital stay and better (nonsignificant) adjusted life expectancy. PC would be cost–effective if it cost US$6400 or SC had an 8% loss of utility or its indirect costs were US$2250. Costs of PC should be reduced to be cost–effective in the Brazilian public health system. Indirect costs and impact on quality of life should be further assessed.

Keywords::

• atrial septal defect
• cost–effectiveness
• public health
• surgery
• transcatheter

Financial & competing interests disclosure

This manuscript was funded by the Brazilian Ministry of Health. CAC Pedra is a consultant for Scitech, Occlutech and Lifetech; proctor for St. Jude Medical; member of the speaker’s bureau for Medtronic and research grant recipient for Atrium. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Key issues

• Safety and efficacy of transcatheter closure of the secundum atrial septal defect (ASD) has been well established both in the literature and clinical practice.

• Incremental cost–effectiveness studies comparing percutaneous (PC) versus surgical (SC) closure of the ASD are scarce in the literature, especially in children.

• Such studies are crucial when a costly novel medical technology is considered for incorporation into a public health system. In this regard, devices for ASD closure are not reimbursed by the public and universal health system in Brazil.

• An incremental cost–effectiveness analysis comparing PC and SC under the Brazilian Unified Health System perspective was performed employing a systematic review of the clinical studies available in MEDLINE and Cochrane Central until 9/9/2011. Studies with more than 50 patients and a mean age of less than 14 years were included.

• Economic analysis was based on a decision tree that took into account costs and consequences during the long-term follow-up for both options. Direct costs of PC and SC were US$8.700 (defined arbitrarily) and US$5.700 (actually paid by the public health system), respectively. Indirect costs were not taken into account. Effectiveness was estimated in years of life. Assessment was performed using a discount tax of 5% and a willingness to pay of three-times the gross domestic product in Brazil (US$28,636.00), as recommended by the Brazilian Ministry of Health for economic assessment of medical technologies. Threshold analyses were also conducted.

• Mortality was similar in both groups (PC: 0.07 vs SI: 0.24%). PC was associated with slightly better albeit nonsignificant effectiveness in years of life gained (19.74 vs 19.71), lower rates of moderate/severe complications (4.5 vs 9.3%) and reduced hospital stay (1.3 days vs 5.2 days) despite a higher probability of a second procedure (1.78 vs 0.17%). Incremental cost–effectiveness ratio (ICER) was high coming to US$104.500 for life years gained.

• This systematic review confirmed that both methods were safe and effective with excellent outcomes; however, PC was associated with less morbidity and in-hospital time.

• Using the direct costs stipulated in this study, the ICER was high limiting the incorporation of PC of the ASD by the Brazilian Unified Health System at this moment. PC would be acceptable from the economic point of view in the local scenario if it cost US$6.400 or SC had an 8% loss of utility or its indirect cost was US$2.250.

• Further studies also considering the indirect costs and impact on quality of life should be performed for better assessment of long-term cost–effectiveness of both strategies in our environment.

Notes