title: Cost-Effectiveness Analysis of Biogeneric Recombinant Activated Factor VII (AryoSeven™) and Activated Prothrombin Complex Concentrates (FEIBA™) to Treat Hemophilia A Patients with Inhibitors in Iran.
abstract: Nowadays, bypassing agents such as recombinant activated factor VII (rFVIIa) and activated prothrombin complex concentrates (aPCC) are used to treat bleeding episodes in the Hemophilia patients with inhibitors. AryoSeven® is an Iranian biogeneric rFVIIa with homogeneity of efficacy and the nature to NovoSeven in a comparative trial. The current clinical trial aimed to evaluate the cost-effectiveness of FEIBA and AryoSeven® by Decision Analytic Model according to the Iranian healthcare system. An open label, multi-center, cross-over clinical trial was designed. Patients were categorized into 3 groups based on their prior tendency to one or none of the products. To determine the premium therapeutic strategy, the Incremental cost-effectiveness ratio (ICER) was calculated. Protocol F led to more treatment success in group F than the other groups (P= 0.03). Also, there was a significant statistical difference between the mean of effectiveness scores in the groups using protocol F (P = 0.01). The effectiveness of protocol F and A were 89% and 72%, respectively. ICER cost US$ to manage an episode of bleeding to get one more unit of effectiveness using FEIBA VS. AryoSeven. Although the results showed that AryoSeven was more cost-effective compared to FEIBA, the two strategies were undominated. In other words, both medicines can be applied in the first line of the treatment if the cost of FEIBA was reduced. The present clinical trial was registered at IRCT website, under ID No.2013020612380N1.
authors.affiliation: School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran, Iranian Center of Excellence in Health Management, Road Traffic Injury Research Center, Tabriz University of Medical Sciences,Tabriz, Iran.
authors.forename: Mina
authors.initials: M
authors.lastname: Golestani
authors.affiliation: Pediatric Congenital Hematologic Disorders Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
authors.forename: Peyman
authors.initials: P
authors.lastname: Eshghi
authors.affiliation: School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
authors.forename: Hamid Reza
authors.initials: HR
authors.lastname: Rasekh
authors.affiliation: School of Pharmacy, University of Baqiyatallah Medical Sciences, Tehran, Iran.
authors.forename: Abdoll Majid
authors.initials: AM
authors.lastname: Cheraghali
authors.affiliation: School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
authors.forename: Jamshid
authors.initials: J
authors.lastname: Salamzadeh
authors.affiliation: Genetics of Non- communicable Disease Research Center, Zahedan University of Medical Sciences, Zahedan, Iran.
authors.forename: Majid
authors.initials: M
authors.lastname: Naderi
authors.affiliation: Tehran University of Medical Sciences, Thrombosis and Hemostasis Research Center, Tehran, Iran.
authors.forename: Mohammad Reza
authors.initials: MR
authors.lastname: Managhchi
authors.affiliation: Inherited Blood Disorders Clinic Seiedshohada Hospital, Isfahan University of Medical Sciences, Isfahan, Iran.
authors.forename: Hamid
authors.initials: H
authors.lastname: Hoorfar
authors.affiliation: Tehran University of Medical Sciences, Thrombosis and Hemostasis Research Center, Tehran, Iran.
authors.forename: Gholam Reza
authors.initials: GR
authors.lastname: Toogeh
authors.affiliation: Iranian Center of Excellence in Health Management, Health Services Management Research Center, Faculty of Management and Medical Informatics, Tabriz University of Medical Sciences, Tabriz, Iran.
authors.forename: Ali
authors.initials: A
authors.lastname: Imani
authors.affiliation: Tabriz University of Medical Sciences, Tabriz, Iran. j Iranian Ministry of Health, Tehran, Iran.
authors.forename: Mohammad Taghi
authors.initials: MT
authors.lastname: Khodayari
authors.affiliation: Pediatric Congenital Hematologic Disorders Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
authors.forename: Behnaz
authors.initials: B
authors.lastname: Habibpanah
authors.affiliation: Tehran University of Medical Sciences, Thrombosis and Hemostasis Research Center, Tehran, Iran.
authors.forename: Razieh
authors.initials: R
authors.lastname: Hantooshzadeh
keywords: AryoSeven; Cost-effectiveness; FEIBA; Hemophilia A; Inhibitor