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

Document Type: Research article

Authors

1 School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran, Iranian Center of Excellence in Health Management, Faculty of Management and Medical Informatics, Tabriz University of Medical Sciences, Tabriz, Iran

2 Pediatric Hematology and Oncology , Pediatric Congenital Hematologic Disorders Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran

3 School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran

4 School of Pharmacy, University of Baqiyatallah Medical Sciences, Tehran, Iran

5 School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran,Iran

6 Genetics of Non-Communicable Disease Research Center, Zahedan University of Medical Sciences, Zahedan, Iran

7 Tehran University of Medical Sciences, Thrombosis and Hemostasis Research Center, Tehran, Iran

8 Inherited Blood Disorders Clinic Seiedshohada Hospital, Isfahan University of Medical Sciences, Isfahan, Iran

9 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

10 Tabriz University of Medical Sciences, Tabriz, Iran

11 Pediatric Congenital Hematologic Disorders Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran

12 Iranian Ministry of Health,Tehran,Iran,

Abstract

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$ 5,146 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.

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