| 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, crossover
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. |