Medication-Use Evaluation of Recombinant Human Factor VIIa

Medication-use evaluation (MUE) is a performance improvement method used to achieve optimal patient outcomes. The recombinant human factor VIIa (rFVIIa) (NovoSeven) is an expensive agent approved by the U.S. Food and Drug Administration (FDA) for specific indications. However, in clinical practice, rFVIIa is often used for conditions unrelated to the one approved, with limited evidence. The use of rFVIIa has been associated with expenditures of more than Saudi riyal (SR)30 million ($8 million) annually at King Abdul-Aziz Medical City-Western Region (KAMC-WR). Therefore, we planned a MUE of rFVIIa. The primary purpose was to determine the off-label use of rFVIIa, and the secondary purpose was to evaluate the cost impact of off-label use of rFVIIa at KAMC-WR.

This was an observational retrospective cohort study conducted to assess the off-label usage pattern and the direct cost of rFVIIa for one year.

A total of 27 patients who received rFVIIa were included. Two out of the 27 patients had hemophilia A with inhibitors (7%), and 23 of the 27 patients received rFVIIa with off-label indications (85%). The total cost associated with the use of rFVIIa was SR18.61 million ($4.96 million). The cost of the rFVIIa used for the appropriate purpose was SR17.83 million ($4.75 million), which represented 95.8% of the expenditures.

Recombinant FVIIa is one of the most expensive medications in our hospital. It has been used mostly in patients having hemophilia A with inhibitors.