Medication-Use Evaluation of Recombinant Human Factor VIIa

Area of Science:

• Pharmacoeconomics
• Health Services Research
• Clinical Pharmacy

Background:

• Medication-use evaluation (MUE) is crucial for optimizing patient outcomes and managing healthcare costs.
• Recombinant human factor VIIa (rFVIIa) is an expensive medication with FDA-approved indications.
• Off-label use of rFVIIa is prevalent, raising concerns about efficacy and financial impact.

Purpose of the Study:

• To conduct a medication-use evaluation of recombinant human factor VIIa (rFVIIa).
• To determine the extent of off-label use of rFVIIa at King Abdul-Aziz Medical City-Western Region (KAMC-WR).
• To evaluate the cost implications associated with the off-label utilization of rFVIIa.

Main Methods:

• An observational retrospective cohort study design was employed.
• Data on patient demographics, indications for rFVIIa use, and associated costs were collected over one year.
• Analysis focused on identifying off-label prescriptions and calculating direct expenditures.

Main Results:

• Out of 27 patients receiving rFVIIa, 85% (23 patients) had off-label indications.
• The total expenditure for rFVIIa during the study period was SR18.61 million ($4.96 million).
• The majority of expenditures, 95.8% (SR17.83 million), were for on-label uses, despite high rates of off-label prescriptions.

Conclusions:

• Recombinant FVIIa is a high-cost medication within the hospital formulary.
• The primary use of rFVIIa is observed in patients with hemophilia A and inhibitors.
• While off-label use is frequent, the majority of financial resources are allocated to on-label indications.