Intravenous immunoglobulin costs are higher for off-label indications in a high-complexity hospital in Colombia

Objectives: Regulatory agency approval of a drug signifies that thedrug’s benefits outweigh the risks of administration. Intravenousimmunoglobulin (IVIg) has been approved for some indications, but itsuse also extends to other off-label (non-approved) indications. Aim:To analyze the use and cost associated with IVIg treatment in ahighly specialized healthcare institution in Bogotá – Colombia. Methods:Descriptive, observational, cross-sectional, drug-utilization study. Thestudy evaluates pattern, determinants of use, and costs of treatment withIVIg, comparing approved and off-label indications, following the WorldHealth Organization (WHO) proposed methodology. Key findings: 66patients were included. The most frequent indications of use wereGuillain-Barré syndrome (50%) and immune thrombocytopenic purpura(22.7%). Ten (10) patients received IVIg for off-label indications, mostfrequently polymyositis and dermatomyositis (10.6%). A total of 156individual prescriptions were registered, 45 of them off-label indications.Off-label administrations had a higher cost compared to approved ones($16,713,213 vs. $8,383,855, p < 0.001). Similar results were found whencomparing costs with FDA and EMA-approved indications ($13,881,994vs 9,570,488, p<0.015). One serious (bradycardia) and three non-serious(headache) adverse reaction were detected. Conclusions: Approximatelya third of IVIg administrations are outside indications approved byregulatory agencies. Costs of off-label IVIg indications were significantlyhigher than approved ones. Consensus among agencies is requiredregarding IVIg, especially in off-label indications.