Intravenous immunoglobulin costs are higher for off-label indications in a high-complexity hospital in Colombia
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Jan 24, 2024
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Néstor F. Correa-González
https://orcid.org/0000-0002-8952-1165
Diana Díaz-Cortés
https://orcid.org/0000-0001-5166-0621
Oscar Mauricio Muñoz Velandia
https://orcid.org/0000-0001-5401-0018
https://orcid.org/0000-0002-8952-1165
Diana Díaz-Cortés
https://orcid.org/0000-0001-5166-0621
Oscar Mauricio Muñoz Velandia
https://orcid.org/0000-0001-5401-0018
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Abstract
Objectives: Regulatory agency approval of a drug signifies that the drug’s benefits outweigh the risks of administration. Intravenous immunoglobulin (IVIg) has been approved for some indications, but its use also extends to other off-label (non-approved) indications. Aim: To analyze the use and cost associated with IVIg treatment in a highly specialized healthcare institution in Bogotá – Colombia. Methods: Descriptive, observational, cross-sectional, drug-utilization study. The study evaluates pattern, determinants of use, and costs of treatment with IVIg, comparing approved and off-label indications, following the World Health Organization (WHO) proposed methodology. Key findings: 66 patients were included. The most frequent indications of use were Guillain-Barré syndrome (50 %) and immune thrombocytopenic purpura (22.7 %). Ten (10) patients received IVIg for off-label indications, most frequently polymyositis/dermatomyositis (10.6 %). A total of 156 individual 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 when comparing costs with FDA and EMA-approved indications ($13,881,994 vs 9,570,488, p < 0.015). One serious (bradycardia) and three non-serious (headache) adverse reaction were detected. Conclusions: Approximately a third of IVIg administrations are outside indications approved by regulatory agencies. Costs of off-label IVIg indications were significantly higher than approved ones. Consensus among agencies is required regarding IVIg, especially in off-label indications.
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References
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How to Cite
Correa-González, N. F., Díaz-Cortés, D., & Muñoz Velandia, O. M. (2024). Intravenous immunoglobulin costs are higher for off-label indications in a high-complexity hospital in Colombia. Universitas Medica, 64(4). https://doi.org/10.11144/Javeriana.umed64-4.offl
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