4.7 Review

FDA Approval of Artesunate for Severe Malaria: Enough to Achieve Best Practice?

Journal

CLINICAL INFECTIOUS DISEASES
Volume 76, Issue 3, Pages E864-E866

Publisher

OXFORD UNIV PRESS INC
DOI: 10.1093/cid/ciac728

Keywords

artesunate; severe malaria; artesunate access

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Intravenous artesunate is now available for the treatment of severe malaria in the US. We propose a hospital tier framework to guide the decision of stocking this drug.
Intravenous artesunate recently became commercially available in the US for the treatment of severe malaria. We propose a framework to inform hospitals on planning prompt diagnosis and treatment, including considerations for stocking artesunate. Intravenous artesunate has been the global standard of care for severe malaria for over 2 decades. Yet, until recently, artesunate has only been available to patients through an expanded-access protocol from the Centers for Disease Control and Prevention. In May 2020, the Food and Drug Administration approved artesunate, allowing US hospitals to stock the drug and ensuring prompt treatment for this life-threatening infection. However, because of artesunate's high cost and the infrequency of severe malaria in the United States, hospitals may be reluctant to stock the drug. As US health systems weigh the decision to stock artesunate, we propose a hospital tier framework to inform this decision and support clinicians caring for patients who present with severe malaria.

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