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

Intravenous artesunate has been the global standard of care for severe malaria for over two 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 US, 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.