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On October 22, 2020, the U.S. Food and Drug Administration (FDA) approved Veklury® (remdesivir), the first drug to treat suspected or laboratory‑confirmed COVID‑19 in hospitalized individuals 12 years of age and older who weigh at least 40 kilograms (approximately 88 pounds). Approved through the FDA’s Coronavirus Treatment Acceleration Program, Veklury represents a milestone in COVID‑19 management.
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Clinical trials are still assessing the safety and efficacy of Veklury in suspected or laboratory‑confirmed COVID‑positive children who are younger than 12 years of age and weigh more than 3.5 kilograms (approximately 8 pounds). These individuals may be able to receive Veklury through the FDA’s Emergency Use Authorization (EUA), which was granted to the drug’s manufacturer, Gilead Sciences, Inc., in May 2020 and revised in August 2020.
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Method of Administration
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According to its label, Veklury “should only be administered by a health care provider in a hospital or health care setting capable of providing acute care comparable to inpatient hospital care.” The typical course of Veklury consists of a loading dose followed by a once‑daily infusion over five days for hospitalized individuals who do not require mechanical ventilation or extracorporeal membrane oxygenation (ECMO). Treatment can be extended for an additional five days for those who do not show clinical improvement.
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Coverage
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Veklury is eligible for coverage under the medical benefit for Independence members who meet the criteria established by the FDA, as stated in the drug’s prescribing information. Coverage is provided as part of the member’s inpatient hospital stay. At this time, Independence is not managing Veklury through medical policy or other utilization management strategies.
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Independence is committed to tracking the development and approval of COVID‑19 therapeutics and vaccines through the FDA pipeline. The approval of Veklury gives health care providers an important therapeutic weapon in the fight against COVID‑19.
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