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On November 9, 2020, the U.S. Food and Drug Administration (FDA) granted an Emergency Use Authorization (EUA) for bamlanivimab (LY‑CoV555). Manufactured by Eli Lilly and Company, bamlanivimab is available to treat mild‑to‑moderate COVID‑19 in recently diagnosed individuals 12 years of age and older, who weigh at least 40 kilograms (approximately 88 pounds) and are at high‑risk for developing severe COVID symptoms that are likely to lead to hospitalization.
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Mild‑to‑moderate symptoms may include, but are not limited to:
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- Fever
- Cough
- Sore throat
- Headache
- Muscle pain, weakness, or fatigue
- Nausea, vomiting, and/or diarrhea
- Loss of taste and smell
- Shortness of breath when being active, not requiring supplemental oxygen
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The FDA has developed a factsheet with detailed information about the EUA.
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It is important to understand that an EUA is not the same as an FDA approval. An EUA grants temporary access to an investigational drug that may be useful in treating a life‑threatening disease when no FDA‑approved alternatives are available. Bamlanivimab is still undergoing clinical trials across a variety of populations to assess its safety and efficacy. Results from these safety and efficacy trials must be available before the drug can be submitted for FDA approval.
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The EUA is only valid for the population identified in the authorization and under the circumstances that necessitated the emergency. At this time, the EUA does not grant access to bamlanivimab for individuals younger than 12 years of age, individuals who are currently hospitalized due to COVID‑19, or individuals who require high‑flow oxygen or mechanical ventilation.
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Method of administration
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Bamlanivimab is a neutralizing monoclonal antibody that inhibits viral attachment into human cells. It is given as a one‑dose intravenous infusion by a health care professional. Due to the risk of a post‑infusion reaction, the drug must be given in a facility that is equipped to handle emergency situations. Bamlanivimab is most effective when it is administered as soon as possible after a positive COVID‑19 test and within 10 days of the onset of symptoms.
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Access
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The process for obtaining this drug is very different from most medications, as access to bamlanivimab is controlled by the U.S. government. The government has purchased 300,000 doses of the drug for high‑risk patients; these doses are managed by the government’s national distributor. Access is proportionally based on the number of weekly confirmed COVID‑19 cases in each state, according to data collected by the U.S. Department of Health and Human Services. Distribution locations are based on which facilities are most accessible to the affected population and most likely to minimize virus transmission. Questions about access to the drug should be directed to each state’s Department of Health.
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At this time, Independence Blue Cross (Independence) is not medically managing bamlanivimab through medical policy or other utilization management strategies. The administration of bamlanivimab is eligible for coverage under the medical benefit for Independence members who meet the criteria in the EUA. There should be no out‑of‑pocket costs for members who receive this drug.
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Independence is committed to tracking the development and approval of COVID‑19 therapeutics and vaccines through the FDA pipeline. Along with the recently FDA‑approved Veklury® (remdesivir), bamlanivimab gives health care providers a new therapeutic weapon in the fight against COVID‑19.
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