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COVID-19 Health Alert # 21:
Bamlanivimab is now available in limited supply for Wisconsin hospitals
Bureau of Communicable Diseases, November 12, 2020
Summary
- Bamlanivimab has been granted emergency use authorization by the U.S. Food and Drug Administration for treatment of patients with mild or moderate COVID-19 who do not require hospitalization.
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Criteria for authorized use, instructions related to storage and administration, and data reporting requirements are now available through the published EUA and the manufacturer’s website.
- A limited supply of bamlanivimab has been allocated to DHS for delivery to Wisconsin hospitals. The initial allocation of 4,260 doses will be distributed to hospitals based on county-level disease burden and the CDC social vulnerability index.
Dear Colleagues,
Bamlanivimab is a new, unapproved treatment for COVID-19 that was granted emergency use authorization (EUA) from the FDA on November 10, 2020. Bamlanivimab is a neutralizing IgG1 monoclonal antibody that binds to the receptor binding domain of the spike protein of SARS-CoV-2. It must be administered as a single intravenous infusion in an appropriately monitored, outpatient setting. Previously known as LY-CoV555, bamlanivimab has been shown to have preliminary evidence of safety and efficacy through an interim analysis of a randomized, placebo controlled Phase 2 trial (the BLAZE-1 Study), published on October 28, 2020. In that study, the percentage of patients who had a Covid-19–related hospitalization or visit to an emergency department was 1.6% in the bamlanivimab group and 6.3% in the placebo group.
Patient Eligibility Criteria
Based on data submitted to the FDA, bamlanivimab is authorized for use in adults and pediatric patients with positive results of direct SARS-CoV-2 viral testing (i.e. a PCR or antigen test, not an antibody test) who are 12 years of age and older weighing at least 40 kg, and who are at high risk for progressing to severe COVID-19 and/or hospitalization. It should be used for patients who have mild to moderate, symptomatic COVID-19 disease, plus one or more high risk criteria, as soon as possible after diagnosis. Clinical data do not support the use of bamlanivimab in patients with severe symptoms who require hospitalization. Specifically, bamlanivimab is not authorized for use in patients who:
- Are hospitalized due to COVID-19, OR
- Require oxygen therapy due to COVID-19, OR
- Require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity.
The manufacturer has specified a list of criteria that can be used to identify patients who are at high risk for progressing to severe COVID-19 and/or hospitalization. These characteristics vary by age, and are listed in Table 1.
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Table 1. High risk criteria for prioritizing patients to receive bamlanivimab
High risk is defined as patients who meet at least one of the following criteria:
- Have a body mass index (BMI) ≥35
- Have chronic kidney disease
- Have diabetes
- Have immunosuppressive disease
- Are currently receiving immunosuppressive treatment
- Are ≥65 years of age
- Are ≥55 years of age AND have
- cardiovascular disease, OR
- hypertension, OR
- chronic obstructive pulmonary disease/other chronic respiratory disease.
- Are 12 – 17 years of age AND have
- BMI ≥85th percentile for their age and gender based on CDC growth charts, OR
- sickle cell disease, OR
- congenital or acquired heart disease, OR
- neurodevelopmental disorders, for example, cerebral palsy, OR
- a medical-related technological dependence, for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to COVID-19), OR
- asthma, reactive airway or other chronic respiratory disease that requires daily medication for control.
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Dosage
The dosage of bamlanivimab in adults and pediatric patients 12 years of age and older weighing at least 40 kg is a single IV infusion of 700 mg bamlanivimab administered over at least 60 minutes. No dosage adjustment is recommended based on age, sex, race, body weight, renal or mild hepatic impairment, during pregnancy or while lactating, or for disease severity or inflammation. Full prescribing information is available for review through the manufacturers Provider Fact Sheet.
Bamlanivimab should be given as soon as possible after positive results of direct SARS-CoV-2 viral testing and within 10 days of symptom onset.
Other Instructions for Providers
Health care providers who prescribe bamlanivimab under the emergency use authorization are required to provide patients and/or their caregivers with information consistent with the conditions of authorization listed in the EUA, and provide a copy of the Fact Sheet for Patients, Parents and Caregivers. Patients and caregivers should be informed that:
- There are significant known and potential risks and benefits of bamlanivimab, and the extent of such potential risks and benefits are unknown.
- The patient or parent/caregiver has the option to accept or refuse bamlanivimab.
- Patients treated with bamlanivimab should continue to self-isolate and use infection control measures (e.g., wear mask, isolate, social distance, avoid sharing personal items, clean and disinfect “high touch” surfaces, and frequent handwashing) according to CDC guidelines.
Prescribing health care providers and/or their designee are responsible for mandatory reporting of all medication errors and serious adverse events potentially related to bamlanivimab treatment within 7 calendar days from the onset of the event. The reports should include unique identifiers and the words “Bamlanivimab treatment under Emergency Use Authorization (EUA)” in the description section of the report. Adverse event reports should be submitted to FDA MedWatch through the FDA online portal.
Distribution to Wisconsin Hospitals
Due to the ongoing surge of COVID-19 disease activity in Wisconsin, and the limited supply of bamlanivimab nationally, the number of patients meeting criteria for authorized use will greatly exceed the number of available doses for the foreseeable future. Rationing decisions are therefore necessary at the federal, state, and health system level, to ensure that the drug is distributed in a way that is equitable and leads to maximum public health impact.
The federal government has allocated an initial supply of bamlanivimab to state health departments based on levels of disease activity in every state. Wisconsin DHS expects to receive 4,260 doses for its initial allocation, and plans to rapidly make the drug available to Wisconsin hospitals using a system similar to prior distributions of remdesivir.
Bamlanivimab will be shipped directly to hospitals in pre-determined allotments based on county-level COVID-19 burden along with an adjustment for social vulnerability, as assessed by the CDC Social Vulnerability Index. This allocation framework was developed by the State Disaster Medical Advisory Committee (SDMAC) and is described in a document released on November 13, 2020. This framework discusses ethical issues that hospitals may consider when allocating this limited drug to patients, which can include involvement of a hospital ethics committee or “crisis triage team.”
Bamlanivimab distributed through this allocation process is provided free of charge to hospitals. Patients should not be charged for the medication, but may be billed for services related to medication infusion and monitoring.
Providers and pharmacists seeking guidance about individual patient treatment requests should not contact DHS but should instead discuss those situations within their health system. Administrators involved with ordering, shipping, and receiving drug from DHS may contact DHSOperations@dhs.wisconsin.gov with any questions.
Sincerely,
Ryan Westergaard, MD, PhD, MPH
Chief Medical Officer and State Epidemiologist for Communicable Diseases
Wisconsin Department of Health Services
About the COVID-19 Health Alert Network
The content of this message is intended for public health and health care personnel and response partners who have a need to know the information to perform their duties. The HAN will be the primary method for sharing time-sensitive public health information with clinical partners during the COVID-19 response. Health care providers and other officials can subscribe and unsubscribe using their preferred email address at the DHS COVID-19 website.
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