COVID-19 Health Alert # 11:
Access to Remdesivir under Emergency Use Authorization
for Wisconsin Hospitals
Wisconsin COVID-19 State Emergency Operations Center, May 21, 2020
Summary
- Remdesivir, an investigational drug being studied for treatment of severe COVID-19, is available for use in the United States after receiving Emergency Use Authorization (EUA) by the FDA.
- A limited supply of remdesivir has been distributed from the federal government to the Wisconsin Department of Health Services, for distribution to Wisconsin hospitals. DHS is making the drug available for hospitalized patients who meet clinical criteria specified under the EUA.
- Hospitals can request one or more cases, each containing 40 single-dose vials of remsdesivir, from the State Emergency Operations Center, for next-day delivery. If more requests are received than can be filled, the state will give priority to hospitals currently caring for the highest number of COVID-19 patients.
Remdesivir is an investigational antiviral drug that is being studied for treatment of COVID-19. Findings from several clinical trials have provided preliminary evidence that patients receiving remdesivir may have a shorter duration of illness, in comparison to patients who received placebo. Studies have not found evidence that remdesivir lowers the risk of death of patients with COVID-19, or prevents progression to severe disease among patients with mild illness. At this time, remdesivir is not an FDA approved treatment for any condition, and there is not sufficient evidence of benefit that the government can recommend for or against its use.
Based on the early findings suggesting a potential benefit, on May 1, 2020, the FDA issued an Emergency Use Authorization (EUA) to allow remdesivir to be distributed and be used by licensed health care providers to treat adults and children hospitalized with severe COVID-19. Severe COVID-19 is defined as patients with an oxygen saturation (SpO2) ≤ 94% on room air or requiring supplemental oxygen or requiring mechanical ventilation or requiring extracorporeal membrane oxygenation (ECMO).
After the FDA’s EUA, the manufacturer of remdesivir, Gilead Sciences, made a donation of the drug to the federal government for distribution to patients hospitalized with severe COVID-19. On May 16, 2020, the US Department of Health and Human Services sent a communication to states which read:
We expect to receive a minimum of 940,000 vials, per the donation agreement with Gilead. This current shipment represents 206,640 vials, or 22%, of the overall expected total. When the initial shipment arrived at HHS from Gilead on May 4, 2020, a partial shipment of the medication was sent directly to hospitals in seven states, which was approximately 3.6% of the total expected donation. When it became clear that each State would need to develop clear, individualized criteria for their communities based on the efficacy data in the initial clinical trial, shipments were shifted to the States for distribution to hospitals as needed, beginning with the previously shipped emergency supply, and followed by this current distribution. We expect to deliver a shipment of 5,275 cases, or 211,000 vials, of remdesivir this week, which will be distributed using the same hospital case-based algorithm.
Wisconsin received two shipments of remdesivir from the federal government, on May 12 and May 15. Because the number of doses received by the state was small in comparison to the number of patients hospitalized with COVID-19, DHS invited hospitals to request remdesivir in batches sufficient for 5- or 10-day treatment courses for individual patients. In the first allocation, hospitals requested treatment courses for 90 patients, and DHS distributed its entire allocation the following day, which included treatment courses for 52 patients.
A smaller number of requests were received from hospitals after Wisconsin received its second allocation on May 15. As a result, all hospitals requesting remdesivir from this allocation received the requested number of doses on May 16. For future allocations of remdesivir, including a new shipment of 26 cases on expected on May 20, 2020, DHS will allocate entire, unopened cases of remdesivir to hospitals, each containing 40 single dose vials. This strategy is consistent with the approach taken by other states in our region, and is advantageous because hospitals may store unused drug at their pharmacy for use in future patients, avoiding potential treatment delays associated with requesting doses from DHS. Hospitals with small numbers of patients with COVID-19 also have the option of requesting individual treatment courses.
To request one or more cases of remdesivir, hospitals must submit a Remdesivir Case Request Form to DHS [DHSOperations@dhs.wisconsin.gov] before 4:00 pm on 5/22/2020, containing (1) the number of cases or treatment courses requested, and (2) the total number of patients currently hospitalized in their facility who meet the eligibility criteria for remdesivir. These criteria include:
- Laboratory-confirmed COVID-19
and
- Oxygen saturation (SpO2) ≤ 94% on room air or requiring supplemental oxygen OR requiring invasive mechanical ventilation or requiring ECMO
Hospitals are required to provide an accurate account of the number of COVID-19 patients in their current inpatient census, and to agree to only administer remdesivir to patients in accordance with the specifications described in the Emergency Use Authorization. Failure to meet these obligations may result in loss of access to future allocations of medications through DHS. If the number of cases of remdesivir available through DHS is not sufficient to fill all requests received from hospitals, DHS will allocate the available cases by giving priority to hospitals with the greatest number of eligible COVID-19 patients.
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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