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Remdesivir is currently the only antiviral effective against COVID-19 in a clinical trial. On May 1, 2020, the FDA issued an emergency use authorization (EUA) allowing use of remdesivir for treatment of COVID-19 in adults and children hospitalized with severe disease (defined as a low blood oxygen level (oxygen saturation < 94%), needing oxygen therapy, or requiring mechanical ventilation or extracorporeal membrane oxygenation (ECMO).
Due to its limited availability, access to remdesivir is currently being coordinated by the federal government, which received an initial donation of ~607,000 doses in May, and will receive a second donation of ~330,000 doses in June. Allocation to the states is based on the number of hospitalized patients with confirmed or suspected COVID-19.
This is our current knowledge about allocation to California:
- The initial May 12, 2020 allocation of remdesivir to California from the federal government was 1200 doses (sufficient to treat 109-200 patients).
- On May 16, 2020 California received an additional 15,800 doses (sufficient to treat 1,436 ā 2,633 patients).
- This coming week California is scheduled to receive 17,280 doses (sufficient to treat 1,571 ā 2,880 patients). Of note, this shipment will be lyophilized medication approved for pediatric administration.
- The fourth shipment is tentatively scheduled for the week of June 1st and is projected to be half the amount of our most recent shipment.
- There will be a fifth shipment in June after receipt of the second donation.
For each new allotment received from the federal government, CDPH will use the most recent hospital data for patients with confirmed COVID-19 to proportionately distribute remdesivir to the countiesā Medical and Health Operational Area Coordinator (MHOAC) per the established Multi-Agency Coordination (MAC) group process.
The methodology used by the MHOACs to distribute the medication to hospitals should be transparent, data-driven, and fair. Wherever possible, MHOACs should work with their hospitals collectively to implement an allocation process that prioritizes patients who are most likely to benefit from the medication.
MHOACs are responsible for tracking the number of doses provided to each hospital in their counties via the spreadsheet provided by the Medical Health Coordination Center (MHCC). All allocation data will be posted publicly.
The following are potential considerations when developing allocation methodology to hospitals; these may need to be adjusted depending on the relative supply and demand for remdesivir.
- Distribute medication in 5 day (6 dose) courses to maximize the number of patients who can be treated (as opposed to 10 day courses).
- Distribute medication based on the proportion of laboratory confirmed COVID-19.
- Distribute medication based on the proportion of laboratory confirmed COVID-19 cases who meet established clinical criteria, including being within 10 days of symptom onset; this requires hospitals to review patient clinical information to establish eligibility.
- To conserve inventory, obtain remdesivir from Gilead directly through compassionate use pathways for children and pregnant women.
- If sufficient quantities are available, provide at least one treatment course to every hospital that is caring for an eligible COVID-19 patient.
- If quantities are not sufficient to even provide one treatment course per hospital, randomly allocate courses to hospitals.
- Take into consideration whether hospitals have access to remdesivir through other avenues, e.g. hospitals participating in a clinical trial that is actively enrolling patients.
- Request that hospitals return any vials that are unused due to a partial treatment course or not having eligible patients for redistribution.
- If there are current patients with severe illness within 10 days of symptom onset, withholding or reserving remdesivir for future use is not recommended.