November 24, 2020
Just days after the US Food and Drug Administration (FDA) authorized emergency use of Regeneron's monoclonal antibody cocktail to treat COVID-19, the federal government will ship out the first 30,000 doses.
Federal officials said they expected to ship out another 50,000 doses on December 2.
"We expect to distribute about 30,000 doses [Tuesday], with more to come in the ensuing weeks," said Department of Health and Human Services (HHS) Secretary Alex Azar in a November 23 briefing with reporters.
The FDA issued an emergency use authorization (EUA) on November 21 for the antibody combination of casirivimab and imdevimab, which was used as part of the treatment regimen for President Donald Trump in October.
The combination is for mild to moderate COVID-19 in adults and in children older than 12 years. It can only be given to patients who test positive for COVID-19 and are at high risk for progression to severe disease.
It is the second monoclonal antibody authorized by the FDA for the treatment of COVID-19. The agency gave an EUA to Eli Lilly's bamlanivimab on November 10. Both products are available by prescription only. They require 1-hour infusions and are intended only for nonhospitalized patients.
Azar said the federal government had been working with states and others to increase interest in the use of the Lilly and Regeneron monoclonals, with the aim of keeping people out of the hospital. HHS has been working to get the word out that "if you have tested positive for COVID-19 and are at high risk for severe disease, we have treatment options that may be able to help you," he said. He noted, "It's vital that Americans be aware of these expanding options."
In mid-October, however, Regeneron CEO Leonard Schleifer said supplies were so tight that the product would have to be rationed. The federal government committed to buying 300,000 doses of the combination in July. When Regeneron received its EUA, it said it expected to have doses for 80,000 patients by the end of November and for 200,000 patients by the first week of January.
John Redd, MD, MPH, chief medical officer in HHS' Office of the Assistant Secretary for Preparedness and Response, told reporters supply would meet demand. "We're very confident in our ability to quickly and fairly allocate casirivimab and imdevimab, as well as bamlanivimab," he said.
Of 120,000 doses that the HHS had on hand for allocation, more than 85,000 bamlanivimab doses have been delivered to states. "We've been very pleased with demand for the product," he said, noting that 98% of the supply that has been offered to states has been accepted.
The federal government said in late October that it would spend $375 million to buy 300,000 doses of bamlanivimab by the end of 2020. The government has the option to buy up to 650,000 additional doses through the end of June 2021 for as much as an additional $812 million.
Distribution Based on Need
The process for distributing casirivimab and imdevimab will be the same as the one used for distributing bamlanivimab, said Redd.
A state or territory will receive an allocation equal to its percentage of the nation's total number of patients confirmed to have COVID-19 and the total number of confirmed hospitalized patients during a 7-day reporting period. State and territorial health departments determine how much of the Lilly or Regeneron monoclonal product each healthcare facility in their jurisdictions can receive.
Initial doses will be earmarked for hospitals and hospital-affiliated locations. Once health authorities determine what's required to safely and successfully administer the drugs, allocations will be expanded to additional outpatient facilities.
The EUA for Regeneron's casirivimab and imdevimab states that the two drugs must be administered together in settings where there is immediate access to medications to treat anaphylaxis. Facilities also must be able to administer the combination in a way that minimizes risk for COVID-19 transmission.
The federal government is allocating portions of the Lilly and the Regeneron product to the Department of Defense, the Veterans Health Administration, and the Indian Health Service.
Allocation figures are publicly available. The most recent data on the bamlanivimab dashboard indicate that nearly 120,000 doses were shipped to states and territories from November 9 to November 23. A similar dashboard is being compiled for the casirivimab and imdevimab combination.
Americans will not have to pay for combination casirivimab and imdevimab or bamlanivimab, although individuals who receive the medications may have to pay an administration fee. "We are working with payers on reimbursement for administration costs," said Azar, who noted that Medicare billing codes have been issued.