HHS is making temporary changes to its distribution policies for monoclonal antibody drugs in response to shortages caused by a spike in demand, according to a Sept. 7 news release from the American Hospital Association.
HHS said the policy changes are in response to a "substantial surge in the utilization of monoclonal antibody drugs, particularly in areas of the country with low vaccination rates," and that they're intended to maintain sufficient supply of antibody drugs to meet current and future demand.
The changes include:
- Limiting immediate orders and shipment to only administration sites with HHSProtect accounts and current utilization reporting
- Reviewing all orders for alignment with utilization, currently estimated at 70 percent of orders
Monoclonal antibody drugs mimic antibodies the immune system naturally produces to fight COVID-19. They have been shown to sharply reduce hospitalization and deaths from the virus when given early in the course of the disease.
In mid-August, the Biden administration called on providers to increase their use of antibody drugs in COVID-19 patients. Anthony Fauci, MD, the White House chief medical adviser, said in late August that monoclonal antibodies are a "much underutilized intervention" for COVID-19 and encouraged hospitals and physicians to make greater use of the treatments.
Florida and Texas have both opened free monoclonal antibody treatment centers to combat the surge in COVID-19 cases caused by the delta variant.
In mid-August, hospitals began experiencing a shortage of Actemra, a monoclonal antibody drug made by Roche subsidiary Genentech that's been FDA authorized to treat COVID-19. Genentech said Aug. 16 it expected the shortage to last "at least the next several weeks."
The drugmaker said recent surges in COVID-19 hospitalizations have caused "unprecedented demand" for Actemra. Demand for the drug increased 279 percent between June and August, according to data from Vizient.
The American Hospital Association said that hospitals with questions about HHS' new distribution policies for monoclonal antibody drugs should email the federal COVID-19 response team at COVID19therapeutics@hhs.gov.