- HHS this week began to distribute 300,000 initial doses of the newest COVID-19 treatment.
- Hospitals need to meet specific infusion requirements to administer the drug.
- Medicare will provide $300 per case to cover infusion costs and may increase that amount in the future.
The federal government is reaching out to encourage hospitals and health systems to provide a new infusion therapy to treat COVID-19.
The U.S. Department of Health and Human Services (HHS) plans to allocate 300,000 initial doses of an investigational monoclonal antibody therapeutic, bamlanivimab, by Eli Lilly. The drug received an emergency use authorization from the Food and Drug Administration (FDA) on Nov. 9.
The treatment for non-hospitalized patients with mild or moderate confirmed cases of COVID-19 is aimed at preventing progression of the disease and the need for hospitalization. The FDA supplied details to providers on which patients should and should not receive the treatment.
Distribution comes amid rising numbers of cases and hospitalizations throughout the country. About 20% of Americans diagnosed with COVID-19 eventually need to be hospitalized.
The federal government may purchase and distribute up to 650,000 additional doses, if needed, through June 30, 2021.
“We are committed to the equitable and efficient distribution of resources like bamlanivimab to help prevent hospitalization from COVID-19 as much as possible,” said Robert Kadlec, MD, assistant secretary for preparedness and response at HHS.
Distribution will focus on areas of the country that are being hit hardest by the pandemic, he said.
Weekly allocations to state and territorial health departments started this week and will be proportionally based on confirmed COVID-19 cases in each state and territory over the previous seven days, as determined by data submitted by hospitals and state health departments to HHS. The largest share of the initial round of distributions went to California, Florida, Illinois and Texas.
Details on the drug’s allocation to specific states, territories and other jurisdictions are available at the allocation dashboard. HHS will update the dashboard weekly with each round of shipments until the FDA indicates the government no longer needs to be involved in the distribution process.
Outreach to hospitals is underway
To accommodate IV infusions, HHS officials said they have been reaching out to hospitals to provide the treatment. To segregate COVID-19-positive patients from noninfected hospital patients, the new treatment is to be delivered in outpatient facilities.
The infusion process takes approximately one hour and may be followed by an observation period. Administration of the drug is limited to settings with:
- Immediate access to medications for treating a severe infusion reaction, such as anaphylaxis
- Capacity to activate an emergency medical system
- Sufficient space to administer the medication while minimizing the risk of infection transmission
Janet Woodcock, MD, director of the Center for Drug Evaluation Research at the FDA, said the administration is talking to health systems and other types of providers about whether they can meet the requirements.
“We will be looking at the ability of the healthcare system to get this into people’s veins,” Woodcock said in a call with reporters.
The treatment also may be administered in hospital emergency departments and “alternate care sites” set up by hospitals and health departments under the “hospital without walls” waiver provided by CMS to support a surge of hospitalized patients.
The drug will be offered at no cost to patients, although healthcare facilities are allowed to charge for administering the medicine. Fee-for-service Medicare beneficiaries without Medigap plan coverage will have to pay $60 in coinsurance.
Uninsured patients will owe no out-of-pocket charges for administration of the drug. Their cost will be paid through funding that is available through the Provider Relief Fund and covers COVID-19 treatment for the uninsured.
Medicare will pay hospitals $300 for the one-hour infusion sessions, administration officials said. CMS is considering policy changes to increase the payments, officials said.
The monoclonal antibody used in the therapeutic was identified from a blood sample taken from one of the first U.S. patients who recovered from COVID-19. The antibodies, which mimic the human immune system, are produced outside the body by a single clone of cells or a cell line with identical antibody molecules and then delivered to patients by injection or infusion. The antibodies bind to certain proteins of a virus, reducing its ability to infect human cells.
Bamlanivimab is the second COVID-19 therapeutic for which HHS is providing allocation oversight. The first, Veklury (remdesivir), gained FDA approval and is now widely available. Multiple other companies are developing additional therapeutics to treat COVID-19.