If COVID-19 antibody drugs are authorized by the FDA, CMS will cover the costs for Medicare beneficiaries, and HHS will distribute it to hospitals in a method similar to its distribution of Gilead's remdesivir, a CMS spokesperson told Becker's.
CMS said that initial doses of the drug purchased by the government would be allocated by the government to hospitals at no cost. Medicare would pay for the costs of drug administration for beneficiaries, and CMS would issue codes soon after the drugs receive authorization, so hospitals could bill for the products they purchase.
HHS is using some of the $100 billion Coronavirus Aid, Relief, and Economic Security Act Provider Relief Fund to reimburse providers at Medicare rates for COVID-19-related treatment for uninsured patients, and hospitals can apply for reimbursement of hospitalization costs through the program, the spokesperson said.
HHS will use the same method to distribute the drugs as it did for remdesivir, based on confirmed case counts of COVID-19 by state or territory, the CMS spokesperson told Becker's. Health departments, not the government, would determine how much of the drug healthcare facilities receive based on the state's total allocation.
Both Regeneron and Eli Lilly have submitted emergency use authorization requests with the FDA for their COVID-19 antibody drugs. But after a pause in Eli Lilly's trial for its drug, the trial was ended after researchers discovered the drug does not improve recovery time or survival rate for patients hospitalized with advanced COVID-19. The drugmaker still plans to test the drug's effectiveness in patients with milder cases of the disease.
Regeneron also halted testing its COVID-19 antibody drug Oct. 30 after an independent data-monitoring committee observed a "potential safety signal and unfavorable risk/benefit profile." The trial halt does not affect other trials, such as one testing the drug in hospitalized COVID-19 patients receiving low levels of oxygen. The drugmaker has reported that the drug significantly reduced the viral load and probability of a medical visit for patients with mild to moderate cases of the disease.
Eli LIlly has signed a $275 million deal with HHS to supply 300,000 vials of its drug. Regeneron has signed a $450 million contract with HHS for thousands of doses of its antibody drug.