Hospitals will be able to purchase remdesivir, Gilead Sciences' antiviral drug used to treat hospitalized COVID-19 patients, directly from distributor AmerisourceBergen, federal authorities announced Thursday.
Supplies of remdesivir, which is the only antiviral drug with emergency use authorization to treat hospitalized COVID-19 patients, have increased over the past several weeks as demand has waned and production has expanded. As a result, HHS will no longer oversee distribution via state health departments as planned.
"There is enough supply on hand to treat every existing COVID hospitalization in the U.S. and ample supply even if incidence surges," Johanna Mercier, Gilead's chief commercial officer, said during a press call with reporters.
Hospitals have not been purchasing the full available amounts of the drug over the past several weeks, which is a good sign, said Dr. John Redd, a captain in the U.S. Public Health Service and chief medical officer of the HHS Assistant Secretary for Preparedness and Response.
Of the 500,000 treatment courses made available in the U.S. between July and September, state and territorial health departments accepted 84% of their allocations, ASPR data show. However, only 32% of the total allocation was actually purchased by hospitals.
"That is a key indicator that the supply exceeds the demand and that there is no need for the federal government to oversee allocations of the drug," Redd said during the call.
AmerisourceBergen will continue to be the sole distributor of remdesivir. If hospitals hadn't secured allocations of the drug with the distributor prior, they should not have trouble getting supplies, Matt Sample, vice president of manufacturer operations at AmerisourceBergen, said during the call. There will be no minimum order threshold, he added.
Preliminary data from a government-sponsored trial showed remdesivir reduced recovery times by about four days, which could save hospitals $12,000 per patient, Gilead estimates, although health policy experts have cautioned that hospital costs vary widely and that the outcomes aren't yet clear.
"There are now 3 (randomized clinical trials) of remdesivir in hospitalized patients with differing results, raising the question of whether the discrepancies are artifacts of study design choices, including patient populations, or whether the drug is less efficacious than hoped," Erin McCreary, infectious disease pharmacist at the University of Pittsburgh Medical Center, and Derek Angus, chair of UPMC's critical care medicine department, wrote in a JAMA editorial.
Remdesivir costs $3,120 for a five-day treatment cycle. Gilead had donated 150,000 treatment courses for the drug, but that supply ran out in late June. Since then, the cost has been incorporated into the DRG payments hospitals receive for treating COVID-19 patients.
Mercier said full FDA approval of the drug is "imminent," which would likely expand its use.