The FDA approved an emergency use authorization (EUA) for remdesivir to treat hospitalized patients with severe COVID-19. HHS signed an Agreement with Gilead for 500,000 treatment courses of remdesivir on 6/29/2020. This represents 100% of July production, 90% of August production and 90% of September production. The U.S. The Department of Health and Human Services will control distribution through AmerisourceBergen and hospitals will pay no more than WAC for the drug. The government will tell AmerisourceBergen how many vials can be shipped to a state. The department of health in each state will direct the wholesaler to deliver doses to the hospitals with the highest number of inpatient COVID-19 cases. The initial supply from the Federal Stockpile of 5 million doses were exhausted at the end of June 2020. HHS will stop managing distribution of remdesivir at the end of September, when supplies are expected to stabilize.
Gilead has set AWP for remdesivir (Veklury) at $520 per vial or $3,120 for five days of treatment. This is the price for private insurance patients in the U.S. The U.S. government price for Medicaid and military hospitals is $390 per vial or $2,340 for a five-day course of treatment. This is also the price for developed countries. Pricing for remdesivir is more aligned with estimates from ICER that take into account the potential effect of dexamethasone. Gilead has entered into agreements with generic manufacturers to make the drug available at a substantially lower cost to developing countries, where healthcare resources, infrastructure and economics are lower.
The National Institute of Health recommends use of dexamethasone 6 mg daily for up to ten days in COVID-19 patients the require supplemental oxygen with or without mechanical ventilation. NIH recommends against using dexamethasone in patients that do not require supplemental oxygen. The recommendation is based on data presented from the RECOVERY trial. The WHO recommends that dexamethasone only be used in patients with severe or critical disease.