- Gilead will charge between $2,340 and $3,120 for a typical course of treatment with its COVID-19 drug remdesivir, which has been shown to speed the recovery of patients hospitalized with the infectious disease.
- The drug's price will depend on whether patients are covered by government insurance or commercial health plans. Gilead will offer remdesivir to governments in developed countries at a price of $390 per vial. In the U.S., private insurers will pay $520 per vial.
- Most patients will be treated for five days, using six vials, Gilead said in announcing its much anticipated pricing decision Monday. If treatment stretches to 10 days — initially the standard treatment course — remdesivir's cost would rise to $5,720 for patients who are commercially insured.
Remdesivir was the first drug proven in a high-quality clinical trial to help patients hospitalized with COVID-19, a benefit that led the Food and Drug Administration to authorize emergency use of the drug in early May.
An emergency authorization is not the same as a full approval, lasting only as long as a public health emergency is in place, but it does allow Gilead to charge for its product.
The biotech, which has courted controversy in the past with high prices for its HIV and hepatitis C drugs, avoided having to declare a price early on by donating its entire supply of remdesivir. Those donated doses have now run out, forcing Gilead's announcement, which could set a bar for other COVID-19 drug developers in the future.
Gilead claims its price for remdesivir is "well below" the drug's value, citing an estimate of $12,000 in hospital savings for each patient discharged early. In the government-run study which led to remdesivir's authorization, treatment hastened recovery from COVID-19 by four days compared to placebo, although the benefit was mostly observed in less sick patients.
The company's pricing overlaps with what the Institute for Clinical and Economic Review, an influential drug price watchdog, estimates would be cost effective for the drug. But ICER's analysis assumes remdesivir helps patients hospitalized with COVID-19 survive, a benefit that has not yet been proven.
Without a mortality benefit, ICER estimates remdesivir would only be cost effective at a price of $310.
At the prices it's set, Gilead will likely be able to earn a profit from remdesivir. In a separate analysis, ICER estimated Gilead could recoup its increased investment in remdesivir development by setting a price between $1,010 and $1,600.
Gilead's pricing for remdesivir will likely be compared to the low cost of dexamethasone, a generic steroid that was recently shown to significantly reduce the risk of dying among the sickest COVID-19 patients. Dexamethasone can be obtained at a cost of just a few dollars per vial, according to the World Health Organization.
"The right announcement [from Gilead] would have been that they are going to run a study of remdesivir on top of dexamethasone with a placebo control and mortality as an endpoint," said Peter Bach, director of Memorial Sloan Kettering's Center for Health Policy and Outcomes, in an email to BioPharma Dive.
"If they want to 'do the right thing' they should flesh out the evidence here rather than following the conventional path for the industry, which is do the bare minimum to get on the market and then never do the rigorous studies because they can go against your shareholder's interest," he added.
Gilead plans to test an inhaled formulation of remdesivir, which is given intravenously, earlier in COVID-19's disease course, as well as study the drug in outpatient settings. The U.S. National Institutes of Health, meanwhile, is evaluating the drug in combination with Eli Lilly's arthritis drug Olumiant.
The drugmaker is also aggressively ramping up production of remdesivir, and expects to produce more than 2 million treatment courses by the end of the year.
Over the next month, however, the drug's availability might be limited, particularly as COVID-19 cases rise dramatically in states like Arizona, Florida and Texas.
HHS will continue to allocate supplies of remdesivir in the U.S. through September, announcing Monday a deal with Gilead for more than 500,000 treatment courses. The agreement secures 100% of Gilead's projected production in July, and 90% in August and September.
Speaking to reporters Monday, senior HHS officials said the first shipments of the new supply would likely happen in two weeks. Each week, the department does a detailed analysis of hospitalization rates across the country, which it will use to determine which states have the greatest need for remdesivir.
Shipping will be handled by drug distributor AmerisourceBergen. State health departments will direct the company to deliver doses to the hospitals with the most number of admitted COVID-19 patients.
After September, when supplies are projected to stabilize, HHS will no longer manage distribution.