The arrangement may serve as a template for distribution of new treatments and vaccines as the pandemic swells, said Ernst Berndt, a retired health economist at the Massachusetts Institute of Technology Sloan School of Management.
The price will be set at $390 per vial, or $2,340 per treatment course, for patients on government-sponsored insurance and for those in other countries with national health care systems.
The drug will be sold only in the United States through September, meaning American patients will receive almost the entirety of Gilead’s output, more than 500,000 treatment courses.
H.H.S. and state health departments have been allocating the drug to hospitals nationwide based on need. After September, they will no longer have a role in determining where the drug is sent.
“This is a U.S.-first policy,” said Rena Conti, a health care economist at Boston University. “Access is guaranteed to the U.S., but worldwide demand could potentially outstrip supplies.”
“I am unaware of any other policy except perhaps in bioterrorism drugs where there might be country-specific supplies,” she added.
Remdesivir is so far the only treatment shown to speed recovery time in severely ill coronavirus patients. A large clinical trial, sponsored by the National Institutes of Health, found that the drug modestly shortened recovery time by four days, on average, but did not reduce fatalities.
The drug’s eventual cost has always been uncertain. “There is no playbook for how to price a new medicine in a pandemic,” Daniel O’Day, chief executive of Gilead, said in a statement.
Since the drug’s emergency authorization, Gilead has donated remdesivir to hospitals for treatment of patients with Covid-19, the illness caused by the coronavirus. The last shipments of donated drug were distributed on Monday.
The new pricing is not exorbitant, many experts said. Other promising drugs now in late-stage testing are already on the market for other purposes, Dr. Conti noted, and cost several times more than remdesivir.
The Institute for Clinical and Economic Review, a nonprofit group that calculates fair prices for drugs, estimated that Gilead would need to charge $1,600 per regimen to recoup its costs. But as much as $5,080 per treatment course would be still be a cost-effective price for insurers, given that patients would be able to leave the hospital sooner.
Critics have long accused Gilead of overcharging for groundbreaking drugs, including the first hepatitis C cures and Truvada, a daily pill to prevent H.I.V. infection.
In a statement on Monday, the Institute for Clinical and Economic Review warned, “Gilead has the power to price remdesivir at will in the U.S., and no governmental or private insurer could even entertain the idea of walking away from the negotiating table.”
But since many Wall Street analysts were expecting the drug to cost about $5,000 for a course of treatment, the lower price “can be viewed as a responsible decision from Gilead,” the institute added.
A Gilead Sciences facility in Oceanside, Calif. The company said supplies of remdesivir would be sufficient this fall. Credit...Mike Blake/Reuters
Public Citizen, the consumer advocacy group, described the new price as offensive, noting that remdesivir was developed with more than $70 million in public money.
A commentary published this month on the website of the British Journal of Sports Medicine points out that covering your face during exercise “comes with issues of potential breathing restriction and discomfort” and requires “balancing benefits versus possible adverse events.” Masks do alter exercise, says Cedric X. Bryant, the president and chief science officer of the American Council on Exercise, a nonprofit organization that funds exercise research and certifies fitness professionals. “In my personal experience,” he says, “heart rates are higher at the same relative intensity when you wear a mask.” Some people also could experience lightheadedness during familiar workouts while masked, says Len Kravitz, a professor of exercise science at the University of New Mexico.
I’ve heard about a treatment called dexamethasone. Does it work?
The steroid, dexamethasone, is the firsttreatment shown to reduce mortality in severely ill patients, according to scientists in Britain. The drug appears to reduce inflammation caused by the immune system, protecting the tissues. In the study, dexamethasone reduced deaths of patients on ventilators by one-third, and deaths of patients on oxygen by one-fifth.
What is pandemic paid leave?
The coronavirus emergency relief package gives many American workers paid leave if they need to take time off because of the virus. It gives qualified workers two weeks of paid sick leave if they are ill, quarantined or seeking diagnosis or preventive care for coronavirus, or if they are caring for sick family members. It gives 12 weeks of paid leave to people caring for children whose schools are closed or whose child care provider is unavailable because of the coronavirus. It is the first time the United States has had widespread federally mandated paid leave, and includes people who don’t typically get such benefits, like part-time and gig economy workers. But the measure excludes at least half of private-sector workers, including those at the country’s largest employers, and gives small employers significant leeway to deny leave.
Does asymptomatic transmission of Covid-19 happen?
So far, the evidence seems to show it does. A widely cited paper published in April suggests that people are most infectious about two days before the onset of coronavirus symptoms and estimated that 44 percent of new infections were a result of transmission from people who were not yet showing symptoms. Recently, a top expert at the World Health Organization stated that transmission of the coronavirus by people who did not have symptoms was “very rare,” but she later walked back that statement.
What’s the risk of catching coronavirus from a surface?
Touching contaminated objects and then infecting ourselves with the germs is not typically how the virus spreads. But it can happen. A number of studies of flu, rhinovirus, coronavirus and other microbes have shown that respiratory illnesses, including the new coronavirus, can spread by touching contaminated surfaces, particularly in places like day care centers, offices and hospitals. But a long chain of events has to happen for the disease to spread that way. The best way to protect yourself from coronavirus — whether it’s surface transmission or close human contact — is still social distancing, washing your hands, not touching your face and wearing masks.
How does blood type influence coronavirus?
A study by European scientists is the first to document a strong statistical link between genetic variations and Covid-19, the illness caused by the coronavirus. Having Type A blood was linked to a 50 percent increase in the likelihood that a patient would need to get oxygen or to go on a ventilator, according to the new study.
How many people have lost their jobs due to coronavirus in the U.S.?
The unemployment rate fell to 13.3 percent in May, the Labor Department said on June 5, an unexpected improvement in the nation’s job market as hiring rebounded faster than economists expected. Economists had forecast the unemployment rate to increase to as much as 20 percent, after it hit 14.7 percent in April, which was the highest since the government began keeping official statistics after World War II. But the unemployment rate dipped instead, with employers adding 2.5 million jobs, after more than 20 million jobs were lost in April.
What are the symptoms of coronavirus?
Common symptoms include fever, a dry cough, fatigue and difficulty breathing or shortness of breath. Some of these symptoms overlap with those of the flu, making detection difficult, but runny noses and stuffy sinuses are less common. The C.D.C. has also added chills, muscle pain, sore throat, headache and a new loss of the sense of taste or smell as symptoms to look out for. Most people fall ill five to seven days after exposure, but symptoms may appear in as few as two days or as many as 14 days.
How can I protect myself while flying?
If air travel is unavoidable, there are some steps you can take to protect yourself. Most important: Wash your hands often, and stop touching your face. If possible, choose a window seat. A study from Emory University found that during flu season, the safest place to sit on a plane is by a window, as people sitting in window seats had less contact with potentially sick people. Disinfect hard surfaces. When you get to your seat and your hands are clean, use disinfecting wipes to clean the hard surfaces at your seat like the head and arm rest, the seatbelt buckle, the remote, screen, seat back pocket and the tray table. If the seat is hard and nonporous or leather or pleather, you can wipe that down, too. (Using wipes on upholstered seats could lead to a wet seat and spreading of germs rather than killing them.)
What should I do if I feel sick?
If you’ve been exposed to the coronavirus or think you have, and have a fever or symptoms like a cough or difficulty breathing, call a doctor. They should give you advice on whether you should be tested, how to get tested, and how to seek medical treatment without potentially infecting or exposing others.
But Jalpa Doshi, of the University of Pennsylvania, noted that one benefit of remdesivir might be intangible. “This treatment and others as well as vaccines may help reduce fear of the virus, an important factor in accounting for its value,” she said.
Just as unusual as the pricing of remdesivir will be its distribution.
The plan is for Gilead to ship the drug to AmerisourceBergen, one of several drug wholesalers that fulfill orders from individual health care providers like hospitals. Until the end of September, AmerisourceBergen will provide remdesivir to hospitals according to need, as described by state health departments and the Department of Health and Human Services.
After September, “once supplies are less constrained, H.H.S. will no longer manage allocation,” Gilead said. It is not clear how patient need will be factored into distribution decisions at that point.
An earlier effort was a fiasco. After remdesivir received emergency authorization in May, Gilead used AmerisourceBergen to allocate the drug. Needy hospitals received none, while hospitals with few coronavirus patients received supplies unasked. H.H.S. and state health departments stepped in to coordinate distribution instead.
The new plan “lets Gilead off the hook,” Dr. Berndt said. If there is more demand than supply this fall, Gilead will not be blamed for decisions about who gets the drug and who does not.
A Department of Health and Human Services official said on Monday that remdesivir would not be stockpiled for the fall, and Gilead said that there would be an adequate supply for all American patients who need it.
But no one really knows what will happen after September, Dr. Conti said: “We will see how access gets rolled out and assured.”
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