David Morrison / AP
The Food and Drug Administration is evaluating two potential drugs that could help people stay healthy after being infected with a coronavirus.
So far, there is no clear system to ensure that they are distributed fairly or how to pay for these expensive drugs in the long run.
“Demand here will exceed supply,” said Rena Conti of Boston University’s Questrom Business School.
Although manufacturers are preparing to produce more than a million doses before the end of the year, about 50,000 Americans become infected every day, so the noise for these drugs is likely to be significant. (If the current rate of infection is maintained, there will be another 3.5 million infected Americans before the end of the year).
President Trump received a dose of one of these drugs and told Americans that they too could get it at little or no cost.
But Conti doubts that. That would be unprecedented for an expensive drug in the United States, she said. “It’s not realistic.”
Initially, the drug itself may be free – as the federal government subsidizes the development and production of the product produced by Regeneron, and promised to buy the first stream of this product.
Conti says that’s only part of the cost. These drugs are given by IV infusion, so they are expensive to administer. This should be done in a hospital or specialized infusion center.
Even people at Medicare have a supplement for many infused drugs. Supplements are usually 20% of the price of the drug. If this model is maintained, the co-payment for these COVID-19 drugs could be many hundreds of dollars, given Conti’s estimate of a price in the range of $ 2,000 to $ 10,000 for treatment.
Then the question arises as to how to distribute limited supplies.
Dr. Jewel Mullen, vice dean for health at Dell’s School of Medicine at the University of Texas, suggests using principles she helped develop as a member of the COVID-19 National Vaccine Academy study.
That would mean giving the highest priority to health workers and first responders, “because we need them to be well,” Mullen said. “They protect us all the time. They are at risk all the time.”
Mullen says the drug should then go to vulnerable people who benefit the most. The greatest benefit would be to keep people at highest risk out of the hospital.
Its goal: “Maximize the benefits, make sure everyone is valued and considered equally, and address health inequalities.”
This means ensuring that populations severely affected by the pandemic, often poor and colored communities, receive fair access, regardless of the cost of these medicines.
Fair distribution was a huge challenge with another scarce drug, COVID-19, remdezivir.
“The difficulty with remdezivir was that it was predictably unpredictable,” said Erin Fox, a pharmacist at the University of Utah. She was part of a commission tasked with distributing drugs across her state, but there was no rhyme or reason for the supplies the federal government provided.
“And that was for a fairly small patient population,” Fox said, initially just seriously ill people in the intensive care unit. Monoclonal antibodies, on the other hand, could be given to many more people – those who have just become infected and are not in the hospital.
If demand again sharply exceeds supply, Fox believes that hospitals will find it difficult to follow a column based on equity.
“If the amount we get is so small, it’s probably very likely that we’ll use it for a short period of time,” she says, “and just use it and not try to make some very difficult rationing decisions.”
Another huge challenge is figuring out how to get these drugs where they are most needed, says Nada Sanders, a professor of supply chain management at Northeastern University. The federal government plans to send supplies to each state.
“Simply saying, ‘We’re going to leave this to the state,’ is not the answer,” Sanders said.
Distribution itself is complex and expensive. Conti notes that these drugs must be sent in temperature-controlled trucks and sent to destinations that are equipped with care for them. And they have to get to the countryside, dealing with outbreaks.
“Ultimately, someone has to pay for it,” Sanders said.
Regeneron has entered into a supply agreement with the federal government’s Warp Speed operation for about 300,000 doses of antibody therapy. If the FDA authorizes the emergency use of the drug, then the government will make these doses of the drug available, Regeneron said in a statement.
Eli Lily has no supply agreement with the government. He says he hopes to produce up to 1 million doses by the end of the year with the help of another pharmaceutical company, Amgen.
Some of the possible costs of treatment with drugs can be covered by a surcharge. If insurance companies raise the tab, these costs will eventually be passed on in the form of premiums. State and federal taxpayers can also bear the brunt. It is unclear how millions of uninsured Americans will have access to these drugs.
If the federal government has a plan, it is not disclosed. And the clock is ticking. The FDA has been reviewing emergency applications from Regeneron and Eli Lilly for two weeks now, and has no opinion on how soon these discussions will end.
You can contact NPR’s scientific correspondent Richard Harris at firstname.lastname@example.org.