Covid researchers are racing the clock. They’ve made enormous progress on therapies and vaccines, but they aren’t far enough along to arrest the current surge of Covid infections as winter approaches. One of the biggest challenges is making sure the new treatments reach the patients who need them most.
The most immediate opportunity comes from antibody drugs that can be used both as treatment and prophylaxis. President Trump and former New Jersey Gov. Chris Christie both recovered after they received antibody combinations when their symptoms were worsening. These medications are likely to be most effective when used before or soon after symptoms begin.
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The Food and Drug Administration is reviewing evidence for the emergency authorization of these drugs, aiming to get them to Covid patients before they need to be hospitalized. We recently wrote on these pages about some important steps to ensure an adequate supply. Available medicine will need to be used wisely on the patients who need it most.
There are also practical challenges of administering these medicines intravenously and under medical supervision. Sending Covid patients to infusion clinics is a bad option, since those facilities are full of cancer patients and others with suppressed immune systems who may be at serious risk if infected.
The federal government is working on a system to control distribution, essentially sending limited supplies to states in proportion to their expected eligible patients. Governors would allocate the drugs to hospitals, as happened with the antiviral drug remdesivir.
This will require collaboration from states and hospitals in setting up special administration sites. Such sites might include emergency departments. But when Covid strikes a metropolitan area, stressed emergency wards may not have the space. Moreover, ideally the antibody drug would be given to patients who aren’t yet very sick. Healthy patients are often reluctant to take infused drugs, which feel riskier than swallowing pills. Having to spend three hours at a hospital will make that perception worse.
A more flexible approach would include modular sites or conversions of other hospital spaces. Health-care providers have also substantially expanded home infusion capabilities during the pandemic. It might be possible to treat some Covid patients at home, staffed by medical professionals trained to handle the small risk of allergic reactions. The FDA would need to authorize the drugs for delivery in home settings. The risk of managing reactions to the drug must be weighed against the risks that patients will avoid the hospital and forgo the therapy altogether.
A related issue is payment. Even if the antibody drug is free for patients, providers need reimbursement for the substantial costs of administering the drug, especially if the goal is flexibility of location. The usual methods won’t work.
In Medicare, for example, the administration fee is typically a percentage of the drug price, which can run into the hundreds or thousands of dollars, with proportionally big copayments for patients. There have been efforts to change this approach. The Trump administration and others have proposed that Medicare move toward a flat fee per dose or encourage specialized centers to compete on the cost and quality of providing complex medications. There is likely strong bipartisan legislative support for fixing this problem for Covid. But such a solution seems unlikely to come together quickly.
Medicare has the authority to try “demonstration programs” on new payment approaches if there’s reason to believe that such a method can reduce Medicare costs without compromising quality or access to care, or increase quality without raising costs. Covid antibody drugs are suited to this authority.
Medicare could provide a payment that accounts for the special conditions of infusing drugs in Covid patients, without copayments for the duration of the public-health emergency. The payment should include the cost of providing data to a registry. If the limited supply of these drugs prevents hospitalizations and other expensive Covid complications, this approach would reduce costs and improve outcomes. Data from such a demonstration could inform Covid care and pave the way for future payment reforms.
It isn’t yet clear how well the antibody drugs will work. But there’s a lot of potential. As new cases surge, it’s essential to take steps now to make sure that safe and effective drugs will be available to patients who need them.
Dr. Gottlieb is a resident fellow at the American Enterprise Institute and was commissioner of the Food and Drug Administration, 2017-19. Dr. McClellan is the director of the Duke-Margolis Center for Health Policy at Duke University and was FDA commissioner, 2002-04. Dr. Gottlieb serves on the boards of Pfizer and Illumina and Dr. McClellan on the boards of Johnson and Johnson and Cigna ; each company is involved in aspects of the Covid response.
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