Finding a way to protect the uninsured and creating incentives for the private sector to continue producing cutting-edge treatments, vaccines and tests—that ideally would find limited use—comprise two of the challenges facing the U.S. in the near future.
Speaking at a Health Wonk Shop webinar hosted by the Kaiser Family Foundation titled “The Commercialization of COVID,” Dawn O’Connell, assistant secretary for preparedness and response at the U.S. Department of Health and Human Services (HHS), said the transition will be a complicated one.
The tests, treatments and vaccines will move to the private sector on different timelines, depending on regulatory status. For instance, “Medicare and Medicaid cover things differently if they’re approved versus whether they’re under emergency use authorization,” O’Connell said.
Joining O’Connell in the discussion were Jen Kates, KFF’s senior vice president and director of global health and HIV policy, and Rena Conti, an assistant professor in the department of markets, public policy and law at Boston University. Larry Levitt, KFF’s executive vice president for health policy, hosted the discussion.
Guaranteeing there will be a market for what the private industry produces to counter future pathogenic threats will be critical, said Levitt.
“The government was essentially guaranteeing a market for tests, for treatments, for vaccines,” Levitt said. “We need to think about making sure that those countermeasures are available in a timely way and in adequate supply.”
Kates agreed, saying that “innovators really do need to understand that there is a market for their products. And even if we see this pandemic kind of receding into the background for ourselves, that doesn’t mean that there isn’t worldwide demand for both preventives and also therapeutics. But also, there will be another pandemic. Making sure that there’s a robust investment by the private sector in such medical countermeasures is critical to moving forward.”
Conti said that those with public or private insurance will still have access to free vaccines for COVID-19 after the government stops giving them out. “There is a supply issue … if manufacturers aren’t making enough. But at least from a coverage perspective, vaccines should be mostly taken care of.”
Uninsured children will have coverage under the Vaccines for Children Program, but, “if you’re an uninsured adult, you’re kind of out of luck.”
Tests and treatments will be a different story, said Conti. “A lot of people are going to face cost sharing. If you have public or private insurance, you’ll still get them but there will likely be cost sharing in your future. And in some cases, you might not even get coverage for it even if you have insurance. Some insurers probably won’t cover it and don’t have to.”
O’Connell said that the government is “learning as we go” about how to shift costs to private industry. She cited Eli Lilly, which manufactures bebtelovimab, the only monoclonal antibody that’s effective against omicron. The company has supplied hundreds of thousands of doses of the drug to the government.
“We give a lot of credit to Eli Lilly for stepping up and being able to do that,” O’Connell said. “And we’ve been working with them to learn some lessons about what that was like to be able to continue to provide accessibility as they think about how they will continue to provide this product to the uninsured moving forward. We’re learning as we go, and in very active and collaborative conversations.”
All the experts enthusiastically praised the role played by the Biomedical Advanced Research and Development Authority (BARDA) during the pandemic. BARDA is an arm of the Administration for Strategic Preparedness and Response in the HHS.
Through BARDA, the “government created incentive to be able to bring some of the smaller biotech companies forward to innovate against some of our more challenging threats across the biological, chemical and radiological landscape that we’re currently facing,” O’Connell said. “BARDA gets to play a role in continuing to do the innovation in the COVID space and keep companies invested while it looks and returns to its regular portfolio of those chemical, radiological, biological and other threats.”
Conti said, “I totally agree. Make sure that people appreciate the role that BARDA played. They were both identifying companies that had standard capacity to make existing products that needed to be on the ground. And to help people in the emergency, they were also identifying innovators who are willing to innovate in a very time-constrained situation. And incredibly, they were investing in manufacturing at risk for products that hadn’t even been authorized or approved, not just for the U.S. population, but also frankly, for the worldwide benefit.”