Why payers should be preparing now for new COVID-19 boosters

Pharmaceutical companies are aiming to continue evolving COVID-19 vaccines as the virus mutates, but the jury is still out on the effectiveness of an annual booster strategy.

For example, Moderna this week announced that it’s developed a new booster to battle subvariants BA.5 and BA.4 of omicron that the company said will prove more effective than the booster the government rolled out in September, partly because the new version includes data from human beings, not just animals, as Fierce Pharma reports.

As payers are going to be on the hook for coverage of these products, they’re going to have to push for critical data on how these vaccines are working for members, experts say.

Paul Offit, M.D., the director of the Vaccine Education Center at Children’s Hospital of Philadelphia, said insurance companies should hold pharmaceutical companies’ feet to the fire. “They should say, ‘Show me the data. Show me the data as to why everyone needs another dose of vaccine. A yearly dose of vaccine. Who benefits? You’ve done those three or four initially. But prove that you need another dose of vaccine. Prove it.’ Because right now it should always be about the data,” he said in an interview.

He added that payers should ask the same questions of the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC).

Offit said he didn’t see such proof in June when the first bivalent boosters were approved. He sits on the Vaccines and Related Biological Products Advisory Committee, a panel of experts that makes recommendations to the FDA. He was one of two experts on the 15-member panel to vote against approval of the bivalent vaccines.

The Affordable Care Act (ACA) mandates that insurers cover what’s approved by the CDC, which comes after the FDA’s approval. But that coverage can come a year after approval. Enter the Coronavirus Aid, Relief, and Economic Security Act—the CARES Act—which requires non-grandfathered employer-sponsored health plans to cover an updated booster 15 days after it’s been approved by the CDC with no out-of-pocket costs for patients. 

Jeff Levin-Scherz, M.D., population health leader for health and benefits in North America at Willis Towers Watson, warns pushing back too hard could turn out to be the wrong move for health plans.

Even for insurers to check vaccine status before allowing a booster shot would be problematic, Levin-Scherz told Fierce Healthcare. It would mean that the party giving the injection, whether a pharmacist or a primary care physician, would have to check the status and then ask for approval from the payer.

Such double-checking would make claims payment substantially more difficult, he said.

“And it might mean that some people who should be vaccinated get turned away, which is a bad thing. Remember also that many people got shots that aren’t in payer records,” Levin-Scherz said. “They could have changed insurers. They could have gotten shots at stadiums where no bill ever got submitted. Health plans don’t have the information to really know whether people really got the first two shots.”

Payers seemingly cannot influence vaccination policy. When asked what leverage payers might have to do so in light of the ACA and CARES Act constrictions, Offit responds: “No idea.” 

Some health plans are aiming to proactively make clear that they cover these vaccines.

“Vaccines and boosters are an important tool to stop the spread of COVID-19. Blue Cross and Blue Shield of North Carolina is covering COVID-19 vaccines and boosters that are FDA approved, including for emergency use authorization (EUA), at no cost for all members, both during the public health emergency and after. Blue Cross NC will continue to monitor guidance from the CDC and other public health authorities,” a spokesperson for Blue Cross NC told Fierce Healthcare.

As employers contract with health plans, they also have more than a passing interest in vaccine uptake. The Northeast Business Group on Health this week announced that it launched “Creating a Vaccination-Friendly Culture: What Employers Can Do,” which it describes as a guide to help human resources and benefits leaders develop and implement strategies to boost employee vaccination rates.

“Uptake of all recommended vaccinations is low across the U.S. population, with average rates between 20% and 60%,” the press release states. “This statistic is especially troubling given the potential loss of life, risk of protracted illnesses and costs—both direct and indirect—of the diseases these vaccines are intended to prevent.”

The potential pros and cons of emerging COVID-19 boosters

Of Offit’s concerns about boosters, Levin-Scherz responded, “I am an internist. I can’t argue the virology with him. I can say from my review of things that this vaccine appears to be at least not inferior to the previous booster and the laboratory tests suggest it’s likely much better.”

He added that with a fast-mutating virus such as SARS-CoV-2, society doesn’t have the luxury of waiting months to see proof of a vaccine’s efficacy in the real world.

“If we wait until we see significant improvements in the community, then we’re going to be waiting during the months where this could have prevented hospitalizations and prevented a lot of deaths,” said Levin-Scherz.

Offit said he understands the push for boosters because “there’s a certain amount of COVID vaccine exceptionalism. “I do think we’ve fallen below the line to some extent here for these bivalent vaccines. There’s no evidence that this bivalent vaccine is any better than what we already had. And so why pay for it? The FDA withdrew the emergency use authorization for the monovalent vaccine. Why? That was still perfectly good; as good as what we now have,” he said.

He’s not the only one with doubts. Fewer than 10% of people over the age of 5 in the U.S. have received the bivalent boosters that were rolled out in September.

Offit acknowledged that bivalent boosters might help certain populations such as the elderly, particularly those living in nursing homes, the immunocompromised and individuals with severe health problems, who could land in the hospital even with mild infection.

“That’s who benefits,” said Offit. “Do they still benefit from a booster dose? I don’t know. But it’s probably reasonable to say that as you head into winter, where this virus is more likely to circulate, it’s probably reasonable to give them another dose, even though we don’t necessarily know that they need it.”

For the rest of the population, the vaccine needs only to protect against severe disease, which the original monovalent vaccines do, said Offit.

“Take me,” said Offit. “I got three doses of the vaccine. Then six months after my last dose that I got in May of this year, I had a mild infection. Well, it was May, so I was probably infected with BA.2. But the point is I had a mild infection. I didn’t get a severe infection. I didn’t require steroids. I didn’t require oxygen. I was good. I had a cough for a few days and that wasn’t fun. But I consider that a win. I was protected against that strain even though I am over 70 years old.”

When asked whether he believes boosters can help ward off long COVID, Offit cites a research letter in JAMA Network in which investigators found that 41.8% of individuals who’d not been vaccinated got long COVID. With one dose, 30% got long COVID; 17.4% got it with two doses; and 16% got it with three doses.

“There didn’t appear to be any benefit beyond the second dose,” says Offit.

He also noted that it’s difficult to pin down exactly what causes long COVID.

“It has a variety of different definitions,” says Offit. “I think it has a variety of different causes, which can be just the persistent reproduction of the virus. It can be clotting, these micro-clots that can appear in lungs and other organs. It can be this sort of dysfunction or hyperactive immune system. I think all of those things have been proposed reasonably, as causes of something that clearly is real, but I think has been kind of hard to describe.”

Levin-Scherz said he got the bivalent booster “as soon as I was able. I think the evidence that all the vaccines and boosters prevent severe illness and death is actually quite good. There’s every reason to believe that the new booster is going to be as good or better than previous boosters.”

People should protect themselves, because “we don’t want people to be getting COVID under any circumstances. There’s the danger of long COVID and as well as the danger of acute illness. But especially now with both RSV and influenza just really raging, being better protected against COVID-19 is a really good idea.”