There’s a new shot to protect newborns from a serious respiratory virus, but parents may not be able to get it

By Brenda Goodman, CNN

(CNN) — A highly anticipated new shot that can protect newborns from the ravages of respiratory syncytial virus may not be available to some families this season because of uncertainties about insurance coverage.

When the US Food and Drug Administration approved the antibody, nirsevimab, in July, pediatricians and parents were jubilant. RSV fills hospitals every winter with babies who are struggling to breathe. As many as 80,000 kids under the age of 5 are hospitalized annually in the United States with this infection, and up to 300 die, according to the US Centers for Disease Control and Prevention.

“Every pediatrician is jumping for joy that this preventative tool is available for newborns, because we see what happens when a healthy baby gets this terrible infection,” said Dr. Sallie Permar, chair of the Department of Pediatrics at Weill Cornell Medicine and New York-Presbyterian Hospital.

The new shot, which goes by the brand name Beyfortus, slashed infants’ risk of being hospitalized for RSV by 80% in clinical trials. It promised to be a game-changer for the youngest patients.

But on Wednesday, members of the American Academy of Pediatrics met with CDC Director Dr. Mandy Cohen for a more somber conversation. Many medical practices say they don’t know how to pay for the shot and may not be able to get it this year. Hospitals too are struggling to figure out how to pay for it.

“We are so thrilled to have something available, but to then have it be so close but then still not getting it into arms, it’s tragic,” said Permar, who also works with the nonprofit Protect Their Future, which advocates for kids’ access to vaccines.

RSV season is already underway, and doctors now acknowledge that Beyfortus may not be widely available this virus season.

“I think it’s really challenging because for the first time in human history, we can prevent RSV in infants, but the ability to get those vaccines or those antibodies is going to be really tough this year,” said Dr. Buddy Creech, a pediatrician at Vanderbilt University who is also president of the Pediatric Infectious Disease Society.

“We have this wonderful product that was approved in the 11th hour before RSV season, and now we’re trying to roll it out for it to be maximally effective. It may take just a little bit more time.”

Legal loopholes may delay coverage

Under the Affordable Care Act, most health insurance plans must cover the cost of immunizations like Beyfortus with no cost to patients. But because of a loophole in the law, insurers have a year to add new products to their plans, and it’s not clear how fast they’ll act or how much they’ll cover.

In a rare move, the directors of the CDC and the Centers for Medicare and Medicaid Services sent a letter to insurance companies last week to spell out their legal requirements to cover three new immunizations for RSV — two designed to protect infants and one for adults over 60 — and stressed the importance of the shots.

Many insurers have expressed enthusiasm for the new RSV vaccines and say they understand their value: that they can keep people out of the hospital. Hospital care is much more expensive on an individual basis.

But the new immunizations are costly, and those costs can add up when they are intended for so many people.

Beyfortus isn’t a traditional vaccine. It’s a shot of long-acting antibodies that are designed to protect infants for about six months while they are most vulnerable to the virus. Like other antibody products, it is expensive: about $500 a dose.

Some doctors don’t think they can afford to order it without knowing whether they’ll recoup the costs.

“The issue is that this is much more expensive than any other product, and they don’t know if they’re going to get paid,” said Dr. Sean O’ Leary, chair of the American Academy of Pediatrics Committee on Infectious Diseases.

Pediatrics offices operate on slim financial margins. Vaccines are typically their second biggest expense behind the cost of staffing, said O’Leary, who is also a professor of pediatric infectious diseases at the University of Colorado Anschutz Medical Campus.

Beyfortus is recommended for every healthy newborn, and for some practices, that’s a lot of babies to cover.

“You’re easily getting into the hundreds of thousands of dollars for a medium-sized practice. That is just way too big of a financial risk if they don’t know they’re going to be paid back,” O’Leary added.

O’Leary says the American Academy of Pediatrics and other advocates have been urging insurance companies to detail the specifics of coverage for Beyfortus, but so far, they haven’t done so.

Although the Affordable Care Act protects people in most health plans from having to pay out of pocket for vaccines, it doesn’t protect doctors from bearing some of the costs. Typically, pediatrics practices negotiate with insurance companies for reimbursement, and those rates may differ among providers.

O’Leary says that because practices don’t know where the numbers will land, some have been reticent to take on the risk of ordering the shots.

“For example, here in Colorado, we’ve gotten assurances from our top four payers that they’re going to cover it, but we have not seen dollar amounts yet. And just because they say they’re going to cover it doesn’t mean they’re going to cover the whole price,” he said.

Pushing for solutions

Beyfortus is meant to be given as close to birth as possible, so ideally, newborns could get it in the hospital or birthing center where they are delivered. But hospitals typically get a lump sum from insurers to cover the cost of birth, and right now, the cost of Beyfortus hasn’t been factored into that.

Creech says he’s heard of hospitals that may try to get around this by giving babies the shot after they are “discharged” to an outpatient clinic or another room in the same facility.

O’Leary says he has heard that pediatricians are taking a variety of approaches to test the health coverage waters for Beyfortus. Some are ordering just a small number of doses to see how their payors reimburse it. Then they plan to renegotiate if they don’t get enough money back. Others plan to offer it just to their high-risk infants, similar to the way an older shot, Synagis, was given.

“I did hear about one practice where there was so much demand from the families within the practice that they said ‘OK, but you have to pay $500 up front, and we’ll give it back if we get paid.’ And they’re getting lots of requests,” O’Leary said.

Sanofi, one of the companies marketing Beyfortus, is also offering extended payment terms for doctors who order directly from the company, so they can order the shots now and pay the company back almost at the end of RSV season, a spokesperson said.

The company said that as of October 1, coverage is in place for more than 90% of infant lives nationwide.

Some health systems are planning to just assume the financial risk of giving Beyfortus until insurance coverage kicks in.

Permar, the chair of pediatrics at New York Presbyterian, said she and “a chorus of others” convinced their health system, which has 11 hospitals that serve children, to assume the financial risk to offer the shot this year.

“We’re going to assume that all of this reimbursement is going to catch up,” she said, “but we’re going to have to take on some risk initially. And that’s a hard pill to swallow when we think about health care reimbursements being so challenged.”

O’Leary said that he expected the rollout to be rough but that it’s actually going better than in anticipated in some respects because people are working so diligently to try to make it happen.

Creech, at Vanderbilt, agreed.

“So I think hospitals are going to be creative; pediatricians are going to be creative, But if the federal payors, the insurance carriers and the CDC can be similarly creative and flexible, then we’re going to see a win for patients,” he said.

Government relaxes rules to expand access

There were moves months ago to try to ensure broader access to the antibody shot.

In August, the CDC acted quickly to add Beyfortus to its schedule of routine childhood immunizations, which will eventually trigger full insurance coverage. It also added it to the Vaccines for Children program, which gives no-cost vaccines to children who might not otherwise get them. About half of babies born in the United States each year are eligible for immunizations through that program.

Many pediatricians participate in Vaccines for Children, but only about 12% of hospitals do, because it has rules that can be onerous in certain settings.

In order to join the program, for example, providers have to agree to carry all vaccines that the program covers. They must also agree to match the vaccines the government gives them with a stock of shots that they buy themselves, and they can’t mix the inventory. This rule was meant to prevent vaccines paid for by the government from going to patients whose insurance would cover the cost.

On Tuesday, the CDC relaxed some of those rules so states can allow hospitals and birthing centers to carry a more limited selection of immunizations, including just the ones that are given to newborns: Beyfortus and hepatitis B vaccines.

The CDC also said doctors who serve only Medicaid-eligible patients don’t have to buy a separate store of vaccines for privately insured kids. And it has dropped the minimum orders for Beyfortus so states can ship out small numbers of doses in areas where demand for the shots may be low.

And doctors can now borrow government doses of Beyfortus to give to paying patients, as long as they replenish the supply within a month or after five doses are borrowed.

These flexibilities will help, O’Leary said, but they won’t eliminate all the barriers that are preventing doctors and hospitals from offering Beyfortus.

In new guidelines about the Vaccines for Children program, the CDC said it recognizes that it may need to do more to help doctors get Beyfortus to their patients.

“CDC is continuing to explore operational policies that can help support these providers and will communicate any changes as soon as possible,” the guidelines say.

Doctors urge patience

For now, doctors are urging parents to be patient.

“It is such a big lift,” Creech said. The goal is to immunize all babies younger than 8 months of age and children with certain risk factors who are younger than age 2, plus the millions of babies yet to be born this season. About 4 million babies are born in the US each year.

“That’s a lot of manufacturing. That’s a lot of distribution. A lot of figuring out who’s going to pay for what and when,” Creech said.

That answer doesn’t sit well with Dr. Sharon Paige, a pediatric cardiologist who lives in the Bay Area. Paige is 37 weeks pregnant and has been hunting for any protection she can get for her baby, a boy who is due any day.

She just missed the window for the new vaccine for people who are pregnant, which is given between 32 and 36 weeks of gestation. The antibodies from that shot protect the baby through the first few months of life.

A few weeks ago, when she called her pediatrician and birthing hospital to ask about Beyfortus, she was told they didn’t have it and didn’t know whether they would get it.

“We know that last year, RSV just hit kids so hard, along with Covid and the flu. And so I just, again, it’s another one of the head scratchers. Like, what is the holdup?” Paige said.

“It’s scary because I know, unfortunately, from my experience on the pediatric wards that RSV can be really dangerous for little babies. It’s really heartbreaking to watch a baby with RSV struggling to catch their breath with a breathing tube down their throat,” she said.

Paige also has a 4-year-old in day care who wears a mask to school to protect her soon-to-arrive baby brother. Paige said she and her husband considered whether they might need to take her out of school for a while just to protect their newborn during the upcoming respiratory virus season but ultimately decided against it.

She says she’s getting bombarded with ads on social media and elsewhere urging her to get the new RSV vaccines for her baby.

“When we hear from public health officials that we should be getting vaccinated … but then we can’t actually go out and get that protection, even if we’re willing to pay for it, It’s just a confusing message, and it’s frustrating,” she said.

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