Discontinuation of popular asthma medication, Flovent, linked with increased hospitalization

After many trips to the doctor's office, five-year-old Burton Hayes's asthma was finally under control with a medication named Flovent.

Then his mother, Alia Hayes, got some bad news. The manufacturer, GSK, was going to stop manufacturing the brand-name medication in 2024.

An asthmatic herself, Hayes understood the importance of being on the right medication. She called Burton's pulmonologist, and switched to another medication.

"My son immediately started showing more signs of illnesses," Hayes told ABC News.

"After that, [I] had to pick him up from school cause he was coughing so hard that he couldn't catch his breath," she said. "It was just a really difficult time for him."

Burton was not alone. Data from over 3 million people who had been using Flovent showed a 17.5% increase in asthma-related hospitalization in the three months after Flovent was discontinued, and a 24.1% increase in the following three to six months.

ICU admissions for asthma in those previously using Flovent increased 17.4% three months after discontinuation, and 23.1% three to six months after discontinuation.

The data included children and adults. It was analyzed by two teams at EPIC Research, who came to similar conclusions. These findings have not gone through the usual peer-review process.

"We're putting kids back in the emergency rooms," said Hayes about the impact of discontinuing Flovent.

"Flovent was by far the most commonly prescribed asthma controller medication for decades," Dr. Robyn Cohen told ABC News. Cohen is a pediatric pulmonologist and director of Boston Medical Center's Pediatric Asthma Program.

"Every pediatrician in America knew about Flovent, knew how to prescribe Flovent," said Cohen. "It had been one of the few inhalers that children could use with this age appropriate spacer device."

Part of Flovent's popularity had to do with the ease of use. The inhaler could be quickly attached to a plastic tube, called a spacer, which children could use with little effort. Alternative medications can be much harder to use, sometimes requiring young children to suction up fine powder from a disk.

Despite Flovent's popularity with doctors and patients, GSK decided to stop manufacturing the brand name version in 2024.

GSK, along with several other drug manufacturing companies, had received a warning letter from the Federal Trade Commission in late 2023. The FTC believed Flovent's patent was "improperly or inaccurately listed," and this could "delay lower-cost generic drug competition."

In addition, regulatory changes from the American Rescue Plan Act went into effect on Jan. 1, 2024, that provided a potential financial disincentive for brand-name drug manufacturers.

As a result, GSK switched to manufacturing an authorized generic version of Flovent. The generic is called fluticasone propionate.

GSK did not immediately respond to ABC News' request for comment.

The authorized generic version contains the same medication and is just as easy to use as Flovent, but without the fancy name or packaging.

The FTC and others argued that generic medications save the consumer money. That was not widely true in the case of fluticasone propionate.

"The de facto result on the ground," said Cohen, "was that the generic alternative was actually more expensive than the previous brand was."

"We were either finding that patients couldn't get access to it at all, or we're being asked to pay $100, $150, a $200 co- pay for a medication that only had a 30 day supply," said Cohen.

Drug pricing is "extraordinarily complicated and opaque," said Erin Fox, the associate chief pharmacy officer at University of Utah Health. Some of this complexity is due to middlemen called pharmacy benefit managers, or PBMs. These middlemen interact with insurance companies and drug manufacturers, but there is little publicly available data about their role in drug pricing.

"In some cases, your [insurance] formulary may actually prefer a branded product over a generic because the PBM is getting a rebate from the branded company and not the generic product," said Fox.

"It's [a] pretty unsustainable model that that we have," said Fox.

Hayes tried other medications approved by her insurance, but nothing seemed to work as well as Flovent. Then, she learned about the authorized generic for Flovent.

However, the authorized generic was not covered by her insurance. Burton's pulmonologist would have to submit a prior authorization to the insurance company, asking them to pay for the medication.

Hayes was shocked. Initially, she was told she could not get Flovent. Now she knew that Burton could have been on the authorized generic all along. She felt that her insurance company was "just cheating the consumer out of understanding really what was happening and it was very frustrating."

Soon after this, Hayes coordinated with Burton's pulmonologist, and Burton was on fluticasone propionate. "He is doing awesome," Hayes said. "He's back to his normal self being able to run and play and not gasping for air."

While Burton was able to get prior authorization, others may not be so lucky. Insurance companies have recently limited the asthma medications they cover, said Cohen.

"The combination of Flovent going off the market and the increasingly restrictive formularies from payers has just made caring for asthma in 2024 much more of a challenge than in previous years," said Cohen.

"We should be able to be doing an amazing job for patients with asthma, and the system is really getting in the way," she said.

Sejal Parekh, M.D., is a board-certified, practicing pediatrician and a member of the ABC News Medical Unit.