The most common asthma inhaler for children was discontinued at the start of this year, forcing parents and pediatricians to scramble to switch to an alternative.
But more than a month later, the situation has not improved, and families remain caught in the middle of a fight between a drug company and pharmacy benefit managers (PBMs) with no end in sight.
Manufacturer GlaxoSmithKline (GSK) stopped making Flovent on Jan. 1 and is instead offering an “authorized generic” version distributed through a different company. It’s the same drug, just without the branding.
GSK introduced the authorized generic of Flovent HFA in May 2022. It has a lower list price than the brand name, which is what a drug costs before any negotiated discounts.
Yet major PBMs like CVS Caremark, Express Scripts and OptumRx have largely refused to pay for the generic. If they cover it, the drug is listed on a nonpreferred tier so patients will face higher copays.
Despite the lower list price, the PBMs argue it will cost more because of the complicated system of rebates drug companies pay to get their products on preferred coverage lists. Even if a drug’s list price is higher, a manufacturer might pay the PBM higher rebates, so the net price for a health plan could end up being lower.
CVS Caremark is giving preferential placement to Pulmicort instead of the authorized generic versions of Flovent. The PBM said it excluded the generic versions even before Flovent was discontinued “and have no plans to add them at this time.”
OptumRx said it has two “clinically appropriate options” on its preferred list that after rebates, cost health plans 70 percent to 80 percent less than the generic fluticasone.
“The manufacturer and its third-party partner introduced an authorized generic of only the HFA form of Flovent at a much higher net price. This puts profits before patients,” OptumRX said.
Pediatricians say Flovent has been the gold standard for treating asthma in young kids for more than 20 years, so changing patients to something different would be complicated even without the payment hurdle.
“The minute I heard Flovent was going to go off the market I knew it was going to throw the system into chaos,” said Robyn Cohen, a pediatric pulmonologist and director of pediatric asthma program at Boston Medical Center. “The amount of work to get patients to switch was going to be an exorbitant lift … it’s actually been worse than I envisioned.”
Shilpa Patel, an emergency medicine physician at Children’s National Hospital and medical director of the hospital’s IMPACT pediatric asthma clinic, said DC Medicaid stopped covering Flovent last summer, catching patients unaware.
Unable to find time to make an appointment to find a new prescription when they realized it wasn’t covered at the pharmacy, many just stopped taking their medicine and wound up in the emergency room.
Doctors said the steroid in Flovent isn’t better than other drugs, but the delivery is simple enough for the youngest children to use it; some alternatives require patients to breathe in and hold their breath before exhaling and using the inhaler.
In some cases, PBMs force doctors to show other medications have failed first. But those other medications are largely not appropriate for the youngest patients, and failure for an asthma patient can mean hospitalization.
“In a best-case scenario, it takes a few days to get the appropriate inhaler to our patients. In a worst-case scenario, it could not only take weeks, but they’d have to pay for an inhaler that we know won’t work,” said Ben Nelson, a pediatric pulmonologist at Massachusetts General Hospital for Children.
“The bottom line is, we’re all really struggling. And we’re all spending so much time trying to figure out what we can get covered for patients, and finding that in some cases, there might not be any suitable alternatives,” Nelson said.
For instance, Cohen said the best alternative to fluticasone became back ordered within two weeks of Flovent being discontinued and is still difficult to find.
Drug pricing experts say the reason for the dustup between the manufacturer and PBMs speaks to the broader problems in the U.S. health care system and shows the unintended consequences of reform attempts.
GSK’s decision to discontinue Flovent was likely due to a new Biden administration policy change targeting drugs with a history of price hikes.
As of Jan. 1, drug companies must pay extra rebates to Medicaid if they raise the price of medicines more than inflation. Until now, rebates were capped at the total price of a drug, so manufacturers would never pay Medicaid more than a drug costs. But now that the cap is lifted, pharmaceutical companies could sell drugs to Medicaid at a loss.
Instead of potentially taking a loss on Flovent with the Medicaid program, experts said GSK just stopped selling it.
William Feldman, a physician and faculty member at Brigham and Women’s Hospital and Harvard Medical School who researches inhalers, said the Flovent saga is a “perfect storm” of everything that’s wrong with the U.S. pharmaceutical system.
Still, he said there wouldn’t be an issue with PBM coverage if there was more generic competition. GSK’s “authorized” version is the only generic form of Flovent approved by the Food and Drug Administration.
“While I too, believe the PBM is here to serve some blame, I just would encourage all of us to think about how we got into this mess in the first place and the role that GSK played in obtaining patents, doing what they could to block generic competition, raising those prices year over year over year … and then pulling the product from the market,” Feldman said.
But amid the standoff, doctors said patients are being denied the most appropriate asthma medicine in the middle of respiratory virus season.
“This is a very tricky time of year because the respiratory viruses can cause [asthma] flare up and hospitalization. And so it is a particularly bad time of year to be taking people off their medication,” said Christy Sadreameli, a pediatric pulmonologist at Johns Hopkins Hospital.
And on the horizon is spring allergies.
“I would say we probably are not going to be in a better situation until after pollen season is over,” said Boston Medical Center’s Cohen.
