- As of January 1, drug manufacturer GSK has discontinued its Flovent asthma inhaler, and is producing authorized generics in its place.
- The authorized generic, fluticasone, may not be covered by insurance for some.
- There's little risk of people going without asthma medication, experts say, but the switch could cause delays or barriers at the pharmacy.
Some people may be starting 2024 in need of a new asthma medication—the popular inhaler Flovent (fluticasone) is no longer available, as of January 1.
Instead, pharmaceutical company GSK is manufacturing an authorized generic of both the Flovent HFA and Flovent Diskus inhalers. These authorized generic medications are considered “therapeutically equivalent” to the brand name drugs.
Though the actual medication itself isn’t changing, some experts are concerned that GSK’s discontinuation of Flovent could make things a bit complicated for users.
The authorized generic fluticasone “is not listed on many insurance formularies and for those that do include it, it is typically not listed as a preferred medication,” according to the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition.
This means that patients may be asked to switch to a different medication to manage their asthma, or might have to find a workaround to get the authorized generic of Flovent covered.
“Hopefully those insurance plans have made the necessary adjustments [for] patients. Hopefully it’s seamless,” Michael Ganio, PharmD, senior director of pharmacy practice and quality at the American Society of Health-System Pharmacists (ASHP), told Health. “But it doesn't hurt to do a little investigation—log on to the [insurance] plan site, see what's covered.”
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Flovent HFA and Flovent Diskus are inhaled corticosteroids that are approved for use in people ages four and up.
Flovent contains fluticasone, an active ingredient found in a host of asthma inhaler medications, Joanne McKell, MD, assistant professor at the Case Western Reserve University School of Medicine and pulmonary and critical care doctor at the VA Northeast Ohio Healthcare System, told Health.
The Food and Drug Administration (FDA) approved Flovent HFA in 2004 and Flovent Diskus in 2000, and the medication has been used for decades.
“It’s commonly prescribed to patients with certain types of asthma,” said Ganio. “It’s not a rescue inhaler—it’s the kind of medication that’s used regularly, usually twice a day, to control asthma symptoms.”
Typically, generic medications are created by other manufacturers, but the term “authorized generics” applies to products made by the manufacturer that created the brand name drug, Ganio explained. Like Flovent itself, the authorized generic versions are made by GSK.
The company launched the authorized generic of Flovent HFA, the standard asthma inhaler, in May 2022, and the generic alternative of Flovent Diskus in October 2023.
The generics for both medications are available in a range of strengths, and according to a GSK statement, the switch from Flovent to authorized generics “will not have an impact on our ability to supply the market and we expect minimal disruption for patients.”
Additionally, data provided to Health by a GSK spokesperson showed that, before rebates or other discounts, the authorized generics of Flovent are less expensive than the brand-name medications.
As an example, the wholesale acquisition cost of the lowest dose Flovent HFA was 3.83 prior to its discontinuation. In late May, the price for the authorized generic version of that same medication was 7.99.
Currently, the authorized generic ranging in price from 8 to 4 depending on the pharmacy.
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Insurance Issues Could Lead to Higher Costs, Logistical Headaches
Depending on the type of insurance coverage a person has, the discontinuation of Flovent may mean they’re paying more for the generic or have to switch to a different medication brand altogether.
“Most people assume that their insurance would make them pay more for a brand name. But it really comes down to how the contracts are written from the [pharmacy benefit managers],” Ganio said. “There are instances where a brand name product may be the preferred product.”
Insurance companies have a list of preferred medications, which depend on contracts between the drug distributor and the insurance provider—it’s possible that Flovent was on that preferred list, while the authorized generic is not.
This is the case with CVS Caremark—it now has Pulmicort Flexhaler as its preferred medication option rather than Flovent. This is because the authorized generics were more expensive, a CVS spokesman told CNN.
Usually people can switch to a different asthma medication with little difficulty, Ganio said. However, some people may be in a situation where they’ve already tried the preferred medication and know it doesn’t work as well for them.
Flovent is also used off-label to treat eosinophilic esophagitis (EoE)—a chronic immune condition of the esophagus that can lead to difficulty swallowing or vomiting. Because people with this condition swallow the Flovent medication, they won’t be able to switch to “breath-actuated inhalers” that many insurers have as their preferred medications.
In these situations, patients with asthma or EoE need to use the authorized generic of Flovent rather than switching to a different related medication. If that generic isn’t one of their insurance’s preferred medications, they’ll need to get in touch with their provider and ask them to petition the insurance plan to get it covered out of medical necessity, said Ganio.
This could lead to short-term disruptions in care, different medication costs, or other issues.
Additionally, patients could experience issues based on how their prescription is written, McKell explained. Usually, doctors will write "generic accepted" or "generic okay" on a prescription, which means the brand name drug can be swapped out easily, she said.
However, if a person's prescription doesn't have that addendum listed, the pharmacist will have to contact the healthcare provider to fill the prescription, resulting in possible delays, said McKell.
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Why Make This Change in the First Place?
Though he hasn’t seen GSK’s market value over time, Ganio explained that in general, drug manufacturers will often create authorized generics to make medications more economical.
“[If] these drugs are off patent and they’ve been off patent for a while, they will lose a lot of the market share,” he said. “It might not make sense for them to continue making and marketing a brand name product when the market share has gone down.”
However, reporting from GoodRX and NPR show that the price of the Flovent inhaler has risen by about 50% in the past decade. According to NPR, the move to authorized generics could be a way for GSK to start over and avoid any price increase penalties instituted by the American Rescue Plan’s Medicaid Drug Rebate Program.
In a statement, GSK said the discontinuation of Flovent in favor of an authorized generic was “part of our commitment to be ambitious for patients,” and that the company “recognize[s] that patients have a number of options in the therapeutic area and therefore remain committed to ensuring the affordability of our medicines.”
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Tips for Navigating This Switch
Anytime patients have to deal with potentially switching medications or assessing new medication costs, it can be a bit of a hassle. Facing that in early January may be even more of a struggle as people adjust to new insurance plans, Ganio said.
Even if someone’s sticking with the same insurance plan, it could be tricky to determine if they’re paying more for asthma medication due to coverage changes, or simply because their deductible has reset.
Sorting all of these things out ahead of time ensures that Flovent users won’t be “surprised at the pharmacy counter,” said Ganio.
People should first reach out to their insurance plans if they have any questions about switching asthma medications or how that may impact costs, Ganio added. And even though doing this “homework” ahead of time is helpful, pharmacists and even healthcare providers can be good resources, too, he said.
“Just have some patience, and a little bit of research ahead of time goes a long way in preventing those headaches at the pharmacy counter,” said Ganio.
Luckily, it’s unlikely that people will be completely out of options as a result of Flovent’s discontinuation. Similar asthma medications are widely available, and this phasing out has been in the works for months now, he explained.
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