On January 1, pharmaceutical company GlaxoSmithKline (GSK) discontinued Flovent, a popular steroid inhaler that is used to lower the frequency of asthma attacks and other symptoms. The company discontinued production of the branded product in preparation for the rollout of an “authorized generic” version of the widely prescribed medication. The Asthma and Allergy Foundation of America estimates that about 25 million people have asthma in the United States and using inhaled corticosteroids like Flovent are among the most effective treatments for the disease. Here’s what you should know.
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What is Flovent?
Flovent is the brand name of fluticasone, a medication that has been sold since 2020. It is an inhaled corticosteroid that can be used by people four years of age and older for treating asthma long term. Fluticasone helps to keep inflammation in the lungs low and the airways open. It is used twice per day and is not a rescue inhaler. When it is taken every day, it can lower the number and severity of asthma attacks.
GSK first notified the FDA about the decision to stop manufacturing Flovent in June 2023.
Why is there a new ‘authorized generic’ version?
According to a statement from GSK to the Allergy Foundation of America, the generic version of the prescription inhaler will have an identical formula and drug-delivery mechanism. GSK says that this new version will provide lower cost alternatives.
However, this switch from the branded version to a generic one occurs at the same time as the elimination of the rebate cap removal of Medicaid drug prices. This provision was made as part of the American Rescue Plan Act of 2021. Under it, pharmaceutical companies are required to pay states higher Medicaid rebates if they raise the cost of the drug more than inflation. According to GoodRx, Flovent’s average price increased from about $207 in 2013 to $292 in 2018 and has gone up by 47 percent since 2014.
“Flovent Diskus has been on the market since 2000 and Flovent HFA since 2004, and GSK has hiked the price on both products numerous times since their launch,” Dr. William Feldman, an associate physician in the Division of Pulmonary and Critical Care Medicine at Brigham and Women’s Hospital, told CNN. “These are precisely the sort of drugs that will be affected by the new policy eliminating the Medicaid rebate cap.”
Instead of being a typical generic medication that is made by a different company to compete with the original product, the “authorized generic” is made by the same company. GSK can continue to set prices.
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Are doctors concerned?
In late 2023, both the American Academy of Pediatrics and the Asthma and Allergy Foundation of America expressed concern that discontinuing Flovent may leave those who rely on it with higher co-pays and delayed access, as patients have to clear coverage with their insurance company.
“In general, people think generics should be cheaper,” Asthma and Allergy Foundation of America president and CEO Kenny Mendez told NPR. “That’s kind of the common knowledge, but it really depends on… your insurance plan and what’s covered and what’s not.”
Doctors are reporting that some insurers are not covering GSK’s new authorized generic version. Even if insurance authorizes coverage, patients may end up paying more than they would have if they were purchasing the previous branded version of the medication at a pharmacy. Some patients will also need to change asthma drugs or get new prescriptions for GSK’s authorized generic, which adds barriers that could disrupt critical asthma care.
Due to its popularity over the past 24 years, some medical professionals fear it will create a “huge shock to the system” for doctors and those with asthma. Patients are advised to see their doctors as soon as possible to explore alternative medications and see if the new authorized generic version of Flovent is not covered by their insurance.
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