Doctors Express ‘Huge Shock’ as Manufacturer Pulls Popular Asthma Inhalers From Market

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GSK plans to sell generic versions of the inhalers, but many are still worried about insurance coverage for alternatives.

Biopharma corporation GSK (formerly GlaxoSmithKline) will cease the manufacture and sale of two extremely popular branded asthma inhalers beginning next year in favor of producing generic versions, triggering concerns about insurance coverage and product access.

Effective Jan. 1, GSK will discontinue its asthma inhaler Flovent HFA and inhalation powder Flovent Diskus. Instead, the company will be offering generic versions of these products at a lower cost. The generic version of Flovent HFA was launched in May 2022.

Discontinuation of Flovent HFA has raised concerns among medical experts as this is happening amid the respiratory virus season. Many insurers may not provide coverage for the generic version of the product.

“This medication has been the most commonly used inhaled medication for the past 25 or 30 years,” Dr. Robyn Cohen, a pediatric pulmonologist at Boston Medical Center, told CNN.

“It’s the one that, overwhelmingly, pediatricians reach for when they decide that their patient needs a daily preventive medication. … The fact that it’s being discontinued is going to be a huge shock to the system for patients, for families, and for doctors.”

Insurance Complications

Since insurance plans largely do not cover the authorized generic equivalent of Flovent, patients may now have to get a new prescription for a different medication in the middle of the winter respiratory virus season.

As such, the Flovent discontinuation is happening at the “worst possible time of the year,” Dr. Cohen said.

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“Flu, Covid, RSV—all these circulating viruses that are going around right now—are one of the biggest, if not the biggest, triggers for asthma attacks in kids. … This is what leads to kids being in the emergency room.”

Dr. Cohen is concerned that many patients, physicians, and pharmacists are not aware of the discontinuation of Flovent and that they will have to work out alternatives for the medication.

The American Academy of Pediatrics (AAP) reported that various insurance providers are handling the discontinuation of Flovent in different ways. Some companies won’t cover the generic or don’t consider it a preferred alternative to the branded medications.

Blue Cross Blue Shield of Illinois notified patients that only Arnuity, Qvar, and Asmanex would be considered preferred alternatives to Flovent, according to AAP.

However, Arnuity and Qvar are not appropriate for children, Dr. Christopher M. Oermann, a member of the AAP Section on Pediatric Pulmonology and Sleep Medicine Executive Committee, pointed out.

Even if a preferred alternative is covered by insurers, switching thousands of children to the new medication would be a challenge, he stated.

“There are lots of children that are hospitalized every day in the United States with asthma exacerbations, and there are kids that die every year in the United States as a result of severe asthma exacerbations,“ Dr. Oermann said. “If those kids that are poorly controlled don’t have access to preventive inhalers, some of those kids could die.”

Price Increases

The discontinuation of Flovent comes at a time when a major change to Medicaid rebates is set to take effect on Jan. 1. Under existing rules, companies that raise the price of their drugs at a rate higher than inflation are required to pay rebates for such items, CNN reported.

These rebates used to be limited to the total price of a drug, so drug manufacturers never had to pay a rebate that was higher than the drug price. However, the new rule removes this limit.

As such, beginning Jan. 1, manufacturers that made large increases in drug prices in recent years could be forced to pay rebates that are higher than their retail prices, thus incurring losses on these items.

Producing generic versions allows drug manufacturers to avoid such a situation. Generic versions are seen as new, separate products that do not have the burden of past price increases of the branded item.

According to data from health care company GoodRX, the price of the Flovent Diskus inhaler jumped from $173.91 in 2014 to $264.26 in 2023, an increase of more than 51 percent. The price of the Flovent HFA inhaler jumped from $226.88 in 2014 to $337.77 in 2023, an increase of 49 percent.
In December, GSK also agreed to delist some of its patents related to Flovent from the U.S. Food and Drug Administration’s Orange Book registry, thus preparing for the approval of more generic versions of the product, Bloomberg reported. The delisting came after the FDA said the patents weren’t valid.
The Asthma and Allergy Foundation of America (AAFA) recommended that individuals who use Flovent should refill their prescriptions as soon as possible before supplies run out. Flovent will be available to order until Dec. 31. GSK is expecting its supply of the drugs to end by early 2024.

AAFA also advised people to quickly consult with their insurance company to find out which asthma medications are covered under their plans.

In a statement to AAFA, GSK said that “the transition from branded to authorized generics will not have an impact on our ability to supply the market and we expect minimal disruption for patients. … The authorized generic may potentially be a lower cost alternative to patients, depending on their insurance coverage and benefit design.”

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