Why and when will Flovent Asthma Inhaler be discontinued from the market?

(CNN) — Starting Jan. 1, a drug that helps thousands of patients breathe will disappear from pharmacies, and doctors worry that patients may have trouble switching to alternatives and getting insurance to cover them.

Manufacturer GSK announced that it would stop marketing the Flovent asthma inhaler and instead manufacture an “authorized generic” version, which would be similar but without the same brand name.

Doctors who treat asthma patients say the authorized generic will work just as well as the brand-name drug, but it seems insurers don’t cover it as well. That could mean patients will have to fill new prescriptions and deal with coverage barriers amid respiratory virus season.

“This medication has been the most commonly used inhaled medication over the last 25 to 30 years,” says Dr. Robin Cohen, a pediatrician at Boston Medical Center. “This is the one that, for the vast majority, pediatricians choose when they decide that their patient needs daily preventive medication…The fact that it has been discontinued is a huge relief to patients and families.” “And it would be a huge shock to the system for both doctors.”

Doctors are urging patients to take action now to make sure they get their medications for the new year, and patient rights groups have tried to spread the word.

But the story of Flovent’s death and the lack of coverage for its seemingly identical replacement affects some of the most complex aspects of American health care and drug pricing.

Major changes in Medicaid drug program

A GSK spokesperson said the company was making the change “as part of our commitment to being ambitious for patients.”

It said the company introduced authorized generics of Flovent HFA, an inhalation aerosol, and Flovent Diskus, an inhalation powder, in May 2022 and October 2023, respectively, and would subsequently stop manufacturing off-patent versions in the United States. On January 1, 2024.

Authorized generics, he said, “will provide patients in the US with potentially cheaper alternatives to these medically important products.”

However, experts who track the industry both on Wall Street and in academia say GSK is making this change just at a time when the company could face large fines for increasing the price of Flovent over several years due to changes in Medicaid reimbursement. May have to pay.

The legal change, which took effect Jan. 1, removes the cap on Medicaid rebates that companies are required to pay if they raise drug prices above inflation.

“Flovent Diskus has been on the market since 2000 and Flovent HFA since 2004, and GSK has raised the price of both products several times since their launch,” said Dr. William Feldman, attending physician in the Department of Pulmonary and Pediatric Medicine. CNN. Critical care at Brigham and Women’s Hospital is studying asthma drugs. “These are exactly the types of drugs that will be affected by the new policy eliminating Medicaid reimbursement limits.”

Until now, rebates were capped at the total price of the drug, so manufacturers would never pay Medicaid more than the drug’s price.

But under a provision of the American Rescue Plan Act of 2021, that limit was removed, and starting Jan. 1, 2024, drugs that have seen large price increases over time can get Medicaid rebates that cover their price. More than. , which means pharmaceutical companies will sell those drugs to Medicaid at a loss.

“Obviously, pharmaceutical companies don’t want to sell anything in their portfolio at a loss,” says Andrew Baum, an analyst of GSK and other pharmaceutical companies for the financial firm Citi. “So it tries to avoid the impact of, one: discontinuation and two: authorized generics.”

Baum told CNN that an authorized generic is viewed as a separate product, “but still allows the drug maker to get some profitability.”

Or, put another way, it’s the same product without the brand name and without the history of price increases that would make the drug vulnerable to those big Medicaid discounts.

According to data from GoodRx, the price of the Flovent brand has increased by approximately 47% since 2014.

Other drugmakers also have made changes ahead of the Jan. 1 removal of the reimbursement limits. Insulin manufacturers announced major price cuts of 70% or more on their products this year, with analysts estimating the move will save them hundreds of millions of dollars per year.

The authorized generics strategy that GSK is using is “broadly speaking, a way to maximize the profitability of the product in question,” said David Amselm, a financial analyst who covers the sector at investment firm Piper Sandler.

Amselm noted that there are no other generic versions of Flovent currently approved by the FDA.

For example, a container of Flovent HFA at the 110 microgram dosage costs US$273.83, approximately 50% more than the wholesale acquisition cost of US$177.99 for its authorized generic counterpart, based on prices provided by the company to CNN. . Wholesale acquisition cost is the price before insurance and discounts.

But CVS Caremark, a major pharmacy benefits manager that determines which drugs are covered by insurance for its members, preferred another brand-name inhaler, Pulmicort, on its formulary, rather than authorized generic versions of Flovent. Giving placement.

“In this case, the authorized generic drugs were more expensive than the brand-name drugs,” a CVS spokesperson told CNN. He said this is based on net prices rather than wholesale acquisition costs, meaning Pulmicort may be less expensive because its manufacturer, AstraZeneca, pays rebates for better insurance coverage.

“The worst time of the year”

The fact that insurance plans are not widely covering Flovent’s authorized generic, BMC’s Cohen said, “means that patients may have to pay for an entirely different drug in the middle of the worst time of the year.” Gotta get a new prescription.”, which is winter respiratory virus season.”

For patients with persistent asthma, Flovent has been the most widely used daily preventive anti-inflammatory drug for decades, Cohen said. It reduces inflammation in the airways and reduces the body’s exaggerated response to triggers that cause breathing difficulties.

He says during cold and flu season, taking medication daily is even more important.

“Influenza, COVID, respiratory syncytial virus, all these viruses that are circulating right now, are one of the main triggers of asthma attacks in children, if not the main one,” Cohen explains. “This is what brings kids to the emergency room.”

Cohen said he is concerned that patients, as well as doctors and pharmacists, are not aware of this change to Flovent, and need to act now to find alternatives and determine insurance coverage.

Options are more limited for some groups. For patients with a rare inflammatory disease called eosinophilic esophagitis (EoE), Flovent HFA is one of the most commonly prescribed topical steroids, and other drugs don’t have as much data to support their use in the disease, attending Dr. Erin Siverson said. Physician in the Department of Gastroenterology, Hepatology and Nutrition at Boston Children’s Hospital.

Because EoE affects the esophagus, patients swallow the medication instead of breathing it in, and this can control inflammation that can cause pain when swallowing or cause food to become trapped, requiring procedures to remove. According to Siverson, EoE in children can cause frequent vomiting, heartburn and stomach pain, and difficulty starting solid foods.

“I worry that stopping treatment is going to be another barrier to a patient population that already has very limited access to medications,” Siverson told CNN. “I don’t know what January will be like, but I’m worried.”

—CNN’s Tammy Luhby contributed to this report.