‘Worst possible time of the year’: Doctors warn about asthma inhaler switch in January

Starting Jan. 1, a drug that thousands of patients rely on for help with breathing will disappear from pharmacy shelves, and doctors worry that could delay patients switching to alternatives and getting them covered by insurance. .

Manufacturer GSK has said it is discontinuing the branded asthma inhaler Flovent, and instead making an “authorized generic” version, which is similar but without the same branding.

Doctors who treat asthma patients say the authorized generic will work just as well as the branded drug, but it appears not to be widely covered by insurers. That could mean patients having to get new prescriptions and navigate coverage barriers at the height of respiratory virus season.

“This drug has been the most commonly used inhaled medication for the last 25 or 30 years,” said Dr. Robin Cohen, a pediatrician at Boston Medical Center. “When pediatricians decide that their patient needs daily preventive medication, this is what happens on a large scale. … The fact that it’s being put off is devastating, for the patients, for the families.” “It’s going to be a big shock to the system for and for doctors.”

Doctors are urging patients to take action now to make sure they get their medicine in the new year, and advocacy groups are trying to spread the word.

But the story of why Flovent is disappearing, and the lack of insurance coverage for its apparently identical replacement, touches on some of the most complex aspects of American health care and drug pricing.

Flovent will no longer be manufactured as of January 1 and a similar generic version will be available.

Martin Shields / Alamy

Major change in Medicaid drug program

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

He said the company introduced authorized generics of Flovent HFA, an inhalation aerosol, and Flovent Diskus, an inhalation powder, in May 2022 and October 2023, and after that, it will stop manufacturing branded versions in the United States on January 1. , 2024.

Authorized generics, he said, “will provide patients in the US with a potentially lower-cost alternative to these medically important products.”

However, industry watchers both on Wall Street and in academia note that GSK is making the changes at exactly the time when changes in Medicaid exemptions could lead to the company paying massive fines because of Flovent in multiple locations. Prices have increased. Of years.

The legal change, which took effect on the first day of the year, 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 increased the price of both products several times since their launch,” said Dr. William Feldman, an associate physician in the Department of Pulmonary and Critical Care Medicine. ” Brigham and Women’s Hospital, which studies asthma drugs, told CNN. “These are exactly the types of drugs that will be affected by the new policy eliminating Medicaid waiver 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 in the 2021 American Rescue Plan Act, that limit was removed, and starting Jan. 1, 2024, drugs that have been subject to large price increases over time can receive Medicaid rebates that reduce their price. is more than – meaning pharmaceutical companies will sell those drugs to Medicaid at a loss.

“Pharma clearly doesn’t want to sell anything in its portfolio at a loss,” said Andrew Baum, an analyst who covers the stocks of GSK and other pharmaceutical companies for financial firm Citi. “So it tries to avoid the impact of, one: dissection; two: authorized normal.”

Baum told CNN that an authorized generic is viewed as a separate product, “but it still enables pharma to collect some economics.”

Or, put another way, it is the same product without the branding and without the history of price increases that would make the drug vulnerable to such a large discount for Medicaid.

The price of branded Flovent has increased nearly 47% since 2014, according to GoodRx data.

Other drugmakers have also made changes ahead of the removal of rebate limits on Jan. 1; This year insulin manufacturers have announced major price cuts of 70% or more on their products, a move that analysts estimate will save them millions of dollars per year.

The authorized generics strategy 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 industry at investment firm Piper Sandler.

There are no other generic versions of Flovent currently approved by the FDA, he said.

GSK priced the authorized generic lower than branded Flovent; For example, a package of Flovent HFA in the 110 microgram dosage costs $273.83, which is about 50% more than the $177.99 bulk acquisition cost of its authorized generic counterpart, according to prices shared by the company with 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, gave preferential placement to another branded inhaler, Pulmicort, on its formulary, rather than authorized generic versions of Flovent. Has been.

“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 to get better insurance coverage.

‘The worst possible time of the year’

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

For patients with persistent asthma, Flovent has been the most commonly 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.

During cold and flu season, it becomes even more important to take daily medication, she said.

“Flu, COVID, RSV — all these viruses that are flying around right now — are one of the biggest, if not the biggest, triggers for asthma attacks in children,” Cohen said. “This is why kids end up in the emergency room.”

Cohen said he’s concerned that patients as well as physicians and pharmacists don’t know this change is coming with Flovent, and they need to act now to work out alternatives and determine insurance coverage. .

Options are more limited for some groups. For patients with a more rare inflammatory condition called eosinophilic esophagitis, Flovent HFA is one of the most commonly prescribed topical steroids, and other medications don’t have as much data to support their use in this condition, says attending physician 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 food getting stuck, requiring procedures to remove. EoE in children can cause frequent vomiting, heartburn, abdominal pain and trouble making progress in starting solids, Siverson said, and Flovent may help keep the condition under control.

“With the possibility of closure, I am concerned that this will become another barrier to this patient population who already have very limited medications available,” Siverson told CNN. “I don’t know what January is going to be like, but I’m worried.”

CNN’s Tammy Luhby contributed to this report.

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