‘Worst possible time of year’: Doctors warn of asthma inhaler replacement coming in January

Starting Jan. 1, a drug that thousands of patients rely on to help them breathe will disappear from pharmacy shelves, and doctors worry that patients may experience delays in transitioning to alternative and cover them with insurance.

Manufacturer GSK said it is discontinuing the branded asthma inhaler Flovent, and is instead producing an “authorised generic” version, which is identical but without the same branding.

Physicians treating asthma patients say the authorized generic will work as well as the branded drug, but insurers don’t appear to be widely covering it. That could mean patients have to get new prescriptions and work around barriers to coverage during peak respiratory virus season.

“This drug has been the most commonly used inhaled drug for the past 25 or 30 years,” said Dr. Robyn Cohen, a pediatric pulmonologist at Boston Medical Center. “This is what pediatricians reach for most when they decide that their patient needs daily preventive medicine. … The fact that this is going to be discontinued will be a huge shock to the system for for patients, for families and for doctors. .”

Doctors are urging patients to act now to make sure they get their medicine for the new year and advocacy groups are working to get the word out.

But the story of why Flovent disappeared, and the lack of insurance coverage for its seemingly identical replacement, touches on some of the most complicated aspects of American health care and drug pricing.

Flovent will be discontinued as of January 1 and there will be an identical generic version.

Martin Shields/Alamy

Major changes to the Medicaid drug program

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

He noted that the company will introduce 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 making the branded versions in the United States in January 1, 2024.

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

However, experts who follow the industry on Wall Street and in academia point out that GSK is making the switch at precisely the time that a change in Medicaid rebates could cause the company to pay large penalties due to increases in Flovent price in a number of years.

A legal change that will take effect early this year removes the cap on Medicaid rebates that companies must 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,” Dr. William Feldman, an associate physician in the Division of Pulmonary and Critical Care Medicine at Brigham and Women’s Hospital who studies asthma medications, to CNN. “These are precisely the types of drugs that will be affected by the new policy that removes the Medicaid rebate cap.”

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

But under a provision in the 2021 American Rescue Plan Act, that limit was lifted, and starting Jan. 1, 2024, drugs that have undergone large price increases over time could have larger Medicaid rebates. than its price – meaning pharmaceutical companies would sell those drugs to Medicaid at a loss.

“Obviously pharma doesn’t want to sell at a loss on anything in its portfolio,” said Andrew Baum, an analyst who covers GSK stock and other pharmaceutical companies for financial firm Citi. “So it seeks to avoid the effect of, one: discontinuation; two: authorized generic.”

An authorized generic, Baum told CNN, is viewed as a separate product, “but still allows pharma to collect some of the economies.”

Or, put another way, it’s the same product with no branding and no history of price increases that would leave the drug vulnerable to such large Medicaid rebates.

According to data from GoodRx, the price of branded Flovent has increased about 47% since 2014.

Other drugmakers made changes before the rebate cap was also lifted on Jan. 1; insulin makers this year announced major price cuts – of 70% or more – on their products, a move analysts estimate will save them hundreds of millions of dollars a year.

The authorized generic strategy used by GSK “is a way, in general, to maximize the profitability of the product in question,” said David Amsellem, a financial analyst who covers the industry at investment firm Piper Sandler.

He noted that there are currently no other FDA-approved generic versions of Flovent.

GSK’s authorized generic is priced lower than branded Flovent; a package of Flovent HFA in a 110 microgram dose, for example, costs $273.83, about 50% more than the $177.99 wholesale acquisition cost of its authorized generic counterpart, according to prices the company shared with CNN. Wholesale acquisition cost is the price before insurance and rebates.

But CVS Caremark, a major pharmacy benefit manager that determines which drugs are covered by insurance for its members, is giving preferred placement to another branded inhaler, Pulmicort, on its formulary, instead. which are the authorized generic versions of Flovent.

“In this case, authorized generics are more expensive than brand-name drugs,” a CVS spokesperson told CNN. He noted that this is based on net prices, rather than the wholesale cost of acquisition, meaning Pulmicort may be cheaper because of rebates paid by its manufacturer, AstraZeneca, to get better coverage. insurance

‘The worst possible time of the year’

The fact that insurance plans don’t broadly cover Flovent’s authorized generic, says BMC’s Cohen, “means that patients will have to get a new prescription for a completely different drug in the middle of the worst possible time. of the year, which is the season of the winter respiratory virus.”

For patients with recurrent asthma, Cohen said, Flovent has been the most commonly used daily preventive anti-inflammatory medication for decades. It reduces inflammation in the airways and reduces the body’s overreaction to triggers that make breathing difficult.

During cold and flu season, he said, having that daily medication becomes even more important.

“Influenza, Covid, RSV – all these circulating viruses that are happening now – are one of the biggest, if not the biggest, triggers for asthma attacks in children,” says said Cohen. “This leads to kids being in the emergency room.”

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

For some groups, the alternatives are more limited. For patients with a rarer inflammatory condition, called eosinophilic esophagitis, Flovent HFA is one of the most commonly prescribed topical steroids, and other drugs don’t have much data to support their use in the condition, says Dr. Erin Syverson, an attendee. physician in the Division of Gastroenterology, Hepatology and Nutrition at Boston Children’s Hospital.

Because EoE affects the esophagus, patients swallow the drug instead of breathing it in, and it can tame inflammation that can cause pain when swallowing or blockage of food, requiring procedures to remove it. In children, Syverson said, EoE can lead to repeated vomiting, heartburn, abdominal pain, and developmental problems when starting solid foods, and Flovent can help keep the condition under control.

“With the upcoming discontinuation, I’m concerned that this is going to be another hurdle for this patient population that already has limited medications available to them,” Syverson told CNN. “I don’t know what will happen in January, but I’m worried.”

CNN’s Tami Luhby contributed to this report.

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