A major shock to the system: 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 has discontinued the branded asthma inhaler Flovent, and is instead producing an authorized generic version, which is identical but without the same branding.

Physicians treating asthma patients say the authorized generic will work just as well as the branded drug, but it doesn’t appear to be covered by a wide range of insurers. 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 the one that, overwhelmingly, pediatricians reach for when they decide their patient needs daily preventative medicine. The fact that it stops will be a huge shock to the system for patients, for families and for doctors.

Doctors are urging patients to act now to make sure they get their medicine in 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.

Major changes to the Medicaids drug program

A spokesperson for GSK said the company is 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, would 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 Womens Hospital who studies asthma medications, to CNN. These are exactly 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 which means pharmaceutical. the companies will sell those drugs to Medicaid at a loss.

Pharma clearly 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: stopping; 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, to put it another way, its 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 based on net prices, rather than wholesale acquisition costs, that means Pulmicort may be cheaper because of rebates its manufacturer, AstraZeneca, pays to get better insurance coverage.

The worst possible time of the year

The fact that insurance plans do not widely cover Flovent’s authorized generic, said BMCs Cohen, means that patients will need to get a new prescription for an entirely different drug in the middle of the worst possible time of 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, Cohen said. This leads to children being in the emergency room.

Cohen said he’s concerned that patients, including 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 do not have much data to support their use in the condition, says by Dr. Erin Syverson, an attending physician in the Division of Gastroenterology, Hepatology and Nutrition at Boston Childrens 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 shutdown, I’m concerned that it’s 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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