Why and when will the asthma inhaler Flovent go off the market?

(CNN) — A drug that helps thousands of patients breathe will disappear from pharmacies on Jan. 1, and doctors fear patients may have trouble switching to alternatives and getting insurance to cover their costs.

Manufacturer GSK has announced it will stop selling the Flovent asthma inhaler and will instead produce an “approved generic” version that is identical but without the same branding.

Doctors who treat asthma patients say the approved generic will work just as well as the brand-name drug, but insurers don’t seem to cover it as well. This could mean patients will have to fill new prescriptions and jump through insurance coverage hurdles during the peak respiratory virus season.

“This drug has been the most widely used inhaled drug for the last 25 to 30 years,” says Dr. Robin Cohen, a pediatric pulmonologist at Boston Medical Center. “This is the method that the vast majority of pediatricians choose when they decide that their patient needs daily preventative treatment… The fact that it would be discontinued would be a huge blow to the system, both for patients and for their families and providers care. “doctors”.

Doctors are urging patients to take action now to secure their medications for the new year, and patient advocacy groups have tried to spread the word.

But the story of Flovent’s demise and the lack of coverage for its seemingly identical replacement touches on some of the most thorny aspects of health care and drug prices in the United States.

Major Changes to the Medicaid Drug Program

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

It noted that the company will introduce authorized generic versions of Flovent HFA, an inhalation aerosol, and Flovent Diskus, an inhalation powder, in May 2022 and October 2023, and will then cease production of generic versions in the United States on January 1. 2024.

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

However, experts who follow the industry both on Wall Street and in academia note that GSK is making the changes at a time when changes in Medicaid reimbursement could leave the company paying large penalties due to increased prices for Flovent over several years.

The legislative change, which takes effect Jan. 1, 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 repeatedly raised prices on both products since their launch,” said Dr. William Feldman, attending physician, Pulmonary and Pediatric Medicine. CNN: The intensive care unit at Brigham and Women’s Hospital is studying asthma drugs. “These are exactly the types of drugs that will be impacted by the new policy that removes the cap on Medicaid reimbursement.”

Until now, rebates were limited to the total cost of the drug, so manufacturers never paid Medicaid more than the cost of the drug.

But under provisions of the American Rescue Plan Act of 2021, that restriction was lifted, and starting January 1, 2024, drugs whose prices have increased significantly over time may end up attracting Medicaid rebates that exceed their price. This means that pharmaceutical companies will sell these drugs to Medicaid at a loss.

“Obviously, drug companies don’t want to sell any of their portfolio at a loss,” says Andrew Baum, an analyst of GSK and other pharmaceutical companies at financial services firm Citi. “So it is trying to avoid exposure through one: discontinuation of use and two: an authorized generic.”

An authorized generic drug, Baum told CNN, is treated as a separate product, “but still allows the drug maker to share in the profits.”

Or, in other words, 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 rebates.

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

Other drugmakers have also made changes ahead of the removal of the reimbursement cap on Jan. 1. Insulin manufacturers this year announced significant price cuts for their products by 70% or more. Analysts estimate the move will save them hundreds of millions of dollars a year.

GSK’s authorized generics strategy “is broadly a way to maximize the profitability of the product in question,” said David Amsellem, a financial analyst covering the sector at investment firm Piper Sandler.

Amsellem noted that there are currently no other FDA-approved generics of Flovent.

For example, a 110 mcg package of Flovent HFA costs $273.83, which is about 50% more than the $177.99 wholesale cost of purchasing its authorized generic equivalent, based on prices the company told CNN. Wholesale purchase price is the price excluding insurance and discounts.

But CVS Caremark, a large pharmacy benefit manager that determines what drugs are covered by insurance for its members, is giving preference on its formulary to another brand-name inhaler, Pulmicort, over the approved generic Flovent.

“In this case, the authorized generic drugs were more expensive than the brand-name drugs,” a CVS spokesperson told CNN. He noted that the price is based on net prices and not wholesale acquisition costs. That means Pulmicort may be cheaper because of the discounts its manufacturer, AstraZeneca, pays for better insurance coverage.

“The Worst Time of the Year”

The fact that insurance plans don’t widely cover the authorized generic Flovent “means patients will have to fill a new prescription for a completely different drug in the middle of the worst time of the year,” BMC’s Cohen said. winter season of respiratory viruses.”

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 overreaction to triggers that make breathing difficult.

During cold and flu season, taking your medications daily is even more important, he said.

“Flu, Covid, respiratory syncytial virus—all of these viruses that are circulating now are some of the leading, if not the leading, triggers of asthma attacks in children,” 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 unaware of this change to Flovent and need to act now to find alternatives and determine insurance coverage.

For some groups, alternatives are more limited. “For patients with a rarer inflammatory disease called eosinophilic esophagitis (EoE), Flovent HFA is one of the most commonly prescribed topical steroids, and other medications do not have much data to support their use in this condition,” said Dr. Erin Siverson, attending physician. in the Department of Gastroenterology, Hepatology and Nutrition at Boston Children’s Hospital.

Because EoE affects the esophagus, patients swallow the medication rather than inhale it, and it can control inflammation that can cause pain when swallowing or food getting stuck, requiring procedures to remove it. In children, EoE can cause recurrent vomiting, heartburn and stomach pain, as well as difficulty eating solid foods, Syverson says.

“I’m concerned that stopping treatment will be another barrier for patients who already have a very limited supply of medications,” Syverson told CNN. “I don’t know what January will be like, but I’m worried.”

— CNN’s Tami Luhby contributed to this report.