CNN
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Starting Jan. 1, the drug thousands of patients rely on to help them breathe will disappear from pharmacy shelves, with doctors warning patients they won't have to switch to alternatives or delay insurance coverage. I'm worried about that.
Manufacturer GSK has announced that it will discontinue its own-brand asthma inhaler Flovent and instead produce a “certified generic” version of the same product without the brand name.
Doctors who treat asthma patients say approved generic drugs are just as effective as brand-name drugs, but insurance companies don't seem to cover them as widely. That could mean patients having to obtain new prescriptions and navigate insurance coverage hurdles in the midst of a respiratory virus outbreak.
“This drug has been the most commonly used inhaler for the past 25 to 30 years,” said Dr. Robin Cohen, a pediatric pulmonologist at Boston Medical Center. “Overwhelmingly, pediatricians reach for this drug when they determine that a patient needs a daily preventive medication. …The fact that it is discontinued is a huge shock to the system for patients, families, and physicians. will give you.”
Doctors are calling on patients to take action now to ensure they have access to medicines in the new year, and advocacy groups are I'm trying to get utter a word.
But the story of why Flovent is disappearing, and why insurance won't cover ostensibly identical replacements, touches on some of the most complex aspects of American health care and drug pricing.
A GSK spokesperson said the company was making the changes “as part of our commitment to being ambitious for patients.”
He said the company will introduce authorized generics of Flovent HFA, an inhaled aerosol, and Flovent Diskus, an inhaled powder, in May 2022 and October 2023, then cease manufacturing the branded versions in the U.S. on January 1. Ta. , 2024.
He said approved generic drugs “will offer U.S. patients the possibility of lower-cost alternatives to these medically important products.”
But experts who follow the industry on both Wall Street and academia say changes in Medicaid rebates could significantly increase the price of Flovent, potentially forcing the company to pay hefty penalties. He points out that GSK is making the switch at exactly that moment. For years.
The law revision will come into effect from the beginning of the year. remove the cap About the Medicaid rebates 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 prices of both products multiple times since their launch.” and Women's Hospital told CNN. “These are exactly the types of drugs that will be affected by the new policy that eliminates Medicaid rebate caps.”
Previously, rebates were capped at the total cost of the drug, meaning manufacturers could never pay Medicaid more than the cost of the drug.
However, under the provisions of the American Rescue Plan Act of 2021, that restriction was lifted and, starting January 1, 2024, drugs that were subject to significant price increases over time will eventually receive more Medicaid coverage than they cost. Rebates may occur. Pharmaceutical companies would sell those drugs to Medicaid at a loss.
“It's clear that drug companies don't want to sell anything in their portfolio at a loss,” said Andrew Baum, an analyst at financial firm Citi who covers GSK and other drug company stocks. Stated. “Therefore, we are trying to avoid the impact by: 1: Discontinuation. 2:” 2: Authorized generics. ”
Baum told CNN that although approved generics are considered separate products, “pharmaceutical companies can still collect some of the economics.”
Or, to put it another way, it is the same product that is not branded and does not have the history of price increases that would make the drug vulnerable to such large rebates to Medicaid.
according to Data from GoodRxbrand Flovent's prices have increased by about 47% since 2014.
Other drug companies also made changes ahead of the Jan. 1 removal of the rebate cap. Insulin makers have announced deep price cuts of more than 70% on their products this year, which analysts estimate will save hundreds of millions of dollars a year.
David Amselem, a financial analyst who covers the industry at investment firm Piper Sandler, said GSK's authorized generics strategy is “broadly speaking a way to maximize the profitability of the product.” said.
He said there is currently no other generic version of Flovent approved by the FDA.
GSK has priced its approved generic drug lower than the branded Flovent. For example, one package (110 microgram dose) of Flovent HFA costs $273.83, about 50% more than the wholesale purchase cost of the approved generic version of $177.99, according to prices the company shared with CNN. Wholesale acquisition costs are before insurance and rebates.
However, CVS Caremark, a large pharmacy benefits management company that determines which medications are covered for its members, prioritized listing another brand of inhaler, Pulmicort, on prescriptions instead of the approved generic version, Flovent. ing.
“In this case, the approved generic drug was more expensive than the brand name drug,” a CVS spokesperson told CNN. He said this is based on net price rather than wholesale acquisition costs, and that the price of Pulmicort could be lower because of rebates that Pulmicort's manufacturer, AstraZeneca, pays to get better insurance coverage. It pointed out.
BMC's Cohen said the fact that insurance plans do not broadly cover the approved generic version of Flovent means that “patients will have to receive a new prescription for an entirely different drug at the worst possible time of the year.” It means that.” Winter is the season for respiratory viruses. ”
For patients with persistent asthma, Flovent has been most commonly used as a daily preventive anti-inflammatory medication for decades, Cohen said. It reduces swelling in the airways and reduces the body's overreaction to triggers that cause breathing difficulties.
She said taking your medication every day is even more important during cold and flu season.
“Influenza, COVID-19, respiratory syncytial virus, all these viruses that are circulating right now are one of, if not the biggest, triggers for asthma attacks in children,” Cohen said. “This is what's sending kids to the emergency room.”
Cohen is concerned that patients, as well as doctors and pharmacists, are unaware that this change is coming to Flobent, and they need to act now to come up with alternative drugs and determine insurance coverage. He said there is.
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Some groups have even more limited choices. For patients with a rarer inflammatory disease called eosinophilic esophagitis, Flovent HFA is one of the most commonly prescribed topical steroids, and other drugs have no data supporting their use in this disease. There aren't that many, said Dr. Erin Cyberson, the attending physician. Physician in the gastroenterology, hepatology, and nutrition departments at Boston Children's Hospital.
Because EoE affects the esophagus, patients can swallow the medication instead of inhaling it to reduce inflammation that causes pain when swallowing and food blockage, which requires an elimination procedure. In children, EoE can cause symptoms such as vomiting, heartburn, repeated abdominal pain, and slow progress on solid foods, and Flovent can help control symptoms, Cyberson said. .
“I'm worried that as we approach discontinuation, it will create an additional hurdle for this patient population who already have very limited access to drugs,” Cyberson told CNN. “I don't know what January will be like, but I'm worried.”
CNN's Tami Luhby contributed to this report.
