A huge shock to the system: Doctors warn against changing asthma inhalers in January

Starting Jan. 1, the drug that thousands of patients depend on to breathe will disappear from pharmacy shelves, and doctors worry that patients may delay switching to alternatives and getting insurance.

Manufacturer GSK has announced that it will discontinue the Flovent-branded asthma inhaler and replace it with an authorized generic version that is identical but without the same brand name.

Doctors who treat asthma patients say the approved generic drug works as well as the brand-name drug, but insurance companies don’t seem to cover it as widely. That may mean patients need to obtain new prescriptions and navigate barriers to coverage during peak respiratory virus season.

This medication has been the most commonly used inhaled drug for the past 25 to 30 years, said Dr. Robyn Cohen, a pediatric pulmonologist at Boston Medical Center. It’s what pediatricians are overwhelmingly after when they decide their patient needs daily preventative medication. Its discontinuation will be a huge shock to the system for patients, families and doctors.

Doctors are urging patients to take action now to make sure they have their medication by the new year, and advocacy groups have been trying to get the word out.

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

A big change to Medicaid’s drug program

A GSK spokesperson said the company is making the change as part of its commitment to be 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, respectively, and that it will then stop making the brand-name versions in the U.S. on Jan. 1. , 2024.

He said that authorized generics offer patients in the United States potentially lower-cost options for these medically important products.

But experts who follow the industry both on Wall Street and in academia note that GSK is making the switch just as a change in Medicaid rebates could cause the company to pay large fines for Flovent’s price hikes. for years.

The law change, which will take effect on the first of the year, removes the cap on Medicaid rebates that companies have to pay if they raise drug prices more than inflation.

Flovent Diskus has been on the market since 2000 and Flovent HFA since 2004, and GSK has raised the prices of both products several times since they were launched, Dr. William Feldman, an associate physician in the Division of Pulmonary and Critical Care Medicine at Brigham and Women’s Hospital who is researching asthma drugs, told CNN. These are exactly the kinds of drugs that will be affected by the new policy that removes the cap on Medicaid rebates.

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

But under a provision of the American Rescue Plan Act of 2021, that limit was removed, and starting Jan. 1, 2024, drugs that have been subject to large price increases over time may end up with Medicaid rebates that are greater than their cost, meaning drugs. the companies sold these drugs to Medicaid at a loss.

Apparently, the drug doesn’t want to sell anything in its portfolio at a loss, said Andrew Baum, an analyst who covers shares of GSK and other pharmaceutical companies for financial firm Citi. So it seeks to avoid the effect by one: suspension; two: accepted general.

Baum told CNN that an authorized generic is considered a separate product, but it still allows the pharmacy to collect some of the financial data.

Or to put it another way, it’s the same product without the brand name and also without the historical price increases that would leave the drug vulnerable to such large discounts for Medicaid.

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

Other drug manufacturers have also made changes before the removal of the discount limit on January 1; Insulin manufacturers announced significant price cuts of 70 percent or more this year. Migration analysts estimate they save hundreds of millions of dollars a year.

The mandated generic strategy used by GSK is generally a way to maximize the profitability of that product, said David Amsellem, an industry analyst at investment firm Piper Sandler.

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

GSK priced the authorized generic drug cheaper than the brand name Flovent; for example, one 110-microgram dose of Flovent HFA costs $273.83, about 50% more than the $177.99 wholesale price of its authorized generic equivalent, according to prices the company shared with CNN. The wholesale purchase price is the price before insurance and discounts.

But CVS Caremark, a major pharmacy benefits administrator that determines which drugs are covered by insurance for its members, is recommending another brand, Pulmicort inhaler, over authorized generic versions of Flovent.

In this case, the authorized generic drugs were more expensive than the brand-name drugs, a CVS spokesperson told CNN. He noted that it is based on net prices rather than the wholesale price, which means Pulmicort could be cheaper because its maker, AstraZeneca, pays for better insurance coverage.

The worst possible time of the year

The fact that insurance plans don’t widely cover Flovent’s approved generic drug, said BMCs Cohen, means patients have to get a brand new prescription for a brand different drug in the middle of the worst possible time of year, which is winter respiratory virus season.

Cohen said that for patients with persistent asthma, Flovent has been the most commonly used daily preventive anti-inflammatory medication for decades. It shrinks airway swelling and reduces the body’s exaggerated reactions to triggers that make breathing difficult.

She said that during colds and flu, getting your daily medication becomes even more important.

Influenza, Covid, RSV, all of these viruses that are circulating right now are one of the biggest, if not the biggest, triggers of asthma attacks in children, Cohen said. This leads to children being in the emergency room.

Cohen said he’s concerned that patients and doctors and pharmacists won’t know this change with Flovent is coming, and they need to act now to find options and determine insurance coverage.

For some groups, the options 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 as much data to support their use in treating the condition, said Dr. Erin Syverson, MD. Department of Gastroenterology, Hepatology, and Nutrition, Boston Children’s Hospital.

Because EoE affects the esophagus, patients swallow the drug instead of inhaling it, and it can tame inflammation that can cause pain when swallowing or food getting stuck, requiring procedures to remove it. Syverson said EoE in children can cause frequent vomiting, heartburn, stomach pains and difficulty progressing on solid foods, and Flovent can help keep the condition under control.

“As the phase-out approaches, I’m afraid it’s just going to be another hurdle for this patient population that already has very few drugs available,” Syverson told CNN. I don’t know what January will be like, but I’m worried.

CNN’s Tami Luhby contributed to this report.

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