United States: Since January 1, a drug used by many patients that helped them breathe has not been available in pharmacies across the United States. Doctors are showing concerns that patients might have delays in switching to alternatives and getting insurance coverage for them.
As per its manufacturer, GSK is discontinuing the branded version of- the asthma inhaler Flovent, and, in place of that, making an “authorized generic” version, which is identical but without the same branding.
Why are doctors concerned?
According to the doctors who treat patients with asthma, the approved generic will work as well as the branded one, but it doesn’t seem to be covered by most health insurance providers. This means that the patients might need to get new medicine orders and figure out insurance issues during the peak respiratory virus season, CNN Health reported.
Dr Robyn Cohen, a pediatric pulmonologist at Boston Medical Center, said, “This medication has been the most commonly used inhaled medication for the past 25 or 30 years,” and added further, “It’s the one that, overwhelmingly, pediatricians reach for when they decide that their patient needs a daily preventive medication… The fact that it’s being discontinued is going to be a huge shock to the system for patients, for families, and for doctors.”
As per the report by CNN Health, doctors started urging patients to take action in December 2023 so they have their medicines ready for the new year. The advocacy group asked to spread the word so every needy person can take the necessary actions timely.
The reason why Flovent is discontinuing and insurance not covering its supposedly same replacement raises some of America’s most complicated facets of health care and drug pricing.
What is the reason given by manufacturers?
The spokesperson from GSK said that the company is making the change “as part of our commitment to be ambitious for patients,” according to CNN Health report.
She further added that the company introduced the authorized generics of Flovent HFA, an inhalation aerosol, and Flovent Diskus, an inhalation powder, in May 2022 and October 2023, respectively. The company subsequently discontinued manufacturing the branded versions in the United States on January 1, 2024.
According to her, the generic version “will provide patients in the US with potentially lower cost alternatives of these medically important products,” as per the report.
What experts have to say?
Experts who follow the industry both on Wall Street and in academia pointed out that GSK is making the switch during a time when Medicaid rebates could cause the company big penalties because of cost increases on Flovent over several years.
The legal change coming into effect on the first of the year removes a cap on Medicaid rebates that companies are required to pay if they raise the price of medicines more than inflation.
Dr William Feldman, an associate physician in the Division of Pulmonary and Critical Care Medicine at Brigham and Women’s Hospital who studies asthma drugs, told CNN, “Flovent Diskus has been on the market since 2000, and Flovent HFA since 2004, and GSK has hiked the price on both products numerous times since their launch.”
He further added, “These are precisely the sort of drugs that will be affected by the new policy eliminating the Medicaid rebate cap.”
As per CNN Health, until now, the rebates were capped at the total price of the drugs, so manufacturers would never pay more than drug costs back to Medicaid.
However, under a provision in the 2021 American Rescue Plan Act, that limit was taken away. Starting from January 1, 2024, drugs that have seen big price jumps over time could end up incurring rebates to Medicaid that are greater than their price — meaning pharmaceutical companies would sell those drugs to Medicaid at a loss.
Andrew Baum, an analyst who covers the stock of GSK and other pharmaceutical companies for the financial firm Citi, said, “Obviously pharma doesn’t want to be selling at a loss on anything in its portfolio,” and added further, “So it seeks to evade impact by, one: discontinuation; two: authorized generic.”
Baum continued telling CNN that an authorized generic is viewed as a separate product “but still enables pharma to collect some of the economics.”
As per the data from GoodRx, the price of branded Flovent has gone up about 47 percent since 2014.
The drug companies are making changes ahead of the January 1 rebate cap removal as well.
Inconveniences that the asthma patients awaiting
BMC’s Cohen said that the fact that insurance plans aren’t broadly covering the authorized generic of Flovent “means that patients are going to need to get a brand new prescription for a completely different medication in the middle of the worst possible time of year, which is the winter respiratory virus season.”
For those patients with constant asthma, Cohen said, Flovent has been the most used daily preventive anti-inflammatory medication for decades. It even shrinks swelling in the airways and reduces the body’s exaggerated response to triggers that make it hard to breathe.
During cold and flu season, it becomes even more crucial to have that daily medicine, she said, and added further, “Flu, Covid, RSV — all these circulating viruses that are going around right now — are one of the biggest, if not the biggest, triggers for asthma attacks in kids,” Cohen said. “This is what leads to kids being in the emergency room.”
She even expressed her concern that patients, as well as physicians and pharmacists, are not aware of this change, and they need to act now to work out alternatives and determine insurance coverage.
Dr Erin Syverson, an attending physician in the Division of Gastroenterology, Hepatology, and Nutrition at Boston Children’s Hospital, said for certain groups, choices are even fewer. For patients with a rarer inflammatory condition called eosinophilic esophagitis, Flovent HFA is one of the most commonly prescribed topical steroids. And other medicines don’t have as much data supporting their use in the condition, he added further in the CNN Health report.
Syverson said that as Eosinophilic esophagitis (EoE) affects the esophagus, and it can cause inflammation that can cause pain with swallowing or food getting stuck, requiring procedures to remove it.
In kids, EoE can lead to recurrent vomiting, heartburn, belly aches, and trouble making progress starting solid foods, and Flovent can help keep the condition under control, said Syverson.
Adding further, Syverson said, “With the discontinuation coming up, I worry it’s going to just be one more hurdle for this patient population that already has very limited medications available to them,” and “I don’t know what January is going to be like, but I’m worried,” CNN Health reported.