GSK is discontinuing the corticosteroid inhaler Flovent HFA (fluticasone propionate inhalation aerosol) on Dec. 31, and some payers aren’t covering the generic version, causing concern among pediatric clinicians who have few alternatives.
The discontinuation exacerbates a larger issue in which some insurers include only breath-actuated inhalers on their formulary, which experts say aren’t appropriate for children with eosinophilic esophagitis (EoE) and may be challenging to use for younger children with asthma.
Pulmonologists and gastroenterologists alike are sounding the alarm and calling on insurers to cover appropriate treatments for their patients.
“Please reassess your formulary. It’s important that you include fluticasone HFA as a preferred medication because of these significant at-risk patient populations,” said Erin P. Syverson, M.D., FAAP, a member of the AAP Section on Gastroenterology, Hepatology and Nutrition.
Flovent use in asthma patients
Flovent HFA is a popular inhaler for children with asthma, one of the most common chronic diseases among children and a leading cause of school absences.
GSK partnered with Prasco to launch a generic version in May 2022, and neither the company nor the Food and Drug Administration expect shortages of the generic.
“The authorized generic (of Flovent) may potentially be a lower cost alternative to patients, depending on their insurance coverage and benefit design,” a GSK spokesperson said.
However, some insurers are not covering the generic and others don’t consider it a preferred treatment, which can lead to higher copays and the need for prior authorizations that delay access.
Each insurer is handling discontinuation of Flovent in its own way. For example, Blue Cross Blue Shield of Illinois sent some patients a letter saying Arnuity, Qvar and Asmanex are the preferred alternatives.
Arnuity and Qvar, however, are not appropriate for children, said Christopher M. Oermann, M.D., FAAP, a member of the AAP Section on Pediatric Pulmonology and Sleep Medicine Executive Committee. Arnuity is a dry powder inhaler that requires high air flow velocities as well as good hand-eye coordination. Qvar is a breath-actuated device with similar issues.
“In order to get the medication to be dispensed, you have to generate large (air) flows that kids aren’t capable of doing, particularly if they use a spacer, which we recommend for all kids to improve drug deposition,” Dr. Oermann said of Qvar.
Dr. Oermann, director of the Division of Allergy, Immunology, Pulmonary and Sleep Medicine at Children’s Mercy Kansas City, said he expects many clinicians will transition asthma patients to generic fluticasone HFA or Asmanex.
“The question is which insurance companies are going to prefer (fluticasone HFA) vs. Asmanex vs. trying to force us to use something else,” he said.
Even if a preferred option is covered, Dr. Oermann said it will be a large undertaking to transition thousands of children. As with EoE patients, ensuring children with asthma have access to medications is crucial.
“There are lots of children that are hospitalized every day in the United States with asthma exacerbations, and there are kids that die every year in the United States as a result of severe asthma exacerbations,” Dr. Oermann said. “If those kids that are poorly controlled don’t have access to preventive inhalers, some of those kids could die.”
Flovent use in EoE patients
While Flovent HFA is primarily an asthma medication, it also is used off-label for EoE, a chronic allergic inflammatory condition in the esophagus. It is the most common treatment for children with EoE and is administered by swallowing the aerosolized medication. Few good alternatives are available, according to Dr. Syverson, associate director of the Eosinophilic Gastrointestinal Disease Program at Boston Children’s Hospital.
The breath-actuated inhalers some insurers are transitioning to as the preferred inhaled steroid formula aren’t appropriate for EoE patients who need to swallow the medication.
“It truly doesn’t work,” Dr. Syverson said. “But I think it’s lost on insurance because although they are the standard of care, Flovent and swallowed topical steroids are not technically FDA approved for EoE.”
The North American Society For Pediatric Gastroenterology, Hepatology & Nutrition (NASPGHAN) has released guidance for clinicians. The group recommends using generic fluticasone HFA. If insurers deny covering the generic, alternative options are oral viscous budesonide and swallowed topical Asmanex HFA or Alvesco HFA.
Dr. Syverson, who is a member of NASPGHAN, said these alternatives have limitations. Budesonide has to be mixed at home and is less palatable. Data are limited on Asmanex and Alvesco for EoE patients. Another alternative not addressed in the guidance is dupilumab (Dupixent), which Dr. Syverson said is significantly more expensive and may not be appropriate for some pediatric patients.
Switching medications could mean delays due to the need for prior authorization, and children may have to undergo additional endoscopies and therefore additional exposure to anesthesia. If patients can’t access an appropriate treatment, they can end up needing emergency care, endoscopic procedures and more expensive alternative medications.
“Because EoE is a progressive, life-long disease, lack of access to effective medications puts our patients with EoE at risk of disease relapse and return in symptoms that can negatively impact their long-term health and quality of life,” Dr. Syverson said.
Steps for pediatric clinicians, families
Dr. Syverson said families who need a Flovent refill may want to refill the prescription before the end of the year.
Dr. Oermann has been talking to patients about potentially needing to switch inhalers and recommends other clinicians do the same. He also suggested parents talk to their insurance company about what will be covered.
“It’s best to think about it now,” Dr. Oermann said, “not wait until it actually happens and then scramble to figure it out.”