Kerry Pearl recalls the moment when the pharmacist displayed the medication vital for her 4-year-old son's breathing assistance.
"He was literally showcasing it, staring at me with a look that said, 'I can't provide this,'" she remembers. "My poor child is at home, unable to sleep through the night, waking up coughing, and you're holding the solution while the insurance company holds the power."
The medication in question was fluticasone, known as Flovent. It's a daily necessity for the youngest asthma patients, preventing their airways from swelling to the point where common triggers like viruses, cold air, or pollen could induce an asthma attack.
Before Pearl's son began using it as a toddler, she recounts how he would cough incessantly throughout the night and sometimes struggle to breathe while speaking. With the medication, however, his asthma was finally manageable.
But in January, the manufacturer of Flovent, British pharmaceutical giant GSK, withdrew the branded drug from the US market. Its replacement, an authorized generic identical in composition but lacking the brand name, doesn't enjoy the same insurance coverage. Without it, the monthly cost skyrockets to hundreds of dollars, leaving families like Pearl's in a state of panic.
Asthma medications are notoriously expensive, prompting the Senate health committee, led by Sen. Bernie Sanders, to launch an investigation into the matter in January.
Following the inquiry, three major manufacturers of asthma inhalers, including GSK, pledged to cap out-of-pocket expenses for certain US patients at $35.
However, as doctors and parents informed CNN, these commitments do not extend to the daily inhalers crucial for the youngest asthma sufferers.
"While the strides made with the out-of-pocket caps are commendable and offer a sense of hope, children are still unable to access preventive asthma inhalers," explained Dr. Robyn Cohen, a pediatric pulmonologist at Boston Medical Center.
This predicament places children at risk of asthma exacerbations and trips to the emergency room.
Asthma drugs for the littlest kids
Cohen elaborated that there are three inhalers suitable for the youngest asthma sufferers. Known as metered-dose inhalers, they are utilized alongside a spacer device, which essentially functions as a face mask connected to the dispenser. This setup facilitates aerosol administration, allowing young children to simply inhale the medication.
"A child just needs to breathe through the face mask, ensuring they receive the medication," Cohen explained. She noted that alternative devices in this category necessitate the patient to initiate a forceful inhalation and hold their breath for 10 seconds afterward.
This process is not feasible for toddlers and young children to learn.
Since GSK withdrew branded Flovent from the market earlier this year, the remaining three options have become increasingly pricey and scarce.
The authorized generic version of Flovent, manufactured by Prasco Laboratories, falls outside GSK's pledge to cap monthly out-of-pocket expenses at $35 for all asthma and COPD products, as it is a different company's product.
However, the generic version lacks the extensive insurance coverage enjoyed by branded Flovent, likely due to the absence of manufacturer rebates that lowered its net cost. Pharmacy benefit managers, responsible for insurance coverage decisions, informed CNN that the authorized generic was costlier than the branded version.
Doctors such as Cohen and Christy Sadreameli, a pediatric pulmonologist at Johns Hopkins, foresaw this issue last year. One proposed solution was transitioning children to an alternative option, Asmanex, but this drug has now fallen into shortage.
"It was much more severe than anticipated," Sadreameli expressed to CNN. "I have very limited resources for this demographic."
The third inhaler in this category, Alvesco, also lacks comprehensive insurance coverage, possibly due to its higher list price. Sadreameli referenced data indicating it costs over $300 per month before insurance coverage, whereas Asmanex is priced at less than half of that.
"We are all aware of children who have suffered as a consequence of this," Cohen lamented.
Going without needed medication
Julie Leach's 13-year-old daughter, Abby, suffers from a highly uncommon condition known as cerebrocostomandibular syndrome, which has hindered her lung development. Flovent had been effectively managing her condition until its discontinuation.
Navigating the insurance complexities for these medications often leads families through labyrinthine bureaucratic processes to obtain the necessary inhalers for their children—a cycle they must endure every month.
When Abby's insurance recommended switching to Pulmicort instead of generic Flovent, her doctor, Sadreameli, advised sticking with metered dose inhalers compatible with spacers due to Abby's tracheostomy tube. Despite efforts by Sadreameli and her team to find a resolution with Leach's insurance provider, they eventually settled on Alvesco.
"Then insurance turned around and denied it, despite prior approval," Leach recounted to CNN.
It took a month to resolve, leaving Abby without medication. Even when the drug was finally approved, a patient assistance coupon with a $65 copay was mistakenly applied, contrary to Leach's secondary Medicaid coverage, which should have incurred no cost.
"It took another two weeks of calling around to rectify the issue," Leach explained. "Meanwhile, she had no inhaler... I was panicking because she'd never been without one before. I didn't know how her lungs would react without the medication."
Leach admitted that every month, when she fills Abby's prescription among the myriad others she requires, she holds her breath in anticipation.
Some insurers offer coverage options; OptumRx, a major PBM, allows children aged 5 and under to receive the authorized generic Flovent without prior authorization, and for other patients, only a notation regarding spacer use is required.
CVS Caremark similarly facilitates access for patients aged 6 and under without necessitating a formulary exception, with reasonable exceptions available for older patients based on clinical rationale.
However, it's often unclear which PBM a patient belongs to when a doctor prescribes a medication, Sadreameli noted. They frequently encounter obstacles, such as lengthy phone calls or paperwork, to obtain coverage. Cohen added that despite coverage, out-of-pocket expenses can remain prohibitively high.
Alvesco and Asmanex, produced by Covis Pharma and Organon, respectively, did not participate in the $35 pledge on asthma and COPD drugs. Organon stated it's actively working to bolster Asmanex supply and offers a savings coupon for privately insured patients, reducing the cost to as low as $15 per prescription.
Covis and Prasco, manufacturer of the authorized generic fluticasone, did not immediately respond to CNN's inquiry regarding price cap implementation.
For parents like Leach and Pearl, the lack of support for children is immensely frustrating.
"I don't understand why children are being treated as a marginalized group," Pearl lamented. "Children need to breathe just as adults do."
