US Senator Maggie Hassan, D-New Hampshire, slammed GlaxoSmithKline (GSK) last week for discontinuing its popular asthma inhaler for children in an alleged attempt to “price-gouge families.”
As of January 1, the British drugmaker stopped making its Flovent (fluticasone propionate) inhaler and instead, is offering an authorized generic version through a different company. Flovent was one of the most commonly prescribed inhalers for young children with asthma. It is also among the only inhalers infants can use.
In March, GSK agreed to cap out-of-pocket costs for all of their asthma and chronic lung disease medications at $35 per month by January 1, 2025. The company joined AstraZeneca and Boehringer Ingelheim, who together, are the three major manufacturers of asthma inhalers.
Hassan claims GSK is backing away from its commitment by shifting its focus to Prasco Laboratories’ fluticasone, an authorized generic version of the drug.
In a letter to GSK CEO Emma Walmsley, Hassan noted that the price of fluticasone is not capped at $35 and that it is not generally covered by insurance.
She asked why GSK decided to withdraw its branded Flovent HFA (fluticasone propionate 44 mcg inhalation aerosol) inhaler and instead focus its efforts on the generic.
“In this way, your company appears to be exploiting a licensing agreement with Prasco Laboratories in order to circumvent your public commitments and price-gouge families without access to affordable alternatives to Flovent,” Hassan wrote in the letter.
Hassan also stated that GSK has “consistently raised the list price of Flovent well above inflation” despite the drug having been on the market for decades. She cited that GSK increased the price of its Flovent HFA inhaler by nearly 50 percent since 2014.
She also claimed that GSK decided to pull its branded Flovent HFA from the market as part of a loophole to evade Medicaid payments for rebates the company owes under the American Rescue Plan Act so that it can “preserve its profits from years of exorbitant price increases.”
To replace both of its branded Flovent inhalers, GSK has licensed Prasco Labs to make the generic fluticasone, which Hassan noted is “conveniently exempt from Medicaid rebates” because it doesn’t have an existing price history.
“Through your arrangement with Prasco Laboratories, GSK appears to be circumventing Medicaid rebates to protect decades of profits gained by price-gouging patients and public programs.”
In the US, approximately 25 million people have asthma, of which 4 million are children with the condition, and an estimated 16 million people have chronic obstructive pulmonary disease (COPD). Childhood asthma is a major cause of emergency department visits, hospitalizations, missed school days and missed workdays for parents, noted Hassan in her notice. Annually, the overall cost burden of childhood asthma on the US healthcare system is $6 billion.
Despite fluticasone’s new list price being lower than the previous list price of Flovent HFA, Hassan said Prasco Laboratories is not offering negotiable pricing terms to insurers in order for the product to be covered on insurance formularies.
“This means that families either must pay the full list price — anywhere from $150 to $250 per month — or go without their children’s medication,” she wrote.
She said that as a result, many children will no longer have a single age-appropriate inhaler covered by their insurance plan.
In response to Hassan’s letter, a GSK spokesperson told Fierce Pharma that the company’s decision to launch authorized generics for Flovent HFA and sister product Flovent Diskus (fluticasone propionate inhalation powder, 100 mcg) was a “business decision” to help preserve access to the drugs at a potentially lower cost.
GSK said the company had been planning to discontinue the branded inhaler products “for some time.”
GSK is also facing heat from the Federal Trade Commission (FTC) about its intellectual property practices around its inhaler products. The FTC sent a warning letter to GSK at the end of April, accusing it of filing patents improperly or inaccurately, terming them “junk listings.”
The commission is specifically targeting the company’s inhalers that use the Ellipta device. These include the COPD and asthma drugs Breo (fluticasone furoate/vilanterol) and Trelegy (fluticasone/umeclidinium/vilanterol).
The more than 300 “junk listings” for 20 brand-name drugs, which include meds for weight loss, asthma and COPD. The FTC issued warning letters to ten companies, which included GSK, AstraZeneca, Novo Nordisk and Boehringer Ingelheim, about improperly listed patents for some of their drugs. Drugmakers could use these patents to quash competition and inflate prices.
Hassan has asked GSK to put Flovent HFA back on the market “in the short term and to work with Prasco to ensure access to affordable fluticasone.”
She advised GSK and Prasco should do this by decreasing the list price of fluticasone and including it in the $35 out-of-pocket cost cap. “These actions will ensure that patients of all ages and abilities can access life-saving asthma treatment,” she said.
Drugmakers have been facing pressure over high drug prices in the US. Over the past few months, Senator Bernie Sanders summoned some of the country’s top drugmakers including Johnson & Johnson and Eli Lilly to testify at senate hearings about the high list prices of some of their drugs in the US compared to other countries like Canada.
A few weeks ago, Sanders also launched an investigation into the “outrageously high” prices of Novo Nordisk’s GLP-1 blockbusters Ozempic and Wegovy, both injectable semaglutide medications.
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