Senator claims GSK pulled popular asthma med to dodge inhaler price caps

It’s been a turbulent few days for GSK’s respiratory business: On Tuesday, the U.S. Federal Trade Commission (FTC) further cracked down on “junk patent listings,” including those related to a quartet of GSK inhalers using the company’s Ellipta device.

And now, to cap off the week, Sen. Margaret Hassan, D-New Hampshire, is calling out the British drugmaker for pulling a popular childhood asthma medication from the market in an alleged attempt to “price-gouge families.”

In a letter sent (PDF) to GSK CEO Emma Walmsley, Hassan questioned the company’s recent decision to withdraw its branded Flovent HFA inhaler in favor of an authorized generic from Prasco Laboratories. The senator accused GSK of shifting its priorities to generic fluticasone to sidestep its previous pledge to cap the price of many of its brand-name inhalers at $35.

Further, GSK’s decision to remove branded Flovent HFA from the market appears to be designed to help GSK evade Medicaid payments the company owed under the American Rescue Plan Act for hiking Flovent’s price faster than the rate of inflation, Hassan argued.

GSK, for its part, contends that it made a “business decision” to launch authorized generics for Flovent HFA and its sister product Flovent Diskus to help preserve access to the drugs at a potentially lower cost. The company “had been planning to discontinue the branded products for some time,” a GSK spokesperson told Fierce Pharma.

GSK’s authorized Flovent HFA generic, made by Prasco, can be substituted for brand-name Flovent at the pharmacy without a new prescription, though admittedly, access “may depend” on patients’ specific pharmacy benefit design and coverage, the spokesperson explained.

Earlier this year, reports poured in that GSK’s Flovent HFA discontinuation was causing major access issues for families and pediatricians.

In her letter, Sen. Hassan noted that GSK has “consistently” raised the list price of Flovent HFA “well above inflation.” She argued that rather than paying rebates, GSK used a “loophole” to preserve profits from “years of exorbitant price increases.”

Prasco Labs, which is licensed to crank out GSK’s generic fluticasone, is “conveniently exempt from Medicaid rebates,” Hassan pointed out.

Now, Hassan is pushing GSK to put Flovent HFA back on the market in the short term and to work with Prasco to “ensure access to affordable fluticasone” by lowering the generic product’s cost. She also wants GSK to expand its $35 out-of-pocket cap program to include the company’s authorized generic.

Hassan’s call to action is familiar territory for GSK. Back in early March, Sen. Elizabeth Warren, D-Massachusetts, sent a similar letter around the Flovent market pull that accused GSK of making a “shameful money grab.”

GSK’s comments at the time were much the same as this week’s, with the company emphasizing that it had long intended to take Flovent HFA off U.S. shelves. GSK also stressed that Prasco “alone” determines the market price for its fluticasone generic.

Toward the end of March, GSK followed in the footsteps of Boehringer Ingelheim and AstraZeneca when it pledged to cap out-of-pocket costs for its inhalers at $35 per month by Jan. 1, 2025.

Aside from Flovent access issues, GSK’s intellectual property practices around its inhaler products were put under a microscope by the FTC this week. On Tuesday, the antitrust watchdog came out swinging against “junk” patents for 20 brand-name products from a range of companies that could be used by drugmakers to stifle competition and inflate medication prices.

The FTC crackdown specifically targeted four GSK inhalers using the Ellipta device, including the chronic obstructive pulmonary disease (COPD) and asthma therapies Breo and Trelegy.

In response, GSK told Fierce that it would do its own analysis of its patents as the law requires. GSK previously retracted four of five patents flagged by the FTC in November, when the commission first challenged more than 100 patents for multiple drug products utilizing special delivery devices like inhalers or injectors.