he controversial EpiPen device is about to get still more competition.
A company that now has the rights to a rival product plans to start marketing its allergic-reaction device in the first half of 2017. However, Kaleo Pharma declined to disclose the pricing for its Auvi-Q, which had previously been sold by Sanofi before being withdrawn late last year over reports that the device delivered inaccurate doses.
“We’re focusing on returning Auvi-Q to the market as an alternative product that all patients can afford,” Kaleo chief executive Spencer Williamson told us. “… We understand that price is central to this conversation. … I can assure you that at the end of the day, after we work with all the stakeholders, patients will have a low out-of-pocket cost.”
The move, which had been indicated several weeks ago, comes amid raging controversy over EpiPen and the larger issue of the rising cost of medicines.
Mylan Pharmaceuticals raised the price by 548 percent over the past decade to $608 for a two-pack of the device. But as insurers passed along more of the cost, consumers confronted bigger bills. And this year, many families did so just in time for the start of the school season, which generated nationwide protest. Since then, the company has signaled plans to sell an authorized generic for $300.
The anger has been heightened by the lack of options.
For the past year, only one alternative — a product known as Adrenaclick — has existed. Although not identical to EpiPen, more prescriptions have been written for the device recently. But last year, Auvi-Q was withdrawn by Sanofi, which owned the US marketing rights at the time. And earlier this year, regulators rejected a generic EpiPen developed by Teva Pharmaceuticals and then required another company called Adamis to expand studies for its own device.
The chain of events has prompted added scrutiny of the approval process employed by the Food and Drug Administration, which has been criticized for purportedly failing to sufficiently speed reviews for products lacking competition. However, the FDA Office of Generic Drugs does have a policy to expedite reviews for certain generic drug applications, and will move applications to the head of the line when a generic is not currently approved.
Kaleo, by the way, has its own history of jacking up prices for medicines. Earlier this year, the company was one of several drug makers contacted by two US Senators for raising the price of naloxone, a decades-old drug that is widely used to reverse the effect of opioid and heroin overdoses.
Last February, Kaleo raised the list price for two single-dose injectors of naloxone to $3,750, from $750, a price that was set last November, after previously costing $575, according to Truven Health Analytics. This past June, Susan Collins, a Maine Republican, and Claire McCaskill, a Democrat from Missouri who chairs the Senate Special Committee on Aging, wrote Kaleo and four other drug makers to explain their price hikes.
As for Auvi-Q, Kaleo did not specify what steps were taken to ready the device for consumers.
The product was withdrawn a year ago after more than two dozen reports in which the device delivered an inaccurate dose. The company has only said that it “conducted a thorough manufacturing assessment and invested in new technology and quality systems to ensure accurate, reliable and consistent delivery from the product.”