Spot shortages persist for Mylan’s lifesaving EpiPens and the epinephrine injectors of some of its rivals, but Kaléo is making sure the public knows its version is available. You just can’t run to your pharmacy and expect to get a box.
Privately held Kaléo Monday said that supplies of its Auvi-Q autoinjectors have been unaffected by the manufacturing delays reported by competitors and are available for prescription.
“Kaléo has sufficient supply to meet any anticipated demand,” it said in its announcement. The catch is that Kaléo injectors must be obtained through its direct delivery service. The other catch is that they can be very expensive.
“We understand how critically important it is for those affected by life-threatening allergies to be able to access an epinephrine autoinjector, especially as families prepare for the back to school season,” Phil Rackliffe, Kaléo’s GM of allergy and pediatrics. “Kaléo is able to fill, and is filling, all the AUVI-Q orders through our Direct Delivery service at www.auvi-q.com.”
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The injectors are to treat life-threatening allergic reactions, including anaphylaxis, from things like peanut allergies. People who are at risk for or have a history of serious allergic reactions, or their parents, keep a pen with them at all times. But they must be replaced when they expire.
Spot shortages of Mylan ubiquitous EpiPen developed last year, when a Pfizer subsidiary that makes them for Mylan had manufacturing delays after FDA inspectors found problems at the plant. The FDA this May added it and the injectors from Impax Laboratories on its drug shortages list.
Mylan said it is receiving continual supply from Pfizer subsidiary Meridian Medical Technologies and hustling shipments to wholesalers as soon as it does. That has made availability across the U.S. spotty. Mylan said customers who can’t find the products should contact its customer relations.
Impax Laboratories’ generic epinephrine injector has been plagued by manufacturing issues as well. In June it said customers needed to inspect their pens before using them because their have been reports of visible particles in some.
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That has left Kaléo in the catbird seat for now. But it has been a tough road to get there. Its Auvi-Q first hit the market in 2013 but couldn’t get much traction. Kaléo struck a commercial agreement with Sanofi, but that collapsed when Sanofi had manufacturing problems and had to recall all of its injectors nationally.
The company then returned its autoinjector to market with a list price of $4,500 for a two-pack—a far cry from Mylan’s $600-for-two price tag. Pharmacy benefit managers and insurers such as Cigna and Humana refused to cover them.
But Kaléo says that through its affordability program, patients with commercial insurance, can get the injector with no out-of-pocket cost. It said the cash price for Auvi-Q is $360 and that Auvi-Q is $0 for anyone with commercial insurance even if insurance does not cover it. The drugmaker has been passing the word about the product with sport-themed advertising, doing a deal last year with Minor League Baseball and getting NASCAR racer Elliott Sadler as a spokesman this year. The ads are pushing its “verbal direction” feature, Auvi-Q’s step-by-step voice instructions that competitors don’t have.
In an email today, the company declined to provide any sales numbers for Auvi-Q.