Competitor to EpiPen to arrive in 2017

Allergy sufferers will have at least one more option to treat lifethreatening allergic reactions in the first half of 2017, but it’s unclear how the price will compare to the EpiPen or its upcoming generic version.

Kaleo, which makes the Auvi-Q, will reintroduce the epinephrine auto-injector at a “very, very low” cost to patients, said Kaleo CEO Spencer Williamson. Mylan Specialty, the maker of EpiPen, came under fire from members of Congress and parents beginning in August for its large price increases.

It’s been a long road to EpiPen competition.

Drugmaker Sanofi, which previously licensed the Auvi-Q from Kaleo, voluntarily recalled all of the injectors late last year amid concerns about incorrect dosing. Sanofi later sold the rights back to Kaleo, which says it fixed the problem and invested in new technology and quality systems to boost reliability.

In March, the Food and Drug Administration rejected an application by Teva Pharmaceuticals to produce a generic version of the EpiPen, citing “certain major deficiencies.”

Impax Labs has a generic version of the EpiPen that can be substituted for EpiPens in 21 states. Last month, Mylan CEO Heather Bresch told a House panel that the company would introduce its own generic of its brand name product.

Data out Tuesday showed EpiPen prescriptions increased despite the price increases in the past few years, Athenahealth reported.

“Mylan is getting a return on their marketing investments,” said Josh Gray, Athenahealth’s vice president of research.

But the share of prescriptions for alternatives to EpiPens also were up last month, Athenahealth reported.

Epinephrine auto injectors are used to treat life-threatening allergic reactions, including anaphylaxis, which can have symptoms including shortness of breath, rashes and nausea.

Kaleo is meeting with drug wholesalers, pharmacy benefit managers and insurers in hopes of getting the price paid by consumers for the Auvi-Q as low as possible, Williamson said.

The move toward high deductible insurance plans led many parents to struggle more with Mylan’s price increases over the past two years. When insurers and employers cover more of the costs of high-priced drugs through low deductibles and co-payments, premiums go up for everyone, drug pricing experts say.

Williamson downplayed those concerns in an interview Tuesday. “What we believe is more important is the price to the patient,” Williamson said.

James Baker, an allergy doctor who is CEO of the patient group Food Allergy Research & Education, said that while the Auvi-Q was originally introduced at a higher price than the EpiPen, its smaller size made it especially popular with young people. Teen boys in particular wearied of carrying around the recommended two full-sized auto injectors at all times, he says.

Eric Edwards, a physician who invented the Auvi-Q with his twin brother, Evan, knows that from personal experience. Both brothers had multiple food allergies from an early age and Eric is now a parent of children with severe allergies.

Eric acknowledged Kaleo has a big challenge ahead catching up with Mylan when it comes to product awareness.