AUVI-Q epinephrine auto-injector manufacturer addresses price concerns

The epinephrine auto-injector AUVI-Q, used for the emergency treatment of anaphylaxis, will be available starting Feb. 14, kaléo, its manufacturer, said today.

Perspective from Tonya Winders

The company also said it will launch a program that could provide the device to certain members of the public for free.

“Finally, patients have more options for [these] injectors,“ Erik Edwards, vice president, product strategy, kaléo, said in a conference call. “We firmly believe that no one, no stakeholder, should be telling patients you only have one choice, you only get this one epinephrine auto-injector. We’re proud of the ability now to bring options back to patients.”

AUVI-Q

Company representatives said AUVI-Q has step-by-step voice instructions to assist those using it through the epinephrine delivery process and automatically retracts the needle back into the device within seconds. The device is about the size of a credit card and the thickness of a cell phone, according to the company, and each AUVI-Q prescription includes two auto-injectors and one trainer for AUVI-Q. Company representatives also said the features on the new, updated version of AUVI-Q are what sets it apart from the earlier version that was voluntarily recalled by the previous manufacturer.

“We have evaluated the manufacturing process that led to the recall …. We understand the manufacturing issue that caused the recall, we have fixed that manufacturing issue, we have installed additional inspection controls,” Spencer Williamson, president and CEO, kaléo, said in the call. “We now have a 100% robotic system that has over 100 inspections for each and every single product, so we have the highest level of confidence that this product is the highest level of quality for patients. We would not be bringing this back, we would not be making this announcement today if we weren’t 100% confident in the quality of our product.”

Kaléo stated the trainer includes audio and visual instructions, and is intended to familiarize patients and caregivers on how to use AUVI-Q in an allergic emergency. The AUVI-Q trainer does not contain a needle or medicine and can be reused to practice an injection.

According to a company press release, for more than 200 million Americans with commercial insurance, including those with high-deductible plans, the out-of-pocket cost for AUVI-Q will be $0. In addition, patients who do not have government or commercial insurance, and have a household income of less than $100,000, will also get the device for free. The cash price for AUVI-Q is $360 and will be available to those patients without commercial or government insurance.

A company spokesperson said there are numerous insurance plans that are going to cover AUVI-Q, with more expected to come on board, but declined to name specific insurance companies that are taking part. A hotline —1-877-30-AUVIQ — will also be available to help physicians, pharmacists and patients who need help filling an AUVI-Q prescription.

The announcement is the latest involving bringing epinephrine auto-injectors to the public.

Adamis Pharmaceuticals announced earlier today the FDA has accepted its New Drug Application for its epinephrine pre-filled syringe, adding that the agency said the company’s application addresses issues the agency had last year.

Just last week, CVS launched its own epinephrine auto-injector, a generic of Adrenaclick, saying that at $109.99, it is the lowest cash-price device on the market.

And in December, EpiPen’s manufacturer Mylan launched its generic, stating its auto-injector would be sold in packs of two and cost $300 at wholesale, half the price of the comparable name brand product.

According to the Asthma and Allergy Foundation of America, anaphylaxis occurs in about one in 50 Americans, but some believe the actual number could be significantly higher. – by Janel Miller

Disclosure: Edwards and Williamson work for kaléo.

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Perspective

Tonya Winders

We are excited to see kaléo’s AUVI-Q epinephrine auto-injector return to the market, giving people at risk for severe allergic reactions greater choice in obtaining these life-saving medications. Access to epinephrine is vital for the millions of families with life-threatening food, insect venom, medication and latex allergies, and kaléo’s ‘Affordability’ program takes significant steps in making epinephrine auto-injectors available for less out-of-pocket expense for patients.

It remains important for patients to discuss epinephrine options with their healthcare provider. Not all epinephrine auto-injectors are the same and patients need to know when and how to use their medication appropriately. We encourage patients to ask their healthcare provider or pharmacist to demonstrate correct use of the epinephrine auto-injector so they are prepared in case of an emergency, as well as learn how to properly maintain the device so that extreme cold or heat does not render it ineffective. When picking up a prescription at the pharmacy, patients should check to ensure the epinephrine auto-injector has not been substituted for a generic version without consent.

Tonya Winders

President and CEO

Allergy & Asthma Network

Disclosures: Winders reports no personal relevant financial disclosures, and notes the Allergy & Asthma Network receives corporate sponsorship support from manufacturers of epinephrine auto-injectors for unbranded disease state awareness and education.