Epic EpiPen price hikes prompt new auto-injector products.
North Carolina resident Elizabeth Powell stood at the pharmacy counter, ready to buy the EpiPens her son needed for his multiple food allergies. She’d done this many times since the boy had his first anaphylactic reaction to peanuts ten years ago. Each time she would buy two EpiPen 2-Paks, ensuring he had one set at home and another when he was out and about.
But this time, in the spring of 2016, she was in for a shock. The bill was over $600 for each 2-Pak. Instead of buying two sets as she had in the past, she walked out with only one. It was all she could afford.
The auto-injector had cost $200 less the previous year and even less before that.
The high costs of epinephrine hit patients hard, especially because those with anaphylactic allergies are medically advised to carry two epinephrine auto-injectors and to replace them every year.
“I was extremely angry,” Powell says. “There was no logical explanation for the price increase, given it was the same exact item with no updates or redesigns to make it a smaller and more user-friendly device.”
Powell’s son is among an estimated 15 million Americans with food allergies. Many of these people, in addition to those allergic to latex and insect stings, rely on epinephrine auto-injectors in case of anaphylaxis, a potentially life-threatening allergic reaction.
But the cost of the life-saving emergency medication can be crippling and even prevent some families from having the protection they need.
“We believe no individual in need of epinephrine should ever be without this life-saving drug due to a lack of affordable access,” says James R. Baker, Jr., MD, CEO and chief medical officer of FARE. “We are supportive of competition and innovation in the epinephrine auto-injector market.”
For years, there was minimal competition, with EpiPen controlling 95 percent of the market. But attention on the soaring prices of the EpiPen has set the stage for new epinephrine options to emerge.
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Epinephrine Products Ripe for Competition
EpiPen, which has been the leading epinephrine auto-injector since it gained FDA approval in 1987, was at the center of public outrage in 2016 over its high cost. Pharmaceutical company Mylan had raised the price of EpiPen from about $100 per set when it acquired EpiPen in 2007 to about $600 in 2016—a 500 percent increase in less than a decade. The price tag still remains above $600.
But the controversy—tagged #EpiGate—continued to deepen. In October 2016, Mylan reached a $465 million settlement with the U.S. Department of Justice over claims that it overcharged the Medicaid program for EpiPens. A recall of some lots of EpiPen in March 2017 from a manufacturing partner and a shortage of EpiPens and the generic version this spring due to manufacturing delays added to Mylan’s troubles.
Mylan’s CEO Heather Bresch has blamed the high price increase on problems with the healthcare system and has said that many patients don’t shoulder the full price due to insurance coverage and Mylan’s discount program. Mylan representatives were contacted for this article but declined to comment.
In the wake of the turmoil, new lower-priced epinephrine products (described below) have been introduced. In 2017, Forbes reported that EpiPen’s share of the market had dropped to 71 percent.
Adrenaclick Generic After seeing complaints about auto-injector pricing, CVS Health worked with Impax Laboratories to launch an authorized generic for Adrenaclick in January 2017. The cost is $109.99 per 2-pack for cash-paying patients at CVS Pharmacy locations.
“We recognized that there was an urgent need in the marketplace for a less expensive epinephrine auto-injector for patients with life-threatening allergies,” says CVS Health spokesperson Erin Shields Britt.
Bethany Schweitzer of Columbus, Ohio, switched to generic Adrenaclick for her two food-allergic daughters when her insurance no longer covered the higher-priced EpiPen. She needed two sets of auto-injectors for each child—one set to keep at school and one set for each child to have with them at home or when out and about.
Generic Adrenaclick features a longer hold time than the other auto-injectors, a needle that doesn’t retract following injection and two caps for removal. Despite these differences, Schweitzer was able to use the generic Adrenaclick successfully when her daughter had an allergic reaction after eating bread that contained traces of tree nuts due to cross-contact.
“It was a little scary because I knew I had to hold it in longer and the needle wouldn’t retract, but it was an otherwise positive experience,” Schweitzer says.
Auvi-Q Pharmaceutical company kaléo was determined to make Auvi-Q, its new epinephrine auto-injector, affordable, says Eric Edwards, MD, PhD, kaléo’s vice president of innovation, research and development. He founded kaléo with his twin brother Evan.
“We decided to go in a radically different direction and be innovative in pricing and the product,” he says.
Based on their own experience living with food allergies, the Edwards brothers invented Auvi-Q to be patient-friendly. Compact in size, it features user-friendly voice instructions and a retractable needle.
Pharmaceutical company Sanofi originally introduced Auvi-Q in 2012; it was pulled from the market due to recalls in October 2015. Kaléo re-introduced Auvi-Q in February 2017 with a commitment to ensuring Auvi-Q’s safety and reliability.
Eric Edwards reminds patients that the product is personal for him, his brother and their families.
“Auvi-Q must be safe enough for us and our own children,” he says. “We’re so thrilled to re-introduce it and to get the product back in the hands of people who depended on it before.”
Bethany Schweitzer has since switched to Auvi-Q because she could get it at no cost through kaléo’s AffordAbility program, which offers direct home delivery for commercially insured patients.
The kaléo program also provides Auvi-Q at no cost to families with an annual income of less than $100,000. For those paying cash who don’t qualify for a free Auvi-Q, the product costs $360.
Elizabeth Powell also switched to Auvi-Q for her son in 2017.
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“My entire family loves the Auvi-Q due to the user-friendliness of this device,” Powell says. “Parents, caregivers and patients need a life-saving device that’s easy, quick and less scary to use when mere minutes can mean the difference between life or death during an anaphylactic reaction.”
Because more children are introduced to common allergens early in life, kaléo recently designed an auto-injector specifically for infants and young children. The Auvi-Q 0.1 mg, released in May 2018, features a shorter needle and lower dose for children weighing 16.5 to 33 pounds.
EpiPen & Generic EpiPen While EpiPens still cost over $600, Mylan began offering a generic EpiPen for $300 in December 2016. Mylan also offers a savings plan that knocks up to $300 off the price of the brand-name EpiPen and $25 off the price of the authorized generic.
Many patients continue to use EpiPen despite its cost.
For Laura Marino of Reno, Nevada, the reliability and familiarity of the EpiPen are important factors. When she had an allergic reaction to scallops, the EpiPen was easy to use and was quickly effective, she says. Her insurance has always covered the EpiPen in full or Mylan’s savings offer has resulted in a co-pay of less than $100.
“I think there’s a certain comfort level for people with food allergies to stick with what they know and what has worked for them in the past,” she says.
That product familiarity is comforting for Marino, who cites EpiPen training conducted in the military, first aid classes and restaurant allergy workshops.
“Having a number of people out there who are familiar with it and don’t have to stop to read directions or feel any apprehension in using it should I not be able to self-inject is reassuring,” she says.
Making an Epinephrine Choice
Allergy experts stress the importance of always carrying two auto-injectors, regardless of the cost. With new auto-injector products available, consumers now have a choice between various design options and price points.
Families should work with their doctors to determine which brand works best for their needs, advises Baker at FARE.
“Do what you’re most comfortable with,” Schweitzer says. “The most important thing is to make sure you have enough auto-injectors so that you have two with you at all times.”
Editor’s note: At press time, the FDA confirmed that there were shortages in the United States of EpiPen and EpiPen Jr., along with Mylan’s generic versions, due to manufacturing delays. Mylan confirmed that there were “intermittent supply constraints” but assured consumers that the product was still available and that the company was expediting shipment. The generic epinephrine auto-injector produced by Impax Laboratories also appeared on the FDA’s drug shortage list. Auvi-Q was not involved in the shortage. The FDA statement came days after FARE put pressure on the agency to take action regarding growing concern about a national shortage and a determination by the American Society of Health-System Pharmacists that the Mylan and Impax epinephrine auto-injectors were in short supply.
Contributor Wendy Mondello is a health writer. She has a teen with asthma and multiple food allergies.