Drugmaker Mylan announced with great fanfare on Monday that it would offer a generic version of its EpiPen, the life-saving epinephrine autoinjector device used to treat severe allergic reactions.
The cash price for the new generic will be about $300 a pair, a marked discount from the current $630 for the branded EpiPen, a figure that has sparked a national furor over pharmaceutical profits.
But an even less expensive alternative has been available since 2013 -- though because of drug regulations, few patients and even doctors know about it. Horsham-based Lineage Therapeutics has offered a generic form of Adrenaclick, an autoinjector that delivers the same dose of epinephrine as EpiPen, that can be purchased for as little as $146 a pair at Walmart or Sam's Club with a discount available at the Good Rx website.
"From a safety standpoint and efficacy standpoint, there's no difference" between the EpiPen and the Adrenaclick generic, said Jonathan Spergel, an allergist at Children's Hospital of Philadelphia. "It's exactly the same medicine."
The mechanical differences in the two devices also are trivial. Spergel said it takes less than 10 minutes to learn to use either.
"You can teach a 5-year-old to do it," Spergel said.
And there soon will be more generics on the market. Teva Pharmaceuticals said it intends to introduce an epinephrine autoinjector in 2017. Mark Baum, CEO of tiny Imprimis Pharmaceuticals, claimed his company will have a $100 generic kit available by the end of the year. The kit will include two customizable autoinjectors and a practice device.
"What we're doing isn't rocket science," Baum said in an interview Wednesday. "The cost of materials is really cheap, under $10. The goal is to marry components that are already commercially available and sell it at an affordable price."
Interest in the Adrenaclick generic has "blown up" in the past two weeks, said Mark Donohue, a spokesman for Impax Laboratories Inc., the California firm that bought Lineage last year. "There's a big demand and we're trying to provide as many as we can."
Sales have more than tripled, as EpiPen pricing exploded into an election year issue and a Congressional investigation. The Adrenaclick generic's share of the market has grown from 2 percent in 2013 to nearly 8 percent, Donohue said, and the company is racing to step up production.
Supplies are "somewhat limited," Donohue said, because unlike Mylan's automated production lines, the generic Adrenaclick is assembled by hand. "You can't produce as many pens that way," he said. The company plans to have an automated manufacturing facility operating by late 2017 or early 2018. Donohue wouldn't say where the devices are made.
Generic Adrenaclick pens are available at all major drugstore chains and mail order pharmacy services, Donohue said. But because of slight differences in its design, pharmacists cannot automatically substitute them for EpiPens.
"There can be one little thing different in the mechanism and the FDA won't approve it as an equivalent," said Maria Taylor, pharmacist at the Baederwood Pharmacy in Jenkintown, where a pair of the Adrenaclick generic pens is $365. "If you want it, you have to ask your doctor to specifically write a prescription for it."
Though it isn't hard to learn how to use a generic Adrenaclick, the fact that EpiPens are standard in so many schools and health care facilities has been cited as a reason not to make the substitution. But Lineage has produced a free how-to video, which can be found at adrenaclick.com.
In the past, consumers with health insurance often didn't notice what medications cost, as they were only responsible for a co-pay. But with the rise of high-deductible insurance plans, many Americans are on the hook for the full price until they have reached their deductible, making drug costs impossible to ignore. As a result, more people are downloading coupons or even seeking out their medications through websites based in Canada, where government regulations that don't exist in the U.S. keep drug prices more manageable.
Others are resorting to filling syringes with epinephrine themselves, which costs just a few dollars per injection. "I hesitate to prescribe that, because drawing up syringes when you're in an emergency situation could be dangerous and confusing," said Andrea Apter, chief of allergy and immunology at Penn Medicine. "You could hurt yourself by injecting it into your fingers."
Apter said she would prefer that epinephrine autoinjectors be priced reasonably.