September 9, 2016
Dr. Robert Glatter, Emergency Medicine Physician, Lenox Hill Hospital
Epinephrine auto-injector options besides the well-known but expensive EpiPen remain limited, according to physicians and published reports. But alternatives do exist and more may be on the way soon, with pharmaceuticals companies promising affordable, safe new products amidst intense public criticism of EpiPen's distributor, Mylan, for raising prices.
"It's such a troubling issue and a concern doctors have," said Robert Glatter, MD, an emergency physician at Lenox Hill Hospital in New York City. "When pharma tries to use these products to drive their profits, it makes medical professionals so angry, especially for something like epinephrine."
Many have criticized Mylan for gradually raising the price of EpiPens (by more than 5-fold since 2004), which has exceeded $600 for a 2-pack after this year's recall of a competing product called Auvi-Q. Not only has Mylan raised the price to push profits, critics say, it is making a critical medication unaffordable for many patients at risk for anaphylaxis. The firm recently announced that it will produce a generic EpiPen copy, but with a list price of $300 that patients and physicians have said is still too expensive.
"It is a life-saving drug," said Howard Mell, MD, an emergency physician and professor at Wake Forest Baptist Medical Center in Winston-Salem, N.C. "People who need epinephrine need epinephrine."
Two more affordable, FDA-approved alternatives to EpiPens are on the market: Adrenaclick and a generic version of that product, both produced by Impax Laboratories. Their list prices run to $300 or more, but can cost patients as little as $140-$205 with a coupon, according to reports. Both operate similarly to the EpiPen.
But sources and reports say these devices are not as readily available in pharmacies as EpiPens, in part because Impax cannot produce large quantities yet. "We do not have an automated process but we are working on [one]," Impax spokesman Mark Donohue told ABC News.
A CVS in northwest Washington, D.C., for example, had only EpiPens in stock when a reporter visited Thursday (at $730 for a 2-pack out-of-pocket). A pharmacist suggested Benadryl as the only alternative available, but did not recommend it.
Angela Karash, who works in a suburban Chicago pharmacy, told MedPage Today that the store has never carried the branded Adrenaclick and started stocking the generic only last year.
"EpiPen has become the trademarked term defining the whole class of products," said Brian Vickery, MD, an allergy fellow at the University of North Carolina in Chapel Hill. "Parents ask for EpiPens and that's what they get."
The Impax devices comprise less than 10% of the quick-delivery epinephrine market, but "there's a big demand and we're trying to provide as many as we can," the Impax spokesman told a Philadelphia reporter.
Also, some reports indicate that the Impax devices are harder for patients -- and even providers -- to use because they require an extra step after administration. Two physicians told MedPage Today that they have seen providers hurt themselves trying to use Adrenaclicks. "These events are rare," Vickery said, adding: "They do happen."
"Patients tell me they prefer the EpiPen" over the Adrenaclick, said Glatter.
At least three potentially better alternatives could be on the market soon, MedPage Today learned.
Imprimis Pharmaceuticals, a San Diego-based compounding pharmacy, is working on its own autoinjector that should operate as efficiently as an EpiPen, CEO Mark Baum said, while being more affordable and customizable. "My goal for the team is to have it out by the end of the year," Baum said, noting he hopes to "get patients taken care of for under $100 a year" total.
"This is epinephrine," he said. "Its a 100-year-old drug, not some biologic. We are just going to dispense it in a different device so patients have access."
Imprimis filed for a patent more than 2 years ago, Baum said, and will not need FDA approval for its device because it will use materials already approved by FDA. "We can go to the market rapidly," Baum said. "This is a passion project. This is not about the EpiPen for us. This is a bigger issue of drug pricing policy and affordability." (Imprimis gained notoriety last year when it began offering a $1 compounded alternative to Daraprim when much-maligned Turing Pharmaceuticals raised the drug's price dramatically.)
Pharma giant Teva is preparing an autoinjector as well, according to reports, after FDA did not approve a previous version. The company declined to comment for this story.
And a firm called Adamis Pharmaceuticals is developing a pre-filled syringe device. The San Diego company is conducting FDA-mandated useability studies, spokesman Mark Flather said, and aims to submit results by the end of the year, hoping for an FDA decision by the second quarter next year.
The treatment will be "much cheaper" than the EpiPen, Flather said, but Adamis has not decided on a specific price yet. It will also be smaller and more portable than the EpiPen, he said, adding: "Competition would be good for this market."
No matter when or if these medications enter the market, all the physicians interviewed for this story agreed that alternatives to EpiPen are overdue. They pointed to Canada and Europe, which both have many more options than the U.S.
"As an allergist and physician," Vickery said, "I'd love to see my patients have multiple options."