EpiPen Users Have Few Options for Generic or Alternate Drugs

Just one other company is approved to make epinephrine auto injectors.

ByABC News
August 26, 2016, 3:48 PM

— -- The rising cost of EpiPens has led many to wonder whether there are cheaper options available on the market.

The drug epinephrine has been around for decades, but the EpiPen, which is made by Mylan, has become the go-to epinephrine auto injector for many people in the U.S. There are multiple reasons why the EpiPen has become so popular, including diminishing competition and the fact that pharmacists in many states cannot automatically substitute a generic alternative.

Recalls from Mylan's competitors have also boosted sales of the EpiPen. Two other companies, AUVI-Q and TwinJect, have recalled their epi injectors over issues with dosage and the device.

There appears to be one other company making an epinephrine auto injector available in the U.S., according to data available from the U.S. Food and Drug Administration. That company, Impax Laboratories, creates an epinephrine injector called Adrenaclick, as well as a generic version of the drug.

“The Adrenaclick is at a lower cost than the EpiPen," Mark Donohue, vice president of investor relations and corporate communications at Impax, told ABC News. “Some pharmacies stock it, and if they do not, they should be able to order it in a day or two."

He did, however, acknowledge that the company does not have the ability to manufacture large quantities of the drug.

"We do not have an automated process but we are working on [one],” Donohue said.

The company is “producing as much as we can to provide it at a lower cost to the patient,” he added.

Impax only acquired the rights to Adrenaclick in March 2015, according to Donohue. Market share of Adrenaclick has since grown from 2 percent to the high single digits.

While Mylan has come under fire for raising the price of EpiPen from approximately $100 in 2009 to more than $600 in 2016, it's difficult to tell how much cheaper either Adrenaclick or its generic alternative will be for the consumer. Two pharmacies in Chicago said Adrenaclick costs approximately $500. On GoodRx.com, which compares drug prices at local pharmacies, the generic injector was listed between $144 to $379 with the use of a coupon. The price for Adrenaclick was $466 to $496 with a coupon.

The EpiPen is covered by Medicaid and other insurance plans, so most consumers do not pay full price for it. At least two health insurance companies partially cover the cost of the generic version of Adrenaclick. It was not clear if the generic version was also covered by Medicaid.

However, even if a generic version of the EpiPen was widely available, patients and pharmacists would still face barriers to switching epi injectors. An EpiPen is classified as both a drug and medical device by the FDA. As a result of this classification, pharmacists in 29 states can't simply switch a generic epi injector for an EpiPen the way they could with medications that do not require a device, such as antibiotics.

Dr. Brian Vickery, clinical assistant professor of pediatrics and a pediatric allergist at UNC-Chapel Hill, pointed out another complication for patients: Young children have to be properly trained to use an EpiPen or another epi injector. If a patient or doctor wants to change devices, it means the patient and family members have to re-learn how to use a new device safely.

"There was a time not long ago where there were other drugs on the market ... and they could be substituted and that was an issue because this is a specialized device that requires training and each functions differently," said Vickery.

Since allergists usually recommend that patients have multiple injectors handy, changing epi devices can become burdensome and dangerous. Different devices may be confusing during an anaphylactic allergy attack.

The device is used "in the context of a rapidly evolving, unpredictable and nerve-wracking situation where a patient or the individual with them is turned into a first responder and they have to make a pretty time sensitive reaction," said Vickery. "The last thing we want is for them to pull out a device they don’t know how to use or misuse it.”

In general, epi injectors have become more commonplace after a 2013 law offered grants to schools if they trained personnel on how to use the devices and kept a supply of epinephrine on hand. While the law pertains to epinephrine auto injectors broadly, on the White House website it's called the "EpiPen Law."

Vickery said he expects more doctors and patients will consider switching to a generic option if possible.

Mylan recently said it has given 700,000 EpiPens to schools for free.

Dr. Kavita Vakharia is a plastic surgery resident at Penn State Hershey Medical Center. She is also a current resident with the ABC News Medical Unit.