An epinephrine auto-injector can mean the difference between life and death for 1 in 50 Americans who could suffer from an anaphylactic reaction. But the high cost of the devices can make it difficult for some patients to obtain them.
Auto-injectors deliver a small, one-time, dose of epinephrine, also known as adrenaline. The drug opens up a person's airway, reduces swelling and stabilizes blood pressure, all of which happen when someone has an anaphylactic reaction.
A single prescription for the name-brand EpiPen—which comes in a two-injector pack—costs consumers about $535 when purchased under two major insurance plans, before a $100-off coupon available to most patients, according to sample data from Oration, a software company that helps companies and their employees reduce prescription costs. Without insurance, the device can cost as much as $574 when paid with the discount card.
Amsterdam-based Mylan, which sells EpiPen in the U.S., declined to comment for this story, as did a number of pharmacy benefit management companies and insurers.
Oration's data shows the price of EpiPens has steadily risen over the past few years. That's mostly because competitors face hurdles to entering the market. And that lack of competition, coupled with high deductibles and a need to buy multiple doses and buy new devices every year, is making the product out of reach for some.
There have been minimal changes EpiPens in recent years, except for the phasing out of single-packs in the last few years. The EpiPen is sold in a two-pack because patients suffering from anaphylactic shock sometimes require a second dose.
Customers often buy multiple devices to have at school or work, and the devices expire which means they must be replaced every year even if they're not used. That can feel like a waste of money to some. Some studies have suggested that the yearlong shelf life approved by the manufacturer and the Food and Drug Administration may be conservative, though the official instruction remains.
For most drugs or devices, patients might look to a competitor for a cheaper price. But Dr. Bobby Lanier, a Fort Worth, Texas-based allergist, said most of his patients end up using the name brand EpiPen rather than competitors such as Adrenaclick, which is made by Horsham, Pa.-based Amedra Pharmaceuticals.
Lanier, executive medical director for the American College of Allergy, Asthma, and Immunology, said his patients choose the EpiPen because it's covered by their insurers and is a good value after a discount from Mylan. In fact, Lanier says that in his experience, low-income patients with some insurance can get the EpiPen “almost for free.”
Consumers and experts who spoke to Modern Healthcare about epinephrine auto-injectors didn't have significant experience with Adrenaclick, and noted that it isn't always covered by insurers. That includes Cheryl Fruiterman, a food allergy support group leader in Albany, N.Y., who purchases EpiPens for her husband and 12-year-old son. Fruiterman said that she pays nothing under her husband's “Cadillac” health plan when she uses the discount from Mylan.
The drugmaker's coupon gives consumers a $100 discount on out-of-pocket expenses for each EpiPen two-pack for a maximum of up to three EpiPen two-packs per prescription.
But customers with high prescription drug deductibles still experience substantial out-of-pocket costs. Lisa Deck of Charlotte, N.C., who buys the EpiPen for her two sons ages 2 and 4, said she paid $440 after the Mylan discount card under her high-deductible plan.
She likes that her high-deductible plan allows her to control her medical costs, but thinks it's unfair that others with copays, like her own sister, get EpiPens for free. "It's not a choice, I need them.”
Even with lower deductibles, some insurers place limits on the amount of auto-injectors covered each year, so consumers who have multiple anaphylactic episodes may end up spending higher out-of-pocket amounts.
Competition could drop the price of EpiPens, but there are hurdles to entering the marketplace. A device can never fail, Lanier, the allergist, said. Therefore, they go through exhaustive, continuous testing that constitutes a significant capital investment for a drugmaker.
“It's not really a competition between anything but the potential for litigation and the fact that you have to have something that always works,” Lanier said. “If I was willing to take something that works 50% of the time then I might take a deal.”
Auvi-Q, a “talking” auto-injector initially thought to be a strong competitor to the EpiPen, was recalled by France-based Sanofi because patients reported that the device delivered an inaccurate dosage of epinephrine. Israel-based Teva Pharmaceutical Industries had entered into an agreement with Mylan and Pfizer, which holds marketing rights for EpiPen in several countries, to market its own generic version of EpiPen starting in summer 2015, but later said approval likely won't happen until late 2016.
“We're encouraging transparent response and communication to the public where there are challenges,” said Scott Riccio, vice president of education and advocacy for McLean, Va.-based Food Allergy Research & Education. “We're actively working with regulators and manufacturers trying to make sure patients are at the center of the discussion.”
Moody's Investors Service said in November that Mylan's “eventual loss of exclusivity” in the EpiPen market won't hurt the company too much given other products it has in the pipeline.
Fruiterman, the allergy mom, said she welcomes competition in the auto-injector market, not because of price but because of the innovation it brings. Her son and husband liked the Auvi-Q concept because it could fit in their pocket unlike the long, circular EpiPen. Her insurer, however, didn't cover Auvi-Q.
For Deck, it boils down to cost. A lower-cost equivalent to the EpiPen could mean a world of difference for her wallet. “If my doctor said it was safe and appropriate, I would of course choose the lowest price option,” she said.