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After rise in EpiPen price, no quick answers for patients

A pair of EpiPens.
A pair of EpiPens. (Chris Walker / Chicago Tribune)

Facing pressure from the public and from lawmakers over increasing the cost of its anti-allergy EpiPen injector, Mylan Pharmaceuticals announced that it will increase co-pay assistance for patients who need the life-saving device.

The price for a two-pack of EpiPen auto-injectors has risen more than 400 percent since 2004, from $100 to more than $600 today, according to STATNews. The device is used by people with severe allergies to nuts, shellfish, insect stings and other allergens as a means to reverse anaphylaxis, a potentially life-threatening allergic reaction.

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On Thursday, Mylan announced it would increase the amount of co-pay assistance it would make available to patients from $100 per two-pack per patient, to $300 per two-pack, according to Reuters.

Mylan benefited from factors including failed competitors, patent protections and laws requiring allergy medications in schools to become a virtual monopoly.

This is something, but it's not enough, according to Dr. Hava Ladinsky, an allergist with practices in Baltimore and Westminster. While people poor enough to receive Medicaid assistance will see their EpiPens covered and those who can afford good insurance may see low co-pays — or no co-pays, after applying Mylan's co-pay assistance coupon — Ladinsky said there are many people of middle income whose relatively high deductible plans make purchasing EpiPens a real burden, especially because many patients might need multiple packs for different locations, or to replace an EpiPen after use.

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"You're looking at a $600 product and that still only brings it down to $300. If you have to buy two or three twin-packs, you are still looking at $600 to $900," Ladinsky said of the new Mylan program. "It will help, but unfortunately still a significant chunk of change."

Given that the price of the EpiPen has been increasing steadily for over a decade, this burden is nothing new to Ladinsky's patients, she said, especially because EpiPens expire after one year and must be replaced even if they have gone unused. The current pricing, however, is worrisome from a physician's perspective, she said.

"We have patients who now are unable to afford the pen and have chosen to go without it, which becomes potentially exceedingly dangerous," Ladinsky said. "I have one patient that needed it and actually took Benadryl instead because they knew that if they used [an EpiPen], they would have to buy another one."

The Benadryl gamble worked out for that patient, but Ladinsky said that as a physician, it made her extremely nervous — she certainly cannot recommend it as a cost-saving measure for anyone who might be experiencing a life-threatening allergic reaction. Anaphylaxis, the type of reaction EpiPen is designed to treat, is to a run-of-the-mill allergic reaction as Major League Baseball is to Little League.

Allergens and adrenaline

The immune system fights pathogens by creating antibodies to attack them, according to Ladinsky, but a person with an allergy has developed antibodies and a conditioned immune response to an otherwise nonharmful allergen.

"Your immune system basically overreacts to these allergens by releasing these chemicals that cause allergy symptoms," Ladinsky said. "One of the things that is released is histamine, which is what an anti-histamine blocks."

Allergic reactions can consist of anything from hives to vomiting to difficulty breathing to a drop in blood pressure, but anaphylaxis typically involves multiple systems, according to Ladinsky, and an immune system reaction that is usually too strong to be blunted by mere anti-histamines.

Mylan, now in the crosshairs over severe price hikes for its EpiPen, says it will expand programs that lower costs for the life-saving drug.

"If you get a couple of hives, I'm not going to tell you to use your EpiPen — use your Benadryl," Ladinsky said. "If it is two or more systems, systems being cardiovascular, respiratory, integumentary — the skin — or gastrointestinal; if you are seeing two or more of those systems involved, you need to use your EpiPen."

Epinephrine is another name for adrenaline, a hormone created by the body and one of the mediators of the "fight or flight" response, which increases blood pressure as well as counteracting other features of anaphylaxis.

"EpiPen actually works on the cardiovascular system by working on the receptors to almost tighten things up," Ladinsky said. "It actually constricts the blood vessels so you don't have that drop in blood pressure."

This action of epinephrine has long been understood, as has the process for synthesizing it; epinephrine is not under patent and is inexpensive to make, according to Ladinsky.

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"The medication itself costs dollars," she said. "You are paying for the injector; that's where the money is coming in."

Outrage

Mylan has recently drawn unwanted attention to its EpiPen pricing from U.S. lawmakers, including Rep. Elijah Cummings, a Baltimore Democrat and ranking member on the House Committee on Oversight and Government Reform, who told The Baltimore Sun, "It's unconscionable that Mylan is taking advantage of a group of people who desperately need their medication to prevent life-threatening allergic reactions."

Two senior U.S. senators are examining Mylan's price increases for the popular EpiPen allergy shot, with one Republican saying the drugmaker's practices may

Rep. Chris Van Hollen, a Democrat who represents a portion of Carroll County, said congressional action might be warranted.

"The skyrocketing price of EpiPens is a real burden for Maryland families," said Van Hollen, who is running for a seat in the U.S. Senate. "While Mylan has taken minor steps to make the lifesaving device more affordable for some families, Congress needs to take action to prevent this price gouging for EpiPens and other prescription drugs."

At the same time, price increases for EpiPens are not an isolated phenomenon, according to Carroll County Deputy Health Officer Dr. Henry Taylor, who said that from a public health perspective, recent increases in the cost of vaccines, insulin and the opioid overdose antidote naloxone have also been problematic. Still, he said, these price increases are not illegal, and are part of the system that drives new drug development.

"Nationally, we have a tough policy choice balancing government interference for the public good, versus respectful free market competition," he said. "Over the coming years, the U.S. needs to explore the best solutions to balance these competing interests."

No immediate solutions

Until such time as regulations are introduced or the nature of the pharmaceutical business changes, there is not much that families or physicians can do to mitigate the cost of EpiPens, according to Ladinsky.

While it is always recommended that students have their own EpiPens, each Carroll County public school stocks two adult and two junior EpiPens in case of emergencies, according to spokeswoman Brenda Bowers. The school system receives EpiPens from Mylan each year free of charge, she said.

This isn't the first time Mylan chief executive Heather Bresch has been under fire. The CEO who raised price of EpiPen got $19 million salary and perks in 2015.

There are also generic epinephrine auto-injectors available, Ladinsky said, but these can still cost $150 or more and, crucially, are of a different design and do not operate like an EpiPen.

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"We train patients one way, they suddenly get the generic version of it and they may not know how to use it," she said.

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Patients obtaining a generic version should make sure they are fully trained on its use by their doctor or pharmacist, Ladinsky said, and "when you walk out of that pharmacy, make sure the expiration date is at least a year off — I have had some people get old batches and it expires a couple of months later."

As for purchasing epinephrine on the cheap and using a syringe to inject it at home, Ladinsky is skeptical — most syringes available to patients are not long enough to inject epinephrine into muscle tissue, where it can take effect within eight minutes.

"Do you really want to sit around waiting 30 minutes for it to fully kick in?"

Whether patients use the Mylan coupon, share with friends, depend on school EpiPens or simply plunk down a load of cash, Ladinsky said the only permanent fix will come at the national level. Until then, it's a waiting game.

"There are options; there's just no great options for everybody," she said. "I don't have an answer."

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