16-38 Segment 1: Epi-Pen Price Hikes

61756232 - saint louis, united states - august 25, 2016: two epipen auto-injectors used for treatment of allergic reactions.

Synopsis: The Epi-Pen brand has become synonymous with epinephrine injectors, which can save the life of a person suffering a severe allergic reaction. Recently there’s been outcry over large price hikes for the devices, which have forced some people to seek other alternatives or go without. Experts discuss the economics involved and what patients can do to be protected without going broke.

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Guests:

  • Dr. Aaron Carroll, Prof. of Pediatrics, Indiana Univ. School of Medicine
  • Dr. Thomas Casale, Prof. of Pediatrics and Medicine, Univ. of South Florida and Exec. Vice President, American Academy of Allergy, Asthma and Immunology

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16-38 EpiPen Price Hikes

Reed Pence: Allergies are extremely common. About 55 percent of Americans test positive to one or more allergen. But some allergies are more serious than others, according to Dr. Aaron Carroll, Professor of Pediatrics at the Indiana University School of Medicine.

Carroll:  The vast majority of them are really just sort of rashes or itching or things that might bother us a little bit. But about one to two percent of people might have what’s a severe allergic reaction which we would call anaphylaxis, which involves not just the symptoms that I described before, but also a closing off of the airways and difficulty breathing. And that, of course would be a serious emergency and something we would want to take care of immediately.

Pence: Doctors usually take care of it by administering a drug called epinephrine.

Carroll:  Epinephrine is a hormone that is secreted by your adrenal glands and it does much of what we often think of as the fight or flight response. So, it would constrict your blood vessels, it would get your heart pumping faster, it might dilate pupils, but most importantly, it also opens up the airways. And that’s the thing we’re most concerned about, because as the airways constrict with anaphylaxis we want to reopen them, and that’s what epinephrine would do.

Pence: Insect stings and food allergies are the biggest causes of life-threatening allergic reactions. About eight percent of children and adolescents in the United States have food allergies, and more than a third of those kids have a history of severe reactions. Each year, food allergies result in about 200,000 visits to the emergency room. And it doesn’t take much to do it, according to Dr. Thomas Casale (cah-sahl-ee), professor of pediatrics and medicine at the University of South Florida and executive vice president of the American Academy of Allergy, Asthma and Immunology.

Casale:  Just an accidental exposure or cross contamination where somebody had a particular food and you get some of that food in yours from using the same dish or using the same pot or sharing a fork, or something like that.

Carroll:  Closing down can be very fast, to the point where people panic and it can be a life threatening emergency very quickly, which is why people want to have epinephrine. Sometimes it can be a bit slower and last 15 minutes or a half an hour even longer; it can be a slow process. Once you actually give the epinephrine, relief is pretty quick, usually within seconds to minutes. It is a life saving drug, there’s just no question about it. And if you’ve seen someone in anaphylaxis get epinephrine and see how quickly they get better, you realize how important it is for them to have it with them at all times.

Pence: That’s why many people with severe allergies carry epinephrine injectors to work or school…or wherever they go. Many people know the devices simply as EpiPens®, the brand name of what’s by far the biggest seller of the two on the market. Carroll says they’re much easier to use than a normal syringe.

Carroll:  It is difficult to draw up epinephrine and to then give yourself a syringe, especially if you’re going through anaphylaxis. And expecting people around you to be able to do that would be very difficult as well. They might fumble, they might break the vial, the vial could break on its own. Epinephrine degrades pretty quickly, so every year it would need to be replaced even in an EpiPen®. The beauty of the EpiPen® is that it’s relatively simple to use. You basically pull off the safety cap at the top, you jab it into your leg and it administers the correct dose. That’s it. You don’t have to worry about drawing it up; you don’t have to worry about getting it in the right place. You can even hand it to someone, they can look at the instructions on the side, pull off the top, look where the needle is, jab in into the leg in a motion and that’s it. So, you’re paying for the ease, you’re paying for the simplicity, you’re paying for the idea that we’re going to get it right every time.

Pence: Some people with severe food allergies can count a dozen or more times that they might have died without them. Even Congress has recognized their value.

Carroll:  Legislation has encouraged this because FDA guidelines increased years ago said that we should start buying two instead of one, and that’s when Mylan stopped even selling a single pack. They only sell them in twos, so that will allow them to effectively double the price. Schools can actually be prioritized and some of the money that they receive in terms of grants if they stock EpiPens® at the school. So, there’s just a lot of push some by legislation, some by recommendations, some certainly by advertising to try to get people to buy more EpiPens®.

Casale:  Like steps to increase the availability of epinephrine auto-injectors in schools, for example, or on ambulances, because this is something that you need to have access to immediately, or on an airplane. So trying to get this life saving drug available to individuals who might not have an epinephrine auto-injector available, but have a situation that they need the medication quickly is one that as a professional medical society the American Academy of Allergy, Asthma and Immunology has advocated for. And Congress has supported that.

Pence: There’s no doubt the devices save lives. But the question lately is…at what price? Carroll says that epinephrine itself is cheap. There’s less than a dollar’s worth in each injector. And when EpiPens® came on the market in 1977, the cost was relatively low. But nine years ago, EpiPen’s® rights were bought by a new owner.

 

Carroll:  When Mylan purchased the EpiPen® in 2007, I think they sold for about $57 each. They’re now only sold in twin packs, but the price of an EpiPen® has gone up more than 450% since they purchased it, and now as we said it costs wholesale the EpiPen® itself more than $600 for a twin pack in the United States.

Pence: Carroll says that might be a little more palatable if EpiPens® were a single, one-time purchase. But many users want to have them readily available at places they spend a fair amount of time. Home and work, and for children, school and maybe grandma’s house. So they need to buy several. What’s more, you have to keep buying each of them over and over…even if you don’t use them.

Carroll:  Epinephrine degrades pretty rapidly over time and after a year it doesn’t have the potency that we need to have in order to make sure that we’re going to counteract anaphylactic reaction. So even in an EpiPen®, it needs to be replaced every year. If you keep it in a syringe it actually degrades over the course of months. You would need to replace it even more often. So it’s not one of those medications you can buy, stick on the shelf and know that you’re good forever. If you need to have a certain number of EpiPens® you need to buy them every year.

Pence: EpiPen® price hikes are a good lesson in the economics of health care, where price doesn’t matter. People whose life may depend on having a product are often willing to pay almost anything to get it. And in the case of epinephrine injectors, there’s very little competition to keep prices down.

Carroll:  A number of companies have tried. There were some more competitors back in the mid 2000’s when this first existed, but there wasn’t a ton of money being made on the EpiPen, so a lot of the competitors dropped out. And then as Mylan, sort of the market and pushed the EpiPen® and the price went up and up, a number of competitors have appeared but some had problems that caused them to withdraw from the market, some just had real difficulty getting FDA approval. So Teva Pharmaceuticals is one of the sellers of generic has attempted for some time and tried again with the FDA this year but got denied. Another company that was trying to bring a competitor to market got denied. There’s still is one competitor left, but they have almost no name recognition and almost no market share and they’re not on formulary for many insurance plans because of that. So when you look and see which of these will my insurance cover, it’s often the EpiPen®. If a doctor writes a prescription for an EpiPen®, the pharmacy can’t just switch it out to another competitor even if they are cheaper because that is not a generic and they’re not substitutable.      

Casale:  There are two products ion the market now  — EpiPen® and Adrenaclick™.

I think EpiPen® because it’s been around so long, is typically the one that most physicians and patients are used to, so it’s frequently prescribed even though it’s more expensive than the Adrenaclick™. But they are both very expensive, so that the cash price of EpiPen® would be almost $600, but the cash price of the Adrenal Click is still $450, roughly.

Pence: The manufacturer of EpiPen® says that it issues coupons that reduce the out of pocket cost to nothing for most people with insurance. But Carroll says there are problems with that argument.

Carroll:  Well there are a lot of holes in that. One is if you have government insurance it’s actually illegal to use the coupon, so that’s right off the bat. The second is if you are uninsured, as they just said, the coupon doesn’t apply at all, so you end up paying the full price of the drug. If you have a high deductible healthcare plan you still have to pay for the co-pay even if the coupon is gone, so even if they reduce the price by a couple hundred dollars you still have to pay $300-$400 for the EpiPen® even with the coupon. But the big thing is that the coupon only works for the co-pay. It still costs the insurance company $600 and because of that, that drives up the premiums and how much we all have to pay for insurance across the board. So it might shield you in the short term from some part of your co-pay, depending upon what insurance you have, but the full cost of it is certainly still being born by patients overall through increased premiums and insurance costs.

Pence: Mylan blames high deductible insurance plans for the problem rather than the price of the drug. In response to the outcry, they’ve recently announced the availability of a generic version, and Casale says doctors are glad to see it.

Casale:  Well, I do think it’ll make a difference. I think we’re all happy that that’s occurring. Although the price could probably still be much lower as far as what we’d like to see. They used to cost about a hundred dollars less than ten years ago. And the device and medicine really hasn’t changed. So it would be nice if we could get that price down a little bit lower. But certainly that will help a number of patients, especially for those that may have to pay out of pocket.

Pence: For some of those patients, Casale says the price is still too high… and they’re forced to either go without or look for lower cost alternatives.

Casale:  In the case of an epinephrine auto injector where it’s something that you need immediately and could be life saving, that’s especially a difficult situation. And that’s the time when physicians are trying to do their best and work with patients to either get them coupons or even though not optimal, perhaps getting an epinephrine ampule, filling the syringe and wrapping it in foil and giving it to them, and instructing them how to use it, because at least they have something and of course the cost of that would be way less.

 

Carroll:  We can teach an adult to do it, but it’s hard to say a child should be able to do that. In fact, very few children probably could. And then we’re relying on the idea that if a child is having an anaphylactic reaction that the friend’s parent, if they were at a friend’s house could do it, or a teacher could do it, or camp counselor could do it, or the coach could do it. That’s not something we can necessarily assume. Moreover, syringes can break, as can vials. They are not as hardy as EpiPen®, and if you draw epinephrine into a syringe it doesn’t even last a year, it can actually last only a couple of months.

Pence: Congress has started looking into the issue of why EpiPen® prices have gone up so fast. And Carroll says the number of similar cases may begin to force the hand of pharmaceutical makers. If they don’t do something to cut the cost of medications… Congress will.

You can find out more about all our guests on our website, radiohealthjournal.net.

I’m Reed Pence.

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