Reference no: EM132468352
Mylan MYL +0% pharmaceutical company has a virtual monopoly on EpiPens after a voluntary recall felled their only competitor*, Sanofi's Auvi-Q, over possible dosage miscalibrations. It's not the drug being delivered that brings the bucks, though-epinephrine's a cheap generic. The cost trickery is in the delivery system, the Mylan EpiPen.
The EpiPen's been around since 1977, but Mylan acquired the autoinjector-which precisely calibrates the epinephrine dosage-in 2007. The patient now pays about 400% more for this advantage to receive a dollar's worth of the lifesaving drug: EpiPens were about $57 when Mylan acquired it. Today, it can empty pockets of $500 or more in the U.S. (European nations take a different approach to these things).
It's what the market will bear, so what's the problem, right? Only this: Somewhere, right now, a cash-strapped parent or budget-limited patient with a severe allergy will skip acquiring an EpiPen. And someday, they will need it in a life-threatening situation involving exposure to a trigger...and they won't have it. And they will die. Because they couldn't afford the delivery mechanism for $1 worth of a drug to keep them alive. Two turning points, a death and one company at the crossroads.
According to NBC, Mylan's profits from selling EpiPens, which they have aggressively, famously marketed with brilliant success, hit $1.2 billion in 2015. That year, Bloomberg reported that the epinephrine-delivery system represented 40% of Mylan's operating profits. Bloomberg calls Mylan's marketing of the EpiPen "a textbook case in savvy branding."
That savvy comes at steep and increasing individual cost. Even after insurance pays, the customer can be out $400 or more for a pack of two pens, a dollar value that can vary depending on how high the deductible is. And most customers need EpiPens for home and at school for their child (Mylan does have a program that offers free EpiPens to U.S. schools). Indeed, guidelines call for prescribing two doses in case the first one fails, which Mylan used as an opportunity to cease selling single pens and begin selling only two-packs. As one parent wrote in response to this article, which has been updated:
You have left out/misreported one important detail, which is that with a life-threatening allergy, you are supposed to have 2 EpiPens at all times. If you administer one and it is more than 15 minutes before you are in emergency care, you have to administer the second one. So the pack of 2 is not meant to have 1 at school and 1 at home; it is because you need both with you at all times. This means that you need a pack of 2 at school and a pack of 2 at home for each person with severe allergies. In our case, with 2 kids, we have to have 8 at all times: 2 for each child at school and 2 for each child at home, and that is if we don't even use them! If we do have to use one, we have to purchase more.
The coup de grâce that will divide the "have intervention for anaphylaxis" from the "have nots and might die as a result"? The EpiPens have an expiration date of one year. So if you don't have a life-threatening allergic reaction within that year, that's obviously a good thing-except that you're out $400 or more and have to spend $400 more for that special device that delivers $1 worth of drug. One respondent to a Facebook query I made about EpiPens noted:
As a school nurse my mom dealt with families who faced this. Sometimes they'd get the prescription filled and the expiration date would be only a few months away--not even long enough to get through a school year. So families would have to buy multiple per school year. (And the school wanted 2 per kid)
Another commenter said:
My mom stopped carrying hers because her insurer won't pay for it.
And another:
In the US my sister got one. After insurance paid their bit it was $600.
One MD who responded said:
i have a mom who has to pay full price because of a high deductible plan.
Do you have to have the pen to deliver the drug? No. It's possible to use a syringe, which is exactly what some consumers are doing, along with some emergency medical technicians-the first responders for an anaphylaxis call when the affected person doesn't, you know, have an EpiPen.
What's wrong with that? A syringe doesn't offer the benefit and safety advantage of a well-calibrated dose, and it carries the risk of injection into a vein, instead of muscle, which can be fatal. PBS reported the experience of one mother whose son has an extreme dairy allergy and whose insurance plan is high deductible. The price of two pens--$1,212-was more than her mortgage payment, so she turned to ampules of epinephrine and a syringe as the "rescue" med for her son. Her older son, PBS reports, who also has allergies, just carries around expired EpiPens.
Mylan has tried to save some face-and probably preclude some of the widespread blowback building up with back-to-school stories-by offering a program, the "$0 co-pay card," but Marketwatch says that only decreases what the insured consumer spends by $100, so the "$0 pay" part depends on the insurance plan deductible. See "out-of-pocket costs more than the mortgage," above.
Uninsured patients can apply to receive EpiPens free of charge through a program that Mylan offers. Of course, people who are insured but who have large deductibles fall between two stools here: They can't afford "white glove" insurance that will provide what can even be full coverage, so they buy high-deductible plans for emergencies and then also have to spend-out-of pocket for EpiPens for...emergencies. In the wake of these stories, the company's stock, as of this writing, had taken a slide.
Update: Consumers do have access to a generic version of a calibrated delivery device for epinephrine, the Adrenaclick. According to Consumer Reports:
But EpiPen isn't the only epinephrine injector on the market; the authorized generic of Adrenaclick (epinephrine auto-injector), is a cheaper option-we found it for $142 at Walmart and Sam's Club using a coupon from GoodRx. While generic Adrenaclick isn't the same technology and is used differently than EpiPen, both auto-injectors contain the same drug, epinephrine, available in the same dosages, says Barbara Young, Pharm.D., of the American Society of Health-System Pharmacists.
The big caveat with using the non-EpiPen version of the delivery system is that the two devices work differently, in ways that can lead to critical errors if users aren't properly trained. For example, the EpiPen requires removal of a single cap for use whereas the Adrenaclick reportedly requires removal of two caps.
Given the Alice in Wonderland nature of this election season, it's not that surprising to see distortion of reality and common sense infecting this EpiPen debacle. In this case, we come as close as humans can to a human pot calling a pharma kettle black: Martin Shkreli, poster boy for grasping pharma greed, actually commented to NBC News about Mylan that "these guys are really vultures" and asked, "What drives this company's moral compass?"
For the uninitiated, Shkreli is the fellow who bested Mylan's 400% price increase when his company jacked up the price of a anti-malarial/toxplasmosis drug used in HIV-positive patients 5,000%.
Shkreli's shenanigans earned him the moniker "pharma bro," but the "bro" in the Mylan case is no bro: She's "pharma sis" Heather Bresch, now the company's CEO. The "textbook" marketing plan she hit on expanded the "find" target-one of the three goals of any pharmaceutical company-reaching for parents of children with allergies. The "what-if" fears of parents are a rich vein to tap, one that clearly has proved immensely valuable to Mylan.
The "find" was a huge success. And once those parents were found, hitting the second goal of a pharmaceutical company-"start," as in "start them on your product"-was almost inevitable. The question now is, in the face of prohibitive pricing, syringe-hacking and all of this negative publicity-in which even Martin "Pharma Bro" Shkreli sees a spot of moral high ground where he can stand-Can Mylan continue to hit that third aim: Keep?
Statement from Mylan:
Mylan has worked tirelessly over the past years advocating for increased anaphylaxis awareness, preparedness and access to treatment for those living with potentially life-threatening (severe) allergies. Ensuring access to epinephrine - the only first-line treatment for anaphylaxis - is a core part of our mission.
We are proud of the programs which we have implemented over the past years to help support access to treatment, including our My EpiPen Savings CardTM, a patient assistance program, and theEpiPen4Schools® program which provides free EpiPen® (epinephrine injection, USP) Auto-Injectors to U.S. schools.
- In 2015, nearly 80% of commercially insured patients using the My EpiPen Savings CardTM received EpiPen® Auto-Injector for $0.
- Since the start of the EpiPen4Schools® initiative in 2013, more than 700,000 free EpiPen® Auto-Injectors have been distributed, and more than 65,000 schools, approximately half of all U.S. schools, have participated in the program.
With changes in the healthcare insurance landscape, an increasing number of people and families are enrolled in high deductible health plans, and deductible amounts continue to rise. This shift has presented new challenges for consumers, and they are bearing more of the cost. This change to the industry is not an easy challenge to address, but we recognize the need and are committed to working with customers and payors to find solutions to meet the needs of the patients and families we serve.
- What are your thoughts about the story?