Where Have All the Epi-Pens™ Gone?

The current shortage of Mylan Epi-PensTM that has been going on for over a year is certainly very scary. This in-depth article describes the current status and provides valuable information on alternatives that are available NOW. For example, many allergists are prescribing the compact Kaléo’s Auvi-Q auto-injectors, which can be ordered via a direct delivery program and are also stocked at Walgreens pharmacies. So don’t rely on expired Epi-PensTM or just carry around one pen. And don’t go without!

Where have all the Epi-Pens gone?/Image credit: Allergy Advocacy Association

Epinephrine Auto-injector Device Shortage Update

Edited by Jon Terry
January 10th, 2019

This article is a summary of the current world-wide epinephrine auto-injector device shortage crisis. All the material utilized was obtained from news sources readily available on the World Wide Web.

Children with life-threatening allergies, and their parents, remain in a state of anxiety as an international shortage of life-saving medication continues. Epi-PensTM, the leading brand of epinephrine autoinjectors used to treat anaphylaxis, have been in short supply since November 2017. The product, which administers epinephrine intramuscularly, is simple enough to be used by parents, teachers, or friends at the first sign of anaphylaxis.

The drug is a must-have for those with dangerous allergies, but for many families, they're struggling to find it. "It's very frustrating. It's hard to explain to patients," said Pharmacist Lisa Rogers, Sullivan's Pharmacy in Roslindale, a suburb of Boston. Epi-Pen has been in a severe shortage for at least the last eight months. "Obviously, it's a lifesaving medication. So, we do everything we can to get it from anywhere we can," said Rogers.

Three boxes of the generic version of the drug came into Sullivan's this week, but if Rogers needs more, she is out of luck because her computer is singing a familiar tune: out of stock. "If there's no more we do try different wholesalers, different companies, to see if we can get them. Unfortunately, if we're out, we're out."

Mylan, the US company who owns the Epi-Pen brand, blames its manufacturer Meridian Medical Technologies for the shortage. But almost a year on from the first supply interruption, the issue remains unresolved and the exact cause remains a mystery. This lack of transparency and failure to resolve the issue is troubling, and further damages Mylan's reputation which has been plagued by accusations of prioritizing profit over patient welfare.

In 2007, Mylan purchased the Epi-Pen brand, which then retailed at approximately $100 for a pack of two pens. The company began an extensive marketing campaign to raise awareness of anaphylaxis and promote Epi-Pens as a household brand and an essential product for schools. It raised the price of the pens and challenged attempts by competitors to develop alternative products. By 2016, the cost of a pack of Epi-Pens had soared to over $600, despite manufacturing costs remaining at only $35 per pen. Outraged families have since been forced to rely on only one pen, or on pens that have passed their use-by date (making them potentially less potent). Some parents have resorted to packing lunchboxes with vials of adrenaline and syringes. Mylan responded to the national outcry by launching an authorized generic, which it retails at $300.

A continuing online survey that Food Allergy Research & Education (FARE) began in August 2018; by December it showed that 82 percent of 821 respondents report that they could not fill or could only partially fill prescriptions for Mylan’s devices. (The survey doesn’t reveal whether earlier participants were eventually able to locate the devices.)

The overarching theme among survey respondents is frustration. The following are direct quotes from FARE’s survey:

  • Tried for several weeks starting in March to find EpiPens anywhere in Seattle; no availability.
  • I am currently without an epinephrine auto-injector. I was willing to get ANY auto-injector, but there are NONE. I’m scared that I might go into anaphylaxis and I will die.
  • CVS in Arlington, VA said they cannot get either the EpiPen or the Mylan generic because it is on “manufacturer back order with no indication of when it will be back in stock.”
  • I tried almost 10 pharmacies before I could find the generic EpiPen.
  • I was told that in case of allergic reaction to just call 911. My daughter is 11 and has severe peanut and tree nut allergies.
  • Two weeks I’ve been waiting and it’s still on hold for back order.
  • I called around and found an Epi-Pen Jr. at Walgreens in Massachusetts but it expires in less than six months. Frustrating for such an expensive drug!

FARE’s monitoring has pointed to a shortage felt by patients in almost the entire country, not necessarily a “spot shortage.”

Mylan and Pfizer, which distribute and manufacture this medication, have not provided a great deal of information to consumers on current supply issues. Even allergists and pharmacists have complained about lack of accountability on the part of “Big Pharma.”

Certainly one of the reasons Mylan has been able to do what they want with the price of the Epi-Pen is their control over the market. Until now, Mylan has held approximately 90% of the epinephrine autoinjector market, and it remains the only autoinjector available in Canada and Australia. Alternative brands such as AUVI-Q and Adrenaclick in the USA, have so far failed to threaten the auto-injector giant's dominance. However, the current shortage has allowed such competitors to come to the fore, with official advice directing doctors and pharmacists to prescribe and dispense alternative brands and generics wherever possible. As a result, stocks of these alternatives are now also threateningly low.

Although Mylan manufactures and sells the actual Epi-Pen device, Pfizer manufactures the drug the device administers. And although the financial deal between the two companies isn’t completely clear, Pfizer has shown increased revenues related to Epi-Pens for the last few years.

Pfizer picked up the Epi-Pen when it bought King Pharmaceuticals in 2010. Mylan, at the time, had marketing rights to the dispenser, rights it still holds.

In 2016, Pfizer reported $339 million in revenues related to Epi-Pen. That was an increase of 15 percent from 2015. Between 2013 and 2014, Pfizer revenues related to the EpiPen rose 8 percent.

Meridian Medical Technologies (a Pfizer subsidiary) is the contract manufacturer of Epi-Pen. The terms of the supply agreement are confidential.

If patients are having problems locating Mylan branded or generic devices, Lauren Kashtan, the company’s head of communications for North America, encourages people to call its 1-800-796-9526 hotline for assistance.

Both national U.S. political parties have demanded Mylan turn over more information about how it sets EpiPen prices. With a new majority of Democrats now in Congress, hearings addressing all issues related the pricing of medications may be scheduled early in 2019.

In more positive news for those who must carry life-saving auto-injectors, there are alternatives in the U.S. marketplace that are becoming increasingly popular. For instance, the American Academy of Allergy, Asthma & Immunology (AAAAI) confirms that many allergists are now prescribing kaléo’s Auvi-Q compact auto-injectors, which are ordered via a direct delivery program and are also stocked at Walgreens pharmacies.

Mark Herzog, kaléo’s vice president of corporate affairs, says the brand has no supply issues, and says Auvi-Q is now “the number one branded epinephrine auto-injector prescribed by allergists in the United States.” However, pharmacists aren’t all aware of certain manufacturers’ programs, such as Auvi-Q’s direct delivery program.

“The health and well-being of our customers is of the upmost importance,” said Richard Ashworth, Walgreens president of operations. “Walgreens pharmacists continue to care for and work with patients and their prescribers to ensure they have access to the epinephrine auto-injectors they need, and we’re pleased to work with kaléo to help meet the demand for epinephrine auto-injectors across the country.”

AUVI-Q’s innovative features include voice instructions that help guide a user step-by-step through the epinephrine delivery process, as well as an auto-retractable needle system, a first for epinephrine auto-injectors, that injects the epinephrine and retracts the needle back into the device within seconds.

“Thanks to this collaboration with Walgreens, any patient who is having difficulty filling a prescription for an epinephrine auto-injector now has the opportunity to get AUVI-Q through Walgreens,” said Phil Rackliffe, general manager of Allergy and Pediatrics at kaléo. “We are working with insurance providers to maximize coverage of AUVI-Q for as many patients as possible.”

For patients who are unable to fill their current epinephrine prescriptions, Walgreens pharmacists will work with each patient’s healthcare practitioner to see if AUVI-Q is right for them. Current AUVI-Q patients should continue to utilize kaléo’s Direct Delivery Service at https://www.auvi-q.com/getting-auvi-q/ to ensure delivery to their home. AUVI-Q 0.15 mg and 0.3 mg are available through Walgreens for patients with commercial insurance. Medicare patients should check with their individual health plan to verify their specific benefits, as AUVI-Q coverage varies by Medicare plan.

To learn more about AUVI-Q, please visit www.auvi-q.com.

Among the generics available, the Amneal-Impax version of the Adrenaclick auto-injector is also growing in popularity, although it too still faces manufacturing delays, according to the FDA’s site.

Teva Pharmaceutical Industriesgeneric version of the EAI device 0.3 mg is now available, at least in limited quantities, with additional distribution of this generic and the 0.15 mg (for young children) expected in 2019.

Sandoz Inc., a Novartis division, is gearing up as well for the launch of its pre-filled epinephrine syringe, called Symjepi, for the first quarter of 2019. Sandoz will sell prefilled syringes with epinephrine under the name Symjepi. The price will be $250 for two, without insurance. What people pay varies, though, depending on insurance, discounts and the pharmacy.

The Allergy Advocacy association will seek all ways and means of ending the EAI device shortage as soon as possible. I personally believe the current situation is totally unacceptable; it places the financial interests of pharmaceutical companies ahead of the lives’ individuals with life-threating allergies. As this year progresses, our association will do our best to provide more information as it becomes available.

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