Food Allergies

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February 2 2017

Mylan Responds with a Press Release that Dodges Concerns and Questions

Robyn O'Brien Food Allergies, Food Politics 0

On January 20th, 2017, almost exactly eleven years to the day since I was thrown into this work in the food allergy world, I heard from from Mylan’s communication’s department for the first time. They wanted to discuss points made in a recent FOX interview. I was grateful. After a decade of working in this space, they finally wanted to talk.

So I turned to our community for feedback, prior to the call.

But the call didn’t happen. Instead, the communications team responded with a press release.

When I first saw it, I sent an email suggesting that we get on a call, as the press release fails to address so many of the concerns that our community has.

But I haven’t heard back.

Since Mylan continues to follow what is written here, we have decided to post the concerns from our community, along with their press release. Thank you so much to all of you who have written, responded and called.

Mylan refers to EpiPen users as “patients.” Referring to our children and loved ones as “patients” suggests that we are sick. While that may be how the company recognizes EpiPens recurring revenue model, many food allergy consumers are healthy, read labels, and many avoid additives, artificial ingredients, GMOs and other synthetic ingredients. Countless times, the community have said that food allergies are a blessing in disguise, as it taught them how to make smarter and healthier food choices. Perhaps rather than using the word “patient” as they do below, Mylan can stick with consumer or even “user” (a term used by Coca Cola).
Our community is composed of pediatricians, allergists, TV producers, journalists, attorneys, MDs, parents, teachers, nurses, investment bankers, Congressmen and women and so many more. Again, “patient” minimizes the incredible diversity of the food allergy world.
The press release below fails to answer a question asked by many allergists: how did Mylan secure exclusivity with the pharmacy benefit managers? Was a deal cut? Did money change hands to secure that EpiPen was the only device offered? Under what terms was Mylan able to secure the exclusivity? Was something done to ensure market foreclosure? Contracts between Mylan and the PBMs could answer that.
Mylan suggests that they “invested over $1 billion in raising awareness and increasing education about the risks of anaphylaxis.”“Mylan increased its branded ad spending on the EpiPen by 357% over five years. During the same time the drugmaker hiked the price of the allergy auto-injector by 179%.Mylan spent $43 million on branded ad spending for the EpiPen in 2015, down slightly from $48.9 million in 2014 and up significantly from $9.4 million in 2011, according to data from Kantar Media. At the same time, the drugmaker has steadily increased the wholesale acquisition price, which excludes rebates and discounts, twice a year since 2011, according to Elsevier Clinical Solutions’ Gold Standard Drug Database. In May 2011 the EpiPen was priced at $164.98, and that price rose to $461 by May 2015. It now costs $608.61.”
Given that the United States and New Zealand are the only two countries in the world that allow pharmaceutical advertising directed at the consumer, is the skyrocketing advertising budget the reason that Mylan jacked up the price of the EpiPen twice a year since 2011?
How did the search ad spending drive pricing decisions? Mylan didn’t just shell out for TV ads as EpiPen prices soared. Search spending was way up, too. According to FiercePharma, “the company shelled out and worked hard to build EpiPen’s profile in the marketplace. Coupled with the company’s repeated price increases, its EpiPen marketing program built the epinephrine injector into a blockbuster product accounting for 20% of the company’s revenue. The thinking goes like this: Potential customers see an ad on TV, go to their smartphones and type a word or brand into Google search to find out more. Why not place an ad linked to allergy keywords?” EpiPen.com increased paid search ad spend by 1,800% as the price of the device hits an all time high in May 2016.
In the fall of 2016, Mylan’s CEO was questioned by Congress in a Congressional hearing about Mylan’s market share. She acknowledged what has also been acknowledged that EpiPen had a 95% market share (Athenahealth states that EpiPen’s market share was 95.7% in August 2016). How was Mylan able to secure that monopoly? Was that exclusivity ensured through the product donations to schools?
The release below does nothing to address consumer concerns that Mylan misrepresented its drug classification to Medicare and Medicaid. The drugmaker reached a $465 million settlement with the U.S. Justice Department and other government agencies to resolve questions over rebates required by the Medicaid program.
And lastly, consumers have been asking for refunds since the price drop. As an anti-trust probe is launched, many are lining up for more answers.

Below is Mylan’s press release:

We appreciate the work that you do for the community and your role in continuing this important conversation. We reached out to you to address some of the concerns that have been raised. We value the comments we read from the community on your social media outlets, and given their engagement and interest in our discussion, we feel it is most appropriate to respond where the broader group can read it. While this post is lengthy, we wanted to address the many topics that were raised.

First and foremost, we were saddened to read about the boy who passed away on Thanksgiving after experiencing anaphylaxis, and we share our condolences with this family. While the collective severe allergy community has made progress over the years in raising awareness and increasing education, tragedies such as this demonstrate there’s more work to be done.

This is the primary reason why we have invested over $1 billion in raising awareness and increasing education about the risks of anaphylaxis. We worked to change laws to allow access to epinephrine in schools so it is readily available for any child who has an anaphylactic event. We have given away nearly 800,000 EpiPen Auto-Injectors to schools across America. These free devices have been used hundreds of times. We don’t want to go back to a time – not that long ago – when awareness of anaphylaxis was much lower and epinephrine auto injectors were only available in schools with a prescription for an individual child. Achieving this level of expansion of awareness requires a significant commitment.
Mylan takes its role within this community seriously and has been – and continues to be – committed to increasing awareness, preparedness and access to treatment.

In regards to price, patients are rightfully concerned about rising drug prices. Mylan has felt the full weight of these concerns in relation to the price of EpiPen® (epinephrine injection, USP) Auto -Injector. However, it is important to understand that the way consumers pay for their healthcare has changed dramatically over the past few years. The stark reality is that a sharp rise in high deductible health plans has exposed more consumers to higher out-of-pocket costs for their medications. And working families will continue to face sticker shock at the pharmacy counter for medications and be forced to make difficult choices until the process of pricing pharmaceuticals is reformed to recognize the increasing shift of costs directly to consumers.

As it relates to EpiPen Auto-Injector, last summer approximately 85% of consumers prescribed EpiPen had an out-of-pocket cost of less than $100 and a majority paid less than $50. However, as a result of the rise in high deductible plans, about 15% of EpiPen purchasers were exposed to a wholesale acquisition cost (WAC), or list price, of $600 or more. While some competitors have recently suggested that patients do not pay the WAC price, you and many in this community know firsthand that this is not always the case in today’s environment. This is why we took immediate and decisive action to cut the price of EpiPen Auto-Injector in half through the launch of our authorized generic and to adjust our enhanced patient programs and resources to help increase access for this patient population. This was the most direct way to reduce the cost for patients. Media coverage has noted how the recent Auvi-Q® announcement reflects the challenges facing our system Mylan offers the lowest WAC* price ($300 for the authorized generic for EpiPen Auto-Injector and $608 for EpiPen Auto-Injector) and cash cost/direct ship cost ($300) to all patients, not just those visiting a select retailer.

There was some confusion from your readers about our resources; let us clarify.

For all patients, the authorized generic for EpiPen Auto-Injector is now widely available at pharmacies across the U.S. at half the wholesale acquisition cost ($300) of EpiPen Auto-Injector.

A savings card and relevant terms and conditions are available online

If you are being charged a cost that significantly exceeds $300 for either dose of product, this is an error. Please contact Mylan Customer Relations at 1-800-395-3376 or [email protected].

Mylan also provides a direct ship option that offers the authorized generic for EpiPen Auto-Injector at a cash price of $300, the lowest direct to patient cost.

For commercially insured patients purchasing EpiPen Auto-Injector, we expanded our My EpiPen Savings Card® program.

This savings card and relevant terms and conditions are available online

For uninsured and underinsured patients, we doubled the eligibility for our patient assistance program to support those earning up to 400% of the Federal Poverty Level. This means an uninsured or underinsured family of four making up to $97,200 pays $0.
Information about all of these resources can be found on Mylan.com/EpiPenAccess.

Many have questioned why we did not just lower the cost of the branded product. It would not have ensured that EpiPen Auto-Injector would be made more affordable for patients, especially for the uninsured, underinsured and those with high deductible health plans. Because we cannot control the costs charged by additional parties involved in the pharmaceutical supply chain and reimbursement system in which we operate, and given contractual arrangements with customers, cutting the list price of the branded product woul d not have guaranteed that patients would pay a lower price at the pharmacy. Therefore, we introduced the authorized generic for EpiPen Auto-Injector, which is identical to the branded product, at 50% of the WAC price, and expanded our savings card and assistance programs to reach more patients.

Contrary to what appears to be a popular misperception, patients at risk for anaphylaxis, a life-threatening allergic reaction, have – and always have had – various alternatives when it comes to epinephrine. For more than 10 years, the market has been a competitive one, providing consumers and healthcare professionals with numerous options for their prescribed epinephrine auto-injector.

Recent media attention about the various epinephrine auto-injectors on the market has generated confusion about patient options. There are important differences between products in terms of the functionality and administration process. We suggest that all patients work with a healthcare professional to determine the option that’s best for them. All patients should receive training on proper administration of a prescribed epinephrine auto-injector in a physician’s office and practice between doctor office visits.
Mylan remains dedicated to meeting the needs of those at risk for anaphylaxis, and we are committed to providing access to EpiPen Au to-Injector. We understand the frustration of anyone facing barriers to access. We respect the opinions that have been shared and welcome continued feedback and dialogue. Our hope is that the conversation surrounding EpiPen Auto-Injector serves as a catalyst for reform and real transparency in pharmaceutical pricing.

*The final retail cost to the patient for EpiPen Auto-Injector and the authorized generic will be dependent upon their insurance and any mark-ups within the supply chain.

January 26 2017

How Americans “Took It On the Chin:” 20 Things to Know About Mylan and the EpiPen

Robyn O'Brien Food Allergies, From Robyn 0

This morning, CBS News ran a story interviewing the CEO of Mylan, Heather Bresch. In it, she discussed the price of EpiPens.

It’s a critical issue. Lives are at risk. Parents sometimes need as many as 4-8 sets of EpiPens, if they have multiple children with food allergies. The skyrocketing price of the device made it so that many parents can no longer afford to keep their children safe. The coupons introduced by the company aren’t always working, as we continue to hear from families paying over $300 for one set.

As the #epigate story broke last year, we heard from pharmacists who spoke about crying mothers at their counters, no longer able to afford EpiPens. We heard from mothers who split their packages in two, putting a child who may need two injections at risk. And we heard from families who chose between buying an EpiPen and paying their rent or mortgage or food bills. But without a doubt, the hardest conversations we had were with the parents who lost their children to a life-threatening allergic reaction.

So I watched with interest when the CBS anchor, Norah O’Donnell, said to Mylan’s CEO, “You really took it on the chin.” To which a remorseful looking Ms. Bresch, nodded “yes,” like a child caught with her hand in the cookie jar.

And my heart broke as I watched it, not for Ms. Bresch, but for the families I know who have lost their children to a life-threatening allergic reaction. The deaths are happening too frequently, too many in the last year alone, as the price of her device skyrocketed.

And I thought, “Ms. O’Donnell, I want you to hear the stories of these parents, because they are the ones who “took it on the chin.””

And as I listened to Ms. Bresch once again try to deflect blame, I thought about how Americans pushed for a Congressional investigation into Mylan’s price gouging, and how she flew into DC on a private jet, yet failed to answer with any certainty almost all of the questions presented by the Congress.

Since then, Mylan’s CEO has been largely missing from the public eye, but in the face of an announcement that Cigna will no longer cover her top revenue generator, that CVS Pharmacy is launching an alternative at 1/6 the price, and the news from Auvi-Q that they are returning to market in February, Ms. Bresch appeared on CBS News this morning.

But I could not stomach her answer that she was the one that “took it on the chin.” Not given how many families I know who have lost their children, not given how many I know who still can not afford the device. I obviously wasn’t alone, as the response to Norah O’Donnell’s tweet about the segment speaks for itself, which you can read here.

It reminded me of points that we shared last year, as #epigate hit: 20 things you may not know about Mylan, the company that makes EpiPen. These 20 points are why, before pointing the finger at anyone else, the company has a lot to take care of internally.

20 Things You May Not Know About the EpiPen Company

The price of the EpiPen has increased 17 times since Mylan acquired the company in 2007.
Mylan left United States for a tax inversion. It moved its headquarters to the Netherlands to avoid paying higher taxes and to avoid a takeover.
The Dutch maneuver and movement of the company’s headquarters overseas, which transferred a large chunk of Mylan shares to a special foundation called a stichting, also acted as a poison pill that would undermine takeovers.
Senator Joe Manchin (of West Virginia) has a daughter who is the CEO of Mylan.
Mylan was originally a West Virginia company where the Senator is from.
Even Senator Joe Manchin said the tax inversion should be illegal.
EpiPens were about $57 when Mylan acquired it. Today, it can empty pockets of $600 or more in the US
EpiPens were invented in 1977, almost 40 years ago. A patent life is usually 17 years.
Mylan’s profits from selling EpiPens, which they have aggressively, famously marketed, hit $1.2 billion in 2015.
That year, Bloomberg reported that the epinephrine-delivery system represented 40% of Mylan’s operating profits.
EpiPen was developed for the U.S. military for treating exposure to nerve agents in the course of chemical warfare
The top five executives of Mylan pull in over $85 million dollars. The CEO makes about $19 million.
The CEO claimed to have an MBA from West Virginia University despite being 22 credits short of completion.
EpiPen Canada has not raised its prices in any significant way.
In France, two EpiPens cost about $85. Two EpiPens in the U.K. cost 89.99 pounds.
EpiPens in Australia cost about $40 AUD.
EpiPens in the U.S. cost more than anywhere else in the world.
The price of EpiPens in the U.S. is up almost 600%. The CEO’s salary is up 800%.
According to Wells Fargo, Mylan raised prices by more than 20% on 24 products, and by more than 100% on seven products. The analyst who wrote the report warned that Mylan could draw “greater regulatory scrutiny and headline risk” as a result of such price boosts.
The CEO, Heather Bresch, interviewed today for “taking it on the chin,” spoke about her over 90% market share and monopoly before Congress. She is one of the top paid executives in the pharmaceutical industry.

The bottom line is that lives are at risk. Kids are “taking it on the chin,” parents are “taking it on the chin.”

Some families need as many as 8 sets of EpiPens if they have multiple children with food allergies. They can no longer afford to keep their children safe. It’s hitting parents and taxpayers.

I have heard from a mother who said two EpiPens didn’t save her child. I’ve also heard from Congressmen and countless others whose lives have been directly impacted by Mylan’s price-gouging.

You have to wonder, in the company’s cost-benefit analysis, what is the value Mylan placed on a child’s life? What price elasticity did they discover when Ms. Bresch and her team decided to jack up the price of EpiPens seventeen times? What process did they go through in deciding to jack up the price of seven other drugs in their portfolio over 100% last year?

And is it really Ms. Bresch who “took it on the chin”?

If you were to speak to the families who lost their children, they would tell you otherwise.

I sincerely hope that their voices are heard, too.

Written in memory of Sabrina, Emily, Oakley, Joseph and the countless other children whose lives have been lost to a life-threatning food allergic reaction.

More information can be found here on their proposed “price cut” and other concerns from families, those in the Senate and business analysts:

http://finance.yahoo.com/news/mylan-says-just-cut-price-143319975.html?soc_src=mediacontentstory&soc_trk=fb

http://www.cnbc.com/2016/08/24/heres-what-you-need-to-know-about-the-ceo-behind-the-big-epipen-price-hikes.html

http://www.nytimes.com/2016/08/24/upshot/the-epipen-a-case-study-in-health-care-system-dysfunction.html

http://video.cnbc.com/gallery/?video=3000545619

January 21 2017

Consumer Feedback On Mylan’s EpiPen Price Gouging

Robyn O'Brien Food Allergies, Health 0

Recently, Cigna announced that they are no longer covering Mylan’s EpiPen, CVS Pharmacy announced a low cost generic alternative, Adrenaclick, an epinephrine device with a price point at 1/6 the cost of an EpiPen, and Auvi-Q announced that they are returning to market in February.

Last week, I appeared on FOX Business to discuss all of this, as well as the impact that the Trump Presidency might have on drug pricing. In the segment, we also discussed the market makers and middle men that help to secure Mylan’s revenue model.

Then a funny thing happened on the way to my inbox. A PR reached out to me from Mylan Pharmaceuticals. FOX Business has been trying to reach them to no avail. I’ve been a voice in this space for over a decade. What struck me is that the day before, Auvi-Q announced that it was returning to the market on Valentine’s Day.

What had once been a monopoly suddenly wasn’t, and from Cigna to CVS Pharmacy to Adrenaclick to Auvi-Q, Mylan now faces some serious competition. They can no longer hide.

So in order to give Mylan’s PR people an idea of what consumers are saying, I reached out to our online community for feedback. Perhaps the most heart wrenching was from a mom who just lost her son over Thanksgiving. Two EpiPen devices were not enough to save his life. It was too late.

Here are some honest and heartfelt messages from consumers (we did not include those laced with profanity), not just for Mylan, but for all who are providing life-saving devices to our families:

They failed the people they were supposed to help. ~Jennifer

They victimized already suffering families. ~Kelly

I just checked prices via my insurance unit d healthcare and all my options seen 370 per two pack or more. I see no change from last year. I would like them to lower their price will all insurance programs to a reasonable price considering I have to buy 4 2 packs (2 kids and 2 schools) ~Colleen

I’ll be going to CVS for their generic, priced at 1/6 the price of the actual Epipen today, and will never again support Mylan as long as Heather Bresch is CEO. ~Cindy

One question: Why haven’t they dropped the price? We all know the answer to that question is greed, but I’d be interested to hear their answer anyway. ~Joe

Too little too late. Maybe they should think next time before gouging families for life saving medications. We will never see that money that we were overcharged. Shameful! ~Barbara

Your corporate culture of arrogance is finally catching up with you.. ~Amanda

Ask them where we sign up for refunds for past overpriced purchases? Last year my out of pocket was $1300 with the coupons and those expire this month. ~Jen

I’m on an insane High ded plan aka catastrophy insurance but pay premiums like it’s a real plan. LOL. $8K family deductible. Epis aren’t my only issue here but for something you HAVE to buy EVERY year and multiple packs to cover school, off site after school, dads house, etc. it’s insane. I’ve had to split packs at school and pray they grab someone else’s if they need a second pop. ~Jen

Please ask how they arrive at pricing, both for brand and generic, as well as pediatric and adult dose. I am referring specifically to the insanity we spoke of a couple weeks ago,whereby my insurance company paid the most for the pediatric generic epinephrine. ~Valerie

Today’s consumers are not as stupid as you take them to be. ~Nina

Please tell them what goes around…comes around. Do the right thing when it comes to pricing in relation to profits. Care about the individuals who are dependent on your products for their health—especially the children. ~Kerry

How can we work together for the greater good, which will increase your bottom line when you give value to people.

That’s if they care about people ~Liz

Apologies would be a good start. ~Alison

No thanks. ~Amy

That it’s too little too late and we are moving on to other devices that we can afford, from companies that did not play with our children’s lives for profit. ~Susie

It’s hard to decide what to tell them. They betrayed the trust of the consumers who need life saving medication. I am struggling to gather questions or thoughts on what to tell them. ~Pamela

Epinephrine is a life saving medication. Deliberately making it into a business money maker took this critical medication out of the hands of those that needed immediate access to it. Trust lost is hard to regain. ~ Ann Marie

Please tell Mylan that the voice of the consumer has been heard. ~Jayne

I just yesterday tried to fill my EpiPen prescription at CVS and even WITH the $300 coupon, my out of pocket cost would’ve still been over $300.

I have commercial health insurance with United Healthcare. Luckily I was at CVS and was able to get the generic alternative for $110 (for two pens.) ~Jennifer

That they should be ashamed for price gouging food allergy families. For taking advantage of our fears of losing our children to anaphylaxis. For not coming up with a way to truly make epinephrine available and affordable to everyone who needs one prior to being “caught.” For not being the leader of taking on the PBMs to help fix healthcare. For doing nothing to bring a more updated, innovative epinephrine device to food allergy families that is smaller and more user friendly. They chose profits over our children and we are mad. ~Elizabeth

They don’t want a cure for us. Then they’d lose their “baby”. Everything is a show. They took advantage of a vulnerable group though, and so the cat is out of the bag that they have no ethics. Yes, they are for profit. But they abused us and everyone knows it! Their image is almost beyond repair. And now that there are multiple options available, including Auvi-Q which totally blows them out of the water, they know they are going to sink. ~Jillian

The Edwards brothers are putting them to shame. The irony is their Auvi-Q brand is going to end up being all about TRUST. Something Mylan took for granted. That is very difficult to gain back. They have to work for it. Actions speak louder than words. They have proven that they only care about lining their pockets. Probably the only thing they can do to even begin to salvage any kind of respect and trust is for Heather Bresch to step down, and appoint someone that really cares. ~Jill

That now that there are more choices on the market, we will CHOOSE to go with companies that have better business ethics and actually see their customers as real people and not just profit centers. ~Marina

They should refund the difference between what they charged and what Audi-Q is charging directly to the families that paid their outrageous prices to save their children. ~Paul

Ask them how much they have paid to pharmacy benefits managers in deals and kickbacks to ensure that EpiPen (or its generic) is the only EAI listed or the preferred EAI listed on national/large formularies. Ask them to outline how’s these deals are negotiated. Ask to see the contracts. ~Leading pediatric allergist

I am so angry and saddened that it wasn’t enough to make a profit (as they should), but making a huge profit and then an even BIGGER profit was the modus operandi here, all at the expense of families who just want to keep their allergic loved ones alive! Heather Bresch’s greed preyed upon families’ fears and that is not ok. We’re not talking about a drug like Viagra (which is covered by Medicare BTW…). Epinpeherine is the only thing that will stop death for those in anaphylaxis. ~Elizabeth

I’d like them to feel the pain of what I’ve been through as a food allergy parent for 18 years. And the financial burden they’ve put on families who are already struggling enough. And tell them I’m glad Auvi-Q is back, hard as Mylan might’ve tried to get rid of them. ~Donna

We were forced to miss house/car payments, not buy groceries, not even be able to afford the expensive allergen safe foods for our daughter.

I want to know -why do they value their $ over so many people’s lives? Why instead of taking a pay cut did they let so many employees go ? ? ? Right before Christmas?

(Obviously more questions than things to tell them. Personally, if I had the chance to say anything to them it wouldn’t be too nice )

You are cruel, selfish bastards. I hope you make peace with God someday, because until you do you, you have a very hot seat next to the devil.

You are in a position that is paid to help people, instead you paid yourselves to willingly put lives at risk. Day after day you woke up and made that choice. ~Jennie

And one more for good measure:

I have 2 daughters who require an epi-pen due to peanut allergies. My older daughter uses the adult dosage, while my younger daughter requires the pediatric, or ‘junior’ version.

During the course of my discussion with my mail in pharmacy regarding the price difference between adult and junior pens, as well as the LACK of a difference in consumer price between the generic and name brand (both of which are manufactured by Mylan, by the way) I was told that my pharmacy’s cost for the epi-pen, epi-pen Jr and the generic equivalents are as follows:

BRAND:
Epi-pen $613.48
Epi-pen Jr. $613.48

GENERIC:
Adult $297
Junior $782.51

No, that is not a typo. The generic junior costs my pharmacy almost $500 more AND is, in fact more than the brand version.

My cost as the consumer is considerably less, however, I am still paying more for my younger daughter than my older one, and my cost is the same, whether I choose the generic or the name brand.

Clearly Mylan has failed to live up to their promise of a less expensive generic version and is continuing their very shady business practice. Despite numerous attempts, I was unable to speak with anyone at Mylan who could provide an answer as to the price discrepancy.

Please feel free to contact me if you have any questions. I am absolutely livid!

Any questions?

January 19 2017

This Valentine’s Day: Kaléo Returns with Auvi-Q

Robyn O'Brien Food Allergies, Health 0

KALÉO announced today that AUVI-Q will be available by prescription nationwide on February 14, 2017. This is a story we have been following since twin brothers, Eric and Evan Edwards, first launched the device several years ago. The company has invested considerable time, meeting with the food allergy community and the pharmacy benefit managers, also known as “PBMs.” The PBMs are the middle men or market makers who decide what products go into which plans and onto which pharmacy shelves. Three PBMs determine the market for the entire pharmaceutical industry. As you can imagine, negotiating with these market makers is difficult given the lack of transparency in the industry.

As a result, Kaléo brings Auvi-Q to market under a new system in order to address the needs and concerns of the food allergy community.

More than 200 million Americans with commercial insurance, including those with high-deductible plans, will be able to obtain AUVI-Q for $0 out- of-pocket.
AUVI-Q will be available free of charge to patients with a household income of less than $100,000 who do not have government or commercial insurance.
The cash price for AUVI-Q is $360, and will be available to those patients without government or commercial insurance.

Kaléo, a privately-held pharmaceutical company, today announced the AUVI-Q® (epinephrine injection, USP) Auto-injector will be available by prescription starting February 14th, and announced AUVI-Q AffordAbility, a first-of-its-kind access program for AUVI-Q. Through this new program, patients with commercial insurance, even those with high-deductible plans, will have an out-of-pocket cost of $0. For patients who do not have government or commercial insurance, and have a household income of less than $100,000, AUVI-Q will be available free of charge. In addition, the cash price for AUVI-Q is $360 and will be available to those patients without government or commercial insurance. Each AUVI-Q prescription includes two Auto-injectors and one Trainer for AUVI-Q.

“We met with patients and physicians and listened to the very real challenges in the current healthcare environment with obtaining access to affordable medicines,” said Spencer Williamson, President and CEO of kaléo. “As a result, starting February 14, for more than 200 million Americans with commercial insurance, including those with high-deductible plans, the out-of-pocket cost for AUVI-Q will be $0.”

AUVI-Q is a FDA-approved prescription medicine used to treat life-threatening allergic reactions, including anaphylaxis, in people who are at risk for or have a history of serious allergic reactions. It is an epinephrine auto-injector with innovative features such as voice instructions that help guide a user with step-by- step instructions through the epinephrine delivery process and an automatic retractable needle system, a first for epinephrine auto-injectors, that injects the epinephrine and retracts the needle back into the device within seconds.

“We know how important it is that severely allergic patients have an epinephrine auto-injector that can be with them at all times and used correctly, even without training, during a panic-stricken allergic emergency,” said Eric Edwards M.D., Ph.D, Vice President of Product Strategy at kaléo. “We are excited to make AUVI-Q, an epinephrine auto-injector with innovative features, available for millions of patients living with severe, life-threatening allergies.”

AUVI-Q AffordAbility is a first-of-its-kind program and commitment for AUVI-Q, designed to provide affordable access to this potentially life-saving epinephrine auto-injector for eligible patients. This new program removes potential and previously experienced insurance barriers, restrictions and delays, even for those commercially-insured patients with high-deductible plans. AUVI-Q will also be available via a direct delivery service, that can ensure the best expiration dating for AUVI-Q. For live assistance in filling an AUVI-Q prescription, any patient, physician or pharmacist will be able to call 1-877-30-AUVI-Q.

Identical twin brothers, Eric and Evan Edwards, the inventors of AUVI-Q, grew up with life-threatening allergies. They know what it is like to live in fear of that life-or- death moment, both as patients and parents of food-allergic children. Their goal was to develop an epinephrine auto-injector that contained innovative features, such as a voice instruction system that helps guide patients and caregivers step-by- step through the injection process. Eric and Evan Edwards believe and trust in AUVI-Q, not only for themselves, but also for their children and other families who may have to depend on it to administer epinephrine during an allergic emergency.

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

About AUVI-Q

AUVI-Q (epinephrine injection, USP) Auto-injector is a prescription medicine used to treat life-threatening allergic reactions, including anaphylaxis, in people who are at risk for or who have a history of serious allergic reactions. AUVI-Q contains epinephrine, a well-established, first-line treatment for severe, life-threatening allergic reactions that occur as a result of exposure to allergens including food such as peanuts, tree nuts, fish, shellfish, dairy, eggs, soy and wheat; insect stings or bites; latex and medication, among other allergens and causes.

AUVI-Q is the only compact epinephrine auto-injector with a voice instruction system that helps guide patients and caregivers step-by-step through the injection process, and a needle that automatically retracts following administration. In anaphylaxis emergencies, it is often individuals without medical training who need to step in and deliver potentially life-saving epinephrine. AUVI-Q was designed through careful analysis of the situations where epinephrine auto-injectors are used and with significant input from the allergy community that relies on it incorporating Human Factors Engineering (HFE). HFE is about designing products or systems that are easy to operate and, most importantly, support correct use, with the goal to remove the potential for error. For more information visit www.auvi-q.com.

January 13 2017

Head of CVS Pharmacy, A Mother of Four Responds to EpiPen Pricing

Robyn O'Brien Health, Food Allergies 1

Today, a life threatening allergic reaction sends someone to the emergency room once every three minutes. It’s costing our economy $25 billion dollars a year—in drug costs, lost productivity, special dietary needs and more.

And it’s costing us over $600 every time we purchase an EpiPen.

That last statistic is what launched the food allergy world into action. Mylan jacked up the price of EpiPens so many times in eight years that families could no longer afford them. So parents made a lot of noise, and in August 2016, we launched #epigate which brought attention to the price-gouging. Mylan’s share price fell 24%.

But even before that started, there was another mom of four, witnessing all of this. She held a huge role, not as an advocate, but as the head of CVS Pharmacy. Like me and millions of others, her youngest suffers from life-threatening allergies. And like all of us, she saw an opportunity to do better.

As the head of CVS Pharmacy, Helena Foulkes has done an incredible job leading CVS Pharmacy, as first seen in the company’s move to remove tobacco products from their stores. She also led her company’s effort to work with Impax, the maker of the generic version of epinephrine, Adrenaclick, to bring an epinephrine product to market at a price point that families can afford.

When the #epigate conversations started in the summer of 2016, Adrenaclick cost about $200. Still high and without a robust supply chain, it was not the right fit. Consumers and pharmacies shared concerns that if demand hit, there were questions about whether or not the the company making Adrenaclick would be able to provide the life-saving devices to the millions who need them.

Through the second half of last year, CVS worked with Impax to ensure that it could. And yesterday, CVS announced that they would carry the Adrenaclick at $109.99—the same price that an EpiPen cost over 8 years ago. A full 1/6 of the price of an EpiPen today.

The headlines took over the food allergy world. They had been heard not only by one of the largest pharmacy chains, but they had also been heard by a mother of four inside of the company who personally understands how food allergies impact millions of lives. And she demonstrated remarkable leadership.

Food allergies don’t care where we work or who we voted for. They don’t discriminate in the lives that they take, and it is on all of us who are part of this to not only find a solution but also to do everything we can to protect the millions of Americans now dealing with this condition.

Adrenaclick is a different device. Education will be required to teach consumers about it, and training is always required with any life-saving epinephrine device. Is it perfect? No, but none of them are yet. And the more choices that we have on the market, the better the devices will become, and the more lives we can save.

Think back to that first cell phone? Imagine if we’d stopped there. Competition is in the best interest of consumers. Competition yields the best product.

When I spoke with CVS today, they said, “We believe in giving consumers informed choice.” That is something that I have said countless times myself in my work in the food industry.

As Americans, our democracy is built on informed choice – from what we choose in the pharmacy, to what we choose in the grocery store, to what clothes or cars we buy.

It’s no surprise that this first move comes from CVS. If you remember, they were the first to remove tobacco products from their stores. Why? Their mission is to help people on their path to better health.

They will be helping millions of Americans with food allergies, by offering a device at a price point that many can afford.

Mylan’s monopoly has put too many lives at risk. They’ve priced consumers out of securing the devices needed to protect their loved ones. CVS stepped in to help.

Americans deserve an informed choice, a basket of products from which to choose when it comes to protecting their loved ones with food allergies.

Monopolies only benefit the monopolist.

As CVS moves to provide more options and choice, it opens up the category to other players, too. And with Auvi-Q coming back on the market in 2017, that can’t happen soon enough.

Thank you, CVS, for opening the door to other products. May the best auto-injector win.

December 10 2016

In Memory of Oakley: What We Can Do Together

Robyn O'Brien Food Allergies, From Robyn 0

Today, a family in Florida gathers to honor their 11 year old son, Oakley. Friends are gathering there and around the world for the beautiful boy who loved wearing red sneakers and lost his life to a food allergic reaction.

Since his death over Thanksgiving, no one in the food allergy world can see a pair of red sneakers and not think of him. Zappos even contacted the family because there had been such a run on red sneakers on their site.

In private chat groups and conversations, many of us have gathered over the last few weeks to discuss what we need to do to bring this issue to light. How can we protect our children? How can we stop this epidemic and find a cure?

What can we do to help raise awareness? To go beyond the bubble that is social media?

Host an event at your school and invite your allergist to attend and speak with you.
Meet with your local representatives, educate them on the numbers and how many children this now impacts
Listen—to what the constraints are in your school, your church, your community—so that you can address them.
Find a friend to do this with—none of us have to go through this alone—we need each other as supportive scaffolding as we work to build an environment that is safe for all children.
#livelikeoak and learn more at the Red Sneaker Foundation.

Today, 1 in 13 American kids have a food allergy, 2 kids in every classroom. A life threatening allergic reaction sends someone to the ER once every three minutes. This is not a fad, it is a life-threatening condition changing the lives of families everywhere.

One of the most important issues to come out of these discussions has been around the use of epinephrine. I reached out to Sarah Romano, a friend who is an MD and also a mother of four to get her thoughts. I have an enormous amount of respect for her.

My friend, Dr Sarah Romano, also known as the Allergist Mom, shares what else we can do below:

As an allergist, I personally carry some of the pain and responsibility for each and every person who dies from anaphylaxis. Have we done enough? Have we educated the patients and their families enough? Do we make it clear that each reaction has the potential to be serious regardless of what previous reactions have looked like? Have we impressed upon each and every patient and parent the importance of always having swift and easy access to injectable epinephrine? Do they truly understand the critical need for early administration of injectable epinephrine during a severe allergic reaction (anaphylaxis)?

Both delayed administration of injectable epinephrine and having asthma are important risk factors for death from anaphylaxis. Allergists know this. Our patients must know this too. Our families must know this. Our school and camps must know. First responders must know. We also all need to know that we do not need to fear giving injectable epinephrine. We need to understand how effective injectable epinephrine is in slowing or stopping an allergic reaction. We need to understand that we must seek medical care for a severe allergic reaction. We need to know that we will never see a needle, that it doesn’t hurt that much, that after getting epinephrine patients most often feel some immediate relief from their symptoms.

I consider this education my personal responsibility and I will continue to spread this education as often as I can. We cannot stand to lose another little guy at Thanksgiving, another innocent darling around a campfire or at a birthday party. We all need to understand that this disease isn’t messing around. All of us, from the patients to the parents to the schools to the food industry to the first responders and EMTs to the physicians. We are in this together.

To better understand anaphylaxis, please read:

http://theallergistmom.com/2016/01/12/the-science-of-anaphylaxis-an-allergic-storm/
Sarah Boudreau-Romano, MD theallergistmom.com

October 26 2016

BREAKING NEWS: Auvi-Q Auto-Injector Returns to Treat Life-Threatening Allergic Reactions

Robyn O'Brien Food Allergies 0

A few weeks ago, I was contacted by the founder of AUVI-Q. Established by twin brothers who had life threatening food allergies, the two brothers leveraged their personal experience and one brother’s work as a paramedic to invent and design a device for 21st century families dealing with life-threatening allergies. With innovative design, a smarter operating systems and voice technology AUVI-Q talks and walks someone through the use of the device during a life threatening reaction. The voice technology feature is similar to Siri, guiding a patient through use during a life-threatening reaction.

If EpiPen was invented in 1977 for the military, AUVI-Q was innovative in its design: invented in the 21st century by and for people with life-threatening food allergies.

The product design is smart and leverages 21st century technology. It is part of the new frontier in healthcare and represents a health+tech company that meets the changing health needs of our families.

I spoke with the founder of AUVI-Q as the #epigate crisis hit, as the founders had been through so much as a competitor in this space.

With the announcement of the new release of AUVI-Q, kaléo, the inventor of AUVI-Q, commits to making the innovative epinephrine auto-injector with industry-first features available in the first half of 2017 as an alternative for the life-threatening allergy community. Since bringing the company back under the inventors roof, the company will provide new manufacturing and quality system controls to ensure reliable and accurate epinephrine dose delivery.

The release of the device represents a milestones for its founders who originally developed the product because they wanted an easy to carry, smarter technology themselves. Today they now have children who need their Auvi-Q device, too.

On the heels of #epigate, it can’t come soon enough.

Last night, I spoke with one of the brothers and founders, Eric Edwards, and the company’s CEO and President, Spencer Williamson. They shared the following:

“This news represents an important milestone for the life-threatening allergy community, which has suffered from a lack of epinephrine auto-injector options for far too long,” said Evan Edwards, Vice President of Product Development & Industrialization at kaléo. “As the inventors of AUVI-Q, my brother and I have dedicated our lives to researching and developing an innovative epinephrine auto-injector that would do for severe allergy sufferers what the AEDs did for cardiac arrest in the community; namely a product that could assist and guide even an untrained user through a life-threatening emergency.”

AUVI-Q is a compact epinephrine auto-injector with industry-first features, including a voice prompt system that guides a user with step-by-step instructions through the delivery process, and a needle that automatically retracts following administration. AUVI-Q is engineered to help patients and their caregivers to confidently administer epinephrine in life-threatening allergic emergencies.

After regaining the rights to AUVI-Q, kaléo conducted a thorough manufacturing assessment and invested in new technology and quality systems to ensure accurate, reliable and consistent delivery from the product. AUVI-Q is manufactured on an intelligent, high-tech, 100% automated robotic production line with more than 100 automated quality checks on each AUVI-Q, ensuring a streamlined and consistent production process.

Eric Edwards M.D., Ph.D, Vice President, Product Strategy at kaléo, added, “As a patient and parent of children with life-threatening allergies, I know how the moment of an allergic emergency can unfold- with panic and fear- and that is why I believe and trust in AUVI-Q, not only for myself, but also for my children and other families who might have to depend on it. Driven by this reality, kaléo strives for flawless manufacturing to ensure each AUVI-Q is built to exceptional quality standards.”

Kaléo is aware of the epinephrine auto-injector access and affordability challenges confronting patients and is working to engage with various stakeholders, including wholesalers, insurance companies, pharmacies and pharmacy benefit managers, to ensure that all patients regardless of insurance coverage, have affordable access to AUVI-Q.

“We believe that patients should have options when it comes to epinephrine auto-injectors for life-threatening allergic reactions,” said Spencer Williamson, President and CEO of kaléo. “When a health care practitioner prescribes AUVI-Q, determining that it is best for a patient, we believe that the patient should be able to obtain the product without insurance barriers or being subjected to a high out-of-pocket cost. As we prepare to make AUVI-Q available once again in the United States, our priority is to return AUVI-Q to the market as an epinephrine auto-injector alternative that all patients can afford.”

“We are very excited about patients once again having a choice in epinephrine auto-injectors,” said Eleanor Garrow-Holding, President and CEO of the Food Allergy & Anaphylaxis Connection Team (FAACT). “As food allergy advocates and families personally affected by food allergies, we understand that each person with food allergies has individual needs and comfort levels. Those living with life-threatening allergies deserve innovative products and choices that meet their individual needs. As such, we are grateful that patients will have options when selecting their potentially life-saving epinephrine auto-injector.”

The latest updates regarding the return of AUVI-Q will be available to members of the public who register online at www.auvi-q.com.

About Anaphylaxis

Anaphylaxis (pronounced ana-fuh-lak-sis) is a serious allergic reaction that happens quickly and may cause death. Anaphylaxis can occur as a result of exposure to allergens including tree nuts, peanuts, milk, eggs, fish, shellfish, soy, wheat, insect bites, latex and medication, among other allergens.

About AUVI-Q

AUVI-Q^® (epinephrine injection, USP) Auto-injector is a prescription medicine used to treat life-threatening allergic reactions, including anaphylaxis, in people who are at risk for or who have a history of serious allergic reactions. AUVI-Q contains epinephrine, a well-established, first-line treatment for severe, life-threatening allergic reactions that occur as a result of exposure to allergens including food such as peanuts, tree nuts, fish, shellfish, dairy, eggs, soy and wheat; insect stings or bites; latex and medication, among other allergens and causes.

Invented by twin brothers Eric and Evan Edwards, a physician and engineer who each suffer from life-threatening allergies, AUVI-Q is a compact epinephrine auto-injector with industry-first features, including a voice prompt system that guides a user with step-by-step instructions through the epinephrine delivery process, and a needle that automatically retracts following administration. In emergencies such as anaphylaxis, it is often individuals without medical training who need to step in and deliver potentially life-saving rescue therapy. AUVI-Q was designed – through careful analysis of the situations where epinephrine is used and with significant input from the allergy community that relies on it – to reflect Human Factors Engineering (HFE). HFE is about designing products or systems that are easy to operate and, most importantly, support correct use, with the goal to remove the potential for error.

Please see the full Prescribing Information and the Patient Information at www.auvi-q.com.

You can learn more about Kaléo, a privately-held company headquartered in Richmond, Virginia here www.kaleopharma.com.

You are encouraged to report negative side effects of for any prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

October 13 2016

Food Allergy Risks: One Autoinjector or Two?

Sarah Chapman Food Allergies, Food Financials 0

As the #epigate crisis hits American families, families in the UK find themselves battling their own issues when it comes to carrying a life-saving device. We are very grateful for our friend and colleague, Sarah Chapman, winner of the Allergy Hero UK award, for this article and her work to keep food allergy families safe.

This is the new and disturbing guidance that has been announced by the British Society for Allergy and Clinical Immunology (BSACI) at their annual meeting this September. Their proposal to change, for those qualifying as being at low risk of requiring a second auto injector, to only have prescriptions for one.

This directly contradicts all previous advice given to those at risk of anaphylaxis, and the Regulating Medicines and Medical Devices Agency (MHRA) still advise patients to carry two. The two main allergy charities in the UK, The Anaphylaxis Campaign and Allergy UK continue to recommend that we follow this guidance from them.

On examining the guidance from BSACI the qualifying statements have created a storm of controversy with the allergy community on social media.

This guidance for children of school age recommends that one auto injector for school and one for home with the following exceptions: obesity, far from medical help, or previously had a life threatening reaction or if previously required the use of two auto injectors.

The guidance for adults explains that the “carrying of adrenaline long term is not required if the trigger can be avoided, even if previous reactions were severe, for example oral prescription drugs, or when food can be avoided.”

In response to this new expert advice has not been received well by those on social media, and in response a new hashtag has now been started #carrytwo it is rapidly gaining in campaign style with many horrified parents and adults with allergy making their feelings known. Many are scathing of what they consider to be a blatant attempt to cut the NHS costs for auto injectors.

Patients in the UK face many difficulties in getting medical support for allergies and feel that it is ironic that the very people who wrote the Unmet need in 2005 (published from the Royal college of physicians explaining the poor care for the allergy community within the NHS) have also published this new carry one advice.

Fear has rapidly been felt at the idea that a reaction may not be halted with one auto injector, when faced with a long wait for medical support. There can be long delays during peak times for ambulances to arrive. Misuse of an autoinjector, fingers in the way or not holding to the thigh long enough for the epinephrine to enter the body, are anecdotally reported.

The very idea that food allergens are easily avoided is regarded as nonsense by many on social media, those who live with allergies have reactions despite continued attempts to avoid.

Many comment that the only reason they live the a normal life is because they have two auto injectors with them at all times. As a parent who has a now adult son with many allergies who had a near miss last year and needed both his jext pens to save his life, I feel that the only reason my son is alive is because of those two jext pens. His previous reactions only required one.

I urge everyone to globally support the #carrytwo campaign, and give personal examples when your auto injectors were needed. There is a dual benefit, support our wish to change this new guidance and firmly get #carrytwo embraced in everyone’s minds. It also will underscore as a reminder to everyone to carry their auto injectors! A plus for everyone! Remember #carrytwo and link #BSACI feel free to follow Sarah Chapman @sarahjchapman on twitter.

Link to the BSACI

http://onlinelibrary.wiley.com/doi/10.1111/cea.12788/full

https://assets.publishing.service.gov.uk/media/54730805ed915d1380000045/con418524.pdf

October 7 2016

Seven Reasons Why the Epipen Crisis is Grimmer than You Know

Jill Negro Food Allergies, Food Financials 0

Guest article written for RobynObrien.com by Jill Negro.

By now, you may get a little sick to your stomach hearing about Mylan’s wrongdoings. Well, it is even worse than most media is likely aware of, and has reported. I am a mom of two boys who require Epipens for nut and egg allergies. They need, at bare minimum, one for home and one for school, each. We spend thousands of dollars on Epipens each year. Yes, this is with insurance. Yes, this is with Mylan’s “free Epipen” coupon. Yes, this is including the new “$300” coupon. Yes, our insurance does cover them—but, subject to our $5,200 deductible. Yes, this is typical of most families with food and other allergies.

I also happen to have a background in health insurance and am, unfortunately, intimately familiar with Epipen price gouging and its impact on the many families like mine. It is ironic that I am Mylan’s target market. And I am also the mom crying at the pharmacy because we can’t afford our children’s prescriptions.

Now that we got that out of the way, here are a few important facts you’ve likely not have read or known:

1. The patient assistance program does not apply to most patients. Mylan’s initial response to this crisis, and make no mistake, it is, indeed, a crisis, despite what Mylan would like you to believe, was to increase the patient assistance program income eligibility limit. I had a glimmer of hope. Until I read the fine print: “The patient must not have prescription insurance coverage through Medicaid, Medicare Part D, TriCare, a qualified health plan purchased on a state-based, partnership, or federally-facilitated Exchange, or any other public or private program or insurer. Verification documents will be required.”

Did you catch that? Mylan is touting the patient assistance program as an answer to the problem of patients and parents with high deductible health plans who can’t afford Epipens for themselves or their children—yet, people with any health insurance, high deductible or otherwise, are not eligible. Since the uninsured population is quite small these days, this “assistance” actually applies to very few (if any).

2. The new, $300 coupon, available for “certain people” expires in less than three months. Mylan has not said whether the coupon will be available beyond the December 31, 2016 expiration date or not. Are they simply hoping the bad press blows over by then? My own family won’t even be able to actually use the coupon because we need to refill our script in January, in order to get the longest time with our Epipens before having to shell out thousands more again next January.

3. The $608 wholesale acquisition cost you see in the media is actually hundreds less than what most patients are paying. Customers pay retail, not wholesale. According to many upset moms across the country I’ve heard from, the costs are now much closer to $800 and up. The Mylan CEO said very little to clarify this, other than indicating in a prepared statement that a “minority” of customers may have paid wholesale acquisition cost, or more. She did, arguably purposefully, not distinguish just how much more that cost really is.

When I last called our local pharmacy, they quoted $743 per box. In order to make sure we have coverage for both of my young kids at home, preschool, and activities we need four boxes, at absolute minimum, and realistically six, if we want to be sure there is one available at all times wherever they are. Next year, when my older son starts elementary school, I’m told that if he wants to play any sports another, separate Epipen is a requirement. If you’re counting, that’s $4,458 for the six boxes we need to keep my kids safe. This is a yearly expense.

Even if Mylan extends the $300 coupon beyond December, it still only brings us back to what we last paid in June, nearly $500 a box. And it is still thousands more than what my family, and most families, can afford.

4. When the $300 “generic” Epipen comes out, no one knows how, or if, it’ll be covered by insurance. Also, for the majority of families who need multiple Epipens for multiple children, this is still thousands of dollars. In addition, it is an extremely high price for a “generic,” off-patent drug. By all accounts, we are talking about a very old, dirt cheap medication housed in a device created by government funded dollars 40 years ago.

Mylan continues to cite “increased awareness” as a reason for their astronomical increases: But is it awareness or advertising? I certainly did not need to be made “aware” that my 11 month old broke out in hives at a restaurant, or that my nephew had trouble breathing after a mild exposure to peanut residue. Our allergist was prescribing Epipens long before Mylan acquired the drug from Merck. They cite increased Epipen prescriptions as proof of this “awareness” without noting that the prevalence of food allergies in children has also been increasing to now 1 out of 4. This is a statistic that Mylan is capitalizing on.

Bresch also loves to talk about the “free Epipens for schools” program, although it does nothing for families who have children with documented allergies who are required to have their own, current prescription, in their own names, in order to even be able to attend school. As Senator Blumenthal indicated in his press conference, you can’t require schools and parents to purchase Epipens and then price gouge them on it. He correctly noted that Mylan is taking advantage of the 2013 law that they lobbied for. While I am certainly happy that schools must stock emergency Epipens, and that they must provide staff training, subsequently increasing the Epipen cost beyond what my family can afford is forcing us to choose between our children’s most basic needs and their Epipens. What would you choose?

Additionally, the “enhancements” to the device mechanism, basically that the needle is covered after injection, has turned out to likely be a minimal investment, according to experts.

Mylan also states they’ve had costs from researching how to extend the shelf life. And lo and behold, they’ve been successful in doing so…but why did it take a congressional hearing for anyone to even hear about this breakthrough?

5. The shelf life for the actual patient is 4- 6 months less than what Heather Bresch admitted, under oath. In the congressional hearing, Bresch stated that the shelf life is 18 months. What she neglected to clarify is that by the time patients pick up an Epipen from the pharmacy, there are usually only 12 of those 18 months left, sometimes less. I’ve never gotten more than 13 months out of our Epipens, and I always ask for the latest expiration available. I feel Mylan intentionally misled congress by saying 18 months and not disclosing the lag time between when the Epipen is manufactured, and when we can pick it up, leaving us one year. In fact, I have a friend who recently only had 6 months before having to buy new Epipens for her 2 year old son.

6. This direr crisis applies to the majority of people with life-threatening allergies. A huge point of frustration for many moms in food allergy networks across the country is Mylan’s insistence that “most” people get Epipens for $100 or less, or even free. In fact, Mylan likes to estimate 85% of consumers, yet no one knows where this number is coming from, or how it could possibly be true. It is certainly not true for the vast majority of my friends’ families, nor the majority of moms I’ve spoken to who are crying out for help. It also does not take into account the many people who leave their Epipens at the pharmacy because they can’t afford them. I alone have three friends who have sadly done just that. They are taking a gamble on their lives. All three are moms.

Importantly, there are also most likely many people who simply wait to fill Epipens until they’ve met their $5,000, or $6,000, or $10,000 deductible. I’ve done this myself. Why? Because we can make payments to our doctors and hospitals. Epipens require thousands of dollars of cash, up front. Why is this important? Because many of us are keeping expired prescriptions at home until we meet those deductibles, or until we can afford to buy more. And again, this puts our children’s lives at risk. The situation is much grimmer than Mylan would like you to believe: My friends and I are risking both our and our kids’ lives—because we simply have no choice!

Further, even if your Epipens are well-covered by your insurance plan that cost is most definitely coming back to you, whether you realize it or not, or whether Mylan admits it or not.

7. Bresch testified, falsely, under oath that the increased cost to insurance plans for people who are lucky enough to pay only a copay for their Epipens would not subsequently come back to consumers with an associated increase in health insurance premiums. That is exactly how insurance works: Healthcare costs go up, premiums and rates go up—or cost sharing, i.e. deductibles and coinsurance and copays, go up. While I do have 10 years of experience in health insurance, this is not exactly an industry secret, but common knowledge, which also happens to be frequently reported on. Did Bresch really not know this as CEO of a major drug corporation?

Let’s give the benefit of the doubt and simply think about it for a minute. What happens if you’re in a car accident? Multiple car accidents each year? Do your car insurance premiums go up or down? Do people purposely avoid putting in car insurance claims to avoid an increase in their insurance costs? Why, yes, they do. Having multiple children with food allergies who require multiple Epipens per year is like having 4-6 accidents per year, every year, year after year…most likely for the rest of their lives. Except what just five years ago was the equivalent of a fender bender, is now like being rolled over five or six times per year by a Mack truck, through no fault or choice of one’s own.

To be fair, while having one, or even a few, increased costs won’t necessarily cause a sole individual’s premium to go up, higher claim costs DO cause increases in premiums; it’s just that it’s not only for you, but everyone covered under the plan–most especially since these are predictable, yearly expenses. Does that make price gouging better? No. It simply means we are ALL paying. And some of us twice because we are also taxpayers paying for services such as Medicare, Children’s Health Insurance Programs (CHIP), and Medicaid. How do you like them apples? Are you outraged, yet? Because if you’re not, you should be.

Offering a $300 “generic” for some, while forcing others—insurers and the government—to pay $700-800, absolutely causes premiums and rates, and/or copays and deductibles, to go up for EVERYONE. The insurer will not simply absorb that cost increase out of the kindness of their hearts. After all, they’re indebted to their shareholders, too. And do you suppose that any company in America can, and would, and even should, absorb the skyrocketing cost from blatant price gouging? Would you be happy to know that if not passed onto you, it must come from somewhere else? Perhaps your bonus? Perhaps your salary? Perhaps your job? Or would you like to instead sacrifice your child’s life?

What options do we have? I was recently invited to share my family’s story on Dr. Oz, and he talked about one alternative: generic Andrenaclick. As you can see, GoodRx coupons for Walmart are, hallelujah, currently about $144 per box. However, this appears to be without insurance. If I’m paying about $700 out of pocket, I would want it to be applied to our deductible so that it is not an added cost on top of the $5,200 we pay out of pocket, but it’s still clearly a huge relief and improvement over paying $4,000 or more all at once. And while it’s unclear at this point if the generic Adrenaclick is an option for our family, since I need to talk to our doctor, you better believe I don’t want to give Mylan any more of our money.

September 21 2016

A Letter from a West Virginia Father and Paramedic about EpiPen Price Gouging

Robyn O'Brien Food Allergies, Health 0

In the last few months, we have heard from families around the country, but perhaps some of the most poignant messages we’ve received are from families in West Virginia. They have watched this story unfold firsthand. As you can imagine, some of the conversations around dinner tables in West Virginia are tough.

So when we received this amazing and heart-felt letter from a father and paramedic in West Virginia eloquently voicing his concern with Heather Bresch and Mylan for their EpiPen price gouging practices, sharing the personal nature of the political issue, we felt it was really important to share.

We are so grateful for all who are speaking out on this issue, as it brings an awareness not only to the skyrocketing price of EpiPens but also to the number of families around the country on both sides of the aisle now struggling with this condition.

Hello Robyn,

As a West Virginia native, born in Wheeling and currently living in Morgantown, WV, I would like to voice my opinion on the EpiPen marketed by Mylan Pharmaceuticals.

As you know Mylan is located here in Morgantown, is well-known as being one of the largest employers in this area and has recently come under fire for the scandal associated with the exorbitant price hikes of their proprietary “EpiPen.”

This issue is near and dear to my heart. I was a paramedic for 30 yrs in this state and know the outcome of untreated anaphylactic shock. This can result from many allergen exposures such as bee stings, shellfish and closest to me, peanuts. My youngest daughter is allergic to peanuts, as are a growing number of children across America each year. As a family, we have had to purchase EpiPens for years to keep close in case of accidental exposure when she was away from home and I always carried a back up with my first aid gear. All schools require parents of children with life-threatening allergies to provide them with an EpiPen, a copy of the prescription and training on how to administer it each school year in cases of emergency. This means that we had to purchase not one EpiPen but multiple devices that could be kept at school when my daughter was younger, one for her to carry with her as she got older and one to keep at home. Another factor to consider with EpiPens is that they have an expiration date, so whether they are used or not, they must be discarded within this timeframe and new ones purchased to be kept everywhere they are needed. We had decent insurance at the time but even with our copay, the devices could be costly when considering the need for purchasing multiples every year, and that was before the recent price hike.

When the facts are broken down, the EpiPen is nothing more than a glorified delivery system for an extremely inexpensive drug that in many cases has the potential to save lives. While I can fully understand the need for companies to occasionally increase prices for certain products based on higher costs required to make and market the product, I cannot fathom the need for a 400% increase in recent years of a device whose main component is a drug that costs around ONE DOLLAR per device. What astounds me even further is the true reason behind the price hike… The increased profit will undoubtedly not be funneled to the workers on the production lines or the creation of more jobs to produce the product or even charitable contributions to find cures for any number of diseases, but as I understand it, at the root of this entire scheme is greed on the behalf of one person at the top of the food chain at this company. The following is an excerpt from an online CNBC article: “As the full retail price for the device rose to more than $600, Mylan CEO Heather Bresch’s annual compensation has soared more than 700 percent, to $19 million. And Bresch, whose father is U.S. Sen. Joe Manchin, D.-W.Va., last year orchestrated a re-incorporation for Mylan in the Netherlands. That so-called inversion will net Mylan a nice break from U.S. taxes despite the fact that its main offices are in Pennsylvania.”

In my humble opinion as a caregiver and father, this act is nothing less than criminal. The substantial price increase causes a huge hardship for families with no other option but to purchase the EpiPen and knowing that the sole reason behind this act is the sheer greed and selfishness of one person, Heather Bresch, is simply unforgivable.

I wholeheartedly believe that Heather Bresch of Mylan Pharmaceuticals is taking every advantage of cornering the market with her monopoly of this product and the recent news reports of her mother, Gayle Manchin, spearheading an effort to encourage schools to purchase epinephrine auto injectors is despicable. I sincerely hope that no lives are lost as a result of families not being able to afford a dollar’s worth of epinephrine, all over a little bit of money.

Mike Katona