10/28/15 – All Auvi-Q Epinephrine Autoinjectors Recalled

Today Sanofi US announced a large scale recall of their .15 and .3 mg epinephrine autoinjectors.  A few folks subscribe to this blog because of the pricing and expiration date updates I’ve provided about autoinjectors so I wanted to link to their announcement right away: http://www.news.sanofi.us/2015-10-28-Sanofi-US-Issues-Voluntary-Nationwide-Recall-of-Auvi-Q-Due-to-Potential-Inaccurate-Dosage-Delivery

auviqrecall

I’m disturbed that I learned about this via twitter even though I’ve registered for emails from Sanofi about the Auvi-Q and received an email from them on October 22 reminding me to use discount cards before they expire.

auviqemailoctober22

Questions folks have right now include:

  • What autoinjector do we get in the meantime if we’re returning recalled ones?
  • Do we need a new prescription?
  • Will Sanofi reimburse for replacements and if so, do they have to be of the same brand or can they be for a competitor model?
  • Will the failures as reported be confirmed and if so, how?
  • Will the expense and public relations fallout mean even higher prices for Auvi-Q in the future?
  • Are expired Auvi-Q models affected or those only within the current expiration date range?

Also, the wording of the announcement has a lot of people confused because it talks about specific expiration dates and then also says all injectors on the market are impacted.  The announcement also talks about hypersensitivity which is odd wording.

You could view the recall as being in an abundance of caution and therefore showing how sensitive Sanofi is being to consumers or you can wonder about the timing and the lack of actual clear instructions for how to handle the issue.  People who have relied on EpiPens may be saying “told you so” while those who embraced Auvi-Q may be wondering about making a switch, we still don’t know enough at this point except that how this is handled going forward will certainly impact consumer perceptions.

The costs of replacing medication, between new doctor’s appointments for prescriptions, potentially missing work or school to sort matters out, and more are factors that Sanofi can’t control.  I have preferred the Auvi-Q in form and function since it was released but will be sending my daughter to school tomorrow with a set of EpiPens.  The sheer expense of a mid-year replacement (ie, replacing the EpiPen with an Auvi-Q if new batches ship) make reverting back to the Auvi-Q another year away for us.

No matter what take we have as the story develops, safety is always a priority.  Though I’m no medical expert or professional, my standard operating procedure for food allergies is: Avoid allergens and respond appropriately in the event of known ingestion or a reaction.  Always carry two autoinjectors and practice your allergy action plan.  If all you have is an Auvi-Q in the event of a reaction before you can replace it, use it.  The same goes for using an expired autoinjector – if it is all there is and there’s no time to waste, use what you can safely use.

A Contract of Adhesion (or: Paying for Priceless Medicine)

A Contract of Adhesion (or: Paying for Priceless Medicine)

In law, the term “contract of adhesion” refers to a deal between parties that are so disparate in their bargaining power as to leave one of them with all the say-so and the other with no other option but to go along with the terms.  Contracts need not be written, a contract is an enforceable promise.  So while some specific laws may require something to be in writing (say, an agreement regarding selling or buying a house), other contracts can exist just from the moment promises are exchanged (like one person promising to do work and the other person promising to pay when the work is performed).

In its own way, purchasing an item at the store is a contract.  You are paying some agreed upon amount and in exchange you receive rights to that item.  Sometimes the rights are broad, such as if you buy a tomato you can eat it right away, cook it, give it away, or forget about it on your counter.  Other rights are limited, such as if you pay for prescription medication, you have the right to use it as directed for the named person.

These types of agreements exist and are often enforceable because there are situations where the bargaining power is unfairly held and there’s nothing one can do about it.  Contracts of adhesion are on my mind as I contemplate rising costs for epinephrine here in the US and a dearth of choices in response.  In other words, I am wrestling with news that Auvi-Qs in the United States have gone up in price.

Increasing Costs (Approx. $200 Increase!)

I read every comment that comes through on the blog and so appreciate the updates I get from readers about food allergy issues.  One hot topic in this space centers around epinephrine auto-injectors.  A while back I was upset to find that I could not buy an injector for my daughter that did not expire too soon.  I have to pay cash prices for medication under our insurance so all the coupons and promotions out there would not defray the costs we faced.  Some families have multiple sets of auto-injectors, we have one set and my daughter also has self-carried (when away from me) since age 4.

At any rate, here’s the detailed comment that came through from a reader named Kelly:

I’m coming into this thread of comments almost a year late, but I wanted to share how helpful Sanofi was regarding the short expiration dates on Auvi-Q. I purchased a 2-pack of Auvi-Q in August 2014 with a March 2015 expiration date. The retail cost at that time was $396 at RiteAid. I purchased another 2-pack in September 2014 with an expiration date of May 2015. Same price…$396 at CVS. I contacted Sanofi by telephone and told them I was disappointed that the expiration date was so soon, and they connected me to someone who asked a few questions, then gave me an email address and instructions to send a picture of the Auvi-Qs with the expiration date and the pharmacy receipt and that they would send me a coupon for $400 per pair to be used between January 2015 and June 2015. Within two weeks I received two $400 coupons toward my next couple of Auvi-Q prescriptions. Just last week I used the first coupon, assuming at $396 the new set would be at no cost to me. I was shocked to learn that the retail price of a set of Auvi-Qs was now $569.99! [Sanofi] covered $400, my insurance covered $120, and my co-pay was $50. I’m not sure if there’s a “game” with the cost of prescription meds when a coupon is being used, but I was quite surprised at the increase in price in only six months. But then again, epinephrine is priceless when it comes to anaphylaxis…

It was Kelly’s last line that got me thinking – how even after appreciating the process for the $400 voucher, and detailing the price increase as observed, there’s acceptance of the cost, whatever it may be, for epinephrine.

Epinephrine is priceless.  We can agree on that point for certain.  You can’t put a price on a life, etc. etc. but going back to the idea of disparate bargaining power, therein lies the imbalance.  Taking it a step further, and to an issue that troubles me, there are those that are prescribed epinephrine and never fill the prescription.  (Source)  The 2013 Medscape article “Anaphylaxis Death Rate Down, but Epinephrine Use Poor” looks at some statistics out of Canada:

Of the 80 deaths recorded in Ontario, Canada from 1986 to 2011, only a quarter involved the administration of epinephrine prior to cardiac arrest, including that by emergency medical personnel, Ya Sophia Xu, MD, from McMaster University in Hamilton, Ontario, reported […]

Of the 80 people who died, 47 had a known or suspected allergy to the fatal allergen, but only 18 had been prescribed an epinephrine autoinjector and only 9 had their autoinjector at the time of the reaction.

Additionally, at least 8 of these people received epinephrine that was either expired or administered incorrectly.

I’d take it an anecdotally based step further and add that there are also those that hesitate to use the injectors they have when every minute is crucial and even those that split up injector two packs to avoid the cost of purchasing a second set.  (See my prior post: When a School Tries to Split Up Epinephrine Auto Injectors).  There are also those that just don’t make the initial purchase at all.

Education regarding recognition of anaphylaxis and use of epinephrine is very important.  Even so, I’ve even had allergists remark that people hesitate to use epinephrine because they don’t want the ER bill that may follow hospitalization secondary to use of the injector.  This of course would be a fallacy where the use of the injector is associated with the hospitalization rather than the allergic emergency, but I know there’s a tendency to convince ourselves a reaction isn’t really happening because we just don’t want to be in that situation.

Dollars and Sense

Operating from the starting point that we should absolutely have and use epinephrine auto-injectors as prescribed and as indicated by circumstances, practice with them, and refill prescriptions when they expire – do we have any voice when it comes to the out of pocket costs imposed by a food allergy diagnosis?

An article from August 2014 delved a little deeper into the money issue and found that the price actually went from $35.59 for an EpiPen in 1986 to $333.00 in 2014.  I paid, with a $100 copay assistance card, $233.86 for the Auvi-Q (with a deficient expiration date), last year.  In the article, “Anaphylactic Sticker Shock” by Terry J. Allen, the focus is on the cost of the EpiPen in the United States versus Canada:

[…] I thought of the nice Canadian pharmacist’s sadness at my having to fork out $94—until I told him how much more EpiPens cost only 10 miles south. “But why?” he asked. Good question, monsieur.

Ms. Allen’s article references a 2012 New York Times article entitled “Tiny Lifesaver for a Growing Worry“.   I went looking and found that the article appeared in the business section of the NYT.  In the piece, Heather Bresch, Mylan’s Chief Executive, refers to just 7 percent of those who need it carry a prescription.  That was a statistic referenced just 3 years ago and seen as not only a market opportunity for Mylan, but for competitors.

(In the interest of disclosure, as I’ve mentioned elsewhere, I did go in April 2014 to Mylan HQ on their dime for a gathering of food allergy advocates.  I found the experience informative.  Mylan and Sanofi were both sponsors of the Food Allergy Bloggers Conference here in Las Vegas in 2013 and 2014 before I stepped down from involvement.)

As a consumer I read the market opportunity as one for competition that would benefit consumers but what if everyone is competing for that 7% (or what have you) of users instead of expanding into untapped groups?  I hesitated to post any of this as Nevada’s legislature is working on expanding stock epinephrine (a measure I wholeheartedly support).  I also, much like the debate I referenced in a recent post, didn’t want to be perceived as harming entities that do take supportive actions of the food allergic community.  Then I thought to myself that the barriers to access presented by expense are a strong reason to continue to support stock epinephrine even though the push for these measures comes from dollars in the coffers of companies paid hundreds of dollars for their devices.

Mulling it Over

As usual, I don’t have a conclusion that satisfies me here.  I turn to research and try to make sense of my own feelings at the same time.  Am I  re-directing anger at my powerlessness every time my 6 year old utters, “Mama, I feel left out” at what should be innocuous childhood interactions?  Am I veering into politics on the subject of business and whether a free market can exist where the big is favored over the small?

I worry that my agitation over the expense of food allergies, whether it is for special food or life saving medication, means I am not grateful that the special food exists or that there are companies willing to provide easy to use auto-injectors and pour staggering amounts of money into marketing them, even assisting with legislative efforts to support stock epinephrine.  I worry that I’m putting a price on my daughter’s life.  Should I gladly pay whatever is necessary for a six to twelve month safety measure?

I have justified paying an already higher cost for the Auvi-Q in the past because I genuinely like it.  My daughter likes it.  I’ve met representatives from both Sanofi US (Auvi) and Mylan (Epi) and they’re just hardworking people like anyone else.  On an individual level, I’m not saying there’s a lack of care.  But I’m also a businessperson, and a glass half empty sort at that.  A narrative is a story but it is also a sales pitch.  If companies are happy to extol the success stories of lives saved by injectable epinephrine, where are the initiatives for access beyond stock epinephrine legislation for limited spaces?  There’s a disconnect as well between the physicians who prescribe medication and the delivery of the medication to the patient.  I always tell physicians what the tests or medications they specify end up costing and they show surprise.  But those doctor’s visits carry a cost in and of themselves, after all, so the joke’s on me.

There’s always the default answers one could turn to, like saying this is the state of medicine in the United States or it is just business.  I think at the end of the day I’m allowed to be frustrated, I’m allowed to vent, and then trot down to the local pharmacy and pay up like everyone else.  I just wish if I’m going to over-pay for a product I knew an actual injector was being put in the hands of someone that couldn’t afford it by virtue of my willingness and ability to pay that increasing price.  (Note: Selena Bluntzer at Amazing and Atopic does detail patient assistance programs that may assist some families in affording Auvi-Qs as well as information about generic epinephrine options that are worthwhile reads.)

The way I feel right now, I want to walk away from our Auvi-Q and go to the most cost-effective option, but the rub is that I have a 6-year-old that doesn’t see her medication as some liquid in a tube or credit card shaped case, she sees a lifeline.  Given that my hope is that each year’s supply passes unused into our medicine cabinet stash of expired auto-injectors, the Auvi or Epi is not so much about the epinephrine inside but instead the symbol of being prepared for what may happen in the wide world.  Even I can feel the difference in the weight of my purse with or without her injectors, and know she’s somewhere else by the absence of it.  I was explaining what “ATM” meant to my daughter on Saturday and how the “auto” prefix also appears in words like “autobiography.”  She interrupted me to offer that it was also in “auto-injector.”  Auto-injectors are a huge part of our daily life and are here to stay.

What Next?

What I want to do is something useful, something concrete. I don’t know what that is yet but I wanted to put this out there for discussion before I talk myself in too many circles.

Now that I’ve railed on for several hundred words my blood pressure is calming and I can see myself refilling our prescription for the Auvi-Q because I don’t feel like I have a choice.  I am suddenly presented with the thought that refill time is an especially sensitive time for food allergy families because it often coincides with an anniversary of a diagnosis.  I remember so vividly getting the call that my daughter’s blood test results were in and I needed to immediately get her an EpiPen.  With that in mind, I want to look back next year at refill time and have accomplished something even for just one other family who may be struggling to afford epinephrine but doesn’t qualify for assistance that may already be out there.

Road trip to Canada, anyone?

Update: 3/23/15 – Check out Danya Glabau’s post – Pricing Health: Skyrocketing Prices for “Drugs for Life” – she eloquently brings her perspective as a social scientist to the pricing issue.

UPDATE – Epi-Pen and Auvi-Q Expiration Dates

(Note: see my latest post about the cost of Epinephrine here)

I wrote to both Mylan (EpiPen) and Sanofi (Auvi-Q) and shared my previous post “Epi-Pen and Auvi-Q Expiration Date Frustrations” along with the wonderful and informative comments I received from readers and received the following responses I wanted to share here.  Please, depending on which product you purchased with an expiration date that was unsatisfactory, read below (for Auvi-Q purchasers, you may be able to get a savings card that offers an up to $400 benefit and for EpiPen purchasers, be sure to call customer service).  Both companies understand that expiration dates are very valid concerns for purchasers of epinephrine auto-injectors.

AuviQandEpiPen
Child doses of Auvi-Q and EpiPen

________________________________________

Epi-Pen

From makers of the EpiPen, Mylan Specialty:

To help facilitate consumers providing us with the necessary information, please share our customer service contact information. Consumers can call Mylan Customer Relations to speak with a representative at 1-800-395-3376 or email at Customer.Service@mylan.com.

We also wanted to provide additional information related to product expiration dates to support you and your readers.

When picking up epinephrine auto-injector prescriptions, we encourage patients or caregivers to check what is dispensed at the pharmacy prior to leaving. If there are concerns about the expiration date, they should speak to the pharmacist immediately.

________________________________________

Auvi-Q

From makers of the Auvi-Q, Sanofi:

Patients or caregivers who, within the last 31 days, purchased an Auvi-Q that expires in less than 12 months are eligible to receive a savings card with a maximum benefit of $400 off one two-pack of Auvi-Q for each Auvi-Q purchase that meets the terms and conditions. Savings cards are valid for useJanuary 1 – June 30, 2015.  Patients or caregivers who purchased an Auvi-Q in the past 31 days with 6 months or less of dating may receive a replacement Auvi-Q or they can opt to receive a savings card.  For more information, including terms and conditions, patients or caregivers should call Sanofi Customer Service at 1-800-633-1610.

________________________________________

Our collection of expired Epi-Pens and Auvi-Qs, the ones in the belt are current through early next year.
Our collection of expired Epi-Pens and Auvi-Qs, the ones in the belt are current through early next year.

In the meantime, it is my understanding that both companies are following issues about epinephrine expiration dates and are taking all consumer comments and concerns into consideration.  They want to hear about issues people may or may not be having as they get prescriptions filled.

No matter what hurdles you face in filling the prescription, by the way, you need to be carrying epinephrine.  See this great post by “Marketing Mama” Missy Berggren: Why do people need to carry EpiPens? Why not just call 911?

___

Disclosure: I attended Mylan’s Summit in April but my opinions are my own – more detailed disclosure here and here.  Sanofi and Mylan have both been sponsors of the Food Allergy Bloggers Conference, of which I am a co-owner.  My opinions, as always, are my own and are not representative of my position at Food Allergy Bloggers Conference LLC or the real or perceived benefits from either company.  Representatives from both will be at the conference this September 2014.

EpiPen and Auvi-Q Expiration Date Frustrations

(Update from 7/30/14: Click here to read statements from both companies referenced below)

When we re-fill epinephrine auto-injector prescriptions it feels a little like checking a scratch card – what will the expiration date be?  I think many of you are in the same situation.

Auv-Q Purchased 5/12/14 with 1/2015 Expiration Date
Auvi-Q Purchased 5/12/14 at Target Pharmacy with 1/2015 Expiration Date

This is not a new issue, I mentioned it in my post about the most recent Legislative Healthcare Committee Meeting and in my Mylan Summit post, but as I type this is I have just returned from paying $233.86 (after the $100 copay card, Mylan has one as well) for an Auvi-Q epinephrine auto-injector set  of two that expires January 2015.  The last Auvi-Q I obtained had an expiration date fourteen months out from the date of purchase and this one is 8 months.  So I know it is possible to be 12-14 months out on an auto-injector.  Anything less than a year is a problem considering the costs for families alone and that the high cost may cause families to stop filling their prescriptions.

Our Voices are Louder Together

I am fortunate that I can pay the cost of the medication (our insurance does not cover or alleviate prescription drug costs) but that does not mean it is ideal.  I specifically requested that they order the Auvi-Q last week in hopes of getting a newer one but it was not enough.  I would love to gather your experiences and submit them to both Mylan and Sanofi as there has to be a better option in all of this. 

When I saw the Auvi-Q expiration date I asked to see an EpiPen one and it was February of 2015 to the Auvi-Q’s January 2015.  I stuck with the Auvi-Q because the voice guidance puts my daughter’s teacher at ease and because the expiration date was not that much better (February 2015).  Still a significant amount of time less than the 12 months we all aim for.  After, I called Jenny and vented and she suggested that I should have left the medicine there and called around town to find a better expiration date but we’re already 12 days into May and my daughter’s injector expired April 2014.  So here I am, hoping that when the time comes in January to obtain a refill that there will have been true changes in the system so that other families as well as ours are not in the same boat.  Also feeling grateful that I have people I can call and know they will share my frustration about things like this.

Anecdotal reports include hearing that pharmacies in town offering a discount on injectors that expire sooner (like 50% off on one that is six months out) but I don’t know which pharmacy that would be.  We only buy one set every time we need a refill because of the cost and because my daughter self carries.  I carry an expired set in my purse just because something is better than nothing as a backup.

Let’s Discuss…

At any rate, please let me know either at my email homa at woodrumlaw dot com or here in the comments about your experiences and I would like to put together a letter to both Mylan and Sanofi asking about our options.  I have a feeling that the issue is on the pharmacy side of things because reps from Mylan and Sanofi have mentioned that the dates should be at least a year out.  I am not placing blame as much as feeling baffled that if companies are telling me all pharmacies have to do is exchange older injectors for newer ones, why are they not doing it?  Why discount them or force them on consumers that aren’t going to risk not having them in the event of an allergic emergency.

Thank you in advance for your input on this one, I will keep you posted.

Disclosure: I attended Mylan’s Summit last month but my opinions are my own – more detailed disclosure here and here.  Sanofi and Mylan have both been sponsors of the Food Allergy Bloggers Conference, of which I am a co-owner.  My opinions, as always, are my own and are not representative of my position at Food Allergy Bloggers Conference LLC or the real or perceived benefits from either company. 

“Food Allergy 101 & Caregiver Training” on February 9, 2013

epi

I wanted to share for local folks that there is a great opportunity to bring a friend, family member, or caregiver for the child in your life to a free training that will help them gain a better understanding of food allergy management!  Be sure to RSVP to fapelasvegas@gmail.com soon so that they know to expect you at:

Food Allergy 101 & Caregiver Training

The event is free, from 3:00 p.m. to 4:30 p.m. at St. Rose Hospital San Martin (8280 West Warm Springs Road, Las Vegas, NV 89113) on Saturday, February 9, 2013.

One thing we discussed at the last Food Allergy Parent Education group planning meeting was what would help FAPE families.  The topic of babysitting came up – how do you trust someone to watch your child with food allergies knowing how our own road to learning about food allergy management is so ongoing?  Also, there’s a feeling sometimes when you’re giving someone the breakdown of what to do in case of a reaction, or even just what food allergies mean for your family on a day to day basis, that they probably think you’re being “overprotective.”  This is a great training to address that.  Dr. Sean McKnight of Allergy Partners (he is the allergist for many of my friends and very supportive of food allergy awareness) is offering his knowledge to attendees to help them understand all the basics.  I haven’t heard one of his presentations yet myself but based on what I hear about past events, it will be well worth your time to attend.

Also, the next FAPE playdate is in Summerlin on February 5, so check out the FAPE Events Calendar page to get the details and RSVP if you are interested!

In other news…

  • Whether you are local or not, if you’d like to sponsor a booth or even get your name on the FARE (formerly FAAN) walk shirt for 2013, there is no time like the present.  I am trying to help gather support for the event in whatever way my schedule can spare so I thought I’d mention it here on the blog.  For a $1,000 sponsorship, for example, you get a booth and recognition on the walk shirt.  The event is fun (see my recap for 2012) and well attended (they are expecting around 3,000 attendees this year).
  • The Auvi-Q is now available in the United States and I am going to try to get a prescription filled for it soon.  It is an Epi-Pen (our Epi-Pen Jr. is pictured above) competitor that is voice guided and compact (see Jenny’s post about it and Caroline’s post as well – they were both able to preview the device recently).  The best news is that the company has a discount coupon right now that will make our epinephrine refill much cheaper this year and you can obtain it at: https://www.auvi-q.com/sign-up.  In a way, this is a perfect tie-in regarding the February 9th Food Allergy 101 presentation – the idea of a voice guided injector is promising because it would offer extra guidance to caregivers at a time when every moment counts.

There are so many dedicated folks out there offering their time and energy to not just care for their own loved ones with food allergies, but to educating others and raising funds for research, that it feels really exciting.  On the other hand, I do admit I have moments where my heart feels a little broken to consider the looming threat that food allergies represent for my children.  I know we are lucky that we can “manage” food allergies to a certain extent, of course, but as we prepare for our daughter to enter kindergarten this year I keep thinking of how life-threatening food allergies are impacting our family.

I don’t mean to not end on a positive note, so I will say that sometimes we aren’t active about something we care about because when the news all seems promising we figure it has been taken care of, that perhaps our help is not needed.  This is not the case.  The more I get to see “behind the scenes” in a field such as this, the more I realize that anything you or I can offer is going to actually make a difference.  For example:  I sometimes start conversations with people at the grocery store that seem to be having a hard time in the gluten-free aisle.  Yes, just like in a product commercial where a random stranger starts gushing about their favorite cough medicine, which is strange considering I’m an introvert (and yet I have a blog, I know).  At any rate, I was looking at site stats for the blog and this link was pointing to one of my posts.  It was a bookmark on Pinterest and the pinner wrote: “As I stared completely confused by the overwhelming types of flours in the market, this sweet woman toting her 2 kiddos went out of her way to help me figure out what was best for my allergen-free diet!”  Let’s just say, reading that made my day.

So, please RSVP at the e-mail above if you can make it to the training and if you have questions about contributing to the Las Vegas 2013 FARE walk, let me know!