What You Need to Know About Auvi-Q, the New EpiPen Alternative

Here’s some welcome news for anyone with severe allergies longing for another option besides the famously overpriced EpiPen: Auvi-Q is coming back on the market in the United States in the first half of 2017, according to its maker, Kaléo.

You may remember that the device was voluntarily recalled in 2015 due to concerns that it could potentially administer an incorrect dose of the life-saving hormone epinephrine (no deaths were reported).

At that time, the high-tech product—lauded for talking you through the proper injection process—was licensed out to rival French pharma company Sanofi. But in February of 2016, Kaléo regained control of the device and implemented manufacturing safety measures, including a robotic production line with more than 100 automated quality checks. 

Still, as a parent of a nut-allergic child (one who weirdly enough had the Auvi-Q when it was recalled), my worry is: Am I sure I can trust this product to deliver the correct dose? 

That’s the question I put to the inventors of Auvi-Q, twin brothers Evan and Eric Edwards, an engineer and physician who are VPs with Kaléo. After telling me about their state-of-the art manufacturing process, Evan shares the company’s backstory: “My brother Eric and I are severe allergy sufferers and parents of allergic children. We take the quality and manufacturing of this product very, very seriously because it’s personal for us.”

RELATED: This EpiPen Hack Can Save You Money, But Is It Safe?

In fact, it was their own experience growing up allergic to almost everything that drove them to invent the device, Eric adds. “Evan and I, when we were 3, were labeled as some of the most allergic children our physician had ever encountered. We grew up allergic to all eggs, peanuts, tree-nuts, seafood, fish, shellfish, most antibiotics, all insect venom.”  

“Back in the 80s, there was not a lot of awareness. We were were those kids that had to sit alone at a table, because there wasn’t a peanut-free zone back then.” They had epinephrine with them at all times, but once they were college age, Eric admits, “We struggled to carry it. Our whole goal was to create a different option.” 

Different how? Well smaller, for one: Auvi-Q is the size of a credit card and the thickness of the average cell phone. The sleek design isn’t for looks but rather to increase the odds that it will be carried everywhere. “Unfortunately, I’ve had to respond to my own child having an anaphylactic reaction,” Eric says. “It doesn’t matter what epinephrine device you have, if it’s not readily available with you and it’s not used correctly during that moment, it could be tragic.”

RELATED: Your 12 Worst Allergy Mistakes

The step-by-step voice instruction walks you through what to do in the moment, including where to place the device (the thigh; like the EpiPen, it’s an intra-muscular injection) and how many seconds to hold in place before removing (5 seconds with Auvi-Q). “It’s about empowering people, even ones that are untrained like a neighbor or babysitter, to be able to manage that emergency situation,” Eric says. 

Because the fact is, you might not be with your child when a reaction occurs. I can’t even count how many times I’ve dropped my son at a party or soccer practice and handed the ”EpiPen” to a terrified-looking mom or dad while instructing them to jab my kid in the thigh in the case of emergency. I’ve left and panicked: What are the chances they’ll remember that?

Another safety innovation is a fully-retractable needle, designed to prevent the needle from breaking off and getting embedded in a squirming child’s leg. Other epinephrine auto-injectors are required by the FDA to include safety warnings that this could happen, according to the Edwards brothers, but Auvi-Q is not because there have never been any reported cases.

RELATED: A 24-Hour Guide to Fighting Allergies

As for the million-dollar question (or, rather, the $ 600 question): Are Auvi-Q’s going to cost $ 600? “We understand that price is central,” says Spencer Williamson, President and CEO of Kaléo. “Our focus is to assure that the out-of-pocket to the patient will be low.”

It’s comforting to know, at least, that they have reason to not cut corners. As Evan says, “We are manufacturing with this in mind: We may have to use it on our own child one day.”

What You Need to Know About Auvi-Q, the New EpiPen Alternative

CVS to Offer 2-Pack EpiPen Alternative For $110 — a Fraction of the $600 Name-Brand Price

This article originally appeared on People.com.

CVS is stepping up to help consumers frustrated with the EpiPen’s price hike.

The drugstore chain announced Thursday that it reduced the price of an EpiPen alternative, Adrenaclick, to just $ 110 for a two-pack, compared to $ 608 for the Mylan-produced EpiPen.

“We recognized the urgent need for a less-expensive epinephrine auto-injector,” CVS says in a press release. “Patients with life-threatening allergies need immediate access to injectable epinephrine. But over time, the brand-name epinephrine auto-injector pens that make it easy to quickly and safely administer the medication have become increasingly expensive.”

The move comes just days after insurance company Cigna said it was dropping coverage for Mylan’s EpiPens. A Cigna spokesperson, Karen Eldred, applauded CVS’ decision in a statement.

“It is positive news for our customers,” said Eldred said, according to NBC News. “The generic version, available now in pharmacies, has the same drug formulation and device functionality as the branded medication, but at a substantial cost savings.”

Mylan is currently under investigation by Congress for raising the price of EpiPen by 500% since they took over production of the life-saving device in 2007. Amid the outcry, Mylan said they would introduce a generic version of the EpiPen, priced at $ 300 for a two-pack.

Mylan CEO Heather Bresch told Congress that the company “never intended” for the price of EpiPens to rise to this level, and claims the hike is due to taxes.

Mylan’s main competitor, Auvi-Q, had stopped production in 2015 because of a lack of name recognition compared to the EpiPen. The company announced in October that it would resume production, hoping to provide another epinephrine auto-injector at an affordable price.

“This is personal for us,” Eric Edwards, who created the Auvi-Q with his twin brother after growing up with severe allergies to nuts, eggs and shellfish, told Forbes. “I’m a patient who may have to respond with this product not only for myself but for my child, and we are committed to making sure that Auvi-Q is going to work during an allergic emergency.”

CVS to Offer 2-Pack EpiPen Alternative For $110 — a Fraction of the $600 Name-Brand Price

Here Are the Real Dangers of Charging $600 for the EpiPen

If you are like me and rely on an EpiPen to keep you or your child safe from a life-threatening allergic reaction, you’ve probably left the pharmacy thinking, “That’s outrageous for such an essential drug.” 

Now we know exactly how outrageous it is: The price of the EpiPen—an auto-injector of the inexpensive hormone ephinephrine—has skyrocketed by more than 600% since 2008, Money reports, from around $ 100 for the standard two-pack in 2008 to more than $ 735 today. 

Fueling the fury is the fact that the epinephrine itself costs about $ 1, according to Consumerist. Even more disturbing is how much some of the executives at Mylan, EpiPen’s maker, have profited: The compensation of Mylan CEO Heather Bresch, for instance, has soared from $ 2,453,456 in 2007, when Mylan first acquired EpiPen, to $ 18,931,068 in 2015, according to NBC News.

The pressing question now is: Is this legal? Members of Congress including Minnesota Senator Amy Klobuchar (D) and Iowa Senator Chuck Grassley (R) are demanding Congressional hearings into the pharma company’s pricing practices. They’re joining a growing chorus who say that the steep price is putting some of the nation’s estimated 15 million people with food allergies in grave danger. (The devices are also commonly prescribed for severe allergies to insect stings and latex.) 

RELATED: Your 12 Worst Allergy Mistakes

Mylan has responded with a statement on their website that details the significant investment the company has made in allergy awareness campaigns and patient coupon subsidy programs. It states that the changes in insurance programs are fueling the high sticker price: ”With the current changes in the healthcare insurance landscape, an increasing number of people and families have enrolled in high deductible plans, and deductible amounts continue to rise. This current and ongoing shift has presented new challenges for consumers, and now they are bearing more of the costs.”

But more people are doing without this critical medicine. Some on high deductible plans are leaving the pharmacy without the injector, unable to pay $ 600 or more. Others are making do with just one set—even though allergists instruct you to leave an EpiPen with a school nurse, the teacher, afterschool programs, etc. Relying on expired pens and DIYing epinephrine-delivering syringes are dangerous practices, allergy experts warn.

So how can Mylan can get away with price gouging for an essential drug? EpiPen has no real competition, according to Fortune. A competing device called Auvi-Q was launched by Sanofi US but recalled in 2015 for administering an incorrect amount of the drug, a potentially deadly problem. There may be a competitor on the horizon though: an epinephrine device with a longer shelf-life is expected from Windgap Medical in 2018.

An EpiPen is something you buy and pray you never have to use. If you do need it, it is a literal lifesaver. When given swiftly and properly—you inject it into the thigh and hold for 10 seconds—it can quickly undo the airway swelling, cardiovascular events, tissue swelling, and other dangerous effects of an anaphylactic reaction. If you don’t have enough epinephrine at the ready for prompt injection, the result can be death. Some reactions require more than one injection, which is why the drug comes in a two-pack (and you are supposed to carry both with you; you don’t leave one at school and one at home, as has been reported).

RELATED: 31 Everyday Things You Didn’t Know You Could Be Allergic To

I have used an EpiPen on my younger son, who is highly allergic to tree nuts and peanuts. I know the drill, as all allergy families do: Do not go anywhere without at least two EpiPens. Do not hesitate to use the EpiPen at first signs of severe reaction, and use the second if needed. Call 911, then go straight to the ER. 

I know the benefits firsthand. It works. It saves. It is the fifth member of our family, with us at all times. I am thankful for epinephrine beyond words.

As a working parent fortunate enough to have solid health insurance, I can curse my $ 60 copay (the highest tier in my ”gold” insurance plan, and twice what it was when I started buying EpiPens in 2009) and plunk down a credit card. For back to school, I’ll spend $ 180 on three; with all the other school costs, we feel that. We can swing it though. Many, many, many families cannot.

This isn’t an optional drug, it isn’t a drug that you can safely use past its expiration date, and it shouldn’t be priced out of anyone’s reach.

Here Are the Real Dangers of Charging $600 for the EpiPen

This EpiPen Hack Can Save You Money, But Is It Safe?

Most people who depend on the drug epinephrine to treat potentially fatal allergic reactions (whether their own, a child’s, or a loved one’s) are well aware of the price-gouging scandal surrounding Mylan Pharmaceuticals’ EpiPen. And despite recent adjustments by the company to make the auto-injector more affordable, many still worry about how much it will cost to keep the life-saving medication on hand.

That’s left some people wondering if they really need an auto-injector after all. Wouldn’t it be much cheaper, some have asked, to just get a prescription for epinephrine and inject it with a regular old syringe?

The question of this so-called EpiPen hack has been raised on social media, health blogs, and even the local news. So to get an idea of how realistic this scenario is (and if it’s actually a good idea) we asked Bob Lanier, MD, executive medical director of the American College of Allergy, Asthma, and Immunology. Here are his thoughts on DIY epinephrine—the good, the bad, and the downright scary.

First things first: Do you really need epinephrine?

“The first question to always ask is whether a patient really needs epinephrine,” says Dr. Lanier. “A lot of people are given EpiPens by their pediatrician or primary care doctor because they have a positive lab test to some allergen, but they’re never really evaluated by an allergist.”

Unfortunately, this can lead to a lot of unnecessary worry. “There’s been a media blitz around anaphylaxis, and there’s concern now that every sign of hives or swelling is equivalent to potential death,” he says. “In many cases, that’s not true.”

If you or a loved one has been given an EpiPen, make sure you know it’s truly needed before you start considering alternatives, says Dr. Lanier. Once you’ve seen an allergist and your condition is definitively diagnosed, read on.

RELATED: Your 12 Worst Allergy Mistakes

DIY doses are a good idea in theory

Before 1987, when EpiPens hit the market, epinephrine was pretty much only delivered via standard syringes. “For the most part, we survived pretty well back to the beginning of time without auto-injectors,” says Dr. Lanier.

Epinephrine is cheap, and so are syringes. “I could make up a kit with a pre-filled syringe for about 35 cents that could have the same effect as a $ 400 auto-pen,” says Dr. Lanier. That’s one reason he only uses syringes himself when he treats allergic reactions in his practice.

There’s another advantage to the DIY approach, too, at least for a trained professional: While EpiPens are only available in two doses, a syringe allows for customized doses—less for small children and more for larger, heavier adults, for example. It even allows for smaller or larger needles, which can also be helpful for different size patients.

But in an emergency, there can be serious downsides

One of the best things about EpiPens is that they can be used with one hand, while measuring liquid medicine into a syringe requires two. “That may not seem like a big difference, but there are certain situations, on the playground or while you’re driving a car, for example, that one-handed operation is crucial,” says Dr. Lanier.

Not to mention, breaking open a vial of medicine and drawing out the correct dosage isn’t something most people want to be doing in an emergency situation.

“The question is, can a doctor teach someone adequately to do this?” asks Dr. Lanier. “We’ve found that even nurses have a little trouble with this, so you can imagine what it might be like for a panicked parent or someone having an allergic reaction themselves.”

We don’t have to imagine, actually: One 2001 study found that it took parents nearly two and a half minutes, on average, to draw a dose of epinephrine for infants using a syringe. Many of those doses were inaccurate, even then.

RELATED: 31 Everyday Things You Didn’t Know You Could Be Allergic To

Can’t my doctor make me a pre-filled syringe?

Carrying a pre-filled syringe everywhere you go can solve some of these problems, Dr. Lanier says, but they bring up additional concerns. A teacher or school nurse may be unwilling to inject a syringe of unknown material into a child, for example. Even if a doctor or pharmacist labels it and includes prescription information, the process would be more daunting for a typical bystander than the practically foolproof EpiPen.

(Then again, Dr. Lanier says, many people are afraid to use the EpiPen. “People show up all the time at the ER with the auto-pen in hand, wanting for someone else to do it for them,” he says. “In that sense, a syringe kit may not actually be that different.”)

Epinephrine can also be easily damaged by light and heat, so a DIY kit would have to be prepared and carried very carefully, and refilled more often than an EpiPen, in order to make sure the medicine doesn’t become ineffective.

Preparing a pre-filled syringe could also open doctors and pharmacists up to legal challenges if something did go wrong with the medication, Dr. Lanier adds. As a matter of fact, he says, pre-filled syringes used to be commercially available until a few isolated problems forced the manufacturers to shut down.

Dr. Lanier recommends that people talk with their doctors about the pros and cons of these low-cost alternatives, and decide together whether they’re worth considering.

“I think the chances of an average family physician or pediatrician prescribing this option are remote,” he says. The possibility of an allergist prescribing it to a well-established patient, he adds, is much better.

Which takes us back to Dr. Lanier’s original point. “First and foremost, you should only be considering this if you have a condition serious enough to be seeing an allergist,” he says. “Once that’s established, a doctor who knows your condition can help you decide what’s best.”

This EpiPen Hack Can Save You Money, But Is It Safe?

Mylan to Offer Generic EpiPen

MONDAY, Aug. 29, 2016 — A cheaper generic version of the emergency allergy treatment EpiPen will be made available within the next few weeks, manufacturer Mylan said Monday.

In the wake of mounting criticism over recent price hikes, the company said the generic version will be distributed by its U.S. subsidiary. It will have a list price of $ 300 for a two-pack, compared with $ 608 for the brand-name version. The generic version will be available in both 0.15 milligram (mg) and 0.30 mg strengths, the Associated Press reported.

EpiPens are used to treat anaphylaxis — a severe, potentially fatal allergic reaction to insect bites and foods like nuts and eggs.

The auto-injection device, which contains the hormone epinephrine, expires after a year. Since most users need several — one for home, and one for school or work, for example — the costs can mount up.

With just one competitor, Mylan has a near monopoly on the device. Now, the company is being accused of price gouging after significantly increasing the EpiPen price in recent years.

The list price for the pack of two was a little more than $ 100 when Mylan first bought the device in 2007. Most of the increase — from $ 265 to more than $ 600 — has come in the last three years, The New York Times reported.

Health insurance doesn’t necessarily help all people who need EpiPens, because those with high deductibles must pay almost the total price.

Some politicians have called for: Congressional hearings on the escalating pricing, an investigation by the Federal Trade Commission, and action by the U.S. Food and Drug Administration to increase competition by hastening approvals of competitors’ products, the AP reported.

EpiPens have been marketed since the 1980s, and some observers have also questioned why Mylan still holds a patent. The patent applies to the device itself, not the active ingredient.

At least two companies are seeking approval to sell a rival brand or generic version of EpiPen in the United States, but none are likely to be available until later next year.

However, the compounding pharmacy Imprimis Pharmaceuticals said it may have a version available for individual patients in a few months. It said it would likely charge about $ 100 for two injectors, the AP reported.

More information

The American Academy of Pediatrics has more about treating anaphylaxis.

Mylan to Offer Generic EpiPen

For my daughter, the EpiPen is a lifeline, not a luxury | Liz Richardson Voyles

This month, pharmaceutical company, Mylan, crowed that they smashed second-quarter expectations; with earnings of $ 2.56bn, up 8% from the year before. Their CEO’s salary has ballooned 671% over the past eight years. The corporation was able to accomplish this in part, because they are the maker of a medical device called the EpiPen, which delivers a life-saving drug to stop an anaphylactic allergy attack. The company has raised the price of this medication 461% since 2007. Mylan’s latest announcement – that it would offer various new pricing concessions to families on lower incomes and those who have to pay out of pocket, cannot alter this stark fact.

American policymakers just woke up to a reality many American families have been living for years: the US medical system is tilted so far in favor of drug companies, that those reliant on life-saving medications are at the mercy of pharmaceutical manufacturers’ nearly limitless desire to line their pockets. I am a mother in one of those families.

When our beautiful daughter Emma was born in 2010, everything about her was perfect – she’d laugh while her 10 soft fingers would grab 10 wiggling toes. The only thing that seemed to trip her up was something that seemed to come pretty naturally to most newborns: eating. She was clearly in pain while she nursed, and we could not figure out why. The answer would emerge over the course of the subsequent months, through many medical visits: Emma was one of millions of children who, due to a series of genetic and environmental factors, was born with food allergies. We would later find out that one of her allergies was severe and life threatening: ingesting peanuts swiftly sends her into anaphylaxis.

The news was terrifying at first, and my husband and I quickly set up systems with her allergist to make sure she was safe in every possible setting or scenario. The central factor in every part of our plan was whether she would have quick and easy access to her EpiPen, which can immediately halt an anaphylaxis attack by delivering epinephrine, via injection. The EpiPen became an essential part of our lives overnight, and we would pay for as many as our health insurance would cover. But we learned over time that this life-saving device – a triumph of modern medical science – was becoming more and more difficult to access. Each dose must be replaced once a year, and each time we refilled the prescription, our pharmacist would report that the price jumped dramatically again.

Mylan was behind those increases, raising the price from $ 57 a shot when it took over sales of the product less than a decade ago to more than $ 600 today. This price jump exposes not just some gaping moral and ethical holes in America’s healthcare system, but some dangerous market distortions taking place in the US pharmaceutical industry.

First, the price has quadrupled in just nine years, with no perceivable improvement to the product to justify the increase. The drug still only contains about $ 1 of active ingredient. Second, consumers have no viable alternative, because Mylan holds a monopoly on the product. Other manufacturers have attempted to diversify the market, only to be stopped short by the US Food and Drug Administration. We’ve seen pharmaceutical executives callously take advantage of this “market opportunity” a number of times before with different drugs, most notably when disgraced Turing Pharmaceuticals CEO, Martin Shkreli, was exposed for price-gouging pills to $ 750.

Third, this drug is quite literally the difference between life and death for many families, because allergies do not discriminate between those who have quality health insurance or none at all. So far, my family has been lucky enough to have the means and insurance to keep adjusting to the jarring price hikes, but many are not so fortunate. Parents all over the country have shared their stories of helplessly watching the price of this life saving medication rise beyond their reach, or taking drastic measures to afford the medication.

The bottom line is that no parent should have to send their child off to school or camp, hoping and praying for their child’s basic safety, because they cannot afford to purchase essential medication. Public officials weighed in this week, from Senator Amy Klobuchar, who is calling for hearings scrutinizing the price hike, to Hillary Clinton, who called on Mylan to “immediately reduce the price of EpiPens”.

The fact is that Mylan, and many other companies like them, were able to inflate prices on life-saving, one-of-a-kind medications, because they could.

The American medical system is simply broken. We are far from a free market where competition is open and companies are incentivized to spur innovation and compete fairly for market share. Instead, the powerful few are able to enjoy exorbitant profits at the expense of desperate families like mine, who will pay anything to simply keep their children safe.

For my daughter, the EpiPen is a lifeline, not a luxury | Liz Richardson Voyles