So What Happened with Mylan and EpiPen Price Hikes?

By now you’ve heard about or even contributed to the media uproar over Mylan’s price hike on the EpiPen of over 600 percent. You also probably heard about Mylan’s attempts to get back in the public’s good graces, like selling a “generic” (identical) version for half the price (still about $300), or like offering aid for uninsured or under-insured patients (but only up to $300). To give you some perspective, a two-pack of EpiPens had a list price of more than $725 at both Kroger and Target.

If you forgot about EpiPen headlines until now, it’s probably because the media is concerned with other… things. But on Oct. 7, Mylan agreed to a $465 million settlement with the U.S. Department of Justice and other agencies over the classification of its anti-allergy EpiPen Auto-Injector under the Medicaid Drug Rebate program.

Now stick with me because this sounds like a lot of political and corporate mumbo jumbo, but it’s important.

At issue in the settlement was whether the EpiPen should be classified as a 1. generic or a 2. brand-name drug under the terms of Medicaid Drug Rebate program. This is key to determining how much a drugmaker pays to Medicaid to be included in the government-run health program.

Under the program, companies that sell generic drugs or products through Medicaid pay a 13 percent rebate to the agency. Alternatively, those who sell brand-name products are required to pay a rebate of at least 23.1 percent.

Back to Mylan’s case: A brand-name classification could have possibly resulted in an even higher percentage rebate because companies that hike a product’s price faster than the rate of inflation are required to pay an additional amount.

CNBC reported that Mylan might have shortchanged Medicaid by more than $700 million over a five-year period based on an estimate by a state Medicaid agency that the company was not paying states 85 percent of what it owes in EpiPen rebates.

Now I’m no Congresswoman or pharmaceutical tycoon, but those sound like pretty solid grounds for a hearing. So, back on Sept. 21, Mylan CEO Heather Bresch appeared before a Congressional committee to answer to… all of the above.

I love this part. During this hearing, Bresch repeatedly placed Mylan profits on the average $600 list-price EpiPen at only $50 per pen, after considering “various costs.” Right. CNBC reported those profits that Bresch cited – before Congress, mind you were under the real value by at least 4 percent and up to 66 percent, “depending on how it’s calculated.”

In short, this whole Mylan EpiPen fiasco is a political and ethical mess.

Sen. Elizabeth Warren recently wrote,

“The Justice Department has rewarded Mylan by imposing a fine that is about $65 million less than the amount Mylan made by defrauding Medicare and Medicaid. In addition, you permitted Mylan to avoid admission of wrongdoing, collected no additional penalties under the False Claims Act, and blocked other actions against the company that would have required greater accountability.”

 Alternatively, attorneys Ellyn Sternfield and Rodney Whitlock of Mintz Levin wrote:

“[The Justice Department] does not have the authority to settle states’ individual drug rebate claims against Mylan, which means any potential ‘global’ settlement with the states raises a variety of issues.”

To put the cherry on top of this allergy-friendly, overly priced sundae, in an interview with CNBC, Bresch said Mylan has spent hundreds of millions on product development. The funny part about that is the drug epinephrine has been around for a hundred years and costs, yep, $3. The auto-injector isn’t exactly made out of gold, either; it’s plastic.

EpiPens earned Mylan more than $1 billion a year. And if you haven’t yet already placed Heather Bresch’s mug on the body of Scrooge McDuck, she told Wall Street analysts, “I think you’ll see opportunities for us to continue to have that price per pen increase.”

cPGPKLZ

If you or someone you provide for has food allergies and you need the EpiPen, check out GoodRx.com/epinephrine and discuss your options with your pharmacy/insurance carrier, cause we aren’t all diving into gold like Heather.

 

Advertisements

The EpiPen Might Save My Life, But Not Before it Breaks My Bank

Epinephrine is the only treatment for an anaphylactic reaction. It is only available through a prescription. It costs way too much, and the price only continues to rise.

I recently had to refill my yearly EpiPen prescription. What a fun time of year, especially since I’ve been paying for everything out of my own pocket, no longer constrained by my parents’ wallets. So when my doctor whipped out this beautiful, $0 copay, My EpiPen Savings CardTM, I couldn’t wait to get to the pharmacy. But when the pharmacist rang up my EpiPen prescription, his brow furrowed. He said, “That can’t be right,” and told me to hang tight while he called my insurance company. Apparently my insurance policy’s full premium wasn’t paid, so they could not honor the savings card to its full extent.

When I asked the pharmacist why the price was so high these days, he said it’s likely because Sanofi US recalled all Auvi‑Q® epinephrine devices – the only major competitor to the EpiPen – so the EpiPen manufacturer can basically charge whatever they want.

After the $0 copay card took off a little over $100, the grand total of one EpiPen box containing two EpiPens (keep in mind, having two EpiPens is recommended in case one isn’t enough in the event of a reaction, so even though there were two provided, they could turn out to be just for a one-time reaction) was $231.89.

IMG_1030

Personally, I’ve never had to use my EpiPen since I’m a pro at playing keepaway from milk and tree nuts. But I can’t not have an epinephrine injector on my person at all times – you never know what could happen. So, I see my purchase as, essentially, life insurance. When my EpiPen expires, I will shoot $231.89 into an old orange before disposing the injector.

But what about the people who do need to use their EpiPens before they expire, then need to purchase more? What about the people who can’t afford to pay hundreds on something that they might need, but it happens to be something that would save their lives?

Making people with food allergies pay hundreds for something that could save our lives, when there is no other product for us to choose from, is exploitation.

Bernstein Research analyst Ronny Gal, in an an article by CNBC, said, “[Pharmaceutical companies] take drugs that have largely been underpriced before—or that’s the way they’d call it… They buy a drug that does not have good alternatives and they raise the price sky-high. And because it’s very hard to say no to those patients; because there’s no alternative, people cover this.”

Of Gal’s three examples of this, one was Mylan’s EpiPen.

The CBS article continued to explain that the EpiPen price, according to data from Evercore ISI, increased 27 percent a year, on average, from 2011 to 2015, to more than $300 each dose. In May 2016 alone, Mylan increased the EpiPen price by 15 percent.

Meanwhile, prescriptions for EpiPen rose 9.5 percent, on average, each year from 2011 to 2014, according to data from IMS Health. Sales in that time, the data show, rose an average of 42 percent a year, to more than $1 billion.

Cha-ching for Mylan.

The EpiPen brand is synonymous with allergies, but it’s not the EpiPen that we need. We need an epinephrine injector to hold us over until we can make it to a hospital. I’ve been an EpiPen customer for 24 years, and I don’t even want to attempt to do the math on how much my family and I have spent on unused EpiPens.

What we need is a competitive market. And when there are simply no competitors, drug companies need to have limits. The CBS article also quoted a letter that Democrats wrote to House Committee on Oversight and Government Reform, which I think sums up my point perfectly:

“We believe it is critical to hold drug companies to account when they engage in a business strategy of buying old neglected drugs and turning them into high-priced ‘specialty’ drugs.”

Disclaimer

Updates to Instructions for Use of Epinephrine Auto-Injectors

Read the full Food Allergy Research Network Blog

Key Takeaways

  • Hold patient’s leg and limit movement during administration to avoid lacerations and bent/broken needles
  • Look out for symptoms of skin and soft tissue infections

For EpiPen® and EpiPen Jr® Auto-Injectors only:

  • Injection hold time reduced from 10 seconds to 3 seconds

 

Disclaimer

What’s So Scary About Food Allergies?

If you ask Food Allergy Research and Education (FARE), a food allergy is a serious medical condition. A food allergy is also considered a disability under federal laws, such as Section 504 of the Rehabilitation Act of 1973 and the Americans with Disabilities Act (ADA).

It is not to be confused with a food sensitivity or intolerance (both refer to digestive problems after eating a certain food). Unlike food allergies, food intolerances do not involve the immune system.

Food allergies are IgE mediated, meaning that the immune system produces excessive amounts of an antibody called immunoglobulin E (IgE for short). These IgE antibodies fight the “enemy” food allergens by releasing histamine and other chemicals, which trigger the symptoms, including anaphylaxis. Anaphylaxis is a type of reaction involving difficulty breathing, reduced blood pressure, vomiting, diarrhea, and, ultimately, throat closing, which could lead to death if not immediately treated with epinephrine.

Delays in getting this medicine can result in death in as little as 30 minuets. More so, up to 20% of patients have a second wave of symptoms hours or even days after their initial symptoms (this is called biphasic anaphylaxis).

Contrary to popular belief, the EpiPen is not meant for one-time use or to stop a reaction on its own. If an EpiPen is needed, you must call 911 to get further care. Sometimes, even two injections of an EpiPen are needed (which means people with food allergies should carry two EpiPens at all times).

There is no cure for food allergies, and the number of people with food allergies is seriously growing. According to the Centers for Disease Control and Prevention, food allergies among children increased about 50% from 1997 to 2011. There is no clear answer why.

For now, the best that people with food allergies can do is to avoid their allergens at all costs.

Disclaimer