Massive price increases in EpiPen raise alarms

[Jacque67 7,328]

Two U.S. senators are raising concerns about massive price increases on a drug used under emergency conditions for food allergy reactions to see if they are justified.

Sen. Chuck Grassley, R-Iowa, has written the manufacturer, Mylan, asking for the reasons behind the price

boosts for EpiPen, an epinephine auto-injector used to treat allergy reactions that has seen its price rise from $57 in 2007 to about $500 today. Sen. Amy Klobuchar, D-Minn., wants the Federal Trade Commission to take a look.

"I am concerned that the substantial price increase could limit access to a much-needed medication, Grassley wrote in the letter to Mylan CEO Heather Bresch.

Since the drug is used for emergency treatment, it's not only patients who buy it, but public schools and other government institutions, Grassley says.

Many of the children who are prescribed EpiPens are covered by Medicaid and therefore the taxpayers are picking up the tab for this medication, Grassley wrote.

Klobuchar says her family is touched directly in hearing about the price increases on the drug.

"Many Americans, including my own daughter, rely on this life-saving product to treat severe allergic reactions, Klobuchar said in letter. Although the antitrust laws do not prohibit price gouging, regardless of how unseemly it may be, they do prohibit the use of unreasonable restraints of trade to facilitate or protect prices

http://www.usatoday.com/story/money/business/2016/08/22/two-senators-urge-scrutiny-epipen-price-boost/89129620/

[Dashinka 24,995]

Isn't this what happens when there is only one option? Also, the statement from the company makes some sense as it appears the price increase has been going on for nearly 10 years now, but apparently, with the changes to insurance, the buyers were not aware of the actual cost until now.

[Jacque67 7,328]

The EpiPen is one of the most important life-saving medical innovations for people with severe food allergieswhich affect as many as 15 million Americans and 1 in 13 children in the United States. But its price has exploded over the last decade despite few upgrades to the product itself. And thats led to criticism from a consortium of critics which includes consumer advocacy groups and notorious drug price-hiker Martin Shkreli himself.

Mylans MYL 0.48% EpiPens price has ballooned about 400% since 2008, rising from about a $100 list price to $500 today (many patients are offered a $100 coupon for the injecting device, but its often not enough to cover costs for American families, especially those who have health insurance with high deductibles). And the products lack of competitors is likely a significant driver of the costs.

Fortune.com

Theses medical companies profit off a lot of government research ,and then get the tax payers to pay , yet again through the nose for their products.

Totally unethical .

[Póg mo 1,749]

America is great. People get to pay for their medications twice. First through taxes for government grants for research and then a second time through inflated prices at the pharmacy. In Australia these same pens are about $35 dollars with a prescription or $150 without. My cousin who is a doctor in California is able to fill syringes from vials of epinephrine for about $2 for her daughter, to use at her home, but has to pay the full price for each classrooms at school.

[Dashinka 24,995]

Not saying I agree or disagree with their business tactic, but this is what happens in a monopoly situation. A monopoly should not exist, but apparently Mylan has positioned itself into one as well as successfully lobbying their product to be stocked preventatively much like a defibrillator. if you compare the cost of an AED for home use (probably something every household should have) you are looking at between $1,200 and $1,600 with rare cases of an insurance company picking up the tab. To top it off, there is only one FDA approved supplier of a home use AED. I am not in a position to judge the cost of these devices, but if the companies cannot make money on them, then they would not exist.

http://health.costhelper.com/aed.html

[Dashinka 24,995]

America is great. People get to pay for their medications twice. First through taxes for government grants for research and then a second time through inflated prices at the pharmacy. In Australia these same pens are about $35 dollars with a prescription or $150 without. My cousin who is a doctor in California is able to fill syringes from vials of epinephrine for about $2 for her daughter, to use at her home, but has to pay the full price for each classrooms at school.

Not sure who supplies the device in Australia, but apperently it is not Mylan, which begs the question why doesn't the FDA approve additional suppliers to keep the monopoly from forming? Also, not all drug research is funded by the government, the last study I saw which is a bit old (2002) showed about 28% of drug research funded by the NIH.

[Jacque67 7,328]

Then in 2010, federal guidelines changed to recommend that two EpiPens be sold in a package instead of one. Studies showed that about 10 percent of children who received epinephrine from an EpiPen needed more than one dose. Better to be safe than sorry. Additionally, the Food and Drug Administration changed its recommendations to allow for the prescription of EpiPens for prevention for at-risk patients, not just for those with confirmed allergies. Mylan stopped selling individual EpiPens and began to sell only twin-packs.

It also raised the price.

In 2013, the government went further. It passed a law that gave funding preferences for asthma treatment grants to states that maintained an emergency supply of EpiPens. As the near sole supplier of the devices, Mylan stood to make even more money.

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That year, Mylan raised the price again.

Of course, competition would bring the price down. But its very hard to bring such a device to market. In 2012, the Adrenaclick and Twinject were discontinued. In 2013, Sanofi began to sell Auvi-Q devices, which even gave audio instructions to walk people though their use. Unfortunately, they were found to give potentially improper doses, and were pulled from the shelves about a year ago.

Teva had hoped to offer a generic version of the EpiPen, but concerns from the F.D.A. sent it back to the drawing board until at least next year.

Adamis hoped to offer prefilled syringes, which would still be harder to use than EpiPens. But it was told by the F.D.A. that much more data would be needed before such a product could be sold.

These setbacks, all in the last year, have once again left Mylan with a veritable run of the market. It raised the price of EpiPens again. As of this May, they cost more than $600 a pack. Since 2004, after adjusting for inflation, the price of EpiPens has risen more than 450 percent.

NY times

[Póg mo 1,749]

Not sure who supplies the device in Australia, but apperently it is not Mylan, which begs the question why doesn't the FDA approve additional suppliers to keep the monopoly from forming? Also, not all drug research is funded by the government, the last study I saw which is a bit old (2002) showed about 28% of drug research funded by the NIH.

Yes but which 28℅ of research? The research gone into developing the likes of Entresto for example would probably be mostly paid for by pharma itself, but considering Entresto is a recombination of existing drugs, so it wouldn't make sense for the government to fund that research. The epi pen on the land was based off a design developed for the US military, so it could easily be argued that mylan is indirectly benefiting from government funding.

[Póg mo 1,749]

No the same pens are used in Australia.

Q 3: What types of adrenaline autoinjectors are available?

In Australia and New Zealand, there are two doses of adrenaline autoinjectors available. EpiPen® is available in a Junior dose (EpiPen®Jr) and a higher dose device (EpiPen®)

http://www.allergy.org.au/health-professionals/anaphylaxis-resources/adrenaline-autoinjectors-faqs

[Rob L 3,811]

More on Mylan

EpiPen Maker Also Hiked Prices on a Slew of Other Medications

by DAN MANGAN, CNBC

And you thought the EpiPen price hikes were big?

The company whose big price increases for its lifesaving EpiPen device are drawing heavy fire from consumers and lawmakers has also sharply raised the prices of a slew of other drugs this year.

Mylan's EpiPen, which counteracts the allergic reaction known as anaphylaxis,has seen a more than fivefold price increase since 2008, with some customers paying more than $600 for a package of two of the auto-injection devices.

Beyond that, "Mylan has taken some exceptionally large price increases in 2016," Wells Fargo senior analyst David Maris wrote in a report in June.

"Mylan has raised the prices more than 20 percent on 24 products, and more than 100 percent on seven products," Maris wrote.

He warned that the Netherlands-based drugmaker — whose CEO Heather Bresch saw her compensation increase by nearly 700 percent from 2007 to 2015 — could draw "greater regulatory scrutiny and headline risk" as a result of such price boosts.

They include a stunning 542 percent increase for the drug ursodiol, which is a generic medication used to treat gallstones.

Maris also flagged a 444 percent increase in another generic drug, metoclopramide, which is commonly used to treat GERD, or gastroesophageal reflux disease as well as gastroparesis. Dicyclomine, a drug used to treat irritable bowel syndrome, had its price jacked up by 400 percent by Mylan.

The price of one of Mylan's biggest selling generics, tolterodine, was increased by 56 percent this year, the Wells Fargo analyst said. Tolterodine is used to treat overactive bladders.

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EpiPen Prices Rocket Along with Drugmaker Executive's Pay1:11

In contrast, Mylan raised the price of EpiPen, its biggest-selling product, by 15 percent this past spring. However, Maris wrote, that EpiPen price hike "follows two 15 [percent] price increases last year."

A price history of EpiPen assembled by Maris notes that in April 2001, the price of an EpiPen package was $75.80. The device then had a series of 3 percent and 4 percent price increases until 2008, when it was acquired by Mylan.

The company kept the price increases to just 5 percent in 2008 and early 2009, but in October 2009 it raised the price by 20 percent. Then, over the next four years, Mylan increased EpiPen's price by 10 percent eight separate times.

In November 2013, Mylan hiked EpiPen's price by 15 percent, and then did so five more times through May of this year.

As of Tuesday, a package of two EpiPen auto-injectors was selling for $614.07 through a membership warehouse with a free coupon that patients had to download, according to the GoodRx online drug price comparison website. The price was $616 with a coupon at Kroger Pharmacy, $630.96 at Target and $633.66 at Walgreens.

Rodney Whitlock, a consultant for the Campaign for Sustainable Rx Pricing, said Mylan's price increases follow a pattern of other drug companies significantly raising prices for commonly used medications for opaque reasons, at best.

"Think about if other industries behaved the same way. Apple would still be selling the first-gen iPhone for 1,400 bucks."

"It's the everyday drugs that are going up by amounts that are just hard to conceptualize why," Whitlock said. "These drugs aren't improving. They're the same drugs approved by the FDA. They're not getting better. But the prices are going up extensively more than inflation."

"And it's very hard to explain to the consumers why that's the case," he said. "Think about if other industries behaved the same way. Apple would still be selling the first-gen iPhone for 1,400 bucks. And Ford would be selling the Pinto for $84,000."

Drug price increases by two companies drew the attention of Congress, the press and patient advocacy groups last year, Maris wrote.

One was Valeant, whose stock price was pummeled for months after the New York Times reported that Valeant and other firms were using a network of specialty pharmacies to sustain sales of high-priced drugs and prevent patients and insurers from switching to less-expensive generic competitors.

The other was Turing Pharmaceuticals, whose then-CEO Martin Shkreli raised the price of the antiparasitic medication Daraprim by more than 5,000 percent. Shkreli was indicted late last year on federal securities charges that are unrelated to the Daraprim controversy. He has pleaded not guilty to the charges.

In his report on Mylan, Maris wrote that while some of the products "may be small relative to Mylan's overall business, we do not believe that the price increases come without a real cost to patients."

"And if this turns to headline risk, the could be an impact to reputation and shareholders as well," Maris wrote in June. "In this environment, we believe 400 percent and 500 percent price increases on products are beacons for scrutiny."

Earlier this week, Senator Amy Klobuchar, saying she was outraged by the price increases for EpiPen, asked the Federal Trade Commission to investigate. And her colleague, Senaor Chuck Grassley of Iowa, chairman of the Judiciary Committee, has written Mylan asking how it determined prices for EpiPen.

Mylan has not yet responded to any request for comment.

On Monday, Mylan noted in a statement that many patients can get access to EpiPens at no cost to themselves through discount programs offered by the company.

Mylan also said that changes in the health insurance "landscape" have led to increasing numbers of people being covered by so-called high-deductible plans, which require them to pay more personally out of pocket for doctor's visits and medications.

"This current and ongoing shift has presented new challenges for consumers, and now they are bearing more of the cost," Mylan said. "This new change to the industry is not an easy challenge to address, but we recognize the need and are committed to working with customers and payors to find solutions to meet the needs of the patients and families we serve."

Doug Hirsch, co-founder and co-CEO of GoodRx, the drug price comparison site, said, "When consumers perceive that the cost of drugs is going up, often it's just their share of the costs that are going up. ... We see that all the time at GoodRx."

But he acknowledged that the price hikes are real, even in cases where an EpiPen user is not paying anything out of pocket for the devices.

Read More From CNBC: EpiPen Prices Are Out of Control

"You may be paying zero, but your company may be paying $500 for that EpiPen," Hirsch said.

When asked about the array of price increases at Mylan, Hirsch said, "I'm never surprised by changes in drug pricing ... in this space, it's always more complicated and complex than you can imagine."

Hirsch said that the price hikes of EpiPen, at least in part, seem to be the result of the recall last year of Sanofi's competing product Auvi-Q, and the denial of regulatory approval for a generic competitor from Teva.

"I think we're seeing a classic scenario that we see in the drug world, which is less competition equals higher prices," he said

[lostinblue 1,989]

Meet PharmaSis: Daughter of Dem Senator behind massive Epi-Pen price spike

Remember PharmaBro? Martin Shkreli, co-founder of Turing Pharmaceuticals and a hedge-fund broker, incurred the wrath of the media and political establishment when he arbitrarily hiked the price for a popular AIDS and malaria medication by 5000%. Congressional hearings pilloried Shkreli in absentia while Shkreli remained obstinately unrepentant. PharmaBro became the symbol of the evils of capitalism, and his arrest on unrelated fraud charges certainly helped cement that reputation.

If Shkreli was PharmaBro, then Heather Bresch qualifies as PharmaSis. The CEO of Mylan and daughter of Democratic Senator Joe Manchin has presided over a 400% price increase for the Epi-Pen, an epinephrine delivery device to prevent anaphylactic shock in those with severe allergies. Costing just $100 dollars in 2008 for a two-pack, the price has now skyrocketed to over $600, and lawmakers want to know why:

http://hotair.com/archives/2016/08/24/meet-pharmasis-daughter-dem-senator-behind-massive-epi-pen-price-spike/

[Dashinka 24,995]

No the same pens are used in Australia.

Q 3: What types of adrenaline autoinjectors are available?

In Australia and New Zealand, there are two doses of adrenaline autoinjectors available. EpiPen® is available in a Junior dose (EpiPen®Jr) and a higher dose device (EpiPen®)

http://www.allergy.org.au/health-professionals/anaphylaxis-resources/adrenaline-autoinjectors-faqs

This is interesting information. Are the injectors price controlled in Australia?

[Sousuke 1,214]

This is interesting information. Are the injectors price controlled in Australia?

Probably. I know the NHS in the UK negotiates directly with companies like this.

Looks like the UK offers Jext too?

Edited August 25, 2016 by Sousuke

[Rob L 3,811]

Meet PharmaSis: Daughter of Dem Senator behind massive Epi-Pen price spike

Remember PharmaBro? Martin Shkreli, co-founder of Turing Pharmaceuticals and a hedge-fund broker, incurred the wrath of the media and political establishment when he arbitrarily hiked the price for a popular AIDS and malaria medication by 5000%. Congressional hearings pilloried Shkreli in absentia while Shkreli remained obstinately unrepentant. PharmaBro became the symbol of the evils of capitalism, and his arrest on unrelated fraud charges certainly helped cement that reputation.

If Shkreli was PharmaBro, then Heather Bresch qualifies as PharmaSis. The CEO of Mylan and daughter of Democratic Senator Joe Manchin has presided over a 400% price increase for the Epi-Pen, an epinephrine delivery device to prevent anaphylactic shock in those with severe allergies. Costing just $100 dollars in 2008 for a two-pack, the price has now skyrocketed to over $600, and lawmakers want to know why:

http://hotair.com/archives/2016/08/24/meet-pharmasis-daughter-dem-senator-behind-massive-epi-pen-price-spike/

The same Martin Shkreli who diagnosed Hillary Clinton with Parkinson's without seeing her ?

Probably. I know the NHS in the UK negotiates directly with companies like this.

Looks like the UK offers Jext too?

This might break the congressional logjam that stops Medicare/Medicaid from negotiations on drug prices.

edit removed VA , they do negotiate and pay 40% less than Medicare

Edited August 25, 2016 by Rob L

[The Nature Boy 7,659]

Yall making all this up. Obama fixed all of our out of control prices in medical care.

Wait until Big Pharma and wall street owned Hillary gets in.

I don't with Obama on a lot but I don't think he is strictly follow the money trail like Hillary.