CVS Announces Super Cheap Generic Alternative To EpiPen (arstechnica.com)

An anonymous reader quotes a report from Ars Technica: Pharmaceutical giant CVS announced Thursday that it has partnered with Impax Laboratories to sell a generic epinephrine auto-injector for $109.99 for a two-pack -- a dramatic cut from Mylan's Epipen two-pack prices, which list for more than $600 as a brand name and $300 as a generic. The lower-cost auto-injector, a generic form of Adrenaclick, is available starting today nationwide in the company's more than 9,600 pharmacies. Its price resembles that of EpiPen's before Mylan bought the rights to the life-saving devices back in 2007 and raised the price repeatedly, sparking outcry. Helena Foulkes, president of CVS Pharmacy, said the company felt compelled to respond to the urgent need for a more affordable alternative. "Over the past year, nearly 150,000 people signed on to a petition asking for a lower-cost epinephrine auto-injector option and millions more were active in social media searching for a solution," she said in a statement. The price of $109.99 for the alternative applies to those with and without insurance, CVS noted. And Impax is also offering a coupon to reduce the cost to just $9.99 for qualifying patients. Also in the press statement, Dr. Todd Listwa of Novant Health, a network of healthcare providers, noted the importance of access to epinephrine auto-injectors, which swiftly reverse rapid-onset, deadly allergic reactions in some. "For these patients, having access to emergency epinephrine is a necessity. Making an affordable epinephrine auto-injector device accessible to patients will ensure patients have the medicine they need, when they need it."

Comments

you mean capitalism works?

[wolfgang_spangler]

That whole supply/demand thing isn't a myth?

Unpossible.

Re:you mean capitalism works?

[Anonymous Coward]

The issue there is that capitalism wasn't in play.

Due to the barrier to entry posed by drug regulation it cost too much for competitors to enter the same market, and would have remained that way if those assholes had not gone full retard.

Re: you mean capitalism works?

[Anonymous Coward]

Iff the practical economic ability to compete exists, safety regulations are enforced, collusion is prevented, consumers are educated well about their purchase decisions, etc.-- then capitalism works pretty darn great.

Re:you mean capitalism works?

[HornWumpus]

None of those things did anything.

CVS is doing it for the money.

Re:you mean capitalism works?

[Daemonik]

Just because this is the only system you know, don't assume it's the only system that works. Before the 80's when boomers became determined to bleed every possible drop of profit out of the economy, hospitals were run by charities and the worlds most famous doctors worked at university teaching hospitals. Even today the majority of medical breakthroughs happen in universities with government grant money, not pharmaceutical giants.

There is credible evidence that in the unregulated free market once a company achieves market dominance all innovation becomes simple incremental upgrades as research money is transferred to investors. Just look at Apple for a perfect example.

For the people who keep saying regulations keep competition low... yeah, most people are perfectly happy with regulations that require companies to actually prove their devices work, they're well funded and their investors aren't gangsters.. so horrible that the people who invented Shake Weights might not be able to bring us their amazing magnet powered pacemakers I'm sure they were working on.

Re:you mean capitalism works?

[Anonymous Coward]

Good luck trying to properly give yourself that injection while suffering from anaphylactic shock, can't breathe, and are about to pass out. If you think it is so easy then would you care to prove it by giving yourself a proper IM injection of saline while being waterboarded?

Re:you mean capitalism works?

[dbIII]

At the same time, for all it's flaws in the patent system, in the grand scheme of things... the patent lasts like 5 or 10 or 20 years (I don't know). My point is it's not that long.

Not that long? Apparently the epipen was invented in the mid 1970s. Most of you here were not even born at that time.

Re:you mean capitalism works?

[silentcoder]

It's worth noting that, prior to the FDA's establishment, more than 80% of all "medicine" sold in the US were so-called "patent medicine". These drugs, contrary to popular myth, didn't all do nothing - most of them were filled with deadly and addictive substances (usually opium) which the buyers had no idea they were buying. They were marketed for things so completely unrelated that it's physically impossible one drug could treat them all - but they sure made you high.

In short - it was a disaster that killed far more people than it ever cured. In the post-FDA world, this problem has shifted exclusively to those things which the FDA cannot regulate due to congressionmen selling out suplements and homeopathy. A recent study found that 1 in 3 supplements contained no shred whatsoever of the plant they are supposed to have been derived from. Suplements kill people on a daily basis due to dangerous ingredients and a lack of proper warnings about correct usage - seeing as they aren't regulated and nobody is making sure they know what correct usage actually means.

Where regulation does not exist, neither does medicine.

Re:you mean capitalism works?

[meerling]

It's not the epinephrine, it's the epipen that's got the protection.

Re:you mean capitalism works?

[Solandri]

No, they're able to do it for money because Mylan stupidly raised the price. If Mylan had kept the price at what it was before they acquired rights to the EpiPen, it would not have been worth it for a competitor to pay to develop their own pen, put it through the arduous FDA approval process, and put aside money to settle liability lawsuits in case something went wrong. When Mylan raised the price, it suddenly became cost-effective for someone to do all that, so CVS did. They still would've done it even if there had been no outrage, because overpricing something just creates an opportunity for someone else to swoop in and underbid you.

Re:you mean capitalism works?

[ilctoh]

Anaphylaxis is a acute state where a few Very Bad Things are happening all at once, and very very quickly (over the course of a few minutes.) The key ideas are:

• The air passages in your throat and lungs swell shut so severely that you cannot physically force air in and out. Within a matter of minutes, you will loose the ability to breathe. Period.
• At the same time, your blood vessels are rapidly dilating, causing a dangerous drop in blood pressure. This is why its commonly called anaphylactic shock, because your blood pressure has dropped to the point that the blood cannot adequately perfuse vital organs, namely your brain and your heart.

So between the fact that you can't get oxygen into your lungs, and the fact that your blood can't deliver oxygen to your brain, and the fact that you feel like shit, and know very well that you're in the middle of a life-threatening emergency... you don't really have the capability to perform tasks requiring concentration and fine motor skills, such as would be required to manually draw up a precise dose of medication into a syringe and inject it into yourself.

An EpiPen or similar device is "necessary" because it is an incredibly simple mechanical device that you can operate even while in extremis. You pop a cap off both ends, and push it against your butt check. Its something that anyone, even children, can be trained to do, and to practice (obviously with a dummy device with no needle or medication). And practice until using it practically becomes a reflex, and not something that requires concentration to perform. Its easy enough to do that, even when overcome with anxiety and decrease oxygenation, people can usually manage to work an EpiPen.

I suspect you probably haven't actually experienced anaphylaxis, if people had time to talk to you and for you to convince them that everything was fine. Anaphylaxis requires rapid administration of epinephrine. So you may have had an allergic reaction, maybe even a bad one, but unless you actually experienced the sensation of being unable to force air in and out of your lungs, even when trying with all your might, you haven't truly experienced anaphylaxis. I'd also take issue with your assumption that administering an EpiPen is a "high risk emergency procedure." I suppose there is some risk of local infection, but I'm not aware of any documented cases of infection, at least anything requiring treatment, as a result of an EpiPen. (There are other risks associated with Epi administration, but infection is effectively not one of them.)

So some sort of autoinjector device, be it an EpiPen or a similar competitor, is effectively required to be able to safely manage anaphylaxis.

Former CVS pharmacist here

[Anonymous Coward]

I'm now clinical cardiac pharmacist, but I still follow the industry news.

This is a generic for the Adrenaclick, not the Epi-pen. It's the same drug but it not AB rated. It's easily fixable by a call from the filling pharmacist to the prescriber of they write for Epi-pen. We do it all the time.

Re:Former CVS pharmacist here

[guruevi]

For those of you who have no experience with the medical industry:

AB rating is to indicate the FDA considers this an equivalent substitute. There are currently at least 3 "EpiPen" systems on the market, EpiPen, Adrenaclick and Twinject and I think Auvi-Q is also entering the market again they all are auto-injectors giving 0.3 mg or 0.15 mg of Epinephrine, yet the FDA has rated these 'others' as BX meaning they cannot be interchanged (legally) without a brand new prescription even though they all do the same thing.

So yes, there are alternatives to the EpiPen but the medical industry has made sure that the consumer is not informed when the market breaks.

Ready...

[guygo]

I see Mylan's PR people have their "I find the Adrenaclick impossible to use" shills ready to go. We can expect them to spend millions on trying to discredit the competitor's much cheaper alternative. Heaven forfend they spend any of that money reducing the price of their own product.

You don't know what a free market is, do you?

[cirby]

You see, a "free market" is actually free, not controlled by government-run bureaucracies that make it very difficult for medical device manufacturers to produce something that ISN'T covered by patents any more.

You know, like epinephrine injectors.

Re:You don't know what a free market is, do you?

[HornWumpus]

It's 'free enough', absolutes don't exist outside the minds of theoreticians.

Re:You don't know what a free market is, do you?

[PopeRatzo]

Nobody who actually wants to run a company would ever settle for a system without patents, copyrights or some form of IP protection

Companies existed long before patents and IP. Almost two centuries, in fact.

Re:You don't know what a free market is, do you?

[Tranzistors]

Indeed they did, and they protected their “rights” with guilds, gunboats and monopoly rights from monarchs. I personally would not want to have FedEx with private army.

Re:You don't know what a free market is, do you?

[PopeRatzo]

Indeed they did, and they protected their “rights” with guilds, gunboats and monopoly rights from monarchs.

So, what you're saying is, corporations have always required government intervention and labor organization to succeed. Duly noted.

At least now we can dispense with the notion that there has ever been anything like a "free market".

Re:You don't know what a free market is, do you?

[Required Snark]

You are too young to for this to be part of your personal experience, but there once was a drug called Thalidomide. It was sold for morning sickness and caused severe birth defects. Thousands of infants died and tens of thousands were born with deformed limbs. This was in the mid 1950's and caused a massive change in how drugs were tested. Thalidomide is still used, but not by pregnant women.

More recently there are significant problems with metal on metal joint replacements. For some designs the failure rate is 75% to 100%. And this was after FDA approval was granted.

So is the requirement for government approval the "bureaucracy" you are talking about? If so, I'm sure you can find somewhere in the world where you can get a completely unregulated major medical procedure, say involving surgery. Before you go, just leave a contact address so we know where to send the condolences for your funeral. I, at least, would consider your demise to be suicide.

Re:You don't know what a free market is, do you?

[Maxo-Texas]

They expire.

https://www.washingtonpost.com...

Looks like the 18 months is aggressive tho. Might depend on storage conditions too.

Re:You don't know what a free market is, do you?

[networkBoy]

generally (and the exceptions are a bitch) an expired drug is safe but its efficacy is reduced. For some products that rate of reduction is low and an expired product can be good for a year or two after the date (Liquamycin for example), for other products the rate of decline is non linear and fast, so are only good a couple months past date with any real efficacy (Covexin®-8. CDT comes to mind).

Epi seems to be between the two, within some limits:

EpiPen's shelf life has been limited by the chemistry of the drug inside it. Epinephrine is an old and cheap medication, but it's also notoriously finicky. If exposed to light, heat or air, it can degrade, turning rust colored.
The FDA-approved label warns that if the liquid in the pen is discolored, it should be discarded: "Epinephrine solution deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from the formation of melanin."

Great! so there's a way to tell, separate from the date!

But what about an expired EpiPen that looks perfectly normal?

The little published data that exists shows that the drug degrades over time -- and color is not an accurate way to gauge whether the epinephrine inside is still good.

well crap, maybe not.

One study, published in the Journal of Allergy and Clinical Immunology in 2000, examined EpiPens one to 90 months after the expiration date. Most were not discolored, but the epinephrine content decreased over time. The study stated that it was best to use EpiPens that had not expired, but found that the pens contained at least two-thirds of the intended dose up to a year after expiration. Even a sub-optimal dose could be better than nothing in a life-or-death situation, the authors concluded.

So...
Looks like if stored in *ideal* conditions the pen will last more than 18 months, but under likely real-world conditions 18 months is it.
FWIW, elsewhere I found that the manufacturer had targeted 27 months, but data only supported 19 months, they went with 18. That's not a large guard band.

"Super Cheap"?

[0100010001010011]

Still $55/pop. I would have gone with 'cheaper'. "Super Cheap" is a bit of hyperbole.

FYI: Epinephrine is $4.79/vial.

Re:"Super Cheap"?

[guruevi]

Someone already did: https://fourthievesvinegar.org...

Now let's fix the stupid laws....

[Lumpy]

That make it so you have to have a prescription to buy them in the USA.
Canada they are over the counter and I buy them for my first aid Kit. it is 100% stupid to not allow anyone to buy them and make sure they can help to save lives.

Re:What lesson is that?

[HornWumpus]

The lesson to smart monopolists is 'don't charge the full tilt monopoly price unless you want to attract competition'.

Had their excess profit been less than the short term amortized cost of entering the market, they could have milked it for decades.

Charging more would have drawn competition faster.

$8 vs $100 vs $600

[primebase]

For something that *costs* about $8, even $100 is not "super cheap"... http://www.mercurynews.com/201...

Re:What lesson is that?

[Motherfucking Shit]

Had their excess profit been less than the short term amortized cost of entering the market, they could have milked it for decades.

American capitalism hasn't thought that far forward in a long time. The CEO has an EPS target to meet so his golden parachute kicks in. Next quarter is someone else's problem, and the next decade might as well not even exist.

Re:And mathematicians, including

[Ol Olsoc]

Including programmers

The problem with the free market, and lassaize-faire capitalism is that it is destroyed by the first group that has major success. Becuse the greed that fuels the market can become very destructive as people with pathological levels of it inevitably take over. And the simplistic early agriculture type arguments for it just don't work in a highy technical and mechanized world. You gotta have some brakes on any "ism". And the reason is, ideology doesn't work at all. Idealogues end up going insane. Its how we have people arguing that we have to put the overpaid American worker out of a job, ignoring that laid off people don't buy the shit that's being produced. Capitalism with some restraints? Now that works a trick.

At least 20 years, sometimes more

[Shane_Optima]

the patent lasts like 5 or 10 or 20 years (I don't know)

Uh, it's 20 years, sometimes including an additional exclusivity period of up to 5 years (or apparently up to 10 years for certain antibiotics) offered by the FDA in some situations such that competitors' products will not be approved during that time. The exclusivity period isn't guaranteed to run consecutive to the patent period, although the drug companies obviously attempt to engineer it that way if possible.

I just thought that was worth clarifying. Like, "I'm don't recall if Joe was two or four or eight feet tall [and it turns out he might've been as much as twelve feet tall]"... that's not something you should hand-wave away. Yes, it's a complicated situation, but the government-created barriers to entry here (of which drug patents are just a tiny piece) are significant. We do need some barriers, obviously, along with some method of incentivization, but given the high or wildly fluctuating prices of some generics when there doesn't appear to be much of a marginal cost involved (I'm not necessarily saying that's the case with the epi-pens), the system as a whole does not appear to be functioning terribly well.

Re:Still Expensive

[raburton]

UK NHS drug tariff price for genuine Epi-Pen £52.90 for a pair (that's approx. what the NHS actually pays), actual cost to patient £8.40 (standard NHS prescription charge, exemptions apply for those on benefits, etc.) The NHS may be systematically being dismantled by the government and the media, and it's hated by Americans because they have been told it's socialist and pushed propaganda to support their country's alternative view on healthcare, and yes it does have real problems too (most of which could be solved by proper funding, but see my first point), but this is an example of why a proper healthcare system is a good thing to have. We are going to miss it in another 10 years when it's gone and find ourselves in the mess America is in.

What

[Dunbal]

$110 is still way too expensive. Syringe = $0.05. Epinephrine = $2.

Re:And mathematicians, including

[Solandri]

The problem with the free market, and lassaize-faire capitalism is that it is destroyed by the first group that has major success. Becuse the greed that fuels the market can become very destructive as people with pathological levels of it inevitably take over. And the simplistic early agriculture type arguments for it just don't work in a highy technical and mechanized world.

There are so many examples which disprove this that I'm amazed it was modded up: IBM PC, Compaq, Apple iPhone, 3dfx, Blackberry, Palm Pilot, Nokia, GeoCities, Myspace, Wordperfect, Lotus, Silicon Graphics, Kodak, Blockbuster, Sony Walkman, Sears, Pan Am, Schwinn, Motorola, Sun, DEC, Yahoo, Xerox copiers, Nintendo (except they managed to claw their way back with the Wii).

All of these were market leaders who in many cases once owned 80% or more of their respective markets, til they were out-competed and were replaced as king of the hill. Contrary to what you claim, it's harder to maintain a dominant market position in a highly technical and mechanized world. The rapid pace of technological progress means it's very easy to fall behind if you misstep (Yahoo, Sony, Pan Am, Blockbuster), or get lazy (Xerox, Kodak, Myspace, Blackberry), or get out-maneuvered (Nintendo - both ways, WordPerfect, Lotus, Apple iPhone, IBM PC).

The free market works most of the time. Monopolies are the exception, not the norm, and I'm fine with bashing those with government regulation when they happen. Believing that monopolies are inevitable and thus everything must be regulated, is just as foolish as believing everything will work just fine if there is no regulation.