Clarification here, CVS cut the retail price of the existing generic for Adrenaclick (known as Epinephrine).
This generic has been around for a while, but isn't an A/B rated generic so it's illegal for a pharmacy to dispense this if a prescription is written for EpiPen. We can dispense this if a prescription is written for Adrenaclick or Epinephrine.
Make sure your doctor writes a script for Adrenaclick or it is illegal for us to dispense this cheaper generic to you
Edit: The injection device of each product is what limits the A/B rating. Adrenaclick and EpiPen have different autoinjector systems. Yes the regulations are that strict. Here's[0] a video showing the difference between Adrenaclick, Epipen, and AuviQ (which has been recalled and discontinued).
That's kind of a fun juxtaposition there. A product withdrawn because it didn't work and a rant about complex regulation of products that consumers expect to be 100% reliable.
And the FDA was right to withdraw it. But the only reason it was around in the first place was that it was a sophisticated but also relatively complicated improvement on the EpiPen. It's Europe's 8 different brands that are basically just as simple as an EpiPen that the author really wants in the US.
Bridgewater, NJ - Sanofi US is voluntarily recalling all Auvi-Q® (epinephrine injection, USP). The recall involves all Auvi-Q currently on the market and includes both the 0.15 mg and 0.3 mg strengths for hospitals, retailers and consumers. This includes lot numbers 2081278 through 3037230, which expire October 2015 through December 2016.The products have been found to potentially have inaccurate dosage delivery, which may include failure to deliver drug.
> How much software do these things have in them, anyway?
Any answer other than "fucking zero" would be terrifying. I'm not risking my life on some guy properly writing a software module (says the guy driving a car to work this morning)
First, pharmacies don't prescribe anything, they dispense medication. Second, if you voiced how expensive EpiPens are to your pharmacist they would not only recommend the generic, but (so long as they're not swamped) call your doctor right there at the desk to get the prescription changed.
The government's position might be considered overly cautious but I agree with it in this case, the two injectors are sufficiently different that they're not drop-in replacements for each other.
Every pharmacist and, moreover, every consumer capable of conducting a transaction with said pharmacists is also capable of spending the two minutes* required to evaluate the difference between these two auto injectors.
Evaluating the distinction doesn't require anything close to an advanced degree but it's not legal for anyone who isn't credentialed to vend/dispense/trade/exchange/grant/supply/provide the still-very-effective, much cheaper alternative based solely on the customer's informed demand--doing so would be "illegal".
Yes, if your highly-trained, well-payed, in-demand pharmacist has the time and interest; they can work through the call tree until he reaches your highly-trained, well-payed, in-demand doctor; who would've wrote a more general prescription in the first place if it didn't increase their chances of being sued, and get the prescription changed. The problem is, apparently, that hasn't happened often enough--probably because it doesn't happen for free. Someone ends up paying for it e.g., the doctor and pharmacologist, other patients, the insurer and their other clientele or the tax payer--multiplied times however many epinephrine injectors are sold in a given year.
There are few incentives to economize in the chain of payers because health-care is an unlimited 'right' that should be provided for by someone (everyone) else: https://en.wikipedia.org/wiki/Tragedy_of_the_commons
I read the other comment as thinking that generic Adrenaclick (the low cost alternative) was illegal. It wasn't.
A prescription written for Epipen still can't be filled with generic Adrenaclick, so "was illegal" isn't a great description of that situation. It's hardly complicated to ask a doctor to write a different prescription, so that's why I talked about consumer behavior and marketing. Given that the different mechanisms require different training, I am somewhat forgiving of the "as written" requirement for auto-injectors.
By volume, it was mostly insurance or non person entities (school systems and the like, by gov mandate) that paid for it. Of course when insurance pays everyone pays through their premiums, but that's where the consumer behavior comes in, who cares what it costs if it is covered.
"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."
It seems that Mylan, the owner of the Epipen brand, was getting criticized about their outrageous prices [1] so they put out a "generic" version of their own product. Unless I'm missing something, that means that until now, the company that makes the brand name drug and artificially inflates the price (and blames it on insurance companies) also made the only generic version of the product. Given that it's the same company making the brand name and the generic, I assume that they must be equivalent products (am I missing something?), so they are literally just charging an additional $300 for the brand. Why would any patient or insurance company in their right mind pay for the brand name in this case? (this question can be asked more widely about brand name vs generic drugs... but in this case, it has literally been the same company making them. So it's hard to claim that there's even a minor difference, unless the company specifically manufactured them differently, which seems unlikely. For example, some generic drugs could have the same active ingredients, but absorb differently [2]. But it's hard to imagine that being the case for an injection).
In any case, it's nice to see that a true competitor is finally entering this market.
A lot of people want the brand name because they think it might be better. They don't do the research and they don't want to take any risk with their health, so they just pay for the brand name. Sometimes this is a reasonable choice (as you say, not all generics are exactly equivalent) and sometimes it's not. People who won't do the research won't know which case they're in.
As for insurance companies, they're probably paying far less than the listed price, and have either negotiated it down to be the same as the generic (why not, it costs the same to make) or got close enough and are willing to absorb some extra cost in order to attract people who think it matters.
Not an epipen, but my wife has to get one of her medications from a specific manufacturer due to side effects from the filler present in the most common version.
More generally, this is why so-called "me too" drugs aren't as bad as they are made out to be.
Also because the epipen's "blue to the sky" media push makes people think that strangers will better use a branded epipen. Schoolkids are taught epipen use, to recognize and deploy them, whereas othe auto-injectors might go disregarded in an emergency. People need to be taught to recognize all such products. If nothing else, it is time for a standard label.
Welcome to medicine. I grew up the child of a doctor, and she always, ALWAYS, bought the generic. They're required BY LAW to have the same "active" ingredients; you just might be paying for a slightly different pill shape, packaging, or taste.
As the second link I've referenced above points out, there's a possibility that two drugs have the same active ingredients but but they absorb differently. Or one company can have a pill and the other a tablet that dissolves in your mouth. But I imagine that the clinical difference is negligible or nonexistent in most cases. I almost always get generic when possible.
But actually, one advantage of brand name drugs is that it could be easier to remember what they do. For example, sometimes I find old prescriptions in my medicine box (yeah, I don't have a good cabinet) and I don't remember what they are for. For example, I might see Zolpidem and and forget what is, but I'd be less likely to forget what Ambien is. But in general, this difference is worth very little to me and I usually get generics on principle.
Another potential difference is that the inactive ingredients can be different. Normally this doesn't matter, but there are rare occasions where people might have an allergy or other bad reaction to those. Of course, it's about as likely for the generic to be the better choice, so that's no reason to prefer the name brands, just a reason someone might want to switch.
This is something I've experienced often, not recognizing a generic drug replacement. My doctor, or at least the pharmacy I use currently, hast started putting the brand name my generic is replacing directly on the label. I've found it to be immensely helpful, especially, in cases where I've been working with my doctor to find the appropriate medication/combination.
I too have noticed this effect with one medicine in particular. I've had several different generics/brands and all worked fine, except this one make. I don't know what it was, but it just didn't work. Quite a strange experience.
There are examples of generics that were different than the branded versions. Wellbutrin is a great example. A few generic versions were pulled since they dissolved at a different rate and delivered much higher doses of drug and causes side effects. Same thing with a few version of valprolic acid for epilepsy.
The law states the generic should be within 80% to 125% bio-equivalent of the branded version. Normally that's good enough, but for some drugs it causes problems.
> hey're required BY LAW to have the same "active" ingredients; you just might be paying for a slightly different pill shape, packaging, or taste.
Yes, but the margin of error of the amount of the active ingredient can be significant (up to 20% in either direction!).
The inactive ingredients can be relevant. Some people have allergies[0], and sometimes the inactive compound can affect the absorption of the drug (which can vary from person to person).
Generics are fine, but it's important to remember that they're not exactly the same as the brand-name drugs, and that can matter.
[0] For example, a lot of drugs contain lactose-based compounds as inactive ingredients, which is one of the reasons that a lot of drugs can cause diarrhea as a side-effect.
What's the mechanism of action for lactose causing stomach irritation? Lactase isn't found in the stomach so it can't be lactose intolerance (as in the common meaning of the phrase, ie. lactase non-persistence).
Microflora in your gut. That's what lactose intolerance basically means--it doesn't directly harm you, but when it's not taken up by the intestines because you lack the lactase enzyme it's consumed by microflora, which create gas and other issues. Kinda like beans which haven't been properly prepared and contain too much non-digestible starch.
It's also why some people who are genetically completely lactose intolerant can actually consume quite alot of lactose, and conversely why people who are genetically lactose tolerant can suffer from gastrointestinal issues pretty easily from dairy products, especially if they haven't consumed them in awhile. The tolerance or intolerance boils down to how the microflora react, not specifically to whether the person produces lactase.
Did the previous poster edit his comment? I realized after the fact that you appeared to be responding to something different from what the post currently states.
Not as far as I know. My response was to "tolerance or intolerance boils down to how the microflora react", which does happen after the stomach, so it seems unlikely that it could influence stomach irritation.
The word "stomach" doesn't appear anywhere in
chimeracoder's post. It only mentions "absorption" and "diarrhea", both of which imply the intestinal tract.
Two words, price segmentation, only in that case you don't get anything for the premium except the illusion of better quality.
On a related note, in Quebec, Canada, 9 months ago, a new law passed forcing doctors to prescribe generic version of drugs if they exist (edit: and of equivalent quality). If you still want the brand name, you have to pay the difference.
Now we are flooded with ads from big pharmas telling us to chose the brand name because they are now miraculously the same price as the generic!
Adrenaclick is the same drug as EpiPen, but a different injection mechanism, so it's a different prescription (if your doctor chooses to prescribive a specific injection mechanism)
The news here is that CVS has a marketing and distribution campaign for a generic alternative to Adrenaclick.
There may be quality-control binning involved. Lots that pass the brand-quality standards tests get sold as EpiPen, and those that pass only the minimum standards tests get sold as the generic. There is probably also a "ship overseas" bin. Those tested as dangerous or defective are destroyed.
Of course, that's how I would do it. It is also likely that there is no binning involved at all, and that quality is exactly the same for a branded EpiPen at $600, a generic at $300, and one smuggled through customs from Canada at $150.
> Unless I'm missing something, that means that until now, the company that makes the brand name drug and artificially inflates the price (and blames it on insurance companies) also made the only generic version of the product.
That's actually quite common. For a lot of drugs, the place that manufactures brand-name drugs will also manufacture (some of) the generic versions available. (This may or may not be operated directly by the pharmaceutical company itself).
For really common medication, there will be multiple plants that manufacture the drug. But for less-common drugs[0], it's possible that there is only one place that manufactures them.
> So it's hard to claim that there's even a minor difference, unless the company specifically manufactured them differently
Quality control, for one. Generics are allowed to have a rather wide margin of error on the amount of the active ingredient they contain, for example. Brand-name drugs tend to keep their range much tighter, because they want to protect their brand.
EDIT: To clarify the statement "wide range of error", there are a couple of different ways of looking at it. Think of mean and variance: a drug is allowed to have varying amounts of drug from pill to pill, and the distributions of the active ingredient can have different first (mean), second (variance), and third (skewness) moments in the generic and brand-name versions[1].
But on top of that, there's the question of measuring the active ingredient by mass in the pill, vs. measuring the bioavailability of the drug (ie, how much actually is available to the body to use). The latter is the thing we actually care about. The problem is that defining that is a tough problem, because it differs from person to person, and some inactive compounds affect absorption in some people but not others. Short of literally manufacturing the generic and brand versions simultaneously and randomly assigning them as they come off the belt[2], there is no way to guarantee that bioavailability will be identical between the two drugs for a specific patient. If they have different inactive compounds, or if any part of the manufacturing process differs in any way, they will be different for some subset of patients, and there's no amount of testing that can change that basic fact.
After a drug is approved and becomes generic, the brand name and generic versions are subject to the same rules[3]. The generic drugs aren't "different" from the brand name in this respect; it's just that the brand name is a known entity, whereas it's hard to request a specific version of a generic compound. So if you know that a brand-name version works, it can be preferable to stick with that, because you can always request a prescription to be filled by the brand-name ("dispense as written").
[0] and this is a very long tail, so it's quite likely that a drug you take or have taken falls into this category
[1] To be pedantic, we know from continuity theory that they have to be different, so the question is how different do we allow those to be?
[2] Which, to be fair, is not too far from how some generic drugs are made, but this is completely opaque to the end-consumer and subject to change without notice.
I've read and heard that FDA rules allow generic to get 80% - 125% of the active ingredient into the bloodstream as the original drug. Of course the manufacturing tolerances are much better than that, so makers often put just enough to make the 80%.
My links says The generic drug manufacturer must prove its drug is the same as (bioequivalent) the brand name drug. For example, after the patient takes the generic drug, the amount of drug in the bloodstream is measured. If the levels of the drug in the bloodstream are the same as the levels found when the brand name product is used, the generic drug will work the same.
So there should be some specific FDA regulation someone can find that explains what they mean by the same there. I can certainly believe that the regulation would specify a range, but I'd like to see it.
My link also contains a suspiciously pertinent paragraph when you consider that 125-80=45:
FACT: FDA does not allow a 45 percent difference in the effectiveness of the generic drug product.
It's not clear that they would actually be referring to the same meaning of 45% but it is at least an amusing coincidence and there is some chance the FDA is frustrated with whatever it is you read.
It's important that people realize that although Epipen's list price was $600, the company saw only about 50% of that. The rest of it was absorbed by the channel as it made it's way to the consumer. Most of those dollar were rebated to the PBMs.[1]
You might ask, why raise the price 15% and rebate back 13%, when you could just raise the price 2%? Well, the PBMs can go back to insurers and say "look! I successfully negotiated a 13% discount for you! All those fees you pay us are worth it!". So the drug companies play along.
If you look at list prices for drugs, they went up 12.4% in 2015, but the net prices only went up 2.8%[1].
How much is absorbed by middlemen seems like a bit of a red herring. Mylan raised the price of the pens from $100 in '07 to $600 this year. Hard to blame that on pharmacies and wholesalers taking their cut.
IMHO, calling it cheap is very exaggerated. It is already expensive at $109.99 compared to the simplicity of the product and the low cost of production and research. At $600, it was insane.
In Belgium they cost about 40 euros (and of course is covered by health care). I can't imagine the manufacturing cost to be much higher, even taking into account the way higher standards for medical equipment. The epinephrine itself is dirt cheap.
This is probably CVS partnering in paying for an expansion in manufacturing capacity (or promising to make some payments if they don't meet some sales goals) and is really a drop from $150 (the previous price point of generic Adrenaclick). I wouldn't count on further drops in price, at least not without other generics coming to market.
Is your assertion that liability insurance only became either required or suddenly much more expensive in 2007 and that it was coincidental that Mylan bought the rights to the injectors the same year the price started going up?
Do you know how much it costs to produce the device and meet all the likely regulations? I would have thought this is to only break even. It's more a marketing move to be the good side in the story and get more business from ethical followers.
Given the $600 of the original, I'd say $109 is cheap.
EpiPens are medical devices, not drugs, so the regulatory approval process is significantly different. Whereas drugs usually take around 15 years and about a billion dollars to develop and approve, medical devices can take as little as 3 years and $25 million. For example, the entire approval process for the Revo MRI-conditional pacemaker was less than two years [1] (although companies enter an active dialog with regulators long before submitting the application).
The prescription you get for adrenaline is actually for the autoinjector mechanism, which is significantly cheaper to develop and test than a pacemaker, so I'd bet the numbers are at most 5 years/$50 million.
That's not quite accurate. It's a device/drug combination. The manufacturer still has to produce the drug under GMP conditions and get an aNDA approved for the drug portion.
One could argue it's more expensive than just a medical device.
I was oversimplifying, but yes the manufacturer still has to prove that their drug is equivalent to the gold standard for therapeutic uses and that they have sufficient quality control. How much it costs depends on the complexity of the drug and who does it. An experienced generic drug manufacturer will have everything in place for patient selection, investigators on their payroll, and expertise in designing protocols for the marketing application. Since we're talking about adrenaline, not some complex drug cocktail, I think the device portion would make up the majority of the cost (life and death emeregency device + has to work in the field without a medical professional tends to be pricey).
Even if they buy the epinephrine they use, they still need to validate the purity, do a sterile fill of the device, track stability in the device, etc.
It's not like they could buy a 100 kg of epinephrine, dissolve it up and just fill syringes with it.
$100 is still outrageously expensive for something that is absolutely essential for some people.
The NHS in the UK pays £52 ($90?) for a two pack of branded EpiPens. Singles of "generics" are available for £26. They are made available to anybody who needs one either for free or the £8 prescription fee.
In Canada, brand name EpiPens are around $100 CAD each ($76 US), and are 100% covered by OHIP when prescribed by a doctor (who will give you a few if you want).
Perhaps your credit card has one of those perks where they'll refund the difference between paid and discounted price of a purchase within x number of days? Then again, it's probably like refunding the difference between two televisions; similar but not equivalent.
Note also that if it is cheap enough people will buy more than they need and keep them laying around in various places.
(I buy portable hard drives like water anyone who remembers way back how expensive they were knows what that feels like. Ditto for computers you use to have one now I have lost count.)
Epinephrine in these autoinjectors degrades relatively quickly (over the course of months). It's good to have more epi-pens laying around, but the expiration makes this a different situation from HDDs (though they, too, have an expiration but usually on a longer time horizon).
Free in the UK due to the NHS - however, the NHS is reluctant to prescribe them unless there's a good chance of anaphylactic shock or life-threatening breathing difficulty, because the pens are expensive, go out of date quickly, and usually need to be issued 2-4 at a time.
> The health economics model assumes that people who receive adrenaline auto-injectors will be allocated two epinephrine pens (EpiPens) with an average shelf-life of 6 months. Each auto-inject EpiPen costs the NHS £28.77 (British national formulary 60). This equates to £115.08 per person per year.
The drug is sitting in front of a spring loaded plunger.
So to refill it you have to release the tension and then correctly reset it. A mechanism that made it simple and reliable to do that would probably cost the same as throwing away the simpler mechanism. People that want to muss with vials and needles are free to do so anyway (you can buy epinephrine and needles for cheap if you aren't concerned about an easy to use and reliable auto-injector).
The systematic failure is that the FDA granted Milan exclusivity for a simple improvement on a 30 year old product. The FDA should have the power to keep small improvements off the market when the innovator chooses not to license them.
Of course this will outrage some people that believe in the freedom of companies to benefit from the patent system, but from a pragmatic standpoint the return to exclusivity was far more harmful to consumers than the simple improvement is beneficial.
I'm guessing the parent was asking about refilling due to the active ingredient expiring, not after an actual injector use. Hopefully most people who have epi-pens have to replace them due to expiry rather than due to frequently having to use them.
Replacing the pen after actually using it seems entirely reasonable - if nothing else, the needle will be contaminated.
> My understanding is the medicine in these epi-pens is fairly inexpensive..
an ampule of 1:1000 epinephrine is about $4. At least that's the price we pay for them on the ambulance. I'm a Paramedic in the US, and we took the Epi-Pens off our units ages ago due to the ridiculous costs. Now we just draw up epi by hand with a typical insulin syringe and deliver it that way.
Clarification here, CVS cut the retail price of the existing generic for Adrenaclick (known as Epinephrine).
This generic has been around for a while, but isn't an A/B rated generic so it's illegal for a pharmacy to dispense this if a prescription is written for EpiPen. We can dispense this if a prescription is written for Adrenaclick or Epinephrine.
Make sure your doctor writes a script for Adrenaclick or it is illegal for us to dispense this cheaper generic to you
Edit: The injection device of each product is what limits the A/B rating. Adrenaclick and EpiPen have different autoinjector systems. Yes the regulations are that strict. Here's[0] a video showing the difference between Adrenaclick, Epipen, and AuviQ (which has been recalled and discontinued).
[0] https://www.youtube.com/watch?v=LRgqwgCh4Fs
https://www.reddit.com/r/news/comments/5njj2x/comment/dcbyju...