CVS just announced a cheap generic alternative to the EpiPen
arstechnica.com
arstechnica.com
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...
The way this sounds it's not mechanical but a software bug. How interesting. I'd love it if someone did some RE on these and found their failure mode.
To me that sounds very much like a mechanical bug - the delivery mechanism failed. 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)
The author's first comment (the first response to the first comment) is (to me) also interesting...
Marketing and consumer behavior contributed to people not seeking out the cheaper option.
Classic case of the government causing abusive artificially high prices for consumers through bad regulation.
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.
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.
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
* Link from above: https://www.youtube.com/watch?v=LRgqwgCh4Fs
The government certified highly trained doctor seems to have simply overlooked that a cheaper and almost as good alternative existed!
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.
[1] http://www.npr.org/sections/health-shots/2016/12/16/50585163... [2] http://www.usatoday.com/story/money/nation-now/2016/08/29/br...
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.
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.
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.
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.
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.
There's also the "death problem". No customer likes to cut corners on something to save their life.
More generally, this is why so-called "me too" drugs aren't as bad as they are made out to be.
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.
Also, I suspect there's a lot of doctor<-rep pay4play going on.
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.
[3] http://www.fda.gov/downloads/AboutFDA/Transparency/Basics/UC...
What's the range?
This FDA brochure says that generics are held to "rigorous" standards "with respect to identity, strength, quality, purity, and potency."
http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsi...
Should I worry that the FDA is blowing smoke?
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.
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.
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].
[1] http://www.drugchannels.net/2016/09/epipen-channel-economics...
And at this rate it only takes a couple more iterations of competition until the thing is almost free.
Excellent, I say.
Given the $600 of the original, I'd say $109 is cheap.
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.
[1] http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma....
One could argue it's more expensive than just a medical device.
It's cheap and widely available (US retail prices seem to be on the order of $1 per dose. Retail.).
It's not like they could buy a 100 kg of epinephrine, dissolve it up and just fill syringes with it.
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.
Get it together, America.
And who's to say that our high prices aren't subsidizing your low cost.
http://www.ibtimes.com/how-us-subsidizes-cheap-drugs-europe-...
(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.)
> 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.
https://www.nice.org.uk/guidance/cg116/resources/costing-rep...
Edit: Current cost to the NHS appears to be:
> net price 2-mL auto-injector device = £26.45, 2 × 2-mL auto-injector device = £52.90
https://www.evidence.nhs.uk/formulary/bnf/current/3-respirat...
My understanding is that these need to be replaced yearly, but you replace the whole thing.
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.
Replacing the pen after actually using it seems entirely reasonable - if nothing else, the needle will be contaminated.
I was thinking of inhalers for asthma. The plastic bit is cheap enough, but they could in theory just give you the medicine filled part.
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.