This article hints at it, but this is the list price that nobody actually pays. Manufacturers offer discounts to pharmacies that lower the net price.
So in fact, this drug could be cheaper than the Mylan version, but it looks like they never dug in deeper to find out if it's true.
Second of all, the first generic approved gets 180 days of market exclusivity whereby the FDA will not approve any other generic versions. This is such that the generic manufacturer can recoup the investment prior to widespread competition that drives down prices.
For example, Lipitor went generic and the price dropped only ~10-20%. After the 180 days, multiple generic companies got approval and now the price is 80-90% lower.
This is one of the major problems with the healthcare industry in the US. There's zero transparency and it's a dark art to figure out how much money anything costs. It's a back and forth war between multiple different parties that all want to extract value out of the system.
Just because you don't pay as much as the sticker price is missing the point a bit, I'd say.
The Mylan version will also probably cost less than list for most people (though Mylan will get their money, just like the generic maker).
Also, you're correct that the price will come down over time. If the FDA had said, "this approval is part of a process that will eventually lower the cost within the next couple of years," then the article would make no sense. That's not what they said when this generic version was released.
The article is not claiming that generic drugs don't reduce prices. It is claiming that the narrative from the FDA, that this approval will reduce costs, is largely false.
The list prices hold up better without this competition. So, the actual price people pay for either drops even when the genric version has a very similar list price.
Yes, the article states that the Mylan product can be purchased for under $150 with a discount.
In fact, several large retailers sell EpiPen for $150 when including a coupon, according to GoodRx.
As for the FDA narrative not being true, how do you know that? The article doesn't actually state the true cost of the Teva product anywhere, which was my original point.
$150 with discount or coupon is still way too expensive. Where I live in Europe (Belgium) pharmacies sell the EpiPen for just $50. No need for a coupon, that's the regular price. It's even cheaper for some patients.
In belgium the government sets the maximum price of drugs. The drug company has to submit a dossier explaining objectively why a particular price that they propose is reasonable.
I think that is what we need in the U.S. When I was in college I survived on a food budget of $100/week during my first year. I have diabetes, and I am supposed to (though not required) test my blood three times a day, 21 times per week, at $1 per strip. My Metformin costs me another $22 per week, and a two other drugs costs me about the same. The result is that a single well-controlled condition costs me $88 per week, $352 per month.
Put another way, if I was working minimum wage without insurance and no other income (12% tax bracket), I'd need to work 13.6 hours to cover the drugs for that one condition, 34% of my take home (roughly, I didn't include state tax, social security, etc.). Where as one person I would have been above the poverty threshold of $12.14k in 2018, now I would effectively be below it.
This is why so many people who don't have steady jobs (e.g., the gig economy) have to choose between drugs and food.
The primary issue with having a high list price with large discounts is that discounts off the retail price are typically negotiated by insurance companies and government purchasers (Medicare, Medicaid). That leaves the most vulnerable portion of the population - the uninsured and under-insured - left to pay the full retail price. That's been true for almost all of medical care for a long time now.
Even worse many times the "discount" or part of it is not a reduction in price but a refund from the drug company back to the insurer. So if you haven't met your deductible you may pay $300 for the drug but your insurance company is getting $100 refunded to them that goes into their coffers even though they expended nothing in the transaction.
In fact if you don't submit the claim for the medication to your insurance you may be able to reap that $100 of savings yourself in the form of a discount. Until very recently when the law changed to prevent it the contracts insurance companies had with pharmacies prevented your pharmacist from telling you that a drug could be obtained cheaper by not using your insurance.
This is the real problem. If the consumer price is $50 but the insurer is paying $250 behind the scenes, then we all pay that price with increased premiums.
Isn't there an argument that if you give people an extra $10M, whether in this case or in any random subsidy, that it will be competed away, and thus it's a waste?
I feel like people use that argument in other contexts but it would apply here too.
A rule of thumb from the European Union is that it takes four competitors before prices come down. Two form a duopoly, and it's to the advantage of both parties not to lower prices. Four have trouble holding prices up. Whoever's losing market share tends to cut prices.
If you want to operate as a pharmaceutical producer / seller in this country, you have to supply this list of emergency medicines at 10% above the price we can import from China / India.”
I mean, I'm talking about maybe a few life saving emergency medicines. Capping the price and allowing / encouraging / requiring other manufacturers to sell in the market.
What availability would those producers need to provide? Some quota of supplies? Low prices don't matter for much if there's a shortage, and there _will_ be a shortage of cheap emergency medicine if the companies that produce it can get away without spending too much on the unprofitable requirement. (and if it were profitable they'd do it anyway, without need for government requirement)
I worry that requiring a pharma company to provide supplies hurts anyone who wants to start up a new pharma company. It's easier to comply with government regulations once you're a big company and have many plants, but new companies have to be lean or else they'll never make it off the ground.
Society isn't some laboratory where you can run experiments to your heart's delight. Decisions have consequences. Harming the market for medical research is particularly insidious, as its costs are very real but hard to see: all of the people who will be worse off because the treatments they need are not invented.
Like, for example, the decision to increase the price of an Epipen to US$300 in the USA, whereas the same product in Australia costs AU$100
> Society isn't some laboratory where you can run experiments to your heart's delight.
In a way that's what policy and regulation are. Since we can't know the full consequences of policy and regulation until they're implemented and time passes. Sure, most policy and regulation aren't willy-nilly.
Trade-offs I guess. Regulate the sale of some emergency medicines so that those who need them now can afford them at the expense of, what exactly? It's not like regulating the sale of one medicine is going to break a pharmaceutical company?
Why do I feel like I'm trying to defend sensible pricing here? Are people really that allergic to the word regulation?
Why not both? I'm serious. It seems like a good idea to promote competition and put a ceiling on the prices of essential medicines based on the global market. 10% above the lowest price may be a bit aggressive, but something must be done to stop these 10,000% markups we're seeing now.
See [1], section "Number of competitors", page 12. This isn't a policy document, but an EU study. An interesting result in that paper is that low interest rates make tacit collusion more profitable. We've been in a period of very low interest rates for some time now, which increases the number of competitors for whom tacit collusion pays.
As before, collusion is sustainable if and only if firms put a sufficient weight on future profits. The critical threshold for the discount factor, δ, now depends on the number of firms: the more competitors there are, and the higher this threshold, meaning that collusion is less and less sustainable. For example, the threshold increases from 1/2 = 0.50 to 1/3 = 0.67 when the number of competitors increases from 2 to 3. This means that if the firms’ discount factor lies around 0.60, say, two “competitors” could in fact maintain the monopoly outcome but three or more competitors would have to price at cost.
The price will probably be lower, as the article suggests, but there are currently epipen shortages so teva can charge more until the shortages are resolved.
Typically the second generic product brings the largest price reduction [0]. However epipen is a unique scenario. I'm not sure how hard it is to develop a generic epipen, but it is definitely not a straightforward small molecule generic, so presumably there will be fewer generic versions than you see with drugs like lipitor. So it is possible that the market resolves to an oligopoly with 3-5 players that all make decent profits; there is precedent for this (i think the pancreatic enzymes market is an example)
It's not even 'building' one, it is literally just buying a commercially available FDA approved autoinjector and a vial of epinephrine to load into it.
It is really strange that the FDA is totally fine with diabetics buying vials of insulin and loading their own autoinjectors, but doing the same thing with epinephrine is apparently extremely dangerous and the FDA doesn't want you to do it[1].
This is a devil's advocate argument, but the difference is between one person who routinely uses the drug versus another who may go for years before needing to use it in an emergency situation.
The EpiPen is designed to be used with minimal training. A diabetic who injects themselves regularly with insulin is presumed to have the skill to do it without screwing it up.
The person using it (performing the injection) doesn't need any more training than an epipen, they are basically the same in that regard. You take off the cap, push it against the skin, and press a button. The slightly tricky part is loading the injector which would presumably be done by the patient well ahead of it actually being used.
Epi is a drug that is a vascodialator in large muscles and a vascoconstrictor in small muscles.
If you inject the right amount of insulin in the wrong place, not much happens. If you inject the right amount of epi in the wrong place like a finger, you could lose that finger.
You could argue a diabetic’s ability to administer during an event is just as bad someone in anaphylaxis all day long... one is passed out and the other is panicking because they are dying...
But epipen’s unique injector is primarily to get the right amount in the right place. Two part problem it solves over the vial.
I bet more people have died because there was no pen present (too expensive) than would have died from incorrect administration of a cheaper pen. So the design of the epipen solves a problem, but are we making the right tradeoff in insisting on using that solution at a high price point?
This is like the fact that TSA searches make another 9/11 less likely, however people driving instead of flying to avoid the hassle is estimated to have killed more people than 9/11 itself did. Risk is a funny thing, and isn't always straightforward to figure out.
Making it personal, in theory my daughter should have 2 epipens close at all times because if she gets stung on the neck, she could need one. Anywhere else is OK, the concern is swelling from her allergy cutting off airflow. That explains one, and the second is in case the first fails to work properly, which sometimes happens.
In practice there is an epipen for her at school, and at her mother's house, but not at my house. We shelled out once. But we're not shelling out over and over again to prevent such an unlikely disaster. (Twice more so that there are the recommended number of pens at school and both places she lives, then more as we lose them since they are supposed to always be on us..soon we're talking about real money!)
So... you can can get checked out on and get a script for the vile of epi. Adjusts typically get .3mg and kids .15mg iirc. For the normal 1mg/mL stuff... and that’s for anaphylaxis of course, not a heart attack.
That’s cheap and pretty easy to do. The problem is while maybe I’m a superstar with a vile on someone else, I wouldn’t trust I could do it while my throat was literally closing, in all scenarios. The pen makes sense a lot of time, but the vile is good if you know you won’t be the target.
Something you wrote also, 2 pens. If you need one, there is a good chance you’ll need two. Depends on how fast you can get to a hospital and the circumstances with the victim.
So in that case, the vile makes even more sense for you to have at home.
Diabetics don't tend to take insulin in a panic. If they are panicking, it's because they are already low, and need glucose (which can be administered in an injectable form, and is usually only used if the diabetic cannot be woken).
In my example the diabetic was passed out. Or like the with diabetics I've had to deal with, stubborn mule-like insistence they're fine! It's the people going into anaphylaxis that I think panic, for pretty good reason.
But it's just an example. My point was more that insulin is generally safer than epinephrine.
> The pricing appears to undercut a notion promoted by FDA officials that approving more generics can help relieve the pocketbook pressure many Americans feel over the cost of their medicines.
I'm surprised the author is making the arugment that more competitiion doesn't drive down prices - despite the large body of evidence to the contrary.
It's accepted belief that when competition fails to drive down pricing among pharmaceuticals, it's usually due to regulatory decisions. There are several studies that have been done on this exact topic, one even finds that price regulation actually leads to higher prices by discouraging market forces [1].
Normally competition means companies can make as many of a product as they want in order to gain market share from each other. FDA regulated drugs often operate on a production quota system where a given company is only allowed to manufacture a pre-approved amount. If the FDA decreased the EpiPen quota by the same amount that the generic was allowed to be produced in then you might not expect to see any reduction in price. Of course they might have just left EpiPen's quota the same, the article doesn't have that sort of information and it might not be publicly available.
There is no quota on EpiPen production, that is just for highly restricted drugs. (Did you know that cocaine has some medical uses and is almost certainly stocked in the hospital near you? That is the kind of drug that has a quota.)
> To date, we aren’t privy to a full account of how Daniel Best sustained his injuries, nor their precise nature, nor any other evidence (such as a suicide note, if one exists) that prompted medical examiners to conclude that he killed himself. But there is clearly nothing contradictory about his having suffered blunt force injuries during the commission of a suicide. Given the facts at hand, there is no reasonable basis for speculation to the contrary.
Interesting read, but towards the bottom it talks about how "blunt force" can be many things like jumping off a roof and hitting the pavement. I'm still personally curious on the exact details, but maybe his family doesn't want it to be public.
I think it's conspicuously worded (ie. "Multiple" blunt force injuries) but no reason to suspect a conspiracy; but, did his death create a leadership vacuum in the fight against high drug costs?
Hmm...odd. We previously would buy my son's EpiPens in Canada (when in Canada for other reasons), but recently CVS has had an equivalent product that we've bought. I forget the price but the fact I forget it tells me it was reasonable.
...<digs pen out>...ok, it is made by "Impax" and labeled "epinephrine injection, USP"
The product you got at CVS [1] is made by Impax and is an FDA 'Authorized Generic' [2] for Adrenaclick, also made my Impax. It's effectively Adrenaclick with the branding intentionally omitted, and the CVS out-of-pocket price is 109.99 USD for pack of two.
You should look at the Auvi-Q product made by kaleo. If you have insurance (even if it is not covered at all) or you are unable to afford insurance, kaleo will send your the product for free. End of story. My insurance does not pay a a cent, and I don't either. That's several thousands of dollars given away for free to each patient over just a few years.
kaleo was founded by twin brothers with food allergies and they've worked from day one to improve patient quality of life, unlike other pharmaceutical companies. Sadly, the media has recently criticized them, paradoxically, for their "high prices" that are paid only by the huge insurance plans with the deepest pockets--they do not receive donations, after all, and this strategy helps make their products free for both the underprivileged and middle classes.
part of what you're paying for with your drugs is quality control to ensure that you 1) made what you wanted to make 2) didn't contaminate it with something you didn't want.
You should take a look at the documents I FOIAd from FDA (the parts they didn't redact that is--apparently my appeal will take 3 years to be processed). Median Medical Technologies, Inc. (a Pfizer company that produces and owns patents for the EpiPen) violated numerous safety rules and breached aseptic manufacturing multiple times, and did not appropriately investigate failures.
Here's one of their violation letters, I was told that sanctions were still being considered for the latest inspection.
i don't know what else mylan makes, or how much is epipens, or whatever, but if we look at their 2017 financials, and removed all R&D, they'd have had a profit of ~1.2B on total revenue of ~11.9B. so they could shave an average of 10% off the cost of their product line and still break even.
What % was spent on revenue; a while back it came out that drug companies were spending more on marketing than on R&D whilst arguing they needed special protections because of the high cost of R&D.
A low profit company, charging a distant lower amount for probably rely on word-of-mouth + news features to some extent.
Also, you can save a lot by not paying shareholders and C-suiters massive amounts.
You might be interested to read a bit about the history of people's attempts to bring EpiPen competitors to market in the first part of this blog post [0]. I don't see how it being non-profit would make much of a difference in this case.
So, why not just import these pens from UK or Canadian producers who make them at scale and for much cheaper? Or better yet, create a joint venture to manufacture them cheaply in places like India?
Unless I'm misunderstanding, it has nothing to do with production cost in the US, and everything to do with the arbitrarily high market value of the drug.
That would be quite illegal, those UK and Canadian epiphendrine injectors haven't been subject to FDA regulation. It would be a really good idea, granted, but there are plenty of less radical ways to solve the problem. It doesn't seem to have a positive effect on health outcomes (due to effects on availability) but US drug regulations are pretty much the tightest in the world and allowing foreign imports would be a relaxation of that.
Unless the drug in question is a controlled substance, it's only illegal to sell Rx-only medications, not to buy them. On the extremely rare chance customs confiscates your shipment (which in practice only happens one week a year, during Operation Pangea), all that will happen to you is that your package will be empty.
I'm not linking them here (just because I don't want to get YC/HN in trouble), but there are a number of highly-reputable online pharmacies in India and Vanuatu that sell non-controlled medications and ship to the US. I haven't checked whether or not they sell EpiPens, but I wouldn't be surprised. I'm aware of them because they are very popular in the transgender community due to high barriers to accessing medical care by legitimate means.
Maybe countries should encourage prescription drug tourism. I can get a flight to London for $400. If I save $300 on an EpiPen, suddenly its a real deal. (Maybe you just need to go to Canada though)
If it costs $12.53 to manufacture an EpiPen equivalent, and the market price of the EpiPen is $300, it would make no sense to sell it for any price other then $300.
Why should the market price be $300? If it only costs $12.53 to manufacture, someone could sell epipen equivalents for much less than $300 and capture the whole market.
Suppose there are only two competitors and the barrier to entry for a third is high. You profit $287.47 per unit with partial market share. If you try to charge $200 so you only make $187.47 per unit, your competitor will also lower the price to $200 and you will both end up with the same market share but less profit. Even if the two participants in the market never communicate, the obvious strategy in a two-player game is keep the high price.
This works when there are two people (who can maybe even use the same golf resorts), but it’s impractical when there are 10 or more since anyone has a temporary advantage to defect. That’s how free markets are supposed to work and I think people might expect that to happen here. It’s just that, as you noted, with only two particiants allowed in the market, forming a cartel is trivial.
That's true because it's not trivial to launch a new drug/delivery system. Even generics have to prove that their drug matches the kinetics of the patent drug and has other similar properties. There is still an FDA process to approving a new drug, and if I'm not mistaken, the new delivery device also has to have it's own approval through the FDA medical devices division.
All of that is before you even take into account how much it costs to re-tool your production line to make something different. Sure, you could lower the barriers to entry until they're barely existent and offer almost no consumer protection, but I'm not really sure we want to make it so easy that a company will spin up a production line to make a drug for 6 months while they think they can undercut the competition.
Then again, I'm a big pharma biologist, so I probably am a bit biased toward safety and large, slow movements.
A solution to this particular problem could be to make the patents on the existing, known to be safe methods expire earlier, so that in order to retain a monopoly on something big pharma must make a significant patentable improvement.
Critics of this policy say that it would disincentive new drug development. That may be true, but for many people it doesn’t matter because they can’t afford them at current monopoly rates anyways, and our insurance industry is broken for them.
I wonder how you would go about researching a better patent-expiration scheme and the effects it would have.
Edit: maybe I misunderstood you- are you saying even with no patent protection, the barrier to entry is still high enough to disincentivize new entrants because of safety regulation and retooling costs? So patents aren’t the only roadblock, or not even necessarily the main roadblock?
I mean what you say in your edit. Even off-patent drugs require basic proof that they are what they claim to be, are similar to the patent drug in important ways, have a safe formulation, require a company to make a production line for it, and even require some marketing in many cases to make sure people know there's a new manufacturer of that drug.
I've never worked in generics, so I'm certainly not an expert, but I am saying both that we need some of the safety and quality controls by the FDA (or some system to replace them without relying on companies' good will) and that there are big hurdles even disregarding the FDA or other regulatory bodies.
”Even if the two participants in the market never communicate”
But you can’t get at identical prices without communication between parties. Without communication, initial price setting is as if both companies make a bid in a sealed envelope.
It would be highly unlikely that both bids would be identical, and the lowest bidder with a price above $12.53 makes all the profit.
The two participants didn't appear at the same time. When the first participant appeared and set the original price, that price became an obvious Schelling point.
No, it's more like this: I'm the CEO of a medical drug supply company. I want a new yacht, or a new Jetstream private plane, or hell--why choose between them when I can get both? What price should I charge for a drug millions of people need each year so that I can continue to enable my decadent lifestyle?
If the historical price is X, but I can charge 4X because people need the drug, let's charge 5X so I can make even more profit because demand is inelastic.
And the bad PR of news reports of people dying because they can’t afford our lifesaving products can be addressed by issuing a press release announcing price cuts and a coupon program which will both be ended after the public moral outrage dies down.
One should be hesitant to proclaim knowledge of the optimal strategy without knowing all the details. Whether or not the default strategy is to cooperate or betray is sensitive to the precise weights of the rewards for each combination of decisions, as well as the number of times the game is played. For example, in the simple version of the Iterated Prisoner's Dilemma, the optimal strategy is tit-for-tat: the default is to cooperate, and only betray in exchange for being betrayed.
I mean, that really isn't the default strategy. As Adam Smith recognized in Wealth of Nations, the default strategy is always to collude:
"People of the same trade seldom meet together, even for merriment and diversion, but the conversation ends in a conspiracy against the public, or in some contrivance to raise prices."
> As Adam Smith recognized in Wealth of Nations, the default strategy is always to collude:
That's a misreading of Smith's point, but it's also irrelevant here, because it's quite a leap to assert that "the default strategy is to engage in blatantly illegal activity".
If it were not the favorable strategy, it wouldn't have to be illegal, because it would not be popular enough to hurt consumers. People habitually favor optimizing for short-term success because there is no long-term if you don't survive the short-term. Furthermore, it is actually repeated interaction that makes collusion/cooperation better than betraying, because of the opportunity to get punished on subsequent iterations. It is this medium-term thinking that pushes collusion (but not too much of it) into a position of dominance. In the truly long term, nothing is stable because we're all dead anyway.
That's only default for actors that are dumb. Most humans are smart enough to take advantage of an obviously better strategy that also doesn't really require coordination.
technically yes, that is the default strategy in perfectly competitive markets, but collusion happens because it maximizes profit for both companies despite it being anti-capitalist.
for plausible deniability, the two companies typically don't directly talk to each other, but a lot of signalling happens via public statements and marketing channels to indicate a desire not to compete (as a simplistic example: raising prices when the competitor lowers theirs).
Can you really say the "market price is X" when there's only been one company making it?
Either way, I think there are some hidden forces here that keep these prices so high. Like if the FDA would open the market to competitors from Europe, or even countries like India, I think that "market price" you say would dramatically lower.
I think the U.S. pharmaceuticals market both lacks competition from generics, as well as has some weird laws like "Medicare can't negotiate prices with pharma companies," which only encourages pharma companies to raise their prices as much as possible.
The law I mention is almost solely responsible for all the "drug X increased price by 5,000%" headlines you've seen lately. Pharma companies have figured out they can shamelessly rob taxpayers and nobody will do a thing about it, as long as they donate to the right politicians (from both parties).
"Medicare can't negotiate prices with pharma companies"
That's a common statement, but not really true.
Medicare Part D, which covered prescription drugs, is managed by private insurers who can negotiate for the price of drugs.
In Medicare Part B, which covered physician administered drugs, Medicare pays the average sales price. Which means every time a private insurer gets a lower price, some of that is passed onto Medicare.
So the statement "Medicare can't negotiate drug prices" is technically true, but ignores all the other ways it can get lower drug prices.
Medicare has a different negotiation system built in -- Medicare reimburses a fixed percentage of the minimum amount you charge, to anyone under any circumstances, for the same procedure. This means that doctors who accept Medicare have a price floor set for everyone else by the minimum they need to get from Medicare patients.
(Yes, procedures from doctors aren't the same thing as drugs from manufacturers.)
It's worth noting that the Teva device that's the subject of the article is what the FDA considers an 'Authorized Generic'. From the press release [1]:
>"An authorized generic is made under the brand name’s existing new drug application using the same formulation, process and manufacturing facilities that are used by the brand name manufacturer. The labeling or packaging is, however, changed to remove the brand name or other trade dress. In some cases, a company may choose to sell an authorized generic at a lower cost than the brand-name drug product."
While this is different from what common language calls a 'generic drug' [2], in some cases either kind of "generic" could, may, or must be substituted by pharmacists, depending on various circumstances and the particular state's regulatory regime [3].
This interacts with the epinephrine autoinjector market in two ways. First, there is little upside for the manufacturer of the authorized generic to make the list price significantly lower, as the list price is rarely paid by the end-user out of pocket, and frequent mandatory substitution laws cause makers of Authorized Generics to gain marketshare as long as they're slightly cheaper than the brand
Second, Authorized Generics of combination devices are only subsitutable for a corresponding brand, so different devices like Auvi-Q and Adrenaclick are technically a different market entirely: the doctor's prescription will note the exact sort of device. Therefore, while there are other epinephrine autoinjectors, the marketshare among them is decided in doctor's offices and insurance plans, rather than by direct consumer choice through the end-user's own spending.
Typically each new entrant prices lower than the previous entrant to gain market share. The PBMs and retailers already buy the Mylan authorized generic, which is the same product and same price as the Teva product. So they have ability to tell Teva that they need to drop the price or they wont work w them. This is a typical dynamic in newly generic pharma markets
I previously worked for a prescription claim processor and can answer this.
The unique thing about the Drug market is there are no knockoffs. A "Brand Name" drug in the USA has the _exact_ same active ingredients (and sometimes inactive, take inhalers) as the Generic. Even more hilariously, most drug companies will create a "generic" version of their drug as well as a "branded" because they can sell the same exact thing at a higher price point.
And yet my mother is 100% convinced that the generic of a drug gives her chronic headaches while the "brand name" version doesn't.
If I'm not mistaken, the formulation could be wildly different as long as they match kinetics, yield, and safety profiles set by the FDA, and an individual may have some issue with one formulation over another.
The FDA certifies the entire formulation, which includes everything from the binding/filler chemicals, anti-caking agents, the pill coatings, and even the ink used to mark the pill (which is why imprinting is very popular).
What you're referring to is the ability of a pharmacist to substitute one drug for another, if for instance it wasn't on your insurance's formulary (list of drugs they'll pay for). Drug A may be slightly different than Drug B, but the Drug B your insurance will pay for. Drug B might also _just happen to be_ a generic (because the pharmacist is trying to get your the best deal for your money). There's guidelines from the FDA, DEA, the state insurance commissioner, and state laws the pharmacists must be aware of so it varies greatly between states on what they're allowed to do. Made for a fun rules engine to implement in software.
Doctors can mark a prescription as DAW (Dispense As Written) which then the pharmacist can make 0 substitutions. Insurance companies aren't usually a fan of said doctors.
"The FDA certifies the entire formulation, which includes everything from the binding/filler chemicals, anti-caking agents, the pill coatings, and even the ink used to mark the pill (which is why imprinting is very popular)."
Sometimes the FDA certifies a dosage of a generic based on a different dosage. This caused a problem not long ago when the dosage they assumed was fine didn't dissolve right, hence the absorbed dosage varied and was sometimes way too low. To add insult to injury, it was a psychotropic drug, so everyone assumed patients complaining were "just imagining things" for a long time.
Parent comment states active ingredients are the same, but the "non-active" ingredients can be different. So there is the possibility that something is different in the generic that could cause a reaction.
I've had to use transdermal medication (patches) before, and one of the inactive ingredients that changes is the adhesive, I've noticed that the "brand name" version didn't cause skin breakouts, and the generic did.
That’s not entirely true when talking about auto-injectors that may or may not have needle hiding mechanisms, convenient form-factor, simple or well-known operation, or voice narration (auvi-q).
I am a parent of two young children with tree nut allergies, and I strongly prefer the Auvi-Q despite them gouging my insurer/employer. I use the generic epi-pen for school and child care since that’s what teachers are familiar with.
List price for Auvi-Q is around $5000 an injector. I carry _four_ of them everywhere I go. It’s utterly ridiculous for a dose of medicine worth less than $2, but when I need to use one I’m glad I’m not using a syringe or more complicated off-brand.
Are you misunderstanding that the ‘medical devices’ I was referring to are just like the Epi-Pen, and pre-filled with epinephrine for one-time use? I assume your reference to inhalers was to drugs similar to albuterol that include aerosol delivery ‘devices.’
Because $300 dollars for a drug that people rely on to live is too high, and it makes more economical sense to continue to sell alive people a drug at a price they can afford for longer, than keep selling it at $300 for a short time, until they go bankrupt and die.
Limit patent licensing for medical patents for prescribed medications to $15 each, or $1/day which ever is less. Limit patent licensing to $50 for prescribed devices.
Reduce extension patents on medications or medical devices to no more than 5 years (same for software).
Make it take an act of congress to change/raise those amounts in the future with a super majority.
My daughter has used the Auvi-Q as an alternative. In addition to the active injectors they provided a test one that helped her when the time came: https://www.auvi-q.com
I have not heard of any issues with Auvi-Q since it was reintroduced
Auvi-Q's pricing is weird. It's free if you have insurance (whether or not insurance pays for it), and free if your household makes < $100k. If you pay cash for it because neither of those is the case, it's $360. And if insurance pays for it, it's $4500.
I asked my son's allergist about those, and was surprised to learn that they cost an order of magnitude more than epi pens. He wouldn't prescribe them because he refuses to support that kind of pricing.
BTW epi pens also come with a tester.
(We have insurance so we pay a small copay for epi pens and auvi-q would be free.)
Cost to patient, or cost to insurance. Auvi-Q is much greater cost to insurance, less to patient. The former is still a major concern given how that leads to increased premiums and general medical pricing inflation, even if it briefly benefits the individual.
Well the part that matters the most is that the FDA has increased the number of generics approved and as long as that statistic keeps improving without putting anyone at risk it is a good thing.
There was not a chance that the price of EpiPen was going to go down. Manchin exists, and Democrats were going to have to drive change. Once Shkreli was jailed for charges completely unrelated to drug pricing, all of the gas was taken out of the media panic. Bresch was an excellent choice for a CEO, even without an MBA.
In my experience 99.9% of people I talk to think that Shkreli went to jail for drug overpricing, take some patriotic joy from that fact, and think that one of the results of his jailing is that EpiPens are cheaper. It's like how everybody thought that Saddam did 9/11.
I agree that this article is misleading but the cost to consume is super hard to get to in most cases. Most pharma companies don't know what price the end consumer ends up paying due to all the complications of the convoluted health insurance system, to find the cost and prior authorizations of a drug you may need to consult a dozen separate documents, and if you've got spousal insurance all that complication doubles or more.
When the cause of food allergies is discovered, a lot of people are going to laugh at how quite so many people could be affected before we found out which chemical causes them.
With the number of changes in farming and GMO products, production soil, other effects of industrial farming, etc, etc, it's not surprising. More diversity in marriage and resulting younger generations can also change/increase allergy profiles as well, since you may now have reactions to things that effect either parent or to a greater extent.
It's complicated, to say the least. Also, you can go most of your life with smaller reactions to something before it starts to get bad. (Discovered legume allergy at 40yo)
i think it could be much worse. the fact that there is a competitor means the former monopolist cannot raise prices of their 'lets avoid a scandal' $300 version back up to 600, which is closer to the profit maximising price for the product in a monopoly market.
Possibly my first post, so sorry if I have make faux pas. In the UK the national health service [NHS] engages nationally to negotiate price. They have the concept of the value of a medicine compared to the improved quality of life it brings. As a result generic medicines are priced against their value.
This means that an epipen is priced at £45 or about $60. Google Lloyds pharmacy epipen - UK only search.
I rather like this approach to healthcare, I am not sure about transnational ability to buy this - but to those that need it I hope you can make it work.
My observation is that the UK approach to healthcare has some advantages in its approach, it is not without faults but value for money [affordability] is embedded in delivery.
So in fact, this drug could be cheaper than the Mylan version, but it looks like they never dug in deeper to find out if it's true.
Second of all, the first generic approved gets 180 days of market exclusivity whereby the FDA will not approve any other generic versions. This is such that the generic manufacturer can recoup the investment prior to widespread competition that drives down prices.
For example, Lipitor went generic and the price dropped only ~10-20%. After the 180 days, multiple generic companies got approval and now the price is 80-90% lower.