epi pens are a life saving miracle drug. this is not good.
(I have seen one work, it is almost instant)
http://money.cnn.com/2017/01/11/news/cigna-drops-mylan-epipen/index.html
on a side note the manufacturer has now released a “generic” version but it is still really expensive .(which cigna will cover)
http://nypost.com/2016/12/16/mylan-releases-generic-epipens-following-outcry/
Generics are just as good, especially with epinephrine. The title of the thread is misleading.
<<<<\on a side note the manufacturer has now released a “generic” version but it is still really expensive .(which cigna will cover)
http://nypost.com/2
[/QUOTE]
Well…there you go!
It is not unusual for an insurer to cover only the generic instead of the brand. Typically there will be unique pateints for whom the generic doesn’t work as well and in that case their doctors can appeal the decision.
it is not really even a generic if the same company is manufacturing it.
for many drugs generics are not “just as good”. and veryhappy there are many policies where an appeal of generic drug use is not allowed. no step therapy, no appeal no chance. I just dealt with that for an employee. we changed insurance companies and got a very very strong plan. first of the year. first refill for their long time RX. it was denied I called the insurance company and the agent. I got a clear and firm “NO” chance of appeal.
In this case, the “generic” version is nothing but a PR effort to try to tamp down the criticism the company received for jacking up the price as much as it did. The “generic” version is still much more expensive than the previous price for an EpiPen.
hunt-agreed. it is not really a “generic” .
generics manufacturers especially the ones in india are having serious issues for years and years to the point that some are banned from shipping to the united states. and many generics come from india.
Sigh. Health insurance/pharmaceuticals/medical costs in general- these days it’s just all horrifying. The epi-pen is just one of many problems. I only hope nobody in my family develops any expensive illnesses until (hopefully, one day) this all gets sorted out.
The epi-pen is a weird one when it comes to drugs. My understanding is that the drug itself only costs about $5/dose. What you’re paying the other $595 for is the injector (the “pen”). Basically a one-time use piece of plastic (purposely designed not to be reusable).
Generic versions are using the same drug, just a different injector. I don’t know why there’s not a reloadable injector you can just get refilled at the pharmacy for $20, but I suppose there’s probably some Byzantine medical law prohibiting it.
an epi pen is designed to fire threw a pair of jeans and rapidly dispense into the fatty tissue /muscle of your thigh.
it is not simply a syringe, if it should cost 600 dollars… that is one question but it is not designed for reuse and not just because of a profit motive.
The company raised the price of an EpiPen 500 % (according to news articles), without any change to the drug or the mechanism. The new “generic” product is half of that price.
In a normal market, competitors would show up and undercut such an inflated price.
But drugs and medical devices are not a normal market. Expectations of safety and effectiveness give rise to regulatory requirements that effectively create high barriers to entry. Also, the potential customers are often mandatory users with no choice about whether to buy, but may be small enough in number that additional competitors may not see a big enough market to bother with. In addition, some users are price insensitive due to third party payment.
it looks like Mylan’s patent protection was waning, and a generic competitor was coming online. But that competitor did pass muster with the FDA, so Mylan still has the market to itself.
@Hunt: “…without any change to the drug or the mechanism…”
Those changes to the mechanism of life-saving drugs which raise the costs 7X make me spitting crazy, with no options but to pay the cost.
Problem you have is a market that due to regulatory oversight (not without reason) can make it difficult even to enter something like the epi pen market. Epinephrine was synthesized a long time ago and I suspect that there hasn’t been all that much rework on doing that basic synthesis (I remember reading about it in my organic chem book, it talked about how it came about), so in theory it should be easy. The cost to entry can be high even for these kinds of products. To be honest, I also wonder since we are talking about something that has been used for over a century, where the dosages are pretty well understood, why they don’t have this under something like these use in food and food additives, something that has been around a long time, long enough, to be assumed to be safe and effective. That could reduce I would assume some of the regulatory burden on getting competitors into the market, the chief burden should be that the firm can prove the quality of the stuff they are selling (as compared to OTC supplements, many of which are garbage).
I will add one thing, as much as businesses complain about regulations, there is an aspect to regulation they like, and that is where regulation is protective regulation, where either by design or by the simple nature of the regulations, it favors certain players. So for example, if developing a new form of ‘epi pen’ requires a ton of paperwork (why I don’t know, not exactly rocket science to develop a throw away injector like that), then it would favor the person in the market.
As to why Mylen raised the cost, pretty simple, hedge funds hold significant blocks of mylen stock and their MO is rapid growth in returns, by raising the price 600% without doing much Mylen was guaranteeing a pretty return on the product, with little extra cost, this goes on all the time. In cases with things like Epi Pen, the FDA should be looking at streamlining the process for drugs like epinephrine that have been out there so long, to allow better competition. I doubt it will happen, the FDA is subject to political pressure, too, and congress isn’t exactly likely to ruin someone nice little monopoly, especially these days, the same way that congress refused to have any kind of basic regulation of the supplement industry, something as simple as having standards of purity the firms need to meet, something Germany and other countries have done for years, but the supplement industry is very lucrative and has companies in areas with very powerful politicans, so nothing gets done.
you can not just start making epi pen(generics) or cars or commercial jets. it costs 100x millions to set up a factory, train people, start distribution and get customers. you still must pay employees, insurance, for materials etc etc etc…
it could be unfeasible just to start production. if you subtract out raw materials cost, shipping, etc… and you charge $100.00 wholesale and your cost are always running you may never make a profit. it is almost impossible. and that is assuming you can assemble the right people, can fend off lawsuits and everything else that comes along with that business.
^^ ludicrous analogy
There will be cheaper alternatives:
http://www.marketwatch.com/story/cvs-takes-on-mylans-epipen-with-much-cheaper-version-of-an-alternative-2017-01-12
It may not be the epinephrine, but the relatively easy to use delivery device that is what Epipen and competitor Adrenaclick offer over pulling out a generic needle, filling the needed amount from a generic vial of epinephrine, and injecting it properly. That may be where the (generally considered necessary) regulatory focus is, creating the barrier to entry as a side effect.
That delivery method wouldn’t be possible here as every child who has an EpiPen is required to have it on them at all times during school hours.