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Talk about inflation...
In my last post, I wrote about Ampyra, an oral drug that was recently approved by the FDA to treat MS. This drug does nothing to treat the Multiple Sclerosis disease process itself, but is meant to increase muscle strength and mobility, and provide some symptom relief for MS sufferers. In trials, Ampyra helped 35% of test subjects taking it increase their walking speed by 25% (in timed 25 foot walks).
Ampyra is basically the same exact drug as a much older compound called 4-AP, in a time released form. 4-AP has been available for years from compounding pharmacies, and can be compounded in a time released capsule.
When purchased from a compounding pharmacy, 4-AP costs something around 30 bucks a month, if I remember correctly.
Now that the drug has been renamed, patented, and marketed by the pharmaceutical company Acorda Therapeutics, the wholesale price of Ampyra, which was announced today, will be $1056 for a 30 day supply, or little more than 1000 bucks a month more than good old 4-AP...
When I first read that price, my eyes nearly fell out.
Can I get a "Holy Shit"?...
UPDATE: received this comment from a reader who was in the Ampyra trials. Turns out I may be wrong about the drug being similar in effectiveness to 4-AP:
Fampridine (the name used for the drug while it was undergoing trials) is not the same as 4-AP SR, no matter how similar they sound. I was on the trial, and it works as least twice as well--my improvements in mobility, walking, balance, cognition, muscle strength, everything, were twice as good as the effects of 4-AP SR, which I have also used. Ampyra is worth it for me, no matter what the cost, which of course is huge, but I will try to afford the co-pay no matter what.
I certainly hope this reader is correct. A drug that effectively treats the range of MS symptoms reflected in the above comment will be quite welcome, indeed. As with all of the other MS drugs, I suspect it's effectiveness will vary widely from patient to patient...
when i first read the price i thought it said $105, which for MS drugs, is cheap. but when i reread it, thinking what the hell are you complaining about i saw 1056.
ReplyDeletenot i see what ur complaining about.
think of it this way. MS patients must just look rich. that is way the drugs cost so much.
so feel better knowing that you (we) aleast give the appearance of wealth. i already feel better knowing that my $30 jeans must look more like $300
pfrox9
I've been watching this drug as Fampridine go through studies for years now. The first study was submitted back in 2002. So that's almost 8 years of studies for FDA approval plus an unknown amount of man hours to design it. So I don't know what pricing it takes to make this process profitable for a drug company, but it's typical for anything medical and certainly lends understanding to the high price of health care in the US.
ReplyDeleteThat said, it seems extremely overpriced when it's only providing 25% improvement for only 35% of people taking it.
best, Barry
pfrox9-well, we may look rich, but somebody else is actually getting rich if the prices of MS drugs are any gauge...
ReplyDeleteBarry-I understand the argument that's made regarding the development cost of drugs, which can be astronomical, and are then recovered via inflated drug prices. With this particular compound, though, there was no actual chemical engineering necessary. The basic compound has been around for years, and Acorda took this already existing substance and basically repackaged it.
True, it was put through the extensive trial regimen required by the FDA, but if 4-AP had been put through the same regimen, I'm pretty sure its efficacy would be almost precisely that of Ampyra. The problem, though, is that there is no real money to be made from marketing 4-AP, just as there is no money to be made from marketing LDN, or many of the herbs, vitamins, and supplements that anecdotally seem to be beneficial to MS patients. There are many older, off patent drugs out there that might have efficacy in the MS arena, but money for studies can't be found because of the lack of profit motive.
The developer of Tysabri, Dr. Steinman at Stanford, has identified one such drug, an older blood pressure medication, but can't get funding for a trial. The folks at Johns Hopkins have had to stop testing revimmune for much the same reason.
Unfortunately, good economics often makes for bad health care (and this will be the subject of an upcoming Wheelchair Kamikaze post).
Fampridine is NOT the same as 4-AP SR, no matter how similar they sound. I was on the trial, and it works at least twice as well--my improvements in mobility, walking, balance, cognition, muscle strength, everything, were twice as good as the effects of 4-AP SR, which I have also used. Ampyra is worth it for me, no matter what the cost, which of course is huge, but I will try to afford the co-pay no matter what.
ReplyDeleteAnonymous-thanks for the input. I hadn't heard from anybody else who was in the trial, so your comment is very helpful.
ReplyDeleteI'll update the post to reflect your opinion of the drug...
I am agast!!! No one (my neuro at Johns Hopkins) mentioned 4-AP and Fampridine are different, so I'm not sure my 2 months on bird poison prove it doesn't work for me. But being PPMS and non-mobile in a chair, think my health insurance will let me have it? I can afford the co-pay but what of others it might help but they can't afford health insurance. This truly goes in Life is NOT FAIR column.
ReplyDeletekicker
How often is development done in the reverse? From basically generic (4-AP) to patent protected, birds chirping marketing soon on a Lifetime channel near you (Ampyra). Surely, there are differences, but Acorda will recoup their development investment and then some and if the drug helps folks, and they can afford it (co-pay or full-pay) that’s great. Just glad to know of the 4-AP option.
ReplyDeleteAnd very nice use of Declan McManus.
Ken
Now Joe - uh Marc,
ReplyDeleteDon't tell me the angels are messing with your shoes!
kicker
PS - he wrote it, right?
As a former pharmaceutical industry exec, I feel I need to speak up for the hand that once fed me. Basically, if Pharmaceutical Companies did not have the potential of making a profit, yes an ATTRACTIVE profit, you probably would not see the many medical developments you see today.
ReplyDeletePharmaceutical development is a very expensive and high risk undertaking. More than 90% of the molecules that are investigated end up dropping and never make it to market. That means that alot of investment is made into potential products and nothing is ever sold.
If a drug DOES make it to market, it is usually after 10 years of development work and hundreds of millions of dollars in investment. The company that does all of that work, usually has about 10 years to make profits before the drug goes off patent and becomes generic. That means that after about 10 years any company can make cheap copies of the drug and the drug becomes basically worthless for the company that developed it.
Who is going to go through all of that if they did not think that they would make an attractive profit as a reward for their troubles??? That is the system we have and it works.
As an example in 1990, if you got HIV, you died in about 2 or 3 years. Today, thanks to anti-virals, if you get HIV you can live 15-20 years. The drugs are expensive, yes. But they are available.
As far as Ampyra goes, I wonder if you are aware that there is a Patient Assistance Program Launched for Uninsured and Underinsured To Provide AMPYRA at No Cost
Guys, it is easy to bash the corporate big shots in the pharmaceutical world. I do it sometimes myself. But they are probably your greatest allies in finding a cure or at least a good treatment for MS.
Wheelchair Pride - your defense of the big pharma sounds nice and dandy, but could you please explain why the cost of Copaxone went from less than $18,000 a year in 2001, when I started it, to current almost $40,000? Did Teva spend so much on research again? In fact they did, on much higher doses, and failed. There are good published preliminary data that half the dose is as efficient as the current one. Guess why they did not put to test THAT proposition.
ReplyDeleteIt is a well known fact that pharmaceutical companies spend more on advertisement (especially that outrageous DTC - direct-to customer - advertisement) than on research? And that software companies spend about 2.5 times higher percentage of their budgets on research than the pharma, but software is only getting cheaper!
Anyway, I suspect that the situation with AMPYRA is similar to statins. There is old good generic lovastatin, no patent protection, cheap, minimal side effects. And then there is patented Lipitor which from time to time kills people and is barely more efficient in reducing cholesterol than lovastatin. Chemical modifications were introduced in Lipitor specifically to obtain new patent protection. Since nobody clinically tested 4-AP with the required rigor, Acorda developed its derivative which can be protected and will now sell it for this astronomical amount of money.
That's how statin drugs work. Statins are really harmful. I think people and doctors who believes in these drugs was paid by the Big Pharmas.
DeleteIs any body aware that the retiring CEO of United Health care got a bonus of 1.1 Billion dollars on top of his retirement pay plus his county club fees paid for life (as if he couldn't afford them himself, and of course the use of the corporate jet)? This is greed and it is the only thing running corporate America. Research cost have nothing to do with it.
ReplyDelete@anonymous, you said:
ReplyDeleteFampridine is NOT the same as 4-AP SR, no matter how similar they sound. I was on the trial, and it works at least twice as well--my improvements in mobility, walking, balance, cognition, muscle strength, everything, were twice as good as the effects of 4-AP SR, which I have also used.
The National MS Society says:
"For the same reasons, Ampyra should not be taken in combination with other forms of 4-aminopyridine (4-AP, fampridine), since the active ingredient is the same." ref URL; http://www.nationalmssociety.org/news/news-detail/index.aspx?nid=2586
Ever since I was taught that effectiveness will vary widely from patient to patient when using drugs, I have always been very careful about what I take.
ReplyDelete