Posted on 08/31/2017 9:33:02 AM PDT by buckalfa
The FDA approved Novartis' revolutionary CAR-T cell leukemia therapy, which uses patients' genetically modified immune cells to fight the disease — at the cost of $475,000 per treatment, according to STAT.
The drug, Kymriah, is the first CAR-T therapy to come before the FDA and was approved for the treatment of patients up to 25 years old with relapsed acute lymphoblastic leukemia.
A clinical trial of the leukemia drug deemed a "breakthrough" by physicians revealed 83 percent of patients treated with CAR-T cell therapy have gone into remission.
While the price tag of $475,000 per treatment seems staggering, it is much less than the $649,000 per treatment price analysts expected.
"We're entering a new frontier in medical innovation with the ability to reprogram a patient's own cells to attack a deadly cancer," said FDA Commissioner Scott Gottlieb, MD.
The FDA's approval came weeks earlier than expected.
Oh please.
It is a pretty neat technique. Some cancers have unique molecules on their cells. So you program a T-Cell to attack the Cancer Cell that has the molecule you've identified...
If it involves the modification and re-introduction of T-Cells then it is definitely an involved process. It's a shame that most people who need it will not be able to afford it or get into sponsored trials.
~3000 potential patients per year for a near miracle treatment that involves separating your freaking immune cells out, altering them and then breeding them and putting them back in and monitoring for negative aspects and efficacy and along with those costs trying to recoup some of the research expense for the previous 10 years and you think they’re making a killing on it???
You can front that argument for something like the Hep C drug because the affected population is large and in cases like that and the AIDS cocktail the foreign countries essentially say they’ll steal it if they don’t get it subsidized and the FEDS go along with it when they should be telling them “do that and we’ll pound you”, but the racket arguement doesn’t really apply here...yet.
I say yet because this is still cutting edge science that will probably end up leading to similar treatments down the road for far more common cancers, and if the cycle ends up repeating along the usual lines it can be bitched about then (unless we “fix” it before then).
do your research on how this drug is made.....no comparison can be made to traditional medicines.
BTW, since we are discussing drug commercials - Next time you see a Harvoni commercial, keep in mind Harvoni is the new Hepatitis C drug with over 90% cure rate. In the US, Harvoni cost is $94500 but in India around $1000.
You have just outlined a $1.425 BILLION market, 95% of which will be paid by Fed.gov. For $1.425 Billion - are they making a killing? I suspect, YES. But I'm not a socialist, so I don't care what they make. What's more important is - does Novartis use undue government influence, corruption, connections, and gaming of complex rules to decide what they produce and at what cost?
The socialization of costs argument has been used for years, and Fed.gov now pays for many such drugs. Are experimental AIDS drugs worthy of $ Billions of subsidies? How about drug addiction replacements? Who decides?
All that argument says is "my socialism is more worthy than your socialism."
Finally, we have ZERO idea what a truly free-market in drugs and health-care would look like. We have perverted it so much, you only see is the next immediate consequence of something hat is not supported by our present expensive, corrupt, debt-supported system.
This is how we have arrived at socialized medicine and drug companies whose motivations are set by gaming Fed.gov rules. Enjoy it for as long as the US can support massive government debt in our printed, unbacked currency.
This drug, through it's different approach may be an exception, but I doubt the families of those left out due to the enormous cost would take much comfort.
Doesn't work with all cancers - if any other organ in your body has the molecule that you programed it to attack, those will get destroyed too.
But unlike Kemo, it doesn't kill everything, just what you program it to kill.
The price will come down once technique is perfected ...
we should all have hope that this transformational therapy can be deployed more broadly, economies of scale reached allowing accessibility to anyone.....
do you have an alternative idea on how to fund this?
Re $475K:
> If you move to some third world hellhole, you can probably get the same drug dirt cheap, or even free.
It isn’t a drug, it’s a process whereby ones immune cells are extracted, the genetics of the cancer cell is analyzed, and the cells are programmed to attack the cancer.
I don’t know (and rather doubt) if it needs to cost 475k, but it is going to be an expensive process because it isn’t just a mass-produced magic pill in a jar like Gildead’s HCV cure; it’s an exacting procedure which has to be carried out for each individual in a specialized laboratory by skilled technicians.
A friend of mine’s boy needs this.
The insurance company won’t cover it. He has other treatment options, but he has the “bad” kind that doesn’t react to chemo.
He has a 30% chance of recovery.
They take your cells out, reprogram them and put them back in.
You want to go to some third world country to have that done, be my guest.
They do.
Next question?
Heard about this on the radio yesterday while driving home from my FFL. Wasn’t paying close attention but it was reported the company will refund the $475K if the treatment doesn’t work.
Does Obamacare cover that?
A few years ago my mother had hysterectomy in India for less than $500 hospital cost.
You understand that the lesser complexities of growing and preparing food, as well as the relatively short time it takes to go from farm to your local cafeteria, make food significantly less costly than pharmaceutical products.
I should also point out that the FDA did not "approve" of this drug with that cost. The cost of a drug is not within the purview of the FDA.
In fact, I'm not even certain that Novartis has made the wholesale price public to date. The $475k price tag was an "estimate" made by a consumer advocacy group, partly to set a ceiling, and strongarm Novartis into a lower price.
“...and was approved for the treatment of patients up to 25 years old with relapsed acute lymphoblastic leukemia.”
Everyone take a deep breath. This treatment is primarily for children who will likely die young without it. As such, spread the cost over years of life for those successfully treated and it doesn’t sound so bad. Now if they proposed giving this to 75 year olds and have Medicare pay for it that would be another story.
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