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.
If you move to some third world hellhole, you can probably get the same drug dirt cheap, or even free. The pharmaceutical industry makes the American Public pay for the R&D of new drugs, so they can promote themselves in "feel good" ads showing how they give them away in "under developed" countries.
The ‘price gouging’ army will be here shortly to perform a collective faint.
In my mind I’m picturing an editorial cartoon where we see an employee’s cafeteria at a major pharma company.
A man is in line considering his options.
The prices are outrageously high but there is a sign advertising programs to help poor people get their lunch at a subsidized price or even free.
Approve it and tell Novartis - Fed.gov isn’t paying a penny.
I expect Novartis will still sell it, only without the obscene, crony-capitalist, deep-state profit margin
I heard 87% success rate.
Another major factor in the price of drugs here in the USA is that many countries have set price controls on drugs and force the drug companies to supply them with threats of not letting them sell any drug. Because of that US citizens pay much more than they need to to cover for the losses in those countries.
We pay for the inexpensive foreign drugs.
If you move to some third world hellhole, you can probably get the same drug dirt cheap, or even free.
...
I don’t think that’s the case with this particular drug.
I don’t think it’s even a drug, but rather an elaborate process of modifying the immune system that requires a series of steps.
Here’s what Novartis says:
“About Kymriah Manufacturing
Kymriah will be manufactured for each individual patient using their own cells at the Novartis Morris Plains, New Jersey facility. Novartis has designed a reliable and integrated manufacturing and supply chain platform that allows for an individualized treatment approach on a global scale. This process includes cryopreservation of a patient’s harvested (or leukapheresed) cells, giving treating physicians and centers the flexibility to initiate therapy with Kymriah based on the individual patient’s condition. Building on our experience, having manufactured CAR-T cells for over 250 patients from 11 countries across various indications, we have demonstrated a reproducible product. Novartis continues to advance its CAR-T manufacturing expertise in Morris Plains, where we have been supplying CAR-T cells for global clinical trials and where we continue to invest in support of the anticipated demand to meet the needs of patients.”
So you have to send in your immune cells to the factory, and they modify them for you and send them back.
“The ‘price gouging’ army will be here shortly to perform a collective faint.”
For that kind of money, I want to look like and be as strong as 22 year old Arnold Swartzenegger, add 40 points to my IQ, and live healthy and youthful until I’m 150.
This isn’t really a drug, its a treatment, customized... but the question remains, why is it that the prices never go down on ANY DRUG with process improvements and volume?
Correct. Even Medicare is forced to pay the inflated prices, and I believe this is one of the things President Trump wants to address.
“... an elaborate process of modifying the immune system that requires a series of steps.”
Thanks to innovation, genetic sequencing has had a cost cut comparable to the drop in price in computing power. I believe this is the first HP calculator-type price of this procedure.
Your blood is drawn, The T Cells are extracted, then modified to attach to the cancer antigens, multiplied up, and then reinfused to the host body.
They then go on the attack and wipe out the cancer...completely.
It's cutting edge science right now
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.
...
I think that means it’s approved only after another therapy has failed.
Yep, I found more info:
ALL is a cancer of the bone marrow and blood, in which the body makes abnormal lymphocytes. The disease progresses quickly and is the most common childhood cancer in the U.S. The National Cancer Institute estimates that approximately 3,100 patients aged 20 and younger are diagnosed with ALL each year. ALL can be of either T- or B-cell origin, with B-cell the most common. Kymriah is approved for use in pediatric and young adult patients with B-cell ALL and is intended for patients whose cancer has not responded to or has returned after initial treatment, which occurs in an estimated 15-20 percent of patients.
What’s the point of nobody can afford it and insurance won’t cover it.
I don’t think it’s even a drug,
...
Not in the traditional sense. It’s gene therapy applied to a person’s own immune cells. When they cells are ready to be injected back into the patient they are considered to be a drug.
I don’t think this is a case of an inflated price. There’s a lot involved in this treatment.
Will the TV commercial include the caveats of, “Side effects may include, dizziness, diarrhea, projectile vomiting, blindness, headaches, trouble breathing, hearing loss, sexual dysfunction, anemia, warts, phlem blossom, memory loss, crawling skin, numbness of limbs, baldness, appendicitis, gender confusion, bile nephrosis, acid refux, gout, and hemorrhoids?
Martin Shkreli was convicted of something bigger companies do all the time. The US is rigged against small business so big business can get bigger.
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