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posted by martyb on Saturday October 21 2017, @12:09AM   Printer-friendly
from the a-third-chance-at-life dept.

The U.S. Food and Drug Administration (FDA) has approved a gene therapy for non-Hodgkin's lymphoma (blood cancer):

The Food and Drug Administration on Wednesday approved the second in a radically new class of treatments that genetically reboot a patient's own immune cells to kill cancer.

The new therapy, Yescarta, made by Kite Pharma, was approved for adults with aggressive forms of a blood cancer, non-Hodgkin's lymphoma, who have undergone two regimens of chemotherapy that failed.

The treatment, considered a form of gene therapy, transforms the patient's cells into what researchers call a "living drug" that attacks cancer cells. It is part of the rapidly growing field of immunotherapy, which uses drugs or genetic tinkering to turbocharge the immune system to fight disease. In some cases the treatments have led to long remissions.

"The results are pretty remarkable," said Dr. Frederick L. Locke, a specialist in blood cancers at the Moffitt Cancer Center in Tampa, and a leader of a study of the new treatment. "We're excited. We think there are many patients who may need this therapy."

He added, "These patients don't have other options."

About 3,500 people a year in the United States may be candidates for Yescarta. It is meant to be given once, infused into a vein, and must be manufactured individually for each patient. The cost will be $373,000.

Also at The Associated Press, CNN, and STAT News.

Previously: FDA Approves a Gene Therapy for the First Time
FDA Committee Endorses Gene Therapy for a Form of Childhood Blindness


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  • (Score: 2) by frojack on Saturday October 21 2017, @12:29AM (17 children)

    by frojack (1554) on Saturday October 21 2017, @12:29AM (#585492) Journal

    And then there's this bit:

    The list price of Yescarta in the United States is $373,000.

    Good luck with that Joe Sixpack.

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  • (Score: 2) by Arik on Saturday October 21 2017, @12:58AM

    by Arik (4543) on Saturday October 21 2017, @12:58AM (#585511) Journal
    I think you answered your own question. The cost itself can be considered part of the package of effects. How much do two courses of chemo cost?

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  • (Score: 1, Redundant) by The Mighty Buzzard on Saturday October 21 2017, @01:41AM (14 children)

    by The Mighty Buzzard (18) Subscriber Badge <themightybuzzard@proton.me> on Saturday October 21 2017, @01:41AM (#585518) Homepage Journal

    Yeah, the price is what gives me pause as well. I'm undecided on if insurance companies should simply not cover it.

    Think about it. Insurance companies are essentially a bunch of people pooling their money to turn peak healthcare costs into flat healthcare costs, with a fairly small percentage of overhead for management of the funds. They are decidedly not infinite piles of money. Paying out more for one person than they will ever be able to pay back in means you're lowering the quality of healthcare for everyone for the sake of one person who is unquestionably not paying their share.

    Before anyone starts in with "you heartless bastard", STFU. I, like every mentally healthy person reading this, care more about myself and my family than about some random stranger. Their health will always be my priority, not yours. This is exactly as it should be.

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    • (Score: 1) by khallow on Saturday October 21 2017, @01:47AM (6 children)

      by khallow (3766) Subscriber Badge on Saturday October 21 2017, @01:47AM (#585521) Journal

      Paying out more for one person than they will ever be able to pay back in means you're lowering the quality of healthcare for everyone for the sake of one person who is unquestionably not paying their share.

      The problems comes when almost everyone is doing that. As long as average costs remain below average insurance premiums, the thing will be stable.

      • (Score: 3, Insightful) by The Mighty Buzzard on Saturday October 21 2017, @02:00AM (5 children)

        by The Mighty Buzzard (18) Subscriber Badge <themightybuzzard@proton.me> on Saturday October 21 2017, @02:00AM (#585526) Homepage Journal

        Indeed. I'm just not sure that's a good way to do things at all. You're essentially laying a monthly bet down that you will get expensively sick. Most people won't, therefore it does not make financial sense for anyone without a history of expensive diseases or disorders in their family to support the current system. It doesn't even do the most good for the most people like our more socialist-leaning types would prefer. It penalizes most people for the sake of a small minority.

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        • (Score: 1) by khallow on Saturday October 21 2017, @02:29AM

          by khallow (3766) Subscriber Badge on Saturday October 21 2017, @02:29AM (#585535) Journal
          The thing is large health care expenses that you can't fully cover are more destructive than paying a relatively small amount every year for decades. Health insurance really is about providing cash flow for extreme health problems with the idea that everyone is at risk of these large costs.
        • (Score: 0) by Anonymous Coward on Saturday October 21 2017, @04:03AM (2 children)

          by Anonymous Coward on Saturday October 21 2017, @04:03AM (#585555)
          Most everyone is going to come down with some kind of expensive disease as they age, and the older you get, the higher the chance of that happening. The number of people who will eventually get seriously ill or injured or will otherwise require expensive medical treatment is by no means a small minority!
          • (Score: 0) by Anonymous Coward on Saturday October 21 2017, @04:59AM

            by Anonymous Coward on Saturday October 21 2017, @04:59AM (#585565)

            even being warehoused in a nursing home (whether you are relatively healthy or not) is not cheap. you effectively get drained of your financial assets before Medicaid takes over paying for it.

          • (Score: 2) by The Mighty Buzzard on Saturday October 21 2017, @10:32AM

            by The Mighty Buzzard (18) Subscriber Badge <themightybuzzard@proton.me> on Saturday October 21 2017, @10:32AM (#585615) Homepage Journal

            See, there's where we fundamentally differ. I do not want to live past an age where I can take care of myself and under no circumstances do I want to be a huge financial burden to my family. I can't even mentally put myself in the position of anyone who does think like that even for the sake of understanding their argument.

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        • (Score: 4, Interesting) by fritsd on Saturday October 21 2017, @09:51AM

          by fritsd (4586) on Saturday October 21 2017, @09:51AM (#585612) Journal

          That is an interesting way to put it, but essentially I can see nothing wrong with what you say. Maybe it's just a difference in viewpoint.

          So why does the USA have a large army, again? That also costs every taxpayer money, for unclear benefits:

          Indeed. I'm just not sure that's a good way to do things at all. You're essentially laying a monthly bet down that you will get foreign bandits on the border, and terrorists. Most people won't, therefore it does not make financial sense for anyone without a history of expensive gang warfare or terrorist attacks on their family to support the current system. It doesn't even do the most good for our proud nation like our more jingoistic types would prefer. It penalizes most people for the safety of a small minority.

          FTFY.

          That's *an* argument for pacifism; I didn't claim that it was a *good* argument :-)

    • (Score: 0) by Anonymous Coward on Saturday October 21 2017, @04:55AM (1 child)

      by Anonymous Coward on Saturday October 21 2017, @04:55AM (#585561)

      could you pay for a heart attack without insurance? no. How long could you afford kidney dialysis without your (or Medicaid) insurance?
      could you even afford to pay out of pocket to bring a new child into the world? pray there are no complications (NICU)...
      shit, pay out of pocket to get a non-complicated broken arm fixed.

      we ALL pay into a system that pays out way more for a few unlucky stiffs, one way or another. Yet we eventually all end up in the same terminal condition anyways. ultimately, how fucked up is THAT system?

      • (Score: 2) by The Mighty Buzzard on Saturday October 21 2017, @10:39AM

        by The Mighty Buzzard (18) Subscriber Badge <themightybuzzard@proton.me> on Saturday October 21 2017, @10:39AM (#585616) Homepage Journal

        Exactly. We're all going to die anyway and we have a choice of either leaving our assets to our our families or to the insurance companies, hospitals, and big pharma. It's really not a choice I need even a moment to consider.

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    • (Score: 1, Interesting) by Anonymous Coward on Saturday October 21 2017, @05:10AM (1 child)

      by Anonymous Coward on Saturday October 21 2017, @05:10AM (#585568)

      so... whats better then..

      Say there is just one big insurance company.

      6000 patients/year die from NHL. say this treatment is 100% effective. thats $240 million.

      Compare with Harvoni (hepatitis vaccine), at ~$120k. its only ~70% effective, but lets say its also 100% effective...
      so same cost treats about 20000 patients...

      so the insurance company has to make some choices.

      source: work for health insurance co. NO insurance co can pay for everyone in its coverage who can/should get Harvoni.

      thats just one treatment.

      • (Score: 0) by Anonymous Coward on Saturday October 21 2017, @05:14AM

        by Anonymous Coward on Saturday October 21 2017, @05:14AM (#585570)

        sorry... $2.4 billion.

    • (Score: 2) by Grishnakh on Saturday October 21 2017, @02:51PM

      by Grishnakh (2831) on Saturday October 21 2017, @02:51PM (#585668)

      This is stupid. Payouts for unexpected and very expensive things are the whole reason we have "insurance". WTF is the point of having insurance if it's just going to pay for stuff you can pay for on your own?

      You probably have a $1M policy for your auto insurance: if you cause a wreck, it'll pay out up to $1M in damages, medical payments, etc. for the other parties. There's no way a lot of drivers would ever be able to pay that back. Are you saying that car insurance policies like that shouldn't exist? That's stupid. This is the whole reason insurance was invented; most people never cause accidents with $1M in damages, so it doesn't matter if you'll never pay that back personally; the insured pool covers that risk collectively. But the big difference is that auto insurance doesn't cover your regular maintenance: oil changes, etc., nor does it cover non-accident repairs (your timing belt broke and now you need to replace your cylinder head). For some odd reason, health insurance is expected to cover this stuff to a certain extent, albeit with "copays" or "coinsurance", but the the idea here is that the insurance company can supposedly negotiate better rates than you can, though this frequently isn't really true, as you'll find if you ask a doctor's office for their "cash price"--all that insurance paperwork is a PITA and costs a lot in staff salaries.

    • (Score: 1, Insightful) by Anonymous Coward on Saturday October 21 2017, @04:53PM (1 child)

      by Anonymous Coward on Saturday October 21 2017, @04:53PM (#585697)

      Yeah, the price is what gives me pause as well

      Presumably, the price of these therapies will come down as technology advances and possibly when patents expire.

      This type of treatment is still in the very early stages. There is a large push to transition these CAR T-cell therapies into a one-size-fits-all or, at least, multiple broadly accepted histocompatibility-types. If any of these are successful, then the prices will come down considerably.

  • (Score: 3, Informative) by Anonymous Coward on Saturday October 21 2017, @12:14PM

    by Anonymous Coward on Saturday October 21 2017, @12:14PM (#585642)

    A friend of mine actually works on a program similar to this, though it's for another form of cancer.

    The $373,000 price tag is because the treatment is custom-tailored to each individual patient's immune system. They have to extract white blood cells (which are part of your immune system) and cancer cells from the patient, and then design a virus that will attack the white blood cells and instead of killing them, change them so that they view the cancer as an invading bacteria instead of ignoring it. Right now the process is mostly manual, so you're involving a bunch of PhD biochemists and a few man-months (or person-months) of work per patient using expensive lab equipment.

    But if the concept keeps working reliably - and my friend said that for the type of cancer he works on, it's over 80% effective - they'll start figuring out how to automate more of the process. It could be a $300 over-the-counter kit from a pharmacist in twenty years.