PHARMA: But this is how it’s done

The NY Times has an article about how a biotech drug that basically is no better than a generic is selling off the shelves at $4,200 a Dose. Doctors think it’s better, patients believe it’s better and payers are too wimpy to stand up to them. Of course they haven’t got a government agency to help them, as exists in the UK.

Interestingly enough this is exactly what happened nearly twenty years ago with one of the the first major biotech drug, Genetech’s Activase (tPA) for the immediate treatment of heart attacks. it cost about ten times what the competing drug (streptokinse) cost, and basically had no better results. At the time there was lots of murky stuff including a positive NEJM article written by scientists with close (and undisclosed) ties to the company. (If you want to know much more about that ugly debate, look at the debate starting at page 3 in this link and particularly the far right column of page 9). And then after a study showed incredibly small relative and absolute benefits in survival from using Activase, allegedly Genetech sent lawyers to lots of hopsitals explaining what a jury might say now that a lawyer could "prove" they weren’t using the best possible drug. Pretty soon everyone switched over.

Sounds like despite lots of talk about cost-benefit analysis, cost controls, and pharmaco-economics, nothing has changed.


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7 replies »

  1. Michelle A. feels that conspiracy theorists Mireille Jacobson, A. James O’Malley, Craig C. Earle, Juliana Pakes, Peter Gaccione, Joseph P. Newhouse, and Neil Love do not have good, legitimate documentation and haven’t presented their case that reimbursement (payment to the oncologist) is the most important criterion for selecting between (what NCI says) a large array of otherwise equally acceptable regimens. While the Michigan/Harvard study showed results before the new Medicare reform, the Patterns of Care study showed results that the Medicare reforms are still not working. It is still an impossible conflict of interest.
    But academic center-based oncologists are misguided in not recognizing that they are trying to mate notoriously heterogeneous diseases into one-size-fits-all treatments. They devote 100% of their clinical trial resources into trying to identify the best treatment for the average patient, even in the face of evidence that this approach is non-productive. But their unsuccessful experiments will never be viewed as such when their careers are supported by these experiments.

  2. “Oncologists have been documented to use reimbursement (payment to the oncologist) as the most important criterion for selecting between the large array of otherwise equally acceptable regimens.”
    THE MOST important?
    Conspiracy theorists rarely have good, legitimate documentation, and none is presented here, again.

  3. But the point is (Bob) that even though there was only a minimal improvement in GUSTO, and some docs felt that any intervention (TPA or streptokinase) was net negative, the entire system went over to tPA very, very quickly.
    Simply because no one had the authority to say–this is not worth it, and because the people who did have the big interest (Genentech).

  4. Although the cumulative cost is high, oral solid drugs have not required plan sponsors to make the uncomfortable tradeoff between incremental health benefits and incremental costs. Very expensive therapies will very like force this issue, and the American workforce will play a pivotal role in the nature of the ensuing discussion.
    By the way, the tPA vs. streptokinase paper to which you refer is an extremely interesting case study. The sample size for the study was based on an effect size (coincidentally) roughly equal to that observed. However, the statistics reported compared the observed effect to an effect of zero. In short, the study proved a positive effect, but not one great enough to switch from streptokinase to tPA.

  5. I say again that it is up to CMS to provide the leadership necessary to introduce QALY metrics in determining what to pay for or not pay for. Of course, they need authorization from Congress first to proceed down this path. Even with QALY metrics, private insurers would still be free to cover drugs and other services that CMS doesn’t if they want to offer policies that do so and can command a premium sufficient to make it profitable.
    Without an entity like CMS (or the UK’s NICE) authorized to “Just Say No” when appropriate, there is, in theory, nothing to stop drug companies for charging $1 million or more for a cancer treatment regimen that might only extend life by a few months. If you ask them why they charge so much, their answer is likely to be: Because we can!

  6. Abraxane is about the same as regular Taxol.
    You wannna bet what the spread is between reimbursement and oncologist cost is for Abraxane vs Taxol?
    Oncologists have been documented to use reimbursement (payment to the oncologist) as the most important criterion for selecting between the large array of otherwise equally acceptable regimens.

  7. Nothing will change until the money runs out. Once the affordability threshold is reached for a majority of Americans, only then will this corrupt money machine be forced to change. My guess is that at that time the industry will look to government to keep the dollars flowing. I think the MA plan is just that, an attempt by the industry to bring in payers by using government force, not an attempt to control costs. This is all based on a system that says poor people have just as much constitutional right to bribe politicians as rich people.

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