The G-BA is the worst

 

A group of regulators from Germany published in the British Medical Journal a recommendation on how drug companies should design clinical trials. These “recommendations” curiously align with Germany’s unwillingness to pay for efficacious drugs.

There are two regulatory bodies in Germany that check whether a new drug is better than an old treatment and pay accordingly, IQWiG and the G-BA. Not surprisingly when the Germans decided to check most new drugs they found that a majority of them (56%) showed “no added benefit.” Notwithstanding the obvious conflict of interest with the German government both approving and paying for new drugs, there are two major problems with Germany’s approval process. The unnecessary cost they are asking the drug companies to absorb and the capricious way they judge whether a drug is efficacious.

It should be simple enough to check if a drug works right? Apparently not. In Germany, the standard for whether a drug treats a disease has nothing to do with whether it actually treats the disease. Rather, it is measured against a benchmark called “standard of care.” This standard of care is usually the drug already on the market to treat the disease. The problem with standard of care is that it’s an ever-changing definition with very hard endpoints for a pharmaceutical company to peg. Sometimes, what appears to be an obvious example of successful care is downgraded by focusing on a sub-population in which it didn’t work as well, or an outright denial of obvious metrics that a doctor is looking for. For example, when the Hepatitis-C drug Harvoni was released in Germany the study submitted for approval showed that the “viral load” of Hep-C in the patient had been reduced to basically 0. IQWiG ruled that these drugs had no added benefit, because “viral load” was not a patient-relevant endpoint to be measured. Ideally, they would like the drug company to show that a viral load very near 0 results in improved patient outcomes. “Sorry your virus has been cured Mr. Smith, but there’s no guarantee that you wouldn’t be sick even if you were cured.”

From IQWiG, “The virus was no longer detectable in almost 100% of patients.”

Also from IQWiG, “No more than a hint can be derived from these kind of data”

Instead, Germany wants drug companies to not only do a study in which their drug is shown to be more effective than a placebo but also against whatever a doctor would usually order for care in the meantime. At first blush that doesn’t seem like a bad idea, until you realize the cost of a large-scale phase-3 clinical trial program, around $200 million. And the German government wants the drug company to do two of these studies per drug. One of these is already getting done to pass the FDA/EMA regulators. The second is for comparative markets i.e. Germany and France. It can give relevant information, but millions of dollars worth? Probably not. So the drug gets submitted to the G-BA against a placebo and they mark it as having no added effect. The base price of a drug is negotiated from the already existing standard of care, which is usually a generic, so marking a drug “no added benefit” saves the government tons of money, the pharmaceutical company doesn’t even bother, and patients are left out to dry.

The upshot is that there are drugs unavailable or unaffordable in Germany, because regulators are asking for an unreasonable, sometimes unscientific, standard.

There is so much inaccurate self-serving dreck in that article about drugs with similar indicators, follow up studies, etc…, and the G-BA is so capricious, selfish, bureaucratic, imperious, and generally ridiculous; the G-BA is the worst.

Published in Healthcare
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There are 18 comments.

  1. DonG Coolidge

    Seems like a good system. All government (taxpayer funded) healthcare should be that way. If a person wants a fancy drug that does no better, pay cash. That it costs $200M to test a drug seems like an invention of Big Pharma to eliminate upstarts. I am certain that Bayer considers it a feature.

    • #1
    • July 11, 2019, at 9:15 PM PDT
    • 1 like
  2. Arahant Member

    Vice-Potentate: There is so much inaccurate self-serving dreck in that article about drugs with similar indicators, follow up studies, etc…, and the G-BA is so capricious, selfish, bureaucratic, imperious, and generally ridiculous; the G-BA is the worst.

    Not like FDA is much better. This is the problem with governmental intervention in markets.

    • #2
    • July 11, 2019, at 9:57 PM PDT
    • 2 likes
  3. Old Bathos Member

    I wonder what medicine would be like if 40 years ago all the Western nations had become single-payer or close to it. How many devices and treatments would have never been devised, much less tested and marketed.

     

    • #3
    • July 12, 2019, at 6:18 AM PDT
    • 7 likes
  4. Steve C. Member

    Old Bathos (View Comment):

    I wonder what medicine would be like if 40 years ago all the Western nations had become single-payer or close to it. How many devices and treatments would have never been devised, much less tested and marketed.

     

    The unseen.

    • #4
    • July 12, 2019, at 6:33 AM PDT
    • 2 likes
  5. HankMorgan Coolidge

    Old Bathos (View Comment):

    I wonder what medicine would be like if 40 years ago all the Western nations had become single-payer or close to it. How many devices and treatments would have never been devised, much less tested and marketed.

     

    I wonder what it would be like if 40 years ago none of the Western nations started pushing the private sector out of medical care.

    • #5
    • July 12, 2019, at 6:47 AM PDT
    • 5 likes
  6. Vice-Potentate Member
    Vice-Potentate Post author

    Arahant (View Comment):

    Vice-Potentate: There is so much inaccurate self-serving dreck in that article about drugs with similar indicators, follow up studies, etc…, and the G-BA is so capricious, selfish, bureaucratic, imperious, and generally ridiculous; the G-BA is the worst.

    Not like FDA is much better. This is the problem with governmental intervention in markets.

    The FDA is a million times better. It doesn’t control the price, too. In Germany if a drug passes EMA standards it’s technically available. In practice, if the G-BA decides not to pay for it, German patients are out of luck.

    • #6
    • July 12, 2019, at 8:11 AM PDT
    • 3 likes
  7. Vice-Potentate Member
    Vice-Potentate Post author

    Old Bathos (View Comment):

    I wonder what medicine would be like if 40 years ago all the Western nations had become single-payer or close to it. How many devices and treatments would have never been devised, much less tested and marketed.

     

    I don’t know how the past would’ve gone, but the future would look bleak. About 80 percent of a new drug’s profit is made in the private U.S. market. 20 percent in the rest of the world. 

    • #7
    • July 12, 2019, at 8:15 AM PDT
    • 3 likes
  8. Darin Johnson Member

    Let’s imagine there were no regulator and people and their doctors decided what drugs to take based on their own estimates of costs and benefits. You know, like, a well-functioning market. Your assessment of whether a drug works is completely dependent on the base case — compared to what?

    Since single-payer systems necessarily substitute the judgment of bureaucrats for that of doctors and patients, I see no problem with the German approach at a tactical level. The problem is strategic: third parties are not actually able to make cost/benefit decisions on behalf of consumers.

    Read your Hayek, regulators. It’s been helpfully translated into German for you…

    PS The idea that most new drugs provide no benefit should not be shocking. This is of a kind with the replication crisis: it’s very hard to learn anything new.

    • #8
    • July 12, 2019, at 8:45 AM PDT
    • 3 likes
  9. ctlaw Coolidge

    What about the situation of non-overlap?

    Standard of care drug may cure five out of ten nose cancer patients.

    Proposed new drug may cure three out of ten nose cancer patients. But what if one of those three is one of the people not cured by the standard of care drug?

    • #9
    • July 12, 2019, at 8:45 AM PDT
    • 5 likes
  10. Arahant Member

    Vice-Potentate (View Comment):

    Arahant (View Comment):

    Vice-Potentate: There is so much inaccurate self-serving dreck in that article about drugs with similar indicators, follow up studies, etc…, and the G-BA is so capricious, selfish, bureaucratic, imperious, and generally ridiculous; the G-BA is the worst.

    Not like FDA is much better. This is the problem with governmental intervention in markets.

    The FDA is a million times better. It doesn’t control the price, too. In Germany if a drug passes EMA standards it’s technically available. In practice, if the G-BA decides not to pay for it, German patients are out of luck.

    You certainly have a point, but it’s like multiplying very small numbers. Is 10^-12 a bigger (better) number than 10^-18? Sure, but if that’s the way your net wealth is measured, you still can’t afford a cup of coffee.

    • #10
    • July 12, 2019, at 9:08 AM PDT
    • Like
  11. Vice-Potentate Member
    Vice-Potentate Post author

    ctlaw (View Comment):

    What about the situation of non-overlap?

    Standard of care drug may cure five out of ten nose cancer patients.

    Proposed new drug may cure three out of ten nose cancer patients. But what if one of those three is one of the people not cured by the standard of care drug?

    The drug company submits the drug with all the data they have for different populations the G-BA decides which subpopulation it applies to. In theory both drugs would be covered. In practice it’s anyone’s guess. The subpopulation and efficacy standards IQWiG and the G-BA are looking for are not given to the drug company ahead of time.

    • #11
    • July 12, 2019, at 9:42 AM PDT
    • 1 like
  12. Vice-Potentate Member
    Vice-Potentate Post author

    Arahant (View Comment):

    Vice-Potentate (View Comment):

    Arahant (View Comment):

    Vice-Potentate: There is so much inaccurate self-serving dreck in that article about drugs with similar indicators, follow up studies, etc…, and the G-BA is so capricious, selfish, bureaucratic, imperious, and generally ridiculous; the G-BA is the worst.

    Not like FDA is much better. This is the problem with governmental intervention in markets.

    The FDA is a million times better. It doesn’t control the price, too. In Germany if a drug passes EMA standards it’s technically available. In practice, if the G-BA decides not to pay for it, German patients are out of luck.

    You certainly have a point, but it’s like multiplying very small numbers. Is 10^-12 a bigger (better) number than 10^-18? Sure, but if that’s the way you net wealth is measured, you still can’t afford a cup of coffee.

    I’m not having it. Nothing is so bad it can’t get worse. A more apt analogy would be having 99 cents to spend on coffee and only tea available.

    • #12
    • July 12, 2019, at 9:59 AM PDT
    • 1 like
  13. Arahant Member

    Vice-Potentate (View Comment):
    A more apt analogy would be having 99 cents to spend on coffee and only tea available.

    For me, that would be a good thing. 😁

    • #13
    • July 12, 2019, at 10:02 AM PDT
    • 1 like
  14. Vice-Potentate Member
    Vice-Potentate Post author

    Darin Johnson (View Comment):

    The problem is strategic: third parties are not actually able to make cost/benefit decisions on behalf of consumers.

    It states the problem well, but doesn’t get to the root of it.

    Doesn’t a third party able to make cost/benefit decisions on behalf of a consumer already describe doctors? Why delegate to your family doctor when you can delegate to a whole panel of experts like IQWiG?

    • #14
    • July 12, 2019, at 10:11 AM PDT
    • Like
  15. Arahant Member

    Vice-Potentate (View Comment):

    It states the problem well, but doesn’t get to the root of it.

    Doesn’t a third party able to make cost/benefit decisions on behalf of a consumer already describe doctors? Why delegate to your family doctor when you can delegate to a whole panel of experts like IQWiG?

    The question is, to whom is said panel liable. If the answer is governmental accountants, their answers will reflect that and it’s cheaper to let people die rather than intervening.

    • #15
    • July 12, 2019, at 10:16 AM PDT
    • 1 like
  16. The Reticulator Member

    HankMorgan (View Comment):

    Old Bathos (View Comment):

    I wonder what medicine would be like if 40 years ago all the Western nations had become single-payer or close to it. How many devices and treatments would have never been devised, much less tested and marketed.

     

    I wonder what it would be like if 40 years ago none of the Western nations started pushing the private sector out of medical care.

    40? In 1979? 

    • #16
    • July 14, 2019, at 5:18 AM PDT
    • Like
  17. Darin Johnson Member

    Vice-Potentate (View Comment):

    Darin Johnson (View Comment):

    The problem is strategic: third parties are not actually able to make cost/benefit decisions on behalf of consumers.

    It states the problem well, but doesn’t get to the root of it.

    Doesn’t a third party able to make cost/benefit decisions on behalf of a consumer already describe doctors? Why delegate to your family doctor when you can delegate to a whole panel of experts like IQWiG?

    I suppose you’re being ironic. The main difference between my doctor and the German panel is that I can fire my doctor. I’m no expert on German regulation, but my guess is that it’s not possible to fire IQWiG and hire a new panel. Am I right about that?

    I don’t know about you, but my doctor makes no cost/benefit decisions on my behalf. He gives me information and I make the decisions. Of course, the current American system is not ideal: my cost/benefit analyses do not include much of he cost, since that is largely borne by others.

    • #17
    • July 15, 2019, at 8:07 AM PDT
    • 1 like
  18. HankMorgan Coolidge

    The Reticulator (View Comment):

    HankMorgan (View Comment):

    Old Bathos (View Comment):

    I wonder what medicine would be like if 40 years ago all the Western nations had become single-payer or close to it. How many devices and treatments would have never been devised, much less tested and marketed.

     

    I wonder what it would be like if 40 years ago none of the Western nations started pushing the private sector out of medical care.

    40? In 1979?

    Was it over when the Germans bombed Pearl Harbor?

    • #18
    • July 17, 2019, at 4:21 PM PDT
    • 2 likes