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