Term drugs – Expensive trade in ineffective drugs

Anyone who is seriously ill wants to be treated with the best medicine possible. And that too as soon as possible. That’s why Switzerland has been offering patients faster access to new drugs since 2019. “Temporary authorisation” means drugs can be approved for up to two years before all studies are completed.

According to the Medicines Act, these are “medicines for diseases which are life-threatening or lead to disability”. The focus is on new cancer treatments. During the Corona epidemic, also in Switzerland, under these rules, the Kovid vaccine was approved for a limited period.

focus on the principle of hope

It is now clear that the provisional admission of these drugs is in most cases based on the principle of hope. Kerstin Noel Wokinger, professor of health law at the University of Zurich, together with her doctoral student Camille Gloss and researchers from Harvard University in the United States, investigated the number of drugs with limited approval that showed a benefit therapeutic high at the time of their approval. ,

The results, which they published in the famous American magazine “JAMA Health Forum”, are worrying. In the United States, only 39% of these drugs have a high therapeutic benefit, in the European Union it is 38% and in Switzerland 8%.

If the benefit is unclear, the question arises: what should the price be like?

The Swiss number should be treated with caution, as only a few drugs are approved in Switzerland for a limited period, but it confirms the problem, as study author Kerstin Wokinger said: “One problem is that patients have access to drugs. . May potentially not work or be associated with major side effects. Another issue is pricing. If the benefits are unclear, the question arises: what should the price be like? »

Falling prices due to data insecurity

Woking points out that she thinks a means of temporary drug approval makes sense in principle. However, if the drug’s benefits are so uncertain at the time of limited approval, that should also be reflected in lower prices.

She suggests a change in the law that would allow the Federal Office of Public Health (BAG) to take data uncertainty into account in price negotiations with pharmaceutical manufacturers: “Pharmaceutical companies profit from the fact that drugs can still hit the market with immatures. Data, where the benefit is still unclear. This should also be reflected in the price. Society shouldn’t pay too much for something that we still don’t know what the benefit is.

Mainly cancer drugs

On request, BAG confirms that “there is indeed a risk of reimbursement for a drug that does not work at all or causes many side effects”. Eventually, the FOPH can use a “prepayment model” for these drugs: “The pharmaceutical company makes the therapy available free of charge until a doctor confirms that it actually works. As soon as it’s clear. If the drug is effective, the drug will be reimbursed by the health insurance fund. »

But even with this model, very high prices are paid. According to BAG, it is mainly cancer drugs that are approved for a limited period. And for these, “prices above 100,000 francs per patient and per year are often requested”.

Incidentally, in her study, lawyer and physician Kerstin Wokinger not only looked at the benefit of the drugs in question at the time of approval, but also – where relevant – the therapeutic benefit once additional data became available. Even there, only about 40% of the drugs showed high benefits. Given the increase in health insurance premiums, the cost of drugs, even approved for a limited period, should be discussed politically and the question should be asked how much the Doctrine of Hope should cost.

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