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‘Off Label Use’ Of Pharmaceuticals - A High Price For Medical Progress

Who foots the bill if a doctor decides on a treatment option that is not approved for the medical condition in question? Insurers say they’re under no obligation to pay, even if the treatment was effective. And if the doctor’s “off label” choice saves a p

A creative use of pills (e-MagineArt.com)
A creative use of pills (e-MagineArt.com)

ZURICHDoctors and researchers have expanded treatment options by developing even more medications and therapies. This wealth of alternatives, however, is also creating a growing – though often overlooked – problem: so-called "off label use."

Off label use is when doctors use treatment options that have not been officially approved for a particular malady, and are not on the list of pharmaceuticals insurance companies reimburse. Why would they do such a thing? Because sometimes the medications or therapies are effective, even life saving. But of course they're also expensive, since insurers are not obliged to cover off label treatment. Swiss law makes an exception if the off label approach is used in the context of life-threatening or severe chronic illnesses.

Not surprisingly, off label use of medication and therapies leads regularly to misunderstandings and conflict, and often to court cases. The Swiss government tried to clarify matters by deciding in March 2010 to enforce a regulation stipulating that health insurers have to pay policy holders the cost of "off label use" when "greater therapeutic benefits' would result.

Many, however, argue that this does nothing whatsoever to clarify the situation. Health insurers, for example, say they're still in the dark about where to draw the line. "Our big challenge is figuring out how the ‘greater benefits' of a medicine can be established," says Martina Weiss of the insurance company Helsana.

Because there are very different interpretation possibilities, the insurers are vulnerable to accusations of using arbitrary definitions. Big firms like Helsana and CSS, therefore, make every effort to standardize how they define ‘greater benefits," using criteria such as "improved quality of life, prolongation of life," and more, Gabriella Chiesa Tanner of CSS explains.

In cases that do not match these criteria, the insurers have been asking manufacturers of the drugs to pay for treatment. So far drugs companies have been cooperative. Spokeswoman Silvia Dobry of Roche, speaking for the Swiss pharmaceutical industry in general, says costs should be secondary. What's more important, she says, is that doctors and patients have access to key drugs.

Just how much the manufacturers are willing to pay, however, is subject to discussion. According to CSS's Chiesa Tanner, neither insurers nor the industry are providing figures. One industry expert says that ultimately off label use is lucrative for the industry: if it turns out that medication can be used for several conditions, drug companies will seek official approval for use of the medication to treat those conditions.

The subject of off label use is not about to disappear any time soon. Helsana alone deals with 2,000 cases annually, and the number of cases is on the increase. CSS claims that it deals with about 700 cases a year. The company expects that number to rise as more and more medications become available.

Read the full story in German by Andreas Möckli

Photo – e-MagineArt.com

*This is a digest article, not a direct translation

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FOCUS: Russia-Ukraine War

A Profound And Simple Reason That Negotiations Are Not An Option For Ukraine

The escalation of war in the Middle East and the stagnation of the Ukrainian counteroffensive have left many leaders in the West, who once supported Ukraine unequivocally, to look toward ceasefire talks with Russia. For Polish daily Gazeta Wyborcza, Piotr Andrusieczko argues that Ukraine simply cannot afford this.

Photo of Ukrainian soldiers in winter gear, marching behind a tank in a snowy landscape

Ukrainian soldiers ploughing through the snow on the frontlines

Volodymyr Zelensky's official Facebook account
Piotr Andrusieczko


KYIVUkraine is fighting for its very existence, and the war will not end soon. What should be done in the face of this reality? How can Kyiv regain its advantage on the front lines?

It's hard to deny that pessimism has been spreading among supporters of the Ukrainian cause, with some even predicting ultimate defeat for Kyiv. It's difficult to agree with this, considering how this war began and what was at stake. Yes, Ukraine has not won yet, but Ukrainians have no choice for now but to continue fighting.

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These assessments are the result of statements by the Commander-in-Chief of the Armed Forces of Ukraine, General Valeriy Zaluzhnyi, and an interview with him in the British weekly The Economist, where the General analyzes the causes of failures on the front, notes the transition of the war to the positional phase, and, critically, evaluates the prospects and possibilities of breaking the deadlock.

Earlier, an article appeared in the American weekly TIME analyzing the challenges facing President Volodymyr Zelensky. His responses indicate that he is disappointed with the attitude of Western partners, and at the same time remains so determined that, somewhat lying to himself, he unequivocally believes in victory.

Combined, these two publications sparked discussions about the future course of the conflict and whether Ukraine can win at all.

Some people outright predict that what has been known from the beginning will happen: Russia will ultimately win, and Ukraine has already failed.

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