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Switzerland

‘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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Economy

Abenomics Revisited: Why Japan Hasn't Attacked The Wealth Divide

Japanese Prime Minister Fumio Kishida promised to tackle wealth inequality and help struggling workers. But a year after he came to power, financial traders are once again the winners.

Japanese workers will still have to wait for the distribution of wealth promised by Prime Minister Fumio Kishida.

Yann Rousseau

-Analysis-

TOKYO — Panic on the Nikkei, the Japanese stock market. Almost a year ago, at the end of September 2021, traders went into a panic in Tokyo. On Sept. 29, Fumio Kishida had just won the general election for the country's main conservative party, the Liberal Democratic Party. He was about to be named Prime Minister, succeeding Yoshide Suga, who'd grown too unpopular in the polls.

Kishida had won through a rather original reform program, which was in stark contrast with years of conservative pro-market politics. In his speeches, he had promised to generate a “new capitalism”. A phrase that makes investors shudder.

While he did not completely renounce his predecessors’ strategy called “Abenomics” — named after free-market stalwart Shinzo Abe, who was killed last July — Kishida declared that the government needed to tackle the issue of the redistribution of wealth in the island nation.

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