‘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
ZURICH – Doctors 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