More MS news articles for June 2002

Off-Label Drug Use Under Scrutiny in Germany

Jun 12, 2002
By Hannah Cleaver

BERLIN (Reuters Health) - The pace is gathering in Germany to lay down formal guidelines on which medications should be entitled to be covered by insurance for off-label use.

An expert committee has announced that it hopes to produce a framework for such guidelines within the next three months, ahead of the federal election in mid-September.

Recent court cases have been contradictory, ruling both for and against state-supported health insurance programs that would pay for medications when they are prescribed to treat conditions for which the drugs are not licensed.

The most controversial off-label medicine use involves patients with cancer or HIV-related illnesses, as well as conditions such as multiple sclerosis. Another common instance of off-label prescribing involves children, as many medicines are not tested and therefore receive no licence for pediatric use.

But prescribing medicines for off-label use is risky for doctors as health insurers do not have to pay for the drugs, and those used for cancer and AIDS are often very expensive. If an insurer refuses to pay, the doctor or patient can be forced to pay themselves.

But until now, doctors and patients have been in a legal grey area, leading to the formation of the German expert committee. The group has been widely welcomed by opposing sides, who hope it will protect their interests against those of their combatants.

A spokesman for the health ministry said it was acting as a moderator between the health insurers and doctors on the committee.

Michaela Gottfried, spokeswoman for the Association of Employees' Health Insurers, which sits on the committee, told Reuters Health there was a danger that the pharmaceutical companies would start selling medications specifically for off-label use -- getting around the rigorous testing needed before a drug is licensed.

She said, "We have to watch very carefully that scientific and medical standards are maintained. If a drug is licensed the duty lies with the pharmaceutical company. With off-label prescription the doctor is responsible, not the pharmaceutical industry."

Dr. Roland Stahl, a spokesman for the KBV, which represents non-hospital doctors accredited by the public insurance system, is playing a leading role on the committee. Dr. Stahl said, "This committee will produce a list, either a positive list of medicines which can be prescribed off-label, or a negative one of those which cannot."

He said, "At the moment we can only tell our doctors that they should ask the insurers first if they will pay for a treatment. It puts doctors into an ethical dilemma when they are treating seriously ill patients. And for cancer or AIDS patients, it is a very practical and immediate problem."

The pharmaceutical industry, although not sitting on the committee, is keeping a close eye on its proceedings.

© 2002 Reuters Ltd