Aug 05, 2002
The German Ministry of Health said it will establish a working group to define when a drug prescribed for off-label use should be reimbursed by public health insurers.
The group should be operational from the autumn and will include members from insurance companies, doctors and the pharmaceutical industry, said Florian Lanz, spokesman for the Federation of German Health Insurers.
The creation of the group answers a recent verdict by the Federal Court of Social Affairs in Berlin, in which judges affirmed that insurers are within their rights to refund drugs only when they are prescribed for approved indications.
But the judges also urged German authorities and professional groups to define conditions under which off-label drugs could be dealt with in grave conditions when no approved therapies are available.
Last week, Dr. Leonhard Hansen, deputy chairman of the National Association of Statutory Health Insurance Physicians (KBV), urgently appealed to public insurance companies to cover the cost of off-label drugs used against ovarian cancer and multiple sclerosis.
Dr. Hansen said in a statement that docetaxel can be an effective therapy for advanced stages of ovarian carcinoma and mitoxantrone for secondary progressive multiple sclerosis, but as neither drug has yet been approved for those indications, public health insurance companies are not required to cover the cost.
Under current healthcare laws, public health insurers have the option to approve payment for off-label medicines when patients are in grave condition and no other alternatives are available. About 90% of all Germans are covered by public health insurance, which covers most of the cost of approved medicines.
Docetaxel is the generic name for Aventis SA's Taxotere, and mitoxantrone
is the generic name for Immunex's Novantrone.
© 2002 Reuters Ltd