German drug watchdog group recommends Avandia insurance reimbursement ban.
The Federal Joint Committee of doctors and health insurers in Germany has not waited until next month’s FDA joint committee on drug safety to tell health insurance companies to stop paying for Avandia. Heart risks and bone fractures were cited in its recommendation to refuse reimbursement for the drug.
“The committee’s course of action is not justified neither from a medical, nor legal point of view,” Glaxo responded in a statement.
Rainer Hess, the chairman of the committee, said: “There are other pharmaceuticals that have no such side effects and long-term risks. We believe that patients should be protected against useless and, more importantly, harmful therapies.”
The whole class of drugs known as glitazones, including Avandia rival Actos, are covered by the watchdog group’s recommendation. The committee also recommended a ban on the glinide drugs NovoNorm/Prandin and Starlix for treatment of diabetes.
FDA researchers recently found that Avandia use increases the risk of heart problems and death compared to Actos; 27% increased risk of stroke and 25% increased risk of heart failure.
Thousands of lawsuits brought by Avandia patients have been settled in the U.S.. More Avandia lawsuit settlements are expected in cases still pending against GSK.