The German regulatory body that decides which prescription medicines will be covered by German state health insurers has classified diet pill Acomplia as a "lifestyle" drug not eligible for reimbursement by insurance funds.
The announcement by Germany's Joint Federal Committee (G-BA) came as a serious blow to Sanofi-Aventis, which has been promoting Acomplia as a drug not just for weight loss but for treatment of a range of cardiometabolic problems.
The German Ministry of Health now has 60 days in which to ratify the G-BA decision.
Germany is the first of a half dozen European countries where Acomplia is already on sale to announce a decision as to whether it will be covered by insurance, or whether patients wanting it will have to bear the entire cost of the drug on their own.
A month's supply of Acomplia in Germany was set by Sanofi at 80.32 Euros ($102). But most Germans typically are charged only a co-pay for drugs covered by state insurance, and in the case of Acomplia, the co-pay would be about $10.
Since some 90 percent of Germans participate in this system, sales in Germany presumably would be far higher if it is covered by insurance.
The Joint Federal Committee, which groups doctors’ federations, sickness insurance funds and hospitals, said in a statement that Acomplia should be placed on the country's negative list which specifies those products which are not reimbursed.
The idea behind the list is to concentrate German public expenditure on prescription drugs which contribute to the treatment of illness deemed "serious."
A revision of the German Social Security Code in 2004 formalized the position that the cost of medicines for dieting, appetite control or weight loss should not be borne by the German healthcare system.
Sanofi said in a statement that the company felt the classification of Acomplia as a "lifestyle" drug was "irregular" and "unjustified.
"Sanofi-aventis firmly stands behind the important clinical benefits Acomplia offers to patients who are obese and overweight and suffer from other serious risk factors which can put them at risk of heart diseases and diabetes," a spokesperson said.
"Should the decision of the G-BA be approved, Sanofi-aventis intends to challenge the reimbursement classification under Section 34 in court."