Rejection of the inclusion of the drug REDUCTIL in the Specialty List

Facts

The company Knoll AG applied for the inclusion of the drug REDUCTIL with the active ingredient Sibutramine for the indication "Obesity with BMI ≥ 30" in the Specialty List. The Federal Office for Social Insurance (BSV) rejected the application, as the preparation was not appropriate. The Federal Appeals Commission for the Specialty List confirmed this decision, as the efficacy of REDUCTIL had not been sufficiently proven. In particular, it was not proven that the achieved weight loss is of a lasting nature.

Considerations

The Federal Supreme Court confirmed the rejection of the inclusion of REDUCTIL in the Specialty List. According to the legal provisions, a medicinal product must be effective, appropriate and economical in order to be included in the Specialty List. The efficacy must be proven by scientific methods. For REDUCTIL, the…