Added benefit of Praluent not proven, says IQWiG

At the request of the Federal Joint Committee (G-BA), the German Institute for Quality and Efficiency in Health Care (IQWiG) has examined French pharma major Sanofi’s (Euronext: SAN) Praluent (alirocumab), approved in Europe since September 2015 for adults with hypercholesterolemia or mixed dyslipidemia whose cholesterol levels are not adequately lowered by diet and other drugs.

The move follows the IQWiG’s recent assessment of Amgen’s (Nasdaq: AMGN) Repatha (evolocumab), which resulted in a negative opinion as to the added benefit (The Pharma Letter December 22, 2105). An added benefit for Praluent in comparison with the appropriate comparator therapies is also not proven for this drug, the Institute said.

G-BA defined three research questions