Sativex regulatory update

Germany's Federal Joint Committee (G-BA) said Sativex from GW Pharmaceuticals provides a "marginal" degree of additional benefit over optimized standard therapy to treat spasticity in multiple sclerosis (MS) patients. In April, the Institute for Quality and Efficiency in Health Care (IQWiG) issued a preliminary assessment that found no additional benefit for the drug. G-BA disagreed with IQWiG's assessment that GW's dossier did not contain data suitable to compare Sativex with optimized standard therapy, which consists of baclofen, tizanidin or other spasticity drugs (see BioCentury, April 9). GW will now negotiate a price for the product with Germany's Statutory Health Insurance Funds Association (GKV-Spitzenverband). ...