No proof of added benefit of Sativex, says German IQWiG

In an early benefit assessment under to the German Act on the Reform of the Market for Medicinal Products (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) examined whether Sativex, a cannabis-based treatment for moderate to severe spastic paralysis and muscle spasms due to multiple sclerosis (MS) offers an added benefit over the optimized standard therapy.

However, no such added benefit can be inferred from the dossier, as the drug manufacturer deviated from the specifications of the Federal Joint Committee (G-BA) – which makes the final decision - and chose a different comparator therapy, stated the IQWiG. Sativex was developed by the UK’s GW Pharmaceuticals (AIM: GWP) and Spain’s largest drugmaker Almirall (ALM: MC) has rights in most of Europe, and the drug gained regulatory approval in Germany (as well as other countries) last year (The Pharma Letter May 27, 2011).

Comparison of different possibilities for optimizing treatment