Extrakt aus Cannabis Sativa (1) – Sativex®

• For the extract from Cannabis sativa L., folium cum flore (a combination of the active substances delta-9-tetrahydrocannabinol and cannabidiol), the final dossier was submitted to the G-BA on 2 January 2012 in accordance with the transitional provisions set out in Section 10(1) and (2) of the Medicinal Products Benefit Assessment Ordinance (AM-NutzenV), the final dossier was submitted to the G-BA on 2 January 2012.
• The G-BA commissioned the IQWiG to assess the dossier.
• Based on the methodology proposed by the IQWiG in accordance with Annex A of the dossier assessment for ticagrelor (dossier assessment A11-02, pages 86–92), was not adopted in the benefit assessment of the extract from Cannabis sativa L., folium cum flore (active ingredient combination of delta-9-tetrahydrocannabinol and cannabidiol).

Patients with spasticity associated with an underlying neurological condition <BR> following at least two previous treatment attempts with various oral antispasmodics, including at least one medicinal product containing baclofen or tizanidine, used at optimised doses

• The G-BA has not yet reached a decision on whether an additional benefit of the extract from Cannabis sativa L., folium cum flore (combination of the active substances delta-9-tetrahydrocannabinol and cannabidiol) can be established compared with the appropriate comparator therapy, based on the dossier assessment prepared by the IQWiG and the statements presented during the written and oral consultation procedures.
• In order to determine the extent of the additional benefit, the G-BA assessed the data justifying the identification of an additional benefit in accordance with the criteria set out in Chapter 5, Section 5(7) of the G-BA’s Rules of Procedure (VerfO), with regard to their therapeutic relevance (qualitative).
• On this basis, and taking into account the comments received and the oral hearing, the G-BA has reached the following assessment:

Courtesy translation only, please refer to the German original.