Extrakt aus Cannabis Sativa (1) – Sativex®
Multiple sclerosis (MS), spasticity
Characteristics
| Start date | 01.07.2011 – Marketing authorisation: 18.05.2011 |
|---|---|
| Resolution | 21.06.2012 repealed |
| Limitation date | 01.05.2018 |
| INN | Extrakt aus Cannabis Sativa |
| Brand name | Sativex® |
| Pharm. company | Almirall Hermal GmbH |
| G-BA Procedure ID | D-010 |
| ATC code | N02BG10 Other analgesics and antipyretics (N02BG) |
| DDD | 42 mg SL |
| Therapeutic area | Nervous system diseases Multiple sclerosis (MS) / Neuromyelitis optica spectrum disorders (NMOSD) |
| Reason for procedure |
Initial assessment
Repealed by: Extrakt aus Cannabis Sativa (2) (01.11.2018) |
| Specialty | Patent/data protection expired |
| Therapeutic indication of the resolution |
|---|
|
Sativex® is used for symptom improvement in patients with moderate to severe spasticity due to multiple sclerosis (MS) who have not responded adequately to other anti-spasticity drug therapy and who demonstrate clinically significant improvement in spasticity-related symptoms during an initial therapy trial. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Patients with moderate to severe spasticity due to multiple sclerosis (MS) who have not responded adequately to other anti-spastic drug therapy and who demonstrate clinically significant improvement in spasticity-related symptoms during an initial trial of therapy. | Optimised standard therapy with baclofen or tizanidine or agents approved for the treatment of spasticity in underlying neurological disease, taking into account the approved dosages. At least two previous therapy trials shall have taken place, in each of which different oral spasmolytic drugs, of which at least one drug with baclofen or tizanidine, are used in an optimised manner. |
Studies and Results
|
No. of studies
(best subpopulation) |
1 (GWSP0604) |
|---|---|
|
Study design
(best subpopulation) |
H2H vs. ACT |
|
Meta analysis
(best subpopulation) |
no |
- 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.
Associated procedures
| Extrakt aus Cannabis Sativa (2) | Sativex® | Almirall Hermal GmbH | Multiple sclerosis (MS), spasticity | 13,400–38,500 | 100% Indication of minor additional benefit | |
| Extrakt aus Cannabis Sativa (1) | Sativex® | Almirall Hermal GmbH | Multiple sclerosis (MS), spasticity |
0
13,400–38,500 |
100% Hint for minor additional benefit repealed |
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