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SATIVEX (cannabis (feuille et fleur de) riche en tétrahydrocannabinol) - Traitement des symptômes liés à une spasticité modérée à sévère due à une sclérose en plaques
Reason for request
Key points
Favourable opinion for reimbursement as treatment for symptom improvement in adult patients with moderate to severe spasticity due to multiple sclerosis (MS) who have not responded adequately to other anti-spasticity medication and who demonstrate clinically significant improvement in spasticity related symptoms during an initial trial of therapy.
What therapeutic improvement?
No clinical added value in the therapeutic strategy for moderate to severe spasticity due to multiple sclerosis.
Role in the care pathway?
The medicinal treatment of moderate to severe diffuse spasticity involves, as a first-line strategy, the combination of physical therapy and oral monotherapy with baclofen, tizanidine or gabapentin. Dantrolene or diazepam may be envisaged if no clinical improvement is observed with the previous medicinal products. In the event of failure of these different monotherapies, a combination of these medicinal products may be considered.
Role of the medicinal product in the care pathway
SATIVEX is a supportive therapy in patients with moderate to severe diffuse spasticity related to multiple sclerosis, inadequately relieved by the physical and medicinal anti-spasticity treatments available. Treatment will not be continued for more than 4 weeks if the clinical response is deemed to be unsatisfactory.
Clinical Benefit
| Low |
The Committee deems that the clinical benefit of SATIVEX remains low in the MA indication.
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Clinical Added Value
| no clinical added value |
SATIVEX provides no clinical added value (CAV V) in the management of moderate to severe spasticity due to multiple sclerosis.
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