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STRESAM
Reason for request
Reevaluation.
Unfavourable opinion for maintenance of reimbursement in the psychosomatic manifestations of anxiety.
Clinical benefit (previously low) now insufficient in the indication.
Role in the care pathway?
In adjustment disorder with anxiety, the psychotherapeutic approach should be favoured in order to enable verbalisation of the stressful situation and its consequences on the subject’s life. Short psychotherapy interventions appear to be the most appropriate. When psychological interventions are insufficient, an anxiolytic medication may be proposed to treat the symptoms of the disorder.
Role of the medicinal product in the care pathway
Given the absence of demonstration of the efficacy of etifoxine versus placebo in the AMETIS study and the confirmed risk of rare but potentially serious adverse effects (dermatological and liver injury), the Committee considers that STRESAM 50 mg capsules no longer have a role in the therapeutic strategy for adjustment disorder with anxiety.
Clinical Benefit
| Insufficient |
The clinical benefit of STRESAM 50 mg capsules is insufficient in the marketing authorisation indication to justify its funding by the French national health insurance system in view of the available alternatives. |
Clinical Added Value
| Not applicable |
