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New HTA Decisions in France
December 2021
Drug name
SPRAVATO® (esketamine)
Janssen Pharmaceuticals
Decision date
Therapeutic area
Mental health and behavioural conditions
Therapeutic sub area
Official notice date
Reimbursement %
Decision (SMR)
Insufficient to justify reimbursement
Decision (ASMR)
SPRAVATO is indicated for adult patients presenting a moderate to severe characterised depressive episode, as short-term acute treatment, for the rapid reduction of depressive symptoms according to clinical evaluation, and in psychiatric emergencies, in co-administration with an oral antidepressant.
Decision Type
Extension of indication
Considering the potential severity of the condition, the poor benefit-risk profile of SPRAVATO®, the partially covered medical need, the place of SPRAVATO® in the therapeutic strategy, and the unlikely impact of SPRAVATO® on public health, the committee considered the actual benefit of SPRAVATO® to be insufficient to justify reimbursement in the indication of the Marketing Authorisation.