PHMR

England

Scotland

France

Germany

New HTA Decisions in France

December 2021

Drug name

SPRAVATO® (esketamine)

Company

Janssen Pharmaceuticals

Decision date

22/09/2021

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Therapeutic area

Mental health and behavioural conditions

Therapeutic sub area

Depression

Official notice date

14/12/2021

Reimbursement %

Decision (SMR) 
Insufficient to justify reimbursement 
Decision (ASMR) 
Unspecified
Indication
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

Summary

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.

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