Favourable opinion for maintenance of reimbursement in combination with a SSRI or SNRI only for the treatment of treatment-resistant major depressive disorder in adults under 65 years of age who have not responded to at least two different treatments with
antidepressants in the current severe depressive episode.
As a reminder, the clinical benefit is insufficient in the other situations of the MA.
Clinical Benefit
Moderate
The Committee deems that the clinical benefit of SPRAVATO (esketamine), in combination with a SSRI or SNRI, is moderate only for the treatment of treatment-resistant major depressive disorder in adults under 65 years of age who have not responded to at least two different treatments with antidepressants in the current severe depressive episode.
Clinical Added Value
no clinical added value
Considering:
the initial data having demonstrated the superiority of esketamine compared to placebo, in combination with a newly initiated oral antidepressant in patients under the age of 65 years with a severe major depressive episode resistant to at least two oral antidepressants:
as an induction treatment after 4 weeks, with a low size effect, in terms of change in MADRS total score (difference of -3.5 points, 95% CI = [-6.7; -0.3] below the clinical relevance level);
as a maintenance treatment after 48 weeks or more in terms of time to relapse (median time not reached in the esketamine group versus 273 days in the placebo group, HR = 0.49; 95% CI = [0.29; 0.84]);
new comparative data from a study having demonstrated a superiority versus quetiapine LP, both in combination with a SSRI or SNRI, on the primary endpoint of remission at 8 weeks (MADRS ≤10) and the limitations associated with this study (open-label study, non-optimal comparator with an insufficient clinical benefit, low representativity of the severe population, short duration);
the safety profile, marked, in the short term, by cases of suicide/suicidal thoughts reported in clinical studies and compassionate use programme data, and by important identified risks, such as dissociative or perception disturbances and cardiovascular disorders, confirmed in the longer term with a mean exposure duration of 42.9 months (up to 79 months);
the absence of robust quality of life data;
the Committee deems that SPRAVATO (esketamine), in combination with a SSRI or SNRI, provides no clinical added value (CAV V) in the care pathway for the treatment of treatment-resistant major depressive disorder in adults under 65 years of age who have not responded to at least two different treatments with antidepressants in the current severe depressive episode.
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