Esketamin (1) – Spravato®
Depression, therapy resistant, combination with SSRI or SNRI
Characteristics
| Start date | 01.03.2021 – Marketing authorisation: 18.12.2019 |
|---|---|
| Resolution | 19.08.2021 repealed |
| Limitation date | 15.06.2023 |
| INN | Esketamin |
| Brand name | Spravato® |
| Pharm. company | Janssen-Cilag GmbH |
| G-BA Procedure ID | D-658 |
| ATC code | N06AX27 Other antidepressants (N06AX) |
| ICD-10 codes (AIS) | F32.1Major depressive disorder, single episode, moderate, F32.2Major depressive disorder, single episode, severe without psychotic features, F32.3Single episode of major depression with mood-congruent psychotic symptoms, F33.1Major depressive disorder, recurrent, moderate, F33.2Major depressive disorder, recurrent severe without psychotic features, F33.3Endogenous depression with psychotic symptoms |
| Alpha-ID codes (AIS) | I2839Moderate depressive episode, I2840Severe depressive episode without psychotic symptoms, I2844Severe depressive episode with psychotic symptoms, I2862Recurrent depressive disorder as a moderate episode, I2863Recurrent depressive disorder as a severe episode with psychotic symptoms, I91672Recurrent endogenous depression without psychotic symptoms |
| DDD | 0.13 g P |
| Therapeutic area | Mental illnesses Depression |
| Reason for procedure |
Initial assessment
Repealed by: Esketamin (3) (21.09.2023) |
| Specialty | Bundling ACT change |
| Therapeutic indication of the resolution |
|---|
|
Spravato, in combination with a SSRI or SNRI, is indicated for adults with treatment-resistant Major Depressive Disorder, who have not responded to at least two different treatments with antidepressants in the current moderate to severe depressive episode. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Adults with treatment-resistant major depression who have not responded to at least two different antidepressant therapies in the current moderate to severe depressive episode. | Therapy according to the doctor's instructions with the choice of: - augmentation with lithium* or quetiapine retard* - a combination with a second antidepressant* - electroconvulsive therapy - a change from antidepressant monotherapy to another substance class. * As an add-on to the last antidepressant monotherapy given. |
Studies and Results
|
No. of studies
(best subpopulation) |
1 (TRD3004) |
|---|---|
|
Study design
(best subpopulation) |
Single-arm + historical comparison |
|
Meta analysis
(best subpopulation) |
no |
| ACT change | 20.07.2021 – Stellungnahmeverfahren, Anhörung |
- Clinical trials
- The pharmaceutical manufacturer identifies the two directly comparable, randomised clinical trials, TRANSFORM-2 and TRANSFORM-3. Both trials investigate acute treatment with esketamine versus placebo, in each case in combination with a newly initiated oral antidepressant from the SSRI or SNRI classes, over a treatment period of 28 days, plus screening and follow-up phases.
Adults with treatment-resistant major depression who have not responded to at least two different courses of antidepressant treatment during their current moderate to severe depressive episode
- For adults with treatment-resistant major depression who have not responded to at least two different courses of antidepressant treatment during their current moderate to severe depressive episode, the additional benefit is not proven.
- There are no studies comparing esketamine with the appropriate comparator therapy. The additional benefit is therefore not proven.
- Overall assessment
- In summary, the TRANSFORM-2 and TRANSFORM-3 studies cannot be used to determine additional benefit due to the failure to implement the appropriate comparator therapy.
- The comparison carried out is therefore not suitable for assessing additional benefit.
Courtesy translation only, please refer to the German original.
Associated procedures
| Esketamin (3) | Spravato® | Janssen-Cilag GmbH | Depression, therapy resistent, in combination with SSRI or SNRI | 317,000–505,000 | 100% Hint for considerable additional benefit | |
| Esketamin (1) | Spravato® | Janssen-Cilag GmbH | Depression, therapy resistant, combination with SSRI or SNRI |
0
932,000–974,000 |
100% additional benefit not proven repealed | |
| Esketamin (2) | Spravato® | Janssen-Cilag GmbH | Depression, acute treatment, combination therapy | 49,100–69,200 | 100% Hint for minor additional benefit |
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