Esketamine in severe treatment-resistant depression: G-BA sees evidence of considerable additional benefit
21.09.2023 16:57
New clinical data indicate that the active ingredient esketamine has considerable additional benefit compared to the appropriate comparator therapy in the treatment of adults with severe treatment-resistant depression. The Federal Joint Committee (G-BA) came to this conclusion after another benefit assessment.
For the first time, the G-BA was able to see a clear advantage for the patients being treated for an active ingredient for the treatment of mental illness. Advantages in achieving symptom improvement (response) or freedom from symptoms (remission) as well as in health-related quality of life and side effects were relevant for the overall result of the benefit assessment. Based on today's decision, the National Association of Statutory Health Insurance Funds and the pharmaceutical company agree on how much statutory health insurance will pay for esketamine in the future.
Esketamine in severe treatment-resistant depression
Esketamine (Spravato®) can be used to treat adults with treatment-resistant major depressive disorder in combination with antidepressants of the SSRI (selective serotonin reuptake inhibitor) or SNRI (serotonin-norepinephrine reuptake inhibitor) classes. The prerequisite is that the patient has not responded to at least two different antidepressant therapies during the current moderate to severe depressive episode. The number of patients who are eligible for therapy with esketamine according to this approval is estimated at approximately 317,000 to 505,000. The medicine has been available for prescription in Germany since March 1, 2021 and is administered as a nasal spray. The medicine may only be prescribed by a psychiatrist and used under the supervision of a medical professional.
G-BA assessment procedure
The renewed benefit assessment of esketamine is based on new clinical data from the ESCAPE-TRD study. This is an open, randomized, controlled, multicenter study in which esketamine was compared with quetiapine retard, each in combination with an SSRI or SNRI. The results on mortality, morbidity, health-related quality of life and safety are based on an observation period of 8 and 32 weeks. The G-BA limited the original benefit assessment decision from 2021 in view of the expected clinical data. The additional benefit was considered “not proven” at the time.