Recent G-BA assessment with substantial benefit!
That it is possible to obtain superior G-BA assessment grades was recently shown by Esketamin in therapy-resistant major moderate to severe depression. The main reasons for this superior assessment, even if the G-BA acknowledged some uncertainty around it (hint for a substantial benefit), were four: a randomized trial design (even if it was open-label) against an accepted Standard of Care in the target population, sufficient trial duration (both 8 and 32 weeks data were presented), usage of accepted and validated outcomes such as PHQ-9, QLDS, but also EQ-5D and SF-36v2, and, above all, significant superiority over the Standard of Care in most of these endpoints, including generic quality of life as measured by the SF-36v2.
Details on this assessment can be found on the G-BA website.
Feel free to contact us for more detailed insights!
More Articles
