Frühe Nutzenbewertung nach § 35a SGB V: AMNOG Nutzendossier

Involved from the beginning: Since the introduction of the Act on the Reform of the Market for Medicinal Products (AMNOG) in 2010, GKM has been offering services around the topic. GKM has successfully completed more than 35 AMNOG projects so far.
Interdisciplinary team: Our AMNOG team is outstanding as it consists of experts with backgrounds in (bio)statistics, medicine, pharmacy, health economics as well as epidemiology.
Always up to date: By regularly attending trainings on the topic our expert group is always up to date on current developments with regard to AMNOG and offers the necessary competence for a successful benefit dossier.
Our individualized offer: The AMNOG team offers a complete range of services from medical and statistical consulting to the preparation of a complete dossier. We also advise on the development of study designs or study programs with regard to the early benefit assessment. Furthermore, we support you in literature searches, endpoint validation or identification of the appropriate comparator therapy.

Set the course for a successful benefit assessment ‑ take advantage of our expertise in the field of AMNOG and early benefit dossiers!

Services SGB V, SECTION 35 A

Study design for early benefit assessments
Statistical and medical evaluation of study synopses regarding its suitability for early benefit assessment
Patient relevant endpoints
Endpoint validation
Appropriate comparator therapy
Strategy development for accompanying studies and patient surveys
Systematic literature and study register search
Statistical & Medical Consulting
Preparation of documents for consultation with the Federal Joint Committee (G-BA)