§137e “trial regulation”
The objective of the §137e “trial regulation”was to enable the G-BA to support the generation of high level evidence for benefit assessments of innovative diagnostic or treatment methods. The costs for the treatment of a patient in such a study and for the medical technology involved will be reimbursed by the health care system. The costs for the study overhead will need to be taken by the manufacturer of the technology.
The §137 procedures are one option for a manufacturer to go into a structured dialogue with the G-BA: In a §137e consultation manufacturers can ask questions to G-BA before making the decision on the usage of the §137e process.
The submission dossier for the §137e process needs to include a detailed description of the method including its role in a treatment pathway, an evidence overview based on a systematic literature research and a proposal of a study protocol. Based on that information, the G-BA needs to decide if the method has the potential of being a required treatment alternative. Once per year methods will be selected for which a directive will be developed by G-BA defining the requirements for a high level clinical study.
Kalms Consulting provides strategic consulting on the opportunities and risks of the §137e process, and can operatively support with a simulation of the §137e process; as well as execution on process from the first consultation, to dossier submission, hearings and other communication with G-BA and other steps required.