Editorial: Conclusions on the G-BA § 137e study trial assessments
Since the § 137e law was introduced five years ago, 33 methods have been assessed within the framework with more than 50% of them showing at least the potential to become a required treatment alternative. In a few cases, the G-BA even assessed that the submitted evidence is good enough to consider the benefit proven.
The G-BA has released four guidelines to perform § 137e study trials and if the financing is secured, these will be co-funded between the G-BA and the manufacturers. The first study is planned to commence in the next few months, as the independent scientific institute performing the study still has to be determined in a pan-European procedure. However, in the future the G-BA expects to shorten the time for the decision to be made.
Manufacturers are expected to submit higher quality applications as the opportunity of a prior consultation is used more frequently and the G-BA itself further improves their internal processes. Dr Harald Deisler, representing the G-BA, draws an overall positive conclusion, highlighting that five years ago it was not possible to foresee how the procedure would be viewed or if it will require improvement.
Background
Assessment of examination and treatment methods in accordance with § 137e
To generate further evidence for methods which show potential to become a required treatment alternative, the G-BA can initiate and financially support a study trial. Manufacturers have the right to request an assessment of their method’s potential. So far, the following methods have fulfilled the requirements for a study trial:
• Measurement and monitoring of pulmonary arterial pressure using an implanted sensor for the optimization of therapy for cardiac insufficiency in NYHA III stage
• MRI-guided HIFU for patients with symptomatic and insufficiently treatable uterine myomas
• Transcorneal electrostimulation in retinitis pigmentosa
• Stem cell transplantation in multiple myeloma