§137e of the Social Code Book V regulates the conduction of co-funded studies to create evidence on safety and effectiveness of innovative and potentially beneficial methods. Assessments are done by the Joint Federal Committee (G-BA) together with the Institute for Quality and Efficiency in Health Care (IQWiG).
A trial directive is released by the G-BA specifying the characteristics of a trial, usually RCT, which it co-funds together with the industry. The study starts within three months after the release of the directive and takes between two and four years. Depending on size and complexity, the overhead costs of such a trial study carried by the manufacturer can be between 600,000 - 3,300,000 Euros. Less contribution is required from small and mid-sized manufacturers.
Trial regulations can be initiated in two ways: application for funding of high-risk medical devices (NUB) or request for consultation.
In the first case, a §137e trial procedure may be induced by the G-BA if the evaluated method shows a potential benefit but evidence is insufficient. The manufacturer should be prepared for this scenario when applying for NUB-funding and be able to provide the necessary funding.
In case of a request for consultation about the potential of a method, the results of the assessment are not legally binding or published until the trial directive is released after the manufacturer declared an interest in conducting the study.
In both cases, once a trial directive has been released, lack of willingness to contribute to the funding of the study by the manufacturer will lead to an assessment about the exclusion of the method from the benefit catalogues in the German statutory health insurance.
Trial regulations were induced by the G-BA for following two methods:
- Ultrasound-controlled high-intensity focused ultrasound in non-surgically treatable hepatocellular carcinomas
- Magnetic resonance imaging-guided high-intensity focused ultrasound therapy for uterine fibroids
The manufacturer of the appropriate medical device for these methods was offered to contribute to the costs for co-funded trials in order to create further evidence of the safety and effectiveness of the methods but was not willing to cover the suggested costs.
If a trial according to §137 e does not take place due to insufficient funding, the G-BA decides about the exclusion of the method from reimbursement from the statutory health insurance in Germany. It is therefore highly recommended for manufacturers and hospitals to assure funding once a trial regulation is induced.
The documents by the G-BA constituting the missing willingness of co-funding by the manufacturers are available regarding high-intensity focused ultrasound therapy for uterine fibroids here and for hepatocellular carcinomas here.
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