Testing of further investigation and treatment methods with potential
The Joint Federal Committee (G-BA) initiated the consultation of test guidelines for six further examination and treatment methods. Medical device manufacturers have submitted corresponding trial applications for these methods. The G-BA has determined that the methods applied for have the potential to provide the treatment alternatives required; yet the benefit is not proven. With the trial of the methods within studies further insights to the medical benefit are to be gained. A decision of the G-BA on the inclusion of methods in the catalogue of benefits of the statutory health insurance is only possible when there is a sufficiently secure level of knowledge in regards to patient safety.
The decision to initiate the advisory procedures will be taken on the basis of the possible financial contribution of the G-BA to the testing in the budget for the following year. Since the introduction of the trial scheme, the G-BA has been able to take into account each of the positive applications for testing in its budget.
The G-BA has initiated the consultation of test guidelines for the following methods:
- Amyloid positron emission tomography in dementia of unknown cause
- Pulsating electromagnetic fields in bone healing disorders of the long bones
- Stereotactic radiosurgery with cobalt 60 gamma radiation sources of acoustic neuromas in need of intervention in the primary treatment that did not reach the brainstem (maximum T3a stage according to Hannover classification)
- Stereotactic radiosurgery with cobalt 60 gamma radiation sources of operable brain metastases
- Stereotactic radiosurgery with cobalt 60 gamma radiation sources of recurrent pituitary adenomas after resection
- Stereotactic radiosurgery with cobalt 60 gamma radiation sources of untreated cerebral arteriovenous malformations with a nidus diameter of up to 30 mm, for which embolization or microsurgery treatment is not an option.
In the next step, the G-BA will publish key points for the test guidelines in order to obtain initial assessments from the specialist public. At the same time, further companies interested in supporting the costs of the pilot study will be identified. Following the so-called assessment procedures, the test guidelines are drawn up. In particular, they include corrections on the corresponding indications, comparative interventions, patient-relevant endpoints, the type of study required in each case, as well as the neural, personal and other requirements for the quality of service provision. The drafting of the test guidelines is subject to a commenting procedure.