On May 6, 2021, the Federal Joint Committee (G-BA) announced the start of consultations about the design of three co-funded studies for cardiovascular methods in accordance with §137e SGB V.
The considered treatment methods include:
- Coronary lithoplasty in coronary artery disease
- Endovascular implantation of a stent-graft with valve element in tricuspid valve insufficiency
- Percutaneously implanted interatrial shunt for the treatment of heart failure with reduced left ventricular ejection fraction (LVEF <40%)
The G-BA has previously evaluated the listed methods within the framework of the early benefit assessment according to §137h SGB V. In its decision of May 6, 2021, the Federal Joint Committee concluded that there is not enough evidence to prove the benefit, harm, or effectiveness of the evaluated methods.
Consequently, a consultation procedure, according to the Rules of Procedure of the G-BA on co-funded studies in accordance with §137e SGB V of these treatment methods, was initiated. This is intended to give leading organizations of manufacturers of medical products and devices and possibly affected manufacturers of medical products the possibility to comment on the study design and objectives.
The feedback should be sent electronically by June 9, 2021.
The full details in German can be found here, here, and here.
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