Since 2016, new legislation introduced in Germany requires an assessment of the potential benefit of new methods using high-risk medical devices before they receive innovation funding (NUB). If the assessment by the Joint Federal Committee (G-BA) shows has no potential benefit the technology, it is likely to be excluded from reimbursement in the inpatient sector by the statutory health insurance (SHI) in Germany.
To minimize this risk, medical device manufacturers and hospitals can get consultation before NUB application. Chapter §137h (6) of the Social Code Book V (SGB V) provides the possibility of consultation to help manufacturers or hospitals understand whether a method needs to undergo a benefit assessment by the G-BA. Consultation is requested through submission of a request document. The consultation is free of charge and includes a formal hearing procedure allowing to hand in additional material and to communicate verbally with the G-BA. However, manufacturers should be aware that the G-BA will release a large content of the request on its website and therefore confidential information cannot be included.
In the §137h (6) consultation framework, the G-BA decides whether the method needs to undergo early benefit assessment, considering following criteria:
- The method is essentially based on the use of a high-risk medical device
- The method is a real innovation and new to the German market
- The method fulfills the criteria for coverage by the SHI according to §135c SBG V
- The method has not been assessed according to §137h SBG V previously
In the current case, the manufacturer, PQ Bypass, made a request for consultation according to §137h (6) SBG V. The subject of this consultation (PQ Bypass Stent Graft System) is a minimally invasive, endovascular procedure for the restoration of blood flow in long occlusions of the superficial femoral artery (AFS). The operating principle is based on bridging the closed vessel section through a bypass that extends from the AFS to the popliteal artery.
The G-BA concluded that the method in question is not based on a high-risk medical device and thus does not fulfill the first point of criteria listed above. This means that, in order to receive NUB funding, the method does not have to undergo early benefit assessment by the G-BA. Hospitals can apply for NUB funding by the Institute for the Hospital Remuneration System (InEK) without the risk of exclusion from reimbursement in the German SHI.
The decision document and rationale of the decision is available in German here.
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