Shockwave lithotripsy (SWL) is a method using extra- or intracorporeally generated shock waves for the physical destruction of hardened masses. It is an established procedure for the treatment of gall- or kidney stones. The method in question is an intracoronary lithography as part of a percutaneous coronary intervention (PCI) for the treatment of otherwise difficult-to-treat calcified coronary stenoses prior to stent placement. The intracoronary emission of the shock waves aims at breaking the calcium structure in the calcified stenosis to facilitate subsequent balloon dilatation and stent implantation. The method uses a medical device system composed of
- A balloon catheter to which a shock wave emitter in the area of the balloon and
- An external shock wave generator.
The Shockwave Medical requested a consultation by the Joint Federal Committee (G-BA) to find out, whether their technology must undergo an early benefit assessment in order to receive innovation funding (NUB) according to §137h of the Social Code Book V (SGB V). This legislation applies to innovative and high-risk or invasive technologies. If the assessment by the G-BA shows no potential benefit of the technology, it will be excluded from reimbursement in the inpatient sector by the statutory health insurance (SHI) in Germany.
Requesting a consultation prior to a NUB funding application helps manufacturers or hospitals understand, whether a technology needs to undergo an early benefit assessment and to reduce the risk of potential exclusion from reimbursement. Consultation is requested through submission of a request document. It is free of charge and includes a formal hearing procedure allowing to hand in additional material and to communicate verbally with the G-BA. Manufacturers should be aware that the G-BA will release large content of the request on its website and therefore confidential information cannot be included.
The G-BA uses following criteria to decide whether the method requires early benefit assessment:
- 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 case of the Shockwave Medical Coronary Lithoplasty® System, all criteria are fulfilled, meaning that it requires benefit assessment to be granted innovation funding. Innovation funding is a relevant option, since currently no procedure code exists leading to sufficient reimbursement of the method in Germany. However, hospital are now alert of the potential risk of exclusion from reimbursement in the SHI in Germany if they should apply for NUB funding by the Institute for the Hospital Remuneration System (InEK).
The decision document and rationale of the decision is available in German here.
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