Nutzenbewertung von Medizinprodukten

Abstract

Medical devices play an important role in both the diagnostic and therapeutic care of patients. The hope is that particularly innovative medical devices can contribute to the improvement of patient care. However, there is no mandatory need to conduct clinical studies with medical devices that allow an assessment of their benefit within the framework of EU market access or on the way to reimbursement by the statutory health insurance (SHI) in Germany. Numerous examples show that the existing legal framework for market access and for reimbursement in the SHI system is insufficient for providing patients with only those examination and treatment methods, i. e., medical devices, that comply with the benefit requirement and the imperative for quality stipulated in the Social Code Book V. However, it is possible to conduct meaningful clinical trials, i. e., randomized controlled trials, with medical devices as well. Hence, regular, indication-related benefit assessment of medical devices with a higher risk class as a prerequisite for reimbursement for a specific medical device is not only necessary, but also feasible. The 2014 report of the Advisory Council on the Assessment of Developments in the Healthcare System contains a promising recommendation for implementing this. A regulatory framework as described in the report would allow patients the fastest possible access to safe and effective medical device innovations, while increasing planning reliability for the development and marketing of new products, which has often been criticized as insufficient by manufacturers.

Gaps in the evidence underpinning high-risk medical devices in Europe at market entry, and potential solutions

“…However, healthcare payers need to assess new interventions to see if they have any added therapeutic benefit. RCTs with medical devices are feasible [ 47 , 48 ]. HTA bodies have published study designs for medical devices that enable the generation of comparative evidence [ 49 , 50 ].…”

“…HTA bodies have published study designs for medical devices that enable the generation of comparative evidence [ 49 , 50 ]. Additionally, RCTs conducted in the context of pre-market approval for innovative high-risk devices in the US demonstrate that it is both ethical and possible to conduct RCTs on medical devices [ 47 ]. Also, in Europe, the device trials approved by a large ethics committee in Berlin show that a growing proportion of the device trials are randomized [ 10 ].…”

Evidence-based decision-making for diagnostic and therapeutic methods: the changing landscape of assessment approaches in Germany

“…However, even if under this approach a study for the assessment of the method in question is initiated, the method can still be provided in the inpatient care setting until a decision based on the completed trial has been taken. Moreover, subsequent regulations, such as the introduction of the two-third majority for the exclusion of a method as well as the establishment of the concept of a ‘potential’, considerably increased the hurdles for an exclusion of a method [ 45 , 46 ]. This is alarming, as patients might be exposed to a potentially harmful method.…”

Barriers and facilitators of patient access to medical devices in Europe: A systematic literature review

“…Three articles were the result of meetings. Data from publications was organized on: market access (n = 9) [6,8,10,[22][23][24][25][26][27], patient access (n = 17) [12,13,[28][29][30][31][32][33][34][35][36][37][38][39][40][41][42], effective patient access (n = 0) or a combination (n = 14) [9,16,[43][44][45][46][47][48][49][50][51][52][53][54]. Depending on the type of access, the included publications provided data about France, Germany, Italy, Spain, the United Kingdom (UK), the Netherlands, Sweden and/or Poland (see 3.2.1., 3.2.2. and 3.2.3. for the specification of reported countries by access type).…”