Challenges and Opportunities of the German ‘Coverage with Evidence Development’ Scheme for New Medical Devices: A Mixed-Methods Study

OBJECTIVES: Conditional reimbursement of medical devices (MDs) is increasingly adopted as a decision-making tool. In Germany, section §137e of the Social Code Book V was introduced in 2012 to enable faster market access for innovative interventions. Since its introduction, approximately 40 applications have been filed, whereas only 6 trials are ongoing, and no trials are completed. This study aimed to investigate the challenges and opportunities for coverage with evidence development (CED) schemes on MDs in Germany, by identifying the most prominent barriers considered by the manufacturers before pursuing such a regulatory pathway.

METHODS: A targeted literature review was performed to identify the theoretical framework within the topic. In a second step, 6 semi-structured interviews with representatives from Institute for Quality and Efficiency in Health Care, Bundesverband Medizintechnologie, clinical research organizations, and the industry were conducted. The interviews were used to reveal external factors and barriers that could impact the CED scheme implementation and success. Following thematic analyses, the framework of the PEST analysis was used to identify and analyze Political, Economic, Social, and Technological factors.

RESULTS: The most prominent challenges are the time aspect, patient recruitment, and the lack of experience. However, the reported challenges are impacted by several factors, and the PEST analysis provides awareness regarding this scheme.

CONCLUSIONS: Most interviewed respondents recognized the potential of market access through the §137e SGB V pathway to reduce the evidence gap for MD. However, further improvement and efforts to accelerate the process could be beneficial. The CED process is timely and difficult to navigate, impacting the attractiveness to manufacturers. Thus, stakeholders need to be aware of these identified challenges before engaging in this pathway.