Utilization of innovative medical technologies in German inpatient care: does evidence matter?

BACKGROUND: The reimbursement of new technologies in inpatient care is not always linked to a requirement for evidence-based evaluation of patient benefit. In Germany, every new technology approved for market was until recently eligible for reimbursement in inpatient care unless explicitly excluded. The aim of this work was (1) to investigate the type of evidence that was available at the time of introduction of 25 innovative technologies and how this evidence evolved over time, and (2) to explore the relationship between clinical evidence and utilization for these technologies in German inpatient care. METHODS: This study combined different methods. A systematic search for evidence published between 2003 and 2017 was conducted in four bibliographic databases, clinical trial registries, resources for clinical guidelines, and health technology assessment-databases. Information was also collected on funding mechanisms and safety notices. Utilization was measured by hospital procedures captured in claims data. The body of evidence, funding and safety notices per technology were analyzed descriptively. The relationship between utilization and evidence was explored empirically using a multilevel regression analysis. RESULTS: The number of included publications per technology ranges from two to 498. For all technologies, non-comparative studies form the bulk of the evidence. The number of randomized controlled clinical trials per technology ranges from zero to 19. Some technologies were utilized for several years without an adequate evidence base. A relationship between evidence and utilization could be shown for several but not all technologies. CONCLUSIONS: This study reveals a mixed picture regarding the evidence available for new technologies, and the relationship between the development of evidence and the use of technologies over time. Although the influence of funding and safety notices requires further investigation, these results re-emphasize the need for strengthening market approval standards and HTA pathways as well as approaches such as coverage with evidence development.

Patients' preferences in dental care: A discrete-choice experiment and an analysis of willingness-to-pay.

INTRODUCTION: Dental diseases are a major problem worldwide. Costs are a burden on healthcare systems and patients. Missed treatments can have health and financial consequences. Compared to other health services, dental treatments are only covered in parts by statutory health insurance (SHI). Using the example of dental crowns for a cost-intensive treatment, our study aims to investigate whether (1) certain treatment attributes determine patients' treatment choice, and (2) out-of-pocket payments represent a barrier to access dental care. METHODS: We conducted a discrete-choice-experiment by mailing questionnaires to 10,752 people in Germany. In presented scenarios the participants could choose between treatment options (A, B, or none) composed of treatment attribute levels (e.g., color of teeth) for posterior (PT) and anterior teeth (AT). Considering interaction effects, we used a D-efficient fractional factorial design. Choice analysis was performed using different models. Furthermore, we analyzed willingness-to-pay (WTP), preference of choosing no and SHI standard care treatment, and influence of socioeconomic characteristics on individual WTP. RESULTS: Out of n = 762 returned questionnaires (response rate of r = 7.1), n = 380 were included in the analysis. Most of the participants are in age group "50 to 59 years" (n = 103, 27.1%) and female (n = 249, 65.5%). The participants' benefit allocations varied across treatment attributes. Aesthetics and durability of dental crowns play most important roles in decision-making. WTP regarding natural color teeth is higher than standard SHI out-of-pocket payment. Estimations for AT dominate. For both tooth areas, "no treatment" was a frequent choice (PT: 25.7%, AT: 37.2%). Especially for AT, treatment beyond SHI standard care was often chosen (49.8%, PT: 31.3%). Age, gender, and incentive measures (bonus booklet) influenced WTP per participant. CONCLUSION: This study provides important insights into patient preferences for dental crown treatment in Germany. For our participants, aesthetic for AT and PT as well as out-of-pocket payments for PT play an important role in decision-making. Overall, they are willing to pay more than the current out-of-pockt payments for what they consider to be better crown treatments. Findings may be valuable for policy makers in developing measures that better match patient preferences.

Physicians' Decision Making on Adoption of New Technologies and Role of Coverage with Evidence Development: A Qualitative Study.

OBJECTIVES: To foster value-based pricing and coverage with evidence development in Germany, certain new diagnostic and treatment methods have been subject to a benefit assessment since 2016 to determine their reimbursement. Although this is a paradigm shift, the German approach is limited to some few specific technologies for which reimbursement is requested. As physicians encounter this regulatory instrument, the aim of the study was to understand physicians' decision making regarding the adoption of new medical technologies and to identify their perspectives on the evidence base and financing with additional reimbursement systems. METHODS: From April to August 2017, semistructured interviews with chief and senior physicians of vascular surgery and cardiology in inpatient care in Germany were conducted (N = 23). The interviews were carried out by one researcher in one-to-one appointments or via telephone. Data were analyzed inductively to identify factors and generate thematic categories using qualitative content analysis. RESULTS: We identified 52 factors in eight categories influencing physicians' adoption of new technologies. The evidence base for new technologies was criticized (e.g., lack of available studies). Physicians' knowledge of the regulation of market approval and innovation payments varied. They recommended the utilization of new technologies in certain specialist centers and the facilitation of observational studies. CONCLUSIONS: Physicians saw the need for the new approach and supported its aim. However, its design and implementation appeared to be questionable from their medical perspective. The provision of summarized information on the benefit of technologies might be a possibility to assist physicians' decision making.

[Jurisdictions on the reimbursement of new medical technologies by public health insurance: A systematic review]. / Rechtsprechungen zur Kostenerstattung von neuen Gesundheitstechnologien in der GKV: Eine systematische Übersicht.

BACKGROUND: In Germany reimbursement for new medical technologies is often enforced before a social court. It is likely that these judicial decisions also affect the sickness funds' decisions on requests for reimbursement and thus patient access to new technologies in general. OBJECTIVES: The aim of this study was to identify the technologies that have repeatedly generated court actions and whether these actions have been successful. The focus was on differences between sectors, technology groups and indications. Based on this, we analysed in a case study whether judicial decisions on the reimbursement of the same technologies vary across the years. MATERIAL AND METHODS: Based on a systematic review, we identified judicial decisions of German social courts on new technologies for the years 2011 to 2016. The analysis included social court decisions on reimbursements for technologies used in the treatment of individual patients. RESULTS: 284 judicial decisions on new technologies were considered in the analysis. In one third of the cases, the sickness funds were required to reimburse the costs, with a higher percentage in inpatient than in outpatient care. Technologies used in treatment of diseases of the eyes and the ears were granted most frequently. In cases involving similar circumstances the social courts sometimes came to conflicting decisions; these decisions are, in part, contradictory to subsequent assessments by the Joint Federal Committee (G-BA). CONCLUSIONS: Decisions as to whether reimbursement for new technologies is granted or not do not appear to follow a systematic approach. In the context of the seemingly innovation-friendly policy in inpatient care, there is uncertainty with regard to the "generally accepted state of medical knowledge." It is problematic for both patients and their treating physicians that over a number of years legal proceedings are being initiated for technologies that have not been subjected to a systematic assessment of their benefit.