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.

Applying a data-driven population segmentation approach in German claims data.

BACKGROUND: Segmenting the population into homogenous groups according to their healthcare needs may help to understand the population's demand for healthcare services and thus support health systems to properly allocate healthcare resources and plan interventions. It may also help to reduce the fragmented provision of healthcare services. The aim of this study was to apply a data-driven utilisation-based cluster analysis to segment a defined population in the south of Germany. METHODS: Based on claims data of one big German health insurance a two-stage clustering approach was applied to group the population into segments. A hierarchical method (Ward's linkage) was performed to determine the optimal number of clusters, followed by a k-means cluster analysis using age and healthcare utilisation data in 2019. The resulting segments were described in terms of their morbidity, costs and demographic characteristics. RESULTS: The 126,046 patients were divided into six distinct population segments. Healthcare utilisation, morbidity and demographic characteristics differed significantly across the segments. The segment "High overall care use" comprised the smallest share of patients (2.03%) but accounted for 24.04% of total cost. The overall utilisation of services was higher than the population average. In contrast, the segment "Low overall care use" included 42.89% of the study population, accounting for 9.94% of total cost. Utilisation of services by patients in this segment was lower than population average. CONCLUSION: Population segmentation offers the opportunity to identify patient groups with similar healthcare utilisation patterns, patient demographics and morbidity. Thereby, healthcare services could be tailored for groups of patients with similar healthcare needs.

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.

The reimbursement of new medical technologies in German inpatient care: What factors explain which hospitals receive innovation payments?

Most hospital payment systems based on diagnosis-related groups (DRGs) provide payments for newly approved technologies. In Germany, they are negotiated between individual hospitals and health insurances. The aim of our study is to assess the functioning of temporary reimbursement mechanisms. We used multilevel logistic regression to examine factors at the hospital and state levels that are associated with agreeing innovation payments. Dependent variable was whether or not a hospital had successfully negotiated innovation payments in 2013 (n = 1532). Using agreement data of the yearly budget negotiations between each German hospital and representatives of the health insurances, the study comprises all German acute hospitals and innovation payments on all diagnoses. In total, 32.9% of the hospitals successfully negotiated innovation payments in 2013. We found that the chance of receiving innovation payments increased if the hospital was located in areas with a high degree of competition and if they were large, had university status and were private for-profit entities. Our study shows an implicit self-controlled selection of hospitals receiving innovation payments. While implicitly encouraging safety of patient care, policy makers should favour a more direct and transparent process of distributing innovation payments in prospective payment systems.

Changing payment instruments and the utilisation of new medical technologies.

This paper empirically investigates the impact of additional reimbursement instruments on the diffusion of new technologies in inpatient care. Using 2010-2014 German panel data on hospital level for every patient undergoing coronary angioplasty, this study examines the utilisation of drug-eluting balloon catheters (DEB) over time while additional payment instruments changed. Hypothesising that the utilisation of DEB increased abruptly when a new reimbursement instrument came into force, we estimate a fixed effects regression comparing years with a change and years where the reimbursement instrument remained the same. The model is adjusted for patient age and severity of the disease. The utilisation of DEB increased from 8407 in 2010 to 19,065 in 2014. Hospitals used significantly more DEB when an additional payment instrument changed compared to years when it remained the same. The increase was roughly twice as large. In short, hospitals are incentivised to utilise new technologies if the reimbursement changes to an instrument that is designed in a more reliable way, e.g. including less bureaucracy or guaranteeing fixed prices.

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.

Pharmaceutical regulation in 15 European countries: review

In the context of pharmaceutical care, policy-makers repeatedly facethe challenge of balancing patient access to effective medicines withaffordability and rising costs. With the aim of guiding the health policydiscourse towards questions that are important to actual and potential patients,this study investigates a broad range of regulatory measures, spanningmarketing authorization to generic substitution and resulting price levels in asample of 16 European health systems (Austria, Belgium, Denmark, England,Finland, France, Germany, Greece, Ireland, Italy, the Netherlands, Poland,Portugal, Scotland, Spain and Sweden).All countries employ a mix of regulatory mechanisms to containpharmaceutical expenditure and ensure quality and efficiency in pharmaceuticalcare, albeit with varying configurations and rigour. This variation alsoinfluences the extent of publicly financed pharmaceutical costs. Overall,observed differences in pharmaceutical expenditure should be interpreted inconjunction with the differing volume and composition of consumption andprice levels, as well as dispensation practices and their impact on measurementof pharmaceutical costs.No definitive evidence has yet been produced on the effects of differentcost-containment measures on patient outcomes. Depending on the foremostpolicy concerns in each country, different levers will have to be used to enablethe delivery of appropriate care at affordable prices.

TAXONOMY OF MEDICAL DEVICES IN THE LOGIC OF HEALTH TECHNOLOGY ASSESSMENT.

OBJECTIVES: The suitability of general HTA methodology for medical devices is gaining interest as a topic of scientific discourse. Given the broad range of medical devices, there might be differences between groups of devices that impact both the necessity and the methods of their assessment. Our aim is to develop a taxonomy that provides researchers and policy makers with an orientation tool on how to approach the assessment of different types of medical devices. METHODS: Several classifications for medical devices based on varying rationales for different regulatory and reporting purposes were analyzed in detail to develop a comprehensive taxonomic model. RESULTS: The taxonomy is based on relevant aspects of existing classification schemes incorporating elements of risk and functionality. Its 9 × 6 matrix distinguishes between the diagnostic or therapeutic nature of devices and considers whether the medical device is directly used by patients, constitutes part of a specific procedure, or can be used for a variety of procedures. We considered the relevance of different device categories in regard to HTA to be considerably variable, ranging from high to low. CONCLUSIONS: Existing medical device classifications cannot be used for HTA as they are based on different underlying logics. The developed taxonomy combines different device classification schemes used for different purposes. It aims at providing decision makers with a tool enabling them to consider device characteristics in detail across more than one dimension. The placement of device groups in the matrix can provide decision support on the necessity of conducting a full HTA.

Structural changes in the German pharmaceutical market: price setting mechanisms based on the early benefit evaluation.

In the past, free price setting mechanisms in Germany led to high prices of patented pharmaceuticals and to increasing expenditures in the pharmaceutical sector. In order to control patented pharmaceutical prices and to curb increasing pharmaceutical spending, the Act for Restructuring the Pharmaceutical Market in Statutory Health Insurance (AMNOG) came into effect on 1st January 2011. In a structured dossier, pharmaceutical manufacturers have to demonstrate the additional therapeutic benefit of the newly approved pharmaceutical compared to its appropriate comparator. According to the level of additional benefit, pharmaceuticals will be subject to price negotiations between the Federal Association of Statutory Health Insurance Funds and the pharmaceutical company concerned (or assigned to a reference price group in case of no additional benefit). Therefore, the health care reform is a first step to decision making based on "value for money". The process of price setting based on early benefit evaluation has an impact on the German as well as the European pharmaceutical markets. Therefore, these structural changes in Germany are of importance for pricing decisions in many European countries both from a political point of view and for strategic planning for pharmaceutical manufacturers, which may have an effect on insured patients' access to pharmaceuticals.

Provision and financing of assistive technology devices in Germany: a bureaucratic odyssey? The case of amyotrophic lateral sclerosis and Duchenne muscular dystrophy.

OBJECTIVE: The regulations for financing assistive technology devices (ATDs) are complex and fragmented and, thus, might influence adequate provision of these devices to people who need multiple ATDs. This study aims to explore and analyze patients' problems with the provision and financing of ATDs for the following two rare diseases: amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD). METHODS: A survey was conducted by means of semi-standardized questionnaires addressing the issues of coverage decisions for ATDs and problems with provision of ATDs. Information was retrieved from ALS (n=19) and DMD (n=14) patients. Conducted interviews were transcribed verbatim and analyzed using qualitative content analysis. RESULTS: Respondents experienced difficulties with the provision and financing of ATDs. They underlined problems such as long approval processes and a serious bureaucratic burden, which induced inadequate provision of ATDs. Experiences of ALS and DMD respondents frequently were similar, especially regarding financing decisions and the process of decision making by sickness funds. CONCLUSION: The results suggest that difficulties in receiving and financing ATDs are common problems among ALS and DMD patients. There is a need for an interdisciplinary approach in the provision of ATDs and their financing, which should be coordinated by case managers.

Coronary stents and the uptake of new medical devices in the German system of inpatient reimbursement.

OBJECTIVES: This study aims to analyze mechanisms for facilitating the uptake of new medical devices in the German system of hospital reimbursement, focusing on the example of coronary stents, including (1) trends in their coding, (2) associated diagnosis-related group (DRG) payments, (3) their integration in the German DRG (G-DRG) system, and (4) their diffusion within the inpatient sector. METHODS: Published and gray literature provide the basis for analyzing the system of hospital reimbursement. Data on coronary stents were obtained from various regulatory and government bodies and examined in a longitudinal fashion. RESULTS: Although German Procedure Classification (Operationen- und Prozedurenschlüssel; OPS) codes were created for a range of stent technologies between 2004 and 2009, the regular system of G-DRG reimbursement does not distinguish between different stents by means of unique DRGs. Instead, supplementary payments or extrabudgetary payments are used to ensure that newer technologies are reimbursed adequately. The limitations of extrabudgetary payments restrict the use of some devices to a small proportion of patients. Data on the diffusion of different stents show that factors other than the reimbursement regime likely also play a role in the frequency with which certain technologies are used. Bare metal stents currently account for most stent implantation procedures in Germany, followed by drug-eluting stents. CONCLUSION: The current system of G-DRG reimbursement and of extrabudgetary payments ensures that even the most recently developed technologies can be used in the German inpatient sector. Nevertheless, certain technologies may not be reaching the broad patient population.