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Regulation and deregulation of insurance markets in the Federal Republic of Germany

Digitised version produced by the EUI Library and made available online in 2020

Promoting vaccinations - an analysis of measures taken by German statutory health insurers

Introduction: Prophylactic vaccinations play a significant role in health care. As a relatively cost-effective preventive measure they can help to avert transmissible diseases and thus protect not only the vaccinated individuals themselves but also those who have not been vaccinated. In order to achieve this, a high vaccination rate is necessary; for many prophylactic vaccinations this rate is not reached in Germany. In order to counteract this trend the importance of prophylactic vaccinations was upgraded in 2007 within the scope of the reform of the health system. The reimbursement of patients' vaccination fees was made compulsory for the statutory health insurance companies and statutory requirements were imposed on the insurers to ensure a nationwide provision of prophylactic vaccinations for insured persons. The objective of this paper is to evaluate to what extent the health insurance companies promote the increasing of vaccination coverage rate today and what measures are being used to present this topic to the public. Methods: In order to assess the public presentation of the topic "prophylactic vaccinations" we have examined the websites of 68 statutory health insurance companies. We have assessed the attitude of the companies towards the promotion of participation in vaccination programs by conducting qualitative, structured interviews with representatives of 8 health insurers. Results: Measures to promote vaccinations, such as information, recall offers, projects to educate people or even monetary incentives, are employed relatively extensively by the health insurers and are considered important. However, it became clear that the discussion about prophylactic vaccinations, in particular concerning the costs and benefits thereof, had not been completed yet within the companies. Vaccination-specific data is not collected or evaluated on a regular or even isolated basis. There are no concrete targets concerning specific vaccination rates and incentives are neither evaluated nor compared with one another. Conclusions: The relatively extensive range of measures used to promote the vaccination rate contrasts with insufficient knowledge about their efficacy and efficiency. There is an urgent requirement for more research here

Affirmative and silent cyber coverage in traditional insurance policies : Qualitative content analysis of selected insurance products from the German insurance market

This paper examines the design of affirmative and silent coverage in view of the cyber risks in traditional insurance policies for select product lines on the German market. Given the novelty and complexity of the topic and the insufficient coverage in the literature, we use two different sources. We analysed the general insurance terms and conditions of different traditional insurance lines using Mayring’s qualitative content analysis. Also, we conducted interviews with experts from the German insurance industry to evaluate how insurers understand their silent cyber exposures, and what measures they take to deal with this new exposure. The study shows a considerable cyber liability risk potential for insurers in the considered insurance lines. This arises from the affirmative as well as silent cover inclusions and exclusions for cyber risks, which result from imprecise wordings of insurance clauses and insufficient descriptions of the contractually specified scope of the insurance coverage

Patient-reported data informing early benefit assessment of rare diseases in Germany: A systematic review

Background Since the implementation of the Regulation on Patient Integration (2003), the Act on the Reorganization of the Pharmaceutical Market (2011), and the Patient Rights Law (2013), the inclusion of patient perspectives has been further anchored in the German early benefit assessment process. During the assessment of rare disease interventions, patient perspectives are particularly important, as clinical studies are often designed acknowledging small samples and patients suffering from severe symptoms and the chronic course of the disease. Therefore, our research question is whether patient perspectives are considered as part of early benefit assessments for rare diseases. We also strive to examine how patient perspectives are methodologically elicited and presented. Methods Our empirical evidence comes from a systematic review of orphan drug value dossiers submitted to the German Federal Joint Committee as well as the corresponding evaluations conducted between January 1, 2011 and March 1, 2019 (n = 81). Data on patient perspective integration were extracted using the following patient-reported outcome subcategories: clinical patient-reported outcomes, health-related quality of life, patient preferences, and patient satisfaction. Results The analysis demonstrates the specific relevance of patient-reported outcomes raised as part of the medical data set and presented during the early benefit assessment process. They are predominantly presented in the form of health-related quality of life data (n = 75%) and clinical outcomes (n = 49%). Preferences (n = 2%) and satisfaction (n = 1%) are still rarely presented, although the heated methodological discussion in Germany would suggest otherwise. While various methodologies for the integration of clinical outcomes and quality of life data were found, presenting data on satisfaction and preferences still lacks methodological rigor. The German Federal Joint Committee has not yet integrated these data in their decision text. Clinical outcomes and quality of life have been included in 46% and 73% of the cases, respectively. Conclusions The underlying analysis demonstrates that there is still a relative high potential for the regular and systematic inclusion of patient perspectives within the early benefit assessment process for rare diseases. In particular, patient preferences and patient satisfaction are still rarely included suggesting the need for a clear-cut methodological foundation and incentives

Benefit assessment in Germany: implications for price discounts

Background: The AMNOG regulation, introduced in 2011 in Germany, changed the game for new drugs. Now, the industry is required to submit a dossier to the GBA (the central decision body in the German sickness fund system) to show additional benefit. After granting the magnitude of the additional benefit by the GBA, the manufacturer is entitled to negotiate the reimbursement price with the GKV-SV (National Association of Statutory Health Insurance Funds). The reimbursement price is defined as a discount on the drug price at launch. As the price or discount negotiations between the manufacturers and the GKV-SV takes place behind closed doors, the factors influencing the results of the negotiation are not known. Objectives: The aim of this evaluation is to identify factors influencing the results of the AMNOG price negotiation process. Methods: The analysis was based on a dataset containing detailed information on all assessments until the end of 2015. A descriptive analysis was followed by an econometric analysis of various potential factors (benefit rating, size of target population, deviating from appropriate comparative therapy and incorporation of HRQoL-data). Results: Until December 2015, manufacturers and the GKV-SV finalized 96 negotiations in 193 therapeutic areas, based on assessment conducted by the GBA. The GBA has granted an additional benefit to 100/193 drug innovations. Negotiated discount was significantly higher for those drugs without additional benefit (p= 0.030) and non-orphan drugs (p= 0.015). Smaller population size, no deviation from recommended appropriate comparative therapy and the incorporation of HRQoL-data were associated with a lower discount on the price at launch. However, neither a uni- nor the multivariate linear regression showed enough power to predict the final discount. Conclusions: Although the AMNOG regulation implemented binding and strict rules for the benefit assessment itself, the outcome of the discount negotiations are still unpredictable. Obviously, negotiation tactics, the current political situation and soft factors seem to play a more influential role for the outcome of the negotiations than the five hard and known factors analyzed in this study. Further research is needed to evaluate additional factors

Genome sequencing: a systematic review of health economic evidence

Recently the sequencing of the human genome has become a major biological and clinical research field. However, the public health impact of this new technology with focus on the financial effect is not yet to be foreseen. To provide an overview of the current health economic evidence for genome sequencing, we conducted a thorough systematic review of the literature from 17 databases. In addition, we conducted a hand search. Starting with 5 520 records we ultimately included five full-text publications and one internet source, all focused on cost calculations. The results were very heterogeneous and, therefore, difficult to compare. Furthermore, because the methodology of the publications was quite poor, the reliability and validity of the results were questionable. The real costs for the whole sequencing workflow, including data management and analysis, remain unknown. Overall, our review indicates that the current health economic evidence for genome sequencing is quite poor. Therefore, we listed aspects that needed to be considered when conducting health economic analyses of genome sequencing. Thereby, specifics regarding the overall aim, technology, population, indication, comparator, alternatives after sequencing, outcomes, probabilities, and costs with respect to genome sequencing are discussed. For further research, at the outset, a comprehensive cost calculation of genome sequencing is needed, because all further health economic studies rely on valid cost data. The results will serve as an input parameter for budget-impact analyses or cost-effectiveness analyses.Marsilius KollegDF

The Role of decision-analytic modelling in German health technology assessments

BACKGROUND: Decision-analytic modelling (DAM) has become a widespread method in health technology assessments (HTA), but the extent to which modelling is used differs among international HTA institutions. In Germany, the use of DAM is optional within HTAs of the German Institute of Medical Documentation and Information (DIMDI). Our study examines the use of DAM in DIMDI HTA reports and its effect on the quality of information provided for health policies. METHODS: A review of all DIMDI HTA reports (from 1998 to September 2012) incorporating an economic assessment was performed. All included reports were divided into two groups: HTAs with DAM and HTAs without DAM. In both groups, reports were categorized according to the quality of information provided for healthcare decision making. RESULTS: Of the sample of 107 DIMDI HTA reports, 17 (15.9%) used DAM for economic assessment. In the group without DAM, conclusions were limited by the quality of economic information in 51.1% of the reports, whereas we did not find limited conclusions in the group with DAM. Furthermore, 24 reports without DAM (26.7%) stated that using DAM would likely improve the quality of information of the economic assessment. CONCLUSION: The use of DAM techniques can improve the quality of HTAs in Germany. When, after a systematic review of existing literature within a HTA, it is clear that DAM is likely to positively affect the quality of the economic assessment DAM should be used

Impact of radiofrequency ablation for patients with varicose veins on the budget of the German statutory health insurance system

Objectives: In contrast to other countries, surgery still represents the common invasive treatment for varicose veins in Germany. However, radiofrequency ablation, e.g. ClosureFast, becomes more and more popular in other countries due to potential better results and reduced side effects. This treatment option may cause less follow-up costs and is a more convenient procedure for patients, which could justify an introduction in the statutory benefits catalogue. Therefore, we aim at calculating the budget impact of a general reimbursement of ClosureFast in Germany. Methods: To assess the budget impact of including ClosureFast in the German statutory benefits catalogue, we developed a multi-cohort Markov model and compared the costs of a “World with ClosureFast” with a “World without ClosureFast” over a time horizon of five years. To address the uncertainty of input parameters, we conducted three different types of sensitivity analysis (one-way, scenario, probabilistic). Results: In the Base Case scenario, the introduction of the ClosureFast system for the treatment of varicose veins saves costs of about 19.1 Mio. € over a time horizon of five years in Germany. However, the results scatter in the sensitivity analyses due to limited evidence of some key input parameters. Conclusions: Results of the budget impact analysis indicate that a general reimbursement of ClosureFast has the potential to be cost-saving in the German Statutory Health Insurance

Regional differences of outpatient physician supply as a theoretical economic and empirical generalized linear model

Scholz S, Graf von der Schulenburg J-M, Greiner W. Regional differences of outpatient physician supply as a theoretical economic and empirical generalized linear model. Human Resources for Health. 2015;13(1): 85.Background Regional differences in physician supply can be found in many health care systems, regardless of their organizational and financial structure. A theoretical model is developed for the physicians’ decision on office allocation, covering demand-side factors and a consumption time function. Methods To test the propositions following the theoretical model, generalized linear models were estimated to explain differences in 412 German districts. Various factors found in the literature were included to control for physicians’ regional preferences. Results Evidence in favor of the first three propositions of the theoretical model could be found. Specialists show a stronger association to higher populated districts than GPs. Although indicators for regional preferences are significantly correlated with physician density, their coefficients are not as high as population density. Conclusions If regional disparities should be addressed by political actions, the focus should be to counteract those parameters representing physicians’ preferences in over- and undersupplied regions