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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

Adjuvant treatment of high-risk melanoma – cost-effectiveness analysis of treatment options for BRAF 600 mutated tumors

Introduction: Until recently, adjuvant treatment options for higher stage resectable cutaneous melanoma were limited. Two studies with a similar set-up, published 2017, led to registration of targeted therapy for BRAF-mutated melanoma with dabrafenib and trametinib as well as of the immunotherapy with nivolumab irrespective of BRAF-mutation status. Both options have been positively assessed in Germany since 2019 for the adjuvant treatment of BRAF-V600 mutated melanoma. This study evaluates the cost-effectiveness of both treatment alternatives (dabrafenib/trametinib and nivolumab) against observation as a comparative therapy from the perspective of German statutory health funds. Methods: Partitioned survival analysis based on published survival curves for the investigated treatment options was used for a cohort model for the health states relapse free survival, progression, and death. The partitioned survival analysis approach was based on the survival curves published for the key studies Combi AD and Checkmate-238. The modelling was performed for the remaining lifetime for a cohort with starting age of 50 years. For extrapolation of the survival curves, convergence to general population mortality rates was assumed in the long term. Within the progression state, a Markov model uses three levels of progressions (locoregional, distant metastases with 1st and 2nd line treatment). Lifetime treatment costs were calculated using the German statutory health fund reimbursement scheme. Quality adjusted life years (QALYs) associated to the health states were adopted from previously published utilities based on the Combi AD study. Results: The treatment with dabrafenib/trametinib yielded an increase in quality adjusted life years of 2.28 QALY at an incremental lifetime cost of 86.1 T€. The incremental cost effectiveness ratio of dabrafenib/trametinib and nivolumab was comparable with 37.8 T€/QALY and 30.0 T€/QALY, respectively. Several sensitivity analyses proved the result to be insensitive. General model parameters like discount rate and length of the time horizon had stronger influence. For nivolumab, the model showed lower discounted lifetime costs (118.1 T€) compared to dabrafenib/trametinib [155.1 T€], associated with a lower gain in QALYs (1.64 years) compared to observation. Conclusion: Both dabrafenib/trametinib and nivolumab turned out to be cost effective within internationally accepted Incremental Cost Effectiveness Ratio (ICER) thresholds with comparable cost effectiveness ratios

Platelet aggregation inhibitors in primary and secondary prevention of ischemic stroke

Background The ischaemic stroke (IS) is one of the most frequent cause of death in Germany. Besides of non-drug many drug-based interventions are used in primary or secondary prevention of IS, among them the thrombocyte aggregation inhibitors (TAI). Objectives The evaluation addresses the questions on medical efficacy and cost-effectiveness of the TAI administration in the prevention of IS as compared to the management of risk factors alone as well as to the use of anticoagulant drugs. Methods The literature search for articles published after 1997 was conducted in December 2003 in the most important medical and economic databases. The medical analysis was performed on the basis of the most up-to date meta-analyses of randomised controlled trials (RCT) as well as of new published RCT. The data from the studies for stroke, bleeding complications as well as for the combined endpoint "severe vascular events" (SVE: death or stroke or myocardial infarction) were summarised in meta-analyses. In order to include grey literature contact has been taken up with the pharmaceutical manufacturers of TAI. Results are presented in a descriptive way. Results The medical analysis included data from 184 RCT (vs. placebo) and from 22 RCT (vs. anticoagulant drugs). The absolute reduction of IS (4.8% vs. 6.6%; p<0,00001) and SVE (10.0% vs. 12.4%; p<0,00001) were definitely higher than the absolute increase of bleeding complications (1.6% vs. 0.9%; p<0,00001), but relatively similar to this absolute increase in a subpopulation with a low risk for SVE. With regard to the stroke prevention, evidence of efficacy could be yielded for acetylsalicil acid (ASA), dipyridamole, cilostazol, ridogrel and the combination ASA with dipyridamole. ASA is less effective than anticoagulants in the prevention of ischaemic stroke in atrial fibrillation, however, it causes fewer bleeding complications. Low dosed ASA can be considered cost-effective in secondary prevention of ischemic stroke, which is not the case for clopridogrel. Dipyridamole/ASA being more effective compared with ASA alone is connected with higher acquisition costs. Discussion The exclusive consideration of stroke prevention is limited, as well as physicians by allocation to TAI expect to avoid all thrombotic events. Since no pharmacoeconomic studies exist for the German context, the economic assessment had to be based on international evidence. Conclusions From the medical point of view, TAI may be recommended for primary and secondary prevention of IS in patients with a high risk of severe vascular events and with low risk for bleeding complications. ASA may be also administered in patients with atrial fibrillation in case of contraindication to anticoagulation drugs. From the health economic point of view a systematic primary prophylaxis of IS with ASA cannot be recommended, whereas in secondary prophylaxis savings can be made. Neither the use of Dipyridamole/ASS nor Clopidogrel is advisable for a systematic secondary prophylaxis of IS.Wissenschaftlicher Hintergrund Der ischämische Schlaganfall (IS) ist eine der häufigsten Todesursachen in Deutschland. Außer nicht-medikamentösen werden auch verschiedene medikamentöse Maßnahmen zur Primär- bzw. Sekundärprävention des IS eingesetzt, darunter die Anwendung von Thrombozytenaggregationshemmern (TAH). Forschungsfragen Es sollen die medizinische Effektivität und der Kosteneffektivität des Einsatzes von TAH in der Prävention des IS im Vergleich zum alleinigen Management von Risikofaktoren sowie im Vergleich zu Antikoagulantien bewertet werden. Methodik Die Literaturrecherche fand im Dezember 2003 in den wichtigsten medizinischen und gesundheitsökonomischen Datenbanken mit Referenzzeitraum ab 1997 statt. In die medizinische Bewertung wurden Übersichtspublikationen zum aktuellsten Wissensstand sowie neu publizierte RCT eingeschlossen. Daten für Schlaganfälle, Blutungskomplikationen sowie für den kombinierten Endpunkt "schwere vaskuläre Ereignisse" (SVE) wurden in Metaanalysen ausgewertet. Im Rahmen der gesundheitsökonomischen Analyse wurde außerdem Kontakt mit den TAH-Herstellern zur Identifikation unpublizierter Studien aufgenommen. Die Ergebnisdarstellung erfolgt deskriptiv. Ergebnisse Es wurden insgesamt Daten aus 184 RCT (vs. Placebo) und aus 22 RCT (vs. Antikoagulantien) in die medizinische Bewertung einbezogen. Die absolute Reduktion IS (4,8% vs. 6,6%; p<0,00001) und SVE (10,0% vs. 12,4%; p<0,00001) war deutlich größer als die absolute Zunahme an Blutungskomplikationen (1,6% vs. 0,9%; p<0,00001), nur in einer Subpopulation mit niedrigem SVE-Risiko dagegen annährend gleich. Hinsichtlich der Schlaganfällprävention konnte ein Wirksamkeitsnachweis für Acetylsalicylsäure (ASS), Dipyridamol, Cilostazol, Ridogrel und der Kombination von ASS mit Dipyridamol erbracht werden. ASS ist weniger wirksam als Antikoagulantien bei Vorhofflimmern, allerdings mit weniger Blutungskomplikationen. Aus gesundheitsökonomischer Sicht ist niedrig dosiertes ASS im Rahmen der IS-Sekundärprophylaxe nicht nur kosteneffektiv, sondern es lassen sich auch Kosten einsparen. Beides trifft für Clopidogrel nicht zu. Die Kombination ASS/Dipyridamol ist bei besserer klinischer Wirksamkeit mit höheren Kosten verbunden, so dass über Art und Umfang der Anwendung die gesellschaftliche Zahlungsbereitschaft entscheidet. Diskussion Die exklusive Betrachtung der Schlaganfallprävention ist nur eingeschränkt hilfreich, da Ärzte bei der TAH-Verordnung von einer Vermeidung aller thrombotischen Ereignisse ausgehen. Auch die gesundheitsökonomische Bewertung wurde durch die vergleichsweise enge Themenstellung methodisch erschwert. Zudem ist zu berücksichtigen, dass keine gesundheitsökonomischen Studien für das deutsche Gesundheitssystem vorliegen, sodass die Bewertung auf ausländischen Quellen beruhen musste. Schlussfolgerung Aus medizinischer Sicht können TAH zur Primär- und Sekundärprävention des IS bei Patienten mit hohem Risiko für SVE und ohne erhöhtes Risiko für Blutungskomplikationen empfohlen werden, für Patienten mit Vorhofflimmern bei Kontraindikationen für Antikoagulation. Eine systematische medikamentöse Primärprophylaxe des IS erscheint aus gesundheitsökonomischer Sicht nicht angezeigt. Durch die Verwendung von ASS im Rahmen der IS-Sekundärprävention können Kosten eingespart werden. Für die übrigen TAH hingegen ist von einer Verwendung bei der systematischen IS-Sekundärprophylaxe Abstand zu nehmen. Insbesondere bei Risikopatienten ist erheblicher gesundheitsökonomischer Forschungsbedarf zu konstatieren

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