Epidemiology and economic burden of meningococcal disease in Germany: A systematic review.

INTRODUCTION: Invasive meningococcal disease (IMD) is a notifiable disease in Germany and other European countries. Due to the high lethality of the disease and the risk of long-term consequences, IMD prevention is of high public health relevance despite the low number of cases in the population. This study aims to describe key epidemiological and economic parameters of IMD in Germany to support national decision-making processes for implementing enhanced prevention measures. METHODS: Based on a systematic literature review in PubMed and EMBASE, all publications on the burden of disease and costs of IMD published up to May 2020 were evaluated. Additionally, notification data were used to report the annual case numbers and incidence of IMD in Germany until the end of 2019. RESULTS: Thirty-six studies were included, of which 35 reported data on the epidemiological burden of disease and three reported data on economic aspects of IMD. The type of reported endpoints and results on the incidence of IMD differed widely by reporting year, population, and data source used. Most of the data are reported without specific information about a serogroup. Data on the economic burden of disease and healthcare resource use are scarce. Based on mandatory notification data, a decrease in the incidence of notified IMD cases has been observed since 2004. Currently, the nationwide annual incidence in Germany is at 0.3 cases per 100,000 persons and has gradually decreased. While the overall decline is mainly attributable to MenB, cases with MenY and MenW are the only ones that have increased on a low level in recent years. CONCLUSION: While IMD is a rare disease, high direct and indirect costs illustrate the relevance of the disease for patients, caregivers, as well as for the health care system. Future research should concentrate on quantifying the long-term economic burden and indirect costs of meningococcal disease. Integrated IMD surveillance with isolate characterisation remains crucial to inform public health policies.

Clinical burden of illness in patients with phenylketonuria (PKU) and associated comorbidities - a retrospective study of German health insurance claims data.

BACKGROUND: Phenylketonuria (PKU) is an inherited deficiency in the enzyme phenylalanine hydroxylase (PAH), which, when poorly-managed, is associated with clinical features including deficient growth, microcephaly, seizures, and intellectual impairment. The management of PKU should start as soon as possible after diagnosis to prevent irreversible damage and be maintained throughout life. The aim of this study was to assess the burden of illness in PKU patients in general and in PKU patients born before and after the introduction of newborn screening in Germany. METHODS: This retrospective matched cohort analysis used the Institut für angewandte Gesundheitsforschung Berlin (InGef) research database containing anonymized healthcare claims of approximately 4 million covered lives. PKU patients were compared with matched controls from the general population within the same database (1:10 ratio via direct, exact matching on age and gender without replacement). PKU patients were included if they were aged ≥18 years on 01/01/15 and were continuously enrolled from 01/01/10 to 31/12/15. The 50 most commonly reported comorbidities and 50 most commonly prescribed medications in the PKU population were analyzed. Differences between groups were tested using 95% confidence interval (CI) of prevalence ratio (PR) values. RESULTS: The analysis included 377 adult PKU patients (< 5 of which were receiving sapropterin dihydrochloride) and 3,770 matched controls. Of the 50 most common comorbidities in the PKU population, those with a statistically significant PR > 1.5 vs controls included major depressive disorders (PR = 2.3), chronic ischemic heart disease (PR = 1.7), asthma (PR = 1.7), dizziness and giddiness (PR = 1.8), unspecified diabetes mellitus (PR = 1.7), infectious gastroenteritis and colitis (PR = 1.7), and reaction to severe stress and adjustment disorders (PR = 1.6). The most commonly prescribed Anatomical Therapeutic Chemical (ATC) subcodes among PKU patients (vs the control population) are for systemic antibacterials (34.7% vs 32.8%), anti-inflammatory and antirheumatic (29.4% vs 27.5%), renin-angiotensin agents (30.0% vs 27.0%), acid-related disorders (29.4% vs 20.2%), and beta-blockers (24.9% vs 19.9%). CONCLUSION: The overall clinical burden on patients with PKU is exacerbated by a significantly higher risk of numerous comorbidities and hence, prescribing of the requisite medication, both for recognized (e.g. major depressive disorders) and more unexpected comorbidities (e.g. ischemic heart disease).

Methods for measuring financial toxicity after cancer diagnosis and treatment: a systematic review and its implications.

Patients experiencing financial distress as a side-effect of cancer are not only reported in the United States, but also in third-party payer healthcare systems in Europe. Since validated survey instruments are a prerequisite for robust and comparable results, we aimed to compile and classify available instruments to enable both a better understanding of the underlying construct of financial toxicity and to facilitate further studies that are adjustable to various healthcare systems. We did a systematic literature search on studies that provide data on perceived cancer-related financial distress experienced by adult patients using PubMed, CINAHL and Web of Science databases up to 2018. We analyzed all detected instruments, items domains and questions with regard to their wording, scales and the domains of financial distress covered. Among 3298 records screened, 41 publications based on 40 studies matched our inclusion criteria. Based on the analysis of 352 different questions we identified 6 relevant subdomains that represent perceptions of and reactions to experienced financial distress: (i) active financial spending, (ii) use of passive financial resources, (iii) psychosocial responses, (iv) support seeking, (v) coping with care or (vi) coping with ones' lifestyle. We found an inconsistent coverage and use of these domains that makes it difficult to compare and quantify the prevalence of financial distress. Moreover, some existing instruments do not reflect relevant domains for patients in third-party payer systems. There is neither a consistent understanding of the construct of financial burden nor do available instruments cover all relevant aspects of a patients' distress perception. We encourage using the identified six domains to further develop survey instruments and adjust them to different health systems.

[FIMA--questionnaire for health-related resource use in an elderly population: development and pilot study]. / FIMA--Fragebogen zur Erhebung von Gesundheitsleistungen im Alter: Entwicklung und Pilotstudie.

AIM: Due to demographic trends towards an ageing population resource use of health care will increase. By collecting health-related costs via questionnaires, the impact of socio-economic variables and other medical factors can be examined. In addition, only patient reported resource use accounts for out-of-pocket payments. Thus, it is necessary to develop an appropriate tool to collect the health-related resource use in an elderly population. METHODS: The development of the FIMA (questionnaire for the use of medical and non-medical services in old age) was carried out in 6 steps. These included the determination of necessary questionnaire contents based on a literature review and the wording and layout were defined. Finally the questionnaire was tested in a pilot study and was modified. RESULTS: All direct medical and non-medical resource use excluding transportation and time costs were recorded. Productivity losses were not included. The recall time frames differed according to resource categories (7 days, 3 months, 12 months). For the pilot study, 63 questionnaires were analysed. The response rate was 69%. The questionnaire took an average of 21 min to complete. Three quarters of respondents completed the questionnaire without help and 90% rated the difficulty as easy or even very simple. There was good agreement between self-reported health-related quality of life and the resource use of nursing and domestic help (phi coefficient values between 0.52 and 0.58). CONCLUSION: The FIMA is a generic questionnaire which collects the health-related resource use within the older population groups.

[Calculation of standardised unit costs from a societal perspective for health economic evaluation]. / Ermittlung standardisierter Bewertungssätze aus gesellschaftlicher Perspektive für die gesundheitsökonomische Evaluation.

PURPOSE: Due to demographic aging, economic evaluation of health care technologies for the elderly becomes more important. A standardised questionnaire to measure the health-related resource utilisation has been designed. The monetary valuation of the resource use documented by the questionnaire is a central step towards the determination of the corresponding costs. The aim of this paper is to provide unit costs for the resources in the questionnaire from a societal perspective. METHODS: The unit costs are calculated pragmatically based on regularly published sources. Thus, an easy update is possible. RESULTS: This paper presents the calculated unit costs for outpatient medical care, inpatient care, informal and formal nursing care and pharmaceuticals from a societal perspective. CONCLUSION: The calculated unit costs can serve as a reference case in health economic evaluations and hence help to increase their comparability.

Economic burden of neural tube defects in Germany.

OBJECTIVE: Failure of closure of the neural tube often leads to serious malformations, including spina bifida, anencephaly and encephalocoele. Despite improvements in medical and surgical treatment, the burden associated with spina bifida is substantial but country-specific data are lacking outside North America. This study aims to improve understanding of the economic implications and burden associated with the morbidity of children and adults with neural tube defects (NTDs) in Germany. STUDY DESIGN: Retrospective data analysis. METHODS: 2006-2009 German health insurance data of persons with NTDs (spina bifida and encephalocoele) were analysed to determine the economic burden of illness associated with NTDs in Germany. Cases were identified using ICD-10 codes; data included outpatient and inpatient care, rehabilitation, remedies and medical aids, pharmacotherapy use, long-term care and information on sick leave. The analysis was stratified by age group to provide a burden estimate specific to a person's age. To obtain an indicator of incremental burden to the Statutory Health Insurance (SHI), results were compared to the standardized healthcare expenditures according to the German Risk Compensation Scheme (RSA). RESULTS: Overall, 4141 persons with an ICD code related to NTDs were identified (out of a population of 7.28 million persons screened). The administrative prevalence ranged from 0.54 to 0.58 per 1000 enrollees. Of those, 3952 (95.4%) were diagnosed with spina bifida. The average annual mean healthcare expenditure of persons with spina bifida was €4532 (95% CI = 4375-4689, SD = 9590, Median = 1000), with inpatient care contributing €1358 (30.0%), outpatient care €644 (14.2%), rehabilitation €29 (0.6%), pharmacotherapy €562 (12.4%), and remedies and medical aids €1939 (42.8%). The incremental cost due to spina bifida was substantially higher than the standardized SHI expenditures for all age groups. The difference was highest for persons ≤ 10 years old (€10,971 vs €2360 for the age group ≤ 1, €8599 vs €833 for the age group 2-5 years and €10,601 vs €863 for the age group 6-10 years). The difference was smallest for the age group 41-50 years (€2524 vs €1101) and for 71 years and over (€5278 vs €4389). CONCLUSION: Expenditures of persons with spina bifida exceeded the standardized SHI expenditures, indicating a considerable economic burden. The economic burden is continuous throughout the person's life, with high monetary impact and exposure to the healthcare system (especially in early years of life). Efforts should be devoted to improve the prevention of NTDs and provide appropriate support for persons with NTDs, parents, and caregivers--especially in early years.

[Economic aspects of integrated care]. / Ökonomische Aspekte der integrierten Versorgung.

For more than 10 years integrated care has been an inherent part of the German healthcare system. The aims of selective contracts are to minimize interface problems between outpatient and inpatient sectors, generalist und specialist care as well as to intensify competition. Despite repeated efforts by the legislator, comprehensive integrated healthcare is still limited to a few flagship projects. This is mainly due to low incentives on the part of both suppliers and customers. Therefore, this article focuses on the economic aspects of integrated care. From a theoretical perspective, integrated care improves efficiency in the healthcare sector by reducing interface problems and asymmetric information as well as by intensifying competition. In practice, however, there are a number of obstacles to implementation. Particularly noteworthy are the financial difficulties in addition to problems regarding sectoral budgeting and the long-term nature of investments. However, the political environment and thus the financial arrangements within the statutory health insurance seem to be more important for further development of integrated care in Germany than the financing issues.

Relationship between multimorbidity and direct healthcare costs in an advanced elderly population. Results of the PRISCUS trial.

OBJECTIVES: The goal of this work was to analyze the impact of the extent of multimorbidity on health service resource utilization and, thus, direct healthcare costs of advanced elderly in the German population. METHODS: Based on a cross-sectional sample aged 72 or above in Germany (n = 1,937), a bottom-up study assessing resource utilization and corresponding costs was performed. Main data sources were patient-reported information concerning morbidity and health service resource utilization administered via telephone interviews within the framework of the PRISCUS trial. To value resource utilization, unit costs were determined for all services under consideration. In order to estimate the impact of multimorbidity on mean annual direct costs, a cumulative multimorbidity index was constructed. Influencing factors on annual average costs were identified via multivariate linear regression models. RESULTS: Mean annual direct costs of 3,315 EUR (95% confidence interval (CI) 3,118; 3,512) at 2010 prices were caused by the involved patients: 25% of mean annual costs were due to inpatient care, 20% to outpatient physician services, 20% to pharmaceuticals, 12% to assisted living and transportation, 8% to healthcare products and dentures, 7% to rehabilitation services, 5% to outpatient nonphysician providers, and 3% to spending from compulsory long-term care insurance. Each additional comorbidity was accompanied by a cost increase of 563 EUR (95% CI 488; 638). Participants with no diseases mentioned in the multimorbidity index caused average annual costs of 1,250 EUR. In contrast, respondents with 10 + diseases caused the highest mean annual costs of 6,862 EUR. CONCLUSION: Longer life expectancy has become commonplace and is often associated with the simultaneous occurrence of several diseases. A clear understanding of the impact of multimorbidity on costs is highly relevant for health policy decision makers. The present study provides a well-founded basis to analyze the relationship between multiple morbidity and associated costs due to healthcare resource consumption of older adults in Germany.

[Analysing the work of medical and nursing staff: comparison between PsychPV requirements and everyday activities on psychiatric wards]. / Tätigkeitsanalyse im ärztlichen und pflegerischen Dienst : Abgleich der PsychPV-Vorgaben mit dem Arbeitsalltag auf einer stationären psychiatrischen Einrichtung.

BACKGROUND: Since 1991 the German psychiatry personnel regulation act (PsychPV) defines the number and tasks of medical doctors and nursing staff on a psychiatric ward. However, there is the suspicion that there are differences, especially with regard to an increased proportion of activities not involving patients, such as documentation and administrative work. METHODS: To detect differences between requirements from the PsychPV and the actual amount of time spent on different activities, a task analysis was performed on a general psychiatric and a gerontological psychiatric ward. In this study the proportions of working time spent on five different types of activities with time that should have been spent according to the PsychPV were compared. RESULTS: Discrepancies were found on both psychiatric wards and for medical doctors as well as for nursing staff. Tasks of documentation and administrative work took significantly higher proportions of working time than required in the PsychPV. On the other hand psychiatric personnel spent less time for treatment or nursing in direct contact with the patients. CONCLUSION: The results of this study confirmed the suspicion that shifting tasks on psychiatric wards has led to changed treatment settings.

[Methods of health economic evaluation for health services research]. / Methoden der gesundheitsökonomischen Evaluation in der Versorgungsforschung.

On August 30, 2010, the German Network for Health Services Research [Deutsches Netzwerk Versorgungsforschung e. V. (DNVF e. V.)] approved the Memorandum III "Methods for Health Services Research", supported by the member societies mentioned as authors and published in this Journal [Gesundheitswesen 2010; 72: 739-748]. The present paper focuses on methodological issues of economic evaluation of health care technologies. It complements the Memorandum III "Methods for Health Services Research", part 2. First, general methodological principles of the economic evaluations of health care technologies are outlined. In order to adequately reflect costs and outcomes of health care interventions in the routine health care, data from different sources are required (e. g., comparative efficacy or effectiveness studies, registers, administrative data, etc.). Therefore, various data sources, which might be used for economic evaluations, are presented, and their strengths and limitations are stated. Finally, the need for methodological advancement with regard to data collection and analysis and issues pertaining to communication and dissemination of results of health economic evaluations are discussed.

[Health economic evaluation of the integrated care project "OPTI-MuM"]. / Gesundheitsökonomische Evaluation der Integrierten Versorgung "OPTI-MuM"

AIM: The objective of this study is to evaluate the economic performance of a population-based integrated care project in comparison to standard care. METHODS: The perspective adopted is that of the participating statutory health insurance companies. The well-defined target region allows the distinction of participants and non-participants. The quasi-experimental study design, which is based on routine data of the participating health insurers, is able to reduce the bias caused by the non-randomised group assignment. Based on the year of enrollment two separate cohorts were generated. RESULTS: The comparison of group differences before and after a propensity score matching shows that this method provides appropriate control groups for both cohorts of participants. Taking into account 4,840 of the 5,164 participants, total savings of € 87,252 were calculated. CONCLUSION: These findings suggest that the method of propensity score matching permits a scientifically sound performance measurement for population-based care contracts.

[Efficacy and cost-effectiveness of smoking cessation courses in the statutory health insurance: a review]. / Wirksamkeit und Kosteneffektivität von Raucherentwöhnungskursen in der GKV: eine Literaturübersicht.

INTRODUCTION: Most of German health insurance funds provide and reimburse cognitive-behavioural group-based courses for smoking cessation according to section sign 20 Abs. 1 SGB V or section sign 20 a SGB V. The main goal of this study is to conduct a review of the efficacy and cost-effectiveness of these smoking cessation courses and their methodical approaches. METHODS: A literature search for available systematic reviews, meta-analyses, health technology assessments (HTA), and guidelines was conducted in relevant databases. RESULTS: Overall, six publications were included. Two sources confirm the long-term efficacy of group-based smoking cessation approach [OR (odds ratio)=1.3 and OR=2.17] with meta-analyses. The majority of available reviews or national guidelines are based on the results of these two researches. Two further reviews estimate the behaviour-based group therapy as effective. The efficacy estimation of single behavioural intervention components (skill training, problem solv-ing, relapse prevention) varies from OR=0.91 to OR=1.5. The evidence is insufficient for the internationally widespread course "Allen Carr's Easyway". No relevant publications on economic issues could be included for the courses currently made available by the statutory health insurance. CONCLUSION: The methodical approaches of smoking cessation courses offered by health insurance funds are effective and recommendable according to the available secondary literature. The efficacy of these interventions is not very high and solely covers general methodical approaches or programme components. Evaluations of current smoking cessation courses are rare and do not meet internationally accepted standards. Further research should be aimed to evaluate the established programmes with high-quality health economic studies.

Clinical outcome and costs of nosocomial and community-acquired Staphylococcus aureus bloodstream infection in haemodialysis patients.

The main aim of this study was to evaluate the clinical outcome and costs of nosocomial and community-acquired methicillin-susceptible Staphylococcus aureus (MSSA) or methicillin-resistant S. aureus (MRSA) bloodstream infection (BSI) in patients undergoing haemodialysis. A multicentre retrospective study was conducted that included 109 patients with end-stage renal disease and S. aureus BSI who were hospitalised in three German centres between 1999 and 2005. Nosocomial and community-acquired infections were analysed separately with regard to costs and outcome. Forty-nine (45%) patients had nosocomial infection. Compared to patients with community-acquired infection, these patients were more likely to have had BSI caused by MRSA (40.8% vs. 13.3%, p <0.05). BSI was the initial reason for admission for 33 (55%) patients who had community-acquired infection. The mean length of hospitalisation was 24 days for patients with community-acquired infection and 51 days for patients with nosocomial infection (p <0.05). Costs per treatment episode were 20,024 Euros for nosocomial infection vs. 9554 Euros for community-acquired infection (p <0.05). The average treatment costs for patients with MSSA BSI were <50% of those for patients with MRSA BSI (10,573 vs. 24,931 Euros, p <0.05). S. aureus BSI is an underlying cause of substantial health risk and high morbidity among the haemodialysis-dependent population, who are already at high-risk for other reasons. This study also highlighted differences according to the source of BSI, including costs arising from hospitalisation and treatment.

Economic evaluation of Durogesic in moderate to severe, nonmalignant, chronic pain in Germany.

We carried out a cost-effectiveness evaluation of transdermal fentanyl compared to three other widely used opioids: transdermal buprenorphine, sustained-release morphine, and controlled-release oxycodone from a third-party-payers perspective. A decision analytic model with data from a structured database search and from panel data and assumptions was used to derive both cost and utility results. Probabilistic sensitivity analysis was performed to ensure the findings. Transdermal fentanyl patients gain more quality adjusted life-days or quality-adjusted life-years per euro. The incremental cost per quality-adjusted life-year is 1,625.65 euro for transdermal fentanyl compared to sustained-release morphine and 1,003.03 euro compared to CO, and it is cost-saving compared to transdermal buprenorphine (-203.38 euro per patient). Transdermal fentanyl is thus cost-effective compared to both sustained-release morphine and CO and dominant compared to transdermal buprenorphine in the treatment of adults with nonmalignant moderate to severe chronic pain.

[Options for a future risc structure compensation in Germany]. / Reformoptionen für einen zukünftigen Risikostrukturausgleich in der GKV.

UNLABELLED: AIM OF THE ARTICLE: The risc structure compensation scheme within the German compulsory health insurance system is intended to enforce the principle of solidarity all over the statutory health insurance and not only within the different sickness funds. Differences in the contribution rates should not reflect different risc profiles, but the differences of the efficiency in social care. The criticism against the current adjustment system in Germany is multifarious and points e. g. on the missing orientation to morbidity. This article follows the question, whether this criticism is valid. METHODS: The variables and methods, which are currently used to calculate the risc structure adjustment are discussed and compared to an alternative proposal for the future form of the risc structure adjustment, which includes both a higher orientation to riscs and incentives for social health insurance funds to decline the costs for the social care system on long-term. RESULTS: Currently, for the calculation of the risc structure adjustment the following variables are used: age, sex, income, number of family members who are exempted from contributions and persons who get occupational disability pension, and number of insured persons who are registered to an accredited Disease-Management-Program (DMP). Especially the last variable includes a high control effort, because the higher co-payments of the adjustment system are aligned to the voluntariness of participation and active collaboration of the patients in DMP. The argument, a further development to a morbidity-oriented risc structure adjustment leads to less cost management of the sickness funds is not totally correct, because not actual, but standardised costs are the basis for compensation. On the other hand the morbidity determined cost components should not totally be adjusted, as a proper distribution of savings to the risc structure adjustment and the single funds would still be an incentive for cost management and prevention. CONCLUSION: An ongoing refining of the risc structure adjustment might cause new incentive problems. Instead a morbidity orientated risc structure compensation scheme should leave a part of the savings due to better social care structures in the sickness funds and should include outpatient care parameters. The change to a new honorarium system could create a better data basis for this improved form of risc structure adjustment in the future.