Health Economic Evaluation of an Online-Based Motivational Program to Reduce Problematic Media Use and Promote Treatment Motivation for Internet Use Disorder-Results of the OMPRIS Study.

Internet Use Disorders (IUD) have a relevant effect on national economies. In the randomized, controlled, multicenter, prospective, and single-blinded OMPRIS study (pre-registration number DRKS00019925; Innovation Fund of the Joint Federal Committee of Germany, grant number 01VSF18043), a four-week online program to reduce media addiction symptoms, was evaluated for cost-effectiveness. The intervention group (IG) was compared to a waiting control group (WCG) from German statutory health insurance (SHI) and a societal perspective. Resource use, namely indirect and direct (non) medical costs, was assessed by a standardized questionnaire at baseline and after the intervention. Additionally, intervention costs were calculated. Determining the Reliable Change Index (RCI) based on the primary outcome, assessed by the "Scale for the Assessment of Internet and Computer Game Addiction" (AICA-S), individuals with and without reliable change (RC) were distinguished. The incremental cost-effectiveness ratio was calculated using the difference-in-difference approach. There were 169 (IG n = 81, WCG n = 88) persons included in the analysis. The mean age was 31.9 (SD 12.1) years. A total of 75.1% were male, and 1.8% diverse. A total of 65% (IG) and 27% (WCG) had an RC. The cost per person with RC was about EUR 860 (SHI) and EUR 1110 (society). The intervention leads to an improvement of media addiction symptoms at moderate additional costs.

Optimization of HIV testing services in Germany using HIV indicator diseases: study protocol of the HeLP study.

BACKGROUND: Despite the potentially accompanying negative clinical, epidemiologic, and health economic effects, a large proportion of persons living with the human immunodeficiency virus (HIV) are diagnosed late. Internationally, numerous diseases are known to be HIV indicator diseases. Adequate HIV testing in the presence of HIV indicator diseases could help to diagnose unknown HIV infections earlier. The objective of the HeLP study is to validate published HIV indicator diseases for the German setting and to identify guidelines in terms of these indicator diseases in order to reduce knowledge gaps and increase HIV testing when HIV indicator diseases are diagnosed. METHODS: A mixed methods approach is used. In a first step, published HIV indicator diseases will be identified in a systematic literature review and subsequently discussed with clinical experts regarding their relevance for the German setting. For the validation of selected indicator diseases different data sets (two cohort studies, namely HIV-1 seroconverter study & ClinSurv-HIV, and statutory health insurance routine data) will be analyzed. Sensitivity analyses using different time periods will be performed. Guidelines of HIV indicator diseases validated in the HeLP study will be reviewed for mentioning HIV and for HIV testing recommendations. In addition, semi-standardized interviews (followed by a free discussion) with guideline creators will identify reasons why HIV testing recommendations were (not) included. Subsequently, a random sample of physicians in medical practices will be surveyed to identify how familiar physicians are with HIV testing recommendations in guidelines and, if so, which barriers are seen to perform the recommended tests in everyday care. DISCUSSION: The HeLP-study adopts the challenge to validate published HIV indicator diseases for the German setting and has the potential to close a knowledge gap regarding this objective. This has the potential to improve targeted HIV testing for patients with HIV indicator diseases and consequently lead to earlier HIV diagnosis. TRIAL REGISTRATION: DRKS00028743.

[Evaluating the introduction of HIV pre-exposure prophylaxis as a benefit of statutory health insurance (EvE-PrEP) : Highly effective protection against HIV without an increase in sexually transmitted infections]. / Evaluation der Einführung der HIV-Präexpositionsprophylaxe als Leistung der gesetzlichen Krankenversicherung (EvE­PrEP) : Hocheffektiver Schutz vor HIV und keine Zunahme von sexuell übertragbaren Infektionen.

BACKGROUND: We investigated the impact of HIV pre-exposure prophylaxis (PrEP) as a new service of the statutory health insurance (SHI) on the incidence of HIV and other sexually transmitted infections (STIs) in Germany. In addition, PrEP needs and access barriers were analyzed. METHODS: The following data were evaluated as part of the evaluation project: HIV and syphilis notification data and extended surveillance by the Robert Koch Institute (RKI), pharmacy prescription data, SHI routine data, PrEP use in HIV-specialty care centers, Checkpoint, the BRAHMS and PrApp studies, as well as a community board. RESULTS: The majority of PrEP users were male (98-99%), primarily aged between 25-45 years, and predominantly of German nationality or origin (67-82%). The majority were men who have sex with men (99%). With regard to HIV infections, PrEP proved to be highly effective. There were only isolated cases of HIV infections (HIV incidence rate 0.08/100 person years); in most cases the suspected reason was low adherence. The incidences of chlamydia, gonorrhea, and syphilis did not increase but remained almost the same or even decreased. A need for information on PrEP for people in trans*/non-binary communities, sex workers, migrants, and drug users emerged. Needs-based services for target groups at increased risk of HIV are necessary. DISCUSSION: PrEP proved to be a very effective HIV prevention method. The partly feared indirect negative influences on STI rates were not confirmed in this study. Due to the temporal overlap with the containment measures during the COVID-19 pandemic, a longer observation period would be desirable for a conclusive assessment.

Quality of life and healthcare costs of patients with allergic respiratory diseases: a cross-sectional study.

BACKGROUND: Allergic rhinitis (AR) and allergic asthma (AA) are chronic respiratory diseases that represent a global health problem. One aim of this study was to analyze the Health-related Quality of Life (HRQoL) of the patients in order to identify statistically significant influencing factors that determine HRQoL. Another aim was to assess and analyze data on cost-of-illness from a statutory health insurance perspective. METHODS:  The EQ-5D-5L was used to evaluate the patients' HRQoL. To identify the factors influencing the HRQoL, a multinomial logistic regression analysis was conducted using groups based on the EQ-5D-5L index value as dependent variable. Routine data were analyzed to determine total healthcare costs. RESULTS:  The average EQ-5D-5L index was 0.85 (SD 0.20). A high age, the amount of disease costs, low internal health-related control beliefs and high ozone exposure in the residential area were found to be statistically significant influencing factors for a low HRQoL, whereas low age, male sex and a good possibility to avoid the allergens were found to be statistically significant factors influencing a high HRQoL. On average, the study participants incurred annual costs of €3072 (SD: 3485), of which €699 (SD: 743) could be assigned to allergic respiratory diseases. CONCLUSIONS:  Overall, the patients in the VerSITA study showed a high level of HRQoL. The identified influencing factors can be used as starting points for improving the HRQoL of patients with allergic respiratory diseases. From the perspective of a statutory health insurance, per person expenditures for allergic respiratory diseases are rather low.

Evaluation criteria for health apps supporting medication adherence in early-stage technology development - a scoping review.

Introduction: Health apps offer an approach to improve the patients' management of their medication. Although the Digital Healthcare Act (DVG) has created a claim in the statutory health insurance (SHI), the large number of health apps available and their varying quality make it difficult for service providers and especially for medical laypersons to select an adequate high-quality medication app. Manufacturers need guidance for the development of high-quality apps right from the start. Various general evaluation concepts for health apps have been available to date. However, the requirements that should be met by healthcare depend largely on the field of application and the type of apps. This article aims to provide an overview of the international evidence on specific criteria for the evaluation of medication apps. Methods: Within the framework of a scoping review, a systematic search was conducted in PubMed and EMBASE on January 29, 2020. The search was limited to publications from 2007 onwards as well as to English and German articles. Additionally, a semi-systematic research of reference lists of the previously included articles as well as a structured search of websites of relevant stakeholders were conducted. Inclusion criteria were the following: the publication deals with health apps that can be used on smartphones and focus on supporting medication intake; the publication does not refer to evaluation criteria for a single app exclusively. The included publications were examined in a qualitative content analysis searching for evaluation criteria and categorizing them according to the framework criteria of the DVG and the Digital Health Applications Ordinance (DiGAV). Results: 2,542 articles were identified in the systematic search (999 in PubMed, 1,543 in EMBASE, 560 duplicates). A total of 16 studies met the inclusion criteria. The semi-systematic research and the structured search identified one further study. A catalog of criteria was developed based on the included 17 studies. This catalog covers the general topics "patient orientation" (data protection and security, consumer protection, user friendliness) and "quality/core functions of medication apps" (reminder, self-monitoring, (drug) information, motivation to change behavior, drug/patient safety, robustness) as well as "interoperability/cooperation". Due to its specific importance for medication apps, the subcategory "motivation for behavioral change" stands out beneath the general topic "quality/core functions of medication apps". This category aims to evaluate the design of individual functions with regard to their potential to actually change the behavior of app users. Discussion: The criteria for the evaluation of health apps mentioned in the DiGAV intersected with the criteria identified in the literature research. However, the area of positive health care effects was hardly covered by the included studies. In the development of the criteria catalog, it was not possible to weight the identified criteria. Therefore, the catalog should be understood as a supporting checklist for service providers, manufacturers, and/or users. Conclusions: A large variety of possible evaluation criteria for medication apps could be shown. Future research should focus on the possibilities of weighting these diverse evaluation criteria, using not only clinical studies but also methods to identify preferences.

Effectiveness and costs of a low-threshold hearing screening programme (HörGeist) for individuals with intellectual disabilities: protocol for a screening study.

INTRODUCTION: Individuals with intellectual disabilities (ID) often suffer from hearing loss, in most cases undiagnosed or inappropriately treated. The implementation of a programme of systematic hearing screening, diagnostics, therapy initiation or allocation and long-term monitoring within the living environments of individuals with ID (nurseries, schools, workshops, homes), therefore, seems beneficial. METHODS AND ANALYSIS: The study aims to assess the effectiveness and costs of a low-threshold screening programme for individuals with ID. Within this programme 1050 individuals with ID of all ages will undergo hearing screening and an immediate reference diagnosis in their living environment (outreach cohort). The recruitment of participants in the outreach group will take place within 158 institutions, for example, schools, kindergartens and places of living or work. If an individual fails the screening assessment, subsequent full audiometric diagnostics will follow and, if hearing loss is confirmed, initiation of therapy or referral to and monitoring of such therapy. A control cohort of 141 participants will receive an invitation from their health insurance provider via their family for the same procedure but within a clinic (clinical cohort). A second screening measurement will be performed with both cohorts 1 year later and the previous therapy outcome will be checked. It is hypothesised that this programme leads to a relevant reduction in the number of untreated or inadequately treated cases of hearing loss and strengthens the communication skills of the newly or better-treated individuals. Secondary outcomes include the age-dependent prevalence of hearing loss in individuals with ID, the costs associated with this programme, cost of illness before-and-after enrolment and modelling of the programme's cost-effectiveness compared with regular care. ETHICS AND DISSEMINATION: The study has been approved by the Institutional Ethics Review Board of the Medical Association of Westphalia-Lippe and the University of Münster (No. 2020-843 f-S). Participants or guardians will provide written informed consent. Findings will be disseminated through presentations, peer-reviewed journals and conferences. TRIAL REGISTRATION NUMBER: DRKS00024804.

Internet-Based Self-Assessment for Symptoms of Internet Use Disorder-Impact of Gender, Social Aspects, and Symptom Severity: German Cross-sectional Study.

BACKGROUND: Internet use disorder (IUD) is a new type of behavioral addiction in the digital age. At the same time, internet applications and eHealth can also provide useful support in medical treatment. OBJECTIVE: The purpose of this study is to examine if an internet-based eHealth service can reach individuals with IUD. In particular, it should be investigated whether both male and female individuals with more severe IUDs can be reached. METHODS: Data were retrieved from the OMPRIS (online-based motivational intervention to reduce problematic internet use and promote treatment motivation in internet gaming disorder and internet use disorder) project (DRKS00019925), an internet-based motivational intervention to reduce problematic internet use and promote treatment motivation in internet gaming disorder and IUD. During the recruitment process (August 2020-March 2022), a total of 3007 individuals filled out the standardized scale for the assessment of internet and computer game addiction (AICA-S). The assessment was accessible via the project homepage. There was no preselection of participants at this stage of the study; however, the offer was addressed to people with hazardous internet use and IUDs. The web-based assessment was free and could be found via search engines, but attention was also drawn to the service via newspaper articles, radio reports, and podcasts. RESULTS: Out of 3007 who participated in the web-based self-assessment, 1033 (34.4%) are female, 1740 (57.9%) are male, 67 (2.2%) are diverse individuals, and 167 (5.5%) did not disclose their gender. The IUD symptom severity score showed a wide range between the AICA-S extreme values of 0 and 27 points. On average, the total sample (mean 8.19, SD 5.47) was in the range of hazardous IUD behavior (AICA-S cutoff>7.0). Furthermore, 561 individuals (18.7% of the total sample; mean 17.42, SD 3.38) presented severe IUD (AICA-S cutoff>13.5). Focusing on female and male participants, 20.9% (363/1740) of the men and 14.9% (151/1033) of the women scored above 13.5 points, which can be considered pathological IUD behavior (χ22,2773=16.73, P<.001, effect size: Cramér V=0.078). Unemployment, being in vocational training or studying at a university, and being male were significantly associated with high IUD symptoms. CONCLUSIONS: Using a large sample, the study showed that both mildly and severely IUD-affected individuals can be reached via the internet. An internet-based eHealth offer can thus be a good way to reach patients with IUD where they are addicted-on the internet. In addition, eHealth services increase the likelihood of reaching female patients, who hardly ever come to specialized outpatient clinics and hospitals. Since social problems, especially unemployment, have a strong association with disease severity, the integration of social counseling into treatment seems advisable in terms of a multidisciplinary approach. TRIAL REGISTRATION: German Clinical Trials Register (DRKS) DRKS00019925; https://drks.de/search/de/trial/DRKS00019925.

Cost of Human Immunodeficiency Virus (HIV) and Determinants of Healthcare Costs in HIV-Infected Treatment-Naive Patients Initiated on Antiretroviral Therapy in Germany: Experiences of the PROPHET Study.

OBJECTIVES: The purpose of the prospective clinical and pharmacoeconomic outcomes study of different first-line antiretroviral treatment strategies (PROPHET) was to examine the healthcare costs of human immunodeficiency virus (HIV)-infected persons in Germany treated with different antiretroviral therapy (ART) strategies and to identify variables associated with high costs. METHODS: The setting was a 24-month prospective multicenter observational cohort study in a German HIV-specialized care setting from 2014 to 2017. A microcosting approach was used for the estimation of healthcare costs. Data were obtained via electronic case report forms. The costs were calculated from both the societal and the statutory health insurance perspective. Regression models were performed that took into consideration the impact of several independent variables. RESULTS: Four hundred thirty-four patients from 24 centers throughout Germany were included. Average annual healthcare costs were €20 118 (standard deviation [SD] €6451) per patient from the societal perspective (n = 336) and €17 306 (SD €4106) from the statutory health insurance perspective (n = 292). Expenditures for the ART medication had the highest impact. Total costs declined in the second year of therapy. There was a significant association between the amount of total cost and clinical or therapeutic variables from both perspectives; a diagnosis of acquired immune deficiency syndrome (AIDS) led to higher costs as well as the chosen ART strategy. Age also increased cost from the statutory health insurance perspective. CONCLUSIONS: The main cost driver of the healthcare costs for HIV-positive patients was antiretroviral drug expenses. Further variables that influenced the costs were identified. The results provide a detailed overview of the resource use of patients in the PROPHET cohort.

The budgetary impact of genetic testing for hereditary breast cancer for the statutory health insurance.

Objectives: Potential opportunities and challenges of predictive genetic risk classification of healthy persons are currently discussed. However, the budgetary impact of rising demand is uncertain. This project aims to evaluate budgetary consequences of predictive genetic risk classification for statutory health insurance in Germany.Methods: A Markov model was developed in the form of a cohort simulation. It analyzes a population of female relatives of hereditary breast cancer patients. Mutation carriers are offered intensified screening, women with a BRCA1 or BRCA2 mutation can decide on prophylactic mastectomy and/or ovarectomy. The model considers the following scenarios: (a) steady demand for predictive genetic testing, and (b) rising demand. Most input parameters are based on data of the German Consortium for Hereditary Breast and Ovarian Cancer. The model contains 49 health states, starts in 2015, and runs for 10 years. Prices were evaluated from the perspective of statutory health insurance.Results: Steady demand leads to an expenditure of €49.8 million during the 10-year period. Rising demands lead to additional expenses of €125.5 million. The model reveals the genetic analysis to be the main cost driver while cost savings in treatment costs of breast and ovarian cancer are indicated.Conclusions: The results contribute to close the knowledge gap concerning the budgetary consequences due to genetic risk classification. A rising demand leads to additional costs especially due to costs for genetic analysis. The model indicates budget shifts with cost savings due to breast and ovarian cancer treatment in the scenario of rising demands.

Economic evaluation of prolonged and enhanced ECG Holter monitoring in acute ischemic stroke patients.

Objective: Atrial fibrillation (AF) is a major cause for recurrent stroke, has severe impact on a patient's health and imposes a high economic burden for society. Current guidelines recommend 24 h ECG monitoring (standard-of-care, SoC) to detect AF after stroke to reduce the risk of future events. However, paroxysmal AF (PAF) is difficult to detect within this period as it occurs infrequently and unpredictably. In a randomized controlled trial (Find-AFRANDOMISED), prolonged and enhanced Holter ECG monitoring (EPM) revealed a significantly higher detection rate of AF compared to SoC, although its cost-effectiveness has not yet been investigated. Methods: Based on the data of FIND-AFRANDOMISED, an economic evaluation was conducted. One group received EPM for 10 days after the event, and at 3 and 6 months; the other group received SoC. Healthcare resource use and quality of life (QoL) data were measured at baseline, and after 6 and 12 months. Incremental costs and quality-adjusted life years (QALYs) between both groups were compared. Non-parametric bootstrapping and one-way-sensitivity analyses were performed. Results: A total of 281 patients with healthcare resource use and QoL data for all measurement points were considered in the economic evaluation (complete case analysis, CCA). The CCA yielded nonsignificant 315€ lower mean costs and 0.0013 less QALYs for patients receiving EPM with no statistically significant differences in any cost categories. Sensitivity analyses revealed robust results. Bootstrapping the results indicated moderate probability of cost-effectiveness. Conclusions: EPM yielded reduced not significantly different costs without affecting QoL and may be a useful strategy to detect PAF in acute ischemic stroke patients in time.

Cost-effectiveness and budget effect of pre-exposure prophylaxis for HIV-1 prevention in Germany from 2018 to 2058.

BackgroundPre-exposure prophylaxis (PrEP) is a highly effective HIV prevention strategy for men-who-have-sex-with-men (MSM). The high cost of PrEP has until recently been a primary barrier to its use. In 2017, generic PrEP became available, reducing the costs by 90%.AimOur objective was to assess cost-effectiveness and costs of introducing PrEP in Germany.MethodsWe calibrated a deterministic mathematical model to the human immunodeficiency virus (HIV) epidemic among MSM in Germany. PrEP was targeted to 30% of high-risk MSM. It was assumed that PrEP reduces the risk of HIV infection by 85%. Costs were calculated from a healthcare payer perspective using a 40-year time horizon starting in 2018.ResultsPrEP can avert 21,000 infections (interquartile range (IQR): 16,000-27,000) in the short run (after 2 years scale-up and 10 years full implementation). HIV care is predicted to cost EUR 36.2 billion (IQR: 32.4-40.4 billion) over the coming 40 years. PrEP can increase costs by at most EUR 150 million within the first decade after introduction. Ten years after introduction, PrEP can become cost-saving, accumulating to savings of HIV-related costs of EUR 5.1 billion (IQR: 3.5-6.9 billion) after 40 years. In a sensitivity analysis, PrEP remained cost-saving even at a 70% price reduction of antiretroviral drug treatment and a lower effectiveness of PrEP.ConclusionIntroduction of PrEP in Germany is predicted to result in substantial health benefits because of reductions in HIV infections. Short-term financial investments in providing PrEP will result in substantial cost-savings in the long term.

[Economic evaluation of a manual-based, multimodal cognitive behavioural therapy for school avoiding children with psychiatric disorder]. / Ökonomische Evaluation eines manualbasierten Therapiekonzeptes für psychisch kranke Kinder und Jugendliche mit schulvermeidendem Verhalten.

Objective: Untreated school refusal increases the risk of a premature discontinuation of the educational career. The aim of this study is the economic evaluation of a manual-based treatment for school refusal in comparison to the standard treatment. Method: Within the cost-minimisation analysis, resource use is measured retrospectively for six months using the CSSRI questionnaire. Unit costs for most health care services are derived from published standard prices. Costs are calculated from the societal perspective based on prices compiled in 2011. The cost comparison during the one-year intervention period applies a difference in differences Approach. Results: The most common diagnoses among the 112 participants are phobic and emotional disorders. The average cost per patient during the intervention period amounts to 7197 € (95 %-CI: 4746 € ­ 10 079 €) for the manual group and 9294 € (95 %-CI: 6313 € ­ 12 878 €) for the control group. The difference in adjusted costs of 1453 € in favour of the manual group is not statistically relevant. Conclusions: The manual-based treatment is equivalent if not slightly advantageous compared to the standard treatment considering the clinical outcomes and cost of illness.

Effectiveness and cost-effectiveness of an integrated care program for schizophrenia: an analysis of routine data.

In Germany, a regional social health insurance fund provides an integrated care program for patients with schizophrenia (IVS). Based on routine data of the social health insurance, this evaluation examined the effectiveness and cost-effectiveness of the IVS compared to the standard care (control group, CG). The primary outcome was the reduction of psychiatric inpatient treatment (days in hospital), and secondary outcomes were schizophrenia-related inpatient treatment, readmission rates, and costs. To reduce selection bias, a propensity score matching was performed. The matched sample included 752 patients. Mean number of psychiatric and schizophrenia-related hospital days of patients receiving IVS (2.3 ± 6.5, 1.7 ± 5.0) per quarter was reduced, but did not differ statistically significantly from CG (2.7 ± 7.6, 1.9 ± 6.2; p = 0.772, p = 0.352). Statistically significant between-group differences were found in costs per quarter per person caused by outpatient treatment by office-based psychiatrists (IVS: €74.18 ± 42.30, CG: €53.20 ± 47.96; p < 0.001), by psychiatric institutional outpatient departments (IVS: €4.83 ± 29.57, CG: €27.35 ± 76.48; p < 0.001), by medication (IVS: €471.75 ± 493.09, CG: €429.45 ± 532.73; p = 0.015), and by psychiatric outpatient nursing (IVS: €3.52 ± 23.83, CG: €12.67 ± 57.86, p = 0.045). Mean total psychiatric costs per quarter per person in IVS (€1117.49 ± 1662.73) were not significantly lower than in CG (€1180.09 ± 1948.24; p = 0.150). No statistically significant differences in total schizophrenia-related costs per quarter per person were detected between IVS (€979.46 ± 1358.79) and CG (€989.45 ± 1611.47; p = 0.084). The cost-effectiveness analysis showed cost savings of €148.59 per reduced psychiatric and €305.40 per reduced schizophrenia-related hospital day. However, limitations, especially non-inclusion of costs related to management of the IVS and additional home treatment within the IVS, restrict the interpretation of the results. Therefore, the long-term impact of this IVS deserves further evaluation.

Budget impact analysis on the introduction of a guideline based hepatitis B and C screening into a routine check-up in the German primary care setting.

OBJECTIVES: Systematic screening for chronic hepatitis B and C does not yet exist in Germany. Therefore, the implementation of a screening approach within a preventive medical examination performed by primary care physicians ('Check-Up 35+') was evaluated in a recent prospective multicenter study. The present analysis estimates the financial consequences for the statutory health insurance by budget impact analysis. MATERIALS AND METHODS: A Markov cohort model was developed consisting of 21 health states. Four different screening scenarios derived from the previous multicenter study were compared to usual care, a strategy without screening for hepatitis. Actual cost data for Germany were calculated and systematic literature searches for all input parameters were performed. RESULTS: The base case results in incremental costs for the screening strategies compared to no hepatitis screening of 165-227 € per patient in a 20-year horizon. Two main parameters influence the financial consequences: (A) detection and treatment increase the costs in the beginning. (B) Screening avoids hepatitis induced end-stage liver disease. The initial higher costs exceed the later savings. Sensitivity analyses demonstrate a strong impact of medication costs for the treatment of additionally detected hepatitis infections on the outcome. This finding is robust to sensitivity analysis. CONCLUSIONS: The screening strategy proposed here implies additional costs for the statutory health insurance, however, a decision regarding its usefulness must consider criteria other than cost. For example, the high burden of disease due to liver cirrhosis and liver carcinoma should be considered. Therefore, an additional cost-effectiveness-analysis should be conducted.

Cost-effectiveness of methods in personalized medicine. Results of a decision-analytic model in patients with acute myeloid leukemia with normal karyotype.

BACKGROUND: During the last years, molecular genetic data are increasingly used as prognostic and predictive factors in acute myeloid leukemia (AML). The molecular genetic profile permits a rapid risk categorization and beyond that a prediction of differential treatment efficacy of post-remission chemotherapy versus an allogeneic hematopoietic cell transplantation (HCT) in specific subgroups. METHODS: The aim of this study was to evaluate cost-effectiveness of two different strategies of risk categorization (conventional cytogenetic diagnostics (CCD) versus molecular genetic diagnostics (MGD)) in patients with AML, using a decision-analytic state-transition model. The model is run as (Monte Carlo) microsimulation in which individuals pass through in cycles with a cycle length of one month and a time horizon of ten years. FINDINGS: Results show that on average, individuals within the MGD group generated about US$ 32,000 higher costs but survived about seven months longer than individuals within the CCD group. This leads to an Incremental Cost-Effectiveness Ratio (ICER) of about US$ 4928 per survived month. INTERPRETATION: With a GDP (Gross Domestic Product) of US$ 26,467 (€ 33,630) per capita in Germany in 2012, the base-case ICER of US$ 4928 per survived month projected to US$ 59,136 per survived year is in between the simple GDP and the three times GDP per capita.

[Entitlement to prophylactic treatment in cases of genetic predisposition for breast cancer : Interdisciplinary perspectives]. / Leistungsanspruch auf prophylaktische Behandlung bei genetischer Prädisposition für Brustkrebs : Interdisziplinäre Perspektiven.

Genetic tests can detect the predisposition to various diseases. The demand for gene diagnostics and corresponding prophylactic measures is increasing steadily. In the German healthcare system, however, legal uncertainties exist as to whether a mere risk of disease is reason enough to bear the costs for prophylactic measures. When medically effective prophylactic measures are available in certain cancer diseases, such as in hereditary breast cancer, the current practice of deciding in individual cases appears to be insufficient.The fact that persons with a high or very increased risk of breast cancer are precluded from a standard care procedure raises questions concerning ethical justification as well as medical plausibility. Moreover, it is remarkable that the statutory healthcare system treats persons at risk differently. In some cases there is a regulated way of reimbursement for preventive measures for persons at risk (factor V Leiden mutation) and in other cases there are only case-by-case decisions. Finally, in light of social regulations for persons at high and very increased risk this article considers the need of optimization regarding the risk communication in the decision-making process and the crucial question of budgetary impact for the German healthcare system.From a medical, ethical and legal perspective, a social regulation for persons at high and very increased risk of disease is inevitable and the consequences should be discussed in advance.

[Dissemination of Patient Education in the Rehabilitation of Chronic Back Pain - Cost Analysis of a Program Implementation]. / Dissemination eines Schulungsprogramms bei chronischem Rückenschmerz ­ Kostenanalyse der Programmimplementierung.

The aim of the project is a cost analysis of 2 different strategies "train-the-trainer-seminar" (ttt-seminar) and "implementation guideline" (ig) in the implementation of a standardised patient education program in the inpatient rehabilitation of patients with chronic back pain. The implementation strategies were assigned by chance to 10 rehabilitation clinics. Expenditure of time was evaluated by questionnaire. Additionally materials and travel expenses were calculated. The total implementation costs accounted 4 582 € for the ttt-seminar and were about one third (35%) higher than the costs for the ig-strategy. The higher total implementation costs can basically be attributed to higher personnel costs due to the time-consuming seminar. However, in the ig-strategy postprocessing costs were 23.5% higher than in the ttt-strategy.

A model to evaluate the costs and clinical effectiveness of human papilloma virus screening compared with annual papanicolaou cytology in Germany.

OBJECTIVES: We modelled human papilloma virus (HPV) primary screening scenarios compared with Pap cytology to evaluate clinical effectiveness and projected annual costs in Germany. STUDY DESIGN: A Markov cohort model was built to compare the budget impact of annual Pap cytology with different 5-yearly HPV screening scenarios: (1) a positive HPV test followed by Pap cytology; (2) a positive HPV test followed by p16/Ki-67 dual-stained cytology; (3) a positive HPV test followed by colposcopy if HPV-16/18-positive or p16/Ki-67 dual-stained cytology if positive for other subtypes; (4) co-testing with HPV and Pap. Screening scenarios were based on a 10-year horizon. RESULTS: All HPV screening scenarios in the model were associated with fewer deaths from missed diagnosis of cervical cancer compared with Pap screening; 10-year totals n=172-344 (1.5-3 per 100,000) versus n=477 (4.1 per 100,000), respectively. Total annual costs were lower with HPV screening than Pap cytology. The projected average annual cost for HPV screening ranged from €117 million to €136 million compared with €177 million for Pap screening, representing annual savings of €41-60 million. The greatest clinical impact was achieved with primary HPV screening (with genotyping) followed by colposcopy for HPV 16/18-positive women or p16/Ki-67 dual-stained cytology for women positive for other HPV subtypes. CONCLUSION: Screening strategies including primary HPV testing for high-risk subtypes (HPV-16/18) in conjunction with p16/Ki-67 dual-stained cytology can improve the detection of cervical cancer at a lower total annual cost than conventional Pap cytology screening.

Cost-effectiveness and cost-utility of a structured collaborative disease management in the Interdisciplinary Network for Heart Failure (INH) study.

BACKGROUND: Non-pharmacological treatment programmes are being developed, in which specialised nurses take care of heart failure (HF) patients. Such disease management programmes might increase survival and quality of life in HF patients, but evidence on their cost-effectiveness remains limited. METHODS AND RESULTS: A prospective economic evaluation piggy-backed onto the randomised controlled Interdisciplinary Network for Heart Failure (INH) Study weighted costs of the intervention HeartNetCare -HF™ (HNC) regarding effectiveness, mortality and quality-adjusted life years (QALYs). To consider uncertainty sensitivity analyses were performed. Compared to usual care (UC), HNC revealed 8,284 per death avoided within the 6 month study follow-up period. The cost-utility analysis showed additional costs of 49,335 per QALY. CONCLUSION: Although HNC did not reduce short-term re-admission rates of HF patients hospitalised for cardiac decompensation within the first 180 days after discharge, HNC might reduce mortality and increase quality of life in these patients at reasonable costs. Therefore, long-term HNC-effects deserve further evaluation.

Cost-effectiveness analysis of coronary artery disease screening in HIV-infected men.

BACKGROUND: HIV-infected patients are at increased risk of coronary artery disease (CAD). We evaluated the cost-effectiveness of cardiac screening for HIV-positive men at intermediate or greater CAD risk. DESIGN: We developed a lifetime microsimulation model of CAD incidence and progression in HIV-infected men. METHODS: Input parameters were derived from two HIV cohort studies and the literature. We compared no CAD screening with stress testing and coronary computed tomography angiography (CCTA)-based strategies. Patients with test results indicating 3-vessel/left main CAD underwent invasive coronary angiography (ICA) and received coronary artery bypass graft surgery. In the stress testing + medication and CCTA + medication strategies, patients with 1-2-vessel CAD results received lifetime medical treatment without further diagnostics whereas in the stress testing + intervention and CCTA + intervention strategies, patients with these results underwent ICA and received percutaneous coronary intervention. RESULTS: Compared to no screening, the stress testing + medication, stress testing + intervention, CCTA + medication, and CCTA + intervention strategies resulted in 14, 11, 19, and 14 quality-adjusted life days per patient and incremental cost-effectiveness ratios of 49,261, 57,817, 34,887 and 56,518 Euros per quality-adjusted life year (QALY), respectively. Screening only at higher CAD risk thresholds was more cost-effective. Repeated screening was clinically beneficial compared to one-time screening, but only stress testing + medication every 5 years remained cost-effective. At a willingness-to-pay threshold of 83,000 €/QALY (∼ 100,000 US$/QALY), implementing any CAD screening was cost-effective with a probability of 75-95%. CONCLUSIONS: Screening HIV-positive men for CAD would be clinically beneficial and comes at a cost-effectiveness ratio comparable to other accepted interventions in HIV care.