Problems and Barriers Related to the Use of mHealth Apps From the Perspective of Patients: Focus Group and Interview Study.

BACKGROUND: Since fall 2020, mobile health (mHealth) apps have become an integral part of the German health care system. The belief that mHealth apps have the potential to make the health care system more efficient, close gaps in care, and improve the economic outcomes related to health is unwavering and already partially confirmed. Nevertheless, problems and barriers in the context of mHealth apps usually remain unconsidered. OBJECTIVE: The focus groups and interviews conducted in this study aim to shed light on problems and barriers in the context of mHealth apps from the perspective of patients. METHODS: Guided focus groups and individual interviews were conducted with patients with a disease for which an approved mHealth app was available at the time of the interviews. Participants were recruited via self-help groups. The interviews were recorded, transcribed, and subjected to a qualitative content analysis. The content analysis was based on 10 problem categories ("validity," "usability," "technology," "use and adherence," "data privacy and security," "patient-physician relationship," "knowledge and skills," "individuality," "implementation," and "costs") identified in a previously conducted scoping review. Participants were asked to fill out an additional questionnaire about their sociodemographic data and about their use of technology. RESULTS: A total of 38 patients were interviewed in 5 focus groups (3 onsite and 2 web-based) and 5 individual web-based interviews. The additional questionnaire was completed by 32 of the participants. Patients presented with a variety of different diseases, such as arthrosis, tinnitus, depression, or lung cancer. Overall, 16% (5/32) of the participants had already been prescribed an app. During the interviews, all 10 problem categories were discussed and considered important by patients. A myriad of problem manifestations could be identified for each category. This study shows that there are relevant problems and barriers in the context of mHealth apps from the perspective of patients, which warrant further attention. CONCLUSIONS: There are essentially 3 different areas of problems in the context of mHealth apps that could be addressed to improve care: quality of the respective mHealth app, its integration into health care, and the expandable digital literacy of patients.

Navigating the path towards successful implementation of the EU HTA Regulation: key takeaways from the 2023 Spring Convention of the European Access Academy.

BACKGROUND: The European Regulation on Health Technology Assessment (EU HTA R), effective since January 2022, aims to harmonize and improve the efficiency of common HTA across Member States (MS), with a phased implementation from January 2025. At "midterms" of the preparation phase for the implementation of the Regulation our aim was to identify and prioritize tangible action points to move forward. METHODS: During the 2023 Spring Convention of the European Access Academy (EAA), participants from different nationalities and stakeholder backgrounds discussed readiness and remaining challenges for the Regulation's implementation and identified and prioritized action points. For this purpose, participants were assigned to four working groups: (i) Health Policy Challenges, (ii) Stakeholder Readiness, (iii) Approach to Uncertainty and (iv) Challenges regarding Methodology. Top four action points for each working group were identified and subsequently ranked by all participants during the final plenary session. RESULTS: Overall "readiness" for the Regulation was perceived as neutral. Prioritized action points included the following: Health Policy, i.e. assess adjustability of MS laws and health policy processes; Stakeholders, i.e. capacity building; Uncertainty, i.e. implement HTA guidelines as living documents; Methodology, i.e. clarify the Population, Intervention, Comparator(s), Outcomes (PICO) identification process. CONCLUSIONS: At "midterms" of the preparation phase, the focus for the months to come is on executing the tangible action points identified at EAA's Spring Convention. All action points centre around three overarching themes: harmonization and standardization, capacity building and collaboration, uncertainty management and robust data. These themes will ultimately determine the success of the EU HTA R in the long run.

Problems and Barriers Related to the Use of Digital Health Applications: Scoping Review.

BACKGROUND: The digitization of health care led to a steady increase in the adoption and use of mobile health (mHealth) apps. Germany is the first country in the world to cover the costs of mHealth apps through statutory health insurance. Although the benefits of mHealth apps are discussed in detail, aspects of problems and barriers are rarely studied. OBJECTIVE: This scoping review aimed to map and categorize the evidence on problems and barriers related to the use of mHealth apps. METHODS: Systematic searches were conducted in the MEDLINE, Embase, and PsycINFO databases. Additional searches were conducted on JMIR Publications and on websites of relevant international organizations. The inclusion criteria were publications dealing with apps similar to those approved in the German health care system, publications addressing problems and barriers related to the use of mHealth apps, and articles published between January 1, 2015, and June 8, 2021. Study selection was performed by 2 reviewers. The manuscript was drafted according to the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) checklist. The analysis of the included publications and categorization of problems and hurdles were performed using MAXQDA (VERBI Software GmbH). RESULTS: The database search identified 1479 publications. Of the 1479 publications, 21 (1.42%) met the inclusion criteria. A further 8 publications were included from citation searching and searching in JMIR Publications. The identified publications were analyzed for problems and barriers. Problems and barriers were classified into 10 categories ("validity," "usability," "technology," "use and adherence," "data privacy and security," "patient-physician relationship," "knowledge and skills," "individuality," "implementation," and "costs"). The most frequently mentioned categories were use and adherence (eg, incorporating the app into daily life or dropouts from use; n=22) and usability (eg, ease of use and design; n=19). CONCLUSIONS: The search identified various problems and barriers in the context of mHealth apps. Although problems at the app level (such as usability) are studied frequently, problems at the system level are addressed rather vaguely. To ensure optimal use of and care with mHealth apps, it is essential to consider all types of problems and barriers. Therefore, researchers and policy makers should have a special focus on this issue to identify the needs for quality assurance. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/32702.

[Reimbursement for New Examination and Treatment Methods of Outpatients: Comparison of Statutory Health and Private Medical Insurance]. / Die Umsetzung neuer Untersuchungs- und Behandlungsmethoden in die vertragsärztliche Kollektivversorgung und in die privatärztliche ambulante Versorgung.

AIM OF THE STUDY: The aim of the study was to compare the timeliness of reimbursement for new examination and treatment methods in outpatient care in the social (SHI) and private insurance system (PHI) in Germany. METHODOLOGY: For the reimbursement in the SHI system, the decisions and further documentation of the Joint Federal Committee and the evaluation committee could be used. For the reimbursement in the PHI system, for example, the resolutions of the Central Consultation Committee for Fee Schedule Questions and those of the Fee Schedule Committee, but also evaluations of the North Rhine Medical Association and a working group of the German Association of PHI were used. Included were medical methods finally assessed for use in outpatient medical care by the Joint Federal Committee between 2010 and 2019. RESULTS: A total of 17 individual resolutions, two series of resolutions consisting of several individual resolutions, and regulations concerning companion diagnostics were included. The time intervals between the start of the procedure and the introduction of the new method into the SHI system varied widely (14 to 216 months). At the same time, the study showed that for the majority of the methods, reimbursement in PHI was possible earlier than in SHI. Furthermore, five methods showed a potential limitation of reimbursement in PHI dependent on individual insurance contracts, but in two cases also reimbursement by PHI for services later assessed as without benefit by SHI. CONCLUSION: Medical procedures based on the included new methods in most cases were reimbursed in the PHI earlier than in the SHI system. However, this also implies a risk of reimbursing services that are subsequently assessed by the Joint Federal Committee as having no medical benefit. If the joint federal committee assessment is used as a benchmark, this could lead to a reduction in the cost-effectiveness of care and, in individual cases, to patient harm due to overuse or misuse of care. Thus, there is a conflict between early access to new examination and treatment methods (especially in the case of very long Joint Federal Committee procedures) and (cost) effectiveness and assurance of the quality of care.

[Reform Implementation of the Psychotherapy Guideline 2017: Results from Focus Groups Within the Framework of the Innovation Fund Project EVA PT-RL]. / Umsetzung der Reform der Psychotherapie-Richtlinie 2017: Ergebnisse aus Fokusgruppen im Rahmen des Innovationsfonds-Projekts EVA PT-RL.

BACKGROUND: Mental illnesses cause both individual and social burdens. The main goal of the structural reform of the Psychotherapy Guideline of 2017 was to improve access to psychotherapeutic care. The focus groups, which were conducted as part of the research project "Evaluation of the Psychotherapy Guideline (Eva PT-RL)" funded by the Innovation Fund, address the implementation of the goals of the reform and the individual newly introduced care elements as well as hurdles to implementation from the perspective of service providers, patients and insurers. METHODS: Six focus groups and five individual interviews were conducted with people from the three stakeholder groups mentioned above. The basis was a semistructured interview guide adapted to the respective group of people based on a structured literature research. The interviews were conducted by a team of moderators via video conference, recorded and transcribed. The analysis was carried out via a qualitative content analysis based on Mayring. RESULTS: The initial psychotherapeutic consultation received a generally positive assessment particularly with regard to timely initial access to psychotherapeutic care. At the same time a delayed transition to subsequent guideline psychotherapy due to a lack of capacity was criticized by all participant groups. Beneficial effects of telephone accessibility as well as increased networking of psychotherapeutic care also with other psychosocial services were mentioned. However the implementation of acute treatment and relapse prophylaxis was found to be inadequate. The central finding was that the impulse for a paradigm shift aimed at by the reform was perceived and implemented differently by the psychotherapists - from a focus on individual therapy processes to a public mental health perspective with a commitment to care coordination. CONCLUSION: Some elements of the reform were criticized by stakeholders, the transition from initial appointments to continuous treatment was considered as not timely enough, and the design of other elements (acute treatment and relapse prevention regulations) was assessed as improvable. There is a need for further research. The results of the focus groups serve as a basis for following project steps including a survey of psychotherapists, patients and GPs.

[Evaluating the reform of the psychotherapy guideline using a mixed-methods approach: a study protocol]. / Mixed-Methods-Ansatz zur Evaluation der Reform der Psychotherapie-Richtlinie: ein Studienprotokoll.

INTRODUCTION: In Germany, psychotherapy in outpatient statutory health care is regulated by the Psychotherapy Guideline (PT-GL). A discussion on waiting times and inadequate care for patients resulted in a structural reform of the PT-GL in 2017. The reform aims to improve access to psychotherapy and the entire course of care and treatment. The purpose of the present study was the evaluation of the new elements and identification of obstacles and barriers in their implementation. METHODS: Quantitative and qualitative methods were used to evaluate the reform of the PT-GL. In a retrospective cohort-based analysis of anonymized administrative claim data from the statutory health insurances BARMER and AOK, the health care situation before and after the reform were compared. In addition, a cross-sectional questionnaire survey evaluated the implementation of the new care elements from the perspective of psychotherapists, general practitioners and patients. The questionnaires were developed based on focus groups with stakeholders and a literature search. The survey results provided the data basis for the cross-sectional analysis together with the routine data on the care situation after the reform of the PT-GL as well as aggregated, anonymized data from the National Association of Statutory Health Insurance Physicians on statutory health insurance care and on the use of the appointment service centers. CONCLUSION: By combining quantitative and qualitative data, the effects of the structural reform of the PT-GL of 2016 can be analyzed at the individual and structural level as well as in relation to the entire care and treatment process. Based on this, proposals for a needs-oriented further development of the PT-GL will be prepared, considering the perspectives of various interest groups.

[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.

Care with allergen immunotherapy for allergic respiratory diseases in Germany-Predictors and deficits.

BACKGROUND: Allergen immunotherapy (AIT) represents the only possibility of causal therapy for allergic respiratory diseases. Although the prevailing high prevalence of allergic diseases and restrictions in the daily lives of patients, AIT is offered to a suboptimal number of patients in Germany. METHODS: Insured patients with documented allergic respiratory disease of one of the largest statutory health insurances in Germany, 'DAK-Gesundheit', were contacted by postal mail and asked to participate in the study. In case of written consent, primary and secondary data of patients were collected and analysed. Patient characteristics, predictors of being offered AIT, predictors of performing AIT and guideline-compliant care were analysed. RESULTS: 2505 subjects were included in the VerSITA study. Allergy to tree pollen and native speaking were identified as predictors, which increase the probability of being offered AIT. The probability was significantly decreased by the characteristics allergic rhinitis only, allergic asthma only, age in years, non-German citizenship, no graduation and lower secondary qualification. Significant positive predictors for an AIT to be actually performed were: Allergy to tree pollen and male sex. Predictors that decrease the likelihood that AIT is performed were: only allergic asthma, current smoker, former smoker, age and non-German citizenship. Furthermore, it was possible to identify characteristics in which guideline-compliant patients differed significantly from the rest of the study population. CONCLUSIONS: Based on statutory health insurance data and patient survey data, the VerSITA study provides a broad and in-depth overview of the care situation with regard to AIT in Germany and identifies deficits.

Self-care time and rating of health state in persons with diabetes: results from the population-based KORA survey in Germany.

BACKGROUND: The amount of empirical research on whether people in fact include health-related changes in leisure time into health state valuations is limited and the results are inconclusive. In this exploratory study, we analyse whether time aspects of diabetes self-care might explain the ratings of the health state (HSR) in addition to the effects of physical and mental health-related quality of life. METHODS: Using the data from participants with diagnosed type 2 diabetes in the population-based KORA FF4 study (n = 190, 60% Male, mean age 69 ± 10 years), multiple logistic regression models were fitted to explain HSR (good vs. poor) in terms of the SF-12 physical and mental component summary (PCS and MCS) scores, time spent on diabetes self-care and a number of background variables. RESULTS: There was no significant association between time spent on diabetes self-care and HSR in models without interaction. Significant interaction term was found between the SF-12 PCS score and time spent on self-care. In models with interaction self-care time has a small, but significant impact on the HSR. In particular, for a PCS score under 40, more time increases the chance to rate the health state as "good", while for a PCS score above 40 there is a reverse effect. CONCLUSIONS: The additional impact of self-care time on HSR in our sample is small and seems to interact with physical health-related quality of life. More research is needed on whether inclusion of health-related leisure time changes in the denominator of cost-effectiveness analysis is sufficient.

One-year follow-up healthcare costs of patients diagnosed with skin cancer in Germany: a claims data analysis.

BACKGROUND: Routine skin cancer screening (SCS) is covered by the German statutory health insurance (SHI) since 2008. The objective of this study was to compare direct healthcare costs between patients in whom skin cancer was detected by routine SCS and patients in whom skin cancer was not detected by routine SCS. METHODS: A retrospective observational study of administrative claims data from a large German SHI was performed. Patients with a diagnosis of malignant melanoma (MM) or non-melanoma skin cancer (NMSC) diagnosed in 2014 or 2015 were included. Costs were obtained for one year before and one year after diagnosis and analyzed in a difference-in-differences approach using regression models. Frequency matching was applied and risk adjustment was performed. Additional analyses were conducted, separately for specific age groups, excluding persons who died during the observation period and without taking costs for screening into consideration. RESULTS: A total of 131,801 patients were included, of whom 13,633 (10.3%) had a diagnosis of MM and 118,168 (89.7%) had a diagnosis of NMSC. The description of total costs (without risk adjustment) shows lower mean total costs among patients whose skin cancer was detected via routine SCS compared to patients in whom skin cancer was not detected by routine SCS (MM: €5,326 (95% confidence interval (CI) €5,073; €5,579) vs. €9,038 (95% CI €8,629; €9,448); NMSC: €4,660 (95% CI €4,573; €4,745) vs. €5,890 (95% CI €5,813; €5,967)). Results of the regression analysis show cost savings of 18.8% (95% CI -23.1; -8.4) through routine SCS for patients with a diagnosis of MM. These cost savings in MM patients were more pronounced in patients younger than 65 years of age. For patients with a diagnosis of NMSC, the analysis yields a non-substantial increase in costs (2.5% (95% CI -0.1; 5.2)). CONCLUSION: Cost savings were detected for persons with an MM diagnosed by routine SCS. However, the study could not detect lower costs due to routine SCS in the large fraction of persons with a diagnosis of NMSC. These results offer important insights into the cost structure of the routine SCS and provide opportunities for refinements.

Risk-Adjusted Prevention. Perspectives on the Governance of Entitlements to Benefits in the Case of Genetic (Breast Cancer) Risks.

This article is a revised version of our proposal for the establishment of the legal concept of risk-adjusted prevention in the German healthcare system to regulate access to risk-reduction measures for persons at high and moderate genetic cancer risk (Meier et al. Risikoadaptierte Prävention'. Governance Perspective für Leistungsansprüche bei genetischen (Brustkrebs-)Risiken, Springer, Wiesbaden, 2018). The German context specifics are summarized to enable the source text to be used for other country-specific healthcare systems. Establishing such a legal concept is relevant to all universal and free healthcare systems similar to Germany's. Disease risks can be determined with increasing precision using bioinformatics and biostatistical innovations ('big data'), due to the identification of pathogenic germ line mutations in cancer risk genes as well as non-genetic factors and their interactions. These new technologies open up opportunities to adapt therapeutic and preventive measures to the individual risk profile of complex diseases in a way that was previously unknown, enabling not only adequate treatment but in the best case, prevention. Access to risk-reduction measures for carriers of genetic risks is generally not regulated in healthcare systems that guarantee universal and equal access to healthcare benefits. In many countries, including Austria, Denmark, the UK and the US, entitlement to benefits is essentially linked to the treatment of already manifest disease. Issues around claiming benefits for prophylactic measures involve not only evaluation of clinical options (genetic diagnostics, chemoprevention, risk-reduction surgery), but the financial cost and-from a social ethics perspective-the relationship between them. Section 1 of this chapter uses the specific example of hereditary breast cancer to show why from a medical, social-legal, health-economic and socio-ethical perspective, regulated entitlement to benefits is necessary for persons at high and moderate risk of cancer. Section 2 discusses the medical needs of persons with genetic cancer risks and goes on to develop the healthy sick model which is able to integrate the problems of the different disciplines into one scheme and to establish criteria for the legal acknowledgement of persons at high and moderate (breast cancer) risks. In the German context, the social-legal categories of classical therapeutic medicine do not adequately represent preventive measures as a regular service within the healthcare system. We propose risk-adjusted prevention as a new legal concept based on the heuristic healthy sick model. This category can serve as a legal framework for social law regulation in the case of persons with genetic cancer risks. Risk-adjusted prevention can be established in principle in any healthcare system. Criteria are also developed in relation to risk collectives and allocation (Sects. 3, 4, 5).

Understanding and avoiding late presentation for HIV diagnosis - study protocol of a trial using mixed methods (FindHIV).

Many patients infected with HIV are diagnosed at an advanced stage of illness. These late presenters are individuals with a CD4 cell count of less than 350 cells/µL and/or an AIDS defining disease at initial HIV diagnosis. Purpose of FindHIV is to develop and distribute a questionnaire/scoring system aimed at a reduction in late presentation. FindHIV uses a mixed methods approach. In a first step, primary data of patients were collected. Inclusion criteria were: age ≥ 18 years, cognitive ability and language skills to participate in the study, initial HIV diagnosis within the past 6 months, and patient informed consent. Descriptive methods and regression models are used to identify: (1) patient characteristics associated with late presentation and (2) contacts to the healthcare system with indicator diseases that did not lead to HIV testing. Secondly, a questionnaire/scoring system is created by an expert panel. Afterwards the questionnaire/scoring system is to be disseminated. The greatest challenge was in reaching an adequate sample size. Another risk may be a recall bias. Nevertheless, FindHIV is devised as an in-depth study of the phenomenon of late presentation with potential to significantly improve HIV detection.

Using INTEGRATE-HTA for the assessment of videorasterstereography in idiopathic scoliosis.

OBJECTIVE: For the assessment of videorasterstereography compared with radiography for monitoring idiopathic scoliosis, new tools given by the INTEGRATE-HTA methodology were included within the frame set by the authority. In contrast to the usual linear approach by covering the single domains' safety and efficacy, costs, and ethical, legal, socio-cultural and organizational issues (ELSOI) separately, the methodology is based on the assumption of interactions of different aspects of the domains. From the very beginning, these interactions are captured systematically using various tools and are repeatedly discussed with stakeholders. METHODS: Relevant databases were systematically searched for studies and question catalogues were processed in order to be able to search for specific aspects in orienting bibliographic research. An initial logic model was developed and successively expanded. A synoptic table showing multiple mapping of aspects to domains, a complexity checklist, and a semantic complex highlighting the socio-cultural impact of the disease were newly developed. RESULTS: Four diagnostic studies with high risk of bias were included. For the clinical outcome, Cobb angle standard deviations up to 8.2 degrees and average measurement differences up to 8.8 degrees were determined. These differences in measurement accuracy correspond to those observed for purely radiographic measurements in other studies. In addition to freedom from radiation as the greatest advantage, there were clear arguments in favor of videorasterstereography when considering ELSOI, for example less harm. CONCLUSIONS: Using INTEGRATE-HTA contributes to identify interactions between domains and to significantly expand the perspective on a technology. It improves patient-centered understanding and facilitates discussions.

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.

Clinical and Economic Benefits of Upper Airway Stimulation for Obstructive Sleep Apnea in a European Setting.

BACKGROUND: Upper airway stimulation (UAS) is a treatment approach for patients with moderate-to-severe obstructive sleep apnea who cannot adhere to continuous positive airway pressure therapy. OBJECTIVE: The objective was to evaluate added patient benefit and cost-effectiveness of UAS in the German health care system. METHODS: We used a decision-analytic Markov model to project major adverse cardiovascular or cerebrovascular events (myocardial infarction [MI] or stroke), motor vehicle collision (MVC), mortality, quality-adjusted life years (QALYs), and costs. The assumed reduction in the apnea-hypopnea index with UAS compared to no treatment is based on German real-world data. Other input data were derived from the literature, public statistics, and multivariate regression. Cost-effectiveness was evaluated in Euros per QALY gained, both discounted at 3%. RESULTS: UAS was projected to reduce event risks (10-year relative risk for stroke, MI, cardiovascular death, and MVC: 0.76, 0.64, 0.65, and 0.34, respectively), and to increase survival by 1.27 years. While the UAS strategy incurred an additional 1.02 QALYs within the patient lifetime, there were also additional costs of EUR 45,196, resulting in an incremental cost-effectiveness ratio of EUR 44,446 per QALY gained. -Conclusions: In the present model-based analysis, UAS therapy provides meaningful benefit to patient-relevant endpoints and is a cost-effective therapy in the German setting.

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.

[Barriers to Accessing HIV Testing Services - A Systematic Literature Review]. / Zugangsschwellen zu HIV-Test-Angeboten ­ Eine systematische Literaturanalyse.

OBJECTIVE: In Germany there are 3,100 new HIV infections per year (2016), mainly homosexual men and intravenous drug users. According to experts from Robert Koch Institute, about 30 % of people with HIV are diagnosed late, well past the optimal moment to start the antiretroviral therapy. The high rate of late presenters seems to be a strong argument for an intensification of voluntary counseling and testing services. The main objective of this literature analysis was to describe the barriers to HIV testing. METHODS: A systematic literature search was done to evaluate current knowledge on theory and practice regarding barriers that keep vulnerable groups from getting tested. The analysis includes all publications between 2000 and 2014 from western industrial states. RESULTS: 132 publications have been included in a full text analysis. Most of these publications present the result of surveys of clients attending counseling and testing services. Hence, we have a clear idea of the elements that are relevant for clients when they decide whether or where to get tested for HIV. First, the individual risk perception influences the decision on getting tested or not. The risk perception can be influenced through public relations and outreach services. All processes within the counseling and testing service should be adapted to assure confidentiality and anonymity. In addition, clients want to have counseling that is accepting and free of prejudices. These elements are therefore important since HIV is often associated with getting stigmatized. Similar concerns regarding stigmatization occur if clie nts have sexual preferences that can be considered as deviant. The clients' fear of stigmatization, judgment and social exclusion requires a high sensitivity for the situation of the clients and acceptance of their lifestyle. CONCLUSION: We have a clear insight into how clients decide on getting tested or not. The factor with the greatest influence in the decision-making process is the individual risk perception and anxiety regarding stigmatization. Stigmatization is suspected as a societal reaction to deviant sexual behavior or to being infected with HIV. Public relations should inform about risk factors and risk perception as well as on confidentiality and anonymity of the service. The use of social media and social networks is highly recommended. New approaches such as home testing could eliminate the concerns regarding confidentiality and anonymity.

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.

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.

Time and cost associated with utilization of services at mobile health clinics among pregnant women.

BACKGROUND: Antenatal care (ANC) is provided for free in Tanzania in all public health facilities. Yet surveys suggested that long distances to the facilities limit women from accessing these services. Mobile health clinics (MHC) were introduced to address this problem; however, little is known about the client cost and time associated with utilizing ANC at MHC and whether these costs deter women from using the provided services. METHODS: Client-exit interviews were conducted by interviewing 293 pregnant women who visited the MHC in rural Tanzania. Two subgroups were created, one with women who travelled more than 1.5 h to the MHC, and the other with women who travelled within 1.5 h. For each subgroup we estimated the direct cost in US$ and time in hours for utilizing services and they hinder service utilization. The Wilcoxon-Mann-Whitney rank sum test was performed to compare the differences between the estimated mean values in the two groups. RESULT: Total direct cost per visit was: US$2.27 (SD = 0.90) for overall, US$2.29 (SD = 1.03) for those women who travelled less than 1.5 h and US$2.53 (SD = 0.63) for those who travelled more than 1.5 h (p = 0.08). Laboratory and medicine cost accounted for 70 and 16% of the total direct cost and were similar across the groups. Total time cost per visit (in hours) was: 3.75 (SD = 1.83), 2.88 (SD = 1.27) for those women who travelled less than 1.5 h and 5.02 (SD = 1.81) for those who travelled more than 1.5 h (p < 0.01). The major contributor of time cost was waiting time; 1.89 (SD = 1.29) for overall, 1.68 (SD = 1.02) for those women who travelled less than 1.5 h and 2.17 (SD = 1.57) for those who travelled more than 1.5 h (p = 0.07). Participants reported having missed their scheduled visit due to lack of money (15%) and time (9%). CONCLUSION: Women receiving nominally free ANC incur considerable time and direct cost, which may result in an unsteady use of maternal care. Improving availability of essential medicine and supplies at health facilities, as well as focusing on efficient utilization of community health workers may reduce these costs.