Sickness Funds Research Articles

11.A. Scientific session: Overcoming Real-World Challenges in Setting up Health Data Linkages for Public Health Policy

Abstract Background Linking available administrative data has gained momentum in the last years to enhance public health research and public health formulation. Linkage of diverse data sources can be leveraged to understand social-determinants of health, the cost-effectiveness of an intervention, and to evaluate impact of policies. For instance, data linkage has been proven to be a powerful approach to periodically analyze real-world progress of the COVID-19 pandemic. Today, we are witnessing an unparalleled increase in electronic health data stemming from citizens who interact with services such as healthcare providers, employers, sick funds, and other governmental structures. This enormous amount of data opens many innovative possibilities in epidemiological research. The main advantages of the secondary use of data are the following: 1) it is enriching for new collected data (e.g. survey study), 2) it provides comprehensive information of the target population, and 3) it is cheaper than new data collection. Data linkage between data sources is, however, often a herculean task, and it comes with considerable challenges such as: 1) juridical complexity related to intra-national and cross-border data governance procedures, 2) fragmented data integration, 3) data delivery delays. Addressing these challenges is essential to unlocking the true potential of data linkages for timely responses to emerging public health questions, thereby contributing to evidence-based policy and care and transforming our health research into a One Health approach. Objectives The workshop’s main aim is to present the researcher’s lessons-learned and approaches in applying data linkage from an European, and a country-level perspective through case-studies while creating a space for the public to share their own view. In this workshop we aim to 1) provide a helicopter overview of current data linkages approaches in Europe, 2) illustrate this with case studies from an international, and a country-level perspective, and 3) emphasize the challenges and disadvantages of those data linkages, while sharing potential solutions. Workshop outline The workshop is divided into a knowledge translation, and an interactive part. In the first part of the workshop, three speakers will give a presentation of each 10 minutes with a Q&A of 5 minutes between each presentation where data linkage will be introduced, and three case studies on how data linkage can be used will be presented. The first presentation will introduce approaches to data linkages in Europe, and will delve into how AI can be used during routine data linkage. The second presentation will show a case-study on how an international data linkages can be done in an European federated manner. The third presentation will further illustrate how nationally data can be linked to investigate health inequalities. In the second part of the workshop, the audience will be invited to interact with the speakers and share their experiences. Key messages • A comprehensive overview of different current data linkages approaches are provided, setting the stage for discussions on methods and best practices. • Administrative data linkages are a powerful tool to answer important public health challenges, but important challenges related to data governance need to be addressed to realize the full potential.

Seeking Dental Healthcare in the Context of COVID-19 Pandemic: A Study Examining the Health Belief Model

Abstract Background and Objectives The main purpose of the study was to examine the factors influencing older adults’ seeking dental care, in the context of coronavirus disease 2019 (COVID-19) pandemic, based on the Health Belief Model (HBM). Research Design and Methods Phone interviews were conducted using a structured questionnaire, among 200 older adults aged 65 and above, who are members of the Israeli largest sick fund Clalit Health Services, that were sampled through a systematic random sample. The data were collected between January 2022 and March 2022 and during September 2022. Results Our findings indicate that since the outbreak of COVID-19 in Israel, 61.5% and 55% of the participants reported visiting a dentist and a dental hygienist, respectively, and about a fifth of the participants have foregone care at both. Seeking dental care was associated with an increase in perceived threat, benefits, willingness to seek care, and with a decrease in perceived barriers. The HBM was found to be a suitable framework for illuminating older adults’ dental behavior, which explains 43% of the variance. Discussion and Implications The results of the study provided first-hand findings regarding seeking dental care during the COVID-19 pandemic. These findings emphasize the importance of providing dental services with clear recommendations about dental care and appropriate protective equipment, even under conditions of health concern, to enhance oral health services utilization.

Unveiling the untreated: development of a database algorithm to identify potential Fabry disease patients in Germany

BackgroundFabry disease (FD), an X-linked lysosomal storage disorder, is caused by mutations in the gene encoding α-galactosidase A, resulting in lysosomal accumulation of globotriaosylceramide and other glycosphingolipids. Early detection of FD is challenging, accounting for delayed diagnosis and treatment initiation. This study aimed to develop an algorithm using a logistic regression model to facilitate early identification of patients based on ICD-10-GM coding using a German Sickness Fund Database.MethodsThe logistic regression model was fitted on a binary outcome variable based on either a treated FD cohort or a control cohort (without FD). Comorbidities specific to the involved organs were used as covariates to identify potential FD patients with ICD-10-GM E75.2 diagnosis but without any FD-specific medication. Specificity and sensitivity of the model were optimized to determine a likely threshold. The cut-point with the largest values for the Youden index and concordance probability method and the lowest value for closest to (0,1) was identified as 0.08 for each respective value. The sensitivity and specificity for this cut-point were 80.4% and 79.8%, respectively. Additionally, a sensitivity analysis of the potential FD patients with at least two codes of E75.2 diagnoses was performed.ResultsA total of 284 patients were identified in the potential FD cohort using the logistic regression model. Most potential FD patients were < 30 years old and female. The identification and incidence rates of FD in the potential FD cohort were markedly higher than those of the treated FD cohort.ConclusionsThis model serves as a tool to identify potential FD patients using German insurance claims data.

Die Bevölkerungsperspektive in der Bewertung der Leistungsfähigkeit des deutschen Gesundheitssystems: Ergebnisse einer Querschnittsbefragung GKV-Versicherter

IntroductionSince the World Health Report in 2000, Health System Performance Assessment (HSPA) has been established as a tool for the evaluation and evidence-informed governance of health systems. So far, the population perspective has not been integrated into HSPA in a systematic manner, although people's experiences and expectations are of great importance to improve health systems and especially to strengthen patient-centered care. Therefore, this study aims to conduct an HSPA of Germany's health system from the population's perspective covering all eight goals of WHO’s Health Systems Framework, and to identify strengths and needs for improvement. MethodsIn 2018, 32,000 people insured with the German sickness fund ‘AOK Nordost’ were invited by mail to participate in the survey. The questionnaire contained a total of 43 items covering the eight goals of WHO's Health Systems Framework (e.g., access, quality, safety) plus socioeconomics and other characteristics of the insured persons. The data on the health system goals were analyzed descriptively and by subgroups (age, sex, income, chronic conditions, health literacy). ResultsThe sample (n=1,481; response rate 4.6%) was 54.8% female and had a mean age of 59.1 years (±18.5). Altogether, the participants saw several needs for improvement within the German health system. For instance, 60.0% found quality differences between hospitals to be big, and between 3.9% and 8.5% reported mistakes related to their treatment or prescription medication in the previous two years. A big need for reform was especially seen regarding out-of-pocket payments (51.5%) and the coordination of ambulatory care physicians among each other (44.2%) and with hospitals (41.9%). In addition, big subgroup differences were seen, especially for income and health literacy. Of the participants in the lower income group, 37.2% reported a (very) strong financial burden due to out-of-pocket payments (vs. 20.7%). People with limited health literacy (52.1%) assessed the access to care generally as not being good, and they perceived greater quality differences and needs for reform, compared to their counterparts. For instance, 36.6% had experienced discrimination in the previous year (vs. 19.9%). DiscussionThe survey results provide a comprehensive picture of Germany's health system from the population perspective. In some areas, previous findings were confirmed (e.g., a lack of coordination between providers). Other results expand existing knowledge (e.g., the role of health literacy in health care provision) or raise new questions (e.g., the difference between the subjectively assessed burden from out-of-pocket payments and the objective measures currently used). The great differences between subgroups are a call to action on the level of both politics and practice to better consider the individual's needs in order to make health better for everyone. Further research could provide deeper insights in this regard. ConclusionStrengthening the population perspective in HSPA allows for a better understanding and evaluation of health systems and, in particular, helps to identify areas for improvement in patient-centered care.

Clinical and economic burden of organ damage among patients with systemic lupus erythematosus in a real-world setting in Germany

BackgroundSystemic lupus erythematosus (SLE), a chronic multisystem autoimmune disease, carries high risk of organ damage and burden to healthcare systems. SLE disease modification aims to reduce disease activity with minimal treatment toxicity and preventing or minimizing organ damage development. This real-world study utilizing healthcare administrative claims data assessed organ damage development, associated costs and healthcare resource utilization (HCRU) in patients with SLE in Germany.MethodsClaims data from January 1, 2007, to December 31, 2017, were obtained from the Betriebskrankenkassen German Sickness Fund Database. Adults (> 18 years) with a confirmed SLE diagnosis between January 1, 2009, and December 31, 2014, (inclusion period) were included. The index date was calculated based on the first recorded SLE diagnosis during this period. Patients were propensity score–matched (1:3) to a comparator cohort without SLE by age, sex, and comorbidities (Charlson comorbidity index). Organ damage was identified using an algorithm developed based on conditions described in the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI), using ICD-10-GM diagnostic codes, healthcare procedures, and/or treatments.Results2121 patients with SLE and 6308 comparator patients were included (mean follow-up time: 6.4 years). Organ damage prevalence increased from 60.5% at baseline to 83.0% during 6 years of follow-up in all patients with SLE, while 17.0% of patients with SLE did not develop organ damage. Patients with newly confirmed SLE diagnosis without organ damage at baseline were nearly twice as likely to develop organ damage within 5 years versus the comparator cohort (52.0% vs. 27.0%). Total annual costs per patient-year for patients with SLE with organ damage were more than double those of patients with SLE without organ damage; both the number of inpatient admissions and length of stay were higher.ConclusionsThe application of a recently developed algorithm allowed us to use claims data to elucidate SLE organ damage, and its associated high clinical and economic burden, in a large, representative sample in Germany. To our knowledge, this is the first European analysis of its kind involving a broad cohort of patients with SLE treated in the routine care setting.

Implementing the EU HTA regulation: Insights from semi-structured interviews on patient expectations, Belgian and European institutional perspectives, and industry outlooks.

Introduction: The goal of the Health Technology Assessment (HTA) Regulation 2021/2282 is to establish a more harmonized HTA framework, fostering member states cooperation and enabling equal patient access to innovative health technologies in Europe. This research aimed to assess the impact of the regulation on national HTAs, the strategic implications for health technology developers, and its influence on price and reimbursement negotiations. Methods: A scoping literature review encompassing peer-reviewed literature as well as grey literature was conducted. Between February and March 2023, semi-structured interviews (n = 20) were performed with stakeholders from Belgian governmental institutions, European institutions, advanced therapy medicinal product developers, academics, and sickness funds. The interviews were analyzed using the framework analysis method. Results: Numerous steps, such as the development of implementing acts and procedural guidelines remain to be taken. At member state level, national/regional HTA bodies and payers must act to adopt the new concepts of Joint Scientific Consultations (JSC) and Joint Clinical Assessments (JCA) within their national legislation, as well as revise their timelines and prepare for interactions at a European level. Compiling a harmonized PICO (Population, Intervention, Comparator, and Outcome), adapting local procedures, and increasing capacity to actively take part in the JSC and JCA are seen as primary barriers by several stakeholders. Training and education will help HTA bodies, payers, and health technology developers to participate in the European processes. Conclusion: While practical and legal challenges were identified, recommendations (such as actively preparing for the upcoming changes and increasing capacity while providing training) were provided to adapt national and European procedures to the needs of the HTA Regulation 2021/2282. The importance of fostering collaborations and aligning local HTA procedures with the new way of working set out by the Regulation was demonstrated with this study.

The Impact of Systemic Lupus Erythematosus Flares on Clinical and Economic Outcomes: The CHAMOMILE Claims Database Study in Germany.

CHAMOMILE (CHaracteristics and impact of flares on clinicAl and econoMic OutcoMes In patients with systemic Lupus Erythematosus [SLE]) examined how flares in the year of SLE diagnosis impact future disease activity and damage, productivity, healthcare resource utilization (HCRU), and costs in patients with SLE in Germany. CHAMOMILE was a retrospective cohort study of adults with an SLE diagnosis in the German Sickness Fund Database from 1July 2010 to 31December 2013. Patients were classified according to their greatest flare severity during the baseline year (none, mild, or moderate/severe). The number and severity of flares were assessed annually over 5-8.5 follow-up years, along with SLE organ/system damage, treatments, work disability, and HCRU metrics. Of 2088 patients (84.6% female; mean age [standard deviation] 51.4 [16.1] years; mean follow-up 6.8 [2.1] years), 34.3% (n = 716) were flare-free, 29.8% (n = 622) had mild flares, and 35.9% (n = 750) had moderate/severe flares at baseline. Baseline flare severity was related to future flares: rates during follow-up were higher in patients with moderate/severe baseline flares compared with those with mild or no baseline flares (89.6 vs 78.5 and 44.2 flares/100 patient years, respectively). Overall, 80.2% (n = 1675) of patients received glucocorticoids at least once during baseline and follow-up. Patients' HCRU was generally greatest in their baseline year. Costs were highest in patients with moderate/severe baseline flares. Baseline flare severity provided insight into a patient's disease course and the clinical and economic burden of SLE over time, highlighting the ramifications of uncontrolled disease for patients with SLE.

Switching within versus out of class following first-line TNFi failure in ulcerative colitis: real-world outcomes from a German claims data analysis.

Biologic agents have demonstrated efficacy in treating ulcerative colitis (UC); however, treatment failure to tumor necrosis factor inhibitors (TNFi) is common in the real world. Data on preferential sequencing in clinical practice after failure remain limited. This study aimed to evaluate real-world outcomes of patients cycling to TNFis or switching to non-TNFi biologics following first-line failure with TNFis. Retrospective cohort study in Germany. Adult patients with UC were identified using administrative claims data from 1 May 2014 to 30 June 2022 provided by a statutory sickness fund. Patients newly initiating first-line therapy with TNFis and then switching to another agent were identified. Patients were defined as within-class switched (WCS), if they cycled to another TNFi, or outside-class switchers (OCS), if they switched to a non-TNFi biologic [ustekinumab (UST) or vedolizumab (VDZ)] and followed from index (switch date) to death, insurance end, or study end on 30 June 2022. Inverse probability of treatment weighting (IPTW) was performed to adjust for differences in baseline characteristics between groups, and weighted Cox regression models were used to compare primary (time to discontinuation and second treatment switch) and secondary outcomes (corticosteroid-free drug survival). We identified 166 patients initiating TNFis and switching to a subsequent treatment (mean age: 42.9 years, 49.4% female). Following IPTW, there were 71 and 76 patients in the WCS and OCS groups, respectively. Compared to OCS, WCS were more likely to discontinue the new therapy [hazard ratio (HR), 1.82, 95% confidence interval (CI), 1.14-2.89, p = 0.012], and switch a second time (HR, 3.46, 95% CI, 1.89-6.36, p < 0.001). Moreover, WCS showed an increased likelihood of initiating prolonged corticosteroid therapy (HR, 1.42, 95% CI, 0.77-2.59, p = 0.260); however, the results were not significant. Following first-line TNFi failure, this study suggests that real-world outcomes among patients with UC are less favorable when cycling to another TNFi, compared to switching to a non-TNFi such as UST or VDZ.

Characteristics of Users and New Initiators of Single- and Multiple-Inhaler Triple Therapy for Chronic Obstructive Pulmonary Disease in Germany.

To assess patient characteristics of users and new initiators of triple therapy for chronic obstructive pulmonary disease (COPD) in Germany. Retrospective cohort study of patients with COPD and ≥1 prescription for single-inhaler triple therapy (SITT; fluticasone furoate/umeclidinium/vilanterol [FF/UMEC/VI] or beclomethasone dipropionate/glycopyrronium bromide/formoterol [BDP/GLY/FOR]) or multiple-inhaler triple therapy (MITT), using data from the AOK PLUS German sickness fund (1 January 2015-31 December 2019). The index date was the first date of prescription for FF/UMEC/VI or BDP/GLY/FOR (SITT users), or the first date of overlap of inhaled corticosteroid, long-acting β2-agonist, and long-acting muscarinic antagonist (MITT users). Two cohorts were defined: the prevalent cohort included all identified triple therapy users; the incident cohort included patients newly initiating triple therapy for the first time (no prior use of MITT or SITT in the last 2 years). Patient characteristics and treatment patterns were assessed on the index date and during the 24-month pre-index period. In total, 18,630 patients were identified as prevalent triple therapy users (MITT: 17,945; FF/UMEC/VI: 700; BDP/GLY/FOR: 908; non-mutually exclusive) and 2932 patients were identified as incident triple therapy initiators (MITT: 2246; FF/UMEC/VI: 311; BDP/GLY/FOR: 395; non-mutually exclusive). For both the prevalent and incident cohorts, more than two-thirds of patients experienced ≥1 moderate/severe exacerbation in the preceding 24 months; in both cohorts more BDP/GLY/FOR users experienced ≥1 moderate/severe exacerbation, compared with FF/UMEC/VI and MITT users. Overall, 97.9% of prevalent triple therapy users and 86.4% of incident triple therapy initiators received maintenance treatment in the 24-month pre-index period. In a real-world setting in Germany, triple therapy was most frequently used after maintenance therapy in patients with recent exacerbations, in line with current treatment recommendations.

Building a caring network of formal and informal help (offline and online) in a super-diverse neighbourhood

Several organisations (i-mens, Steunpunt Mantelzorg, Hoplr, city of Aalst, sickness funds, Eerstelijnszone regio Aalst, informal carers organisations...) came together for the project ‘Neighbourhood Building Blocks’ to create a caring neighbourhood in a super-diverse area in Aalst, a city close to Brussels, Belgium. It is an area with an older ‘Belgian’ population and a younger population with a migration background. People in this neighbourhood are generally less wealthy, less healthy and more socially isolated than in other areas in Flanders.&#x0D; The goal of the project is to ensure that people only must ask help once to get the appropriate answer or support at the right time. To achieve this, we are creating a virtual and physical network of informal and formal support in the neighbourhood, putting together several existing building blocks: capacities of neighbours, professional care, volunteers, support for informal carers, a digital platform of neighbours (Hoplr) and the building complex of i-mens – a care organisation, with an office building for their home care services, a day care and service flats. The underlying assumption is that everyone has something to contribute and something to gain from the network.&#x0D; We have 3 intervention axes: 1. Neighbourly help network 2. Empowerment of informal carers 3. Connecting the professional care network with the informal network. We have a neighbourhood concierge and connector. She connects the 3 axes of the project, and ensures that the project is driven by and embedded in the neighbourhood, together with the key partners.&#x0D; &#x0D; We start from the capacities of neighbours (ABCD-model) to create neighbourly help networks, both offline and online. We match people based on their capacities and needs, and track this through a dashboard (people matched – help provided – after care). To find capacities and needs we organise activities and informal contact at the gathering room of the service flats and the meeting rooms of i-mens. All activities have 3 functions: information in group on rights and possible support, conversation and encounters in group (social contact), and one-on-one questions and support with individual cases.&#x0D; Learning from the experience of previous caring neighbourhoods, we give specific attention to informal carers. We know that they find it more difficult to rely on help from neighbours and professional caregivers. Empowering and informing informal carers through specific interventions ensures their involvement and support from the network.&#x0D; We connect professional actors (care organisations, local traders, …) with each other and with the informal actors, tailored to the needs and capacities of the neighbourhood. We aim to make professional support and care more accessible to people in the neighbourhood. At the back-office side, we are developing a decision-making tree so we know which question for help can be resolved by which formal or informal actor. The dashboard to match neighbourly help will be expanded in order to track matches with formal actors.&#x0D; &#x0D; We will present the first results of the project, and share experiences of neigbhours, informal carers and profesionnal actors.&#x0D;

Claims-based algorithm to estimate the Expanded Disability Status Scale for multiple sclerosis in a German health insurance fund: a validation study using patient medical records.

The Expanded Disability Status Scale (EDSS) quantifies disability and measures disease progression in multiple sclerosis (MS), however is not available in administrative claims databases. To develop a claims-based algorithm for deriving EDSS and validate it against a clinical dataset capturing true EDSS values from medical records. We built a unique linked dataset combining claims data from the German AOK PLUS sickness fund and medical records from the Multiple Sclerosis Management System 3D (MSDS3D). Data were deterministically linked based on insurance numbers. We used 69 MS-related diagnostic indicators recorded with ICD-10-GM codes within 3 months before and after recorded true EDSS measures to estimate a claims-based EDSS proxy (pEDSS). Predictive performance of the pEDSS was assessed as an eight-fold (EDSS 1.0-7.0, ≥8.0), three-fold (EDSS 1.0-3.0, 4.0-5.0, ≥6.0), and binary classifier (EDSS <6.0, ≥6.0). For each classifier, predictive performance measures were determined, and overall performance was summarized using a macro F1-score. Finally, we implemented the algorithm to determine pEDSS among an overall cohort of patients with MS in AOK PLUS, who were alive and insured 12 months prior to and after index diagnosis. We recruited 100 people with MS insured by AOK PLUS who had ≥1 EDSS measure in MSDS3D between 01/10/2015 and 30/06/2019 (620 measurements overall). Patients had a mean rescaled EDSS of 3.2 and pEDSS of 3.0. The pEDSS deviated from the true EDSS by 1.2 points, resulting in a mean squared error of prediction of 2.6. For the eight-fold classifier, the macro F1-score of 0.25 indicated low overall predictive performance. Broader severity groupings were better performing, with the three-fold and binary classifiers for severe disability achieving a F1-score of 0.68 and 0.84, respectively. In the overall AOK PLUS cohort (3,756 patients, 71.9% female, mean 51.9 years), older patients, patients with progressive forms of MS and those with higher comorbidity burden showed higher pEDSS. Generally, EDSS was underestimated by the algorithm as mild-to-moderate symptoms were poorly captured in claims across all functional systems. While the proxy-based approach using claims data may not allow for granular description of MS disability, broader severity groupings show good predictive performance.

Budget Impact of the Oncotype DX Breast Recurrence Score® Test in Patients with Early Primary Hormone-Receptor-Positive, HER2-Negative, Node-Positive Breast Cancer in Germany

Background: Gene expression tests can inform decisions on whether to recommend or omit chemotherapy for patients with early HR+, HER2− breast cancer. The benefit of these tests is well established and fully reimbursed by sickness funds for lymph node-negative (pN0) patients in Germany. A budget impact model was built to evaluate the effect of using the Oncotype DX Breast Recurrence Score^® test also for node-positive (pN1: 1–3 positive lymph nodes) patients. Methods: The prospective randomized clinical trial, RxPONDER, defined conditions (Recurrence Score result 0–25 for postmenopausal patients with 1–3 positive lymph nodes) under which omitting chemotherapy does not significantly impact invasive disease-free survival with results currently reported for 5-year follow-up. The present budget impact model calculates average total cost per node-positive patient versus no testing from a sickness funds perspective, taking into account not only the budgetary impact of avoiding chemotherapy and associated side effects, but also the costs of treating those patients who develop distant metastasis. The stability of the results was investigated by probabilistic multivariate sensitivity analysis. Results: After deducting testing cost, applying the Oncotype DX Breast Recurrence Score test yielded an average savings per node-positive patient of EUR 4,272. Without the test costs, the greatest savings resulted from reductions in direct treatment costs and costs arising from the treatment of chemotherapy-related side effects, which together averaged EUR 6,677. The targeted use of chemotherapy after testing also resulted in slightly lower costs for treatment of distant metastasis, if it did occur. The multivariate sensitivity analysis also almost exclusively resulted in cost savings. Conclusion: Analogous to the pN0 situation, this budget impact model demonstrates that the Oncotype DX Breast Recurrence Score test can also reduce healthcare costs in Germany in treatment of node-positive (pN1: 1–3 positive lymph nodes) patients by minimizing both unnecessary chemotherapy and undertreatment. Additional benefits to patients would include reduced morbidity and improved quality of life for those patients who can safely avoid chemotherapy or undertreatment.

Policy implications of heterogeneous demand reactions to changes in cost-sharing: Patient-level evidence from Austria

Cost-sharing is a prominent tool in many healthcare systems, both for raising revenue and steering patient behaviour. Although the effect of cost-sharing on demand for healthcare services has been heavily studied in the literature, researchers often apply a macro-perspective to these issues, opening the door for policy makers to the fallacy of assuming uniform demand reactions across a spectrum of different forms of treatments and diagnostic procedures. We use a simple classification system to categorize 11 such healthcare services along the dimensions of urgency and price to estimate patients’ (anticipatory) demand reactions to a reduction in the co-insurance rate by a sickness fund in the Austrian social health insurance system. We use a two-stage study design combining matching and two-way fixed effects difference-in-differences estimation. Our results highlight how an overall joint estimate of an average increase in healthcare service utilization (0.8%) across all healthcare services can be driven by healthcare services that are deferrable (+1%), comparatively costly (+1.4%) or both (+1.6%) and for which patients also postponed their consumption until after the cost-sharing reduction. In contrast, we do not find a clear demand reaction for inexpensive or urgent services. The detailed analysis of the demand reaction for each individual healthcare service further illustrates their heterogeneity. We show that even comparatively minor changes to the costs borne by patients may already evoke tangible (anticipatory) demand reactions. Our findings help policy makers better understand the implications of heterogeneous demand reactions across healthcare services for using cost-sharing as a policy tool.

Covering digital health applications in the public insurance system: how to foster innovation in patient care while mitigating financial risks-evidence from Germany.

Digital health applications that support patients in managing their condition can have a positive impact on patients' health and improve the overall care process. In late 2019, as the first country worldwide, Germany included digital health applications in the benefit basket of the statutory health insurance (SHI) system to enable fast, broad-scale patient access and encourage innovation in the digital health industry. While the policy is widely recognized as a pioneering step toward improving patient care through digital technologies, there are concerns regarding the mechanics of the policy and the resulting financial risks for the SHI system. The primary objective of this article is to provide a comprehensive and balanced overview of the German policy by evaluating its success in achieving its goals and by reviewing challenges that have emerged. The secondary objective is to delineate prospective policy options and areas warranting future research. The article analyzes publicly available data of the Federal Institute for Drugs and Medical Devices collected between February 1st and July 17th, 2023, and complements it with empirical findings published by academic institutions and sickness funds. It discusses policy options and related areas of future research to overcome the identified challenges without jeopardizing the purpose of the legislation to encourage innovation in the digital health industry to improve patient care. In line with the goals of the reimbursement policy, the inclusion of digital health applications in the SHI benefit basked has entailed new digital treatment options for patients across multiple disease areas. However, from a health policy perspective, the policy has several shortcomings, including low prescription rates, the temporary reimbursement of digital health applications that lack proven benefit, and a pricing framework that does not take into account the efficacy and efficiency of a treatment and may lead to a suboptimal allocation of public resources. Rather than the public system covering digital health applications without proven benefit, the authors suggest giving SHI organizations more budget authority to directly incentivize research and development activities and to introduce value-based pricing. More research is needed to determine the details of these mechanisms.

O.2.2-5 Health promotion in rural areas. Findings from two German projects on physical activity promotion among disadvantaged populations

Abstract Purpose Communities play a crucial role for health promotion, especially for disadvantaged groups. At the same time, rural communities face specific challenges when planning and conducting health promotion projects. This presentation focuses on the challenges and opportunities rural communities experienced in two German projects for physical activity promotion. Methods Data were obtained from city administration staff participating in the GESTALT and the BIG projects (N = 13). Data were gathered via three storywall surveys. In addition, a real-world lab with city-administration staff, representatives of sickness funds and researchers was used to follow the communities over time and consult them on project implementation. Results The challenges and opportunities occurred can be categorized in five domains: Infrastructure/mobility: Rural areas are often not well connected to public transport. This can hinder people to attend exercise classes. Voluntarily organized transport services or neighborhood assistance might help overcoming this challenge. Networking Networking is a double-edged sword. Some staff reported to experience benefits of already existing contacts to relevant stakeholder due to closely-knit communities. Others reported that it is challenging to get in touch with the network partners in the rural areas. Durability In some cases, the project funding was seen as a window of opportunity and a starting point for developing new structures for health promotion. Range of offers A need of exercise classes in rural areas resulted in the success of the projects. However, the implementation of new programs and activities can be time-consuming. Especially in rural districts, solutions often are planned and implemented on a very small scale. Implementation Regarding implementation, there are several challenges to overcome. The communities lacked gyms and qualified instructors for the classes. Reaching the target population was another challenge. Conclusions Rural communities face unique as well as general challenges when implementing exercise programs, which can impact success of project implementation. However, rural structures can also result in opportunities for the participating communities. Support/Funding Source Funded by the German Federal Centre for Health Education (BZgA) on behalf of and with funds from the statutory health insurance companies according to § 20a SGB V.

Insurance medicine in Belarus in the first third of the twentieth century

Objective. To characterize the process of development of insurance medicine in Belarus in the first third of the twentieth century.Materials and methods. Archival, periodical and narrative sources processed using general scientific and special historical research methods.Results. Insurance medicine in Belarus originated in the early twentieth century in the form of hospital sick funds, which provided medical care to workers in case of illness, but was actually destroyed during the First World War. In Soviet Belarus the development of insurance medicine began during a period of massive reduction in healthcare funding associated with the New Economic Policy. In fact, insurance medicine became only a financial donor to the People’s Commissariat for Healthcare, but it was not distinguished as an independent branch, which was typical for the pre-revolutionary period, so the principle of unity of Soviet medicine was preserved. A characteristic feature of the studied period was the small social coverage of medical insurance, which applied only to workers and employees, who constituted a small part of the population of Soviet Belarus, where the rural population was greatly dominated.Conclusion. Despite the successful experience of organizing insurance medicine, it was only a temporary measure to maintain the resources of unified Soviet state medicine and in reality covered an extremely small percentage of the population, so after the crisis in health care was overcome it was abolished.

How to Predict Drug Expenditure: A Markov Model Approach with Risk Classes.

Although pharmaceutical expenditures have been rising for decades, the question of their drivers remains unclear, and long-term projections of pharmaceutical spending are still scarce. We use a Markov approach considering different cost-risk groups to show the possible range of future drug spending in Germany and illustrate the influence of various determinants on pharmaceutical expenditure. We compute different medium and long-term projections of pharmaceutical expenditure in Germany up to 2060 and compare extrapolations with constant shares, time-to-death scenarios, and Markov modeling based on transition probabilities. Our modeling is based on data from a large statutory sickness fund covering around four million insureds. We divide the population into six risk groups according to their share of total pharmaceutical expenditures, determine their cost growth rates, survival and transition probabilities, and compute different scenarios related to changes in life expectancy or spending trends in different cost-risk groups. If the spending trends in the high-cost groups continue, per-capita expenditure will increase by over 40% until 2040. By 2060, pharmaceutical expenditures could more than double, even if these groups would not benefit from rising life expectancy. By contrast, the isolated effect of demographic change would "only" lead to a long-term increase of around 15%. The long-term development of pharmaceutical spending in Germany will depend mainly on future expenditure and life expectancy trends of particularly high-cost patients. Thus, appropriate pricing of new expensive pharmaceuticals is essential for the sustainability of the German healthcare system.

Is pre-bereavement collaboration between family caregivers and healthcare professionals associated with post-bereavement emotional well-being? A population-based survey

ObjectiveTo investigate pre-bereavement collaboration with healthcare professionals and its association with emotional well-being of family caregivers of people with serious illness post-bereavement. MethodsPopulation-based cross-sectional survey of bereaved family caregivers of people with serious illness (N = 3000) who died two to six months before the sample was drawn (November 2019), identified through three sickness funds in Belgium. ResultsResponse rate was 55%. As measured by the Positive and Negative Affect Schedule (PANAS), family caregivers scored lower on positive affect (PA) and higher on negative affect (NA) compared to a normative sample. Most family caregivers evaluated the pre-bereavement collaboration with healthcare professionals positively. Family caregivers’ evaluation of collaboration with healthcare professionals pre-bereavement was positively associated with PA and negatively with NA, also when controlling for confounding effects of socio-demographic and clinical characteristics of the bereaved family caregiver and the deceased person. ConclusionThere is a positive association between perceived quality of collaboration at the end of life between healthcare professionals and family caregivers and post-bereavement emotional well-being of family caregivers. Practice implicationsOur findings suggest the pertinence of attention from healthcare professionals to effective collaboration with family caregivers.

Data Resource Profile: The Multiple Sclerosis Documentation System 3D and AOK PLUS Linked Database (MSDS-AOK PLUS)

Real-world evidence in multiple sclerosis (MS) is limited by the availability of data elements in individual real-world datasets. We introduce a novel, growing database which links administrative claims and medical records from an MS patient management system, allowing for the complete capture of patient profiles. Using the AOK PLUS sickness fund and the Multiple Sclerosis Documentation System MSDS3D from the Center of Clinical Neuroscience (ZKN) in Germany, a linked MS-specific database was developed (MSDS-AOK PLUS). Patients treated at ZKN and insured by AOK PLUS were recruited and asked for informed consent. For linkage, insurance IDs were mapped to registry IDs. After the deletion of insurance IDs, an anonymized dataset was provided to a university-affiliate, IPAM e.V., for further research applications. The dataset combines a complete record of patient diagnoses, treatment, healthcare resource use, and costs (AOK PLUS), with detailed clinical parameters including functional performance and patient-reported outcomes (MSDS3D). The dataset currently captures 500 patients; however, is actively expanding. To demonstrate its potential, we present a use case describing characteristics, treatment, resource use, and costs of a patient subsample. By linking administrative claims to clinical information in medical charts, the novel MSDS-AOK PLUS database can increase the quality and scope of real-world studies in MS.

P457 Treatment duration of ustekinumab in patients with Crohn’s disease (CD) and psoriasis (PSO) – real-world evidence from German claims data

Abstract Background Ustekinumab is a monoclonal antibody approved for the treatment of inflammatory diseases such as Crohn’s disease (CD) or psoriasis (PSO). Real-world evidence about treatment persistence of patients treated with ustekinumab is scarce. This retrospective observational study uses German claims data to analyse average treatment duration of ustekinumab in CD and PSO patients in a real-world setting. Methods Patients with at least two confirmed outpatient diagnoses or one inpatient diagnosis of Crohn’s disease (ICD-10 code: K50*) between 01/01/2016 and 30/06/2020 and a subsequent incident prescription of ustekinumab (ATC code: L04AC05) between 01/01/2017 and 30/06/2020 were identified in the AOK PLUS database, a sickness fund with more than 3.4 million patients from the states of Saxony and Thuringia in the eastern part of Germany. Similarly, patients with at least two outpatient diagnoses or one inpatient diagnosis of psoriasis (ICD-10 code: L40*) between 01/01/2010 and 30/06/2020 and an incident prescription of ustekinumab between 01/01/2011 and 30/06/2020 were identified. Treatment durations were quantified by assessing the time from the first ustekinumab prescription until treatment discontinuation. Discontinuation was defined as a gap of at least 90 days between the end date of the last prescription and the date of the next prescription or switch to another biologic agent. Deaths were counted as treatment discontinuations, and patients were censored at the end of follow-up or disenrolment from the sickness fund. Stockpiling was taken into account (i.e., accumulated medications were assumed to be taken consecutively), and hospitalizations were considered as a part of treatment. Treatment duration was explored in a Kaplan-Meier analysis. Results A total of 251 CD and 848 PSO patients with incident ustekinumab treatment were identified. 39 CD (15.5%) and 375 PSO patients (44.2%) discontinued treatment during the study period (median follow-up: 16.1 and 44.9 months; total patient years: 383.6 and 3338.7 for CD and PSO, respectively). For CD, median time to treatment discontinuation was not reached, as most patients were still on treatment at the end of the follow-up period; for PSO, median time to treatment discontinuation was 51.5 months (Table 1 &amp; Figure 1). Conclusion Our results provide real-world evidence of ustekinumab treatment duration in patients with CD and PSO in Germany. A low proportion of CD patients discontinuing treatment over the available follow-up period and a median treatment duration of more than four years for PSO indicate that ustekinumab treatment persistence is high in these patient groups.