Publications & presentations

Infectious diseases

• In cooperation with: Sanofi-Aventis Deutschland GmbH
• Journal: Vaccine
• https://pubmed.ncbi.nlm.nih.gov/41337979/
• Abstract:
  Background: Despite recommendations from German public health authorities for seasonal influenza immunization, vaccination coverage rates (VCRs) fall short of targets. This study explores gaps in influenza VCRs, focusing on the intensity of outpatient care of adults for whom vaccination is recommended.
  Material and methods: We conducted a retrospective study based on a large German statutory health insurance claims database provided by GWQ ServicePlus AG. For influenza seasons 2016-2017 to 2022-2023, we examined seasonal VCRs in the adult population differentiated by age, prevalence of chronic conditions, and participation in disease management programs (DMP) or GP-centered care programs. We also explored the relationship between VCRs and physician contact frequency during the vaccination-relevant period from September to February.
  Results: Seasonal VCRs of individuals aged 60+, for whom influenza vaccination is generally recommended, varied between 34.8 % (2016-2017) and 47.0 % (2020-2021). We observed higher VCRs among individuals with chronic conditions and among individuals who participated in GP-centered care in all age groups. Among adults with DMP-relevant chronic conditions, VCRs were higher for participants than for individuals not participating in 4 out of 5 examined DMPs. VCRs consistently increased with number of GP contacts. In the 60+ group, cross-seasonal average VCRs increased from 24.0 % for individuals with one GP contact to 52.7 % for individuals with five or more GP contacts. However, most unvaccinated individuals with chronic conditions in this age group had 5 or more GP contacts during the vaccination-relevant period.
  Conclusion: VCRs remain below targets for all investigated groups. Higher VCRs among DMP and GP-centered care participants and patients with multiple GP contacts emphasize the relevance of outpatient care intensity for the vaccination process. However, most unvaccinated individuals with prevalent chronic conditions have frequent contacts with care providers, underlining the need for care providers to routinely assess and discuss the vaccination status of their patients.
  Keywords: Care intensity; Influenza; Outpatient care; Vaccination coverage rates.

Infectious diseases

• In cooporation with: Sanofi-Aventis Deutschland GmbH
• Journal: Vaccine
• https://pubmed.ncbi.nlm.nih.gov/41360028/
• Abstract:
  Background: In 2021, German authorities introduced a preferential recommendation for inactivated quadrivalent high-dose (HD) influenza vaccines for adults aged 60 years and older. This recommendation was motivated by randomized and observational studies showing higher efficacy and effectiveness compared to standard-dose (SD) influenza vaccines in older adults. It is unknown to which extent this recommendation was followed.
  Material and methods: This retrospective study uses IQVIA™ Vaccine Analyzer (VA) data from the 2021-2022 to 2023-2024 influenza seasons to examine vaccination coverage rates and proportions of HD among administered influenza vaccines in age group ≥60 years stratified by different individual-level and practice-level characteristics.
  Results: Influenza vaccination coverage rates in the older German population remain far below national targets. However, the proportion of HD vaccinations increased significantly up to 92.4 % in 2023-2024, implying that the preferential recommendation was increasingly followed. Overall, our results indicate high acceptance of HD vaccines among physicians and patients.
  Keywords: High-dose vaccination; Influenza; Vaccination rates.

Oncology / Orphan Diseases

• In cooperation with: Rhythm Pharmaceuticals
• Journal: European Journal of Heatlh Economics
• https://pubmed.ncbi.nlm.nih.gov/40343652/
• Abstract:
  Background: Rapid and abnormal weight gain resulting in severe persistent obesity due to physical, tumor- and/or treatment-related damage to the hypothalamus, is called acquired hypothalamic obesity (aHO), and is often linked to craniopharyngioma and/or sellar/suprasellar tumors. Here, we examine the healthcare resource use (HCRU) and costs of aHO following treatment of these tumors.
  Methods: We used a retrospective matched cohort design with German statutory health insurance data on 5.42 million people from 2010 to 2021. We applied a novel three-step approach using diagnostic and prescription data to identify patients with treatment- or tumor-related (TTR)-aHO. We measured HCRU and costs across hospitalizations, outpatient visits, visits per specialist group, and outpatient prescription medications.
  Results: Compared to non-HO obesity, TTR-aHO is associated with increased hospitalizations, increased outpatient physician visits, and increased prescription use in the two years after incident tumor surgery/radiotherapy. Excess costs of TTR-aHO are €19,900 per patient in the first year and €10,700 in the second, driven by inpatient costs. Cost-intensive hormone replacement therapies like somatropin lead to a sharp increase in prescription costs in the second year.
  Conclusions: This study provides the first real-world analysis of TTR-aHO economics, emphasizing the importance of HCRU and costs for decision-making. Previously, economic evaluations have been missing due to the lack of a standard method to identify patients with aHO in retrospective studies. Using a new identification approach, the study reveals that TTR-aHO poses a significant burden in extensive treatment requirements for patients and high related costs for the healthcare system.
  Keywords: Craniopharyngioma; Endocrinology; Hypothalamic obesity; Rare sellar/suprasellar tumors; Tumor/treatment related aHO.

General Medicine

• In cooperation with: Daiichi Sankyo Deutschland GmbH
• Journal: Journal of Clincal Lipidology
• https://pubmed.ncbi.nlm.nih.gov/40287347/
• Abstract:
  Background: 2019 European Society of Cardiology (ESC)/European Atherosclerosis Society (EAS) guidelines on management of dyslipidemia outline treatment goals of low-density lipoprotein cholesterol reduction in patients with high and very high cardiovascular (CV) risk.
  Objective: To describe the proportion, clinical characteristics, and treatment practices of adult patients with dyslipidemia and high or very high CV risk in Germany.
  Methods: Based on German claims data from 2010 to 2019, a retrospective cross-sectional study on prevalence, incidence, and treatment pathways in patients with dyslipidemia and high and very high CV risk was performed.
  Results: Between 2010 and 2019, there were 213 to 233 adult patients per 1000 with prevalent dyslipidemia based on ICD 10 codes. Annual incidence ranged from 31.7 to 40.2 per 1000. In 2019, 1.2% and 22.8% of the prevalent patients were classified to high or very high CV risk. Out of these patients, 61.7% and 78.5% received lipid-lowering treatments (LLT). Among incidence patients, prescription rates were further apart between high-risk and very-high-risk patients, at 56.6% and 79.2%. Cross-sectional analysis showed that in 2019 statin monotherapy was the most common LLT (87.2%) administered mainly at moderate dose (59.9%). In that year, 2.7% and 8.4% of the patients received ezetimibe as monotherapy or in combination with statins. The proportion of treatment pause, or discontinuation was 56.6% over time, with subsequent reinitiation for 42.0% of patients.
  Conclusion: Analysis indicates that despite recommendations, intensive treatment therapies are underutilized in clinical practice even in high and very high CV risk patients with primary hypercholesterolemia/mixed dyslipidemia, who may have benefited from LLT optimization.
  Keywords: Cardiovascular risk; Dyslipidemia; Epidemiology; Hypercholesterolemia; LLT; Lipid-lowering treatment; Treatment pathways.

Infectious diseases

• In cooperation with: Moderna
• Journal: Infectious Diseases and Therapy
• https://pubmed.ncbi.nlm.nih.gov/40279020/
• Abstract:
  Introduction: Respiratory syncytial virus (RSV) is a pathogen that may cause severe respiratory infections. Recent research indicates that RSV may be underdiagnosed, especially in adult populations. This study aims to investigate the burden of RSV in hospitalized adults.
  Methods: A retrospective, matched-control cohort study covering the seasons 2011/2012 to 2021/2022 was performed on the basis of anonymized claims data from 6 million individuals in multiple German statutory health funds. Analyses comprise hospitalized persons aged 18+ years. Patients with RSV were identified using the International Classification of Diseases, tenth revision, German Modification (ICD-10-GM) codes directly related to RSV (narrow approach) and indirectly related to RSV (ICD-10-GM codes covering lower respiratory tract infections, broad approach). Comparing these cohorts can provide a reasonable estimate of upper and lower bounds. For patients with a secondary inpatient diagnosis of RSV, we evaluated mortality rates, lengths of stay (LOS), costs, special fees, intensive care unit (ICU) admission rates, ventilation rates, and use of high-flow oxygen. Cohorts were matched with controls using an 1:1 exact matching approach using age, sex, Charlson Comorbidity Index (CCI, excluding age), main inpatient diagnosis, and quarter/year of admission.
  Results: Mortality rates were between 15.5 (standard deviation, SD 1.031) and 19.8 (SD 0.070) times higher for patients with secondary inpatient diagnosis of RSV compared with their controls. Average LOS was 1.77 (SD 0.007) times longer than in controls, and healthcare costs were between 5600 EUR (SD 132.81) and 8400 EUR (SD 2313.54) higher for patients with RSV. No significant differences were found between patients with RSV and controls with respect to rehospitalization rate, invasive ventilation rate, or high-flow oxygen rate; however, patients indirectly related to RSV were admitted more often to intensive care (10.54% versus 3.25%).
  Conclusions: Our study provides a deeper understanding of how RSV secondary diagnosis affects hospitalized patients, finding that RSV infection dramatically increases mortality rate, LOS, and inpatient healthcare costs. These findings support a broad RSV-vaccination recommendation for this patient group.
  Keywords: Burden of disease; Hospitalization; Patient outcome assessment; RSV; Respiratory syncytial viruses.

Infectious diseases

• In cooporation with: Sanofi-Aventis Deutschland GmbH
• Journal: Infectious Diseases and Therapy
• https://pubmed.ncbi.nlm.nih.gov/40153135/
• Abstract:
  Introduction: Invasive meningococcal disease (IMD) is a rare but serious condition caused by Neisseria meningitidis, with rising cases of serogroups W and Y in Germany. Currently, routine vaccination in Germany includes MenC vaccination in toddlers, and as of early 2024, MenB vaccination has been recommended in infancy. MenACWY vaccination, however, is currently only recommended for high-risk individuals. This study evaluates the potential public health impact and cost-effectiveness of introducing routine adolescent MenACWY or MenC vaccination in Germany.
  Methods: This study presents a health economic evaluation based on a previously published dynamic transmission model, which simulates the introduction of MenACWY vaccination in adolescents in Germany. The evaluation incorporates costs and quality-adjusted life years (QALYs), and is conducted from a societal perspective. Deterministic and probabilistic sensitivity analyses were performed to assess the robustness of the findings and to account for parameter uncertainty.
  Results: The introduction of adolescent MenACWY vaccination was estimated to prevent 1467 IMD cases and 156 deaths by 2060, leading to a total gain of 2333 QALYs. The MenACWY vaccination strategy was associated with incremental costs of approximately €306 million, resulting in an incremental cost-effectiveness ratio (ICER) of €131,150 per QALY gained. Scenarios assuming higher levels of carriage protection reduced the ICER to as low as €76,000 per QALY. In contrast, adolescent MenC vaccination had a comparatively minor impact on IMD incidence and mortality, with ICERs exceeding €1 million per QALY. Sensitivity analyses highlighted the significant influence of assumed vaccine carriage protection and duration of protection on the ICER.
  Conclusions: Adolescent MenACWY vaccination in Germany has the potential to reduce the incidence and mortality of IMD, particularly from serogroups W and Y. Although the cost-effectiveness of the strategy depends on several assumptions, particularly the extent of carriage protection, the ICER for MenACWY introduction appears favorable.
  Keywords: Cost-effectiveness; Germany; Invasive meningococcal disease; MenACWY; MenC; Meningococcal conjugate vaccination; Neisseria meningitides.
  

Infectious diseases, Epidemiology, Risk assessment

• In cooperation with: GlaxoSmithKline
• Journal: Infectious Diseases and Therapy
• https://pubmed.ncbi.nlm.nih.gov/39987321/
• Abstract:
  Introduction: Patients with depression were shown to be at increased risk of herpes zoster (HZ). However, an in-depth description of depression as a risk factor for HZ, postherpetic neuralgia (PHN), and HZ recurrence is lacking. The goal of this study was to quantify the risk of HZ, PHN, and HZ recurrence in people with depression and among depression-related subgroups in Germany.
  Methods: Using health insurance claims data from 2012 to 2021 from a large German claims database, people ≥ 18 years old diagnosed with depression were identified and matched to control persons without depression using a rolling cohort design. Incidence rates (cases per 1000 person-years [PYs]) and incidence rate ratios (IRRs) were calculated using Poisson models.
  Results: Overall, 1,768,701 people with depression were matched to controls without depression. HZ incidence rates were higher in people with depression (10.51 cases/1000 PYs) than in people without depression (9.04 cases/1000 PYs). Overall, people with depression had a significantly increased risk of HZ (IRR = 1.16; p < 0.0001), PHN (IRR = 1.16; p < 0.0001), and HZ recurrence (IRR = 1.22; p < 0.0001). IRRs were highest in the 18 to 49 years age group (IRR HZ = 1.24; p < 0.0001; IRR PHN = 1.35; p < 0.0001). IRRs for HZ were highest in people with mental disorder comorbidities (IRR = 1.23; p < 0.0001).
  Conclusions: A diagnosis of depression is associated with an increased risk of HZ, PHN, and HZ recurrence. People with depression should be considered when developing HZ vaccination recommendations.
  Keywords: Depression; Germany; Healthcare claims data; Herpes zoster; Incidence; Postherpetic neuralgia; Risk factors.

Oncology / Orphan Diseases

• In cooperation with: Rhythm Pharmaceuticals
• Journal: Scientific reports
• https://pubmed.ncbi.nlm.nih.gov/39814823/
• Abstract:
  Survivors of sellar/suprasellar tumors involving hypothalamic structures face a risk of impaired quality of life, including tumor- and/or treatment-related hypothalamic obesity (TTR-HO) defined as abnormal weight gain resulting in severe persistent obesity due to physical, tumor- and/or treatment related damage of the hypothalamus. We analyze German claims data to better understand treatment pathways for patients living TTR-HO during the two years following the index surgical treatment. A database algorithm identified patients with TTR-HO in a representative German payer claims database between 2010 and 2021 (n = 5.42 million patients). Claims from 37 patients with TTR-HO were analyzed on a quarterly basis over 2 years. The analysis considered inpatient, outpatient, and prescription data. In the follow-up period, patients with TTR-HO are hospitalized 3.68 times on average; 37% of hospitalizations in year 1 and 31% in year 2 are due to TTR-HO. On average, patients see a general practitioner 12.27 times and various specialists 20.45 times. The need for complex neuroendocrine therapy develops quickly, with most patients having 2-3 neuroendocrine prescriptions in any given quarter. The management of patients with TTR-HO requires frequent inpatient and outpatient visits for tumor follow-up and management of incident comorbidities, and most patients with TTR-HO require intense polytherapy.
  Keywords: Craniopharyngioma; Endocrinology; Hypothalamic obesity; Rare sellar/suprasellar tumors; Tumor/treatment related HO.

Oncology / Orphan Diseases

In cooperation with: Rhythm Pharmaceuticals
Journal: Journal of Neuroendocrinology
https://pubmed.ncbi.nlm.nih.gov/41236025/

Abstract:

Acquired hypothalamic obesity (aHO) is characterized by rapid and persistent weight gain resulting from structural or functional damage to the hypothalamus, typically accompanied by neuroendocrine dysfunction. While aHO is well described in the context of hypothalamic or suprasellar tumors, particularly craniopharyngioma, little is known about its epidemiology in non-tumor-related etiologies such as traumatic brain injury (TBI) or subtle, unrecognized hypothalamic injuries. This study estimates the incidence and clinical characteristics of aHO in patients with traumatic brain injury (TBI-aHO) and hypothalamic-pituitary axis dysfunction of unclear origin, referred to as unspecified microinjury (UM-aHO). We conducted a retrospective cohort study using German statutory health insurance claims data (N = 6.3 million, 2010-2022). Patients were included based on either an incident diagnosis of TBI or a diagnostic algorithm indicating hypothalamic-pituitary axis dysfunction without a documented causal event. aHO was defined via incident obesity coding and validated by concomitant arginine vasopressin deficiency (AVP-D) and desmopressin prescription. For UM-aHO, additional validation required at least three concurrent neuroendocrine replacement therapies. Sensitivity analyses assessed the robustness of case definitions. The estimated incidence of TBI-aHO was 1.78 per million persons (mean age: 42 years; 27% female), corresponding to approximately 520 prevalent cases in Germany. UM-aHO showed a slightly higher incidence of 2.12 per million (mean age: 37 years; 55% female), with an estimated 660 prevalent cases. Following the diagnosis of incident obesity, most patients in both cohorts received at least two neuroendocrine therapies in addition to desmopressin, most commonly including hydrocortisone and levothyroxine sodium. This is the first population-based study to characterize aHO following non-tumor-related hypothalamic injury. Both TBI and subtle, nonspecific hypothalamic microinjuries contribute meaningfully to the burden of aHO in clinical practice. These findings underscore the need for increased clinical awareness and early recognition of hypothalamic dysfunction in patients beyond classical tumor etiologies.

Keywords:

acquired hypothalamic obesity; neuroendocrine disease; rapid weight gain; septo‐optic dysplasia; traumatic brain injury.

General Medicine

• In cooperation with: Robert Koch-Institute
• Journal: Journal of Health Monitoring
• https://pubmed.ncbi.nlm.nih.gov/39411331/
• Abstract:
  Background: Attention-deficit/hyperactivity disorder (ADHD) is associated with increased costs for the family, the health care system and the society. Previous cost-of-illness studies in Germany usually focused on prevalent ADHD. This study addressed the research gap on health care resource utilisation and costs of children and adolescents with incident ADHD diagnosis using nationwide claims data from the statutory health insurance DAK-Gesundheit.
  Methods: A matched-control design (propensity score matching, 1:3 ratio) was used to examine the health care costs of incident ADHD patients compared with a non-ADHD control group, considering an observation period of four quarters. Besides bivariate statistics, multivariate analyses of total costs were used to consider relevant covariates.
  Results: Total health care costs for children and adolescents with ADHD in the first year after diagnosis exceeded those of the control group by € 1,505.3. According to the multivariate analysis, the group with incident ADHD had significantly higher (2.86-fold) health care costs when compared with non-ADHD peers. Sensitivity analyses proved these findings. In addition, the analyses identified children’s age and comorbidity index to be significantly associated with increased costs.
  Conclusions: ADHD in children and adolescents is associated with a significant economic burden. The results emphasise the need for social awareness, prevention, appropriate treatment and research efforts.
  Keywords: Adolescent; Attention-deficit disorder with hyperactivity; Child; Comorbidity; Delivery of health care; Financial stress; Health; Health care costs; Insurance; Multivariate analysis; Propensity score.

General Medicine

• In cooporation with: Robert Koch-Institute
• Journal: Journal of Health Monitoring
• https://pubmed.ncbi.nlm.nih.gov/39411330/
• Abstract:
  Background: The study examines the psychometric properties of the ADHD section of the semi-structured diagnostic interview ILF-EXTERNAL, which was conducted online via video chat.
  Methods: As part of the INTEGRATE-ADHD research project, 202 children and adolescents (age M = 12.87 years, SD = 3.04, 28.2 % female) with an administrative diagnosis of ADHD registered with their health insurance company were clinically assessed for the presence of ADHD according to the German ADHD S3 guideline. Using the ILF-EXTERNAL, one parent and, from the age of eight, also the children themselves were interviewed. A proxy rating by a parent was made using the German FBB-ADHS rating scale. In a subsample (n = 65), an independent blind interviewer rated the videorecordings of the ILF-EXTERNAL parent interview to determine the interrater reliability of the ILF-EXTERNAL.
  Results: All ADHD symptom scales of the ILF-EXTERNAL showed good to excellent internal consistency (α = 0.89 to 0.93). Interrater reliability was high for both categorical and dimensional analyses (κ = 0.78 and κ = 0.81; ICC(1,1) = 0.97 and 0.98). High correlations of the ILF-EXTERNAL parent interview with the FBB-ADHS (r = 0.79 to r = 0.85) and with the ILF-EXTERNAL child interview (r = 0.60 to r = 0.71) demonstrated convergent validity.
  Conclusions: Sound psychometric properties of the ILF-EXTERNAL were also confirmed for its use in an online setting. High interrater reliabilities demonstrate the quality of the ADHD diagnostics carried out in the consortium project INTEGRATE-ADHD.
  Keywords: ADHD; Attention-deficit/hyperactivity disorder; Children; ILF-EXTERNAL; adolescents; clinical interview; online diagnostics; psychometric properties; psychometrics; reliability; validity.

Infectious diseases

• In cooporation with: GlaxoSmithKline
• Journal: Infectious Diseases and Therapy
• https://pubmed.ncbi.nlm.nih.gov/38294623/
• Abstract
  Introduction: Pertussis is a highly contagious respiratory infection. It affects people of all ages, yet evidence of the impact of pertussis in adults with underlying conditions (UCs) is scarce. This study investigated the incidence and complication rate of pertussis in adult patients with and without UC.
  Methods: A retrospective analysis was conducted using routinely collected German claims data between 2015 and 2019. Patients with and without different pneumological, cardiovascular, endocrinological, musculoskeletal, and psychological UCs were matched for incidence estimation. Logistic regression models were used to estimate the risk of pertussis depending on the presence of UCs. Negative binomial models were used to assess complication rates in patients with pertussis and with and without UC.
  Results: In total, 4383 patients were diagnosed with pertussis during the study period. Patients with any UC had an increased risk for pertussis compared to matched patients without UC (odds ratio [OR] 1.72; 95% confidence interval [CI]1.60-1.84, p < 0.0001). Underlying asthma had the highest risk of pertussis (OR 2.70; 95% CI 2.50-2.91, p < 0.0001), followed by chronic obstructive pulmonary disease (OR 2.35; 95% CI 2.10-2.60, p < 0.0001) and depression (OR 2.08; 95% CI 1.95-2.22, p < 0.0001). Severe complications occurred in 10.8% of the pertussis cohort (13.4% with UC vs. 9.5% without UC). The UC-attributable effect on the risk of severe pertussis-related complications was significantly increased for any UC (incidence rate ratio [IRR] 1.29, 95% CI 1.19-1.39). The severe complication risk was also increased for patients aged 60+ (IRR 1.59, 95% CI 1.46-1.72).
  Conclusion: This study shows that adults with certain UCs have an increased risk for pertussis and are more likely to have complications. These results provide further evidence that pertussis is a relevant and impactful infectious disease in adults with and without certain UC, indicating that these patients need to be considered when developing vaccination recommendations to avoid pertussis and its associated complications. A graphical abstract is available with this article.
  Keywords: Comorbidity; Incidence; Older adults; Pertussis; Real world evidence; Risk factor; Whooping cough.

Infectious diseases

• In cooporation with: Sanofi-Aventis Deutschland GmbH
• Journal: Infectious Diseases and Therapy
• https://pubmed.ncbi.nlm.nih.gov/38570446/
• Abstract
  Introduction: Invasive meningococcal disease (IMD) causes significant mortality and long-term sequelae. This study assesses the potential public health impact of adolescent vaccination strategies employing MenACWY and MenC vaccines in Germany, where the existing meningococcal immunisation programme predominantly involves MenC administration in toddlers.
  Methods: A dynamic transmission model was developed to simulate the carriage of five meningococcal serogroup compartments (AY/B/C/W/Other) from 2019 until 2060 within 1-year age groups from 0 to 99 years of age. IMD cases were estimated based on case-carrier ratios. The model considered vaccine effectiveness against carriage acquisition and IMD.
  Results: The model predicts that introducing MenACWY adolescent vaccination could lead to a considerable reduction in IMD incidence, with the potential to prevent up to 65 cases per year and a cumulative total of 1467 cases by 2060. This decrease, mainly driven by herd effects, would result in a reduction of IMD incidence across all age groups, regardless of vaccination age. Furthermore, implementing MenACWY vaccination in adolescents is projected to decrease annual MenACWY-related IMD mortality by up to 64%, equating to an overall prevention of 156 IMD deaths by 2060. These protective outcomes are expected to culminate in approximately 2250 life years gained (LYG) throughout the model’s projected time horizon. In contrast, the adoption of MenC vaccination in adolescents is predicted to have minimal influence on both IMD incidence and mortality, as well as on LYG.
  Conclusion: The results of this study demonstrate that implementing MenACWY vaccination for adolescents in Germany is likely to notably reduce IMD incidence and mortality across age groups. However, the introduction of MenC adolescent vaccination shows only limited impact. Considering the extensive healthcare resources typically required for IMD management, these findings suggest the potential for economic benefits associated with the adoption of MenACWY adolescent vaccination, warranting further cost-effectiveness analysis.
  Keywords: Dynamic transmission model; Epidemiological modelling; Germany; Herd effects; Invasive meningococcal disease; Life years gained; MenACWY; MenC; Meningococcal conjugate vaccination.

NA

• In cooporation with: None
• Journal: BMC Med Inform Decis Mak
• https://pubmed.ncbi.nlm.nih.gov/38965569/
• Abstract
  Background: Medication errors and associated adverse drug events (ADE) are a major cause of morbidity and mortality worldwide. In recent years, the prevention of medication errors has become a high priority in healthcare systems. In order to improve medication safety, computerized Clinical Decision Support Systems (CDSS) are increasingly being integrated into the medication process. Accordingly, a growing number of studies have investigated the medication safety-related effectiveness of CDSS. However, the outcome measures used are heterogeneous, leading to unclear evidence. The primary aim of this study is to summarize and categorize the outcomes used in interventional studies evaluating the effects of CDSS on medication safety in primary and long-term care.
  Methods: We systematically searched PubMed, Embase, CINAHL, and Cochrane Library for interventional studies evaluating the effects of CDSS targeting medication safety and patient-related outcomes. We extracted methodological characteristics, outcomes and empirical findings from the included studies. Outcomes were assigned to three main categories: process-related, harm-related, and cost-related. Risk of bias was assessed using the Evidence Project risk of bias tool.
  Results: Thirty-two studies met the inclusion criteria. Almost all studies (n = 31) used process-related outcomes, followed by harm-related outcomes (n = 11). Only three studies used cost-related outcomes. Most studies used outcomes from only one category and no study used outcomes from all three categories. The definition and operationalization of outcomes varied widely between the included studies, even within outcome categories. Overall, evidence on CDSS effectiveness was mixed. A significant intervention effect was demonstrated by nine of fifteen studies with process-related primary outcomes (60%) but only one out of five studies with harm-related primary outcomes (20%). The included studies faced a number of methodological problems that limit the comparability and generalizability of their results.
  Conclusions: Evidence on the effectiveness of CDSS is currently inconclusive due in part to inconsistent outcome definitions and methodological problems in the literature. Additional high-quality studies are therefore needed to provide a comprehensive account of CDSS effectiveness. These studies should follow established methodological guidelines and recommendations and use a comprehensive set of harm-, process- and cost-related outcomes with agreed-upon and consistent definitions.
  Prospero registration: CRD42023464746.
  Keywords: Decision support systems, clinical; Medical Order Entry systems; Medication errors; Outcome Assessment (Health Care); Primary Health Care; Systematic review.

Infectious diseases

• In cooporation with: DAK-Gesundheit
• Journal: Infection
• https://pubmed.ncbi.nlm.nih.gov/39285063/
• Abstract
  Purpose: Evidence on the incidence and persistence of post-acute sequelae of COVID-19 (PASC) among children and adolescents is still limited.
  Methods: In this retrospective cohort study, 59,339 children and adolescents with laboratory-confirmed COVID-19 in 2020 and 170,940 matched controls were followed until 2021-09-30 using German routine healthcare data. Incidence rate differences (ΔIR) and ratios (IRR) of 96 potential PASC were estimated using Poisson regression. Analyses were stratified according to age (0-11, 12-17 years), and sex. At the individual level, persistence of diagnoses in patients with onset symptoms was tracked starting from the first quarter post-infection.
  Results: At 0-3 month follow-up, children and adolescents with a previous SARS-CoV-2 infection showed a 34% increased risk of adverse health outcome, and approximately 6% suffered from PASC in association with COVID-19. The attributable risk was higher among adolescents (≥ 12 years) than among children. For most common symptoms, IRRs largely persisted at 9-12 month follow-up. IRR were highest for rare conditions strongly associated with COVID-19, particularly inflammatory conditions among children 0-11 years, and chronic fatigue and respiratory insufficiency among adolescents. Tracking of diagnoses at the individual level revealed similar rates in the decline of symptoms among COVID-19 and control cohorts, generally leaving less than 10% of the patients with persistent diagnoses after 12 months.
  Conclusion: Although very few patients presented symptoms for longer than 12 months, excess morbidity among children and, particularly, adolescents with a history of COVID-19 means a relevant burden for pediatric care.
  Keywords: COVID-19; Electronic health records; Epidemiology; Pediatrics; Post-COVID

Infectious diseases

• In cooporation with: Viatris
• Journal: Journal of Health Monitoring
• https://pubmed.ncbi.nlm.nih.gov/39376163/
• Abstract
  Background: In 2003, the WHO aimed for a 75% or higher influenza vaccination rate among at-risk populations. However, this target was achieved in a few groups during selected seasons in some European countries, and never in Germany. Adults with underlying conditions (UCs) are a critical negleted group for influenza vaccination. This study aimed to identify data gaps in influenza burden and vaccination coverage among adults under 60 with UCs in Germany and bridge these gaps using real-world data.
  Material and methods: We conducted systematic research and analyses using German administrative and claims databases from June 2016 to April 2024. We report on epidemiology, direct care costs, indirect costs from work incapacity, vaccination coverage rates, and describe data gaps.
  Results: Influenza data for high-risk populations are limited. Comprehensive data on influenza epidemiology and vaccination coverage rates (VCR) is available, though with a delay in data availability. Before and after the pandemic, individuals aged 50-59 had the highest rates of influenza-related hospitalization and ICU admission compared to younger age groups. Across all age groups and seasons, individuals with UC experienced higher rates of medically attended influenza cases, hospitalizations, and healthcare costs, with those aged 35-59 being particularly vulnerable. Vaccine coverage was higher in adults aged 35-59 compared to those aged 18-24, and in females compared to males.
  Limitations: Discrepancies of vaccination status, limited data availability, and variations among the extent of UCs.
  Conclusion: In Germany, recent policy measures have mainly targeted those aged 60 and above. While this elderly population experiences the highest disease-related impact, influenza can also lead to substantial healthcare resource utilization (HCRU) and costs in younger populations with chronic UCs; Facilitating vaccination access for this group, such as through pharmacies, is essential. Definition of quantifiable vaccination targets and measures to increase vaccination rates based on these targets are required.
  Keywords: I; I1; I10; I11; I19; Influenza in humans; adults; economics; germany; hospitalization; influenza vaccines; risk factors; vaccination coverage.

Infectious diseases

• In cooporation with: DAK-Gesundheit
• Journal: BMC Infectious Disease
• https://pubmed.ncbi.nlm.nih.gov/39385128/
• Abstract
  Background: Post-viral symptoms have long been known in the medical community but have received more public attention during the COVID-19 pandemic. Many post-viral symptoms were reported as particularly frequent after SARS-CoV-2 infection. However, there is still a lack of evidence regarding the specificity, frequency and persistence of these symptoms in comparison to other viral infectious diseases such as influenza.
  Methods: We investigated a large population-based cohort based on German routine healthcare data. We matched 573,791 individuals with a PCR-test confirmed SARS-CoV-2 infection from the year 2020 to contemporary controls without SARS-CoV-2 infection and controls from the last influenza outbreak in 2018 and followed them up to 18 months.
  Results: We found that post-viral symptoms as defined for COVID-19 by the WHO as well as tissue damage were more frequent among the COVID-19 cohort than the influenza or contemporary control cohort. The persistence of post-viral symptoms was similar between COVID-19 and influenza.
  Conclusion: Post-viral symptoms following SARS-CoV-2 infection constitute a substantial disease burden as they are frequent and often persist for many months. As COVID-19 is becoming endemic, the disease must not be trivialized. Research should focus on the development of effective treatments for post-viral symptoms.
  Keywords: Claims data; Cohort study; Influenza; Post-COVID; SARS-CoV-2.

General Medicine

• In cooporation with: Robert Koch-Institute
• Journal: Journal of Health Monitoring
• https://pubmed.ncbi.nlm.nih.gov/39411326/
• Abstract
  Background: The health-related quality of life (HRQoL) of individuals living with Attention-deficit/hyperactivity disorder (ADHD) is known to be impaired. Identifying factors that influence HRQoL can provide important information for the development of prevention and intervention programmes for affected children and adolescents. The aim of the present study was to investigate health care-related and psychosocial risk and protective factors for HRQoL in children and adolescents with an administrative ADHD diagnosis.
  Methods: In the consortium project INTEGRATE-ADHD, n = 4,809 parents of children and adolescents aged 7 to 17 years participated in an online survey between October 2021 and August 2022 and answered questions regarding HRQoL (KIDSCREEN-27), health care utilisation, and psychosocial risk and protective factors. Multiple linear regression analyses were conducted to assess the association between these factors and the five HRQoL dimensions of the KIDSCREEN-27.
  Results: Findings indicate that parental psychopathology and parental burden were risk factors for lower HRQoL in children and adolescents with ADHD. Further, a positive association was found between the five HRQoL dimensions and the psychosocial factors family climate and social support, indicating that these are protective factors.
  Conclusions: The results highlight the importance of prevention and intervention programmes for individuals with ADHD that consider parental mental health and aim to strengthen resources such as the availability of good family climate and social support.
  Keywords: ADHD; Adolescents; Children; Health care utilisation; Health-related quality of life; Mental health; Parents; Protective factors; Resources; Risk factors; Social support.

General Medicine

• In cooporation with: Robert Koch-Institute
• Journal: Journal of Health Monitoring
• https://pubmed.ncbi.nlm.nih.gov/39411327/
• Abstract
  Background: In the project INTEGRATE-ADHD, administrative and parent-reported ADHD diagnosis data of children and adolescents were linked at person level for the first time in Germany. This contribution analyses discrepancies between the data sources, considering sociodemographic characteristics.
  Methods: Parents of 5,461 0- to 17-year-olds insured with the German statutory health insurance company DAK-Gesundheit in 2020, who had a confirmed administrative diagnosis of ADHD (ICD-10 F90.0-9) in at least one quarter (M1Q criterion), were surveyed online about their child’s ADHD diagnosis and other health and care-related topics. Using logistic regression, associations between the presence of a parental report of the child’s administrative ADHD diagnosis and sociodemographic predictors were analysed.
  Results: 71.6 % of parents reported their child’s administrative diagnosis of ADHD in the survey. The diagnosis was significantly less likely to be reported by parents of girls, younger children, children with a migration background and children from nuclear families with both biological parents. There were no differences with regard to parental education, urbanisation (urban/rural) or density of care. Bivariate findings were confirmed in the multivariable model.
  Conclusions: Approximately one third of parents do not report their child’s administrative diagnosis of ADHD. The likelihood of parental reporting varies according to sociodemographic factors. This should be considered when contextualising the data sources in the future.
  Keywords: ADHD; Data linkage; administrative; adolescents; children; epidemiological; parent report; prevalence; survey.

General Medicine

• In cooporation with: Robert Koch-Institute
• Journal: Journal of Health Monitoring
• https://pubmed.ncbi.nlm.nih.gov/39411328/
• Abstract:
  Background: The consortium project INTEGRATE-ADHD compared administrative data on the presence of attention-deficit/hyperactivity disorder (ADHD) in children and adolescents with the results of a parent survey and a comprehensive clinical assessment based on the S3 guideline of the Association of the Scientific Medical Societies in Germany (AWMF). Due to the COVID-19 pandemic, the clinical assessment was carried out online.
  Methods: The article describes how a guideline-based clinical assessment of ADHD can be implemented in an online setting. A specially developed diagnostic matrix is presented to illustrate the assessment procedures and the diagnostic decision-making process. The matrix is intended to help the diagnostician to gain an overview of the numerous individual findings that have been collected using different assessment perspectives and methods (e.g. diagnostic interviews, rating scales, performance tests) in order to make a well-founded and transparent diagnostic decision.
  Discussion: The consortium project INTEGRATE-ADHD has shown that an online assessment can be implemented in a guideline-compliant manner and allows a valid clinical decision. The diagnostic strategy is discussed with reference to international guidelines and recommendations for online diagnostics (e.g. aspects of feasibility, acceptability and safety of the assessment procedures). The challenges and opportunities of using online assessments in clinical practice are also described.
  Keywords: ADHD; Adolescents; Children; Feasibility Studies; Germany; Online assessment; S3 guideline; Telehealth.

General Medicine

• In cooporation with: Robert Koch-Institute
• Journal: Journal of Health Monitoring
• https://pubmed.ncbi.nlm.nih.gov/39411329/
• Abstract:
  Background: The consortium project INTEGRATE-ADHD compared administrative data on the presence of attention-deficit/hyperactivity disorder (ADHD) in children and adolescents with the results of a parent survey and a comprehensive clinical assessment based on the S3 guideline of the Association of the Scientific Medical Societies in Germany (AWMF). Due to the COVID-19 pandemic, the clinical assessment was carried out online.
  Methods: The article describes how a guideline-based clinical assessment of ADHD can be implemented in an online setting. A specially developed diagnostic matrix is presented to illustrate the assessment procedures and the diagnostic decision-making process. The matrix is intended to help the diagnostician to gain an overview of the numerous individual findings that have been collected using different assessment perspectives and methods (e.g. diagnostic interviews, rating scales, performance tests) in order to make a well-founded and transparent diagnostic decision.
  Discussion: The consortium project INTEGRATE-ADHD has shown that an online assessment can be implemented in a guideline-compliant manner and allows a valid clinical decision. The diagnostic strategy is discussed with reference to international guidelines and recommendations for online diagnostics (e.g. aspects of feasibility, acceptability and safety of the assessment procedures). The challenges and opportunities of using online assessments in clinical practice are also described.
  Keywords: ADHD; Adolescents; Children; Feasibility Studies; Germany; Online assessment; S3 guideline; Telehealth.

Infectious diseases

• In cooporation with: Sanofi-Aventis Deutschland GmbH
• Journal: Influenza & other repiratory viruses
• https://pubmed.ncbi.nlm.nih.gov/36181357/
• Abstract
  Background: The significant annual burden caused by seasonal influenza has led to global calls for increased influenza vaccination coverage rates (VCRs). We aimed to estimate the proportion of the German population at high risk of serious illness from influenza due to chronic conditions and to estimate age-specific VCRs of people with/without chronic conditions.
  Methods: Using health insurance claims data covering nine influenza seasons (2010-2019), we assessed up to 7 million insured individuals per season across all German regions. Individuals were classified according to age and presence of chronic health conditions. VCRs were estimated using outpatient healthcare utilization documentation.
  Results: In the 2018-2019 influenza season, 47.3% of individuals had ≥1 chronic condition. Most common were circulatory disorders, accounting for more than a third of individuals with ≥1 condition. Prevalence of chronic diseases, and therefore the proportion of high-risk individuals, increased slightly over time across most age groups. A downward trend in influenza VCRs was observed in all age groups until the 2017-2018 season, followed by a noticeable increase in the 2018-2019 season. Highest VCRs occurred among individuals of ≥60 years, with a 38.5% VCR for this age group in the 2018-2019 season. Several factors, including age, chronic condition type, and geographical location, affected VCRs.
  Conclusions: Influenza VCRs in individuals at high risk of severe complications from influenza infection are insufficient. Our results suggest that intensified public health efforts are necessary to reach the World Health Organization vaccination coverage target of 75%.
  Keywords: Germany; chronic disease; influenza, human; prevalence; vaccination coverage.

NA

• In cooporation with: None
• Journal: Drugs & Aging
• https://pubmed.ncbi.nlm.nih.gov/36972012/
• Abstract
  Introduction: Worldwide, polypharmacy and medication appropriateness-related outcomes (MARO) are growing public health concerns associated with potentially inappropriate prescribing, adverse health effects, and avoidable costs to health systems. Continuity of care (COC) is a cornerstone of high-quality care that has been shown to improve patient-relevant outcomes. However, the relationship between COC and polypharmacy/MARO has not been systematically explored.
  Objective: The aim of this systematic review was to investigate the operationalization of COC, polypharmacy, and MARO as well as the relationship between COC and polypharmacy/MARO.
  Methods: We performed a systematic literature search in PubMed, Embase, and CINAHL. Quantitative observational studies investigating the associations between COC and polypharmacy and/or COC and MARO by applying multivariate regression analysis techniques were eligible. Qualitative or experimental studies were not included. Information on the definition and operationalization of COC, polypharmacy, and MARO and reported associations was extracted. COC measures were assigned to the relational, informational, or management dimension of COC and further classified as objective standard, objective non-standard, or subjective. Risk of bias was assessed by using the NIH Quality Assessment Tool for Observational Cohort and Cross-Sectional Studies.
  Results: Twenty-seven studies were included. Overall, substantial differences existed in terms of the COC dimensions and related COC measures. Relational COC was investigated in each study, while informational and management COC were only covered among three studies. The most frequent type of COC measure was objective non-standard (n = 16), followed by objective standard (n = 11) and subjective measures (n = 3). The majority of studies indicated that COC is strongly associated with both polypharmacy and MARO, such as potentially inappropriate medication (PIM), potentially inappropriate drug combination (PIDC), drug-drug interaction (DDI), adverse drug events (ADE), unnecessary drug use, duplicated medication, and overdose. More than half of the included studies (n = 15) had a low risk of bias, while five studies had an intermediate and seven studies a high risk of bias.
  Conclusions: Differences regarding the methodological quality of included studies as well as the heterogeneity in terms of the operationalization and measurement of COC, polypharmacy, and MARO need to be considered when interpreting the results. Yet, our findings suggest that optimizing COC may be helpful in reducing polypharmacy and MARO. Therefore, COC should be acknowledged as an important risk factor for polypharmacy and MARO, and the importance of COC should be considered when designing future interventions targeting these outcomes.

Infectious diseases

• In cooporation with: DAK-Gesundheit
• Journal: Clinical Rheumatology
• https://pubmed.ncbi.nlm.nih.gov/37335408/
• Abstract
  Objectives: To investigate whether the risk of developing an incident autoimmune disease is increased in patients with prior COVID-19 disease compared to those without COVID-19, a large cohort study was conducted.
  Method: A cohort was selected from German routine health care data. Based on documented diagnoses, we identified individuals with polymerase chain reaction (PCR)-confirmed COVID-19 through December 31, 2020. Patients were matched 1:3 to control patients without COVID-19. Both groups were followed up until June 30, 2021. We used the four quarters preceding the index date until the end of follow-up to analyze the onset of autoimmune diseases during the post-acute period. Incidence rates (IR) per 1000 person-years were calculated for each outcome and patient group. Poisson models were deployed to estimate the incidence rate ratios (IRRs) of developing an autoimmune disease conditional on a preceding diagnosis of COVID-19.
  Results: In total, 641,704 patients with COVID-19 were included. Comparing the incidence rates in the COVID-19 (IR=15.05, 95% CI: 14.69-15.42) and matched control groups (IR=10.55, 95% CI: 10.25-10.86), we found a 42.63% higher likelihood of acquiring autoimmunity for patients who had suffered from COVID-19. This estimate was similar for common autoimmune diseases, such as Hashimoto thyroiditis, rheumatoid arthritis, or Sjögren syndrome. The highest IRR was observed for autoimmune diseases of the vasculitis group. Patients with a more severe course of COVID-19 were at a greater risk for incident autoimmune disease.
  Conclusions: SARS-CoV-2 infection is associated with an increased risk of developing new-onset autoimmune diseases after the acute phase of infection. Key Points • In the 3 to 15 months after acute infection, patients who had suffered from COVID-19 had a 43% (95% CI: 37-48%) higher likelihood of developing a first-onset autoimmune disease, meaning an absolute increase in incidence of 4.50 per 1000 person-years over the control group. • COVID-19 showed the strongest association with vascular autoimmune diseases.
  Keywords: Autoimmune diseases; COVID-19; Claims data; Cohort study; SARS-CoV-2.

Infectious diseases

• In cooporation with: DAK-Gesundheit
• Journal: Journal of Public Health
• https://pubmed.ncbi.nlm.nih.gov/37361269/
• Abstract
  Aim: We aimed to develop a risk score to calculate a person’s individual risk for a severe COVID-19 course (POINTED score) to support prioritization of especially vulnerable patients for a (booster) vaccination.
  Subject and methods: This cohort study was based on German claims data and included 623,363 individuals with a COVID-19 diagnosis in 2020. The outcome was COVID-19 related treatment in an intensive care unit, mechanical ventilation, or death after a COVID-19 infection. Data were split into a training and a test sample. Poisson regression models with robust standard errors including 35 predefined risk factors were calculated. Coefficients were rescaled with a min-max normalization to derive numeric score values between 0 and 20 for each risk factor. The scores’ discriminatory ability was evaluated by calculating the area under the curve (AUC).
  Results: Besides age, down syndrome and hematologic cancer with therapy, immunosuppressive therapy, and other neurological conditions were the risk factors with the highest risk for a severe COVID-19 course. The AUC of the POINTED score was 0.889, indicating very good predictive validity.
  Conclusion: The POINTED score is a valid tool to calculate a person’s risk for a severe COVID-19 course.
  Supplementary information: The online version contains supplementary material available at 10.1007/s10389-023-01884-7.
  Keywords: COVID-19; Claims data; Prediction score; Vulnerable groups.

Infectious diseases

• In cooporation with: Sanofi-Aventis Deutschland GmbH
• Journal: Vaccine
• https://pubmed.ncbi.nlm.nih.gov/35227520/
• Abstract
  Introduction: Invasive meningococcal disease (IMD) is a notifiable disease in Germany and other European countries. Due to the high lethality of the disease and the risk of long-term consequences, IMD prevention is of high public health relevance despite the low number of cases in the population. This study aims to describe key epidemiological and economic parameters of IMD in Germany to support national decision-making processes for implementing enhanced prevention measures.
  Methods: Based on a systematic literature review in PubMed and EMBASE, all publications on the burden of disease and costs of IMD published up to May 2020 were evaluated. Additionally, notification data were used to report the annual case numbers and incidence of IMD in Germany until the end of 2019.
  Results: Thirty-six studies were included, of which 35 reported data on the epidemiological burden of disease and three reported data on economic aspects of IMD. The type of reported endpoints and results on the incidence of IMD differed widely by reporting year, population, and data source used. Most of the data are reported without specific information about a serogroup. Data on the economic burden of disease and healthcare resource use are scarce. Based on mandatory notification data, a decrease in the incidence of notified IMD cases has been observed since 2004. Currently, the nationwide annual incidence in Germany is at 0.3 cases per 100,000 persons and has gradually decreased. While the overall decline is mainly attributable to MenB, cases with MenY and MenW are the only ones that have increased on a low level in recent years.
  Conclusion: While IMD is a rare disease, high direct and indirect costs illustrate the relevance of the disease for patients, caregivers, as well as for the health care system. Future research should concentrate on quantifying the long-term economic burden and indirect costs of meningococcal disease. Integrated IMD surveillance with isolate characterisation remains crucial to inform public health policies.
  Keywords: Costs; Epidemiology; Germany; IMD; Meningococcal disease; Systematic review.

None

• In cooporation with: Techniker
• Journal: Cost Effectiveness & Ressource Allocation
• https://pubmed.ncbi.nlm.nih.gov/39411329/
• Abstract
  In December 2019, the Digital Health Care Act (“Digitale-Versorgung-Gesetz”) introduced a general entitlement to the provision and reimbursement of digital health applications (DiGA) for insured persons in the German statutory health insurance. As establishing a new digital service area within the solidarity-based insurance system implies several administrative and regulatory challenges, this paper aims to describe the legal framework for DiGA market access and pricing as well as the status quo of the DiGA market. Furthermore, we provide a basic approach to deriving value-based DiGA prices.To become eligible for reimbursement, the Federal Institute for Drugs and Medical Devices evaluates the compliance of a DiGA with general requirements (e.g., safety and data protection) and its positive healthcare effects (i.e., medical benefit or improvements of care structure and processes) in a fast-track process. Manufacturers may provide evidence for the benefits of their DiGA either directly with the application for the fast-track process or generate it during a trial phase that includes temporary reimbursement. After one year of \]reimbursement, the freely-set manufacturer price is replaced by a price negotiated between the National Association of Statutory Health Insurance Funds and the manufacturer. By February 2022, 30 DiGA had successfully completed the fast-track process. 73% make use of the trial phase and have not yet proven their benefit. Given this dynamic growth of the DiGA market and the low minimum evidence standards, fair pricing remains the central point of contention. The regulatory framework makes the patient-relevant benefits of a DiGA a pricing criterion to be considered in particular. Yet, it does not indicate how the benefits of a DiGA should be translated into a reasonable price. Our evidence-based approach to value-based DiGA pricing approximates the SHI’s willingness to pay by the average cost-effectiveness of one or more established therapy in a field of indication and furthermore considers the positive healthcare effects of a DiGA.The proposed approach can be fitted into DiGA pricing processes under the given regulatory framework and can provide objective guidance for price negotiations. However, it is only one piece of the pricing puzzle, and numerous methodological and procedural issues related to DiGA pricing are still open. Thus, it remains to be seen to what extent DiGA prices will follow the premise of value-based pricing.
  Keywords: DiGA; Digital health applications; Fast-track process; Market access; Statutory health insurance; Value-based pricing; eHealth.

NA

• In cooporation with: None
• Journal: Journal of personalized Medicine
• https://pubmed.ncbi.nlm.nih.gov/35887612/
• Abstract
  Structured management programs have been developed for single diseases but rarely for patients with multiple medications. We conducted a qualitative study to investigate the views of stakeholders on the development and implementation of a polypharmacy management program in Germany. Overall, we interviewed ten experts in the fields of health policy and clinical practice. Using content analysis, we identified inclusion criteria for the selection of suitable patients, the individual elements that should make up such a program, healthcare providers and stakeholders that should be involved, and factors that may support or hinder the program’s implementation. All stakeholders were well aware of polypharmacy-related risks and challenges, as well as the urgent need for change. Intervention strategies should address all levels of care and include all concerned patients, caregivers, healthcare providers and stakeholders, and involved parties should agree on a joint approach.
  Keywords: medication management; multimorbidity; polypharmacy; qualitative research; stakeholder analysis; structured care program.

General Medicine

• In cooporation with: Viatris
• Journal: Multiple Sclerosis
• https://pubmed.ncbi.nlm.nih.gov/36000489/
• Abstract
  Background: As patents for multiple sclerosis (MS) therapies expire, follow-on disease-modifying treatments (FO-DMTs) become available at reduced cost. Concerns exist that cheaper FO-DMTs are used simply to reduce healthcare costs. However, the well-being of people with MS should take priority.
  Objectives: To identify best practices for FO-DMT development and use by agreeing on principles and consensus statements through appraisal of published evidence.
  Methods: Following a systematic review, we formulated five overarching principles and 13 consensus statements. Principles and statements were voted on by a multidisciplinary panel from 17 European countries, Argentina, Canada and the United States.
  Results: All principles and statements were endorsed by >80% of panellists. In brief, FO-DMTs approved within highly regulated areas can be considered effective and safe as their reference products; FO-DMTs can be evaluated case by case and do not always require Phase III trials; long-term pharmacovigilance and transparency are needed; there is lack of evidence for multiple- and cross-switching among FO-DMTs; and education is needed to address remaining concerns.
  Conclusion: Published data support the use of FO-DMTs in MS. The consensus may aid shared decision-making. While our consensus focused on Europe, the results may contribute to enhanced quality standards for FO-DMTs use elsewhere.
  Keywords: Biosimilar; consensus; disease-modifying treatments; expert opinion; guidelines; interchangeability; multiple sclerosis; non-biological complex drugs; switching.

NA

• In cooporation with: None
• Journal: ZEFQ
• https://pubmed.ncbi.nlm.nih.gov/36085136/
• Abstract
  Due to market access of high-priced new drugs, the financial burden on the health care system and the appropriateness of drug prices are often doubted. Is it time for a broader perspective of health technology assessment in Germany, which has so far focused on clinical value? Should cost and benefit aspects of new technologies be given equal weight in future assessments of market access for new technologies? The experiences of European neighbors and the Standing Committee on Vaccination with cost-benefit analyses are encouraging. Introducing cost-benefit analyses as a further decision criterion in the pricing of new technologies naturally creates additional work for the players involved but also offers the opportunity to provide transparent and understandable answers to the question of what a health improvement is worth. In view of the increasing funding challenges facing the statutory health insurance system in Germany, this question will continue to gain importance.
  Keywords: Cost-benefit evaluation; Cost-utility-analysis; Economic evaluation; Kosten-Nutzen-Bewertung; Kosten-Nutzwert-Analysen; QALY; Quality-adjusted life years; Qualitätsadjustierte Lebensjahre; Ökonomische Evaluation.