Agnes Kisser

Background: Sickle cell disease (SCD) is a rare inherited hemoglobinopathy associated with substantial morbidity and high healthcare needs. In Germany, population-based evidence on SCD epidemiology and real-world care patterns remains limited, despite increasing relevance in the context of migration and the introduction of nationwide newborn screening in 2021. Methods: We conducted a retrospective, non-interventional study using anonymized German statutory health insurance claims data from the InGef database (2015–2024). Patients with SCD were identified using ICD-10-GM codes D57.0, D57.1, D57.2, and D57.8 based on inpatient and confirmed outpatient diagnoses. Administrative prevalence was estimated using a carry-forward cohort approach, whereby SCD patients diagnosed in the current year and alive/observable in subsequent years were counted as prevalent. Administrative incidence was assessed in children aged < 6 years using the first recorded SCD diagnosis in claims data as the date of incidence. Analyses of patient characteristics, clinical outcomes, treatments and healthcare resource use (HCRU) were conducted cross-sectionally by calendar year, stratified by age group and sex. Results: Across 2015–2024, 1,019 individuals with SCD were identified. As might be expected using a carry forward cohort approach, annual prevalent counts increased from 225 (2015) to 864 (2024), and nationally extrapolated prevalence increased from 2.75 per 100,000 in 2015 to 10.50 per 100,000 in 2024. Median time to recorded diagnosis in children < 6 years decreased from 31 months (2015) to 11 months from 2021 onwards (2021–2024). In 2024, infections were the most frequently documented clinical outcome (34.5% [298/864]), followed by vaso‑occlusive crises (19.2% [166/864]) and mental health comorbidities (depression 19.1% [165/864]; anxiety 9.1% [79/864]). The proportions of patients with inpatient or outpatient visits, and with medication prescriptions (e.g. for antibiotics, antirheumatics, hydroxyurea), decreased over time. Conclusion: This claims-based analysis indicates increasing documented SCD prevalence in Germany. However, the extent to which prevalence increased due to a true increase in the general population, due to our carry-forward cohort approach, or due to other factors such as changes in coding practices or healthcare seeking behaviors, cannot be disentangled.We observed earlier recorded diagnosis timing in young children over time, alongside substantial age-dependent burden reflected in complications, mental health comorbidity, and healthcare utilization. Possible explanations for lower proportions of patients with inpatient/outpatient visits and medication prescriptions over time may include changes in disease awareness, patient management and/or healthcare seeking behaviours over time, and/or broader capture of patients with milder disease. Overall, our findings can inform healthcare planning and structured life-course–oriented SCD care pathways in Germany.

Background: Evidence on the economic burden of post-COVID syndrome in Germany remains limited. This study quantifies post-COVID-associated healthcare resource utilization (HCRU), sick leave, and costs. Objectives: To compare HCRU, sick leave, and costs borne by the statutory health insurance (SHI) among incident pediatric and adult post-COVID patients with matched post-COVID-free controls. Methods: This retrospective cohort study analyzed an anonymized German SHI claims database provided by GWQ ServicePlus AG. The observation period spanned October 2021 to June 2025 and included all individuals with incident COVID-19 diagnosis until September 2024. Incident post-COVID was defined as the first ICD-10-GM code (U07.4!; U09.9!) recorded ≥90 days after first COVID-19 diagnosis. Post-COVID cases were exactly matched 1:2 to post-COVID–free COVID-19 controls by calendar quarter of incident COVID-19 diagnosis, acute severity, cohort entry quarter, 5-year birth interval, sex, and Elixhauser Comorbidity Index. We estimated mean differences in HCRU, sick leave, and direct SHI-borne costs per case. Rate ratios of HCRU, sick leave, and costs per person-year were estimated using Poisson (HCRU/sick leave) and linear (costs) regression. Analyses covered 365-day, 730-day, and any follow-up period. Results: We matched 25 485 identified post-COVID cases with 49 671 controls. Matched cases and controls were comparable in age, sex, and comorbidities. Overall, during 365 days of follow-up, post-COVID patients showed higher HCRU and sick leave rates across all sectors, especially sick leave days. Mean differences per case were greatest for sick leave days (365 days: +27 days) and outpatient physician contacts (365 days: 6.9 contacts). HCRU and sick leave rates remained significantly increased over extended follow-up periods. Total SHI-borne costs per person-year were higher among post-COVID patients across all follow-up periods (all P < .001). Sector-specific costs per person-year were increased primarily in the outpatient sector and for sickness benefits (all P < .001). Mean total cost differences per case were +€1806 per case (365 days) and mean excess sickness benefits per case were +€1077. Conclusions: Documented post-COVID was associated with a substantial and sustained economic burden on the German healthcare system and society. Targeted strategies are needed to mitigate potential long-term impacts on HCRU and labor productivity.

Atopic dermatitis (AD) is a prevalent, chronic, inflammatory skin disorder causing significant quality-of-life impairment. Some patients need systemic therapy depending on disease course and effectiveness of topical treatment. Current systemic treatments may have limitations for long-term use and/or for different patient age groups. This study investigates conventional systemic therapy use and indicators of insufficient disease control on the basis of German statutory health insurance health claims data. This retrospective cohort study used claims-based data from the Institute for Applied Health Research Berlin GmbH (InGef) sample database from 1 October 2019 to 31 December 2022, with the index period defined as 1 October 2021 to 30 September 2022. The pre-index period was from 1 October 2019 to 30 September 2021, and the observation period was from 1 October 2021 to 31 December 2022. Patients diagnosed with AD (ICD-10-GM code L20.8 or L20.9) with continuous insurance during the index period were included. Of 4 million eligible patients in the InGef sample database, 3400 were eligible for systemic drug therapy. Of these patients, 1016 were treated with targeted systemic therapy, and 1719 treated with conventional systemic therapy had insufficient disease control. The overall 1-year administrative prevalence of AD was estimated at 2.4%, and the incidence of AD was estimated at 0.3%. Prevalence was highest in children aged ≤ 4 years (7.0%) and decreased with advancing age. The most prevalent criterion of insufficient disease control was AD-related infections, affecting 58.4% of patients, followed by prolonged use of topical treatment (44.2%) and frequent active flares (36.9%). These findings highlight the challenges in managing AD with conventional systemic therapies and underscore the need for improved treatment strategies. Insights into the patterns of systemic therapy use and disease control can inform future therapeutic approaches and policy decisions to enhance patient outcomes in AD management.

Purpose To assess the epidemiology, treatment patterns, and Bacillus Calmette–Guérin (BCG) instillations in Non-Muscle-Invasive Bladder Cancer (NMIBC) patients to evaluate guidelines compliance and effectiveness of adherence on real-world outcomes. Methods NMIBC patients with BCG-treatment were identified in a retrospective cohort study using German health claims data. The first BCG prescription was defined as index date. Crude and standardized annual incidence were calculated. Subsequent treatment regimens were described based on prescriptions to assess adherence. BCG-maintenance adherents were compared with non-adherents using a landmark time approach and Cox proportional hazard model. Results The annual standardized incidence per 100,000 for intermediate- and high-risk NMIBC patients ranged from 7.6 to 10.4 in males and 1.2 to 1.9 in females from 2017 to 2021. The main cohort consisted of 817 patients (mean age: 72.5; male: 78%). Most patients (98%) received transurethral resection of bladder tumor (TURBT) as initial treatment followed by BCG, with a median number of 13 BCG instillations per patient (IQR: 8–21). 28% continued BCG in the maintenance phase at 24 months post-induction and 62% received at least one Re-TURBT post-index. BCG maintenance-adherent patients showed lower risk compared with non-adherent patients: adjusted hazard ratio (aHR): 0.92 [0.73–1.18] for all-cause death; aHR: 0.49 [0.36–0.67] for advanced treatment; aHR: 0.65 [0.53–0.80] for disease progression. Conclusion Real-world compliance with clinical guidelines may require improvement based on BCG maintenance duration and adherence to treatment schedules. The benefits of BCG adherence in improving oncology-relevant outcomes support guidelines recommendations for sufficient BCG maintenance.

AimTo estimate the cost-effectiveness of Nirmatrelvir/ritonavir (NMV/r) versus best supportive care (BSC) in patients at high-risk for progression to severe COVID-19 from a German health payer perspective.MethodsA closed cohort static model of 1,000 COVID-19 patients capturing the short-term (<1 year) via decision-tree and long-term (lifetime) outcomes via Markov model was used to assess the cost-effectiveness of NMV/r versus BSC. Model inputs were derived from the EPIC-HR clinical trial and published contemporary real-world data. Probabilistic and deterministic sensitivity analyses (PSA, DSA) were conducted to test the robustness of model results.ResultsIn the base case, treatment with NMV/r versus BSC reduced COVID-19 related hospitalisations (-0.042), intensive care unit admissions (-0.006) and inpatient deaths (-0.003), while increasing life-years (LY) (0.047) per patient, which results in an incremental cost-effectiveness ratio of 10,845 €per hospitalisation avoided and 9,773 €per LY gained. Sensitivity analysis suggests the magnitude of the benefits increased with increasing hospitalisation risk. NMV/r emerged as the dominant strategy in a population with a hospitalisation risk equivalent to 60 years and older. Outcomes were similar with real world effectiveness data. DSA showed the model was most sensitive to hospitalisation and inpatient mortality risk, NMV/r medication cost and efficacy/effectiveness of NMV/r in reducing hospitalisation. PSA confirmed the robustness of the model results.LimitationsAs COVID-19 is a dynamic disease, caution should be taken in generalizing these results. Contemporary data is essential to ensure the model inputs and the outcomes remain relevant as there may be changes in natural disease course or effectiveness of NMV/r.ConclusionsThis cost-effectiveness analysis of NMV/r treatment from a German healthcare payer perspective demonstrates how by preventing progression to severe COVID-19, NMV/r reduces healthcare resource use, associated costs and preserves LY of patients. This analysis provides crucial economic rationale for decision making by policy makers.

In Germany, hemophilia patients with a severe bleeding phenotype receive lifelong prophylactic treatment with intravenous concentrated factor VIII (FVIII) or IX (FIX) to prevent bleeding events. To assess the economic value of emerging treatment options, studies describing the economic burden of hemophilia under the current standard of care in Germany are needed.This study classified hemophilia A (HA) and B (HB) patients by treatment regimen in administrative claims data to examine the real-world economic burden of Hemophilia in Germany from 2016 to 2021.Hemophilia patients were identified in InGef statutory health insurance claims data via ICD-10 codes D66 (HA) and D67 (HB) in combination with one or more claims for hemophilia-related medication.Each patient's factor regimen was classified as either indicative of a severe phenotype needing prophylaxis or a non-severe phenotype treated on demand using a classification threshold of 100,000 International Units (IU) FVIII/year (HA) and 80,000 IU FIX/year (HB). Health care resource utilization and cost outcomes were captured for each study year.Male prevalence per 100,000 ranged from 6.39 to 7.81 (HA) and 1.26 to 1.89 (HB), with 43 to 53% (HA) and 40 to 56% (HB) categorized as severe. In 2021, mean (standard deviation [SD]) per-patient medication costs were €321,987 (€157,915) in the severe treatment group versus €43,487 (€92,821) in the non-severe group for HA and €289,411 (€132,400) versus €19,253 (€23,655) for HB.The results demonstrate the high economic burden of severe HA and HB in Germany, driven by the need for continuous factor replacement therapy, and give an estimate of treatment costs based on a real-world therapy mix.

Aim: Direct oral anticoagulant (DOAC) switching often occurs in patients with nonvalvular atrial fibrillation (NVAF) for medical and nonmedical reasons. Limited data describe the economic consequences of DOAC switching in patients with NVAF. This study evaluates the cost–effectiveness and budget impact of initiating apixaban and switching to rivaroxaban versus initiating and continuing apixaban for patients with NVAF, from a German payer perspective. Materials & methods: Built on an existing model, a cohort-level lifetime Markov model was developed, including dynamic pricing assumptions to account for anticipated generic entry of DOACs. The modeled population (n = 1000) included German patients with NVAF, eligible for oral anticoagulation, who initiated on apixaban. The primary model outcome was the incremental cost–effectiveness ratio, assessed using cost per quality-adjusted life year (QALY) gained and a willingness-to-pay threshold of €48,750/QALY. A secondary model outcome was a 5-year budget impact analysis. Results: Switching patients from apixaban to rivaroxaban led to 285 additional events per 1000 patient years, resulting in 0.079 fewer QALYs and higher total costs per patient (€21,357 vs €16,390 for apixaban continuers). In the base case analysis (with generic pricing assumptions), switching from apixaban to rivaroxaban was dominated (i.e., less effective and more costly) by continuing apixaban. In the budget impact analysis (with generic pricing assumptions), switching from apixaban to rivaroxaban led to additional cumulative costs of €490 per patient over 5 years. Conclusion: Despite the introduction of generic discounting, switching patients with NVAF from apixaban to rivaroxaban led to higher total costs and fewer QALYs under base case assumptions, meaning apixaban switchers were dominated by apixaban continuers from a German payer perspective. Switching patients from apixaban to rivaroxaban also led to greater budget impact over 5 years.