Background This study analyzes the impact of skeletal-related events (SRE) on healthcare resource utilization (HCRU) and costs incurred by patients with bone metastases (BM) from solid tumors (ST), who are therapy-naïve to bone targeting agents (BTAs). Methods German claims data from 01/01/2010 to 30/06/2018 were used to conduct a retrospective comparative cohort analysis of BTA-naive patients with a BM diagnosis and preceding ST diagnosis. HCRU and treatment-related costs were compared in two matched cohorts of patients with and without a history of SREs, defined as pathological fracture, spinal cord compression, surgery to bone and radiation to bone. The first SRE was defined as the patient-individual index date. Conversely, for the non-SRE patients, index dates were assigned randomly. Results In total, 45.20% of 9,832 patients reported experiencing at least one SRE (n = 4444) while 54.80% experienced none (n = 5388); 2,434 pairs of SRE and non-SRE patients were finally matched (mean age: 70.87/71.07 years; females: 39.07%/38.58%). Between SRE and non-SRE cohorts, significant differences in the average number of hospitalization days per patient-year (35.80/30.80) and associated inpatient-care costs (14,199.27€/10,787.31€) were observed. The total cost ratio was 1.16 (p < 0.001) with an average cost breakdown of 23,689.54€ and 20,403.27€ per patient-year in SRE and non-SRE patients. Conclusion The underutilization of BTAs within a clinical setting poses an ongoing challenge in the real-world treatment of BM patients throughout Germany. Ultimately, the economic burden of treating SREs in patients with BM from ST was found to be considerable, resulting in higher direct healthcare costs and increased utilization of inpatient care facilities.

Background Idiopathic pulmonary fibrosis (IPF) is a progressive form of fibrosing interstitial pneumonia with poor survival. This study provides insight into the epidemiology, cost, and disease course of IPF in Germany. Methods A cohort of incident patients with IPF (n = 1737) was identified from German claims data (2014–2019). Incidence and prevalence rates were calculated and adjusted for age differences compared with the overall German population. All-cause and IPF-related healthcare resource utilization as well as associated costs were evaluated per observed person-year (PY) following the initial IPF diagnosis. Finally, Kaplan–Meier analyses were performed to assess time from initial diagnosis to disease deterioration (using three proxy measures: non-elective hospitalization, IPF-related hospitalization, long-term oxygen therapy [LTOT]); antifibrotic therapy initiation; and all-cause death. Results The cumulative incidence of IPF was estimated at 10.7 per 100,000 individuals in 2016, 10.9 in 2017, 10.5 in 2018, and 9.6 in 2019. The point prevalence rates per 100,000 individuals for the respective years were 21.7, 23.5, 24.1, and 24.1. On average, ≥ 14 physician visits and nearly two hospitalizations per PY were observed after the initial IPF diagnosis. Of total all-cause direct costs (€15,721/PY), 55.7% (€8754/PY) were due to hospitalizations and 29.1% (€4572/PY) were due to medication. Medication accounted for 49.4% (€1470/PY) and hospitalizations for 34.8% (€1034/PY) of total IPF-related direct costs (€2973/PY). Within 2 years of the initial IPF diagnosis (23.6 months), 25% of patients died. Within 5 years of diagnosis, 53.1% of patients had initiated LTOT; only 11.6% were treated with antifibrotic agents. The median time from the initial diagnosis to the first non-elective hospitalization was 5.5 months. Conclusion The incidence and prevalence of IPF in Germany are at the higher end of the range reported in the literature. The main driver for all-cause cost was hospitalization. IPF-related costs were mainly driven by medication, with antifibrotic agents accounting for around one-third of the total medication costs even if not frequently prescribed. Most patients with IPF do not receive pharmacological treatment, highlighting the existing unmet medical need for effective and well-tolerated therapies.

Achieving good glycemic control in type 2 diabetes (T2DM) may require individualized pharmacological approaches. We aimed to compare direct healthcare costs in patients treated with empagliflozin (EMPA) compared to dipeptidyl peptidase-4 inhibitors (DPP-4i) or glucagon-like peptide-1 receptor agonists (GLP-1-RA). Patients and Methods: This German claims data study included continuously insured persons with at least two outpatient diagnoses and/or one inpatient diagnosis of T2DM if they started EMPA, DPP-4i, or GLP-1-RA in 2015-2018. Healthcare costs were assessed from therapy initiation until the end of data availability, death, or therapy discontinuation and compared among propensity scorematched cohorts. Results: Of 24,465 patients included, 3285 received EMPA, 19,443 DPP-4i, and 1747 GLP-1-RA. Matched cohorts were balanced on baseline characteristics (EMPA versus DPP-4i: n 1 /n 2 = 3100/3100 and EMPA versus GLP-1-RA: n 3 /n 4 = 1346/1346). Mean total costs after start of DPP-4i were €7009 (95%-CI: 6573-7444) versus €4274 (3982-4566) for EMPA. Costs associated with GLP-1-RA treatment were also significantly higher compared with versus €4895 ). Conclusion: Although the individual clinical patient profile and physician assessment are paramount in treatment decisions, substantial differences in the economic impact of different antidiabetic therapies should be considered.

Background Ulcerative colitis (UC) is a chronic inflammatory bowel disease that requires continuous medical treatment. Current epidemiological data about UC in Germany are lacking, and in particular, it is unknown how many patients are treated with advanced therapies. This study aimed to investigate the prevalence and incidence of UC in Germany and describe the frequency of advanced therapy use in this population. Methods We used claims data from a regional German sickness fund (AOK PLUS). Continuously insured persons from 01/01/2015 until 31/12/2019 or death with at least 2 outpatient diagnoses documented by a specialist in 2 quarters within 12 months or one inpatient diagnosis (ICD-10: K51.-) were defined to be UC prevalent. Patients were defined to be incident in 2019 if the respective selection criteria could be observed in 2019, but no UC diagnosis was documented in the previous 4 years. Age- and gender-standardized point prevalence was calculated on 01/01/2019, cumulative incidence was evaluated for the year 2019. Standardization was based on the age/gender distribution within the entire population of the German statutory insurance (KM-6 statistic), which covers about 90% of the whole German population. Main characteristics and comorbidity status were assessed at the index date based on diagnoses documented in the 12-month pre-index period (index: 01/01/2019 or date of incident diagnosis in 2019). The proportion of prevalent patients receiving advanced therapies (infliximab, adalimumab, golimumab, vedolizumab, tofacitinib) was evaluated in 2019, considering both out- and inpatient treatments. Results The standardized incidence in 2019 was 0.36 cases/1,000 persons. Incident patients were, on average, 59.7 years old (SD: 21.6; 95% CI: 58.2–61.1), and 56.1% were females. The mean Charlson Comorbidity Index (CCI) was 2.7 (SD: 3.1; 95% CI: 2.5–2.9). The standardized prevalence at 01/01/2019 was 5.29 cases/1,000 persons. In 2019, 12,736 prevalent patients were observed (12,510.8 person-years), with 56.2% of the patients being female. The mean age was 60.6 years (SD: 18.8; 95% CI: 60.2–60.9), and the mean CCI was 2.3 (SD: 2.8; 95% CI: 2.2–2.3). 827 patients (6.5%) were treated with advanced therapy in 2019. These patients were considerably younger (44.9 (95% CI: 43.9–46.0) versus 61.7 years (95% CI: 61.3–62.0)) and less comorbid (CCI: 1.2 (95% CI: 1.0–1.3) vs. 2.4 (95% CI: 2.3–2.4)) than patients who have not been treated with an advanced therapy. Conclusion Our analysis showed a considerable UC incidence and a high disease burden in Germany, with a prevalence surpassing 0.5%. Advanced therapies were prescribed only in a minority of UC patients, who were generally younger and less comorbid.

adopted for the analysis of association between bevacizumab use and pulmonary embolism. The data mining algorithm used for the analysis were Reporting Odds Ratio (ROR) and Proportional Reporting Ratio (PRR). A value of ROR-1.96SE.1, PRR$2 were considered as positive signal. Results: A total of 52,770 reports for Pulmonary embolism have been reported in the FDA database. Amongst which 1,264 reports were associated with bevacizumab. Pulmonary embolism ranked 25 th among 900 bevacizumab associated adverse drug events. The mean age was 61.21 and female to male ratio was 1.01:1. A positive signal was obtained with ROR: 3.40 and PRR: 3.42. 394 death reports and the non-death serious reports included hospitalization, lifethreatening, disability, and other serious events with 53, 36, 4 and 626 reports respectively. Linear regression analysis indicated there was no significant correlation between the PRR and time (R=0.045; p=0.876) and ROR and time (R=0.60; p=0.831). The Log Likelihood ratio for pulmonary embolism with bevacizumab was found to be 548.23 and the reporting ratio was 2.94 (Critical value-5.68). Conclusions: A positive signal was observed for bevacizumab associated pulmonary embolism, although a causal relation cannot be definitively proved. Health care professionals should be cautious about the possibility of serious adverse events associated with bevacizumab and should report to concerned regulatory authorities.