Aims To examine the manifestation of cardiovascular or renal disease (CVRD) in patients with type 2 diabetes (T2D) initially free from CVRD as well as the mortality risks associated with these diseases. Methods Patients free from CVRD were identified from healthcare records in England, Germany, Japan, the Netherlands, Norway and Sweden at a fixed date. CVRD manifestation was defined by first diagnosis of cardiorenal disease, or a stroke, myocardial infarction (MI) or peripheral artery disease (PAD) event. The mortality risk associated with single CVRD history of heart failure (HF), chronic kidney disease (CKD), MI, stroke or PAD was compared with that associated with CVRD‐free status. Results Of 1 177 896 patients with T2D, 772 336 (66%) were CVRD‐free and followed for a mean of 4.5 years. A total of 137 081 patients (18%) developed a first CVRD manifestation, represented by CKD (36%), HF (24%), stroke (16%), MI (14%) and PAD (10%). HF or CKD was associated with increased cardiovascular and all‐cause mortality risk: hazard ratio (HR) 2.02 (95% confidence interval [CI] 1.75–2.33) and HR 2.05 (95% CI 1.82–2.32), respectively. HF and CKD were separately associated with significantly increased mortality risks, and the combination was associated with the highest cardiovascular and all‐cause mortality risk: HRs 3.91 (95% CI 3.02–5.07) and 3.14 (95% CI 2.90–3.40), respectively. Conclusion In a large multinational study of >750 000 CVRD‐free patients with T2D, HF and CKD were consistently the most frequent first cardiovascular disease manifestations and were also associated with increased mortality risks. These novel findings show these cardiorenal diseases to be important and serious complications requiring improved preventive strategies.

Introduction We evaluated incidence, prevalence, costs, and healthcare utilization associated with systemic lupus erythematosus (SLE) in patients in Germany. Methods Adult patients with SLE were identified from the German Betriebskrankenkassen (BKK) health insurance fund database between 2009 and 2014. SLE incidence and prevalence were calculated for each year and extrapolated (age and sex adjusted) to the German population. The 2009 SLE population was followed through 2014. Healthcare utilization and costs for patients with SLE were calculated and compared with controls matched by age, sex, and baseline Charlson Comorbidity Index scores. Results This analysis included 1160 patients with SLE. Estimated SLE incidence between 2009 and 2014 ranged from 4.59 to 6.89 per 100,000 persons and prevalence ranged from 37.32 to 47.36 per 100,000. SLE incidence in Germany in 2014 was 8.82 per 100,000 persons; prevalence was 55.80 (corrected for right-censored data). At baseline, 12.8, 41.7, and 45.5% of patients were categorized as having mild, moderate, and severe SLE, respectively. Patients with SLE had greater mean (standard deviation [SD]) annual medical costs compared with matched controls 1 year after index diagnosis (€6895 [14,424] vs. €3692 [3994]; P < 0.0001) and in subsequent years. Patients with moderate or severe SLE had significantly more hospitalizations, outpatient visits, and prescription medication use compared with matched controls. Mean annual costs for 5 years ranged from €1890 to 3010, €4867 to 5876, and €8396 to 10,001 for patients with mild, moderate, and severe SLE, respectively. Conclusions SLE incidence in Germany increased 1.4-fold over 5 years. Patients with SLE have higher healthcare costs, and costs increase with baseline severity. Early and effective treatments may delay progression and reduce the burden of SLE. Supplementary Information The online version contains supplementary material available at 10.1007/s40744-021-00277-0.

ObjectiveTo estimate both the number of patients with hepatocellular carcinoma (HCC) eligible annually for second-line therapy following sorafenib in Germany and the healthcare costs accrued by patients meeting eligibility criteria.MethodsPatients with an HCC diagnosis and one or more sorafenib prescription were identified from samples of > 3 million insured persons in each of 2012, 2013 and 2014 using the anonymised Betriebskrankenkasse health insurance scheme database. Incidence rates from 2013 were extrapolated to the German population using data from the statutory health insurance system database and Robert Koch Institute. Resource use and cost data were collected for a subset of patients with follow-up data post-sorafenib.ResultsBetween 1032 and 1484 patients with HCC in Germany (893–1390 publicly insured patients) were estimated as likely to be eligible for second-line therapy after sorafenib annually. For post-sorafenib analyses, 117 patients were identified with HCC, one or more sorafenib prescription and considered potentially eligible for second-line treatment, 15 of whom were alive after 12 months’ follow-up. Total mean costs per patient accrued in the 12 months after sorafenib treatment ended were €11,152 (hospital care, €6483 [58.1%]; outpatient prescriptions, €3137 [28.1%]).ConclusionThe estimated number of publicly insured HCC patients annually eligible for second-line therapy in Germany was < 1400 and mean total costs accrued in the year after completion of sorafenib therapy were approximately €11,000 per patient for the German statutory healthcare system. These estimates can be used when evaluating the budgetary impact of new second-line therapies for advanced HCC in Germany.Electronic supplementary materialThe online version of this article (10.1186/s13561-018-0199-1) contains supplementary material, which is available to authorized users.

Aim: This retrospective observational study aimed to evaluate the epidemiology of advanced gastric cancer (GC) in Germany. Methods: Data were extracted from the Betriebskrankenkassen (BKK) database, which consists of different company health insurance funds throughout Germany and contains anonymized records of medical services. Patient data were retrospectively reviewed from January 2008 and followed prospectively until 31st of December 2011. The identification of GC patients (ICD-10 C16) was based on data from 2011 (main cohort). Two alternative approaches were used to detect patients with advanced GC who were treated with any first-line chemotherapy. Results: The database included 2?890?285 persons. In total, 3184 patients with a GC diagnosis were identified across all areas of medical care (main cohort). Of these, an estimated 585 patients (or 342, depending on the estimation approach) had advanced GC and received first-line chemotherapy. Age- and gender-adjusted extrapolation resulted in approximately 15?200 (8800) advanced GC patients in the entire German statutory health insurance system in 2011, equating to 22 (13) per 100?000 insured. It was estimated that 4119 (2416) advanced GC patients treated with first-line chemotherapy were newly diagnosed in 2011; an incidence rate of 6 (3) per 100?000 insured. Conclusion: This is the first retrospective observational study that provides plausible epidemiologic data of advanced GC in Germany. It gives a representative estimation of incidence and prevalence of patients with advanced GC who were treated with first-line chemotherapy in 2011 and could be potentially eligible for second-line therapy.

BackgroundSLE is a severe, chronic autoimmune disease of the connective tissue involving multiple organ systems. Understanding the economic burden of SLE in the context of disease severity is important when considering new therapeutic options.ObjectivesHCRU and costs associated with SLE were examined retrospectively using anonymized data from a German Sickness Fund database.MethodsReal-world claims for adult (≥18 years old) patients (pts) with SLE from a German Sickness Fund database of company health insurance schemes were analysed. HCRU and costs were assessed annually for 2009–2014 for pts diagnosed with SLE in 2009 and validated using repeated SLE-related claims, co-diagnosis codes, laboratory tests, prescription treatment, and the diagnosing physician’s specialty. Pts had to have data available for 2009 and ≥3 years before the index quarter in 2009. HCRU and costs for SLE cases were compared with those of controls matched (4:1) by age, sex, and baseline Charlson Comorbidity Index (CCI). Continuous outcomes were compared with a nonparametric test (e.g., Wilcoxon–Mann-Whitney) because most outcome distributions were positively skewed.ResultsOf the 3,290,701 persons with data available for 2009 and ≥3 years prior, 1228 had an SLE diagnosis in 2009. SLE prevalence steadily increased from 37.32/100,000 (incidence: 5.96/100,000 per year) in 2009 to 47.36/100,000 in 2014. The final sample comprised 1,160 SLE-confirmed pts (mean age: 52 years; females: 84%; baseline CCI range: 1–13). Most (85%) pts were diagnosed with SLE before 2009 SLE disease severity at baseline was classified as mild for 148, moderate for 484, and severe for 528 pts using a combination of International Classification of Diseases-10 GM and medication/procedures codes. Compared with matched controls, SLE pts, overall and those with moderate and severe disease, had significantly greater mean annual medical costs in 2009 (all SLE: €6895 vs. €3,692; moderate SLE: €4867 vs. €3,380; severe SLE: €10 001 vs. €4,239; p<0.0001 for each comparison) and each year thereafter. Mean costs, total number of hospital days, numbers of outpatient visits, hospital stays, and outpatient prescriptions, and other benefits were significantly greater for all pts with SLE and for those with moderate and severe disease vs. matched controls. For example, for pts with severe SLE vs. controls, mean costs for hospital stays, outpatient prescriptions, and other benefits were €4335 vs. €1,414, €2582 vs. €1,087, and €1068 vs. €691, respectively, in 2009.ConclusionsIn Germany, the economic burden of moderate and severe SLE was greater than that of sociodemographic- and morbidity-adjusted controls between 2009 and 2014. Pts with SLE incurred greater HCRU and total annual medical costs vs. matched controls. HCRU increased with increasing SLE disease severity, with the greatest burden among pts with severe disease. New treatments could reduce HCRU and future costs.Disclosure of InterestE. Hammond Employee of: AstraZeneca, H. Friedel: None declared, E. Garal-Pantaler: None declared, M....