Real-world treatment persistence in patients with rheumatoid arthritis initiating DMARDs in Germany-a health insurance claims data analysis.

OBJECTIVE: To investigate treatment patterns in patients with rheumatoid arthritis (RA) in Germany who had previously received conventional synthetic (cs) or biologic (b) disease-modifying antirheumatic drugs (DMARDs). METHODS: Patients with RA who initiated treatment with a csDMARD, bDMARD, or Janus kinase (JAK) inhibitor between 2017 and 2018 and who had previously received csDMARD or bDMARD therapy were retrospectively selected from the Institute for Applied Health Research Berlin GmbH (InGef). Time on treatment and discontinuation risk were assessed using the Kaplan-Meier method. Cox regression identified variables associated with an increased discontinuation risk. RESULTS: A total of 990 patients had received prior csDMARD therapy; 375 had received prior bDMARD therapy. Tumor necrosis factor (TNF)-α inhibitors and JAK inhibitors were the most commonly prescribed DMARD class in those previously treated with a csDMARD or bDMARD, respectively. In both cohorts, more patients received DMARD monotherapy than combination therapy. In the prior csDMARD cohort, median time on treatment was 276, 252, and 148 days with JAK inhibitors, TNF­α inhibitors, and csDMARDs, respectively, and those treated with JAK or TNF­α inhibitors were less likely to discontinue treatment than those on csDMARDs (log-rank test p-value < 0.01 for both comparisons); no significant differences were found within the prior bDMARD cohort. CONCLUSION: This is among the first detailed analyses of RA treatment patterns in a real-world setting in Germany since the introduction of JAK inhibitors. TNF­α inhibitors were the most commonly prescribed DMARD after failure of an initial csDMARD, while JAK inhibitors were the most common among patients previously treated with a bDMARD. In both groups, monotherapy with bDMARD or targeted synthetic DMARD was common. In the prior csDMARD cohort, treatment duration was significantly longer with JAK or TNF­α inhibitors than with csDMARDs.

Economic burden of secondary hyperparathyroidism in Germany: a matched comparison.

PURPOSE: Secondary hyperparathyroidism (SHPT) of renal origin is a progressive complication in chronic kidney disease (CKD) and is associated with serious osseous and non-osseous complications, CKD progression, and economic burden for healthcare systems worldwide. We aimed at assessing characteristics, healthcare resource utilization, and costs of incident SHPT patients in CKD stage 3 (CKD3) and 4 (CKD4), using administrative claims data. METHODS: German claims data were used to identify CKD3 and CKD4 patients, who were stratified by the occurrence of incident SHPT. Patients with SHPT were matched 1:1 to non-SHPT patients with the same CKD stage using propensity scores. Matched groups were compared during a 2-year follow-up period. RESULTS: Overall, 1156 CKD3 and 517 CKD4 incident SHPT patients and their respective matches were identified. Mean number of all-cause hospitalizations were significantly higher among SHPT patients (2.7 vs. 2.0 in CKD3, 2.8 vs. 1.5 in CKD4) during follow-up. Similarly, the mean number of outpatient encounters was significantly higher among the SHPT cohorts (95.0 vs. 64.3 in CKD3, 101.4 vs. 49.8 in CKD4). SHPT patients progressed to CKD5 more often (6.1% vs. 1.2% from CKD3, 26.7% vs. 2.9% from CKD4, both P < 0.01) resulting in a higher proportion of dialysis (6.1% vs. 1.3% in CKD3, 22.1% vs. 3.7% in CKD4, both P < 0.01). Consequently, average all-cause healthcare costs significantly increased per patient (€19,477 vs. €15,115 in CKD3, €25,921 vs. €12,265 in CKD4). CONCLUSIONS: Patients with CKD3&4 and incident SHPT of renal origin presented with significantly higher healthcare resource utilization and costs, as well as increased disease progression compared to non-SHPT patients.

A comparative assessment of neutropenia events, healthcare resource use, and costs among cancer patients treated with lipegfilgrastim compared with pegfilgrastim in Germany.

PURPOSE: We assessed the occurrence of neutropenia and febrile neutropenia (FN) and the associated healthcare resource in cancer patients receiving myelosuppressive chemotherapy in combination with pegfilgrastim versus lipegfilgrastim. METHODS: This is a retrospective analysis using a German health insurance claims database. Adults receiving chemotherapy with a prescription code for pegfilgrastim (n = 734) or lipegfilgrastim (n = 346) were observed over a 1-year follow-up period. Patient subgroups were analyzed according to cancer type and FN risk. FN risk was based on the chemotherapy regimen and any additional neutropenia risk factors. Outcomes were adjusted via regression analysis. RESULTS: Most patients were classified as high FN risk (70.0% pegfilgrastim; 65.6% lipegfilgrastim cohort). The mean age was 58.2 years in the pegfilgrastim cohort and 58.0 years in the lipegfilgrastim cohort, with more female patients than male patients (77.3% vs 79.8%, respectively), and the majority had breast cancer (64.9% and 68.8%, respectively). Overall, 10.0% and 10.4% of patients receiving pegfilgrastim or lipegfilgrastim experienced a neutropenia event (p = 0.82), with 4.4% and 3.5% of patients experiencing a FN event (p = 0.49). The mean neutropenia event-related healthcare costs were €604 and €441 for the pegfilgrastim and lipegfilgrastim cohorts; among patients with lymphoma, these costs were significantly greater (p = 0.03) with pegfilgrastim (€1,612) versus lipegfilgrastim (€382). The mean all-cause hospitalizations were significantly (p < 0.01) higher for lymphoma patients receiving pegfilgrastim (2.76) versus lipegfilgrastim (1.60). CONCLUSION: Overall, patients treated with pegfilgrastim and lipegfilgrastim were comparable in terms of neutropenia occurrences in the 1-year follow-up. In patients with lymphoma, neutropenia event-related healthcare costs and all-cause hospitalizations were significantly higher with pegfilgrastim compared with lipegfilgrastim in this study; however, this should be interpreted with caution in light of the limited sample size and the absence of clinical information.

Health Resource Utilization and Associated Health Care Costs of Biologic Disease-Modifying Antirheumatic Drugs in German Patients With Psoriatic Arthritis.

OBJECTIVE: To investigate health care costs associated with biologic disease-modifying antirheumatic drugs (bDMARDs) in a German real-world cohort of adult biologics-naive patients with psoriatic arthritis (PsA). METHODS: Claims data from the Institute for Applied Health Research Berlin (InGef) research database for patients with a PsA diagnosis and bDMARD claims record (index date) between January 1, 2014, and December 31, 2017, and no bDMARD prescriptions for 365 days before the index date were retrospectively analyzed. Primary outcomes were determination of health care resource utilization and associated annual health care costs for overall and individual bDMARDs in the 12-month pre-index and post-index periods. These outcomes were compared between persistent and nonpersistent groups. Nonpersistence was defined as treatment gap or switch to a bDMARD other than the index therapy. RESULTS: Among 10,954 patients with a PsA diagnosis, 348 were eligible. Although mean ± SD post-index costs were significantly higher in the persistent group than the nonpersistent group (€27,869 ± 8,001 versus €21,897 ± 10,600, P < 0 .001) due to higher bDMARD acquisition costs (€23,996 ± 4,818 versus €16,427 ± 9,033, P < 0.001), persistence reduced inpatient treatment costs (-€760), outpatient treatment costs (-€192), other drug costs (-€724), and sick leave costs (-€601). CONCLUSION: Although initiation of bDMARDs increased the total health care costs irrespective of persistence status, partial cost offsets were observed in the persistent patient population.

Healthcare resource utilization and costs among nonalcoholic fatty liver disease patients in Germany.

BACKGROUND: Patients with nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH) are associated with progression to advanced liver diseases that include compensated cirrhosis, decompensated cirrhosis, liver transplantation, and hepatocellular carcinoma (HCC). This study characterized comorbidities, healthcare resource utilization (HRU), and associated costs among NAFLD patients in Germany. METHODS: German healthcare claims data between 2011 and 2016 were analyzed retrospectively. Adult patients diagnosed with NAFLD and/or NASH were categorized as NAFLD, NAFLD non-progressors, compensated cirrhosis, decompensated cirrhosis, liver transplant, or HCC. Within each stage, annual all-cause HRU and costs were measured during the pre- and post-index periods. RESULTS: Among 4,580,434 patients in the database, proportion of NAFLD was 4.7% (n=215,655). Of them, 36.8% were non-progressors, 0.2% compensated cirrhosis, 9.6% decompensated cirrhosis, 0.0005% liver transplant, and 0.2% HCC. Comorbidity rates were significantly higher in compensated cirrhosis, decompensated cirrhosis, and HCC compared with non-progressors (52.07%, 56.46%, 57.58% vs. 27.49% for cardiovascular disease; 77.13%, 76.61%, 83.47% vs. 54.89% for hypertension; 47.20%, 53.81%, 52.89% vs. 35.21% for hyperlipidemia; 49.88%, 36.67%, 48.21% vs. 20.38% for type 2 diabetes mellitus). The mean annual numbers of post-index outpatient visits and inpatient hospitalizations were significantly higher in patients with advanced liver diseases versus non-progressors. Mean annual costs were significantly higher among patients with advanced liver diseases (compensated cirrhosis, €10,291; decompensated cirrhosis, €22,561; liver transplant, €34,089; HCC, €35,910) than non-progressors (€3,818, P<0.001, except liver transplant cohort). This trend remained consistent after adjusting for baseline demographics and comorbidities. CONCLUSIONS: NAFLD patients in Germany are grossly underdiagnosed and exert substantial healthcare resource use and economic burden, particularly those with advanced liver diseases. Optimal strategies for early identification and management are needed to prevent disease progression and limit the rising costs.

Real-World Treatment Persistence with Biologic Disease-Modifying Antirheumatic Drugs Among German Patients with Psoriatic Arthritis-A Retrospective Database Study.

INTRODUCTION: To investigate drug survival for biologic disease-modifying antirheumatic drugs (bDMARDs) in a real-world cohort of German adult biologic-naïve patients with psoriatic arthritis (PsA). METHODS: Claims data for patients with a diagnosis of PsA, a bDMARD claims record (index date) between 1 January 2014 and 31 December 2017, and no bDMARD prescription for 365 days before the index date were retrospectively analyzed. The primary outcomes were the overall and individual bDMARD persistence rates over 12 months. Nonpersistence was defined as a treatment gap exceeding the days of supply plus 60 days or switching to a bDMARD other than the index therapy. Sensitivity analysis was performed, wherein the treatment gap was found to vary depending on the bDMARD regimen. Kaplan-Meier curves were plotted to determine persistence; the log-rank test was used to evaluate differences in the persistence rate. Factors associated with treatment discontinuation were evaluated using Cox regression analysis. RESULTS: Among 10,954 patients with a PsA diagnosis, 348 were eligible. The overall bDMARD persistence rate was 57.5%; individual bDMARD persistence rates were 81.3% for ustekinumab, 66.7% for infliximab, and 60.0% for golimumab. The mean (SD) overall persistence with bDMARDs was 289 (103) days; the mean persistence was 334 (72) days for ustekinumab, 309 (82) days for golimumab, and 305 (92) days for infliximab. The main reasons for nonpersistence were switching to another bDMARD (15.8%) and treatment discontinuation (26.7%). Male gender was significantly associated with a lower risk of treatment discontinuation (hazard ratio 0.54, 95% confidence interval 0.39-0.77; P < 0.001). The sensitivity analysis yielded similar results. CONCLUSION: The one-year persistence rate for bDMARDs in German PsA patients is modest, although the persistence rate depends on the bDMARD considered.

Patterns and predictors of mortality and disease progression among patients with non-alcoholic fatty liver disease.

BACKGROUND: Factors associated with mortality and disease progression in non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) are poorly understood. AIMS: To assess the impact of liver disease severity, demographics and comorbidities on all-cause mortality and liver disease progression in a large, real-world cohort of NAFLD patients. METHODS: Claims data from the German Institut für angewandte Gesundheitsforschung database between 2011 and 2016 were analyzed retrospectively. Adult patients diagnosed with NAFLD and/or NASH were categorised as NAFLD, NAFLD non-progressors, compensated cirrhosis, decompensated cirrhosis, liver transplant or hepatocellular carcinoma (HCC). The longitudinal probability of mortality and incidence of progression were calculated for disease severity cohorts and multivariable analyses performed for adjusted mortality. RESULTS: Among 4 580 434 patients in the database, prevalence of NAFLD was 4.7% (n = 215 655). Of those, 36.8% were non-progressors, 0.2% compensated cirrhosis, 9.6% decompensated cirrhosis, 0.0005% liver transplant and 0.2% HCC. Comorbidity rates were significantly higher in compensated cirrhosis, decompensated cirrhosis and HCC compared with non-progressors. The longitudinal probability of mortality for non-progressors, compensated cirrhosis, decompensated cirrhosis and HCC was 3.6%, 18.7%, 28.8% and 68%, respectively. Independent predictors of mortality included cardiovascular disease, type 2 diabetes mellitus, hypertension, obesity and renal impairment. The cumulative incidence of progression in NAFLD and compensated cirrhosis patients was 10.7% and 16.7%, respectively, over 5 years of follow-up. CONCLUSION: NAFLD patients were severely under-diagnosed and had a high probability of mortality that increased with disease progression. Early identification and effective management to halt or reverse fibrosis are essential to prevent progression.

Ankylosing spondylitis causes high burden to patients and the healthcare system: results from a German claims database analysis.

To compare healthcare resource utilization and costs between ankylosing spondylitis (AS) patients and a matched sample from the general population without AS covered by the German Statutory Health Insurance (SHI) system, a non-interventional retrospectively matched cohort analysis was conducted using anonymized SHI claims data. Data from January 1st, 2011 through December 31st, 2014 were analyzed. Individuals with a coded diagnosis of AS during the enrollment period comprising the full year of 2013 were directly matched (1:5) to individuals without AS diagnosis in the whole study period by age, gender, hospitalizations, and comorbidities. All-cause healthcare resource utilization and direct costs were analyzed for the year 2013. Statistical tests were applied to compare the differences between the two sampled populations. In 2013, 10,208 AS patients were identified and matched to a sample of 51,040 patients without AS from the general population. Healthcare resource utilization was significantly higher in all healthcare sectors (inpatient, outpatient, pharmaceuticals, remedies, devices and aids, and sick leave) in the AS cohort. Mean all-cause healthcare costs per patient were about €2475 higher in the AS cohort compared to the general population. Most important cost drivers were hospitalizations and pharmaceuticals in terms of bDMARDs prescribed in 10% of the patients. Real-world data from this German claims database analysis showed that AS is associated with a substantial incremental economic burden to the healthcare system.