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.

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.

The burden of hyperkalemia in Germany - a real world evidence study assessing the treatment and costs of hyperkalemia.

BACKGROUND: Hyperkalemia (HK) can affect health outcomes and quality of life, as it is referred to as a potentially life-threatening condition caused by an increased serum potassium concentration in the blood. Patients suffering from heart failure or chronic kidney diseases are at a higher risk of HK, which can further be amplified by the treatment received. To date, data on HK prevalence is lacking for Germany and the aims of this study were to assess HK and compare health-relevant outcomes and healthcare costs between HK patients and non-HK patients. METHODS: The InGef research database containing healthcare claims of over 4 million individuals in Germany was utilized for this retrospective, matched cohort analysis. Patients with non-acute outpatient treated and a subgroup of patients with chronic HK, were identified in 2015 with an individual 1 year pre- and post-index period, taking the first observable HK diagnosis/treatment in 2015 into account as the index event. To identify non-acute outpatient treated HK patients, at least two ICD-10-GM diagnosis codes E87.5 "Hyperkalemia" and/or prescriptions of polystyrene sulfonate were required. Chronic HK patients had additional diagnoses and/or prescriptions in all quarters following the first observable HK diagnosis. Patients without HK were matched 1:1 to the respective HK cohorts. RESULTS: In the year 2015, 3333 patients with non-acute outpatient treated HK were identified of which 1693 were patients with chronic HK. After matching, 3191 and 1664 HK patients and controls were available for analysis. A significantly higher number of hospitalizations was observed for both HK cohorts in comparison to their matched controls. Dialysis initiation as well as the healthcare costs were higher for both HK cohorts when compared to their matched counterparts. CONCLUSIONS: The disease burden was higher for patients with HK, based on a higher proportion of patients with dialysis initiation and higher healthcare costs.

Comedication prescription patterns and potential for drug-drug interactions with antiretroviral therapy in people living with human immunodeficiency virus type 1 infection in Germany.

PURPOSE: Various first-line recommended antiretroviral therapy (ART) regimens have different drug-drug interaction (DDI)/contraindication profiles. The aim of this study was to estimate the rate of potential DDIs/contraindications of real-world prescribed non-ART comedication with first-line recommended ART in people living with HIV (PLHIV) in Germany. METHODS: A retrospective, cross-sectional cohort design was used to collect non-ART comedication prescription data from a representative sample of a German health insurance claims database. PLHIV who were prescribed ART during 2016 were included in the analysis. Patients were stratified by sex, age, comorbidities, and time on ART. Prescribed comedications were used to estimate potential DDIs/contraindications for each recommended first-line ART per patient based on criteria from www.hiv-druginteractions.org. RESULTS: Records from 2680 PLHIV were analyzed. Prescriptions for non-ART comedications were common (mean of seven per patient in the overall population, 10.2 in PLHIV aged 50 years and older). Antiretroviral regimens with the lowest proportion of patients with at least 1 potential DDI/contraindication were unboosted integrase inhibitor, non-tenofovir disoproxil fumarate-based regimens that included raltegravir + emtricitabine/tenofovir alafenamide fumarate (13%), dolutegravir + lamivudine (14%), dolutegravir/abacavir/lamivudine (14%), dolutegravir/emtricitabine/tenofovir alafenamide fumarate (15%), and bictegravir/emtricitabine/tenofovir alafenamide fumarate (19%). Boosted regimens and efavirenz-based regimens presented the highest potential for DDIs/contraindications. CONCLUSIONS: Comedication with potential DDIs/contraindications with ART is frequently prescribed among PLHIV in Germany. Potential risks for DDIs/contraindications vary by ART, with the lowest potential seen in unboosted integrase strand transfer inhibitor-based regimens, including raltegravir + emtricitabine/tenofovir alafenamide fumarate, followed by three dolutegravir-based regimens.

Oral versus intravenous iron therapy in patients with inflammatory bowel disease and iron deficiency with and without anemia in Germany - a real-world evidence analysis.

BACKGROUND: Iron-deficiency anemia and iron deficiency are common comorbidities associated with inflammatory bowel disease (IBD) resulting in impaired quality of life and high health care costs. Intravenous iron has shown clinical benefit compared to oral iron therapy. AIM: This study aimed to compare health care outcomes and costs after oral vs intravenous iron treatment for IBD patients with iron deficiency or iron deficiency anemia (ID/A) in Germany. METHODS: IBD patients with ID/A were identified by ICD-10-GM codes and newly commenced iron treatment via ATC codes in 2013 within the InGef (formerly Health Risk Institute) research claims database. Propensity score matching was performed to balance both treatment groups. Non-observable covariates were adjusted by applying the difference-in-differences (DID) approach. RESULTS: In 2013, 589 IBD patients with ID/A began oral and 442 intravenous iron treatment. After matching, 380 patients in each treatment group were analyzed. The intravenous group had fewer all-cause hospitalizations (37% vs 48%) and ID/A-related hospitalizations (5% vs 14%) than the oral iron group. The 1-year preobservation period comparison revealed significant health care cost differences between both groups. After adjusting for cost differences by DID method, total health care cost savings in the intravenous iron group were calculated to be €367. While higher expenditure for medication (€1,876) was observed in the intravenous iron group, the inpatient setting achieved most cost savings (€1,887). CONCLUSION: IBD patients receiving intravenous iron were less frequently hospitalized and incurred lower total health care costs compared to patients receiving oral iron. Higher expenditures for pharmaceuticals were compensated by cost savings in other domains.

Healthcare resource use and costs of multiple sclerosis patients in Germany before and during fampridine treatment.

BACKGROUND: Multiple sclerosis (MS) patients often suffer from gait impairment and fampridine is indicated to medically improve walking ability in this population. Patient characteristics, healthcare resource use, and costs of MS patients on fampridine treatment for 12 months in Germany were analyzed. METHODS: A retrospective claims database analysis was conducted including MS patients who initiated fampridine treatment (index date) between July 2011 and December 2013. Continuous insurance enrollment during 12 months pre- and post-index date was required, as was at least 1 additional fampridine prescription in the fourth quarter after the index date. Patient characteristics were evaluated and pre- vs post-index MS-related healthcare utilization and costs were compared. RESULTS: A total of 562 patients were included in this study. The mean (standard deviation [SD]) age was 50.5 (9.8) years and 63% were female. In the treatment period, almost every patient had at least 1 MS-related outpatient visit, 24% were hospitalized due to MS, and 79% utilized MS-specific physical therapy in addition to the fampridine treatment. Total MS-related healthcare costs were significantly higher in the fampridine treatment period than in the period prior to fampridine initiation (€17,392 vs €10,960, P < 0.001). While this difference was driven primarily by prescription costs, MS-related inpatient costs were lower during fampridine treatment (€1,333 vs €1,565, P < 0.001). CONCLUSIONS: Physical therapy is mainly used concomitant to fampridine treatment. While healthcare costs were higher during fampridine treatment compared to the pre-treatment period, inpatient costs were lower. Further research is necessary to better understand the fampridine influence.

Burden of disease of reoperations in instrumental spinal surgeries in Germany.

PURPOSE: To estimate the incidence of instrumental spinal surgeries (ISS) and consecutive reoperations and to calculate the related resource utilization and costs. METHODS: ISS and subsequent reoperations were identified retrospectively using surgery codes in claims data. The study period included January 01, 2009 to December 31, 2011. The reoperation rate was calculated for 1 year after the primary ISS. Resource utilization and costs were analyzed by group comparison. RESULTS: A total of 3316 incident ISS patients were identified in 2010 with an annual reoperation rate of 9.98% (95% CI 8.98-11.02%). Mean costs per patient were €11,331 per ISS and €11,370 per reoperation, with €8432 directly attributed to the reoperation and €2938 to additional resources. CONCLUSIONS: Costs of ISS and subsequent reoperations have a significant impact on health insurances budgets. The annual cost of reoperations exceeds the direct cost of the primary surgery driven by the need for further inpatient and outpatient care.