Hepatocellular carcinoma after prior sorafenib treatment: incidence, healthcare utilisation and costs from German statutory health insurance claims data.

OBJECTIVE: To 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. METHODS: Patients 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. RESULTS: Between 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%]). CONCLUSION: The 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.

Use of Structural Equation Modeling to Demonstrate the Differential Impact of Storage and Voiding Lower Urinary Tract Symptoms on Symptom Bother and Quality of Life during Treatment for Lower Urinary Tract Symptoms Associated with Benign Prostatic Hyperplasia.

PURPOSE: Lower urinary tract symptoms associated with benign prostatic hyperplasia typically respond well to medical therapy. While changes in total I-PSS (International Prostate Symptom Score) are generally accepted as measurement for treatment response, I-PSS storage and voiding subscores may not accurately reflect the influence of symptom improvement on patient bother and quality of life. MATERIALS AND METHODS: Structural equation modeling was done to evaluate physiological interrelationships measured by I-PSS storage vs voiding subscore questions and measure the magnitude of effects on bother using BII (Benign Prostatic Hyperplasia Impact Index) and quality of life on I-PSS quality of life questions. Pooled data from 4 randomized, controlled trials of tadalafil and placebo in 1,462 men with lower urinary tract symptoms/benign prostatic hyperplasia were used to investigate the relationship of storage vs voiding lower urinary tract symptoms on BII and quality of life. RESULTS: The final structural equation model demonstrated a sufficient fit to model interdependence of storage, voiding, bother and quality of life (probability for test of close fit <0.0001). Storage aspects had a twofold greater effect on voiding vs voiding aspects on storage (0.61 vs 0.28, each p <0.0001). The direct effect of storage on bother was twofold greater than voiding on bother (0.64 vs 0.29, each p <0.0001). Bother directly impacted quality of life by the largest magnitude of (-0.83), largely driven by storage lower urinary tract symptoms (p <0.0001). CONCLUSIONS: Total I-PSS is a reliable instrument to assess the therapeutic response in lower urinary tract symptoms/benign prostatic hyperplasia cases. However, an improvement in storage lower urinary tract symptoms is mainly responsible for improved bother and quality of life during treatment. Care should be taken when evaluating the accuracy of I-PSS subscores as indicators of the response to medical therapy.

Expenditures of the German statutory health insurance system for patients suffering from acute coronary syndrome and treated with percutaneous coronary intervention.

Patients with acute coronary syndrome (ACS) are in need of cost-intensive treatment involving different aspects of the German Health System. Percutaneous coronary intervention (PCI) is the treatment of choice for a large proportion of cases. In the present study, an analysis of the cost impact of ACS with focus on PCI therapy was conducted across-the-board for the German Health System. Results indicated that 85% of all costs arising from treatment of ACS with a trial of PCI are due to in-patient care. Projection of results onto the entire insurant collective of the statutory health system estimated a total of Euro 954,995,603-a proportional 0.7% of all expenditure by statutory health insurance in 2005.

Diabetic retinopathy and health-related quality of life.

OBJECTIVE: To describe the impact of co-morbidities, visual acuity, diabetic retinopathy (DR) grade, and macular edema (ME) on the health-related quality of life (HRQOL) among patients with diabetic retinopathy. METHODS: Analysis of data of 207 patients with diabetic retinopathy from Germany in 2003. HRQOL assessment was done using the generic (SF-12) questionnaire. It was hypothesized that exogenous variables (co-morbidities, visual acuity impairment, DR, and ME) would have an impact on HRQOL. Using a structural equation modelling procedure, the effects of exogenous variables on endogenous variables physical component summaries (PSC) and mental component summaries (MCS) reflecting HRQOL were tested. RESULTS: The number of co-morbidities had a negative effect on visual acuity (b = -0.26, standardized) and a similar negative effect on PCS (b = -0.27). DR grade had a negative effect on visual acuity (b = -0.19) and a positive effect on the variable ME (b = 0.44). ME displayed a negative effect on visual acuity (b = -0.58) and also on MCS (b = -0.29). Visual acuity had a positive effect (b = 0.48) on PCS. CONCLUSIONS: Presence of DR and ME, visual acuity impairment and patient co-morbidities lead to significant impairment of both the physical and mental components of HRQOL.

The quality of life and economic burden of neuropathy in diabetic patients in Germany in 2002--results from the Diabetic Microvascular Complications (DIMICO) study.

OBJECTIVE: To describe the health-related quality of life (HRQOL), the resource utilization and annual costs associated with diabetic neuropathy (DN) in Germany. METHODS: In this retrospective, observational study German internists, diabetologists and general practitioners provided information on 185 adult type 1 and type 2 diabetic patients with DN. Health-related quality of life (HRQOL) was assessed using generic and disease specific questionnaires. Socio-demographic and resource use data were assessed from medical charts and through patient interviews. Based on these results, national-level cost estimates were calculated using German unit costs. RESULTS: The majority of DN patients were severely impaired with regard to general physical HRQOL. Disease specific HRQOL decreased continuously with increasing DN severity. In accordance, costs associated with DN increased as DN progressed, with costs from the societal perspective increasing about 50-fold from the lowest severity stage (patients with sensory-motor neuropathy without symptoms) (euro431) to patients with lower extremity amputation in the year 2002 (euro21,476). The German statutory health insurance covered more than two thirds of the total costs of DN. CONCLUSIONS: The results described in this report show that diabetic neuropathy in adults with type 1 or type 2 diabetes generates significant reductions in the patient's quality of life and a substantial economic burden both for society and health insurance.

[Costs of early retirement--the case of schizophrenia]. / Kosten der Frühverrentung am Beispiel der Schizophrenie.

Schizophrenia is a severe psychic disorder that occurs at young age and often leads to a work disability. The disease not only induces direct costs in the health care system but also indirect costs that show up in the social security system. In this study, we apply statistics from the social security administration on early retirement due to disability. Over 6000-males and females per year retire with the diagnosis schizophrenia (classified as 295, ICD-9). The average retirement age is 39 for males and 42 for females. Schizophrenia is the most important single reason for early retirement before age 40. Of all male cases of disability retirement under the age of 40, 14.7 % are due to schizophrenia. The present discounted value of pensions paid out before the standard retirement age of 65 is 215 000 Euro for an average male. Moreover, the revenue loss in income taxes and payroll contributions amounts to 345 000 Euro. In the year 2000, a total of 125 000 persons under the age of 65, who originally entered retirement with the diagnosis schizophrenia, are estimated to be receiving a pension. The corresponding annual expenditures of the social security system reach 1.3 Billion Euro; the revenue loss (pay-roll plus income taxes) reaches 2 Billion Euro. Since only two thirds of the working age population is covered by the social security system, the costs of early retirement due to schizophrenia are underestimated by a factor of at least one third.