[Hepatitis C in Germany: an analysis of statutory sickness funds claims data]. / Hepatitis C in Deutschland.

BACKGROUND: The aim of this study was to investigate the number of persons who obtain medical attention for Hepatitis C Virus (HCV). In addition, we wanted to get an overview of the supply situation (frequency and length of therapy or lab controls) for patients with HCV infection. METHODOLOGY: Data obtained from statutory insurance companies were analyzed. RESULTS: The prevalence of HCV diagnosis was 0.19 % within 3 years. Following a positive HCV-test in 19 % of patients the diagnosis of acute HCV was documented. In 2008, 9.3 % of patients were treated with pegylated Interferon alpha with or without Ribavirin (11.9 % for chronic and 3.6 % for acute HCV). A general practitioner initiated in about 5.1 % and a specialist in 21.7 % of cases a therapy within a year. 37.0 % of patients treated by a general practitioner and 57.0 % of patients treated by specialists received prescriptions in the third quarter after initiating the therapy. Not all patients had a documented test for viral load prior to therapy. CONCLUSIONS: 50 % of HCV-patients visited a physician in a 3 year time period while an average of 9 % received a therapy within a year. For the coding of acute HCV diagnosis, duration of therapy and the necessary viral load test prior therapy, the analyses showed deviations from the guideline and differences between general practitioners and specialists. For future therapies, patients with HCV-infection should be treated in specialized centers so that these therapies may develop their efficiency in the health system.

[Antiretroviral therapy for HIV/AIDS in claims data from statutory health insurance funds in Germany]. / Häufigkeiten antiretroviraler Therapie in Sekundärdaten von gesetzlichen Krankenkassen in Deutschland.

The objective of this study is to determine the number of patients who receive anti-retroviral medicinal products (ARMs) and to assess the frequency of prescriptions depending on age, gender and treatment regimen by evaluating German statutory health insurance data. We analysed a number of databases of several million customers of various nationwide statutory sickness funds and extrapolated the results to the overall population of the statutory health insurance. The number of HIV-positive patients with ARMs varied considerably between the statutory sickness funds analysed. The number of patients with HIV diagnosis receiving ARMs that are exclusively approved for HIV increased from about 23,262 in 2008 to 30,200 in 2010. For ARMs labelled for both, HIV and HIV/chronic hepatitis B, indications, we calculated about 34,032 patients for the year 2011. In about 24.2% of the cases with HIV-only and HIV plus HIV/chronic hepatitis B-approved ARMs no HIV-diagnosis was documented. Patients in this group were significantly younger and more often female as compared to patients with documented HIV diagnosis who received prescriptions of ARMs. 16.5% of the patients received treatment within the label for chronic hepatitis B. In 7.7% of the patients ARMs were used off-label for prophylaxis (10.0%), for hepatitis (65.0%) or for unknown reasons (25.0%). Hence, the number of people under ARMs was estimated to be below the 44,000 patients calculated for statutory sickness funds patients on the basis of prescription data in 2011. According to our analysis only 39,000 of those could have a documented HIV diagnosis.

Treatment strategies for treatment naïve HIV patients in Germany: evidence from claims data.

A recent observational study of HIV patients in Germany suggests that treatment naïve patients that are in a more advanced stage of their disease are more likely to receive a treatment regimen based on a boosted protease inhibitor (PI/r) compared with a non-nucleoside reverse-transcriptase-inhibitor (NNRTI) base regimen. To validate those results we analysed claims data of seven German sickness funds from 2009 to 2012 with approximately 4 million beneficiaries. Patients in a more advanced disease state (CDC class C) had a higher likelihood to receive a PI/r based regime rather than a NNRTI based regimen as their initial treatment. There was also a significant correlation between PI/r based regimen and number of comorbidities but not with age. Our results confirm a highly significant relationship between being in a more severe stage of HIV disease and a PI/r based treatment regimen.

Converging or Crossing Curves: Untie the Gordian Knot or Cut it? Appropriate Statistics for Non-Proportional Hazards in Decitabine DACO-016 Study (AML).

INTRODUCTION: Among patients with acute myeloid leukemia (AML), the DACO-016 randomized study showed reduction in mortality for decitabine [Dacogen(®) (DAC), Eisai Inc., Woodcliff Lake, NJ, USA] compared with treatment choice (TC): at primary analysis the hazard ratio (HR) was 0.85 (95% confidence interval 0.69-1.04; stratified log-rank P = 0.108). With two interim analyses, two-sided alpha was adjusted to 0.0462. With 1-year additional follow-up the HR reached 0.82 (nominal P = 0.0373). These data resulted in approval of DAC in the European Union, though not in the United States. Though pre-specified, the log-rank test could be considered not optimal to assess the observed survival difference because of the non-proportional hazard nature of the survival curves. METHODS: We applied the Wilcoxon test as a sensitivity analysis. Patients were randomized to DAC (N = 242) or TC (N = 243). One-hundred and eight (44.4%) patients in the TC arm and 91 (37.6%) patients in the DAC arm selectively crossed over to subsequent disease modifying therapies at progression, which might impact the survival beyond the median with resultant converging curves (and disproportional hazards). RESULTS: The stratified Wilcoxon test showed a significant improvement in median (CI 95%) overall survival with DAC [7.7 (6.2; 9.2) months] versus TC [5.0 (4.3; 6.3) months; P = 0.0458]. CONCLUSION: Wilcoxon test indicated significant increase in survival for DAC versus TC compared to log-rank test. FUNDING: Janssen-Cilag GmbH.

Potential cost saving of Epoetin alfa in elective hip or knee surgery due to reduction in blood transfusions and their side effects: a discrete-event simulation model.

OBJECTIVES: Transfusion of allogeneic blood is still common in orthopedic surgery. This analysis evaluates from the perspective of a German hospital the potential cost savings of Epoetin alfa (EPO) compared to predonated autologous blood transfusions or to a nobloodconservationstrategy (allogeneic blood transfusion strategy)during elective hip and knee replacement surgery. METHODS: Individual patients (N = 50,000) were simulated based on data from controlled trials, the German DRG institute (InEK) and various publications and entered into a stochastic model (Monte-Carlo) of three treatment arms: EPO, preoperative autologous donation and nobloodconservationstrategy. All three strategies lead to a different risk for an allogeneic blood transfusion. The model focused on the costs and events of the three different procedures. The costs were obtained from clinical trial databases, the German DRG system, patient records and medical publications: transfusion (allogeneic red blood cells: €320/unit and autologous red blood cells: €250/unit), pneumonia treatment (€5,000), and length of stay (€300/day). Probabilistic sensitivity analyses were performed to determine which factors had an influence on the model's clinical and cost outcomes. RESULTS: At acquisition costs of €200/40,000 IU EPO is cost saving compared to autologous blood donation, and cost-effective compared to a nobloodconservationstrategy. The results were most sensitive to the cost of EPO, blood units and hospital days. CONCLUSIONS: EPO might become an attractive blood conservation strategy for anemic patients at reasonable costs due to the reduction in allogeneic blood transfusions, in the modeled incidence of transfusion-associated pneumonia andthe prolongedlength of stay.