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

A recent observational study of HIV patients in Germany suggests that treatment naive 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

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

A recent observational study of HIV patients in Germany suggests that treatment naive 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

Algorithm of Patient Creation and of Modeled Blood Transfusion.

<p>Algorithm of Patient Creation and of Modeled Blood Transfusion.</p

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

<div><p>Objectives</p><p>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.</p><p>Methods</p><p>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.</p><p>Results</p><p>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.</p><p>Conclusions</p><p>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.</p></div

ABT vs. EPO – Sensitivity Analyses: Other Influential Parameters.

<p>ABT vs. EPO – Sensitivity Analyses: Other Influential Parameters.</p

Sensitivity analysis –PAD vs. EPO by preoperative Hb level subgroups.

<p>Sensitivity analysis –PAD vs. EPO by preoperative Hb level subgroups.</p

Incremental costs of ABT vs. EPO strategy – Sensitivity Analyses: Most Influential Parameters (Factor 1.11 and 1.29 are referring to lower and upper 95% Confidence interval).

<p>Incremental costs of ABT vs. EPO strategy – Sensitivity Analyses: Most Influential Parameters (Factor 1.11 and 1.29 are referring to lower and upper 95% Confidence interval).</p