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Objectives: Emerging treatments for relapsed or refractory multiple myeloma (rrMM) have led to increasing options for many patients. This study aimed to assess changes in utilization of these options in Germany with a focus on modern triplet regimens including new agents, such as carfilzomib, ixazomib, elotuzumab and daratumumab, and to evaluate whether this had an impact on rrMM‐related outcomes over time. Methods: The study population consisted of 1255 rrMM patients who were assigned to one of the following 6 treatment groups: immunomodulatory drug (IMiD)‐based doublets, proteasome inhibitor (PI)‐based doublets, daratumumab monotherapy, PI‐IMiD‐based triplets, monoclonal antibodies (mAbs)‐based triplets, or other treatment. Results: Use of triplet‐based therapy regimens increased from 5.9% in 2014 to 31.4% in 2017. In parallel, use of IMiD‐based doublets decreased from 74.3% in 2014 to 37.6% in 2017. Over the same time period, the risk of death decreased by 32% and the risk of hospitalization which was reduced by 30%. The risk for serious adverse events remained unchanged. Conclusions: Between 2014 and 2017, the use of triplet‐based therapy regimens for rrMM in Germany has significantly increased and this was associated with a significant decline in deaths and hospitalizations without an increased incidence of serious adverse events. [ABSTRACT FROM AUTHOR]

Background: In Germany, several triplet therapies for treating relapsed or refractory multiple myeloma (rrMM) patients have recently been approved. While most of them are administered intravenously, ixazomib-based combination is the only orally bioavailable regimen. Objective: To conduct a 1-year and 3-year budget impact analysis (BIA) of different novel triplets to treat patients with rrMM in second or subsequent therapy lines accounting for costs covered by German statutory health insurance (SHI). Methods: A 3-state partitioned survival model (PSM) was developed to evaluate the budget impact of the following regimens: carfilzomib plus lenalidomide plus dexamethasone (KRd), elotuzumab plus lenalidomide plus dexamethasone (ERd), daratumumab plus lenalidomide plus dexamethasone (DRd), and ixazomib plus lenalidomide plus dexamethasone (IRd). The analysis included direct medical costs such as drug acquisition, comedication and preparation for parenteral solutions, drug administration and other 1-time costs, adverse event management costs and direct non-medical costs, such as transportation costs. Results: Based on current drug market shares in German healthcare market, the estimated costs after 1 year of treatment was €551 million (KRd), €163 million (ERd), €584 million (DRd), and €95 million (IRd). The total budget impact of €1393 million is mainly driven by drug acquisition and subsequent therapy costs. Conclusion: Among the regimens of interest, the oral-based therapy regimens offered cost advantages over intravenous-based therapy regimens. The higher overall costs of intravenous therapy regimens were attributed primarily to higher drug acquisition costs. [ABSTRACT FROM AUTHOR]

Background: Underuse of oral anticoagulation (OAC) for stroke prevention in atrial fibrillation (AF) results in thousands of preventable strokes in Germany each year. This study aimed to assess changes in antithrombotic therapy in AF patients after increased use of direct oral anticoagulants (DOACs) in Germany and to evaluate whether the adoption of DOAC therapy was associated with changes in AF-related stroke and bleeding over time. Methods: Analyses were carried out on a large claims-based dataset of 4 million health-insured Germans. The study population consisted of 601,261 prevalent AF patients between 2011 and 2016 who were assigned to one of the following four treatment groups: DOAC, VKA, antiplatelets or no antithrombotic treatment. Treatment patterns were descriptively analysed and represented by cohort and CHA2DS2-VASc score. Clinical outcomes before and after the adoption of DOAC therapy were assessed using Poisson regression models. Results: Use of OAC increased from 42 to 61% between 2011 and 2016, mainly due to more frequent prescription of DOACs. However, some underuse of OAC therapy remained even in high risk AF patients. In parallel with the increased prescription rate of OAC, there was an overall 24% incidence reduction in stroke between 2011 and 2016 which was mainly driven by reductions in ischemic strokes. Over the same time period the risk for major bleeding remained unchanged. Conclusion: Between 2011 and 2016, the use of guideline-conform antithrombotic therapy in Germany has significantly increased. This was associated with a significant decline in strokes without an increased incidence of bleeding complications. [ABSTRACT FROM AUTHOR]

Background: Patients with non-valvular atrial fibrillation (NVAF) have a five times higher stroke risk. For more than 50 years, vitamin K antagonists (VKAs) have been the primary medication for stroke prevention. Apixaban, a non-vitamin K oral anticoagulant (NOAC), has demonstrated better efficacy and safety characteristics than the VKA warfarin in the ARISTOTLE trial. This study aims to quantify the potential societal effects of using apixaban instead of VKA in the German NVAF population from 2017 to 2030.Methods: Using an existing Markov model and a dynamic population approach, we modelled the health benefits of apixaban in patients with NVAF compared to VKA therapy in the German population from 2017 to 2030.Results: The results represent the extrapolated direct long-term health benefits of apixaban over VKA therapy for the German NVAF population. From 2017 until 2030, the use of apixaban instead of a VKA could avoid 52,185 major clinical events. This includes 15,383 non-fatal strokes or SEs, 22,483 non-fatal major bleeds, and 14,319 all-cause deaths, which correspond to 109,887 life years gained.Conclusion: This study demonstrated that using apixaban instead of VKA for stroke prevention can lead to considerable reduction in cardiovascular events. [ABSTRACT FROM AUTHOR]

Background: Non-vitamin K antagonist oral anticoagulants (NOACs) are at least as effective and safe as vitamin K antagonists (VKAs) for stroke prevention in atrial fibrillation (AF). All pivotal trials have compared NOACs to warfarin. However, other VKAs are commonly used, for instance phenprocoumon. Patients and methods: A retrospective cohort study using a German claims database assessed the comparative risks of bleeding leading to hospitalization during therapy with NOACs and phenprocoumon in AF patients. Endpoints consisted of major bleeding, gastrointestinal bleeding, and any bleeding. Data were collected from January 1, 2013 to March 31, 2015. Patients newly initiated on dabigatran, apixaban, rivaroxaban, or phenprocoumon were included. Hazard Ratios for bleeding events were derived from Cox proportional hazard models, adjusting for differences in baseline characteristics. Propensity score matching was performed as a sensitivity analysis. Results: A total of 35,013 patients were identified, including 3138 on dabigatran, 3633 on apixaban, 12,063 on rivaroxaban, and 16,179 on phenprocoumon. Patients prescribed apixaban or phenprocoumon were older compared to those on dabigatran or rivaroxaban and had a higher CHADS-VASc score. After adjusting for baseline confounders, apixaban was associated with lower risks of major bleeding (HR 0.68, 95% CI 0.51-0.90, p = 0.008), gastrointestinal bleeding (HR 0.53, 95% CI 0.39-0.72, p < 0.001), and any bleeding (HR 0.80, 95% CI 0.70-0.92, p = 0.002) compared to phenprocoumon. There were no significant differences in bleeding risk between dabigatran and phenprocoumon. Rivaroxaban was associated with more gastrointestinal bleeding (HR 1.39, 95% CI 1.21-1.60, p < 0.001) and any bleeding (HR 1.19, 95% CI 1.10-1.28, p < 0.001). Sensitivity analysis using propensity score matching confirmed these observations. Conclusions: Apixaban therapy is associated with a significantly reduced risk of bleeding compared to phenprocoumon. Bleeding risk with dabigatran was similar to that of phenprocoumon but bleeding risk with rivaroxaban was higher. [ABSTRACT FROM AUTHOR]

The German Microcensus (MC) is a large scale rotating panel survey over three years. The MC is attractive for longitudinal analysis over the entire participation duration because of the mandatory participation and the very high case numbers (about 200000 respondents). However, as a consequence of the area sampling that is used for the MC, residential mobility is not covered and consequently statistical information at the new residence is lacking in the MC sample. This raises the question whether longitudinal analyses, like transitions between labour market states, are biased and how different methods perform that promise to reduce such a bias. Similar problems occur also for other national Labour Force Surveys (LFS) which are rotating panels and do not cover residential mobility, see Clarke and Tate (2002). Based on data of the German Socio-Economic Panel (SOEP), which covers residential mobility, we analysed the effects of missing data of residential movers by the estimation of labour force flows. By comparing the results from the complete SOEP sample and the results from the SOEP, restricted to the non-movers, we concluded that the non-coverage of the residential movers can not be ignored in Rubin’s sense. With respect to correction methods we analysed weighting by inverse mobility scores and log-linear models for partially observed contingency tables. Our results indicate that weighting by inverse mobility scores reduces the bias to about 60% whereas the official longitudinal weights obtained by calibration result in a bias reduction of about 80%. The estimation of log-linear models for non-ignorable non-response leads to very unstable results. [ABSTRACT FROM AUTHOR]

The German Microcensus is a rotating panel, where the units stay in the survey for four observations. Because of the very large sample size and the mandatory participation it appears to be a valuable data base for short duration analysis. However, the German Microcensus (MC) uses area sampling where participants are not followed if they leave the area. Consequently there is no information on participants after they move. We investigate how the use of the German Socio-Economic Panel (SOEP) can help to measure the non-coverage bias of the MC. Our methodology is evaluated for labour force flows. The results indicate that the SOEP is a valuable instrument for assessing the non-coverage bias in the MC. For labour force flows the non-coverage bias of the MC appears to be only of moderate size. [ABSTRACT FROM AUTHOR]