Background Prescribing of menopausal hormone therapy (MHT) declined drastically after publication of the Women's Health Initiative's (WHI) findings in 2002, but studies on longer‐term trends and details of use are scarce. Methods We used the German Pharmacoepidemiological Research Database (GePaRD) containing health insurance claims data from ~25 million persons. Using data from 2004–2016, we conducted cross‐sectional analyses to determine the prevalence of MHT use overall and by type and route of administration in women aged 45–75. In longitudinal analyses, we assessed MHT use over 5 years and compared the patterns between different time periods. Results From 2004 to 2016, prevalence of systemic MHT prescriptions decreased by >60% in women aged 55–65 and by >50% in women aged 50 and 70 years old. Prevalence declined for most types and routes of administration at all ages (−16% to −79%) with some exceptions, for example, local MHT (vaginal estrogen). Among 50‐year‐old women in 2012, 6% were already prescribed systemic MHT at age 49 and of the remaining women, 16% were newly prescribed systemic MHT before age 55. At all ages, the cumulative dose of systemic MHT prescribed over 5 years was lower in the period 2012–2016 compared to 2005–2009 (−6% to −46%). Conclusions For most types of MHT and all age groups, prevalence declined considerably between 2004 and 2016 in Germany. The cumulative dose per MHT user also decreased, suggesting a trend towards a shorter duration of use.
Background We aimed to explore the potential of German claims data for describing initial and long-term treatment patterns of breast cancer patients undergoing surgery. Methods Using the German Pharmacoepidemiological Research Database (GePaRD, ~ 20% of the German population) we included patients with invasive breast cancer diagnosed in 2008 undergoing breast surgery and followed them until 2017. We described initial and long-term treatment patterns and deaths. Analyses were stratified by stage (as far as available in claims data), age at diagnosis, and mode of detection (screen-detected vs. interval vs. unscreened cases). Results The cohort comprised 10,802 patients. The proportion with neoadjuvant therapy was highest in patients < 50 years (19% vs. ≤ 8% at older ages). The proportion initiating adjuvant chemotherapy within four months after diagnosis decreased with age (< 50 years: 63%, 50–69: 46%, 70–79: 27%, 80 + : 4%). Among women < 69 years, ~ 30% had two breast surgeries in year one (70–79: 21%, 80 + : 14%). Treatment intensity was lower for screen-detected compared to interval or unscreened cases, both in year one (e.g., proportion with mastectomy ~ 50% lower) and within 2–10 years after surgery (proportions with radiotherapy or chemotherapy about one third lower each). Conclusions This study illustrates the potential of routine data to describe breast cancer treatment and provided important insights into differences in initial and long-term treatment by mode of detection and age.
Aims: Premarketing clinical trials are typically conducted under controlled conditions and in selected study populations, so real-world information on the utilization of new cancer drugs is limited. We aimed to explore the potential of German claims data in this regard, exemplified by the ALK inhibitor crizotinib, used in non-small-cell lung cancer therapy. Materials & methods: We identified patients treated with crizotinib in the German Pharmacoepidemiological Research Database (2004–2017; 20% of the German population) and assessed patient characteristics, treatment and survival. Results: We identified 348 crizotinib-treated patients (56% female; 25% first-line users). After 2 years, overall survival was 48%, with higher survival in men than in women (58 vs 40%). Overall, 76% of patients discontinued crizotinib treatment. Of those, 41% received another ALK inhibitor afterward. Conclusion: The results underline the potential of German claims data for real-world monitoring of oncological drug utilization.
Background The efficacy of mammography screening in reducing breast cancer mortality has been demonstrated in randomized trials. However, treatment options - and hence prognosis – for advanced tumor stages as well as mammography techniques have considerably improved since completion of these trials. Consequently, the effectiveness of mammography screening under current conditions is unclear and controversial. The German mammography screening program (MSP), an organized population-based screening program, was gradually introduced between 2005 and 2008 and achieved nation-wide coverage in 2009. Objective We describe in detail a study protocol for investigating the effectiveness of the German MSP in reducing breast cancer mortality in women aged 50 to 69 years based on health claims data. Specifically, the proposed study aims at estimating per-protocol effects of several screening strategies on cumulative breast cancer mortality. The first analysis will be conducted once 10-year follow-up data are available. Methods and Analysis We will use claims data from five statutory health insurance providers in Germany, covering approximately 37.6 million individuals. To estimate the effectiveness of the MSP, hypothetical target trials will be emulated across time, an approach that has been demonstrated to minimize design-related biases. Specifically, the primary contrast will be in terms of the cumulative breast cancer mortality comparing the screening strategies of “never screen” versus “regular screening as intended by the MSP”. Ethics and Dissemination In Germany, the utilization of data from health insurances for scientific research is regulated by the Code of Social Law. All involved health insurance providers as well as the responsible authorities approved the use of the health claims data for this study. The Ethics Committee of the University of Bremen determined that studies based on claims data are exempt from institutional review. The findings of the proposed study will be published in peer-reviewed journals.
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