Treatment Pathways and Health Outcomes of German Patients with Chronic Graft-Versus-Host Disease After Allogeneic Hematopoietic Cell Transplantation: A Retrospective Health Claims Data Analysis.

BACKGROUND: Although chronic graft-versus-host-disease (cGvHD) is an important long-term complication after allogenic hematopoietic cell transplantation (allo-HCT) and is associated with increased healthcare resource utilization, real-world evidence is scarce. OBJECTIVES: The aim of the study was to evaluate survival of patients with cGvHD in Germany and to analyze hospitalization and treatment patterns. PATIENTS AND METHODS: Based on a German claims database with 4.9 million enrollees, a retrospective longitudinal analysis covering a 6-year period between 2013 and 2018 was conducted. Patients with allo-HCT in 2014 or 2015 (index date) and no record of transplantation or documentation of GvHD 365 days prior to index were included. Patients who subsequently developed a cGVHD were compared with those who did not develop a cGVHD within 3 years after index date. cGVHD cases were identified based on documented International Classification of Diseases, Tenth Revision (ICD-10) diagnosis and treatment algorithms. Since the onset of cGvHD is defined at 100 days after allo-HCT, only those alive beyond day 100 were considered in the survival analysis. Patients who did not survive the first 100 days after allo-HCT were censored to prevent a selection bias due to early mortality within patients without GvHD. Survival rates were plotted using the Kaplan-Meier estimator. The number of hospitalizations and average lengths of stay as well as treatment patterns were descriptively examined. RESULTS: Overall, 165 cGvHD patients were identified and compared with 43 patients without cGVHD. Short-term survival rates were better for patients with cGvHD; the 6-month survival probability was 95.8% for patients with cGVHD and 83.7% for patients without cGVHD. However, long-term survival was better in patients without GvHD; The 30-month survival probability was 65.5% for patients with cGVHD and 76.7% for patients without cGVHD. While overall 90% of cGvHD patients were hospitalized at least once, the share was only half for patients without GvHD (44%). 78.2% of patients with cGVHD received corticosteroids in combination with other predefined immunosuppressants. CONCLUSION: Findings from this study reveal a high disease burden associated with cGvHD. This underlines the high medical need for new interventional strategies to improve survival and morbidity after allo-HCT.

Care reality of menopausal women in Germany: healthcare research using quantitative (SHI claims data) and qualitative (survey) data collection.

PURPOSE: The transition from the fertile phase of life to menopause is associated with numerous physical changes. Hormone replacement therapy (HRT), as the most effective and efficient form of drug treatment, involves the use of oestrogens and progestins with the aim of increasing health-related quality of life through symptom reduction, sleep improvement and affect enhancement. METHODS: The medical care situation and disease burden of menopausal women was investigated by means of a survey of 1000 women aged 45-60 years on the topics of quality of life, menopause and HRT and a quantitative, longitudinal healthcare study based on an anonymised and age- and sex-adjusted Statutory Health Insurance (SHI) routine data set with approximately four million anonymous insured persons per year. RESULTS: Out of more than half a million women aged 35-70 years, and with statutory health insurance, (n = 613,104), 14% (n = 82,785) had climacteric disorder documented as a first diagnosis in 2014. The proportion of women with the climacteric disorder, who were prescribed HRT on an outpatient basis, was 21%; according to the forsa survey, 50% of the women surveyed felt moderate to poorly/very poorly informed about treatment options. CONCLUSION: Findings from the health insurance research conducted with different data sources (survey and SHI claims data) indicate the need for increasing awareness and providing an early and informative education on HRT and its risks and benefits.

Persistence With Biologic Therapy and Associated Costs of Patients With Inflammatory Bowel Disease: A German Retrospective Claims Data Analysis.

Background: In recent years, biologic agents became a relevant and promising treatment option for inflammatory bowel diseases (IBDs). However, high treatment costs and moderate remission rates lead to a high interest in treatment persistence and corresponding economic consequences. Methods: A retrospective health claims data analysis was conducted including biologic naive patients diagnosed with IBD between 2013 and 2018. Observation points were at 12 and 18 months of follow-up, starting from the first biologic prescription. Nonpersistence was defined as either no further prescription or prescription of another biologic agent within the days of supply per original prescription. Biologic agents included were Adalimumab, Golimumab, Infliximab, Ustekinumab, and Vedolizumab. Results: In total, 1444 patients with IBD were included in this analysis, mostly treated with Adalimumab (46.9%) and Infliximab (39.9%) as their first biologic treatment. After 12 months, 72.2% of patients were still persistent with their initial biologic treatment with the highest shares for Infliximab (74%) and Vedolizumab (72.4%). 27.8% of patients were nonpersistent, mostly due to a switch of biologic agent (75.8%). Cox regression identified female, hospitalizations, and simultaneous prescriptions of corticosteroids and immunomodulators as risk factors for nonpersistence. Treatment costs per year were approximately 3000€ higher for nonpersistent patients (27,146€) than for persistent patients (23,839€), mostly due to inpatient treatment costs. Conclusions: The persistence of biologic therapy in this study was rather high at 72% after 12 months, while nonpersistence was mostly due to switches to other biologic agents. Lack of persistence is associated with increased cost, mostly due to nonbiologic medication and inpatient treatment.

Best-worst scaling to assess the most important barriers and facilitators for the use of health technology assessment in Austria.

BACKGROUND: Although Health Technology Assessment (HTA) is increasingly used to support evidence-based decision-making in health care, several barriers and facilitators for the use of HTA have been identified. This best-worst scaling (BWS) study aims to assess the relative importance of selected barriers and facilitators of the uptake of HTA studies in Austria. METHODS: A BWS object case survey was conducted among 37 experts in Austria to assess the relative importance of HTA barriers and facilitators. Hierarchical Bayes estimation was applied, with the best-worst count analysis as sensitivity analysis. Subgroup analyses were also performed on professional role and HTA experience. RESULTS: The most important barriers were 'lack of transparency in the decision-making process', 'fragmentation', 'absence of appropriate incentives', 'no explicit framework for decision-making process', and 'insufficient legal support'. The most important facilitators were 'transparency in the decision-making process', 'availability of relevant HTA research for policy makers', 'availability of explicit framework for decision-making process', 'sufficient legal support', and 'appropriate incentives'. CONCLUSION: This study suggests that HTA barriers and facilitators related to the context of decision makers, especially 'policy characteristics' and 'organization and resources' are the most important in Austria. A transparent and participatory decision-making process could improve the adoption of HTA evidence.