[Position paper of the German Network for Health Services Research (DNVF) on application-related data collection according to Social Code Book V]. / Positionspapier des Deutschen Netzwerk Versorgungsforschung (DNVF) zur anwendungsbegleitenden Datenerhebung nach Sozialgesetzbuch V.

Within the framework of the early benefit assessment, the Federal Joint Committee (G-BA) has been authorised since 2019 by the law for more safety in the supply of pharmaceuticals GSAV to request additional application-related data capture for certain pharmaceutical drugs. This results in certain challenges, especially in the area of conflict between methodological requirements and practical feasibility. The position paper provides an overview and takes up the general regulations defined by the Federal Ministry of Health (BMG) as well as the process defined by the G-BA. Subsequently, possible solutions are discussed and recommendations for implementation are given from the perspective of health care research.

[Memorandum Registry for Health Services Research: Update 2019]. / Memorandum Register für die Versorgungsforschung: Update 2019.

Health registries could be used to analyze questions concerning routine practice in healthcare. Therefore, registries are a core method in health services research. The German Network for Health Services Research (Deutsches Netzwerk Versorgungsforschung, DNVF) promotes the quality of registries by scientific exchange, organization of advanced training, and recommendations in the form of a memorandum "Registry for Health Services Research". The current recommendations are an update of the memorandum's first version of 2010. The update describes the capabilities and aims of registries in health services research. Furthermore, it illustrates the state-of-the-art in designing and implementing health registries. The memorandum provides developers the methodological basis to ensure high quality health registries. It further provides users of health registries with insights that enable assessing the quality of data and results of health registries. Finally, funding agencies and health policy actors can use the quality criteria to establish a framework for the financing and legislative requirements for health registries. The memorandum provides first a definition of health registries and presents an overview of their utility in health services research and health care improvement. Second, several areas of methodological importance for the development and operation of health registries are presented. This includes the conceptual and preliminary design, implementation, technical organization of a health registry, statistical analysis, reporting of results, and data protection. From these areas, criteria are deduced to allow the assessment of the quality of a health registry. Finally, a checklist is presented.

Time to Treatment Discontinuation in German Patients with Schizophrenia: Long-Acting Injectables versus Oral Antipsychotics.

BACKGROUND AND OBJECTIVE: Long-acting injectable antipsychotics (LAIs) are associated with better treatment adherence and persistence than oral antipsychotics (OAPs) in patients with schizophrenia. However, real-world evidence assessing the impact of treatment with LAIs in Germany is limited. To fill this gap, we compared antipsychotic medication adherence and risk of treatment discontinuation (TD) among schizophrenia patients newly initiated on LAI or who switched their OAP regimen (overall cohort; OC). METHODS: Claims data of German schizophrenia patients who initiated LAIs or switched their OAP during 2012-2016 (index date) were retrospectively analyzed. Treatment switch was defined as add-on medication to existing prescription or terminating the existing prescription and initiating another OAP. Adherence and time to treatment discontinuation (TTD) were estimated. Determinants of treatment discontinuation were analyzed using two Cox regression models. Model 1 controlled for age, sex, and Charlson Comorbidity Index (CCI); model 2 also included insurance status, and medication, visit, and psychiatric inpatient stay costs. Sensitivity analysis on patients who terminated existing prescriptions and initiated new OAPs (complete switch cohort; CSC) was performed. RESULTS: In OC (n = 2650), LAI users had better adherence (35.4% vs. 11.6%), persistence (no 60-day gap; 40.7% vs. 19.8%), and longer TTD (median [95% confidence interval (CI)] 216 [193-249] vs. 50 [46-56] days) than OAP users. OAP usage (hazard ratio [HR] 1.89, 95% CI 1.73-2.06; p < 0.001) and greater CCI (HR 1.04, 95% CI 1.00-1.07; p = 0.023) were associated with greater risk of TD in model 1. Model 2 showed similar results. LAI users in CSC also had better adherence, persistence, and longer TTD. In CSC too, OAP usage and greater CCI were associated with greater risk of TD in model 1, but only CCI was significant in model 2. Higher pre-index psychiatric inpatient costs were associated with lower risk of TD (HR 0.99, 95% CI 0.98-1.00; p = 0.014). LIMITATIONS: Inherent limitations of claims data and lack of control on OAP administration may have influenced the results. CONCLUSION: This real-world study associates LAIs with better medication adherence and lower antipsychotic discontinuation risk than OAPs.

Hospitalization Rates and Therapy Costs of German Schizophrenia Patients Who are Initiated on Long-Acting Injectable Medication: A Mirror-Image Study.

BACKGROUND: Long-acting injectable (LAI) antipsychotics can reduce relapse, hospitalization, and costs in patients with schizophrenia. However, real-world evidence assessing the impact of treatment with LAIs in Germany is limited. OBJECTIVE: To provide updated evidence on the impact of LAI initiation on hospitalization rates and therapy costs. METHODS: Using a mirror-image design, claims data of 850 German patients with schizophrenia who initiated treatment with LAIs during 2013-2015 was retrospectively analyzed. For the included patients, costs and resource utilization were compared for the 12 months before the index date (first initiation of LAI) and the 12 months after the index date. Annual treatment costs, hospitalization rates, ambulatory visits, sick leaves and medical aids were assessed. Two models were used to evaluate hospitalization and its costs. In model 1, hospitalization during the index date (first LAI prescription in 2013-2015) was allocated to the "pre-" time interval, while in model 2 it was neither attributed to the pre- nor to the post-index date. Regression analysis was performed to identify patients who benefited the most in terms of cost reduction from LAI initiation. RESULTS: Medication costs were significantly higher post-switching to LAI compared with pre-switching period (€3832 vs €799; p < 0.001). In model 1, number of hospitalizations, days hospitalized, and associated costs were significantly lower post-switching compared with pre-switching (2.3 vs 2.6; 59.2 vs 73.4; and €5355 vs €11,908, respectively; all p < 0.001). Similar results were obtained for costs in model 2 (€5355 vs €10,276; p < 0.001). Mean total costs reduced significantly from pre-switching to post-switching period in model 1 (€13,776 vs €10,418; p < 0.001). Patients with characteristics such as higher number of non-psychiatric and psychiatric inpatient stays during the pre-index period (all p < 0.05) benefited the most from cost reduction after LAI initiation. CONCLUSION: In this cohort of German patients with schizophrenia, treatment initiation with LAI resulted in reduced hospitalization rates and total costs.

Systematic Review of Invasive Meningococcal Disease: Sequelae and Quality of Life Impact on Patients and Their Caregivers.

INTRODUCTION: Invasive meningococcal disease (IMD, septicaemia and/or meningitis) has a severe acute and long-term burden: 5-10% of patients die within 48 h, and long-term sequelae have been reported in 10-20% of survivors. Health-related quality of life (HRQoL) is increasingly but inconsistently assessed. METHODS: A systematic literature review on Neisseria meningitidis IMD sequelae and HRQoL in survivors of all ages and their caregivers, including family, was conducted for high-income countries from 2001 to 2016 (in Medline and Embase, following Cochrane and PRISMA guidelines). RESULTS: A total of 31 studies, mostly of childhood IMD cases, were included. A broad range of physical, neurological and psychological IMD sequelae were identified. The literature has evolved, with more types of sequelae reported in more recent studies; however, meningococcal disease-specific and sequelae-specific HRQoL data are lacking, and existing studies used a wide variety of instruments. Physical sequelae included: amputations (up to 8% of children, 3% adolescents/adults) and skin scars (up to 55% of children, 18% adolescents, 2% adults). Neurologic sequelae included: hearing loss (up to 19% of infants, 13% children, 12% adolescents, 8% adults). Psychological sequelae included: anxiety, learning difficulties, emotional and behavioural difficulties. IMD negatively affects HRQoL in patients and also in their family and close caregiver network, both in the short- and long-term. Even IMD survivors without sequelae experienced an adverse impact on HRQoL after many years, affecting self-esteem, physical, mental and psychosocial health, and HRQoL was worse in those with cognitive and behavioural sequelae. CONCLUSION: A high proportion of IMD survivors are affected by a broad range of sequelae and reduced HRQoL that persists years after infection. Childhood IMD survivors had more sequelae and more severe sequelae compared with adult survivors. HRQoL was affected in patients and also in their families, caregivers and surrounding network over the long term. More research is needed to resolve data gaps and to standardise HRQoL assessment. FUNDING: GlaxoSmithKline Biologicals SA (Rixensart, Belgium).