Verordnung cannabinoidhaltiger Arzneimittel in Deutschland unter besonderer Berücksichtigung der Privatversicherten (2017-2020)

Seit 2017 können niedergelassene Ärzte Cannabisarzneimittel zu Lasten von GKV und PKV verordnen. Es gilt damit vor allem die Palliativversorgung zu verbessern. In der GKV steht die Kostenerstattung unter dem Genehmigungsvorbehalt der Krankenkassen. In der PKV gibt es diesen Genehmigungsvorbehalt nicht. Es sind jeweils die Vorgaben des Betäubungsmittelgesetzes zu beachten. Auf Basis der Daten unseres PKV-Arzneimittelprojektes und von öffentlich zugänglichen Daten der GKV werden die Verordnungen der Cannabisarzneimittel seit 2017 ausgewertet und Erkenntnisse zur Versorgung abgeleitet. Die Auswertung zeigt, dass die Anwendung und der Verbrauch von cannabinoidhaltigen Arzneimitteln und Zubereitungen deutlich zugenommen hat. Der PKV-Marktanteil nach Packungen lag 2020 bei 7,8 % und damit unter dem PKV-Versichertenanteil von 11 %. Die nachfragenden Privatversicherten sind im Schnitt zehn Jahre älter als die GKV-Versicherten, die entsprechende Medikamente erhalten. Neben dem höheren Altersschnitt des PKV-Kollektives kann hier auch das Genehmigungsverfahren in der GKV eine Rolle spielen. Aus anderen Studien ist bekannt, dass etwa 1/3 der Genehmigungsverfahren in der GKV abgelehnt werden

Prognostic relevance of the loss of stromal CD34 positive fibroblasts in invasive lobular carcinoma of the breast

CD34+ fibroblasts are constitutive stromal components of virtually all organs, including the mammary stroma, being involved in matrix synthesis, antigen presentation, and tumor-associated stromal remodeling. The most common subtype of invasive breast carcinoma, invasive carcinoma of no special type (IBC-NST), is known for its stromal loss of CD34+ fibroblasts while acquiring alpha smooth muscle actin-positive (α-SMA+) myofibroblasts, i.e., cancer-associated fibroblasts (CAF), whereas invasive lobular carcinoma (ILC) displays partial preservation of CD34+ fibroblasts. The aim of this study was to evaluate the prognostic relevance of stromal CD34+ fibroblasts and α-SMA+ myofibroblasts in an extended collection of ILC. A total of 133 cases of ILC, primarily resected between 1996 and 2004 at University Hospital Marburg, were examined semiquantitatively for stromal content of CD34+ fibroblasts and α-SMA+ myofibroblasts. Partial preservation of CD34+ fibroblasts in the tumor stroma of ILC was confirmed. Absence of CD34+ fibroblasts in the tumor stroma significantly correlated with the presence of α-SMA+ myofibroblasts (p = 0.010), positive lymph node status (p = 0.004), and pN stage (p = 0.006). Stromal loss of CD34+ fibroblasts was significantly associated with lower overall and disease-free survival rates (p = 0.012 and 0.013, respectively). Multivariate analysis adjusted for pT and pN stage revealed stromal loss of CD34+ fibroblasts as independent prognostic parameter (p = 0.05). To our knowledge, this is the first report defining prognostically relevant stromal subtypes of ILC with long-term follow-up. Future research targeting the potential diagnostic and therapeutic implications of CD34+ fibroblasts and CAF in breast cancer, especially ILC, is a promising field of interest

Practice network-based care management for patients with type 2 diabetes and multiple comorbidities (GEDIMAplus): study protocol for a randomized controlled trial

Contains fulltext : 136561.pdf (publisher's version ) (Open Access)BACKGROUND: Care management interventions in the German health-care system have been evaluated with promising results, but further research is necessary to explore their full potential in the context of multi-morbidity. Our aim in this trial is to assess the efficacy of a primary care practice network-based care management intervention in improving self-care behaviour among patients with type 2 diabetes mellitus and multiple co-occurring chronic conditions. METHODS/DESIGN: The study is designed as a prospective, 18-month, multicentre, investigator-blinded, two-arm, open-label, individual-level, randomized parallel-group superiority trial. We will enrol 582 patients with type 2 diabetes mellitus and at least two severe chronic conditions and one informal caregiver per patient. Data will be collected at baseline (T0), at the primary endpoint after 9 months (T1) and at follow-up after 18 months (T2). The primary outcome will be the differences between the intervention and control groups in changes of diabetes-related self-care behaviours from baseline to T1 using a German version of the revised Summary of Diabetes Self-Care Activities (SDSCA-G). The secondary outcomes will be the differences between the intervention and control groups in: changes in scores on the SDSCA-G subscales, glycosylated haemoglobin A level, health-related quality of life, self-efficacy, differences in (severe) symptomatic hypoglycaemia, cost-effectiveness and financial family burden. The intervention will be delivered by trained health-care assistants as an add-on to usual care and will consist of three main elements: (1) three home visits, including structured assessment of medical and social needs; (2) 24 structured telephone monitoring contacts; and (3) self-monitoring of blood glucose levels after T1 in 3-month intervals. The control group will receive usual care. The confirmatory primary analysis will be performed following the intention-to-treat (ITT) principle. The efficacy of the intervention will be quantified using two-level linear regression stratified by type of medical treatment adjusted for baseline values on the SDSCA-G. Secondary analyses will be performed according to the ITT principle. In health economic evaluations, we will estimate the incremental cost-effectiveness ratios. DISCUSSION: We hope that the results of this study will provide insights into the efficacy of practice network-based care management among patients with complex health-care needs. TRIAL REGISTRATION: Current Controlled Trials ISRCTN 83908315 (ISRCTN assigned 25 February 2014)