[Sustainable reimbursement of the B­centres for rare diseases in Germany-status quo and solution approaches]. / Nachhaltige Vergütung der B­Zentren für Seltene Erkrankungen in Deutschland ­ Status quo und Lösungsansätze.

BACKGROUND: To ensure specialized care of patients with rare diseases, numerous centres for rare diseases were funded over the past few years. The reimbursement of patients' ambulatory care in hospitals, however, is characterized by a plurality of forms of care and payment. There is some evidence of deficits in the reimbursement of care of patients suffering from a rare disease from studies on individual rare diseases. OBJECTIVES: To investigate current forms of care provision and reimbursement of centres for rare diseases and to develop future approaches for sustainable compensation. MATERIALS AND METHODS: Initially, centres for rare diseases in Germany were asked to provide information about their forms of care and reimbursement using questionnaires. Subsequently, two focus group interviews and one expert interview with representatives from centres for rare diseases, health insurance, health politics and patients were conducted to discuss current and future meritocratic forms of care provision and reimbursement. The data were evaluated using content analysis. RESULTS AND CONCLUSIONS: Thirty-nine centres for rare diseases participated in the questionnaire survey. Of those, 38% receive a flat fee/allowance for university outpatient departments, the amount of which varies notably, and 41% obtain a mixed payment comprising an allowance for university outpatient departments and other forms of reimbursement. An under-recovery of costs in centres for rare diseases and its impact on patient care were mentioned in the interviews. In this context, a need to further develop forms of care provision and reimbursement has been identified. Participants prefer a special flat fee/allowance for rare diseases that covers the time-consuming care for patients with rare diseases.

The State of Care for Persons With a Diagnosis of Depression.

BACKGROUND: Depression is one of the most common mental illnesses. There are well-known deficiencies in the care of patients with depression, particularly at the interfaces between health service areas or sectors. The aim of this study was to analyze the characteristics and state of care of persons with a diagnosis of depression. METHODS: The analysis was based on diagnosis and billing data obtained from a statutory health insurance carrier in Germany. Patients carrying a diagnosis of depression in 2018 (ICD-10 F32, F33, F34.1) were identified and studied with respect to their utilization of care services for depression. Sociodemographic characteristics and the degree of severity of depression were also taken into account. RESULTS: More than 285 000 individuals with a diagnosis of depression were included in the analysis. Their mean age was 57.5 years, and 67.5% were female. About three-quarters had at least one comorbid mental disorder. Primary care physicians were involved in the treatment of depression for 82.8% of patients with severe depression; 41.1% of such patients had contact with a medical specialist, and 9.2% with a psychologist-psychotherapist. Antidepressants were prescribed for 60.3% of patients with severe depression, and 10.2% were receiving psychotherapeutic services in accordance with the psychotherapy directive. CONCLUSION: Our findings point to existing deficiencies in the care of patients with depression, particularly in the establishment of the diagnosis and in the assessment of disease severity. These are essential matters for the initiation of guideline-oriented therapy and therefore deserve to be more strongly emphasized in continuing medical education.

Resource usage in outpatient care and reimbursement for cystic fibrosis in Germany.

OBJECTIVE: Objective of this study is to assess and evaluate resource use in outpatient treatment in Germany and to compare it with remuneration. METHODS: Outpatient treatment was evaluated in seven different centers for pediatric and adult CF patients. Data were recorded during one representative month in 2006. A micro-costing approach was used to value resource use data. RESULTS: For outpatient treatment mean costs (excluding drugs) of 488 € per patient per quarter occurred. Correlation analyses identified significant cost drivers including age and co-morbidities (pancreatic insufficiency, hepatobiliary complications, lung function capacity, or bacterial lung colonization). Remuneration covered only 51% of the total costs (252 € per patient/quarter). CONCLUSIONS: As the human resources available to these centers today are already below the requirements set by the European consensus for standards of CF care it will be important for a high level of patient care to reach a cost-covering remuneration scheme.

Quality of life results of balloon kyphoplasty versus non surgical management for osteoporotic vertebral fractures in Germany.

BACKGROUND: To compare improvement in quality of life (QoL) and symptoms' relief in vertebral compression fractures (VCF) due to osteoporosis for patients undergoing balloon kyphoplasty (BKP) to those undergoing non-surgical management (NSM) in a real-life setting. METHODS: In this prospective, comparative study, quality-of-life was evaluated in eight centres in Germany between 2005 and 2008, for 82 patients, with the EQ-5D questionnaire, and the Roland Morris Disability Questionnaire (RMDQ). RESULTS: BKP patients demonstrated a statistical and clinical significant higher improvement in EQ-5D than NSM patients, 0.44 and 0.25 from baseline to 12 months, respectively. Moreover, BKP patients showed a clinically relevant improvement in the RMDQ by 6.25 from baseline to 12 months, whereas NSM patients had no significant improvement in the RMDQ. CONCLUSIONS: This study demonstrates for VCF patients that in real-life quality of life for BKP patients improves more than for NSM patients; confirming the results of a large randomized clinical trial.

Outpatient medication costs of patients with cystic fibrosis in Germany.

BACKGROUND: Cystic fibrosis (CF) patients need specialized long-term treatment. In order to support lung function, pharmaceuticals such as bronchodilators, mucolytic agents or anti-inflammatory drugs have to be used. Oral, inhaled or intravenous antibacterial therapy is of special importance for patients who have problems with chronic bacterial colonization of the lung and airways. In case of pancreatic insufficiency, digestive enzymes have to be substituted with every meal. Furthermore, patients often need additional supplements of vitamins as well as high caloric food. All of these aspects lead to high medication use in CF patients. OBJECTIVE: To analyse outpatient medication costs for CF in Germany from a sickness funds perspective (plus some out-of-pocket payments by patients). METHODS: Medication data were evaluated from seven different outpatient CF centres. Data were recorded via medication lists by the physicians, reporting name of medication, dosage and pharmaceutical form. As the medications are mostly used long term, resource use was valued using the largest available package sizes. Prices were taken from the German 'Rote Liste' with year 2006 values. Annual and daily medication costs were analysed for different age groups. In addition, cost-influencing factors were analysed via correlation analyses. RESULTS: A total of 3150 pharmaceutical records from 301 CF patients were collected. Mean annual costs for medication were €21,603 per patient (range €69-104,477). Correlation analyses showed significant correlations between costs of medication and age, co-morbidities (such as pancreatic insufficiency and diabetes mellitus) and clinical parameters such as bacterial colonization of the lung, as well as functional parameters (percent of vital capacity, forced expiratory volume in 1 second, maximal expiratory flow at 25% of forced vital capacity). For example, mean annual costs for medication were €23,815 and €14,884 for patients with and without bacterial colonization of the lung, respectively. Other correlation factors yielded similar cost dispersions between patients with and without the factors. CONCLUSIONS: Costs of outpatient medication for CF patients significantly depend on age, co-morbidities and other clinical parameters. Hence, non-optimal treatment could lead to a significantly higher burden for the healthcare system.

Cross-sectional validity of the EQ-5D-Y as a generic health outcome instrument in children and adolescents with cystic fibrosis in Germany.

BACKGROUND: Quality of life is recognized as an important additional outcome measure in clinical trials and health economic evaluations. The EQ-5D is an important generic health outcome instrument often used for economic evaluations as a complement with disease-specific outcome measures. In this study quality of life data was assessed using the EQ-5D-Y (new EQ-5D version for children and adolescents) and the Cystic Fibrosis Questionnaire (CFQ). The objective of the study is to evaluate the cross-sectional validity of the EQ-5D-Y as a generic health outcome instrument in children and adolescents with cystic fibrosis in Germany. METHODS: In 2006 a multi-centre study was conducted in four cystic fibrosis centres in Germany. Quality of life data from 96 patients between eight and seventeen years was collected using the EQ-5D-Y as a generic outcome instrument and the Cystic Fibrosis Questionnaire (CFQ) as a disease-specific instrument. Results of both instruments were compared by statistical analyses using Spearman's rank correlations. RESULTS: 44.6% of the patients stated that they had no problems in any of the EQ-5D-Y dimensions. Several low to high correlations between separate dimensions and the visual analogue scale of the EQ-5D-Y and the different scales of the CFQ for children, their parents and adolescents can be presented in this paper. Looking at the five EQ-5D-Y dimensions the highest correlation (rS = 0.625, p = 0.01) was found between the dimension 'mobility' and the CFQ scale 'physical functioning' in adolescent patients. The overall highest correlation was found between the 'subjective health perception' and the visual analogue scale (rS = 0.744, p = 0.01) in adolescent patients older than 13 years. CONCLUSION: The EQ-5D-Y can be considered a cross-sectional valid generic health outcome instrument which reflects differences in health according to the progression of the life-long chronic disease cystic fibrosis.