Determination of the target population in early benefit assessments in Germany: challenges for non-small-cell lung cancer.

OBJECTIVES: Dossiers submitted for early benefit assessments in Germany also provide information on the precise determination of the target population (patients eligible for a drug). The situation is complex for non-small-cell lung cancer (NSCLC) due to highly specific therapeutic indications. Our aim was to compare the different methodological steps applied to determine the target population in dossiers on drugs for NSCLC. METHODS: We analysed NSCLC dossiers assessed by the German Institute for Quality and Efficiency in Health Care (IQWiG) between 01.01.2011 and 31.12.2017. Methodological details regarding the determination of the target population were extracted and compared. RESULTS: We analysed 23 NSCLC dossiers. In all dossiers, the target population was determined using the number of all patients with lung cancer as the basis for calculations. This patient population was further reduced in several successive steps by assuming proportions of patients with a specific characteristic (e.g. disease stage). The most important calculation steps were patients with NSCLC (n = 23 dossiers), with a specific disease stage (n = 23), with a specific tumour mutation (n = 14), with a specific tumour histology (n = 7), without prior treatment (n = 15), with pretreatment in second or further treatment lines (n = 17), and/or with specific pretreatments (n = 9). The proportions of patients determined within the same calculation step varied considerably between dossiers. DISCUSSION: The calculation methods applied and the target population sizes reported in NSCLC dossiers vary considerably. A consensus with regard to the databases and calculation methods used to determine the target population in NSCLC would be helpful to reduce variations.

Evaluation of an integrated care program for schizophrenia: concept and study design.

Concept and design of an independent scientific evaluation of different pathways of care for schizophrenia patients in Germany with respect to effectiveness and efficiency are presented. In this prospective, observational study, schizophrenia patients receiving an integrated care treatment, the intervention group (IG), are compared with patients under routine care conditions treated by the same physician (first control group, CG 1). A second control group (CG 2) of patients treated by office-based psychiatrists not participating in the integrated care program will be recruited and their data compared with the two other groups. The total amount of psychiatric hospital days after 12 months is defined as primary outcome parameter. Secondary outcome parameters comprise the frequency of psychiatric inpatient readmissions, severity of schizophrenia symptoms, remission rates and quality of life. Patients undergo assessments at baseline, month 6 and 12 using standardized and experimental questionnaires. Routine data of a regional German social health insurance fund complement information on included patients. Additionally, a cost-effectiveness and cost-utility analysis will be performed. Until now, 137 psychiatrists included 980 patients in the integrated care project in Lower Saxony, Germany, and 47 psychiatrists (IG and both CGs) are willing to participate in the independent evaluation. For the first time, a prospective observational controlled evaluation study of a countrywide integrated care project planning to recruit 500 schizophrenia patients has started using comprehensive assessments as well as routine data of a social health insurance fund.

[Efficacy and cost effectiveness of case management in patients with dementia]. / Wirksamkeit und Kostenwirksamkeit eines Case-Management-Programms bei Patienten mit Demenz.

BACKGROUND: The aim of the project was to evaluate case management for patients suffering from dementia in order to improve the quality of care and offer patients a chance to stay at home for a longer time. METHODS: The evaluation was prospective with a follow-up of 12 months. Data regarding efficacy and costs were taken from one local and three supraregional health insurance funds. Primary outcome was time remaining at home. RESULTS: Time remaining at home was 16.1 months with a mean of 12.2 months (p=0.02) in the control group. Regarding cost effectiveness, an additional month remaining at home costs between 41 and 53 EUR. CONCLUSION: Regarding time remaining at home, institutionalization and all-cause death, data indicate that case management seems to be an effective intervention in patients with dementia; however, further evaluations with a major number of observed patients and longer follow-up are necessary.

[Public expenditure caused by the consumption of illicit drugs in Germany]. / Schätzung der Ausgaben der öffentlichen Hand durch den Konsum illegaler Drogen in Deutschland.

AIM: A scientifically based overview of public expenditures related to illicit drugs was lacking for Germany. The aim of the present project is to carry out for the first time a comprehensive estimation of direct (labelled and non-labelled) expenditures of the government and the social insurance funds related to the use of illicit drugs in Germany for the year 2006. METHODS: Depending on the respective financing bodies, different ways of data collection were required. Data on drug-related expenditure were searched in publically available budget documents and statistical reports; moreover written requests were sent to the relevant public authorities. Information on the expenditures of social insurance funds was collected through standardised questionnaires, which were sent to the Statutory Pension Insurance Scheme (Rentenversicherung Bund) and the 40 biggest statutory health insurance companies. The collected data were extrapolated for the total statutory health insurance. RESULTS: All in all, on the government side an amount of 3.7-4.6 billion Euro spent on the task of tackling illicit drugs (i. e., for prevention, intervention and law enforcement measures) was identified. The expenditures of the pension funds related to illegal drug use amount to 171.7 million Euro. For the statutory health insurances a total expenditure of 1.4 billion Euro was estimated. CONCLUSION: The aim of the project - a first estimation of the public expenditures concerning illicit drugs in Germany - has been achieved. Nevertheless, there remains some degree of uncertainty regarding the overall result because of the heterogeneous data quality. The approximation of the amount of public expenditures concerning illegal drug use still gives no information about adequate spending or actual benefits. However, it provides the indispensable basis for such an assessment and contributes to a more objective discussion.

[Cost-effectiveness of study nurses in the management of patients with heart failure. A systematic review]. / Kosteneffektivität des Einsatzes von Studienschwestern in der Betreuung von Patienten mit Herzinsuffizienz.

BACKGROUND AND PURPOSE: Heart failure is currently one of the most common and cost-intensive diseases. Furthermore, high morbidity and mortality are distinctive for this disease. Therefore, new treatment programs are increasingly developed; especially the care of heart failure patients by specialized nurses (study nurses) represents a frequent new concept. This review gives a systematic overview of the cost-effectiveness of new treatment concepts with study nurses in comparison to the conventional care of heart failure. METHODS: A systematic literature search in MEDLINE was performed for the period from 1995 till April 2008. The search strategy included terms from three essential areas relating to the working subject: twelve search keys with regard to the clinical picture, 21 words concerning the intervention with study nurses, and 27 terms with reference to health economics. The literature selection was carried out on the basis of a priori defined in- and exclusion criteria. Economic evaluations based on randomized controlled trials with a study duration of at least 6 months which were published in English or German were enclosed. An extraction of the relevant data as well as a qualitative synthesis of information were conducted. RESULTS: A total of 13 studies were identified. With five of nine of the enclosed publications, a statistically significant reduction of the number of all-cause rehospitalizations was reported. Two of twelve publications showed a statistically significant decrease in mortality in favor of the intervention group. Twelve of 13 publications only reported the costs and effects of both groups separately. For the five of nine publications with significant reductions of rehospitalization, an own calculation of the incremental cost-effectiveness ratio (ICER) could be carried out based on the cost and effect data. It turned out an ICER of costs at the rate of 490 Euros up to savings of 7,330 Euros per prevented rehospitalization. CONCLUSION: This systematic review shows an international trend that concepts for the care of patients with heart failure that involve study nurses are cost-effective. For the German context there are no comparable data available.