Early benefit assessment (EBA) in Germany: analysing decisions 18 months after introducing the new AMNOG legislation.

Objectives: Since the introduction of the German health care reform in January 2011, an early benefit assessment (EBA) is required for all new medicines. Pharmaceutical manufacturers have to submit a benefit dossier for evaluation by the Institute for Quality and Efficiency in Health Care (IQWiG). A final decision is made by the Federal Joint Committee (G-BA).

[Conceptual and methodological basics of cost assessments in rheumatology].

Cost-of-illness studies in rheumatic conditions show an enormous variability in reported costs. Reasons are-among others-a lack of standardization with regards to relevant cost domains and the utilization of various insufficiently validated costing sources. A flow scheme is presented which may serve as a systematic basis for a valid costing analysis.

Patient-reported health care utilization in rheumatoid arthritis: what level of detail is required?

Objective: To investigate the level of detail required in self-reported health care utilization questionnaires for administration to patients with rheumatoid arthritis (RA).

Methods: A preliminary questionnaire was developed on the basis of existing tools for use in rheumatic conditions and in-depth interviews with 10 RA patients. Data gathered over 1 year of administration in a clinical setting were then matched to a comprehensive database of payer-reported information.

Comparison of estimated medical costs among patients who are defined as having rheumatoid arthritis using three different standards.

Accurate estimation of medical care costs raises a host of challenging issues. We examined whether pure administrative claims data without clinical validation of diagnosis allow reasonable estimation of disease-related costs in rheumatoid arthritis (RA). Three patient groups were examined: patients with clinically confirmed RA (group A, n=338), patients with likely RA (administrative claims data reported the diagnosis of RA and patients were treated with disease modifying antirheumatic drugs, DMARDs; group B, n=303), and patients with possible RA (same as group B but patients had no DMARD treatment; group C, n=685).

Costs of rheumatoid arthritis in Germany: a micro-costing approach based on healthcare payer's data sources.

Objective: To develop a systematic set of German cost data in rheumatoid arthritis (RA) based solely on valid healthcare payer's cost data sources.

Methods: Retrospectively one year cost data of 338 patients with RA were generated and analysed. The cost data were derived from a major statutory health insurance plan ("Allgemeine Ortskrankenkasse Niedersachsen") and the regional physicians' association ("Kassenärztliche Vereinigung Niedersachsen").