CONTRIBUTE - Switch from OFF-Label & Best Supportive Care to approved therapies in various autoimmune diseases: Implementation, impact on disease progression and adverse events

>Federal Joint Committee | Innovation Fund

Statistical AnalysesSupply curves

CONTRIBUTE is a project funded by the GBA's Innovation Fund in the area of “Drug Safety”. The overall aim of the project is to investigate the changes in care brought about by newly approved drugs. The main objectives are as follows: 1) Analysis of care implementation, taking into account inhibiting and promoting factors, 2) Analysis of efficacy and safety in routine care, investigation of possible influencing factors, comparison with the results of clinical studies, 3) Health economic evaluation, 4) Recording of care practice from the perspective of patients and service providers, 5) Development of measures for the transfer of study results and 6) Pharmacological consequences.

PMV is primarily responsible for data preparation, data provision and then for the work package 1: The evaluations of the implementation of medications in care and the characteristics of the patient groups are based on the claims data analysis with data from a German statutory health insurance (BARMER). For the evaluation, populations of prevalent patients are formed in the observation years and evaluated with regard to the first and subsequent prescriptions of the new drugs. In addition, diagnoses and other service events in temporal connection with the prescriptions are evaluated, as are demographic characteristics of the patients. Factors that affect first prescriptions and long-term therapy with the drugs are determined and the extent to which the use of an off-label drug instead of a newly approved drug for the indication under investigation can be explained by factors that can be mapped using claims data is investigated.

Duration: 2024–2026
Project partners: Private Universität Witten/Herdecke gGmbH | Ruhr-Universität Bochum | Universitätsklinikum Köln | Universität zu Köln | BARMER
Funding reference number: 01VSF23041
Methods: Statistical Analyses
Topics: Supply curves, Pharmacotherapy
Data: Data preparation, Claims data