Database study of lenalidomide (Revlimid®) in Germany: Monitoring off-label use

Description

Lenalidomide, a derivate of thalidomide, is in combination with dexamethasone indicated for the treatment of multiple myeloma in patients who have received at least one prior therapy. In the USA, lenalidomide is also licensed for the treatment of a certain form of myelodysplastic syndromes. The study is part of a risk management plan required by EMA (European Medicines Agency) and the German Federal Institute for Drugs and Medical Devices (BfArM).
The retrospective epidemiological study was based on claims data of the year 2007 from four statutory health insurances (SHIs) with more than 14 million enrollees. Off-label use (use of a drug outside the terms of its marketing authorisation) of lenalidomide in Germany was low and mainly related to myelodysplastic syndromes.
The results were published in a national peer-reviewed journal and were presented at the annual meeting of the “Deutsche Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie e.V. (GMDS).” For the year 2008, analyses were performed based on data from two large SHIs with approximately 13 million insurants. The results were presented in a report, which was sent to the BfArM by the manufacturing pharmaceutical company.

Funding period

Begin:   December 2007
End:   December 2014

Sponsor

  • Pharmaceutical industry

Contact

Dr. rer. nat. Ingo Langner

Selected project-related publications

    Articles with peer-review

  • Dörks M, Langner I, Behr S, Timmer A, Garbe E. Database study of Lenalidomide (Revlimid®) in Germany: Monitoring off-label use. GMS Medizinische Informatik, Biometrie und Epidemiologie. 2013;9(3):Doc12.
    https://doi.org/10.3205/mibe000140
  • Presentations at scientific meetings/conferences

  • Dörks M, Langner I, Heuer D, Behr S, Timmer A, Garbe E. Database study of lenalidomide (Revlimid®) in Germany: Monitoring off-label use. 57. Jahrestagung der Deutschen Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie (GMDS), 16.-21. September 2012, Braunschweig.