gms | German Medical Science

Komplexe Interventionen – Entwicklung durch Austausch: 13. Jahrestagung des Deutschen Netzwerks Evidenzbasierte Medizin

Deutsches Netzwerk Evidenzbasierte Medizin e. V.

15.03. - 17.03.2012, Hamburg

Health-related quality of life assessment in the marketing authorization application of anticancer drugs in Europe

Meeting Abstract

  • corresponding author presenting/speaker Ramon van Poppel - Berlin School of Public Health, Charité – Universitätsmedizin Berlin, Berlin, Germany
  • Jacqueline Müller-Nordhorn - Berlin School of Public Health, Charité – Universitätsmedizin Berlin, Berlin, Germany
  • Wolf-Dieter Ludwig - Arzneimittelkommission der deutschen Ärzteschaft / Klinik für Hämatologie, Onkologie und Tumorimmunologie, HELIOS Klinikum Berlin-Buch, Berlin-Buch, Germany
  • Gisela Schott - Arzneimittelkommission der deutschen Ärzteschaft, Berlin, Berlin, Germany

Komplexe Interventionen – Entwicklung durch Austausch. 13. Jahrestagung des Deutschen Netzwerks Evidenzbasierte Medizin. Hamburg, 15.-17.03.2012. Düsseldorf: German Medical Science GMS Publishing House; 2012. Doc12ebm054

doi: 10.3205/12ebm054, urn:nbn:de:0183-12ebm0541

Veröffentlicht: 5. März 2012

© 2012 van Poppel et al.
Dieser Artikel ist ein Open Access-Artikel und steht unter den Creative Commons Lizenzbedingungen ( Er darf vervielfältigt, verbreitet und öffentlich zugänglich gemacht werden, vorausgesetzt dass Autor und Quelle genannt werden.



Background: Since 1995, for each anticancer drug registered in Europe following the so called Centralized Procedure, an “European Public Assessment Report” (EPAR) is made available by the European Medicines Agency (EMA).

Especially for anticancer drugs, the impact of the drug on health-related quality of life (HRQoL) is of major importance [1].

To date there is no overview of the current European regulatory practice regarding HRQoL assessment for anticancer drugs.

Methods: For all anticancer drugs approved since 1995, the EPARs are collected and screened on different characteristics including “assessment of HRQoL” and, when applicable, “name of the health status instrument used”.

Results: Until 28/11/2011, EPARs for 87 anticancer drugs are available. The EPARs of 44 (51%) of these drugs mention HRQoL assessment in a total of 103 clinical trials in which 126 different HRQoL assessments are described. In 27 of the 126 cases (21%), the applied HRQoL instrument is not specified. In 64 of the 99 specified cases (65%), the applied instrument belongs to one of the two most commonly used health status instruments in cancer patients, the FACT- or QLQ-C30 questionnaire [2]. The average percentage of new anticancer drugs with HRQoL is as follows: 70% (1995–1999), 73% (2000–2004), 47% (2005–2009) and 78% (2010–2011).

Conclusion: In only about half of all anticancer drugs approved by EMA, the EPAR mentions the assessment of HRQoL, which is not specified in 21% of the cases. Under the specified instruments, the most established ones (FACT- or QLQ-C30-questionnaires) are the two most frequently applied types. Over the period 1995–2011 the average percentage of new anticancer drugs with HRQoL is constant at around 75% with a decline seen in the period 2005–2009. To fully evaluate the harms and benefits of new anticancer drugs, it is important to improve the inclusion of HRQoL assessment in clinical trials. In addition, reporting on HRQoL should be more detailed.


Committee for medicinal products for human use. Reflection paper on the regulatory guidance for the use of healthrelated quality of life (hrql) measures in the evaluation of medicinal products. Lomdom: European Medicines Agency; 2005.
Giesinger J, Kemmler G, Meraner V, Gamper EM, Oberguggenberger A, Sperner-Unterweger B, Holzner B. Towards the Implementation of Quality of Life Monitoring in Daily Clinical Routine: Methodological Issues and Clinical Implication. Breast Care (Basel). 2009;4(3):148-154.