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21. Jahrestagung des Deutschen Netzwerks Evidenzbasierte Medizin e. V.

Deutsches Netzwerk Evidenzbasierte Medizin e. V.

13. - 15.02.2020, Basel, Schweiz

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Published evidence of health-related quality of life benefits associated with cancer drugs approved by the European Medicines Agency between 2009 and 2015

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  • Nicole Grössmann - Ludwig Boltzmann Insitute, for Health Technology Assessment, Österreich; Medical University of Vienna, Department of Health Economics, Center for Public Health, Vienna, Österreich
  • Martin Robausch - Ludwig Boltzmann Insitute, for Health Technology Assessment, Österreich; Austria and Lower Austrian Sickness Fund, Österreich
  • Eleen Rothschedl - Ludwig Boltzmann Insitute, for Health Technology Assessment, Österreich
  • Claudia Wild - Ludwig Boltzmann Insitute, for Health Technology Assessment, Österreich
  • Judit Simon - Medical University of Vienna, Department of Health Economics, Center for Public Health, Vienna, Österreich; Ludwig Boltzmann Insitute, Applied Diagnostics, Österreich

Nützliche patientenrelevante Forschung. 21. Jahrestagung des Deutschen Netzwerks Evidenzbasierte Medizin. Basel, Schweiz, 13.-15.02.2020. Düsseldorf: German Medical Science GMS Publishing House; 2020. Doc20ebmS2-V1-01

doi: 10.3205/20ebm011, urn:nbn:de:0183-20ebm0118

Published: February 12, 2020

© 2020 Grössmann et al.
This is an Open Access article distributed under the terms of the Creative Commons Attribution 4.0 License. See license information at http://creativecommons.org/licenses/by/4.0/.

Outline

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Background/research question: Health-related quality of life (HRQoL) is one of the most important patient-relevant study endpoints for the direct measurement of the benefit of cancer drugs. Therefore, our aim was to detect cancer drugs with no published information on HRQoL at the time of European Medicines Agency (EMA) approval and monitor any reported HRQoL evidence updates after at least three years follow-up.

Methods: We included all cancer drugs that were approved by the EMA between January 2009 and October 2015. Our main sources of information were the EMA website, clinicaltrials.gov and a systematic literature search in PubMed with the search terms ‘(name of the active substance) AND (NCT number OR trial name)’. Information on HRQoL outcomes was extracted alongside evidence on median overall survival (OS).

Results: In total, we identified 110 therapies, of which more than half (n=58, 53%) were lacking available information on HRQoL assessments at the time of EMA-approval. After a monitoring period of at least three years, 24 updates were identified, resulting in 34 (31%) therapies where information on HRQoL was still not available. For the 76 therapies with reported information on HRQoL, cancer specific instruments were mostly used (n=49/76) followed by individual disease specific instruments (n=47/76) and then generic instruments (n=17/76). Regarding cumulative evidence on median OS and HRQoL, 33 (n=33/110, 30%) as well as 15 (n=15/110, 14%) cancer drugs were lacking information on both study endpoints at the time of approval and after a minimum 3 years monitoring period, respectively.

Conclusion: Our results demonstrate that there is an urgent need of routine re-evaluation of reimbursed cancer drugs with initially missing information on major outcomes. Standardisation of the typology and quality of HRQoL assessments need to be improved to allow better comparability of results.

Competing interests: None to declare.