Gesundheitswesen 2020; 82(05): 456-457
DOI: 10.1055/s-0040-1708976
Vorträge und Poster

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

N Grössmann
1   Ludwig Boltzmann Institut für Health Technology Assessment, Wien, Österreich
2   Abteilung für Gesundheitsökonomie, Zentrum für Public Health, Medizinische Universität Wien, Wien, Österreich
,
M Robausch
3   Ludwig Boltzmann Institut für Health Technology Assessment, Wien, Österreich
4   Niederösterreichische Gebietskrankenkasse, St. Pölten, Österreich
,
E Rothschedl
1   Ludwig Boltzmann Institut für Health Technology Assessment, Wien, Österreich
,
C Wild
1   Ludwig Boltzmann Institut für Health Technology Assessment, Wien, Österreich
,
J Simon
5   Abteilung für Gesundheitsökonomie, Zentrum für Public Health, Medizinische Universität Wien, Wien, Österreich
6   Ludwig Boltzmann Institut Applied Diagnostics, Wien, Österreich
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Background 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 indications 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 indications 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. Information on HRQoL outcomes was extracted alongside evidence on median overall survival (OS).

Results In total, we identified 110 indications, of which more than half (53 %) were lacking available information on HRQoL assessments at the time of EMA-approval. After a three years monitoring period, 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). Regarding cumulative evidence on median OS and HRQoL, 33 (30 %) as well as 15 (14 %) cancer drugs were lacking information on both study endpoints at the time of approval and after monitoring, 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.



Publication History

Article published online:
26 May 2020

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