IQWiG specifies and intensifies the conditions for an added-value assessment in oncology studies with cross-over
About the author
Prof. Matthias P. Schönermark, M.D., Ph.D.
Founder and Managing Director
Founder and Managing Director
Fon: +49 511 64 68 14 – 0
Fax: +49 511 64 68 14 18
Fax: +49 511 64 68 14 18
The Institute for Quality and Efficiency in Health Care (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen, IQWiG) has already carried out dossier assessments for eleven studies, which made it possible to switch from the control group to the test group. Taking the endpoint of overall survival as an example, the IQWiG examined the effect of a cross-over on the risk of bias. For the derivation of (added-) benefits, an observed effect should be sufficiently certain to be due to only one factor. To adjust the treatment effect, naive methods are available, such as the intention-to-treat (ITT)-analysis and complex methods, such as the Inverse Probability-of-Censoring-Weighting (IPCW)-method or the Rank-Preserving-Structural-Failure-Time (RPSFT)-method. According to IQWiG, it turns out that the dossiers under consideration, in which methods such as the IPCW or RPSFT were used, are methodologically incomplete with regard to the cross-over effect. However, these complex methods were only planned and applied in three studies (27%).
Consequently, an added benefit could only be derived if there were evaluations for which a change of treatment for the testing intervention did not have to be taken into account or was not regarded as decisive for the significance. According to the literature, IQWiG concludes that there is currently no statistical methodology that allows the analysis of patient-relevant outcomes under the influence of a cross-over effect with sufficient certainty. Statistical procedures themselves are subject to the risk of biased analysis or are tied to taking into account drug assumptions that are not verifiable in practice. This is especially problematic, as the study sponsor is exposed to an unsolvable dilemma. Very effective therapies must, at least due to ethical reasons, allow a cross-over.
As an established strategy consultancy in the healthcare sector with a focus on the process of early benefit assessment according to §35a SGB V, especially in the framework of the AMNOG, SKC consulting deals intensively with the current methodological standards and their argumentation of the IQWiG in order to work together with their clients to not only anticipate any pitfalls as part of an overall strategy, but to be able to tackle them at an early stage.
BY Prof. Matthias P. Schönermark, M.D., Ph.D., managing director and Bianca Prelle, B. A. Health Management
Source:
IQWiG: Treatment Switching in onkologischen Studien