The AMNOG assessment procedure requires that manufacturers submit indirect comparisons for the evaluation of molecules in the absence of the availability of direct comparisons versus the G-BA designated appropriate comparator(s). Although guidelines have been established on how indirect comparisons should be structured and carried out, the methodological robustness sought by IQWiG and the G-BA has established significant hurdles to a successful HTA evaluation when using an indirect comparison as the basis for submission. Therefore, it is critical that manufacturers look to prior analogues in order to understand the role of indirect comparisons in the assessment procedure and extract key learnings they can employ as part of their submission strategy.
The objective of this study was to understand the role that indirect comparisons play during IQWiG’s assessment of a product’s additional clinical benefit and subsequently on the G-BA decision outcome. This evaluation will lead to insights that will help manufacturers optimise their submission strategy, especially if they will be required to provide an indirect comparison due to comparator limitations.
The figure below shows the results of a detailed review of all of the AMNOG evaluations as of the end of 2014. The review revealed that out of a total of 104 submissions, 16 included indirect comparisons. Of the 16 molecules with indirect comparisons, only 6 were recognized to have a significant added benefit.
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