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the G-BA website. 104 molecules that had gone through the AMNOG procedure were identified and further categorized in order to determine whether they had submitted direct, indirect, or both types of comparisons. The G-BA publications by means of the classification score were used to source and quantify the outcome of the decision. RESULTS: 16 out of the 104 analyzed molecules were found to have submitted indirect comparisons. Out of these, the G-BA decisions recognized that 6 molecules had mild or significant overall added benefit. All of these 6 molecules presented both direct and indirect comparisons. On the other hand, molecules that only submitted indirect comparisons were found to have no additional benefit. The most common reasons for dismissals of indirect comparisons by IQWiG were the inappropriate patient population selection, the choice of inappropriate bridge comparators, and that population uniformity was not guaranteed. CONCLUSIONS: These results demonstrate that submission of indirect comparisons alone are unlikely to result in a positive added benefit classification by IQWiG and the G-BA. However, if the indirect comparison is coupled with a direct comparison, the outcome of the assessment by the G-BA is more likely to result in a positive added benefit classification.

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