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If atypical bleeding in patients with known malignant melanoma of the skin occur endometrial metastasis should be excluded by gynaecologists.

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A423 were included and assessed with respect to their evidence for special subgroups. Regulatory guidelines were compared against the IQWIG evaluation methods with respect to the handling of subgroups and its impact on the clinical benefit assessment. Furthermore GBA decisions and potential price impact with the GKV-Spitzenverband are taken into account for the pricing impact of new evidence with special subgroups based on target profiles developed. Results: Overall, ten new compounds were approved by the EMA in the last 2.5 years for which no subgroup trials were presented. Regulatory guidelines and IQWIG methods differ significantly with respect to subgroup handling from a statistical and health policy perspective. Most important clinical trials with a special focus on subgroups of interest could even have a negative outcome on the market access of such a compound with respect to subgroup-only reimbursement (in case of positive subgroup results) or exclusion of subgroups (in case of negative results) based on target profiles included in the analyses. ConClusions: Incentives from a health policy and investment decision perspective are low for the pharmaceutical industry in terms of research focus towards subgroups of special interest. Further research with respect to incentives is needed. PCN176 Does PersoNaliseD HealtH Care (PHC) iN oNCology require New aPProaCHes to CliNiCal DeveloPmeNt, regulatory assessmeNt, aND eCoNomiC evaluatioN?