G-BA requirements for COAs

Pricing & Reimbursement
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Hello everyone! I’m curious about the significance and requirements of clinical outcomes assessments for G-BA assessments. Can anyone share their experience and provide any useful links on this topic?

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Hello! Based on my prior experience in Germany, interventions can claim added benefit based on patient-relevant endpoints like mortality, morbidity, HRQoL, and safety. G-BA typically categorises COA data into morbidity and HRQoL. COA data can lead to a positive, “added benefit” rating based on patient-relevant endpoints in either morbidity and HRQoL. HRQoL data can independently drive a positive, “added benefit” rating even if no other endpoints show added benefit. However, for particularly serious or life-threatening diseases, it is not enough to demonstrate only an HRQoL advantage – the product must show that mortality and morbidity are at least not adversely affected. Failing to include HRQoL data in pivotal trials is consistently criticized by G-BA and impacts benefit assessments negatively.

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Hi everyone! I’d like to share a link to a comprehensive publication that explains G-BA requirements for COA data collection, analysis, and reporting:

Böhme, S., Gerlinger, C., Huschens, S., Kucka, A., Kürschner, N., Leverkus, F., … & Hofmann-Xu, L. (2021). Patient-reported outcomes in the context of the benefit assessment in Germany. arXiv preprint arXiv:2107.03249.

Enjoy your reading!

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Hi everyone! I’d like to share a link to a comprehensive publication that explains G-BA requirements for COA data collection, analysis, and reporting:

Böhme, S., Gerlinger, C., Huschens, S., Kucka, A., Kürschner, N., Leverkus, F., … & Hofmann-Xu, L. (2021). “Patient-reported outcomes in the context of the benefit assessment in Germany.” arXiv preprint arXiv:2107.03249.

Enjoy your reading!

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Hi everyone! I’d like to share a link to a comprehensive publication that explains G-BA requirements for COA data collection, analysis, and reporting:

Böhme, S., Gerlinger, C., Huschens, S., Kucka, A., Kürschner, N., Leverkus, F., … & Hofmann-Xu, L. (2021). “Patient-reported outcomes in the context of the benefit assessment in Germany.” arXiv preprint arXiv:2107.03249.

Enjoy your reading!