# G-BA requirements for COAs

**URL:** <https://magic.discourse.group/t/g-ba-requirements-for-coas/153>\
**Category:** Pricing & Reimbursement\
**Tags:** hta, germany, coa\
**Created:** [April 28, 2024, 7:24am UTC](https://magic.discourse.group/t/g-ba-requirements-for-coas/153 "2024-04-28T07:24:22Z")\
**Posts on this page:** 5\
**Page:** 1

<div class="post-metadata">

**Author:** ![Walter](https://avatars.discourse-cdn.com/v4/letter/w/85e7bf/32.png) [@Walter](https://magic.discourse.group/u/Walter)\
**Post date:** [April 28, 2024, 7:24am UTC](https://magic.discourse.group/t/g-ba-requirements-for-coas/153/1 "2024-04-28T07:24:22Z")

</div>

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?

---

<div class="post-metadata">

**Author:** ![Meriem](https://avatars.discourse-cdn.com/v4/letter/m/e95f7d/32.png) [@Meriem](https://magic.discourse.group/u/Meriem)\
**Post date:** [April 28, 2024, 7:28am UTC](https://magic.discourse.group/t/g-ba-requirements-for-coas/153/2 "2024-04-28T07:28:25Z")

</div>

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.

---

<div class="post-metadata">

**Author:** ![Luis](https://avatars.discourse-cdn.com/v4/letter/l/3e96dc/32.png) [@Luis](https://magic.discourse.group/u/Luis)\
**Post date:** [April 28, 2024, 7:30am UTC](https://magic.discourse.group/t/g-ba-requirements-for-coas/153/3 "2024-04-28T07:30:16Z")

</div>

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!

---

<div class="post-metadata">

**Author:** ![Luis](https://avatars.discourse-cdn.com/v4/letter/l/3e96dc/32.png) [@Luis](https://magic.discourse.group/u/Luis)\
**Post date:** [April 28, 2024, 7:31am UTC](https://magic.discourse.group/t/g-ba-requirements-for-coas/153/4 "2024-04-28T07:31:00Z")

</div>

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!

---

<div class="post-metadata">

**Author:** ![Nadia](https://avatars.discourse-cdn.com/v4/letter/n/f19dbf/32.png) [@Nadia](https://magic.discourse.group/u/Nadia)\
**Post date:** [April 28, 2024, 7:34am UTC](https://magic.discourse.group/t/g-ba-requirements-for-coas/153/5 "2024-04-28T07:34:20Z")

</div>

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!