Ramucirumab (4) – Cyramza®

• Clinical trials
  • For the assessment of the additional benefit of ramucirumab in combination with paclitaxel, the G-BA (patient population a), the G-BA drew on the study results (RAINBOW study) from its initial decision of 16 July 2015 on the benefit assessment of ramucirumab.

a) Ramucirumab in combination with paclitaxel

• In order to determine the extent of the additional benefit, the G-BA assessed the data justifying the identification of an additional benefit in terms of their therapeutic relevance (qualitatively), in accordance with the criteria set out in Chapter 5, Section 5(7) of the VerfO.
• The methodology proposed by the IQWiG in accordance with the General Methods was not applied in the benefit assessment of ramucirumab.

b) Ramucirumab as monotherapy when patients are not suitable for combination therapy with paclitaxel

• In order to determine the extent of the additional benefit, the G-BA has assessed the data justifying the determination of an additional benefit in terms of their therapeutic relevance (qualitatively), in accordance with the criteria set out in Chapter 5, Section 5(7) of the VerfO.
• The methodology proposed by the IQWiG in accordance with the General Methods was not applied in the benefit assessment of ramucirumab.

Courtesy translation only, please refer to the German original.