Ramucirumab (4) – Cyramza®

Gastric or gastro-oesophageal junction adenocarcinoma; combination with paclitaxel

Characteristics

Start date 01.05.2016 – Marketing authorisation: 19.12.2014
Resolution 20.10.2016
INN Ramucirumab
Brand name Cyramza®
Pharm. company Lilly Deutschland GmbH
G-BA Procedure ID D-224
ATC code L01FG02 VEGF/VEGFR inhibitors (L01FG)
ICD-10 codes (AIS) C16.0Malignant neoplasm of cardiac orifice, C16.1Malignant neoplasm of fundus of stomach, C16.2Malignant neoplasm of body of stomach, C16.3Malignant neoplasm of gastric antrum, C16.4Malignant neoplasm of prepylorus, C16.5Malignant neoplasm of lesser curvature of stomach, not classifiable to C16.1-C16.4, C16.6Malignant neoplasm of greater curvature of stomach, not classifiable to C16.0-C16.4, C16.8Malignant neoplasm of overlapping sites of stomach, C16.9Gastric cancer NOS
Alpha-ID codes (AIS) I103100Malignant neoplasm of the gastroesophageal junction, I107038Malignant neoplasm of the anterior stomach wall n.c, I17994Stomach cancer, I25400Malignant neoplasm of the pylorus, I29937Malignant neoplasm of the ventricular fundus, I29941Malignant neoplasm of the corpus ventriculi, I29944Malignant neoplasm of the antrum pyloricum, I29947Malignant neoplasm of the small curvature of the stomach, I29950Malignant neoplasm of the large gastric curvature
DDD 40 mg P
Therapeutic area Oncological diseases Adenocarcinoma (AC)
Reason for procedure Reassessment: Loss of orphan status
Original resolution: Ramucirumab (1) (16.07.2015)

Therapeutic indication of the resolution

Cyramza in combination with paclitaxel is indicated for the treatment of adult patients with advanced gastric cancer or gastro-oesophageal junction adenocarcinoma with disease progression after prior platinum and fluoropyrimidine chemotherapy. Cyramza monotherapy is indicated for the treatment of adult patients with advanced gastric cancer or gastro-oesophageal junction adenocarcinoma with disease progression after prior platinum or fluoropyrimidine chemotherapy, for whom treatment in combination with paclitaxel is not appropriate.
Subpopulation Indication Comparator
a) Treatment of adult patients with advanced adenocarcinoma of the stomach or gastro-oesophageal junction with tumour progression after previous platinum- and fluoropyrimidine-containing chemotherapy: in combination with paclitaxel Therapy according to the doctor's instructions
b) Treatment of adult patients with advanced adenocarcinoma of the stomach or gastro-oesophageal junction with tumour progression after prior platinum- and fluoropyrimidine-containing chemotherapy: as monotherapy Best-Supportive-Care

Studies and Results

No. of studies
(best subpopulation) 		1 (Rainbow)
Study design
(best subpopulation) 		H2H vs. ACT
Meta analysis
(best subpopulation) 		no
Reason for dividing into subpopulations (G-BA) Number of medications

  • 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.

Associated procedures



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