[Pharmaceutical Directive (AM-RL): Annex XII – Benefit assessment of medicinal products with new active ingredients according to section 35a SGB V brentuximab vedotin (new therapeutic indication: Hodgkin lymphoma, first line)]

The Federal Joint Committee [Gemeinsamer Bundesausschuss] (G-BA)
Record ID 32018002129
English, German
Original Title: Arzneimittel-Richtlinie/Anlage XII: Brentuximab Vedotin (neues Anwendungsgebiet: Hodgkin-Lymphom, Erstlinie)
Authors' objectives: The Federal Joint Committee [Gemeinsamer Bundesausschuss (G-BA)] has had the legal task of carrying out an (additional) benefit assessment for all newly approved drugs with new active ingredients immediately after market entry (§ 35a SGB V). The result of this assessment is the basis for deciding how much the statutory health insurance pays for a new drug with a new active ingredient. The G-BA was commissioned to carry out the benefit assessment through the Pharmaceuticals Market Reorganisation Act [Gesetz zur Neuordnung des Arzneimittelmarktes (AMNOG)]. In the context of the early benefit assessment of medicinal products containing new active substances, the following rules apply to orphan drugs: According to the legal requirements (§ 35a SGB V), the additional medical benefit of these drugs is already considered to be proven by the approval. The G-BA determines the extent of the additional benefit for orphan drugs that do not exceed a turnover of 50 million Euros in the last twelve calendar months, on the basis of the approval and the studies justifying the approval.
Authors' results and conclusions: The benefit assessment of Brentuximab Vedotin (ADCETRIS®) relates to the indication of adult patients with previously untreated CD30+ Stage IV Hodgkin lymphoma (HL) in combination with doxorubicin, vinblastine and dacarbazine (AVD). The benefit assessment is based on a subgroup analysis of the pivotal study ECHELON-1, a multicentre, open-label, randomised controlled, parallel-group (1:1) phase III study evaluating the efficacy and safety of brentuximab vedotin in combination with AVD compared to doxorubicin, bleomycin, vinblastine and dacarbazine in the treatment of therapy-naïve patients with advanced classical HL aged ≥ 18 years. Treatment phase consisted of a maximum of six 28-day therapy cycles. Primary endpoint was the modified progression-free survival. 846 patients represent the subgroup of disease stage IV that is relevant for the benefit assessment. Based on 14 events in the brentuximab vedotin arm (3%) and 26 events in the control arm (6%), the interim analysis showed a statistically significant benefit for brentuximab vedotin in overall survival after a median observation time of 27-28 months. Validity of the results is limited as the median survival was not yet reached. There were no statistically significant differences in health status measured by the EQ-5D-VAS at the end of treatment and in the follow-up period. Statistically significant negative effects of brentuximab vedotin on symptoms und quality of life, were shown based on several scales of EORTC QLQ-C30 after completion of treatment, although the clinical relevance of the difference could not be assessed. Regarding safety, brentuximab vedotin showed statistically significant disadvantages with regard to AE of CTCAE grade ≥ 3 and serious AE, but a lower risk of treatment discontinuation due to AE. The risk of bias of these findings was high.
Project Status: Completed
Year Published: 2019
Requestor: The Federal Joint Committee [Gemeinsamer Bundesausschuss] (G-BA)
English language abstract: An English language summary is available
Publication Type: Full HTA
Country: Germany
MeSH Terms
  • Hodgkin Disease
  • Adult
  • Brentuximab Vedotin
  • Antineoplastic Agents, Immunological
  • Antibodies, Monoclonal, Humanized
  • Immunotoxins
  • Brentuximab Vedotin
  • Doxorubicin
  • Vinblastine
  • Hodgkin Disease
  • Dacarbazine
Organisation Name: The Federal Joint Committee
Contact Address: Gutenbergstr. 13, 10587 Berlin, Germany
Contact Name: Fachberatung Medizin [Department of Medical Consultancy]
Contact Email: Fachberatung-Medizin@g-ba.de
Copyright: https://www.g-ba.de/sys/impressum/
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