Original Title: Arzneimittel-Richtlinie/Anlage XII: Brentuximab Vedotin (Neubewertung nach Fristablauf: Systemisches anaplastisches großzelliges Lymphom; Erstlinie; Kombination mit Cyclophosphamid, Doxorubicin und Prednison)

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 objective of this benefit assessment is to evaluate the efficacy and safety of brentuximab vedotin in the treatment of adult patients with previously untreated systemic anaplastic large cell lymphoma (sALCL) in combination with cyclophosphamide, doxorubicin, and prednisone (CHP). The current benefit assessment is based on the pivotal study ECHELON-2, which investigated the efficacy and safety of brentuximab vedotin in combination with CHP compared to cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) polychemotherapy in the treatment of untreated adult patients with various CD30-positive peripheral T-cell lymphomas. Only the subgroup of patients diagnosed with sALCL were considered for the benefit assessment. Benefit Median overall survival was not reached in any of the study arms. There was a statistically significant benefit of the brentuximab vedotin group compared to the control group at the first data cut-off, but not at the final data cut-off. An advantage for brentuximab vedotin was shown for the endpoint event-free survival. The high risk of bias for this outcome measure must be taken into account. In contrast, there were no statistically significant differences in recurrence-free survival and complete response with B symptoms at baseline measurement. In the patient-reported endpoints for health-related quality of life (EQ-5D), symptom scales (EORTC QLQ-C30) and neurotoxicity (FACT/GOG-Ntx), there were no relevant differences between the treatment arms during the treatment phase. No meaningful results are available for follow-up. Quality of life The functional scales of the EORTC QLQ-C30 are used to assess the endpoint category quality of life. In both treatment arms, there were small to moderate improvements across all functional scales and the global scale on general health at the end of treatment compared to baseline measurement. There were no statistically significant differences between the treatment arms. There is also a high risk of bias for the functional scales and the global scale on general health. Safety Statistically significant differences in overall rates of adverse events did not occur in the pivotal safety population. In general, the safety profile was balanced between the treatment and control arms. The risk of bias of this safety endpoint is low.

Project Status: Completed

URL for project: https://www.g-ba.de/bewertungsverfahren/nutzenbewertung/709/#english

Year Published: 2021

URL for published report: https://www.g-ba.de/downloads/39-1464-5178/2021-12-16_AM-RL-XII_Brentuximab-Vedotin_D-709_EN.pdf

Requestor: The Federal Joint Committee [Gemeinsamer Bundesausschuss] (G-BA)

URL for additional information: https://www.g-ba.de/bewertungsverfahren/nutzenbewertung/709/#nutzenbewertung

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Germany

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/