Original Title: Arzneimittel-Richtlinie/Anlage XII: Tafasitamab (Diffus großzelliges B-Zell-Lymphom, Kombination mit Lenalidomid)

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: Tafasitamab (TAF) is approved for the treatment of adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) for whom autologous stem cell transplantation (ASCT) is not an option. TAF is used in combination with lenalidomide (LEN), followed by TAF monotherapy. The benefit assessment is based on the pivotal study L-MIND which is an ongoing multicentre, open-label, single-arm phase II study investigating the safety and efficacy of LEN + TAF in adults with DLBCL who are R/R to 1-3 prior systemic DLBCL therapies and who are not eligible for high-dose chemotherapy followed by ASCT. Since the study is uncontrolled, no comparative effect estimates are available. Two indirect treatment comparisons (RE-MIND and RE-MIND2) were not accepted for the benefit assessment since the comparability of the populations was in part not sufficient and overall could not be conclusively assessed. During the median FU time of 42.7 months, half of the patients treated with TAF died. There is a high potential for bias and limited reliability of the results. Overall, no clear statements can be made about the results on B-symptoms (morbidity) due to many ambiguities and limitations. Data on QoL was not collected. The median total treatment duration was 9.2 months. All patients experienced AE. 77.8% experienced severe AE and 53.1% experienced serious AE (SAE). The occurrence of SAE appears to be heterogeneously distributed, with the exception of infections and parasitic diseases (25.9%). Conclusive assessments of AE of special interest (AESI) are hampered by a lack of outcome presentations of prespecified AESI. There is a high potential for bias and limited reliability of the results. The extent to which the combination therapy with TAF+LEN or the therapy with TAF contributes to AE could not be conclusively assessed. An amendment was assigned after publication of the benefit assessment. It did not lead to significant changes of the benefit assessment.

Project Status: Completed

URL for project: https://www.g-ba.de/bewertungsverfahren/nutzenbewertung/740/#english

Year Published: 2022

URL for published report: https://www.g-ba.de/downloads/39-1464-5314/2022-03-03_AM-RL-XII_Tafasitamab_D-732_EN.pdf

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

URL for additional information: https://www.g-ba.de/bewertungsverfahren/nutzenbewertung/740/#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/