Original Title: Arzneimittel-Richtlinie/Anlage XII: Talquetamab (Multiples Myelom, mind. 3 Vortherapien)

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: Talquetamab is approved for the treatment of adults with relapsed and refractory multiple myeloma who have received at least 3 prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody, and who have shown disease progression during the last therapy. The benefit assessment of talquetamab is based on the non-TCRDT pre-treated and TCRDT pre-treated cohorts of the pivotal MonumenTAL-1 study, an ongoing multicenter, international, single-arm, open-label Phase I/II study evaluating the efficacy and safety of talquetamab in adults with relapsed and refractory multiple myeloma. Mortality The effect of talquetamab on mortality cannot be assessed on the basis of the data presented. Morbidity Due to the uncontrolled study design, a comparative interpretation and evaluation of morbidity to other possible treatment approaches is not possible. Furthermore, in view of the open study design, it should be noted that possible placebo effects cannot be ruled out. The effect of talquetamab on morbidity cannot be assessed on the basis of the data presented. Quality of life The effect of talquetamab on quality of life cannot be assessed on the basis of the data presented. Safety All study participants in the all-treated population in the MonumenTAL-1 study experienced at least one AE. The median observation time between the first administration of talquetamab and the end of the safety follow-up period of 30 days was between 5.7 and 8.8 months in the all-treated population at the data cut-off on January 17, 2023. The long-term safety cannot yet be estimated based on the available data.

Project Status: Completed

URL for project: https://www.g-ba.de/bewertungsverfahren/nutzenbewertung/997/#english

Year Published: 2023

URL for published report: https://www.g-ba.de/downloads/39-1464-6497/2024-03-07_AM-RL-XII_Talquetamab_D-981_EN.pdf

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

URL for additional information: https://www.g-ba.de/bewertungsverfahren/nutzenbewertung/997/#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/