Original Title: Arzneimittel-Richtlinie/Anlage XII: Mosunetuzumab (Follikuläres Lymphom, nach ≥ 2 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: Mosunetuzumab received a European marketing authorization under "special conditions" on June 03, 2022. According to the SmPC, Mosunetuzumab is used for the treatment of adults with relapsed or refractory follicular lymphoma who have received at least 2 prior systemic therapies. The benefit assessment of Mosunetuzumab is based on the pivotal study GO29781. GO29781 is an ongoing single-arm study evaluating the efficacy and safety of Mosunetuzumab for multiple indication-specific cohorts. For the benefit assessment, the FL-RP2D cohort of the pivotal study GO29781 was used, which corresponds to the specifications of the SmPC regarding population and dosage. The primary efficacy endpoint for the pivotal FL-RP2D cohort is complete response (CR) as assessed by an independent review facility (IRF). The initial treatment phase of 8 cycles in the FL-RP2D cohort has been completed. Ninety subjects were enrolled in the FL-RP2D cohort. Almost 40% of the study participants had already received 2 and all other study participants at least 3 prior therapies. The study excluded individuals with cardiovascular or pulmonary disease and required study participants to have adequate liver and kidney values. Study participants were on average 60 years old and the diagnosis was made approximately 7 years earlier. Age at diagnosis averages > 60 years according to the S3 guideline on follicular lymphoma. The study population is therefore presumably younger and healthier in terms of cardiovascular, pulmonary, renal and hepatic pre-existing conditions than the expected population in everyday care for the underlying approval of third-line therapy. A total of 8 of 90 (8.9%) enrolled subjects in the FL-RP2D cohort of the GO29781 trial died by the data cut-off of August 27, 2021, and the median OS had not been reached. At month 12, overall survival was 93%. Impairment of health status measured by EQ-5D-VAS and impairment of quality of life measured by FACT-LymS was rated as relatively low at all time points. Since no responder analysis and no control group is available, interpretation of the results is limited. The most common AE observed was cytokine release syndrome (CRS) (45,6 %). CRS events occurred predominantly in Cycle 1 and were mainly related to dose administration on Day 1 and Day 15. All documented CRS events were resolved.

Project Status: Completed

URL for project: https://www.g-ba.de/bewertungsverfahren/nutzenbewertung/848/#english

Year Published: 2022

URL for published report: https://www.g-ba.de/downloads/39-1464-5769/2022-12-15_AM-RL-XII_Mosunetuzumab_D-825_EN.pdf

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

URL for additional information: https://www.g-ba.de/bewertungsverfahren/nutzenbewertung/848/#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/