Original Title: Arzneimittel-Richtlinie/Anlage XII: Belantamab-Mafodotin (Multiples Myelom, mind. 4 Vortherapien, Monotherapie)

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: Belantamab-Mafodotin (Blenrep) is indicated as monotherapy for the treatment of adult patients with multiple myeloma (MM), who have received at least 4 prior therapies and whose disease is refractory to at least one proteasome inhibitor (PI), one immunomodulatory agent (IMiD), and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy. The recommended dose is 2.5 mg/kg body weight. The benefit assessment is based on the pivotal study DREAMM-2, a phase II study evaluating the efficacy and safety of two doses of belantamab mafodotin (2.5 mg/kg and 3.4 mg/kg BW) in patients with MM who have received 3 or more prior lines of therapy, are refractory to a PI and IMiD, and have failed treatment with an anti-CD38 antibody. Treatment doses were applied in two parallel cohorts, respectively. A third cohort of patients was initiated after enrolment of the first 2 cohorts and was treated with belantamab mafodotin in a lyophilizate at a dose of 3.4 mg/kg BW. Treatment was continued until disease progression, death, or until the onset of unacceptable toxicities. Primary endpoint was the overall response rate. For the benefit assessment, only data of the cohort, in which belantamab mafodotin was investigated at the dose of 2.5 mg/kg BW (n = 97) was used. Due to lack of control, no valid conclusion can be drawn regarding the effect of belantamab mafodotin on overall survival. The estimated median survival was 13.7 months and the probability of survival at 12 months is reported to be 57% (95% CI: [46; 66]). Regarding morbidity, no valid results were available. The study did not allow for a conclusive assessment of the effect of belantamab mafodotin on quality of life. As the safety results are based on uncontrolled data, no conclusions can be derived in comparison to other antineoplastic therapies. Frequently observed AE during treatment with belantamab mafodotin mainly related to ocular toxicities and hematologic toxicities.

Project Status: Completed

URL for project: https://www.g-ba.de/bewertungsverfahren/nutzenbewertung/594/#english

Year Published: 2021

URL for published report: https://www.g-ba.de/downloads/39-1464-4731/2021-03-04_AM-RL-XII_Belantamab-Mafodotin_D-582_EN.pdf

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

URL for additional information: https://www.g-ba.de/bewertungsverfahren/nutzenbewertung/594/#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/