Original Title: Arzneimittel-Richtlinie/Anlage XII: Belantamab-Mafodotin (Aufhebung des Beschlusses vom 5. Oktober 2023)

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 multiple myeloma in adult patients, who have received at least four prior therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy. The benefit assessment of Belantamab-Mafodotin is based on the study DREAMM-3 and the pivotal study DREAMM-2. The DREAMM-3 study is a multicenter, open-label, randomized controlled phase III study comparing Belantamab-Mafodotin to Pomalidomid/Dexamethason. As the study population of the DREAMM-3 study also includes people in previous lines of therapy not included in the indication, a subpopulation (nintervention = 29; ncontrol = 15) was used for the assessment. Overall, the potential of bias in the DREAMM-3 study is high at study and endpoint level. There was no statistically significant difference in overall survival between the two treamtent arms in the DREAMM-3 study. The median survival time in the intervention arm is 9.5 months (95% CI: [5.1; n. b.]), while it has not yet been reached in the control arm. Due to low response rates (<70%) or differences in response rates between the study arms (>15%), the patient-reported endpoints on morbidity and quality of life could only be presented for week 4 or not at all and interpretation is not meaningful. AEs occurred in almost all patients in both study arms. The DREAMM-2 study is a phase II study to evaluate the efficacy and safety of two doses of belantamab mafodotin. For the benefit assessment, only the treatment cohort in which belantamab mafodotin was investigated in the professional information-compliant dose of 2.5 mg/kg bodyweight, will be used (n = 97). As the DREAMM-2 study does not use a control group, a high potential of bias at study and endpoint level is assumed. The DREAMM-2 study showed a longer median survival time of 15.3 months (95% CI: [9.9; 18.9]) compared to the DREAMM-3 study. Possible explanations for the deviating results are not available. Due to insufficient response rates, patient-reported endpoints on morbidity and quality of life could not be presented at all or only at week 4. AEs occurred in almost all patients. AEs of CTCAE grade ≥ 3 were documented in 84% of those treated and SAEs in 45%. 11% of patients discontinued therapy due to AEs.

Project Status: Completed

URL for project: https://www.g-ba.de/bewertungsverfahren/nutzenbewertung/933/#english

Year Published: 2023

URL for published report: https://www.g-ba.de/bewertungsverfahren/nutzenbewertung/933/#english

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

URL for additional information: https://www.g-ba.de/bewertungsverfahren/nutzenbewertung/933/#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/