Original Title: Arzneimittel-​​​Richtlinie/Anlage XII: Mogamulizumab (Mycosis fungoides, Sézary-Syndrom)

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: Mogamulizumab is approved for the treatment of adult patients with mycosis fungoides (MF) or Sézary syndrome (SS) who have received at least one prior systemic therapy. The benefit assessment of mogamulizumab is based on the MAVORIC study, which was the basis for the approval. The MAVORIC study is an open-label, multicenter, randomized, phase III study in a parallel-group design (1:1) to evaluate the efficacy and safety of mogamulizumab in pre-treated adults with MF or SS compared to vorinostat. Mortality: With a high potential for bias and assuming a possible efficacy advantage over vorinostat, there is a possible underestimated effect. Overall, the risk of death during the MAVORIC study was comparable in both treatment arms. Morbidity: With a high potential for bias, there were no differences in itching measured by the Pruritus Numerical Rating Scale (NRS), in the maximum improvement in cutaneous disease burden measured by the symptom domain of the Skindex-29, and for general health measured by the VAS of the EQ-5D. In addition, surveys after treatment cycle 3 show insufficient response rates of less than 70% with sometimes severe differences between treatment arms. Valid conclusions on the change in general health status as well as cutaneous disease burden are not possible after cycle 3. Quality of life: Regarding disease-specific quality of life, measured by ItchyQol and Skindex-29, there was no difference between treatment arms at high potential bias. Regarding quality of life, measured by the generic PRO instrument FACT-G, there was a statistically significant difference in favor of the mogamulizumab arm for the total score and the physical well-being domain at cycle 1 at high potential bias. Safety: Overall, the main risks associated with treatment with mogamulizumab are infusion-related reactions, drug rash, and infections-which were generally mild or moderate in severity. The Committee for Medicinal Products for Human Use (CHMP) believes the following actions are necessary to address safety-related issues: Post-Authorization Safety Study to characterize the safety of allogeneic hematopoietic stem cell transplantation (HSCT) in patients with cutaneous T-cell lymphoma (CTCL) treated with mogamulizumab.

Project Status: Completed

URL for project: https://www.g-ba.de/bewertungsverfahren/nutzenbewertung/558/#english

Year Published: 2020

URL for published report: https://www.g-ba.de/downloads/39-1464-4588/2020-12-03_AM-RL_Mogamulizumab_D-544_EN.pdf

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

URL for additional information: https://www.g-ba.de/bewertungsverfahren/nutzenbewertung/558/#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/