Original Title: Arzneimittel-​​​Richtlinie/Anlage XII: Polatuzumab Vedotin (Diffus großzelliges B-Zell-Lymphom, Kombination mit Bendamustin und Rituximab)

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: Polatuzumab vedotin (Pola; lyophilised) is approved for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) who are not eligible for haematopoietic stem cell transplantation (HSCT). Pola is used in combination with bendamustine and rituximab (BR). The benefit assessment of Pola is based on the study GO29365 which justified the approval. It is an ongoing multicentre, open-label phase Ib/II trial. The objective of the study is to evaluate the safety, tolerability and anti-tumour activity of Pola+BR or bendamustine and obinutuzumab (BG) in adults with R/R DLBCL or R/R follicular lymphoma (FL). Patients were not eligible for autologous HSCT and had to have received ≥ 1 prior therapy. A randomised controlled comparison of Pola (liquid) + BR and BR as well as a study arm with Pola (lyophilised), all in patients with R/R DLBCL, are relevant for the benefit assessment. The latter arm is uncontrolled, so no comparative effect estimates are available. Pola+BR shows a statistically significant advantage in OS compared to BR. The effect estimate has a low bias potential, even though, there were imbalances between the study arms related to the sociodemographic and disease-specific variables. Also, the small number of patients (N = 80) must be considered. The neuropathy questionnaire TNAS (morbidity) was not considered suitable for deriving patient-relevant and valid statements. No data was collected on health-related QoL. There were statistically significant differences to the disadvantage of Pola+BR compared to BR in therapy discontinuations due to AE. A statistically significant difference was observed in peripheral neuropathy to the disadvantage of Pola+BR and in cardiac toxicity and arrhythmia in favour of Pola+BR (all selected AE). The effect estimates have a high potential for bias. New data was submitted after publication of the benefit assessment. The resulting amendment did not lead to significant changes of the benefit assessment.

Project Status: Completed

URL for project: https://www.g-ba.de/bewertungsverfahren/nutzenbewertung/518/#english

Year Published: 2020

URL for published report: https://www.g-ba.de/downloads/39-1464-4429/2020-08-20_AM-RL-XII_Polatuzumab-Vedotin_D-507_EN.pdf

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

URL for additional information: https://www.g-ba.de/bewertungsverfahren/nutzenbewertung/518/#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/