Original Title: Arzneimittel-Richtlinie/Anlage XII: Bulevirtid (chronische hepatitis-delta-virus (HDV)-infektion)

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: Bulevirtide is indicated for the treatment of chronic hepatitis delta virus (HDV) infection in plasma or serum in HDV-RNA positive adult patients with compensated liver disease tested positive for HDV. The benefit assessment of bulevirtide 2mg/d was based on the pivotal studies MYR202 and MYR203. Study MYR202 and MYR203 were multicenter, open-label, randomized phase II studies to evaluate the efficacy and safety of three doses of bulevirtide: MYR202 bulevirtide+tenofovir (N=28) compared to tenofovir (N=30) for 24 weeks and 24-weeks follow-up with tenovofir and MYR203 bulevirtide alone (N=15) or with peg-IFN-alfa-2a (PEG-IFN) compared to PEG-IFN (N=15) or tenofovir (N=15) in patients with HDV and hepatitis B co-infection for 48 weeks, followed by 24-week follow-up. For both studies, the risk of bias was considered high due to open, exploratory study design and limitations regarding allocation concealment and the conduction of both studies. Virological response, e.g. HDV response, is an important parameter for clinical and therapeutical response and was presented additionally in the report despite unclear patient relevance. In both studies, for HDV response a statistical significant benefit for the intervention was shown only for week 24 in MYR202 (RR 15.0 [95% CI: 2.12; 105.99], p-value:

Project Status: Completed

URL for project: https://www.g-ba.de/bewertungsverfahren/nutzenbewertung/582/#english

Year Published: 2021

URL for published report: https://www.g-ba.de/downloads/39-1464-4709/2021-02-18_AM-RL-XII_Bulevirtid_D-579_EN.pdf

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

URL for additional information: https://www.g-ba.de/bewertungsverfahren/nutzenbewertung/582/#nutzenbewertung

English language abstract: There is no English language summary 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