Authors' objectives: The Academic Technology Assessment Group (ATAG) reviewed a report submitted by the manufacturer of tezepelumab (AstraZeneca K.K.) on the additional benefit and cost-effectiveness of tezepelumab for severe uncontrolled asthma. This report summarizes the results of the review and reanalysis by the ATAG. In assessing additional benefit, the manufacturer referred to data from clinical trials of tezepelumab (NAVIGATOR trial) and other biologic agents used in the published network meta-analysis (NMA) by Menzies-Gow et al. (2022). The endpoint was the ratio of the annual asthma exacerbation rate (AAER), which was considered the primary endpoint in phase III clinical trials of tezepelumab. The manufacturer determined 'no additional benefit' or 'cannot be judged to have additional benefit' because there were no data comparing tezepelumab with a comparator (dupilumab) in the (a-1) type 2 asthma population (blood eosinophil count ≥150/µL and negative IgE antigen sensitization). For the (a-2) type 2 asthma population (IgE antigen sensitization positive), a NMA was conducted using data from a subgroup of the randomized controlled trial (RCT) of tezepelumab and the RCT of the comparator (omalizumab). The manufacturer claimed that the results showed an additional benefit of tezepelumab, with a clinically meaningful reduction in the rate of asthma exacerbations. For (b) non-type 2 asthma patients (blood eosinophil count...

Project Status: Completed

URL for project: https://c2h.niph.go.jp/en/

Year Published: 2024

URL for published report: https://c2h.niph.go.jp/en/results/C2H2210.html

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Japan

Organisation Name: Center for Outcomes Research and Economic Evaluation for Health

Contact Address: 2-3-6 Minami, Wako-shi, Saitama 351-0197 Japan

Contact Name: Takeru Shiroiwa

Contact Email: t.shiroiwa@gmail.com