Authors' objectives: The Academic Technology Assessment Group (ATAG) reviewed a report submitted by the manufacturer of insulin icodec (Novo Nordisk Pharma Ltd.) on the additional benefits and cost-effectiveness of insulin icodec in patients with diabetes requiring insulin therapy. This report summarizes the results of the review and reanalysis conducted by ATAG. The target population was categorized into four groups: (a) type 1 diabetes, (b) insulin-naïve type 2 diabetes, (c) basal insulin-treated type 2 diabetes, and (d) basal-bolus insulin-treated type 2 diabetes. Insulin glargine U300 was used as the comparator. The manufacturer conducted a systematic review (SR) of insulin icodec, insulin glargine U300 and insulin degludec U100. The manufacturer identified the ONWARDS 6, ONWARDS 3, and ONWARDS 2 studies for populations (a), (b), and (c), respectively. For population (d), no head-to-head trials were identified. The manufacturer identified the ONWARDS 4 and EDITION 1 studies for an indirect comparison. ATAG accepted the use of head-to-head trial results comparing insulin icodec with insulin degludec U100, given that no clear differences in efficacy or safety were identified between insulin glargine U300 and insulin degludec U100. ATAG independently conducted an SR and confirmed that the key studies identified were largely consistent with those identified by the manufacturer. For population (a), the manufacturer concluded that insulin icodec was “inferior or could not be considered comparable” based on the ONWARDS 6 study, citing a less favorable HbA1c change and a statistically significantly higher incidence of clinically significant or severe hypoglycemia compared with insulin degludec U100. ATAG determined that the difference in HbA1c change was within the non-inferiority margin and was not necessarily clinically meaningful. ATAG also confirmed that the incidence of hypoglycemia was significantly higher with insulin icodec. ATAG concluded that there were no additional benefits of insulin icodec over insulin glargine U300. For populations (b) and (c), the manufacturer concluded that insulin icodec demonstrated additional benefits, as the superiority of insulin icodec in HbA1c change was demonstrated in the ONWARDS 3 and ONWARDS 2 studies, respectively. However, ATAG determined that both studies were designed as non-inferiority trials and that the differences in HbA1c changes were not necessarily clinically meaningful. ATAG also confirmed that the incidence of hypoglycemia was higher with insulin icodec in both populations. ATAG concluded that there were no additional benefits of insulin icodec over insulin glargine U300. For population (d), the manufacturer conducted a network meta-analysis (NMA) and found no significant differences in HbA1c change or the incidence of hypoglycemia, concluding that no additional benefits were demonstrated. ATAG independently conducted the NMA and largely confirmed this assessment. ATAG examined the manufacturer’s economic evaluations. The manufacturer did not conduct a cost-effectiveness analysis for population (a). For populations (b) and (c), the manufacturer conducted cost-effectiveness analyses using a cohort model consisting of health states for microvascular and macrovascular complications, and death. For population (d), the manufacturer conducted a cost-minimization analysis. ATAG conducted cost-minimization analyses for all populations. In the reanalysis, ATAG applied the latest drug prices. Additionally, because the manufacturer applied different proportions of concomitant medications across groups, ATAG standardized these proportions using pooled data. At the Expert Committee of Cost-Effectiveness Evaluation, the manufacturer asked the committee to consider the potential reduction in related medical costs for patients receiving home-visit nursing care, given that insulin icodec is administered once weekly. ATAG conducted an additional analysis based on the committee’s instructions. ATAG’s additional analysis suggested that insulin icodec, compared with insulin glargine U300, was likely to indicate “cost increase” for populations (a) and (d), and “comparable cost” for populations (b) and (c), from the perspective of public healthcare payers in Japan.

Project Status: Completed

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

Year Published: 2026

URL for published report: https://c2h.niph.go.jp/en/results/C2H2408.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