国立保健医療科学院 保健医療経済評価研究センター
Center for Outcomes Research and Economic
Evaluation for Health (C2H), National Institute of
Public Health (NIPH) | URL: http://c2h.niph.go.jp

September 28 2022

[C2H2007] Summary of cost-effectiveness evaluationof semaglutide (Rybelsus®)
1. Indications
Type 2 diabetes mellitus (T2DM)
2. Price of the drug
Semaglutide has been reimbursed from November 2020 at JPY 143.20 for 3mg, JPY 334.20 for 7 mg, and JPY 501.30 for 14 mg (as of August 2022). The
price was calculated using a similar efficacy comparison method (I), with ausefulness premium (II) of 5%, a foreign average price adjustment, and a pricemaintenance premium. This product is designated as an H1 cost-effectivenessevaluation item.
3. Scope of the cost-effectiveness evaluation
This product is indicated for the treatment of T2DM. The scope of evaluationagreed upon at the first session of the Expert Committee of Cost-EffectivenessEvaluation (ECCEE) is described below.
(A) T2DM patients with inadequate glycemic control using
oral hypoglycemics, including dipeptidyl peptidase 4(DPP-4) inhibitors. They need to be treated with otheroral hypoglycemics.
Population(B) T2DM patients with inadequate glycemic control using
oral hypoglycemics, excluding DPP-4 inhibitors. They
need to be treated with other oral hypoglycemics.
(C) T2DM patients with inadequate glycemic control using
oral hypoglycemics. They need be treated with glucagonlike peptide-1 (GLP-1) receptor agonists (injection).

Population (A): DPP-4 inhibitors and sodium-glucose
cotransporter-2 (SGLT2) inhibitors with the lowest priceComparator

combination
Population (B): SGLT2 inhibitors with the lowest price
Population (C): GLP-1 receptor agonist (injection) with thelowest price

4. Evaluation of additional benefits
In the systematic review, the manufacturer conducted a network meta-analysis
based on clinical trials in previously treated Japanese patients with T2DM for
populations (A) and (B). The systematic review demonstrated significant
improvements in glycated hemoglobin (HbA1c) with semaglutide and themanufacturer deduced that semaglutide had an additional benefit overcomparators. In response, the academic group added other publications andreconducted the network meta-analysis with a different network diagram. Fromthe view of the academic group, there was no significant difference in the change
HbA1c and body weight for populations (A) and (B), and a point estimate of thedifference in these endpoints was not clinically meaningful. The academic groupconcluded that semaglutide has ”no additional benefit.”
For population (C), the manufacturer and the academic group concluded that
semaglutide has additional benefits compared with GLP-1 receptor agonist(injection) because the PIONEER 10 study showed that semaglutide significantly
reduced body weight versus the existing GLP-1 receptor agonist (injection).
The third session of the ECCEE concluded that the results of the academic groupare more appropriate. Based on the discussion, semaglutide has additional
benefits only for population (C).
5. Results of the cost-effectiveness analysis
The academic group conducted a cost-minimization analysis for populations (A)and (B). For population (C), the academic group conducted a cost-effectivenessanalysis after modifying the parameters of effectiveness, quality of life (QOL)
values, and health-related cost. The ECCEE accepted the following:Population(A) T2DM patients with inadequate glycemic control
using oral hypoglycemics, including DPP-4

ICER (JPY/QALY)
Cost increaseinhibitors. They need to be treated with other oral
hypoglycemics.
(B) T2DM patients with inadequate glycemic control
using oral hypoglycemics, excluding DPP-4
inhibitors. They need to be treated with other oral

Cost increase

hypoglycemics.
(C) T2DM patients with inadequate glycemic control
using oral hypoglycemics. They need be treated with
GLP-1 receptor agonists (injection).

Dominant