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

2023 年 4 月 13 日

[C2H2104] Summary of cost-effectiveness evaluationof daratumumab and vorhyaluronidase alfa
(DARZQURO®)
1. Indications
Multiple myeloma

Systemic AL amyloidosis

2. Price of the drug
Daratumumab and vorhyaluronidase alfa (DARZQURO®) has been reimbursed
from May 2021 at JPY 445064 (as of January 2022). The price is calculated using
a similar efficacy comparison method, with a 5% usefulness premium (II). This
product is designated as the H1 item for cost-effectiveness evaluation.
3. Scope of cost-effectiveness evaluation
This product is intended for treating multiple myeloma or systemic AL
amyloidosis. The evaluation scope, which was agreed upon during the firstsession of the Expert Committee of Cost-Effectiveness Evaluation (ECCEE), isdescribed below.
Multiple myeloma
Newly diagnosed multiple myeloma (NDMM) ineligible forPopulation

hematopoietic stem cell transplantation and relapsed orrefractory multiple myeloma (RRMM)
Systemic AL amyloidosis
Newly diagnosed AL amyloidosis
Multiple myeloma

Comparator

Intravenous daratumumab (DARA IV) (Selected technology：
Subcutaneous Daratumumab (DARA SC))

Systemic AL amyloidosis
Cyclophosphamide,bortezomib,anddexamethasone(CyBorD) (Selected technology：•

Daratumumab

bortezomib,andcyclophosphamide,plus

dexamethasone(DCyBorD))
4. Evaluation of additional benefits[NDMM and RRMM] As a result of the systematic review, the randomized
COLUMBA trial was detected, which compared the DARA SC with the DARA IV.
The trial results indicated that DARA SC demonstrated no additional benefit over
DARA IV in terms of ORR, PFS, and OS. Thus, the academic group concluded thatDARA SC has “no additional benefits” over DARA IV.
[Systemic AL amyloidosis] The randomized ANDROMEDA trial was detected in
the systematic review, which compared DCyBorD with CyBorD. In this trial, CR
was higher in the DCyBorD group than in the CyBorD group (OR:5.1,95% CI:3.2
to 8.2, p<0.001). Furthermore, MOD-PFS was significantly longer in the DCyBorD
group than in the CyBorD group. However, OS data were still premature during
the primary analysis. Consequently, the academic group concluded that DCyBorD
has additional benefits for the comparator.
5. Results of the cost-effectiveness analysis
The manufacturer performed a cost-minimization analysis for the NDMM andRRMM. For systemic AL amyloidosis, the manufacturer developed a cost-utilityanalysis model consisting of a decision tree paired with a Markov model.
In the NDMM and RRMM analyses, the academic group estimated thehospitalization period for patients treated with DARA SC or IV based on theNational Database of Health Insurance Claims and Specific Health Checkups ofJapan (NDB). In the case of systemic AL amyloidosis, the manufacturer’s analysis
was acceptable, and the academic group renewed the drug price.

Population

Comparator

ICER (JPY/QALY)DARA IV

Cost-saving

CyBorD

5,645,767

Newly diagnosed multiple
myeloma (NDMM)
ineligible for hematopoietic
stem cell transplantation
and relapsed or refractory
multiple myeloma (RRMM)
Newly diagnosed ALamyloidosis