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 27 2022

[C2H2002] Summary of cost-effectivenessevaluation of cabozantinib (cabometyx®)
1. Indications･ Unresectable or metastatic renal cell carcinoma (RCC)･ Hepatocellular carcinoma (HCC) in patients who have previously been treatedby chemotherapy.
2. Price of the drug
Cabozantinib has been reimbursed since May 2020 at JPY 8007.6 for 20mg
and JPY 22,333.00 for 60mg (as of June 2022). The price is calculated using asimilar efficacy comparison method (I), with a usefulness premium (II) of 10%.
This product is designated as an H1 cost–effectiveness evaluation item.
3. Scope of cost-effectiveness evaluation
This product is indicated for metastatic RCC or HCC. Hereafter, the scope ofevaluation agreed upon at the first session of the Expert Committee of CostEffectiveness Evaluation (ECCEE) is described.
[RCC]
Patients with unresectable or metastatic renal cell carcinoma
who receiving(A) First-line therapy (intermediate or high risk by IMDC
Populationclassification)(B) Second-line or subsequent therapy (after the treatment
by anti-VGFR inhibitor)[HCC]
Second-line or subsequent therapy

[RCC](A) Sunitinib
Comparator(B) Everolimus and Axitinib[HCC]
Regorafenib

4. Evaluation of additional benefits[RCC] As a results of systematic review, randomized CABOSUN trial for
population (a) and randomized METEOR trial for population (b) was detected.
METEOR trial compared cabozantinib with everolimus. In the CABOSUN trial,cabozantinib significantly extended PFS. Based on it, the academic groupconcluded that cabozantib has an additional benefit compared with sunitinib. In
the METEOR trial, superiority of cabozantinib to everolimus was shown. On theother hand, to evaluate additional benefit to axitinib, indirect comparison wasused. As a result, the manufacturer and the academic group concluded
cabozantinib has an additional benefit compared with axtinib. For indirectcomparison, the manufacturer perform network meta-analysis using METEOR
trial, RECORD-1 trial, TARGET trial and AXIS trial. However the academic group
it is not appropriate to include TARGET trial because crossover is permitted.
Instead, the academic group assumed everolimus has the same effectivenesswith axitinib.
The third session of the ECCEE concluded that the results of the academic groupare more appropriate.
[HCC] As a result of systematic review, CELESTIAL trial which comparescabozantinib with placebo was detected. In addition to CELESTIAL trial, RESORCE
trial which compared regorafenib with placebo was used for indirect comparison.
As a result, the manufacturer concluded cabozantinib has no additional benefit
to regorafenib. The academic group agreed with the manufacturer’s conclusion.
5. Results of the cost–effectiveness analysis
The manufacturer performed cost-effectiveness analysis for RCC using partition
survival model. Cost-minimization analysis was applied to the HCC population.
The manufactures’ analysis is basically acceptable and the drug price wasrenewed by the academic group.

Population
RCC (a) first line
RCC (b) second line
HCC

Comparator

ICER (JPY/QALY)

Sunitinib

6,074,752

Everolimus

5,064,156

Axitinib

6,268,535

Regorafenib

Cost-saving