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

May 9th, 2023

[C2H2101] Summary of cost-effective analysis
evaluation of galcanezumab (Emgality®)
1. Indication
Prevention of migraine attacks
2. Price of the drug
Galcanezumab has been reimbursed since April 2021 at JPY 44.943 for Emgality®
Subcutaneous Injection Autoinjectors and at JPY 44,811 for Emgality®
Subcutaneous Injection Syringes as of December 2022. The prices were
determined based on the Cost Calculation Method. The products were designatedas items for Cost-effectiveness Evaluation with H1 classification.
3. Scope of Cost-effectiveness Evaluation
The scope of Cost-effectiveness Evaluation determined in the first session of theExpert Committee on Cost–Effectiveness Evaluation (ECCEE) is described. The
target populations were as follows: (a) episodic migraine patients who had failed/not tolerated one or two migraine preventive drugs, (b) chronic migraine
patients who had failed /not tolerated one or two migraine preventive drugs, (c)episodic migraine patients who had failed/not tolerated three migraine preventive
drugs, and (d) chronic migraine patients who had failed/not tolerated threemigraine preventive drugs.
There were no significant differences in the 3 migraine preventive drugs interms of efficacy. Therefore, as lomerizine is the most frequently used first-line
treatment, the comparator for target populations (a) and (b) is a drug with alower cost between propranolol and valproic acid (propranolol was chosen as acomparator in the cost-effectiveness analysis). The comparator for the target
populations (c) and (d) is “Best Supportive Care” as treatment options for these
populations are limited.

(a) Episodic migraine patients that have failed/not tolerated 1
or 2 migraine preventive drugs(b) Chronic migraine patients that have failed/not tolerated 1
Targetor 2 migraine preventive drugs

populations(c) Episodic migraine patients that have failed/not tolerated 3
migraine preventive drugs(d) Chronic migraine patients that have failed/not tolerated 3
migraine preventive drugs
Populations(a)(b)：Drug with a lower cost between propranolol

Comparatorsand valproic acid (propranolol)
Populations (c)(d): Best Supportive Care

4. Evaluation of additional benefits
The manufacturer used integrated patient data from five randomized controlled
trials (CGAG, CGAH, CGAW, CGAI, and CGAN) to evaluate the additional benefitsof galcanezumab based on the number of monthly migraine headache days
(MHD). For populations (a) and (b), indirect comparison between galcanezumab
and propranolol showed that the galcanezumab group had significantly fewer
MHDs, respectively. For populations (c) and (d), the results of the meta-analysis
comparing galcanezumab and placebo, which was a substitute for the Best
Supportive Care, showed that the galcanezumab group had significantly fewer
MHDs, respectively.
Based on the aforementioned results, the manufacturer concluded thatgalcanezumab had additional benefits to both propranolol and Best SupportiveCare.
The academic group accepted the manufacturer’s conclusion.
5. Results of the cost-effectiveness analysis
The manufacturer performed a cost-effectiveness analysis using a Semi-Markovmodel. The utility values used in the model were generated by mapping thescores of the Migraine Specific Questionnaire to those of EQ-5D-3L. The mapping
algorithm was created using the U.K. tariff, which may underestimate the utility
values for Japanese patients. While the academic group considered that utility
values measured in clinical trials should be used, it used the mapped values
adjusted for the difference in the EQ-5D-3L tariffs between the U.K. and Japan
under an order from the ECCEE. In addition, the frequency of hospitalization andthe drug price were changed in the academic analysis.
The ECCEE accepted the following:
Population

Comparator

ICER (JPY/QALY)

Propranolol

11,060,803Propranolol

5,371,334(a) Episodic migraine patients that
havefailed/nottolerated

1or2

migraine preventive drugs(b) Chronic migraine patients that havefailed/not tolerated 1 or 2 migraine
preventive drugs(c) Episodic migraine patients thathave failed/not tolerated 3 migraine Best Supportive Care

5,741,268

preventive drugs(d) Chronic migraine patients that havefailed/not

toleratedpreventive drugs

3migraine Best Supportive Care

3,459,856