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

July 20th, 2023

[C2H2112] Summary of Cost-effective Analysis
Evaluation of Micra Transcatheter Pacing System(Micra AV)
1. Purpose of use
Leadless transcatheter pacemakers
2. Price of the device
Micra AV has been reimbursed since December 2021, and the device has been
priced at JPY 1,170,000 as of March 2023. The price was determined using theSimilar Efficacy Comparison Method with a 10% premium. The product wase
designated as an item for the cost-effectiveness evaluation with H2 classification.
3. Scope of the cost-effectiveness evaluation
Micra AV is a dual-chamber transcatheter leadless pacemaker. The scope of thecost-effectiveness evaluation determined in the first session of the Expert
Committee of Cost–Effectiveness Evaluation (ECCEE) is described below.
The target population was patients who have atrioventricular block, indicatedfor a pacemaker without atrial fibrillation, and who should be precluded fromusing a transvenous pacemaker to avoid complications.
The comparator is a DDD-mode transvenous pacemaker because it is
exclusively used for the target population.

Targetpopulation
Comparator

Patients who have an atrioventricular block indicated for apacemaker without atrial fibrillation and who should beprecluded from using a transvenous pacemaker
DDD mode transvenous pacemaker4. Evaluation of additional benefits
The manufacturer used data from studies on Micra VR and VVI leadless
pacemakers because, as the manufacturer explained, the complication profiles ofMicra VR and Micra AV are considered the same. In the Micra Transcatheter Pacing
Study, complication rates were significantly lower for Micra VR (n=725) than fortransvenous pacemakers, collected from historical control data

(n=2,667)(HR:0.46 (95%CI:0.28 to 0.74)).
The manufacturer concluded that Micra AV had additional benefits.
In addition, several observational studies have showed that complication rates
were lower in Micra (leadless pacemakers) than in transvenous pacemakers.
Therefore, the academic group accepted the manufacturer’s conclusions.
5. Results of the cost-effectiveness analysis
The manufacturer performed a cost-effectiveness analysis using a Markovmodel. Utility values until six months after implantation were generated bymapping the aggregated SF-36 scores reported in a previous study to those of
the EQ-5D using the algorithm developed in another study. The utility values 12months after implantation was estimated from the simple assumption that thedifference in utility values between Micra AV and the comparator after 12 months
was one-fourth of that until six months. Hospitalization costs were estimatedfrom the claims data analysis.
In the academic analysis, utility values up to six months were derived from dataon SF-36 scores from another study in which the results were matched withcovariates. No additional benefit in terms of utility was observed after 12 months.
Hospitalization costs were estimated using the National Database of Health
Insurance Claims and Specific Health Checkups of Japan (NDB) for larger samples,excluding those with primary diseases that were not indications for pacemakers.
The ECCEE accepted the following:
Population

Comparator

ICER (JPY/QALY)Patients who have an atrioventricular
block indicated for a pacemaker without
atrial fibrillation and who should beprecluded from using a transvenous
pacemaker

DDD mode transvenous
pacemaker

14,073,538