JMIR Publications

ABSTRACT

Background:

Cardiac resynchronization therapy with defibrillator (CRT-D) improves survival, reduces hospitalization, and enhances quality of life in patients with heart failure and reduced ejection fraction (HFrEF). As heart failure prevalence increases in aging societies such as Japan, the associated clinical and economic burden continues to rise. Previous cost-effectiveness analyses conducted in multiple countries indicate that CRT-D may be cost-effective in selected patients with HFrEF. However, its cost-effectiveness within the Japanese healthcare system remains uncertain.

Objective:

To evaluate the cost-effectiveness of CRT-D in patients with HFrEF within the Japanese healthcare setting.

Methods:

A partitioned survival model was developed with three health states: post-treatment (follow-up), hospitalization, and death. Survival for CRT-D was estimated by reconstructing individual patient-level data from the Kaplan–Meier curve of the RAFT trial using the Guyot method, followed by fitting multiple parametric models; the gamma distribution was selected for the base-case analysis. Survival for optimal medical therapy (OMT), the comparator, was estimated by applying a hazard ratio (HR) from a published meta-analysis. Hospitalization rates and device longevity were derived from prior studies. Cost estimates were obtained from the JROAD-DPC database and the Japanese medical fee schedule. Utility values were assigned according to New York Heart Association class, assuming treatment-specific distributions. The analysis was conducted from the public healthcare payer perspective using a monthly cycle over a 20-year time horizon. Deterministic and probabilistic sensitivity analyses were performed, along with scenario analyses varying treatment effect duration.

Results:

In the base-case analysis, per capita costs were ¥12,258,410 for CRT-D and ¥732,899 for OMT, resulting in an incremental cost of ¥11,525,511. CRT-D generated 7.07 quality-adjusted life years (QALYs), compared with 4.74 QALYs for OMT, yielding an incremental gain of 2.32 QALYs. The incremental cost-effectiveness ratio (ICER) was ¥4,961,999 per QALY. Scenario analyses showed that when treatment effect waned after 7.5 years, the ICER increased to ¥5,296,224 per QALY. When the time horizon was shortened to 10 years or extended to 30 years, the ICERs were ¥8,434,184 and ¥4,346,484 per QALY, respectively. Deterministic sensitivity analysis identified CRT-D efficacy (HR), discount rate, and initial treatment cost as primary ICER drivers. Probabilistic sensitivity analysis produced a median ICER of ¥4,978,334 per QALY, with a 95% credible interval of ¥3,621,650–7,766,971. At a willingness-to-pay value of ¥5,000,000 per QALY, CRT-D had a 50.9% probability of being cost-effective.

Conclusions:

CRT-D demonstrated acceptable cost-effectiveness in patients with HFrEF in Japan. Treatment efficacy and initial cost were the primary determinants of economic value, emphasizing the importance of appropriate patient selection and strategies to reduce device costs.