Cardiac Resynchronization Therapy With Defibrillator Using the JROAD-DPC Database: Cost-Effectiveness Analysis.

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 health care system remains uncertain. Objective: This study aimed to evaluate the cost-effectiveness of CRT-D in patients with HFrEF within the Japanese health care setting. Methods: A partitioned survival model was developed with 3 health states: after 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 (Resynchronization-Defibrillation for Ambulatory Heart Failure Trial) study using the method proposed by Guyot et al 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 from a published meta-analysis. Hospitalization rates and device longevity were derived from prior studies. Cost estimates were obtained from the JROAD-DPC (Japanese Registry Of All cardiac and vascular Disease-Diagnostic Procedure Combination) 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 health care payer perspective using a monthly cycle over a 20-year time horizon. Deterministic and probabilistic sensitivity analyses were performed. Additionally, scenario analyses were conducted by varying the duration of treatment effect. Results: In the base case analysis, per capita costs were ¥12,258,410 (¥1=US $0.006 as of July 7, 2026) for CRT-D and ¥640,056.90 for OMT, resulting in an incremental cost of ¥11,618,353. CRT-D generated 7.07 quality-adjusted life years (QALYs) compared with 4.75 QALYs for OMT, yielding an incremental gain of 2.32 QALYs. The incremental cost-effectiveness ratio (ICER) was ¥5,009,880 per QALY. Scenario analyses showed that, when treatment effect waned after 7.5 years, the ICER increased to ¥5,423,235 per QALY. When the time horizon was shortened to 10 years or extended to 30 years, the ICERs were ¥8,523,072 and ¥4,386,803 per QALY, respectively. Deterministic sensitivity analysis identified CRT-D efficacy (hazard ratio), discount rate, and initial treatment cost as primary ICER drivers. Probabilistic sensitivity analysis produced a median ICER of ¥5,022,618 (IQR ¥4,448,306-¥5,760,425) per QALY, with a 95% credible interval of ¥3,804,418 to ¥7,178,795. At a willingness-to-pay value of ¥5,000,000 per QALY, CRT-D had a 49.2% 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.