Cost-effectiveness analysis of cardiac implantable electronic devices with reactive atrial-based antitachycardia pacing.

AIMS: Reactive atrial-based anti-tachycardia pacing (rATP) in pacemakers (PMs) and cardiac resynchronization therapy defibrillators (CRT-Ds) has been reported to prevent progression of atrial fibrillation, and this reduced progression is expected to decrease the risk of complications such as stroke and heart failure (HF). This study aimed to assess the cost-effectiveness of rATP in PMs and CRT-Ds in the Japanese public health insurance system. METHODS AND RESULTS: We developed a Markov model comprising five states: bradycardia, post-stroke, mild HF, severe HF, and death. For devices with rATP and control devices without rATP, we compared the incremental cost-effectiveness ratio (ICER) from the payer's perspective. Costs were estimated from healthcare resource utilisation data in a Japanese claims database. We evaluated model uncertainty by analysing two scenarios for each device. The ICER was 763 729 JPY/QALY (5616 EUR/QALY) for PMs and 1,393 280 JPY/QALY (10 245 EUR/QALY) for CRT-Ds. In all scenarios, ICERs were below 5 million JPY/QALY (36 765 EUR/QALY), supporting robustness of the results. CONCLUSION: According to a willingness to pay threshold of 5 million JPY/QALY, the devices with rATP were cost-effective compared with control devices without rATP, showing that the higher reimbursement price of the functional categories with rATP is justified from a healthcare economic perspective.

Delayed Patient Access to Innovative Medical Technologies in South Korea: A Lead-Time Analysis of Reimbursement Coverage Determinations.

Background and ObjectivesTimely access to innovative medical technologies driven by accelerated patient access pathways can substantially improve the health outcomes of patients who often have few therapeutic alternatives. We analyzed lead-times for the medical procedure reimbursement coverage process undertaken in South Korea from 2014 to 2017, which is considered one of the most important factors contributing to delays in patient access to new medical technologies. METHODS: This analysis was performed using the open datasets source of "Medical Procedure Expert Evaluation Committee (MPEEC)" meeting results and medical procedure coverage application information published on the Health Insurance Review and Assessment Service Web site. RESULTS: From 2014 to 2017, 90 percent of all new coverage determinations took on average >250 days with almost 20 percent taking more than 2 years (>750 days), The average lead-time from the medical procedure coverage application to MPEEC meeting in 2015 was 435.0 ± 214.7 days (n = 26), which was significantly shorter than the average lead-time in 2014 (624.9 ± 290.3 days, n = 16) (p < .05). The average lead-time from application to official enforcement in 2015 was significantly shorter than that of 2014 (540.8 ± 217.4; n = 16 versus 734.1 ± 299.7 days; n = 26, respectively) (p < .05). CONCLUSIONS: While this analysis showed a general trend of a reduction in the time taken to receive a positive coverage determination for a new medical technology, the average lead-time remains well over the government mandated 100 days. To continue this trend and further enhance the patient access pathway for medical procedure coverage determinations, some measures can be applied. In particular, the extended "One-Stop Service" program encompassing coverage determinations is one such recommendation that could be considered.

Reimbursement Coverage Decision Making for Digital Health Technologies in South Korea: Does It Fit the Value Framework Used in Traditional Medical Technologies?

OBJECTIVES: The introduction of digital health technologies (DHTs) that have the potential to improve health outcomes and lower the costs of healthcare services has seen an explosion in recent years. Indeed, the expectation that these innovative technologies can ultimately fill a gap in the patient-healthcare provider model of care with the hope of bending the continuously increasing healthcare expenditure curve has not yet been realized in many countries including South Korea (from herein referred to as Korea). We examine reimbursement coverage decision making status for DHTs in South Korea. METHODS: We examine the regulatory landscape, health technology assessment process, and reimbursement coverage determination for DHTs in Korea. RESULTS: We identified the specific challenges and opportunities for reimbursement coverage of DHTs. CONCLUSIONS: To ensure DHTs can be used effectively in medical practice, a more flexible and nontraditional approach to assessment, reimbursement, and payment determination is required.

Coverage with Evidence Development Programs for Medical Technologies in Asia-Pacific Regions: A Case Study of Japan and South Korea.

In this article, the operational characteristics of coverage with evidence development (CED) programs in Asia-Pacific regions, focusing on two countries-Japan and South Korea-are reviewed. Both countries recommended the introduction of CED to overcome the barrier of lack of robust clinical evidence in the early stages of the introduction of a medical technology. However, each country has a unique approach to CED implementation that reflects the differences in establishment and healthcare and policy environments. Japan adopted a "Challenge Application (CA)" program in 2018, and South Korea introduced the "Conditional Selective Benefit (CSB)" program in 2014. Despite the positive effects of CED programs, their governance and implementation should be improved to benefit patients in both countries from the improved access to new and innovative medical technologies. To this end, CED practices in the United States (the USA) can provide insights on how to improve CED operations in both countries.

Laparoscopic surgery versus open surgery for gastric cancer: big data analysis based on nationwide administrative claims data.

PURPOSE: Accumulated evidence indicates laparoscopic surgery (LS) has the advantages of less wound pain, less blood loss, shorter hospitalization, and faster functional recovery than open surgery (OS). Previous studies have analyzed the advantages of LS based on hospital data. This study is the first to compare surgical outcomes and health economic data using nationwide administrative claims datasets for gastric cancer. METHODS: The claims datasets of the Health Insurance Review and Assessment Service for patients that underwent gastrectomy from May 2012 to April 2017 were analyzed. A total of 76,445 cases (LS, 42,395 and OS, 34,050) were included. Postoperative complications and medical costs were included in the analysis. RESULTS: We analyzed 76,445 cases of gastrectomy. Analysis showed LS was associated with fewer surgical wound infections (2,114 [6.21%] vs. 1,057 [2.49%], P < 0.001), minor abdominal infections and abscesses (826 [2.43%] vs. 390 [0.92%], P < 0.001), cases of surgery-related peritonitis (50 [0.15%] vs. 31 [0.07%], P = 0.0019), repair surgeries (28 [0.08%] vs. 3 [0.01%], P < 0.001), reoperations (504 [1.48%] vs. 343 [0.81%], P < 0.001), less antibiotic use (1,717 [5.04%] vs. 1,268 [2.99%], P < 0.001), and shorter hospital stays (13.61 days vs. 9.97 days, P < 0.001). However, average medical cost was 510,734 Korean Won (444 US dollar) higher for LS than OS. CONCLUSION: The study confirms the clinical benefits of LS over OS for gastrectomy in terms of fewer postoperative complications and shorter hospital stays. However, the average medical cost of LS was higher than that of OS.