PP032 Holistic Patient Access Processes Of Medical Devices In South Korea

Abstract

(OSs) were included. Compared to cataract surgery alone, implantation of iStent®combined with cataract surgery was associated with a decrease in IOP at 12 months in RCTs (-1.37 mmHg; 95 percent Confidence Interval, CI: -2.76 to .03 mmHg, p = .055). Results from RCTs and OSs on the effect of iStent® combined or not with cataract surgery suggest also a 12-month positive effect on IOP (mean reduction: 1.5 to 9.5 mmHg) and on mean number of medications (reduction: .3 to 2.0) compared to baseline. Scattered results were found on the proportion of patients who no longer use glaucoma medications. Small sample size, short duration of follow-up, and potential conflicts of interest were among studies limitations. The most common adverse events reported were posterior capsular opacification, decrease in visual acuity, and stent obstruction or malposition.

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

“…Despite these factors, it is evident that the medical procedure coverage determination process is the main bottleneck in the current patient access pathway. Various stakeholders have requested process improvement, but there has been little meaningful lead-time reduction in the past several years (2;3).…”

“…Delayed patient access weakens the reward for innovation and provides a greater benefit to fast followers or imitators. The importance of accelerated patient access is even greater in medical devices compared with pharmaceutical products, as medical devices are characterized by shorter product life-cycles (e.g., 18–24 months) and their protection against intellectual property is relatively weak (3). Fast-followers are more likely to benefit from the delayed patient access pathways, which were endured and solved by innovation creators because manufacturers that follow innovators are not required to undergo both the nHTA and new medical procedure coverage application processes (16).…”

“…The application to HIRA must outline safety and effectiveness of the new technology but should also include a cost-effectiveness and budget impact analysis. The “medical procedure coverage determination” process is among the three-step coverage determination processes at HIRA and is considered the biggest delay for patient access (2;3).…”

“…The delays in patient access to new medical technologies are influenced by a series of decision-making processes that appear fragmented as little coordination and collaboration with the engaged authorities and departments within the same entity despite opportunity to remove underlying redundancy in requirement and of potential simultaneous review process, starting from regulatory approval to a nHTA, and to the three step-wise coverage determination processes. In addition to the fragmented processes, various factors such as lack of infrastructure and resources, and inefficient communication among relevant stakeholders have been indicated as potential causes of delayed patient access (2;3).…”