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

Abstract

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.MethodsThis 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.ResultsFrom 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).ConclusionsWhile 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.

Enhancing Health Technology Assessment Establishment in Asia: Practical Issues From the Pharmaceutical and Medical Device Industry Perspectives

“…There are reports about delays in the HTA process, 18,19 including countries in this region. 20 One issue that might have contributed to the inefficiency is that most HTA systems in Asia currently conduct technical assessment and appraisal internally. 21 One option to improve the efficiency would be to contract out the technical assessment component to prequalified evaluation centers, but keep the appraisal and recommendation processes internal.…”