Current Status and Improvement of Reimbursement Policy for Insulin Delivery Device in Korea: Toward Universal Use of Artificial Pancreas

Abstract

Intensive insulin therapy is the primary treatment option for patients with type 1 and uncontrolled type 2 diabetes. Insulin pump therapy and multiple daily insulin injections (MDI) are the principal methods of intensive insulin therapy. The clinical utility of an insulin pump is generally greater than an MDI regimen. An artificial pancreas, which is an insulin pump with an integrated continuous glucose monitor (CGM), has recently been introduced on the market with emerging clinical evidence. Although it may offer clinical benefits and reduce the self-management burden among patients with diabetes, its potential for inappropriate use and unaffordability are the major barriers to its universal utilization. Despite the medical assistance program offered by the Korean National Healthcare System, which provides coverage for consumables and devices for diabetes treatment, some patients cannot afford to use an advanced insulin delivery system (i.e., the artificial pancreas). Under the current reimbursement policy, the healthcare system considers an insulin pump and a CGM as separate items for regulatory and reimbursement purposes. In other words, the artificial pancreas is categorized as an insulin pump and reimbursed at the same amount as a traditional insulin pump. The fundamental operating function may be the same between the artificial pancreas and a traditional insulin pump; however, there should be a different reimbursement pathway to make a novel category for the artificial pancreas instead of categorizing it under insulin pumps and to differentiate pricing based on the comparative (cost-) effectiveness among insulin delivery devices. Other countries such as the United States, the United Kingdom, Germany, and France are moving toward rapid and universal adoption of the artificial pancreas supported by their clinical governance and regulatory affairs. In this review, we highlight the need to improve the accessibility and affordability of advanced diabetes technology by discussing the current issues in the reimbursement policy that limit the universal use of advanced insulin delivery devices in Korea.