[Edaily Reporter NA EUN-KYUNG ] The government has expanded health insurance coverage for continuous glucose monitors (CGMs) to include patients with severe type 2 diabetes, marking a turning point that is expected to boost the low penetration rate of the domestic CGM market. i-SENS, Inc.(099190), the first South Korean company to develop a CGM, is also preparing for the increase in demand by expanding its production capacity and distribution network linked to hospitals and clinics.

According to the pharmaceutical and biotech industry on the 16th, the Ministry of Health and Welfare approved the “Phase 1 Innovation Plan for Health Insurance Coverage” at the 15th Health Insurance Policy Deliberation Committee meeting on the 8th. Accordingly, starting this December, patients with severe pancreatic dysfunction or islet insufficiency—regardless of diabetes type—will receive financial support for the purchase of CGMs and insulin pumps.

Type 1 CGM usage rate stands at 10.7%… Price barrier lowered through expanded insurance coverage

The support program will expand coverage to include approximately 11,000 patients with severe Type 2 diabetes, in addition to the existing approximately 36,000 patients with Type 1 diabetes. The copayment rate for CGMs among adult Type 1 diabetes patients will also be reduced from the current 30% to between 10% and 20%, depending on the severity of their condition. Patients with severe Type 2 diabetes, who previously bore the full cost of CGMs, will now pay only 10% for pancreatic dysfunction and 20% for islet cell failure (based on adult standards).

The severity level referred to in this support program is determined not by how high blood glucose levels are, but by whether the pancreas is capable of secreting insulin on its own. The presence of pancreatic dysfunction or islet insufficiency is determined by evaluating a combination of factors, including C-peptide levels—which are secreted alongside insulin during insulin production—and the patient’s history of insulin therapy. Even patients with Type 2 diabetes are eligible for support if their pancreatic function is significantly impaired, requiring intensive blood glucose management comparable to that of Type 1 diabetes.

Type 1 diabetes is a condition in which the immune system attacks the insulin-secreting cells of the pancreas, resulting in little or no insulin production. Patients must receive insulin for life, starting from the time of diagnosis. In contrast, type 2 diabetes often begins with insulin resistance, a condition in which the body does not respond properly to insulin even when it is secreted. In the early stages, the condition can be managed through diet, exercise, or oral medication, but as the disease progresses, pancreatic function declines, making insulin therapy necessary.

The reason CGM support has historically focused on type 1 diabetes is that type 1 patients must take insulin for life to survive, and because the clinical necessity for CGM was clear given the high risk of blood glucose fluctuations and hypoglycemia. Type 2 diabetes, which affects a much larger number of patients, presents varying degrees of severity and treatment approaches, making it difficult to define the scope of coverage and placing a significant financial burden on the national health insurance system. However, as concerns were raised that some Type 2 patients have significantly impaired pancreatic function and require a level of management virtually equivalent to that of Type 1, the government lowered the eligibility threshold based on severity rather than disease type.

CGM is a device that uses a sensor attached to the skin to monitor blood glucose levels in real time. Unlike blood glucose meters (BGMs), which require a finger prick, CGM can track blood glucose trends throughout the day and identify risks of hypoglycemia and hyperglycemia. However, because the sensor must be replaced periodically, cost has long been cited as a major barrier to widespread adoption.

Nevertheless, the adoption rate of CGM in Korea remains low compared to its clinical necessity. According to a study analyzing Type 1 diabetes patients from 2020 to 2022 using data from the National Health Insurance Service, only 10.7% of patients used CGM continuously. The continuous usage rate by age group was 37.0% for those under 19, 15.8% for those aged 19–39, 10.7% for those aged 40–59, and 3.9% for those aged 60 and older, showing that the rate decreased with increasing age. This suggests that even type 1 diabetes patients receiving insurance coverage had low continuous usage rates due to barriers such as cost, prescription requirements, and lack of education.

An i-SENS, Inc. official analyzed, “According to examples provided by the government, for patients with severe Type 2 diabetes, the patient copayment for CGM—which previously cost approximately 3.65 million won annually—will be reduced to about 365,000 won for patients with pancreatic dysfunction,” adding, “Patients who previously found it difficult to use CGM consistently due to cost are now more likely to use it as a routine blood glucose management tool, rather than just a one-time experience.”

i-SENS, Inc., with a 7.5% Market Share, Prepares to Expand Market Presence Through Capacity Expansion

Currently, the domestic CGM market is dominated by foreign companies such as Abbott and Dexcom. i-SENS, Inc. entered the market in September 2023 with the launch of its domestically produced CGM, “CareSense Air,” but as of last year, its domestic market share stood at only about 7.5%. However, with this expansion of eligibility lowering the price barrier for patients, all eyes are on whether the company can leverage its price competitiveness to increase its market share.

Although its domestic market share remains in the single digits, both domestic and international sales of CareSense Air are growing rapidly. i-SENS, Inc.’s consolidated CGM revenue for the first half of this year reached 17.8 billion won, surpassing last year’s full-year revenue of 17.6 billion won in just six months. Domestic revenue totaled 7.6 billion won, combining 4.0 billion won in the first quarter and 3.6 billion won in the second quarter. Once the new system takes effect this December and the influx of new patients gains momentum, the resulting impact is expected to be reflected in next year’s domestic sales.

i-SENS, Inc. is reviewing its production, distribution, and customer support systems ahead of the expansion of insurance coverage. The company explains that, as it currently operates a fully automated CGM production line with an annual capacity of 2 million units at its Songdo Plant No. 2, there will be no supply issues even if domestic demand increases immediately. Furthermore, by 2027, when the expansion of the production line for its next-generation product, “CareSense Air 2,” is completed, total annual production capacity will expand to 5.4 million units.

An i-SENS, Inc. official stated, “Based on the fully automated production line with an annual capacity of 2 million units at the Songdo Plant No. 2, we have established a supply system capable of reliably meeting increased domestic demand.” The official added, “While strengthening our supply system linked to prescriptions from hospitals and clinics, we are also enhancing our customer support and reimbursement guidance systems so that newly eligible patients can easily understand the medical expense reimbursement process and product usage instructions.” The spokesperson added, “To ensure that the expansion of coverage leads to an actual increase in CGM usage, we are making comprehensive preparations—not only in product supply but also in prescribing, usage training, and customer support.”

However, this support is limited to patients with significantly impaired pancreatic function, rather than all general Type 2 diabetes patients. The key question is whether this program will serve as a starting point for expanding the scope of support—such as to patients requiring multiple daily insulin injections—in the future, rather than focusing solely on the scale of short-term beneficiaries.

An official from i-SENS, Inc. stated, “The government has not yet announced whether or when coverage will be expanded to all general Type 2 diabetes patients,” but “Since the Ministry of Health and Welfare has outlined in its roadmap for strengthening health coverage a plan to continuously expand National Health Insurance support for home-based care and the treatment and preventive management of chronic diseases in response to changes in the healthcare environment driven by technological advancements and an aging population, we believe there is a possibility that, starting with this measure, discussions will follow to expand coverage to a broader group of Type 2 diabetes patients after evaluating clinical necessity and treatment efficacy.”

The official went on to emphasize, “We will continue to accumulate data that demonstrates the clinical utility of CGM based on quality and price competitiveness, and we will respond flexibly to any market changes should the scope of support be expanded to a broader population of Type 2 diabetes patients in the future.”