The significance of Ozempic's reimbursement coverage in KOR

Reimbursement restricted to those who failed treatment with existing therapies…to switch after using triple therapy

“Limitations persist compared with guidelines … Greater flexibility reflecting complication risks needed”

Novo Nordisk’s GLP-1 receptor agonist Ozempic has entered Korea’s reimbursement system.

Experts consider this development highly significant, as this newly reimbursed therapy has demonstrated not only glucose-lowering efficacy but also evidence supporting reductions in cardiovascular and renal risks. However, discussion continues regarding the gap between reimbursement criteria and real-world clinical practice, as the coverage requirements are structured around failure with existing therapies such as sulfonylureas (SU), potentially limiting patient access.

On the 13th, Novo Nordisk held a briefing at the Four Seasons Hotel in Jongno-gu, Seoul, to commemorate the domestic reimbursement approval of Ozempic (semaglutide), a type 2 diabetes treatment.

(From the left) Hee Woo Lee, Director of Diabetes BU at Novo Nordisk Korea; Jang Won Son, Professor of Endocrinology at Bucheon St. Mary's Hospital; Cheol-Young Park, Professor of Endocrinology at Kangbuk Samsung Hospital; Ju Ok Lim and Ji Hyun Kim from Medical Affairs, Novo Nordisk Korea

Ozempic is indicated for patients who have received metformin + an SU agent for at least 2–4 months but maintain HbA1c ≥7% who are a BMI ≥25 kg/m² or who are unable to undergo basal insulin therapy. For these patients, only triple combination therapy (metformin + SU + Ozempic) is reimbursed initially. Switching to dual combination therapy (metformin + Ozempic) is only permitted if significant glycemic improvement is achieved thereafter.

Additionally, if HbA1c remains ≥7% despite 2-4 months of basal insulin monotherapy or metformin combination therapy, or if HbA1c remains ≥7% despite Ozempic combined with metformin (±SU), reimbursement is granted for use of Ozempic + basal insulin (±metformin) combination therapy.

In clinical trials, Ozempic demonstrated improvements not only in glycemic control but also across cardiovascular and renal endpoints.

Specifically, in the Phase III SUSTAIN 1-5, 7, and 9 trials, Ozempic showed a higher rate of achieving HbA1c below 6.5% compared to placebo.

Furthermore, in the Phase III SUSTAIN 6 trial, Ozempic reduced the risk of major adverse cardiovascular events (MACE) by 26% compared to the placebo group. In the Phase III FLOW trial, it reduced the risk of the composite renal outcome measure by 24% compared to placebo.

Ozempic is the only GLP-1 receptor agonist to demonstrate therapeutic benefits in reducing cardiovascular and renal disease risks.

Dr. Jang Won Son, Professor of Endocrinology at Bucheon St. Mary's Hospital, emphasized, “With the clinical value of GLP-1 receptor agonist-based therapy reaffirmed, Ozempic’s reimbursement coverage represents a significant step forward in improving treatment accessibility.”

Reimbursement criteria remain restricted... Need for consideration to improve patient access

Despite guideline recommendations supporting the use of GLP-1 therapies for patients with inadequate glycemic control or coexisting cardiovascular/renal disease, treatment access had remained limited due to its non-reimbursed status.

According to the Diabetes Fact Sheet 2025 released by the Korean Diabetes Association, approximately half of diabetes patients are obese, with 61.1% of them exhibiting abdominal obesity. Consequently, there is high potential for utilizing GLP-1 agents, which can demonstrate weight loss effects among diabetes treatments.

Dr. Cheol-Young Park, Professor of Endocrinology at Kangbuk Samsung Hospital, said, “While disease awareness among Korean diabetes patients is relatively high at 74.7%, only 32.4% achieve HbA1c below 6.5%, indicating persistent challenges in glycemic control.”

He added, “Major domestic and international guidelines recommend a comprehensive approach that considers various risk factors alongside blood glucose management to reduce the risk of diabetes complications. Semaglutide formulations, in particular, can be considered a treatment option for patients with type 2 diabetes accompanied by chronic kidney disease and atherosclerotic cardiovascular disease (ASCVD), as well as for those requiring weight management.”

However, concerns have been raised about limitations in the reimbursement criteria. In current clinical practice, combination therapy using DPP-4 inhibitors and SGLT-2 inhibitors is widely used, with sulfonylurea increasingly being avoided due to the risk of hypoglycemia and patient characteristics.

Yet, the need to use sulfonylureas again to meet the treatment failure requirement in Ozempic’s reimbursement criteria borders on a regulation that forces failure. The fact that even discretionary non-reimbursed prescriptions are not permitted for patients who fail to meet reimbursement criteria is also controversial. This has led to backlash, with critics questioning whether the government is preemptively assuming patients' treatment needs.

Professor Park said, “Although GLP-1 agents are recommended in numerous guidelines, limitations in reimbursement access have constrained their practical application in domestic clinical settings. Many guidelines recommend integrated treatment, but this remains difficult in the Korean environment. It has been over 10 years since DPP-4 inhibitors emerged. Even when DPP-4 inhibitors first appeared, most clinicians did not consider SUs as first-line therapy. The reimbursement criteria need to change."

Professor Son emphasized, “The recently announced domestic reimbursement criteria have some limitations compared to current guidelines. Therefore, continued discussions are needed to enable a more flexible application that reflects complication risks. It is crucial to confirm whether measures initially taken out of excessive concern for misuse could be reevaluated later.”