Novo's Ozempic to gain insurance coverage for diabetes in Korea from February under new criteria

Starting in February, Korea's national health insurance will cover Novo Nordisk's Ozempic Prefilled Pen, which contains the active ingredient semaglutide, as a diabetes treatment.

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The Ministry of Health and Welfare announced an administrative notice regarding the “Revised Details on the Application Criteria and Methods for Medical Benefits,” which is open for public comment until Monday. Accordingly, the semaglutide injection for type 2 diabetes, including the Ozempic Prefilled Pen 2 mg, will be covered by medical benefits when administered to patients with type 2 diabetes.

Patients qualify if their HbA1c remains at or above 7 percent after two to four months of combined metformin and sulfonylurea treatment. This group specifically includes those with a body mass index (BMI) of 25 kg/m² or higher, or those unable to undergo insulin therapy.

For administration, triple combination therapy (metformin + sulfonylurea + Ozempic Prefilled Pen) is approved. If significant blood glucose improvement is achieved with triple combination therapy, then dual combination therapy (metformin + Ozempic Prefilled Pen) is also approved.

Combination therapy with insulin is approved in specific cases. These include when HbA1c remains at or above 7 percent after two to four months of insulin monotherapy or insulin plus metformin, and when HbA1c remains at or above 7 percent after treatment with Ozempic Prefilled Pen and metformin (plus sulfonylurea). In these cases, basal insulin with Ozempic Prefilled Pen (plus metformin) is approved.

However, healthcare providers must submit objective documentation, such as the patient's drug administration history and test results, with the initial prescription. Thereafter, they must measure HbA1c and BMI and submit the results every three months. Initially, prescriptions will be limited to four weeks during the first three months to allow for necessary dosage adjustments. After this, the prescription period may be extended to three months.

The Ministry of Health and Welfare explained why it set separate reimbursement criteria for this medication, which differ from those for other diabetes medications. It stated, “Although the drug's approved indication covers type 2 diabetes, cases outside the existing reimbursement scope could cause patients to misuse it as an anti-obesity drug because they would cover the full cost. Therefore, we issued a separate notice that adds criteria for eligible patients, evaluation methods, and prescription periods.”

For limiting the prescription period, it noted, “Because the drug requires starting at a low dose and gradually increasing it—as approved by indications and expert opinions—we limit the prescription period to four weeks during the initial administration phase when dose adjustments are necessary.”