Novo Nordisk's latest diabetes drug, Ozempic (active ingredient: semaglutide), has encountered a suspension in its coverage inclusion process. Simultaneously, Eli Lilly and Company's competitive drug, Mounjaro (active ingredient: tirzepatide), has not yet applied for reimbursement, raising questions about the potential alignment of the coverage inclusion timelines for both medications.

According to industry sources on July 25th, a second-line diabetes treatment, Ozempic, received product approval from the South Korean Ministry of Food and Drug Safety (MFDS) in April 2022. Subsequently, the process for coverage inclusion commenced, and in February 2023, the Health Insurance Review and Assessment Service (HIRA) committee deemed it reasonable for coverage inclusion, provided the price is accepted below the assessed amount.

Ozempic is administered as a once-weekly, long-acting injectable drug. It stands out as the sole GLP-1 receptor agonist (GLP-1 RA) with indications for reducing the risk of major cardiovascular events in adults with type 2 diabetes and established cardiovascular disease, setting it apart from other drugs in the same class.

In clinical settings, healthcare professionals eagerly awaited the addition of GLP-1 receptor agonist treatment options for patients with concomitant cardiovascular disease. However, Novo Nordisk suspended the coverage inclusion process due to issues related to the drug's supply.

In the first half of 2022, Ozempic witnessed a surge in global demand, leading to its inclusion in the U.S. Food and Drug Administration (FDA) drug shortage list. Some analysts attribute this increased demand to the growing prevalence of off-label prescriptions of Ozempic, a GLP-1 receptor agonist with the same active ingredient as the obesity treatment drug Wegovy.

Consequently, uncertainty shrouds the timing of Ozempic's introduction into the South Korean market. Novo Nordisk is carefully considering these factors before deciding on the future application for coverage inclusion.

While the news of Ozempic's approval unfolds, attention also turns to its competitor, Mounjaro, which received product approval in June 2023, approximately one year after Ozempic.

Mounjaro stands out as a synthetic peptide that selectively binds to GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 receptor agonists, exhibiting superior potency in reducing blood glucose levels and inducing weight loss compared to all existing diabetes and obesity treatments. Notably, a direct comparison study with Ozempic demonstrated its effectiveness in blood glucose control.

Despite the opportunity to close the gap caused by the difference in approval timings, Eli Lilly has not yet proceeded with the application for coverage decision. Challenges in Mounjaro's domestic supply are believed to be contributing to this delay.

A representative from Eli Lilly stated, "The domestic release date for Mounjaro has not been determined, so we have not applied for coverage inclusion at this time." They further added, "Currently, there is high demand for Mounjaro, along with the growth of the incretin market. We are doing our best to ensure that Mounjaro can be promptly supplied to patients with type 2 diabetes in the domestic market."