Lilly to launch Mounjaro in Korea in August without reimbursement

Eli Lilly Korea is moving forward with the launch of its blockbuster Mounjaro (tirzepatide) next month, even as pricing negotiations with the government remain incomplete.

The company said Tuesday it will begin supplying 2.5mg and 5mg doses of the once-weekly prefilled pen for type 2 diabetes and obesity in mid-August. 

While it did not give a specific date, a Lilly Korea spokesperson later told Korea Biomedical Review (KBR) that the company is planning to launch during the week of Aug. 18 and will issue an update once the timing is confirmed.

The announcement follows weeks of uncertainty after Lilly told KBR earlier this month that no timeline had been finalized and dismissed reports of an August rollout as “groundless.”

“We have not yet completed reimbursement discussions,” a Lilly Korea spokesperson told KBR on Wednesday, confirming the product remains in the pre-pricing stage. The company added that it intends to move forward within the currently approved indications.

In a follow-up statement, the spokesperson said the domestic launch schedule had shifted over time due to both internal and external factors, including the regulatory status of the KwikPen and vial formulations.

Asked whether the mid-August launch signaled imminent reimbursement, Lilly did not directly respond.

Instead, the company reiterated that it submitted its reimbursement application to the Health Insurance Review and Assessment Service (HIRA) following regulatory approval in 2023. The application is currently awaiting review by the Drug Reimbursement Evaluation Committee.

“To improve treatment access for patients with type 2 diabetes, Lilly is actively engaging with health authorities and other key stakeholders,” the spokesperson said. 

The company is also aiming to make Mounjaro “the first chronic disease therapy to benefit from flexible application of the ICER framework for innovative drugs,” citing its status as the first GIP/GLP-1 receptor dual agonist and a novel treatment option for type 2 diabetes.

John Bickel, general manager of Eli Lilly Korea, framed the launch as part of a broader strategy. “Mounjaro will be made available to patients in Korea who truly need treatment,” he said in a statement. "We aim to actively engage with healthcare professionals and patients in Korea to ensure broader access to Mounjaro.”

The launch follows months of regulatory limbo. As of July 8, Lilly was still seeking approval for additional delivery formats, including a vial formulation and a four-dose pen. Reimbursement talks for the single-dose pen, approved last month, had reportedly stalled over disagreements regarding the covered patient population.

Mounjaro, also known as tirzepatide, is the first and only therapy to target both GIP and GLP-1 receptors. The once-weekly injectable boosts insulin secretion, improves sensitivity, reduces glucagon, slows gastric emptying, and supports weight loss. 

Global guidelines, including those from the World Health Organization, classify it as a distinct category from traditional GLP-1 receptor agonists.

In Korea, Mounjaro is approved as an adjunct to diet and exercise for adults with type 2 diabetes, and for chronic weight management in adults with obesity or overweight and at least one weight-related comorbidity.

Backed by phase 3 data from the SURPASS and SURMOUNT trials, the drug has demonstrated strong clinical performance. In SURMOUNT-1, patients on 15mg lost 20.9 percent of body weight over 72 weeks, versus 3.1 percent with placebo.

In SURMOUNT-5, which compared Mounjaro to semaglutide in overweight and obese adults without diabetes, the drug delivered statistically superior outcomes in both weight reduction and waist circumference.