Lilly's Mounjaro faces launch delay in Korea over reimbursement scope

Much attention has been focused on the timing of the Korean launch of Mounjaro (tirzepatide), known as a next-generation obesity drug.
However, the developer, Lilly Korea, has said that there is no clear release schedule yet. Moreover, negotiations with the government over reimbursement are reportedly stalled, making it unclear whether the drug will be released this year.

Lilly Korea has a different strategy for launching Mounjaro in Korea than in the United States. In the U.S., the drug is branded as Mounjaro for the treatment of type 2 diabetes and as Zepbound for the treatment of obesity. However, in Korea, all indications are covered under the single product name, Mounjaro.

Lilly Korea is negotiating reimbursement for the once-daily formulation of Mounjaro's prefilled pen, which was approved last month. However, there are reportedly disagreements between the company and the government over the patient population to be covered. Additionally, the company is still seeking approval for a vial formulation and a four-dose-per-prefilled-pen formulation of Mounjaro to enhance dosing convenience.

Given that Novo Nordisk's competing product, Wegovy (semaglutide), is prescribed in a four-dose-per-prefilled-pen formulation, it is necessary to offer a similar formulation for Mounjaro. Still, even the one-dose-per-prefilled-pen formulation is not yet available in Korea.

"The domestic launch of Mounjaro has not yet been finalized," a Lilly Korea official said. "The talk about an August launch circulating in the market is groundless."

One of the areas of disagreement between Lilly Korea and the government is the scope of coverage. As it is difficult to expand benefits once coverage criteria have been set in Korea, Lilly is reportedly proposing as broad a scope as possible.

Experts are looking forward to the reimbursed launch of Mounjaro.
"In the case of Mounjaro, we can consider prioritizing patients who exceed a certain BMI with comorbidities, such as diabetes and hypertension," said a professor of endocrinology at a university hospital in Korea. "Since Ozempic (which shares the same ingredient as Wegovy) is also in the process of getting reimbursement, covering Mounjaro from the beginning may help prevent issues such as misuse."