As the official launch of Mounjaro (tirzepatide, Eli Lilly Korea), approved in Korea as an adjunct therapy for chronic weight management following its indication for adult type 2 diabetes, is imminent, the reimbursement status of the drug is garnering attention.

The focus is on whether it will be recognized and reimbursed as the first 'innovative new drug' for a chronic disease.

According to pharmaceutical industry sources on the 25th, Eli Lilly Korea recently submitted a reimbursement application for Mounjaro as a 'treatment for adult type 2 diabetes' to the Health Insurance Review & Assessment Service (HIRA).

Mounjaro was initially approved for its indication in June 2023 as an adjunct therapy to diet and exercise to improve glycemic control in adults with type 2 diabetes.

In August of last year, it was approved as a once-weekly subcutaneous injection as an adjunct therapy to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients. Mounjaro can be used in▲obese patients with an initial Body Mass Index (BMI) of 30 kg/m² or higher, or ▲overweight patients with an initial BMI of 27 kg/m² or higher but less than 30 kg/m², who have at least one weight-related comorbidity (e.g., hypertension, dyslipidemia, type 2 diabetes, obstructive sleep apnea, or cardiovascular disease).

In other words, Mounjaro received indications for both diabetes and obesity treatment.

Eli Lilly Korea has decided to prioritize the launch of the 'pre-filled pen' formulation, which was first approved in 2023, due to delays in obtaining approvals for the vial and quick-pen formulations. This is interpreted as a strategy to launch the pre-filled pen first, while continuing to pursue domestic approvals for the vial and quick-pen formulations.

Concurrently, Eli Lilly Korea plans to accelerate its efforts to secure reimbursement for Mounjaro for adult type 2 diabetes.

For reference, 'Ozempic Prefilled Pen (Ozempic), a semaglutide diabetes treatment from Novo Nordisk Pharma Korea that could compete in clinical settings, is also being re-pursued for reimbursement.

Novo Nordisk Pharma Korea attempted to get Ozempic reimbursed in 2023 but withdrew its application during the drug price negotiation process with the National Health Insurance Service, which is considered the final stage. Although it had received conditional reimbursement approval from HIRA's Drug Reimbursement Evaluation Committee (DREC) in the preceding stage and had even agreed on a price with the NHIS, uncertainties regarding product supply in Korea hampered its progress.

However, having overcome the supply issue, active reimbursement discussions are now possible.

In this situation, Eli Lilly Korea plans to seek reimbursement for Mounjaro by having it recognized as the first 'innovative new drug' for a chronic disease. This means it aims to be the first chronic disease treatment to be listed through the innovative new drug reimbursement process, which has primarily focused on anticancer drugs such as Gilead's triple-negative breast cancer treatment Trodelvy (sacituzumab govitecan).

An Eli Lilly Korea official stated, "We have applied for National Health Insurance reimbursement with HIRA, and are currently awaiting deliberation by the DREC." They added, "We expect Mounjaro, a new type 2 diabetes treatment and the first GIP/GLP-1 receptor dual agonist, to provide differentiated clinical value. Therefore, we are doing our best to ensure it can be recognized as the first chronic disease drug to receive flexible application of the ICER value for innovative new drugs."

However, the pharmaceutical industry is offering a cautious interpretation regarding the possibility of Mounjaro's reimbursement as an innovative new drug.

This implies that there are limitations in applying Mounjaro, a chronic disease treatment, to the innovative new drug eligibility criteria established by the government. For reference, HIRA revised the 'Detailed Evaluation Criteria for Negotiable Drugs (New Drugs)' in August last year, specifying the 'innovativeness' evaluation criteria. This provided a standard for evaluating the appropriate value of new drugs by specifically defining the meaning of 'innovativeness' as one of the ICER value evaluation factors.

Consequently, a new drug's innovativeness is recognized only when it satisfies all three of the following conditions: ▲there is no available alternative or therapeutically equivalent product or treatment; ▲significant clinical improvement in final outcome measures, such as extended survival, is recognized ▲it is a new drug approved through MFDS's expedited review (as per Article 35-4, Paragraph 2 of the Pharmaceutical Affairs Act) or a comparable drug recognized by the Committee.

A pharmaceutical industry official, who remained anonymous, questioned, "It's uncertain whether Mounjaro can meet the definition of innovativeness established by the government." They added, "Of course, this doesn't mean Mounjaro has no innovative value. However, we need to consider whether it fits the currently established criteria and the government's definition of innovativeness. Consequently, it seems that questions will inevitably follow regarding whether it can be applied."