Surge in GLP-1 Anti-Obesity Drug Prescriptions Highlights Need for 'Proper Management' Over Regulation

Semaglutide Reduces Kidney Disease Risk by 24% and Cardiovascular Death by 29%

"Obesity Is a Chronic Disease... Insufficient Management Due to Non-Reimbursement"

Experts: "A Prescription Management System Tailored to Different Types of Misuse Is Needed"

Experts have suggested that, instead of uniformly restricting distribution and treatment channels, a system should be established to manage clinical appropriateness at the prescription stage to prevent the misuse of glucagon-like peptide-1 (GLP-1) anti-obesity drugs. There was also an opinion that a stepwise inclusion of such drugs in the national health insurance plan should be considered for patients with a high need for treatment, such as those with severe obesity.

At the symposium titled 'Exploring the Clinical Value and Optimal Prescription Environment of GLP-1 Obesity Treatments' held on the 10th at Lee Geonhee Hall, Cancer Research Institute, Seoul National University, Professor Jeonghwan Park from the Department of Endocrinology and Metabolism at Hanyang University Hospital presented on the topic 'Clinical Value of GLP-1 Obesity Treatments.' Photo by Korea Biotechnology Journalists Association

The Korea Medical Biotechnology Journalists Association and the Korean Society for the Study of Obesity held a symposium titled 'Finding Real Solutions to Anti-Obesity Drug Misuse: Exploring the Clinical Value and Optimal Prescription Environment for GLP-1 Anti-Obesity Drugs' at Lee Geonhee Hall, Seoul National University Cancer Institute on the 10th.

Jung-Hwan Park, Professor in the Department of Endocrinology and Metabolism at Hanyang University Hospital, delivered a presentation titled 'The Clinical Value of GLP-1 Obesity Drugs - Changing Paradigm in Obesity Treatment,' explaining that GLP-1 therapies are becoming a key approach not just for weight loss but also as a novel axis in the treatment of chronic metabolic diseases.

Professor Park emphasized, “Obesity is not just a matter of personal appearance, but affects diabetes and hypertension, and is ultimately linked to diseases such as myocardial infarction, stroke, and cancer. It is a chronic, progressive, and highly recurrent disease.”

According to Professor Park, the active ingredients semaglutide (the main ingredient in Wegovy) and tirzepatide (the main ingredient in Mounjaro) not only demonstrated significant weight reduction in large-scale clinical trials, but also showed a reduction in cardiovascular risks. Notably, in a study involving 3,533 adults with type 2 diabetes and chronic kidney disease, those treated with 1.0 mg semaglutide had a 24% lower risk for major kidney events and a 29% lower risk of death from cardiovascular causes compared to the placebo group. In another study administering semaglutide for 68 weeks to obese adolescents aged 12 to 17, 73% of the patients saw more than a 5% reduction in body weight, with improvements also observed in BMI, waist circumference, glycated hemoglobin, and blood lipids, all of which are key cardiovascular and metabolic risk factors.

However, despite the number of prescriptions surpassing 2 million in less than two years since its launch in the country, the management system has been criticized as insufficient. Professor Park remarked, “In Korea, GLP-1 anti-obesity drugs are not covered by the national health insurance and are thus in the non-reimbursed category, which exists outside the core regulatory framework and is not properly monitored. For this reason, it is difficult to collect objective data on what problems may occur among our citizens when using GLP-1 anti-obesity drugs.”

On the 10th, at the Lee Geonhee Hall of the Seoul National University Cancer Research Institute, Professor Lee Sang-Yeol from the Department of Endocrinology and Metabolism at Kyung Hee University Hospital delivered a presentation on "The Effectiveness of Current Regulatory Discussions and Desirable Alternatives" under the theme "Clinical Value of GLP-1 Obesity Therapeutics and the Exploration of Desirable Prescription Environments" symposium. Photo by Korea Biotechnology Journalists Association

The number of Drug Utilization Review (DUR) checks for GLP-1 anti-obesity drugs in South Korea increased about 15.7 times, from 21,457 cases in December 2024 to 337,026 cases in May of this year. However, even with current DUR data, it is difficult to verify "to whom" and "on what clinical grounds" the drugs were prescribed.

Sang-Yeol Lee, Professor in the Department of Endocrinology and Metabolism at Kyung Hee University Hospital, pointed out, “DUR allows us to indirectly confirm the number of prescriptions, but it only tells us whether a prescription was made or not. It does not provide detailed information on whether the drug was medically necessary or how, in which case, it was prescribed.”

Professor Lee argued that, rather than regulating the misuse of GLP-1 anti-obesity drugs as a single issue, responses should be tailored to specific types: (1) non-fulfillment of approved indications; (2) prescriptions to high-risk populations in terms of safety; (3) prescriptions based on insufficient clinical information; and (4) non-prescription or illegal distribution. He explained that regulations focusing solely on restricting distribution and treatment channels have limitations in verifying clinical obesity and the fulfillment of drug indications, and therefore, it is more important to prioritize the establishment of a management system that records and evaluates clinical appropriateness at the prescription stage rather than merely tightening regulations.

Professor Lee also proposed establishing a system in Korea to support appropriate prescriptions by recording BMI, comorbidities, and age-based approval requirements in the DUR, and by providing medical staff with pertinent information. He suggested that health insurance coverage should be applied in stages, starting with high-risk patients such as those with severe obesity, type 2 diabetes, or cardiovascular and kidney diseases. In addition, he discussed the use of verified hybrid (in-person and remote) medical consultations to reduce regional disparities in access to care.

Professor Lee stated, “The solution to the misuse of anti-obesity drugs lies not in the strength of regulation but in the design of management. Going forward, regulation should shift from simply blocking to actively managing, so that we can assess whether patients are receiving safe and sustainable treatment.”

"Guarantee Necessary Treatment Instead of Simply Reducing Prescriptions"

In the subsequent discussion, the decline in access to treatment and concerns about equity due to stricter regulations were also raised as major issues. Hyun-Young Shin, Professor of Family Medicine at Seoul St. Mary's Hospital, while cautioning against relying solely on anti-obesity drugs for weight management, drew a line, saying, “Rather than imposing blanket government regulations, there should be positive support measures that enable those truly in need to have access to these drugs.”

On the other hand, the drug approval and regulatory authorities agreed on the effectiveness of GLP-1 therapies but emphasized the need for caution regarding their long-term safety. Jung Ho, Director of the Pharmaceutical Management Division at the Ministry of Food and Drug Safety, said, “There are excellent numbers regarding efficacy and so far, no clear evidence of major side effects. However, since this drug has not been on the market for a long time, it is important for clinicians and medical scientists to monitor these aspects closely so that it may become a medication that can be used safely for prolonged periods.”

Eun-Young Cho, President of the Korea YWCA Association, stated, “Before blaming consumers for the misuse of anti-obesity drugs, we must first create a medical environment that allows for correct choices. The most important task in upholding the public's right to health is to evaluate regulatory outcomes not by how much prescriptions have declined, but by how well necessary treatments are guaranteed to those who need them, and to ensure that no patient is excluded from care due to economic or geographic conditions while balancing safety and equitable access.”

This content was produced with the assistance of AI translation services.