[Edaily Reporter Kim Seung-kwon ] The center of gravity in the obesity treatment market is shifting rapidly. As oral glucagon-like peptide-1 (GLP-1) drugs are being commercially launched one after another in the United States and the European Union (EU), their entry into the Korean market is just around the corner.

The issue is not “when they will arrive,” but rather “at what price and for whom they will be prescribed.” While the U.S. has ushered in an era of $50 per month through public insurance pilot programs, obesity treatments in South Korea remain 100% out-of-pocket. PharmEdaily examined the scenarios for the domestic launch of oral obesity drugs and the prospects for their inclusion in health insurance coverage.

U.S. Enters the $50-Per-Month Era… “Inclusion in Public Insurance Has Expanded the Market”

According to industry sources on the 27th, Novo Nordisk’s oral semaglutide “Wegovy,” received approval from the European Commission (EC) on the 15th (local time) as the EU’s first oral GLP-1 obesity treatment. This marks the fifth approval, following those in the U.S., the U.K., the United Arab Emirates (UAE), and Bahrain. In the OASIS 4 clinical trial, which served as the basis for the approval, the average weight loss rate was approximately 17%, with about one-third of the treatment group losing 20% or more of their body weight.

The response in the U.S. market has been explosive. Launched on January 5 of this year, Wegovy Pill surpassed 3 million cumulative prescriptions in just over five months. This indicates that the market itself has expanded, rather than simply reflecting substitution demand. In contrast, Eli Lilly’s “Foundayo” (oroglifron), which received U.S. Food and Drug Administration (FDA) approval and was launched on April 1, is experiencing somewhat slower initial momentum.

The situation in South Korea is likely to be the exact opposite. Lilly Korea has finalized the domestic product name for Foundayo and is preparing for the approval process with the Ministry of Food and Drug Safety (MFDS), with a launch as early as next year being discussed. Novo Nordisk has not yet finalized the launch date for Wegovy in Korea. Wegovy is considered more effective (averaging 14–17%), while Foundayo, with its non-peptide, low-molecular-weight structure that allows for administration without meal or time restrictions, is seen as having greater convenience.

The real driving force behind the spread of oral medications is not the formulation but the payment structure. The Centers for Medicare & Medicaid Services (CMS), under the U.S. Department of Health and Human Services, launched the “Medicare GLP-1 Bridge” pilot program on July 1, providing Medicare Part D enrollees with Wegovy injections and tablets, Zepbound, and Foundayo for $50 per month, regardless of dosage. The government plans to decide whether to formalize the program after accumulating 18 months of cost-effectiveness data.

The government also drove down the prices themselves. Last year, the Trump administration reached a Most-Favored-Nation (MFN) pricing agreement with Novo and Lilly to lower the Medicare supply price for the injectable formulation to $245 per month and preemptively agreed to supply the oral formulation at a starting price of $149 per month upon its launch. In practice, the out-of-pocket price for Wegovy in the U.S. ranges from $149 to $299 depending on the dosage, while Foundayo ranges from $149 to $349.

Reimbursement is also expanding in Europe and Japan. Starting on the 15th of last month, France became the first EU country to cover Wegovy and Mounjaro for patients with severe obesity (BMI of 40 or higher, or BMI of 35 or higher plus two or more comorbidities) at a 65% reimbursement rate. Japan has added semaglutide to its reimbursement list, but has restricted eligibility to patients with a BMI of 35 or higher, or a BMI of 27 or higher plus two or more comorbidities. However, the government has decided to lower the price by approximately 25%.

Kim Min-jeong, an analyst at DS Investment & Securities, noted, “This goes beyond a simple price reduction; it changes prescribing patterns.” Under this model, where the manufacturer supplies the drug at a net price of $245 per month—with patients paying $50 and the government covering $195—more than 3 million of the 30 million Medicare enrollees will be eligible, and the market is expected to expand by $8.8 billion (approximately 12 trillion won) annually.

South Korea Still Has 100% Non-Reimbursed Coverage… The Barrier of

“Appendix 2”
South Korea is different. Obesity treatment is, in principle, non-covered under Item 1, Subitem (a) of Appendix 2 of the “Regulations on Standards for Medical Benefits under the National Health Insurance Act.” Coverage is granted only in exceptional cases, such as treatment for obesity-related complications, bariatric surgery, and gastric balloon insertion. In other words, even if an oral obesity drug receives approval, the current system makes it difficult for it to immediately qualify for coverage under the “obesity indication.”

Realistically, the only viable pathway is the “diabetes indication.” Ozempic, a diabetes medication containing semaglutide, had its coverage appropriateness recognized by the Drug Reimbursement Evaluation Committee last October, and a separate notice establishing reimbursement criteria for GLP-1 receptor agonists took effect on February 1 of this year.

Mounjaro, on the other hand, stumbled at the threshold. Although the Drug Reimbursement Evaluation Committee recognized the appropriateness of reimbursement for the type 2 diabetes indication last December, price negotiations with the National Health Insurance Service (NHIS) ultimately broke down on May 12. The key point of contention was the actual contract price level under the Flexible Drug Pricing System (dual pricing system), which was introduced in July. Analysts suggest that the potential for market price volatility of the same brand—which is currently prescribed off-label for obesity at around 300,000 won per month—served as a stumbling block.

Eli Lilly Korea resubmitted its reimbursement application last month, and the industry expects that, if negotiations proceed smoothly, the drug could be listed in the first half of next year.

Experts believe this case will apply directly to oral medications as well. Since Foundayo is also highly likely to receive approval by combining diabetes and obesity indications into a single brand, it is expected to face the same challenge—a conflict between the “reimbursed price for diabetes” and the “non-reimbursed price for obesity”—upon entering the reimbursement system.

Some observers believe that, given the gradual shift in the government’s stance, rapid inclusion in the reimbursement list is a possibility. On July 16, during its second-half work report, the Ministry of Health and Welfare officially announced that it would review the inclusion of treatments for severe obesity and hair loss in the reimbursement list.

In fact, Minister of Health and Welfare Jeong Eun-kyung stated, “Since there are demands for coverage for conditions such as severe obesity and hair loss, we are preparing a plan to strengthen health insurance coverage based on a comprehensive assessment.” However, the Ministry’s Division of Health Insurance and Pharmaceuticals maintains its position, noting, “To date, no pharmaceutical company has applied for reimbursement listing for obesity treatments,” and stating that it will conduct a comprehensive review of clinical efficacy, cost-effectiveness, fiscal impact, and the potential for misuse should an application be submitted.