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- 2025-12-17 19:41:21
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- 'Mounjaro' confirmed to have reimb appropriateness
- by Son, Hyung Min Dec 17, 2025 09:51am
- There are ongoing concerns that the treatment landscape for Type 2 Diabetes (T2D) in South Korea is facing limitations.While this issue persists, the GLP-1/GIP receptor dual agonist Mounjaro has passed the initial hurdle for national health insurance reimbursement coverage for diabetes, drawing significant attention to whether it will lead to a paradigm shift in domestic treatment.According to industry sources on December 17, Mounjaro (tirzepatide) passed the initial stage for national health insurance reimbursement earlier this month. Consequently, Mounjaro's developer, Eli Lilly, will now enter price negotiations with the National Health Insurance Service (NHIS). Lilly has been pursuing reimbursement for Mounjaro since early 2024, achieving the positive result after approximately two years.Lilly confirmed that Mounjaro demonstrated improved clinical utility compared to comparator drugs. Following discussions on cost-effectiveness based on economic evaluation with the Health Insurance Review and Assessment Service (HIRA), Mounjaro was considered for the final Drug Reimbursement Evaluation Committee (DREC) meeting of the year and was received reimbursement appropriateness decision. Experts anticipate that the remaining steps will proceed quickly, given Mounjaro’s acknowledged clinical value, economic feasibility, and necessity within the domestic treatment environment.Type 2 diabetes treatment 'Mounjaro'T2D diabetes management becomes harder over time...demands for new treatment option↑Given rising obesity rates and an aging population, there is a growing demand for treatment options that can manage not only blood glucose but also body weight and overall metabolism. T2D is a chronic condition where prolonged disease duration leads to cumulative decline in insulin secretion function and increased insulin resistance, resulting in a significant number of patients failing to reach target blood glucose levels with conventional strategies alone.According to the 2025 Factsheet by the Korean Diabetes Association, 6 out of 10 diabetes patients in South Korea are not achieving the treatment goal of a hemoglobin A1c (H1A1c) level of 6.5%. T2D is a progressive disease with difficulty achieving remission. With prolonged disease duration, pancreatic insulin secretion deteriorates, worsening insulin resistance and leading to difficulties in glucose regulation.The prevalence of obesity is also rising. Over half of diabetes patients (52.4%) are also obese, and 61.1% have abdominal obesity. Conversely, the prevalence of diabetes among the obese population is 17.6%, about twice as high as in the non-obese population. Among the obese population aged 65 and over, one in three (31.6%) has co-morbid diabetes.The problem is that, in patients with high Body Mass Index (BMI), visceral fat contributes to insulin resistance, and inflammatory responses in adipose tissue impair insulin action. This not only makes blood glucose management difficult but also reduces overall metabolic function. Consequently, blood glucose regulation can be challenging with conventional oral treatments or insulin alone. Failure to control blood glucose in T2D patients increases the risk of various complications, including retinopathy, neuropathy, stroke, angina, and myocardial infarction due to arteriosclerosis. One study showed that T2D patients who fail to control their blood glucose have a 2–3 times higher risk of cardiovascular disease in men and 3–5 times higher risk in women compared to the general population.Thus, there is high demand among healthcare providers and patients for GLP-1 class treatments that offer benefits not only in blood glucose control and weight loss but also in overall metabolic health. Mounjaro, which can be administered once weekly, is the first and only therapeutic agent designed to bind to and activate both GLP-1 and GIP receptors selectively.Mounjaro has mechanistic advantages that stimulate insulin secretion, improve insulin sensitivity, lower glucagon levels to lower blood glucose, and delay gastric emptying to reduce food intake, leading to weight loss.Mounjaro demonstrated superior HbA1c reduction across all doses compared to all comparator arms in the five Phase 3 clinical trials (SURPASS 1–5) involving T2D patients. The achievement rate of the T2D treatment goal, which is HbA1c level below 6.5%, in the Mounjaro group was up to 95% (SURPASS-5, 10mg), and the achievement rate of HbA1c < 5.7%, indicating a near-normal blood glucose level, reached up to 62% (SURPASS-5, 15mg). Furthermore, since a weight reduction of over 10% significantly improves blood glucose in T2D patients, up to 69% of patients in the Mounjaro group achieved this goal (SURPASS-3, 15mg).Notably, despite effective blood glucose reduction, the risk of clinically significant or severe hypoglycemia did not increase compared to the control groups. This means that even patients whose treatment options were limited by hypoglycemia risk can now expect to reach their target blood glucose (HbA1c < 6.5%) and achieve higher levels of glycemic control with Mounjaro.Mounjaro recommended in major guidelines..."Effective strategy needed for long-term metabolic health"In October, the Korean Diabetes Association (KDA) issued a statement emphasizing the need to manage comorbid conditions in T2D. A key change in the KDA's newly proposed T2D management algorithm is the initial separate listing of the GIP/GLP-1 receptor dual agonist from existing GLP-1 receptor agonists. The KDA also specified the GIP/GLP-1 receptor dual agonist as a preferred medication for T2D patients with co-morbid obesity.Professor Byung-Wan Lee (Endocrinology and Metabolism, Department of Internal Medicine, Yonsei University, Severance Hospital), who directed Guidelines for the KDA stressed, "T2D patients with co-morbid obesity require a more effective treatment strategy that includes weight loss and improved insulin sensitivity, in addition to overall and long-term metabolic health improvement."Professor Lee stated, "It is significant that, following the last guideline revision where Mounjaro was first listed as a distinct component name separate from existing GLP-1 receptor agonists to emphasize its efficacy in blood glucose and weight control, this algorithm update reconfirms the clinical utility of the GIP/GLP-1 receptor dual agonist in T2D patients with obesity."He added, "For T2D patients with obesity who failed to reach target blood glucose levels even with existing oral treatments or insulin, We hope access to Mounjaro is improved as quickly as possible so that these patients can benefit from Mounjaro's blood glucose and weight loss results."An algorithm for Type 2 diabetes management.Based on Mounjaro's clinical and practical value, domestic and international guidelines categorize it separately from existing GLP-1 receptor agonists. Furthermore, the World Health Organization (WHO) designated Mounjaro as an Essential Medicine in September for T2D patients with comorbid conditions such as obesity.This decision is significant as it officially recognizes Mounjaro as an essential, public-health-critical drug for T2D treatment with co-morbid obesity, underscoring the need to improve access through expanded insurance coverage.Professor Lee stated, "In a situation where the number of T2D patients with obesity is rising, ensuring accessibility to innovative treatments that can improve overall metabolic health beyond simple blood glucose reduction, regardless of economic status, is beneficial, both for individual patients and for long-term national health improvement," and added, "As Mounjaro has been recognized globally as an essential medicine for T2D patients with obesity, prompt policy action is needed so that it can be managed under the system and safely used by patients who critically need it."
- Company
- CKD and Bayer sign copromotion agreement for Eylea
- by Lee, Seok-Jun Dec 17, 2025 09:51am
- Chong Kun Dang Pharma (CEO Young-joo Kim) announced on the 16th that it has signed a domestic copromotion agreement with Bayer Korea (CEO JinA Lee) for the retinal disease treatment Eylea (aflibercept) at its headquarters in Chungjeong-ro, Seoul.Under the agreement, Chong Kun Dang will be responsible for sales, marketing, and distribution of both Eylea 2 mg and Eylea 8 mg, targeting clinic-level medical institutions.Bayer’s Eylea is an anti-vascular endothelial growth factor (anti-VEGF) therapy used to treat a range of retinal diseases, including wet age-related macular degeneration (AMD), diabetic macular edema, macular edema secondary to retinal vein occlusion, and vision impairment due to choroidal neovascularization associated with pathological myopia. Based on its innovative therapeutic efficacy and trust, Eylea has maintained its position as a standard of care for more than 10 years.In particular, Eylea 8 mg, the high-dose formulation that was launched last year, demonstrated comparable vision improvement and safety to Eylea 2 mg while allowing the dosing interval to be extended to up to 20 weeks, significantly improving treatment convenience for patients.Young-joo Kim, CEO of Chong Kun Dang Pharma, said, “Chong Kun Dang has already built extensive sales and marketing capabilities in the ophthalmology field through our diverse product lineup. Leveraging our expertise and sales strength in ophthalmic diseases, we will actively promote the excellence and stability of Eylea and further expand the market.”JinA Lee, CEO of Bayer Korea, stated, “Through our collaboration with Chong Kun Dang, we aim to further enhance patient access to Eylea, which has led the anti-VEGF market for over a decade. Building on our strong partnership, we will continue to provide reliable treatment options more smoothly to patients with retinal diseases and healthcare professionals in Korea, and contribute to improving patients' quality of life.”Chong Kun Dang and Bayer Korea have maintained a successful partnership, co-promoting the antibiotics Ciprobay and Avelox since 2005, and the type 2 diabetes-associated chronic kidney disease treatment Kerendia since 2024. In addition, Chong Kun Dang independently distributes Bayer Korea’s cardiovascular drugs Aspirin Protect and Adalat OROS, as well as the hepatocellular carcinoma treatments Nexavar and Stivarga.
- Policy
- Keytruda completes price negotiations for reimb in KOR
- by Jung, Heung-Jun Dec 17, 2025 09:50am
- MSD Korea’s immunotherapy drug Keytruda (pembrolizumab) has completed price negotiations with the National Health Insurance Service (NHIS), with reimbursement coverage expected to expand to additional indications starting next month.Keytruda previously received approval for reimbursement appropriateness for 11 indications, including gastric cancer and esophageal cancer, at the 9th Drug Reimbursement Evaluation Committee meetingAccording to industry sources on the 16th, MSD Korea has finalized a drug price agreement with the NHIS regarding the reimbursement expansion for Keytruda. Following review by the Health Insurance Policy Deliberation Committee (HIPDC), the Ministry of Health and Welfare is expected to issue a formal notice next month.The 11 additional indications approved by the Drug Reimbursement Evaluation Committee this time include gastric cancer, esophageal cancer, endometrial cancer, colorectal cancer, squamous cell carcinoma, cervical cancer, breast cancer, small intestine cancer, and biliary tract cancer. Approximately 2 years after the initial reimbursement expansion request in 2023, the decision now awaits only the Health Insurance Review and Assessment Service (HIRA) resolution.Previously, Keytruda was granted reimbursement for seven indications across four cancer types: non-small cell lung cancer, Hodgkin lymphoma, melanoma, and urothelial carcinoma.For metastatic or unresectable recurrent head and neck squamous cell carcinoma, reimbursement was granted for first-line treatment as ▲ monotherapy in PD-L1-positive patients, ▲ combination therapy with platinum and fluorouracil-based chemotherapy.Keytruda to show strong momentum in both regulatory approvals and reimbursement expansion in head and neck cancer.In October, the Ministry of Food and Drug Safety approved an expanded indication for Keytruda as perioperative therapy (pre- and post-surgery) in patients with resectable locally advanced head and neck squamous cell carcinoma.Given this expanded approval in head and neck cancer, MSD is expected to pursue further reimbursement expansion for the approved indications. Beyond head and neck cancer, it holds 35 indications across 18 cancer types, leaving significant potential for additional reimbursement expansion.Keytruda’s annual claims exceed KRW 400 billion, and claims are expected to increase starting next year as additional reimbursed indications start being prescribed.
- Policy
- President Lee "Review reimb of hair loss·obesity drugs"
- by Lee, Jeong-Hwan Dec 17, 2025 09:50am
- President Lee Jae Myung has drawn attention by instructing the Minister of Health and Welfare, Jeong Eun Kyeong, to specifically review the possibility of extending National Health Insurance (NHI) coverage to hair loss and obesity treatments.President Lee stated, "I previously made a campaign pledge to support hair loss medication. Isn't hair loss also part of a disease? I hear many young people use it, so have you reviewed the possibility of coverage?" He added, "I would like you to examine the potential costs, and if unlimited support poses a financial burden, consider limiting the number of doses or imposing a total expenditure cap."President Lee asked, "I assume the reason for the lack of coverage is that genetic factors cause baldness. But isn't a genetic disease also caused by genetics? It becomes a matter of defining whether something is a disease or not." He concluded, "This does not seem logical."President Lee further added, "In the past, hair loss was viewed as a cosmetic issue, but these days, it seems to be perceived as a matter of survival." He then asked, "The same seems to be true for obesity treatment. Is coverage for severe obesity medication under review?"Minister Jeong responded that it is necessary to consider medical urgency or priority when covering hair loss medication.Minister Jeong explained, "NHI supports treatment for alopecia areata caused by medical reasons. NHI does not cover hair loss due to genetic factors because its link to medical treatment is considered low." She added, "It is true that many non-covered medical services include treatments for hair loss, acne, and obesity."Minister Jeong said, "Since they are not life-threatening diseases, other treatments deemed cosmetic are also not covered by the NHI," and added, "We will review [NHI coverage] for these conditions."Regarding coverage for obesity medication, Lee Jung-kyu, Director of the NHIS Bureau, replied, "For severe obesity, we currently provide partial coverage for surgical treatments based on the Body Mass Index (BMI) criteria."Minister Jeong further explained, "We are still reviewing these medications. Since an application for reimbursement has just been submitted, we need to proceed with the review for reimbursement appropriateness.
- Company
- Takhzyro enters pricing negotiations with NHIS for reimb
- by Eo, Yun-Ho Dec 16, 2025 08:36am
- The hereditary angioedema drug ‘Takhzyro’ has entered the final stage towards reimbursement listing in Korea.Takeda Pharmaceuticals Korea, in accordance with an order from the Ministry of Health and Welfare, has begun price negotiations with the National Health Insurance Service (NHIS) for Takhzyro (lanadelumab), a treatment for hereditary angioedema (HAE). This marks the first tangible step toward reimbursement nearly 5 years after the drug received approval from the Ministry of Food and Drug Safety (MFDS) in February 2021.Therefore, attention is now focused on whether the company will successfully conclude pricing negotiations for Takhzyro so that the drug could emerge as a new treatment option in the HAE, where therapeutic choices remain limited. The drug passed the Drug Reimbursement Evaluation Committee of the Health Insurance Review and Assessment Service (HIRA) in November.Hereditary angioedema is a rare disease characterized by recurrent, unpredictable episodes of acute swelling throughout the body caused by abnormalities in the C1 esterase inhibitor (C1-INH) protein.Respiratory swelling can lead to breathing difficulties or even asphyxiation, while gastrointestinal edema causes severe pain and emergency conditions such as bowel obstruction.Approximately 40% of patients experience their first attack before age 5, and 75% before age 15. However, the majority undergo a prolonged “diagnostic odyssey” and receive an accurate diagnosis only in adulthood. Despite an estimated 1,000 HAE patients in Korea, only 200–250 cases had been diagnosed as of last year.On average, it takes about 19 years for patients to receive a diagnosis, and even after diagnosis, they remain constantly exposed to unpredictable attacks and emergency situations.Until now, access to disease-modifying therapies in Korea has been limited, prompting repeated calls from the medical community for the reimbursement of Takhzyro.Whether Takhzyro will successfully complete price negotiations with the NHIS and establish itself as a new therapeutic option in the underserved HAE treatment landscape remains to be seen.Meanwhile, Takhzyro demonstrated its efficacy in the Phase III HELP study. According to the results, patients receiving Takhzyro every two weeks experienced an 87% reduction in the mean monthly number of HAE attacks compared with placebo, while those receiving the drug every four weeks showed a 74% reduction.
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