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- Company
- Only Ozempic undergoes DREC review for reimb, not Mounjaro
- by Eo, Yun-Ho Oct 13, 2025 06:03am
- The reimbursement journey for the two diabetes drugs that have recently gained attention as obesity treatments is taking different paths, drawing industry interest. On October 2, the Health Insurance Review and Assessment Service (HIRA)’s Drug Reimbursement Evaluation Committee reviewed Novo Nordisk Korea’s Ozempic (semaglutide) but did not review Eli Lilly Korea’s Mounjaro (tirzepatide)&8212;which had been widely expected to be reviewed simultaneously. Ozempic received a positive evaluation for reimbursement adequacy and passed the committee. The product had already accepted the “setting a price below the assessed value” condition when it first submitted the application in 2023, but the company had withdrawn the application due to supply issues during price negotiations with the National Health Insurance Service. Given that, many predicted its second review would pass smoothly under the same terms. The interesting part is the non-review of Mounjaro. Typically, when multiple drugs of similar classes apply for reimbursement listing for the same indication, the government conducts reimbursement evaluations for the drugs simultaneously to gain leverage in negotiations. This raises questions about the background and implications of this outcome. Since receiving domestic approval in 2023, Lilly has been under negotiations with the Health Insurance Review and Assessment Service (HIRA) for Mounjaro for a considerable period since early 2024. Throughout this process, Lilly has demonstrated confidence that it can prove the cost-effectiveness of Mounjaro by conducting a pharmacoeconomic evaluation based on the efficacy confirmed in the type 2 diabetes field, which was not conducted for Ozempic. Normally, new drugs establish cost-effectiveness through PE analysis and then negotiate prices based on the results. However, in markets like diabetes, where existing drugs have a solid presence and market entry speed is critical, pharmaceutical companies sometimes choose to accept the weighted average price of substitute drugs to hasten the process. But Lilly chose a different path. In the pivotal SURPASS clinical trial, which became the basis for approval, Mounjaro demonstrated statistically superior reductions in HbA1c and body weight compared to all control arms, including semaglutide (1 mg, brand name Ozempic), insulin degludec, and insulin glargine&8212;showing potential for diabetes remission and underlining Lilly’s confidence. Furthermore, at the European Association for the Study of Diabetes (EASD) conference held last September, Lilly presented results from the SURPASS-CVOT Phase III clinical trial, which directly compared its GLP-1 receptor agonist Trulicity. This reinforced the data on cardiovascular prevention effects and overall survival improvement. Based on such circumstances, the Health Insurance Review and Assessment Service's (HIRA) decision to submit only Ozempic to the October Drug Reimbursement Evaluation Committee, rather than both drugs simultaneously, may not necessarily be a negative signal for Mounjaro. For Mounjaro, which has already undergone pharmacoeconomic evaluation, being assessed under different criteria than Ozempic could be advantageous. However, Mounjaro's future is not entirely bright. Korea’s reimbursement framework rarely applies a flexible ICER (Incremental Cost-Effectiveness Ratio) threshold for chronic disease indications, making it difficult for even innovative drugs to gain higher valuation. When Minister Eun Kyeong Jeong, who was appointed as the new Minister of Health and Welfare in the Lee Jae-myung administration last July, agreed to her National Assembly confirmation hearing on the need for policy changes to recognize the innovation of new drugs. She specifically mentioned Trodelvy as the first case of flexibly applying the ICER threshold. It remains to be seen whether the government's policy direction for innovative new drugs and the treatment of new drugs for chronic diseases, such as Mounjaro, will change. A Lilly representative stated, “Mounjaro offers differentiated clinical value compared to existing oral agents, insulins, and GLP-1 receptor agonists. We will continue to collaborate closely with health authorities and stakeholders to ensure that Mounjaro’s innovation can promptly benefit more Korean patients with diabetes.”
- Policy
- Demands for expanded reimbursement for NMOSD
- by Jung, Heung-Jun Oct 13, 2025 06:02am
- The demand to improve reimbursement to enhance treatment accessibility for Neuromyelitis Optica Spectrum Disorder (NMOSD) is anticipated to heat up again in this year's parliamentary inspection. During the parliamentary inspection of the Health Insurance Review & Assessment Service (HIRA), on October 17, a NMOSD will attend as a testifier, urging improvements to reimbursement for new drug insurance. NMOSD treatments are gradually receiving reimbursement and expanded criteria. The scope of reimbursement for Roche Korea's Enspryngg (satralizumab), listed for reimbursement in 2023, was expanded in August this year after the symptom relapse criteria had been eased. Uplizna (inebilizumab) recently received conditional reimbursement decision from the Drug Reimbursement Evaluation Committee (DREC) on the 2nd and is awaiting drug price negotiation. AstraZeneca Korea's Soliris (eculizumab) has been covered by reimbursement since April of last year, and Ultomiris (ravulizumab) added the NMOSD indication in July last year but is not yet covered by reimbursement. While access to pharmaceuticals is gradually improving with expanded reimbursement coverage, there are ongoing demands to relax the stringent criteria associated with expensive orphan drugs. In August, a caregiver of an NMOSD patient had requested a lowering of reimbursement hurdles, such as the relapse criteria, through a National Assembly petition. Rep. Seo Mi-hwa of the Democratic Party last month also pointed out the unreasonableness of the new drug reimbursement criteria being conditional on relapse and being preconditioned. Furthermore, there were several arguments that accessibility must be increased for drugs that could prevent relapse. The reimbursement criteria are based on symptom relapse for Enspryngg and Soliris and they also include a conditional clause requiring the administration of MabThera (rituximab) with reimbursement. Since Rep. Seo has requested a NMOSD patient as a testifier for the upcoming parliamentary inspection, more attention is likely to be paid to requests for expanded reimbursement and criteria improvement. Strengthening access to orphan drugs is a key issue that has frequently been raised during the Health and Welfare Committee's parliamentary inspection. Following last year's criticism of the low prio-approval rate for Soliris, the prior-review criteria for its use in Atypical Hemolytic Uremic Syndrome (AHUS) were improved this month.
- Policy
- Ozempic nears reimb approval…next is Mounjaro
- by Jung, Heung-Jun Oct 13, 2025 06:02am
- With Novo Nordisk’s GLP-1 injectable Ozempic (semaglutide) deemed adequate for reimbursement for diabetes, attention is now turning to whether Eli Lilly’s Mounjaro (tirzepatide) will be reviewed next by the Health Insurance Review and Assessment Service (HIRA). At the same time, voices are growing in favor of extending insurance coverage&8212;at least partially&8212;to high-risk obesity treatment, based on body mass index (BMI) criteria. On the 2nd, the Health Insurance Review and Assessment Service's Drug Reimbursement Evaluation Committee recognized the appropriateness of coverage for Ozempic 2mg/1.5mL and 4mg/3mL, used for diabetes patients. Following price negotiations, the final listing procedure will be complete.. Lilly Korea’s Mounjaro, which was being prepared for reimbursement evaluation simultaneously with Ozempic, was not included in the list of drugs submitted to DREC this time. However, Lilly has reportedly been actively pursuing reimbursement for Mounjaro as a diabetes treatment since before its launch, submitting supplementary data. The key question is whether Mounjaro will be submitted to the next DREC meeting while Ozempic undergoes the price negotiation process. Apart from the push for the drugs’ reimbursement as a diabetes treatment, calls for the drugs’ reimbursement as an obesity treatment continue. A reimbursement plan limited to high-risk obesity treatment was mentioned in review materials on GLP-1 reimbursement that Representative Mi-hwa Seo of the Democratic Party of Korea received from the National Assembly Research Service. The review contained an opinion suggesting restricting the target population to patients with severe obesity and those at risk of complications. Furthermore, Representative Seo emphasized the need for public support, citing the higher obesity incidence rate among low-income groups compared to higher-income groups. The Korean Society for the Study of Obesity is also pushing for coverage. At a symposium on health insurance policies for obesity management last September, the society proposed a tiered coverage system based on BMI. Their stance is to prioritize improving treatment access for severe obesity, not cosmetic concerns. However, opinions on introducing coverage remain divided, citing concerns about misuse of obesity drugs and the current state of Korea’s health insurance finances. Furthermore, even if a phased coverage approach based on severity is implemented, challenges remain, including establishing appropriate criteria.
- Company
- Will gastric cancer-targeted therapy Vyloy pass CDDC review?
- by Eo, Yun-Ho Oct 10, 2025 06:06am
- Attention is focused on the second attempt for insurance reimbursement of the gastric cancer-targeted anticancer drug Vyloy. According to industry sources, Astellas Korea’s Vyloy (zolbetuximab), a Claudin 18.2-positive gastric cancer-targeted therapy, is currently coordinating its schedule for review by the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee. The application is expected to be listed on the agenda this month. Vyloy failed to pass CDDC review last February. Astellas resubmitted its reimbursement application in June. Approved in Korea in September last year, Vyloy is the first globally approved Claudin 18.2-targeted treatment, an immunoglobulin monoclonal antibody that binds to Claudin 18.2, a protein expressed and exposed in the stomach. According to the Phase III SPOTLIGHT study that became the basis of Vyloy’s approval, the median progression-free survival (mPFS) of the combination of Vyloy and mFOLFOX6 (oxaliplatin, leucovorin, fluorouracil) was 10.61 months, compared to 8.67 months for the placebo group. The median overall survival (mOS) was also longer&8212;18.23 months versus 15.54 months in the placebo group. In the GLOW study as well, the combination of Vyloy and CAPOX (capecitabine plus oxaliplatin) achieved an mPFS of 8.21 months, reducing the risk of disease progression or death by approximately 31%. However, Vyloy remains non-reimbursed in Korea. It was listed for discussion at the CDDC in February, but failed to establish reimbursement standards. Additionally, a companion diagnostic issue delayed its launch in Korea until March this year. To use Vyloy, patients must be identified as Claudin 18.2-positive, but the companion diagnostic device (CDx) used for this test was under consideration for new medical technology evaluation. To address this, Astellas began an Early Access Program (EAP) even before approval so that patients in need could use the drug in advance. Currently, 51 patients across 10 institutions are enrolled. Professor Sun-Young Rha, Department of Medical Oncology at Yonsei Cancer Center, commented, “About 90% of metastatic gastric cancer patients are HER2-negative, and there has been a pressing need for new biomarker-targeted therapies. About 40% of HER2-negative patients are reported to be Claudin 18.2-positive, so the emergence of Vyloy, which selectively binds to Claudin 18.2, offers a new therapeutic possibility.”
- InterView
- "New landscape in DLBCL trt…Columvi·Polivy's bigger role"
- by Hwang, byoung woo Oct 10, 2025 06:06am
- Diffuse large B-cell lymphoma (DLBCL) has been known to lack new treatment options besides rituximab (MabThera) for over 20 years. Approximately one-third of DLBCL patients who undergo existing treatments (primarily R-CHOP) experience relapse or become non-responsive, and the second-line treatment has been limited to intensive chemotherapy and autologous stem cell transplant. However, the treatment paradigm is changing as innovative treatments, including antibody-drug conjugate (ADC), bi-specific antibodies, and CAR-T cell therapies, have emerged recently. During the meeting with DailyPharm, Professor Gareth Gregory of Monash University in Australia emphasized the role of treatments with new mechanisms, such as Polivy and Columvi, for older adults or patients who failed previous therapies. DLBCL still lacks treatments for older adults or transplant-ineligible patients…second-line treatment alternatives are needed According to Professor Gregory, the highest unmet needs for DLBCL are the second-line treatment. Exiting treatment data show that approximately one-third of all patients with DLBCL experience disease progression despite undergoing first-line treatments. To date, treatment options have been limited to intensive chemotherapy and autologous stem cell transplant. Professor Gregory said, "A significant proportion of DLBCL patients globally are elderly, aged 68 or older, and often have comorbidities, thus most of them are ineligible for autologous stem cell transplant," and added, "Given the high relapse rate characteristic of lymphoma, the response rate for patients receiving CAR-T or autologous stem cell transplant treatment in the second line is only about 21%, highlighting a significant need for more effective and safer therapeutic options." For this reason, interest has grown in treatments with new mechanisms, like bispecific antibodies. The need for monotherapy or combination therapy options, particularly for elderly patients or those who have failed previous treatments, is persistently being raised. Among the therapies currently driving a paradigm shift in DLBCL treatment are Polivy (polatuzumab vedotin) and the combination therapy of the bispecific antibody Columvi (glofitamab) with Gemcitabine and Oxaliplatin (GemOx). Particularly in the first-line setting, Polivy in combination with R-CHP is emerging as the new standard of care, replacing the traditional R-CHOP. For relapsed/refractory patients, the combination of the bispecific antibody Columvi and GemOx is gaining attention as a powerful alternative that shows long-term efficacy. Regarding this, Professor Gregory emphasized that the core of DLBCL treatment is not the 'effectiveness of a single agent,' but the 'design of the entire treatment journey.' For example, this involves a strategy in which Polivy reduces the risk of relapse in the first line, and Columvi increases the complete response rate in the second-line treatment setting, thereby extending treatment continuity. Professor Gregory said, "Polivy reduces the risk of relapse and death in first-line treatment, and Columvi offers the potential for long-term survival for relapsed patients," and added, "Both treatments are evolving to improve the patient's entire treatment journey." Polivy drives changes to the first-line setting...increased expectation of expanded reimbursement Polivy is evaluated as a key therapy for reducing the risk of recurrence associated with the conventional R-CHOPregimen and for improving long-term patient survival. Fortunately, it recently passed the Cancer Disease Review Committee (CDRC) in Korea, raising expectations for expanded reimbursement for first-line treatment. The 5-year follow-up data from the POLARIX study showed that the Polivy + R-CHP combination therapy improved both progression-free survival (PFS) and overall survival (OS) compared with conventional R-CHOP, and the rate of transition to subsequent treatments was significantly lower. Professor Gregory said, "Polivy combination therapy has been included in the first-line recommendations in guidelines in multiple countries, including Australia," and added, "Tolerability was similar to or better than R-CHOP, and we confirmed a long-term trend of reduced risk of relapse and death." Furthermore, Professor Gregory also pointed out that, given the characteristic of DLBCL, where the risk of relapse increases sharply if complete response is not achieved in the first line, the Polivy combination therapy is significant for its role in reducing treatment burden and medical resource consumption. He said, "Polivy combination therapy is significant not only for its treatment results but also for the efficiency of medical resources," and added, "Reducing relapse shortens the complex treatment process that leads to high-intensity therapies, and can also reduce patient hospitalization time, medical costs, and the loss of social productivity." Columvi offers long-term survival potential for relapsed patients...reimbursement remains a hurdle Meanwhile, in the second-line setting, Columvi is showing new possibilities. Columvi, a bispecific antibody, targets T cells and B cells simultaneously, achieving a high response rate even in relapsed/refractory patients with reduced chemotherapy response. In the 2-year follow-up analysis of the STARGLO Phase 3 trial, the Columvi + GemOx combination group had a 4-fold increase in PFS (13.8 months vs. 3.6 months) and a more than 2-fold improvement in complete response rate (58%) compared with the rituximab + GemOx group. Notably, 82% of patients who achieved remission maintained their response for at least 1 year, demonstrating the potential for long-term survival despite the fixed duration of therapy. Columvi's step-up dosing strategy is highlighted as a clinical feature that secures safety by minimizing immune-related side effects. Professor Gregory said, "Bispecific antibodies carry the risk of Cytokine Release Syndrome (CRS) due to immune system activation, but Columvi can be managed safely through step-up dosing and pre-treatment," and emphasized, "Columvi has the biggest advantage in that it is an 'off-the-shelf' therapy, meaning it can be administered immediately after diagnosis." He assessed, "Some patients in the STARGLO trial have maintained a long-term response for over four years, and for patients ineligible for CAR-T or transplant, the Columvi combination therapy offers a possibility of cure." Despite these therapeutic effects, the issue of utilization in Korea remains a reimbursement barrier. Polivy was stuck in a non-reimbursed state for five years after its 2020 approval, and Columvi also failed to pass the CDRC in December last year. Although Polivy initiated its first step toward reimbursement this year with discussions for first-line coverage, Columvi is still waiting for reimbursement listing for its second-line indication. Professor Gregory mentioned, "Effective treatment is meaningless if it is not delivered to the patient," and added, "Drugs with better accessibility and tolerability should realistically be reimbursed, especially compared to high-cost therapies like CAR-T, which are restricted to limited facilities." According to Professor Gregory, Australia has already approved reimbursement for the combination therapy of Columvi + GemOx for autologous stem cell transplant-ineligible patients, using the same criteria as those used in the clinical trial patient population. Finally, he said, "The ultimate goal of lymphoma treatment is to create patient-centered outcomes. If a treatment has sufficient accumulated clinical data, it should be applied to the field quickly," and added, "Institutional support is needed so that patients can receive the best care more safely and rapidly."
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