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- 2025-12-20 04:48:46
- Policy
- New Divisions for Essential & Public Healthcare proposed
- by Lee, Jeong-Hwan Oct 15, 2025 06:11am
- Ministry of Health and Welfare Minister Eun-kyeong Jeong The Ministry of Health and Welfare has decided to establish a new director-level organization, the ‘Regional, Essential, and Public Healthcare Policy Office,’ to ensure the success of the Lee Jae-myung administration's national policy task of people-focused healthcare reform. It has been confirmed that this request has been submitted to the Ministry of Interior and Safety as a top priority. This effectively kicks off the organizational restructuring process, where the existing ‘Healthcare Policy Office’ under the Second Vice Minister will handle legislative and policy-based tasks, while the new ‘Regional, Essential, and Public Healthcare Policy Office’ will focus on practical healthcare reform initiatives such as the regional doctor system, public medical schools, and telemedicine projects. Alongside the separate establishment of the Regional, Essential, and Public Healthcare Policy Office, the Ministry also conveyed to the Ministry of the Interior and Safety its request for the creation of a director-general level organization (second priority) dedicated to the ‘Integrated Support Act for Regional Care, including Medical and Nursing Care,’ set to take effect next March, and the establishment of a director-level ‘Pharmaceutical and Bio Industry Policy Office’ (third priority). According to National Assembly and Ministry of Health and Welfare officials on the 14th, the Ministry is considering an organizational restructuring plan targeting successful healthcare reform, the smooth implementation of systems related to the Integrated Care Act, and the promotion of the domestic pharmaceutical and bio industry. The Ministry has conveyed its request to the Ministry of the Interior and Safety for the creation of a director-level organization and a bureau-level organization. It plans to accelerate the administrative process for organizational restructuring and expansion based on the Ministry of the Interior and Safety's decision. Currently, under the Second Vice Minister of Health and Welfare, there is one Office — the Healthcare Policy Office — and three Bureaus: the Health Insurance Policy Bureau, the Health Policy Bureau, and the Health Industry Policy Bureau. Additionally, three temporary organizations—the National Pension Reform Support Team, the Biohealth Innovation Promotion Team, and the Medical Reform Promotion Team—are operating separately. The Healthcare Policy Office is responsible for government legislative and administrative tasks concerning health and medical policy and health and healthcare finance overall. Ministry of Health and Welfare Minister Eun-kyeong Jeong has emphasized the need for a dedicated unit focused on regional, essential, and public healthcare operations while maintaining the existing policy-based Healthcare Policy Office structure. The rationale is that for the Lee administration to properly succeed with essential healthcare strengthening policies—which the previous Yoon administration failed to unilaterally implement, including plans to increase medical school enrollment by 2,000—a dedicated director-level organization for regional, essential, and public healthcare operations would be essential. Currently, the Ministry has the ‘Medical Reform Promotion Team,’ a temporary director-level organization established during the Yoon administration. Led by Director Gyeong-sil Jeong, this team is handling the transfer of related duties to the Public-Focused Medical Reform Committee following the launch of the Lee administration. Minister Jeong is expected to abolish this temporary team and establish the new director-level Regional, Essential, and Public Healthcare Policy Office. Furthermore, Minister Jeong reportedly holds the view that the Healthcare Industry Policy Bureau should be elevated to a director-level Pharmaceutical and Bio-Industry Policy Office to properly foster the domestic pharmaceutical-bio industry and biohealth industry. She has also asked MOIS to elevate the temporary unit under the Senior Policy Office for Population and Social Services, which currently handles elderly policy, into a full-fledged “Integrated Care Bureau for Medical, Nursing, and Community Services.” As strengthening regional, essential, and public healthcare, fostering a globally competitive pharmaceutical and biotech industry, and ensuring a smooth landing for a regionally integrated care system are all presidential campaign pledges and national policy tasks, attention is focused on how much the Ministry of the Interior and Safety will accommodate the Ministry of Health and Welfare's requests. Multiple officials from the National Assembly and the Ministry of Health and Welfare agree on the necessity of establishing a separate Regional-Essential-Public Policy Office alongside the Healthcare Policy Office. The prevailing view is that the Ministry of the Interior and Safety must also accept the establishment of a Pharmaceutical and Bio Industry Policy Office and the elevation of the Integrated Care Bureau to successfully advance these national policy tasks. An MOHW official stated, "The Healthcare Policy Office will operate as a policy and legislative foundation organization, while the Regional-Essential-Public Policy Office handles comprehensive administrative tasks by sector. We see no overlap or conflict in their duties. If the Regional-Essential-Public Policy Office takes charge of practical tasks related to regional healthcare, public medical schools, and advancing the healthcare delivery system, the work will be clearly separated. Other ministries, such as the Ministry of Trade, Industry, and Energy, also have director-level organizations structured as Policy Division, Infrastructure Division, and Business Division."
- Company
- GSK’s myelofibrosis drug Omjjara faces reimb hurdles
- by Eo, Yun-Ho Oct 14, 2025 06:41am
- The reimbursment of GSK’s new myelofibrosis drug Omjjara has become uncertain in Korea. According to Dailypharm coverage, the reimbursement application for GSK Korea's myelofibrosis treatment Omjjara (momelotinib), which had passed the Cancer Disease Deliberation Committee of the Health Insurance Review and Assessment Service (HIRA) in March, was not placed on the agenda of the Drug Reimbursement Evaluation Committee. It appears that differences arose between GSK and HIRA over the selection of a comparator drug used for pricing, effectively halting Omjjara’s first reimbursement attempt. As a result, it remains to be seen whether GSK will resubmit a reimbursement application and proceed with the listing process. Omjjara has a triple mechanism of action that inhibits JAK1 and JAK2 as well as ACVR1 (activin A receptor type 1). In myelofibrosis treatment, JAK1 and JAK2 inhibition helps relieve systemic symptoms and reduce splenomegaly, while ACVR1 inhibition decreases hepcidin expression and thereby alleviates anemia. Anemia management remains one of the major unmet needs in treating myelofibrosis. Transfusion-dependent anemia brings more than just the commonly perceived issue of dizziness - depending on its severity, it can be life-threatening. Phase III trials SIMPLIFY-1 and MOMENTUM demonstrated that Omjjara significantly improved key symptoms such as splenomegaly and reduced transfusion dependence in anemic myelofibrosis patients regardless of prior JAK-inhibitor exposure. In SIMPLIFY-1, which compared Omjjara to ruxolitinib (Jakavi) in JAK-inhibitor-naïve myelofibrosis patients, Omjjara demonstrated non-inferiority to ruxolitinib in the primary endpoint of spleen volume response at week 24. The proportion of transfusion-independent patients was 66.5 % in the Omjjara group versus 49.3 % in the ruxolitinib group, showing a statistically significant reduction in transfusion dependence in the Omjjara arm. Professor Seo-yeon Ahn of Chonnam National University Hwasun Hospital’s Department of Hematology stated, “Existing JAK inhibitors relieve splenomegaly and systemic symptoms but often worsen anemia or increase transfusion needs, leaving an unmet clinical need. Omjjara demonstrated significant clinical value in improving anemia, which is closely tied to prognosis in myelofibrosis patients.”
- Company
- Hugel appoints Carrie Strom as global CEO
- by Chon, Seung-Hyun Oct 14, 2025 06:41am
- Hugel announced on October 13 that it has appointed Carrie Strom, a medical aesthetics leader and a former Senior Vice President at AbbVie, as its new Global CEO. Carrie Strom, HugelCarrie Strom will lead Hugel's global business operations. She is highly regarded as an expert in the aesthetics field, having served for five years, from May 2020 to February this year, as the Senior Vice President at the global pharmaceutical company AbbVie and the President of Allergan Aesthetics Global. Strom initially joined Allergan (now AbbVie) in 2011 and has since led the aesthetics portfolio, which includes the botulinum toxin product 'Botox' and the HA filler 'Juvéderm,' across more than 50 countries. Previously, she served as Senior Vice President of Allergan's U.S. Medical Aesthetics division and spent 11 years as a sales and marketing expert at Pfizer. Following the recent appointment of Jang Doo-hyun as the Chief Executive Officer for the Korean operations, Hugel plans to accelerate its growth, particularly in the Americas, with the addition of the new Global CEO. Carrie Strom stated, "I am excited to work with Hugel's talented and dedicated employees and Board of Directors," and added, "My top priority will be to build upon Hugel's leadership in Korea to become a global leader in the aesthetics market, raising the standards of service we provide to customers and patients worldwide." Suk-yong Cha, Chairman of Hugel's Board of Directors, stated, "CEO Carrie Strom is an expert who has gained extensive experience and driven change in the global medical aesthetics industry. We expect her to maximize Hugel's future value during this critical transition to a global enterprise, particularly in the Americas."
- Product
- KMA forms special committee to block INN prescribing
- by Kang, Shin-Kook Oct 14, 2025 06:41am
- KMA President Taek-woo Kim The Korean Medical Association (KMA) has formed a special countermeasure committee to block the institutionalization of international non-proprietary name (INN) prescribing. This is seen as a response to demands by some delegates for an extraordinary general meeting. KMA (President Taek-woo Kim) said on the 13th, “Policies such as INN prescribing and changes to laboratory test consignment rules are being unilaterally promoted despite threatening patient safety.” He announced plans to launch a Pan-Medical Countermeasure Committee for National Health Protection (tentative name, “Countermeasure Committee” and to hold a nationwide delegates meeting at 5 p.m. on the 25th in the KMA hall’s main auditorium to unite the opinion of medical organizations. KMA argued, “INN prescribing is a system where only the generic name of the drug is written instead of the brand name prescribed by the physician, allowing pharmacists to arbitrarily substitute and dispense medications. This infringes upon the physician's medical judgment, which is the core of personalized prescriptions issued for patient treatment, and poses serious systemic risks threatening public health by causing drug side effects and treatment confusion.” It further contended, “The primary causes of the instability in drug supply mentioned in the proposed bill lie in various structural problems, such as the government's unilateral drug pricing structure, insufficient production lines at pharmaceutical companies, and shortages in raw material supply. This refers not just to the unstable supply of a single specific brand-name drug, but to the scenario where the supply of all drugs with the same ingredient (due to raw material shortages, etc.) is interrupted. Addressing this with INN prescribing is a completely illogical idea.” The KMA emphasized, “Choosing the dangerous and misguided method of INN prescribing while ignoring the fundamental problems causing drug supply instability is a declaration of abandoning public safety and lives.” Furthermore, the KMA strongly opposed the proposed changes to unilateral revision of laboratory-testing consignment rules, calling it an attempt to eliminate essential and primary medical care. The KMA stated, “The specimen testing outsourcing system being unilaterally pushed by the government is a one-sided measure that ignores the realities of the medical field. It is a detrimental change that effectively paralyzes the diagnostic testing functions of medical institutions, safeguarding essential and primary care. In July 2023, the Ministry of Health and Welfare responded that it planned to consult sufficiently with the medical community regarding issues such as the lack of distinction between fees for outsourcing and consignment institutions when setting fees related to the notice on standards for laboratory-testing consignment rules. Yet, breaking this promise is pushing the policy forward unilaterally.” The KMA emphasized that it will gather the entire medical community's resolve through the formation of the committee and hold a national meeting of physician representatives, vowing never to back down and fight to the end.
- Company
- Entresto patent dispute near its end, yet 0 generic approval
- by Kim, Jin-Gu Oct 14, 2025 06:40am
- Product photo of EntrestoThe patent dispute of Novartis' heart failure treatment, 'Entresto,' is nearing its final judgment. Still, generic companies may be unable to launch their products early, regardless of the ruling. To launch a generic early, companies need not only to win the patent dispute but also to secure product approval from the Ministry of Food and Drug Safety (MFDS). The MFDS is reportedly demanding supplementary data from the relevant generic companies. In other words, generic manufacturers, after fighting patent battles for five years, risk winning the legal fight only to be unable to launch their product. Not a simple combination drug but a 'cocrystal complex'...may be delaying generic approval According to the MFDS on October 13, there are currently zero product approvals for Entresto generics. This is considered unusual given that generic product approvals are typically processed within a year and a half of application. Approximately 10 generic companies involved in the Entresto patent dispute applied for generic product approval sequentially from April 2022 to July of the following year. They filed these applications based on their first-instance victory in the patent dispute. However, there has been no news of Entresto's generic product approval for almost 3 years. It is reported that the MFDS is requesting supplementary approval documentation. The pharmaceutical industry is paying attention to the MFDS's request for supplementation regarding Entresto's unique crystal structure. Entresto is a heart failure treatment in which the active ingredients, sacubitril and valsartan, act on cardiac neurohormones through separate pathways. The unique feature is that the two ingredients form a single crystalline structure, a cocrystal complex. Medicines combining two or more ingredients typically involve a simple mixture of the crystalline forms of each component. In contrast, a cocrystal involves two or more components bound together at the molecular level like a single compound. They exhibit single-compound properties until just before absorption into the body. For this reason, the industry refers to Entresto not merely as a 'combination drug' but as a 'complex' with a singular characteristic. The problem is the scarcity of approved generics for this cocrystal formulation. Entresto is reportedly the only drug approved as an API-API cocrystal complex, not only in Korea but also in the U.S. and Europe. Furthermore, there is no precedent anywhere in the world for the approval of a generic for a cocrystal complex drug. The MFDS is contemplating this issue. The Ministry is struggling to find an appropriate analytical method for generic approval. Critics suggest that because the cocrystal structure differs from traditional combination products in its physicochemical properties, applying the same analytical methods may not be suitable for generic approval. A pharmaceutical industry official said, "If it were a typical combination product's crystal form, there would have been no issue with approval, but I understand the MFDS is deeply concerned about whether it is appropriate to use existing methods to analyze this special cocrystal structure and grant generic approval." Winning in the Supreme Court, yet generic companies may face a failed launch Given the circumstances, companies preparing Entresto generics are now in a position where they may be unable to launch their products even if they win the final patent dispute. Generic companies initiated a declaratory judgment action against Novartis's Entresto crystal form patent in January 2021. This was followed by the filing of invalidation and circumvention trials against the use patent, salt/hydrate patent, and formulation patent. Generic companies won successive victories in the first and second instances. Disagreeing with these rulings, Novartis appealed the cases to the Supreme Court. Of the two cases appealed to the Supreme Court, the ruling in the use patent case was finalized in April of last year, with Novartis losing. The remaining pending case is the dispute over the crystal form patent. The full merits review is currently underway, following the dismissal without deliberation deadline in April of this year. Separately, the salt/hydrate patent dispute is awaiting a ruling from the Patent Court. The pharmaceutical industry reportedly anticipates that the final ruling regarding the crystal form patent could be issued as early as this year. If the Supreme Court sides with the generic companies, as in the first and second instances, the generic companies' patent risk would be effectively eliminated. However, regardless of the Supreme Court's decision, if MFDS approval continues to be delayed, generic companies will face a dual burden: winning a five-year-long dispute only to be unable to launch the product.
- Opinion
- [Desk’s View] Lift botulinum toxin’s core tech designation
- by Lee, Seok-Jun Oct 14, 2025 06:40am
- Calls to lift the “national core technology” designation from botulinum toxin are rising once again — and this time, the long-standing issue must be resolved. The industry has been calling for this for a long time. The demand was made in 2023, and again the following year. Yet, it remains stuck in neutral. The decision must now be made with resolve. Over 75% of the field wants the designation lifted. According to a January survey by the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA), 12 out of 16 companies surveyed expressed support for lifting the designation. The government should listen — it’s time to face industrial reality. The reasoning is clear. Botulinum toxin technology is already a key part of the global market, yet in Korea, it remains shackled by its “core technology” label. Regulations meant to protect it are now hindering growth. It's not protection; it's a hindrance. Botulinum toxin extends far beyond cosmetic use — it’s a therapeutic tool for conditions like dystonia, migraines, and cerebral palsy. But researchers struggle even to conduct clinical trials, and in the meantime, patients lose access to potential treatments. The rhetoric of “safety” has come to block the right to health. The rest of the world has been taking a different approach — adjusting regulations to strengthen competitiveness. Only Korea stands still. This must change. Of course, deregulation does not mean neglect. Safety measures must become tighter. Strengthen the basics: quality control, crackdowns on illegal distribution, and side effect monitoring. The key is balance. Restriction does not guarantee safety, and deregulation does not create danger. Smart regulation is the answer. The government must judge with an industrial strategy perspective. Companies must maintain trust through quality. The medical community and civil society must also join in the oversight. The botulinum toxin debate is not a technological issue. It is about how our society treats technology. We must move forward with trust, not fear. This is the time for wise regulatory innovation. The answer is to ‘remove’ toxin from the National Core Technology list.
- Policy
- Gov't to unveil New drugs·Generic Drug Pricing System Rev.
- by Lee, Jeong-Hwan Oct 14, 2025 06:40am
- Director General Lee Jung-kyu The Ministry of Health and Welfare (MOHW) has announced plans to release the drug pricing system revision next month (November), including both new drugs and generics. It is drawing the attention of Korean and international pharmaceutical companies. The MOHW plans to disclose the timing of the re-evaluation of reimbursement appropriateness for listed drugs, along with the new drug pricing improvement plan. The reform is expected to include significant measures that will impact the Korean pharmaceutical industry, including enhancing patient access to new drugs, strengthening the stability of essential medicine supply, standardizing the post-market drug price reduction system, and improving the conventional generic drug pricing structure. On October 12, Lee Jung-kyu, Director General of Health Policy of the MOHW, shared some of the direction for the new drug pricing improvement plan, including reimbursement re-evaluation, during a meeting with the Korea Special Press Association. Lee stated that the re-evaluation of reimbursement appropriateness is currently under review as part of the overall drug pricing system revision plan. Lee explained that the delay is due to efforts to align the re-evaluation's direction with the new improvement plan, following earlier subcommittee discussions. The 'actual transaction price-based drug price reduction system' will proceed as scheduled, as its implementation timeline was recently announced. However, the MOHW plans to discuss it with revisions under review, including post-market drug price management. Furthermore, the MOHW's drug pricing revision plan for next month is expected to include items discussed at the World Bio Innovation Forum, which President Lee Jae Myung attended on the 5th of last month. At the forum, a plan to expand the application of a dual pricing system was stated. The dual pricing system is one in which the actual price of a medicine differs from its officially listed price. The goal is to provide Korean pharmaceuticals with a competitive advantage when exported overseas, thereby facilitating drug price negotiations. The MOHW has already implemented a form of dual pricing through a drug pricing system revision in March. This revision allows the National Health Insurance Service (NHIS) to enter into a separate contract with a manufacturer, contract manufacturer/seller, or importer if the drug is deemed necessary after assessing its impact on public health and if the company wishes to pursue strengthening global competitiveness. The MOHW is now considering expanding the application of this provision to other medicines. The system for concurrently processing approval, evaluation, and negotiation (Concurrent Approval-Evaluation-Negotiation) is currently in a pilot phase and is expected to transition to a formal system. The integration of post-market drug price management, such as price reductions, is being discussed to align the currently separate price adjustment systems (the drug price cap adjustment system) so they are implemented on a single date and time. This would unify the timing and application of systems like the NHIS's price-volume agreement (PVA)-linked reduction and HIRA's reimbursement re-evaluation and actual transaction price reductions. While the MOHW emphasizes that post-market management and re-evaluation have distinct goals and objectives for each system, it has commissioned policy research in response to demands from pharmaceutical companies and local pharmacies to enhance the predictability of drug price reductions. The MOHW also conducted policy research on the integration of drug price cap adjustment mechanisms in March of this year, to finalize specific plans and financial impact analyses based on the results of the preceding research. Regarding preferential drug price regulations, new provisions are expected to be established, such as preferential pricing for drugs that contribute to the supply of essential medicines, executing the government's national goal of stable supply for drugs with unstable supply. Lee said, "Last year's research service analyzed the current situation," and added, "Based on that data, it has been analyzed that further research is needed on how to improve the system, and that additional research will be commissioned soon."
- Policy
- No companies apply for domestic API pricing premium
- by Lee, Jeong-Hwan Oct 13, 2025 06:07am
- Although the Ministry of Health and Welfare has implemented a policy since March this year offering a 68% pricing premium on essential medicines made with domestic APIs, it has been confirmed that as of October—7 months after implementation—not a single pharmaceutical company has benefited. Criticism is mounting that the Ministry's overly stringent criteria for applying the pricing premium to domestically produced raw materials severely undermine the policy's effectiveness and hinder the development of the domestic API industry, which is directly linked to public health and national security. According to the ‘Status of Domestic API Drug Price Preferential Treatment’ submitted to People Power Party lawmaker Jong-heon Baek by the Ministry of Health and Welfare on the 10th, despite several months since the policy's implementation, not a single pharmaceutical company has applied for the preferential treatment. The MOHW stated that since the relevant regulations were revised last December and the policy took effect this March, the number of applications for the ‘68% pricing premium for domestically produced active pharmaceutical ingredients used in national essential drugs’ and the number of drugs receiving the benefit are both zero. Although the system aims to promote the use of domestically produced APIs, reduce dependence on foreign APIs, and foster the development of the pharmaceutical industry, it has effectively failed 7 months after its implementation. The domestic pharmaceutical industry is voicing concerns that unless the Ministry revises the relevant price discount regulations, the policy will become a dead letter, effectively meaningless. Reasons behind the domestic API price preferential policy fail National Essential Medicines are defined under the Pharmaceutical Affairs Act as ‘medicines essential for public health, such as disease management and radiation disaster prevention, but for which stable supply is difficult through market mechanisms alone, which are designated by the Minister of Health and Welfare and the Minister of Food and Drug Safety in consultation with the heads of relevant central administrative agencies.’ As of August this year, 473 drugs are designated as National Essential Drugs in Korea. Despite how a policy is in place that adds 68% to the drug price when domestic APIs are used to manufacture these National Essential Drugs, with the benefit lasting up to 10 years, domestic pharmaceutical companies claim the reason there are no applicants or items is because the Ministry of Health and Welfare's standards are excessively stringent. The domestic pharmaceutical industry has long demanded that the 68% drug price advantage be applied even to pharmaceutical companies already producing essential medicines using domestic APIs. They are also calling for regulations to be established that would allow the benefits to be applied retroactively to drugs manufactured before the pricing premium policy was implemented this March. Notably, compound drugs that use both domestic and imported APIs from multiple sources, not just one, are excluded from the 68% price discount. The MOHW currently requires that all major active ingredients contributing to pharmacological efficacy must be individually recognized as domestic APIs to qualify for the price advantage. Pharmaceutical companies criticized that such conditions are unrealistic, warning that very few medicines could ever meet the 68% incentive criteria under the current framework. Politicians agree on the need to improve drug pricing system regulations Some political circles also agree with the domestic pharmaceutical industry's arguments and are urging the Ministry of Health and Welfare to improve the system. Rep. Jong-heon Baek plans to summon Ssang-Soo Han, CEO of Inist ST, as a witness during the upcoming National Assembly audit of the Ministry of Health and Welfare on the 15th. He intends to question him about the inadequacies of the domestic API drug price premium policy and measures to foster the domestic API drug industry. Baek emphasized that in the wake of the COVID-19 pandemic, global protectionism in pharmaceutical supply chains has intensified, and the Korean government must treat the domestic API sector as a matter of public health and national security, not merely industrial policy. Accordingly, Rep. Baek urged the Ministry to prepare countermeasures against the risk of the domestic API preferential pricing policy becoming obsolete. The Ministry has only stated a general position, indicating it will seek solutions by thoroughly gathering opinions from the industry, experts, and the field regarding the demands of the pharmaceutical sector and Rep. Baek. This includes exploring new measures such as retroactive application rules or preferential regulations for compound drugs. Rep Baek pointed out, “The fact that not a single pharmaceutical company has applied for the preferential pricing as essential medicines with domestically produced APIs for 7 months is proof that this is a nominal system. Despite ongoing complaints from the pharmaceutical industry that the application criteria are excessively stringent, if the Ministry of Health and Welfare does not move to make the regulations more realistic, the policy to foster the domestic API drug industry will fail.” He added, “During the NA audit, I plan to question the Minister of Health and Welfare's perception of the API industry and demand that the system be revised, viewing it as an issue concerning public health and national security.”
- 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)—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—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.
