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- 2025-12-18 12:22:05
- Opinion
- [Reporter’s View] ‘Blind’ drug price cuts continue
- by Kim JiEun Dec 18, 2025 08:01am
- A reduction in the reimbursement ceiling prices of more than 4,000 pharmaceutical products under the national health insurance scheme is imminent. The Ministry of Health and Welfare (MOHW) recently sent an official notice to local governments, relevant agencies, and organizations regarding the temporary acceptance of paperwork-based returns in connection with the drug price cuts scheduled to take effect on the 1st of next month.However, rather than easing concerns, the notice has instead fueled confusion across the pharmaceutical manufacturing and distribution sectors, as well as among pharmacies. While the notice states that “the insurance price ceiling for approximately 4,000 items is scheduled to be lowered,” indicating a significant impact, there is no way for stakeholders to prepare in any concrete way.With less than two weeks remaining until the Ministry's announced implementation date of the 1st of next month, the field has no information on which products are affected, the exact number of items involved, or the reduction rates.This problem has been repeatedly observed in the field for years. The MOHW has frequently announced drug price cuts affecting anywhere from several hundred to several thousand products on specific dates, and such notifications have typically been issued only shortly before the effective date.As a result, until the official notice is released, those in the field are left without access to detailed lists of affected products or specific reduction rates. This recurring situation has even given rise to the term “blind drug price cuts.”Such “blind” drug price cuts have had significant repercussions in the field. For pharmaceutical companies, it often becomes difficult to adjust production lead times and inventory policies.Distributors, meanwhile, face a surge in system adjustments and administrative paperwork when large-scale price revisions are finalized, only when the implementation date is imminent. This includes adjusting wholesale prices, return prices, and inventory valuation. With return deadlines and criteria varying by pharmaceutical company, differing processing methods per company inevitably lead to significant confusion.Pharmacies are no exception. The short interval between the announcement and implementation dates makes it difficult to assess inventory levels and prepare insurance claims. This process often leads to billing errors or failure to process returns in time, resulting in repeated instances where they must bear the economic loss.To minimize disruption, the government has occasionally taken ad hoc measures, such as releasing affected product lists in advance or temporarily allowing paperwork-based returns. However, critics point out that these measures amount to little more than short-term, short-sighted solutions.The government must consider institutional alternatives to minimize the recurring chaos during large-scale price reductions and enhance policy effectiveness.One possible approach would be to disclose, prior to formal notification, the list of products subject to price reductions and the corresponding reduction rates in cases where large-scale adjustments are expected, thereby enabling pharmaceutical companies, distributors, and pharmacies alike to prepare in a systematic manner.In addition, it appears necessary to review measures to widen the gap between the notification date and the implementation date. Realistic institutional improvements are needed to ensure that stakeholders have a minimum amount of time to adjust inventory, billing, and settlement systems.There is no doubt that drug price cuts are an important policy tool that must strike a balance between health insurance finances and industrial policy. However, implementing such measures in a “blind” manner risks going beyond on-site confusion to cause inconvenience for the public. The government must recognize that allowing repeated disorder and confusion to persist can undermine policy credibility and deepen distrust among stakeholders.
- Opinion
- ‘Discuss long-term prognosis for polycythemia vera now’
- by Son, Hyung Min Dec 18, 2025 07:55am
- “Treatment of polycythemia vera does not end at simply lowering blood cell counts. We have now reached a point where we must consider controlling the root cause of the disease itself and, in the long term, even the possibility of discontinuing treatment.”Professor Junshik Hong of the Division of Hematology and Oncology at Seoul National University Hospital explained that the reimbursement listing this year of the interferon agent Besremi (ropeginterferon alfa-2b) marks the beginning of a meaningful shift in the domestic treatment environment for polycythemia vera.Professor Junshik Hong, Division of Hematology and Oncology at Seoul National University HospitalProfessor Hong stated, “Until now, treatment in Korea has focused primarily on thrombosis prevention and symptom control. Now, however, we can begin to discuss approaches that address JAK2 mutations—the fundamental driver of the disease—and manage its long-term progression.Polycythemia vera is a type of myeloproliferative neoplasm (MPN), a rare hematologic malignancy characterized by excessive bone marrow activity that leads to abnormal increases in red blood cells, as well as white blood cells and platelets. More than 95% of patients harbor a JAK2 gene mutation, which is presumed to be the primary cause of the disease.According to the Health Insurance Review and Assessment Service, the number of polycythemia vera patients in Korea recorded as of 2024 was 5,068, with the number of newly diagnosed patients continuing to rise each year. Polycythemia vera increases blood viscosity, raising the risk of cardiovascular complications such as thrombosis and embolism. In the long-term, it carries the risk of progressing to fatal blood cancers like myelofibrosis or acute myeloid leukemia.The average survival period is approximately 14 years; however, survival declines sharply to 5–7 years if the disease transforms into myelofibrosis, and to only several months if it progresses to acute myeloid leukemia.Until now, treatment of polycythemia vera in Korea has focused on thrombosis prevention and control of blood cell counts. Hydroxyurea, which is inexpensive and has proven efficacy in preventing thrombosis, has been widely used as first-line standard therapy, but has limitations in fundamentally controlling the disease. In particular, patients who develop resistance or intolerance to hydroxyurea face a renewed increase in thrombotic risk, yet lack adequate second-line treatment options, which result in persistent unmet medical needs.Against this backdrop, the reimbursement listing in September of this year of Besremi for patients with hydroxyurea-resistant or -intolerant polycythemia vera is expected to herald a shift in Korea’s treatment paradigm.Besremi is a third-generation mono-pegylated interferon that selectively reduces the burden of the JAK2 mutation gene, the root cause of the disease. In a clinical trial involving Korean patients, Besremi achieved a complete hematologic response rate of 52.8% and a molecular response rate of 39.4% at 12 months of treatment. Response rates showed a tendency to increase with longer treatment duration.In some patients, responses have been maintained even after treatment discontinuation, raising the possibility of a “potential operational cure.”Daily Pharm met with Professor Jun-Shik Hong of the Division of Hematology and Oncology at Seoul National University Hospital, who has extensive clinical experience in treating polycythemia vera (PV), to discuss changes in the domestic treatment landscape following the reimbursement of Besremi and its future role.Q. What kind of disease is polycythemia vera? Please explain its pathogenesis as well.Myeloproliferative neoplasms (MPNs) are diseases where acquired genetic mutations occur during the process of hematopoietic stem cells in the bone marrow, producing various blood cells, leading to excessive proliferation of blood cells. Polycythemia vera is a type of MPN specifically characterized by an excessive increase in red blood cells among the various blood cells.Specific genetic mutations that cause excessive production of blood cells are found in MPNs. The most representative mutation in polycythemia vera is the JAK2 gene mutation, with JAK2V617F being the most common variant. Approximately 95% of polycythemia vera patients carry the JAK2V617F mutation, meaning nearly all patients with this condition possess a JAK2 mutation.In polycythemia vera, not only red blood cells but also white blood cells and platelets are often elevated. This increases blood viscosity and raises the risk of thrombotic complications. Arterial occlusion can lead to cerebral infarction or myocardial infarction, while venous occlusion can result in venous thromboembolism. Many patients experience significant morbidity from these complications, which can, in some cases, lead to reduced quality of life or death.Another important point is that polycythemia vera arises from acquired genetic mutations, and prolonged inflammatory conditions within the bone marrow can drive progression to more severe diseases. Polycythemia vera may progress to myelofibrosis, or in the most severe cases, to acute myeloid leukemia (AML).While thrombosis is far more common, progression to acute myeloid leukemia poses the greatest risk in terms of severity. If it progresses to acute myeloid leukemia, survival is often limited to just a few months, making treatment to prevent progression crucial.Q. How has the treatment landscape changed since the introduction of Besremi?Besremi holds significant meaning as the first treatment for polycythemia vera to clearly demonstrate efficacy and mechanism of action through modern clinical trials while also achieving reimbursement coverage. Previously, treatment options were limited, often relying on prescribing the older drug hydroxyurea and managing side effects through dose adjustments—essentially symptomatic management. The most significant change is that we can now pursue a more advanced and systematic approach that considers the fundamental aspects of the disease while enabling long-term, stable management.The most immediately noticeable change is that patients are being relieved of adverse effects associated with hydroxyurea. Patients who switched from hydroxyurea to Besremi are experiencing marked improvements in quality of life, with reduced burdens such as oral ulcers and gastrointestinal symptoms. Given the realities of the domestic treatment environment, I believe this aspect represents the most immediate and crucial change.In terms of clinical efficacy, complete hematologic responses are also being observed. Of course, since sufficient time has not yet passed since reimbursement coverage began, it is still a bit early to definitively state that the effects confirmed in multi-year clinical trials are being replicated identically in real-world practice. Nevertheless, the reason Besremi is receiving high expectations is that it offers significant advantages for managing the disease from a long-term, fundamental perspective.While hydroxyurea lowers blood cell counts by cytotoxic destruction of already-formed blood cells, Besremi, as an interferon-based agent, acts at the level of hematopoietic stem cells or earlier hematopoietic cells, thereby regulating the fundamental drivers of the disease. This mechanism is expected to reduce thrombosis in the long term through blood cell count control and, further, decrease the risk of progression to myelofibrosis or acute myeloid leukemia.Q. I'm curious about the precise definition of operational cure. Does this mean we can expect a cure for the disease through Besremi?Operational cure refers to a state in diseases that typically require continuous drug therapy, where the drug's efficacy is so exceptional that the causative genes or mechanisms are sufficiently suppressed or eliminated, allowing disease stability to be maintained even after treatment discontinuation. Such cases have already been demonstrated in certain hematologic diseases, notably chronic myeloid leukemia (CML).When the gene load decreases to undetectable levels, patients can maintain a stable condition without relapse for years, even after discontinuing tyrosine kinase inhibitors. Accumulation of such data has established operational cure as a clinically achievable concept. In these cases, patients can take drug holidays, which significantly reduces both economic and treatment burdens.With the emergence of Besremi in polycythemia vera, expectations for the possibility of an operational cure are also rising. This is because Besremi is the first drug to meaningfully reduce the allele burden in this disease. Furthermore, based on experience with chronic myeloid leukemia, even if the causative gene reappears after discontinuing medication, treatment efficacy returns upon re-administration. Similarly, with Besremi, it has been confirmed that even if JAK2 mutant allele burden or blood counts increase after discontinuation, re-administration can re-establish stable disease control.Q. Could you explain the reimbursement criteria for Besremi? Is it reimbursed for all as second-line treatments?Besremi is reimbursed for patients with polycythemia vera who are resistant or intolerant to hydroxyurea. The greatest significance of this reimbursement is that it provides a new treatment option for patients who previously had no alternatives beyond hydroxyurea. Conversely, patients who respond adequately to hydroxyurea, or low-risk patients who can be managed with aspirin alone, are not eligible for reimbursement.Once a patient who meets the criteria initiates Besremi, reimbursement is provided for the first year. At the one-year mark, treatment response is assessed. If a complete hematologic response is maintained, reimbursement is extended for an additional two years, allowing for up to three years of reimbursed treatment. In polycythemia vera, a complete hematologic response is defined as a hematocrit below 45%, platelet count below 400,000/µL, and white blood cell count below 10,000/µL.Q. Global guidelines increasingly recommend Besremi as a first-line therapy. What is your opinion on introducing Besremi as a first-line treatment option in Korea?In Korea, Besremi’s reimbursement is limited to patients resistant or intolerant to hydroxyurea. This reflects the practical realities of our healthcare environment and national health insurance finances. In fact, the PROUD/CONTINUATION-PV study, which supported Besremi’s approval, did not restrict its patient population to those with resistance or intolerance. It included all patients requiring hematologic suppression, regardless of whether they were newly diagnosed or had prior hydroxyurea experience, to evaluate treatment efficacy.Results showed that patients treated with Besremi from the outset achieved better outcomes on key endpoints, including complete hematologic response, compared with those previously treated with hydroxyurea. From a medical standpoint, this suggests that using Besremi as first-line therapy, regardless of resistance or intolerance status, is a meaningful approach.Besremi is also noteworthy for its potential to allow treatment-free intervals. In European studies, treatment discontinuation was attempted in patients who maintained a complete hematologic response for more than two years and had JAK2 mutant allele burden reduced to below 10%. A substantial proportion of these patients maintained prolonged drug-free intervals. From a health insurance perspective, the ability to achieve drug holidays could also translate into reduced financial burden, although reimbursement decisions must consider multiple factors.Q. What unmet needs remain in the treatment landscape for polycythemia vera?With the introduction of Besremi, new treatment goals, such as genetic modulation, operational cure, and the potential for long-term treatment discontinuation, have become achievable. This necessitates improvements in the diagnostic environment to support these advancements. Currently, in Korea, JAK2 mutation status is often confirmed only as positive or negative, and quantitative (allele burden) assessment is difficult to perform regularly. While the initial testing is covered, reimbursement is often restricted for follow-up tests, creating challenges for routine monitoring in clinical practice. Fortunately, discussions led by domestic experts on standardizing quantitative testing are underway, and improvements are expected in the near future.There is also a need to expand the clinical use of Besremi across a broader spectrum of MPNs based on clinical evidence. This requires understanding polycythemia vera within the broader context of MPNs. Other MPNs, such as essential thrombocythemia and myelofibrosis, share pathogenic mechanisms with polycythemia vera, and clinical studies of Besremi in these diseases are already underway. Based on these clinical results, expanded application across a broader disease spectrum is necessary.In addition, for chronic diseases with potential for severe progression, it is important to introduce effective therapies as early as reasonably possible. Currently, reimbursement for Besremi is limited to hydroxyurea-resistant or -intolerant patients, but there is hope that future cost-effectiveness evaluations may allow for relaxation of these criteria.Finally, one significant unmet need is the treatment of pregnant patients with myeloproliferative neoplasms. During pregnancy, hydroxyurea cannot be used, making interferon the only practical treatment option. In Korea, available interferon agents are limited, making Besremi essentially the only alternative. In fact, there have already been cases in which five pregnant patients in Korea received Besremi under off-label circumstances. Ensuring broader access to safe treatment options in these specialized clinical situations remains a critical challenge.
- Opinion
- [Reporter’s View] What about the ‘everyday’ drugs?
- by Kim, Jin-Gu Dec 15, 2025 11:03am
- The government’s newly announced drug pricing reform plan clearly reflects its intention to restructure Korea’s pharmaceutical and biotech industry: reward innovative new drugs, streamline generics, and reduce the public’s drug expenditure burden.However, one critical element is conspicuously absent—supply stability. The ‘supply’ issue, which directly impacts the site and the patients, has not been sufficiently addressed. While an item titled ‘Establishing a Stable Supply System for Essential Medicines’ exists midway through the reform plan, the overall weight given to this area appears insufficient.In recent years, the medical field has suffered from repeated drug supply disruptions. Antibiotic shortages paralyzed pediatric care, while fever and pain reliever shortages made pharmacies reminiscent of rationing. Medical institutions have repeatedly sweated bullets securing substitutes as essential medicines like contrast agents, local anesthetics, and basic IV fluids that are indispensable for treatment, have repeatedly run out. Supply instability has spread beyond specific essential medicines to encompass ‘everyday drugs’ used in routine care, exposing structural weaknesses in Korea’s pharmaceutical supply chain.Of course, supply stabilization measures are included in this reform plan. The threshold for designating exit-prevention drugs was raised by 10%, and the cost recovery standard for low-priced drugs was expanded from an annual claim amount of KRW 100 million to KRW 500 million. A new policy surcharge of up to 7% will be introduced, and the calculation methods for manufacturing and labor costs will be adjusted to reflect reality. For essential medicines, the surcharge pricing period will be stably guaranteed, and the scope of surcharge eligibility will be expanded. A ‘reshoring surcharge’ will also be considered when switching imported items to domestic production. Furthermore, the government will strengthen the public-private joint response system and push to establish a system that automatically guides users to substitute items during the prescription and dispensing stages.However, the pharmaceutical industry's response remains lukewarm. This is because the revised plan still fails to provide pharmaceutical companies with a ‘clear reason’ compelling them to produce low-cost essential medicines. Raw material costs and fixed expenses rise every year, yet numerous items have seen drug prices stagnate for years. Critics argue that limited price incentives confined to specific items cannot resolve structural issues. While plans exist to encourage compliance with supply commitments, encouragement alone cannot sustain manufacturing lines.For these reasons, the reform plan reads like a structure sacrificing fundamentals for innovation. The medicines citizens take daily, the drugs used in emergency rooms, and the medications needed on hospital wards are not mere pharmaceuticals but the very ‘medical infrastructure’ itself. No matter how many innovative new drugs emerge, if the supply of ‘everyday medicines’ – the foundation of the healthcare system – remains unstable, the impact of policy reforms will inevitably fall short.The direction hereon is clear. We must elevate the stability of pharmaceutical supply from a ‘side clause’ in drug pricing system reforms to a ‘core pillar’. Practical and sustained incentives are needed to encourage pharmaceutical companies to compete for the production of essential medicines. Beyond minor adjustments that merely cover costs, we must design realistic and sustainable profit structures that ensure supply continuity. System-level frameworks to support this also require an overhaul.Developing global innovative new drugs is important. However, safeguarding the supply chain to prevent disruptions in medicines that patients urgently need must take precedence over any other policy. What the pharmaceutical industry, the medical community, and patients ultimately desire is a policy that solidly establishes these fundamentals. This is precisely the part the current reform plan has overlooked.
- Opinion
- [Reporter's View] Besides speeding reform of pricing system
- by Jung, Heung-Jun Dec 15, 2025 11:03am
- If the government's goal for reforming the drug pricing system is to improve structure of the pharmaceutical and biotech industry, then an appropriate processing speed is necessary.To encourage pharmaceutical companies to expand R&D investment and align their interests, the government must provide sufficient time for companies to devise new plans.The government will gather industry-wise opinions and finalize the pricing system reform by January. Then, it plans to implement the policy in July, half a year later. The schedule is too fast-paced, as concerns arise about potential exhaustion rather than improvements to the industry structure. The Ministry of Health and Welfare (MOHW) has repeatedly stated that the system reform is not intended to achieve pharmaceutical cost savings. The MOHW asks that the reform, which has been designed to encourage innovations, should be viewed as an attempt to establish South Korea as a strong nation for new drugs.The question is whether companies devising plans in a hurry following the Health Insurance Policy Review Committee's decision in February next year can bring innovation to the industry? Even if the rate of R&D investment can be increased, the policy is highly likely to be a half-baked deal to maximize drug pricing.Furthermore, the greed to reach the goal in a short period may be the underlying reason that pharmaceutical companies with high potential for change give up.The government has suggested direction of the drug pricing system. Now, it should give enough time for the industry to reorganize portfolio and devise 5- to 10-year plans. Six months is too short for the industry to finalize revision measures.If the government were to ignore the industry's reality and focus solely on the roadmap for system implementation, there may be unintended consequences beyond the expected goals.Besides the industry, the government must consider well-designed implementation measures to achieve both goals, including innovation and stable supply.There are concerns about anticipated side effects of changes to the post-marketing management system, including the side effects of simply offering drug pricing priority based on R&D rate or actual transaction price survey.Once the post-marketing monitoring system is reduced to twice a year, remaining tasks to specify include how to permit retroactive application or how to promote listing within 100 days for rare disease pharmaceuticals.It is difficult to build a healthy ecosystem. It carries the danger of collapsing the existing ecosystem while failing to establish the intended ecosystem. Once collapsed, an ecosystem requires substantial financial resources.Setting the right direction and improving the system requires the government's firm stance. However, as this is a critical decision impacting the industry and future business, the government should take the time to carefully review the policy, while the industry works to monitor and develop effective plans.
- Opinion
- ADCs in the frontline in triple-negative breast cancer
- by Son, Hyung Min Dec 12, 2025 07:54am
- “In the metastatic stage, nearly half of breast cancer patients still do not survive beyond five years. A significant number of HER2-overexpressing patients experience disease progression within two years after first-line treatment, and those with triple-negative breast cancer (TNBC) relapse even faster due to the lack of targeted treatment options. Ultimately, providing stronger therapeutic options earlier in the treatment sequence is key to improving survival.”Professors Sung-Bae Kim (Medical Oncology, Asan Medical Center) and Kyong-Hwa Park (Medical Oncology, Korea University Anam Hospital) stressed the above during an interview with journalists at ESMO Asia 2025 in Singapore, noting that the greatest unmet need in metastatic breast cancer is redefining effective first-line treatment strategies.(from the left) and Professor Kyong-Hwa Park (Medical Oncology, Korea University Anam Hospital), Professor Sung-Bae Kim (Medical Oncology, Asan Medical Center)For metastatic breast cancer, the realistic goal remains not a cure, but how long and how well patients can endure. This is because while the 5-year survival rate for early-stage breast cancer exceeds 99%, the 5-year survival rate for patients diagnosed at the metastatic stage is only about 49%. In particular, the subtype and treatment strategies for metastatic breast cancer are completely divided based on HER2 and hormone receptor (HR) expression, with distinct unmet needs remaining for each subtype.For HER2-positive breast cancer with HER2 overexpression, survival extension has been achieved over the past decade with the so-called ‘THP regimen’ (taxane + Herceptin (trastuzumab) + Perjeta (pertuzumab)). However, in reality, disease progression occurs within two years in a significant number of patients, and brain metastases develop in about 25%, highlighting its limitations.The most aggressive subtype, triple-negative breast cancer (TNBC), which lacks expression of HER2, HR, and estrogen receptors, has a high rate of distant metastasis within 5 years of diagnosis and a sharply elevated risk of recurrence between 1-2 years post-diagnosis. However, the limited availability of targetable therapies remains a significant challenge.As a result, the importance of frontline therapy is becoming increasingly important in the field. In metastatic breast cancer, drug treatments tend to show a clear decline in efficacy as treatment lines progress. This means that the effectiveness of therapies deployed in the earlier treatment sequence, when patients are in relatively good condition, can significantly influence the overall survival curve.In the DESTINY-Breast09 trial, the HER2-targeted antibody-drug conjugate (ADC) ‘Enhertu (trastuzumab deruxtecan)’ extended progression-free survival (PFS) by approximately 1.5 times (40.7 months) compared to the THP regimen, which has been the first-line standard for HER2-positive metastatic breast cancer for over a decade, signaling a paradigm shift in first-line treatment. Particularly noteworthy is its consistent benefit even in high-risk subgroups, such as those with brain metastases or PIK3CA mutations.Signs of change also emerged in TNBC. Until now, only a subset of PD-L1-positive TNBC patients could receive immunotherapy, while the remaining 60-70% of patients had to rely on cytotoxic anticancer drugs, which are highly toxic and frequently develop resistance. The Trop-2-targeted ADC ‘Datroway (datopotamab deruxtecan)’ emerged as a key first-line ADC-based option in this field. In the Phase III TROPION-Breast02 trial, it significantly improved both PFS and overall survival (OS) compared to standard cytotoxic chemotherapy in the first-line treatment of metastatic TNBC patients ineligible for immunotherapy.Professors Kim and Park concurred that ADCs are demonstrating strong efficacy in key areas of breast cancer, signaling that the time has come to shift treatment strategies.Q. The treatment line of Enhertu has been pulled forward to first-line treatment based on the DESTINY-Breast09 study. What is the clinical significance of this study?Professor Park: Approximately 25% of HER2-positive metastatic breast cancer patients develop brain metastases, and THP has limitations in preventing or treating this. PIK3CA mutations also predict shorter PFS. Furthermore, biomarker-related clinical studies show that patients with resistance genes like PIK3CA mutations exhibit slightly shorter PFS compared to those without such mutations.In this context, Enhertu, which achieved significant benefits as a second-line treatment for HER2-positive metastatic breast cancer, has now been moved forward to first-line therapy. In the DESTINY-Breast09 trial, Enhertu demonstrated an unprecedented PFS of 40.7 months when used as first-line treatment. Furthermore, the study included approximately 10% of patients with pre-existing brain metastases and patients with PIK3CA mutations. Enhertu consistently demonstrated superior efficacy compared to existing first-line treatments across all patient subgroups. It is anticipated to provide clear therapeutic benefits in patient populations with significant unmet medical needs.Q. If Enhertu is introduced as first-line therapy in practice, how should its treatment strategy be established?Professor Sung-Bae Kim (Medical Oncology, Asan Medical Center) Professor Kim: We should use the therapy proven to be most effective. THP remains effective, and Enhertu carries an ILD risk in approximately 10% of patients. THP (which includes the cytotoxic agent taxane) is typically given for 6–8 cycles to maximize tumor reduction, but maintaining only trastuzumab and pertuzumab therapy after 6 cycles of THP therapy can extend survival by more than 12 months.Nevertheless, the fact that Enhertu has clearly surpassed THP therapy carries great significance. Furthermore, since HER2-positive breast cancer is inherently an aggressive type, Enhertu is likely to be the preferred initial therapy. Establishing subsequent maintenance treatment strategies is a separate issue. Professor Park: THP can offer an excellent quality of life in select patients. Although not approved in Korea, for HER2-positive, hormone receptor-positive cases, hormone therapy can be added while maintaining Herceptin and Perjeta. Furthermore, the recently published PATINA study confirmed that adding a CDK4/6 inhibitor significantly prolongs PFS, generating considerable expectation.While Enhertu has good therapeutic efficacy, there are some concerns regarding quality of life as well. Even if Enhertu is introduced as a first-line treatment with reimbursement in actual clinical practice, not every patient will need it in the first line. Ultimately, a strategic, individualized approach is essential. Q. Which patients should receive the Enhertu+Perjeta combination therapy first?Professor Park: Patients with CNS metastases from the outset or those with PIK3CA mutations are known to have slower responses or develop resistance more quickly. Patients like this, who have extensive metastases at diagnosis and a high tumor burden, need rapid tumor reduction. In these cases, the Enhertu+pertuzumab combination therapy can achieve faster tumor reduction compared to the existing THP regimen, and I believe it can be a more preferred therapy for this patient group.Professor Kim: In the pivotal CLEOPATRA trial for the THP regimen, less than 10% of participants had previously received trastuzumab as adjuvant therapy. If Herceptin was used as prior adjuvant therapy, but recurrence still occurred, the disease could be considered more aggressive. The DESTINY-Breast09 study included such patients and still achieved a PFS of 40.7 months, making the combo’s significance even greater.Q. How will the first-line standards change if the Enhertu combination therapy gains approval and reimbursement in Korea? Also, what is the likelihood of its reimbursement?Professor Park: If Enhertu is approved as first-line therapy, the decision will ultimately depend on the patient's situation. In Korea, if Enhertu becomes reimbursed in the first line, patients might feel they'd be at a disadvantage if they don’t use it, leading many to want it. However, using THP therapy first doesn't eliminate the opportunity to use Enhertu later. Therefore, a thorough discussion with the patient and their family is necessary to determine which treatment to use first, considering factors like underlying diseases or quality of life. Personally, I would likely use THP therapy first in HER2-positive, hormone receptor-positive patients, except in special cases like brain metastases, PIK3CA mutations, or high tumor burden. This is because if THP therapy is effective, adding the PATINA regimen (Ibrance(palbociclib) maintenance therapy) can sustain efficacy for a considerably long period. However, if the patient is HER2-positive or has a high tumor burden requiring rapid symptom relief, I would likely use Enhertu first.Professor Kim: The recent DESTINY-Breast11 study compared neoadjuvant Enhertu (4 cycles) followed by THP (4 cycles) vs. cytotoxic chemotherapy (4 cycles) followed by THP (4 cycles). The Enhertu group showed a higher rate of pathological complete response (PCR), particularly in the hormone receptor-negative breast cancer subgroup, where PCR was reported at 83.1%.Also, the DESTINY-Breast05 study reported favorable outcomes when Enhertu was administered for an additional 14 cycles to patients who did not achieve PCR after neoadjuvant therapy. In such cases, if both approaches demonstrate efficacy, a dilemma may arise regarding the optimal treatment sequence. The principle is to make decisions considering the patient's overall situation. Generally, the more effective treatment will eventually be moved to an earlier stage.Q. I'd like to follow up on the Dartroway question. It's said that about 70% of TNBC patients cannot use immune-oncology drugs. Why do so many patients not respond to these drugs? I'm curious if the same goes for other cancer types, or if this is a characteristic unique to triple-negative breast cancer.Professor Kyong-Hwa Park (Medical Oncology, Korea University Anam Hospital)Professor Park: The situation has completely changed with the advent of ADC (Antibody-Drug Conjugate) drugs, which deliver the drug much more precisely. The drug being carried by the ADC was also a new agent not previously used in breast cancer treatment, and its mechanism kills cancer cells much more effectively than conventional chemotherapy drugs. Therefore, the synergy between immuno-oncology drugs and ADCs has improved the efficacy of breast cancer treatment.Particularly for PD-L1-negative patients, only cytotoxic anticancer drugs were available until now, but even these couldn't be used long-term due to toxicity, and PFS was only around 4-5 months at best. Furthermore, many patients passed away after just 2-3 treatments, resulting in an OS of just over a year. However, with the advent of the innovative ADC anticancer drug, a clear survival extension effect has now been confirmed. Datroway, in particular, demonstrated this effect for the first time in the TROPION-Breast02 study.Professor Kim: mmunotherapy efficacy depends on PD-L1 expression, which is present in only 30–40% of TNBC. The remaining 60-70% of patients without PD-L1 expression have no choice but to use conventional cytotoxic anticancer drugs.Fundamentally, ADCs appear effective because they selectively target cancer cells. Previously, 60-70% of TNBC patients who were PD-L1 negative and thus unable to use immune-oncology drugs posed a problem. Recently developed ADC anticancer drugs target TROP2, which is expressed in most cancers and is relatively more prevalent in triple-negative breast cancer, making it a promising target. The emergence of these ADC anticancer drugs has created treatment opportunities for patients who previously could not use immune checkpoint inhibitors. Q. I understand that recent discussions are leaning toward using Enhertu if there is even minimal HER2 expression. I'm curious how this discussion might change if Datroway becomes available.Professor Park: Enhertu has not been studied as a first-line treatment in TNBC patients. If a patient has already used one other anticancer drug and shows even minimal HER2 expression, Enhertu can be considered based on findings from the DESTINY-Breast04 study. Currently, for first-line treatment of TNBC, TROP2 ADC is the only option with clinical trial data-based evidence, so the introduction of Datroway will be a new treatment option that has been previously unavailable.Professor Kim: Based on the DESTINY-Breast04 study, if the disease progresses after using cytotoxic chemotherapy and there is even minimal HER2 expression, Enhertu can be used, though it is not yet reimbursed. Alternatively, it can be used after one course of cytotoxic chemotherapy following hormone therapy. For hormone receptor-positive breast cancer, using Enhertu before cytotoxic chemotherapy, after hormone therapy, is supported by the DESTINY-Breast06 study.Q. For PD-L1-negative patients, two ADC options appear available. In a situation where one drug has OS data, and the other only has PFS2 data, should the drug with OS benefit be considered more valuable?Professor Kim: A similar example is Kisqali (ribociclib) versus Verzenio (abemaciclib) in the adjuvant setting. Kisqali started development earlier and could demonstrate OS data, while Verzenio, developed later, faced difficulties in providing OS data. Therefore, ribociclib, which showed benefits in both PFS and OS, was considered the gold standard. Given the same cost, it was reasonable to choose the treatment with confirmed OS evidence.Some argue that simply preventing cancer recurrence is meaningful enough, so meeting the primary endpoint has significance. Later, Kisqali and Verzenio were indeed found to have similar OS levels. However, since OS is the most critical indicator, under identical conditions, this patient would prefer a treatment with a confirmed improvement. Additionally, confirming treatment benefit through OS can also help secure reimbursement.Professor Park: In Korea, reimbursement status primarily influences treatment selection.Q. If Datroway is introduced in Korea, what role do you think it will play in TNBC treatment?Professor Kim: Datroway can be used for patients who relapse within 6 months after treatment or within 12 months of disease-free survival. For TNBC patients, it's necessary to first confirm whether recurrence occurred within one year. Dartroway's advantage lies in its slightly different criteria in terms of recurrence compared to existing treatments.Professor Park: The situation Professor Kim mentioned represents the patient group most urgently in need of ADCs. However, the currently available ADC anticancer drug for triple-negative breast cancer in Korea, sacituzumab govitecan, cannot be used in that specific situation. Therefore, the current approach involves first administering other treatments whose efficacy is uncertain, followed by sacituzumab govitecan as a second-line therapy. Once Datroway is introduced in Korea, it may be able to fill this treatment gap.
- Opinion
- "Personalized first-line therapy for EGFR-mutated NSCLC"
- by Hwang, byoung woo Dec 02, 2025 12:37pm
- The treatment paradigm for EGFR-mutated Non-Small Cell Lung Cancer (NSCLC) is changing.Given the high incidence of brain metastases at diagnosis in EGFR-mutated NSCLC, the key criteria for first-line treatment selection are now centered around Central Nervous System (CNS) inhibition and a favorable toxicity for long-term administration.The integrated analysis of LASER201 and LASER301, published recently in 'Clinical Lung Cancer,' provides additional evidence supporting the intracranial efficacy of the domestically developed third-generation EGFR TKI, Leclaza (lazertinib). The study is providing evidence for redefining the treatment strategy for patients with EGFR mutations.DailyPharm met with Professor Ji-Youn Han, from the Division of Hematology-Oncology at the National Cancer Center, a co-author of the paper mentioned above, to hear about the latest trends in the treatment of EGFR-mutated Non-Small Cell Lung Cancer (NSCLC), the CNS strategy, and the direction of customized therapy in the era of combination therapies."Brain metastases account for 40% at diagnosis…key determining factor for prognosis"Professor Ji-Youn Han, Division of Hematology-Oncology at the National Cancer CenterFirst, Professor Han emphasizes that "CNS management is now the starting point of treatment, rather than simply an additional factor."Professor Han stated, "Approximately 20-25% of all lung cancer patients already have brain metastases at diagnosis, but this rate rises to as high as 40% in patients with EGFR·ALK·HER2 mutations or who are non-smokers," and added, "Recent global Phase 3 (MARIPOSA·FLAURA2) trials also reported that 40% of patients have baseline brain metastases."These data indicate that not only are baseline brain metastases common, but a significant number of participating patients with good performance status have accompanying brain metastases.However, the prognosis varies significantly depending on symptom status. While approximately 40% of brain metastases cases are detected while still asymptomatic, the prognosis rapidly worsens once neurological deficits occur.Professor Han stated, "Symptoms of brain metastases include persistent headaches, nausea/vomiting, visual impairment, dizziness, and stroke-like symptoms, which severely limit daily life. Ultimately, symptomatic brain metastases is regarded as a major worsening factor that significantly decreases the patient's Quality of Life."Integrated Analysis of LASER201/301...reconfirming Leclaza's effect on suppressing the CNSProfessor Han summarized the limitations of existing first- and second-generation EGFR TKIs as being 'not initially designed to target the EGFR mutation itself.'Professor Han explained that side effects from inhibiting normal EGFR made it difficult to achieve sufficiently high drug concentrations, resulting in restricted BBB permeability and, consequently, a structural limitation in CNS management.In contrast, third-generation EGFR TKIs were developed from the start to enhance mutant EGFR selectivity and BBB permeability. This gained attention because it opened an era where much more stable and consistent effects on CNS can be expected, even in patients with brain metastases.Furthermore, the differences in toxicity profiles are evident. Professor Han said, "If the clinically perceived toxicity severity of first·second generation agents is rated at 10, the third generation is at the 2–3 level, which significantly improves their suitability for long-term use."Regarding the results of the LASER201 and LASER301 integrated analysis released, Professor Han evaluated them as additional evidence supporting Leclaza's global competitiveness.Professor Han stated, "The key finding is that this study provided objective data confirming that Leclaza has intracranial efficacy comparable to Tagrisso (osimertinib), the Korean standard of care, in EGFR-mutated lung cancer patients with brain metastases." She found this consistent with the trend from the MARIPOSA study, in which lazertinib monotherapy showed a Hazard Ratio (HR) of less than 0.9 compared to osimertinib in this patient group.Professor Han also mentioned, "Although the two drugs have generally similar efficacy, their side effect profiles do not entirely overlap. The fact that an option exists for patients to switch to the other drug if they cannot tolerate a specific adverse event is a major clinical advantage."Consequently, the availability of two third-generation EGFR TKIs is viewed as having significance for expanding the treatment strategy.Leclaza has a demonstrated advantage for suppressing brain metastases, supported by clear data proving the BBB permeability in preclinical studies.Professor Han stated, "This integrated analysis strengthens Leclaza's intracranial evidence, enhancing its global credibility, and expands the treatment strategy by enabling customized drug selection based on the patient's side effects and status. It is significant because it lays the foundation for broadening the scope of clinical judgment amid the future flow of combination therapies and new drug development."Toxicity management and drug switching...differentiating strategy garners attentionProfessor Han stressed that 'toxicity management' is a critical factor in determining the actual clinical treatment strategy, as EGFR-mutated lung cancer is a disease that requires long-term use of agents from the same class.In the case of Tagrisso, specified severe side effects, such as thrombocytopenia, ILD (interstitial lung disease), and cardiac toxicity like QTc prolongation, may necessitate dose reduction."According to the current guidelines, dose must be reduced to 40 mg if the same adverse event recurs. However, the evidence for maintaining drug efficacy at the 40 mg reduced dose is extremely limited, and the lack of data ensuring sufficient CNS control in patients with brain metastases is the biggest concern in the clinical setting," she said.Professor Han said, "Since CNS progression in EGFR-mutated lung cancer is directly linked to treatment failure, disease progression during dose reduction significantly limits the scope of subsequent drug switching strategies." She emphasized, "The medically recommended option in this scenario is a switch to Leclaza monotherapy, whose efficacy and tolerability have already been proven at the standard dose (240 mg)."Professor Han also suggested that the reimbursement criteria need be improved.The current reimbursement criteria require a Tagrisso dose reduction before switching to Leclaza, forcing the patient to risk the same side effects again. Professor Han also pointed out that if the disease progresses during the dose reduction, reimbursement for the subsequent switch to Leclaza may be denied.Professor Han concluded, "Since there is little difference in the drug price between the two agents, and Leclaza is sometimes even cheaper, there is insufficient evidence to mandate dose reduction for financial reasons," and added, "Ultimately, these regulations are criticized as being unreasonable from the perspectives of patient safety, treatment continuity, and insurance finances."
- Opinion
- [Desk View] Dual pricing for the sake of our own citizens
- by Eo, Yun-Ho Nov 24, 2025 06:19am
- The government intends to expand the number of dual-priced listed drugs to prevent disclosure of actual transaction prices. By raising reference prices through higher public list prices, it aims to improve access to new drugs. The government has announced a major overhaul of Korea’s drug pricing system. The forthcoming reform plan, which the government plans to reveal concrete details soon, is drawing significant attention from the pharmaceutical industry. It is expected to include adjustments to the generic drug pricing calculation rate, reform of the tiered drug pricing system, consolidation of post-market management systems, expansion of the Risk Sharing Agreement (RSA) and dual pricing scheme, and R&D investment-linked drug price premiums. Multinational pharmaceutical companies are particularly focused on expanding the dual pricing system. Among RSAs, the refund-type model—which assigns dual prices by separating the actual transaction price from the listed price—has consistently been the preferred contract type since its introduction. However, calls for improvements to its scope have been persistent. Many even suggested excluding the refund-type from RSAs altogether. The government has also partially accommodated these opinions, making minor adjustments to the system. Initially applied under a strict criterion, only to ‘anticancer drugs or rare disease treatments with no equivalent substitutes or therapeutically equivalent alternatives’, the ‘life-threatening’ qualifier has now successfully been removed from the criteria. Yet, the prevailing sentiment remains that its application conditions are still stringent. However, this time appears to be different. Pressure from the U.S. Trump administration’s Most-Favored-Nation (MFN) drug pricing policy served as a trigger, and the health authorities appear to have internalized growing alarm over the long-discussed but uncomfortable issue of “Korea passing” within the global pharma industry. Given the circumstances, the upcoming expansion of RSA and dual pricing will likely loosen at least the criteria tied to disease severity. Whether the current price cap, “below the A7 adjusted average price,” will be modified is another point to watch. It is never right for a game of brinkmanship to unfold over reference prices, leading to the bypassing phenomenon. The products sold by multinational pharmaceutical companies are not luxury goods like Mercedes-Benz or Chanel. It is also true that drug prices are set higher in relatively poorer countries—those with weaker negotiating power. Still, many countries are expanding the share of non-public drug pricing—a second-best solution, though not ideal— to secure access to new therapies for their own citizens. While the global moral imperative of ‘transparent drug pricing’ is commendable, the government must also make decisive choices for the sake of patients in our country.
- Opinion
- [Reporter’s View] K-Pharma bets its survival on new drug R&
- by Choi, Da-eun Nov 24, 2025 06:18am
- The R&D direction of major Korean pharmaceutical companies is shifting from generics to new drug development. This shift comes as the perception grows that generics, long the mainstay of domestic pharma growth, are no longer a safe bet. With tighter price regulations, intensified competition, and shrinking distribution margins, the generic ecosystem is being pushed into relentless price pressure. As the sense of crisis deepens that generics alone cannot guarantee the future, leading pharmaceutical companies are increasingly willing to bear the cost burden to secure mid-to-long-term growth engines. Hanmi Pharmaceutical is aggressively investing in R&D, raising expectations that it may be the first Korean company to launch a homegrown obesity drug. Hanmi's R&D expenditure for the third quarter of this year reached KRW 169.1 billion, a KRW 15.5 billion increase year-on-year, accounting for 15% of its sales. CKD (Chong Kun Dang) is moving away from a generic-centric model toward a bio-focused structure, expanding its pipeline from ADC (antibody-drug conjugate) oncology drugs to advanced biopharmaceuticals. It recently announced a KRW 2.2 trillion investment, making a major ‘bet’ by constructing a large-scale biopharmaceutical complex R&D center in Siheung. Its R&D expenses are on the rise - from KRW 151.2 billion in 2023, KRW 157.4 billion in 2024, to KRW 126.5 billion in the third quarter of this year. JW Pharmaceutical is also steadily increasing its annual R&D spending. Its third-quarter R&D expenses this year reached KRW 74.9 billion, a 26.9% increase compared to KRW 59.0 billion in the same period last year. It is currently conducting a Phase III multinational clinical trial in Asia for its core pipeline, the gout treatment ‘epaminurad (URC102)’. Considering the growth potential of the gout treatment market and the limitations of existing uric acid-lowering drugs, analysts view it as having significant mid-to-long-term pipeline value. Even manufacturing-oriented giants like Celltrion and Samsung Biologics are jumping into the R&D competition, expanding their own pipelines as new growth pillars. Celltrion emphasized ambitions beyond biosimilars, outlining plans to develop ADCs, multi-specific antibodies, and obesity drugs. Samsung Biologics launched Samsung Epis Holdings, a bio-investment holding company, through a spin-off. Samsung Epis Holdings plans to strengthen new drug development based on EPIS NexLab’s biopharmaceutical development platform. Behind these bold future investments by domestic companies lies a shared understanding that sustainable growth is difficult to achieve, relying solely on generic drug profits. The global M&A market, policy direction, and investment capital all operate based on ‘innovation’. This means that companies unable to break free from a domestic-focused, generic-centric structure will inevitably fall behind. Of course, strengthening R&D does not guarantee immediate success. The risk of clinical failure is significant for any company, and securing funding grows increasingly difficult. Risks clearly exist behind the banner of ‘investment for the future’. However, it is becoming increasingly clear that competitiveness in the pharmaceutical industry is shifting from price to technology. These days, the phrase “We will increase our R&D investment” appears like a motto in all pharmaceutical companies' new year business plans. To the reporter, it reads as a strategic declaration directly tied to survival. The reality that generic drugs alone cannot defend corporate value is pushing companies harder for reinvestment in R&D. As the market landscape shifts, clinging solely to safe strategies leads only to regression. The direction is becoming clearer: decisively shedding inefficient businesses and concentrating resources on next-generation drug development. This is why domestic pharmaceutical companies have chosen the difficult path of restructuring toward high-value-added focus, and why their ‘long-term’ challenge deserves close attention.
- Opinion
- [Reporter’s View] K-BIO needs strength to go the distance
- by Cha, Jihyun Nov 21, 2025 06:12am
- New drug development is a war of capital. The amount of money and time required to develop a drug candidate, push it through clinical trials, and finally reach approval is beyond imagination. It is widely known that developing a single new drug typically takes 10–15 years and costs KRW 1–2 trillion. When developing high-complexity modalities such as antibody–drug conjugates (ADCs) or bispecific antibodies, the initial R&D cost grows exponentially. This is why biotechs inevitably rely on early-stage technology out-licensing models. Without a revenue base, it is difficult to independently conduct late-stage clinical trials that require hundreds of billions to trillions of won. As a result, secure preclinical or early clinical data and quickly move to out-license the technology. For drug development biotechs, technology transfer is not a choice but a survival strategy. But recently, a shift is emerging. Rather than out-licensing technologies at early stages, some leading biotechs are now moving to carry their core pipelines into late-stage clinical trials themselves. LigaChem Bio, which strengthened its capital base after Orion Group became its largest shareholder, has declared plans to push certain ADC pipelines into late-stage clinical trials independently. ABL Bio, which signed two major licensing deals with global big pharma this year alone, has also indicated its intention to take its key pipeline into late-stage trials on its own. This trend is noteworthy as it signifies that domestic companies are moving into a phase where they directly secure control over new drug development. Under the traditional licensing model, the fate of development was effectively handed over the moment the license was transferred. If the partner changed strategy or de-prioritized the project, the original developer had no way to intervene or revive it. Conversely, by directly advancing into late-stage clinical trials, the company itself can determine the value and direction of the new drug. The decision to take a pipeline into late-stage development is also a major shift in terms of corporate value. Licensing deals grow larger the further the pipeline progresses. While early-stage technology exports typically result in contracts worth tens to hundreds of billions of won, the contract size jumps to at least hundreds of billions of won, and can reach trillions of won, by the time late-stage clinical trials commence. Behind the decision to “carry it all the way through” lies the calculation that taking on additional risk is worth it if it means the results and rewards remain with the company. Above all, the attempt to directly navigate through to the late-stage clinical phase holds significant meaning in terms of accumulating the ‘core know-how involved with new drug development’ that Korea has been lacking. Under the license-out-centric structure, most late-stage experiences determining a drug's success—such as Phase 2b/3 trials, global regulatory strategies, FDA meetings, and commercialization preparation—were largely ceded to overseas partners. The recent move by some companies to take their pipelines through late-stage clinical trials into their own hands holds value in internalizing the experience and know-how that previously flowed overseas, thereby elevating Korea's drug development capabilities to the next level. Technology exports remain necessary and will continue to be a vital survival strategy. However, companies aiming to compete on the global stage should resolve to “see at least a few pipelines through to the end.” While not every biotech company can conduct late-stage clinical trials directly, simply accumulating one or two more companies with ‘full-cycle experience’ will undoubtedly elevate the standing of Korea's biotech sector. May technology transfer become not the final destination for survival, but the starting point toward completing the full cycle.
- Opinion
- [Reporter's View] New obesity drug sparks dilemma
- by Son, Hyung Min Nov 18, 2025 06:13am
- Following approval of an expanded indication for Wegovy (semaglutide), a Glucagon-like Peptide-1 (GLP-1)- based obesity treatment, to include adolescents aged 12 and older in South Korea, the discussion surrounding pediatric and adolescent obesity has once again come into the spotlight. While the global market already defines pediatric obesity as a medical disease requiring early intervention, South Korea is still lagging in both social awareness and institutional support. Obesity cannot be explained merely as an aesthetic or lifestyle issue. In particular, obesity during the growth period is highly likely to persist into adulthood. It serves as the starting point for chronic diseases such as Type 2 diabetes, hypertension, non-alcoholic fatty liver disease, and cardiovascular disease. The Obesity Fact Sheet 2025, published by the Korean Society for the Study of Obesity (KSSO), demonstrates this reality. Although the obesity rate in children and adolescents has slightly decreased in the last five years, approximately three out of 10 are still classified as obese. The obesity rate peaked at age 14 for boys and after age 16 for girls. It was also confirmed that the probability of obesity in children is five times higher if their parents are in obesity class 2 or higher. The problem is that it does not end with simple weight gain. Adult chronic diseases such as Type 2 diabetes, hypertension, and liver disease are actually increasing among obese and overweight children and adolescents. The pace of change has accelerated to the point where Type 2 diabetes in adolescents is no longer considered a rare condition in modern clinical practice. Experts note that obesity during the growth period is not a short-term problem; instead, the timing of exposure determines the severity of the disease. Obesity starting early in life has a prolonged duration, increasing the risk of complications and potentially exploding lifelong management costs and medical burden. The current situation is different from the era when obesity was dismissed as merely an aesthetic concern. Despite this severe situation, the treatment environment in South Korea remains stagnant. While innovative treatments like GLP-1 drugs have emerged, the perception that obesity is a treatable disease is spreading among adult patients. Conversely, in the U.S., major new obesity drugs have already been approved for adolescents and are actively used in clinical practice. Although South Korea tends to tighten regulations due to concerns over misuse and abuse, some critics suggest that patients in need are being deprived of the right to choose treatment. Obesity cannot be explained solely by willpower or lifestyle choices. Appetite is a biological system involving the pituitary-hypothalamic axis, adipose tissue, and various hormones. It is structurally harder for growing adolescents to control their appetite than it is for adults. Without addressing the underlying physiological factors, lifestyle modifications alone will inevitably face apparent limitations. However, drug therapy is not an answer for everyone. The effectiveness of obesity treatments is maximized when combined with healthy lifestyle modifications. Especially during the growth period, lifestyle education, continuous counseling, and long-term management are essential. However, experts are deeply concerned that delaying drug treatment for adolescents who already show signs of complications, such as hypertension, elevated liver enzymes, or pre-diabetes, will exponentially increase the future disease burden. The core of the problem is the social frame through which obesity is viewed. Many still interpret obesity as a failure of lifestyle or lack of willpower, and the perception exists that obesity during childhood and adolescence will 'naturally resolve itself as individuals grow.' However, obesity during the growth period cannot be solved by time. Delayed early intervention exponentially increases long-term health risks and places an even greater medical and social burden on the patient than adult obesity. While the perception of obesity as a disease is slowly being built, regulations remain overly strict, and access to treatment is restricted. While preventing misuse is critical, a situation where even patients in need cannot access medication is another form of neglect. What is needed now is not more regulation, but balance. Ensuring safety and preventing misuse must be fundamental policy goals, but those principles should not stand in the way of timely treatment. Obesity during childhood and adolescence is a key turning point that determines lifelong health. The treatments are available. The remaining challenge is for social awareness and institutional support to catch up so that these treatments can reach the patients who need them.
