- LOGIN
- MemberShip
- 2026-07-22 03:12:18
- Opinion
- [Reporter's View] New drugs for intractable cancers
- by Son, Hyung Min Feb 20, 2026 10:04am
- Although there are diverse types of intractable cancer, different diseases and varying prognoses coexist. The common feature of platinum-resistant ovarian cancer, small cell lung cancer (SCLC), and bile duct cancer is clear. They are characterized by limited treatment options, a short average survival period, and quickly diminishing next-line options.Drug discovery is fundamentally challenging in this field. The number of patients is limited, biological heterogeneity is significant, and designing a clinical trial scheme is difficult because many patients have worsened systemic conditions at diagnosis. Furthermore, it is difficult to set up a control group and clearly demonstrate a difference in overall survival (OS) due to crossover or follow-up treatments.As a result, clinical outcomes are mostly reported as improvements in Progression-Free Survival (PFS) or Hazard Zatios (HRs). There have been studies in which the difference in PFC between the control and treatment groups is only 1 month. The outcomes, such as HR 0.73, a 27% reduction in disease progression or risk of death, and an HR below 1, indicate effective treatment and statistical significance.However, what patients experience is not the relative risk reduction or the time they have saved. Studies with PFS extended from 3.8 months to 5.2 months translate to HR 0.73 and a 1.4-month extension. It shows progress in terms of statistics; however, the clinical significance is much more complicated.Nevertheless, a tiny improvement in PFS cannot be taken lightly. For patients with few treatment options remaining, disease control of 6 to 8 weeks can represent an opportunity to bridge to the next treatment and time to preserve quality of life. If Objective Response Rate (ORR) or PFS2 appear meaningful, and a patient group with a long Duration of Response (DoR) exists, the 'long tail' behind the median is by no means small. In the HR 0.72 value, the varying times of different patients are contained.The problem arises when these figures assume identical expectations for all patients. Outcomes such as a 1 to 2-month improvement in PFS must be interpreted alongside toxicity burden, treatment discontinuation rates, and Patient-Reported Outcomes (PRO). Particularly in situations where OS data is not sufficiently mature, the criteria for 'meaningful time' become more complex as PFS-centered evaluations are repeated.This concern extends beyond the clinical field into institutional judgment. Within limited budgets, which drugs should be permitted for which patient groups and at what point? The fact that the risk of death was reduced by 20% does not necessarily translate into the same reduction for all patients. It is more important to determine how precisely patients with a high likelihood of response can be selected, and how to verify and enhance efficacy in clinical practice.The approach must be more careful in the field of intractable cancers. Rather than opening the door uniformly to all patients, a structure is needed that applies treatments stepwise, starting with patient groups where evidence is confirmed. A system must be operated in parallel, with access initially permitted on a limited basis while accumulating Real-World Data (RWD), followed by a re-evaluation of OS, PFS2, treatment durability, and quality-of-life improvements after a certain period.The issue is not the size of the number, but how it is interpreted. Between the desperation of intractable cancer and statistical significance, judgment must be more delicate and transparent.However, if OS improvement is used as the sole absolute criterion without sufficient consideration of the characteristics of intractable diseases and the difficulties of drug development, patient access to new drugs will inevitably remain low. It is difficult to justify a structure where treatment opportunities are narrowed simply because a patient has a specific type of cancer.
- Opinion
- [Reporter's View] Why the rush for drug pricing reform?
- by Jung, Heung-Jun Feb 13, 2026 08:28am
- While the pharmaceutical industry and citizen groups are calling for a postponement of the drug pricing system reform, the government is remaining silent.With the conclusion from the Health Insurance Policy Review Committee imminent, doubts persist regarding the effectiveness and feasibility of the reform.The reform plans appear underdeveloped, leading to concerns that achieving National Health Insurance (NHI) financial savings may prove difficult. Under these circumstances, the government may need a break to ensure the successful achievement of its policy goals.Voices calling for the establishment of a social consultative body are mounting. Following the pharmaceutical industry and the Federation of Korean Trade Unions (FKTU), civic groups, including the Citizens' Coalition for Economic Justice, have joined in expressing concern over the enforcement of policies without adequate communication.Regarding the price reduction of generic drugs, a backlash involving the weakening of the industrial base and employment instability is anticipated. If the reform is implemented in its current state, pharmaceutical companies are predicted to shift toward austerity measures rather than expanding investment in research and development (R&D).Furthermore, the policy to enhance access to treatments for rare diseases continues to draw demands for clarity on financial management and post-monitoring measures. This is precisely the concern raised recently by these organizations.Critics question whether a management plan is in place for the NHI budget, which is expected to increase as the entry barriers for high-priced new drugs are lowered. If the funds saved from generic price cuts are entirely absorbed by high-priced drugs, the anticipated drug expenditure reduction effect of the reform will vanish.The Ministry of Health and Welfare (MOHW) cites the restructuring of the Korean pharmaceutical industry and the creation of momentum for global expansion as the expected goals of this reform. However, the policy could unexpectedly cause industrial imbalance and exacerbate an unstable growth foundation. This suggests a need for the government to take the time to address concerns from the field.No one disputes the justification for improving the generic industry's constitution or enhancing access to rare disease treatments.However, policy is not made by good intentions alone. The MOHW repeatedly emphasizes the number of generic items to justify the need for structural reform. In response to the industry's question, "Why the rush?", the government must show a willingness to discuss qualitative strategies for constitutional improvement rather than merely listing quantitative figures.On the 10th, the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA) announced a resolution calling for a postponement of the reform and presented the government with an impact assessment of the proposed changes. Additionally, citizen groups have announced a follow-up press conference on the impact of the generic drug pricing reform. As industry, citizen, and labor groups all express a sense of crisis, the government must communicate to find ways to minimize adverse side effects.
- Opinion
- ‘Elahere demonstrates OS benefit in ovarian cancer’
- by Son, Hyung Min Feb 10, 2026 08:14am
- The treatment landscape for platinum-resistant ovarian cancer (PROC), which is characterized by high relapse rates and limited effectiveness of standard therapies, is showing signs of change.Elahere (mirvetuximab soravtansine), the first folate receptor alpha (FRα)-targeted antibody–drug conjugate (ADC) approved for ovarian cancer, has demonstrated improved overall survival (OS) in a global Phase III clinical trial and obtained regulatory approval in Korea.Kidong Kim, Department of Obstetrics and Gynecology, Seoul National University Bundang HospitalProfessor Kidong Kim from the Department of Obstetrics and Gynecology at Seoul National University Bundang Hospital said, “Ovarian cancer relapses frequently, and once it progresses to platinum resistance, median survival is often less than one year. With the advent of Elahere, identifying FRα expression earlier during diagnosis is becoming increasingly important in establishing individualized treatment strategies.”Ovarian cancer is a gynecological cancer originating in the ovaries, fallopian tubes, or primary peritoneum. Approximately 3,000 to 3,500 new cases are diagnosed annually in Korea. Due to accumulated risk factors such as reduced childbirth rates, early menarche, and late menopause, the number of patients is on the rise. Notably, as more than two-thirds of patients are in their 40s to 60s, the age group most active in family and social life , diagnosis is particularly impactful on patients, families, as well as society as a whole.Upon diagnosis, standard first-line treatment consists of surgery followed by platinum-based chemotherapy. While many patients respond to first-line therapy, approximately 80% eventually experience recurrence.With each recurrence, the tumor acquires resistance to platinum-based anticancer drugs, eventually progressing to the stage of platinum-resistant ovarian cancer, where this treatment becomes largely ineffective. Patients who relapse within six months of initial treatment are classified as having typical platinum-resistant ovarian cancer. By this stage, the patient's overall health is often significantly compromised, and available subsequent treatment options are extremely limited.Elahere, which was approved in Korea in December last year, is the first novel mechanism therapy introduced for ovarian cancer in nearly a decade. Elahere is an FRα-targeted ADC expressed on the surface of cancer cells, enabling a form of precision therapy distinct from conventional cytotoxic chemotherapy.FRα is minimally expressed in normal tissues but is highly overexpressed in ovarian cancer cells. Studies indicate that approximately 35–40% of ovarian cancer patients are FRα-positive and meet Elahere’s treatment criteria. More importantly, FRα expression tends to remain relatively consistent from diagnosis through recurrence, making it a useful biomarker throughout the disease course.Elahere consists of an FRα-targeting antibody linked to a cytotoxic payload. Upon administration, the antibody selectively binds to FRα on tumor cells, is internalized, and releases the payload to induce cancer cell death while exerting a bystander effect on neighboring tumor cells. This mechanism enables a precision anticancer strategy that minimizes damage to normal tissue with potent antitumor activity.Professor Kim explained, “While there have been various attempts to develop new drugs in the field of platinum-resistant ovarian cancer in the past, few have achieved clinically significant success. With the broader adoption of the ADC platform, some drugs have begun to show meaningful results, and Elahere is one drug that represents this trend.”Q. How were platinum-resistant ovarian cancer patients who do not respond to platinum-based therapy treated in the past?First-line treatment typically involves platinum-based chemotherapy. Upon relapse, platinum-based chemotherapy may be reused depending on the relapse interval, but for patients who relapse shortly after platinum-based therapy, other drugs are used, excluding platinum-based agents. Recurrence within 6 months after platinum-based therapy is termed platinum-resistant ovarian cancer, which has limited treatment response and a very poor prognosis, with survival typically under 1 year.Currently approved options include pegylated liposomal doxorubicin and topotecan (as non-platinum-based regimens for platinum-resistant ovarian cancer). The overall efficacy of these agents is similar, and there have been challenges in practice due to their limited efficacy and response rates.While study results vary, some report objective response rates as low as 5%. This means only about 5 out of 100 patients show tumor size reduction. Failure of such treatment typically leads to a cycle of switching to different anticancer drugs and continuing treatment with diminishing benefit.Q. Could you explain the MIRASOL trial that supported Elahere’s approval? What were the characteristics of the patients enrolled, and what were the study results?MIRASOL was a randomized clinical trial in platinum-resistant ovarian cancer patients. The experimental arm received Elahere monotherapy, while the control arm received standard non-platinum chemotherapy (paclitaxel, pegylated liposomal doxorubicin, or topotecan). Approximately half of the participants had received three or more prior lines of therapy, and some had prior exposure to bevacizumab or PARP inhibitors.The study results confirmed a statistically significant improvement in progression-free survival (PFS) in the Elahere treatment group compared to the control group. However, Elahere garnered even more attention because it demonstrated a difference in overall survival (OS). While drugs showing PFS improvement had existed before, a drug proving a statistically significant improvement in overall survival had been absent for a long time. In this context, Elahere became the first drug to demonstrate an OS improvement of approximately 4 months (mOS 16.46 vs 12.75), and these results were why Elahere received such significant attention.Q. Confirming FRα expression status is essential for Elahere treatment. When is the most appropriate time to perform the companion diagnostic testing to determine FRα positivity?Ideally, FRα expression should be assessed at initial diagnosis using tumor tissue obtained during surgery. There are two reasons for this.First, some studies indicate that FRα expression tends to remain relatively consistent both at initial diagnosis and at recurrence. While some biomarkers may show changing expression levels as the disease progresses, FRα has demonstrated consistent expression in research. This allows the results from the initial diagnostic test to be utilized for subsequent treatment decisions.Another reason lies in the nature of ovarian cancer. Ovarian cancer frequently recurs, and during recurrence, multiple drugs are selected and used sequentially. In this process, prior treatment choices often influence the treatment options available at recurrence. Determining FRα expression at the initial diagnosis stage helps establish the best overall treatment strategy for the patient.Selecting the most effective drug early on can lead to more favorable outcomes for the patient, especially in the current environment where various treatment options exist. Conversely, if FRα expression is confirmed and Elahere is used only after all other options have been exhausted, there is a possibility that a better choice could have been made at an earlier stage. For these reasons, we believe it is advantageous to perform the FRα companion diagnostic test as early as possible in the diagnostic process.Q. The MIRASOL study demonstrated PFS improvement with Elahere. However, based solely on absolute numbers, the PFS benefit may appear modest numerically. What is its clinical significance?When discussing treatment options with patients, the question inevitably arises: ‘How much tangible benefit would this drug actually provide?’ Two key points warrant consideration here.First, platinum-resistant ovarian cancer is a disease that is extremely difficult to treat. Despite the development of numerous drugs over the years, none have demonstrated sufficient clinical benefit. Therefore, the fact that a statistically significant improvement was observed, regardless of the absolute median difference, is meaningful.Moreover, while median values reflect population averages, individual patient responses may vary greatly. In MIRASOL, Elahere achieved an objective response rate of 42.3%. For example, consider a patient with two or three tumor lesions. After Elahier treatment, two lesions completely disappeared, leaving only one. In such a responding patient, the possibility of attempting a cure through additional radiotherapy or surgery, while rare, clearly exists.In other words, the finding that progression-free survival was extended by an average of about 2 months is merely the result of a group comparison. The actual benefit for individual patients could be significantly greater.Q. How do you assess Elahere’s safety profile?ADC therapies function by binding cytotoxic anticancer agents to antibodies for delivery to tumor cells, so they can be considered to have characteristics similar to traditional cytotoxic anticancer agents (chemotherapy). Therefore, while the degree and presentation may differ, adverse events seen with traditional cytotoxic anticancer agents can occur, and a similar approach to adverse event management would be necessary.Ocular adverse events are notable, and because clinical experience is still accumulating, it is important to recognize that healthcare providers are still in the process of gaining sufficient clinical experience with ocular adverse events caused by this drug. Therefore, I believe clear management guidelines and clinical consensus regarding ocular adverse events for ADC-based therapies will be established as real-world use expands.Q. I understand you have experience prescribing Elahere. Could you share your treatment experience?I have experience treating patients with Elahere through the Expanded Access Program (EAP) and clinical trials. A patient currently receiving treatment through EAP has completed approximately 5 cycles of the drug. The patient is still responding to treatment and continuing therapy without any particular adverse events.Another patient who participated in a clinical trial experienced a reduction in tumor size but also encountered ocular adverse events. While more data is being accumulated, appropriate management strategies and sufficient clinical data still need to be further established.Q. Do you have any recommendations on improving the ovarian cancer treatment environment?Ultimately, the hope of all patients and medical professionals is for the development of a treatment that can achieve a cure even in platinum-resistant ovarian cancer. While rare cases of near-complete remission have been observed with existing treatment options, the mechanisms underlying such high treatment responses remain unclear. Active research and development of various novel drugs are underway to understand these mechanisms and identify more effective treatment strategies.Alongside this, I believe that managing adverse events is just as critical as treatment efficacy in the real-world setting. It is not uncommon for patients to have poor treatment adherence due to difficulty making outpatient visits because of their circumstances. In such situations, the occurrence of adverse events can lead to rapid treatment discontinuation. Therefore, I believe that the better the drug, the more crucial adverse event management becomes in actual clinical practice.Treatment accessibility is also a crucial factor. Elahere is the first treatment to demonstrate a statistically significant improvement in overall survival (OS) in platinum-resistant ovarian cancer. If practical access improves in the future, we expect more patients will have the opportunity to receive this treatment.
- Opinion
- [Reporter's View] Is reimb criteria restricting patient access?
- by Son, Hyung Min Feb 05, 2026 07:47am
- The same question is asked whenever the reimbursement criteria for a new drug are unveiled. "Is regulation aligning with the disease treatment flow?"Concerns are mounting about the reimbursement criteria for Ozempic, a GLP-1-based diabetes drug. Despite the goal of its criteria to suppress prescriptions for obesity, the criteria may narrow treatment access.Professionals in clinical practice are continually raising issues. They assert that the government's goal in reducing unregulated prescriptions for obesity treatments can be acknowledged. Yet if this goal is applied too broadly, it could undermine effective diabetes treatments.The government limited Ozempic reimbursement recipients by considering factors such as body mass index (BMI), blood sugar levels, and prior medication history. The problem is that the criteria were designed to focus on reducing the risk of abuse rather than reflecting patient condition variables.According to the reimbursement criteria for Ozempic, the drug can be prescribed as part of a triple therapy including metformin and sulfonylurea (SU), or in combination with insulin to Type 2 diabetes patients whose glycated hemoglobin (HbA1C) levels remain at 7% or higher despite at least 2 to 4 months of combination drug therapy. Following the initial treatment, when patients experience substantial improvement in blood sugar levels, their treatment scheme can be switched to a dual combination therapy (metformin + Ozempic).Additionally, reimbursement is applied to the combination therapy of Ozempic plus basal insulin (±metformin) if the glycated hemoglobin (HbA1c) level remains at 7% or higher even after administering basal insulin monotherapy or metformin combination for more than 2-4 months, or if the HbA1c remains at 7% or higher following the combination therapy of Ozempic and metformin (±SU).In current clinical practice, combination therapies centered on DPP-4 inhibitors and SGLT-2 inhibitors are widely used, and there is a trend toward increasingly excluding SU due to the risk of hypoglycemia and specific patient characteristics.Despite this, requiring patients to return to sulfonylureas and essentially forcing a "treatment failure" to meet reimbursement requirements feels less like a typical clinical pathway and more like a regulatory mandate that mandates failure.Another concern is that even non-reimbursement prescriptions are not permitted for patients who fail to meet the reimbursement criteria. While the intent is to block use for obesity purposes, the result is the elimination of even the minimum leeway to adjust treatment strategies based on individual patient characteristics. This has resulted in backlash, with accusations that the government has arbitrarily and preemptively defined the therapeutic needs of patients.A bigger problem is the high probability that these criteria will be applied identically to other GLP-1 class diabetes treatments to be released in the future. If the structure of the criteria is finalized, with even innovative new drugs having their reimbursement status judged through a single frame of BMI, blood sugar, and prior treatment conditions, the domestic reimbursement policy will inevitably tilt further toward regulation. This serves as a warning that South Korea's clinical practices may continue to diverge from international treatment guidelines.In the case of migraine treatments, international and domestic guidelines recommend calcitonin gene-related peptide (CGRP) class agents as first-line medications.However, because Korean insurance criteria are excessively stringent, there are cases where patients must wait until their pain worsens or repeat multiple medication failures to meet reimbursement requirements. Consequently, new drugs that were granted reimbursement to increase treatment accessibility have become even more out of reach for patients.Everyone acknowledges that institutional mechanisms to prevent misuse and abuse are necessary. However, a structure in which regulations are created first without clear standards ultimately result in uncertainty and disadvantages patients.If the purpose of regulation is to aid patient treatment, what is needed now is not simple control, but a sophisticated design that places the patient at the center.
- Opinion
- [Reporter's View] On downsizing global pharma sales force
- by Son, Hyung Min Jan 27, 2026 06:56am
- The notable change currently observed in the global pharmaceutical industry is a series of organizational restructurings, commonly referred to as Early Retirement Programs (ERP).Major global pharmaceutical companies have already implemented large-scale ERPs centered on sales positions, and the trend of downsizing continues even in traditional areas where sales force strength was historically critical, such as chronic diseases. This trend is similarly impacting the South Korean subsidiaries of multinational corporations.The most apparent reason for this trend is cost efficiency; however, the term "Role Redesign" is increasingly used within these organizations. These adjustments are not intended merely to reduce the workforce; instead, job functions are being restructured as AI-based sales models become fully operational.For several years, global headquarters have been building AI-based systems for visibility optimization, digital channel automation, and prescription-prediction models, while downsizing sales organizations. The information that was previously gathered through field-based sales activities is now presented first by the system, which even recommends specific behavioral strategies.Multinational subsidiaries in Korea and domestic pharmaceutical companies find themselves at a similar crossroads, having reviewed or implemented ERPs in recent years. However, a persistent issue is that ERP in the pharmaceutical sector is still often interpreted as a short-term efficiency measure to improve sales productivity.Global trends indicate that ERP is linked to organizational redesign, job redefinition, and the acceleration of AI and digital transformation. The era where simply reducing staff created efficiency has ended. The more critical question now is which roles should remain.Specifically, the functions of a sales organization are beginning to be divided into tasks AI can perform and those it cannot. The first category includes repetitive and standardized tasks that AI and data can replace. Systems now provide visibility ranking, channel mixes, and basic messaging faster and more accurately than humans.The second category involves high-difficulty roles that AI cannot replace. This includes areas requiring qualitative judgment, such as understanding hospital decision-making structures, regional characteristics, differences in patient distribution, subtle market fluctuations at the time of competing drug launches, and identifying the actual needs of medical professionals.These are the underlying reasons why global firms have expanded Key Account Management (KAM), Hospital Access, and Medical collaboration organizations following their restructurings. Traditional sales are cut down, not strategic sales.As ERP becomes more prevalent in the Korean market, the most significant challenge lies in updating Key Performance Indicators (KPIs) and job standards simultaneously. If an organization implements AI-based strategies but continues to evaluate employees based on legacy metrics, such as the number of visits, simple sales volume, or regional distribution, ERP will only serve to make the organization more inefficient.ERP must be a process of redefining what the organization considers "performance," rather than just adjusting headcount. Immediately following downsizing, global companies transitioned their KPIs to focus on strategy execution, targeting appropriateness, and multi-channel utilization. Conversely, many domestic companies remain tethered to past metrics.Ultimately, ERP is the starting point of change. Whether that change becomes a foundation for new competitiveness or remains a short-term cost-cutting exercise depends on how quickly an organization can redefine roles and standards.In the era of AI, a salesperson's status is determined not by who has accumulated the most data, but by who interprets it correctly. As global restructuring accelerates, pharmaceutical companies must redesign the future of their sales organizations. What remains is more important than what is cut down.
- Opinion
- [Reporter’s View] Reform of reimb reevaluations
- by Jung, Heung-Jun Jan 19, 2026 09:02am
- While it is difficult to predict whether the revision of reimbursement reevaluation standards lead to an expansion or contraction of the list of targeted products, a transparent selection process appears necessary to prevent unnecessary controversy.Without proper discussion on the designation of active ingredients subject to re-evaluation, there is concern that wasteful debates will follow.Even before today's (15th) discussion on revising the reevaluation criteria at the Drug Reimbursement Evaluation Committee, the Pharmaceutical Society for a Healthy Society (PSHS) has voiced opposition, stating, “The direction is tilting solely toward the convenience of the pharmaceutical industry.”The group claims that the revised criteria lack clarity, particularly in cases where medicines are recommended by academic societies or experts, or where conflicting clinical data and efficacy evidence exist.Compared to the previous system, under which old drugs were filtered annually based on overseas reimbursement status and reimbursement claims, the new standards are seen as more ambiguous. As a result, critics fear that the reform may be aimed at shrinking the scope of products subject to re-evaluation.Conversely, however, this also means that any drug deemed necessary can be reevaluated, regardless of factors like listing countries or claim amounts.For instance, even drugs with claims under 0.1% (approximately KRW 20 billion) or listed in at least one foreign country (A8) would no longer be completely excluded from reevaluations.Last year, HIRA announced plans to revise the criteria, discussing expanding the scope to include items with claims under KRW 10 billion and fewer than three overseas countries listed.If that original direction is maintained, the revision of reimbursement reevaluation criteria could actually lead to an expansion of reevaluation targets, contrary to the concerns raised by the Pharmaceutical Society for a Healthy Society.Of course, industry backlash is expected even in this case. It will be difficult to accept the inclusion of ingredients that were not previously subject to reevaluation under the old criteria.Ultimately, regardless of where the impact of the standard revision lands, mechanisms are needed to minimize unnecessary controversy.At present, the revised criteria have not yet passed the Health Insurance Policy Deliberation Committee, nor has a concrete implementation plan been announced, making it too early to reach any firm conclusions. However, if a clear and broadly acceptable selection process is established, the reform could achieve meaningful progress in post-listing management of reimbursed drugs in Korea.
- Opinion
- [Reporter’s View] Need rationale to establish a new fund
- by Lee, Jeong-Hwan Jan 15, 2026 08:47am
- The Ministry of Health and Welfare has made clear its intention to secure approximately KRW 1 trillion in savings for the National Health Insurance (NHI) system by implementing a drug pricing reform centered on a dramatic reduction in generic drug reimbursement rates (from 53.55% to the low 40% range).At the same time, the ministry has announced plans to expand reimbursement coverage for innovative new medicines in order to strengthen patient access.Domestic pharmaceutical companies, whose operations rely heavily on generics as a primary revenue source, are criticizing this move, calling it “health insurance administration that cuts domestic generic drug prices to pay for multinational pharma’s innovative new drugs.”Their opposition stems from the fact that the announced pricing reform includes virtually no price-reduction mechanism for new drugs, while the government continues to send positive signals toward expanding reimbursement for increasingly expensive high-priced innovative drugs.Critics argue the policy has failed to strike a balance within the limited health insurance budget between domestically produced generics and innovative drugs largely supplied by multinational pharmaceutical companies.As a result, it is becoming increasingly clear that expanding reimbursement for new drugs, fostering the domestic generics industry, and maintaining the sustainability of the NHI system are difficult goals to achieve simultaneously under a single insurance budget.Amid this situation, the proposal by Jung-gu Kang, President of the Health Insurance Review and Assessment Service (HIRA), is drawing renewed attention.At a policy briefing held on January 12 under Minister of Health and Welfare Eun-Kyoung Jeong, Kang strongly advocated for a new approach to expanding reimbursement for ultra-high-priced drugs such as anticancer drugs and treatments for rare and intractable diseases.He reiterated the need to establish a separate fund dedicated exclusively to reimbursing ultra-high-priced “one-shot” curative therapies that demonstrate near-complete disease remission after a single administration.Kang had already raised this idea in his New Year’s address in 2025, proposing a separate fund for ultra-high-priced drugs with limited cost-effectiveness in order to improve patient access.The intent is to create a separate funding source outside the national health insurance budget to increase the coverage rate for high-cost treatments used for severe diseases.Discussions on establishing a separate fund for ultra-high-priced new drugs have been raised by multiple lawmakers in the 20th, 21st, and current 22nd National Assemblies, with several lawmakers introducing bills on the matter.A prime example is the bills to amend the National Health Insurance Act and the Lottery Act to allow the National Health Insurance Service to receive lottery revenue allocations as stipulated by the Lottery Fund Act.Minister Jeong believes it is necessary to consolidate the Ministry of Health and Welfare's position and rationale based on Kang's proposal and the pending legislative bills in the National Assembly. This would involve creating a separate fund dedicated to covering the reimbursement of ultra-high-priced treatments costing hundreds of millions to billions of won, thereby alleviating the burden on the NHIS budget.Prior to her appointment as Minister, during her confirmation hearing, Jeong had expressed some skepticism regarding the establishment of a separate fund for rare diseases.At the time, Jeong stated, “If the required finances exceed the fund's size due to factors like the application of high-cost treatments, flexible management could become difficult. Rather than establishing a separate fund, the priority should be given to continuously expanding reimbursement coverage.”Now, with domestic pharmaceutical companies strongly opposing the generic price cuts for KRW 1 trillion in NHIS savings, Jeong’s more forward-looking review of a separate fund may be necessary to avoid criticism that the government is simply ‘wringing a dry towel’ through drug price controls.Just as the ministry is aggressively considering the establishment of a Regional Healthcare Development Fund to strengthen local, essential, and public healthcare, a similar approach should be applied to the dual mission of expanding access to ultra-high-priced medicines and fostering Korea’s pharmaceutical and biotech industry.
- 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.
