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- 2026-04-28 23:25:28
- Opinion
- [Reporter's View] KIMES calls for policy making
- by Hwang, byoung woo Mar 26, 2026 09:29am
- 'The 41st Korea International Medical & Hospital Equipment Show (KIMES 2026)' unveiled the Korean medical device trend shift.More companies are showcasing Artificial Intelligence (AI), which is now regarded as essential, and the technology is shifting to 'how AI is utilized.'A prominent feature of this year’s exhibition is the presentation of specific visions for the stage after adopting technology. Rather than simply emphasizing AI's accuracy, major companies provided detailed explanations of interoperability with hospital systems (PACS/EMR), the repurposing of accumulated data, and revenue structures based on Software as a Service (SaaS) models.This means that the medical AI industry has moved past the initial stage of debating 'whether to adopt' and has entered a maturity phase, focusing on clinical utility and sustainable business models. However, a brutal reality confirmed at the show is that this technological advancement is not immediately translating into market expansion.While there is a consensus that new technology is necessary in the field, the pace of implementation often falls short of expectations due to cost burdens and institutional limitations.This trend in the industrial field aligns with the direction of the recently launched "Second Stage of the Korea Interagency Medical Device R&D Project."While the first stage focused on establishing a technological foundation and building a pipeline for domestic medical devices, the second stage clearly defines a 'market entry-centered' support structure that covers clinical trials, licensing, and commercialization to ensure these technologies take root in actual medical settings.It is encouraging that government policy and industrial trends are aligned with the same goal. The second stage serves as a 'verification stage' to confirm whether developed technologies can avoid being shelved and instead have their value recognized in the market. However, industry workers remain concerned about the disconnect between each stage.The reason for this concern is that the process leading from technological development to hospital adoption, reimbursement application, and market expansion often fails to connect organically, frequently stopping at individual stages.Ultimately, the success or failure of the domestic medical device industry will depend not on the perfection of the technology itself, but on how the 'connection structure' is designed to allow that technology to flow into the actual market.Industry experts suggest that leaving the integration of technology entirely to the market may take too long and face inherent limitations. They point out that more proactive consideration is needed, especially since the global market is currently competing on a similar level.In fact, the platform strategies and subscription models emphasized at KIMES will inevitably face constraints on expansion unless the reimbursement system and institutional support functions are provided.The industry goals identified at KIMES 2026 and the policy direction of the second interagency project are in alignment. However, a gap in speed and execution remains between these two trends. How effectively this policy-wise and field-wise gap can be bridged will likely be the key variable determining the global competitiveness and market growth rate of Korea's medical devices in the future.It is now time for policy-making that ensures R&D achievements do not remain confined to show booths but lead to outcomes in patient clinics.
- Opinion
- From pharmacy practice to new drug review
- by Jung, Heung-Jun Mar 25, 2026 07:20am
- Even after a new drug is developed and released to the market, there is one hurdle that must be cleared for patients to fully benefit from it: the National Health Insurance reimbursement listing.How this initial step is handled, in reviewing whether a drug should be covered by health insurance, determines both patients’ access to treatment and the balance of Korea’s insurance budget.The organization guarding that crucial gate is the Department of Drug Management of the Health Insurance Review and Assessment Service (HIRA). It is also one of the operational departments where pharmacists can create synergy based on their understanding of pharmaceuticals.Assistant Directors Jae-young Choi (left) and Jin-woo Song of the New Drug Listing Division, Department of Drug ManagementDailyPharm met with Jin-woo Song (38) and Jae-young Choi (34), assistant directors working in the Department of Drug Management, by drawing on their clinical experience in hospitals and pharmacies. We were able to hear their candid thoughts on what their new roles entail after hanging up their pharmacist’s coats, as well as the challenges and satisfactions they face.Both have been with the agency for 1-2 years. What has your career as pharmacists been like?Jin-woo Song (hereinafter Song): After graduating from pharmacy school in 2023, I worked at the Pharmacy Department of Severance Hospital for 2 years. I gained experience in the Inpatient Dispensing Unit, Special Dispensing Unit, Pharmacy Information Unit, and Outpatient Dispensing Unit before joining HIRA last June.Jae-young Choi (hereinafter Choi): I also have experience working as a night-shift pharmacist at a hospital and in a community pharmacy after graduation. I joined HIRA in December 2024, so it’s been just over a year now.Among various career options, why did you choose to join HIRA?Song: While working at the hospital, I realized that I am well-suited to a well-established system-based institution. I became curious about how reimbursement criteria and procedures for pharmaceuticals are set and decided to move to HIRA.Assistant Director Jin-woo SongChoi: After graduation, I became increasingly interested in social pharmacy. I applied because I became interested in new drug listing and management of already listed drugs to improve patient access to treatments. I found the idea of approaching pharmaceuticals from the public sector appealing.Did you prepare anything specifically in order to join HIRA?Song: Since they make the hiring process very convenient for pharmacists, there was nothing specific I needed to prepare. If you have at least 1 year of experience at a university, research institute, pharmaceutical company, hospital, or pharmacy, you only need to submit a cover letter. The written test is waived. As long as you meet the requirements, you can take the interview, and even upon joining, you are hired at Grade 4 (assistant director).What kind of work are you doing in the Department of Drug Management?Song: I have been working in the New Drug Listing Division since June last year. My work involves the overall process related to reimbursement listing for new drugs. I handle cost-effectiveness reviews related to expanded criteria for risk-sharing agreement drugs as well as assessments of the appropriateness of renewing RSAs for such drugs.Choi: I’m part of the Agenda Team within the New Drug Listing Division. I joined in December 2024, so it’s been just over a year. When I’m assigned cases involving new drugs or RSA drugs, such as applications for reimbursement decisions, requests to expand reimbursement criteria, or evaluations related to contract expiration, I review them based on criteria like clinical utility and cost-effectiveness. I then present those results to the Drug Reimbursement Evaluation Committee.How has your experience in hospitals and pharmacies been helpful?Song: I handled many anticancer drugs and medications for severe diseases at a tertiary hospital. Many of the drugs I encountered back then are now being submitted for reimbursement listing. The drug information, reimbursement criteria, and guidelines I referred to while handling information management tasks have been very helpful.Choi: I worked at a pharmacy until just before joining the agency, so there wasn’t much direct overlap with my current duties. However, having studied pharmacy for many years, my background knowledge helps when exploring new areas.Assistant Director Jae-young ChoiHas your perception of HIRA changed since joining?Song: At first, I worried that the rigid organizational culture might be difficult to adapt to. But after experiencing it firsthand, I found that there is a very horizontal and mutually respectful organizational culture.Choi: It wasn’t until I was about to graduate from pharmacy school that I learned there were pharmacists working at HIRA and that they handled drug management tasks. After joining, I realized that the drug-related work HIRA handles is more diverse than I had imagined.What is the most challenging aspect of your work?Song: Newly launched drugs are expensive, so using them as treatments without reimbursement places a heavy financial burden on patients. We receive many requests for reimbursement, but the challenge is that we cannot simply grant the requests of those who are just waiting for reimbursement.Choi: The fact that I have to continuously study new diseases is both the best part and the most challenging aspect of the job.When do you feel a sense of accomplishment?Song: As part of the New Drug Listing Division’s duties, we review the appropriateness of reimbursement at the DREC. I feel a sense of accomplishment when the reimbursement appropriateness of an item I reviewed is approved.Choi: It’s the moment a new drug I’ve reviewed gets actually listed. I still lack experience and have a lot to learn. Going forward, I want to think more deeply about the social impact as I do my work.Do you have any advice for pharmacy students or pharmacists interested in joining HIRA?Song: While you may be fulfilling various roles in hospitals or pharmacies, there are tasks that can only be performed at HIRA. You’ll likely find a sense of fulfillment and accomplishment here that’s distinct from what you’d experience elsewhere.Choi: Given the nature of our work, I feel we’re doing things that are hard to experience elsewhere. If you’re interested in the public sector beyond clinical practice, I encourage you to apply during our recruitment period.
- Opinion
- [Desk’s View] On exempting innovative pharmas from price cuts
- by Lee, Tak-Sun Mar 10, 2026 08:56am
- Fostering the pharmaceutical and biotech industry while ensuring the soundness of the national health insurance budget is no easy task.The two are intertwined like a double-edged sword. Cutting drug prices indiscriminately to save money risks stifling the industry, yet allowing skyrocketing drug prices to go unchecked in the name of industry growth will quickly drain the health insurance coffers.That is why the government’s push to cut generic drug prices is undoubtedly a card played as the health insurance coffers are running dry. Yet, it is equally impossible to neglect the pharmaceutical and biotech industry, which is only now beginning to gain stature.The ‘Korea Innovative Pharmaceutical Company’ certification system emerged after long deliberation between fostering industry and maintaining fiscal soundness. The government aimed to identify and nurture the so-called ‘pharmaceutical companies capable of developing new drugs’ through this certification.However, 15 years have passed since the system's establishment in 2011, and one can't help but wonder if it has effectively achieved its original goal of fostering companies. The number of certified innovative pharmaceutical companies has now risen to 49, yet very few have developed drugs capable of competing on the global stage.The pharmaceutical industry claims the current certification doesn't offer ‘significant enough benefits to push promising companies forward.’ Rather, it's seen as merely ‘enough to keep them afloat within their group.’The most significant benefit pharmaceutical companies perceive from the Innovative Pharmaceutical Company certification is preferential drug pricing. Holding this title grants preferential treatment in pricing calculations for first generics or incrementally modified new drugs. For instance, while a standard company's first generic listing is priced at 59.5% of the highest price, an Innovative Pharmaceutical Company can set its price at 68%. Considering that drug prices directly translate to sales revenue, this means that certified companies can earn 7.5% more than non-innovative companies.However, this pricing preference is only a temporary benefit. After one year, the premium disappears, and “non-innovative” pharmaceutical companies end up with the same drug prices as the certified innovative ones.Even so, starting from the same line with even a slightly higher price is undeniably advantageous. This is why many pharmaceutical companies celebrate or despair over the results of the innovative pharmaceutical company review, which takes place every two years.If the innovative pharmaceutical company certification system is to better fulfill its purpose of ‘screening and fostering’ firms, the direction should be to tighten the review standards while expanding the benefits.In other words, the government should identify companies that truly have the capability to develop new global drugs while providing full support until they actually develop them.Some argue that innovative pharmaceutical companies should be exempt from unilateral price cuts made for listed drugs. From the perspective of fostering domestic pharmaceutical companies, this isn't entirely wrong. But would any company spend tens or hundreds of billions of won on new drug R&D while facing the risk of declining sales just to be saved from price cuts on existing drugs? Just for the title of being a certified innovative pharmaceutical company?However, even such benefits, if granted only to the 49 certified innovative pharmaceutical companies, would trigger backlash from non-innovative companies. There is already distrust in the field regarding the standards used to certify innovative pharmaceutical companies.But still, current discussions on drug price cuts for already-listed products and on reforming the innovative pharmaceutical company system need to be somewhat aligned. Rather than pushing through generic drug price cuts in a hasty manner despite strong opposition from the industry, perhaps it would be better to take a little more time and discuss them along with substantive benefits for innovative pharmaceutical companies. At the same time, the criteria for selecting innovative pharmaceutical companies should be reorganized so that they are truly centered on companies that genuinely engage in R&D.From a cautious standpoint, that may be the only way to both foster the industry and maintain health insurance sustainability.
- Opinion
- [Reporter’s View] Era of drugs better known than diseases
- by Son, Hyung Min Mar 10, 2026 08:55am
- A notable shift has recently emerged in clinical practice where drug names are increasingly being known before the diseases they treat.For example, when discussing obesity treatment, many people now think first of ‘Wegovy (semaglutide)’ or ‘Mounjaro (tirzepatide)’ rather than the disease itself. A similar trend is emerging for major immune disorders like atopic dermatitis. This change is also evident in the field of cancer treatment. It is now commonplace to hear specific drug names mentioned before the broader category of immuno-oncology drugs.Whereas diseases were traditionally recognized first, followed by treatments, we now frequently see drugs becoming symbolic markers that define or represent the disease itself.This shift cannot be explained simply by increased brand recognition. As more new drugs actually shift treatment paradigms, these therapies have taken on the role of driving disease awareness.For certain conditions, the emergence of specific treatments has altered diagnostic and therapeutic strategies, leading the drug name to become synonymous with the disease's treatment.The role of pharmaceutical companies has also evolved. Whereas disease awareness preceded the introduction of treatments, it is now common for disease awareness activities to proceed alongside new drug development. With treatment development and disease education occurring simultaneously, the drug name naturally becomes central to shaping disease awareness.The shift does have positive aspects. When innovative treatments emerge for diseases with limited therapeutic options, they inherently attract patient and clinician attention, serving as catalysts for heightened disease awareness. Indeed, for some conditions, social awareness of diagnosis and treatment has increased significantly following the introduction of such drugs.However, there are also concerns. If the structure where drug names become known before the disease itself solidifies, there is a risk that awareness could center around specific treatments rather than fostering a deeper understanding of the disease itself. While medicine inherently evolves through diverse treatment strategies and multiple options, public perception can be simplified around a single brand name.The influence of new drugs continues to grow. At the same time, the role of the pharmaceutical industry is expanding beyond developing therapies to shaping disease awareness itself. This means companies are becoming entities that shape disease perception, going beyond just treatment developers.Consequently, the social responsibility that the pharmaceutical industry must shoulder is also growing. As the influence of new drugs expands, so does the need to examine how this power operates and what its implications mean for the healthcare environment and patients. Now that pharmaceutical innovation can reshape disease awareness itself, the industry must consider its public responsibility towards patients and society, alongside its private corporate interests.
- Opinion
- ‘LEO Pharma serves as a KOR–DEN healthcare bridge’
- by Son, Hyung Min Feb 20, 2026 10:04am
- Korea and Denmark share similarities. Both nations operate universal healthcare systems and face the dual challenges of introducing innovative treatments while maintaining fiscal sustainability. The policy environment in both countries shares the dilemma of preserving public value while promoting research and development.Building on these shared priorities, the two nations have expanded multilayered partnerships involving governments, companies, and research institutions across various healthcare fields, including infectious disease response, aging populations, digital health, and chronic disease management.Established in 2011, LEO Pharma Korea has served as a bridge within the Korea–Denmark healthcare collaboration framework, particularly in dermatology. Through close engagement with Korean clinicians and evidence-based medical research, the company has executed a patient-focused innovation strategy while functioning as a strategic hub connecting the results to the Danish market.Against this backdrop, Frederik Kier, Executive Vice President of International Operations at LEO Pharma, who was appointed in June last year, recently visited Korea. His visit focused on reviewing the Korean subsidiary's strategy and discussing the direction of Korea–Denmark pharmaceutical and biotech collaboration with Mikael Hemniti Winther, Ambassador of Denmark to the Republic of Korea.Dailypharm recently met with Ambassador Winther and Executive Vice President Kier at the Danish Ambassador's residence in Seongbuk-dong, Seoul, to discuss bilateral healthcare cooperation, Korea’s strategic role, and the practical implementation plans for patient-focused innovation.“Designing public value and innovation together”… Emphasizing Korea-Denmark healthcare cooperationMikael Hemniti Winther, Ambassador of Denmark to the Republic of Korea.Ambassador Winther identified how Korea and Denmark's commonality lies not just in systems but in values. He emphasized that both nations have democratic systems and operate their healthcare systems on the basis of social agreement on welfare and public responsibility.Ambassador Winther said, “The Danish government views patients not as customers but as individuals for whom it bears responsibility. Policies are designed around that responsibility.”Denmark established a universal healthcare system early and has operated a healthcare infrastructure centered on public hospitals. Within this structure, pharmaceutical companies have served as a vital link, acting as a critical link that translates public research outcomes into real-world therapies beyond mere supply.He explained, “Denmark has pursued a welfare society relatively early on. Health insurance and the healthcare system serve as its core pillars. The system functions only when high-quality treatments are available for the patients. To achieve this, the government and pharmaceutical companies need to collaborate toward common goals.”He added, “The welfare system entails enormous costs. The key challenge is how to design incentives that encourage innovation while maintaining competition and transparency.”He also emphasized the culture of cooperation between the government and pharmaceutical companies. In Denmark, public research institutes, universities, hospitals, and companies are organically connected, and industry opinions are partially reflected in the system design process.He explained that cooperation between Korea and Denmark can also be understood within this context. The two countries continue policy exchanges across various fields, including infectious disease response, aging populations, and digital health. The embassy regularly communicates with Danish companies operating in Korea.Ambassador Winther stated, “Currently, Danish companies are actively collaborating not only in the pharmaceutical sector but across diverse industries, sharing the fundamental values Denmark upholds. I believe there remains substantial potential for expanded collaboration going forward.”LEO Pharma's execution strategy… Securing leadership in ‘medical dermatology’Frederik Kier, Executive Vice President of International Operations at LEO PharmaEVP Kier described Korea’s importance from an industry perspective. LEO Pharma, he noted, has dedicated more than 115 years to dermatology, defining its mission as leadership in Medical Dermatology.EVP Kier stated, “LEO Pharma aims to become a global leader in dermatology and is offering a broad range of treatment options for patients with skin conditions in Korea. Our existing portfolio includes diverse product lines, from acne therapies to treatment for psoriasis and atopic dermatitis.”Marking its 15th anniversary in Korea, the company has expanded its presence in recent years. One prime example is its atopic dermatitis treatment ‘Adtralza (tralokinumab)’, which received domestic approval in 2023 and was added to the national health insurance reimbursement list in 2024.The EVP explained that Adtralza has secured differentiated data in improving lesions on exposed areas like the head and neck and hands, establishing itself as a meaningful option in clinical practice.EVP Kier said, “The Korean market already has various atopic dermatitis treatment options. Nevertheless, Adtralza deserves attention for its superior efficacy on exposed areas like the head, neck, and hands. These areas are known to be challenging to treat, and it is precisely in these areas that we believe Adtralza provides tangible and meaningful benefits to Korean patients.”LEO Pharma has also secured Korean approval for ‘Anzupgo Cream (delgocitinib),’ a topical pan-JAK inhibitor targeting chronic hand eczema, and added it to its dermatology portfolio. Anzupgo is a topical formulation that inhibits JAK1, JAK2, JAK3, and TYK2 and was developed for patients who do not respond sufficiently to existing therapies.EVP Kier explained, “Chronic hand eczema is an inflammatory disease that persists for more than 3 months or recurs frequently, with a significant patient population not responding adequately to existing topical treatments. It represents a clear area of unmet medical need. Anzupgo Cream demonstrated strong clinical efficacy and was shown to improve multiple eczema symptoms. We are currently in the final stages of preparation for its official launch in Korea.”LEO Pharma is also preparing reimbursement procedures for Spevigo (spesolimab), a treatment for acute exacerbations of generalized pustular psoriasis (GPP). The company recently acquired commercialization rights through a licensing agreement with Boehringer Ingelheim.EVP Kier described the developments as part of building an end-to-end portfolio spanning mild localized diseases to severe and rare dermatologic conditions.EVP Keir specifically highlighted the Korean market as a strategic operational base in Asia. In his view, Korea is not merely a sales market, but an operational hub for data generation through clinical trials involving Koreans and a joint promotional base for raising awareness on the necessity of long-term treatment among healthcare professionals.EVP Keir stated, “Chronic skin diseases are not conditions resolved with short-term prescriptions. Both clinicians and patients must share a common understanding of the need for long-term management.”He added, “LEO Pharma views providing therapies for diseases with significant unmet medical needs as its most important contribution. To further establish leadership in dermatology, we will continue developing new candidates and treatment options within these disease areas.”“Healthcare as both industry and diplomacy”… the need for government–private collaborationThe significance of the discussion extended beyond introducing LEO Pharma’s corporate strategy. Its weight lay in the shared recognition, based on the common ground that both Korea and Denmark are welfare states operating public healthcare systems, of how to design and implement healthcare as a pillar of national strategy.Ambassador Winther said, “Denmark holds Korea's healthcare system in high regard. To address common challenges like aging populations and fiscal burdens, cooperation between the government and private sectors will become increasingly vital going forward. Healthcare is not merely an industry but a policy domain that the state must shoulder responsibility for. We need a structure where intergovernmental policy dialogue and corporate activities are discussed together.”EVP Kier echoed this perspective. “Korea possesses an advanced healthcare system, and its medical professionals demonstrate high understanding and implementation capabilities regarding innovative therapies. LEO Pharma seeks to act not merely as a supplier but as a long-term partner aligned with Korean healthcare professionals.”Both Ambassador Winther and EVP Kier expressed confidence in the expansion of Korea–Denmark cooperation.Another key theme emerging from this discussion was LEO Pharma's expansion of its domestic communication scope.EVP Kier stated, “While engagement previously centered on patient groups in the past, it has recently expanded to include academic exchanges and clinical discussions with Korean medical professionals, broadening the scope of collaboration. This expansion of domestic communication contributes to enhancing understanding within the healthcare field and strengthening the practical implementation capabilities for innovative therapies.”EVP Kier also added that certain skin conditions significantly impact patients' social lives and work performance. He remarked, “These conditions require greater attention from the medical community and society at large. LEO Pharma will continue being committed to introducing innovative new drugs to Korea.”Ambassador Winther said, “Korea and Denmark face significant demographic and economic challenges. Through close cooperation among health authorities, governments, and the private sector, both nations can share experience and deliver greater benefits to patients,” he stated.He concluded, ”The values shared by companies rooted in Denmark are reflected not only in LEO Pharma's treatments but also in the overall operations of Danish companies in Korea. We hope LEO Pharma's activities will contribute positively to Korean society.”
- 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.
