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- 2026-04-28 13:12:41
- Company
- Lokelma launches in Korea…targeting the gap in hyperkalemia management
- by Son, Hyung Min Apr 26, 2026 01:45pm
- A new drug capable of resolving the treatment dilemma of discontinuing RAAS inhibitors during hyperkalemia management has been introduced in Korea.The new potassium binder ‘Lokelma,’ supported by clinical evidence, is being presented as an option to support a strategy of maintaining RAAS inhibitors, raising the possibility of a shift in the treatment paradigm.On the 22nd, AstraZeneca Korea held a press conference at the Plaza Hotel in Jung-gu, Seoul to mark the domestic launch of Lokelma (sodium zirconium cyclosilicate, SZC), a treatment for adult hyperkalemia.Lokelma is a new drug approved by the Ministry of Food and Drug Safety last November, and represents the first new treatment option in the hyperkalemia field in Korea introduced in about 40 years. Unlike existing organic polymer-based adsorbents, it is an inorganic crystalline potassium binder that selectively captures potassium throughout the gastrointestinal tract and excretes it from the body. In vitro studies confirmed that its potassium selectivity is more than 125 times higher than that of existing treatments, and its non-absorbable nature is also cited as a key differentiator.Hyperkalemia is defined as a serum potassium level exceeding 5.0 mmol/L and commonly occurs in patients with chronic kidney disease, heart failure, and diabetes. In particular, it occurs in 40–50% of patients with chronic kidney disease, and it is reported that approximately one in three (32.8%) patients taking RAAS inhibitors experience hyperkalemia at least once. If it progresses to a severe stage, it can lead to fatal outcomes such as arrhythmia and cardiac arrest.Bum Soon Choi, Professor of Nephrology at Eunpyeong St. Mary’s HospitalThe problem lies in conflicting treatment strategies. While RAAS inhibitors are key medications for protecting the heart and kidneys, their tendency to elevate potassium levels often leads to dose reduction or discontinuation when hyperkalemia occurs.Bum Soon Choi, Professor of Nephrology at Eunpyeong St. Mary’s Hospital, said, “Hyperkalemia is highly recurrent and must be managed as a chronic condition. However, reducing or discontinuing RAAS inhibitors for this reason can worsen the prognosis of cardiac and renal diseases. Since guidelines also recommend maintaining RAAS inhibitors whenever possible, we need treatment strategies that support this.”In fact, guidelines including those from KDIGO and the Korean Society of Nephrology also mention the use of potassium binders as an adjunct strategy to maintain RAAS inhibitor therapy.The presentation highlighted data on the clinical efficacy and treatment persistence of Lokelma.Professor Kim Se-jung of Nephrology at Seoul National University Bundang Hospital evaluated, “Lokelma has demonstrated potassium reduction within one hour of administration, long-term maintenance of potassium control, continuation of RAAS inhibitor therapy, and good tolerability.”Sejoong Kim, Professor of Nephrology, Seoul National University Bundang HospitalIn the Phase 3 ZS-003 study, 753 patients with hyperkalemia were administered 10 g of Lokelma. The results showed a significant decrease in serum potassium levels within one hour, and the proportion of patients reaching normal ranges within 48 hours was 86.4%, which was higher than the 47.8% observed in the placebo group.Furthermore, in the HARMONIZE (ZS-004) study, the mean serum potassium level decreased from 5.6 mmol/L to 4.5 mmol/L within 48 hours, and patients maintained stable, low potassium levels during the maintenance phase.The efficacy was also sustained in long-term data. In the ZS-005 study, 88% of patients maintained normal potassium levels after up to 12 months of treatment, and 87% of patients previously using RAAS inhibitors were able to continue or increase their treatment.In terms of tolerability, an overall favorable safety profile was confirmed in clinical trials involving approximately 1,760 non-dialysis hyperkalemia patients. The most common adverse event, edema, was mostly mild to moderate, and gastrointestinal symptoms such as constipation were manageable through dose adjustment or discontinuation.Professor Choi stated, “Existing chelate-based potassium binders had limitations such as slow onset of action and low compliance due to inconvenience in administration. There has been a continuous demand in clinical practice for new options that allow sustained treatment.”Professor Sejoong Kim emphasized, “Locelma is a treatment option that can help patients maintain RAAS inhibitor therapy without discontinuation when hyperkalemia occurs. Based on clinical evidence, it will serve as a meaningful alternative capable of changing treatment strategies in actual clinical practice.”
- Policy
- First public-private meeting on drug pricing system reform imminent
- by Jung, Heung-Jun Apr 26, 2026 01:45pm
- Photo of the Health Insurance Policy Review Committee meetingThe first meeting of the public-private consultative body, which will determine the specific details of the drug pricing system reform, is imminent. Schedules for working-group meetings are being discussed for next week, and the pharmaceutical industry is forming a Drug Pricing System Task Force (TFT).With the system implementation set for the second half of the year, strategic discussions between the government and the private sector are expected to intensify within this tight timeframe.According to industry sources on the 23rd, the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA) recently formed a Drug Pricing System Response TFT after receiving applications from all pharmaceutical member companies.Five distinct TFTs have been established, including ▲Reorganization of calculation standards ▲Essential and withdrawal-prevention-drugs ▲Raw materials ▲Innovative and semi-innovative models ▲New drugs. The public-private consultations that will decide the specifics of the drug pricing reform will be addressed primarily through these TFTs.The government is also preparing to set the negotiation table, with plans to coordinate the schedule for working-group meetings as early as next week.Among the drug pricing reform measures, the government has scheduled the implementation of price cuts for currently listed drugs, price premiums for innovative and semi-innovative models, and the management of multi-item listings for the second half of the year.This is a tight schedule if discussions are to be finalized by the end of the first half. While behind-the-scenes discussions have already begun, the process of determining details through the public-private consultative body is expected to proceed at a breathless pace.Pharmaceutical companies are particularly focused on reorganizing calculation standards, including price reductions for existing listings and multi-item management. It is reported that most pharmaceutical companies expressed interest in participating in the "calculation standards reform TFT."Among these, the most heavily debated issue is the criteria for determining the timing of price cuts for currently listed drugs. Based on the 2012 listing date, tiered price adjustments will be implemented in Stages 1 and 2; however, the interpretation of combination drugs and data-submission drugs could become a major point of argument.For instance, matters requiring negotiation include how to classify combination drugs that mix single-agent components from both Stage 1 and Stage 2, and how to categorize data-submission drugs that were listed after 2012 but share the same ingredients and administration routes as reference products listed before 2012.Furthermore, regarding 'Multi-item listing management,' where prices are significantly reduced one year after the listing of 13 or more items, it is anticipated that voices will emerge demanding exception clauses for categories such as first generics.Like previous briefings on 'International drug price comparison re-evaluation,' fierce debates over each point of items are expected during public-private consultative body meetings for drug pricing reform.
- Company
- Can rare disease access reforms resolve the blind spots?
- by Eo, Yun-Ho Apr 26, 2026 01:45pm
- Attention is focused on whether the government’s policy to strengthen access to rare disease drugs can be properly implemented in Korea.As many new drugs still remain unattended, in the “blind spots,” some are also expressing doubts about the effectiveness of the policy.Last March, the Ministry of Health and Welfare approved measures to improve the drug pricing system, and formalized its direction to increase patient access to treatments for severe and rare diseases and to appropriately evaluate the value of innovative new drugs.While the pharmaceutical industry views this as a meaningful first step toward lowering the reimbursement barrier for rare disease treatments in Korea’s health insurance system, it notes that innovative rare disease drugs subject to cost-effectiveness evaluations remain in a blind spot.The pharmacoeconomic evaluation is a stage that takes the longest in South Korea’s health insurance reimbursement evaluation process. New drugs that do not meet the criteria for exemption from pharmacoceconomic evaluation or for which the weighted average price of alternative drugs cannot be accepted must follow the existing procedure.One example is ‘Reblozyl (luspatercept),’ a treatment for anemia in myelodysplastic syndromes (MDS) and beta-thalassemia. Reblozyl, which was approved in Korea in 2022, has remained a non-reimbursed drug to date after failing to pass the Health Insurance Review and Assessment Service (HIRA) Drug Reimbursement Evaluation Committee in August 2023.This drug is the first erythropoiesis-inhibiting agent introduced in the MDS and anemia treatment landscape in decades. Based on the Phase III COMMANDS study, it is evaluated to have fundamentally reduced transfusion dependency by achieving a 1.7 times higher transfusion independence compared to existing treatment. A follow-up analysis published last year also suggested the potential for long-term survival benefits, including extended overall survival (OS).Reblozyl is facing structural limitations in the reimbursement entry process. This is because the current health technology assessment framework, which requires setting the low cost of blood transfusions as the comparator, makes it difficult to reflect the drug’s true value.Professor Joonshik Hong, Secretary of the Acute Myeloid Leukemia and Myelodysplastic Syndrome Research Group at The Korean Society of Hematology (Professor, Department of Hematology, Seoul National University Hospital) said, “Reblozyl not only practically changes the treatment paradigm by reducing prolonged hospital stays and the high burden of complications in patients who required repeated transfusions, but also has significant clinical meaning in that it is the first in the hematologic malignancy field to demonstrate long-term transfusion independence, thereby alleviating the burden on healthcare resources.”He added, “Although it is effectively the optimal alternative and the only hope for patients with MDS-related anemia at moderate risk or lower who require blood transfusions, delays in its inclusion in the national health insurance reimbursement list mean that patients are forced to bear the full burden of transfusions and complications.”In addition, in clinical practice, the need for a flexible evaluation system that reflects disease-specific characteristics is being raised for patients with de facto rare diseases who have difficulty making their voices heard within institutional blind spots.In the case of MDS, there are only about 1,700 new cases annually in Korea, and only a very small fraction of those require treatment for transfusion-dependent anemia. Last March, a petition urging reimbursement coverage for Reblozyl was posted on the National Assembly’s public petition platform, but due to such limitations, the agreement rate remained at around 2% until just before its closure.Professor Hong added, “The fact that MDS was excluded from the special calculation for rare diseases is merely because a separate review was not conducted due to it being applied a special designation for severe cancers. But it is, in fact, a rare disease. Just as paroxysmal nocturnal hemoglobinuria, which has a similar pathophysiology and requires chronic blood transfusions, is recognized as a rare disease, MDS also urgently requires flexible evaluation that takes into account its disease-specific characteristics.”
- Opinion
- Anzupgo emerges as a new option in chronic hand eczema
- by Son, Hyung Min Apr 26, 2026 01:45pm
- As the steroid-centered stepwise approach in the treatment of chronic hand eczema reveals its limitations, the non-steroidal topical JAK inhibitor ‘Anzupgo Cream’ is emerging as a new turning point in treatment.In particular, as it is gaining attention as an option to fill the treatment gap before moving on to systemic therapy following treatment failure, the need to redefine treatment strategies in actual clinical practice is being raised.Andrea Bauer, Professor of Dermatology at University Hospital Carl Gustav Carus Dresden, GermanyAndrea Bauer, Professor of Dermatology at University Hospital Carl Gustav Carus Dresden, Germany, recently spoke with Dailypharm about the paradigm shift observed in the treatment of chronic hand eczema.Chronic hand eczema is an inflammatory skin condition that causes red patches, cracking, itching, and pain on the hands. It is aggravated by water, detergents, allergic reactions, and stress, and in severe cases, it can make daily life difficult.Professor Bauer stated, “Chronic hand eczema is defined as a condition in which symptoms persist continuously for more than three months or recur at least twice within one year. It is a disease with a high prevalence, affecting approximately 10% of the total population in European countries, and there are globally agreed-upon diagnostic criteria.Traditional treatment for chronic hand eczema has been based on a step-wise approach.Treatment begins with moisturizer-based management, followed by topical corticosteroids (TCS) and calcineurin inhibitors (TCI). Subsequently, phototherapy or oral alitretinoin may be used, and in severe cases, biologics or JAK inhibitors may be used off-label.The problem is that each step has clear limitations.Until now, treatment options for chronic hand eczema have been limited, leading to the predominant use of potent topical steroids. However, long-term use carries risks of various side effects, including skin barrier damage, skin atrophy, and telangiectasia.Alitretinoin, an oral therapy approved for chronic severe hand eczema, is used in patients who do not respond to at least four weeks of potent topical steroid treatment. It improves symptoms through skin regulation, anti-inflammatory, and immunomodulatory actions, and is known to be effective for the long-term management of chronic severe hand eczema, which has a high risk of recurrence.However, long-term use raises concerns about various side effects such as headaches, elevated lipid levels, and teratogenicity, limiting continued treatment.Professor Bauer said, “Steroids carry a risk of skin atrophy when used for more than 3–4 weeks, making long-term use difficult, and alitretinoin is limited in use not only due to headaches and lipid abnormalities but also because of the risk of birth defects in women of childbearing age. Ultimately, there had been a clear treatment gap with no distinct alternative before moving to systemic therapy following the failure of topical treatment."Anzupgo cream blocks the JAK-STAT pathway… addresses limitations of topical therapy"Anzupgo Cream (delgocitinib) has been proposed as an option to fill this gap.Anzupgo Cream is the only non-steroidal topical cream formulation approved for the treatment of moderate to severe chronic hand eczema in adult patients who do not respond to topical steroid preparations or for whom such treatment is not appropriate.Anzupgo Cream does not contain parabens or steroids. It helps alleviate skin inflammation and itching by inhibiting the JAK-STAT signaling pathway, which is involved in various inflammatory responses, thereby suppressing the activity of JAK1, 2, and 3, as well as TYK2. Anzupgo Cream was approved in Korea last September and was officially launched in the domestic market this year.Professor Bauer said, “Unlike oral JAK inhibitors, it has minimal systemic exposure, giving it an advantage in terms of safety. In clinical studies, adverse event rates were similar to or lower than those in the placebo group.”He continued, “Another important advantage is that it absorbs quickly and has good usability, leading to high patient adherence.”Anzupgo cream has demonstrated broad efficacy across all subtypes of moderate to severe chronic hand eczema in multiple clinical studies.In the clinical trials designated DELTA 1 and 2, adult patients with moderate to severe chronic hand eczema who applied Anzupgo Cream twice daily for 16 weeks showed significant relief from itching starting on the first day of application and from pain starting on the third day, compared to the placebo. Furthermore, at the 16-week mark, the proportion of patients achieving the Hand Eczema Severity Index (HECSI-75) was significantly higher compared to the placebo group.In the subsequent DELTA 3 extension study, the long-term efficacy and safety of Anjupgo Cream were further evaluated, confirming generally good tolerability and consistent clinical improvement even with long-term administration. The initial treatment effect was stably maintained in the 52-week data, which included the 16-week main study and the 36-week extension study.Recent expert consensus positions Anzupgo cream as the only non-steroidal topical option between steroid failure and systemic therapy.Professor Bauer stated, “In German clinical practice, we are also observing cases where skin that has thickened due to chronicity returns to a near-normal state upon application of Anjupgo Cream. Patient satisfaction is high as it gradually improves wrinkled and rough skin.”The professor emphasized the importance of treatment timing.Professor Bauer noted, “If the condition remains uncontrolled after 1–2 cycles of steroid treatment or recurs immediately after discontinuation, treatment should be switched without delay. As the disease becomes more chronic, treatment becomes more difficult, so early intervention is key.”He explained, "Anjupgo Cream can be effective in various subtypes of chronic hand eczema, such as bullous and hyperkeratotic types. In particular, patients with prominent inflammatory symptoms show a rapid response. For patients with hyperkeratotic eczema who have thickened skin, absorption may take some time, but consistent use will yield results.”
- InterView
- [Reporter's View] What's fair for addressing unmet needs
- by Son, Hyung Min Apr 26, 2026 01:44pm
- Now, cancer therapy has entered a stage where a single option cannot explain it all. Previously, when cytotoxic chemotherapy was the center of treatment, the type of cancer was the core criterion for determining a treatment strategy.However, the situation is different now. Even within the same cancer type, entirely different agents are selected based on biomarkers, and even the sequence of treatment and combination strategies varies. The structure has changed to the point where a single disease is effectively split into several different diseases.This change is not a phenomenon limited to specific areas. Non-small cell lung cancer (NSCLC) treatment has been subdivided based on various genetic mutations, and the approach to colorectal cancer also varies depending on biomarker characteristics such as BRAF. Targeted-based therapy is also expanding in rare cancers like biliary tract cancer.Even in diseases where options were limited in the past, the treatment strategy must be redesigned.The problem is that this variation does not stop at simply increasing options but leads to an expansion of the treatment scope.Treatments previously applied primarily to metastatic patients are gradually expanding to include patients with stages 1 to 3, the early-stage patient group. As neoadjuvant, adjuvant, maintenance, and combination therapies are discussed simultaneously, treatment is shifting toward a structure that starts earlier and lasts longer.Of course, from the patient's perspective, the ideal scenario is to receive reimbursement for all possible treatments. If newly emerging agents can be used for more patients at an earlier stage, the opportunity for treatment expands. However, the fact that these changes are occurring simultaneously across multiple cancer types rather than in a specific disease presents another dilemma.Each treatment expansion may be a valid choice. However, the story changes if the same trend is repeated across various cancer types. This is because it is realistically difficult to raise all areas at the same pace with limited resources. Ultimately, it becomes necessary to decide which area to invest more resources in first.In this process, there is one point to be cautious of. The needs of other cancer types must not be ignored simply because discussions are active and voices are loud in a specific cancer type.Unmet needs are not a concept confined to specific diseases. Unmet needs are presented in different forms across various cancer types. There is a possibility that while the necessity of one area is emphasized, the gaps in other areas may be relatively overshadowed.Ultimately, the question is clear: "To what extent and by what criteria will we apply the increased treatment options?" Applying all treatments to all patients may be ideal, but it is not a realistically possible option. Therefore, a discussion is needed on what criteria will be used to set priorities.More opportunities for patients are available due to advances in cancer treatment. However, consideration must also be given to how to distribute those opportunities and to striking a balance to prevent bias toward specific areas during that process. This is why we must reconsider the concept of unmet needs from a broader perspective.
- Company
- Philips Korea's sales staggering…shift to service-centric
- by Hwang, byoung woo Apr 23, 2026 10:51am
- Philips Korea’s sales growth, which had been on a recovery trend since 2023, has stalled, with growth rates remaining in the 1% range.However, during the same period, operating profit increased significantly, showing an actual improvement in profitability. This is interpreted as the result of a shift in the sales mix, moving away from a hardware sales-centric structure toward services, including maintenance and software.Analysis suggests that amid intensifying competition in the large-scale medical equipment market, the future growth is shifting from hardware to software and solutions.Sales Growth 'Stalls,' Operating Profit 'ReboundsAccording to Philips Korea’s recently disclosed audit report, the company’s sales growth appears to have entered a period of stagnation.Specifically, sales, which recorded KRW 336.6 billion in 2021, decreased to KRW 316.1 billion in 2022 before rebounding to KRW 352.9 billion in 2023.Since then, however, sales reached KRW 361.6 billion in 2024 and KRW 364.6 billion in 2025, marking two consecutive years of growth limited to the 1% range following the 2023 rebound, maintaining a slowing growth.One of the primary reasons for this sales stagnation can be traced back to the large-scale business restructuring carried out in 2021. As of September 9, 2021, Philips Korea completed the divestment of its Domestic Appliances division, which was highly profitablePhilips Korea's 5-Year Sales & Operating Profit: BLUE-Sales, RED-Operating profit (source: audit report, unit: KRW 100 million)This was part of Philips’ global 'Selection and Concentration' strategy to focus on the healthcare B2B (business-to-business) sector.Considering that the Domestic Appliances division generated approximately KRW 41.8 billion in annual sales at the time, the separation of this core consumer cash cow is interpreted as a factor in the reduction of the company's overall scale.In contrast to the slowdown in top-line growth, profitability improved significantly. Philips Korea’s operating profit shifted from KRW 42.7 billion in 2021 to a loss of KRW -4.9 billion in 2022.After successfully returning to a surplus of KRW 1.8 billion in 2023, profit showed a recovery to KRW 7 billion in 2024, followed by KRW 36.4 billion in 2025, a more than five-fold improvement compared to the previous year.This indicates that focusing on internal stability and reorganizing the portfolio toward high-value-added businesses, rather than external expansion, has proven effective.Philips Diversifies the Profit Structure, Shift From Product Sales to 'Service'The primary reasons for the improvement in operating profit are cost reductions and lower selling, general, and administrative (SG&A) expenses.The cost of goods sold, which was KRW 270.7 billion in 2024, decreased to KRW 246.3 billion in 2025, and SG&A expenses also fell by approximately 2 billion KRW, from 83.8 billion KRW to KRW 81.8 billion. Essentially, while sales barely grew, profit rose by simultaneously reducing costs and expenses.Furthermore, the fact that the sales structure is increasing 'service sales,' which provides maintenance and software-linked solutions in addition to equipment delivery, appears to have influenced the improvement in profitability.Looking at Philips Korea’s sales structure by business segment (item), product sales decreased from KRW 242.9 billion in 2021 to KRW 219.6 billion in 2022, before recovering to ▲KRW 249.9 billion in 2023 and ▲KRW 254.6 billion in 2024.However, in 2025, product sales recorded KRW 253.6 billion, showing negative growth compared to the previous year.In contrast, service sales has been on a steady upward trajectory, with no negative growth. Service sales, which was KRW 93.7 billion in 2021, recorded KRW 96.5 billion in 2022, ▲KRW 102.9 billion in 2023 ▲KRW 106.9 billion in 2024 ▲KRW 110.9 billion in 2025.The share of service sales in total sales also expanded from 27.8% in 2021 to approximately 30.4% in 2025.Considering the characteristics of the Korean market, where replacement cycles for large medical equipment (MRI, CT, ultrasound, etc.) are long and large-scale orders following the establishment of new hospitals are limited, the expansion of service-oriented sales, such as software upgrades and Service Level Agreements (SLA) for pre-installed equipment, is analyzed to have played a key role in defending profitability.Philips is expanding its cooperation by signing smart hospital business agreements with major hospitals.Intensifying Imaging Competition… The Challenge of Growth DriversBecause of this, Philips Korea is also seeking a breakthrough by creating a digital healthcare environment centered on artificial intelligence (AI) technology.As global competitors such as Siemens Healthineers and GE HealthCare integrate AI solutions with hardware, Philips is moving to capture the early market.For example, Philips Korea is establishing smart hospital collaborations focused on AI-based improvements to ultrasound and imaging workflows.With the recent domestic medical environment emphasizing smart hospitals amid personnel shortages, Philips appears focused on embedding its portfolio, spanning diagnostic imaging·ultrasound·interventional procedure systems, into these systems.However, expanding the influence of diagnostic imaging equipment, which is the most fundamental driver of external growth, remains a challenge.In this context, Philips' next-generation spectral CT, the Verida system, which recently received U.S. Food and Drug Administration (FDA) clearance, could potentially provide a way forward.The core of Verida system is its spectral technology. While most CT scanners focus on providing structural information by imaging the human body at a single energy, spectral CT analyzes differences in tissue composition across multiple energy spectra.As it promotes clinical efficiency improvement rather than just simple image quality enhancement, there is potential for synergy with future smart hospital system construction.An official from the medical device industry stated, "While Philips Korea's new products and technological innovations, such as helium-free MRI and cardiac ultrasound, are receiving positive responses, hospital investment decisions are made on a mid-to-long-term basis due to the nature of the market," and added, "The impact of new products is more likely to be reflected in mid-to-long-term trends rather than short-term performance."
- Policy
- Will the DoctorNow Prevention Act pass the National Assembly?
- by Lee, Jeong-Hwan Apr 23, 2026 10:51am
- Whether the amendment to the Pharmaceutical Affairs Act, which prohibits non-face-to-face medical treatment platforms from operating as pharmaceutical wholesalers, can be tabled and passed during the final plenary session of the 22nd National Assembly, scheduled for the 23rd, is drawing significant attention.The bill, called the "Doctor Now Prevention Act," was originally expected to be processed in a plenary session last year alongside the amendment to the Medical Service Act to institutionalize non-face-to-face treatment. However, it has been pending for over five months due to opposition from some ruling and opposition party lawmakers, as well as the Ministry of SMEs and Startups, for the reason that it undermines the revenue-generating models of startups.On the 21st, the ruling and opposition parties agreed to holding a plenary session on the 23rd to wrap up the first half of the 22nd National Assembly ahead of the June 3 local elections.In particular, the ruling party has expressed its determination to process as many livelihood bills awaiting final disposal as possible at this closing point of the first-half session, citing that approximately 120 bills are currently pending in the plenary session.This is why all attention is on whether the inclusion of the Doctor Now Prevention Act to the Pharmaceutical Affairs Act can be tabled and passed during this plenary session.For now, the Democratic Party of Korea’s Policy Committee maintains the position that there is no reason for the bill not to be processed. Their view is that it is irrational and abnormal to delay the passage of the bill due to backlash from a specific company, especially after the bill already passed the committees, including the Health and Welfare Committee and the Legislation and Judiciary Committee, with bipartisan agreement.Furthermore, despite the strong determination of the Ministry of Health and Welfare to pass the bill, the leadership of the Democratic Party reportedly views it as unprecedented for a bill, which is only awaiting plenary processing following legitimate legislative procedures, to be suddenly modified because a related ministry, the Ministry of SMEs and Startups, raised a differing opinion, leading to inter-ministerial conflict.Nevertheless, the outlook for tabling and processing the Pharmaceutical Affairs Act amendment in the plenary session on the 23rd remains challenging. This is because the legislative opposition from lawmakers in 'Unicorn Farm,' a bipartisan research group for startups and ventures, remains intense, and internal party alignment has not been definitively settled.Consequently, the Ministry of Health and Welfare has been placed in a position where it can do nothing but wait for the National Assembly's decision. Even if a non-face-to-face treatment brokerage platform establishes and operates its own pharmaceutical wholesaler to generate revenue through management that carries a high risk of conflict of interest, the ministry has no choice but to remain a bystander.An official from the ruling party explained, "The Democratic Party’s Policy Committee views that a platform's operation of a wholesaler cannot be regarded as startup innovation or a legitimate revenue model, and thus believes it is necessary to pass the Pharmaceutical Affairs Act in its original form in the plenary session on the 23rd," and added, "This bill is also essential for the institutionalization of non-face-to-face treatment. However, the fact that some disagreements within the party remain is an issue that must be resolved promptly."
- Policy
- CPAC agrees on designating GLP-1 obesity drugs as medicines of concern
- by Lee, Tak-Sun Apr 23, 2026 10:50am
- The majority of members of the Central Pharmaceutical Affairs Council agreed on the need to designate GLP-1 obesity treatments as 'drugs of concern for misuse or abuse.' There were also reactions suggesting that the designation is expected to raise awareness among the public who may not recognize these as prescription-only medications.According to the minutes released on the 21st regarding the meeting held by the Central Pharmaceutical Affairs Council (CPAC) on ‘Validity of Designating GLP-1 Class Obesity Treatments as Medicines of Concern for Misuse or Abuse,’ committee members unanimously agreed that the designation is appropriate to curb indiscriminate use by patients and the sharing of misinformation online.As a result of the meeting, all 9 attending members voted in favor of the designation, and the motion was passed. The CPAC members assessed the current situation where GLP-1 class treatments are being misused by the general public despite being prescription-only drugs as serious.One member stated, “The designation can provide a reminder to the public that these are prescription drugs,” supporting the designation.Another member pointed out, “We need a mechanism to eradicate inappropriate behaviors, such as the sharing of reviews on platforms like YouTube describing how people ‘splitting’ expensive medications.”The fact that the need for this designation has been consistently raised by the media and the National Assembly, as well as the need for equity with other medications, were cited as key grounds for the decision. One of the key regulatory measures of this designation is restricting handling in pharmacies located in areas exempt from the prescription–dispensing separation system, specifically blocking purchases without prescriptions.Committee members viewed prescription restrictions in these exempt areas as necessary to prevent cases where the drugs are prescribed to inappropriate groups, such as pregnant women or children.One committee member emphasized that “pharmaceutical companies are unlikely to suffer significant losses from this designation,” stressing that the public interest outweighs the administrative burden of the regulation.The designation includes liraglutide (Saxenda), semaglutide (Wegovy), and tirzepatide (Mounjaro).In particular, the MFDS explained that ‘Mounjaro,’ which is used to treat both diabetes and obesity, is subject to the ‘drug of concern for misuse or abuse’ designation because it includes an obesity indication.However, some committee members added, “We are concerned that designating these drugs as ‘drugs of concern for misuse or abuse’ may create a negative perception of the medication in a situation where obesity should be treated as a disease.”Based on the results of this review, the MFDS plans to require the phrase ‘drug of concern for misuse or abuse’ to be printed on the packaging of GLP-1-based obesity treatments and to strengthen oversight to ensure they cannot be sold without a prescription, even in exception areas.
- Policy
- Kanarbzet, Sogroya newly reimbursed next month
- by Lee, Jeong-Hwan Apr 23, 2026 10:50am
- Boryung Pharmaceutical’s triple-combination drug for hypertension and dyslipidemia, ‘Kanarbzet Tab,’ will be newly reimbursed from next monthBoryung Pharmaceutical’s triple-combination drug for hypertension and dyslipidemia, ‘Kanarbzet Tab,’ and Novo Nordisk Pharmaceutical’s long-acting growth hormone ‘Sogroya’ will be newly listed for reimbursement next month (May).Viatris Isoptin Inj, Epic Cholestyramine Powder, and Senra 5-HTP, supplied through the Korea Orphan & Essential Drug Center, will also newly obtain reimbursement.Ono Pharmaceutical’s Opdivo Inj(120 mg) and the autoinjector formulation of GSK’s Nucala will be newly listed for reimbursement, while Daewon Pharmaceutical’s Pelubi and Janssen’s Erleada will have their reimbursement price ceilings reduced.LG Chem’s Zemidapa, which had been scheduled for a price reduction, will retain its current price.On the 21st, the Ministry of Health and Welfare partially revised and issued the “Drug Reimbursement List and Reimbursement Price Ceiling Table” containing these changes.Boryung’s Kanarbzet Tab, a combination of the antihypertensive drug Kanarb (containing fimasartan) and the hyperlipidemia drugs atorvastatin and ezetimibe, will be priced at KRW 1,644 per tablet for the 30/10/10 mg formulation, the 30/20/10-milligram formulation is KRW 1,646, the 60/10/10-milligram formulation is KRW 1,753, and the 60/20/10-milligram formulation is KRW 1,755.Sogroya Prefilled Pen 15mg/1.5ml will be listed for reimbursement at KRW 277,624 per pen, and Opdivo Injection 120mg at KRW 1,318,822 per vial.The price of Viatris Isoptin 5 mg Inj is set at KRW 3,491 per 2 ml vial, Epic Cholestyramine Powder for Susp at KRW 1,604 per 4 g packet, and Cenra 5-HTP 100 mg Cap at 2KRW 790 per capsule. The price of the Nucala autoinjector is set at KRW 1.28 million per pen, the same as the existing injectable formulation.Among already listed drugs, Pelubi Tab and Pelubi SR Tab will have their reimbursement ceilings reduced by 46.7% and 23.0%, respectively, on the 1st of next month. Among these, the reimbursement ceiling for Pelubi SR Tab will be further reduced by 23.5% starting August 1.The reimbursement ceiling for Janssen’s Erleada Tab will also be reduced by 29.3% on the 1st of next month, while Kyowa Kirin’s Orkedia Tab 1 mg and 2 mg will each be reduced by 2.0%.Kolon Pharmaceutical’s Kotuss 50 mg will be reduced by 0.4%, and Chong Kun Dang’s Dilatrend SR 32 mg by 0.1%Meanwhile, Zemidapa Tab, which had been scheduled for a 15.5% reduction next month, will maintain its current ceiling, and the reduction will be postponed to May 1 next year.
- Company
- Will Perjeta be reimbursed as postoperative adjuvant therapy?
- by Eo, Yun-Ho Apr 23, 2026 10:50am
- Insurance reimbursement criteria for the breast cancer drug Perjeta may be expanded to cover its use as postoperative adjuvant therapy.The breast cancer division of the Korean Society of Medical Oncology submitted an application to expand reimbursement for the postoperative adjuvant use of Roche Korea’s HER2-positive breast cancer drug, Perjeta (pertuzumab). The society has previously submitted a reimbursement application for the early-stage breast cancer indication of the CDK4/6 inhibitor ‘Verzenio (abemaciclib).’Perjeta’s adjuvant therapy indication was expected to be presented to the Cancer Disease Deliberation Committee of the Health Insurance Review and Assessment Service (HIRA) last October, but the discussion itself was canceled due to revisions to Korea’s positive listing reimbursement criteria.Consequently, it remains to be seen whether discussions regarding Perjeta’s reimbursement as postoperative adjuvant therapy will proceed this time.Currently, Perjeta is reimbursed for HER2-positive metastatic or unresectable locally recurrent breast cancer. In addition, Perjeta is reimbursed as neoadjuvant therapy in early breast cancer at a 30% patient co-insurance rate.However, postoperative adjuvant therapy, a critical treatment step to prevent recurrence, remains non-reimbursed (100% patient coinsurance rate) since the indication was added in Korea in 2018, limiting patient access.This is because its use as postoperative adjuvant therapy lacked long-term follow-up data or a high recommendation grade in global guidelines at the time of the 2019 review, unlike its use as neoadjuvant therapy (preoperative adjuvant therapy), which is covered with 30% selective reimbursement.However, the 10-year follow-up results from the global Phase III APHINITY study that was released last year are expected to fill this gap.According to the study, the Perjeta and Herceptin combination as adjuvant therapy demonstrated clear benefits, including a 21% reduction in the risk of death compared to monotherapy in patients with lymph node-positive early-stage breast cancer at high risk of recurrence.Meanwhile, the Perjeta-Herceptin combination therapy is currently recommended as Category 1 in the U.S. NCCN guidelines for postoperative adjuvant therapy in patients with HER2-positive early-stage breast cancer who have lymph node metastasis. It is also recommended as Category 1 for postoperative adjuvant therapy in high-risk patients with lymph node metastasis who achieved a pathological complete response (pCR) following neoadjuvant chemotherapy.
