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- 2026-04-29 06:18:26
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- Multiple myeloma drug Elrexfio seeks reimb again in KOR
- by Eo, Yun-Ho Jun 02, 2025 05:51am
- The new multiple myeloma drug Elrexfio is again seeking insurance reimbursement coverage in Korea. Pfizer Korea recently submitted a reimbursement application for Elrexfio (elranatamab) and is aiming to receive the Health Insurance Review and Assessment Service's Cancer Disease Deliberation Committee review. Following its rejection by CDDC in February, the company swiftly regrouped and is now proceeding with the necessary procedures required for Elrexfio’s reimbursement. Elrexfio has been designated by the Ministry of Food and Drug Safety as a Global Innovative Products on Fast Track (GIFT) and received fast-track approval. Therefore, it remains to be seen whether the company’s second attempt will be successful. Elrexfio is a fourth-line immunotherapy composed of two monoclonal antibodies - one targeting the antigen specific to multiple myeloma and the other engaging T cells. Bispecific antibody therapies are a form of immunotherapy composed of two monoclonal antibodies—one that recognizes a target antigen of multiple myeloma and another that binds to T cells. Typically, they are structured as bispecific IgG2 kappa antibodies that recognize BCMA (B-cell maturation antigen), the primary target antigen in multiple myeloma, and CD3. These therapies represent a novel approach that directly targets cytotoxic T cells to multiple myeloma cells expressing BCMA. Multiple myeloma, a cancer of plasma cells in the bone marrow, is a type of hematologic malignancy that primarily affects older adults. It is a disease where prolonged treatment can bring extended survival. Although various new therapies are being developed for the disease, monoclonal antibodies and bispecific antibody therapies are currently typically used in practice. In particular, the bispecific antibody mechanism is regarded as a safe and effective treatment for relapsed and refractory multiple myeloma, in which resistance increases with each treatment cycle, shortening the remission period and reducing the available treatment options. Since multiple myeloma is a disease where extended survival is achievable through continuous treatment, it is essential to have various therapeutic options available at each stage of treatment. This is why extending reimbursement coverage to fourth-line and later therapies remains an urgent priority. Currently, bispecific antibody therapies such as Elrexfio, Tecvayli (teclistamab), and Talvey (talquetamab) are approved in Korea, but none are granted reimbursement. Amid the failed discussions over coverage of a series of bispecific antibody drugs in the early stages, whether any drug will be granted reimbursement and improve patient access is gaining attention. Meanwhile, Elrexfio was designated by the Ministry of Food and Drug Safety as a GIFT item and was approved as a monotherapy for adult patients who have received more than three lines of treatment, including proteasome inhibitors, immunomodulators, and anti-CD38 monoclonal antibodies, in May last year. The US FDA has also designated it as an innovative drug and granted accelerated approval for the drug. Elrexfio’s efficacy was demonstrated through the Phase II MagnetisMM-3 trial, an open-label, multicenter, non-randomized study that was conducted on 123 who had not received prior BCMA-directed therapy (i.e., BCMA-naïve patients). Results of Cohort A showed that the drug recorded an objective response rate (ORR) of 61.0% and a complete response (CR) of 37.4%. The progression-free survival (PFS) period was 17.2 months, and the overall survival (OS) period was 24.6 months, demonstrating an unprecedented long-term treatment effect. The data demonstrated that Elrexfio provided long-term survival benefits and slowed down disease progression to improve the quality of life of patients who had no other treatment options.
- Company
- Vocabria+Rekambys for HIV lands in more hospitals in KOR
- by Eo, Yun-Ho Jun 02, 2025 05:51am
- More general hospitals are securing prescriptions for the long-acting HIV treatment combination therapy Vocabria+Rekambys. According to industry sources, the combination therapy of GSK Korea’s Vocabria (cabotegravir) and Janssen Korea’s Rekambys (rilpivirine) has recently been approved by the drug committees (DCs) of several major hospitals, including the "Big 5" HIV treatment centers—National Medical Center, Seoul National University Hospital, and Kyungpook National University Hospital—as well as Korea University Anam Hospital and Chung-Ang University Hospital. The combination has been gradually expanding its prescription areas before and after the reimbursement listing last month. The upper insurance price ceiling for Vocabria 30mg is KRW 16,303 per tablet and KRW 991,882 per vial. The Vocabria+Rekambys combination was approved by the Ministry of Food and Drug Safety in February 2022 as a combination therapy for the treatment of HIV-1 infection in adult patients who are virologically suppressed, have no history of virological failure, and have no known or suspected resistance to cabotegravir or rilpivirine. The advantage of this combination therapy is undoubtedly its convenience in administration. While existing HIV treatments require patients to take a tablet formulation once a day, the two injectable drugs will reduce the frequency of administration to once a month or once every two months with intramuscular injections, increasing satisfaction and reducing the burden on patients. The two drugs were originally developed as oral medications and then were developed into injectable drugs. While this long-acting injectable drug cannot cure HIV infection, it is a treatment that targets white blood cells to help lower and maintain the level of the AIDS virus. The Vocabria+Rekambys combination demonstrated non-inferior viral suppression efficacy compared to the existing three-drug oral regimen (BIC/FTC/TAF) in the SOLAR Phase III clinical trial, with a treatment failure rate of 1% over 12 months. During the same period, the rate of maintaining HIV RNA levels below 50 copies/mL was 90% in the injection group and 93% in the oral medication group. In terms of safety, there were no significant differences between the two groups other than injection site reactions. According to a treatment satisfaction survey released by GSK, 90% of HIV-infected individuals who had been taking existing oral medications reported higher satisfaction after switching to the injection therapy, with 85% citing “convenience of not having to take medication daily” and 75% highlighting “reduced HIV exposure concerns” as key benefits. Meanwhile, the Vocabria+Rekambys regimen demonstrated efficacy and safety in clinical trials where it was administered every 4 weeks or every 8 weeks as combination therapy and received approval in Europe in December 2020. Recently, its treatment indication was expanded to include adolescent patients in Europe.
- Company
- Samsung Bioepis’ Xgeva biosimilar approved in KOR
- by Chon, Seung-Hyun Jun 02, 2025 05:50am
- Samsung Bioepis announced on the 30th that it has received approval from the Ministry of Food and Drug Safety for its biosimilar Xbryk, a bone disease treatment. Xbryk, which contains denosumab, is used to prevent skeletal complications in cancer patients and treat tumor diseases such as giant cell tumor of bone. Prolia, which contains the same ingredient, has been approved as a treatment for endocrine disorders such as postmenopausal osteoporosis. Last year, the combined global sales of Prolia and Xgeva reached USD 6.599 billion (approximately KRW 10 trillion). The domestic market prescription volume amounted to approximately KRW 187 billion. Samsung Bioepis has pursued separate product approvals for each indication, just like the original medications. In April, it received approval for the Prolia biosimilar Obodence, and this time, it has added approval for the Xgeva biosimilar. With the approval, Samsung Bioepis has received 11 product approvals in Korea. All of the company’s biosimilars in its pipeline that have completed global clinical trials have reached the commercialization stage in Korea. Byoungin Jung, Vice President and Regulatory Affairs Team Leader at Samsung Bioepis, said, “The marketing authorization for both Obodence and Xbryk in the domestic market following global approval is significant as it enables us to broaden treatment opportunities for patients with bone diseases by offering more cost‑effective therapeutic options.”
- Company
- Janssen attempts Darzalex’s reimb for AL amyloidosis in KOR
- by Eo, Yun-Ho May 30, 2025 05:58am
- Darzalex, which has been expanding its insurance coverage to multiple myeloma, is now seeking to receive reimbursement for amyloidosis in Korea. According to Dailypharm coverage, Janssen Korea recently applied for reimbursement expansion of Darzalex SC (daratumumab) in combination with cyclophosphamide, bortezomib, and dexamethasone (CyBorD). The amyloidosis indication was approved by the US FDA in 2021 and the Ministry of Food and Drug Safety in 2024. In the indication, the Darzalex combination has shown a dramatic improvement, increasing the hematological response rate in patients with amyloidosis by nearly threefold. The efficacy of Darzalex in amyloidosis has been demonstrated in the Phase III ANDROMEDA study. Amyloidosis is a disease characterized by the accumulation of amyloid—a special type of fibrous glycoprotein—in various tissues throughout the body. The study primarily focused on patients newly diagnosed with AL (amyloid light-chain) amyloidosis. Darzalex is the first human monoclonal antibody approved for multiple myeloma. Its active ingredient, daratumumab, targets and binds directly to CD38, a surface glycoprotein overexpressed on multiple myeloma cells. The ANDROMEDA study evaluated the efficacy and safety of adding Darzalex SC to the existing CyBorD combination therapy in patients with AL amyloidosis in comparison with the CyBorD monotherapy group. In the study, 71% of patients had cardiac involvement and 59% had renal involvement, with 65% of patients having involvement in two or more organs. The primary endpoint, hematologic complete response rate, was 53% in the Darzalex combination group, nearly three times higher than the 18% in the CyBorD monotherapy group. In addition, the overall reported hematological response rate was 92% in the Darzalex combination group and 77% in the CyBorD monotherapy group. The very good partial response rate also showed a clear difference at 79% and 49%, respectively. The company has been continuing to expand Darzalex’s reimbursement coverage in Korea. In February, a four-drug combination therapy (DVTd therapy: Darzalex, bortezomib, thalidomide, and dexamethasone) was approved for reimbursement as a first-line treatment, and recently, the DVd therapy (Darzalex, bortezomib, and dexamethasone was approved by the Health Insurance Review and Assessment Service's Cancer Disease Review Committee as a second-line treatment.
- Policy
- Unveiling pledges of 2021 presidential election candidates
- by Lee, Jeong-Hwan May 30, 2025 05:58am
- Lee Jae-myung (Candidate No.1), the presidential candidate of the Democratic Party of Korea, and Kim Moon-soo (Candidate No.2), the presidential candidate of the People Power PartyAhead of South Korea's 21st presidential election, two candidates from main political parties have unveiled their key election pledges in the areas of public healthcare·biopharma·national healthcare insurance. Lee Jae-myung (Candidate No.1), the presidential candidate of the Democratic Party of Korea, and Kim Moon-soo (Candidate No.2), the presidential candidate of the People Power Party, have promise success of medical reform, focusing on strengthening regional and essential healthcare, amid ongoing dispute between medical community and the government. They have also proposed pledges to resolve drug shortage issues. However, their detailed pledges slightly differed. They have proposed similar but slightly differing pledges in strengthening the areas of the biopharma industry and the national health insurance finances and coverage. Given the nature of the healthcare and biopharma industries, it is difficult for dramatically different policy directions to emerge. Furthermore, with the presidential impeachment leading to a rapid entry into an early presidential election, it is assessed that the two major parties had insufficient time to design pledges with significant distinctions. The following is a closer look at the pledges of candidate Lee Jae-myung and candidate Kim Moon-soo, as of May 28, on the healthcare, pharmaceutical industry, and national health insurance Healthcare Reform, Drawing a Line from the Yoon Suk Yeol Administration Since declaring their presidential candidacies, both candidates have repeatedly expressed that they will not repeat the policy failures of the Yoon Suk Yeol administration, which led to the collective resignations of medical residents and mass leaves of absence by medical students due to the forceful implementation of the 2,000-person increase in medical school admissions quota. Accordingly, they proposed ways to prevent a repeat of medical-government conflicts. These include candidate Lee Jae-myung's proposal for a new 'National-Centered Medical Reform Deliberation Committee' and candidate Kim Moon-soo's proposal for a new 'Presidential Committee for Future Healthcare with Medical Student Participation.' Effectively, the commonality between the two candidates is the establishment of a new public-private collaborative national body to develop a blueprint for healthcare reform, including the policy to increase medical school quota. However, the difference lies in the Democratic Party's emphasis on 'people' and the People Power Party's detailed focus on 'medical students.' Depending on the presidential election results, the new body is expected to determine a detailed plan for healthcare reform in Korea. Highlighting notable pledges, Candidate Lee proposed strengthening interprofessional cooperation among healthcare professionals and establishing a primary care system centered on regular clinics-pharmacies. Candidate Kim, on the other hand, announced the enactment of laws to foster essential medical care and resolve regional healthcare disparities, along with a pilot project for primary care innovation. Candidate Lee's pledge to strengthen interprofessional cooperation among healthcare professionals appears to indicate a commitment to legal and policy efforts to resolve disputes over licensing rights and conflicts in scopes of practice among various healthcare professions, such as doctors, traditional Korean medicine practitioners, pharmacists, and nurses. The pledge to establish a local primary care system centered on regular clinics- pharmacies is likely to lead to the revitalization of the primary care ecosystem and local pharmacies, aiming to normalize the disrupted healthcare delivery system. Candidate Kim chose to resolve disparities in essential and regional medical care through legislation. The specific legislative framework has not been disclosed. The 'Primary Care Innovation Pilot Project' is a policy that the Ministry of Health and Welfare (MOHW) has announced as part of its healthcare reform initiatives. It reflects a commitment to fostering primary care that focuses on the prevention, management, and treatment of chronic diseases, such as diabetes, hypertension, and hyperlipidemia. Solving Drug Shortages, National Management from Raw Materials to Distribution Regarding solving the unstable supply of pharmaceuticals, both candidates' pledges generally aim to strengthen government intervention and support, from the manufacturing of active pharmaceutical ingredients (APIs) to their distribution and management, which are the primary causes of drug shortages. Similarities between the two candidates include support for production facilities and the expanded stockpiling of essential·discontinuation-prevention drugs, along with incentives for finished drugs using domestic raw materials (Candidate Lee) and support for the automation of essential drug production and manufacturing facilities, as well as the expansion of national stockpile drug items and quantities (Candidate Kim). However, Candidate Lee made a somewhat unconventional pledge to selectively allow generic name prescribing limited to drugs experiencing recurring supply instability. This is interpreted as a plan to create administrative and legal grounds for designating frequently short-supplied drugs and allowing generic name prescribing based on the experience of acetaminophen shortages during the COVID-19 pandemic. However, since generic name prescribing is an issue of licensing conflict with doctors opposing and pharmacists supporting it if Candidate Lee is elected, seeking ways to minimize conflict will likely be necessary. Candidate Kim's pledges did not include addressing drug shortages through the use of generic names. Kim stated a policy to manage patient inconvenience with drug shortages by establishing a public electronic prescription system. Biopharma Industry Pledges, Converging on Advanced Drug Pricing Systems Both Candidate Lee and Candidate Kim proposed various pledges to foster the biopharma industry, ultimately converging on establishing policies to improve the current drug pricing system or expanding drug price incentives to encourage new drug development. Candidate Lee plans to enhance benefits by improving the innovative pharmaceutical company certification system and increasing opportunities for pharmaceutical companies to contribute to society. Notably, Candidate Lee's pledge also includes the 'establishment of a new drug R&D investment-linked drug price compensation system,' which would provide drug price incentives proportional to a pharmaceutical company's investment in new drug research and development (R&D). Candidate Kim also promised government support, including improving the R&D innovative new drug price compensation system, establishing a new drug development incentive system, setting up a drug pricing system that reflects the value of innovative new drugs, and strengthening incentives for essential pediatric and geriatric drugs. A distinguishing point between Candidate Lee and Candidate Kim is Kim's proposals for promoting various drug reimbursement models, such as implementing a high-priced drug pre-listing·post-evaluation system, creating a separate fund for severe·rare disease drugs, and utilizing multi-year·multi-indication contracts and indication-specific drug pricing systems. These pledges are evaluated as being able to significantly lower the barrier to national health insurance reimbursement for new drugs for rare and intractable diseases, which are expensive and have limited patient accessibility. Non-face-to-face treatment, Differences in Perspectives on Healthcare and Industry Promotion Both Candidate Lee and Candidate Kim pledged to formalize the pilot project for non-face-to-face treatment. Both candidates share a vision of establishing a non-face-to-face treatment model that combines safety and efficacy while also prohibiting dedicated medical institutions and implementing management·regulatory mechanisms for intermediary platforms. However, a closer examination of the detailed content reveals some differences. Candidate Lee placed more emphasis on institutionalizing non-face-to-face treatment as a means to supplement the healthcare system. At the same time, Candidate Kim expressed an intention to leverage the institutionalization of non-face-to-face treatment also to benefit the promotion of the digital healthcare industry. Specifically, Candidate Lee plans to legalize non-face-to-face treatment as a supplementary means to in-person consultations and halt indiscriminate non-face-to-face treatment pilot projects. Candidate Lee stated that he would establish rational scopes and standards for non-face-to-face treatment and prevent prescription forgery, alteration, or misuse by introducing a public electronic prescription system. Candidate Kim promised to enhance healthcare accessibility for patients residing in medically underserved areas like rural regions, elderly individuals with mobility issues, and chronic disease patients through non-face-to-face treatment while simultaneously targeting the cultivation of digital healthcare companies by easing R&D support and regulations. Notably, he also announced plans to promote the delivery of prescription drugs via non-face-to-face treatment for patients residing in medically underserved areas. Healthcare professionals and those in the biopharma industry state that it is challenging to predict future-specific policy models based solely on the pledges of the two-party candidates. However, based on the reflection of their respective policy proposals, they express their intent to proceed with the concretization of detailed policies after the new president is elected. A pharmaceutical industry official said, "The new drug R&D ratio-drug pricing linkage system requested by domestic pharmaceutical companies and the diversification of the rapid national health insurance reimbursement system for high-priced drugs, requested by multinational pharmaceutical companies, are proposed by both candidates' pledges." He added, "Healthcare and biopharma pledges inherently find it difficult to have entirely different directions depending on the political party. Detailed policies will emerge during public-private consultations after the presidential election results are announced."
- Policy
- Novo Nordisk applies for Wegovy’s use in adolescents
- by Lee, Hye-Kyung May 30, 2025 05:58am
- With Novo Nordisk Korea applying for approval of Wegovy’s use in adolescents aged 12 and older, the Ministry of Food and Drug Safety is planning strengthened measures to prevent its misuse and abuse. Wegovy is a glucagon-like peptide-1 (GLP-1) class obesity treatment that was launched in Korea in October last year. The drug has surpassed KRW 100 billion in cumulative sales since. According to industry sources on the 28th, Wegovy is currently only available for prescription to adults with a body mass index (BMI) of 30 kg/m² or higher in Korea. However, the US Food and Drug Administration (FDA) has approved Wegovy for use in adolescents aged 12 and older, and the European Medicines Agency (EMA) has also approved its use in obese adolescents aged 12 and older. In line with the global trend, efforts to expand the indication for adolescent use have begun in Korea as well. Joon-Soo Shin, director of the MFDS’s Biopharmaceuticals and Herbal Medicines Bureau, said, “There is growing interest in the domestic obesity treatment market. Not only Wegovy but also other drugs such as Mounjaro, which is scheduled to be released soon, are stirring up a craze.” Shin added, “When Wegovy was first launched, the government could not help but be concerned about its misuse or abuse. While it is impossible to completely prevent such issues, we conducted intensive monitoring for one month after launch to prevent exaggerated online advertising and illegal distribution before things escalated.” As a result, 359 posts violating the Pharmacy Affairs Act by illegally facilitating sales or advertising were identified, with 57 cases (16%) involving Wegovy. Shin added, “Recently, there have been requests for approval to administer Wegovy to adolescents, but unlike other countries, Korea has stricter criteria. We are paying close attention to ensure that the adolescent indication also meets our standards and do not allow their indiscriminate use of obesity treatments.” Director Shin added, “Some countries have lower BMI standards than Korea and are already allowing the use of obesity drugs in adolescents. If the scope of obesity drug use is expanded to include adolescents in Korea, we will need to strengthen checks for misuse, as we did when Wegovy was first released.” The MFDS also plans to continue its public awareness campaign to reduce the misuse of obesity drugs. This is to prevent the indiscriminate use of obesity treatment drugs among those who are not aware of misuse and to prevent misuse and abuse of obesity treatment drugs. Shin explained, “We are focusing our efforts on promoting the prevention of misuse and abuse of obesity treatment drugs rather than distributing any product-related materials. We regularly distribute pamphlets and educational materials separately for professionals and patients.” Meanwhile, according to the pharmaceutical research institution IQVIA, Wegovy’s sales reached KRW 79.4 billion in the first quarter. Wegovy accounted for 73.2% of sales in the overall obesity drug market.
- Policy
- Partial reimb for anticancer drug combos to be postponed
- by Lee, Tak-Sun May 30, 2025 05:57am
- The announcement of drugs eligible for partial reimbursement as anticancer drug combination therapy, which is currently in effect as of this month, is expected to be delayed until after June 1. Initially, the Health Insurance Review and Assessment Service's Cancer Disease Deliberation Committee (CDDC) which convened on the 14th, planned to announce 35 combination therapies on June 1, but due to delays in internal government discussions, the commitment could not be fulfilled. As of the 28th, HIRA had not conducted the “public opinion survey on the revised draft of the announcement on drugs prescribed and administered to cancer patients” that contained the partial reimbursement for anticancer drug combination therapies. With only three days remaining until June 1, and considering the usual opinion survey period, it is practically impossible to announce the list by June 1. The opinion survey period typically lasts around seven days, and even if the timeline is shortened, the prevailing view is that a June 1 announcement is unlikely. As a result, confusion in the field is unavoidable for the time being. Earlier, the MOHW established partial reimbursement for anticancer drug combination therapies by revising the “Details on the Application Standards and Methods for Medical Care Benefits (Drugs)” starting this month. Although this falls within the scope of the MFDS's approval, the MOHW intends to apply the existing coinsurance payment for existing anticancer therapies in cases where such anticancer therapies are reimbursed and used in combination with other anticancer drugs that are not included in the reimbursement standards. However, confusion arose in the medical field as it was unclear which drugs were eligible for reimbursement. This was because the MOHW did not provide detailed information on which drugs were eligible when it announced the revision. In response, HIRA hastily opened a CDDC meeting and decided to announce the 35 cases eligible for partial reimbursement as of June 1. At the time, HIRA stated, “In order to reduce confusion in practice and ensure predictability in the application of the detailed notification on existing reimbursed anticancer therapies used in combination with other anticancer drugs, we discussed the list of combination therapies, taking into consideration each indication and the opinions of academic societies. We decided to announce the list as soon as possible, to implement it on June 1.” “We also plan to review other combination therapy options that academic societies apply for after deliberation by the Cancer Disease Deliberation Committee.” However, it is now unlikely that the June 1 announcement committeemen will be kept. The MOHW has been showing a cautious stance, explaining that HIRA's partial reimbursement announcement was working against the original intent of the revision and included elements that would rather limit reimbursement. As a result, internal discussions have been prolonged, and it is believed that HIRA was unable to seek opinions on the revised announcement in time. However, HIRA has confirmed that it believes the announcement of the drugs eligible for partial reimbursement is necessary to reduce confusion in the field. Therefore, even if the announcement is delayed, it is expected that HIRA will seek opinions on the revised announcement soon.
- Opinion
- [Reporter's View] Addressing drug shortage, healthcare
- by Lee, Jeong-Hwan May 30, 2025 05:57am
- Ahead of Korea's early presidential election, scheduled for June 3, leading candidates have prioritized pledges to strengthen government support for essential medicines·address drug shortages. Lee Jae-myung, the candidate for the Democratic Party of Korea, included the resolution of a supply shortage of essential medicines in his top 10 pledges, suggesting the possibility of a partial introduction of generic name prescribing for drugs such as flu treatments and cold medicines. Kim Moon-soo, the candidate for the People Power Party, also promised to create a system for detecting drug supply shortages, establish a public electronic prescription system, and set up a drug supply management committee. Lee Jun-seok, the candidate for the Reform Party, also acknowledged that frequent drug shortages are a pressing concern for pharmacists, indicating his intention to establish an independent channel with the Korean Pharmaceutical Association (KPA) to discuss related solutions. Likewise, the inconvenience faced by pharmacies and patients due to shortages of frequently sought-after essential medicines has remained unresolved for several years, becoming a nationwide headache to the extent that presidential candidates have uniformly listed it as their top pharmacy-related pledge. While pharmacists review their drug shortage checklists every morning and respond to the chaos by exchanging drugs with nearby pharmacies through local communities and KakaoTalk, they are frustrated that the process remains haphazard. These are the reasons the KPA proposed to the presidential candidates the establishment of a government-level drug shortage management system. The aim is to advance beyond merely sharing information about some drug shortages through the Drug Utilization Review (DUR) service and for the government to establish a system that assumes social responsibility. The newly appointed president, following the election, and the new government need to design and implement policies with a mission to find fundamental solutions to drug shortage issues, thereby strengthening national health security and pharmaceutical sovereignty. The drug shortage problem arises due to the instability of active pharmaceutical ingredient (API) supply due to accelerating drug nationalism. To domestically produce APIs that have low profitability, the government must provide sufficient incentives. In other words, the government must exert its public role to the fullest, encouraging domestic approval and manufacturing of essential drugs by pharmaceutical companies to improve self-sufficiency rates and also advance the distribution lines of produced medicines. Suppose a system is also created that can quickly promote the supply of the relevant active ingredient/product or alternative drugs when sudden shortages occur in local pharmacies. In that case, the frequent occurrence of drug shortages being raised at the annual national audit will decrease. We anticipate the election of a president who will operate the existing public-private consultative body for drug shortages, thereby implementing policies and budgetary solutions into actual systems to ensure organic cooperation among the pharmaceutical industry, the pharmacy community, and drug distribution.
- Opinion
- [Reporter’s View] Reimbursing the only RET-targeted therapy
- by Eo, Yun-Ho May 29, 2025 05:52am
- News of a new drug failing to be listed for insurance reimbursement always upsets patients. The blow is even harder when it is the only treatment option available. Such was the case in 2023 when the National Health Insurance Service and Lilly failed to reach an agreement on the price of the RET-targeted anticancer drug Retevmo (selpercatinib). This was the only case of a drug price negotiation failure that year. This drug was the first treatment option for patients with RET fusion-positive non-small cell lung cancer and thyroid cancer, and the only drug that was being reviewed for reimbursement in Korea. With the reimbursement listing of Retevmo falling through, patients were left to endure an indefinite wait. Then, this year, the developer, Lilly Korea, finally reaffirmed its commitment. Lilly recently submitted a reimbursement application for non-small cell lung cancer along with an indication for thyroid cancer. This is the company’s third attempt. Prior to the approval of Retevmo, there were no targeted treatment options available for patients with RET-mutated NSCLC or thyroid cancer. Therefore, the Ministry of Food and Drug Safety approved Retevmo through a fast-track review for the treatment of:▲ adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC); ▲adults and pediatric patients 12 years of age or older with advanced or metastatic RET-mutated medullary thyroid cancer who require systemic therapy; and ▲ adult patients who are refractory to radioactive iodine therapy and who have prior sorafenib and/or lenvatinib treatment, with advanced or metastatic RET-fusion benign thyroid cancer who require systemic therapy. Among the A7 countries that are used as Korea’s drug price reference countries, Retevmo is covered and used in 6 countries (US, Germany, Italy, UK, Switzerland, and Japan) other than France. However, despite the considerable time that has passed, it is still not reimbursed in South Korea. The MFDS has been operating an expedited review system to promptly launch and supply highly innovative drugs for life-threatening or serious conditions to the market and patients. However, only a handful of the 23 approved through the fast track is currently being reimbursed by insurance. This means that even after the drugs receive accelerated approval through fast-track review, it is difficult for cancer patients to receive treatment benefits without reimbursement. While regulatory authorities often determine that rapid introduction is necessary, it is frequently the case that insurance authorities remain cautious and conservative. When it comes to the introduction and improvement of systems, ‘effectiveness’ is always a top priority. This reporter hopes that policies aimed at improving patient access to innovative new drugs can achieve the intended effect.
- Company
- Galderma challenges the atopic dermatitis market in KOR
- by Whang, byung-woo May 29, 2025 05:52am
- Galderma is challenging the Korean market for atopic dermatitis treatment with its first biologic, 'Nemluvio (nemolizumab).' Given the market's already competitive nature, Galderma is likely to secure a market presence with the drug's mechanistic differentiation, convenient administration, and expanded indication. Product photo of NemluvioGalderma Korea submitted an application for Nemluvio's Korean marketing authorization to the Ministry of Food and Drug Safety (MFDS) in August of last year. The company expects to obtain approval by the end of the fourth quarter of this year. Nemluvio's indications submitted for marketing authorization in Korea are two types: atopic dermatitis and prurigo nodularis. Approval of Nemluvio gathers attention because it is the first biologic from Galderma Korea. While Galderma has supplied ethical-the-counter (ETC) drugs such as acne treatments and botulinum toxins to the Korean market, most of these have been topical agents or aesthetic products. In that context, approval of nemolizumab for the atopic dermatitis indication is significant in terms of portfolio expansion. However, the current situation for nemolizumab, as a latecomer, is not easy given that global big pharma companies are fiercely expanding their presence in the severe atopic dermatitis treatment market in Korea. Starting with Dupixent, a biologic like nemolizumab, and followed by JAK inhibitors, as well as LEO Pharma's Adtralza and Lilly's Ebglyss, these drugs are also expanding their influence in the market. In the market for atopic dermatitis, where strong early entrants have been introduced, the key competitive advantage for Galderma's nemolizumab is projected to be its 'mechanistic differentiation.' Nemluvio is the first drug to inhibit the IL-31 pathway, which is central to itching, rather than the IL-4/13 or IL-13 pathways targeted by existing biologics. By binding to the IL-31 receptor alpha (IL-31RA) and blocking the itching signal itself through neuronal transmission, it is expected to provide a rapid and robust improvement in pruritus compared to existing drugs. The efficacy of Nemluvio was demonstrated in the multi-national Phase 3 clinical trial, the ARCADIA program. In a comparison study against topical corticosteroid (TCS) combination therapy, involving a total of 1,728 patients with moderate to severe atopic dermatitis, both the EASI-75 achievement rate and the itch improvement index (NRS)showed significant improvement at 16 weeks, meeting the co-primary endpoints. Furthermore, the administration method was designed with patient convenience in consideration, involving subcutaneous injections every 4 weeks, and a pre-filled pen for self-administration has also been secured. This method offers the advantage of a lower medication burden compared to treatments that require administration once every two weeks or daily oral intake. Galderma is also accelerating the global launch of nemolizumab. Following obtaining initial approval in Japan at the end of 2023, nemolizumab was approved in Europe and the United States for the prurigo nodularis indication earlier this year. This strategy targets a niche market that shares a similar immunopathologic structure with atopic dermatitis but has had limited treatment options available. Indeed, Galderma is differentiating nemolizumab as a dual-indication product for treating both prurigo nodularis and atopic dermatitis, attempting to distinguish its marketing strategy in a market with high entry barriers. However, for Galderma Korea, as a latecomer, challenges remain, including initial price barriers and the uncertainty of reimbursement listing. That is, whether or not it achieves reimbursement is considered a crucial variable for its success or failure. This is a pattern that has been repeated with previous competitor drugs. Given that it is a latecomer compared to existing drugs, the drug pricing evaluation process is likely to be complicated. How Galderma designs its non-reimbursement marketing or specialized sales targeting healthcare professionals in preparation for this will be key. Additionally, nemolizumab is expected to test Galderma Korea's capabilities in building hospital and specialized channel networks in the Korean market. For Galderma, whose primary business has focused on aesthetics and general dermatology, this presents new challenges. How nemolizumab can quickly be established as an 'essential drug' among healthcare professionals and patients and gain market presence in Korea is expected to become clearer during the approval process in the second half of this year and the launch preparation in 2026.
