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- 2025-12-18 03:04:58
- Policy
- Premium pricing for 11 linagliptin products ends on the 9th
- by Lee, Tak-Sun Jun 04, 2025 06:19am
- As one year has passed since the entry of generic versions of the DPP-4 inhibitor diabetes treatment Trajenta (linagliptin), the price ceiling of 11 products that received pricing premiums will be adjusted on the 9th. Three products that entered the market in March following the expiration of the first generic exclusivity period will also have their prices reduced. According to industry sources on the 3rd, the price premiums set for the original linagliptin and 11 generic products will expire on the 9th, as 1 year has passed since the entry of its generics. The original Trajenta Tab (Boehringer Ingelheim Korea), which had been adjusted to 70% of the highest price due to the entry of generics, will be reduced from KRW 525 to KRW 402. Additionally, Hanmi Pharmaceutical's “Linaglo Duo Tab,” DongKoo Bio&Pharma’s “Linatop Tab 5mg,” and Daewon Pharmaceutical's “Tralitin Tab,” which received drug pricing premiums as products from innovative pharmaceutical companies, will also be adjusted from KRW 510 to KRW 402. Furthermore, the following products, which met all the 3 criteria and have received the first generic exclusivity premium, will have their price ceiling reduced from KRW 447 to KRW 402: Kukje Pharma’s ‘Tradi-M Tab 5mg,' Kyung Dong Pharma’s ‘Litagin Tab,’ Sinil Pharm’s ‘Tragliptin Tab,' Huons' ‘Linadipo Tab 5mg,' Jeil Pharmaceuticals 'Linatin Tab,,' Aprogen Biologics’ 'Linahana Tab,' and Genuone Science's ‘Tra-K Tab.' The first 15 Trajenta generics were listed for reimbursement on June 9 last year after successfully challenging the original drug’s patent and the expiry of the original drug’s remaining patents. At that time, 61 generic items were approved, but 15 items obtained the first generic exclusivity through successful patent challenges and initial approval applications, so the remaining items were listed for reimbursement at the time. And on March 8, after the 9-month first generic exclusivity period ended, 12 companies, including Hanmi Pharmaceutical, were able to enter the market. The list of products whose premium pricing has ended includes three products, including Hanmi Pharmaceutical's ‘Linaglo Tab,’ which was listed in March. Due to the patent issue, the market entry of the three drugs was delayed, so the premium pricing benefit for the drugs ended after only three months. Pharmaceutical companies whose premium pricing has ended are currently notifying their business partners of the price changes. This is a measure to minimize confusion during billing and return processing. Trajenta generics have been gradually increasing their market share upon their launch. According to UBIST, the outpatient prescription sales of generic versions of Trajenta (including Trajenta Duo) reached KRW 3.1 billion in the first quarter, accounting for 13% of the total linagliptin market. Starting this month, with the expiration of the pricing premiums, the original and generic versions will be priced identically, intensifying market competition. It remains to be seen whether the original product, now with improved price competitiveness, will mount a counterattack against the generics.
- 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.
- Policy
- Lee pledges ‘generic prescribing for essential medicines'
- by Lee, Jeong-Hwan May 29, 2025 05:51am
- The Democratic Party of Korea’s presidential candidate Jae-Myung Lee (No. 1) pledged to introduce a limited implementation of the generic (ingredient-based) prescription system for essential medicines with unstable supply. The pledge also included plans to institutionalize telemedicine (non-face-to-face treatment) and establish a public electronic prescription transmission system to enhance patient safety and convenience. Also, plans to establish a neighborhood-based primary healthcare system centered on the patients’ regular clinics and pharmacies, and strengthen interprofessional collaboration among healthcare professionals, and secure adequate personnel were included. To resolve the instability in the supply of essential medicines, the candidate promised to establish a public consignment manufacturing and distribution system. To lay the groundwork for this, the candidate plans to expand support for the production and stockpiling of essential and shortage prevention medicines, actively support the development of technologies for the localization and self-sufficiency of essential raw materials and vaccines, and expand incentives for finished drugs using domestically produced raw materials. Lee also revealed his intention to establish a system linking new drug R&D investment ratios with drug price compensation systems and to strengthen the social responsibility of pharmaceutical companies by improving the Korea Innovative Pharmaceutical Company certification system. Lee issued the Democratic Party of Korea’s Central Policy Pledge Book on the 28th and announced that he would “strengthen national investment and responsibility in the pharmaceutical and biotechnology industry and establish a stable supply system for essential medicines.” Will address drug shortages through ingredient name-based prescriptions... establish a public electronic prescription system The most notable part was the pledge to introduce ingredient name-based generic prescriptions for essential medicines to address the problem of unstable supply. In addition, Lee announced plans to promote substitute prescriptions to resolve drug shortages and establish a public manufacturing and distribution system to stabilize the supply of essential drugs. At the same time, the candidate promised expanded support and stockpiling for manufacturing facilities of essential and drug shortage prevention medications, and active support for the development of domestic manufacturing and self-sufficiency technologies for essential raw materials and vaccines. Incentives for finished drugs using domestically produced raw materials will also be expanded. Telemedicine will also be institutionalized with consideration for medical quality and safety. The plan aims to establish a legal basis for telemedicine as a complementary means to face-to-face medical care and halt indiscriminate pilot projects. Lee will ensure medical quality and safety by setting reasonable scope and standards for telemedicine, while announcing plans to prohibit dedicated medical institutions and strengthen the management system for platform operators. The construction and utilization of a public electronic prescription transmission system are also included in the policy pledge. The plan is to establish a public electronic prescription system to ensure patient safety and prevent prescription forgery and misuse. Patient safety will be strengthened by preventing prescription information input errors in advance. Introduction of a drug price linkage system for new drug R&D…Improvement of the Korea Innovative Pharmaceutical Company certification system For the pharmaceutical and biotechnology industry, Lee included the establishment of a support system for innovative pharmaceutical companies and the strengthening of social responsibility for pharmaceutical companies. Lee also pledged to establish a drug price compensation system linked to R&D investment ratios, whereby pharmaceutical companies that invest more in new drug R&D will be rewarded with higher drug prices. Also, the pledge included a proposal to improve the certification system for Korea Innovative Pharmaceutical Companies, taking into account continuous investment and innovation, and encouraging pharmaceutical companies to expand their social contributions and diversify their contribution methods. Notable proposals for expanding national investment and reforming the compensation system to foster a pharmaceutical and biotechnology powerhouse included strengthening the strategic R&D investment system and the performance-based public return support system, establishing an investment ecosystem such as a bio-specialized fund, and concentrating efforts to cultivate specialized human resources. To encourage R&D investment, Lee pledged to integrate drug price management reforms to ensure predictability and create an ecosystem that integrates new technologies such as AI and big data for global new drug development. To improve the accessibility and innovation of medicines, Lee will promote the expansion of risk-sharing agreements (RSA) and, as part of its commitment to preparing for the next pandemic, expand support for research and development of next-generation vaccine platforms such as mRNA and synthetic antigen technology. The candidate will establish a governance framework for responding to the next pandemic, advance the infectious disease response system, expand joint research on infectious diseases, and strengthen international cooperation in responding to public health crises. Additionally, he pledged to support sustainable and appropriate ODA cooperation in the health sector commensurate with the nation's standing.
- Policy
- Lee ‘promises support for essential medicine companies’
- by Kang, Shin-Kook May 29, 2025 05:50am
- Jae-Myung Lee, presidential candidate for the Democratic Party of Korea, promised to support pharmaceutical companies producing essential medicines. On the 28th, Lee posted on his social media, “The state will take responsibility for supporting the supply of essential medicines. Over the past 5 years, the supply of over 100 essential medicines has been discontinued due to poor sales and deteriorating profitability. If essential medicines are not supplied on time, the damage will ultimately fall on the people.” He also stated, “We will expand the emergency introduction of essential medicines through the Korea Orphan & Essential Drug Center and push for support for domestic pharmaceutical companies.” Additionally, Lee noted, “Last year, there were 370,000 patients with rare diseases and 750,000 patients with severe and intractable diseases. This represents a 27.4% increase over the past 5 years.” He emphasized, “For these patients, what’s even harder to bear than the disease itself is that there is either no treatment available or the existing one is too expensive to afford?” He added, “The state must stand close to the pain of its people. We will ensure that patients with rare and intractable diseases are diagnosed early and receive timely treatment. We will strengthen the medical safety net with broader and thicker coverage.” The candidate promised to reduce the burden of medical expenses for patients with rare and intractable diseases. Currently, the out-of-pocket maximum system reimburses medical expenses exceeding a certain annual threshold, but this remains a significant burden for patients and their families who must pay large sums upfront. The candidate emphasized, “We will gradually reduce the out-of-pocket coinsurance rate under the health insurance special calculation system for rare and severe intractable diseases from the current 10%. We will alleviate concerns about treatment costs.” He also stated, “We will expand health insurance coverage for treatments for severe and rare intractable diseases. Currently, only about half of rare drugs are covered by health insurance. We will expand coverage to improve access to treatment and reduce the economic burden.” Additionally, he declared, “The primary responsibility of the state is to protect the lives of its citizens. We will build a country that does not give up on rare diseases or turn away from intractable diseases.”
- Policy
- 'Cabometyx' for ncRCC, failed to nego for expanded reimb
- by Lee, Tak-Sun May 28, 2025 05:57am
- Product photo of Cabometyx The anticancer drug Cabometyx tab (cabozantinib, Ipsen Korea), a treatment of kidney cancer, did not pass the expanded reimbursement during negotiations with the National Health Insurance Service (NHIS). Cabometyx tab gatherered attention following reimbursement for the first-line treatment of patients with non-clear renal cell carcinoma (ncRCC), which account for 10-15% of all kidney cancer. However, it will take more time due to the current failed negotiation. On May 26, the National Health Insurance Service (NHIS) announced on its website that 'Cabometyx' had failed to negotiate. This drug was determined to have appropriateness for expanded reimbursement by the Drug Reimbursement Evaluation Committee (DREC) of the Health Insurance Review & Assessment Service (HIRA) in February, provided that the company accepted a price below the evaluated amount. After that, the pharmaceutical company accepted a price below the evaluated amount, and drug price negotiations withthe NHIS have been ongoing since March. Cabometyx was initially listed for reimbursement in February 2019 as a monotherapy for patients with advanced renal cell carcinoma who had previously received VEGF-targeted therapy. As of March 2022, it was reimbursable in combination therapy with the immuno-oncology drug nivolumab (Opdivo) in patients with advanced renal cell carcinoma. The company continued to push for further expanded reimbursement. In August of last year, the Cancer Disease Review Committee (CDRC) reviewed its use as a 'monotherapy in patients with locally advanced or metastatic differentiated thyroid cancer (DTC) who have previously received VEGF-targeted therapy or whose disease has progressed during treatment, and who are ineligible for or refractory to radioactive iodine therapy (RAI)' and 'first-line monotherapy in patients with non-clear cell renal cell carcinoma.' However, reimbursement criteria were not established at that time. However, in February of this year, DREC approved the ncRCC indication. Clear cell renal cell carcinoma (ccRCC) accounts for 80-85% of kidney cancers, with the remaining 10-15% being ncRCC. Despite ncRCC having a poorer treatment response compared to clear cell, there are currently few drugs covered for reimbursement. However, Cabometyx has emerged as a targeted therapy, gaining attention as a next-generation treatment option. The problem is the lack of reimbursement. With the breakdown of these negotiations, it is expected to take more time for Cabometyx to obtain reimbursement for ncRCC. Meanwhile, the NHIS announced that it is in negotiations with Novartis for 'Leqvio pre-filled syringe.' This drug, intended for the treatment of primary hypercholesterolemia or mixed dyslipidemia, passed the DREC in April.
- Policy
- Expanded reimb for Jardiance's CKD indication imminent
- by Lee, Tak-Sun May 27, 2025 06:19am
- Jardiance Tab It is to be watched whether the SGLT-2 inhibitor Jardiance (empagliflozin, Boehringer Ingelheim) will be approved for expanded reimbursement to include chronic kidney disease (CKD) indication, in addition to diabetes and chronic heart failure indications. The evaluation by the Health Insurance Review & Assessment Service (HIRA) is expected to be nearing end following the reimbursement expansion filed in the first half of last year. According to industry sources on May 26, HIRA is reportedly reviewing expanded usage scope and pre-drug price reduction system for Jardiance's CKD indication. The pre-drug price reduction system for expanded usage scope drugs is designed to quickly enhance patient access to treatment by omitting the cost-effectiveness evaluation and applying a pre-reduction rate table, with a maximum 5% reduction in the ceiling cap, considering the estimated additional claim amounts due to the expanded reimbursement criteria. Once the pharmaceutical company submits financial impact analysis data and HIRA determines the pre-reduction rate through practical review, the Drug Reimbursement Evaluation Committee (DREC) will deliberate. If the pharmaceutical company accepts the deliberation results, the revised reimbursement criteria notification is completed after negotiation with the National Health Insurance Service (NHIS). The company applied to HIRA for reimbursement expansion for Jardiance's CKD indication in the first half of last year. Jardiance was the first SGLT-2 inhibitor to file. The approved indications for Jardiance 10mg tablets are: 1. Type 2 diabetes mellitus, 2. chronic heart failure, and 3. chronic kidney disease. Jardiance Tab, which were listed for reimbursement as a diabetes treatment in 2017, have also been reimbursed for chronic heart failure since February 2024. Since January, the reimbursement criteria have been expanded, allowing patients with heart failure with preserved ejection fraction (HFpEF) who have symptoms and signs of heart failure and a left ventricular ejection fraction exceeding 40% to receive national health insurance benefits. Currently, the only SGLT-2 drugs covered for diabetes and chronic heart failure patients, besides Jardiance, are Forxiga (dapagliflozin) and HK inno.N's DapaN Tab, which transferred Forxiga's indications. However, there is currently no drug reimbursable for CKD. If the reimbursement expansion procedure for Jardiance is completed, it is expected to be the only SGLT-2 drug with CKD reimbursement coverage. The efficacy of Jardiance has been demonstrated through clinical trials, showing a statistically significant 28% relative risk reduction in the progression of kidney disease or cardiovascular death compared to placebo. The competition in the market for SGLT-2 has been intensified due to the expiration of dapagliflozin patent in 2023 and the launch of generic drugs, Jardiance's expanded reimbursement scope to include CKD will give Jardiance a competitive advantage. Generic drugs are expected to launch following Jardiance's substance patent expiration in October. However, Jardiance's heart failure and kidney disease indications are expected to remain protected, so expanded reimbursement is anticipated to minimize the impact of generic entry. The pharmaceutical industry anticipates that the reimbursement expansion for Jardiance's CKD indication will be approved after July or by the end of the year.
- Policy
- Rinvoq reimbursed for active progressive psoriatic arthritis
- by Whang, byung-woo May 27, 2025 06:18am
- Pic of Rinvoq AbbVie Korea's Rinvoq has become the first oral JAK inhibitor to be covered by insurance for psoriatic arthritis in Korea. On the 26th, AbbVie Korea announced that Rinvoq (upadacitinib), a once-daily oral treatment and selective JAK inhibitor, will be reimbursed for the treatment of active and progressive psoriatic arthritis in adults starting June 1, in accordance with the Ministry of Health and Welfare’s official notification. With the reimbursement decision, adult patients with active and progressive psoriatic arthritis who have been treated with two or more types of disease-modifying antirheumatic drugs (DMARDs) for a total of six months or more (at least three months each) but have not responded adequately to treatment or have discontinued treatment due to side effects will now be eligible for Rinvoq’s use with insurance reimbursement. An initial evaluation will be conducted three months after administration of Rinvoq, and if the number of active joints is reduced by 30% or more, insurance coverage will continue, with evaluations conducted every 6 months thereafter. In addition, if treatment with tumor necrosis factor inhibitors, interleukin inhibitors, or phosphodiesterase-4 inhibitors is ineffective or cannot be continued due to side effects, or if medication compliance needs to be improved, insurance reimbursement will be granted even if the patient has switched to Rinvoq. In such cases, a treatment recommendation form for the switch must be attached, and the patient is recommended to maintain the use of the new treatment for at least 6 months after the switch. Seung-Jae Hong, Professor of Rheumatology at Kyung Hee University Hospital said, “Psoriatic arthritis greatly affects the quality of life of patients, but many patients still struggle to find treatment options to reduce disease activity. Rinvoq, which has been approved for insurance reimbursement, has been shown in clinical studies to improve joint symptoms and significantly improve the quality of life of patients by restoring physical function and reducing fatigue.” Professor Hong also noted, “With the convenience of once-daily oral administration, we anticipate that this treatment to become a practical and useful option in practice.”, This insurance reimbursement was approved based on Rinvoq’s efficacy and safety confirmed in SELECT-PsA 1 and SELECT-PsA 2, which are phase III, multicenter, randomized, double-blind, placebo-controlled clinical studies in patients with moderate-to-severe adult active and progressive psoriatic arthritis. SELECT-PsA 1 included patients who had an inadequate response to or were unable to tolerate one or more non-biologic disease-modifying antirheumatic drugs (DMARDs), while SELECT-PsA 2 included patients who had an inadequate response to or were unable to tolerate one or more biologic disease-modifying antirheumatic drugs.
- Policy
- Moderate-risk trial granted for 'Amtagvi' for melanoma
- by Lee, Jeong-Hwan May 26, 2025 05:56am
- The government has approved a moderate-risk clinical study to treat refractory melanoma patients using the T-cell therapy, Amtagvi. The government also approved a high-risk clinical study that administer multi-virus antigen-specific immune T-cells to pediatric and adolescent patients with resistant·refractory multi-virus infections who underwent allogeneic hematopoietic stem cell transplantation. On May 23, the Ministry of Health and Welfare (MOHW) announced these decisions as part of the resolution results of the 5th Advanced Regenerative Medical and Advanced Biopharmaceutical Review Committee. The Committee reviewed a total of four clinical study plans (two high-risk, two moderate-risk) from institutions, including Catholic University of Korea Seoul St. Mary's Hospital and Samsung Medical Center. Of these, two were approved, and two were deemed unsuitable. Approval of 'Amtagvi' clinical study for melanoma patients The approved project is a moderate-risk clinical study to evaluate the safety and efficacy of tumor-infiltrating lymphocytes (TIL) derived from the patient's own body, in refractory (intractable) melanoma patients who have failed immune checkpoint inhibitor therapy. Melanoma is a malignant tumor originating from melanin cells in the skin. Although it accounts for 1-4% of skin cancers, it has the highest mortality rate. Tumor-infiltrating lymphocytes (TIL) are lymphocytes present in the tumor microenvironment that recognize and destroy tumor cells. They have a high potential to overcome tumor heterogeneity and tumor cell immune evasion, leading to tumor cell death. The TIL therapy 'Amtagvi' is the world's first approved T-cell therapy for solid tumors. Clinical trials of TIL therapy are currently underway for various solid tumors both domestically and internationally. This study aims to evaluate safety by confirming adverse reactions and to assess efficacy by checking objective response rates and progression-free survival, following the administration of TILs manufactured using a domestically developed method. This is to provide a new treatment option using TIL for domestic melanoma patients who have failed most existing treatments. Approved for T-cell therapy in multi-virus infected patients The study was a high-risk clinical study that involved administering multi-virus antigen-specific immune T-cells (VST) to pediatric and adolescent patients who have undergone allogeneic hematopoietic stem cell transplantation and show resistance· refractoriness to standard treatment for multi-virus infections or related infectious diseases. Graft-versus-host disease (GVHD), which primarily occurs during allogeneic hematopoietic stem cell transplantation, is a major severe complication where donor immune cells attack the patient's tissues. To manage this, strong immunosuppressants are used, and as a side effect, the patient's overall immunity is weakened, making them susceptible to infections. This leads to the reactivation of latent viruses within the patient's body, causing infections. Existing antiviral drugs find it difficult to suppress multiple viruses simultaneously, can lead to resistance with long-term use, and have high kidney·liver toxicity. This study aims to simultaneously suppress multiple viruses using VSTs and prevent long-term recurrence through immune memory. The director of the Minister of Food and Drug Safety (MFDS) informed the committee that the research data submitted by the researchers were valid through a rapid and combined review of the high-risk clinical study. Following the procedure, regenerative clinics will conduct the clinical study after receiving approval notification from the MFDS. Kim Woo-ki, Secretary-General of the Advanced Regenerative Medical and Advanced Biopharmaceutical Review Committee, explained, "Based on a re-deliberation decision regarding clinical study plans that required adjustments, the committee granted final approval so researchers can submit supplements."
