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- 2025-12-19 14:19:24
- Policy
- NA requests rapid reimb listing for diabetes drug Mounjaro
- by Jung, Heung-Jun Nov 11, 2025 06:08am
- The Ministry of Health and Welfare (MOHW) announced that it will reflect the results of the October expert advisory meeting in reimbursement criteria for Mounjaro (tirzepatide), Eli Lilly’s dual GIP/GLP-1 receptor agonist, following growing calls for its rapid inclusion under the National Health Insurance for type 2 diabetes. The ministry also stated it is working to ensure the smooth reimbursement process for Ozempic (semaglutide), Novo Nordisk’s GLP-1 receptor agonist, which was reviewed by the Drug Reimbursement Evaluation Committee in October. On the 10th, Miae Kim, a lawmaker from the People Power Party, inquired about the current status of the reimbursement application process for Mounjaro for type 2 diabetes during a written inquiry session for the Ministry of Health and Welfare's comprehensive audit. She also questioned the plans for utilizing the expedited listing system, which reflects international drug prices and reimbursement cases. According to the Ministry of Health and Welfare, Mounjaro applied for reimbursement approval in March last year and was discussed by the Drug Reimbursement Criteria Subcommittee in May of the same year. Subsequent evaluations on its reimbursement adequacy were conducted in August and December 2023, and March and June 2024 by the Cost-Effectiveness Evaluation Subcommittee. The Ministry explained, “The company applied for reimbursement of Mounjaro in March last year and is currently undergoing a review on its reimbursement adequacy. The drug is being reviewed in accordance with HIRA regulations, referencing factors such as its listing status in other countries, listed prices, and coverage criteria.” It added, “To ensure appropriate use of the GLP-1 agonists Mounjaro and Ozempic for diabetes patients, HIRA held an expert advisory meeting last October to discuss patient selection criteria and evaluation methods. The findings will be reflected in the drug's reimbursement criteria.” Rep. Seo Mi-hwa of the Democratic Party of Korea also inquired about the Ministry's stance on reviewing insurance coverage for new drugs to strengthen diabetes management. The Ministry responded, “We agree that the health insurance coverage of new diabetes drugs should be actively reviewed. Currently, GLP-1 receptor agonists Ozempic and Mounjaro are undergoing the listing process. We will closely monitor to ensure the listing process proceeds smoothly and continue our efforts to improve treatment accessibility.”
- Policy
- Cancer & orphan drugs apply for reimb within 1 week of apv
- by Jung, Heung-Jun Nov 10, 2025 06:10am
- Anticancer drugs and rare disease drugs that were approved in Korea this year are racing to apply for reimbursement as quickly as within a week. Six rare/serious disease treatments approved by the Ministry of Food and Drug Safety this year are undergoing reimbursement review, excluding those subject to the approval-evaluation-negotiation system. According to industry sources on the 7th, multiple new drugs, including those designated under the Global Innovative product on Fast-Track (GIFT) scheme, are applying for reimbursement quickly after approval. Takeda Korea’s Fruzaqla (fruquintinib), which was approved in March for metastatic colorectal cancer, was submitted for reimbursement last month and is currently being assessed for clinical benefit. The drug, designated GIFT No. 20, was specifically requested for expedited coverage during this year’s NA MOHW audit as a third-line therapy for metastatic colorectal cancer. Qalsody (tofersen), Biogen’s amyotrophic lateral sclerosis (ALS) treatment and GIFT No. 31, received approval on August 20 and was immediately filed for reimbursement to expand its prescription. Imdelltra (tarlatamab), Amgen Korea’s small-cell lung-cancer drug (GIFT No. 25), was approved on May 30 and submitted for reimbursement on August 28. Augtyro (repoterrectinib), Bristol Myers Squibb’s therapy for metastatic non-small-cell lung cancer and solid tumors, followed a similar path — approved in June, filed 2 months later. Gilead Sciences’ Yescarta (axicabtagene ciloleucel), a CAR-T therapy for diffuse large B-cell lymphoma, and Janssen Korea’s Opsynvi (macitentan + tadalafil) for pulmonary arterial hypertension, both received approval in July and August, respectively, and each applied for reimbursement within just 1 week of approval. Opsynvi is now undergoing a cost-effectiveness evaluation. Industry analysts attribute this accelerated pace partly to the current administration’s policy direction under President Jae-myung Lee, which emphasizes improving patient access to orphan and severe-disease treatments. However, even with early reimbursement filings, such drugs typically face lengthy review cycles as significant time is required for clinical utility and cost-effectiveness reviews. Even if they clear the threshold of proof, a protracted drug price negotiation process remains. Currently, 33 drugs that applied for reimbursement last year and this year remain under review, suggesting fierce behind-the-scenes competition among drugs for priority listing.
- Policy
- Budget cut 20% despite increased COVID-19 vaccine uptake
- by Lee, Jeong-Hwan Nov 10, 2025 06:08am
- The Korea Disease Control and Prevention Agency (KDCA) has cut the national immunization program (NIP) budget for COVID-19 vaccines for the 2026-27 season by 20% compared to the previous year, raising societal concern over potential drops in immunity among high-risk groups like the elderly, increased mortality risk, and the possibility of early vaccine stock depletion. Moreover, the KDCA’s 20% cut to the COVID-19 NIP budget was based on the 2023-2024 season's vaccination rate of 42%, failing to reflect the 48% rate from this season (2024-2025 season). This has drawn criticism as an administrative decision that undermines effective epidemic prevention. The National Assembly Budget Office pointed out that both the number of vaccinated individuals and the coverage rate are on the rise, and has urged the KDCA to raise its target vaccination rate and revise the budget accordingly. The Budget Office recommends increasing the budget from the government’s draft of KRW 175.8 billion to KRW 200.8 billion – a KRW 25 billion increase. On the 10th, the National Assembly Health and Welfare Committee will review the KDCA budget, including the COVID-19 vaccine NIP budget, during its plenary session. The COVID-19 vaccine NIP covers high-risk groups - persons aged 65 and older, residents in communal or institutional facilities aged 6 months to 64 years, and immunocompromised individuals – with the aim of securing immunity and preventing severe illness and death. The KDCA set the 2026 NIP budget based on a vaccination rate of 42%. But looking at recent seasons, the number vaccinated was 2.90 million (39.3%) in 2022-23; 4.10 million (41.3%) in 2023-24; and 4.97 million (47.8%) in 2024-25, it was for the 65+ age group, continuing an upward trend. The major issue highlighted by experts and the Budget Office was that, despite rising vaccine uptake, the KDCA’s budget estimate remains anchored to the 42% figure from the 2023-24 season. Given statistics showing the 2024-2025 season vaccination rate approaching 48%, experts and the Office believe that setting the budget based on an incorrect baseline will inevitably lead to early vaccine depletion if the vaccination levels stay the same or increase, making it impossible to achieve the target vaccination rate. The argument is that recognizing the vaccine budget as an investment rather than an expense and rationally increasing the budget for infectious disease response is necessary to prevent potential outbreaks among high-risk groups and increases in mortality rates. In fact, 5.3 million doses of COVID-19 vaccines were secured this year based on last year's vaccination rate. However, increased uptake due to simultaneous COVID-19 and flu vaccination campaigns by health authorities and local governments led to vaccine shortages at some medical institutions just 2 weeks after the National Immunization Program (NIP) began. The NIP is a public health investment to protect citizens' lives. Prioritizing long-term effects over short-term costs will lead to socioeconomic benefits, including reduced healthcare expenses, alleviated burden on the medical system, and maintained national productivity. Furthermore, since the 2023 declaration of endemic status, COVID-19 has continued to mutate repeatedly, with the number of hospitalized patients and mortality rates constantly being reported. According to the KDCA’s infectious disease portal sample surveillance results, the number of COVID-19 hospitalizations last year was approximately 3 times that of influenza hospitalizations. The mortality rate was also higher for COVID-19 hospitalized patients at 5.97%, compared to 3.75% for influenza hospitalized patients. In the National Assembly, lawmakers, including Representative Jin-sook Jeon and Representative Nam-hee Kim of the Democratic Party of Korea, have been scrutinizing the KDCA's unreasonable NIP budget cuts. In response, the NA Budget and Planning Office has proposed the need to increase next year's NIP budget to reflect the rising trend in COVID-19 vaccination numbers and rates. The request is to increase the budget by KRW 25 billion, raising it from the KDCA's budget of KRW 175.8 billion (based on a 42% target vaccination rate) to KRW 200.8 billion (based on a 48% vaccination rate). The Budget and Planning Office analyzed, “Considering the recent trend of increasing COVID-19 NIP vaccinated individuals and vaccination rates across all 3 seasons, there seems to be a need to increase the project budget. Calculating the budget based on raising the target vaccination rate from 42% to 48% (a 6 percentage point increase) results in an estimated KRW 200.8 billion, an additional KRW 25 billion .”
- Policy
- ‘No drugs are benefitting from Korea's dual pricing scheme'
- by Jung, Heung-Jun Nov 10, 2025 06:08am
- Although a separate contract system was introduced for dual pricing of drugs in March this year, following a Ministry of Health and Welfare notice, no drugs are currently subject to the dual drug pricing system, prompting the government to review expansion plans. The NHIS stated it is reviewing with the government on expanding the scope of drugs eligible for the separate contract system. On the 7th, Democratic Party of Korea lawmakers Young-seok Seo and Byeong-hoon So submitted written inquiries during the NHIS’s comprehensive NA audit, seeking clarification on the direction and intent behind expanding the dual pricing policy. The Ministry of Health and Welfare had enacted a new notice titled “Evaluation criteria for drugs requiring assessment based on their impact on healthcare” in March, thereby introducing the separate contract system. Rep Young-seok Seo questioned the drugs currently subject to the system and the operational plan. The NHIS responded, “To be subject to the separate contract system, a drug must satisfy all 3 conditions: being an innovative new drug developed by an innovative pharmaceutical company, being approved under the expedited review system, and having undergone domestic clinical trials. Currently, there are no drugs that meet all the criteria. It added, “We are reviewing with the government and other stakeholders the expansion of drugs subject to the separate contract system to facilitate the early introduction of innovative new drugs for patient treatment access.” Representative Byeong-hoon So inquired about plans for expanding the dual pricing system. He also questioned whether plans exist to ensure fiscal stability when expanding the refund-type contract system. The NHIS stated, “Considering the enhancement of health insurance sustainability and the promotion of an innovative industrial ecosystem, we will consult with the government to improve the drug listing system, including expanding the separate contract system, and establish a balanced roadmap.”
- Policy
- The application for selective reimb of new drugs is stalled
- by Jung, Heung-Jun Nov 07, 2025 06:17am
- Roche Korea's 'Perjeta (pertuzumab),' a breast cancer treatment, was not on the recent Cancer Disease Review Committee (CDRC) agenda, despite expectations, raising questions about the background of its exclusion. One analysis suggests that the government's policy shift toward strengthening access to rare and severe disease treatments may have contributed. The view is that the Health Insurance Review & Assessment Service (HIRA) must exercise caution in applying selective reimbursement to drugs, as it aligns with impending changes to government policy. According to industry sources on the 5th, discussions on establishing reimbursement criteria for Roche Korea's HER2-positive breast cancer treatment, Perjeta, were not considered in the recent CDRC meeting, reportedly due to an application for selective reimbursement. The CDRC meeting results determined the reimbursement status for 6 products from 5 companies. Perjeta, which was expected to be on the agenda, was not included in the list of drugs discussed. Perjeta is currently applicable for selective reimbursement (with a 30% patient co-payment) for neoadjuvant (pre-operative) therapy for early breast cancer. It is reported that the company has now also applied for selective reimbursement for the post-operative therapy indication. Selective reimbursement was first implemented in 2018 under the previous Moon Jae-in administration as part of its healthcare policy to provide coverage for non-reimbursed treatments. At the time, the government planned a 3-year timeline for anti-cancer drugs and a 5-year timeline for general drugs under the Moon Jae-in Care policy, aiming to reduce patient burden for drugs with high social demand but difficult full reimbursement. With this policy, some new drugs, including anti-cancer agents, received selective reimbursement, but attempts to enter this category have been rare since. Most recent changes involve adjustments to the patient co-payment ratio for drugs already under selective reimbursement. Looking at the current list of reimbursed drugs, 123 items are subject to selective reimbursement. Excluding 97 choline alfoscerate products, which were transitioned to selective reimbursement (with an 80% co-payment) last September, the number of new drugs granted selective reimbursement is small. No new drugs have been granted selective reimbursement this year. The Lee Jae Myung administration is currently pushing a plan to expand access to treatment for rare and severe diseases. Although specific implementation plans have not been formalized, a systemic reform is anticipated. Consequently, analysis suggests that the implementation of selective reimbursement for new drugs, which was part of the previous administration's 3- to 5-year plan, is being delayed to align with the latest, changing policy direction.
- Policy
- MFDS to ease orphan drug designation eligibility criteria
- by Lee, Tak-Sun Nov 06, 2025 06:32am
- Yu-Kyoung Oh, Minister of the MFDS, is speaking at the As the criteria for Orphan Drug Designation are set to be significantly eased, this is expected to expand the introduction of rare disease treatments currently not approved in Korea. The Ministry of Food and Drug Safety (MFDS) plans to revise the regulations by February of next year. The MFDS announced this during the 'Top 50 Food and Drug Safety Tasks National Briefing Session' held on the 5th at the International Conference Hall on the first floor of the Seoul Foundation of Women and Family in Dongjak-gu, Seoul. The relaxation of the Orphan Drug Designation requirements was introduced as the very first of the seven key projects. Yu-Kyoung Oh, Minister of the MFDS, said, "We will ease the designation requirements for rare drugs not yet approved in Korea to expand treatment opportunities for patients." Currently, a drug is designated as an orphan drug if the prevalent patient population is 20,000 or fewer and if comparative data are available with an alternative medicine. During this process, it is required to submit data demonstrating that the drug is significantly safer and more effective than existing alternatives, but the industry reports difficulty providing this documentation. There have been calls to ease designation requirements to expand treatment options for rare disease patients with limited or difficult treatment options. In response, the MFDS plans to revise the criteria. Under the revised plan, a drug will be designated as an orphan drug simply by being used for the treatment or diagnosis of a rare disease, effectively eliminating the requirement to submit comparative data against an alternative therapy. The exemption of the superiority requirement for orphan drug designation is already unnecessary in countries like the United States, Switzerland, and Taiwan. The relaxation of the orphan drug designation will be implemented through the revision of the 'Regulations on Orphan Drug Designation' planned for February of next year. In addition, the MFDS plans to tag medications currently imported directly by patients for self-treatment as urgently imported drugs to ensure proper inventory stockpiling and supply. The policy aims to sequentially transition over 10 items annually, starting next year. To achieve this, the MFDS plans to secure the necessary budget through inter-ministerial consultation and expand the scope of the related program. The seven key tasks also include: ▲Operating a hotline for rapid and convenient one-stop preliminary consulting ▲Faster announcement of harmful food information via 'consumer-customized SNS' ▲Expanding treatment opportunities for innovative anti-cancer drugs by improving clinical trial participant requirements ▲Quick confirmation of safe information on dietary supplements via QR code ▲Rapid safety management of contaminants in livestock products (meat) using AI ▲Establishing clear standards for safe consumption of decaffeinated coffee. The task of improving anti-cancer clinical trial participant requirements involves establishing review criteria for early-stage anti-cancer clinical trials. This is intended to expand patient choice, invigorate anti-cancer clinical trials, and support the development of treatments for intractable cancers in situations where a cure is difficult. The MFDS plans to issue the 'Considerations for Participant Selection in Early-Stage Anti-Cancer Clinical Trials' guideline in December, which will clearly present the review criteria for clinical trials involving patients with established alternative treatments. Minister Oh emphasized that through these seven key tasks, the MFDS aims to "add security to food and drug safety so that the daily lives of the people can be healthier."
- Policy
- 'Rebate points deduction system' has been stalled
- by Lee, Jeong-Hwan Nov 04, 2025 06:13am
- The revision of South Korea's Innovative Pharmaceutical Company Certification System, which the Ministry of Health and Welfare (MOHW) is pursuing to foster the Korean pharmaceutical industry, is stalling. This is likely due to arguments for and against 'conversion to a rebate scoring system.' Following agreement with the pharmaceutical industry, the MOHW had tentatively finalized a revision to switch the 'one-strike-out' rule for innovative pharmaceutical companies caught giving illegal pharmaceutical rebates to a 'points deduction system.' However, due to recent concerns about revising the scoring system, the MOHW has yet to decide. The MOHW is criticized by opponents who argue that the current one-strike-out rule is a "poison clause" and an excessive·dual regulatory burden for companies penalized for past rebate incidents. In contrast, the counter-argument is that it is illogical to grant the Innovative Pharmaceutical Company designation, along with tax and drug price benefits, to unethical and unlawful pharmaceutical companies. Some in the pharmaceutical industry even express concern that the conversion of the rebate penalty rule from a penalty to a points system, which had been discussed positively by the Yoon Suk Yeol administration until the inauguration of the Lee Jae Myung administration, might not be pursued. The MOHW is internally reviewing the final proposal and the timing for the administrative pre-announcement of the certification system on November 2. MOHW delays the administrative pre-announcement for revision from October The MOHW had planned to complete the administrative pre-announcement procedure for the certification system revision last month (October), aiming for implementation in January of next year. Specifically, this involved amending the 'Regulations on the Certification of Innovative Pharmaceutical Companies (Notice)'. However, the ministry failed to proceed with the notice revision because it could not reach an internal conclusion on provisions such as converting the penalty for revision-violating pharmaceutical companies to a points deduction system. Consequently, the administrative pre-announcement of the revision was delayed, making the planned January implementation of the revision impossible. Pharmaceutical companies caught giving rebates, dispute over certification The point of the argument is a regulatory proposal that would ease penalties for innovative pharmaceutical companies that previously provided illegal drug rebates. This involves differentiating and converting the current standard, which immediately revokes the designation, to a lesser penalty, such as a '10-point deduction'. Pharmaceutical companies have long maintained that the Innovative Pharmaceutical Companies system, intended to encourage domestic new drug R&D and increase the potential for new drug creation, is burdened by excessive regulation that allows the certification to be revoked instantly for a debate violation. The MOHW had tentatively decided to partially reflect the pharmaceutical industry's views by abolishing the one-strike-out rule and changing the disqualification criteria to a scoring system that would deduct points from companies' scores for rebates. A 10-point deduction during the certification review for a company found to have provided rebates was highly likely. This decision by the MOHW was made during the Yoon administration, and according to the original plan, the reform, which included converting the rebate penalty to a points system, should have been finalized and revised during the first quarter of this year. However, the situation surrounding the revision changed with the transition of government. The argument gained traction that the conversion to a points system could have a negative effect, softening vigilance against illegal drug rebates or hindering the deterrent effect against unlawful activities. Accordingly, Vice Minister of Health and Welfare Lee Hyung-hoon and others were reportedly instructed to review and reconsider the detailed proposal for the rebate points deduction system. Will the scoring system be abandoned? The conversion of the rebate penalty to a points deduction system is an administrative reform strongly requested by domestic and international industry stakeholders. With news emerging that the MOHW is struggling with the transition to the points system, some parts of the pharmaceutical industry are even speculating that the conversion of the rebate penalty might be abandoned entirely. The pharmaceutical industry is considering the possibility that the MOHW may set more specific, stringent criteria for the 10-point deduction proposal. For instance, some in the pharmaceutical industry anticipate that the current regulation will be further refined into a cumulative strike-out system, where the deduction points would be increased based on the number of violations and the amount of rebates: a 10-point deduction for the first violation, 15 points for the second, and certification revocation for the third. Another side of the pharmaceutical industry predicts that the transition to a points deduction system will be abandoned. This is due to prevailing social opposition, which argues that implementing the reform could grant re-certification opportunities to pharmaceutical companies whose certification was previously canceled due to rebates (despite the penalty period), which would be socially unacceptable. In fact, during this year's parliamentary inspection, Democratic Party Rep. Kim Yoon had planned to question the CEO of a domestic pharmaceutical company as a witness regarding the appropriateness of granting re-certification opportunities and associated benefits to companies involved in rebates, but the subpoena for the witness was later withdrawn. There is also an argument for implementing the rebate deduction system, but applying the one-strike-out rule (revocation of certification) only to pharmaceutical companies that provide rebates after the new system's introduction date. This logic attempts to reflect the claim that revoking certification based on old illegal rebate incidents is overly archaic and excessive regulation, while still securing a deterrent effect against future rebate activities. The certification system revision, which appeared to be progressing smoothly, has encountered an unexpected barrier, drawing the attention of both the pharmaceutical and healthcare sectors toward the MOHW's administration. An official from a mid-sized domestic pharmaceutical company said, "It's true that there were strong complaints that the rebate revocation rule contradicted the purpose of the Innovative Pharmaceutical Company Certification System, which is to expand benefits for R&D-focused pharmaceutical companies." He added, "I understand that the MOHW accepted this, decided to switch to a points system, and even went through the deliberation of the MOHW. However, the administrative delay, coupled with the change in administration and the appointment of new ministers, altered the atmosphere." The official added, "The MOHW is reconsidering because of the growing perception that the conversion to a rebate deduction system could be viewed externally as regulatory easing that partially condones illegal activities by pharmaceutical companies." He said, "We cannot rule out the possibility that the points system transition will be abandoned. Even if the conversion proceeds, we hear that the direction will likely be to clarify the disqualification criteria for companies whose certification has already been revoked or to increase the severity of the deduction penalties." Minister of Health and Welfare Jeong Eun Kyeong stated during this parliamentary inspection regarding the revision, "The MOHW is internally reviewing the comprehensive drug pricing system revision proposal as well as the Innovative Pharmaceutical Company Certification System improvement plan."
- Policy
- AI-driven drug R&D key to narrowing gap with global leaders
- by Lee, Jeong-Hwan Nov 04, 2025 06:09am
- Soon-do Cha, President of KHIDI The President of the Korea Health Industry Development Institute (KHIDI stressed that Korea must strategically nurture AI and data capabilities to dramatically improve the productivity of AI-based drug R&D and rapidly close the technology gap with advanced pharmaceutical nations. He also revealed a plan to create a KRW 1-trillion mega-fund by 2027 to support large-scale clinical trials and global expansion of domestic biopharma companies. He further stated that support would be strengthened throughout the entire lifecycle for global market entry, including expanding open innovation and exports between global pharmaceutical companies, domestic anchor companies, and startups. Soon-do Cha, President of KHIDI, responded so to a written inquiry from Representative In-soon Nam of the Democratic Party of Korea regarding the promotion of the pharmaceutical and biotech industry during the National Assembly audit on the 31st. First, Cha agreed with Nam's views on the necessity of full-cycle support for the global expansion of the pharmaceutical and biotech industry, the cultivation of core talent, and regulatory improvements. He further stated that selection and focus are crucial for achieving the government's national policy tasks, emphasizing that the core lies in convergence-based selection and concentration, namely convergence-type R&D. Accordingly, the KHIDI will actively pursue support projects in collaboration with various government ministries, including the Ministry of Health and Welfare, to successfully execute the national task of realizing Korea into a medical AI, pharmaceuticals, and biohealth powerhouse. Cha explained, “We will strengthen support for open innovation and export expansion among global pharma companies, domestic anchor companies, and startups. We will also establish a KRW 1 trillion mega-fund by 2027 to support large-scale clinical trials and global expansion, and support the implementation of a plan to cultivate 110,000 core biohealth talents.” He further emphasized, “We will operate a regulatory reform forum to continuously identify field challenges and pursue ongoing regulatory improvements. Our strategy is to steadily increase investment in basic and translational research in areas like pharmaceuticals, regenerative medicine, and medical devices—where we face technological gaps but hold national health and industrial importance—to narrow these gaps.” Cha added, “Strategically nurturing our strengths in AI and data is also part of our strategy. Ultimately, focusing on convergence R&D that combines these two fields will secure a global competitive advantage. A Applying AI to drug development to sharply raise R&D productivity is one prime example.” He further noted, “The findings from the healthcare and industrial technology level survey indicate that addressing technological gaps in core areas like drug development and advanced regenerative medicine, along with cultivating specialized personnel and securing government policy support, are extremely urgent. KHIDI will focus on enhancing the efficiency of government R&D investment and cultivating the specialized personnel needed by industry, including physician-scientists.”
- Policy
- Minister Jeong backs INN prescribing for shortage drugs
- by Lee, Jeong-Hwan Nov 03, 2025 06:08am
- Minister of Health and Welfare Eun-kyeong Jeong expressed support for introducing international nonproprietary name (INN) prescribing and expanding substitution dispensing by pharmacists for medicines facing supply instability, as they are national policy tasks. However, she stressed the need to build social consensus given strong opposition from the medical community. Minister Jeong also expressed her intent to establish a direction through research services on how to monitor out-of-stock drugs and set criteria and definitions to resolve the unstable supply of pharmaceuticals. During the National Assembly Health and Welfare Committee audit on the 30th, Minister Jeong responded so to Rep. Jong-tae Jang Democratic Party of Korea) on his inquiries. Rep. Jang had proposed a bill mandating limited INN prescribing for pharmaceuticals with unstable supply. Minister Jeong appealed to the validity of limited INN prescribing, citing factors such as the excessively low domestic substitution rate compared to advanced countries overseas. Rep Jang’s view is that legislating INN prescribing and promoting substitution can simultaneously achieve three goals: resolving the unstable supply of medicines, reducing the National Health Insurance Service's drug expenditure burden, and strengthening patients' choice of medicines. Rep. Jang explained, “In the U.S., nearly all states legally allow pharmacists to substitute with equivalent generic drugs. Some states have even introduced automatic substitution. They also adopt a system where the National Health Insurance prioritizes generic drugs for reimbursement and imposes additional coinsurance rates when original brand drugs are prescribed. As a result, generic prescriptions account for 91% of prescriptions.” He added, “In Japan, pharmacists can freely substitute drugs unless specifically prohibited by a ‘do not substitute’ label. Since last year, they've even introduced a surcharge for requesting brand-name drugs when an original prescription is specified. Pharmacies and medical institutions receive incentives based on their generic drug prescription rates, resulting in an 82% generic prescription rate.” Rep. Jang stated, “The domestic situation, with generic substitution at only 1.5%, is woefully low compared to the US at 90% and Japan and the UK at 80%. The Lee Jae-myung administration's core pledges are resolving essential drug shortages, promoting generic substitution, optimizing drug expenditure efficiency, and solving the rebate issue. The amendment to the Pharmaceutical Affairs Act mandating INN prescriptions is a proven policy to achieve this. What does the Minister think about this?“ Minister Jeong replied, “It is included in the national agenda to review INN prescribing and utilize substitution for drugs with unstable supply. We will consider introducing INN prescribing for essential medicines with unstable supply first.” She added, “Given the significant opposition and disagreement in the medical community, we will proceed through social consensus and dialogue. We also need to discuss how to monitor and define drugs with unstable supply, so we will conduct a short-term research project and discuss the results with MFDS.”
- Policy
- Reimb expanded for Opdivo, Yervoy…set for Vyloy, Padcev
- by Jung, Heung-Jun Oct 31, 2025 06:11am
- BMS Korea’s Yervoy (ipilimumab) and Ono Pharmaceutical Korea’s Opdivo (nivolumab) passed their first hurdle toward expanding reimbursement in Korea. Meanwhile, Janssen Korea’s Tecvayli (teclistamab), Pfizer Korea’s Elrexfio (elranatamab), and Astellas Korea’s Padcev (enfortumab vedotin) and Vyloy (zolbetuximab) had their reimbursement standards established, clearing the first hurdle toward reimbursement listing. The Health Insurance Review and Assessment Service (HIRA) held its 8th Cancer Disease Deliberation Committee meeting for 2025 on the 29th to deliberate on reimbursement criteria for anticancer drugs. Among these, Astellas Pharma Korea saw a double win, as reimbursement criteria were set simultaneously for two of its products. In the case of Vyloy, the National Assembly had requested expediting its reimbursement decision process. In a written inquiry during the Ministry of Health and Welfare's National Assembly audit. This time, Vyloy’s reimbursement criteria were established for ‘First-line treatment for patients with unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma who are CLDN18.2-positive and HER2-negative’ For Padcev, reimbursement criteria were set for both combination therapy and monotherapy, as ‘combination therapy with pembrolizumab as first-line treatment for adult patients with locally advanced or metastatic urothelial carcinoma’ and ‘monotherapy for adult patients with locally advanced or metastatic urothelial carcinoma who have previously received treatment with a PD-1 or PD-L1 inhibitor and platinum-based chemotherapy.’ In addition, Pfizer Korea’s Elrexfio (elranatamab) and Janssen Korea’s Tecvayli (teclistamab) also had their reimbursement criteria established, clearing their first hurdle for listing. For Opdivo, which sought to expand the scope of reimbursement, criteria were set for its use in combination therapy as first-line treatment for metastatic esophageal squamous cell carcinoma. The reimbursement criteria have also been established for the Opdivo and Yervoy combination, but only for specific patient populations. It was granted reimbursement for ‘first-line treatment of adult patients with unresectable malignant pleural mesothelioma,’ but not for hepatocellular carcinoma or non-small cell lung cancer.
