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- Policy
- HIRA to disclose all off-label drug approval/disapprovals
- by Lee, Tak-Sun Sep 12, 2025 06:19am
- All approval decisions regarding off-label drugs will be disclosed on the official website from now on. Currently, only non-approved general drugs are listed publicly, but going forward, both approved and non-approved cases will be made available in order to reduce the administrative burden on medical institutions submitting applications. On the 10th, the Health Insurance Review and Assessment Service (HIRA) pre-announced a partial amendment to its regulations governing the approval of non-reimbursed off-label use of drugs beyond their authorized or reported indications, and will collect industry opinion until the 16th. Applications for non-reimbursed off-label drug use must first be reviewed by a hospital or academic society with an Institutional Review Board (IRB). Among these, general drugs are referred by HIRA to the Ministry of Food and Drug Safety (MFDS) for evaluation of safety and efficacy, while anticancer drugs are reviewed monthly by the Cancer Disease Deliberation Committee. The issue has been that for off-label general drugs, only non-approved cases were published on the website, making it difficult for medical institutions to prepare applications due to a lack of information. By contrast, for off-label cancer drugs, both approved and non-approved cases are disclosed, raising concerns over fairness when only non-approved cases were listed for general drugs. A HIRA official stated, “With the disclosure of both approvals and non-approvals for all off-label drugs, we expect that medical institutions will face less administrative burden when preparing applications.” Industry voices are also calling for the relaxation of current approval criteria. In particular, they argue that the IRB review requirement should be abolished and the clinical data requirements eased. One industry insider pointed out, “For infectious disease treatments like COVID-19, it is difficult to conduct clinical trials due to the nature of the disease. Yet, off-label non-reimbursed use requires clinical literature similar to that for general drugs. This is an unreasonable measure that fails to account for the urgent characteristics of infectious disease treatments.” HIRA has also shown willingness to improve the system, having commissioned an external research project last year on “Improvement Measures for the Use of Drugs and Medical Devices Beyond Approved Indications,” and hosting an international symposium on the issue on the 29th of last month. This regulatory amendment marks the first step toward system improvement,, with further reforms are expected to be discussed in the future.
- Company
- Anticipation for the survival-extending effects of Fruzaqla
- by Hwang, byoung woo Sep 12, 2025 06:18am
- A new option has emerged for fourth-line metastatic colorectal cancer (CRC) treatment. Previously, there were no more drugs available to use, increasing expectations in clinical practice. In Korea, the survival-extending effect of Fruzaqla (fruquintinib) is evaluated as a potential solution to the unmet needs of CRC patients. The number of patients with CRC is rapidly increasing, making it the number one cancer in Korea, excluding thyroid cancer. DailyPharm met with Professor Jin Won Kim of Seoul National University Bundang Hospital's Division of Hematology and Medical Oncology and Professor Dirk Arnold of Asklepios Tumorzentrum Hamburg's Division of Hematology and Oncology to discuss Fruzaqla's potential as a standard of care for fourth-line treatment. Young patients with colorectal cancer surging...20% still diagnosed at stage 4 Approximately 20% of colorectal cancer patients are first diagnosed at the metastatic Stage 4, and even half of those diagnosed with early localized disease develop distant metastasis during treatment. While the 5-year survival rate drops to about 20% when metastasis occurs, there were virtually no treatment options available after the third line, leading to high unmet needs for patients. Current standard treatments for metastatic colorectal cancer are mainly concentrated on first- and second-line treatments, primarily consisting of combinations of conventional chemotherapy and targeted therapies. In later lines, such as the third line and beyond, effective drugs are rare, and development is slow. Professor Arnold said, "In the typically-defined first- and second-line treatments, anti-VEGF or anti-EGFR monoclonal antibodies are used in combination with chemotherapy based on fluoropyrimidine, oxaliplatin, and irinotecan." He added, "In later lines, maintaining quality of life becomes the main goal. Third-line and later treatments require a balanced approach that simultaneously considers both prognosis improvement (life extension) and maintaining quality of life." According to Professor Kim, chemotherapy is the key treatment for Stage 4 colorectal cancer. If the diseases are concentrated in a localized area, such as a liver-only metastasis, surgery is attempted after chemotherapy to reduce tumor size, or surgery is performed immediately depending on the situation. Professor Kim said, "The pace of new drug development for colorectal cancer is very slow compared to other cancer types, and options remain limited, with treatments used 10 years ago still holding a major position," and added, "Colorectal cancer patients can survive for a little over two years with basic treatment alone, which makes it difficult to prove a 'definite improvement' over existing therapies, often leading to clinical trial failures." He pointed out that various pharmaceutical companies were reluctant to develop fourth-line treatments for colorectal cancer because profits are uncertain. As a result, the launch of new drugs has been slow compared to other cancer types, forcing patients to continue treatment with drugs that have been in use for over 10 years. Professor Kim also said, "The first and second-line treatments are well-covered by insurance in Korea. However, third-line and beyond have limited coverage, which significantly reduces treatment options." He added, "Because of this, treatment options decrease, and drug efficacy tends to diminish as the treatment line advances." VEGFR-targeting Fruzaqla effective after anti-VEGF treatment Takeda Pharmaceutical Korea's oral targeted anti-cancer drug, Fruzaqla, is expected to shed light on the fourth-line treatment landscape for metastatic colorectal cancer in Korea. Fruzaqla is a tyrosine kinase inhibitor (TKI) that selectively inhibits vascular endothelial growth factor receptors (VEGFR) 1, 2, and 3, which are essential for tumor angiogenesis. Notably, this drug demonstrated effectiveness even in patients who have become resistant to prior anti-VEGF treatment. Professor Arnold said, "While bevacizumab (a conventional anti-VEGF antibody treatment) binds to VEGF somewhat non-specifically, Fruzaqla has a very high specificity and binding affinity for all known VEGF receptors. It has been reported to be effective even in patients who have failed prior anti-VEGF treatment." In other words, this drug maximizes drug exposure while minimizing toxicity by precisely targeting only the VEGF pathway and not attacking unnecessary targets. Professor Arnold explained that in real-world clinical settings, a survival-prolonging effect was confirmed with Fruzaqla administration even in a patient group that had already received various anti-VEGF drugs. The efficacy and safety of Fruzaqla were proven in the large-scale global Phase 3 FRESCO-2 study. This randomized controlled trial included 691 metastatic colorectal cancer patients who had received treatments such as trifluridine/tipiracil (TAS-102) or regorafenib after failing standard therapy. Professor Arnold said, "Even in some patients who had received both TAS-102 and regorafenib, Fruzaqla's effect was at a level almost identical to the original study." He added, "This is a very encouraging result that shows Fruzaqla provides patients with a consistent and robust therapeutic effect." Professor Kim also commented, "Fourth-line treatment refers to treatment administered after all existing treatments have been used. Considering this, Fruzaqla is noteworthy for showing a significant therapeutic effect in a patient group with no other alternatives." Non-reimbursed status·reimbursement listing present challenges...advantage of oral formulation gains attention Meanwhile, Fruzaqla as an oral formulation is considered a major advantage in terms of patient convenience. Professor Kim said, "Most colorectal cancer patients have no difficulty with oral intake, and oral drugs can be more effective and convenient for colorectal cancer patients compared to gastric cancer or other cancer types." In Korea, Fruzaqla was officially launched in June after receiving approval from the MFDS in March, but it has not yet been approved for insurance reimbursement. Currently, drugs for third-line and later stages of colorectal cancer are not covered by insurance due to concerns about their cost-effectiveness relative to efficacy, resulting in a high burden on patients. Professor Kim emphasized, "While there are a few drugs that can be used for third-line and later treatments for colorectal cancer, none of them are covered by insurance," and added, "If a new drug comes out and helps patients, we believe it should definitely be covered by insurance." However, since the requirement for a health-economic evaluation for reimbursement listing is high, it appears that Fruzaqla will also need to undergo subsequent procedures to be included in the reimbursement list, just like other non-reimbursed drugs. Finally, the experts shared the opinion that it is most important not to give up on treatment for metastatic colorectal cancer. Professor Kim said, "Colorectal cancer is not a disease that can be completely resolved at once. Continuously pursuing treatment and using every drug available is key to prolonging a patient's survival," and added, "It is important not to give up even during difficult times in the treatment process and to continue with it."
- Policy
- MOHW will reform system for certifying innovative companies
- by Lee, Jeong-Hwan Sep 12, 2025 06:18am
- The Ministry of Health and Welfare (MOHW) plans to announce a legislative notice in October for reforms to the Korea Innovative Pharmaceutical Company certification system, aiming to implement the changes in January next year. The reform plan includes converting the certification system into a point-based structure and establishing separate certification criteria for multinational pharmaceutical companies. Regarding whether to abolish the current penalty clause&8212;which bars companies whose certification has been canceled from reapplying for three years&8212;the MOHW responded that it is “under review.” An MOHW official explained so during a meeting with the MOHW press corp on the 10th. The delay in announcing and implementing the reform plan that was originally scheduled earlier, appears to have been influenced in part by the change of administration and the launch of the new government. At the core of the reforms is a shift from the current system&8212;where certification is immediately revoked if illegal practices such as pharmaceutical rebates are uncovered&8212;to a point-based system. The ministry aims to enforce the anti-rebate rule while moving to a flexible, point-based certification system. The MOHW official stated, “The reform plan for Korea Innovative Pharmaceutical Company Certification includes converting to a point-based system covering acts such as illegal rebates, and establishing separate certification criteria for domestic versus multinational pharmaceutical companies. We are aiming to publish the legislative notice in October and implement it in January next year.” The official added, “We are still reviewing whether to lift the rule that prevents companies whose certification was canceled due to illegal rebates from reapplying for certification for three years.”
- Policy
- Improvement to the post-marketing management for pharma
- by Lee, Tak-Sun Sep 11, 2025 06:11am
- A comprehensive discussion regarding the post-marketing management program of pharmaceuticals, including actual transaction price-based drug price reduction and re-evaluation of pharmaceutical reimbursement, is anticipated once research results become available at the end of this year. Improvement plans to the actual transaction price-based drug price reduction and re-evaluation of pharmaceutical reimbursement programs have already been discussed with the pharmaceutical industry. However, with the release of the 'Research on a Unified Mechanism for Post-marketing Drug Price Management,' commissioned by the Ministry of Health and Welfare, scheduled for the end of this year, the policy is to conduct a comprehensive discussion based on results. On September 9, the Ministry of Health and Welfare officially announced the detailed operational guidelines for adjusting the ceiling price based on its actual transaction price survey, which is conducted once every two years. The survey will target 19,588 drugs and inspect 104,275 medical institutions from July 1 of last year to June 30 of this year. However, as before, public and national hospitals will be excluded from the survey. Additionally, low-priced drugs, discontinuation-prevention drugs, narcotics, orphan drugs, radiopharmaceuticals, artificial perfusion solutions, and oxygen·nitrous oxide are excluded. Oxygen and nitrous oxide were added to the list of excluded items this time. Discussions on improving the actual transaction price reduction program began late last year. Based on the 'Research on Improving the Actual Transaction Price-Based Drug Price Reduction System' (led by Professor Kim Jinhyun of Seoul National University), which was commissioned by the Health Insurance Review & Assessment Service, a consultative body was formed with the pharmaceutical industry to gather opinions until the first half of this year. The consultative body discussed issues such as abolishing the 10% price reduction cap and including public and national hospitals in the survey. The proposal to include public and national hospitals in the survey is a matter that the pharmaceutical industry strongly opposes, as drug dumping is a structural problem in public hospital bidding, where drugs are often awarded for as low as KRW 1. Although the process of gathering opinions from the pharmaceutical industry has been completed, the actual transaction price survey will proceed as before, excluding public and national hospitals. Only oxygen and nitrous oxide were included in the list of excluded items. An industry official said, "We understand that the improvement plan for the actual transaction price-based drug price reduction program will be discussed as part of a discussion with other post-marketing management programs after the unified post-market mechanism research is released at the end of the year." He added, "At that time, the issue of including public and national hospitals may be re-discussed." The improvement plan for the re-evaluation of drug reimbursement appropriateness is also scheduled for re-discussion after the unified post-market management research. The plan was discussed at a subcommittee meeting of the Health Insurance Policy Deliberation Committee last month, but it was not included on the review agenda for the main session. The details of the re-evaluation improvement plan are to change the selection criteria from the existing average claim amount of 0.1% or more over three years (approx. KRW 20 billion) to KRW 10 billion or more, and to expand the condition for not being listed in other countries from fewer than two A8 countries to fewer than three countries. Notably, seven ingredients, including ginkgo leaf extract, were selected for next year, which is the first year of the second re-evaluation phase under the comprehensive health insurance plan. However, with the discussion delayed, the progress of the re-evaluation next year itself is now uncertain. An industry official said, "If the confirmation of the re-evaluation targets is delayed, it may be difficult to proceed next year, considering the time needed to prepare materials like textbooks," and added, "It will be necessary to wait and see how the discussion proceeds after the post-marketing unified mechanism research is released at the end of the year."
- Policy
- Generic dispensing, collusion ban pass legislative committee
- by Lee, Jeong-Hwan Sep 11, 2025 06:11am
- On September 10, the National Assembly’s Legislation and Judiciary Committee passed two amendments to the Pharmaceutical Affairs Act. One expands the post-notification method for generic substitution at pharmacies to include information systems operated by the Ministry of Health and Welfare and the Health Insurance Review and Assessment Service; the other expands the scope of essential medicines and elevates the legal basis for operating the Stable Supply Council from presidential decree to law. The National Assembly's Legislation and Judiciary Committee has also passed an amendment to the National Health Insurance Act, which allows for the reduction of drug prices or the suspension of reimbursement for unfairly traded drugs when reverse payment agreements are detected. These agreements involve originator and generic drug companies colluding to delay the launch of generics, thereby avoiding price reductions for the original drug. Once these bills are passed in the plenary session, they will complete the necessary legislative process and take effect on the enforcement date stipulated in the addenda following government promulgation. Bill to simplify the post-notification of generic substitution notificationseB (Partial Amendment to the Pharmaceutical Affairs Act) establishes a new Article 27-2 (Establishment and Operation of a Substitution Information System) in the Pharmacuetical Affairs Act, enabling the MOHW to establish and operate an information system to support post-substitution notification. Specifically, the bill allows the Minister of Health and Welfare to delegate this task to the Health Insurance Review and Assessment Service (HIRA), with the necessary details to be stipulated by MOHW ordinance. The bill retains the existing obligation that when a pharmacist substitutes a drug listed on a prescription with an item recognized by the Ministry of Food and Drug Safety as having bioequivalence, the pharmacist must inform the patient of this fact and notify the prescribing physician or dentist within one day (or three days if unavoidable circumstances exist). National Essential Medicines definition expansion bill(Partial Amendment to the Pharmaceutical Affairs Act) allows medicines without substitutes or facing supply instability to be designated as National Essential Medicines. The basis for the composition and operation of the National Essential Medicines Stable Supply Council, previously established by Presidential Decree, has been elevated to the Pharmaceutical Affairs Act. The chairmanship of the council was revised: instead of appointing a single Vice Minister of MFDS as chair, it now requires adding one ‘senior public official designated by the Minister of Health and Welfare of the MOHW’. Generic drug collusion prohibition bill (Partial Amendment to the National Health Insurance Act) mandates that if the Fair Trade Commission detects collusive reverse payment agreements between originator and generic drug companies, the prices of the unfairly traded drugs must be reduced or their reimbursement suspended. Specifically, it stipulates that cases violating Article 40(1) or Article 45(1) of the Monopoly Regulation and Fair Trade Act, where the violation was committed “for the purpose of increasing or maintaining the upper limit of drug reimbursement costs,” the insurance drug price can be reduced or reimbursement suspended. When a reverse payment agreement violation is first detected, drug prices can be reduced by up to 20%. If another reverse payment agreement is detected within five years of the price reduction, drug prices can be reduced by up to 40%. If another illegal reverse payment agreement is detected within five years after the second price reduction, drug reimbursement can be suspended for up to one year.
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