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- 2026-03-10 20:00:45
- Policy
- Govt-ind sees consensus on 'AI-based new drug governance'
- by Lee, Jeong-Hwan May 22, 2025 06:09am
- The current administration has promised support and promotion for the establishment of a national governance system for AI-based new drugs, which the domestic pharmaceutical industry has called for the attention of the presidential election candidates. The National Bio Committee, which reports directly to the president, has selected AI-based new drug development as one of the 10 key tasks that the government will focus on for research and development (R&D) in the future. The vision is to discover optimal new drug candidates based on AI and big data, and to fulfill national responsibilities by supporting the entire cycle, including design and validation. On the 20th, the pharmaceutical and biotechnology industry expressed their broad consensus on the needs of the pharmaceutical industry in response to the announcement of the vision of the National Bio Committee. The domestic pharmaceutical industry has repeatedly suggested that the infrastructure for new drug development utilizing AI and big data should be established at the national level. In fact, the Korea Pharmaceutical and Bio-Pharma Manufacturers Association has proposed a policy to establish AI-based drug development governance for each candidate ahead of the June 3 presidential election. The demand is that the government should aggressively provide budget and policy support to utilize AI and big data to revitalize new drug development, which requires astronomical investment and time, and has a significantly low success rate. In particular, global big-tech companies such as Google AlphaFold 3-AlphaProteo, Nvidia BioNeMo, and Microsoft are developing AI super gap technology to be utilized in the whole stage of drug development based on large-scale investments and resources from global pharmaceutical companies. The KPBMA believes that Korea must not fall behind in the AI drug development competition with advanced countries to become a new drug powerhouse. Therefore, it is suggested that the government's full support is needed to create a national data-based open innovation ecosystem, build a big data platform for new drug development, and develop an AI-based intelligent autonomous laboratory optimization model. The next administration should collect national bio R&D public data for each field of drug development and create a new drug development big data platform for pharmaceutical companies’ access. Also, KPBMA’s policy proposal includes securing skilled professionals through an academia-industry collaborative training program for AI-driven drug discovery, as well as carrying out a joint platform project for shared use of AI-bio computing resources. As the National Bio Committee directly agreed with the pharmaceutical industry's policy proposal, there are expectations that the green light has been given for national-level budget and policy support for AI-based drug development even after the presidential election. An industry official said, “All previous administrations have set the goal of fostering the pharmaceutical industry as a future growth driver for the country, including developing new domestic drugs and discovering indigenous blockbusters. The government that will be established after the presidential election should realize that establishing governance for AI drug development is a prerequisite for creating domestic blockbusters, and should provide policy support and budgetary investment at the entire government level.” “The National Bio Committee's selection of developing infrastructure for AI-based drug development as one of the top 10 key R&D tasks has become a cog in the domestic pharmaceutical industry's policy proposals. We expect the new government to recognize that it is difficult for the private sector to create AI and big data drug development platforms, which are costly, and to take active policy and budgetary measures.”
- Policy
- 'AI-enabled stem cell for pediatric epilepsy proves effect'
- by Lee, Hye-Kyung May 21, 2025 06:36am
- A new treatment possibility has opened up for pediatric epilepsy patients who have shown little response to existing treatments. The Korea Health Industry Development Institute (President: Soondo Cha) announced on the 19th that Professor Hoon-Chul Kang’s research team at Yonsei University Severance Children's Hospital has successfully discovered a new drug candidate personalized for patients and experimentally proven its efficacy by utilizing AI-based drug discovery technology and induced pluripotent stem cells (iPSCs) obtained from patients. Pediatric epilepsy is a representative intractable neurological disorder, affecting approximately 250,000 people in Korea, with about 30-40% of patients suffering from drug-resistant epilepsy that does not respond to existing antiepileptic drugs. (from the left) Professor Hoon-Chul Kang and Ji-hoon Kim from Yonsei University and Professor Do Kyun Na from Chung Ang University In particular, pediatric epilepsy patients with rare genetic mutations, such as SCN2A gene mutations, exhibit significant differences in experimental responses by individual patient, rendering it difficult to achieve significant improvements with existing treatments. In addition, the lack of precise disease models and appropriate drug screening technologies has made the development of personalized drugs an urgent necessity. A joint research team led by Professor Hoon-Chul Kang and Ji-hoon Kim from Yonsei University and Professor Do Kyun Na from Chung Ang University addressed this issue by creating induced pluripotent stem cells (iPSCs) from patients' blood cells to develop precision disease models in the same disease environment as actual patients. Also, the team successfully identified new drug candidates, surpassing existing treatments through AI-driven high-throughput compound screening and validation. The research team used the latest gene editing technology to correct the SCN2A mutation to its normal state to reveal that the mutation is the direct cause of epilepsy, and confirmed that seizure symptoms disappeared. Furthermore, based on personalized neural cell models, the team analyzed approximately 1.6 million compounds using AI-based simulations and selected 5 optimal new drug candidates by considering blood-brain barrier permeability, toxicity, and gene binding affinity. Among these, 2 candidates demonstrated approximately 100 times higher efficacy than the existing treatment phenytoin, paving the way for personalized treatment. This study can be evaluated as a case of precision medicine that provides a practical alternative for intractable patients whose symptoms have not improved with existing treatments by combining the genetic characteristics of patients with rare genetic diseases with cell-based models and AI-based new drug discovery techniques. Professor Kang explained, “This study is a case where patient-derived cell-based personalized drug discovery technology for patients with intractable epilepsy demonstrated an effect. We plan to continue expanding our research to develop personalized precision therapies for patients with various genetic mutations, including SCN2A.” Professor Na emphasized, “This study demonstrates the practical applicability of precision medicine technology in the field of rare diseases. We believe that the findings from this study will help establish an innovative treatment strategy that can be applied to patients with various genetic disorders in the future.” This study was conducted with support from the Public Health Technology Research Project promoted by the Ministry of Health and Welfare and the Korea Health Industry Development Institute, and was published in the 2025 issue of Computers in Biology and Medicine, a world-renowned academic journal in the field of medical information.
- Policy
- Citus generics price raised, Ameliebou Inj huge price cut
- by Lee, Tak-Sun May 20, 2025 06:00am
- Prices of Citus generic drugs will be raised. As the price of original Citus has been adjusted, the prices of generic drugs that were reimbursement-listed in January have been recalculated. Meanwhile, the price of Samsung Bioepis' Lucentis biosimilar 'Ameliebou Inj' has been substantially cut, resulting in a significant difference from the original. According to industry sources on May 19, the prices of some items, including Citus generics, will be adjusted on the 1st of next month. Four Citus (Pranlukast Hydrate) generic products will see price increases following applications to adjust their upper-limit price. The price of Dasan Pharmaceutical's 'Prituss Tab 50 mg,' which met all the criteria, will rise from KRW 344 to KRW 526. In comparison, Daewoong Bio's 'Cituone Tab 50 mg,' Green Cross' 'Neopran 50 mg,' and DongKook Pharmaceutical's 'Pranpid 50 mg,' each meeting only one criterion, will increase from KRW 263 to KRW 447. Prices of Citus generics have been increased: 1. At the the Health Insurance Review and Assessment Service (HIRA)'s Drug Reimbursement Evaluation Committee (DREC) meeting held on April 3, the committee accepted the manufacturers' objection to HIRA's mandatory price reduction of Citus Tab 50 mg. SAMA Pham argued that its Citus development reference product was not the one identified by HIRA and that the ceiling price of Citus had already been adjusted to 53.55%. The committee accepted this argument, and the mandatory cut was effectively canceled. Because the generics listed in January were also assumed never to have had their ceiling price adjusted, their prices were calculated at 53.55% of the highest price for the same formulation. However, when HIRA acknowledged its error in using the original's price-setting criteria and launched a recalculation procedure, the generic prices were adjusted as well. In addition, after price-adjustment applications and negotiations with the National Health Insurance Service, the prices of two Custodiol Solution (Zenith Pharm) products will be raised. The 1,000 mL formulation will rise from KRW 140,492 to KRW 161,981, and the 5 L formulation from KRW 703,347 to KRW 809,905. Ceiling prices of six products will be loswered at the manufacturers' voluntary reduction request. Among these, the dramatic cut for the Lucentis biosimilar 'Ameliebou Inj 10 mg' (Samsung Bioepis), is notable. Ameliebou Inj was listed for reimbursement at KRW 463,773 in January 2023 but was cut to KRW 350,000 that March. It has now been reduced further to KRW 150,000. Since the original Lucentis 10 mg is priced at KRW 579,716, the price gap has widened even more. However, with competitor Chong Kun Dang's LucenBS also set at KRW 150,000, competition between the two drugs is expected to be intense. Ameliebou Inj is currently marketed domestically by Samil Pharmaceutical. Voluntary price cut items (as of June 1): 1. Yungjin Pharmaceutical's Demenduo Tab 10/20 mg (Donepezil Hydrochloride Monohydrate+Memantine Hydrochloride), combination therapy for dementia, will be cut from KRW 3,879 to KRW 3,650. Of the eight reimbursement-listed combination therapies approved in March, three have already cut their prices, indicating fierce price competition.
- Policy
- MFDS to review reference drug application every 2 months
- by Lee, Hye-Kyung May 20, 2025 05:59am
- The change in the procedure for selecting reference drugs for pharmaceutical equivalence tests is being well received by the domestic pharmaceutical industry. The Ministry of Food and Drug Safety recently announced a revision to the 'Guideline for Selecting Reference drugs for Pharmaceutical Equivalence Tests' and is seeking opinions on the change, deciding to proceed with the application and announcement of reference drugs every 2 months instead of every quarter. With the revision of the guideline, reference drug applications will be accepted six times a year (September 16-November 15, November 16-January 15, January 16-March 15, March 16-May 15, May 16-July 15, and July 16-September 15) and reference drugs will be announced in February, April, June, August, October, and December, respectively. The shortened period for selecting reference drugs is expected to help facilitate the smooth conduct of pharmaceutical equivalence tests and the development of generic drugs. In this regard, an official from pharmaceutical company A said, “In the past, the delay in designating a reference drug has often delayed the development schedule. If the designation of a reference drug is regularly conducted two months rather than every quarter, this will well speed up development.” Another official from pharmaceutical company B also said that shortening the schedule for selecting and announcing reference drugs will basically revitalize generic drug development, which is why domestic companies cannot be opposed to it. However, the official added that in practice, shortening the reference drug designation by 2-3 months cannot significantly reduce the drug development period. He emphasized, “We also expect improvements in operational methods, starting with the revision of the reference drug selection and announcement procedures. While designating reference drugs is important, it is also necessary to make reasonable judgments on whether to maintain the reference drug status for drugs that are not imported or produced domestically, despite being designated as reference drugs.” When reviewing applications for the designation (or change) of reference drugs, the government selects products from the same active ingredient type and content, formulation, and route of administration among approved (or reported) products, but those of a higher priority. The priority order for selecting reference drugs is as follows: ▲New drugs as defined in Article 2 of the Pharmaceutical Affairs Act that have received approval as prescription drugs for manufactured (imported) products; ▲Products by the original developer (if there are multiple products, the product with the earliest approval date); ▲Products that are subject to data submission under Article 2, Paragraph 8 of the Regulations on the Approval, Notification, and Review of Drug Products, and are the first products approved in Korea; ▲Products that meet Item 1 or Item 2 and have undergone bioequivalence testing ▲Domestically first-approved products (if the product has been canceled or withdrawn, it refers to products with the same active ingredient type and administration route as the domestically first-approved product, following the order below) etc. A representative from Company B stated, “If there is no reference drug, the reference drug must be purchased from overseas to conduct equivalence tests, but the company whose drug was designated as the reference drug does not disclose all details, such as the quantity of the active pharmaceutical ingredient. While the selection and announcement of reference drugs are important, the system must be improved to ensure proper operation, including measures to revoke reference drug status.”
- Policy
- GSK starts domestic trial on its B7-H3-targeted ADC
- by Lee, Hye-Kyung May 19, 2025 05:56am
- GSK's antibody-drug conjugate (ADC) drug candidate 'GSK5764227,' designated as a breakthrough therapy by the US FDA last year, will begin clinical trials in Korea. On the 16th, the Ministry of Food and Drug Safety approved GSK's application for a Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics, and clinical activity of GSK5764227 in patients with advanced solid tumors. This Phase I trial will be conducted at three hospitals: Samsung Medical Center, Seoul National University Hospital, and Severance Hospital. GSK5764227 is a B7-H3-targeted antibody-drug conjugate (ADC) intended as an investigational new drug (IND) for adult patients with advanced small cell lung cancer (SCLC) whose disease has progressed after platinum-based chemotherapy, and for adult patients with relapsed or refractory osteosarcoma who have progressed on at least two prior lines of therapy. The FDA designates breakthrough therapies to expedite the development and review process for drugs that show significant improvement over existing treatments for serious conditions. GSK acquired exclusive worldwide rights for GSK5764227 from Chinese pharmaceutical company Hansoh Pharma earlier this year, excluding China, Hong Kong, Macau, and Taiwan. GSK will progress with its global clinical development and commercialization. GSK5764227 is composed of a fully human anti-B7-H3 monoclonal antibody covalently linked to a topoisomerase inhibitor payload (TOPOi). The FDA designated GSK5764227 as a breakthrough therapy for small cell lung cancer last year and added a bone cancer indication earlier this year. Additionally, GSK574227 received Priority Medicines (PRIME) designation from the European Medicines Agency (EMA) last year. Meanwhile, Hansoh Pharma is conducting Phase I, II, and III clinical trials of HS-20093 for lung cancer, sarcoma, head and neck cancer, and other solid tumors in China.
- Policy
- New drugs Bimzelx and Adempas reimbursed from June
- by Lee, Jeong-Hwan May 19, 2025 05:55am
- UCB Pharma Korea's Bimzelx and Bayer Korea's Adempas will be reimbursed by national health insurance starting on the first of next month. The Ministry of Health and Welfare announced an amendment to the Details on the standards for application of drug reimbursement (drugs). Bimzelx is a monoclonal antibody drug that targets both interleukin-17A and 17F and is used to treat moderate-to-severe plaque psoriasis. It can be used for patients who have not responded adequately to existing biological agents or those who have poor tolerability. Specifically, patients with chronic severe plaque psoriasis (adults aged 18 years or older) who have had the condition for six months or longer must meet the following criteria. Patients with plaque psoriasis covering 10% or more of their total body surface area, with a PASI (Psoriasis Area and Severity Index) score of 10 or higher, who have been treated with MTX (Methotrexate) or Cyclosporine for 3 months or longer but have not responded or cannot continue treatment due to side effects are eligible for Bimzelx’s use with reimbursement. However, patients who are contraindicated for both photochemotherapy (PUVA) and medium-wave ultraviolet B (UVB) therapy are only eligible if they have received MTX (Methotrexate) or Cyclosporine for at least 3 months with no response, or if treatment cannot be continued due to side effects. In addition, reimbursement is also available for patients with plaque psoriasis covering more than 10% of the total skin surface area who have been treated with photochemotherapy (PUVA) or medium-wave ultraviolet (UVB) therapy for more than 3 months but have not responded or cannot continue treatment due to side effects. Bayer Korea's Adempas Tab (riociguat) will also be newly covered by reimbursement. Adempas is an oral soluble guanylate cyclase (sGC) stimulator used for the treatment of pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH). It reduces pulmonary vascular resistance by dilating blood vessels, improving exercise capacity, and delaying functional decline. It is indicated for patients diagnosed with pulmonary arterial hypertension (WHO Group I) corresponding to WHO functional classification Stages II–III, who have insufficient response to ERA and/or PDE-5 inhibitor pulmonary arterial hypertension medications, or who are contraindicated for both ERA and PDE-5 inhibitor pulmonary arterial hypertension medications. Among the approved indications, reimbursement is recognized in accordance with the general principles for pulmonary arterial hypertension drugs in the “Details” section when administered for pulmonary arterial hypertension.
- Policy
- Trodelvy and new drugs reached an agreement with the NHIS
- by Lee, Tak-Sun May 16, 2025 06:21am
- Product photo of Trodelvy Three new drugs, including the triple-negative breast cancer (TNBC) treatment Trodelvy (sacituzumab govitecan), have completed negotiations with the National Health Insurance Service (NHIS) and are about to be included in the reimbursement list. These drugs passed the Health Insurance Review and Assessment Service (HIRA)'s Drug Reimbursement Evaluation Committee (DREC) in February and were undergoing negotiations with the NHIS. According to industry sources on May 15, the NHIS posted on its website that the companies of the TNBC drug 'Trodelvy,' the pulmonary hypertension drug 'Adempas Tab (riociguat, Bayer Korea),' and the plaque psoriasis drug 'Bimzelx Autoinjector (bimekizumab, UCB Korea)' have agreed on negotiation deals. During the 2nd DREC meeting on February 6, these drugs were acknowledged for their reimbursement appropriateness. The DREC granted reimbursement appropriateness for Trodevly's TNBC indication and Adempas' pulmonary hypertension among its efficacy·effectiveness. The efficacy·effectiveness of Adempas in chronic thromboembolic pulmonary hypertension (CTEPH) was not acknowledged for reimbursement appropriateness. For Bimzelx, the company received a decision that Bimzelx would meet the appropriateness of reimbursement if the company accepted an amount below the standard. After that, UCB accepted the condition and proceeded to negotiations with the NHIS. The company may have undergone negotiations with the NHIS for drug pricing and estimated claim amount, ultimately reaching an agreement. Among these drugs, Trodelvy received a decision of new drug innovativeness. It gained attention for becoming the first case to clear the DREC review, with its price being measured based on their ICER values. The Korea Alliance of Patients Organization (hereafter, Patients Organization) is asking for a quick reimbursement process since Trodelvy is the third-line treatment for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC). The Patients Organization said, "Trodelvy is a high-cost drug, costing approximately KRW 1,500-2,000 per one cycle and some hundreds of millions of KRW yearly." They added, "Patients cannot continue treatment due to high-cost non-reimbursed drug costs and inevitably give up on receiving treatments." As these companies reached drug pricing negotiations with the NHIS, the drugs will be reviewed by the Health Insurance Policy Deliberation Committee. The drugs have higher chances of being included in the reimbursement list next month (June).
- Policy
- CDDC to discuss partial reimb of anticancer drug combos
- by Lee, Tak-Sun May 16, 2025 06:18am
- The Health Insurance Review and Assessment Service announced today (14th) that it held a Cancer Disease Review Committee meeting and discussed the list of drugs eligible for partial reimbursement as anticancer drug combination therapies, as it had recently announced. The reimbursement standard for anticancer drugs will be revised starting next month based on the list made today. The details discussed at the meeting are expected to be disclosed when the reimbursement standard for anticancer drugs is announced. The Health Insurance Review and Assessment Service (President Jung-Gu Kang) announced that it had deliberated on the “Reimbursement Standards for Drugs Used for Cancer Patients” at the 4th Cancer Disease Deliberation Committee meeting in 2025. The details discussed on that day are follow-up measures to the revision of the general principles regarding “the scope and cost burden of drugs prescribed and administered to cancer patients among severely ill patients as drugs determined and announced by the Health Insurance Review and Assessment Service in accordance with Article 5, Paragraph 4 of the Rules on National Health Insurance Medical Care Benefits” among the details on the application criteria and methods for medical care benefits. At the meeting, the committee discussed the list of combination therapies eligible for reimbursement coverage, taking into account the indication and opinions from academic societies, with the aim of reducing confusion in clinical practice and enhancing predictability when applying the detailed guidelines to existing anticancer therapies and combination therapies with other anticancer drugs. The revised list will take effect on June 1. A total of 54 combination therapies were discussed, and 35 will be included in the revised guidelines. Therapies exceeding the approved indication were excluded. This decision was made as a minimum safety measure against the inappropriate use of combination therapies, such as those exceeding approved indications. The authorities explained that in the future, when academic societies submit requests for combination therapies related to this matter, the Cancer Disease Review Committee will review them and update the list of eligible therapies.
- Policy
- Gov't begins patient advocacy service for medical incidents
- by Lee, Jeong-Hwan May 15, 2025 06:24am
- The Korean Ministry of Health and Welfare (MOHW)The Ministry of Health and Welfare (MOHW) will start implementing the 'patient advocacy service,' which provides a legal representative matching service for mediating disputes to strengthen the rights of patients who are victims of medical incidents, effective this month (May). The service supports the conflict between a patient and a medical institute·healthcare provider. The MOHW will initiate the program on the 16th by appointing approximately 50 lawyers. The patient advocacy service will include patients who are victims of medical incidents during surgical operations and prescription·drug preparation errors that occur in hospitals. During the meeting with the Korea Special Press Association on May 14, Minjung Kwon, Director of MOHW's Healthcare Institution Policy Division, stated this. Medical incident patient advocacy service is related to the MOHW's 'Act on Special Cases Concerning Medical Accident,' which was part of the essential healthcare package. The 'Special Act for Handling Medical Accident' exempts criminal punishment of doctors when accidents occur during medical practice in essential healthcare departments. Accordingly, patient·citizen organizations shared criticism that the act invades the patient's rights while maximizing doctors' benefits. The MOHW has established a patient advocacy service for medical incidents to safeguard patient rights. To carry out this plan, the MOHW has completed the selection of patient advocates, focusing on lawyers with experience in medical malpractice litigation, among those who are both lawyers and hold medical licenses, and individuals with expertise and experience in medical accidents. The patient advocacy service is activated·operated during the dispute mediation stage before or instead of proceeding to court when a medical accident occurs. Patients who wish to use the advocate system must apply to the Korea Medical Dispute Mediation and Arbitration Agency. The MOHW plans to implement the patient advocate system as a provisional program while preparing the legal basis for it in the future. Director Kwon explained, "Many lawyers applied for the patient advocate service," and added, "We aimed to select around 50 people, but received more applications. After the appointment ceremony on the 16th and the training course, we plan to start the service at the end of May." "This is a program in which patients who wish to apply for medical accident mediation can apply to the advocate system, receive assistance, and proceed with mediation together," Director Kwon added, "The advocacy service is not intended for patients who want to file law suits. If mediation is activated through the advocate system, reducing cases that proceed to law suits will be possible." Lastly, Director Kwon said, "The term for a patient advocate is two years. After two years, performance will be evaluated, and reappointment will be made if no special circumstances exist." And added, "Many lawyers are interested in public service and have applied for this system. We intend to encourage advocates' participation and develop these various medical dispute mediation and assessment systems together."
- Policy
- Reimb of comb cancer therapies w/o detailed criteria
- by Lee, Tak-Sun May 14, 2025 06:09am
- The reimbursement policy for combination cancer therapies, announced this month, has been implemented without detailed criteria, causing further confusion in medical practices. This was contributed by the Ministry of Health and Welfare (MOHW) and the Health Insurance Review and Assessment Service (HIRA), which had differing schedules for revision. Accordingly, the HIRA will convene a Cancer Drug Review Committee (CDRC) meeting, notify of detailed criteria, and implement it in June. As of May 1, the MOHW approved that 'when combining a reimbursed chemotherapy regimen with another anticancer drug, the existing co-payment for the previously initiated chemotherapy shall continue to apply to that regimen.' Previously, all combination therapies not approved by insurance reimbursement were entirely non-reimbursed. However, with the establishment of this clause, one anticancer agent now recognized for reimbursement is expected to alleviate patients' financial burden and improve treatment accessibility. Patient organizations and foreign pharmaceutical companies have welcomed such notification. The problem is that no detailed criteria for reimbursement eligibility have been issued, confusing the field. An industry professional explained, "Even hospitals don't know whether the combination therapy will be covered when prescribing it, so they ask the sales representatives, but the pharmaceutical companies themselves cannot provide a clear answer." There have also been repeated inquiries about which of the two drugs in an approved combination regimen is eligible for reimbursement. The MOHW's revision containing the principles for partial reimbursement of combination cancer therapies (Detailed Criteria and Methods for Applying Reimbursement-Drugs) was announced on April 28. It took effect on May 1. Meanwhile, the CDRC, which was to discuss the HIRA's detailed notice on 'Detailed Criteria and Methods for Applying Reimbursement (of Medications Prescribed·Administered to Cancer Patients),' convened on April 30. In other words, the CDRC met to discuss the details just two days after the notice was announced, and reportedly did not have enough time for proper deliberation. In its administrative notice explaining the reasons for the revision, the MOHW stated that, since the dosing criteria for agents used in anticancer regimens are scheduled to change in the 'Detailed Criteria and Methods for Applying Reimbursement (of Medications Prescribed·Administered to Cancer Patients),' (the HIRA announcement), it would simultaneously revise the cost-sharing regulations; however, it pushed the notice through before HIRA's detailed announcement was issued. This suggests that the MOHW and HIRA did not adequately coordinate on the timing of implementation. It is reported that the two sides had differing views on preparing the list of partially reimbursable drugs. Critics argue that the MOHW rushed a policy that will require massive additional spending. Because setting reimbursement criteria for anticancer drugs falls under both HIRA and the MOHW, issuing the notice without consultation with the NHIS, which administers reimbursements, has been controversial. Some suggest that the MOHW bowed to pressure from the National Assembly, patient groups, and pharmaceutical companies without adequately debating fiscal savings. Notably, a policy forum on improving patient access to combination therapies was hosted by Rep. Lee Joo-young's office in March, during which government representatives expressed caution. Yet, barely two months later, the notice was issued. An unintended side effect of partial reimbursement for combination therapies is that if new drugs are used in first-line treatment, there may be no reimbursable options for second-line therapy after failure. To reduce confusion and unintended outcomes, HIRA plans to convene an unscheduled CDRC meeting this month to finalize the details. In a letter sent to relevant organizations on the 7th, HIRA stated that it will "discuss as soon as possible at the CDRC meeting the approved indications and academic society opinions to reduce confusion in practices when applying the detailed notice to existing anticancer regimens and combination therapies," and that it intends to implement the 'Detailed Criteria and Methods for Applying Reimbursement (of Medications Prescribed·Administered to Cancer Patients)' on June 1.
