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- 2025-12-21 05:01:29
- Policy
- Orphan drug 'Bylvay Cap' wins reimb approval after reeval
- by Lee, Tak-Sun Jul 14, 2025 06:03am
- 'Bylvay Cap,' which is being considered for the expedited reimbursement listing process as a designated drug for 'Pilot Project for Integration of Product Approvals, Reimbursement Coverage Reviews, and Drug Price Negotiations,' received reimbursement appropriateness decision after reevaluation. Consequently, Bylvay Cap will be subjected to negotiation with the National Health Insurance Service (NHIS) before its inclusion in the reimbursement list. Health Insurance Review and Assessment Service (HIRA) stated that it has held the 7th Drug Reimbursement Evaluation Committee (DREC) meeting on July 10 and decided as such. During the meeting, the DREC decided on the reimbursement appropriateness for Bylvay Cap 200, 400, 600, and 1200 μg (odevixibat sesquihydrate). Drug Reimbursement Evaluation Committee (DREC) Bylvay Cap is used to treat progressive familial intrahepatic cholestasis (PFIC). This drug was designated as the first concurrent approval-evaluation-negotiation pilot project in 2023. The criteria for the concurrent approval-evaluation-negotiation pilot project were drugs with sufficient efficacy intended for treating cancer or rare diseases with a life expectancy of less than one year, as well as those proving superior survival·treatment effectiveness for over two years when alternative treatments are not available. Bylvay Cap obtained marketing authorization from the Ministry of Food and Drug Safety (MFDS) in August 2024 and entered into the reimbursement evaluation process. Yet, the reimbursement evaluation process has been uneasy. A complaint was heard from an expert who attended the reimbursement review meeting from the evaluation stage. In the DREC meeting held last April, a conclusion was not reached, and it was decided to re-evaluate. It was only today, three months later, that it passed the DREC review. As drugs under the concurrent approval-evaluation-negotiation pilot project undergo a one-stop process without following separate stages, Bylvay is likely to have already entered negotiations with the NHIS. If the NHIS negotiations are completed, patients will be able to receive National Health Insurance coverage for this drug immediately after review by the Health Insurance Policy Review Committee. Meanwhile, the DREC decided on HLB Pharma's Citrelin ODT to receive a conditional approval, stating that reimbursement appropriateness if the company accepts a price below the evaluated amount. This drug is used for 'improving ataxia caused by spinocerebellar degeneration.'
- Company
- Bimzelx may be prescribed at general hospitals in KOR
- by Eo, Yun-Ho Jul 11, 2025 06:12am
- The new psoriasis drug Bimzelx may be prescribed at general hospitals in Korea. According to industry sources, UCB Pharma Korea's Bimzelx (bimekizumab) has been approved by the Drug Committees (DCs) of major hospitals nationwide, including tertiary hospitals like Seoul Asan Medical Center and Severance Hospital as well as major hospitals including Kyungpook National University Hospital, Pusan National University Hospital, Seoul National University Bundang Hospital, Chonnam National University Hospital, Jeonbuk National University Hospital, and Hanyang University Hospital. The company appears to be rapidly working to expand Bimzelx prescriptions following its reimbursement listing in June. i1Bimzelx is the first plaque psoriasis treatment that dually inhibits interleukin-17A and 17F (IL-17A and 17F). IL-17A and IL-17F are key cytokines that trigger the inflammatory process in psoriasis, and Bimzelx selectively and directly targets and inhibits both simultaneously. This dual inhibition mechanism against IL-17A and 17F is what makes the drug’s introduction significant. Despite the emergence of various psoriasis treatments, there remained an unmet need in practice due to resistance and other factors, which is why health professionals saw the introduction and reimbursement of Bimzelx encouraging. Yong-Beom Choi, President of the Korean Society for Psoriasis (Department of Dermatology, Konkuk University Medical Center), said, “Psoriasis is an intractable disease that recurs and improves repeatedly, and the quality of life of patients with severe psoriasis in particular tends to deteriorate significantly, affecting their mental health. Therefore, the reimbursement and launch of Bimzelx, which has been proven to be highly effective, is very meaningful for both medical professionals and patients.” He added, “Based on its next-generation mechanism of action, Bimzelx is expected to be an excellent treatment option for both new patients and those who have not seen sufficient results with existing treatments.” Meanwhile, in the Phase III BE READY trial, 90.8% of patients in the Bimzelx group achieved PASI 90 at Week 16, and 68.2% of patients achieved PASI 100. In another clinical trial that compared Bimzelx with another biological agent, there was a clear difference in the percentage of patients who achieved complete clearance of skin lesions at Week 16, or 'PASI 100'. Specifically, PASI 100 for the drug and control drug were as follows: ▲BE VIVID: Bimzelx 59%, ustekinumab (Stelara) 21% ▲BE SURE: Bimzelx 60%. 8%, adalimumab (Humira) 23.9% ▲BE RADIANT: Bimzelx 61.7%, secukinumab (Cosentyx) 48.9%, etc.
- Opinion
- [Reporter's View] US tariffs…variable that must be faced
- by Whang, byung-woo Jul 11, 2025 06:12am
- Tension is growing in the domestic pharmaceutical and biotech industry as President Donald Trump recently announced the potential imposition of tariffs on imported pharmaceuticals. If the tariff hike is imposed, it is expected to directly impact not only the procurement costs of raw materials and sub-materials for Korean companies but also their price competitiveness when exporting finished products. According to the announcement, the tariffs are projected to be imposed approximately 1 to 1.5 years from now. While opinions within the industry are divided on the realistic feasibility of applying tariffs as high as 200%, the burden companies would face, even if tariffs are partially imposed, would be substantial. In particular, the U.S. market is crucial for Korean pharmaceutical and biotech companies as an export destination. For domestic companies that have rapidly grown in areas such as biosimilars and active pharmaceutical ingredients (APIs), securing global competitiveness, tariff barriers pose a significant threat. If a deterioration in profitability and a decline in price competitiveness materialize, significant disruptions to companies' global strategies are inevitable. Furthermore, Korean companies that have relied on the Contract Manufacturing Organization (CMO) and Contract Development and Manufacturing Organization (CDMO) industries as key growth pillars could face direct pressure, such as demands to relocate production sites or re-evaluate contract structures. Although specific implementation plans have not yet been released, long-term and strategic responses are required. Thus, there is a growing need to establish various tariff imposition scenarios and prepare stepwise countermeasures starting now. This tariff issue is likely to affect not only the pharmaceutical and biotech industries but also industries across the board, including automobiles, electronics, and steel. Therefore, individual corporate responses alone have apparent limitations. Ultimately, the government and businesses must collaborate to develop various scenarios based on potential tariff increases and formulate corresponding phased countermeasures. At the government level, while diplomatic efforts are necessary to reduce the likelihood of tariff increases, it is also essential to implement policy support measures, such as financial assistance and tax benefits, to minimize the impact on companies. Especially given that the government has identified the pharmaceutical and biotech sector as one of the future growth engines, neglecting this anticipated threat or delaying a response would be a strategic misstep. The pharmaceutical and biotech industries, by their nature, require long-term preparation and investment. The pharmaceutical and biotech industries, which are highly susceptible to the negative effects of trade conflicts, demand even more concrete and proactive preparation. It is crucial to recognize that this President Trump-initiated tariff issue is not merely a political discussion but a significant variable that will determine the overall competitiveness and survival of the industry. Therefore, discussions on a pan-governmental response must be initiated fully. The pharmaceutical and biotech industries should use this tariff issue as an opportunity to comprehensively re-evaluate the structural risks associated with global market entry and formulate new strategies. The government must actively consider and implement consultative bodies in collaboration with the private sector to prepare for tariff increases and long-term competitiveness strategies.
- Policy
- Will drugs subject to reimbursement reevals be expanded?
- by Lee, Tak-Sun Jul 11, 2025 06:11am
- The government is reportedly planning to tighten the selection criteria ahead of the second phase of the drug reimbursement adequacy reevaluations, which is set to begin next year. As a result, it is expected that the number of ingredients subject to reassessment may be expanded. According to industry sources on the 10th, the Health Insurance Review and Assessment Service (HIRA) is currently collecting feedback from the pharmaceutical industry before finalizing its second-phase drug reimbursement adequacy reevaluation plan. The first phase will conclude this year. Since the pilot reevaluation was conducted for choline alfoscerate in 2020, HIRA has completed four full reevaluation rounds from 2021 to 2024, and the fifth round is currently underway. Thus far, the reassessment has focused on ingredients listed for reimbursement from 1998 to 2006, before the positive listing system was implemented, and ingredients currently undergoing clinical reevaluation by the Ministry of Food and Drug Safety. Also, ingredients with an annual total reimbursement claim exceeding 0.1% (approximately KRW 20 billion), and those reimbursed in only one foreign country among the A8 reference countries was the criteria. Industry observers anticipate that the selection criteria stated above will change significantly from the second phase of reevaluations. In particular, the strengthened criteria may lead to the inclusion of ingredients that were previously excluded from reevaluations. It is reported that authorities are considering expanding the annual claims threshold to identify ingredients that have remained in a regulatory blind spot. The criteria under discussion include lowering the reimbursement claim threshold from KRW 20 billion to KRW 10 billion, and expanding the eligibility from being listed in only one A8 country to fewer than three. As in the first phase of reevaluations, the second phase will also continue to target drugs listed before the implementation of the positive listing system, making it likely that previously excluded products will be included. If the criteria are expanded as proposed, pharmaceutical companies will likely begin reviewing their product portfolios to identify those that may be subject to reevaluation. Unlike in the first phase, drugs with lower claims may also be included, posing new challenges for the companies preparing for reevaluations. However, as the selection criteria are still under review, companies are expected to limit their response until the final criteria are confirmed. Given the delay in finalizing the criteria and scope for the second phase, the industry is calling for the 2025 revisions to be postponed to allow sufficient preparation time.
- Policy
- Pfizer discontinues the supply of 'Viviant' in KOR
- by Lee, Tak-Sun Jul 11, 2025 06:09am
- Product photo of ViviantPfizer announced of discontinuing the supply of its 'Viviant Tab (bazedoxifene acetate)' in Korea. They stated that supply discontinuation is due to the difficulty in securing a stable and continuous supply. Viviant had previously been out of stock in May due to delays in the manufacturing site. An analysis suggests that Viviant's market competitiveness has also weakened following the emergence of generics and fixed-dose combinations in the Korean market, as well as the arrival of biologics. According to industry sources on July 10, Pfizer Korea recently sent an official letter to its distributors and other trading partners, stating its decision to discontinue the supply of Viviant Tablet 20mg (28BLP formulation). Pfizer stated, "This supply discontinuation was an unavoidable decision due to difficulties in securing a continuous and stable supply," and explained, "The estimated depletion date for the current inventory is by December." The inventory depletion date could be brought forward depending on market demand. Viviant obtained domestic product approval in November 2011. Pfizer Korea launched it in the Korean market the following year. This drug is a once-daily selective estrogen receptor modulator (SERM) class osteoporosis treatment, which garnered attention as Pfizer's first osteoporosis drug. Until its patent expiration in 2018, Viviant gained significant success with approximately KRW 10 billion in prescription sales. However, its performance has been declining since the introduction of domestic pharmaceutical companies' generics and fixed-dose combinations. Currently, 15 fixed-dose combinations containing bazedoxifene acetate, Viviant's active ingredient, and Vitamin D are listed for reimbursement, and 5 generic drugs with the same active ingredient are also reimbursed. Last year, Viviant's outpatient prescription sales amounted to KRW 2.4 billion, a 9.4 percentage point decrease from the previous year. The osteoporosis treatment market is now dominated by biologics like Prolia, which offer both efficacy and convenience of administration, leading to a diminished market competitiveness for Viviant compared to previous years. Consequently, analysis suggests that not only the stated reason of supply source instability but also a decline in performance in Korea likely influenced Pfizer Korea's withdrawal from the market.
- Policy
- Hanmi’s BTK inhibitor poseltinib approved for P1T in KOR
- by Lee, Hye-Kyung Jul 11, 2025 06:09am
- Hanmi Pharmaceutical's BTK inhibitor ‘poseltinib,’ which was licensed out to Nobo Medicine last year, will enter Phase I clinical trials in Korea as a monotherapy. On the 7th, the Ministry of Food and Drug Safety approved an open, multicenter, monotherapy, dose escalation Phase I clinical trial of NB02 (poseltinib) for patients with relapsed or refractory non-Hodgkin lymphoma. Following the approval granted last year to initiate a Phase II clinical trial for NB02 (poseltinib) in combination with rituximab and lenalidomide as a salvage therapy for patients with relapsed or primary central nervous system lymphoma (PCNSL), this marks the first Phase I clinical trial for poseltinib as a monotherapy. The Phase II trial is expected to enroll 18 patients in South Korea and will be conducted at Seoul National University Hospital until June 2028. Poseltinib is an oral drug candidate for autoimmune diseases and blood cancers that selectively inhibits BTK (Bruton's Tyrosine Kinase), an enzyme related to B lymphocyte activation signals in the human body. Hanmi Pharmaceutical first developed the drug and licensed it out to Eli Lilly in 2015 for USD 690 million, but the rights were returned in January 2019 after the drug failed to demonstrate efficacy in a Phase II clinical trial for rheumatoid arthritis patients. Hanmi Pharmaceutical continued developing poseltinib after the rights were returned and in October 2021, the company signed a joint development agreement with Genome Opinion, which became Nobo Medicine. In June last year, Hanmi Pharmaceutical signed a license-out agreement with Nobo Medicine for poseltinib. The total contract value and license fee are undisclosed, as agreed by both parties. Under the agreement, Nobo Medicine secured the global exclusive rights to poseltinib. Nobo Medicine was established in October 2017 under the name Genome Opinion and changed its name to Nobo Medicine in April last year. In addition to poseltinib, the company’s pipeline includes candidates for cardiovascular and ophthalmic diseases.
- Company
- Gastric cancer-targeted therapy 'Vyloy' seeks reimb again
- by Eo, Yun-Ho Jul 10, 2025 06:10am
- Product photo of Vyloy Vyloy, a gastric cancer-targeted therapy, is once again vying for inclusion in the National Health Insurance reimbursement list. According to industry sources, Astellas Pharma Korea recently submitted a reimbursement application for Vyloy (zolbetuximab), a targeted treatment for Claudin 18.2-positive gastric cancer. Vyloy did not pass the Health Insurance Review & Assessment Service's (HIRA) Cancer Disease Review Committee (CDRC) in February. Consequently, it remains to be seen whether it will achieve success in this second attempt. Vyloy, approved in Korea last September, is the world's first approved Claudin 18.2-targeted therapy. It is an immunoglobulin monoclonal antibody that acts by binding to Claudin 18.2, a protein expressed and exposed in the stomach. The basis of Vyloy's approval was the SPOTLIGHT Phase 3 study, which showed that the median progression-free survival (mPFS) for the Vyloy and mFOLFOX6 (oxaliplatin, leucovorin, fluorouracil) combination therapy was 10.61 months, higher than the placebo group's 8.67 months. The median overall survival (mOS) for the treatment group also surpassed that of the placebo group, which was 15.54 months, reaching 18.23 months. The GLOW study also found that the Vyloy and CAPOX (capecitabine and oxaliplatin) combination therapy recorded a median PFS of 8.21 months, reducing the risk of disease progression or death by approximately 31%. However, Vyloy is currently an unreimbursed drug. It was submitted to HIRA's CDDC in February but failed to establish reimbursement criteria. Additionally, due to a companion diagnostic (CDx) issue last year, Vyloy was officially launched in Korea only in March. To use Vyloy, it's necessary to identify patients who are Claudin 18.2-positive. This was complicated because the companion diagnostic device used for Claudin 18.2 diagnosis was being considered for the evaluation of new medical technology. In response, Astellas initiated an Expanded Access Program (EAP) even before Vyloy's approval to ensure that patients in need could access the treatment quickly. Currently, 51 patients are enrolled in 10 institutions through this program. Professor Sun Young Rha of Yonsei Cancer Center's Division of Medical Oncology stated, "Approximately 90% of metastatic gastric cancer patients are HER2-negative, creating a critical need for new biomarker-targeted therapies." Rha added, "In a situation where about 40% of HER2-negative patients are reported to be Claudin 18.2-positive, the introduction of Vyloy, which selectively binds to Claudin 18.2, presents new treatment possibilities."
- Opinion
- [Reporter’s View] Time to verify K-radiopharmaceuticals
- by Son, Hyung Min Jul 10, 2025 06:09am
- Radiopharmaceuticals are special preparations that combine drugs with radioactive isotopes for diagnostic or therapeutic use. In particular, radioligand therapy (RLT), which delivers radiation directly to tumor cells, is known for its high precision, being referred to as "moving radiation surgery." As beta particle-based radioligand therapy enters the commercialization stage, the global industry is shifting its focus to alpha particle-based therapies, which offer higher energy, shorter range, and more precise killing power. Leading candidates include actinium-225 and astatine-211. These agents, which have a shorter range and higher linear energy transfer (LET) than the existing beta-particle-based lutetium-177, are gaining attention as next-generation targeted therapies for their ability to precisely target cancer cells while minimizing damage to surrounding tissues. Multinational pharmaceutical companies are also making bold investments. Novartis, which developed Lutathera and Pluvicto, acquired a radioligand therapy developer Mariana Oncology last year. AstraZeneca has begun joint development with Actinium Pharmaceuticals. The United States, Canada, and Europe have already incorporated the development of actinium production and purification infrastructure into their national strategies. In contrast, Korea is still in its early stages. Although the Korea Atomic Energy Research Institute (KAERI) and the Korea Institute of Radiological & Medical Sciences (KIRAMS) have isotope production and some research platforms, vertical integration encompassing isotope purification, labeling technology, ligand design, and clinical development has not yet been achieved. Above all, the connection between hospitals, nuclear power, and pharmaceutical companies remains weak. While platforms exist, they rarely lead to the development of pharmaceuticals. Radiopharmaceuticals for diagnostic use have been commercialized, but the development of therapeutic agents is still lagging behind. Nevertheless, companies in Korea have also begun to explore this field. Currently, Cellbion is completing Phase II clinical trials for prostate cancer and is expected to apply for approval. They expect therapeutic effects comparable to or better than those of the already commercialized Pluvicto. FutureChem has completed a Phase II clinical trial for prostate cancer and plans to proceed with Phase III trials. The company plans to apply for conditional approval as soon as it receives authorization for the Phase 3 Investigational New Drug (IND) application. In this sense, the rumored development of K-radiopharmaceuticals is finally beginning to show some tangible results. However, the companies’ pipelines still have gaps in key technological elements such as target protein design, clinical strategy, and formulation optimization compared to global standards. Therefore, structural government support is necessary to secure independent competitiveness. Radiopharmaceuticals are a complex technology with a high barrier to development. However, as the entry barriers become extremely high, some experts believe that successful localization could enable market dominance even beyond that of antibody-drug conjugates (ADCs) once a company enters the field. The solution for domestic production of radiopharmaceuticals lies not in isolated technologies but in “strategic integration.” It is now time to establish a “Korean RLT Alliance” that encompasses everything from target proteins to hospital networks, clinical design, and isotope supply. Otherwise, domestically produced radiopharmaceuticals will remain mere objects of technology transfer rather than becoming market leaders.
- Company
- Ono Pharma Korea’s sales double in 4 years with Opdivo
- by Son, Hyung Min Jul 10, 2025 06:09am
- Ono Pharmaceutical Korea continued its sales growth, powered by its immuno-oncology drug Opdivo. The company's sales doubled in 4 years. The company is preparing for the expiration of Opdivo's patent by securing a diverse pipeline of new anticancer drugs, including antibody-drug conjugates (ADCs) and novel immuno-oncology drugs with different mechanisms of action. According to the Financial Supervisory Service's electronic disclosure system on the 9th, Ono Pharmaceutical's sales last year reached KRW 60.3 billion, a YoY increase of 10.7%. During the same period, operating profit rose by 11.7% from KRW 3.9 billion to KRW 4.4 billion. The sales and operating profit recorded by Ono Pharmaceutical last year are the highest figures since the company began submitting audit reports in 2017. Ono Pharmaceutical recorded sales of over KRW 40 billion in 2021 and exceeded KRW 50 billion for the first time the following year. Comparing the company’s sales of KRW 60.3 billion last year with the KRW 31 billion in 2020, it has increased by 94.5% in four years. The immuno-oncology drug Opdivo drove Ono Pharmaceutical's sales growth. Opdivo is an anti-PD-1 class immune-oncology drug jointly developed by Ono Pharmaceutical and BMS, and was approved in Korea in 2015. Ono Pharmaceutical holds the development and marketing rights for Opdivo in Asia, including Korea, Japan, and Taiwan. Ono Pharmaceutical's sales have risen significantly since 2017, when Opdivo was granted reimbursement. The first indication reimbursed was for non-small cell lung cancer. Ono Pharmaceutical's sales in 2018 were KRW 44.8 billion, up 44.4% from KRW 31 billion the previous year. However, competition from MSD's Keytruda had an impact on Opdivo’s sales. Opdivo recorded sales of KRW 32.4 billion in 2019, down 27.8% from the previous year. Ono Pharmaceutical sought to reverse the trend by expanding the indications and reimbursement for Opdivo. In particular, the combination of Opdivo and BMS's CTLA-4 targeted immuno-oncology drug Yervoy has been effective in various solid cancers, such as melanoma, renal cell carcinoma, and hepatocellular carcinoma, contributing to an increase in market share. In addition, Opdivo became the first immuno-oncology drug to be approved for the treatment of gastric cancer in 2021. According to the market research institution IQVIA, Opdivo surpassed KRW 100 billion in domestic sales in 2022. Company busy securing future pipeline following Opdivo Ono PharmaceuticalOno Pharmaceutical is preparing for the expiration of Opdivo's patent. Opdivo's patent is scheduled to expire in the United States in 2028, followed by other markets around the world. First, the company is defending the market with Opdivo Qvantig, a subcutaneous injection (SC) formulation of Opdivo. Opdivo Qvantig was approved in the United States last year, and Ono Pharmaceutical and its partner BMS are seeking approval in major countries. The existing intravenous (IV) formulation of the anticancer drug requires administration for over an hour, but the SC formulation has the advantage of reducing the administration time to less than 10 minutes. The SC formulation of the anticancer drug can provide convenience to patients who must visit the hospital once every 3 weeks on average to receive the IV formulation. Ono Pharmaceutical is also seeking to enter the antibody-drug conjugate (ADC) market. Last year, Ono Pharmaceutical acquired LCB97, an ADC candidate substance developed by LigaChem Biosciences, a domestic ADC developer. LCB97 targets L1CAM, a protein expressed in various solid tumors, such as lung cancer, pancreatic cancer, and colorectal cancer. LCB97 incorporates LigaChem Biosciences’ proprietary ConjuALL linker technology. ADCs consist of a linker, payload (drug), and antibody, and the ConjuALL linker is evaluated to overcome issues such as the release of cytotoxic drugs in the bloodstream and attacks on normal cells. LigaChem Biosciences and Ono Pharmaceutical have also signed a contract to transfer the company’s proprietary technology for ADCs that target multiple targets along with LCB97. Under this contract, Ono Pharmaceutical has secured the rights to discover and develop ADC candidates targeting multiple targets using LigaChem Biosciences’ platform technology. Additionally, Ono Pharmaceutical has entered into a technology transfer agreement with domestic company NEX-I and will begin developing the immunotherapy candidate ‘NXI-101.’ NXI-101 is a next-generation immunotherapy drug candidate that inhibits the function of ONCOKINE-1, a newly identified target discovered through the ‘ONCOKINE’ platform, which identifies factors causing resistance to cancer immunotherapy. Currently, Ono Pharmaceutical has completed preclinical trials for NXI-101 and is conducting Phase I clinical trials.
- Policy
- Discussion on "Indication-specific drug pricing system"
- by Lee, Tak-Sun Jul 10, 2025 06:09am
- Kim Gook-hee, Director of the Pharmaceutical Benefits Department at HIRA (left) and Lee So-young, Director of the Pharmaceutical Performance Assessment Department, (right) are answering to questions during the Q&A session. The Health Insurance Review & Assessment Service (HIRA) announced that the issue of 'indication-specific drug pricing system' proposed by the pharmaceutical industry may require further discussion, and the immeditate implementation is difficult. They explained that further discussion is needed, particularly regarding the prevention of confusion in clinical practice and post-market management. Kim Gook-hee, Director of the Pharmaceutical Benefits Department at HIRA, stated this at a press conference with specialized journalists held on July 8th at the main office in Wonju. The press conference was held with the Pharmaceutical Management Department and the Pharmaceutical Performance Assessment Department (TF), with Director Kim and Lee So-young, Director of the Pharmaceutical Performance Assessment Department, participating in the Q&A session. Kim explained the need for introducing an indication-specific drug pricing system: "Multi-indication drugs refer to cases where 'a single product has two or more indications,' and the current system applies a single reimbursement cap regardless of the number of indications." She added, "I understand that the need for an indication-specific drug pricing system is emerging due to the increasing trend of adding indications after approval and expanding reimbursement after listing, especially for anticancer drugs." Kim emphasized, "Regarding this system, it is necessary to review it cautiously, considering the appropriateness of setting different drug prices per indication and its actual applicability." Currently, countries that have adopted an indication-specific drug pricing system either apply differentiated refund rates per indication or calculate a weighted average price based on the prices of individual drugs per indication. Countries applying differentiated refund rates per indication include Italy, Switzerland, Australia, and Belgium. Countries using weighted average prices per indication include Italy, France, Australia, and Japan. Kim stated, "Measures to minimize confusion in clinical settings, such as issues of fairness among patients and concerns about prescription distortion that could arise if a single product's drug price varies by indication, must be prepared concurrently." Kim also added, "Even when applying a single weighted average price, careful discussion must precede regarding data collection methods for weighted average price calculation, drug price setting methods, and post-market management." Regarding the criticism that domestic natural new drugs are included in the re-evaluation targets for drug reimbursement appropriateness this year, which is contrary to industrial promotion policies, Kim stated there is no issue. She explained, "When reviewing clinical usefulness, we comprehensively examine not only overseas data but also domestic materials such as local medical textbooks, clinical practice guidelines, and domestic clinical literature listed in SCIE journals." Furthermore, regarding the reimbursement application for combination therapies of new drugs, Kim explained, "Combination therapies of new drugs lead to a significant cost increase compared to monotherapies. Therefore, reimbursement will only be possible in cases where a clear improvement in clinical efficacy is demonstrated." Kim also stated, "Regarding the reimbursement evaluation of new drugs used in combination with already listed drugs from other companies, if one pharmaceutical company applies for reimbursement, we request relevant data from the other company involved in the combination. However, if the other company has no intention of expanding reimbursement, it is difficult to mandate reimbursement under the current selective listing system." Meanwhile, Lee So-young, Director of the Pharmaceutical Performance Evaluation Office, stated that re-evaluation of drugs exempted from cost-effectiveness evaluation has not yet been specifically reviewed. Lee added, "A commissioned research study on 'Guidelines for Generating Real-World Evidence (RWE) for Pharmaceutical Performance Evaluation' has been underway since March and is expected to conclude in November." She explained, "We plan to prepare the guidelines through sufficient discussion with stakeholders during the research process." Once the research results are available, the plan is to discuss specific implementation directions with relevant organizations, including the Ministry of Health and Welfare (MOHW), as well as pharmaceutical companies. The following is a summary of the Q&A session: 1. Related to Proposals for Improving Medical Reimbursement Criteria Last year, 57 improvement suggestions were submitted by 7 associations and academic societies (including 7 sub-associations/societies). This year, 42 suggestions were submitted by 8 associations and academic institutions (including 21 sub-associations/societies). All 57 improvement suggestions submitted last year have been reviewed. Among them, 28 items have either had their notices or announcements revised, or are undergoing subsequent procedures. For other items involving misunderstandings, the medical community has been properly informed. Among the 42 improvement suggestions submitted this year, 32 related to general drugs were proposed. For instance, the Korean Association of Internal Medicine requested a general revision of the principles governing diabetes medications, and the Korean Hospital Association requested clarification of the diagnostic criteria for osteoporosis. For anticancer drugs, a total of 10 suggestions were made. These included the Korean Association of Internal Medicine (KAIM)'s opinion on the need to improve the eligibility criteria for treatment regimens to align with clinical reality, and requests to clarify phrases like 'refractory' or 'surgical or local treatment impossible' where interpretation differences might arise. In response, HIRA prioritizes reviewing items where numerous claim adjustments occur due to unreasonable or unclear criteria, or where prompt guidance is needed to address misunderstandings in interpretation. 2. Related to Indication-Specific Drug Pricing System Multi-indication drugs refer to cases where 'a single product has two or more indications,' and the current system applies a single reimbursement cap regardless of the number of indications. Recently, I am aware that the need for an indication-specific drug pricing system is emerging due to the increasing trend of adding indications after approval and expanding reimbursement after listing, particularly for anti-cancer drugs. Regarding this system, it is necessary to review it cautiously, considering the appropriateness of setting different drug prices per indication and its actual applicability. Measures to minimize confusion in clinical settings, such as addressing issues of fairness among patients and concerns about prescription distortion that could arise if the drug price of a single product varies by indication, must be prepared concurrently. Even when applying a single weighted average price, careful discussion must precede regarding data collection methods for weighted average price calculation, drug price setting methods, and post-market management. 3. Related to Requests for Reimbursement of Combination Therapies The trend of increasing anticancer combination therapies has been significant recently. To expand treatment opportunities for patients, the Ministry of Health and Welfare's notice in May and HIRA's announcement in June improved the system to allow reimbursement for existing anticancer drugs when combined with new anticancer drugs, thereby strengthening access to anticancer combination therapies. Combination therapies of new drugs incur a significant cost increase compared to monotherapies, etc. Therefore, reimbursement will only be possible in cases where a clear improvement in clinical efficacy is demonstrated. Combination therapies of new drugs incur a significant cost increase compared to monotherapies, etc. Therefore, reimbursement will only be possible in cases where a clear improvement in clinical efficacy is demonstrated. Furthermore, regarding the reimbursement evaluation of new drugs administered in combination with already listed drugs from other companies, if one pharmaceutical company applies for reimbursement, relevant data is requested from the other company involved in the combination. However, if the other company has no intention of expanding reimbursement, it is difficult to mandate reimbursement under the current selective listing system. 4. Related to Re-evaluation of Reimbursement Appropriateness for Domestic Natural New Drugs Eight ingredients are targeted for reimbursement appropriateness re-evaluation in 2025. Currently, a practical review is underway based on data submitted by pharmaceutical companies, relevant evidence, and academic opinions. The Drug Reimbursement Evaluation Committee (DREC)'s review is scheduled for the second half of this year. The re-evaluation targets include all drugs that meet the selection criteria and are not selected based on the original country of development of the ingredient. Among the 8 ingredients targeted for re-evaluation this year, Clematis root, Trichosanthes root, Prunella spike, and Mugwort extract are classified as natural new drugs. Even if these drugs are selected for evaluation, their reimbursement will be maintained if clinical usefulness is recognized during re-evaluation. Additionally, when reviewing clinical usefulness, not only overseas data but also domestic materials such as local medical textbooks, clinical practice guidelines, and domestic clinical literature listed in SCIE journals are comprehensively examined. 5. Related to Delays in Drug Evaluation for Concurrent Approval-Evaluation-Negotiation Pilot Program The 'Concurrent Approval-Evaluation-Negotiation Pilot Program' was initiated to expedite the reimbursement listing time by simultaneously conducting the review processes of the Ministry of Food and Drug Safety, HIRA, and the National Health Insurance Service. It primarily selected drugs that showed superior efficacy for life-threatening diseases without alternative treatments, and reimbursement for the pilot program's target drugs was not a prerequisite. However, if changes occur during the approval and reimbursement evaluation process or supplementary data is submitted after a drug has been selected as a pilot program target based on the pharmaceutical company's application data, additional review time may be required. Unlike medical procedures or treatment materials, drugs are subject to a selective listing system that applies health insurance coverage to drugs with excellent therapeutic and economic value. This is operated through HIRA's reimbursement evaluation and the National Health Insurance Service's negotiation procedures. 6. NHIS's Stance on Participation in DREC As the NHIS is the insurer and a direct party to negotiating drug reimbursement caps with pharmaceutical companies, if the NHIS were to participate in the committee's composition, concerns might arise regarding the fairness and objectivity of the decisions made. Currently, the NHIS attends and monitors every meeting of the DREC, and relevant data is shared periodically. We will continue to collaborate with the NHIS for efficient drug management. 7. Related to Revision of Indirect Comparison Guidelines If a clinical study has been conducted to evaluate the clinical usefulness of a new drug, such as its improvement in efficacy, as a single-arm study of the applicant drug, or if there is no direct comparison data with an alternative drug, objective evidence derived through a valid indirect comparison is required. To this end, HIRA conducted the "Research on Revising Indirect Comparison Guidelines (March-December 2024)" in 2024, and the final research report was published on our website in February this year. Furthermore, an expert advisory meeting regarding the guideline revision was held in early May. Based on this, a draft will be prepared, and the guideline revision will be pursued this year after gathering internal and external opinions. 8. Pharmaceutical Performance Assessment Department Organization and One-Year Achievements Last year, the Pharmaceutical Performance Assessment Division operated with one department, the Pharmaceutical Performance Evaluation Department. However, starting this year, it has been reorganized into a one-office, two-department system. A new Pharmaceutical Performance Assessment Department was established to strengthen development functions, including RWD data analysis methods, performance evaluation models, and guidelines for generating real-world evidence (RWE). We have focused on establishing a system to ensure patient access to high-cost severe disease treatments while managing evidence uncertainty through post-listing performance evaluation. Following the review stage of a drug reimbursement application, the head of the Pharmaceutical Performance Assessment Department participates in discussions within the relevant three subcommittees to select target drugs for performance evaluation. To date, performance evaluations have been conducted for drugs such as Kymriah and Zolgensma, and we have efficiently managed high-cost severe disease treatments. Based on the revised risk-sharing agreement (RSA) type notification in March this year, the system is being operated to create good models for pharmaceutical performance evaluation, aiming for complete system completion by appropriately selecting and reviewing evaluation targets. We will also strive to standardize the entire performance evaluation review process to establish it as a rational and acceptable system. 9. Related to RWD Drug Evaluation Procedures If the DREC approves a submitted drug with a condition for post-marketing collection of RWD. In that case, the pharmaceutical company must submit a performance evaluation plan, detailing specific conditions such as collection period, frequency, and indicators, after consultation with the Pharmaceutical Performance Assessment Department. Subsequently, the pharmaceutical company periodically submits the collected data (RWD) to HIRA, and HIRA cross-validates it with claims and review data to verify reliability. Before the end of the risk-sharing agreement period, the pharmaceutical company submits the performance evaluation results, analyzing the collected data (RWD) according to the predefined plan, to HIRA. After that, the DREC then evaluates these results. 10. Related to RWE Guidelines and Re-evaluation of Cost-effectiveness Evaluation Exempted Drugs The commissioned research on 'Guidelines for Generating Real-World Evidence (RWE) for Pharmaceutical Performance Evaluation' has been underway since March and is expected to conclude in November. We plan to develop the guidelines through thorough discussions with stakeholders during the research process. Once the research results are available, the plan is to discuss specific implementation directions with relevant organizations, including the MOHW and pharmaceutical companies. The re-evaluation of drugs exempt from cost-effectiveness evaluation has not yet been specifically reviewed.
