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- 2026-05-04 15:38:45
- Policy
- Lucentis biosimilar enters KRW 35B market in Korea
- by Lee, Tak-Sun Dec 21, 2022 06:05am
- Samsung Bioepis’s Lucentis biosimilar that was released in the US in June Competition in the macular degeneration treatments market is expected to intensify with the imminent entry of the first biosimilar of ‘Lucentis’ in the Korean market. Sales of Lucentis alone had been nearly KRW 35 billion in Korea last year. Lucentis biosimilars from Chong Kun Dang and Samsung Bioepis were preannounced to be listed for reimbursement starting next month. According to industry sources on the 20th, the Ministry of Health and Welfare issued an administrative notice announcing the partial amendment to the reimbursement standards of some pharmaceuticals that included the introduction of Lucentis biosimilars. Previously, 2 Lucentis biosimilars were approved in Korea this year. Samsung Bioepis first received approval for its biosimilar under the name ‘Amelivu inj’ in May, followed by Chong Kun Dang’s ‘LucenBS inj’ in October. Both products are expected to be released with reimbursement next month. Like Lucentis, the two biosimilars will be reimbursed for all 4 indications: neovascular wet age-related macular degeneration (AMD), macular edema caused by diabetes, macular edema caused by retinal vein occlusion, and choroidal neovascularization secondary to pathologic myopia. Amelivu will be sold by Samil Pharmaceutical, which specializes in ophthalmic treatments. Samsung Bioepis and Samil Pharmaceutical signed a commercialization agreement for Amelivu in June this year. LucenBS is the second biosimilar to be developed by Chong Kun Dang. Its first biosimilar product,’Nesbell,’ which is a biosimilar of the anemia treatment NESP, was approved in November 2018. Considering the considerable size of the domestic market for Lucentis in Korea, Chong Kun Dang is expected to launch a large-scale marketing campaign to take a share of the market. The domestic macular degeneration treatment market is currently shared by two products – Bayer’s ‘Eylea,’ and Novartis’s Lucentis. According to IQVIA, their sales last year were KRW 70.5 billion for Eylea and KRW 35.1 billion for Lucentis. The global macular degeneration treatment market size is around KRW 13 trillion. This is why domestic biosimilar companies are also eyeing the global market. Samsung Bioepis released its Lucentis biosimilar ‘Byooviz’ in June in the US and is planning to also advance into the European market. In the case of Chong Kun Dang, the company is working to advance into Japan and Southeast Asia. Also, Celltrion, Sam Chun Dang Pharm, and Samsung Bioepis are developing Eylea biosimilars.
- Policy
- Shingrix will be released as a national lot on the 16th
- by Lee, Tak-Sun Dec 21, 2022 06:05am
- GSK shingles vaccine against herpes zoster preventionShingrix (GSK), a shingles virus vaccine, received a national lot release on the 16th and began full-scale vaccination. It was also stocked in general hospitals, and vaccinations began this week. On the 16th, the Ministry of Food and Drug Safety released four production numbers (six in total, 0.5ml in packaging) with an expiration date of October 31, 2024. The National lot release is a system in which the Ministry of Food and Drug Safety allows only suitable items to be sold through quality inspection. Shingrix products approved for shipment were immediately stocked at general hospitals and vaccination began this week. GSK held a press conference on the 15th to commemorate its launch in Korea. In Korea, GC Pharma and Kwang Dong sell together. Shingrix is the first shingles vaccine in Korea that has been approved by combining GSK's immune enhancer with a non-live antigen. Two global phase 3 (ZOE-50 and ZOE-70) conducted on 15,411 adults over the age of 50 have a 97.2% preventive effect and more than 90% preventive effect in all age groups over the age of 70. This is because existing commercially available products have a preventive effect of less than 70%. It is known that the price is a little high. Shingrix is inoculated twice every two months, and it is known to cost about 500,000 won for two vaccinations. Zostervax, which is most commonly used to prevent shingles, is only inoculated once and sold for about 150,000 won.
- Policy
- Pfizer & Novartis generic drugs disappear from the market
- by Lee, Tak-Sun Dec 20, 2022 06:06am
- All generic drugs released by Novartis and Pfizer Korean branches in the domestic market have disappeared. Although it was successfully released, it is interpreted that it left the market after losing a lot of competition with domestic pharmaceutical companies. According to industries on the 19th, Novartis' Pneumast 10mg and Pneumast 3mg were removed this month due to voluntary withdrawal of item permits. Pneumast is an organon asthma treatment Singulair generic drug licensed by Novartis Korea in October 2012. In the domestic market, Singulair generic was released in December 2011. Pneumast came out belatedly, and it is analyzed that it failed to show off its presence among numerous domestic generics. Sandoz, a generic subsidiary that Novartis recently decided to spin off, has also withdrawn from the Singulair generic business in the Korean market. As the benefit of Pneumast of Novartis Korea was deleted, all generic drugs under the name of Novartis Korea disappeared. Earlier in June 2020, Novartis withdrew its license to treat hyperlipidemia, Atorvin. Atorvin is Viatris' Lipitor generic drug. Pfizer also lost all generic drugs in a few years. Pfizer introduced Pfizer Vitals, a generic brand, in 2012. It was a business that LG Chem produced and sold licensed products by Pfizer. All products that were approved at that time have disappeared. Norvasc V withdrew the permit due to the Balzartan impurity incident in December 2019, followed by Montelu V in February 2020, Cilo V in May 2021, and Clo V in December 2021. In addition, in December 2021, Norvasc T, a high blood pressure compound, was involved in the false preparation of Jeil's data, and the license was revoked. As a result, domestic generics of Pfizer and Novartis have all disappeared. "At first, foreign pharmaceutical companies put forward their brands and quality through quality generics, but it was difficult to compete with domestic pharmaceutical companies with large hospital distribution networks based on their sales power," said an official in the domestic pharmaceutical industry.
- Policy
- President Yoon said, block medical shopping
- by Kang, Shin-Kook Dec 20, 2022 06:05am
- As concerns arose that it might lead to a reduction in health insurance coverage, President Yoon Suk Yeol mentioned a second plan to reform health insurance. Regarding the direction of health insurance reform at the first state affairs inspection meeting at the Blue House guesthouse on the 15th, President Yoon said, "It means that we will eliminate it and re-define the insurance system because moral hazard hurts other good insurance subscribers." President Yoon said, "When I and my family have a serious disease that is really expensive, we will normalize the health insurance system to get proper treatment and recover health without worrying about the money (treatment cost)." "There is a person who goes to the hospital thousands of times a year because it is so-called medical shopping." In addition, there are cases where expensive MRI (Magnetic Resonance Imaging Device) is used indefinitely, he said. "We want insurance subscribers to receive fair support for serious diseases and essential medical care." President Yoon said, "I don't think it's desirable for us to set up a principle called the Medical Judgment Rule and treat it according to normal medical judgment. We'll design and operate a very effective objection procedure system for screening and evaluation." Health and Welfare Minister Cho Kyu-hong, who attended the National Policy Task Inspection Meeting, also stressed that the recent measures to improve the sustainability of health insurance do not reduce the role of health insurance. Minister Cho said, "What the government is trying to reorganize is to provide essential and severe medical care to the public as it is, not to reduce its role, but to improve sustainability," adding, "However, it is to prevent medical abuse or theft of qualifications." The Ministry of Health and Welfare held a public hearing on measures to improve health insurance sustainability and support essential medical care on the 8th and announced measures to recognize benefits only when medical needs are recognized in large-scale items such as paid brain and cerebrovascular MRI and ultrasound. When the Yoon Suk Yeoln government formalized health insurance reform that virtually abolished the so-called "Moon Jae In Care" (a policy to strengthen health insurance coverage), the opposition party strongly protested, saying that there was no case of reducing coverage in the conservative government.
- Policy
- ICER of general drugs KRW 15.97 mil for the past 15 yrs
- by Lee, Tak-Sun Dec 19, 2022 04:35am
- The median ICER (Incremental Cost-Effective Ratio) value of general drugs from 2007 to 2021 was KRW 15.97 million in Korea. The ICER value of anticancer drugs was KRW 45.16 million, and rare diseases KRW 15.97 million in the same period. This was the first time that the ICER results were disclosed, and the disclosed results are expected to be useful for pharmaceutical companies that seek to reimburse new drugs. On the 16th, the Health Insurance Review and Assessment Service announced that it had disclosed the cost-effectiveness evaluation results of drugs that are required to submit pharmacoeconomic evaluation data (ICER) for the past 15 years (2007-2021) since the positive-listing system was first introduced to Korea. ICER is a value used to evaluate the economic feasibility of a new drug that offers an improved effect and shows the additional cost required per unit of increased effect or efficacy of a new drug compared to its alternative. Accordingly, a new drug is interpreted as being cost-effective compared to its alternative if the ICER of a certain drug is lower than a certain threshold. However, instead of using an explicit threshold, Korea flexibly refers to the results of previous deliberations in consideration of the severity and social burden of the disease, its impact on quality of life, and innovativeness. The disclosure follows the deletion of the 'GDP per capita' standard and the addition of the ‘existing review results' standards in the revised regulations for the ICER threshold in the ‘Detailed Evaluation Standards for Drugs Subject to New Drugs, Etc.’ in September last year. HIRA explained that the revision specifies the use of the alternative reference value that is used in Korea, as Korea does not use an explicit threshold value. After the initial disclosure this year, HIRA plans to disclose the 5-year ICER data every December, but in consideration of the number of ingredients in each drug category each period to prevent specifying the evaluation results of individual drugs. In the case of the ICER results of rare disease drugs from 2007 to 2013, HIRA disclosed the minimum and maximum ICER values, but not the median value to prevent the evaluation results of individual drugs from being specified. The ingredients subject to disclosure are ingredients deemed cost-effective by the Drug Reimbursement Evaluation Committee and evaluated for reimbursement. Only for 2022, all data from 2007 to 2021 were disclosed at once. Also, the evaluation results from 2007 to 2013 and 2014 to 2021 were separately disclosed in consideration of the major policy changes that had been made in 2014, such as the ▲increased ICER limit to strengthen coverage for severe diseases (from November 2013) and the ▲ implementation of the risk-sharing system (from December 2013), etc. HIRA explained that the data disclosed are divided into three categories: general drugs, anticancer drugs, and rare disease drugs, and the number of ingredients and cost-effectiveness evaluation results for each category are disclosed. In the case of anticancer and rare disease drugs, the classification is made according to the classifications made during DREC evaluations, and all other drugs are included in the general drug category. The number of ingredients was calculated based on the results of the cost-effectiveness analysis and subject ingredients, and HIRA will be disclosing the median, minimum, and maximum values based on drug category. The ICER results of drugs that submitted data for economic evaluations showed that the median ICER of generic drugs from 2007 to 2021 was KRW 15.97 million. Also, the ICER value of anticancer drugs was KRW 45.16 million, and rare disease drugs KRW 32.32 million. The ICER results of drugs subject to PE data submissions can be found on HIRA’s webpage. Mi-Young Yoo, Deputy Minister of HIRA's Pharmaceutical Benefits Management Department, said, “The ICER results that were disclosed this time are meaningful as this is the first time the data had been disclosed since the introduction of the positive-listing system, and the annual regular disclosure of the data is expected to be used as an alternative reference value related to ICER.” Yoo added, “However, in evaluating the reimbursement adequacy of drugs, not only the ▲cost-effectiveness from PE evaluation results, but also the ▲clinical effectiveness, and ▲its impact on NHI finances, are comprehensively considered. Korea does not use an explicit ICER threshold value; it rather evaluates the value in consideration of the uncertainties based on the results of the sensitivity analysis in addition to the basic analysis results. Therefore, we ask people to play caution in interpreting the published cost-effectiveness evaluation results.”
- Policy
- Pfizer Cibinqo, re-applied to the HIRA
- by Lee, Tak-Sun Dec 19, 2022 04:35am
- Pfizer Cibinqo, which aims to pay for atopic dermatitis indications as a JAK inhibitor, is being paid later than expected. It was expected to be deliberated by the Drug Benefit Evaluation Committee within the year after passing the HIRA Drug Benefit Standards Subcommittee in August, but it is expected to take some time for the salary to be converted as it is known to have recently withdrawn and submitted a new application. According to the industry on the 15th, Pfizer Cibinqo recently withdrew its application for benefits decision and immediately resubmitted it. The screening is expected to be delayed further as the salary application has been withdrawn and resubmitted. Initially, Cibinqo applied for salary registration in April and passed a review by the Drug Benefit Standards Subcommittee in August. According to the procedure, it should have been reviewed by the Drug Benefit Evaluation Committee this month, but it was not. In the industry, Cibinqo was expected to proceed without difficulty as the same JAK inhibitors Oluminant and Rinvoq were previously applied not only to rheumatoid arthritis but also to adult atopic dermatitis since May. Pfizer is currently leading the related market with JAK inhibitor Xeljanz. However, compared to competing drugs, there is no atopic dermatitis indication, so we are counting on Cibinqo. Cibinqo has dropped the permit The reasons for reapplying are not known exactly. Although Cibinqo is struggling with salary, it has recently passed the Drug Commission (DC) of large hospitals such as Seoul National University Hospital one after another, laying the foundation for a prescription. If the salary is made, it is expected to settle in the market quickly. Cibinqo has the efficacy and effect of treating severe atopic dermatitis in moderate symptoms of adults and adolescents aged 12 or older who are subject to systemic therapy.
- Policy
- Green light for the reimb of Onureg, Rolontis, etc.
- by Lee, Tak-Sun Dec 19, 2022 04:35am
- A green light has been lit for the reimbursement of BMS Korea’s leukemia treatment ‘Onureg tab,’ with its agenda passing deliberations for setting reimbursement standards. Also, reimbursement standards have been prepared for 5 neutropenia treatment products including Hanmi Pharmaceutical’s Rolontis. The Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee (CDDC) held its 10th meeting on the 14th and made the deliberations above. First, Onureg tab (azacitidine, BMS Korea), which is attempting to establish a new reimbursement category, succeeded in establishing reimbursement standards as ‘maintenance therapy in adult patients with acute myeloid leukemia (AML) who achieved complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following induction therapy with or without consolidation treatment and who are not candidates for, including those who choose not to proceed to, hematopoietic stem cell transplantation (HSCT). On the other hand, Novartis Korea failed to receive reimbursement standards for Scemblix tab (asciminib, Novartis Korea) as a treatment for adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (CML) in chronic phase (Ph+ CML-CP) previously treated with two or more tyrosine kinase inhibitors (TKIs). Also, the CDDC did not approve the establishment of reimbursement standards for Inrebic cap (fedratinib hydrochloride, BMS Korea) as a treatment for enlarged spleen or other symptoms related to primary myelofibrosis, post-polycythemia vera myelofibrosis, and post-essential thrombocythaemia myelofibrosis in adult patients that have been previously treated with ruxolitinib. In addition, Nerlynx tab (neratinib maleate, Bixink) failed to receive reimbursement for use as monotherapy as extended adjuvant treatment for patients with early-stage HER2-positive breast cancer in those who have received adjuvant trastuzumab-based therapy within a year. 10th CDDC deliberation results On the other hand, the green light has been lit for neutropenia treatment products that are in use in Korea. The products are: Neulasta prefilled syringe inj (pegfilgrastim, Kyowa Kirin Korea), Neulapeg (pegteograstim, GC Corp), Dulastin prefilled syringe (tripegfilgrastim, Dong-A ST), Lonquex prefilled inj (lipegfilgrastim), and Rolontis prefilled syringe ing (eflapegrastim, Hanmi Pharmaceutical). The products succeeded in establishing reimbursement standards on reducing the incidence and period of febrile neutropenia in patients undergoing cytotoxic chemotherapy for malignant tumors, and on reducing the period of severe neutropenia in patients undergoing cytotoxic chemotherapy for solid tumor and malignant lymphoma.
- Policy
- HIRA, established a management system for high-priced drugs
- by Lee, Tak-Sun Dec 19, 2022 04:34am
- Medical institutions submit administrative information and response evaluation results to the Board of Audit and Inspection. The HIRA (Director Kim Sun-min) announced that it has been operating a "high-priced drug management system" since the 12th to increase the work efficiency of analyzing the results of response evaluations for patients receiving high-priced drugs and to facilitate data submission. It is explained that the high-priced drug management system was promoted to analyze and monitor the entire administration process from administration information of ultra-high-priced drug administration patients such as Kymriah and Zolgensma to response evaluation of drugs. Medical institutions that claim expensive drugs log in to the "care institution work portal" and fill out and submit "administration information and response evaluation results" according to the drug-specific evaluation form, and the application will be completed after inspection by the evaluation agency. Looking at the evaluation period by drug, Kymriah submits it for one year every six months and Zolgensma for five years every six months. Medical institutions that administer ultra-high-priced drugs such as Kymriah and Zolgensma, which were registered this year, were cumbersome and uncomfortable by submitting patient-specific administration information by e-mail, but it was improved by directly entering or uploading data according to the system. It is explained that the administrative convenience of medical institutions' submission of data has been increased, and the HIRA has improved work efficiency as accurate data can be collected through real-time data checks. Recently, as social demands for expensive new drugs with high treatment effects are increasing, there is a need to strengthen patient access and secure the sustainability of health insurance through proper management of expensive drugs. In response, the HIRA Pharmaceutical Management Office established a salary management roadmap for the proper management of high-priced drugs in July and formed a dedicated organization to prepare a driving force for the post-management of high-priced drugs. In the future, it will lay the legal foundation for the stable promotion of high-priced drug performance management by specifically defining the targets for high-priced drug management, follow-up management period, and billing method. "The establishment of a high-priced drug management system is the first step to establish a performance-based follow-up system for ultra-high-priced new drugs," Yoo Mi-young, head of the drug management office, said. "The performance evaluation results will be used as data to calculate the NHIS's drug refunds and contribute to securing health insurance sustainability."
- Policy
- Discard Moon Care Policy
- by Lee, Jeong-Hwan Dec 19, 2022 04:34am
- President of Yoon Suk YeolPresident Yoon Suk Yeol announced a normalization policy, emphasizing the necessity and urgency of reforming the health insurance system. Analysts say that it has virtually formalized the abolition of the policy to strengthen health insurance coverage, which is the core of the so-called "Moon Jae-in Care" promoted by the previous government. "We urgently need to normalize health insurance, the last bastion of protecting public health," President Yoon Suk Yeol said in a statement at a Cabinet meeting held at the presidential office in Yongsan this morning (13th). "Health insurance reform is not an option, but a necessity," he said. President Yoon criticized, "We have spent more than 20 trillion won on strengthening coverage over the past five years, but the government has neglected medical abuse and free riding of health insurance," adding, "The burden is being passed on to the majority of the people." This is a criticism of the Moon Jae In government's policy to strengthen coverage, and the Ministry of Health and Welfare has recently decided to review whether to apply benefits to MRI and ultrasound tests suspected of abuse among salary items covered by health insurance. President Yoon said, "Popular populism that wastes taxpayers' money is supposed to destroy finances, harm the foundation of the health insurance system, and eventually force the public to make great sacrifices," and stressed, "We need to strengthen health insurance benefits and qualification standards and prevent waste and leakage of health insurance." "We will strongly support those suffering in medical blind spots with reduced funds," he said. "The key to the health insurance system is to ensure that essential medical care that is expensive like serious diseases but must be included."
- Policy
- MFDS approves Jemperil, the third PD-1 inhibitor in Korea
- by Lee, Hye-Kyung Dec 15, 2022 05:55am
- The Ministry of Food and Drug Safety (Director Oh Yoo-kyung) approved GlaxoSmithKline's new drug endometrial cancer treatment Jemperil on the 14th. Jemperil will be the third PD-1 inhibitor to be licensed in Korea after Opdivo of Ono and BMS and Keytgruda of MSD. Jemperil is a monoclonal antibody targeting cell predetermined history 1 (PD-1), an immune gateway receptor for immune cells (T cells). PD-1 is an inhibitory immune checkpoint receptor belonging to the CD28 family and is expressed in activated T cells, B cells, NK cells, and bone marrow cells, and plays a pivotal role in immune regulation. The drug has been approved as an indication for the treatment of adult patients with recurrent or progressive inconsistency recovery defects (dMMR)/high-frequency microsatellite instability (MSI-H) endometrial cancer, which has been treated or progressed after treatment. It uses PD-1 expressed on the surface of immune cells (T cells) to block the survival mechanism of cancer cells avoiding immune cell attacks, and helping immune cells remove cancer cells. The Ministry of Food and Drug Safety said, "We will continue to do our best to quickly supply treatments that have been sufficiently confirmed for safety and effectiveness based on regulatory science."
