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- 2026-05-18 13:59:02
- Policy
- 30 new drug items reimbursed or extended coverage this year
- by Kim, Jung-Ju Nov 30, 2021 05:52am
- 30 new drugs were newly listed on the reimbursement list or extended reimbursement standards from January this year to this month. Among these, 25 were newly listed new drugs, and 5 were already-listed new drugs that have extended their scope of reimbursement and increased coverage. The reinforced coverage of new drugs this year benefited only 107,000 patients in Korea until last month, but the new listing of Bronpass Tab had increased the number of beneficiaries sevenfold to record 781,725. First, 30 drugs (based on representative dosages) were enhanced coverage being newly listed on the reimbursement list or extended reimbursement standards from January to November. Drugs that were newly listed as of the 1st this month are the severe neutropenia treatment Rolontis Prefilled Syringe inj and acute bronchitis treatment Bronpass Tab. No drugs were extended reimbursement standards this month. The two drugs that were newly listed differ greatly in the expected number of patients in Korea and annual financial requirements. Reimbursement for Rolontis Prefilled Syringe inj is expected to be applied to 4,000 people, costing ₩10 billion. On the other hand, Bronpass Tab is reimbursed for 670,000 people and will be applied to the most amount of patients among all newly listed drugs this year, however, its annual fiscal spending is relatively small, by ₩2.9 billion. This is interpreted as a result of comprehensively reflecting to flexibly expand coverage even for expensive drugs required for a small number of rare diseases and the social maturity to accommodate them. The number of beneficiaries greatly varies due to policies that now allow flexible expansion of NHI coverage to high-price drugs that are used for a small number of rare diseases, that were established based on the increased social maturity that can now accept such policies. The government and payer expect the new listing and extended reimbursement standards to cost ₩256.4 billion and grant access to 781,725 people.
- Policy
- Review period & material improved for COVID-19 Txs, etc.
- by Lee, Jeong-Hwan Nov 29, 2021 05:58am
- The government will lead the improvement of administrative effectiveness and predictability by preparing specific standards on the review period and scope of materials submitted for the marketing approval of pharmaceuticals. The measure was made as means for the government to preemptively respond to the expedited approval of new drugs, anticancer drugs, orphan drugs, and infectious disease treatments such as COVID-19 drugs. On the 25th, Prime Minister Boo-Kyum Kim held the 137th State Affairs Inspection and Coordination Conference and announced “the 8th measure for regulatory innovation to address difficulties in the new industry” The regulatory innovation that will directly affect the pharmaceutical industry is the measures made for the bio-health industry. In line with the Ministry of Food and Drug Safety, the Office for Government Policy Coordination had agreed on the need to improve the priority review system for pharmaceuticals. Currently, the MFDS has an expedited review process in place during marketing authorization for the prompt introduction of new drugs such as new drugs, anticancer drugs, orphan drugs, and infectious disease treatments. However, unlike the US FDA, the system does not specify the review period or the scope of materials submitted in detail, which undermines the administrative effectiveness and predictability of the system. On this, the Ministry of Food and Drug Safety decided to prepare specific standards on the review period and scope of submitted materials by revising the Pharmaceutical Affairs Act & Regulation on Safety of Drugs, Etc. The pre-announcement of legislation was issued on October 19th, and the revised Regulation on Safety of Drugs will be in full effect from January 21st next year. The scope of submitted materials will be specified to define the evidence data, development process, manufacturing method, dosage/administration, efficacy/effect of drugs subject to priority review. The MFDS expects the regulatory innovation to preemptively respond to the need for pharmaceuticals and promote the protection of national health. The regulations on chemical materials used for pharmaceutical manufacturing and quality inspections will also be alleviated. The MFDS exempts import requirements for raw materials that are essential for drug manufacturing when importing chemicals for drug manufacturing or quality inspection. The problem is, the MFDS reviews the cases case-by-case, only after the importer inquires to the ministry whether its chemical material is applied the exemption of import requirements. Due to this, criticism arose that the lack of criteria within the system is causing inconvenience for the importers. Accordingly, the MFDS decided to provide detailed criteria for determining substances subject to the exemption of import requirements and provide detailed case examples to aid better understanding among civilians and improve administrative processes for its employees. More specifically, the ministry plans to revise the ‘Tacts for recommending pharmaceuticals among those subject to import requirement confirmation exemption’ guidelines for business conduct in the coming December.
- Opinion
- [Reporter’s View] On the best way to issue impurity recalls
- by Lee, Tak-Sun Nov 29, 2021 05:58am
- Once again, impurities were detected in the losartan ingredient of antihypertensive drugs that are being used by many patients. Some pharmaceutical companies have already started product recalls under orders from the Ministry of Food and Safety. With the results of the companies’ impurity investigations being released one after another, the number of items subject to recall will continue to increase. The problem is in recalling drugs that were already taken by the patients. The MFDS had held roundtable meetings with doctors’ and pharmacists’ associations that had prescribed and sold the affected drugs and their manufacturers in preparation of the consumer recall in plan. The purpose of the meetings was clear: Who will bear the burden of the cost incurred during consumer recalls? As the government, doctors’ and pharmacists’ associations have unanimously pointed to the manufacturer/seller, these companies are expected to bear most of the recall costs. But what about the consumers? No discussions have been made with consumers on the consumers' part. Of course, for the consumers to receive re-prescriptions and switch drugs, advance discussions with medical/ pharmaceutical associations and manufacturers are inevitable. However, with the risk that medicines containing the impurities may continue to be prescribed, a ban should first be issued on the release and prescription of drugs that had excess impurities. If it is difficult to issue bans on the release and prescriptions of individual drugs, ton how to address this problem should be first discussed. However, the MFDS had warned and forbade individual action on the companies’ part before it issues a compressive announcement, fearing confusion. The MFDS' priority seems to be on muddling the voice of confusion and dissatisfaction that may arise in the recall process rather than on the prompt ban of harmful drugs. If consumer recall measures are implemented, we need to put more consideration into how to recall even one more tablet that contains such impurities. Looking at the past measures made by the MFDS, the authority had prepared a manual for the recall and let the consumers handle the exchange for themselves. With such inadequate publicity and post-measures, it is questionable whether any statistics have been collected on how much was recalled during the last impurity-related drug recall. Maybe the consumer recall is just a publicity gimmick to arouse public opinion rather than a sincere measure. In fact, neither the pharmaceutical associations nor pharmaceutical companies welcome consumer recalls, as such measures give rise to many cumbersome tasks including re-prescription, redispensing, and reimbursement of costs, etc. If consumer recall is inevitable, the MFDS should first consider measures that would minimize its effect on the consumers rather than discussing recalls with medical/pharmacist associations and pharmaceutical companies. And as the consumer recall is already considered certain, we need to now ask whether we are missing the ‘golden time’ for the recalls busy making pre-arrangement discussions before full recalls.
- Company
- Ildong started developing a treatment for COVID-19
- by Nho, Byung Chul Nov 29, 2021 05:58am
- Ildong Pharmaceutical and Shionogi Pharmaceutical have begun joint development of oral COVID-19 treatments, drawing keen attention to whether they will succeed in commercializing them in the future. Ildong Pharmaceutical officially announced on the 17th that it will participate in the development of S-217622 as a candidate for oral COVID-19 treatment along with Shionogi Pharmaceutical, and attention is being paid to whether it will create the third drug in the world to contribute to the end of the pandemic after Pfizer and MSD. Accordingly, Ildong Pharmaceutical plans to start the development process as soon as the recruitment of patients is completed after obtaining IND approval for the domestic clinical trial (P2/3) of S-217622 from the Ministry of Food and Drug Safety in Korea. According to Ildong Pharmaceutical, it aims to become the EUA of the Ministry of Food and Drug Safety within the first half of 2022. Although Pfizer and MSD, two global big pharmas, are already set to commercialize oral treatments for COVID-19, the pipeline should be expanded in terms of high drug costs worth nearly 850,000 won and protection of doctors and patients' drug options. In particular, S-217622 is a candidate substance for a new drug targeting the COVID-19 virus from the beginning, so it is different from drug re-creation development cases that utilize existing substances that have already been licensed or developed with other indications. According to previous studies, S-217622 prevents virus proliferation by inhibiting protease (3CL-protase), which exists only in the SARS-CoV-2 virus, the source of infection that causes COVID-19. It has also been confirmed that alpha, beta, gamma, and delta COVID-19 mutations all have similar levels of virus proliferation inhibition capabilities. More efficient medication convenience is also drawing attention. Pfizer's Paxlovid requires a total of 30 tablets, twice a day for 5 days, and the 5-day dose of MSD's Lagevrio reaches 40. On the other hand, S-217622 is being developed once a day for 5 days. It is expected to be smaller than the previous two treatments. The prospect that localization of treatments according to the terms of the joint development contract and improvement of access to domestic patients will have an advantage over other competitive drugs is also receiving positive reviews. If Ildong Pharmaceutical succeeds in developing the S-217622, it is planning domestic production through technology transfer. An official from Ildong Pharmaceutical said, "Korea's clinical design aims at more than 200 asymptomatic, mild, and severe patients. If development is successful, stable drug production and supply are expected by establishing sovereignty over treatments. Considering the data so far, it shows excellent safety, he said. Ildong Pharmaceutical and Shionogi Pharmaceutical have maintained a partnership for 40 years since the 1980s. Japan Pharmaceutical introduces and sells Shionogi Pharmaceutical's antibiotic Flumarin and Pirespa, a treatment for idiopathic pulmonary fibrosis, in Korea, and cooperates in the clinical phase for the first time. Shionogi is the world's top 50 pharmaceutical company that has focused on developing innovative treatments by focusing on treatment areas in the fields of anti-infectious diseases and central nervous system disorders, including antibiotics and antiviral drugs, for 144 years since its foundation in 1878. It has also developed large global new drugs such as flu treatment Xofluza, antibiotic Petroja, and hyperlipidemia treatment Crestor.
- Policy
- A new pre-approval system for Ultomiris was established
- by Lee, Hye-Kyung Nov 29, 2021 05:58am
- The pre-approval application system for Ultomiris, a treatment for night hemoglobin (PNH) in Handok, has just been established. The HIRA recently established a new Ultomiris pre-approval application system in the nursing institution business portal. The application for pre-approval of Ultomiris is in the same position as Soliris, which is previously prescribed in the benefit certificate. Nursing institutions that want pre-approval of Ultomiris and Soliris can register their applications after selecting the drug name from the pre-approval of medical standards management → Eculizumab and Ravulizumab on the nursing institution portal. Monitoring application data can also be submitted through the same menu. Monitoring data should be submitted for each subject every six months after treatment begins. In accordance with Article 6 of the Method and Procedure for Pre-Approval, etc., approval application and monitoring data related to pre-approval, such as Ultomiris and Soliris, shall be submitted from the 1st to the 10th of the even month in accordance with the subject's deliberation period. Meanwhile, Ultomiris was listed at KRW 5,598,942 per bottle on June 7, and should be administered once every eight weeks after the initial dose per patient is administered. Soliris is an insurance cap of 5,132,364 won per vial (30 ml), and if three vials are administered every other week, the drug price alone reaches 400 million won per year. Both Ultomiris and Soliris were expensive new drugs, and pre-approval and monitoring were essential for registration. Since the registration of Ultomiris in June, pre-approval has been steadily made since July, and in August, one Soliris and four Ultomiris were approved for new PNH patients during the deliberation of the HIRA Medical Review and Assessment Committee.
- Company
- Samsung BIOEPIS set a new sales record in a year
- by Chon, Seung-Hyun Nov 29, 2021 05:58am
- Samsung BIOEPIS has generated the largest quarterly sales since its launch. Overseas sales of biosimilars have increased, and milestones have flowed in due to overseas permits for subsequent biosimilar products. According to the Financial Supervisory Service on the 23rd, SAMSUNG BIOEPIS saw its sales rise 14.4% year-on-year to 271 billion won in the third quarter. It surpassed the previous maximum sales of 236.9 billion won recorded in the third quarter of last year in a year, breaking a new quarterly sales record. The company's cumulative sales in the third quarter were 625.2 billion won, up 9.2% from the previous year. Samsung Bioepis Most of Samsung BIOEPIS sales are generated through overseas sales of its own biosimilar products. SAMSUNG BIOEPIS succeeded in commercializing biosimilars of six products, including Enbrel, Remicade, Herceptin, Humira, Avastin and Lucentis. In Europe, all six products were approved, and in the United States, five products excluding Avastin were approved for sale. SAMSUNG BIOEPIS's performance has slowed slightly as sales have been on the decline for the second consecutive quarter since the third quarter of last year. Sales in the first quarter of this year amounted to KRW 166.7 billion, down 29.6% from the third quarter of last year. With the aim of securing inventory in preparation for the prolonged COVID-19, pre-orders from hospitals and wholesalers in Europe have recovered their performance. However, it rebounded in the second quarter and broke a new sales record in the third quarter, recovering from the sluggishness caused by COVID-19. Overseas sales sold by Biogen and Organon showed growth. Samsung Bioepis biosimilar's overseas sales in the third quarter were $342.8 million (about 406 billion won), up 11% from $369.9 million a year earlier. SAMSUNG BIOEPIS is selling five biosimilars in global markets excluding Korea through marketing partnerships with Biogen and Organon. Quarterly SAMSUNG BIOEPIS sales (unit: 1 million won, data: Financial Supervisory Service) Biogen is in charge of distributing and selling three types of autoimmune disease treatments in Europe, including Enbrel biosimilar Benepali, Remicaid biosimilar Flixabi, and Humira biosimilar Imraldi. Organon (formerly MSD) sells these three products under the product names Renflexis (Remicade biosimilar), Brenzys (Enbrel biosimilar), and Hadlima (Humira biosimilar) in the rest of the world except the United States, Korea, and China. Organon is also in charge of overseas sales of two types of anticancer drugs, Herceptin biosimilar Ontruzant and Avastin biosimilar Aybintio. Sales of biosimilars sold by Biogen reached $22.8 million in the third quarter, up 2% from the previous year. Organon's biosimilar sales in the third quarter rose 41% year-on-year to $140 million. The combined sales of biosimilars sold by Biogen and Organon in the third quarter amounted to $916.2 million (about 1.8 trillion won), up 11% from the previous year. In the third quarter, additional milestones were also introduced with the overseas approval of biosimilars. Lucentis biosimilar Byooviz, developed by Samsung Bioepis in August, was approved for sale by the European Commission (EC), and a month later, it was approved by the U.S. Food and Drug Administration (FDA).
- Company
- Keytruda's sales have been leading for two consecutive years
- by Chon, Seung-Hyun Nov 26, 2021 05:54am
- Keytruda, an immuno-cancer drug, has been leading the domestic pharmaceutical market for the second consecutive year. K-CAB continued to soar among new drugs from multinational pharmaceutical companies. According to IQVIA, a pharmaceutical research institute on the 26th, Keytruda of MSD Korea recorded 145.5 billion won in sales in the third quarter of this year, the largest number of all medicines. It recorded a high growth rate of 27.8% year-on-year, widening the gap with the second-ranked Lipitor by more than 30 billion won. Until the first half of the year, the gap between Keytruda and Lipitor was 19.9 billion won. Keytruda ranked first among all medicines for the first time with sales of 155.7 billion won last year. Keytruda, released in Korea in 2015, is an immune checkpoint inhibitor that treats cancer through activation of immune cells by inhibiting "PD-1" protein on the surface of immune cells T cells to prevent binding with PD-L1 receptors. In Korea, 18 indications were approved for 14 carcinomas, including melanoma, lung cancer, and head and neck cancer. Keytruda's quarterly sales remained around 3 billion won immediately after its release, but sales began to rise rapidly since August 2017 when insurance benefits were applied as a secondary treatment for non-small cell lung cancer. Keytruda surpassed 50 billion won in sales in the third quarter. If this trend continues, sales are expected to surpass 200 billion won this year. Keytruda also posted cumulative sales of $12.6 billion in the third quarter of this year in the global market. Perjeta and Prolia, new drugs from multinational pharmaceutical companies, also showed high sales growth. Roche's Perjeta recorded 69.1 billion won in cumulative sales in the third quarter, up 29.9% from the previous year. Perjeta is a drug administered in combination with Docetaxel and Trastuzumab in metastatic or localized HER2 positive breast cancer patients who are not operable and have never received HER2 targeted anticancer drugs or chemotherapy. Amgen's Prolia's cumulative sales in the third quarter amounted to 65.2 billion won, up 18.7% from the same period last year. Prolia, released in Korea in November 2016, is a biopharmaceutical osteoporosis treatment targeting protein RANKL. Since 2017, sales of Prolia have started to rise since salaries were applied only to secondary treatment therapy. Since April 2019, sales of Prolia have increased rapidly as insurance benefits have been recognized for primary treatment therapy. Chong Kun Dang is jointly selling Prolia with Amgen. It is an interesting phenomenon that Sanofi's antithrombotic drug Plavix increased 18.6% year-on-year to 46.8 billion won in cumulative sales in the third quarter. Plavix's patent expired in 2007, and more than 100 generics have entered. More than 10 years have passed since the patent expired, and sales have rather increased despite competing with more than 100 generics.
- Policy
- Winner of pricing suits will be compensated for damages
- by Kim, Jung-Ju Nov 26, 2021 05:54am
- The countless litigations between government and companies regarding reimbursements such as drug price cuts or reduced scope of reimbursement are causing wasteful losses to both parties. On this, the government and the National Assembly have been proposing various solutions to prevent excessive stay of executions. The NA has proposed an amendment to the National Health Insurance Act which allows government authorities to recover the reflective profits the companies accrued during the suspension of execution period if it wins the main lawsuit, and refund them to companies when vice versa after a pharmaceutical company applies for administrative litigation and suspension of execution in opposition to the disposition of drug price cuts. The bill passed the plenary session after passing the Health and Welfare Committee's bill review subcommittee. The biggest contributor to the implementation of this refund system was the stay of execution the companies filed with their drug pricing lawsuits. The stay of execution is filed by a pharmaceutical company to suspend execution of the government’s drug price cut disposition based on the presumption of innocence. In general, the court cites or accepts the stay of execution request because of ‘irrecoverable damages’ that may occur from the company’s aspect. Since 2018, 36 out of 38 stays of executions were accepted, with the other two suits withdrawn. Most of the litigations have resulted in favor of the government. The problem is that the company’s only option during the suit to defend its drug price is to use the stay of execution and minimize damage or maximize profits during the litigation period. In this case, any cost that arises from the non-change in the drug price during the trial period results in a loss in health insurance finances. The government estimates that the financial loss caused by the suspension of drug price cuts since 2018 amounts to nearly ₩400 billion. Broadly applied to price cuts, reimbursement suspensions, selective reimbursement, etc. Will include added interest… price-cut drugs may choose either a lump-sum payment or price raise The refund system will be used to reduce such side effects. The system will be applied when a stay of execution filed by the pharmaceutical company is dismissed at the administrative ruling or litigation, but accepted in the original suit. In other words, the system will be applied when the government loses and the pharmaceutical company wins the suit. The compensation for damages will be applied to all pharmaceutical dispositions that are directly related to pharmaceutical sales, such as pricing adjustments, reimbursement suspensions or exclusions, reduced scope of reimbursement, selective reimbursement (changed copayment rate), etc. If these requirements are met, the NHIS needs to pay the pharmaceutical companies for the losses as a “binding act,” meaning that the government must compensate for losses. The government has decided to announce the standard rules and amendments to the medical insurance benefit criteria next month. Considering the administrative procedures such as legislative notice, regulatory review, legislative review, and public announcement, the amendment is expected to be implemented within the first half of next year.
- Company
- Will the sale of impurity Losartan be okay?
- by Kim, Jin-Gu Nov 26, 2021 05:53am
- It is focusing on announcing the results of the MFDS. Anxiety in production and sales sites surrounding Losartan impurities is rising. As self-inspection results begin to come out for each manufacturer, consignment companies that received these results are agonizing over whether to preemptively suspend sales or continue sales. According to the pharmaceutical industry on the 24th, Arlico Pharmaceutical, Aju, and CTC Bio decided to stop selling Losartan-containing products. In the case of Arlico, the company decided to voluntarily withdraw along with the suspension of sales. At least five companies are confirmed to have officially decided to suspend sales about a week after concerns over Losartan impurities arose in earnest on the 16th. In addition to the three companies that decided to suspend sales on the 24th, Hutecs Pharmaceutical has begun to suspend sales. Mothers Pharmaceutical has not stopped selling Losartan, but has temporarily suspended the supply to new customers. On top of that, it is confirmed that many companies have unofficially suspended sales and supply. It is predicted that the number of companies suspended from sales is likely to increase further in the future. An official from the pharmaceutical industry said, "We have virtually stopped supplying it. "We don't know what measures the MFDS will take later, but it's to reduce the burden of voluntary recovery just in case," he said. Another company official said, "We have not yet received results from the consignee. However, if there is a problem, we plan to preemptively suspend sales", he explained. On the contrary, some pharmaceutical companies say they will continue to sell and supply until the MFDS announces. In this regard, a company official said, "There are many requests from suppliers. Since it has become difficult to obtain the product as several companies have stopped selling on their own, we will continue to supply it for now, even if we recover it later."
- Policy
- Cost bearer in debate ahead recall of some losartan products
- by Lee, Tak-Sun Nov 26, 2021 05:53am
- The MFDS has mentioned ‘re-prescribing or re-dispensing' some items at meetings with medical, pharmacist, and pharmaceutical associations while discussing measures to recall some of the antihypertensive ‘losartan’ products that were found to contain azido impurities during inspections. The re-prescribing or re-dispensing measures are prepared for cases when patients cannot exchange their drugs at pharmacies, and all lot numbers of some losartan items are highly likely to be recalled. In other words, some items will be subject to full recalls. Previously, the valsartan and ranitidine products that were fully recalled due to impurities had also been re-prescribed or re-dispensed. At the time, the patients’ out-of-pocket cost was borne by medical care institutions for valsartan, and by the National Health Insurance Service for ranitidine. The NHIS had later filed a suit to claim the re-prescribing and re-dispensing cost borne to the pharmaceutical companies. However, as medical and pharmaceutical associations believe the patients’ out-of-pocket cost should be borne by pharmaceutical companies, the issue is expected to raise much controversy this time. According to the industry on the 25th, the MFDS had held a series of meetings with doctors, pharmacists, and pharmaceutical associations on the 24th. At the meetings, the MFDS had mentioned the possibility of re-prescribing and re-dispensing some losartan items, upon which the associations expressed the position that pharmaceutical companies should bear the patients’ out-of-pocket costs that arises from prescribing and re-dispensing while minimizing product recalls. In summary, it seems that full recall of some losartan items will be inevitable. If re-prescribing or re-dispensing measures take place, conflict may arise over who pays for the patients’ out-of-pocket cost and NHIS cost. The government, as well as the medical and pharmaceutical groups, believe that pharmaceutical companies should bear the cost, whereas the pharmaceutical industry is reluctant to bear the cost as this is an unintentional impurity event. However, the analysis is that the companies may accept bearing the out-of-pocket cost of patients. If only a few products are subject to exchange or re-prescriptions, there is the possibility that the recall will proceed without much confusion like in the case of the last AZBT losartan recalls. Therefore, the attention is focused on how many items will be recalled, and what proportion of the products will be re-prescribed at the official announcement made by the MFDS. The MFDS announcement is highly likely to come in early December after the MFDS receives and aggregates pharmaceutical companies’ product impurity test results at the end of this month. The MFDS also plans to hold a meeting soon with pharmaceutical companies that possess products subject to recalls.
