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- 2026-05-20 14:21:57
- Policy
- A market return track is needed for NDMA-related drugs
- by Lee, Jeong-Hwan May 29, 2020 06:16am
- The production and sales of Valsartan, Ranitidine, and Metformin have been discontinued due to the detection of NDMA (N-nitrosodimethylamine), a carcinogen, and prescriptions have been limited, and people's anxiety and the blow to the pharmaceutical industry are increasing. In particular, while NDMA detected in Valsartan in the past was identified as a Chinese raw drug, NDMA in Ranitidine and Metformin are said to be 'fighting against invisible enemies' in the pharmaceutical industry without knowing the exact cause. Therefore, the view of the pharmaceutical industry says that the government should not focus solely on the ban on the sale of impurity drugs, but should establish a regulatory measure to return the drugs that have been proven to be harmful to the market, so that NDMA detection can soon erase the stigma of permanent withdrawal from the market. 23 pharmaceutical companies with 31 items of Metformin diabetic drugs that were manufactured and discontinued on the 26th are busy with follow-up measures according to government announcements without prior notice. Their worries are how to find the cause of NDMA detection beyond basic administrative measures, such as the recovery of distribution drugs, and how to seek survival measures for drugs that are prohibited for sale. In particular, pharmaceutical companies with high impact are JW-Pharma and Hanall,, which prescription amount of ₩10 billion is banned. Last year's prescription amount of Guardmet (100/1000mg,100/500mg, 100/850mg) by JW-Pharma was ₩9.7 billion. Prescriptions amount of Glucodown OR (500, 750, 1000mg) by hanall was ₩ 8 billion over the same period. With three consecutive NDMA detection bans occurring, pharmaceutical companies are sympathizing with the MFDS' prompt response, but are also urging them to make efforts to prepare for a resurgence of the bans. The MFDS announced that suspension of manufacturing, sales and prescription for 31 items of Metformin would be discontinued, and the possibility of developing additional cancer was negligible. Specifically, the MFDS estimates that the likelihood of developing additional cancer in patients taking the item is 0.21 out of 100,000, and said "the risk is very low." The ICH (International Drug Regulatory Organization) guidelines evaluate the level of negligibility in cases where there is less than one out of every 100,000 cancers. In particular, the FDA estimated that the cause of the NDMA detection occurred in the manufacturing process of the drug rather than the raw drug. Therefore, some of the pharmaceutical industry is arguing that there is a need to upgrade the regulation method of NDMA detection drugs compared to the existing ones. It is to ask for regulations to be manufactured, sold, and prescribed again after the forbidden drugs meet the safety and risk criteria. Currently, the MFDS analyzes the cause of NDMA detection and confirms that there is no need to reoccur in the manufacturing process, and then meets the three conditions for recovering the entire quantity of the problem in question, allowing it to be banned and re-released. The time it takes to meet this condition is about 10 months in the past when comparing to the situation in Valsartan. Even if the prescription is discontinued in the prescription market for only one month, the prescription drugs suffer the same level of damage as leaving the market. The pharmaceutical industry claims that if it takes 10 months to re-release a prohibited drug, it is actually a fatal condition that cannot be returned to the market. Accordingly, the pharmaceutical industry is not inadvertently manufacturing and selling the drug itself that exceeds the NDMA provisional management standard of the MFDS, but requires that 'Pincette regulation' in which the drug is applied only to the lot detected after the investigation of the items in question. In this case, the pharmaceutical industry believes that not only can the pharmaceutical industry's NDMA povia be partially resolved, but also the fear of vague drug impurities in the public can be relieved. An official from a pharmaceutical company in Korea said that it is necessary to consider not to ban or recover all NDMA-detected drugs, but to go through detailed inspections to ban sales of exceeding standards. Ironically, the MFDS pointed out that it is distributing a press release saying that the hazard level is 0.21 per 100,000 people, which is negligible. An official from domestic pharmaceutical company B explained that after confirming the impurity detection, all items to be produced and shipped after NDMA inspection have been shipped, and products with a lower than the standard value are released, but the lot number exceeding the standard is prohibited and sold, if that is difficult, the burden of pharmaceutical companies will be reduced by creating a procedural track that allows forbidden drugs to return to the market after meeting safety standards. The official said, "The NDMA situation has continued with Valsartan, Ranitidine, and Metformin, and impurities have emerged from multi-drug drugs of various diseases. Some of the drugs that have been taken this time have been below the standard in the pharmaceutical company's self-examination." "If we ban all sales at all times, the stigma of drug and drug companies will be repeated."
- Product
- Metformin's alternative medicine sold out in an hour
- by Kim JiEun May 29, 2020 06:16am
- As the discontinuation of sales of 31 items of Metformin used as a treatment for type II diabetes patients is decided, the shortage of alternative products is intensifying. The MFDS announced that it will temporarily manufacture, sell, and discontinue prescriptions for 31 items containing Metformin, which are used as a primary treatment for type II diabetes patients today (26). Along with the announcement of the MFDS, a notice was sent to the pharmacists of Korean Pharmaceutical Association, and pharmacists had a busy time checking the related items and organizing their inventory immediately after work. Pharmacists need to order replacement items immediately if the product they normally prepare is included among the 31 items that have been supended from today. In fact, as of 9:00 am today, Metformin alternative medicines have been rapidly sold out at major drug online malls. One of the alternatives to the metformin formulation that has been discontinued this time In the case of Glucodown OR 750mg, which were relatively prescribed in hospitals and clinics, among the discontinued items, was replaced by a pharmacy actually Yuhan’s Metformin XR 750mg, and the product was found to be sold out at major online malls less than 10 am. In addition, Yuhan’s Metformin XR 500mg 300T & 30T are currently out of stock in some pharmaceutical online malls. Pharmacists say that Daewoong’s Diabex XR is not easy to secure inventory as orders are concentrated in the morning as well as in major online retailers. A pharmacist in Seoul said, “I immediately ordered Yuhan’s Metformin as soon as I came to work today.” “Yuhan’s Metformin XR 750mg doesn't have any alternatives, so I think it will be more ordered. I know that the product is currently out of stock." Some pharmacies contacted a nearby internal medicine clinic this morning to discuss discontinued Metformin and to discuss alternative prescription products. A pharmacist in Seoul said, “I thought that Yuhan’s Metformin XR 750mg is the only substitute in a nearby hospital, but I know it is currently out of stock.” "Instead, there was a question about how to prescribe." Another pharmacist said, “It seems that pharmacists ordered quickly from online malls, etc., as information related to them was announced last night. "There seems to be some hoarding.”
- Policy
- Bayer’s NUBEQA was approved by the MFDS
- by Lee, Tak-Sun May 28, 2020 10:08am
- Another prostate cancer drug, Bayer's Nubeqa, was approved in Korea. On the 27th, the MFDS approved a new drug for Bayer Korea's 'Nubeqa 300mg' (Darolutamide) as a treatment for patients with non-metastatic castration-resistant prostate cancer(nmCRPC). Darolutamide, the active ingredient, is a nonsteroidal antiandrogen (NSAA), and acts as a selective antagonist of the androgen receptor (AR) by directly binding to a receptor ligand binding domain with high affinity. It also competitively inhibits androgen binding, androgen receptor nuclear translocation and androgen receptor mediated transcription. In particular, it has a strong in vivo anti-tumor efficacy (reduction of tumor cell proliferation) and thus has a mechanism of reducing tumor volume in a xenograft model of prostate cancer, including a castration-resistant model overexpressing androgen receptors. In a Phase III clinical trial (ARAMIS) of 1,509 high-risk nmCRPC patients, the drug demonstrated a statistically significant improvement in metastasis-free survival (MFS) compared to placebo. The median survival period was 40.4 months for the Nubeqa group and 18.4 months for the placebo group. In addition, the overall survival (OS) and time to pain progression compared to placebo were also delayed. Nubeqa obtained FDA approval in July of last year, and was released to the Japanese market on May 26th. When Nubeqa is released in Korea, it will likely compete with Astellas' Xtandi, which has the same indications. Xtandi signed a risk-sharing contract with the NHIS in November 2014, and last year's IQVIA sales amounted to ₩23 billion. Other prostate cancer treatments include Pfizer's Zytiga and Janssen's Erleada, which has not yet been approved in Korea.
- Product
- KDA “Agree with government action on metformin with NDMA”
- by An, Kyung-Jin May 28, 2020 10:07am
- Medical academic societies expressed their support for the Korean government’s decision to suspend manufacturing and sales of metformin with excessive level of impurity found. However, the scholars noted diabetic patients should not stop taking metformin without consulting their doctors. On May 26, Korean Diabetes Association (KDA) and Korean Endocrine Society (KES) issued a joint statement on the government suspension on manufacturing and sales of metformin upon discovery of N-Nitrosodimethylamine (NDMA) exceeding an acceptable level. The statement first expressed gratitude for the Ministry of Food and Drug Safety’s (MFDS) prompt but proactive action on the metformin products and their safety issue, and also showed support for the government’s decision. The two academic societies urged, “For similar cases in the future, the government should continue to directly conduct investigation, disclose the result transparently and provide solution for the people and healthcare providers to feel free of concerns.” Prior to the statement, MFDS has disclosed 31 out of 288 metformin products available in the Korean market were discovered with NDMA exceeding the acceptable daily intake limit (96 nanograms), and halted manufacturing and sales of those 31 products. Metformin is the most widely used first-line treatment for type 2 diabetes with outstanding effect of lowering blood sugar level and many other advantages. But when Singapore’s Health Sciences Authority (HSA) announced last December that three out of 46 metformin products were found with NDMA surpassing the acceptable level, KDA has officially requested the Korean government to run a full investigation on the contamination of NDMA in metformin ingredients and finished products used in Korea. However, the medical experts stressed the government’s action should not cause a confusion for the diabetic patients using metformin. The statement advised, “31 products exceeding the acceptable limit of NDMA should not be prescribed anymore, but as MFDS has elaborated, the risk of developing cancer only from taking those products is extremely low,” and “it is not advisable for diabetic patients to stop consuming those metformin drugs without consulting their doctors, but they should rather seek for new prescription for other metformin product with safe level of NDMA.” According to the human body impact assessment by MFDS, 0.21 out of 10,000 patients, who have been taking the maximum dose of metformin product with unacceptable level of NDMA since the point of approval to the end of this year, would be risked to develop cancer. The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guideline (ICH M7: Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk) mentions the risk of developing cancer could be dismissed, if it is lower than 1 out of 10,000 people. The academic societies highlighted, “Metformin is an important drug recommended by international practice guidelines as a first-line medicine to treat patients with type 2 diabetes. And as there are nine different classes of diabetic treatments available, the government should amend the healthcare reimbursement standard to disperse concentrated use of one specific pharmaceutical substance and give various options for first-line drug based on patients’ condition.” They also added, “KDA and KES would closely cooperate with the government for enhance the health and the rights of diabetic patients, and actively participate in improving the medical system.”
- Company
- Alvogen Korea secures domestic rights for Evista
- by An, Kyung-Jin May 28, 2020 10:06am
- Alvogen Korea took over the domestic rights of 'Evista', an osteoporosis treatment for Takeda. Alvogen Korea announced on the 26th that it had obtained domestic permission for the osteoporosis treatment drug, Evista ( Raloxifene ) from Takeda Pharmaceuticals on the 25th. Evista is a second-generation estrogen receptor modulator (SERM) family and are oral drugs taken once a day. It is prescribed for the treatment and prevention of osteoporosis in postmenopausal women. At one time, sales were close to ₩15 billion a year, but sales of the complex have been plunged recently with the emergence of multiple combinations of vitamin D ingredients. According to the drug research agency IQVIA, Evista's sales last year were ₩6.4 billion. Since September 2018, Alvogen Korea has been in charge of domestic distribution and sales by signing a co-promotional agreement with Takeda Pharmaceuticals, which has domestic rights of Evista. Through this contract, Alvogen Korea has secured all rights for domestic licenses, exclusive distribution and marketing as a marketing authorization holder. Alvogen Korea announced its ambition to expand the influence of the specialized drug market by acquiring domestic rights, such as 'Seroquel', a treatment for schizophrenia, following the launch of 'Qsymia', an anti-obesity drug earlier this year. Lee Jun-su, CEO of Alvogen Korea, said, "With this agreement, we plan to firmly strengthen our expertise and market position in the field of osteoporosis treatment." "We will actively engage in marketing activities aimed at providing stable products and steady growth."
- Policy
- The MFDS suspends sales of 31 items of Metformin
- by Lee, Tak-Sun May 28, 2020 10:06am
- As the MFDS temporarily suspends manufacturing, selling, and prescribing 31 items containing Metformin, which are being used as the primary treatment for patients with type II diabetes, the issue of impurities in pharmaceuticals is expected to re-occur. However, due to the same NDMA issue, 175 Valsartan products and 269 Ranitidine were discontinued, but 31 of all the Metformin were discontinued, thus there was no major confusion in patient prescriptions. Only 31 out of about 288 items are discontinued, alternative medications are sufficient. According to the industry on the 25th, the MFDS has released a safety bulletin containing 31 items (22 pharmaceutical companies) of Metformin preparations that exceed the provisional management criteria of the carcinogenic substance N-nitrosodimethylamine (NDMA), and discontinued the prescription. As a result, it was reported that the items had been suspended from 00:00 on the 26th. Although the details are not yet known, the MFDS explains that 31 out of 288 finished products in circulation in Korea exceeded the NDMA provisional management standard. As of the 25th, there were only 672 approved items containing metformin. Of these, replacement items are sufficient in that only 31 items have been discontinued. In September of last year, 269 items of Ranitidine, a gastric ulcer treatment drug that NDMA was over-detected, were banned from sales, and there was great confusion in the medical field, such as replacing prescriptions with other ingredients. On the other hand, Metformin formulation is expected to be easily replaced with products of the same ingredients, as there are relatively few items forbidden to sell. Nevertheless, this is the strongest action among countries worldwide. Metformin's NDMA issue broke out on December 4, last year, when the Singapore Health Sciences Authority (HSA) recovered three products. HSA said three out of 46 items of Metformin on sale detected NDMA above the daily allowance. Subsequently, three pharmaceutical companies in Canada decided to voluntarily recover Metformin preparations, and in February, Ranbaxy in India began voluntarily recovering six lots of two products. However, The U.S. Food and Drug Administration (FDA) did not take any action when it surveyed 10 items in February and found that a small amount of NDMA was detected in two products. The European Medicines Agency (EMA) has not yet released an official position. Investigation over a long period of 5 months from 900 raw materials to finished products After a problem in Singapore, the MFDS identified the manufacturer of the raw material in question in exchange with HSA, and immediately went into the investigation into the drug substance. The MFDS said it was investigating raw materials for more than 900 products at the time. Starting in April, the drug investigation began. The survey targets appear to be 288 finished products in circulation in this letter. Some people say that NDMA exceeded the tentative standard in products using some Indian raw materials. Experts have claimed that Metformin preparations are used as the primary treatment for patients with type II diabetes, so be careful with NMDA measures. Therefore, the MFDS seems to have conducted a long-term investigation for 5 months for screening. However, if detailed items are released, the pharmacy will be confused again with problems of return, exchange, and recovery.
- Company
- K-Bio in ASCO 2020: Seeking the optimal combination
- by Choi sun May 27, 2020 06:07am
- From May 29, ten of Korean pharmaceutical and bio companies are to participate in the virtually held American Society of Clinical Oncology Annual Meeting (ASCO) 2020. GC Pharma, SillaJen, Genexine and many other Korean companies are planning to present various clinical study outcomes related to anticancer treatments. # The ASCO annual meeting invites approximately 40,000 oncology specialists around the world every year, but this year the event is to be convened online. The biggest theme of this year is seeking the optimal combination for anticancer therapy. Many of studies to be presented are focusing on improving the treatment utility better than the existing epidermal growth factor receptor (EGFR) targeted therapy through combination therapy. ASCO has chosen GC Pharma’s abstract reporting the interim findings of phase 1b/2a study on the novel targeted therapy ‘GC1118,’ in joint development with Mogam Institute for Biomedical Research, to be presented at the annual meeting. GC1118 is a novel monoclonal antibody targeting overexpressed EGFR. By binding with EGFR that triggers proliferation of tumor cell and metastasis, the targeted therapy inhibits proliferating cancer while promoting killing of tumor cells by activating lymphocytes. The phase 1b/2a study is testing the combination of GC1118 and other chemotherapies including irinotecan and FOLFIRI, which its interim findings are selected for poster presentation. On May 29, SillaJen is to publish an abstract as well. The Korean company’s study is testing combination therapy between SillaJen’s oncolytic virus Pexa-Vec and the U.S.-based company Regeneron’s immune checkpoint inhibitor Libtayo. The report could provide promising first human testing evidence raising anticipation on commercialization. NK Max developing targeted therapy ‘SNK01’ is unveiling three abstracts related to the anticancer treatment—interim report of phase 1/2a clinical study in non-small cell lung cancer (NSCLC) conducted in Korea, interim report of phase 1 study in solid tumor conducted in the U.S., and study testing NK cell activity as a biomarker for Keytruda. The SNK01 plus Keytruda combination marked overall response rate (ORR) at 66 percent and confirmed improved effect against Keytruda monotherapy. The nine study subjects were divided into three in Keytruda monotherapy group and six in SNK01 plus Keytruda combination group. The ORR, showing the pharmaceutical treatment effect, reached 66 percent, in which four out of six patients demonstrated outstanding effect of lessening the tumor level. The three out of four that had positive treatment effect confirmed partial remission with 50 percent reduction in tumor cell and the other one resulted in partial remission with 30 percent reduction in tumor cell. Specifically, combining Keytruda seems to have improved adverse event issues, as well as treatment effect, of the immune checkpoint inhibitor. #Genexine is preparing to showcase interim outcome of phase 1b/2 clinical study testing the hyleukin-7 plus immune checkpoint inhibitor Keytruda (pembrolizumab) combination therapy in patients with advanced triple-negative breast cancer (TNBC). It was a first clinical study to test hyleukin-7 combined with an immune checkpoint inhibitor. Also, MedPacto is to reveal phase 1 clinical data testing a transforming growth factor beta (TGF-β) inhibitor vactosertib plus leukemia treatment imatinib to treat patients with Desmoid tumor. Testing the early anti-tumor activity of vactosertib combined with imatinib, the therapy reached ORR of 28.6 percent (two out of seven patients), which was significantly higher than the previously reported one-year response rate of imatinib monotherapy (11 to 13 percent). The combination therapy also demonstrated improved six-month progression free survival (PFS) at 100 percent, which was exceptionally higher than the imatinib monotherapy at 65 to 80 percent. Pharmabcine is announcing interim outcome of phase 1b study on neovascularization inhibitor olinvacimab combined with Keytruda treating patients with glioblastoma. Moreover, Yuhan has three abstracts to be presented at the ASCO annual conference regarding clinical studies with NSCLC treatment Lazertinib. The first abstract is to report phase 1/2 clinical trial testing anti-tumor effect and safety of administering 240 mg Lazertinib once-daily as a second-line therapy, and the second abstract is to report a subgroup analysis on 64 NSCLC patients with T790 mutation confirmed to have brain metastases receiving 20 mg to 320 mg of Lazertinib. The last abstract analyzes clinical genetics of resistance against Lazertinib. Cancer cells develop resistance against targeted therapy by inducing new genetic mutation. The study delves into types of resistant mutation against Lazertinib with 47 patients whose stage of cancer has advanced after receiving Lazertinib.
- Company
- KRPIA-MOHW meeting rescheduled on May 28
- by Eo, Yun-Ho May 27, 2020 06:05am
- Korean Research-based Pharmaceutical Industry Association (KRPIA) and Ministry of Health and Welfare (MOHW) have rescheduled their meeting canceled last week due to a confirmed case of COVID-19. According to a pharmaceutical industry source, a meeting between MOHW Pharmaceutical Benefits Division and KRPIA Market Access (MA) and Government Affair (GA) representatives is to be convened on coming Thursday. The new Director of Pharmaceutical Benefits Division, Yang Yoon Seok, would officially meet with KRPIA representatives for the first time. Also, Senior Deputy Director Lee Seon-joo and Deputy Director Choi Kyung-ho would accompany Director Yang at the meeting to listen to the industry’s opinion and discuss prospective approach on the drug pricing policy. KRPIA representatives are expected to address their perspective on the government’s plan to revise the drug pricing system. The industry source reported the regulation on the National Health Insurance (NHI) healthcare reimbursement would be the focus of the talk. The industry organization would likely to raise voice regarding the government setting down detailed principles and prioritizing the order of pharmaceutical reimbursement listing to take account of the NHI finance status. In particular, the organization would question the government officials about the ‘detailed principles,’ specific standard of prioritization, and exempting the negotiation period from the currently aimed duration of 150 days. Moreover, the industry organization would ask the government officials to provide information on specified negotiation and its procedure for projected claim amount of drugs, and prospective listing procedure and required listing period for negotiation-exempted drug with pricing lower than weighted average price. On May 21, KRPIA started working from home as a confirmed case of COVID-19 was reported from the Twin City Namsan building, where its office is located. The organization resumed their regular work from May 25.
- Opinion
- [Reporter’s view] We must prepare for the post impurity era
- by Kim, Jin-Gu May 27, 2020 06:04am
- The situation wasn't the worst. Unlike Ranitidine, not all Metformin sales have been stopped. It is expected that the confusion of patients and the potential damage of pharmaceutical companies will not be greater than in the case of the Valsartan·Ranitidine crisis. The MFDS decided to stop selling 31 of the 288 finished Metformin products in Korea on the 25th. The reason was the same as in the previous situation. N-nitrosodimethylamine (NDMA) was detected above the provisional management criteria. As a result, the case of impurities, starting from Valsartan and Ranitidine to Metformin, has been closed. At present, there are no other ingredients that raise concerns about impurities. However, it is not the end, it’s the beginning. Impurities have become a new disease and standard for drug safety management. The time has come for us to manage unexpected impurities in advance. It must be a contradictory situation. It is contradictory to anticipate and manage unexpected impurities in advance. However, this contradictory situation is the reality faced by the pharmaceutical bio industry. The paradigm of drug safety management has changed completely. The MFDS has been obliged to submit proof of safety for carcinogenic impurities, metal impurities, etc. when pharmaceutical companies apply for drug approval from September. It is only possible to preemptively check for harmful substances that can occur on its own and to prove safety. There are many problems that have not been solved. First, it is a standard for impurity management. Currently, NDMA·NDEA are all impurities that have been established as management standards. However, NDMA·NDEA are only some of the many impurities. The possibility of Nitrosamine-based impurities such as NMBA, DIPNA, and EIPNA cannot be excluded. If the range is extended to impurities other than Nitrosamines, theoretically, impurity problems close to infinity occur. These impurities should be cataloged, and separate control standards should be prepared for each impurity. The MFDS has announced that this work will be done in cooperation with regulatory authorities in each country. However, as COVID-19 suddenly became world-wide, it was postponed. The issue of responsibility derived from this is another problem. The regulatory authorities and the pharmaceutical industry may not be able to predict in advance, but the damage caused by the pharmaceutical industry should be more concerned. Discussions with the regulatory authorities and the pharmaceutical industry should begin to rationalize responsibility. At present, the Metformin situation is thought to be over. However, the new era of drug safety management has just begun. You can't have the same confusion every time. We look forward to setting new standards for the new era as soon as possible.
- Policy
- PVA lowers Entresto and Synovian pricing
- by Kim, Jung-Ju May 27, 2020 06:04am
- The prices of Novartis Korea’s Entresto film-coated tablet (sacubitril plus valsartan plus sodium salt hydrate complex) and LG Chem’s Synovian injection (BDDE bridged sodium hyaluronate gel) have been negotiated to be lowered by 7 percent and 2.7 percent, respectively, due to their increased use. Daewoong Pharmaceutical, Ildong Pharmaceutical and Amgen Korea voluntarily requested to lower the prices of their Gliasta soft capsule (choline alfoscerate), Pirespa (pirfenidone) 200 mg tablet and Blincyto (Blinatumomab) 35μg injection, respectively. Korea’s Ministry of Health and Welfare (MOHW) has recently finalized the revised ‘List of Reimbursed Drugs and Maximum Reimbursed Price’ with the changes mentioned above. The new list would come in effect from June 1. First, Novartis Korea has negotiated with National Health Insurance Service (NHIS) over Entresto film-coated tablet according to the Type Ga (가) of the price-volume agreement (PVA) system. The Type Ga applies on an item listed with pricing negotiation, when the claimed amount has exceeded the amount projected from the point of negotiation by 30 percent. The item’s claimed amount is calculated from the claims made under the same supplier, administration method, active ingredient and form of the item. The tablet’s reimbursed price would be reduced by 7 percent from 2,200 won to 2,046 won. The dose varies from 50 mg to 100 mg and 200 mg, but the same price is applied to all. LG Chem’s Synovian injection, for instance, was negotiated for pricing reduction under Type Na (나). An item that has been listed for over four years without pricing adjustment by Type Ga PVA, but the total claim amount has surpassed the projected amount at the point of listing by 30 percent. For such items, NHIS negotiate with the supplier depending if the claimed amount has surpassed 60 percent more than the previous year’s amount, or the increased amount has surpassed over 10 percent and adds up to over 5 billion won. The injection’s price, effective from next month, would be brought by 2.7 percent from 67,200 won to 65,400 won. Pricing of total six items would be reduced due to preliminary price reduction based on additional indications. The government preemptively lowers price of an item with extended indication by taking account of additional claim projection and increase rate. The six items include Pfizer Pharmaceutical Korea’s Benefix (Recombinant Blood Coagulation Factor Ⅸ) injection in five doses and AstraZeneca Korea’s Faslodex (fulvestrant) injection. The price of Benefix injection in 250 I.U, 500 I.U and 3000 I.U would be lowered from 789 won to 777 won, and the injection in 1000 I.U and 2000 I.U would be lowered from 788 won to 776 won, all by 1.5 percent. Faslodex injection’s price would be lowered by 5 percent from 567,595 won to 539,215 won. Three items have voluntarily requested for pricing reduction. The government adjusts the maximum price as requested, when a drug manufacturer, CMO or importer requests for the pricing lower than the listed maximum price. Daewoong Pharmaceutical’s Gliasta soft capsule (choline alfoscerate) pricing would be bought down by 0.4 percent from 508 won to 506 won, and Ildong Pharmaceutical’s Pirespa (pirfenidone) 200 mg tablet pricing would be lowered by 0.3 percent from 3,304 won to 3,294 won. Amgen Korea’s Blincyto (Blinatumomab) 35μg injection pricing would be reduced by 5.2 percent from 2,346,000 won to 2,223,503 won, effective from next month.
