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- 2025-12-24 06:42:03
- Policy
- Kwang Dong competes with Elyson for Nebivolol
- by Lee, Tak-Sun Sep 29, 2020 06:21am
- Kwang Dong headquarters located in Seocho-dong Kwang Dong is challenging the market by obtaining approval for all three high and low doses of the hypertension treatment 'Nebivolol HCl'. This is the second case that 3 doses have been approved since Elyson was approved. On the 28th, the MFDS approved Kwang Dong's Nebilet M 1.25mg, 2.5mg and 5mg. Nebilet M is a generic for Menarini's Nebilet that was approved in Korea in 2006. However, Menarini has Nebivolol 5mg. Only Kwang Dong and Elyson have Nebivolol 1.25mg and 2.5mg. Elyson's Nebistol 5mg was approved in 2012, Nebistol 2.5mg in 2013, Nebistol 1.25mg in 2017. The indication requires a low-dose product. For indications for hypertension, adults with essential hypertension should take 5mg once a day, and patients with renal failure should take 2.5mg once a day as an initial dose. In addition, the elderly over 65 years old are also required to take 2.5mg orally at the initial dose. For chronic heart failure indications, elderly patients over 70 years of age start treatment with 1.25 mg once a day, and if necessary, the dose is increased to 2.5 mg once a day, 5 mg once a day, and 10 mg once a day. Although Elyson has already licensed three doses and is selling them, Kwang Dong's generic is drawing attention because the product name is similar to the original. It seems that it inherits the originality because only M was added to the original drug name, Nebilet. Kwang Dong is expanding its alliance by signing an exclusive sales contract with Menarini, an original company of Nebilet, for nail athlete's foot treatment 'Flucare' earlier this year. Interest is also focused on whether there was a partnership between the two companies this time. However, Nebilet is an imported drug, and Nebilet M, which was approved this time, is an item produced in Korea by Kwang Dong. Currently, there are only 12 single formulations of Nebivolol HCl in Korea, including the original. It is analyzed that the number of participating companies is limited due to the small market size. In the first half of this year, Menarini's Nebilet sales amounted to ₩3.5 billion, and Elyson's Nebistol was ₩1.5 billion. It is noteworthy whether Kwang Dong, which has been approved for three doses at once, will emerge as a new dark horse.
- Policy
- Immunotherapy Bavencio coverage green lit for skin cancer
- by Lee, Hye-Kyung Sep 28, 2020 06:20am
- The South Korean health authority has granted reimbursement on Merck’s immunotherapy Bavencio injection (avelumab). The Health Insurance Review and Assessment Service (HIRA) plans to accept public opinion on the unveiled revised Notice on Pharmaceuticals for Cancer Patient’s Prescription and Administration until Sept. 17. Without much of objection, the reimbursement would be granted from Oct. 1. Bavencio was initially approved as a single agent therapy to treat adult patients with metastatic Merkel cell carcinoma (MCC). The treatment is now listed as a second-line treatment in adult patients with metastatic MCC, who have not been treated with immune checkpoint inhibitor like a PD-1 inhibitor. To expand the treatment’s reimbursement standard, HIRA has confirmed the National Comprehensive Cancer Network (NCCN) guideline recommending Bavencio as Category 2A for treating patients with metastatic MCC, based on a single-arm, open-label Phase II trial findings on the treatment’s efficacy in patients aged over 18 with Stage IV MCC progressed after receiving one or more anticancer therapy, which demonstrated median overall survival (mOS) of 12.9 months, median progression-free survival (mPFS) of 2.7 months, and overall response rate (ORR) of 33.0 percent. The reimbursement decision was passed as a retrospective observational study on MCC patients who have used second-line or later chemotherapy that found the treatment’s improved clinical efficacy compared to mOS 5.7 months, mPFS 2.0 months and ORR 23 percent. However, the general immune checkpoint inhibitor reimbursement condition, ‘to be used only in healthcare institutes capable of responding on emergency cases of unpredicted adverse reaction, and administered by a well-experienced doctor with sufficient knowledge in anticancer therapies,’ would be applied the same. And also the healthcare benefit would be limited to patients who have not been treated with other PD-1 inhibitor-like immune checkpoint inhibitor. Now the reimbursed use of Bavencio would be available to patients with MCC, as well as basal cell skin cancer and squamous cell skin cancer. Also, HIRA clarified the off-label chemotherapy use evaluation standard and exempted case of post-approval (use prior to HIRA president’s approval) with the new notice the agency disclosed. Previously, the standard only stipulated a healthcare institute meaning to use off-label chemotherapy to undergo review by a multidisciplinary review board and request an approval by the president of HIRA via template application for off-label use of chemotherapy supplemented with evidential data. Nonetheless, the amended standard added new standard for the president of HIRA to either dismiss or return the off-label use application, if the required evidential data is not submitted. And the applicable healthcare institute would be not allowed to request or use off-label chemotherapy in following cases; an alternative standard of care exists within the scope of notified, approved or already-recognized off-label therapy; inevitability or medical necessity cannot be proven; the off-label use is for supplementary or maintenance therapy before or after a surgery; and use of an off-label cancer therapy seeking for the approval has been rejected previously after a review. Meanwhile, the stipulated re-assessment period clause—‘the president of HIRA should constantly monitor the system execution status, and re-assess relevant laws and environment at a one-year point since the regulation is notified, to reflect needed changes until the two-year point of the regulation’—was removed. HIRA official said, “As the progress and status are reported to Cancer Disease Deliberation Committee, the agency decided to delete the regulation on the re-assessment period after reviewing the public opinion.”
- Policy
- Teribone's price will be cut from the 26th
- by Kim, Jung-Ju Sep 28, 2020 06:20am
- The price cut was finally decided in an administrative lawsuit to cut the drug price of Teribone inj 56.5 μg (Teriparatide). Since the company voluntarily withdrew the lawsuit due to lack of profit, no other drug price changes are expected in the future. The Seoul Administrative Court recently ruled against a lawsuit for cancellation of drug price cuts (revision of the 'Pharmaceutical Benefit List and Upper Limit Table No. 2020-38) filed by Dong-A ST. Accordingly, the suspension of execution, which the company requested and accepted by the court along with the lawsuit, also ended and price cut was imminent. According to the court, the suspension of enforcement of the notice will end in 25th. Accordingly, from the next day, the 26th, the price will drop to the price planned by the government through ex officio adjustment. The lawsuit came when the MOHW included the drug in the drug price cut list last month. The MOHW applies the so-called `half-price drug price' when a generic is registered for the first time, and is listed at a price of 53.55% of the original. However, if the number of companies with the same product is less than 3 even after a year has passed, the addition is maintained until the number of companies with the same product reaches 4 or more, and when the conditions disappear, the drug price is lowered through ex officio adjustment. Initially, Teribone inj was listed on the reimbursement list at 90% level in conjunction with the drug price of Forsteo in accordance with the 'Pharmaceutical Determination and Adjustment Criteria.' The cut was decided, and in conjunction with this, the drug price of Teribone inj 56.5μg was also reduced. Accordingly, the company has filed a lawsuit against the MOHW. The expected reduction is 22.2% from the current ₩73,287 to ₩57,001. In August, Lilly lost to Daewon in a lawsuit to cut the drug price of Forsteo, and the drug price cut of Dong-A ST Forsteo was finally decided without appeal. In other words, Teribone inj is automatically reduced in price separately from litigation. Due to such circumstances, Dong-A ST decided that the lawsuit was not profitable and decided to withdraw. Medical institutions should take care when making a claim, reflecting the drug price cut.
- Policy
- More than 20 companies, to apply for Atozet's generics
- by Lee, Tak-Sun Sep 25, 2020 06:05am
- Atozet by MSDIt is reported that more than 20 pharmaceutical companies have contracted to produce generics for Atozet (Ezetimibe/Atorvastatin) with Chong Kun Dang. Accordingly, it is expected that the number of drugs applied for permission after PMS through bioequivalence test will be lowered by about 15% compared to Chong Kun Dang products. Chong Kun Dang signed contracts with consignment companies on the 22nd. According to the industry, contrary to the concerns of the participating companies, it is reported that more than 20 companies have signed contracts. In the new cascaded drug price system, up to 20 items in the order of listing will receive 53.55% of the drug price compared to the original if the condition of DMF-self-biological equivalence is satisfied. On the other hand, starting from 21st generics, drug prices are calculated at 85% of the lowest price, so generics are more advantageous the sooner they are listed. If there are no more than 20 contractors entrusted to Chong Kun Dang, including the original company and Chong Kun Dang, the companies applying for permission after the end of the PMS in January of next year could receive the drug price at the same level. Accordingly, some of the consignment companies that undertake Chong Kun Dang's contracts also commented that it would be better to entrust the same drug price to a bioequivalence generic company that has low production costs. However, it is reported that Chong Kun Dang responded to the consignment company to not worry because there are more than 20 contractors. Chong Kun Dang's drugs for data-based re-evaluation are expected to be approved next month, and the consignees are planning to apply within this week. From September 30, when applying for permission, it is mandatory to submit data on the possibility of causing genotoxicity of impurities. The evaluation data on the possibility of inducing genotoxicity of impurities is a system introduced by the MFDS in order to strengthen management in the subsequent NDMA incidents of carcinogenic substances. An industry official said, "In consideration of the MFDS’ confirmation schedule, Chong Kun Dang's consignment companies decided to apply for a permit within 25 days at the latest. It is likely that the exact number of consignment contractors will be disclosed after applying for permission." If more than 20 Atozet consignment contractors are confirmed, the demand for the restriction on the number of delegated generic licenses is expected to increase. This is because generics that have been tested for bioequivalence may suffer damage from the drug price due to late listing. Therefore, some in the industry have come up with an opinion that the number of delegated generic licenses should be limited.
- Policy
- The post-assessment system has many problems
- by Lee, Hye-Kyung Sep 25, 2020 06:05am
- The necessity of introducing post-assessment system for prior registration was raised to expand patient access to new drugs, but the government said it needed complex concerns. Choi Gyeong-ho, an official at the insurance pharmaceutical department of the MOHW, said at the 'Non-face-to-face discussion for enhancing patient accessibility of new drugs in the era of COVID-19' held at 2 p.m. on the 23rd hosted by member of the National Assembly, Lee Yong-ho and hosted by the Future Health Network. "The post-admission evaluation system is theoretically very good, but there are a lot of concerns." In the process of reducing Choline alfoscerate’s benefit, the notice was suspended due to lawsuits, etc., and Choi said, "we tried to subtract the ineffective Choline alfoscerate from reimbursement, but it is suspended." He said, "The post-admission evaluation system may have complex problems such as what to do with patients who have been taking it if there is a situation where they have to leave." "I have no choice but to have doubts whether pre-listing at temporary prices is a system that can actually work." Lee Hyung-ki, a professor of clinical pharmacology at Seoul National University Hospital, who was in charge of the topic presentation on the day, said that there is no simple approach to the increase of the ICER threshold. He said, “If we raise the price of ICER, it will help with positive aspects and high-priced new drugs or listings, etc. in terms of reinforcement of security, However, it is bound to be accompanied by an increase in drug prices. Therefore, there are many opinions, and there are opinions that the current value is okay, so a lot of discussion is needed.” It was also said that the law will be revised sooner or later regarding the listing of drugs after risk sharing (RSA). He said, "There are plans to improve the RSA system, such as generic drugs system, but it is a matter that needs to be revised and linked in practice and it will be implemented soon."
- Policy
- Better new drug access with pre-listing reimbursement
- by Lee, Hye-Kyung Sep 25, 2020 06:04am
- Pharmaceutical affairs expert argues, to enhance patients’ access to new drugs, the government should induce pharmaceutical companies to voluntarily set and lower generic pricing on their own, while also considering flexible ICER threshold and pre-listing reimbursement. And the expert criticizes the upcoming pilot program, effective from October to provide coverage on Korean herbal medicine, as ‘medical service coverage without sound evidence of cost-effectiveness,’ and urges the government to revisit the matter and review appropriately allocating the National Health Insurance (NHI) finance. A non-contact discussion panel on enhancing access to new drug amid COVID-19, convened by Lawmaker Lee Yongho and ‘Future Health Network’ on Sept. 23 The said claims were made at a non-contact discussion panel on enhancing access to new drug amid COVID-19, convened by Lawmaker Lee Yongho and ‘Future Health Network’ on Sept. 23. Professor Howard Lee at Seoul National University Hospital Department of Clinical Pharmacology presented his analytic findings on recommended policies to improve patients’ access to new drugs. Professor Lee proposed four policies on reinforcing the accessibility to new drugs. First, the professor urged the incremental cost-effectiveness ratio (ICER) threshold should be based off of the national income level, disease severity and properties, and patients’ need for the treatment. Currently, the Health Insurance Review and Assessment Service’ (HIRA) ‘Detailed Evaluation Standards of New Drug and Negotiating Drugs’ do not clearly state ICER threshold, but it refers to GDP per capita (36 million won as of 2019). Professor Lee said, “If the reference subject is used in combination with a high-cost standard therapy or other drugs, it is difficult to prove the cost-effectiveness,” and “ICER threshold should be flexibly applied in brackets for pharmaceuticals challenged to conduct pharamacoeconomic (PE) analysis, or cancer or severe disease treatments.” The second proposal is to seek alternatives for PE analysis. Professor Lee pointed out, “The risk sharing agreement (RSA) system was initially introduced, because proving cost-effectiveness was difficult,” but “these new drugs still take 746 days until the listing and 729 days with RSA, making not much of a difference. Nevertheless, there is no alternative option other than RSA.” Based on his criticism, he argued the mindset on enhancing new drug accessibility should be shifted and suggested adopting ‘pre-listing reimbursement.’ The third recommendation is to adequately appropriate NHI finance. His argument is that the price competition-induced generic pricing reduction and coverage on medical service, which cannot prove cost-effectiveness, should be taken into account again. The professor reprimanded, “South Korea’s generics are usually expensive but their markets generate more than sufficient sales. It means the true market functions is missing,” and “in case of Japan, where drug pricing controlled, its government decides the generic pricing preventing the price competition. But South Korea is different.” Regardless of the government’s pricing control, the generic sales are high, as well as the sales profit. So the professor stated, “Rather than the government-forced pricing control, voluntary generic pricing by companies is more effective to motivate generic pricing reduction.” The fourth proposal was opening a separate fund for the new drugs. He emphasized the government should seek for the social consensus to create an independent fund for the new drug coverage that can be operated regardless of NHI financial status.
- Policy
- The generic competition of Circadin PR is intensifying
- by Lee, Tak-Sun Sep 25, 2020 06:04am
- Circadin PR by KuhnilGenerics for Circadin PR, a melatonin-based insomnia treatment drug, began to be approved on the 22nd. Kuhnil's Circadin PR was removed from data protection due to the expiration of PMS in June. With the end of PMS, applications for permission for generic drugs were followed, and product approval was finally received this month. Prior to the release of generics, the entrusted generics, which signed a contract with Kuhnil, were pre-released, and attention is focused on the competitive structure. On the 22nd, the MFDS approved generics of the same ingredients as Circadin PR, such as SK Chemicals' Raton 2mg. Seven companies were approved on the 22nd and more companies are expected to receive approval for generic drugs within this month. On the 22nd, generic drugs produced by Inist and Mothers Pharm were approved. The original, Kuhnil's Circadin PR, obtained an item approval in June 2014. It is an item developed by NEURIM, headquartered in Israel, and imports and sells items produced by SwissCo Services AG located in Switzerland. In a domestic clinical trial for insomnia patients over 55 years of age, Kuhnil said that after taking Circadin, the quality of sleep, time to fall asleep, total sleep time, sleep efficiency and activity during the day were improved, but no special side effects occurred. In addition, while existing sleeping pills are limited to 3-4 weeks per time as psychotropic drugs, Circadin PR is a non-psychotic drug that can be prescribed for up to 13 weeks at a time. Circadin PR which was released as a non-reimbursement drug in July of that year, continued to increase in sales, but last year, it was evaluated that it successfully settled in the market at ₩6.5 billion based on IQVIA. However, with the end of PMS, which releases new drug data protection this year, it has become difficult to maintain market share due to the entry of generic drugs. Accordingly, Kuhnil has devised a strategy to increase its side through delegated generics. In February and March, before the expiration of the PMS, Kuhnil provided data to four companies, including Jeil, Penmix, Hanlim, CMG pharm and helped with the authorization of the delegated generic type. These four delegated generics, like the original, are drugs produced by SwissCo Services AG. The intention is to preoccupy the generic market with delegated generics manufactured in the same producer before generics are released. Sales of delegated generics released six months earlier are still not good. The fact that this drug is a non-reimbursement Rx drug, but it is an unpredictable indicator of how the market competition will flow. It is noteworthy how well domestically produced generic generics will perform.
- Policy
- The answer is to improve the drug price system
- by Lee, Hye-Kyung Sep 24, 2020 06:20am
- The drug price system should be improved in order to enhance patient access to new drugs such as cancer and rare disease treatments. Through the 'non-face-to-face discussion to enhance patient accessibility of new drugs in the era of COVID-19' hosted by Lee Yong-ho, a member of the National Assembly and hosted by the Future Health Network on the 23rd, clinical field experts, patients, and pharmaceutical companies gathered opinions about ▲Flexible application of ICER values ▲ Risk-sharing system and expanded exemption from economic feasibility evaluation ▲ Post-priority evaluation ▲ Generic drug price cut ▲ Separate fund. The government also acknowledged the need to improve the drug price system, but emphasized that limited in reality. Lee Hyung-ki, a professor of clinical pharmacology at Seoul National University Hospital, who was in charge of the topic presentation, said, "Economic evaluation is difficult or the ICER value should be flexibly applied in the form of a band for cancer and severe disease treatments, and it still took 746 days for the total drug to pay and 729 days for the risk-sharing system, so there is no difference, but there is no alternative to the risk-sharing system." Choi Young-hyun, honors professor at Korea national university of Welfare (former head of the Department of Welfare) also said, "In the case of anticancer drugs, it takes 757 days to pay. Patients and their families have no choice but to mourn." After paying, in the process of negotiating a drug price with the NHIS, the method of adjusting the amount of use through drug price linkage can be an alternative." Choi In-hwa, managing director of Roche Korea (Chairman of the KRPIA reimbursement improvement Subcommittee) said that under the current situation, listing new drugs with Korea as a priority would be difficult for global pharmaceutical companies. Managing Director Choi added, "Korea is a country that can invest in new drugs because of the late payment of reimbursement and the high prices. We need to secure various solutions such as improving the drug price system such as total amount or positive list system for new drugs.“ On behalf of the patient, Baek Min-hwan, the representative of the Korea Multiple Myeloma Patients Association, asked about the government's measures to improve the RSA system and pay ultra-high-priced anticancer drugs. CEO Baek suggested, "It takes too long to be registered for benefits after approval. Patients are told to increase accessibility through positive list system altogether rather than waiting for them to die." The health authorities also sympathized with this, but said that there were some differences in perception. "The flexible application of the ICER value is simpler or not easier than expected, and it is good in terms of reinforcing guarantees, but we have to consider rising drug prices." said Choi Gyeong-ho, the secretary of the MOHW's insurance drug department. However, he said that the system could be supplemented by continuously collecting opinions. Kim Ae-ryeon, head of the pharmaceutical management department of the HIRA, said that she would release a proposal to improve the ICER value sooner or later. Kim said, "We are conducting a study on the ICER threshold, and we will be able to disclose the improvement plan once it is finished." Regarding the expansion of the economic evaluation exemption, she explained that as of June this year, 17 ingredients and 28 items were registered as an economic evaluation omission system. The NHIS also promised to prepare a mechanism for transparency in drug price negotiations by the second half of this year so that it can escape from 'drug price negotiations that are not known at all'. While negotiating drug prices, Park Jong-heon, head of the NHIS' reimbursement strategy department, said that we should have disclosed data such as the status of reimbursement and price hikes due to increased usage, and transparently disclose data to review if there is a disagreement. He said, “Until now, there were restrictions due to personal information protection or infringement of third party rights, and we will make a track on the part that can be shared as much as possible until the second half of the year so that there is no talk of negotiating without knowing anything.” On the other hand, the MOHW mentioned re-evaluation of registered materials regarding the expansion of insurance finances to strengthen access to new drugs. Choi said, "The overall health care budget is about ₩19 to 20 trillion, but it is impossible to set a budget for how much to spend in a certain field, through a reasonable increase in health care costs or re-evaluation of drugs such as Choline alfoscerate, and it will be possible to expand the coverage of cancer or rare diseases." In connection with the point of YouTube viewers that the Severe Disease Deliberation Committee of the HIRA is struggling to pay for cost-effectiveness, Choi said, “We cannot help but consider the overall cost of health care while judging the usefulness of the new drug in cancer, and tt any stage, we have to judge the cost.”
- Policy
- Certican keeps weighted pricing for now, Samsca lowered 30%
- by Kim, Jung-Ju Sep 24, 2020 06:19am
- Novartis Korea’s immunosuppressant Certican (everolimus) has ultimately dodged the double pricing reduction. Although dismissed from patent litigation and lost from the administrative litigation against the government, the immunosuppressant is to keep its premium pricing benefit as stipulated by the policy that sustains the benefit when the number of companies with same substance drugs is three or less. The pricings on Relestat eye drops 0.05% (epinastine hydrochloride) by Allergan Korea and Samsca tablet (tolvaptan spray dry powder) by Korea Otsuka Pharmaceutical would be lowered by 30 percent from next month as authorized by the government. Nevertheless, the pricings would be lowered 23.5 percent more a year later as they lose the premium pricing. The pharmaceutical industry sources reported South Korea’s Ministry of Health and Welfare is in process of reflecting the said changes on the List of Reimbursed Drugs and Upper Limit Pricing. The finalized listed would come in effect from Oct. 1. First, Daewon Pharmaceutical’s Codaewon S syrup and Kisan Pharma’s Paricitol injection would receive weighted pricing of 21.2 percent and 10 percent, respectively, for a year. For a first generic, the South Korean government grants pricing of 59.5 percent of the original for a year from the date of listing. The pricing goes up to 68 percent for generics by an Innovative Pharmaceutical Company. But if the number of generic companies is three or under, the weighted pricing would be maintained until another company launches the generic. As for a latecomer generic listed within a year the first generic is listed, the same premium pricing would be granted for a year from the point of the first generic listing. The weighted pricing on Codaewon S syrup and Paricitol injection would expire on Oct. 1 and Apr. 1 next year, respectively. Total five items would get to keep their premium pricing benefit. The premium on Novartis’ Certican tablet would be maintained for all doses. In fact, Certican has undergone a pricing reduction once this month, as its patent litigation was rejected and it lost the litigation against the government regarding the pricing reduction order. The pricing on Novartis’ drug was supposed to drop with expired premium benefit, but its initial weighted pricing would remain unchanged as long as the same substance generic-supplying companies are three or less. Along with Certican, Myungmoon Pharm’s Taro Ammonium Lactate Lotion 12% would also keep its weighted pricing. The government authorized the 30-percent pricing reduction on Allergan Korea’s Relestat eye drops 0.05% and Korea Otsuka Pharmaceutical’s Samsca tablet, effective next month. The government-authorized pricing reduction is applied to first-in-class drugs and products with same administration route, substance and formula, when a generic is listed. But when the first generic is listed, the first-in-class drug’s pricing is brought down to 53.55 percent but the premium benefit keeps the pricing at 70 percent of the initial pricing for a year. The upper limit pricing of Relestat eye drops 0.05% would be revised to 7,213 won, originally at 10,305 won, while the pricings on Samsca tablet 15 mg and 30 mg would be adjusted from 14,366 won to 10,056 won and from 14,400 won to 10,080 won, respectively. The premium pricing benefit would be dropped from Sept. 1 next year, automatically reducing their pricings by 23.5 percent, each. Two products’ pricings would be voluntarily lowered as requested by respective companies. The government allows adjustment of listed drug’s upper limit pricing, when a manufacturer, CMO, or importer requests to lower the pricing as a part of sales strategy or due to a corporate circumstances. The pricings on Newmantine tablet by Korea Prime Pharm and Pamcirac tablet by Ildong Pharmaceutical would be lowered by 17.2 percent and 2.6 percent, respectively, from next month.
- Policy
- Italian-made Gliatirin and Vesseldue-F efficacy questioned
- by Lee, Tak-Sun Sep 23, 2020 06:21am
- ‘Aju Vesseldue-F Soft Capsule A series of drugs from Italian manufacturers are in a tight spot, as they have been selected as an efficacy reevaluation subjects. These drugs do not have sufficient evidence to prove the efficacy, because they hardly have much records of use in countries other than South Korea. The pharmaceutical industry sources reported on Sept. 20, South Korea’s Ministry of Food and Drug Safety (MFDS) has unveiled its plan to conduct clinical reevaluation on three drugs. In last January, June and August, Kolmar Pharma’s cinnarizine, choline alfoscerate and heparinoids received order to undergo reevaluation, respectively. Particularly, the public’s spotlight was on reevaluation for cognitive function enhancer choline alfoscerate with the biggest market value in Korea, and anticoagulant heparinoids. Both the original choline alfoscerate Gliatirin and the best-selling heparinoids Vesseldue-F have been developed by Italian pharmaceutical companies. An Italian-based Italfarmaco developed Gliatirin and signed a license with Daewoong Pharmaceutical in 2000 for the marketing in Korea. Currently, the deal has been taken over by Chong Kun Dang. Choline alfoscerate, the main substance of Gliatirin, generates 300 billion won annually in Korea. However, the drug’s sales in some countries have been restricted, except in South Korea and Italy. While the drug is used as a health supplement in the U.S., most of the choline alfoscerate products have been withdrawn from the Japanese market after reevaluation. Learning from those countries, Korean Pharmacists for Democratic Society and other civic groups raised the issue and the National Assembly audit last year questioned the medicine’s efficacy. In early this year, the drug was called out for reevaluation and the government put limitation on the use. The clinical reevaluation was also ordered on heparinoids as their uses in foreign countries raised questions. One of heparinoids, Vesseldue-F (sulodexide) sold by Aju Pharm in Korea, is a bestseller generating 25 billion won annually. A heparin antagonist, heparinoids are extracted from porcine cartilage. The substance is known to have anticoagulant effect like heparin. In the recently disclosed minutes from Central Pharmaceutical Affairs Deliberation Committee discussing the heparinoids clinical reevaluation, experts apparently mentioned of the need for the drug use. An expert participating in the meeting pointed out, “It is true that latest evidences in efficacy of heparinoids are insufficient,” but also defended the drug by stating “The drug has been used frequently in the past, and has relatively low bleeding tendency compared to antiplatelets agent.” Another expert elaborated, “Heparinoids are used to treat peripheral vascular and venous diseases. Although the drug lacks vast amount of evidence of improving survival rate, the drug still has evidence of improving the symptoms of those disease,” and “in some cases, patients with phlebothrombosis switch to heparinoids after using NOAC for six months.” The heparinoids market leader, Vesseldue-F was first developed by an Italian company Alfa-Wassermann. Aju Pharm licensed in the technology and received the Korean health authority’s approval in 1997 under the name of ‘Aju Vesseldue-F Soft Capsule.’ Italy is one of A8 countries MFDS refers to when reviewing pharmaceuticals. Drugs with use history from the A8, consisting of the U.S., the U.K., France, Italy, Japan, Germany, Switzerland and Canada, are highly likely to pass the license renewal review. Choline alfoscerate was able to renew the license in 2018 with its prescription history from Italy. But as clinical reevaluations were recently ordered on two Italian-made drugs, some claim the A8 roster should be revisited. A pharmaceutical industry insider commented, “Coincidentally, a couple of drugs made by Italian companies have been controversial with their efficacy,” and “because a number of drugs developed in Italy are old, some countries have started not using them.”
