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- 2025-12-25 21:24:34
- Policy
- A government-ruling party, pay attention to Syntekabio
- by Lee, Jeong-Hwan Oct 05, 2020 06:21am
- As it is known that the drug efficacy of the new drug substance for COVID-19 being developed by Syntekabio is more than twice that of Remdesivir, a government-ruling party is paying attention to this. On the 28th, Lee Nak-yeon, leader of the Democratic Party and Representative Han Jeoung-ae (General Manager of the National Disaster Recovery Committee), Seo Youngseok (Health and Medical Special Committe), Jo Seounglae, Kim Youngbae, and Han Junho visited the KRIBB in Daedeok Innopolis in Daejeon. Yong Hong-taek, head of the R&D policy department of the Ministry of Science and ICT, attended. On this day, the government-ruling party met with an official who took the lead in the development of COVID-19 treatment and vaccine to discuss the current status of treatment and vaccine, and to discuss a message to the public. Jang Seong Kim, the KRIBB’s chairman, explained that the efficacy of Syntekabio's COVID-19 treatment candidate was twice as high as that of the standard treatment Remdesivir. Syntekabio's new drug substance is known to have a therapeutic effect of 94.3% compared to 44.3% of Remdesivir as a result of animal experiments conducted through the KRIBB. Lee Nak-yeon expressed interest by encouraging the researchers of the KRIBB, and at the same time confirming whether the COVID-19 candidate is twice as effective as Remdesivir in animal experiments. He said, “Amid the COVID-19 crisis, we must protect the quarantine and economy and prepare for the future. The KRIBB, which developed the world's fourth primate infection model, is making a feat of stabilizing the COVID-19 clinical trial. We want to hear how our party can help.”, also he added, “the expansion of research facilities and data centers seemed urgent and we will help.”
- Policy
- Pfizer Korea withdraws a lot of OTC products
- by Lee, Tak-Sun Oct 05, 2020 06:20am
- Pfizer Korea has withdrawn a large number of domestic OTC products. There are only three items left. According to the MFDS on the 28th, Pfizer Korea recently withdrew permission for seven items, including Stresstabs Plus and Caltrate plus. Accordingly, only three items left by Pfizer Korea were Minulet, Alesse, and Cofrel. Even this is not sold directly by Pfizer Korea. Ildong has been selling Minulet and Alesse, and Cofrel has been discontinued due to a manufacturer’s problem. The suspension of Pfizer's OTC department was announced last year when it merged with GSK. The domestic copyright of major items, such as the OTC products, Advil, Caltrate, and the multivitamins, Centrum, has already been transferred to GSK. In December 2018, when the two companies announced the merger of the Consumer Health Care, they reported that GSK owns 68% and Pfizer owns 32%.
- Policy
- Bavencio, listed on next month at ₩1,226,243/bottle
- by Kim, Jung-Ju Sep 29, 2020 06:21am
- Bavencio (Avelumab) by Merck, used for the treatment of metastatic Merkel cell carcinoma, will be covered by insurance benefits at ₩1,226,243 per bottle starting next month. Since it is an expensive drug, it will follow the RSA track, and will be listed as a refund type in which pharmaceutical companies reimburse a certain percentage of the drug claims to the HIRA, and a expenditure cap. The MOHW announced that the 'revision of Criteria for pharmaceutical reimbursed list & upper limit table' with the above contents was submitted to the agenda of the 17th plenary meeting of the Health Insurance Policy Deliberation Committee on the afternoon of today (25) and was deliberated and resolved. Merkel cell carcinoma is a neuroendocrine cancer that occurs in the skin, and Bavencio is an injection drug that has been approved for 'a monotherapy for the treatment of metastatic Merkel cell carcinoma in adults'. It is treated by intravenous infusion at 10mg/kg every two weeks for 60 minutes. It is a rare cancer that occurs in a very small number of populations (0.35 per 100,000 males and 0.15 per 100,000 females). Life expectancy is less than 2 years. The number of patients for this product in Korea is known to be around 10. On March 22 last year, the company obtained an item permission from the MFDS and submitted an application for insurance registration on May 2 of the same year. After deliberation by the Economic Evaluation Subcommittee under the Pharmaceutical Benefits Advisory Committee held on April 17 of this year, it was officially proposed on June 11, two months later. At that time, the committee recommended the use of this drug in the treatment of metastatic Merkel cell cancer according to the evidence in textbooks and clinical practice guidelines, so it has clinical utility. It was determined that the result of the economic evaluation (cost-effectiveness analysis, ICER) compared to chemotherapy was reviewed at an acceptable level. The Korean Cancer Association and the Korean Cancer Study Group also said that it is a drug that can be considered as a preferred treatment method for patients with metastatic Merkel cell boxes who have failed the first line treatment. It was listed in the excluded countries A7 (US, Japan, France, Germany, Italy, Switzerland, and the UK), and the adjusted average price is ₩1,317,952 per bottle. After passing the committee, when discussing the price of a new drug with the NHIS, the company proceeded with negotiations by following the RSA refund type and Expenditure Cap type. This is a contract in which a pharmaceutical company refunds a certain percentage of the drug billed amount and a certain proportion of the excess of the estimated cap amount to the NHIS. The two sides agreed to ₩1,226,243 taking into account the level of drug prices and fiscal impact of excluded countries. The fiscal impact analysis value is about ₩301 million per year, and the registration date is October 1.
- 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.
