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- 2026-04-16 21:14:34
- Policy
- It started supplying Remdesivir to Korea for free for July
- by Lee, Tak-Sun Jul 03, 2020 06:17am
- Remdesivir (BBC)Gilead's 'Remdesivir', a COVID-19 treatment, is supplied to Korea. In the month of July, the supply will be used free of charge. It is planned to be purchased and used through price negotiations after August. The director of The KCDC (Jung Eun-Kyeong) announced that it will supply Remdesivir, which was specially imported as a treatment for COVID-19, from July 1. On June 29, after the MFDS' decision on special imports, the KCDC signed a free drug supply contract with importer Gilead Science Korea (USA) on the 29th of last month through consultation on domestic introduction. However, it was decided that the amount of introduction would be closed according to the terms of the contract with Gilead. Patients who can receive Remdesivir are limited to severe patients with pneumonia and who need oxygen therapy. Therefore, hospitals that treat severely ill patients should request the National Medical Center to supply medicines, and the National Medical Center, if necessary, consults with the central clinical committee for emerging disease control to determine who should be administered. Jung Eun-Kyeong, Director of the KCDC, said, "We plan to do our best to secure treatments by continuing to cooperate with Gilead Sciences Korea to secure additional volumes of Remdesivir." The KCDC plans to secure free supplies until July, and purchase from price negotiations after August.
- Policy
- Lipiodol takes government’s pricing reduction to the court
- by Kim, Jung-Ju Jul 03, 2020 06:17am
- The government’s price reduction on Lipiodol Ultra Solution (iodized oil), supposed to be effective from July 1 with the release of generic, is now heading to the courts as the company objected to the decision. Until the judgment is made, the court has allowed Guerbet Korea to sell the drug for the original reimbursed price temporarily. The Seoul Administrative Court has ordered a suspension on the execution of the new list of reimbursed drugs and maximum reimbursed price, as the company filed a litigation case to drop the government’s action. On June 23, Korea’s Ministry of Health and Welfare (MOHW) has initially decided to lower the pricing of Lipiodol as the generic drug Fattiodol by Dongkook Pharmaceutical was listed. According to the government’s calculation of reimbursed drug price, MOHW authorizes adjustment of maximum prices of first-in-class drug and other products with the same administration method, substance and formulation when a generic drug is listed. The initial adjustment of the pricing would have lowered the price of Lipiodol in 12.8 g/ 10 mL dose at 190,000 won to 133,000 won by 30 percent from July 1. And the premium pricing benefit on the original was supposed to be removed from May 1 next year, which would once again lower the pricing from 133,000 won to 101,745 won. However, the company has filed litigation against the government decision and now the court is taking over the decision. The original price of 190,000 won would be temporarily maintained until Aug. 24. But if the case extends in longer period of time, the suspension of the pricing reduction would also be prolonged. For now, MOHW plans to follow the court’s order until Aug. 24, and inform further changes accordingly.
- Policy
- Amgen's Eylea biosimilar has been approved for Phase III
- by Lee, Tak-Sun Jul 02, 2020 06:10am
- Amgen is conducting a phase III clinical trial on Eylea biosimilar in Korea. Recently, Samsung Bioepis' Eylea biosimilar has also been approved for phase III clinical trials in Korea, so the Korean market is expected to face strong competition between Big Pharma and native biosimilar companies. On the 29th of last month, the MFDS approved a multi-national clinical trial phase III for 'ABP-938' by Korea Parexel. An Eylea biosimilar, ABP-938 is being developed by Amgen. This is a randomized, double-blind, phase III clinical trial comparing the effectiveness and safety of ABP938 and Eylea (Aflibercept) in subjects with wet age-related macular degeneration. A total of 566 people from various countries will participate, and 50 people will be recruited in Korea. Clinical trials will be conducted at SMC, SNUH, AMC, Seoul St. Mary’s hospital, and Korea University Anam Hospital. Eylea, along with Lucentis, is the world's most used treatment for macular degeneration, licensed in March 2013. Based on IQVIA, last year's sales amount was ₩46.8 billion. Competition for the development of biosimilars is intensifying as patents expire in the US this year. Samsung Bioepis, SCD Pharm, and Alteogen are developing as domestic pharmaceutical companies, and Amgen and Mylan have entered the development competition as US companies. As a domestic clinical trial, Samsung Bioepis' biosimilar was approved for phase III on the 11th of last month along with Amgen. Alteogen is undergoing clinical trial phase I in May last year. SCD Pharm announced in May that it had been approved for phase III clinical trial by the US FDA. It is expected that sales competition will intensify as Big pharma such as Amgen have recently entered the development of biosimilars.
- Company
- Lee Heeseung to oversee MA-GA-PR at MSD Korea
- by Eo, Yun-Ho Jul 02, 2020 06:09am
- A former senior director at Novartis Korea, Lee Heeseung is to be appointed as a leader of the External Affairs department at MSD Korea. According to the pharmaceutical industry sources told the latest personnel decision by MSD Korea. Lee Heeseung would take over the position of External Affairs Lead from July 15. Three teams including Market Access (MA), Government Affairs (GA), and Public Relations (PR) are operating under the umbrella of the External Affairs department at MSD Korea. The soon-to-be Lead would oversee all three teams. Lead Kim So Eun, who has been in charge of the External Affairs so far, is newly appointed as a Translation Leader for MSD spin-off Organon. A new CEO would be appointed for the full-fledged spin-off company. MSD Korea insiders are speculating the latest personnel decision was made to appoint Kim as the CEO of Organon Korea. Lee Heeseung started her career from a PR agency Edelman Korea and joined Novartis Korea in 2016 managing the PR operation. In 2019, she worked at Visa Korea to manage marketing in Korea and Mongolia.
- Policy
- MFDS-EMA, temporary confidentiality agreement for COVID-19
- by Lee, Jeong-Hwan Jul 02, 2020 06:08am
- The MFDS announced on the 30th that it had temporarily signed a confidentiality agreement with the European Medicines Agency (EMA) when exchanging information for the diagnosis, prevention and treatment of related infectious diseases including COVID-19. This agreement has the significance of establishing a close information exchange system for external non-public information such as clinical trial information, examination data, and safety issues of drugs used or developed for COVID-19 treatment. On this day, the MFDS and the EMA will also discuss ways to collaborate, such as cooperation in the field of health and defense related to COVID-19 and international solidarity in vaccines and therapeutics development, through a videoconference summit. "We will support the rapid development of therapeutic drugs and vaccines through mutual cooperation in the global COVID-19 panthemic crisis," said Lee Eui-kyung. "With this agreement, we will establish a formal confidentiality agreement in the future to solidify our cooperation."
- Policy
- Pharmaceutical coverage list updated with Xolair and Akave
- by Kim, Jung-Ju Jul 02, 2020 06:08am
- As an allergic asthma treatment Xolair injection (omalizumab) was newly listed, the detailed criteria for healthcare reimbursement was also updated. Also the reimbursement standard on hypertension and hyperlipidemia combination drug added new ‘fimasartan plus atorvastatin’ combination due to the new listing of Akave tablet. Korea’s Ministry of Health and Welfare (MOHW) revised and updated the detailed pharmaceutical reimbursement criteria and method with the said changes coming in effect from July 1. ◆Xolair injection: The updated list added detailed standards and method of granting reimbursement for using Xolair injection listed from this month. A patient aged 12 and above with moderate to severe persistent asthma, whose symptoms are inadequately controlled despite administering inhaled-corticosteroid-and-long-acting beta agonist (ICS-LABA) or long-acting muscarinic receptor antagonists (LAMA) should qualify all following criteria to receive reimbursement; demonstrating immunoglobulin E (IgE) level over 161 IU/ mL prior to the treatment, skin test exhibiting positive or in vitro reactivity to a perennial aeroallergen, having a baseline forced expiratory volume in one second (FEV1) less than 80 percent, and has experienced acute asthma attack requiring systemic corticosteroid more than twice in 12 months before the treatment. A pediatric patient from age six to 12 with moderate to severe persistent asthma, whose symptoms are inadequately controlled with ICS-LABA or LAMA should qualify all following criteria to receive reimbursement; demonstrating IgE level over 76 IU/ mL prior to the treatment, skin test exhibiting positive or in vitro reactivity to a perennial aeroallergen, and has experienced acute asthma attack requiring systemic corticosteroid more than twice in 12 months before the treatment. For patients prescribed with Xolair injection before the listing (July 1), the reimbursement would be provided if all the required criteria are met and confirmed by medical record and healthcare provider’s diagnosis. The eligibility would be evaluated, according to the criteria in effect from July 1, by reaction assessment at week 16 followed by a series of continuous reaction assessments in every three to six months. ◆Akave tablet: A ‘fimasartan plus atorvastatin’ combination drug Akave tablet is also newly listed from this month, adding a new criteria on reimbursement standard for hyperlipidermia. The four combinations of hyperlipidermia treatments including ‘amlodipine plus atorvastatin,’ ‘amlodipine plus rosuvastatin,’ ‘candesartan plus rosuvastatin,’ and also ‘fimasartan plus atorvastatin’ are now covered.
- Company
- Nicetile's Rx has decreased by 40% over the past year
- by Chon, Seung-Hyun Jul 02, 2020 06:08am
- Sales of 'Acetyl-L-Carnitine (ALC)', a brain function improving agent, fell sharply. As a result of clinical re-evaluation, the market size has decreased by 40% in one year as indications have been reduced. The market for 'Choline alfoscerate', which is predicted for clinical re-evaluation, is also expected to change depending on the results. According to UBIST, a pharmaceutical research institute on the 28th, the outpatient prescription amount of ALC in the first quarter was ₩11.7 billion, a 37.9% decrease from the same period last year. Dong-A ST's ALC, generic for Nicetile, is approved for use in 'primary degenerative diseases' or 'secondary degenerative diseases caused by cerebrovascular diseases'. However, as a result of the clinical reevaluation ordered by the MFDS in 2015, the indication was deleted in July as it was unable to prove the efficacy of the 'primary degenerative disease'. Quarterly Rx amounts of ALC (Unit: ₩1 million, Source: UBIST) Acetyl-L-Carnitine (ALC) formulations have steadily formed a market size of nearly ₩20 billion every quarter. In the first quarter and the second quarter of last year, the prescription results were ₩18.9 billion and ₩17.9 billion respectively. However, the scale of prescriptions has dropped significantly since the reduction of indications. In the third quarter of last year, it fell 26.8% from the previous year to ₩13.5 billion, and in the fourth quarter of last year, it decreased by 38.0% compared to the previous year to ₩12.1 billion. This year, This trend has accelerated. It is analyzed that the prescription avoidance phenomenon has spread due to the reduction in indications according to the reevaluation results. The market for ALC products has been slower since the recent spread of COVID-19. In April and May last year, the prescription amounts of ALC were recorded at ₩6.5 billion and ₩6.4 billion, respectively. The ALC based products had a large reduction in prescription sales amount. Major ALC outpatients prescription amount (Unit: ₩ 1 million, %, Source: UBIST) Hanmi's 'Carnitil', which is currently in the top position in the market, has a 32.8% decrease in prescription performance in the first quarter to ₩3.7 billion. Dong-A ST's 'Nicetile ' decreased 29.4% from ₩2.7 billion in the first quarter of last year to ₩1.9 billion in the first quarter of this year. Daewoong Bio, Samik, and Myungmoon, all of which have the highest prescriptions, have significantly reduced their prescription amounts from last year. As a result of re-evaluation of the Choline alfoscerate, which has recently been decided on a clinical re-evaluation policy, such as Acetyl-L-Carnitine, it is predicted that prescription reduction will be inevitable if some indications are deleted. Choline alfoscerate is a drug that has three indications: ▲secondary symptoms due to cerebrovascular defects and degenerative or degenerative cerebral stromal psychological syndrome ▲emotional and behavioral changes ▲senile pseudoplastic depression. It recorded a total of ₩352.5 billion in prescriptions last year, and has established itself as a new source of revenue for pharmaceutical companies. The MFDS approved an item renewal for Choline alfoscerate in 2018, but announced that it would conduct a clinical re-evaluation of Choline alfoscerate on the 23rd as the efficacy controversy continued. The MFDS ordered 255 items from 134 companies to submit domestic clinical trial results. When conducting a clinical trial, it was instructed to submit IND by December 23.
- Policy
- α-GPC can be adjusted in advance up on to clinical plan
- by Lee, Tak-Sun Jul 01, 2020 05:56am
- The MFDS briefed on the clinical evaluation of Choline alfoscerate on the 30th.The MFDS announced its position for the first time in the clinical re-evaluation of 'Choline alfoscerate', a brain function improving agent. The MFDS said there were no procedural issues related to this evaluation, and the duration or number of tasks will be decided after the clinical plan is received. However, it emphasized that approval could be adjusted even before clinical re-evaluation. The drug safety evaluation department, the main department of clinical re-evaluation of Choline alfoscerate, held a briefing for reporters at the headquarters in Osong on the morning of the 30th. The briefing was attended by Kim Jung-yeon, director, and Yoo-bin Lee, Secretary of the Department of Pharmacy Safety Evaluation, and Kim Mi-jung, who conducted internal review of Choline alfoscerate formulations. The MFDS actively explained the suspicion of protests surrounding clinical re-evaluation on the day, but was cautious about specific schedules and methods. When the clinical re-evaluation decision was later than the reimbursement re-evaluation, Kim Jeong-yeon said, “The drug price re-evaluation and drug efficacy re-evaluation were operated separately.” Although communication between agencies was different, the timing of the decision was different because the decision range was different. She added, "When conducting a clinical reevaluation, we do not consult with the MOHW regarding the drug price." The Central Pharmaceutical Affairs Review Committee said, it was not true that there was no vote. "The committee asked whether the clinical re-evaluation of Choline alfoscerate approval was conducted, and all agreed," said Kim. "We plan to open a committee on the validity of the proposal and decide whether to target it." The committee decides when a majority (2/3) or more agree, and the clinical re-evaluation of Choline alfoscerate is 'all agree'. However, the MFDS explained that the future schedule and direction should be reviewed by reviewing clinical plans from companies by December 23. "The number of clinical tasks for each indication and the time period to set the plan must come in and it is difficult to determine whether or not dementia is present even in the first indication," said Lee Yu-bin. "Choline alfoscerate is an old item that has been approved for 95 years, and its efficacy and effectiveness are wide in current standards. If the company prepares a clinical plan with specific indications, it will be possible to adjust the permit even before re-evaluation." "When conducting clinical trials for patients with dementia, it can be done alone or in combination with other drugs, and although there are some standards internally, it is necessary to look at the data submitted by the company," she said. She said that if there is a new overseas basis among domestic clinical reevaluation, it can be used as a reference. The MFDS plans to clarify the special reevaluation target in the future. In this regard, it is an explanation that the details of the reasons for selection have not been detailed in the past, and have not been conducted in connection with the re-evaluation of Choline alfoscerate. "In the future, we will select a special reevaluation target by reviewing it according to standards," said Kim Jeong-yeon. "Choline alfoscerate needs to be validated by the current standards even if there were no problems 25 years ago according to the standards at the time," he said.
- Opinion
- [Reporter’s view] Listed drug reevaluation, now what?
- by Lee, Hye-Kyung Jul 01, 2020 05:56am
- The Korean health authority issuing a statement on reducing choline alfoscerate coverage is just a beginning. On June 11, Health Insurance Review and Assessment Service (HIRA) Drug Reimbursement Evaluation Committee (DREC) announced the decision to raise the patient copayment rate on choline alfoscerate, which has been covered by the National Health Insurance so far, from 30 percent to 80 percent for the effect and benefit of treating neurometabolic disease, emotional and behavioral change, and senile pseudo-depression. Increasing the copayment rate means the authority is to narrow the coverage on the drug. The selective reimbursement on the drug would impose 80 percent of copayment rate. The original full coverage would be limited the indication treating severe dementia case among the patients showing secondary symptoms of cerebrovascular insufficiency and degenerative brain-organic psychiatric syndrome. HIRA revisited the cost-effectiveness of choline alfoscerate products by studying the clinical efficacy, alternative options, and administration cost of the drug based on textbooks, clinical guideline, Health Technology Assessment (HTA) and clinical research literature (SCI, SCIE). Reviewing the clinical evidence and other considerations like social demand focusing on financial impact, medical importance and patient’s economic strain, the reimbursement on the drug except for the dementia indication was switched to selective reimbursement. Regarding the reevaluation result of the already-listed drug, a pharmaceutical company with a drug subject to reimbursement adjustment may appeal the decision for 30 days. Accordingly, the final decision on the coverage reduction would be enforced in coming August at earliest, after undergoing DREC re-deliberation and Ministry of Health and Welfare (MOHW) Health Insurance Policy Deliberation Committee (HIPDC) review. The government’s announcement has been expected since the National Health Insurance Master Plan was disclosed. MOHW has hinted of a listed drug reevaluation that generally takes account of clinical efficacy, financial impact and foreign country reimbursement status of the listed drug, as the ministry claimed reimbursement adequacy reevaluation mechanism reflecting the clinical efficacy was missing so far, unless the Ministry of Food and Drug Safety (MFDS) removes the coverage. For about a year, the public raised many issues regarding the first target of the reimbursement reevaluation. The reevaluation on choline alfoscerate was mentioned during the National Assembly Audit last fall, and eye drops were also mentioned as a target as well. However, it was narrowed down to the dementia treatment alone, as the eye drops have ongoing legal case. The pharmaceutical industry is reactively seeking for responsive plan after the announcement by HIRA DREC. Some say they would go as far as filing an administrative litigation to halt the execution, but it could be too late in the end. HIRA could have selected the second and the third listed drugs to reevaluate following choline alfoscerate. The next target would highly likely to be a drug prescribed as a supplement and not for unique effect or benefit. The pharmaceutical industry’s next action should be trying to predict the next target drug and concentrating on how to demonstrate clinical efficacy, cost-effectiveness and social demand better.
- Company
- European license for Avastin biosimilar is imminent.
- by Chon, Seung-Hyun Jul 01, 2020 05:55am
- Samsungbioepis Samsung Bioepis said on the 28th (local time) that it received a positive opinion on the approval of ‘Avastin biosimilar, Aybintio' from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). It received positive feedback from the CHMP about 11 months after the launch of EMA's marketing authorization review in July last year. As a result, Samsung Bioepis expected that it would be able to obtain an official sales license after a final review by the European Commission (EC), which usually takes 2-3 months. Avastin, the original for Aybintio, is a treatment for tumor diseases sold by Roche, Switzerland. In Europe, it has indications such as metastatic colorectal cancer, non-small cell lung cancer, and metastatic breast cancer. Avastin's global market sales last year amounted to about ₩8.5 trillion, of which Europe accounts for about a quarter. Amgen’s and Pfizer’s Avastin biosimilars are currently licensed by the United States and Europe. Among Korean companies, Celltrion is conducting Phase III clinical trials of Avastin Biosimilar. Samsung Bioepis announced the results of Phase III clinical trials of Aybintio at the regular conference of the European Society for Medical Oncology in Barcelona, Spain last September. Aybintio proved the equivalence of risk ratio of best ORR2 to the original drug through a study of a total of 763 non-small cell lung cancer patients. Aybintio is the fifth biosimilar product from Samsung Bioepis. In November of last year, the U.S. Food and Drug Administration (FDA) launched an approval test. Samsung Bioepis currently treats anti-cancer drugs such as 'Benepali' (Enbrel biosimilar), 'Imraldi' (Humira biosimilar), 'Flixabi' (Remicade biosimilar), and ‘Ontruzant' (Herceptin biosimilar) in Europe. "The company's R&D capability has been proven once again, and it has opened up the possibility of further expanding the treatment benefits of cancer patients through high-quality biopharmaceuticals," said Koh Seung-han, president of Samsung Bioepis.
