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- 2025-12-24 09:59:33
- Policy
- Hanmi's Cossac was voluntarily withdrawn
- by Lee, Tak-Sun Jun 26, 2020 06:23am
- Cossac, which was once a representative medicine of sinus cold, disappeared. It was predicted when Hanmi switched marketing to 'Cossac-L', an upgraded item when it switched to Pseudoephedrine combination drug. However, since products converted to precription drugs at that time did not recover sales during OTC, it is understood that the re-classification of Pseudoephedrine combinations has weakened competitiveness. According to the industry on the 25th, 'Cossac' (Cetirizine HCl + Pseudoephedrine HCl) was voluntarily withdrawn on the 24th. As Hanmi strategically launched the upgraded drug 'Cossac-L' (Levocetirizine HCl + Pseudoephedrine HCl) in 2014, targeting the Prescription drug market, Cossac’s sales was decreased. However, Cossac is the first licensed product among the combinations of Cetirizine HCl and Pseudoephedrine HCl, and it is a pity that it was a popular item in the pharmacy market before switching to prescription drugs. At the end of 2013, the MFDS switched the combination drug containing Pseudoephedrine 120 mg from OTC drug to prescription drug. Cossac was a product of ₩2 billion at the time. Hanmi has been keeping in the lead in related items, considering the conversion of prescription drugs and switching marketing to 'Cossac-L', an upgraded item. Cossac had no outpatient prescription sales last year. 34 out of 50 Pseudoephedrine combinations that have been converted from OTC to are considered to have retained permission in 2013. 16 items were withdrawn from the market. An official in the pharmaceutical industry said, "Re-classification in 2013 became a bad news as items like Cossac lost competitiveness when switching to prescription drugs."
- Policy
- Penalty on 14 drug companies failed to report serialization
- by Lee, Hye-Kyung Jun 26, 2020 06:20am
- 14 pharmaceutical manufacturers and importers are facing administrative actions for neglecting serialization reporting mandate. Penalties on the nine out of 23 companies announced initially were dropped as the authority accepted their appeals. According to the ‘2019 Semi-annual Report on Manufacturer and Importer Subject to Administrative Penalty,’ Korea’s Health Insurance Review and Assessment Service (HIRA) has decided to request administrative action on 14 companies. The penalty for violating serialization reporting mandate is imposed on pharmaceutical companies failed to meet semi-annual average shipment serialization reporting rate of 95 percent, or not complying to 100-percent serialization reporting rate for more than three times (reporting less than 95 percent for more than once is subject to penalty). After reviewing submitted explanatory evidence during the appeal period, 14 pharmaceutical companies and 246 items are subject to the action. The detailed list of the companies and items are kept undisclosed but informed to affected companies, individually. 178 companies that retrospectively reported the serialization after the reporting deadline would receive mitigated penalty. The mitigated level of the penalty would be at two-thirds of the full penalty level as stated in the ‘Regulation on Pharmaceutical Safety Management.’ The standard of administrative penalty and fine imposes one-month business suspension on a company failed to meet the serialization reporting rate for a first offense. Meanwhile, the penalty has been already imposed on 13 distributors that failed meet the shipment serialization reporting rate of 55 percent in the second half of last year. The standard of administrative penalty and fine stipulates 15-day business suspension on distributor for a first offense. The business suspension period extends a month, if the company violates the regulation for a second offense.
- Policy
- The goal is to develop a corona vaccine in next year
- by Lee, Jeong-Hwan Jun 26, 2020 06:20am
- The Ministry of Health and Welfare said it was supporting a domestic COVID-19 vaccine with the goal of developing in the second half of next year and in 2022. Corona vaccines such as MERS and SARS were not developed because of the low global demand for vaccines. On the 24th, the MOHW replied to the written question of Nam In-soon, Democratic Party Member of the National Assembly's Health and Welfare Committee. Nam asked the prospects, such as when to develop a domestic COVID-19 vaccine. He also asked why corona vaccines such as MERS and SARS were not developed. The Ministry of Health and Welfare said it was supporting the private sector with the goal of developing a domestic Corona 19 vaccine in the second half of 2021 or 2022. The reason for the undeveloped corona vaccine is that world demand is low. The high fatality rate of SARS was ended during R&D, and the low infectious MERS occurred only in the Middle East. The MOHW said, "The domestic corona vaccine is expected to be developed in the second half of next year and in 2022."SARS was ended during vaccine research and development, and MERS only occurred in the Middle East, so the worldwide demand was low and vaccines were not developed."
- Policy
- COVID-19 global clinical growth rate is about 17 times
- by Kim, Jung-Ju Jun 25, 2020 06:31am
- The global clinical trial of 'COVID-19' is steadily increasing. The increase rate is close to 17 times from March to the present. 15 cases have been approved in Korea, and research is actively underway, and as a whole, clinical trials of plasma devices using plasma of cured patients have surged 36 times. According to the trend of domestic and foreign clinical trials for the development of vaccines and treatments for COVID-19 vaccines updated by the Korea National Enterprise for Clinical Trials (Chairman Byung-Joon Bae) on the 23rd, there were 941 Drug Interventional Clinical Trials in COVID-19 newly registered at the National Institutes of Health (NIH) ClinicalTrials.gov on the 22nd. As of March 11, the total number of clinical trials increased 16.8 times from 56 cases to 941 cases. In particular, the number of sponsor-investigator trials increased by 19.1 times from 32 to 612, and it was analyzed that the sponsor-investigator trials aimed at the public interest in responding to the national public health crisis are driving clinical research. 905 were clinical trials related to treatment and 36 were clinical trials related to vaccines of the 941 clinical trials. Among clinical trials related to treatment, 591 cases of researcher's clinical trials, 297 of clinical trials of pharmaceutical companies, NIH and U.S. Fed-sponsored clinical trials were 17 cases, and the proportion of sponsor-investigator trials was 65.3%. In particular, clinical trials for blood plasma treatments using plasma of cured patients surged 36 times from 3 cases to 108 cases as of March 11th. COVID-19 related clinical trial plans approved by the MFDS were 15 cases on the 22nd of this month. 13 clinical trials related to treatments and 2 clinical trials related to vaccines were conducted, and 7 clinical trials (46.7%) were reported to be in progress. Meanwhile, information on the current status of clinical trials related to COVID-19 can be viewed and downloaded from the Korean Clinical Trial Portal (K-CLIC).
- Policy
- The addition of Lipiodol will end in next May
- by Kim, Jung-Ju Jun 24, 2020 11:07am
- Lipiodol (Iodized oil) was lowered by 30% due to the government's authority adjustment, and was confirmed until the end of the addition. This is because Fattiodol by Dongkook has been released. Anagre by Yuhan and Agrylin by Shire Plc have secured the same number of products, and the surplus, which has been retained since the end of the second half, will be reduced by 20%. According to the pharmaceutical industry, the MOHW is pursuing a partial revision of criteria for pharmaceutical reimbursed list and limit amount table'. It will take effect on July 1st once the amendment is confirmed. ◆Addition and Termination= 8 items are subject to next month's addition, of which 6 items add up to 59.5% of the same price as the highest price. The government adds 59.5% for the first year (first generic) to the price calculated at the same price as the highest price if the upper limit price of the same product is different from other companies. If the number of companies with the same product is 3 or less, it is applied until 4 or more. Daewoo Pharmaceutical's Pajilect 1 mg (Rasagilin mesylate), Ahn-gook’s Risirect 1 mg and Ilhwa’s Maorect 1 mg cost ₩ 2,083 for each item, 0.5mg dose of these products are ₩ 1,397 each. Addition is due until January 31 of next year. As of July 1st, 2 items were added. In the case of biopharmaceuticals, the total amount of biopharmaceuticals is added for 2 years from the date of the initial notice of the same biopharmaceuticals, and if the number of companies with the same product is less than 3 companies, the addition is maintained within an additional 1 year. By item, Yuhan's Anagre Capsule 0.5mg, dropped 21.1% from ₩2,748 to ₩2,167, and Shire's Agrylin capsule 0.5mg fell 23.5% from ₩2,832 to ₩2,167. ◆Compulsory arbitration and compulsory arbitration product addition end= As generics are listed, the upper limit value of the first listed product and the product with the same administration route, ingredients, and formulation as the first listed product is lowered by the government's authority adjustment. There are a total of 7 items that are cut in this way due to the adjustment of authority on the first day of next month. Huons’ Zopista (Eszopiclone) 1mg is ₩92, 14.8%, 2mg dose is 29.6%, 3mg content is 30% drop. Astellas Pharmaceutical's Betmiga PR 50mg (Mirabegron) is ₩498, and 25mg content is ₩332, each dropping by 30.1%. Hanmi's Liplatin 5mg/ml (Oxaliplatin) is also cut by 14.6% to ₩317,627. In particular, Guerbet Korea's Lipiodol Ultra Liquid, which had influence over the state audit due to the suspension of supply two years ago, will be cut by 30% from ₩193,000 to ₩133,000. The drug has emerged as a social issue in the aftermath of the supply disruption in the past, and the system has been strengthened so that the strengthening of supply responsibility for pharmaceutical companies can be selectively adopted in the contents of the current drug price agreement. Currently, Dongkook’s Fattiodol has been registered on May 1st, and domestic replacement items have been secured. All six items that were cut due to the next month's authority adjustment were products that had been added, and their closing date and the upper limit after the completion were also confirmed. As of next June 1, Zopista 1mg will be cut to 23.9%, ₩70, Zopista 2mg to 23.7%, ₩87 in the same month, and Zopista 3mg to ₩109 in the same month. Betmiga PR 50mg is reduced by ₩381, and Betmiga PR 25mg by 23.5% ,₩254, respectively, and Lipiodol falls by 23.5% to ₩101,745.
- Policy
- Promote to fast track bill for innovative companies
- by Lee, Jeong-Hwan Jun 24, 2020 06:14am
- Legislation is being put in place to give special cases of 'fast tracks' that speed up the approval and review process for new drugs developed by innovative pharmaceutical companies. The goal is to revitalize new drug development, grow innovation, and create jobs. On the 22nd, Ki Dongmin, a member of Democratic Party of Korea announced on the 19th that he had initiated a partial amendment to the Special Act on the Promotion and Support of the Pharmaceutical Industry. Current law certifies pharmaceutical companies that invest in research and development of new drugs over a certain scale to foster the domestic pharmaceutical industry as innovative pharmaceutical companies. Ki Dongmin, a member of Democratic Party of Korea said, “Innovative pharmaceutical companies are receiving national R&D preferential treatment, tax support, and research facility support, but they are not enough to receive practical help in developing new drugs.” Also, he added that a bill is needed to introduce fast tracks to new drug licensing and review developed by innovative pharmaceutical companies.
- Policy
- Reimbursement cut on prescribing multiple low-dose Verzenio
- by Lee, Hye-Kyung Jun 24, 2020 06:13am
- The healthcare benefit would be cut for prescribing multiple unit of Lilly Korea’s Verzenio 50 mg, instead of 100 mg or 150 mg doses. Both of Verzenio’s low and high-dose tablets are priced at 49,587 won, and more reimbursement is paid out on prescribing two 50 mg tablets instead or one 100 mg tablet or prescribing three 50 mg tablets instead of one 150 mg tablet. Korea’s Health Insurance Review and Assessment Service (HIRA) disclosed the list of cost-effective dose prescription subject as of June 2020. The list issued on June 22 listed total 2,899 drugs including 2,488 oral regimen drugs and 411 injections subject to reimbursement cut for prescribing multiple unit of lower-dose. The deduction would be automatically calculated when reviewing DUR and healthcare reimbursement billing. The revised review procedure would be enforced from Aug. 1. The list of cost-effective dose prescription subject was amended according to the list of reimbursed drug and maximum pricing updated on May 22. The combination of following oral regimen dose are subject to DUR-based benefit cut; Danagen’s Clicid tablet (250 mg/ 500 mg) and Donetek (250 mg/ 500 mg), Daewoong Pharmaceutical’s Dimenpezil ODT (5 mg/ 10 mg) and Dimenpezil tablet (5 mg/ 10 mg), CTC Bio’s Remecept tablet (5 mg/ 10 mg), Handok’s Aricept Evess tablet (5 mg/ 10 mg) and Aricept tablet (5 mg/ 10 mg), Huons Medicare’s Hunepezil tablet (5 mg/ 10 mg), Myung In Pharmaceutical’s Esven SR tablet (50 mg/ 100 mg) and Zos tablet (1 mg, 2 mg, 3 mg) and The U Pharmaceuticals’ Epinaon tablet (10 mg/ 20 mg). Moreover, following combination of dose are subject to benefit cut when prescribing multiple units of low-dose; Kolmar Pharma’s Lansira capsule (15 mg/ 30 mg), Lilly Korea’s Verzenio (50 mg/ 100 mg/ 150 mg), and Han Lim Pharma’s Prenexa SR tablet (50 mg/ 100 mg).
- Policy
- HIRA clarifies coverage standard of Imfinzi following CCRT
- by Lee, Hye-Kyung Jun 23, 2020 06:21am
- To receive healthcare reimbursement when using AstraZeneca’s immunotherapy Imfinzi (durvalumab), a patient has to receive platinum-based concurrent chemoradiotherapy (CRT). Affected patients should be aware that the reimbursement benefit would not be provided for using Imfinzi after using sequential CRT or induction chemotherapy. Korea’s Health Insurance Review and Assessment Service (HIRA) recently published answers to frequently asked questions related to the reimbursement listing standard. Imfinzi is indicated to treat patients with unresectable, locally advanced non-small cell lung cancer (NSCLC) without progression after platinum-based concurrent CRT. The healthcare reimbursement on the treatment was approved and listed from Apr. 1, in case of a PD-L1 positive (expression rate 1%) patient with unresectable locally advanced (stage III) NSCLC, who is in stable disease without progression after two cycles of platinum-based concurrent CRT, using the treatment within 42 days after the concurrent CRT. The reimbursement is provided for 12 months (not granted for maximum 24 months), only if the beneficiary has not received immune checkpoint inhibitor treatment such as PD-1 inhibitor. Regarding the reimbursement standard, HIRA informed, “Administrating the drug within 42 days after the completion of concurrent CRT means ‘within 42 days since the last day of the CRT.’” The government agency also clarified the platinum-based concurrent CRT means platinum-based concurrent CRT for radical purpose. To pass the reimbursement standard, a patient should receive radiation therapy administering over 54 Gy dose of radiation, or take weekly regimen CRT for over four cycles. The healthcare reimbursement is not granted to a patient using Imfinzi after other alternative therapies like sequential CRT. However, when using Imfinzi after induction chemotherapy followed by concurrent CRT, the healthcare benefit is provided if the two therapies used a same type of chemotherapy.
- Policy
- Minister Choi said, COVID-19 treatment may come out
- by Lee, Jeong-Hwan Jun 23, 2020 06:20am
- Choi Kiyoung, Minister of Science and ICT, said that as soon as possible, COVID-19 treatment could be developed within two months. Minister Choi said that the development of treatments through the ‘drug repositioning method’ to discover the effect of COVID-19 treatment of already-approved drugs has been revealed, not through the approval of new drugs through new clinical trials. However, vaccines is expected to require a relatively long time because it is impossible to apply the drug repositioning method and clinical trials are required. On the 19th, Minister Choi said on Kim Hyun-jung's News Show(CBS Radio). Minister Choi said "The Ministry of Science and ICT is collaborating with the MOHW and the KCDC. The Ministry of Science and Technology mainly conducts basic research on sources." Minister Choi explained that clinical trials take a long time, but the drug repositioning method can target drugs that have already been clinically developed, which can significantly speed up drug development and the drug repositioning is the use of a drug that has been previously approved for other uses as COVID-19 treatment." In particular, when asked about the timing of the development of COVID-19 treatment, he said "As soon as possible, the treatment may come out within 2 months, but it is not a medicine targeting COVID-19, but the effect may be reduced." It was diagnosed that the vaccine development time would require a lot of time compared to treatment. He said that vaccines are not able to reposition a drug, so it can take a very long time. Fortunately, many people around the world have researched and some vaccines are in clinical trials. It will be released in the first half of next year as soon as possible, and it is possible to come out in Korea in the second half of next year."
- Policy
- Generic for Daxas was applied
- by Lee, Tak-Sun Jun 23, 2020 06:20am
- Generic for Daxas (Roflumilast, AZ), which was approved in Korea, was first applied. Particularly, the generic that has been applied are noted because they also contain low doses (250 mcg). According to the MFDS on the 19th, Generics for DAXAS (Roflumilast), were applied for approval as of the 5th and notified to patent holder AstraZeneca. The generic includes 250 mcg dose, as well as 500 mcg dose, which are the same as Daxas. Daxas 250 mcg is available abroad, but is not sold in Korea. The domestic patent right of Daxas is valid until February 19, 2023. In last March, Sama Pharmaceutical succeeded in evading the patent right through a passive judgment on the scope of rights. In last August, Sama was approved for a bioequivalence test that compares the bioequivalence between Daxas and its generic. However, it was not disclosed whether Sama applied for this license or not. Daxas is used as a maintenance therapy for severe chronic obstructive pulmonary disease with chronic bronchitis with a history of worsening symptoms. Adults over the age of 18 take one tablet a day, regardless of meals. As of last year's IQVIA, sales amounted to ₩1.5 billion. Generic for Daxas has not been approved in Korea so far.
