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- 2026-05-20 10:25:11
- Policy
- Benefit of COVID-19 medications completed in just one day
- by Lee, Hye-Kyung May 27, 2020 06:04am
- In order to prevent the spread of COVID-19 infection, the HIRA is the one which is drawing attention. The DUR system was used to help medical institutions check immigration visit information from around the world, and it shortened the review period for drug benefit standards that took more than 80 days on average to one day, promptly resolving the benefits of COVID-19 treatment. Medicines that are approved for treatment of COVID-19 beyond the scope of the permits include Interferon (including pegylated interferon), Kaletra (Lopinavir/Ritonavir), Hydroxychloroquine, Ribavirin, Immunoglobulin G, Oseltamivir ,Zanamivir, etc. Based on the latest medical experience and expert recommendations, the HIRA decided to review the health insurance standards for COVID-19 related therapies in the shortest period (1 day) and review the reimbursement standards for these drugs one year later. In addition, the HIRA is in charge of managing the distribution and usage status, such as monitoring the current status of treatments and providing them to medical institutions and pharmacies. In addition to pharmaceuticals, the support of the HIRA for the treatment of COVID-19 includes the dispatch of 181 specialists, rapid application of diagnostic tests (average from 30 to 60 days → shortened to 2 days), quarantine treatment· emergency medical services·National Security Hospital·fee for phone consultations. The government also provided support for the development of government guidelines (announcements), development and provision of patient guidelines for living treatment centers, financial support for medical institutions, and policy materials. In particular, the mask purchase confirmation system, which enables the sale of day-of-day masks to check public information on the purchase history of masks and lead fair distribution by using a medical institution business portal connected to pharmacies, was evaluated to have played a major role in preventing the spread of COVID-19. In this regard, Kim explained that the mask purchase confirmation system is a marvelous program in the world, and the HIRA has been using the existing information and communication channels to make it easier and fairer for people to buy masks. Earlier in the occurrence of COVID-19, the HIRA announced the visitor information from all over the world by monitoring foreign immigrants and using the DUR · ITS system connected to medical institutions. and helped them establish the movements of the confirmed patients and connect them to 1339. The HIRA's efforts were introduced in the 'OECD Health Care Quality and Outcome Working Group', chaired by Sun Min Kim, president of the HIRA. The HIRA currently releases COVID-19 confirmed patients’ data to authoritative academia and government agencies around the world (applied to 1,232 people in 55 countries), provides the basis for diagnosis and patient treatment by physicians, and makes policy decisions such as prevention through case analysis. President Seon Min Kim said that he had been busy responding to COVID-19 since taking office, and emphasized that the HIRA has worked extensively to prevent early detection, treatment, and spread of COVID-19. He said that while suffering a global disaster called COVID-19, everyone is paying attention to how good the Korean health system is.
- Policy
- Ultomiris, a successor to Soliris, was approved in Korea
- by Lee, Tak-Sun May 27, 2020 06:04am
- Handok acquired a domestic item license for paroxysmal nocturnal hemoglobinuria (PNH) treatment 'Ultomiris'. Ultomiris is a product that was expected as a successor to Soliris, and is a drug developed by Alexion, like Soliris. In particular, it has attracted attention in that it has increased convenience by significantly reducing the number of doses than Soliris. On the 21st, the MFDS approved a license for Ultomiris (Ravulizumab) by Handok as a treatment for paroxysmal nocturnal hemoglobinuria (PNH) in adults on the 21st. Ultomiris is a drug approved by the U.S. Food and Drug Administration (FDA) in December 2018 and the European Medicines Agency (EMA) in July 2018. In Korea, a phase III clinical trial has been conducted in 8 patients. PHN disease is a rare, life-threatening blood disease characterized by the destruction of red blood cells by complement system, which is part of the immune system. In particular, 4 out of 10 people die within 5 years if not treated after diagnosis. It is known that there are about 200 patients in Korea. Soliris (Eculizumab, Handok), which was released in Korea in 2012, is the only treatment for PHN, and patients treated with Solis showed a 5-year survival rate improved to 95.5%. However, the price is expensive. In Korea, the insurance price is applied to ₩5.13 million per bottle. Accordingly, the total annual sales of the administered patients amount to at least tens of billions won. As of IQVIA, Soliris sales last year were ₩43.8 billion. The industry believes that the expected sales will be high if 'Ultomiris', a follow-on drug with improved administration frequency, is also released. Ultomiris is a drug that can be administered as a maintenance dose once every 8 weeks from 2 weeks after the initial dose. On the other hand, Soliris should be administered a maintenance dose every two weeks. It is expected that patients suffering from injections will be reduced as Ultomiris significantly reduces the number of doses than Soliris. Since it is a very expensive drug, it is expected to focus on negotiating a price with the government after the approval.
- Policy
- Chloroquine was approved for export due to COVID-19
- by Lee, Tak-Sun May 26, 2020 06:06am
- #iUnder the influence of COVID-19, the approval of Chloroquine for export used as a therapeutic agent has been followed. It seems that domestic pharmaceutical companies are targeting overseas exports and making items due to the worldwide pandemic phenomenon. According to the MFDS on the 25th, permission to Chloroquine and Hydroxychloroquine for export reached 12 items in five companies this year. Starting with Korea Prime Pharm, on the 4th, CTC Bio, Korea United Pharm, Ahngook Pharm, and Unimed have obtained export licenses. They seem to have been granted permission for the purpose of developing and exporting formulations by importing raw materials from overseas. An industry official said, "The MFDS' export permits simply by the documentation." Countries that require Chloroquine will be licensed for export, and later approved by local countries. " In Korea, 27 items have already been approved, so there is no problem with the supply and demand of Chloroquine. However, companies believe that there is a high likelihood of a treatment gap in a sudden infectious disease abroad, especially in developing countries. Chloroquine has been used since the early days of COVID-19 along with Kaletra ( Lopinavir + Ritonavir), an AIDS treatment, and is in high demand as it is encouraged in some countries. Although this agent is used for the treatment and prevention of malaria, it is used as the primary treatment for COVID-19 in the medical field. In Korea, the Central Clinical Committee recommends Chloroquine as a standard treatment through literature review, and thus Hydroxychloroquine is used. However, there is a controversial situation about the actual effect. Trump believes Hydroxychloroquine could be a "game-changer" against the coronavirus, there are reports that the death rate has increased. On the other hand, other studies have shown that there are few side effects and there is an actual effect of preventing COVID-19. Nevertheless, it is an analysis that demand from overseas countries is increasing. PMG Pharm decided to export about 2 million dollars worth of Hydroxychloroquine to South America. CTC Bio, which has been granted permission for export, said, "The global demand has surged, so there are a lot of needs in existing countries as well as in overseas customers." It is known that domestic pharmaceutical companies are considering exporting not only Chloroquine, but also generic for Kaletra. Kaletra, in particular, has opened up opportunities for generic companies as Abbvie, the original developer, abandoned the patent. It is said that some domestic companies are currently pursuing export licenses while importing raw materials from India and developing formulations.
- COVID-19 treatment guideline recommends hydroxychloroquine
- by Lee, in-bok May 26, 2020 06:06am
- Korean Association of Internal Medicine (KAIM) and its member academia have co-published a prescription guideline for treating patients with COVID-19. The guideline recommends hydroxychloroquine as the first preference, but does not recommend interferon or ribavirin monotherapy. The guideline also recommends Kaletra monotherapy, but it advises remdesivir and Avigan should be prescribed only for clinical purposes. Prescription guideline for patients with COVID-19 lists out all major treatment options On May 19, KAIM and related ten specialist academia including Korean Academy of Tuberculosis and Respiratory Disease unveiled a practice guideline on COVID-19 infection compiled for the members to refer recommendations fitting to the Korean healthcare scene. # The practice guideline talks about treatment options focusing on drug prescription for the patients with COVID-19. The pharmaceutical treatment guideline recommends 800 mg loading dose of hydroxychloroquine and maintaining the treatment with 400 mg dose afterwards. Twice-daily administration of Kaletra is recommended, and syrup form of the drug is suggested for pediatric patients. Type I interferon recently mentioned as potential option is not recommended to be used as a monotherapy for patients with COVID-19. In case type I interferon is needed inevitably, combined therapy with Kaletra should be considered. And among various types, IFN-β1b is advised as the most effective interferon. Moreover, the use of ribavirin is not suggested as a frontline treatment due to too many reports of adverse events. Only when hydroxychloroquine cannot be used as frontline treatment, ribavirin could be used in combination with Kaletra, but not as itself alone. Meanwhile, the guideline states remdesivir and Avigan, respectively registered as official treatment against COVID-19 in the U.S. and Japan should be prescribed strictly for clinical study purposes. Recommendations covering steroidal and other treatment option including convalescent plasma Besides the most talked about COVID-19 treatment options mentioned above, strategies of using other frequently used drugs are laid out as well. # First, the general use of steroidal drugs is ruled out. But urgent cases of asthma attack or severe septic shock in need of vasopressor are listed as exceptions to consider using the steroidal drugs. Intravenous immunoglobulin (IVIG) was also ruled out as a typical treatment against COVID-19. But again, in case of septic shock the responsible doctor is advised to make the call. The guideline discourages the use of influenza treatment zanamivir. The flu drug is exceptionally recommended when a patient is strongly suspected of having both COVID-19 and influenza. General use of antibiotics on confirmed case of COVID-19 is also not advised. However, when a patient is strongly suspected of bacterial infection along with COVID-19, the use of antibiotics is exceptionally advised. The guideline left the door open for the plasma therapy. Although it could be mentioned as a treatment option that can help with prognosis and progress of the disease, the guideline points out that the option lacks evidence from a large-scale study. Also, the guideline orders the prescriber to prioritize the selection of convalescent plasma donor, as the antibody level in the plasma could vary depending on the severity of disease the donor had or the time of plasma collection. KAIM official said, “So far, COVID-19 treatment did not have a set standard of care using antiviral drug except for supportive therapy,” and “we advise the responsible healthcare provider’s prescription based on their judgment should be the standard, but the guideline would be constantly updated with latest evidences found.”
- Policy
- Will Vyleesi known as Viagra for women be released?
- by Lee, Tak-Sun May 26, 2020 06:05am
- A product known as Viagra for Women conducts clinical trials in Korea. It is Vyleesi (Bremelanotide, injection type) introduced by Kwangdong Pharmaceutical. The MFDS approved a clinical trial phase III bridging study plan by Kwangdong Pharmaceutical on the 22nd. Bridging study is a test to prove whether new drugs developed in foreign countries have the same effect on Korean people. Vyleesi conducted a phase III clinical trial in 1,267 premenopausal women who were diagnosed with underactive sexual desire disorder in the United States after being approved by the US FDA in June last year. At the time, the clinical results showed an effect in improving sexual desire and reducing pain associated with low sexual desire. The clinical trial will verify whether this effect is the same for domestic patients. The domestic patient population is 146, and is limited to pre-menopausal women with or without hypoactive sexual desire disorder (HSDD). The clinical trial will be conducted at Korea University Hospital in Seongbuk-gu. In 2017, Kwangdong Pharmaceutical signed a license agreement with Palatin Technologies, an American developer of Vyleesi, and obtained a sales right in Korea. The drug is a disposable pen-type subcutaneous injection, which is self-administered medication. The company has passed the bridge study and aims to release it in Korea around 2022. An official from the company said, "We expect Vyleesi to greatly contribute to improving the quality of life for women."
- Company
- Prevenar13 by Pfizer sales increased 50%
- by An, Kyung-Jin May 26, 2020 06:05am
- Prevenar13 Pfizer's pneumococcal vaccine 'Prevenar 13' had a high sales. It is evaluated that reflex profits appeared as anticipation for the effect of preventing pneumonia increased due to prolongation of COVID-19 outbreak. According to the drug research agency IQVIA on the 21st, 'Prevenar 13' sales in the first quarter increased 52.2% to ₩17.6 billion, compared to ₩11.6 billiona year earlier. After the fourth quarter of last year, the quarterly sales exceeded ₩17 billion for the second consecutive quarter. Privenar 13 peaked in sales in the fourth quarter, when demand for vaccination increased, and repeated the pattern of decreasing in the first quarter. However, in the first quarter of this year, sales increased rather than the fourth quarter of last year. This is the first time that Privenar 13's sales in the first quarter increased from the fourth quarter of the previous year. In contrast, sales of pneumococcal vaccine Synflorix pfs, which is prescribed to children, fell 37.6% YoY, and sales of pneumococcal vaccine Prodiax 23 for adults increased 4.3% YoY. Trend of quarterly sales of major pneumococcal vaccines (Unit: ₩1 million, Source: IQVIA) 'Prevenar 13' is a 13-valent protein conjugate vaccine (PCV13) that prevents infection against 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F). Pfizer was granted 'Prevenar' (PCV7) in 2010 to prevent pneumococcal disease caused by 7 pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F, 23F) in 2010. Six years of serotypes (1, 3, 5, 6A, 7F, and 19A) have been added to 'Prevenar 13'. It is a product that can be inoculated at any age over 6 weeks of age. Chong Kun Dang is in charge of distribution nationwide for adults, and for infants and toddlers, Korea vaccine is in distribution. It seems that the situation in COVID-19 had some influence on 'Prevenar' setting a new record in the first quarter. Although prevenar does not prevent COVID-19 caused pneumonia, Some experts argue that it can help weaken the symptoms of pneumonia. It is an analysis that the demand for inoculation in adults has increased. At the time of the first quarter of April, Pfizer's head office announced, "As the COVID-19 pandemic has reduced the number of patients visiting hospitals, most vaccination rates have decreased. On the other hand, sales of some medicines used for the purpose of preventing infection or treating symptoms of COVID-19 have increased, including 'Prevenar 13', sterilized injection products, and anti-infective agents. Currently, no vaccine is available to prevent COVID-19. As a result, overseas academia is actively recommending that high-risk groups vulnerable to COVID-19 follow the national immunization guidelines such as pneumococcal vaccine. The American Heart Association (ACC) recommended that patients with cardiovascular disease be considered for the simultaneous inoculation of pneumococcal vaccines and influenza vaccines to prevent secondary bacterial infections. The World Health Organization (WHO) has issued guidelines to provide flu vaccines and pneumococcal conjugate vaccines to workers in long-term care institutions such as rehabilitation centers. The reason for long-term care is that the elderly and high-risk patients are relatively vulnerable to infection.
- Company
- Improving access to Lenvima and its later-line treatment
- by Eo, Yun-Ho May 25, 2020 06:27am
- #1 The Korean pharmaceutical industry is keeping a close eye on the Cancer Deliberation Committee’s June meeting to discuss the coverage on later-line treatment following Lenvima treating liver cancer. The pharmaceutical industry sources reported the Cancer Deliberation Committee could talk about extending the access of patient with hepatocelluar carcinoma on Eisai’s Lenvima (lenvatinib) to second-line treatment. The medical experts have been in a heated dispute over the access of second-line treatment against liver cancer. When a patient is to choose Lenvima over Bayer’s Nexavar (sorafenib) for the NHI-covered first-line treatment, there is no later-line treatment with the NHI coverage. Before the launch of Lenvima, Nexavar was the only option for treating patients with liver cancer. Over a decade, Nexavar has been the only hope as many pharmaceutical companies have failed developing another treatment option. And then along came Lenvima that conducted head-to-head clinical study against Nexavar and demonstrated improved overall response rate (ORR) and progression-free survival (PFS). But its overall survival (OS) was not a significant improvement against sorafenib. Regardless of the OS result, Lenvima’s clinical evidences were meaningful. A novel treatment option for liver cancer is rare. For many years, sunitinib, brivanib, linifanib and erlotinib have challenged against sorafenib’s position to treat patients with liver cancer who cannot easily expect five-year survival. And eventually, they all have failed. , But Lenvima still lacks a second-line treatment option. On the contrary, Bayer has released liver cancer treatment Stivarga (regorafenib) and even received NHI reimbursement in Korea. Stivarga’s indication and reimbursement standard focus on ‘patients who have failed treatment through Nexavar.’ Basically, Lenvima threatened Nexavar’s position with superior ORR and PFS outcomes, but Nexavar has provided a later-line option in case it fails. Accordingly, the recently updated 2018 Korean Liver Cancer Association-National Cancer Center Korea Practice Guidelines for the Management of Hepatocelluar Carcinoa lowered the recommendation class of Lenvima than Nexavar. It caused a fierce conflict within the academic society, but the conclusion has been made. Although the U.S. and European medical experts recommend two drugs at a same class, the Korean healthcare professions have decided otherwise. Surely, there were many Korean specialists who argued the two treatments should be at a same level, and other academic society with reliable prescription experience has submitted a formal statement. Professor Lim Ho Yeong of Hematology and Oncology Department at Samsung Medical Center commented, “As the liver cancer does not have so optimistic prognosis, access on covered later-line treatments are integral and urgent. A treatment option with promising effect having a limitation, only because it lacks later-line treatment option, is regrettable.” Moreover, the professor added, “A retrospective analysis has recently confirmed Lenvima effectively prolonging OR in patients who have continued with later-line treatment after frontline Lenvima treatment. As a result, academic societies are also raising their voice again to enhance patients’ access to the treatment.”
- Company
- Erectile dysfunction treatment market suffered from COVID-19
- by An, Kyung-Jin May 25, 2020 06:26am
- (Clockwise from top left) Product of Palpal, Viagra, Gugu, and Cendom The well-established domestic erectile dysfunction treatment market was stagnant. As the sales of large products sold by Hanmi Pharm, Chong Kun Dang, and Pfizer decreased, the overall market size was lowered. According to the analysis, the market for erectile dysfunction treatment, which has a relatively low disease severity, has been suffered from the spread of COVID-19. According to the drug research agency IQVIA on the 25th, the size of the domestic erectile dysfunction drug market in the first quarter was ₩26.9 billion, a 4.8% decrease from the previous year's ₩28.2 billion. It was 9.5% lower than ₩29.7 billion in the previous quarter, showing the lowest level in a year and a half. COVID-19 outbreak seems to have had some impact on the contraction of the erectile dysfunction market, which has maintained quarterly sales of around ₩29 billion since the fourth quarter of 2018. It is said that the prolonged COVID-19 situation led to a decrease in patients' visits to the hospital and restrictions on sales and marketing activities, which prompted the market to stagnate. Quarterly sales of major erectile dysfunction treatments (Unit: ₩1 million, Source: IQVIA) Looking at the sales of major erectile dysfunction treatments, sales of large items such as Hanmi Pharm's 'Palpal', Chong Kundang's 'Cendom', and Pfizer's 'Viagra' decreased significantly. In the first quarter of the year, sales amount of Palpal was ₩5 billion, down 7.8% from the same period of the previous year. Sales fell by ₩1 billion (15.5%) from the previous quarter. 'Palpal' is a generic for Sildenafil released by Hanmi Pharm immediately after the expiration of Viagra in 2012. After defeating Viagra in 2013 and Cialis in 2015, it is selling well. The market share of all erectile dysfunction drugs in the first quarter was 18.6%. The decline in sales was bigger for 'Cendom'. 'Cendom' maintained the second place in sales in the first quarter of last year, selling ₩2.4 billion, down 11.2% year-on-year. Cendom (Tadalafil) is a generic for of Cialis that was released after the patent expired in September 2015. Since its launch, the market share has gradually increased, surpassing the original Cialis in the fourth quarter of 2017. In the 4th quarter of last year, it is surpassing the sales of 'Viagra' and is following the leading 'Palpal'. Despite the overall market shrinking, domestically developed generic products were relatively stronger than those of multinational pharmaceutical companies. 'Viagra' by Pfizer had a 15.8% year-on-year decrease in sales in the first quarter, with ₩2.1 billion, which widened the gap with the second place 'Cendom'. The sales of Cialis' of Lilly in the first quarter was ₩1.5 billion, down 10.6% from the same period last year. This is about a quarter of sales in the first quarter of 2015. Since February 2018, after dealing with Cialis' domestic distribution, marketing, and sales activities in February 2018, Handok’s sales has not been rebounded. This is in contrast to the sales of another generic product, Hanmi’s Gugu and Donga ST's 'Zydena' (Udenafil), which increased slightly compared to the same period last year. In the first quarter, 'Gugu' took the fourth place, selling ₩1.8 billion, a 6.8% increase over the same period last year. In the same period, 'Zydena' sales rose 3.1% YoY to ₩1.6 billion, surpassing 'Cialis' and took the 5th place. The industry says that the erectile dysfunction treatment market is less vulnerable to external factors such as infectious disease epidemics because it has a lower severity and less essential nature than chronic diseases such as hypertension and diabetes. According to a recent analysis by Korea IQVIA, cardiovascular products such as angiotensin receptor blockers (ARB) hypertension drugs and lipid lowering agents have maintained unchanged growth before and before the COVID-19 epidemic, whereas systemic anti-infective agents, musculoskeletal systems, and urinary system drugs are all pharmaceuticals. It was found that it did not reach the market growth rate. An official from IQVIA in Korea said, “In the first quarter, the entire pharmaceutical market recorded sales and growth that were more than expected, but the urinary genital market had a slower growth rate than usual. "The main reason is that quarterly sales growth was not as good as before, and sales of hormone-related products decreased in the outpatient market."
- Company
- Pfizer stopped Duavive due to quality problems
- by Kim, Jin-Gu May 25, 2020 06:26am
- DuavivePfizer Pharmaceuticals voluntarily recovers its own menopausal treatment drug Duavive. This is based on the identification of potential quality problems in the results of self-investigation. On the 21st, Pfizer Pharmaceuticals requested each drug distributor to discontinue certain lot numbers of Duavive 0.45mg / 20mg folowing as ▲DC5278 ▲CW7990 ▲CG3243 ▲AG5438 ▲AG6437 ▲X34636 ▲W78860 ▲W78858 ▲T42330 ▲T34122 etc. Duavive is a medicine used to prevent osteoporosis and treat menopause symptoms. According to the drug research institute IQVIA, the sales amount last year was about ₩ 6.9 billion. Pfizer confirmed the potential impact on product quality and said the reason for asking to stop shipping. Next, the company said, “The product with the corresponding manufacturing lot number will be voluntarily recovered as soon as possible and the shipment would be stopped to minimize the distribution of the manufacturing number before proceeding with the recovery”. In this regard, an official from Pfizer Korea said, “It is not related to the safety and effectiveness of the drug, and I think there were some problems in manufacturing the product with the corresponding manufacturing number in a factory located in Ireland.”
- Company
- Alvogen Korea secures domestic rights for Seroquel
- by An, Kyung-Jin May 25, 2020 06:26am
- Alvogen Korea took over the domestic rights of the drug 'Seroquel' (Quetiapine), a treatment for schizophrenia. Alvogen Korea announced on the 21st that it has signed an exclusive distribution and marketing contract for 'Seroquel' and 'Seroquel XR' with Luye Pharma in China, and approval of the domestic license has been completed. Seroquel and Seroquel XR are atypical antipsychotic drugs with antidepressant properties. It is used alone or in combination therapy to treat schizophrenia and bipolar disorder. During the drug investigation period, the total sales of Seroquel last year were ₩12.9 billion, based on the IQVIA. Alvogen Korea has been supplying Seroquel and Seroquel XR to the domestic market since 2015 through exclusive domestic sales contracts with Astrazeneca Korea. Astrazeneca sold two products to Luye Pharma in 2018, and this agreement will allow Alvogen Korea to secure all rights to the license, exclusive distribution and marketing in Korea. Alvogen Korea plans to strengthen its position in the central nervous system (CNS) treatment market. Lee Jun-su, CEO of Alvogen Korea, expects stable and continuous growth in the market while securing expertise in the area of central nervous system treatment with this agreement. He said the company will try to contribute to improving the treatment of patients suffering from the spread of COVID-19.
