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- 2026-04-17 08:54:41
- Policy
- ‘Korea Passing’ Xolair returns for second attempt on DREC
- by Lee, Hye-Kyung Mar 10, 2020 06:29am
- Although it abruptly dropped out from pricing negotiation in Korea for a better reimbursement listing in China, Novartis’ asthma treatment Xolair (omalizumab) has crossed the first threshold of reimbursement listing in Korea. Daehwa Pharmaceutical’s Liporaxel would proceed to negotiate pricing with National Health Insurance Service (NHIS) if it accepts the weighted average pricing proposed by Health Insurance Review and Assessment Service (HIRA). HIRA (President Kim Seung-taek) has unveiled the result of pharmaceutical reimbursement feasibility review during the third Drug Reimbursement Evaluation Committee (DREC) session of 2020. Novartis’ allergic asthma treatment Xolair injection and Xolair prefilled syringe, AbbVie Korea’s treatment for moderate to severe psoriasis Skyrizi prefilled syringe (risankizumab), Lilly Korea’s breast cancer treatment Verzenio tablet (abemaciclib), and Daehwa Pharmaceutical’s stomach cancer treatment Liporaxel solution (paclitaxel) were on the committee’s agenda. DREC acknowledged the feasibility of reimbursement for Xolair, Skyrizi and Verzenio. The respective companies would be negotiating their pricing with NHIS for 60 days, when Ministry of Health and Welfare (MOHW) gives an order for the negotiation with NHIS. As for Xolair, it received DREC’s nod in 2018 and started negotiation with NHIS immediately, but it withdrew the listing process amid the negotiation on Dec. 20 of the year. The global company has given up on reimbursement listing in Korea back then, as the Chinese health authority has decided to refer to drug pricing in Korea right when the negotiation with NHIS initiated. The incident was branded as the first ‘Korea Passing’ phenomenon. After receiving reimbursement on Xolair in China last year, Novartis has been working on pharmacoeconomic analysis for the second attempt at reimbursement listing in Korea. Started the reimbursement listing procedure from 2018, Liporaxel would earn the rights to initiate drug pricing negotiation with NHIS if it accepts the HIRA’s evaluated pricing (weighted average pricing). The treatment would remain non-reimbursed, unless Daehwa Pharmaceutical takes the proposed pricing. The outcomes of DREC deliberation could be altered depending on changes in detailed reimbursement scope and standard item, and also changes in approved item’s label and license termination. Due to the COVID-19 outbreak, the DREC meeting sessions from Mar. 3 to 4 were substituted to on-paper review.
- Company
- How long do pharmaceuticals have to work from home?
- by Kim, Jin-Gu Mar 10, 2020 06:28am
- More domestic pharmaceutical companies have decided to work from home to prevent the spread of COVID-19. Following Dong-A ST and GC Pharm, Chong Kun Dang joined the ranks of all employees from home. Chong Kun Dang said five days ago that it will start working from home for all employees. it will be up to the 13th. Chong Kun Dang and its affiliates do not go to the office, not only salespeople, but also internal employees, except for core employees. On that day, the entire headquarters became quiet as if it had been muted. Among major domestic pharmaceutical companies, Dong-A ST, LG Chem, and GC Pharm made a decision to work from home. In the case of Dong-A ST, the trigger was COVID-19 confirmed staff at the Yong-in R&D Center. On the 27th of last month, Dong-A ST research staff member A was confirmed and the Yong-in research center was closed. Dong-A ST decided to work from home at the head office on the next day. GC Pharm has joined the full-time workforce from the 2nd. This was a quick response to concerns over community infections, including the first confirmed person in Yongin, Gyeonggi-do, on the 23rd, and five more people confirmed by March 1. With Chong Kun Dang's joining, the decision to work from home is spreading among domestic pharmaceutical companies. A Chong Kun Dang official said, “We extended the telecommuting scope to all employees to prevent the spread of COVID-19 and protect our employees”. Most multinational pharmaceutical companies have already started telecommuting. At the end of last month, when the KPAI conducted a questionnaire, none of the 10 surveyed members went to work normally. It has been confirmed that all employees have worked from home or only those who wish to work from home. Other pharmaceutical companies that have not made a full-time telecommuting decision are responding flexibly. Only sales workers with a high risk of infection or transmission will be telecommuted or decided to work from home at the discretion of the team leader or general manager. It includes Yuhan Corporation, Daewoong pharm, Hanmi, Ildong, Jeil Pharm, Dong-Wha, Daewon, Korea United Pharm, LG Chem, Whan In Pharm, and Samil-Pharm. ◆Distributed working system' spreads instead of working from home, every other day Recently, more and more companies are doing distributed work instead of working from home. Two or three teams are organized to work from home once every two days or once every three days. Samjin Pharm has all of its sales staff working from home. In the case of in-office work, two groups are organized to distribute work days. Kolmar Korea and CJ Healthcare are similar. Internal workers have been telecommuting every other day since this week. SK Chemicals has been working in three groups and working from home on every fourth day since the 4th. The first group works at home and the other two companies. Instead, they ordered them to work in different spaces, even if they went to work. It is a compromise between normal work and telecommuting. A pharmaceutical company who introduced distributed work explained, "It is intended to reduce the inefficiency caused by all employees' telecommuting work, and to prevent large gaps in case of COVID-19 confirmed patients". ◆No choice but to determine the length of work from home based on the situation While a few pharmaceutical companies have entered the COVID-19 special action, attention is focused on 'How long will telecommuting work period?' Companies that actually decide to work from home are notified whether they are working from home on a weekly or daily basis. The complaint is currently being raised, but the company is in a difficult position to announce in advance because the situation is so urgent. A domestic company official who is working at home or working at office voluntarily said, “The decision, including the extension of telecommuting, is at the discretion of the company's senior management, which is difficult at this point and the extension will be decided based on the situation”. An official at another pharmaceutical company that has started all employees' telecommuting said, “Work from home was decided until this week. The COVID-19 situation is very urgent, and if the company goes to work normally, it is being discussed to exclude all salespeople or sales workers in Daegu-Gyeongbuk region first”. In response to this, the government announced in a regular briefing on the 5th that the number of new COVID-19 confirmed patients will gradually decrease. According to the government, the number of confirmed patients has declined to 400 at midnight on the 5th after peaking at 813 on last Feb 28. As the mass inspection of Shincheonji Believers in Daegu was completed, it is carefully judged that the biggest peak was passed. Daily COVID-19 confirmed patients status (Based on March 5, 0:00, Source: the KCDC) The government has delayed the opening of kindergartens and elementary and high school schools nationwide by Mar 23. Given this situation, it is cautious that each pharmaceutical company will resume its normal work in the second week (March 9) or third week (March 16). An official of a domestic pharmaceutical company said, “We are waiting for the government to lower the crisis alert stage from serious to boundary. However, it is not easy to continue working from home without worry. We expect to return to normal work before the 23rd, the beginning of elementary and secondary school”. A foreign pharmaceutical company official who has been working from home for about a month said that the employees who are working from home are complained of decreased work efficiency and increased fatigue, and the company is discussing a resumption next or next week.
- Company
- Verzenio pricing negotiation to overlap with Ibrance
- by Eo, Yun-Ho Mar 09, 2020 08:00am
- Ibrance and Verzenio After passing Ibrance, Health Insurance Review and Assessment Service (HIRA) continuously passed Verzenio. The newly passed drug would likely to overlap its pricing negotiation with Ibrance. Korean pharmaceutical industry source reported Lilly’s cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor Verzenio was given a green light for National Health Insurance (NHI) reimbursement from HIRA’s Drug Reimbursement Evaluation Committee (DREC). The medication is in process of settling risk sharing agreement (RSA) to receive reimbursement to treat patients with HER2- advanced breast cancer in combination with AstraZeneca’s Faslodex (fulvestrant). As soon as Ministry of Health and Welfare (MOHW) gives a nod, Lilly would initiate negotiation with National Health Insurance Service (NHIS) for 60 days. Pfizer’s Ibrance, already at the negotiation table with NHIS after DREC’s clearance, would overlap its negotiation period with Verzenio. And as Faslodex’ financial impact evaluation data has been submitted, the two would be competing against each other intensely. On the other hand, Cancer Deliberation Committee has cleared another competitor, Novartis’ Kisqli (ribociclib), in last January. The industry is also keen on the third CDK4/6 inhibitor’s listing process. Ibrance’ efficacy of significantly improving progression-free survival (PFS) as a second-line therapy has been confirmed during PALOMA-3 clinical study. Besides for patients with early stage breast cancer, the CDK4/6 inhibitor showed consistent effect on patients with stage 4 metastatic breast cancer that affected their lungs and bones. As for Verzenio, recently completed MONARCH2 study attracted the industry’s interest as it not only improved PFS, but also improved overall survival (OS). The achievement was unprecedented for a DDK4/6 inhibitor. As a part of secondary endpoints, the OS of both pre and postmenopausal women was observed.
- Hospitals tighten their belts due to COVID-19
- by Lee. Ji hyun Mar 09, 2020 08:00am
- #In the metropolitan area, Obstetrics and Gynecology Hospital A operates from 9 am to 1 pm as gynecological and internal outpatients dropped sharply due to prolonged COVID-19 crisis. The small and medium 200 beds hospital, in the Seoul metropolitan area, has withheld a contract for one of five pediatricians. As usual, the hospital would have re-signed, but it was unreasonable to keep five pediatricians when the number of pediatric patients dropped sharply due to the recent COVID-19 crisis. #With the spread of COVID-19, first-line regional hospitals are tightening their belts due to fewer patients. In particular, since the situation may not improve, they are striving to minimize expenses such as labor costs. In fact, the bed operation rate of small hospital B is 40%. It's been down by more than half, considering that it's near 90% and full operation. The director of small hospital said that the number of patients declined so much that recruitment of nurses for March was withheld. In addition, the existing nursing staff also need to schedule the paid leave, so he is not even thinking about hiring a new nurse. With this situation, front-line small and medium-sized hospitals are in high demand for government-level support measures for hospital management damages caused by fewer patients. In particular, many small- and medium-sized hospitals whose patients have dropped sharply act as base hospitals in the region and most of the time, they set up screening clinics and operate relief care hospitals In fact, the leaders of Small & Medium Hospital who attended the COVID-19 emergency meeting hosted by the Korea Small & Medium Hospital Association (the KSMHA) presented difficulties in management. #Director of small and medium-sized hospital A said, "If the confirmed patient visits during the operation of the screening hospital, the local government will disclose the name of the specific hospital on the confirmation line, which will increase the difficulty due to the decrease in the number of hospital patients". Another small and mid-sized hospital director said, "Employment adjustment is inevitable due to the closure of wards or reduced sales, but paid leave is expected to make hospitals more difficult”. Young-ho Chung, chairman of the KSMHA, said, “Fortunately, Reimbursement will be preemptively paid, but there is a need for improvements to postpone loan repayment or loan credit guarantee funds at low interest rates and to increase the medical loan cap”. He added, “There is also a need to increase of benefits for outpatients and inpatients other than the respiratory patients who visited the screening clinics and relief care hospitals, in this case, however, reimbursement concentration phenomenon may occur to the advanced general hospital, which requires correction”. #As the management concerns of hospitals have risen, the Korea Hospital Association has introduced a policy to support overtime work as well as employment retention support policies. Medical institutions that suffered from management difficulties due to the reduction of patients were required to apply for employment maintenance support fund, and they were asked to use special extended working systems for more than 52 hours a week for medical institutions lacking medical personnel due to the recent surge in confirmed patients. Employment maintenance support fund is a system that supports a part of the labor cost when a business owner, whose employment adjustment is inevitable due to temporary management difficulties, takes measures to maintain employment such as temporary closure or leave of absence. The Ministry of Employment and Labor intends to apply this to medical institutions that are expected to experience difficulties due to COVID-19. Eligible employees are required to take 2/3 or 1/2 of their usual labor costs (₩60,000 per day, up to 180 days a year) if the hospital is closed for more than 20% of their working hours or leave of absence for more than one month. On the other hand, medical institutions that have no choice but to increase the working hours of medical staff due to the successive check-ups of Daegu and Gyeongbuk can use a special extended work permit system. As of March 2018, the 52-hour workweek was implemented from 68 hours per week, so the working hours of employees in frontline medical institutions were set to 52 hours per week. The Ministry of Employment and Labor permits extended hours of work up to 12 hours per week, in order to deal with temporary and unusual situations, such as natural disasters such as infectious diseases and disasters. In response to this, the officials of the Korea Medical Association said, "The long-term COVID-19 crisis is causing difficulties for front-line medical institutions. Therefore, we hope to minimize the damage by appropriately using the government system according to the situation".
- Company
- Tylenol leads the pain relief market
- by Kim, Jin-Gu Mar 09, 2020 07:59am
- Tyreno made the most sales in the antipyretic analgesic market last year. Tylenol 8hrs ER performed poorly due to safety controversy, but overall brand sales increased slightly as Tylenol sold more. Geworin, the second-largest product, has grown significantly in the last five years. However, the sales gap between the 1st and 2nd places is unlikely to narrow. 2018~2019 Sales Change of Major Antipyretic Analgesic Brands (Unit: ₩100 Million, Source: IQVIA) ◆Tylenol ranks first with ₩29.8 billion Tylenol 8hrs ER's sales impact was minimal. According to drug research institute IQVIA on the 5th, Janssen's Tylenol series posted sales of ₩29.8 billion last year. It is up 5.8% from 2018's ₩28.2 billion. Expanding the scope to the past five years, the increase is 7.8% from ₩27.7 billion in 2015. The change in sales of individual items is very interesting. The two flagship products, Tylenol and Tylenol 8hrs ER , are plotting opposite sales figures. First, Tylenol tablets are steadily increasing. The company recorded ₩11.7 billion in 2015, ₩12.3 billion in 2016, ₩13.1 billion in 2017, ₩14.5 billion in 2018, and ₩18.3 billion in 2019. On the other hand, Tylenol 8-hour ER is showing signs of slowing. The figure is decreasing every year, including ₩13.8 billion in 2015, ₩13.3 billion in 2016, ₩12.9 billion in 2017, ₩10.8 billion in 2018, and ₩8.5 billion in 2019. In 4 years, it has dropped 38.0%. Sales changes of Tylenol and Tylenol 8hrs ER in the last five years (Unit: ₩100 Million, Source IQVIA) This is attributed to the safety controversy of Tylenol 8 hour ER. This product has been constantly worried about liver damage caused by misuse. As a result, the Ministry of Food and Drug Safety implemented measures to strengthen safety in 2018. In the process, the Tylenol ER was renamed Tylenol 8hrs ER . In addition to Tylenol 8hrs ER, other slow-release tablets are observed to be on a similar path. Since 2015, Penzal's 8-hour ER has decreased by 19.3% and Maxibufen ER by 23.0%. ◆Geworin 25% increase over 4 years Samjin's flagship product, Geworin was followed. Geworin's revenue last year was ₩15.2 billion, up 9.7% from ₩13.8 billion in 2018. This is an increase of 25.1% compared to 2015, five years ago. However, the gap between the 1st and the 2nd places did not seem to narrow. The gap between Tylenol and Geworin remains around ₩15 billion, including ₩15.6 billion in 2015, ₩14.2 billion in 2016, ₩16 billion in 2017, ₩14.4 billion in 2018, and ₩14.7 billion in 2019. Sales changes of major antipyretic analgesic brands in recent 5 years (Unit: ₩100 Million, Source IQVIA) Third place was Hanmi’s Maxibufen. Last year, it recorded sales of ₩7.5 billion. It has been ranked third for five years in a row, but sales are on the decline. Compared with 2015 (₩8.5 billion), it decreased 11.7%. In addition to the Maxibu fen ER, the sales of Maxibufen are also on the decline. Daewoong Pharm's EZN series ranked fourth with ₩6 billion. Contrary to Maxibufen, the growth rate is steep. It is up 82.5% from last year's ₩3.3 billion. The ranking in the antipyretic analgesic market also jumped from eighth to fourth in the same period. In addition, GC Pharma's Taksen (₩5.6 billion), Ildong’s Carol (₩5.5 billion), Chong Kun Dang’s Penzal (₩5.5 billion), Ahn-gook’s Anyfen (₩5.2 billion), Samil’s Brufen, and Dong-A’s Champ were in the top ten. In addition to last year's rankings, the increase in sales over the last five years has increased for Tylenol, Geworin, EZN, Taksen, Carol, Champ, Advil, and Gnal-N. In particular, growth of Champ (246.6%), Gnal-N(91.5%), and EZN (82.5%) is noticeable. On the other hand, Maxibufen, Penzal, Anypen, Brufen, and Trisfen have generally lost sales. The reduction ranged from a minimum of 1.5% to a maximum of 61.7%.
- Policy
- What is the difference between Remdesivir & VSF
- by Lee, Tak-Sun Mar 09, 2020 07:59am
- There are two investigational drugs approved by the MFDS for COVID-19 patients as of the 5th. The first is the antiviral drug 'Remdesivir' of the US global pharmaceutical company Gilead Science, and the other is the antiviral candidate called 'VSF' of Korean bioventure Immunemd. However, the reasons for authorizing the administration of the two candidates to the patient are somewhat different. If Remdesivir is a commercial trial for commercial purposes, VSF is an emergency treatment. 'Remdesivir' is the first candidate for COVID-19 treatment for clinical trial Gilead is the best pharmaceutical company to make nucleotide analogue antiviral agents. So this Remdesivir is attracting more attention as a treatment for COVID-19.Gilead is the best pharmaceutical company to make nucleotide analogue antiviral agents. So this Remdesivir is attracting more attention as a treatment for COVID-19. Remdesivir was approved by the MFDS on the Phase III trial of COVID- 19 patients. The plan is to conduct 120 domestic and 75 severe patients at Seoul Medical Center, the NMC, and Kyungpook National University Hospital. The trial is a global clinical trial (total 1,000 patients worldwide), the first COVID-19 clinical trial conducted by a pharmaceutical company. The Remdesivir trial, which is conducted in 761 patients in Wuhan, China, is a clinical trial led by a researcher. In addition, a recent clinical trial launched in the United States is a clinical trial led by the National Institutes of Health. To be recognized as a formal treatment, Remdesivir must be validated in commercialized clinical trials. Once the trial has been completed, it is difficult to be approved as a formal treatment in the first half of this year. However, because COVID-19 occurred suddenly, it cannot be identified as a pandemic. Even if it is not approved as a formal treatment, it is meaningful to be used only for patients who are currently occurring for therapeutic purposes. Gilead Science Korea also said the trial is more humane for patient care opportunities than for immediate approval. However, if clear efficacy data are available in this clinical trial, the license can be applied as a formal treatment. Remdesivir is one of the nucleotide analogues that has had antiviral effects. Nucleotide analogs act as nucleic acid analogs in the synthesis of viral DNA to inhibit the growth of the virus. Gilead has a nucleotide-like blockbuster product that acts on antivirals, such as hepatitis B and HIV, including Viread and Stribild. Immunemd’s VSF approved for treatment for one patient on a humane basis On the other hand, Immunemd’s VSF, which is approved for therapeutic purposes, cannot be applied as a formal treatment with this data, even if it is effective after patient administration. This is because it is temporarily approved for therapeutic purposes and not for commercialized clinical trials. The MFDS has made an exception for the purpose of granting treatment opportunities to patients who do not have other treatment and have life-threatening diseases. The condition is to treat a patient with a serious life-threatening condition, such as terminal cancer or AIDS or to treat an emergency patient prescribed by the prime minister's order, such as life-threatening or no alternative treatment. VSF mechanism of action (provided by Immunemd) Immunemd’s VSF has been conducting Phase I clinical trials with antiviral drugs since 2018 at Seoul National University Hospital. Then, was approved on February 21 for treatment of COVID-19 confirmed patient who had no treatment, The company plans to administer a total of four (Day1/Day3/Day7/Day14) doses, and officials from Seoul National University Hospital, the MFDS, and Immunemd are conducting joint monitoring of drug effects and side effects after dosing. Immunemd added that it applied to the Food and Drug Administration on 4th last month to approve the use of a provider (Immunemd) for therapeutic purposes, which can be administered for up to 25 people, separately from those currently available only to individual patients. VSF binds to cells infected with viruses and regulates DNA damaging agents and tumor necrosis factors, thereby preventing infected cells from proliferating or inhibiting inflammation. Immunemd teamed up with Lonza, a British company, to develop a humanized version of VSF (hzVSF), which Lonza produces for clinical trials.
- Policy
- Off-label Mabthera use on NMO patient rejected
- by Lee, Hye-Kyung Mar 09, 2020 07:59am
- Non-reimbursed use of Mabthera injection (rituximab) on a female patient with neuromyelitis optica (NMO), who is planning on a pregnancy, has been denied. Korea’s Health Insurance Review and Assessment Service (HIRA) preliminarily reviews off-label non-reimbursed use of drugs to prevent using drugs lacking medical evidence or having safety risk. The detailed information regarding ‘Unapproved Use of Off-label Non-reimbursed Drug’ was recently disclosed by HIRA, which stated total 173 cases of off-label non-reimbursed use of drugs have been rejected including the latest three cases of Mabthera, Sirturo (bedaquiline fumarate) and Truxima (rituximab). HIRA informed on Mar. 5, a healthcare institute’s approval application to administer 375 mg of Mabthera once-weekly for four times, or to intravenously inject 1000 mg once-biweekly for two times, considering patient’s condition and drug’s adverse reaction and treatment effect, has been unapproved due to ‘insufficient submission of medical data.’ Currently, Mabthera has been approved to treat patients with lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, Wegener’s granulomatosis with polyangiitis and microscopic polyangiitis. Another healthcare institute has applied for a non-reimbursed use of Sirturo on an adult patient with mycobacterium tuberculosis lung disease (without general disease like severe underlying liver or renal disease) and on a patient with chronic and advanced nontuberculous mycobacteria lung disease not responding to existing treatment option. However, both of the applications were rejected as well. Due to insufficient medical data, the healthcare institute’s application to orally administer 400 mg of Sirturo everyday for first two weeks and to continuously administer half the dose for three times a week, was unapproved even though the institute said the administration would be stopped when the treatment fails. Lastly, the off-label non-reimbursed use of Truxima was turned down, because the submitted data of bioequivalent pharmaceutical lacked sufficient medical evidence. The off-label non-reimbursed use of Truxima was submitted initially to treat a patient diagnosed with inflammatory myopathy, who experienced adverse reaction or is refractory to existing steroidal treatment, immunosuppressant treatment, or immunoglobulin treatment.
- Company
- Fear of unstable Indian API supply spreads with COVID-19
- by Chon, Seung-Hyun Mar 09, 2020 07:59am
- Due to the outbreak of 2019 novel coronavirus (COVID-19), Indian government started limiting the export of active pharmaceutical ingredient. Pharmaceutical companies’ concern of supply shortage is now imminent as COVID-19 could impede pharmaceutical ingredient export from China and India in a long-term. According to industry sources on Mar. 4, the Indian government has decided to restrict the export of 26 active pharmaceutical ingredients (API) as of Mar. 3 (local time), because pharmaceutical shortage they are experiencing with COVID-19. The restricted export list includes pain reliever acetaminophen (paracetamol), vitamin and antibiotics. Indian companies would have to receive the government’s approval to export the APIs. Almost 10 percent of APIs exported from India is on the restricted list. India means to limit the pharmaceutical export before the country is faced with pharmaceutical shortage from COVID-19 outbreak. As most of APIs manufactured in India use chemical substance imported from China, the API manufacturing in India would be affected if China were to struggle exporting the substance due to the outbreak. Restriction on Indian-made API export could affect Korean pharmaceutical industry. API and finished product import volume by year (Unite: USD 1,000) Source: MFDS Korea’s Ministry of Food and Drug Safety (MFDS) said the total import volume of Indian-made pharmaceuticals reached USD 204.13 million in 2018, making it the tenth biggest pharmaceutical exporter to Korea. Although the Indian-made finished product takes up only five percent of overall pharmaceutical market in Korea, the export restriction would still affect Korea as most of the imported products are API used by Korean companies. In 2018, total of 195.59 million dollars of Indian-made APIs was imported, following the top export volume from China and Japan. The Indian API import volume has been constantly increasing over the years. The figure surged by 39.3 percent in seven years, starting from 140.43 million won in 2011. The API import volume from India was at sixth place in 2011, following Japan, China, Italy, Germany and France, but the Korean pharmaceutical industry’s dependency on India has not ceased to grow. Top API exporting countries to Korea by year (Unit: USD 1,000) Source: MFDS Along with Chinese-made APIs, Indian-made imported API volume has gone up the most, mostly because of the low cost. Experts assess Korean pharmaceutical companies have been increasingly preferring APIs from China and India to reduce production cost. Some point out the Korean companies’ demands for inexpensive APIs have soared as the Korean government continuously lowered pricing of finished products and did not sufficiently compensated for their value, while their sales marketing activities have been strained with tightened regulation against illegal rebate. But also, the enhanced quality of Chinese and Indian-made APIs has influenced the companies’ preference. Pharmaceutical companies are now calculating the impact of Indian API export restriction. The companies fear of the direct impact on pharmaceutical manufacturing caused by Indian-made API supply issues, as COVID-19 outbreak has already affected API supply from China. The Korean companies are already struggling with Chinese API supply of stomach ulcer treatment cimetidine. Chongqing Qingyang Pharmaceutical, based in Chongching City, China, has temporarily stopped manufacturing cimetidine API due to the outbreak. As the outbreak is relentlessly spreading, the industry has to prepare for the actual API shortage of some herbal medicinal product ingredients solely depended on China. As a result, pharmaceutical companies would have to seek for other API manufacturing sites to substitute Chinese or Indian-made APIs. Apparently, most of APIs from China and India could be alternatively sourced from either Korea or other countries. However, registering new API is not as easy. MFDS has to approve of the use of currently unregistered imported API, but the ministry has suspended all overseas on-site inspection. Also the companies are worried about increase in production cost by changing the API source. A pharmaceutical company insider complained, “Majority of APIs imported from China and India are substitutable. Although we could use reserved stock of APIs for a while, prolonged COVID-19 outbreak would inevitably cause problem in manufacturing schedule of drug products.”
- Save Daegu! Professors jumped into the COVID-19 front
- by moon, sung ho Mar 08, 2020 10:06pm
- The Life Care Center for the mild COVID-19 confirmed patients in Daegu and Gyeongbuk area is opening one after another, and the dispatch of large hospital medical staff to manage it continues. In effect, they are acting as controller for the management of patients who enter the care center. According to the medical community on the 6th, medical staff from major university hospitals in Seoul were dispatched to the Life Care Centers in Daegu and Gyeongbuk. In order to treat patients with COVID-19, which are concentrated in the Daegu and Gyeongbuk areas, the Central Disaster and Safety Countermeasures Headquarters, (CDSCHQ) started and operated with the Daegu-1 Center (the National Training Institute of Education, Science and Technology), the Gyeongbuk & Daegu-1 Center (Samsung Human Resource Development Center), and Gyeongbuk & Daegu-2 Center (Nonghyup Gyeongju Education Center) in turn. At the same time, a total of five locations including the Gyeongbuk Daegu-3 Life Care Center (Seoul National University Hospital Human Resources Development Center) and the Gyeongbuk Daegu-4 Care Center (Chilgok Hanti Retreat House Catholic Archdiocese of Daegu ) have been in operation since the 5th. From left: Prof. Jae-Tae Lee (Nuclear medicine, KNU Hospital), Prof. Cheol Jung (Preventive medicine, the SMC), and Prof. Jang-Wook Son, the KMC#Among them, except for the Daegu-1 Center, which was first opened and operated by Professor Jae-Tae Lee, medical teams in Seoul are dispatched and are in charge of treatment. Specifically, the Kyungpook Daegu-1 Center and Gyeongbuk Daegu-2 Center are operated by the SMC and the KUMC respectively. Prof. Cheol Jung, who leads the Suwon Health Examination Center in Gangbuk Samsung Hospital, is going down to look for COVID-19 confirmed patients. Professor Jung, who also holds two specializations in preventive medicine and occupational environmental medicine, serves as the head of the Health Center, but he is the first to volunteer for dispatch to Daegu and Gyeongbuk. In the case of the KMC, a support team centered on Prof. Jang-wook Son, infectious medicine, is in charge of treatment at the center in Gyeongju Nonghyup Education Center. In particular, Professor Son moves to other centers as well as his center, which he specializes in, and he is also working directly with patients and medical staff to prevent infectious diseases. Subsequently, the centers were also recruited by medical staff from Hospitals in Seoul. In case of the Kyungpook Daegu-3 Center, the medical staff of Seoul National University Hospital will take care of it. Min-sun Kim , head of the Public Health and Welfare Center (Pediatrics), has four specialists, 12 nurses, and imaging and diagnostic tests personnel. Medical staff at Seoul St. Mary's Hospital was assigned at the Kyungpook Daegu-4 Center. It was confirmed to have a support team centered on professors, Hye-ran Jeon in the department of mental health medicine.. From left: Prof. Hye-ran Jeon , Prof. Min-sun Kim, Prof. Jae Sun Eom, & Prof. Sangwon Chung#In addition to the centers, there are also a large number of hospital staff members dispatched to Daegu and Gyeongbuk. In the case of Severance Hospital, a support team centered on Professor Jae-sun Eum of Cardiac Medicine is helping to treat COVID-19 confirmed patients at Keimyung University Dongsan Medical Center. Although Prof. Um was dispatched as a primary support team, he will continue to stay at the Daegu medical site after returning to the secondary support team. Moreover, he is the opening member of Yongin Severance Hospital, which opened in March. In addition, in case of Cheongdo Daenam Hospital, where the situation of COVID-19 is improving, since the beginning of the crisis, Professor Sangwon Chung of the Department of Emergency Medicine, Ilsan Hospital, has been dispatched to treat patients. Ilsan Hospital colleague said, "Daenam Hospital is still working as a cohort isolation hospital in order to block the spread of COVID-19. Since the beginning of the crisis, he has been playing a role in Daenam Hospital, he volunteers and works at the front line to solve the COVID-19 incident".
- Company
- MOHW: “Cancer Committee to be rescheduled in March”
- by Eo, Yun-Ho Mar 06, 2020 06:06am
- The Cancer Deliberation Committee meeting initially canceled due to COVID-19 outbreak would be rescheduled again soon. Pharmaceutical industry sources reported Korea’s Ministry of Health and Welfare (MOHW) plans to review some of drugs on paper, but to conduct vis-à-vis review on significant drugs applying for reimbursement expansion within March. Specifically, major pharmaceuticals like AstraZeneca’s targeted therapy Tagrisso (osimertinib) and Ono Pharmaceutical and Bristol-Myers Squibb’s Opdivo (nivolumab) would resume their reimbursement listing talks. Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) Tagrisso is under review for expanding reimbursement as a first-line therapy for EGFR mutation-positive non-small-cell lung cancer (NSCLC). PD-1 inhibitor Opdivo has a number of indications seeking for reimbursement, such as renal cell carcinoma-treating first-line combination therapy with Yervoy, second-line treatment for renal cell carcinoma, second-line treatment for relapsed or metastatic head neck squamous cell carcinoma, and second-line treatment for classical Hodgkin’s disease. But, the controversial indication of second-line treatment for NSCLC regardless of expression of PD-L1 was omitted from the application. Also, Ipsen Korea’s Cabometyx (cabozantanib) was supposed to be deliberated as well. After getting listed as a second-line treatment for advanced renal cell carcinoma last month, Cabometyx has applied for reimbursement on its liver cancer indication as well. The medication also could resolve the issue of Eisai’s Lenvima (lenvatinib) without a second-line therapy option. MOHW official said, “Although the government is hectic with COVID-19 outbreak, we have decided the reimbursement listing review for anticancer treatment cannot wait. The ministry would finalize the schedule as promptly as possible to push on with the listing procedure, including Cancer Deliberation Committee, without a delay.” Meanwhile, MSD’s immunotherapy Keytruda would be excluded from this month’s agenda, but would be included in April’s agenda of the Cancer Deliberation Committee. Keytruda is waiting for the committee to deliberate reimbursement feasibility of its expanded indications. The global company’s listing application included indications for first-line treatment for NSCLC, bladder cancer and Hodgkin’s lymphoma, which have been denied previously, but also two new indications of first-line treatment for metastatic non-squamos NSCLC as a combination therapy with pemetrexed and platinum chemotherapy, and first-line treatment for metastatic squamous NSCLC as combination therapy with carboplatin and paclitaxel were included as well.
