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- 2026-04-17 03:16:39
- Policy
- Most clinics have 60,000 calling in prescriptions
- by Kim, Jung-Ju Apr 21, 2020 06:27am
- COVID-19 outbreak showed that the government has temporarily allowed some phone consultations and prescriptions, and until recently, Clinics claimed about 60,000 cases, most actively making phone calls. The total amount of medical treatment totaled ₩1.28 million, of which the total amount of clinics was ₩736.7 million. The MFDS has compiled and released claims for a month and a half from February 24 to the 12th of this month when infectious diseases were most prevalent for phone consultations and prescriptions for medical institutions that are in limited use to prevent the spread of COVID-19. This count is also interlocked with pharmacy drug proxy receipt, which was allowed at the same time as telephone consultations and prescriptions, so it is meaningful as an objective data for pharmacies to indirectly measure billing flow, location, and trends. First, the number of medical institutions that conducted phone consultations and prescriptions in the past month and a half was 3072, and a total of 103,998 cases were charged as related examination fees. In other words, 33.9 cases per agency that conducted telephone consultations and prescriptions during this period. The total amount of medical bills they charged was ₩1,288,127,000, which is about ₩419,000 per institution, which is a bill for phone in counseling and prescriptions. Looking at each type, both the number of claims and the size of medical expenses were by far the most overwhelmingly high in clinics. It is analyzed that phone in counseling and prescriptions are mainly focused on the elderly and chronic patients. During the month and a half, 2,231 clinics participated, claiming 59,944 cases, and the scale was about ₩736,792,000. Subsequently, 109 general hospitals claimed 2,522 phone in consultations and prescriptions for reimbursed cost of ₩274,707,000. It was found that 275 hospitals were implemented at a total of 1,493 cases and claimed at a scale of 1,673.4 million won. Subsequently, 14 senior hospitals participated and claimed 2,858 cases. The total amount was calculated as ₩43,551,000, which was similar to the nursing homes’ medical fee of ₩38,186,000. On the other hand, this count reflects only the data requested by the medical institution, and may differ from the actual number of cases due to the different billing time and consultation time. The Ministry of Health and Welfare explained that in the future, the number of medical institutions could change when they request additional examination fees.
- Policy
- Futhan, clinical trial of COVID-19 pneumonia treatment
- by Lee, Tak-Sun Apr 21, 2020 06:26am
- Futan (Nafamostat mesylate, SK Chemicals), which is used as an anticoagulant for hemodialysis patients and patients with acute pancreatitis, begins clinical trials in patients with COVID-19 pneumonia. The MFDS approved Sponsor-Investigator Trials on the treatment effect of Futhan's COVID-19 pneumonia patients submitted by Gyeongsang National University Hospital on the 17th. This clinical trial will be conducted at 84 patients with COVID-19 pneumonia at Gyeongsang National University Hospital, Kyungpook National University Hospital, Dankook University Cheonan Affiliated Hospital, Pusan National University Hospital, Seoul Medical Center, and Yangsan Pusan National University Hospital. This is a randomized, open trial for the analysis of treatment effects. Futan is a product obtained by SK Chemicals in June 2004, and currently has 15 items with the same ingredients.
- Policy
- MOHW to consider HIPDC meeting after stabilizing outbreak
- by Kim, Jung-Ju Apr 21, 2020 06:26am
- Yoon Tae-ho, Overall Officer of Disinfection (Director of Public Health Policy Bureau at MOHW) at Central Disaster Management Headquarters, is giving a regular online COVID-19 briefing at the Government Complex. The Korean government has announced major vis-à-vis meetings like Health Insurance Policy Deliberation Committee (HIPDC) would be scheduled after the COVID-19 outbreak is better contained. Although international experts view the COVID-19 curve in Korea has been bent, the government has not halted its effort to control the outbreak in fear of seasonal variables. Yoon Tae-ho, Overall Officer of Disinfection (Director of Public Health Policy Bureau at Ministry of Health and Welfare (MOHW)) at Central Disaster Management Headquarters, answered media’s questions after convening a video conference for the COVID-19 Central Disaster and Safety Countermeasures Headquarters (CDSCH) on Apr. 17. Officer Yoon said, “The government is prioritizing the order of healthcare policy execution as simultaneous execution is unfeasible at the moment,” and he explained the biggest reason is the ministry’s human resources preoccupied by the infectious disease control. According to the health ministry official, approximately 40 percent of the ministry officers are responding against COVID-19 outbreak. And with the officers working from home, normalizing policy execution was impossible for months. Sources predict the rescheduling of HIPDC meeting would be considered after the government makes an official announcement of stabilized COVID-19 outbreak state and alleviating social distancing. Officer Yoon supported the prediction by stating “The vis-à-vis HIPDC meeting would be rescheduled only after the situation is considered contained.” Regarding the prioritized order of policies, the officer explained “The ministry would prioritize policies closely related to healthcare institute operation and the people’s daily life as operating MOHW, human resource and the Central Disaster Management Headquarters would center on social distancing.” However, the officer also stressed COVID-19 policies does not only respond against the outbreak, but also affect the safe use of healthcare institute for general patients, because they are naturally related to safe medical practice policies, such as healthcare institute policy and support plan, emergency room support and designation of tertiary hospital.
- Policy
- Pan-government working group for COVID-19 was established
- by Kim, Jung-Ju Apr 21, 2020 06:26am
- Pan-government working group for the development of treatments and vaccines for COVID-19, a public-private joint government presided over by the President, was established. In the future, the Working Group plans to serve not only for R&D, but also for full-time support such as production, national stockpiling, and the use of a quarantine site. On the 17th, the government announced that it had formed a joint public-private joint government support group to provide rapid results by intensively supporting the development of COVID-19 treatments and vaccines through a joint meeting of industry, academia, research, and hospitals presided over by the president on the 9th. The support group is co-directed by the Minister of Health and Welfare and the Minister of Science, ICT and Future Planning, and Deputy Minister of related ministries, the Head of the KCDC, the Director of the MFDS, and the private experts participate. The Pan-Government Working Group analyzes the situation throughout the entire cycle and identifies issues in the field, including COVID-19 treatments, vaccines, R&D, production, national stockpiling, and use of quarantine sites, and prepare a support plan. The Working Group is co-chaired by the Director of the Korea National Institute of Health & Head of R & D Policy of the Science, ICT and Future Planning. In addition, a general subdivision consisting of each division head and the heads of related ministries is operated. The Working Group will hold the first meeting at 8 am today (17th) at the Korea Press Center (Maehwa Hall) as the co-host of the Director of the Korea National Institute of Health and Head of R&D Policy of the Science, ICT and Future Planning. The current status of domestic and foreign COVID-19 treatment, vaccine research and development, and the supply and demand of quarantine products and devices will be reviewed, and the role of the working group to quickly discuss ways to resolve difficulties in the field and plans to support related ministries will be discussed. In particular, the government will prepare a roadmap for the development of COVID-19 treatments and vaccines that contains the government's R&D investment in promising items for COVID-19 treatments and vaccines in Korea, supporting periodic R&D from basic research to commercialization, and plans to improve regulations on licensing and commercialization. According to the Ministry of Health and Welfare, it is planning to discover detailed agendas through regular and intensive discussions on a weekly basis by three divisions (therapeutics, vaccines, quarantine products and devices) under the Working Group. In addition, it is planning to provide professional consulting to quickly resolve the difficulties of domestic therapeutic and vaccine development companies in connection with the 'Company Grievance Relief Support Center (the Korea Health Industry Development Institute)' to be installed under the government support group. In addition, the Ministry of Health and Welfare explained that it will cooperate with each other in the search for solutions to scientific and technological difficulties through the “research and development support council” consisting of government-funded research institutes, universities, and so on. The Joint Promotion Director said that in order to completely overcome Corona 19, early development of therapeutic drugs and vaccines, and proper distribution of quarantine products and devices are essential. He also said that the Working Group would support the pan-government support group and play an active role in identifying and implementing practical improvement measures and solutions based on major issues.
- Company
- Bridion generic makers lose patent dispute after all
- by Kim, Jin-Gu Apr 20, 2020 06:34am
- Product image of Bridion Indicated for the reversal of neuromuscular blockade in people undergoing surgery, MSD’s Bridion (sugammadex) has successfully defended its patent rights. On Apr. 17, the Intellectual Property Trial and Appeal Board has ruled favorable for the original patentee MSD over a patent dispute with CTC BIO. A pharmaceutical market research firm IQVIA reported, Bridion, indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery, has generated approximately 38.0 billion won in Korea last year. ◆After an appeal, generic loses the patent battle at last MSD has released and patented the drug in 2013. The patent term would expire on Apr. 12, 2022. Many of Korean pharmaceutical companies have challenged against the patent. The first trial was to invalidate the patent. In March and April of 2015, nine companies including Navi Pharm, Kukje Pharm, Hana Pharm, Intro Pharm Tech, Han Wha Pharma, Huons, Dream Pharma, Chong Kun Dang, and BC World Pharm have filed the invalidation trial. But BC World Pharm, Dream Pharma, Navi Pharm and Kukje Pharm have immediately withdrew the case. First, the original patentee has won the Intellectual Property Trial and Appeal Board. But in January 2017, Chong Kun Dang, Huons, Intro Pharm Tech and Hana Pharm have filed an appeal against the ruling to the Patent Court. However, the Court also ruled against the generic makers. ◆Retried with different approaches but dropped the case after the Supreme Court’s ruling The Korean companies’ patent challenge did not stop there. Instead of invalidation, they tried to take down Bridion’s patent by requesting a negative confirmation of scope. Accordingly in March of 2018, Chong Kun Dang, Daewoong Pharmaceutical and CTC BIO have requested a negative scope confirmation. Their case claimed a part of the extended substance patent term is not covered by the patent scope. During the proceeding of the case, the Supreme Court has made a crucial decision on the Solifenacin (vesicare) case, which would significantly affect the Bridion case. The Supreme Court has ruled that a generic with modified salt base infringes the original’s extended patent term. Afraid the court’s decision has set a precedent, the Korean pharmaceutical industry was swayed and most of them interpreted it negatively. Ultimately, Chong Kun Dang and Daewoong Pharmaceutical withdrew the case in January and November of 2019, respectively. ◆The original wins at the final trial, patent to be protected until its expiration Regardless of others giving up on the patent dispute, CTC BIO continued its lone tough journey. However, the Supreme Court’s decision has already been set as a precedent. The Intellectual Property Trial and Appeal Board has ruled against the Korean company on Apr. 17. Sources report the company would unlikely to file another appeal. The generic maker does not see another approach to further battle against Bridion. Since the Supreme Court’s ruling, the negative confirmation of scope on modified salt base drug has become useless. And the Korean company has already lost the appeal on the invalidation case. Sources predict Bridion would likely to have its patent protected until April 2022.
- Company
- Half of multinational companies in Korea restructured 2019
- by An, Kyung-Jin Apr 20, 2020 06:30am
- Apparently, one out of two multinational pharmaceutical companies in Korea has downsized last year. The outcome contrasts with Korean pharmaceutical and bio companies that have increased employment in the same time, despite the worsened profitability. Analyzing audit reports submitted to the Financial Supervisory Service (FSS) on Apr. 16, 13 out of 29 multinational pharmaceutical companies in Korea have reported lessened number of employees last year than in the year before. Except for three companies without a change in employment size, basically a half of multinational companies in Korea have reduced the employment. From the end of 2018 to the end of 2019, Galderma Korea’s number of employee has dropped the most from 94 to 73 with a one fifth cut. After hiring 99 employees in 2014, the company has maintained the size for about four years, but the number has dipped significantly in about a year. After the appointment of General Manager Rene Wipperich at the Korean affiliate in August 2018, Galderma Korea has offered early retirement programs twice and the employment number has fallen. The company reported it has been in the red since 2015. Changes in employment size in 29 major multinational pharmaceutical companies (Unit: Number of employee) Source: Financial Supervisory Service In general, the multinational companies with underwhelming performance have restructured. Janssen Vaccines has maintained the same number of employees from 2018 to 2019, but the number actually halved from five years ago at 296. Janssen Vaccines’ performance has been stagnating for a while. Since it made operating loss of 20.9 billion won in 2016, the company has been in the red for four consecutive years. The sales have been rapidly falling from 99 billion won in 2016 to 42.7 billion won and 27.6 billion won in 2017 and 2018, respectively, and at last, the company has made no profit last year. The company plans to operate in minimal human resources until it finishes refining anticancer and next generation vaccine production line. It also has opened an opportunity for employees to request for transfer after it closes the Hyangnam manufacturing facility in 2021. Other multinational companies had changes in employment size while reorganizing the businesses. Even Pfizer Korea, currently with the highest number of employees among multinational pharmaceutical companies in Korea, has downsized slightly in a year. In last May, the company has transferred 264 employees to its spin-off company Pfizer Upjohn Korea. The number of total employee in both Pfizer Korea and Pfizer Upjohn Korea combined was 724, with 10 employees less than the year before. Regardless of business restructuring, some companies have increased the number of employees. Although Merck Korea has closed GM sector last year, the company has hired 22 more by the end of the year, reaching the total of 339 employees. The figure was not drastically affected as only a handful applied for the ERP and the number of employees of other non-pharmaceutical sectors like Life Science or Performance Material sectors easily outnumbers that of the Biopharmaceutical sector. Not all Korean affiliates have reduced employment size. As of late December last year, the 29 multinational pharmaceutical companies had 6,884 employees in total, which was 170 more than 6,714 employees in the year before. Among the 29 companies analyzed, Sanofi-Aventis Korea has reportedly hired new employees the most. In last June, Sanofi has legally finalized the merge with Genzyme Korea. As of last December, Sanofi-Aventis Korea had 64 more employees than the year before and had total of 506 employees. Considering Genzyme Korea had 53 employees as of last 2018, the number of employees has increased over a year. Sanofi-Aventis has shown outstanding performance by combining Genzyme Korea’s performance from the latter half of last year. Over the year, the sales has increased by 17.7 percent, marking 438.3 billion won, and operating profit reached 34.8 billion won with 68.4 percent surge. Number of employees in major multinational pharmaceutical companies in Korea as of last 2019 (Unit: Number of employee) Source: Financial Supervisory Service Except for Pfizer Korea and Pfizer Upjohn Korea, Bayer Korea has the highest number of employees as of late 2019. From late 2018 to late 2019, Bayer Korea has downsized from 588 to 562 with 26 less employees, but it still has the highest number of employees as a multinational pharmaceutical company in Korea. Novartis Korea reported it has 542 employees as of last 2019.
- Company
- Pfizer Korea Upjohn, last year's sales were ￦385.8 billion
- by Kim, Jin-Gu Apr 20, 2020 06:30am
- It was confirmed that the annual sales of Pfizer Korea Upjohn, which was split from Korea Pfizer Pharmaceuticals last year, amounted to ￦385.8 billion. Korea Pfizer Pharmaceuticals(￦395.7 billion) is not much different. Considering that Pfizer and the Pfizer Upjohn have a global sales ratio of 8 to 2, the sales share of Pfizer Upjohn in Korea is high. According to the audit report of Pfizer Korea Pharmaceuticals and Pfizer Korea Upjohn submitted to the Financial Supervisory Service on the 9th, the sales of the two companies over the past year (December 2018 to November 2019) totaled a total of ￦745.5 billion. The fiscal year of Pfizer Korea Pharmaceuticals and Pfizer Korea Upjohn is November, and the results are calculated from December of the previous year to November of this year. Of these, Pfizer Pharmaceuticals' sales were ￦395.7 billion. This is a 7.2% increase from 2018's ￦369.1 billion. It recorded an operating loss of ￦1.1 billion. However, in 2018, the operating loss decreased from ￦2.3 billion. The sales of Pfizer Korea Upjohn were ￦385.8 billion. This sales amount is calculated by adding the sales of the patent expiration business departement to ￦205.8 billion and the sales from May 27, 2019 to November 30, 2019, to be ￦ 179.9 billion. This is an increase of 5.6% compared to ￦365.3 billion in 2018. Operating profit was ￦15.8 billion before division and ￦5.4 billion after the division, operating profit fell to a third. Sales of Pfizer Korea in the past 5 years (Unit: ￦100 million, The FSS) The size of Pfizer Korea Upjohn with annual sales of ￦385.8 billion is comparable to that of domestic mid-sized pharmaceutical companies. The share of sales between Pfizer Korea and Pfizer Korea Upjohn is equal to 50.6% versus 49.4%. Considering that Pfizer Korea Upjohn deals only with patent-expired drugs, industry officials say that sales proportion is unusually high. This is analyzed because of the characteristics of the Korean market with high original loyalty. The representative example of Pfizer Korea Upjohn is Lipitor. Since its launch in 1999, Lipitor has been ranked first and second in outpatient prescriptions. Lipitor's 10mg insurance price was cut from ￦1241 to ￦644 in 2007, and as the patent expired in 2009, more than 130 generic products were released, but Lipitor’s prescription amount increased. Last year, Lipitor had the most outpatient prescriptions. It was prescribed ￦176.2 billion, an increase of 8.4% from ￦162.6 billion in 2018. The share of sales in Pfizer Korea Upjohn, which is the highest in Korea, is also confirmed by comparison with global. According to a 2019 report released by Pfizer earlier this year, Pfizer's global sales last year were $51.7 billion (about ￦63 trillion). Of these, Pfizer Korea Upjohn's sales are $10.2 billion (about ￦12 trillion). The proportion is only 19.8%. Global and Pfizer Korea vs. Pfizer Korea Upjohn sales share. Pfizer Korea UpjohnPreviously, Pfizer divided Pfizer Korea Upjohn on May 27 last year. The key is to manage patent expiration drugs by Pfizer Korea Upjohn. Representative items such as Lipitor, Novasc (Amlodipine), and Celebrex (Celecoxib) have been moved to the Pfizer Korea Upjohn. The newly established division, Pfizer Korea Upjohn, plans to merge with Mylan and change its name to Viatris and start again by September.
- Policy
- The NHIS agreed the drug price negotiation rate to 95.5%.
- by Lee, Hye-Kyung Apr 20, 2020 06:30am
- The NHIS last year negotiated drug prices on 176 items, including new drugs. Of these, 96.5%, 168 items, completed the drug price negotiations, and 8 items had to be broken. Looking at the current status of the NHIS, which Dailypharm confirmed on the 7th, has negotiated the drug price in the past 6 years, a total of 870 drug price negotiations have been introduced since 2014. Among them, 840 items were negotiated, and 30 items were broken. In the NHIS' reimbursement strategy division, the Drug Price Negotiation Department, the Drug Price Post-Management Department, and the Drug Price Department are in charge of negotiating six items such as new drugs, risk-sharing (RSA) contracts, expected claims, expanded scope of use, and Price-Volume Agreement (PVA). The price of the new drug is negotiated between the NHIS and the pharmaceutical companies and it is listed after the Health Insurance Policy Deliberative Committee. Some IMDs and generic drugs omit drug price negotiations and are decided based on calculation standards. On December 29, 2006, as part of the plan to optimize drug costs, the health insurance listing method of medicines was changed to a positive method, and the NHIS is negotiating drug prices. In the case of last year's drug price negotiations, 56 items increased compared to 2018, which was analyzed because the price of eye drops was reduced due to PVA (Price-Volume Agreement).
- Policy
- Strong sanctions, to expel drugs through re-evaluation
- by Lee, Hye-Kyung Apr 17, 2020 06:22am
- It was suggested that strong sanctions to ban prescriptions as a way to expel drugs that have not been proven safe and effective through re-evaluation of benefits. It is necessary to take effective administrative measures beyond the preparation of a plan for drug withdrawal by the Minister of Health and Welfare, based on the National Health Insurance Act. This opinion was presented through the 'Research plan to improve the re-evaluation of preliminary benefits (Researcher Kwon Yong-jin, Seoul National University Public Health and Medical Center)', which was conducted as an external research service for the Health Insurance Review and Assessment Service. Currently, the withdrawal of drugs is possible through the disposition of the Minister of Health and Welfare's reimbursed list deletion based on Article 13 of the Rules on National Health Insurance Benefits Standards. However, the research team pointed out that, in the case of reimbursed list deletion, it is not a strong sanction means because the medical institution can arbitrarily delete the benefit of the benefit to the patient as non-reimbursement. As a result, it was said that for effective administrative measures, it could be considered to indirectly impose prohibition obligations through disposition of unfair profit or disposition of business suspension to medical institutions that is acting as an evacuation plan. However, according to Article 12 of the Medical Act, the implementation of medical technology by medical personnel cannot be interfered with unless there is a restriction by law. He added that there should be clear regulations as a law to impose prohibition obligations on medical personnel or medical institutions while devising plan after reevaluating benefits. Meanwhile, this study was conducted to prepare a plan to improve laws related to the preliminary benefit policy included in the health insurance coverage expansion policy (Moon Jae-in Care) announced by the government in August 2017. The Positive list system is a policy that aims to put the targets that appear to be close to non-payment rather than cost-effectively into the framework of the reimbursement first, if the provisions are to be differentiated before the change of wages for a specific item. In the case of the screening benefit, the ratio of copayment is 50%, 80%, but in the preliminary benefit, the ratio is further subdivided into 50%, 80%, and 90%, and drugs are included. In the case of drugs, clinical usefulness (therapeutic effectiveness), cost effectiveness, replaceability, and social needs were comprehensively evaluated to determine the application rate and self-pay rate. The research team said, "The basic purpose of re-evaluating Preliminary Reimbursement is to determine whether the reimbursement standards are met or not satisfied, and to determine the maintenance of reimbursement, preliminary reimbursement, and the suspension of benefits. And it can be used as a basis for price renegotiation to minimize the impact on insurance finance."
- Company
- Twice-delayed amid COVID-19 Cancer Committee rescheduled
- by Eo, Yun-Ho Apr 17, 2020 06:22am
- The Cancer Deliberation Committee’s meeting, postponed twice already, has been rescheduled. The Korean pharmaceutical industry sources reported the Health Insurance Review and Assessment Service (HIRA) has decided to resume the Cancer Deliberation Committee’s talks on expanding anticancer treatment coverage on Apr. 29. Amid COVID-19 outbreak, the committee’s earlier meeting schedule has been postponed on Feb. 26 and on Apr. 8. In February, the committee was supposed to review major items like AstraZeneca’s targeted therapy Tagrisso (osimertinib) and Ono Pharmaceutical and Bristol-Myers Squibb’s (BMS) immunotherapy Opdivo (nivolumab). And in the April agenda, reviews on BMS’ multiple myeloma treatment Revlimid (lenalidomide) and MSD’s immunotherapy Keytruda (pembrolizumab) were initially included. However, the delayed meeting schedule would add more items on the committee’s agenda, and likely to put off some items to May agenda depending on their priority level. Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) Tagrisso has an ongoing deliberation over expanding its reimbursed indication to cover a first-line treatment for patients with EGFR-mutated 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 as a second-line treatment for NSCLC regardless of expression of PD-L1 was omitted from the application. Moreover, Revlimid was targeting reimbursement expansion on its maintenance treatment indication as a monotherapy, and Keytruda’s reimbursement expansion application included an indication as a first-line treatment for NSCLC, bladder cancer and Hodgkin’s lymphoma, which have been denied previously, but also included two new indications—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.
