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- 2026-04-11 21:14:16
- Opinion
- [Reporter’s View] Unresolved insulin cold chain issue
- by Aug 24, 2022 05:56am
- With no clear alternative found for insulin distribution in Korea, on how to set the regulations for cold chain transport of insulin remains unresolved and beleaguered. Unlike other biological agents that are mainly prescribed in hospitals, insulin is often dispensed at outside pharmacies. And the lives of patients with Type 1 diabetes, who cannot produce insulin in their own bodies, may be threatened if this insulin is not readily available. However, on the pharmaceutical distribution companies’ part, insulin is a ‘white elephant.’ Although it is not a favored item on the companies' part due to its low distribution fee, it is an essential item when considering the companies' business relationship with patients and customers. For this reason, distributors refer to insulin as "a drug that is being distributed as a service item with little or no distribution margin." In other words, although the companies are currently distributing insulin, there is no reason or benefit for the company to distribute it at a loss. When the transport regulations for vaccines were revised earlier last year, and then extended application to all biological products, the government did not consider the difficulty and complexity the revised regulations would bring to insulin distribution. The fact that insulin would be included as biologics may not have even crossed their minds during the revision process. There Ministry of Food and Drug Safety had newly enacted guidelines thereafter to reflect the voices of the industry after receiving countless complaints from the distribution companies but to no avail. Although the newly enacted guidelines showed some progress, such as allowing insulin to be contained in various transport containers and not taking issue with temperature fluctuations during delivery to pharmacies as long as the company can verify the validity of the cold chain process. However, even these changes were not worth the excessively increased workload and cost required to maintain the thorough cold chain requested by the government. In fact, as of July 17th, when the revised regulation was implemented, instability in insulin supply and demand arose at distribution sites. Also, with orders piling up due to fears of stock shortages, this instability in supply and demand continued to deepen. The reduced number of insulin deliveries and extended terms between deliveries to pharmacies further heightened the anxiety of the patients. And due to railing opposition from diabetes patient groups, the MFDS granted an additional 6-month guidance period specifically for insulin distributions. However, anxiety continues to sweep through the industry with the sentiment that this problem cannot be resolved without further consideration of the fundamentals of the revision itself. Officials from distribution companies jointly voiced that “the guidance period is virtually meaningless.” With no distribution, an increased amount of insulin stock would be useless. Also, with the government holding a close eye over the issue, insulin may be better distributed in the short term during the guidance period, but it is clear that the same problem would return as soon as the eye moves away. In other words, there is no other viable option without the additional review of the revised regulations. However, how the revisions should be re-revised remains a further issue, and concerns deepen due to lack of reasonable grounds required for additional revisions of regulations. It is not easy to make further revisions because the regulations were not made after collecting sufficient data and identifying realistic situations in the first place. The government is continuing discussions with the industry, patient organizations, and relevant organizations, and the proposal for holding a public hearing is only now being discussed. It is odd that a public hearing, which should have been conducted before the revision was finalized, is only being discussed now, 8 months after the enforcement of the regulation. It is understandable how frustrated the patients would feel about the unresolvable insulin distribution issue.
- Policy
- Gov't “will reinvestigate overused reimbursed items”
- by Lee, Jeong-Hwan Aug 24, 2022 05:55am
- The government will begin discussions on fiscal reform of the National Health Insurance areviewreivew the overused healthcare items ng on already-listed reimbursed items to expand essential healthcare and ensure the sustainability of NHI finances. On the 23rd, the Ministry of Health and Welfare launched and held the first meeting of the NHI Fiscal Reform Promotion Team that was established to strengthen essential healthcare and create a sustainable health insurance system. Relevant institutions, including the Ministry of Health and Welfare, National Health Insurance Service, and Health Insurance Review and Assessment Service will jointly participate in the Promotion Team to discover and promote projects for NHI fiscal reform. The NHI system has been improving access to medical care for the public, achieving a universal health insurance system in a short period of time since its implementation in 1977. As a result, Korea was able to achieve high levels of health outcomes in key indicators such as life expectancy and cancer mortality, etc. while spending less on medical expenses compared to the average spent by other OECD countries. However, in the process of reimbursing non-reimbursed items and reducing the burden borne by patients, an unexpected side effect where usage of some items have surged to a greater extent than expected arose. The government plans to operate the Promotion Team to review whether reimbursed items are being used in excess and prepare a measure for its management. In addition, the government plans to reinforce essential healthcare services that are necessary for the public by preparing a measure for the structural reform of medical expenditures and inducing reasonable and appropriate use of healthcare by examining whether any financial leaks in NHI fiances arose from ▲excessive medical use ▲the increase in the amount of non-reimbursed and reimbursed healthcare usage and their relationship with indemnity insurance ▲theft of health insurance qualifications ▲inappropriate use of the foreign dependent system, etc. For this, the Promotion Team plans to intensively discuss and announce plans to restore essential healthcare until October and prepare detailed implementation plans for each task. Ki-il Lee, second vice minister of MOHW said, “The Promotion Team will work to reinforce the management of reimbursed items and excessive medical use while maintaining the health insurance benefits received by the public. We will do our best to ensure a trusted and sustainable NHI system that covers essential areas of healthcare such as emergency, high-risk operations, childbirth, etc.”
- Company
- Celltrion Applies to Europe for IND to designate Yuflyma
- by Aug 24, 2022 05:55am
- Celltrion announced on the 23rd that it has applied to European regulators for IND to designate Humira biosimilar Yuflyma (CT-17) as an interchangeable similar. If it is designated as an interchangeable similar, it can be prescribed by replacing the original at a pharmacy without intervention by MD. Celltrion recently submitted IND to the U.S. Food and Drug Administration (FDA) to secure a mutual exchange between Yuflyma and Humira. European clinical trials are conducted on 366 Plaque psoriasis patients in many countries, including Estonia and Poland. It plans to compare and verify pharmacokinetics, efficacy, and safety between the multiple cross-medication group between Yuflyma and Humira and the Humira maintenance medication group. Celltrion previously confirmed the efficacy, pharmacokinetics, and safety results similar to Humira through Global Phase 3 clinical trials of Yuflyma in patients with rheumatoid arthritis. Based on the clinical results, Yuflyma obtained permission to sell all indications held by Humira, such as RA, IBD, and PS, from EMA in February 2021 and is in progress. In the U.S., it has completed a patent agreement in the U.S. with its developer AbbVie so that it can start selling on July 1st next year. Celltrion expects FDA approval to sell Yuflyma within this year. When sales of Yuflyma begin in the U.S., it is expected that the advantages of high-concentration formulation, whether to secure interchangeable similarity status, and clinical results on various indications will serve as important competitiveness. Yuflyma is the first high-concentration Humira biosimilar to obtain permission from EMA, characterized by halving drug administration compared to low concentrations and removing citrate that can cause pain. An official from Celltrion said, "We believe that if Yuflyma secures its interchangeable biosimilar status through interchangeable clinical trials, it will greatly help expand its market share by strengthening its competitiveness." "High-quality bio at reasonable prices for global markets, including in Korea, while making every effort to prepare for clinical and licensing, and we will do our best to proceed with the supply of medicines."
- Product
- There are about 2,300 pharmacies dedicated to COVID-19
- by Jung, Heung-Jun Aug 24, 2022 05:55am
- Increase in active prescription recommendations of the Korea Medical Association, and short expiration date also affects prescription volume. The number of pharmacies in charge of COVID-19 treatments has more than doubled in a month. The number of pharmacies in charge increased from 996 on the 11th of last month to 2,314 on the 19th of this month. The number of participating pharmacies has increased, but the number of treatment preparations per pharmacy has not decreased. This is because the number of confirmed patients has increased and the number of prescription lawmakers has increased. The number of prescription preparations is expected to increase further in the future as the Korea Medical Association actively recommended prescriptions last week. Pharmacy A in Seoul said, "On average, there are 30 prescriptions a day, and when there are a lot, there are up to 50 prescriptions. It is mainly focused on Paxlovid, and Lagevrio is also on the rise in prescriptions. "We have room for government inventory, so we are properly secured when we are aware of it and when it is insufficient," the pharmacist said. Pharmacy A said, "As the number of clinics to prescribe treatments increased, nearby pharmacies applied for participation and the number of base pharmacies increased. It will be distributed to new pharmacies, but the increase in the number of prescriptions shows that the total number of prescriptions has increased." Until now, the amount of prescriptions for treatments has varied by region, but recently, the number of treatments has also been increasing in areas where demand for treatments has been low. Pharmacy B in Seoul said, "In our region, there were few prescriptions. It was about one to two cases a day, but recently it has increased to five to six cases, he said. "We are prescribing at a clinic located in apartment complex , and patients are visiting and receiving prescriptions." In our region, pharmacies have been designated more than twice, and the number of prescriptions is increasing as lawmakers actively prescribe them," he said. Pharmacists analyzed not only the severe prevention of COVID-19 confirmed patients, but also the short expiration date of the treatment as a reason for encouraging prescription. It is explained that the number of patients is increasing after the Korea Medical Association's recommendation for prescription. "The number of newly designated pharmacies in our district has increased as much as existing pharmacies," said the pharmacy in charge of C in Seoul. However, the number of preparations has increased a lot, and about 15 to 20 cases are received per day. The large number of elderly patients in the region is also the reason for the large number of prescriptions. Pharmacy C said, "The Korea Medical Association encourages prescriptions and feels the increase. The expiration date of the treatment is short, but it seems that there is an intention to prescribe it to patients who need it within the deadline, the pharmacist said.
- Policy
- Na Kyung-won is considering being the Minister of Health
- by Lee, Jeong-Hwan Aug 23, 2022 06:04am
- The opposition party is immediately criticizing the new government as Yoon Seok-yeol's office is reportedly considering Na Kyung-won, a former lawmaker with four-term experience, as a candidate for the next health and welfare minister. According to political circles of the ruling and opposition parties on the 22nd, President Yoon Seok-yeol put former lawmaker Na on the list of candidates for the welfare minister, which was compressed three times. She is said to have experience in related fields by working at the National Assembly's Health and Welfare Committee in the past and has experience and expertise in the field of health and welfare, including an honorary doctorate in social welfare at Soonchunhyang University in July. Having political power, such as serving as the floor leader of the Liberty Korea Party, the predecessor of the people's power, is also cited as the reason why former lawmaker Na is considered as the minister of welfare. Former lawmaker Na herself shows a cautious position or denies it. Regarding the appointment of the minister, former lawmaker Na is repeatedly answering in media interviews, saying, "There was no such thing at all," "There was no communication with the president's office," and "I didn't hear it." In response to this situation, politicians are speculating that it is a roundabout way of expressing their position to challenge the leadership of the people. She was recently mentioned as a strong candidate for the next party leader and said she was considering whether to challenge for the party's leadership. Na has recently been leading in several polls related to party leadership of the party. Lee Soo-jin, floor spokesman of the Democratic Party of Korea, said, "The appointment of Yoon Seok-yeol should signal a personnel reshuffle, not an extension of the personnel disaster," adding, "President Yoon is reportedly considering former lawmaker Na Kyung-won as a candidate for the welfare minister." "It is disastrous to consider a person who ran as a candidate for Seoul mayor in the 2011 local elections and was criticized for bathing teenagers in front of reporters as welfare minister," she pointed out. "President Yoon said at a 100-day press conference that the most important thing in the management of state affairs is the will of the people first and second," spokesman Lee Soo-jin said. "All policies, people, and attitudes should be changed." It is the will of the people to reform personnel and completely change the stance of state administration," she said.
- Policy
- Bill for 'state compensation for Paxlovid's side effects'
- by Lee, Jeong-Hwan Aug 23, 2022 06:04am
- A bill proposing the government's compensation for damages arising from the administration of COVID-19 treatments that were granted Emergency Use Authorization (EUA) such as Paxlovid or Lagevrio etc. has been filed. On the 22nd, People Power Party member Mi-Ae Kim proposed a bill as representative for the partial revision of the “Special Act for Promotion of the Development and Emergency Supply of Medical Products in Response to Public Health Crisis” which contained the abovementioned contents. Currently, side effects arising from COVID-19 vaccines are compensated based on the ‘Infectious Disease Control and Prevention Act,’ and the side effects arising after administration of drugs that are granted marketing authorization are compensated based on the “Pharmaceutical Affairs Act’ under respective side effect damage relief systems. However, under current laws, no clear grounds existed to provide compensation for side effects arising from the use of oral COVID-19 treatments that were granted EUA. To address this, People Power Party member, lawmaker Miae Kim submitted a bill that allows for the state to compensate for damages occurring due to the use of drugs approved for emergency use and the standards, scope, and procedure for compensation and investigation and appraisal for compensation payment to be applied the Pharmaceutical Affairs Act. As of the 22nd, the Ministry of Food and Drug Safety has granted EUA for 5 COVID-19 treatments – Evusheld inj., Lagevrio cap., Actemra inj., Vekury Powder For Concentrate For Solution For Infusion, and Paxlovid. If the National Assembly passes Kim’s bill, a safety net will be established for the state’s compensation for side effects that arise from the treatments that were granted EUA. In addition, the bill contained a provision to add separate subcommittees for each area of the Public Health Crisis Response Medical Product Safety Management and Supply Committee. It also provided a basis to entrust the maintenance and management of the crisis response medical product information system to the President of the Korea Institute of Drug Safety & Risk Management. Kim said, “We need to protect the lives and safety of our people from the damages and side effects caused by the use of EUA treatments."
- Policy
- When will the CSO reporting system be legislated?
- by Lee, Jeong-Hwan Aug 23, 2022 06:04am
- In consensus, the government and pharmaceutical industry are voicing the need to legislate the pharmaceutical contract sales organization (CSO) reporting system and urging the National Assembly to review the bill. Both the government and pharmaceutical industry share the position that a bill needs to be passed by the National Assembly to accurately identify CSOs that perform drug sales and promotion activities for pharmaceutical companies, such as one-person CSOs, to abolish indirect illegal rebates. On the 21st, the Ministry of Health and Welfare and the pharmaceutical industry were found to be busy closely following the National Assembly’s review and passage of the bill for the establishment of the CSO reporting system. Both the MOHW and industry believe that identifying the status of CSOs that are acting on behalf of domestic pharmaceutical sales is difficult because of the delay in the timely review of the CSO reporting system. In particular, the MOHW is closely eyeing the legislative timeline because the ministry can only publicly announce the standards and guidelines on the eligibility of the CSO reporting system after the bill is passed by the National Assembly. The CSO reporting system is a bill to regulate the CSO's drug promotion activities conducted on behalf of pharmaceutical companies that have not been reported to the government and local governments as illegal. The bill, if legislated, is expected to have a significant impact on the domestic pharmaceutical business environment. The MOHW plans to discuss and finalize the details of the system, such as the subject for the CSO report and the reporting system, with related ministries such as the Ministry of the Interior and Safety as soon as the bill passes NA review and is finalized. The industry has also long been awaiting the legislation of the CSO reporting system. Relevant laws have already been revised and CSOs are subject to filing and submitting expenditure reports. However, as the bill for the CSO reporting system is yet to be passed, the specific size of the CSOs industry is difficult to identify. This is why the criticism that a legal loophole has been created as the subjects for filing and submitting expenditure reports had been expanded, but those subject to the system are not identifiable, leaving open the risk for the rise of illegal indirect rebates. In addition, the bill to legislate the CSO reporting system needs to be passed for the pharmaceutical sales order education to be legislated, and the obligation to write and manage consignment reports be introduced for further reinforcement of the drug distribution order. Also, the passage of the bill will abolish the rebate attempts where some companies pay excessive promotion fees to CSOs for indirect rebates. An official from the Korea Pharmaceutical and Bio-Pharma Manufacturers Association said, “CSOs are being imposed the same level of obligations as pharmaceutical companies in filling out and submitting economic profit expenditure reports but without the passage of the CSO reporting system, which companies will be applied the system, including one-person CSOs cannot be clearly identified. The CSO system will allow the government to clearly identify and distinguish CSOs and assign the duty to prepare and manage consignment reports and prevent indirect rebates.” An official from a pharmaceutical company said, “Also, the system needs to be introduced to solidly establish a distribution order through pharmaceutical sale order education, etc. Currently, there is a widespread perception that CSOs are used as a window for rebates after being paid excessive promotional fees. The legislation is expected to have the effect of preventing excessive competition by allowing the pharmaceutical companies to pay appropriate fees to their CSOs while strengthening the government’s management and supervision function." Meanwhile, the MOHW plans to publicly disclose the expenditure report content submitted by pharmaceutical companies and medical device companies from January 2024 on its webpage and through other public systems. The MOHW and the pharmaceutical industry believe the CSO reporting system needs to be implemented in a timely manner in line with the public disclosure system for the expenditure report.
- Policy
- There is no concern about the disposal of COVID-19 PO tx
- by Lee, Jeong-Hwan Aug 23, 2022 06:03am
- Regarding the criticism that many of the COVID-19 PO treatments held by the quarantine authorities are likely to be discarded due to the expiration date early next year, it expressed that there is no problem in proper inventory management. As the use of PO drugs is increasing due to the re-proliferation of COVID-19 and an active prescription environment has been established, the current reserves can be used until November, so the introduction of additional supplies should be coordinated, not discarded. On the 18th, the KDCA made this announcement at a regular briefing for COVID-19. Some media reported that based on a report by the National Assembly's Budget Office, 700,000 of the 960,000 PO drugs brought in so far, will have to be discarded after the expiration date in February next year. In the briefing, a question was also asked about the criticism that many of the treatments will be discarded in February next year. The KDCA explained that in order to minimize damage to high-risk groups, it expanded hospital prescription institutions, increased pharmacies in charge, and encouraged medical staff to actively prescribe oral drugs. It also said that the current amount of oral drugs is doses for 690,000 people, which can be responded to by November this year, considering the recent weekly usage. The move is aimed at exhausting all of the current holdings before the disposal time in February next year. An official from the KDCA said, "We plan to flexibly adjust the additional introduction of the COVID-19 oral drug as it currently has a quantity that can be responded to by November rather than concerns about disposal." "We are also discussing with related agencies about extending the expiration date of Paxlovid and Lagevrio," he said. The official said, "We will push for proper inventory management without disposal for Paxlovid, which is scheduled to expire in February next year."
- Company
- Omega-3 prescription market doubles in 3 Years
- by Kim, Jin-Gu Aug 23, 2022 06:03am
- KuhnilIt is expected that generic companies will join and fierce competition is expected. The market for Omega-3 is rapidly expanding. The performance of outpatient prescriptions in the first half of the year has more than doubled in three years. The prescription performance of Omega-3 and Statins has increased significantly. It is predicted that competition in this market will become fiercer in the future, centering on the omega-3 and Statin complex. According to UBIST, a pharmaceutical market research firm on the 17th, the size of outpatient prescriptions in the Omega-3 Rx market in the first half of this year is 72 billion won. Compared to the first half of 2019, it has expanded 2.1 times. This market is growing rapidly around 2020. Based on the quarterly prescription amount, it was below 20 billion won until the third quarter of 2019, but it surpassed 20 billion won in the fourth quarter and exceeded 30 billion won in the second quarter of 2021. In the second quarter of this year, it recorded 36.8 billion won, looking at the quarterly prescription amount of 40 billion won. While the Omega-3 single system has steadily expanded its influence, the Omega-3 and statin complex has joined in earnest, driving the market expansion. In fact, the prescription amount of omega-3 and statin composites in the first half of 2019 was only 2.4 billion won, but it increased 5.9 times in three years to 14.3 billion won this year. In July 2017, Kuhnil was approved for Rosumega as the first omega 3+ Rosuvastatin complex. Rosumega paid 600 million won in prescription that year, and increased to 4.1 billion won the following year. After recording 6.7 billion won in 2019, it has become a large item that pays about 10 billion won in prescriptions since 2020. With Rosumega on the market, other generic companies have joined the competition. In December 2020, Jeil, Yuyu, Boryeung, Kyung Dong, Korea Prime, and Futecs were granted generic of the Omega 3·Rosuvastatin complex. These products are manufactured by Kuhnil. Last year, United joined the new competition. Instead of commissioning production to Kuhnil, United challenged Kuhnil head-on through patent raids. United, which won the patent dispute, released Atmeg Combigel Soft Cap in the second quarter of last year as an Omega 3+ Atorvastatin compound. Atmeg Combigel is rapidly expanding its prescription performance with its release. The prescription amount, which was 1.2 billion won in the second quarter of last year, increased seven times to 8.3 billion won in the second quarter of this year. United plans to expand its performance to 20 billion won a year. It is expected to have more intense competition in the future, centering on the Omega-3 and Statin complex. Kuhnil was licensed for combination generics such as Atmeg Combigel, signaling competition. Along with Kuhnil, Daehannupharm, Dongkoo Bio, Hutecs, and Penmix are expected to enter the market. Kuhnil plans to produce their products on consignment. United plan to face Atmeg Combigel with new dosages. In addition to the existing Atorvastatin 10mg + Omega-3 1,000mg product, United has recently received approval for Atorvastatin 5mg + Omega-3 1000mg product. On top of that, it plans to release additional medicines with the same ingredients through its affiliated company Korea Biochem.
- Company
- Abilify 1mg can be prescribed at tertiary hospitals
- by Eo, Yun-Ho Aug 22, 2022 05:53am
- A new 1mg strength formulation of ‘Abilify’ can now be prescribed at general hospitals According to industry sources, Korea Otsuka Pharmaceutical's antipsychotic ‘Abilify (aripiprazole)’ has passed the drug committees (DCs) of major hospitals in Korea, including the Seoul National University Hospital, Seoul Asan Medical Center, and Sinchon Severance Hospital. The company has been working to make prompt entry into the market after receiving reimbursement approval for its new strength in March this year. The 2mg, 5mg, 10mg, and 15mg strengths of Abilify have already been approved in the past. The introduction of the 1mg strength is the first change made in the product lineup in 6 years since the company received approval for ‘Abilify Maintena inj.’ In 2015. When narrowing the product line to Abilify tablets alone, this is the first change made in 13 years since 2008 when the 2mg tablet formulation was approved. Although a 1mg strength for Abilify did not exist in the past, prescriptions of the 1mg dose have been frequently made by splitting the 2mg strength tablet. The 1mg dose was used for dose-sensitive first-time patients with neuropsychiatric disorders etc. Whether Abilify may be able to secure its sales in the market that is being challenged by generics by introducing the low-strength formulation remains to be seen. According to the market research institution IQVIA, Korea Otsuka Pharmaceutical's Abilify series makes the most sales among all schizophrenia treatments in Korea. Its 3 products - Abilify tab, Abilify OD tab, and Abilify Maintena inj – had raised ₩50.9 billion in sales in 2020. With the same product line, the company made ₩27.4 billion in the first half of the year last year.
