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- 2026-07-01 12:03:09
- Company
- AKLIEF can be prescribed at general hospitals
- by Eo, Yun-Ho Aug 10, 2022 05:53am
- According to related industries, Galderma Korea's AKLIEF passed the Drug Committee (DC) of higher general hospitals such as Samsung Medical Center and Sinchon Severance Hospital. AKLIEF is a retinoid-based treatment that has been recommended as the primary treatment for acne, and is evaluated as an innovative treatment that can simultaneously treat face and torso acne by overcoming the limitations of existing treatments that have been limited to face acne treatment. Acne is known to occur mainly on the face, but body acne is a common phenomenon. 50% of patients with acne on their faces develop body acne together. According to a clinical study of 965 people, chest and torso acne rates were 45% and 61%, and another study found that about 22% of patients with face and torso acne did not voluntarily report body acne, but more than 75% of those who were offered body acne treatment wanted treatment. Since most treatments have focused on treating facial acne, the reality has been that there has been no appropriate treatment to treat the face and body at the same time. AKLIEF is evaluated as an alternative to overcome the limitations of existing acne treatment. AKLIEF targets retinoic acid receptor gamma (RAR-), the most common RAR on the skin, and is the only large-scale clinical three-phase study to demonstrate efficacy, drug resistance, and safety for face and torso acne. According to PErFEcT1 and 2, a 12-week phase 3 of more than 2,400 people, AKLIEF reduced inflammatory and non-inflammatory lesions quickly from week 1 compared to the control group and effectively decreased body acne from week 2.
- Policy
- Will approval of brain function enhancers be revoked?
- by Lee, Hye-Kyung Aug 10, 2022 05:53am
- Whether acetyl-L-carnitine, which failed to verify its efficacy in its ‘secondary degenerative diseases caused by cerebrovascular disease’ indication during clinical reevaluations, will be able to maintain its marketing authorization status will be determined within September this year. The Ministry of Food and Drug Safety issued a Dear Healthcare Professional Letter on the 5th recommending the use of alternative drugs and discontinuing the prescription and dispensing of drugs that contain acetyl-L-carnitine. At the MFDS correspondents’ briefing held on the 9th, Kyung Seung Shin, Director of the Pharmaceutical Safety Evaluation Division at MFDS, said, “We have disclosed the reevaluation results in compliance with our administrative procedure, and will be receiving objection submissions for 10 days starting on the 20th day of the public announcement. When the final result will be announced may vary depending on whether or not an objection is filed and other circumstances." Director Shin said, “The process will likely be completed within September. If the Ministry does not accept the objections submitted by the companies, acetyl-L-carnitine drugs will be recalled, suspended from sales, and revoked of their marketing authorization.” Currently, 39 acetyl-L-carnitine products from 35 companies are sold in the Korean market, with representative products being Dong-A ST’s ‘Dong-A Nicetile Tab.’ and Hanmi Pharmaceutical’s ‘Carnitil Tab.’ Pursuant to Article 33 of the Pharmaceutical Affairs Act, the MFDS ordered related companies to reevaluate and verify the efficacy of acetyl-L-carnitine through domestic clinical trials based on the latest scientific standards. The companies have already failed to demonstrate acetyl-L-carnitine’s efficacy in ‘primary degenerative disease’ in a previous clinical trial that was conducted in June 2019, which resulted in the deletion and removal of the indication. Shin said that the most frequent request made by the companies during clinical reevaluations is to extend the reevaluation period. “The companies wish for more time. We have partially accepted such requests per claims that patient recruitment is difficult due to COVID-19.” However, the ministry takes thorough reports on the interim progress of the clinical reevaluations for the safety of the consumers. Shin said, “Although the companies say that conducting domestic trials within the period is difficult, as their drugs are still being sold in the market during the period, it is our responsibility to confirm the progress for the consumers. We receive interim result reports so as to prevent delays or discontinuation." Regarding the increased burden borne by the industry due to MFDS’s clinical reevaluations and HIRA’s reimbursement evaluations, Shin said, “The companies may feel burdened by the reevaluations being separately conducted by different institutions on one product, but this is just standard procedure that needs to be carried out by each institution." “HIRA conducts reevaluations on the adequacy of a drug’s reimbursement, while the MFDS reevaluates whether the clinical effectiveness of a drug meets the latest scientific standards. Although the institutions closely share their progress, as the reevaluations are conducted for different purposes, their evaluation systems have to be operated separately." Shin also explained the risk management plan system that was included in the new government's regulatory reform innovation plan, which will be operated in integration with the post-marketing safety management system after the abolition of the re-examination system. Shin said, “There had been industry burden of additionally needing to conduct risk mitigation measures if a drug is designated as a drug subject to risk management while conducting mandatory PMS for 4-6 years from a drug’s marketing date. The two laws in effect have many similar and overlapping parts, so a plan was made to integrate the laws into a single risk management system. We will promptly work to amend the Pharmaceutical Affairs Act for this.” Shin also mentioned the pharmaceutical equivalence reevaluations that are set to begin next year and end in 2025. The MFDS recently disclosed the total list of items subject to pharmaceutical equivalence reevaluations for the next 3 years, which includes 130 ingredients such as levodropropizine in 2023, 420 ingredients including amlodipine in 2024, and 286 ingredients including piroxicam in 2025. Shin said, “We plan to receive supplementary documents for items subject to reevaluations this year until the end of the year. Some companies requested deadline extensions due to difficulty generating data, so we may receive data until early next year."
- Company
- Gov improvement plan may reduce patient drug access
- by Eo, Yun-Ho Aug 10, 2022 05:53am
- The focus is on lowering the price of the drug rather than improving the registration, shortening the time and effectiveness are insignificant." "There was no discussion with the consultative body. It's hard to gather opinions from the industry." The KRPIA expressed strong opposition to the government's plan to strengthen access to new drugs. Rather, it is pointed out that it will reduce patient accessibility. According to KPRIA on the 9th, the "plan to enhance patient access to high-priced severe disease treatments and strengthen salary management" reviewed by the Health Insurance Policy Review Committee of the MOHW on the 20th of last month focuses only on strengthening follow-up management of insurance drugs such as "PVA reduction rate revision" and "foreign drug price adjustment". Among the contents of "Quick registration through benefit evaluation and negotiation" included in the management plan, the part that shortens 60 days during the 210-day deliberation period of the current regulation does not have a practical shortening the period. It is argued that this not only hinders the motivation for innovative growth of the domestic pharmaceutical bio industry, which is currently developing new drugs, but also goes against the new government's stance to become a bio powerhouse as it can shrink the entire industry. According to a 2022 study, the average period for new drugs registered over the past 10 years was more than 690 days for rare drugs and 930 days for anticancer drugs. Through this, the association has already suggested that the effect of improving accessibility felt by patients will be very insignificant by shortening some periods (60 days) in the current salary evaluation system, which requires more than three to four times the actual legal period. The KRPIA said, "It is necessary to review and introduce a more proactive rapid registration system." It evaluated that "expansion of the PVA rate" and "additional restriction of the PE system to minority patients" included in the announcement of the management plan overlooked the fact that it could reduce the motivation to develop innovative new drugs and hinder access to treatments for severe rare diseases. The current system is already listed as the lowest in the world through comparison of foreign drug prices and has a longer evaluation period, making it difficult for domestic pharmaceutical companies as well as global pharmaceutical companies to release new drugs. The KRPIA also expressed concern about the fact that it did not collect opinions with related industries in the process of reviewing management plans. He added, "The MOHW's public-private consultative body for improving the drug price system, which has been operated by the HIRA, the NHIS and pharmaceutical organizations since early last year, also had a chance to review and discuss it in advance with the industry."
- Policy
- AZ seeks reimb of its triple inhaled therapy for COPD
- by Lee, Tak-Sun Aug 10, 2022 05:52am
- The first single-inhaler triple therapy for COPD in Korea, New triple drug inhaled therapies for COPD (Chronic Obstructive Pulmonary Disease) are working to receive insurance reimbursement in Korea. After GSK cut the first tape to reimbursement with its ‘Trelegy Elipta’ in June last year, AstraZeneca has also applied for the reimbursement of its ‘Breztri Aerosphere,’ which was approved in November last year. According to industry sources on the 8th, AstraZeneca applied for reimbursement of its Breztri Aerosphere to the Health Insurance Review and Assessment Service. Breztri Aerosphere is a single-inhaler, fixed-dose triple-combination of budesonide glycopyrrolate (undifferentiated), budesonide (undifferentiated), and formoterol fumarate (undifferentiated). The inhaler is indicated for the maintenance treatment of moderate-to-severe COPD in patients who are not adequately treated by a combination of a long-acting beta2-adrenergic agonist (LABA) and inhaled corticosteroid (ICS) or a combination of a long-acting muscarinic antagonist (LAMA) and LABA. In other words, this triple therapy emerged as a new alternative for patients with COPD that did not respond well to existing ICS-LABA or LABA-LAMA combination therapies. Triple inhaled therapies have first entered the Korean market with the reimbursement approval of GSK’s Trelegy Elipta in June last year. The insured ceiling price of the drug was set at ₩45,602 for 30-day supply. At the time of listing, its price received attention for being similar to that of existing dual combination therapies. Trelegy Elipta’s price is expected to act as a benchmark for the other drugs that will follow. Triple inhaled COPD therapies that are currently approved in Korea are: Trelegy Elipta, which was approved in 2018,; Breztri Aerosphere, which was approved in November last year; and Kolon Pharma’s Trimbow, which was approved in September 2019. Although Kolon is yet to apply for the reimbursement of Trimbow, AstraZeneca is quickly pushing to reimburse Breztri Aerosphere. AstraZeneca’s hastening the release of its triple therapy combination to prevent GSK's monopoly in the COPD inhaler market. However, the key is price. AstraZeneca cannot help but consider price competitiveness as Trelegy Elipta was listed with reimbursement at a relatively nice price'. Currently, it is estimated that around 50,000 COPD patients in Korea will be in need of treatment with triple inhaled therapies. With so many patients present, the competition between GSK and AZ is expected to heat up in the market.
- Policy
- When replacing Spinraza→Zolgensma, it should be injected
- by Lee, Hye-Kyung Aug 10, 2022 05:52am
- If SMA patients who were administering Biogen's Spinraza want to be replaced with Zolgensma, an ultra-high-priced one-shot treatment from Novartis Korea, they should have a minimum administration interval of 4 weeks. Regardless of whether or not benefit of Zolgensma is applied, replacement administration to other treatments after Zolgensma administration does not recognize the application of benefits. On the 4th, the HIRA guided "Questions and Answers on Zolgensma benefit standards." Zolgensma will be reimbursed from the 1st of this month as the insurance drug price of 1,981,726,933 won per kit was set through the Health Insurance Policy Review Committee on July 20. It is recommended to have an administration interval of at least 4 weeks (ideally 4 months) as there may be additional risks, such as an increase in the number of Zolgensma replacement administration times in Spinraza. Age conditions are judged on a calendar basis. Under 9 months of age means the day before the birth date + 9 months of age, up to 12 months of age / up to 12 months of age (temporary replacement) until the day before the birth date + 13 months. Permanent respiratory use refers to the case of using a ventilator for more than 16 hours a day and more than 14 consecutive days. Submission of consent to implement a long-term follow-up investigation for Zolgensma administration is mandatory for the application of Zolgensma insurance and must be submitted when applying for prior approval. Medical institutions are encouraged to fully explain Zolgensma effects and side effects to patients (caregivers) and to obtain consent from patients and carers before administering this drug.
- Policy
- Administration of Evusheld begins to prevent COVID-19
- by Kim, Jung-Ju Aug 09, 2022 05:57am
- From today (8th), the quarantine authorities will administer Evusheld, an antibody injection for prevention, for severely immunocompromised patients. The COVID-19 Vaccination Response Promotion Team (Director Baek Kyung-ran) announced today (the 8th) that it will start taking Evuseld to prevent COVID-19 among immunocompromised people. Evuseld is a preventive antibody injection that directly injects antibodies into the body to cause preventive effects to those who are unable to form immunity due to immunosuppressive treatment and severe immunodeficiency symptoms. Evuseld was introduced in Korea under the approval of the MFDS. As a result of clinical trials, preventive effects were confirmed, such as 93% reduction in infection and 50% reduction in severe and death. Recently, the Korea Centers for Disease Control and Prevention explained that the effectiveness of BA.4 and BA.5, which are subvariables of omicron, has also been confirmed to be maintained. The most common adverse event among reported adverse reactions in safety was injection site response (2%), mostly mild (73%) or severe (24%), and no particular safety problem was identified. The subjects of the medication are blood cancer patients receiving immunosuppressive treatment, organ transplant patients, and congenital (primary) immunodeficiency patients. This standard was prepared through consultation with related professional societies and experts such as the KSID, The Korean Society of Hematology, The Kosaids, and Korean College of Rheumatology. Currently, there are 35 high-level general hospitals, 99 general hospitals, and 76 hospitals, with 210 designated nationwide, and medical staff must receive medication training such as drug characteristics, medication targets, injection methods, and contraindications. If there is a patient who believes that medication is necessary according to the medication guidelines, reservations and applications can be made through the COVID-19 vaccination management system. When an application from a medical institution is received, the Korea Centers for Disease Control and Prevention will check with the local health center and apply for the allocation of drugs to the relevant medical institution before the scheduled date. The promotion team said, "In order to prevent COVID-19, vaccination is recommended first, but if it is difficult to expect antibody formation even after vaccination, additional protective effects can be expected through Evusheld, a preventive antibody injection."
- Policy
- Oxiracetam’s next...ordeal of brain function enhancers
- by Lee, Tak-Sun Aug 09, 2022 05:56am
- Korean Drug Co.’s It’s a time of ordeal for brain function enhancers. In addition to choline alfoscerate, whose scope of use has been reduced through reimbursement reevaluations, acetyl-L-carnitine failed to demonstrate its efficacy during clinical reevaluations. As a result, acetyl-L-carnitine is expected to completely disappear from the prescription market. Oxiracetam, which accounts for the third-largest share of the brain function enhancer market, is set to receive clinical reevaluations and reimbursement reevaluations soon. If oxiracetam also takes a blow, industry officials predict that the brain function enhancer market itself will greatly retract. On the 5th, the Ministry of Food and Drug Safety announced that it will suspend prescriptions and dispensing of acetyl-L-carnitine as the drug failed to demonstrate its efficacy in ‘secondary degenerative diseases caused by cerebrovascular disease’ during clinical reevaluations. In other words, acetyl-L-carnitine was unable to prove its efficacy in the indication. Acetyl-L-carnitine had previously been unable to demonstrate its efficacy for 'primary degenerative diseases' during clinical reevaluations. Being unable to demonstrate efficacy for both of its indications, the ingredient is set to be removed from the reimbursement list. Acetyl-L-carnitine had been subject to reimbursement reevaluations next year, however, if it is removed from the reimbursement list, the ingredient will naturally be excluded from reevaluations as well. The average annual claims amount of acetyl-L-carnitine over the last 3 years was ₩58.1 billion, the second-best grossing ingredient in the brain function enhancer market next to choline alfoscerate, which boasts a market size of ₩500 billion. The problem is that the next-in-place brain function enhancer is also up for reevaluations soon. The drug up for the next reevaluation is oxiracetam, which is represented in Korea by Korean Drug Co.’s Neuromed tablet. Clinical reevaluation reports for oxiracetam are also due for submission by the end of this year. Like other ingredients, oxiracetam’s indication for improving Alzheimer-type dementia had also been deleted due to the inability to demonstrate its efficacy, and a clinical reevaluation is being conducted to verify its efficacy for the remaining indication, for the 'improvement of vascular cognitive disorder symptoms.’ If the year-end reports submitted are unable to verify the drug’s efficacy in the remaining indication, the prescription and dispensing of oxiracetam will likely be discontinued, just like in acetyl-L-carnitine's case. However, another great obstacle remains even after verifying the clinical efficacy as oxiracetam is also subject to reimbursement reevaluations next year. Oxiracetam’s 3-year average claims amount is ₩23.3 billion, less than that of choline alfoscerate or acetyl-L-carnitine. But as Neuromed raised ₩11.5 billion in prescriptions last year, the amount earned in terms of each item is by no means small. If oxiracetam also suffers a blow from that reevaluation, all the main brain function enhancers will be reduced reimbursement or removed from the reimbursement list, thereby contracting the total market. Brain function enhancers have been widely used to prevent dementia in elderly patients and have well served as a cash cow for domestic pharmaceutical companies. Reimbursement for choline alfoscerate was maintained through the reimbursement reevaluations that were conducted to verify the drug’s efficacy in dementia in 2020. However, the patient coinsurance rate for the main indication in improving cognitive disorders rose from 30% to 80%, and was applied selective reimbursement. Despite this, the previous reimbursement rate is being applied because some of the affected companies appealed the decision, and filed for a stay of execution of the reimbursement reduction disposition. However, Chong Kun Dang and the other companies lost the suit that they filed to cancel the reimbursement reduction, and the stay of execution will be lifted soon. Also, the fact that the companies must demonstrate their drug’s efficacy through clinical reassessments by 2025 will add a significant burden on the companies.
- Opinion
- [Reporter's view] COVID-19 vaccination strategy
- by Aug 09, 2022 05:56am
- The MFDS has begun a preliminary review of the vaccine for COVID-19 in Moderna and Pfizer. The preliminary review is to review the submitted clinical data in advance and to quickly determine whether to grant permission when the company applies for an item permit by adding non-clinical and quality data in the future. The divalent vaccine, which Moderna and Pfizer applied for a preliminary review, is a vaccine that expresses each antigen for the initial coronavirus (Wuhan) and the omicron mutation virus BA. It is a combo vaccine that combines two antigens in half, and the two companies began developing it early this year and announced major clinical results in June. The two vaccines were found to have produced more neutralizing antibodies to omicron mutations than conventional vaccines. The problem is that BA.5, an omicron subvariant, spread rapidly and became dominant in Korea. According to the detection rate of major mutant viruses compiled by the Korea Centers for Disease Control and Prevention, the BA.5 detection rate in the fourth week of July was 66.8%, up 10.5 percentage points from the previous week. It became the dominant species 11 weeks after the first BA.5 stool confirmed in Korea on May 12. Modena and Pfizer's divalent vaccine basically expresses antigens against the circular omicron virus, so it has a higher preventive effect on sub-variations than conventional vaccines. However, it was relatively ineffective as it targeted BA.1. According to the announcement of the two companies, the neutralization value of the bivalent vaccine for BA.4/5 was one-third of the number shown in the BA.1 mutation. That's why the FDA has demanded that Moderna and Pfizer develop a new vaccine containing BA.4/5 which is included. At that time, sub-variations were spreading rapidly in the United States, so the FDA seems to have decided that it was necessary to target these mutations. The two companies are focusing their efforts on developing a new vaccine targeting submutation of omicron. South Korea should also consider what vaccination strategy to establish at a time when the omicron submutation has become the dominant species. The FDA is showing its willingness to inoculate vaccines targeting submutations even while minimizing clinical trials of the new vaccine. If there are more BA5 confirmed patients in Korea, the introduction of a BA4/5 vaccine should be accelerated. At the same time, there are differences between the U.S. and Korea. The United States, the mainland, spends the least time getting permits and vaccines. The U.S. health authorities have already signed a purchase contract for the BA.4/5 vaccine with Moderna and Pfizer. On the other hand, South Korea has relatively late permits, contracts, and domestic introduction schedules. A situation beyond the end of this year may occur. Unlike the United States, which has not been approved for a divalent vaccine, Korea needs to have an alternative solution called a divalent vaccine for omicrons. Health authorities should benefit the public most through reasonable choices within limited time and resources.
- Company
- Baxter International’s GM Dong-Wook Hyun suddenly resigns
- by Eo, Yun-Ho Aug 09, 2022 05:56am
- Former General Manager Dong-Wook Hyun Dong-Wook Hyun, General Manager of Baxter International Korea, resigned. According to industry sources, Hyun submitted his letter of resignation last month and left the company. The exact reason for his resignation remains unknown. With Hyun’s resignation, Baxter is now seeking a new head, during which Kwang-hyuk Im, Vice President of Renal Care at Baxter Korea, will be acting as interim CEO. The former GM Dong-Wook Hyun graduated from the University of California in the U.S. with a degree in Biology and Bioscience. Hyun accumulated extensive experience in the industry, beginning at the medical device company Medtronic from 1999 to 2004. After serving various posts in sales and marketing in the Asia-Pacific region, Hyun was appointed the Country Manager of Medtronic. Since then, Hyun served as the General Manager of Baxter from 2004 to 2008, and then as the Managing Director of MSD Korea for 8 years, after which he was again appointed as the General Manager of Baxter Korea in 2018. Meanwhile, Baxter is a global healthcare company based in the U.S. that entered the Korean market with its hemodialysis business in 1972. The company established its Korean subsidiary in 1991 and has been supplying pharmaceuticals such as anesthetics, intravenous nutrition, etc. as well as medical devices including peritoneal dialysis solutions and automated peritoneal dialysis systems to Korea.
- Policy
- It's hard to prescribe oral medicine for COVID-19
- by Kim, Jung-Ju Aug 09, 2022 05:56am
- Amid the remarkable re-proliferation of COVID-19, the newly proposed National Infectious Disease Crisis Response Advisory Committee advised medical staff to create detailed guidelines for prescriptions in consideration of difficulties in the dispensing process. The National Advisory Committee on Infectious Disease Crisis Response (Chairman Chung Ki-seok) held the 3rd National Advisory Meeting on Infectious Disease Crisis Response on the 4th to discuss such issues. The third meeting was attended by 21 members of the National Advisory Committee on Infectious Disease Crisis Response, including Chairman Chung Ki-seok, the Central Disease Control Headquarters, and the COVID-19 Vaccination Response Promotion Team. The advisory committee first said that in-depth analysis of related cases should be added to establish a data-oriented quarantine policy as re-infected cases and deaths of children and adolescents are being confirmed in relation to the current epidemic. In the prediction of trends, it was asked to create a system that allows a number of research teams to conduct systematic mid- to long-term modeling research that reflects various policy effects beyond supporting the results of mathematical modeling-based predictions. In the case of PO treatments, the operation status of the currently operating one-stop medical institution was checked so that patients visiting the hospital could be prescribed and treated in a timely manner to discuss the need for a system in which all citizens are guaranteed proper COVID-19 treatment services without inconvenience. In particular, the advisory committee said that guidelines should be drawn up so that medical institutions can pay close attention to the on-site procedures and processes of pharmacies that prepare eating treatments. In fact, unlike ordinary dispensing patients in pharmacies, the preparation and medication guidance for COVID-19 oral preparation patients are complicated, and the billing method is differentiated from other health insurance, so it takes a lot of time and requires concentration. In response, the advisory committee reviewed, "The government should also try to expand medical institutions and pharmacies, but it is necessary to produce and distribute detailed prescription guidelines to medical staff so that they can help in the medical field." He suggested that the system needs to be checked and prepared so that children wishing to be vaccinated can be vaccinated quickly as the number of COVID-19 children and adolescents has increased since the Omicron epidemic.
