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- 2025-12-18 10:42:58
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- H. pylori with 50% prevalence requires active examination/tx
- by jung, sae-im Aug 07, 2022 11:29pm
- Helicobacter pylori is a bacteria that causes digestive diseases such as acute gastritis, chronic gastritis, gastric ulcer, duodenal ulcer, gastric lymphoma, and gastric cancer, and is defined by the World Health Organization as a first-class carcinogen. As half of the nation's population is evaluated as Helicobacter infections, the importance of eradication treatment is increasing in recent clinical sites. On the 5th, Park Sun-jae, director of the Myongji Hospital in Busan, stressed the need for treatment, saying that the prevalence in Korea has decreased to around 50% due to the introduction of Helicobacter eradication treatment, but still maintains a high prevalence. Helicobacter pylori is a spiral bacterium that can be activated even in the stomach, which is a strong acid environment. It is known to induce chronic gastritis and intestinal epithelium, increasing the risk of gastric cancer by about 10 times. Park Sun-jae, director of Myongji Hospital in Busan In Korea, as benefits for all Helicobacter pylori treatments have been recognized since 2018, eradication treatments have also continued to expand their influence. Specifically, health insurance benefits are applied to MALT lymphoma, peptic ulcers, early gastric cancer surgery (endoscopic resection), and idiopathic thrombocytopenia. Iron deficiency anemia, functional dyspepsia, atrophic gastritis, intestinal metaplasia, gastric cancer family history, and other cases where eradication is evaluated as necessary due to medical judgment are being used in clinical sites as non-reimbursement. Director Park said, "The criteria for primary treatment therapy have been expanded to the 2020 guidelines of the Society," adding, "However, patients who can be strongly recommended will be divided depending on whether they are diseases that meet the health insurance benefit standards." "If intestinal metaplasia or atrophic gastritis is clearly confirmed through endoscopy or if there is a family history of gastric cancer, it is recommended to patients regardless of whether health insurance benefits are applied or not." Currently, primary therapy is classified into four types according to the recommendation criteria of the 2020 Korean Upper Gastrointestinal and Helicobacter Society. Conventional triple therapy (Amoxicillin + Clathromycin + PPI), quadruple therapy without Bismuth (Amoxicillin + Clathromycin + PPI + Metronidazole), triple therapy selection after Clathromycin resistance testing, and etc. are recommended in some patients. Director Park said, "As a first-line treatment, conventional triple therapy has changed OTC period from 7 days to 14 days. In the case of the 7th, the success rate of treatment may decrease, he said. "In fact, there are cases where 14 days fail due to the high resistance rate in Korea such as Clarithromycin." This varies depending on the region or the age group that uses a lot of antibiotics, she said. She said, "Quadruple therapy is an additional Metronidazole-based drug, but depending on the patient, it is not a drug that the patient suffers when prescribed compared to the three-drug therapy on the 14th." She evaluated, "As a secondary treatment, it is not burdensome to feel in actual clinical trials rather than quadruple-drug therapy including Bismuth." Recently, P-CAB along with PPI has become possible for eradication treatment, but in terms of safety, existing treatments with accumulated clinical data are preferred, she explained. Director Park said, "It varies from doctor to doctor. If a specific item has a poor eradication rate, we do not change the treatment." Regarding PPI and P-CAB prescriptions, there is also a problem with drug prices, she said. "As the number of prescriptions on the 14th increases as the primary treatment therapy, the difference in drug prices is greater." Although antibiotics are similar, the difference in drug prices of these ingredients can be a burden on patients.
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- Nearly 100,000 COVID-19 confirmed cases
- by Kim JiEun Jul 28, 2022 05:54am
- Society has no guidelines despite the spread of the disease. As COVID-19 spreads again, face-to-face administration at pharmacies is also increasing significantly. Individual pharmacies are trying to quarantine, but confusion is also detected as it goes against social sentiment. On the 26th, the Central Disease Control Headquarters of the Korea Centers for Disease Control and Prevention announced that as of midnight, there were 99,327 new confirmed cases (98,974 domestic cases and 353 overseas inflows). It is the largest in 97 days since April 20, when it was around 110,000 people. As the number of new COVID-19 confirmed patients approached 100, the ratio of face-to-face administration at pharmacies has also increased significantly since last week. Pharmacists say that there are many cases in which so-called "Shy Corona" patients, who have symptoms but are reluctant to visit or test medical institutions, visit pharmacies to purchase OTC drugs. As the number of direct administration and medication guidance of confirmed patients increases and pharmacists and employees continue to be confirmed, front-line pharmacies are reinforcing their own quarantine, which has been loosened. A pharmacist in Busan said, "Until a few weeks ago, the average daily face-to-face administration of confirmed patients fell to about one, but since last week, the number has increased to an average of 20 per day. This week, as one pharmacist was confirmed, all pharmacy employees were tested, he said. "We stopped self-disinfection as the number of confirmed patients decreased and the number of face-to-face administrations of confirmed patients decreased, but we are disinfecting them every day again." A pharmacist in Seoul also said, "The number of face-to-face administrations of confirmed patients has increased recently, but the number of patients with suspected symptoms has definitely increased." He said, "I'm worried that it can increase even more after the holiday season." This is because the lifting of social distancing has loosened public sentiment on quarantine than before, and the government is actually pursuing autonomous quarantine, saying it is scientific quarantine. There is also a conflict between pharmacists and patients over whether to wear masks or take medicines at pharmacies. The Pharmaceutical Affairs Association also said that considering current government policies and social sentiment, there is an ambiguous aspect in notifying member pharmacies of quarantine-related guidelines or guidance text messages. An official from the Korea Pharmaceutical Association said, "Currently, the crisis warning is clearly in the 'serious' stage. The Pharmaceutical Affairs Association is also guiding member pharmacists in line with the crisis alert stage, but it added that there are ambiguous aspects as it seems to be different from the national quarantine policy and social atmosphere.
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- Medical institutions earned ₩7 trillion with COVID-19
- by Kang, Shin-Kook Jul 27, 2022 05:50am
- A whole ₩7.1028 trillion was spent on medical fees for COVID-19-related matters over the past two and a half years since the pandemic first hit Korea. The medical staff, acclaimed for their efforts in the pandemic, have also earned much for their incredible amount of hard work. In the same period, pharmacies have only earned around ₩59 billion in COVID-19 fees, as drug administration safety management fees (₩3,101) and face-to-face drug administration management fees (₩6,020). This accounts for less than 1% - 0.83% - of the total ₩7.1028 trillion that was spent on COVID-19. 'The current state of claims made for COVID-19 fees' that was reported to the Health Insurance Policy Deliberative Committee (Jan.2020 – June.2022) showed that the total medical expenses amounted to ₩6.244 trillion. An additional ₩858.8 billion was paid out for vaccinations to raise the total to ₩7.1028 in medical fee payments to medical institutions. Current medical fee claims for COVID-19 (2022 1~2022.6.30. cumulative claims ) By category, medical institutions filed claims for ₩2.3426 trillion in COVID-19 diagnostic tests and received ₩1.5948 trillion as residential treatment and at-home treatment fees, the fees received by pharmacies were included in this category. The payment of ₩1.2848 trillion that was made to support the treatment of hospitalized patients including severe patients went to COVID-19 dedicated hospitals. Also, ₩1.1026 trillion was used to support medical personnel and public health centers, ₩422.1 billion as non-COVID-19 personalized medical fees, and ₩263.5 billion as COVID-19-related infection prevention management fees, and ₩92.4 billion as emergency medical fee at screening centers. With no copayment, the claimed amounts have been fully supported by insurance premiums and the national treasury. In particular, the majority of the resources came from the supplementary budgets that were passed several times over the past 2.5 years. Meanwhile, the Ministry of Health and Welfare plans to continue applying the existing medical fees for in-patient treatment, diagnostic tests, face-to-face treatment and drug administration, diagnosis, and childbirth among others to prepare for the resurge of COVID-19. However, whether to apply individual fees will be decided upon after deliberation by the HIPDC’s subcommittee in accordance with the NHI Disaster Response Manual.
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- MOHW meets Doctornow to listen to platform guidelines
- by Kim JiEun Jul 27, 2022 05:49am
- The timing of the announcement of the guidelines for the non-face-to-face treatment brokerage platform announced by the government is later than expected. In addition to the opinions of the medical and pharmaceutical sectors, the government's intention to reflect some of the opinions of platform companies is read. It has been confirmed that the MOHW plans to visit Doctornow's headquarters, the representative of the non-face-to-face treatment platform, at 2 p.m. on the 28th to hold an on-site meeting of the non-face-to-face treatment brokerage platform. Vice Minister of Health and Welfare Lee Ki-il will attend the meeting. The visit by the MOHW seems to be aimed at listening to opinions and suggestions from industries related to the "Temporary non-face-to-face treatment intermediation platform guidelines." At the Health and Medical Development Council held on the 12th, the MOHW also announced plans to announce the guidelines as soon as possible while collecting opinions from doctors and pharmacies on the guidelines for non-face-to-face treatment brokerage platforms. The MOHW received additional opinions from the Medical Association and the Pharmaceutical Affairs Association until the 15th, three days after the meeting, and also conveyed to the organizations that they would announce guidelines within this week. Shortly after the Health and Medical Development Council meeting, an official from the Ministry of Health and Medical Development told Dailypharm, "The basic framework was based on a temporary non-face-to-face medical notice, and each case was judged and subdivided." With the confirmation of the MOHW's visit to Doctornow's headquarters, guidelines for operating a non-face-to-face treatment brokerage platform are expected to be announced as early as next Thursday. According to officials from the MOHW and those attending the meeting, the guidelines are expected to include restrictions on services that match specific hospitals and pharmacies on brokerage platforms. The guidelines are likely to include restrictions on "getting prescriptions, storing desired drugs" on some recently controversial platforms, as well as sanctions on illegal medical care and drug advertisements. The Pharmaceutical Affairs Association said in additional opinions delivered until the 15th that it proposed disclosing the names of affiliated pharmacies of non-face-to-face treatment platforms and suspending Rx drug advertising. An official from the Pharmaceutical Association said, "Non-face-to-face treatment platforms are not disclosing specific pharmacies due to matching of short-range hospitals and pharmacies, but we additionally requested to stop this part. In addition, we demanded sanctions for illegal advertising of Rx drugs."
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- Sell Saxenda directly after non-face-to-face treatment?
- by Jung, Heung-Jun Jul 10, 2022 03:31pm
- Can hospitals sell Saxenda, known as diet injections, directly to patients after non-face-to-face treatment? It is an expensive drug worth more than 100,000 won per unit and there is a high demand for purchase, so it is not prescribed for outpatients. The problem is that some hospitals sell and deliver directly to patients even in non-face-to-face treatment. On blogs, people can find reviews of prescriptions that seem to have received Saxenda directly from the hospital. Pharmacists have increased their outpatient prescriptions since the controversy over abuse of Saxenda in the past, and it is pointed out that it is inappropriate to use non-face-to-face treatment to administer inpatients Rx. Pharmacist A in Seoul said, "After the controversy over misuse a few years ago, more doctors prescribed outpatient Rx. Since it is a self-injection and the price is high, there may be some places that sell it directly, but that doesn't mean that it can be sold through non-face-to-face treatment, the pharmacist said. He then expressed concern, saying, "There are many people who visit non-face-to-face treatment to get diet pills, but they will only repeat the problem of misuse again." The MOHW also says that the principle of self-injection, such as Saxenda, is to prescribe outpatient Rx. It was stated that the temporary notice of non-face-to-face treatment only stipulated that drug delivery should be done through pharmacies. An official from the MOHW said, "Whether it is face-to-face or non-face-to-face, self-injection should be prescribed outpatient Rx unless injected within a medical institution. It cannot be seen as an exception to the division of medicine. In addition, the official said, "There is no content on the delivery of drugs by medical institutions even in the announcement of temporary permission for non-face-to-face treatment. We are making sure that medicine is delivered through pharmacies," he said. He added that the related internal review is in the final stage as there have been questions recently received by the MOHW related to outpatient Rx of Saxenda. Meanwhile, in 2020, Rep. Nam In-soon of the Democratic Party of Korea also argued for mandatory outpatient Rx, saying that the frequency of non-reimbursed self-injection systems such as Saxenda is high.
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- “Need to raise awareness and seek early diagnosis of Sjogre
- by Eo, Yun-Ho Jul 01, 2022 05:49am
- Dr. Ji Sun Lee “We can fully provide the standard of care at local rheumatoid clinics. Have trust and visit a local clinic near you.” If you are experiencing symptoms such as dry mouth, eyes, nose and mucous membrane, skin, or indigestion without underlying diseases or other medication histories for over 3 months but haven’t found its cause, it can be Sjogren's syndrome. Sjogren's syndrome is an autoimmune disorder whose cause has not been identified yet. Scientists believe it is a multifactorial disease that involves various factors such as genetics, hormone, virus or bacteria infection, nervous system, cytokines, and autoimmune antibodies. It is known to occur relatively more often in middle-aged women over the age of 40. According to National Health Insurance Service statistics, the number of patients who received treatment for Sjogren's syndrome in Korea had increased from 17,634 in 2015 to 21,282 in 2019. 2019 statistics show that its incidence was 7.7 times higher in women than men, and 83% of the patients were women over 40 years of age. Despite the inconveniences felt by the patients and its rarity, Sjogren's syndrome is not as dangerous as it seems. This is why doctors emphasize the need for accurate, prompt diagnosis and treatment. Ji Sun Lee (43), Director of the RheumaEZ Clinic in Busan, Korea, said, “It is not a disease of serious concern from the doctor’s point of view. Although it is an autoimmune disorder, using an immunomodulator may be excessive. There is no fundamental cure, but its symptoms can be alleviated through continuous medication and lifestyle management.” Lifestyle modification is very important to control dryness. Patients with Sjogren's syndrome need to drink water often to keep the mouth moist. Chewing sugarless gum can help boost saliva production. Patients should avoid highly caffeinated drinks such as coffee, black tea, and green tea, as they promote the diuretic effect and aggravate dry mouth. However, as Sjogren's syndrome is an unfamiliar condition, it takes some time for patients to be confirmed after symptom onset. Lee said, “Such delays in diagnosis result in unfortunate cases where patients are unable to see any effect from treatment due to their worsened condition. These days, there are genetic tests available to preemptively check the risk of typical eye diseases including Sjogren's syndrome before onset" Lee added “If you have severe dryness in mouth and eyes for more than 3 months and experience frequent swelling and pain in your salivary gland area under the ears, please visit a rheumatologist near you for diagnosis. Sjogren's syndrome is nowadays better recognized at general internal medicine clinics, and therefore is well it is recommended to visit the rheumatologist for diagnosis." Fortunately, Sjogren's syndrome is better recognized in general internal medicine recently and is being better referred these days.” Sjogren's syndrome is also well covered insurance-wise. With the application of the special calculation system, the co-insurance rate borne by the patient is around 10%. Lee said, “Although not a severe disease, Sjogren's syndrome does have a considerable impact on the quality of life of affected patients. Many experience insomnia and even depression. Therefore, the condition needs to be better managed by improving disease awareness and establishing an environment for its rapid diagnosis.”
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- Approval of OTC teleconference bending machine project
- by Kang, Shin-Kook Jun 23, 2022 05:49am
- OTC teleconference bending machine issue, which has been on hold for 10 years, has secured a bridgehead for entering the market under the new government deregulation stance. The Ministry of Science and ICT held an ICT regulatory sandbox review committee on the 20th and approved the OTC teleconference bending machine based on the MOHW's conditional acceptance opinion as an empirical special project. The OTC teleconference bending machine has long been an issue. When the issue of selling OTC at supermarkets occurred in 2012, the Gyeonggi Pharmaceutical Association voluntarily discussed the introduction of the OTC teleconference bending machine in the name of preventing it. Since then, in 2016, during Park government, the "Amendment to the Pharmaceutical Affairs Act" to introduce the OTC teleconference bending machine was pushed in the form of government legislation, but pharmacists opposed it. As the amendment to the Pharmaceutical Affairs Act was automatically scrapped at the end of the term of the National Assembly, it was a good opportunity for OTC teleconference bending machine companies. This is because of the regulatory sandbox introduced by Moon's government. Regulatory sandboxes are a system that exempts or suspends existing regulations for a certain period of time when new products and services are released in new industries and new technologies. The system was first launched in the UK to foster the fintech industry and was adopted by Moon's government as one of the regulatory reform measures. In the end, the Ministry of Science and ICT held a meeting to allow regulatory sandboxes for OTC teleconference bending machines in 2019, and it was likely to pass. At that time, the Pharmaceutical Association withheld deliberation, but the attempt continued. There was a second attempt to enter the regulatory sandbox in 2020. Moon's government received much help from pharmacists about public masks. It was not easy for Moon's government, which was well aware that innocent pharmacists suffered from public criticism due to public mask issues, to blindly push ahead with video medication machines. According to a statement from the Pharmaceutical Affairs Association at the time, "Pharmacists are doing their best to supply public masks in pharmacies, which has an unprecedented role in supporting the national public health and medical functions." To push ahead with the OTC teleconference bending machine demonstration special, which 80,000 pharmacists across the country oppose, just as they brutally trample on the efforts of these pharmacists, is a one-sided example of administration with no minimum form and common sense." In 2021, the Ministry of Science and Technology tried to deliberate on the OTC teleconference bending machine again, but it was put on hold again and it was handed over to the new government and Choi Kwang-hoon executive. However, Yoon's administration recognized deregulation as the top national task. The new government's economic policy was also focused on regulatory innovation. It was also a negative factor for the pharmaceutical society that Jeon Hye-sook, Kim Sang-hee, and Seo Young-seok, who were former pharmacists, became opposition lawmakers in the ruling party, making it difficult to exert power on the government. On top of that, unlike Moon's government, Yoon's government had no debt to the pharmaceutical society. The MOHW, which was skeptical of the OTC teleconference bending machine, also seems to have been forced to jump on the new government's regulatory innovation stance. On top of that, there is an analysis that the situation in which the MOHW is for nothing and it has also expanded the scope of the Ministry of Science and Technology. In the end, the OTC teleconference bending machine, which had been seeking to enter pharmacies for 10 years, began to enter the long-awaited pharmacy market after meeting the new government's market economy policy, and the pharmacist society, which resisted by even opening-air meeting, fell into despair. The problem is that open-air meeting is the beginning of deregulation. There is a possibility that the expansion of safety emergency medicine items at convenience stores and the permission of non-face-to-face treatment and drug delivery may also be a second open-air meeting. The government has already announced the formation of a task force for regulatory innovation in health care, and two important issues, economic revitalization and national health, have been forced to continue to collide.
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- Prescription of oral COVID-19 drugs drop to 1,800 last week
- by Kang, Shin-Kook Jun 13, 2022 05:54am
- Prescriptions of the oral COVID-19 treatments Paxlovid and Lagevrio have been rapidly decreasing in line with the decrease of confirmed COVID-19 cases in Korea. On the 10th, the Korea Disease Control and Prevention Agency announced that it had prescribed Paxlovid and Lagevrio to 1,800 patients during the past week. From 6:30 p.m. on May 3rd to 6:30 p.m. on May 9th, 1,549 courses of Paxlovid had been prescribed to patients receiving treatment from home, at residential treatment centers, and at infectious disease hospitals. In the case of Lagevrio, another oral COVID-19 treatment, 258 courses were prescribed in the same period. Compared to two months ago when prescriptions of Paxlovid amounted to 29,746 in the week of April 11th, the 1,549 prescriptions made last week is a 1/19th decrease in just two months. As a result, 469,923 courses of Paxlovid and 78,402 courses of Lagevrio remain in stock, amounting to a total of 548,325 courses of oral COVID-19 treatments available for use in Korea.
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- The supply of Tylenol suspension has been postponed again
- by Kim JiEun May 25, 2022 05:47am
- The sale of children's Tylenol suspension will be extended further. The supplier originally promised to supply it in June, but it seems that it will not be available until August, two months later. Johnson & Johnson Korea recently sent an official letter to drug distributors on the "Delay Notice on the Supply Schedule of Children's Tylenol Suspension 500ml." As of January 3, children's Tylenol suspension 500ml was distributed from Janssen Korea to Johnson & Johnson Korea, and the vendor was changed. In this official letter, the company said, "The supply schedule of children's Tylenol suspension 500ml products will be delayed from June to August due to internal circumstances," and added, "We will do our best to provide stable products." Earlier this month, the government also decided to urgently introduce Tylenol suspension and tablets distributed in Australia due to the prolonged sale of children's antipyretic analgesics containing acetaminophen. Tylenol suspension 50ml for children was scheduled to be supplied from this month, and Tylenol 500mg tablet from June through wholesalers nationwide. As of last week, Australian children's Tylenol suspension 50ml began to be distributed to pharmacies, but this is also not easy to order. Currently, 100, 500, 200ml of Tylenol suspension is on sale at drug store, It has been confirmed that only Tylenol suspension 200ml can be ordered in small quantities. In most pharmacies, consumers' perception has changed to some extent compared to the early Tylenol crisis, so the number of cases of explaining and selling generics for Tylenol has increased. A pharmacist in Seoul said, "Since there are many products from domestic pharmaceutical companies, I understand and purchase them when I explain them to mothers these days," adding, "As even orders are not easy for years, I have virtually given up ordering them these days." In the case of Australian Tylenol suspension, caution is required when instructing drugs at pharmacies as the dose per dose is unknown due to the difference in the concentration of active ingredients compared to domestic products. For ages 7 to 8, 10ml of existing Tylenol suspension, 7.5ml of Australian Tylenol, 15ml of existing Tylenol and 11ml of Australian Tylenol are recommended. At the age of 12, 20ml of existing Tylenol suspension and 12.5ml of Australian Tylenol suspension are recommended doses.
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- Unsure efficacy of Alzheimer's drug aducanumab
- by Choi-sun May 10, 2022 06:07am
- The Korean Dementia Association has reviewed the clinical potential of aducanumab (Aduhelm), the first new drug for Alzheimer's disease to be introduced to the field in 18 years. With the efficacy of the drug under constant debate, and being barely approved for its effect in reducing surrogate biomarkers such as amyloid reduction in Korea and turned down in Europe, KDA’s position is that verification over time is required to confirm the drug’s actual effect. On the 16th, KDA held its KDA Annual Fall Conference at the Baekbeomgimgu Memorial Hall. At the event, held a panel discussion session with 4 members including KDA Chair Dong-Won Yang and KDA President Ae Young Lee. In June 2021, the US FDA granted conditional approval for aducanumab as a treatment for Alzheimer’s. Aducanumab, which is a monoclonal antibody developed to target the mechanism of Alzheimer’s Disease, had become the first new drug to be approved for Alzheimer’s since 2003. As abnormal accumulation and aggregation of beta-amyloid plaques are reported in the brains of patients with Alzheimer’s, the widely-accepted theory in the field was that these protein buildups (plaques) generate neurotoxins and gradually deteriorate the cognitive function of the brain. Aducanumab was developed to remove this plaque, and although it is not a cure, its effect in was in slowing down cognitive decline in patients was recognized. But still, there is an ongoing debate on whether the drug is ‘clinically effective’ in academia, including among FDA’s internal advisors. As the drug failed to demonstrate efficacy in the clinical trial that used the change from baseline on the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) as the scale, experts judged that it is difficult to definitively acknowledge the drug’s effect only with the surrogate endpoint that demonstrated reduced amyloid accumulation. Fully aware of such controversy during its review, the FDA had set a condition upon approval that Biogen will have to conduct post-approval studies to verify the treatment’s anticipated clinical benefit in addition to the amyloid PET results. However, the EMA refused to grant marketing authorization for the drug. Through a statement, KDA had announced, “Despite much controversy, approval of aducanumab is in itself encouraging news for patients, clinical doctors and researchers in the field,” and stressed that the association will make efforts to rigorously verify the drug’s effect with science in the future to members while sharing relevant information. The panel discussion also focused on whether the amyloid plaque removal mechanism translates to real clinical efficacy. Jae Hong Lee, Professor of Neurology at Seoul Asan Medical Center, said, “As the drug wasn’t able to reach the primary efficacy endpoint of the trial, it is difficult to readily embrace the FDA's approval result. However, I believe the FDA approved the new drug despite headwinds as the promise of a cure with new drugs in development is a long way off. Lee added, “Considering the strict standards that have been applied to new drugs for Alzheimer's disease so far, the drug was difficult to be approved. To some, the CDR-SB improvement in patients who were administered the 10mg high-dose over 14 times in the post-analysis may seem far-fetched.” “Results show only 0.1% of the patients passed the final clinical review. This is an unconventional and proactive attitude on the FDA’s part when considering FDA’s traditional approval standards. In the ENGAGE trial, the drug failed to demonstrate its clinical efficacy but demonstrated a reduction in biomarkers, therefore, whether the improvement in biomarkers will bring clinical effect needs to be seen,” said Lee, warning caution over overinterpretation of the trial results. In other words, although clinical improvement can be expected due to the reduced biomarker effects demonstrated by amyloid and tau protein, Lee believes the time is needed to verify the efficacy of the drug. KDA Chair Dong-Won Yang said, “It is quite interesting that the drug continued to reduce amyloid plaques and tau in up to 1 and 2 years after high-dose administration. We need to recognize its effect in removing amyloid plaques.” Sang-Yoon Kim, Professor of Neurology at Seoul National University Bundang Hospital said, “The drug does have an amyloid reduction effect, but its clinical effect may differ by months. Also, the tau protein reduction was observed, but due to the small number of patients, we would need to wait longer to observe its actual effect," he said. KDA President Ae Young Lee limited the drug’s utility in terms of its side effects. ARIA (amyloid-related imaging abnormalities) more commonly occurred in the aducanumab administered group (43%). In addition, ARIA-E occurred in about 50% of the 7th dose and 90% of the 12th dose of aducanumab. President Lee said, “With over 40% of patients administered the high-dose experiencing ARIA, observation according to administration period and the number of doses will be needed. As the occurrence rate differs by up to 7 times in ApoE E4 carriers, we need to play caution in using the drug for treatment.” Professor Kim said, “ Patients were recruited under very strict standards for the clinical trial, to the extent that patients with other diseases were excluded from the trial. This is very different from the characteristics of patients in the actual clinical environment. As there is a possibility of side effects in case patients have heart conditions or other diseases, a guideline for its administration needs to be set.” Kim added, “Since the effect has been confirmed in a specific patient group in the trial if the drug is introduced in Korea, we would also need to strictly select a patient group in consideration of the side effects and effects in line with the clinical trial. We need to leave the decision on whether to administer the drug at the discretion of each clinician,” However, considering the current treatment environment in which there is no suitable new drug, most HCPs have shown a positive response to ‘making an attempt’ with aducanumab. The larger issue is its price, which costs tens of millions of won. Professor Lee said, “Price of aducanumab fell from the ₩65 million early on to ₩25-30 million currently. If the price becomes more reasonable, I plan to attempt administering the drug to patients who are less likely to develop ARIA and see an effect. Chair Yang said, “I believe the drug may be of help as I've seen many patients whose condition deteriorates with amyloid accumulation. It would be great if we can use the drug in the early stages of the disease, but we need to gradually increase the dose with continuous MRI monitoring due to the possibility of ARIA."
