- LOGIN
- MemberShip
- 2026-05-02 11:39:34
- Policy
- Alvogen receives approval for its Humira biosimilar in KOR
- by Lee, Hye-Kyung Oct 17, 2024 05:51am
- AbbVie A fifth Humira biosimilar has been approved in Korea. On the 15th, the Ministry of Food and Drug Safety approved Alvogen Korea's Simlandi pen40mg/0.4mL (adalimumab, recombinant), Simandi Prefilled Syringe Inj 40mg/0.4mL and 80mg/0.8mL.. Simlandi is imported and manufactured on consignment by Alvotech, a subsidiary of Alvogen Korea. It is the fourth biosimilar to be approved in Korea after Samsung Bioepis, Celltrion, and LG Chem, with more than 10 biosimilars approved globally following the patent expiry of the original, AbbVie's Humira. Simlandi is indicated for rheumatoid arthritis, psoriatic arthritis, ankylosing spondyloarthritis, adult Crohn's disease, psoriasis, ulcerative colitis, Behçet's enteritis, hidradenitis suppurativa, and uveitis in adults. In pediatrics, it is also approved for the treatment of Crohn's disease in children (6 to 17 years of age). In February, Simlandi was approved by the U.S. FDA as the 10th Humira biosimilar. At the time of FDA approval, it was recognized for its high-concentration, citrate-free biosimilar formulation and for being the first biosimilar that pharmacies can substitute for the original drug without consulting a physician (prescriber) in the U.S. In the case of Humira, 88% of the prescriptions in the US are for high-concentration formulations. High-concentration products have the advantage of requiring fewer injections and less frequent dosing. They are usually subcutaneous (SC) rather than intravenous (IV), allowing for self-injection at lower doses. In the U.S., Humira biosimilars include Amgen's ‘Amgevita,’ Boehringer Ingelheim's ‘Cyltezo,’ Sandoz's ‘Hyrimoz,’ Samsung and Organon's ‘Hadlima,’ Pfizer's ‘Abrilada,’ Biocon’s ‘Hulio,’ Coherus‘ ‘Yusimry,’ Fresenius Kabi’s ‘Idacio,’ and Celltrion's ‘Yuflyma.’ Humira is a blockbuster drug that posted global sales of approximately USD 21.27 billion (approximately KRW 27.926 trillion) in 2022, with the adalimumab market valued at approximately KRW 100 billion.
- Policy
- ‘Will raise ICER threshold for innovative new drugs’
- by Lee, Jeong-Hwan Oct 16, 2024 05:50am
- The government has reaffirmed its policy to flexibly evaluate the ICER (incremental cost-effectiveness ratio) threshold for drugs that demonstrate innovativeness in order to strengthen patient access to new drugs. The intent is to increase the ICER threshold of new drugs based on previously announced criteria such as substitutability, prolonged survival outcomes, and whether the drug is a fast-track drug. The government maintained its position that it should be cautious about the need to extend the pharmacoeconomic exemption system to pediatric rare disease drugs and anti-cancer drugs. The Ministry of Health and Welfare's Pharmaceutical Benefits Division explained so in response to a written inquiry made during the NA Audit by Representative Myung-ok Seo of the People Power Party. Rep Seo pointed out the limitations and problems with the economic and non-economic indicators used to evaluate life. Rep. Seo asked whether the MOHW plans to raise the ICER threshold to improve access to new drugs based on analyses of recently listed drugs that have undergone pharmacoeconomic evaluations in comparison to those set in major overseas countries. The MOHW judges the cost-effectiveness of a new drug by comparing its clinical utility, such as the length of patient survival, to the additional cost. The MOHW replied that it revised the relevant regulations in August this year by specifying the ‘innovativeness’ condition among the ICER threshold evaluation factors based on the ‘Measure to Improve the Drug Pricing System Reflecting Innovation Value of New Drugs’ announced in December last year. Based on this, new drugs that satisfy the conditions of innovativeness will have their ICER value adjusted upward. The conditions for innovativeness are: ▲ there is no equivalent product or treatment that is substitutable or therapeutically equivalent; ▲ is recognized for a significant clinical improvement in the final outcome indicator, such as prolongation of survival; or ▲ the drug is a new drug approved under Article 35(4)(2) of the Pharmaceutical Affairs Act as a GIFT or equivalent. The MOHW said, “New drugs that meet the conditions of innovativeness will be flexibly evaluated with ICER thresholds that reflect their fair value. The government will strive to improve public health and ease economic burdens by strengthening patient access to new drugs for serious diseases such as cancer and rare diseases." In addition, the MOHW also plans to support the improvement of patient access to rare disease drugs through policy operations. Specifically, the ministry explained that it has reviewed measures to improve insurance listing of rare disease drugs in accordance with the ‘Specific tasks for improving access to rare disease drug reimbursement benefits’ in the Comprehensive Plan for Rare Diseases to support the prompt registration of treatments. It added that it secured flexibility in the ICER value, a criterion for pharmacoeconomic evaluation by adding 'innovation' to the evaluation factor, and has been implementing a parallel negotiation-evaluation system since January last year and a pilot project for the approval-evaluation-negotiation system since the second half of last year. The MOHW also pointed out that overseas cases such as Canada and the United Kingdom are applying measures such as flexible application of ICER values and expansion of the risk-sharing agreement systems to strengthen access to rare disease treatments, and the MOHW is also promoting policies modeled after them. To expedite the reimbursement of rare disease drugs, the MOHW replied that it will operate a pharmacoeconomic evaluation exemption system and a risk-sharing agreement system, and actively identify improvements to the system by collecting opinions on-site. However, the ministry expressed caution about expanding the pharmacoeconomic evaluation exemption criteria to include rare disease drugs and anti-cancer drugs for children. “In January last year, the MOHW revised the relevant regulations to add new drugs that treat non-life-threatening pediatric diseases but have a small number of patients and are clinically proven to improve quality of life,’ the MOHW said, explaining that “Crysvita Inj, a new drug for treating X-linked hypophosphatemia, which was approved in May last year, is a typical example.” “The pharmacoeconomic evaluation exemption system is operated as an exception that substitutes the cost-effectiveness evaluation by referencing a drug’s listed price in other countries,” the MFDS said, adding, “The proposal to expand the pharmacoeconomic evaluation exemptions to adult patients needs to be carefully promoted through public discussion.”
- Policy
- Govt ‘is considering measures to overcome Korea Passing’
- by Lee, Jeong-Hwan Oct 16, 2024 05:50am
- The government has responded that it will come up with measures to ensure a stable supply of new drugs, including a dual pricing system, to overcome the so-called ‘Korea passing’ phenomenon, in which domestic and foreign pharmaceutical companies avoid launching their drugs in the domestic market and target overseas markets first, citing excessively low drug prices set by the government. The government also said it would consider measures that could boost the development of new drugs targeting chronic diseases. On the 14th, the MOHW responded so to a written inquiry submitted during the NA Audit by Representative Myung-ok Seo of the People Power Party. The lawmaker asked for the MOHW’s opinion on the introduction of a dual pricing system, pointing out that Korean patients' access to new drugs is deteriorating due to the Korea Passing phenomenon. The MOHW said it would take reasonable measures to stabilize the supply of new drugs, including dual pricing, to overcome Korea Passing. The MOHW said it negotiates drug prices in consideration of the impact on insurance finances, but acknowledged that there are cases of pharmaceutical companies abandoning domestic insurance reimbursement listing as it may hinder overseas drug price negotiations when the prices are set low in Korea. “For this reason, we will take reasonable support measures, such as a dual pricing system, to ensure that domestic patients‘ access to new drugs is not compromised,” said the MOHW. The ministry also promised to support policies to encourage the development of new drugs for chronic diseases. First, the MOHW explained that previously, the risk-sharing agreement system was applied to serious diseases that threaten survival with anti-cancer drugs and rare disease treatments that have no substitutes, but from August this year, the system was improved to apply RSA to new drugs for chronic severe diseases that have no substitutes and irreversibly worsen the quality of life and have a large disease burden. This means that severe asthma and atopic dermatitis drugs are also eligible for RSA. The MOHW agreed on the need to develop support measures for the development of new drugs for chronic diseases but said that national health insurance finances should be considered. “Chronic diseases have a large number of patients and varying degrees of severity, so it is necessary to review rational support measures that take into account health insurance finances,” said the MOHW. “We will review the targets of support in consideration of chronic diseases with a large disease burden and come up with rational support measures for the development of new drugs for chronic diseases.”
- Policy
- Stopping illegal online sales·advertisements of 'Wegovy'
- by Lee, Hye-Kyung Oct 16, 2024 05:50am
- Product photo of Wegovy. As 'Wegovy,' a dream treatment for obesity, is set to launch in South Korea, the health authority plans to focus on monitoring online illegal sales and fraudulent advertising. It will also implement post-marketing safety management related to side effects and drug abuse. The Ministry of Food and Drug Safety (Minister Oh Yu-kyoung, MFDS) announced on October 15th of plans to implement intense monitoring of cases of sales·advertising online and SNS for a month aligninig with the launching of the obesity drug, a type of glucagon-like peptide-1 (GLP-1) agonist. A GLP-1 type obesity drug is effective in increasing glucose-dependent insulin secretion, inhibiting glucagon secretion, and delaying hunger and weight loss. The drug is Novo Nordisk Korea's Wegovy. Wegovy is a non-reimbursable drug that is not covered by the health insurance, and the domestic supply price is KRW 372,025 (4-week dose). However, as it is non-reimbursable, the sales price, including prescription fee and distribution, is expected to be about KRW 800,000 to KRW 1 million. Wegovy can be used in obese patients who have a Body Mass Index (BMI) of 30kg/m2 or higher or those who are overweight with early BMI of 27kg/m2 or higher and below 30kg/m2 and have one or more weight-related accompanying diseases, with doctor's prescription and pharmacist's filling·medication counseling. "It is illegal for people who do not have pharmacy license to sell the obesity drug," MFDS stated. "To prevent the potential risk of consumers buying obesity drugs through online·SNS, the MFDS will implement an intense monitoring of individuals selling or advertising the obesity drug online·SNS for a month aligning to the launching date." The MFDS, in collaboration with the Korea Institute of Drug Safety & Risk Management, will also monitor cases of side effects·adverse reactions related to the use of the obesity drugs and organize a monitoring task force to implement necessary safety measures. The MFDS will collaborate with the Health Insurance Review and Assessment Service (HIRA) and review· analyze the supply volume and increasing·decreasing trends in each clinic. It will also conduct on-site monitoring for fraudulent advertisements. "We will ensure people use medicines safely by monitoring domestic and overseas safety information and adverse reaction cases for obesity drugs, and we will also check online sales advertisements and conduct on-site monitoring," the MFDS stated.
- Policy
- 'Will adjust the price of generic drugs through reevals'
- by Lee, Jeong-Hwan Oct 16, 2024 05:50am
- The Ministry of Health and Welfare responded to the NA’s inquiry on the ministry's policy operation plan to realize generic drug prices in Korea, explaining that the MOHW is promoting a plan to reduce and adjust drug prices through ‘external reference pricing re-evaluations.’ This means that the ministry will start the external reference pricing reevaluations, which it has continuously discussed with the pharmaceutical industry. In other words, the ministry has no plans to reduce the price of generic drugs unilaterally and is only considering reviewing the need to reduce or adjust their price by comparing the domestic drug prices with overseas drug prices. On the 15th, the MOHW responded to a written inquiry on generic drug prices from Representative Yoon Kim of the Democratic Party of Korea. Rep Yoon Kim pointed out that the generic drug prices in Korea are excessively high and asked MOHW Minister Kyoo Hong Cho about their policy on reducing the generic drug price during the last NA audit, and made an written inquiry about plans on realizing the generic drug price. The MOHW explained that to properly manage the pharmaceutical expense, a differentiated drug price is set according to the order of entry upon listing and then adjusted through re-evaluations. Specifically, for 19 or fewer listed generic drugs, domestic generic drug prices are calculated at 53.55%, 45.52%, and 38.69% of the original drug’s insurance price cap, depending on each generic drug's fulfillment of standard requirements such as submission of bioequivalence testing data and use of MFDS-registered raw materials, etc. Based on this differentiated generic drug price calculation system, the MOHW has vowed to further reduce and adjust domestic generic drug prices through external reference pricing reevaluations. “To improve the soundness of Korea’s pharmaceutical expenditure structure, we are considering adjusting domestic generic price by comparing and reevaluating the level of domestic generic drug prices with overseas drug prices,” the MOHW said, adding, “We have been collecting on-site opinion through industry meetings since last year, based on which we plan to prepare and implement reasonable measures.”
- Policy
- Amgen starts negotiations to extend reimb of Kyprolis
- by Lee, Tak-Sun Oct 15, 2024 05:50am
- The reimbursement extension process for the multiple myeloma drug Kyprolis (carfilzomib, Amgen) has entered the final stage. Its insurance drug price is being negotiated with the National Health Insurance Service. The discussion is likely for the use of Kyprolis in the Kyprolis+daratumumab+dexamethasone (DKd) regimen, which passed the Cancer Disease Review Committee (Cancer Quality Review) in April. According to industry sources on the 14th, the NHIS started drug pricing negotiations with Amgen for the reimbursement expansion of Kyprolis 60mg this month. The reimbursement standards for Kyprolis Inj was set in April as a ‘combination therapy used with daratumumab and dexamethasone for the treatment of multiple myeloma patients who have received one or more prior therapies’ by the Cancer Disease Deliberation Committee. However, the coinsurance rate for daratumumab is set at 100%, for the patient to pay in full as out-of-pocket price. It is understood that the company has since passed the Drug Reimbursement Evaluation Committee stage and started drug prices with the NHIS. In February 2018, Kyprolis was successfully listed on the reimbursement list as part of the RSA (risk-sharing agreement, refund type) scheme. The covered therapies are KRd therapy (Kyprolis+lenalidomide+dexamethasone) and Kd therapy (Kyprolis+dexamethasone). With the reimbursement, the out-of-pocket cost for the patients was reduced from KRW 10 million to KRW 500 to 600 thousand. The DKd regimen had shown evidence that it was effective in patients exposed to lenalidomide, which is why it is expected to be beneficial to patients if reimbursed. If the pharmaceutical company and the NHIS reach an agreement through negotiations, the final reimbursement list will be approved by the Ministry of Health and Welfare’s Health Insurance Policy Deliberation Committee. Kyprolis is a blockbuster drug that posted sales of KRW 32.2 billion last year (source: IQVIA). Due to the large amount of claims expected with the drug, the NHIS is expected to negotiate in a way that minimizes the financial expenditure when expanding reimbursement benefits.
- Policy
- Reduced reimb for medicines-containing choline alfoscerate
- by Lee, Tak-Sun Oct 15, 2024 05:49am
- Complaints have been circulating regarding the decision made by the Health Insurance Review and Assessment Service (HIRA) to reduce reimbursement on medical care reimbursement claims for medicines containing 'choline alfoscerate,' a brain function-improving agent. Medicines-containing choline alfoscerate received selective reimbursement decision during the re-evaluation of reimbursement appropriateness. However, its previous reimbursement criterion is being maintained due to pharmaceutical companies fling lawsuits. However, HIRA requires even stricter criterion by designating medicines-containinig choline alfoscerate as targets for 'intensive screening.' According to industry sources on October 14th, more claim cases of choline alfoscerate have received reduced decisions over the past year. HIRA has designated medicines-containing choline alfoscerate as target items for intensive screening since 2022 and has been managing them. Intensive screening is a preventative screening that pre-notifies items that need improvements in prescriptions and manages them. It is a voluntary system to promote improvement through prior notices and marketing. There have been reports of a significant increase in reduction decisions on medicines-containing choline alfoscerate over the past year. They think that it has intensified following last year's parliamentary audit. Rep. Nam In-soon of the Democratic Party of Korea stated during the last year's parliamentary audit that "The prescription of medicines-containing choline alfoscerate for diseases other than dementia should be restricted for the National Health Insurance finances." "We must actively intervene in the practice of prescriptions of medicines-containing choline alfoscerate, which have not been proven effective to prevent dementia, disguised as dementia prevention drugs and brain health nutrients," Rep. Nam said during this year's parliamentary audit. "The National Health Insurance saved by inhibiting prescriptions related to dementia should be used to expand reimbursement for new anticancer drugs to ease burden of medical costs." Prevailing opinions in clinical practices are that the review of reimbursement claims has become stricter due to requests from the National Assembly. Several have pointed out that more reductions are being made for surpassing criterion for approval and reimbursement despite uses according to the approval criterion. "We received a reduction decision from the HIRA officer because we have not provided documents for the cerebrovascular deficit," a Hospital-A worker said. "We have doubts about HIRA's review criteria because approval criteria do not require submission of documents related to cerebrovascular deficits in case of patients with organic mental disorders related to brain function. According to the current medical care reimbursement criterion, medicines-containing choline alfoscerate are reimbursable when used within the approval criterion. The Ministry of Food and Drug Safety (MFDS) approved medicines-containing choline alfoscerate for 'Secondary symptoms due to cerebrovascular deficit, degeneration, or organic mental disorder related to degenerative brain function: reduced memory and confusion, loss of direction due to reduced drive and spontaneity, reduced drive or spontaneity, and reduced concentration." Doctors have explained that prescribing medicines-containing choline alfoscerate to patients with mental disorders with degenerative brain function who have memory loss and confusion should be no problem for issuing reimbursement, based on the criterion. Several opinions are that before the inclusion of medicines-containing choline alfoscerate were reimbursable in intensive screening, submitting patient records was sufficient. However, not, the HIRA is arguing that documents prepared according to the approval criterion are insufficient. "We were notified by HIRA to submit test results, such as MRI and MMSE, for medical care reimbursement. Neither approval of medicines-containing choline alfoscerate nor medical care reimbursement criterion require such additional tests. We inquired about the reasons for submitting such test results but have not heard a clear answer," a Hospital-B worker said. "HIRA keeps requesting submission of documents, but we are unsure what documents are needed to receive reimbursement." Complaints are circulating against different notifications from the person-in-charge, and requests do not meet reimbursement criteria or approval criteria. However, clinical practices tend not to raise appeals for practice reasons. Due to continued reduction decisions, patients complain because doctors are less likely to prescribe the medicines. "The HIRA has been avoiding providing a clear criterion related to reimbursement for medicines-containing choline alfoscerate," medical industry personnel said. "We need to determine whether patient's healthcare or doctor's prescription rights are limited due to political issues."
- Policy
- Will generics dominate the oral psoriasis treatment market?
- by Lee, Tak-Sun Oct 14, 2024 05:49am
- Dong-A ST The global market for oral psoriasis treatment amounts to KRW 5 trillion. In the Korean market, generic medicines are likely to dominate. The original medicine company withdrew its drug from the Korean market due to dissatisfaction with the reimbursement decision, whereas generic medicines are likely to accept the term. A new type of oral medicine is likely to be competitive because psoriasis treatments that are available in South Korea are primarily injectables. The Drug Reimbursement Evaluation Committee (DREC) of the Health Insurance Review held its 10th meeting for 2024 on October 10th and ruled that medicines containing apremilast would be appropriate for reimbursement coverage if the company accepted the drug price below the evaluated amount. These medicines include 5 products: Otelia (Dong-A ST), Apsola (Daeowoong Pharmaceutical), Otebell (Chong Kun Dang), Otemila (Dongkoo Bio), and Psopre Tab (Hanlim Pharm). The originial medicine containing apremilast is Amgen's 'Otezla.' Otezla received marketing authorization in South Korea in November 2017. However, the company voluntarily withdrew approval in 2022 due to dissatisfaction with the domestic reimbursement decision. Otezla is a PDE4 (phosphodiesterase 4) inhibitor used to treat psoriasis. A PDE4 inhibitor blocks the activation of PDE4 enzyme that causes inflammatory responses. The Korean market for psoriasis treatments is led by injectable interleukin agents. These include Stelara (Janssen) and Cosentyx (Novartis). Like the case of generics, Otezla also received a conditional pass during the DREC review. In May 2018, the DREC review decided that Otezla is non-inferior to Enbrel inj for the treatment of psoriasis and Stelara for the treatment of psoriatic arthritis, but the drug is not cost-effective due to its high cost relevant to the treatment duration. The government said it would agree on reimbursement appropriateness if the pharmaceutical company accepted the drug price below the weighted mean price of substitute medicines. However, the pharmaceutical company did not accept it. Although the original medicine did not accept the conditional agreement for reimbursement, generic companies are likely to wrap up the reimbursement listing process by accepting it. Dong-A ST has already launched Otelia as non-reimbursable in July and began sales·marketing. Generic companies have no problems launching their products after avoiding patents and reaching an agreement with Amgen. When generic companies accept the DREC review decision, they will start a negotiation with the National Health Insurance Service (NHIS). If a company accepts a drug price negotiation exemption criterion (90% below the weighted average price of substitute medicines), it can conclude the negotiation early by skipping the drug price negotiation and starting the estimated claim amount negotiation. "Patients would have had difficulty accessing the medicine containing this active ingredient if it had not been for the Korean pharmaceutical company," pharmaceutical industry personnel said. "We look forward to seeing whether generic companies with new types of oral products would take the market share in the psoriasis treatment market dominated by foreign pharmaceutical companies."
- Policy
- NA-MFDS clash on the approval of abortion pills
- by Lee, Jeong-Hwan Oct 14, 2024 05:49am
- With the National Assembly strongly pressing the need for domestic marketing authorization of the abortion drug ‘Mifegymiso,’ the NA’s request is set to affect the future administration of the MFDS’s marketing authorization review. The MFDS has repeatedly argued that the Criminal Act and the Mother and Child Health Act must be amended before the drug receives marketing authorization, but the National Assembly responded that this is an unacceptable excuse and that the drug’s listing should not be delayed any longer. On the 10th, Democratic Party of Korea lawmaker In-soon Nam made inquires to Yu-Kyoung Oh, the head of the Minister of Food and Drug Safety, that the government should take steps to identify the illegal distribution, trade, misuse, and side effects of Mifegymiso by granting marketing authorization for the abortion drug. In fact, 705 cases of illegal sales of abortion drugs such as Mifegymiso were found by July this year. Rep Nam pointed to the fact that doctors, pharmacists, and civil society organizations have filed multiple requests for the designation of abortion drugs as essential medicine and their urgent introduction, and requested the MFDS to be proactive in grating their marketing authorization. “The Board of Audit received an audit claim that the MFDS is neglecting its responsibility to introduce abortion drugs,” Nam said, adding, “I think the MFDS should respond quickly.” Rep. Nam added, “There are WHO guidelines, and preparations (permits) that need to be made. Please study cases overseas and review and submit these contents until the general audit. You shouldn't just blame it on the law. Women are being harmed.” Minister Oh said that she would submit the data that the MFDS had prepared for the marketing authorization, but replied that “MFDS is a licensing agency” and that “We lack the requirements to grant marketing authorization (for abortion pills).” So what does Minister Oh mean by ‘lack of requirements’? Hyundai Pharm, which had been preparing to distribute the abortion drug Mifegymiso in Korea, applied for marketing authorization to MFDS several times. Specifically, Hyundai applied for the marketing authorization of Mifegymiso in July 2021, and then voluntarily withdrew the application in December 2022. In March 2023, the company reapplied for Mifegymiso, and the MFDS currently has the application and supporting data. The MFDS has repeatedly explained that the Criminal Act and the Mother and Child Health Act must be amended before granting marketing authorization for the drug. The amendments to the Criminal Act and the Mother and Child Health Act need to be made to clarify the period of abortion permitted by law so that the risk management plan required for the approval and review of abortion drugs can be confirmed. In other words, the MFDS’s position is that the relevant laws must be amended first, and then the pharmaceutical company must submit the risk management plan approval data for the Ministry to resume the review and decide whether to approve the drug for marketing authorization. However, members of the National Assembly's Ministry of Health and Welfare, including Rep Nam, have been pointing out that the MFDS’s position is difficult to accept. The criticism is that the agency is using the risk management plan as an excuse to avoid getting involved in the controversy over the approval of the abortion pill. “It is difficult to understand the MFDS’s explanation that it cannot approve abortion pills because the National Assembly has not passed subsequent legislations related to abortion, such as the Criminal Act and the Mother and Child Health Act,” said an official from the National Assembly's Welfare Committee. “Drugs should be approved based on safety and efficacy based on scientific and medical review data. Whether the abortion period is set at 16 weeks or 36 weeks should not affect MFDS’s safety and efficacy review.”
- Policy
- Approval process for 'Leqembi' heavily debated
- by Lee, Hye-Kyung Oct 14, 2024 05:49am
- A heated debate is expected during the National Assembly regarding the approval process for Leqembi (lecanemab), a new drug for treating dementia that received domestic approval in May. Rep. Jeon Jin-sook, a member of the Democratic Party of Korea.At a parliamentary audit of the Health and Welfare Committee held at the National Assembly on October 10th, Rep. Jeon Jin-sook, a member of the Democratic Party of Korea, issued an allegation that the approval of a new drug for dementia in South Korea has been granted without a review by the Central Pharmaceutical Affairs Council. This drug received a recommendation for non-approval from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) due to side effects. "Although this drug is a new drug, approval has been granted without seeking expert opinion," Rep. Jeon said. "In the United States, this drug was approved with the required warning label statement in the prescribing information after the FDA's advisory committee meeting. Europe postponed approval," Rep. Jeon explained. Although the product name of the drug had not been disclosed during the parliamentary audit, the only new drug to have received approval as a treatment for dementia is Eisai Korea's Leqembi. Leqembi was approved for an indication to treat 'Mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD dementia.' The drug's effects and safety have not yet been confirmed for AD patients with moderate symptoms or higher. "No medicines can guarantee a 0% side effects, even for innovative products," Rep. Jeon said. "This drug is known to damage walls of the blood vessels, thereby causing edema of the brain, cerebral hemorrhage, confusion, and convulsion." The representative also pointed out a diagnostic test that needs to be periodically performed when using Leqembi. "To continuously check on side effects of this drug, a targeted medicine, patients are required to take expensive diagnostic tests," Rep. Jeon said, adding, "Stock traders are saying that a new diagnostic test era has begun." "We have an allegation that (during the approval process for this new drug) a privilege has been granted to high-priced diagnostic testings," Rep. Jeon said. "It may require an official audit. We want a detailed explanation before the comprehensive review about skipping expert review during the approval process for this dementia drug."
