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- 2026-05-02 14:55:42
- InterView
- "JAK inhibitors bring a paradigm shift to RA treatment"
- by Whang, byung-woo Oct 16, 2024 05:50am
- As patients with autoimmune diseases, including rheumatoid arthritis, have better access to medical care, early diagnosis and treatment have been pointed out as the key. Early diagnosis and treatments previously available in university hospitals are now possible in local clinics. As a result, patient-personalized therapies, even for patients with mild symptoms, through local clinics have become increasingly important. "More patients are visiting clinics at early stages compared to the past," Dr. Won-Suk Lee, Chief of Easy Rheumatis Clinic in Jeonju, said. "It is important to provide personalized treatments to improve patient's daily life." JAK inhibitors for treating rheumatoid arthritis…"We have observed fast treatment effects" Dr. Won-Suk Lee, Chief of Easy Rheumatis Clinic in JeonjuRheumatoid arthritis is an autoimmune diseases in which abnormally activated immune cells invade joints, causing inflammation and pain. In the past, it was regarded as a disease that required treatment at university hospitals. However, without properly treating it at an early stage, repeated inflammation over time can cause joint deformity, leading to loss of function. So, the importance of early diagnosis has been emphasized. Specialists in the field of rheumatoid arthritis have opened clinics all over the nation, improving patient access. "As more specialists in the field of rheumatoid arthritis have opened clinics, patients have better access. More patients now visit clinics at an early stage of the disease compared to the past,"Dr. Lee explained. "There may be differences in disease awareness depending on geographical location, but overall disease awareness has increased." Along with improved disease awareness, doctors have more treatment options to utilize. Janus Kinase (JAK) inhibitor has brought a significant paradigm shift to the treatment of rheumatoid arthritis. "Patients initially begin the treatment with DMARDs, a methotrexate (MTX)-based therapy, but when drug response lowers, patients resort to TNF-α inhibitors or JAK inhibitors," Dr. Lee said. "I have been employing a step-wise increasing prescription in patients of young age, according to the guideline." Dr. Lee quickly switches from prescribing conventional medicine to JAK inhibitors because of the 'effects' and 'convenience.' Compared to conventional medicines, JAK inhibitors have the advantages of requiring less use of steroids and pain killers. They also relieve the patient's administration burden because they are oral drugs. However, in 2021, an issue of cardiovascular system-related side effects of JAK inhibitor was reported, so there are 'safety'-related concerns. At the time, the U.S. Food and Drug Administration (FDA) issued warnings related to cardiovascular disease and cancer for JAK inhibitors. The Korean Ministry of Food and Drug Safety (MFDS) also posted safety documents. Ultimately, the FDA decided to include the safety information, including cardiovascular-related instances, thrombosis, and death, on the box warning label. Dr. Lee commented regarding this issue, "We cannot deny the research, but I have not had cardiovascular-related side effects issues during my years of prescription experience. In my opinion, side effects could be manageable, and the occurrence of shingles is seven times higher in Asia, I explain the vaccination option and prescribe it." Emphasizes the need to improve medication switching for personalized treatment The latest issue for rheumatoid arthritis treatment is obtaining insurance reimbursement authorized for switching between JAK inhibitors. Notification was expected within October, but it has been extended. Dr. Lee commented that we need to consider the criteria for using conventional medicines in addition to the issue of JAK inhibitor switching. "When medication switching is allowed, patients can choose better treatments, which is the most important point," Dr. Lee said. "The current criteria indicate that when a patient uses conventional medicine and does not benefit, one can use JAK inhibitor after six months. However, we should also consider three months amid the early intervention trend." Lastly, Dr. Lee emphasized the need for early diagnosis and personalized treatment for the management of rheumatoid arthritis. "For rheumatoid arthritis, early diagnosis and early treatment are most important, so we focus on treating patients without hindering daily lives, along with pain management," Dr. Lee said. "Rather than repeatedly prescribing the same drug, we need to consider complications and accompanying disease."
- 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.
- Company
- oHCM drug Camzyos's last hurdle to reimb remains high
- by Eo, Yun-Ho Oct 15, 2024 05:50am
- The reimbursement journey for ‘Camzyos’, which is seeking insurance reimbursement in Korea, is going to be a rocky road until the end. According to industry sources, the drug pricing negotiations between BMS Pharmaceuticals Korea and the National Health Insurance Service (NHIS) for the obstructive hypertrophic cardiomyopathy (oHCM) drug Camzyos (mavacamten) have been extended after failing to finalize the deal within the deadline. The deadline extension was primarily due to a disagreement over the number of patients eligible for Camzyos. Camzyos’ reimbursement journey faced difficulties, receiving a redeliberation decision from the Health Insurance Review and Assessment Service's Drug Reimbursement Evaluation Committee. The drug passed the committee and entered pricing negotiations in August, but the negotiations were not concluded within the 60-day deadline. Camzyos is the first and only cardiac myosin inhibitor that specifically targets excess cross-bridge formation of myosin and actin proteins, the main cause of oHCM. It improves left ventricular hypertrophy and left ventricular outflow tract obstruction by separating myosin from actin, relaxing the overcontracted heart muscle. Due to the lack of a cure, oHC has long been managed with off-label drug use. In fact, the European Society of Cardiology (ESC) revised its HCM guidelines for the first time in 9 years with the introduction of Camzyos. Before then, HCM guidelines have been based on small observational data reported from individual institutions, retrospective analyses, or expert consensus opinions. Therefore, Camzyos was a game-changer in the field. After demonstrating its significant effect in two large-scale Phase III randomized controlled trials (RCTs), Camzyos was recommended at the highest evidence level, A, for the first time among treatment options in the ESC guidelines. The American College of Cardiology (ACC) and American Heart Association (AHA) are also currently preparing to update their guidelines. Based on the Phase III trial data, Camzyos received a breakthrough therapy designation (BTD) and was approved by the US FDA. In the Phase III EXPLORER-HCM trial, which served as the basis for Camzyos’s approval, Camzyos achieved and improved the primary composite endpoint of the proportion of patients with decreased symptom burden (by NYHA class) and functional capacity (peak oxygen consumption, pVO2) by more than 2 times compared with placebo. In particular, 20% of the patients who received treatment with Camzyos achieved both primary endpoints, pVO2 improvement, and the NYHA class requirement. Also, the dynamic left ventricular outflow tract obstruction was reduced by over 4 times with the use of Camzyos. 7 out of 10 patients treated with Camzyos improved to the extent that they would not consider surgery, and showed consistent benefits over 30 weeks. “Many patients with oHCM have been anxiously awaiting a new drug due to the lack of a suitable treatment,” said Hyung-Kwan Kim, Professor of Cardiology at Seoul National University Hospital. “In particular, expectations for the drug's reimbursement have increased since it was approved by DREC in July, and we hope that the remaining procedures will be completed as soon as possible so that patients and their caregivers in Korea can benefit from the use of the new drug.”
- Company
- “Market for veterinary drugs expected to grow rapidly”
- by Son, Hyung Min Oct 15, 2024 05:50am
- Seung-Hwan (SH) Jung, General Manager at MSD Animal Health Korea “MSD Animal Health Korea’s clients are animals. We believe that the drug distribution channels for animals should be carefully designed to contribute to the health of animals in Korea. Supplying our products to animals that need them quickly, sufficiently, and safely is the biggest principle in designing our domestic distribution network. Seung-Hwan (SH) Jung, General Manager at MSD Animal Health Korea, emphasized so to reporters about the company’s plans for supplying veterinary drugs in Korea. Over the years, MSD Animal Health Korea has launched various new products and provided technical support to meet the needs on-site. In doing so, the company has prevented and treated diseases in economic and farm animals and contributed to improving the productivity of farmers and the health and welfare of companion animals in Korea. MSD Animal Health Korea's flagship products include the ‘Porcilis PVC M Vaccine,’ which prevents the Porcine Circo Virus (PCV) and M.hyo, and the ‘Prime Pac PRRS Vaccine,’ which prevents Porcine Reproductive and Respiratory Syndrome in the swine industry; ‘Exzolt,’ a parasiticide for chickens that eliminates mites; ‘Nobilis SG9R Vaccine,’ which prevents chicken typhoid. The company also has ‘Bravecto,’ which prevents ectoparasites in pets, and ‘Caninsulin,’ the only insulin for pets in Korea. “The global veterinary drug market is estimated to be around USD 45.8 billion in 2023, of which our sales recorded USD 5.6 billion,’ said Jung. “The animal health sector is generally divided into ruminants, poultry, swine, aquaculture, and companion animals, and MSD Animal Health is the global sales leader in four of these five categories, except for companion animals.” In Korea, the veterinary drug market is estimated to be worth around KRW 1.4 trillion, with two-thirds of the market being domestically produced and one-third being imported. MSD Animal Health Korea generated sales of KRW 45 billion last year. ‘Our main business areas in Korea are swine, poultry, and companion animals,’ says Jung. In terms of total sales, the swine and poultry division accounts for the largest share, but we are also expecting rapid growth in the companion animal and livestock sectors.” “Due to issues such as superbugs, most developed countries, including Korea, have banned the addition of growth-promoting antibiotics to feed, and it is becoming increasingly difficult to use therapeutic antibiotics in livestock,’ he explained. ’Personally, I see this as a positive change that is in line with the concept of One Health, which has a common goal of seeking animal and human health. As a result, I believe the veterinary drug industry is also shifting towards prevention rather than treatment, promoting the use of vaccines rather than antibiotics.’ Jung also sees much growth potential in the domestic animal health market. With the rise in the number of people living with companion animals, the demand for animal healthcare has been growing along with the market. “The sector has been growing at an average annual growth rate of 10% with the rising demand for pet healthcare,” said Jung. “The scale of the swine and poultry industry is also large compared to Korea’s population. In particular, consumer demand is shifting to seeking safe animal products from the abundance of animal products in the past. We believe that the use of veterinary drugs to prevent diseases and promote animal welfare in farm animals, including food poisoning and zoonotic diseases, will continue to increase.” Various channels such as veterinary hospitals and pharmacies...”We plan to distribute ETCs and OTCs separately” MSD Animal Health Korea plans to utilize various distribution channels such as veterinary clinics and pharmacies. The veterinary drug market is being developed similarly to that of human drugs such as digestive and diabetes diseases, using various channels. And many pharmaceutical companies, including MSD Animal Health Korea, are looking to enter the field. “The specialization of veterinary drugs is predictable in the same way as the changes we have seen in human medicines,” said Jung, “and we interpret this as a favorable change for our business because we own many products that are unique to MSD Animal Health that other companies do not have.” ‘MSD Animal Health employees around the world are sensitive to changes in the market and disease outbreaks, and these changes are immediately reported to R&D at headquarters, resulting in new products being developed to respond quickly to changes in the market as well as diseases. We expect this strength to persist.’ MSD Animal Health's mission is ‘The science of healthier animals’. At the end of the day, Jung says, MSD's customers are animals, and providing products for healthy animals is the company's number one goal. “We are considering carefully designing the distribution channels of our medicines to contribute to animal health,” said Jung. “The overarching principle of our distribution network design is to get our products to the animals that need them quickly, sufficiently, and safely.” ‘We plan to establish different distribution networks for specialized and over-the-counter products. We will design a new distribution network in the future based on domestic laws.’
- 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."
- Policy
- Drug pricing negotiations for Qarziba gather pace
- by Lee, Tak-Sun Oct 14, 2024 05:49am
- With Qarziba Inj (dinutuximab beta, Recordati Korea), the first drug that has been applied the approval-evaluation-negotiation pilot project, passing the Health Insurance Review and Assessment Service's Drug Reimbursement Evaluation Committee, the drug price negotiation for the drug is also expected to progress quickly. However, the drug’s post-listing management is expected to be key rather than the speed of approval. Qarziba was recognized as adequate for reimbursement at the 10th Drug Reimbursement Evaluation Committee (DREC) meeting in 2024 that was held on the 10th of this month. The committee had made a non-reimbursement decision in August, but after reconsideration, the drug passed HIRA’s reimbursement review stage. Qarziba is the first drug in the approval-evaluation-negotiation pilot project, which received MFDS approval, drug price evaluation, and drug price negotiation in parallel to support its prompt reimbursement listing. It also succeeded in setting reimbursement standards before approval. On May 29, the 4th Cancer Disease Deliberation Committee set the reimbursement standard for Qarziba as children aged 12 months or older with ▲high-risk neuroblastoma who have previously received myeloablative therapy and stem cell transplantation and shown partial response or after induction chemotherapy, and ▲recurrent or refractory neuroblastoma. On June 19th, the company also received formal marketing authorization from the MFDS. The approval period was also shortened from 115 days to 90 days as it was designated a drug for the Global Innovative Product Fast Track (GIFT) support system. Its drug price negotiation period is also expected to be shortened. This is because the negotiation period for drugs in the approval-evaluation-negotiation pilot project is shortened from 60 days to 30 days through preliminary discussions before passing the Drug Reimbursement Evaluation Committee. Therefore, its reimbursement is expected within the year. However, it was pointed out that there are limitations to sufficient pre-validation of the drug due to its fast-track status. Therefore, it is likely that its financial sharing plan will be considered through a post-listing evaluation process. In fact, HIRA is reportedly reviewing applying patient-level performance evaluations. The patient-level performance evaluation measure was applied to the one-shot high-priced drugs Kymriah and Zolgensma. It mainly involves a contract that monitors the performance of each patient, after which the pharmaceutical company reimburses a percentage of the drug cost if the treatment fails. This type of post-listing management measure is likely to be set as a prerequisite during the NHIS pricing negotiations. If Qarziba is listed within the year, it will have taken just one and a half years from approval to reimbursement. Normally, the process takes 3 years. With more approval-evaluation-negotiation pilot projects being processed, Qarziba’s reimbursement listing will help solidify the review and negotiation processes of the project. An industry official said, ‘The key to Qarziba’s drug price negotiation will be in the financial sharing plan after registration,’ adding, ‘As it is a fast-track drug, the NHIS would also have much to consider.”
