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- 2025-12-19 20:30:42
- Policy
- Will RWD-based reimb agreements be more beneficial?
- by Lee, Tak-Sun Aug 29, 2024 04:31am
- On the 28th, HIRA held an international symposium on Drug reimbursement contracts satisfy all parties involved when they achieve three goals: The first is patient access, the second is sustained revenue for the pharmaceutical company, and the third is budget management for the payer. “A fair price is one that can satisfy both the seller and the buyer,” said So-young Lee, Director of Health Insurance and Assessment Service’s Pharmaceutical Performance Assessment Division. ”A fair price should guarantee transparency, R&D, production costs, and innovation.” So, what kind of reimbursement agreement can satisfy all three conditions? Experts say that a reimbursement agreement based on RWD (real-world data) can be a good alternative. On the 28th, HIRA held an international symposium on 'RWD-based performance assessment of high-priced drugs' at the Ambassador Seoul Pullman Hotel in Jangchung-dong, Seoul. At the symposium, Lee delivered a keynote address on the topic of 'Sustainable access to high-cost drugs through RWD-based cooperation'. The use of the performance-based assessment system using RWD is in its infancy in Korea and other countries. In Korea, the system was first introduced in 2022 for the rare disease drug Kymriah. In order to reduce the uncertainty of drugs that received an exemption from pharmacoeconomic evaluations, the system applies post-reimbursement patient evaluation to determine whether or not to reimburse the drug. Until now, the cost-effectiveness evaluations of new drugs were determined based on clinical trial data rather than real-world patient data, but there is a global movement to use RWD data of high-priced drugs as clinical trial results do not resolve uncertainties. The UK established a real-world evidence (RWE using RWD) framework in February 2022 and has been continuing to update its guidance on valuation using RWE. “Ultra-high-priced drugs present uncertainties due to disease characteristics and ethical issues,” said Lee, adding, “ It is difficult to standardize clinical trials, and there may not be a comparator drug or enough follow-up data.” In such cases, it is difficult to analyze the cost-effectiveness, and even then, it is difficult to ensure reliability. Among the high-priced drugs listed for reimbursement in Korea, there are already 11 drugs that cost more than KRW 100 million per year. For these drugs, performance-based managed reimbursement contracts are being implemented as their pharmacoeconomic evaluation are difficult and clinical uncertainty high. To date, 5 drugs are receiving patient-level performance-based evaluations and 1 drug-level evaluation. “The industry is negative about the outcome-based drug evaluation,” Director Lee said, ”The industry believes that the system is not objectively valid or reliable.” However, Lee emphasized that RWD, if utilized well, can be used to ensure reliability and fair pricing that satisfies patients, pharmaceutical companies, and the payer. “The advantage of RWD is that evidence can be gathered from the R&D stage to benefit patients, and the incompleteness of the system can be reduced if pharmaceutical companies and the insurer can work together to link a lot of data. If we can ensure full-cycle collaboration based on transparency, the system will not shrink the pharmaceutical industry while ensuring access to good drugs for patients.” Of course, there are limitations. Data analysis needs to be done while protecting patient privacy, and transparency and uniformity of data still remain a challenge. However, standardization efforts are underway in each country. “There is still a lack of confidence in the system using RWD to evaluate cost-effectiveness, as well as limited transparency, data quality issues, and bias,” said Dr. Vandana Ayyar Gupta, Scientific Advisor of NICE in the UK, another keynote speaker at the event, ”This is why NICE is working to update its guidance and create an RWE framework for its support.” “Real-world data and real-world evidence are being used by NICE in a variety of ways, and the number of use cases is expanding,” said Dr. Gupta. ”The RWE framework will continue to be updated through communication between developers and NICE based on rapidly evolving methodologies and technological advances.”
- Policy
- Price of 17 items cut 30% during Type C PVA negotiations
- by Lee, Tak-Sun Aug 28, 2024 05:52am
- The National Health Insurance Service (NHIS) has announced that it has achieved health insurance financial savings of KRW 52.1 billion (USD 52.1 million) through ‘Type C’ Price-Volume Agreement (PVA) negotiations this year. This is an 85.5% increase from the KRW 28.1 billion in the previous year. In particular, the revision of the detailed operating guidelines contributed to a 36% increase in the price reduction rate of high-cost drugs that billed more than KRW 30 billion per year compared to before the guidelines were revised. The National Health Insurance Service (President: Ki-suck Jung, NHIS) announced that it has completed negotiations for 63 product groups (207 items) subject to the 2024 PVA 'type Type c negotiations, of which the price of 162 items will be reduced unilaterally as of September 1, and the remaining 45 items have signed a one-time refund agreement. ‘Type C’ negotiation is held once a year, and this year's negotiation was conducted for drugs whose claims amount in 2023 increased by '60% or more' compared to 2022, or '10% or more and the increased amount exceeds KRW 5 billion', and the pharmaceutical companies and the NHIS negotiated to reduce the drug price or make a one-time reimbursement of the claimed amount based on the reduction rate. This year's negotiations were the first to apply the 'Detailed Operating Guidelines for PVA Linkage Negotiations,' which was revised in May after collecting opinions from the 2023 System Improvement Council, which included the Ministry of Health and Welfare, NHIs, and the pharmaceutical industry. The main improvements included ▲differentiation of the reference formula used to link the claims amount ▲raising the exclusion criteria to improve the acceptability of pharmaceutical companies and encouraging R&D ▲one-time reimbursement contract ▲introduction of a reduction rate reduction system, to practically improve the financial savings. As a result, the price reduction rate of high-costing drugs that billed more than KRW 30 billion per year increased by 36%, compared to how guideline revision due to the improvement of the reference formula linked to the amount of charges. The NHIS also reported that the efficiency of system operation was improved by raising the criteria for claims that are eligible for exclusion of pricing negotiation, which excluded 64 items, helping to resolve difficulties faced by small and medium-sized pharmaceutical companies. In addition, the NHIS claimed that it applied a one-time reimbursement contract for 45 items whose usage temporarily increased due to unavoidable reasons, such as the COVID-19 pandemic crisis, instead of reducing drug prices to ensure a stable supply of medicines. In addition, the NHIS explained that it enhanced the sustainability of the pharmaceutical industry ecosystem by setting a price reduction rate of 30% for 17 items that had undergone negotiations 3 times within 5 years among innovative pharmaceutical companies. As a result, this year's 'type c’ negotiations resulted in health insurance financial savings of KRW 52.1 billion, up 85.5% from the 28.1 billion won in the previous year. id. “Considering the increasing trend of health insurance drug costs due to the aging population and chronic diseases, the importance of PVA negotiations in the post-management of drug prices is becoming increasingly important,” said Yoo-kyung Yoon, Director of the pharmaceutical management division at NHIS. ”We will continue to strive to improve the sustainability of health insurance and reduce the actual burden of drug costs on the public through effective PVA negotiations.”
- Policy
- MFDS to review side effects relief imposed on companies
- by Lee, Jeong-Hwan Aug 28, 2024 05:52am
- The Ministry of Food and Drug Safety (MFDS) comments on the The Ministry of Food and Drug Safety (MFDS) announced that it would try to set the reasonably sized 'Payment for Benefits for relief of Injury from Side Effects of Drugs, (hereafter referred to as payment for benefits for relief) ' which is currently charged to pharmaceutical companies. MFDS' audit of the Korea Institute of Drug Safety and Risk Management (KIDS) indicated excessive charging of pharmaceutical companies. As the committee members of the Health and Welfare Committee of the National Assembly pointed out, MFDS seems to be promising to evaluate the appropriateness. On August 27th, the MFDS announced such in a statement submitted after last week's plenary session. The committee members of the Health and Welfare Committee commented that the appropriateness of the rate of payment for benefits for relief must be continuously examined. Additionally, the committee members questioned the MFDS about devising a solution to improve the payment awareness, such as strengthening promotions, expanding the percentage of relief, and recognizing the side effects. Such comments seem to stem from the recent discovery by MFDS during the KDIS audit. The MFDS discovered that KIDS overcharged pharmaceutical companies the payment for benefits for relief. The MFDS promised to devise an appropriate size of the payment for benefits for relief charged to pharmaceutical companies. It also explained that the MFDS has been reducing the percentage of charges covering the payment for benefits for relief since 2018. In fact, MFDS' rate of charge is decreasing, with 0.027% for 2018-2020, 0.022% for 2021-2023, and 0.018% for 2024-2026. The MFDS also mentioned that in the early stages of the system implementation, relief for adverse effects initially covered only death benefits but has since been expanded to include funeral expenses, disability relief, and medical costs. The MFDS stressed, "While death relief was only provided in the early stages of the system implementation, we have expanded the relief size to funeral expenses, disability relief, and medical costs," and added, "Since 2018, we have been reducing the rate of payment by setting the rate of payment yearly in the early stages of the system implementation and every three years since from 2018." The MFDS announced that it will enhance the promotion of the relief providing system. The MFDS added, "MFDS will continue to improve awareness of the system so that citizens can benefit from the relief," and, "We will post promotions on public transportation, buildings, and online platforms. We will also create and distribute informational posters and medicine bags to provide information on the relief."
- Policy
- SK Chemicals strengthens migraine drug lineup with Suvexx
- by Lee, Tak-Sun Aug 27, 2024 05:50am
- Suvexx, a combination migraine treatment imported and supplied by SK Chemicals, will be reimbursed in Korea next month. Suvexx is a combination of sumatriptan, a triptan-class drug most commonly used for migraine, and naproxen, a non-steroidal anti-inflammatory drug (NSAID). According to industry sources on the 26th, Suvexx will be listed for reimbursement at KRW 5,042 per tablet starting on the first of next month. There has never been a combination drug combining sumatriptan naproxen in Korea. Furthermore, the individual ingredients, sumatriptan succinate 85mg and naproxen sodium 500mg, are not registered on the reimbursement list. Therefore, HIRA applied a formula based on the upper insurance price limit of products that contain similar dosages of the ingredients to calculate the upper limits of each component and then added them up. The resulting price was KRW 5,042 per tablet. The total price is higher than the maximum price of KRW 3,615 set for sumatriptan succinate 50 mg and KRW 420 for naproxen 1 g, which are currently registered on the reimbursement list. Suvexx is indicated for the treatment of acute migraine attacks with or without prodromal symptoms in adult patients 18 years of age and older. In clinical trials, a significantly higher proportion of subjects achieved headache relief 2 hours after dosing compared to placebo, and the proportion of patients who remained pain-free for 24 hours after dosing without taking any other medication was significantly higher in the treatment group compared to placebo, sumatriptan monotherapy, and naproxen monotherapy, demonstrating the drug’s efficacy. The product was co-developed by global pharmaceutical giant GSK and Pozen, a subsidiary of Canada's Aralez Pharmaceuticals, and SK Chemicals signed a contract with the original developer to introduce the drug in Korea in 2021. SK Chemicals received domestic approval for the drug on August 1 last year. SK Chemicals has been supplying various products in the domestic migraine market. Recently, it co-marketed Emgality, a migraine prevention injection that targets calcitonin-gene-related peptide (CGRP), with Lilly. The company also owns the triptan-based Migard Tab (frovatriptan), so the launch of Suvexx is expected to create synergy, strengthening the company’s product lineup. The annual prescription volume of triptan-based migraine drugs is approximately KRW 20 billion.
- Policy
- Eliquis generics re-enter the market, 35 reimbursed drugs
- by Lee, Tak-Sun Aug 26, 2024 05:46am
- Product photo of the original drug Eliquis. Drugs that are generic versions of the coagulant agent Eliquis (apixaban) will re-enter the market three and five months after discontinuing sales due to a failing patent nullification challenge. It is because the original drug's substance patent is set to expire on September 9th. According to sources on August 23rd, generics containing apixaban will be listed for reimbursement on September 10th. 18 drugs from 35 pharmaceutical companies will be reimbursed. The following companies will be launching their products in the market: Kyongbo Pharmaceutical, Medica Korea, Boryung, Vivozon Pharmaceutical, Ilhwa, Chong Kun Dang Pharmaceutical, Huvist Pharmaceutical, Huons, Daewoong Bio, Dong Kwang Pharmaceutical, Dongkook Pharmaceutical, Samjin Pharmaceutical, Shinil Pharma, Alicon Pharmaceutical, Genuone Sciences, Hana Pharm, Hutecs Korea Pharmaceutical, and Hanlim Pharmaceutical. Eliquis generics have been on the market since June 2019 after the Supreme Court decision. Generics won the substance patent nullification trial and the Supreme Court trial. However, the situation reversed. In April 2021, the Supreme Court ruled against the previous decision and destroyed the case in favor of the original company. Consequently, products that could potentially infringe on the patent were withdrawn from the market in two years. The original Eliquis' price was restored. Chong Kun Dang Pharmaceutical's Liquisia recorded KRW 4.1 billion (based on UBIST) in outpatient sales during the sales. Chong Kun Dang Pharmaceutical's Liquisia aims to regain the market presence. The price of drugs meeting the requirement criteria and receiving 59.5% credit as first generics are set as KRW 633 per tablet. Drugs meeting only one requirement criteria are set as KRW 484, which is 45.52% of the highest price. Boryung's Viala Fix will be listed as KRW 724, a 68%, credited as the innovative drug. Products that are set for listing have been previously launched. Some are new products. A pharmaceutical industry official said, "Eliquis was worth KRW 50 billion when listed in 2020. After generics withdrew from the market due to the Supreme Court ruling in 2021, Eliquis' price was restored. Therefore, it became the blockbuster drug with KRW 77.3 billion in prescription sales last year, based on UBIST," and added, "The market is expected to grow when new anticoagulants become prescribed in private practices. As a result, Korean pharmaceutical companies will actively pursue sales and marketing."
- Policy
- Hanmi faces competition from cheaper Zytiga generic drug
- by Lee, Tak-Sun Aug 26, 2024 05:45am
- Product photos of Janssen A new competing drug has entered the 'Zytiga' generic market, where Hanmi Pharmaceutical was the only company to launch a product last year. Ace Pharmaceutical has introduced a drug imported from India to the South Korean market. While Hanmi Pharmaceutical is strengthening its market presence by recently launching a combination drug, the new generic entry garners attention due to its impact on market competition. According to industry sources on August 25th, Ace Pharmaceutical listed 'Aviron Tab 500 mg (abiraterone acetate)' for reimbursement. The drug has the same active ingredient as Janssen Korea's Zytiga. Zytiga is an anticancer used in treating three types of prostate cancer: ▲patients with asymptomatic or mildly symptomatic metastatic castration-resistant prostate cancer (mCRPC), ▲patients with mCRPC previously treated with docetaxel, ▲patients newly diagnosed with hormone-sensitive metastatic prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT) plus prednisolone. The drug is expected to be used more as the patient burden decreases with the transition from selective reimbursement coverage (30% co-payment rate) to essential reimbursement coverage (5% co-payment rate). It generated KRW 19 billion last year, down -13%p year over year (YoY), based on IQVIA. Such a decrease in Zytiga's sales may be due to the generic entry. Hanmi Pharmaceutical launched 'Abiteron Tab 500 mg,' the first Zytiga generic in South Korea, last October. Last month, Hanmi Pharmaceutical launched a combination drug, 'Abiterone Duo Tab,' a combination of Zytiga and prednisolone. The company developed the product after noting that reimbursable Zytiga therapy can be combined with prednisolone. The industry draws attention to whether Hanmi Pharmaceutical can establish a presence in the market for anticancer agents with its proprietary combination drug. However, the company encountered a surprise. Ace Pharmaceutical, which imports foreign anticancer agents to South Korea, has recently introduced Zytiga generic. Ace Pharmaceutical has recently distributed 'Actepa Inj (thiotepa),' used as a conditioning regimen for allogeneic or autologous stem cell transplantation before the treatment of adult lymphoma and pediatric neuroblastoma or retinoblastoma, to Asan Medical Center. Therefore, the company demonstrated competitiveness in the market for anticancer agents. Aviron Tab's drug price is less expensive than 'Abiteron.' It was listed for reimbursement as KRW 8,498 per tab, which is lower than the calculated drug price. Aviron Tab's drug price is lower than KRW 8,537 for Abiteron tab and substantially differs from the original Zytiga tab (KRW 11,746). While original drugs show a strong presence in the market for anticancer agents, the competition in the market sized KRW 20 billion is expected to heat up after the entries of the first generic, Hanmi Pharmaceutical's combination drug, and a new generic.
- Policy
- DREC to review the COVID-19 drug Paxlovid a week earlier
- by Lee, Tak-Sun Aug 23, 2024 06:17am
- Product photo of Paxlovid. The Drug Reimbursement Evaluation Committee (DREC) of the Health Insurance Review and Assessment Service (HIRA) will convene a week earlier than scheduled. The DREC review evaluates the appropriateness of new drugs for reimbursement. Industry analysis suggests that the schedule has changed to quickly list the COVID-19 treatment 'Paxlovid (nirmatrelvir·ritonavir, Pfizer Korea)' for reimbursement. Previously, Minister of Health and Welfare Cho KyooHong stated that, due to the COVID-19 resurgence, Paxlovid will be reimbursed beginning in October. According to industry sources on August 22nd, the 9th DREC review for 2024 will convene on August 29th, a week earlier than the initially planned date of September 5th. The date change to the DREC review is likely due to hastening reimbursement process for Paxlovid. There is not much window of time to implement reimbursement by October, as Director Cho suggested. Typically, even if the duration it takes to negotiate with the National Health Insurance Service (NHIS) can be shortened by prior agreement, it takes 30 days to reach the drug price agreement after a drug passes the DREC review. If the drug were to pass the DREC review in early September as initially scheduled, it would be uncertain whether an agreement could be completed before the late September reporting session of the Ministry of Health and Welfare (MOHW)'s Health Insurance Policy Review Committee. As a result, it appears that an earlier DREC review date was set to provide more time for negotiation. Sources said that NHIS and Pfizer have begun discussing a prior agreement for drug price negotiation. During the COVID-19 spread, the government purchased Paxlovid so patients could use it for free. Since May, patients must pay KRW 50,000, which is approximately 5% of the drug price. It is a temporary measure before the implementation of reimbursement. However, due to the recent COVID-19 resurgence, demand for Paxlovid surged beyond the volume purchased by the government, so the drug is not being delivered to patients on time. As a result, the government aims to proceed with the reimbursement process quickly so that patients with severe diseases can receive medications properly. However, some argue that such a measure is inappropriate because once the reimbursement is applied, the co-payment would be much higher than the current KRW 50,000. Seo Youngseok, a member of the Democratic Party of Korea, criticized, " If Paxlovid price were to be set as KRW 700,000 and with 30% co-payment applied, patient's co-payment will be approximately KRW 200,000," and added, "What it means is that the National Insurance finance and patients will have to bear the financial burden of medication. In other words, the Korea Disease Control and Prevention Agency (KDCA) would fail to fulfill its job." Youngmee Jee, Commissioner of the KDCA, said, "Most countries have listed COVID-19 oral treatments for reimbursement, providing the treatments covered by insurance," and added, "Patient co-payments can be adjustable. We will minimize the financial burden on patients." Some expect Paxlovid's co-payment rate to be further reduced from 30%.
- Policy
- Ildong to continue oral 'GLP-1 receptor agonist' trial
- by Lee, Hye-Kyung Aug 22, 2024 05:55am
- Ildong Pharmaceutical will conduct an additional round of Phase 1 clinical trial for its proprietary new drug candidate, 'ID110521156,' for the treatment of type 2 diabetes. The drug, by the development code ID110521156, is an oral new drug targeting type 2 diabetes and obesity. On August 20th, the Ministry of Food and Drug Safety (MFDS) approved a 'Randomized, double-blind, placebo-controlled, multiple-ascending oral dose Phase 1 study of ID110521156 in healthy adults to evaluate the safety, tolerability, and pharmacokinetic and pharmacodynamic characteristics of the drug,' which has been submitted by Unovia. Unovia is an independent company established through a simple asset split by Ildong Pharmaceutical to spin off its R&D division. Ildong Pharmaceutical holds 100% of Unovia's shares as the parent company. The Phase 1 trial for ID11052115 was conducted from September 2023 to February 2024 in South Korea. The previous goal was to study 'single oral administration,' but this time, the study will evaluate the drug's safety by multiple-dose administration of ID110521156. When the clinical trial is completed successfully, Ildong Pharmaceutical plans to develop the new drug candidate as an oral new drug targeting type 2 diabetes and obesity. ID110521156 is a type of glucagon-like peptide-1 receptor agonist, and it works as an analog of GLP-1 hormone that induces insulin secretion in the body and regulates blood sugar levels. GLP-1 hormone is synthesized in the beta cells of the pancreas. It is known to be involved in insulin synthesis and secretion in the body, reducing blood sugar levels, regulating gastrointestinal movement, and suppressing appetite. ID110521156 is a small-molecule compound with the same function as GLP-1 hormones. It is structurally more stable and has a longer plasma half-life than peptide-based biological agents. The company explained that ID110521156's efficacy and toxicity evaluations using disease animal models have demonstrated significant effectiveness in insulin secretion and blood glucose control and superior safety compared to competing drugs in the same class. The company has already registered the candidate's substance patent in countries including South Korea, the United States, China, Japan, India, and Australia. Ildong Pharmaceutical's official stated, "We have evaluated the efficacy and toxicity profile of ID110521156 using disease animal models and have confirmed its effectiveness in insulin secretion, blood glucose control, and safety," and added, "We are currently in discussions with several global pharmaceutical companies regarding licensing and partnerships."
- Policy
- Preferential pricing delayed for homegrown new drugs
- by Lee, Tak-Sun Aug 22, 2024 05:50am
- The delay in issuance of a revised draft that includes preferential drug pricing measures for domestic new drugs is raising concerns in the pharmaceutical industry. This month, a revised draft that reflects the innovative value of new drugs was released by the Health Insurance Review and Assessment Service, but the revision lacked a measure for homegrown new drugs. The preferential treatment for such homegrown new drugs was expected to be included in the amendment to the Ministry of Health and Welfare’s “Criteria for Decision or Adjustment on Drugs,” but it is difficult to predict when the notification of the amendment will be issued due to the recent change in the Director Division of Pharmaceutical Benefits at MOHW. On the 8th, HIRA issued an amendment to the "Criteria for Detailed Evaluation of Drugs Subject to Negotiation, such as New Drugs" upon DREC deliberations. The amendment included: ▲ New criteria for flexible ICER threshold evaluation; ▲ Addition of severe diseases to the risk-sharing agreement scheme; ▲ Omission of the Drug Evaluation Committee review when expanding the reimbursement range of RSA drugs that claim less than KRW 1.5 billion; ▲ New conditions that require submission of clinical evidence such as RWD and RWE when renewing RSA schemes. However, the draft did not include preferential treatment of domestically developed drugs, which raised questions in the industry. The plan to apply preferential measures for homegrown new drugs was already included in the ‘2024 Implementation Plan for the 2nd Comprehensive National Health Insurance Plan’ in April. The plan contained preferential drug pricing measures for companies that lead healthcare innovation through R&D investment, supply of essential drugs, job creation, and stable supply and plans to expand the scope of new drugs eligible for preferential pricing and risk-sharing agreement to include those made by pharmaceutical companies with a high R&D ratio. It also included content that generic drugs that contain ingredients designated as national essential drugs will be given higher drug prices than other generics if they newly registered the drug after using domestic ingredients. The Ministry of Health and Welfare announced that it would revise the criteria for determining and adjusting drug prices by the first half of this year. However, the amendments have not been made two months into the first half of the year, raising concerns among some in the industry that it will become a non-event. In particular, the Director of the Division of Pharmaceutical Benefits of MOHW, who is in charge of the work, was replaced last month, making the timing of the amendment less predictable. The MOHW changed the Director of the Division of Pharmaceutical Benefits from Chang-hyun Oh (currently the Director of the Division of Health Industry Promotion) to Yang-soo Song on March 29th. The new director Song is an administrative officer who past the 50th Public Administrative Examination and has served as the head of the research and planning department at the Korea Centers for Disease Control and Prevention's Korea National Institute of Health. An industry insider said, “There is also talk that the new head, Song, is reviewing the preferential pricing treatment for homegrown new drugs again. At first, The amendment was expected to be released in the first half of the year, but no news has been heard on its issuance even after HIRA issued an amendment to the ‘Criteria for detailed evaluation of drugs subject to negotiation, such as new drugs.’” HIRA and the NHIS are having difficulty giving a clear answer on when the measure will be implemented, except that the MOHW is reviewing it. The new Director Song is reportedly revisiting major issues of industry interest, from preferential drug pricing for homegrown new drugs to raising the maximum reduction rate for Price-Volume Agreement drugs, to external reference pricing reevaluations. As such, there is talk that the review and outcome may differ from the new review. In particular, as the price of homegrown new drugs that are currently being reviewed for reimbursement by HIRA may change depending on Song’s review, the industry is eyeing its outcome. Another industry official said, “There are many areas that need to be addressed through notification, such as RSA for domestic non-inferior new drugs. There are also drugs that are currently under review that are applicable, which is why the pharmaceutical industry is eagerly awaiting MOHW’s notification.”
- Policy
- Takeda receives P3T approval for TAK-861 in Korea
- by Lee, Hye-Kyung Aug 21, 2024 05:48am
- The Japanese pharmaceutical company Takeda Pharmaceuticals will enter Phase III clinical trials for TAK-861, its new drug candidate for narcolepsy, in Korea. On the 20th, the Ministry of Food and Drug Safety (MFDS) on Tuesday approved a randomized, double-blind, placebo-controlled Phase III clinical trial to evaluate the efficacy and safety of TAK-861 for the treatment of narcolepsy with cataplexy (narcolepsy type 1). The Phase III trial will be conducted at Seoul National University Hospital, St. Vincent's Hospital, and Keimyung University Dongsan Medical Center. Narcolepsy is a neurological disorder and sleep disorder characterized by episodic drowsiness during daily life. Narcolepsy is categorized into two types: Type 1 narcolepsy, which is characterized by cataplexy or a cerebrospinal fluid hypocretin level of 110 pg/mL or less; and Type 2 narcolepsy, which is characterized by a hypocretin level of 110 pg/mL or higher without cataplexy or no measure. TAK-861 is being developed for the treatment of patients with Type 1 narcolepsy, as stimulation of orexin receptor 2 in patients with Type 1 narcolepsy may restore orexin signaling by targeting the underlying pathophysiology of the disease. According to data presented by Takeda at SLEEP 2024 in June, which outlined the results of the company’s clinical trial evaluating 112 patients with type 1 narcolepsy, TAK-861 demonstrated statistically significant and clinically meaningful improvements compared to placebo in objective and subjective measures of wakefulness, including the primary endpoint, the Maintenance of Wakefulness Test (MWT) at week 8. Consistent statistically significant and clinically meaningful improvements were also observed in secondary endpoints, including the Epworth Sleepiness Scale (ESS) and Weekly Cataplexy Rate (WCR), Products available in the domestic narcolepsy treatment market include JW Pharmaceuticals' Provigil, Hanmi Pharmaceutical's Modanil, and Handok Teva's Nuvigil, all of which contain modafinil. Mitsubishi Tandabe’s Wakix is a pitolisant hydrochloride drug used for narcolepsy in adults with or without cataplexy. Wakix is the only product approved in Korea for the treatment of narcolepsy with cataplexy, which is defined as a sudden loss of muscle tone provoked by strong emotion.
