- LOGIN
- MemberShip
- 2026-04-08 13:42:22
- Policy
- Ulcerative colitis drug Omvoh is approved in Korea
- by Lee, Hye-Kyung Feb 13, 2024 05:51am
- The Ministry of Food and Drug Safety (MFDS, Minister: Yu-Kyoung Oh) announced that it has approved Lilly Korea's new drug Omvoh Inj (mirikizumab-mrkz, recombinant) for the treatment of ulcerative colitis on the 7th. Omvoh Inj. 20 mg/ml is a monoclonal antibody drug that binds to the p19 subunit of interleukin (IL)-23, providing a new therapeutic opportunity for patients with ulcerative colitis by inhibiting interleukin receptor downstream signaling that causes inflammatory responses. Omvoh Inj. is indicated for the treatment of adult patients (aged 18 years or older) with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or biologic treatment. It binds to interleukin (IL)-23, which plays a central role in the pathogenesis of several immune-mediated and chronic inflammatory diseases, including ulcerative colitis, to help maintain resistance to bacterial and viral infections in the gut while supporting clinical improvement of inflammation. The MFDS added, "We will continue to make our best efforts to ensure that treatments with sufficiently verified safety and efficacy are promptly supplied based on regulatory science.”
- Policy
- Janssen’s Spravato required to submit domestic trial data
- by Lee, Hye-Kyung Feb 13, 2024 05:51am
- With Janssen’s novel drug for treatment-resistant depression (TRD), ‘Spravato Nasal Spray (esketamine hydrochloride)’ failed to demonstrate efficacy in Japanese and Chinese patients, the Korean authorities also held discussions on whether to maintain its marketing authorization status in Korea as well. The drug was approved in June 2020. As a result, the authorities decided that no immediate action such as suspension of sales should be taken as no results have shown that the drug was ineffective in Korea. However, the company will be required to submit Phase III clinical trial-level data to further prove its efficacy. For now, the product has been kept on the shelves, but attention will continue to be focused on whether or not it will remain on the shelves by demonstrating its efficacy in Koreans. According to the industry on the 8th, according to the minutes of the Central Pharmaceutical Affairs Council that was released by the Ministry of Food and Drug Safety, the CPAC held an advisory meeting on whether to maintain the marketing authorization (sales) of the medical narcotic drug Stravato and whether it would need to further demonstrate its efficacy. Janssen representatives that had been present at the CPAC meeting, explained “The trials in Chinese and Japanese patients failed due to the lack of statistical significance in the efficacy endpoint. The failure was due to an unexpectedly high placebo effect, which resulted in a lack of significant difference between the Stravato and placebo group, and it is difficult to judge this as a lack of efficacy because the MADRS (Montgomery-Asberg Depression Rating Scale) score did fall with the use of Stravato. In particular, the initial clinical design, which was designed based on FDA guidelines, did not include Korean patients, as Korea does not require data from its own population for approval, so no efficacy data for Koreans are available. Regarding the CPAC member’s question on whether the company can demonstrate Stravato’s efficacy in Koreans at the level of the Phase III clinical trial conducted at the time of initial approval, Janssen said, "The number of subjects had been about 200 to 300, so it may be difficult to recruit the same with Koreans alone, but we are currently working hard on post-marketing surveillance, and we have collected about 70 safety stories and efficacy assessment statements from patients. We will add more number of subjects by the end of the 6-year period." Janssen added that the results of a one-year, single-arm, open-label clinical trial involving 26 Koreans and an investigator-initiated multicenter trial are underway. After Janssen’s explanation, the CPAC chair said, "The CPAC acknowledges that the drug cannot be said to be effective in Japan and China, that is, Asia. We need to decide whether to go through the process of receiving and reviewing the use status, clinical efficacy, and additional supplementation plans through the company or make a decision here and now." After discussions, the CPAC has decided to wait for further clinical data to be submitted rather than make an immediate decision, such as the suspension of sales. In the process, the CPAC concluded that the changes to the labeling information (the drug has not been proven effective in Chinese and Japanese people) should be shared with experts and that it is necessary to receive opinions from doctors organizations, and mental health associations that actually prescribe the drug on-site.
- Company
- ‘Biobetter Nexviazyme is a better treatment option'
- by Eo, Yun-Ho Feb 13, 2024 05:51am
- Professor Hyunjoo Lee There are times when a single treatment has a significant impact on the overall management of the disease. This is especially true for rare and incurable diseases. In the field of metabolic diseases, a paradigm shift occurred when researchers found that certain rare patients lacked a single enzyme, which led to the development of therapies to introduce a substitute into the body to fulfill the enzyme’s role. As a result, patients suffering from these conditions, which are referred to as ‘LSDs (Lysosomal Storage Diseases),’ include Hunter syndrome, Gaucher disease, Fabry disease, and Pompe disease, are currently being treated with enzyme replacement therapy (ERT). Among these diseases, recent advances have been made in the treatment landscape of Pompe disease. About a decade after the ERT drug Myozyme (alglucosidase alfa) was introduced, the biobetter Nexviazyme (avalglucosidase alfa-ngpt) has been granted reimbursement coverage in Korea. Nexviazyme, which was added to the reimbursement list in September last year, became the first drug to receive pricing benefits as a biobetter in Korea. Dailypharm met with Hyunjoo Lee, Professor of Pediatrics at Gangnam Severance Hospital, to learn more about the significance of Nexviazyme’s arrival in Korea. -Nexviazyme can now be prescribed with reimbursement in Korea. What is the benefit of this new treatment option? Pompe disease is a progressive, genetic neuromuscular disease. Despite the many advances in the treatment landscape, there still remained an unmet need as patients were unable to achieve 100% improvement with existing treatments. Nexviazyme was developed to address this unmet need. Nexviazyme is a biobetter drug that was approved for its improved formulation and advancements over the existing Myozyme. It increases intracellular drug uptake by expressing approximately 15 times more mannose 6-phosphate (M6P) on the surface of the therapeutic enzyme than existing therapies. As a result, it can reduce muscle cell damage through effective glycogenolysis by improving glucosidase activity, and it is also beneficial in terms of safety due to improved immunogenicity. -Could you elaborate on the unmet needs that had existed in Korea? Pompe disease is divided into 2 types: infantile-onset Pompe Disease (IOPD), and late-onset Pompe Disease (LOPD), which is characterized by irreversible muscle damage. Myozyme use in patients with infantile-onset Pompe disease has been associated with rapid improvement in heart-related symptoms, such as enlargement of the heart, but there remained room for improvement in muscle-related symptoms, which did not improve 100% and progressed over time. Patients with Pompe disease experience ongoing issues, such as difficulty walking due to arm and leg muscle damage and breathing difficulties due to respiratory muscle damage, but they had limited options as there was only one treatment available for their use. - I understand that forced vital capacity (FVC) and the ability to walk were key endpoints in the Nexviazyme trial. That is correct. In addition to cardiac symptoms, improvements in respiratory and skeletal muscles are important in Pompe disease, to the extent that researchers seek to understand which muscles are most affected. This is most often determined by a six-minute walk test or a forced vital capacity test, but since the walk test cannot be conducted on pediatric patients, symptom improvement in these patients is determined by respiratory and infectious disease susceptibility, and muscle strength for daily activities. The FDA approval in late-onset Pompe disease was granted first for Nexviazyme because of the drug’s effect in improving skeletal muscle, respiratory failure, and muscle-related symptoms. - Are there any risks associated with long-term treatment with Nexviazyme? Because it is an injectable, an infusion-related reaction may occur. Also, regular hospital visits are needed for the injections, which can be challenging. Younger children may have difficulty with vascularization, but there are no other risks. - I remember a few years ago, there was a lot of talk on the need to improve the diagnostic system for genetic diseases such as Pompe disease. What is the current diagnostic landscape like for Pompe disease in Korea? Early diagnosis is important in infantile-onset Pompe disease because of its rapid symptom progression, which can to severe cardiorespiratory disorders and death within a year if the patient does not start treatment immediately. In Korea, diagnostic testing itself is not difficult due to good medical access, and since January this year, lysosomal storage diseases have been included in the neonatal screening test, which means that many patients will be diagnosed more quickly. This is expected to increase the diagnosis rate of lysosomal storage diseases and enable better collection of accurate data about the disease, including the prevalence of Pompe disease patients in Korea. - Lastly, what area do you think needs improvement in the Pompe disease treatment environment? Despite much support from the government, relevant organizations, and pharmaceutical companies, there still are some neglected areas that require attention. For example, in adults, we can evaluate the patient's improvement through FVC and 6-minute walk tests, etc. but it is difficult to do these tests on children. Urine tests are a good option, but these tests are often performed overseas, making it difficult to find out the results immediately. I hope that national or rare disease organizations will recognize this need and create a system to enable efficient testing in Korea. False positives can occur in newborn babies that are born too small or prematurely, depending on their condition. In such cases, I believe the additional tests that are performed at the discretion of the doctor on these patients should also be covered. Also, screening newborns after 28 days of age or those with late-onset Pompe disease is not reimbursed in Korea, and I would like the initial screening process for these patients to be covered so that those with late-onset Pompe disease can be more proactively diagnosed.
- Policy
- Good pharma companies will receive better drug price
- by Lee, Jeong-Hwan Feb 08, 2024 05:49am
- The government decided to further enhance the preferential drug pricing benefits for pharmaceutical companies that have contributed to public health and economic development in Korea, such as by increasing R&D investment in new and incrementally modified drugs, creating many jobs, and supplying essential medicines. The government will promote innovation in the pharmaceutical industry by overhauling the existing system that only provides preferential treatment – a drug price at the highest level among its substitutes - for companies that supply essential drugs or receive a new drug approval for the drug for the first time in Korea. It will also continue expanding insurance coverage through measures such as reflecting the value of innovative new drugs that demonstrated high therapeutic effects in severe and rare diseases in the drug price, and expediting and expanding the number of targets that benefit from health insurance coverage. Furthermore, the government plans to prepare measures for drug price reevaluations, high-priced drug management, and advancing the generic drug pricing structure. These are the contents of the 2nd Comprehensive National Health Insurance Plan (2024-2028) that was released by the Ministry of Health and Welfare on February 4th. Basically, the ministry will strengthen economic support using health insurance finances for pharmaceutical companies that have made achievements in innovating healthcare, health security, and national economic development. The changes were made as part of the government’s efforts to create a system that reflects the growing public and social demand for innovative medical technologies that provide new treatment opportunities for patients with severe and incurable diseases or are more cost-effective than existing technologies. In terms of health security, the government plans to support the establishment of a basic infrastructure to enable the domestic supply of essential medicines that are directly related to the life and health of the people so that the drugs can be stably produced in Korea even if there is a disruption in the overseas supply chain. Pharmaceutical companies that contribute through drug innovation, or drive national development, etc. will benefit from higher drug prices The Ministry of Health and Welfare will improve policies to strengthen access to innovative new drugs. First, it will continue to expand coverage for highly effective severe and rare disease treatments. The order of the reimbursement listing will be prioritized based on disease severity, availability of alternative drugs, superiority of treatment, cost-effectiveness, and financial burden. It will also continue to expedite health insurance listing of new drugs for life-threatening diseases. The approval, evaluation, and negotiation linkage system that has been implemented will reduce the time required for health insurance reimbursement from 330 days to 150 days. To be eligible for the parallel review system, the drug has to have no alternative and be a treatment for a life-threatening disease, demonstrate a significant improvement in clinical effect compared to existing drugs, and be approved for fast-track review by the MFDS. The MOHW will also expand eligibility for expediting listings. Currently, the expedited listing system is being piloted in 2 rare pediatric disease groups - neuroblastoma and hereditary cholestatic stasis – based on which the scope of diseases eligible for fast-track registration will be expanded from 2025. New drugs that are recognized as innovative will be able to receive expedited listing support by recognizing their economic feasibility even if their incremental cost-effectiveness ratio (ICER) exceeds a certain level. The drug pricing premiums provided for each pharmaceutical company will also be expanded. The MOHW believes that it is necessary to calculate drug prices differently based on the company’s degree of contribution to improving public health, health sustainability, and national economic development. Therefore, the ministry will prepare a mechanism that provides preferential drug prices to pharmaceutical companies that have led healthcare innovation and contributed to building a stable supply chain by investing in R&D for new and incrementally modified drugs, supplying essential drugs, and creating jobs. Currently, only companies that supply essential medicines that received a new drug approval for the drug for the first time in Korea receive a preferential price at the highest price level of its alternatives. The government will improve patient access to drugs by expanding risk-sharing system (RSA) treatments for serious diseases that cause significant and irreversible deterioration in quality of life. Reinforce the system for the stable supply of essential medicines In terms of health security, the MOHW will monitor the supply and demand of national essential medicines as well as frequently prescribed drugs such as cold medicines to immediately respond to any abnormalities that may arise. The price of national essential drugs made with domestic ingredients will receive preferential treatment. First, in the case of newly designated national essential medicines, this drug will be given preferential drug prices over other generics when the main ingredient of the generic drug is produced domestically. Drug prices will also be raised quickly to resolve the issue of unstable drug supply. The MOHW is preparing a procedure to quickly raise drug prices of drugs that have become difficult to produce due to rising costs that arose due to their unstable supply and demand after COVID-19. By simplifying the review process based on the criteria for adjusting the insurance price ceiling and concurrently progressing with the NHIS drug pricing negotiations, the MOHW plans to reduce the time required for drug price increases from '210 days+@' to '30 days+@.’ In addition, the MOHW will continue to improve the adequacy of compensation for drug shortage prevention drugs by reflecting manufacturing costs. It will expand the scope of national essential medicines that are eligible for drug price increases and differentiate support to specific classifications. The upper limit for Korean herbal medicine formulations will also be adjusted. Considering the rising cost of APIs and strengthened manufacturing and quality control regulations, the government will consider raising the insurance price ceiling for herbal medicines based on the results of a field survey. Will reduce drug expenditures through drug price reevaluations, management of high-priced drugs, restructuring of generics, etc. The MOHW will establish an integrated price adjustment mechanism for reasonable drug cost management. First, it will prepare a mid to long-term strategic plan to unify the currently fragmented mechanisms for adjusting the price ceiling. Starting this year, the ministry will conduct policy research on establishing a mid- to long-term strategy. The MOHW will also review patent-expired drugs and adjust the price if their domestic price is higher than their highest price in foreign countries. In the case of reevaluating patent-expired drugs, the government plans to start with chronic disease drugs that have a large number of generics. However, drugs that require a stable supply, such as antidepressants, will not be subject to reevaluations. In addition, the management of high-priced drugs for serious diseases will be strengthened. To reduce the patient’s burden of medical expenses as well as the government’s health insurance finances, various types of risk-sharing systems, including outcome-based reimbursement, will be applied to newly listed drugs. The MOHW will also strengthen follow-up management of high-priced drugs for serious diseases based on patient safety and medical effects. It will also rationalize the price-volume agreement system, improving such as increasing the price cut rate for drugs that have a high claims amount or expanding the subjects that can be excluded from being subject to PVA.
- Policy
- Korean gov. to introduce preferential drug pricing criteria
- by Lee, Jeong-Hwan Feb 08, 2024 05:49am
- Director Chang-Hyun Oh explained the pharmaceutical policy directions in the 2nd comprehensive National Health Insurance plan. By the first half of this year, the government plans to establish a detailed criteria for ‘National Economic Growth,’ including the research and development (R&D) of new drugs and incrementally modified drugs, essential drugs supply, and new job creations, which will be the basis for preferential drug pricing intended for pharmaceutical companies in Korea. The criteria will be used to implement a new policy aimed at enhancing preferential drug pricing benefits for pharmaceutical companies that have contributed to Korea’s economic growth. The government has promised to strengthen drug pricing support using the National Health Insurance finance if a pharmaceutical company shows achievements, such as enhancing R&D efforts, alleviating essential drug shortages, and increasing hires, regardless of its status as an innovative pharmaceutical company. Notably, the government has announced a plan to establish a new direction for generic drug pricing system. The current stepwise pricing system for generic drugs was analyzed in research service report, upon which this revision is based. On the 5th, Lee Joongkyu, Director of the National Health Policy at the Ministry of Health and Welfare (MOHW), held the meeting for the 2nd comprehensive National Health Insurance plan with the KSPA NEWS and announced the plan. Chang-Hyun Oh, Director of Pharmaceutical Benefits, attended the meeting and answered the questions regarding the 2nd National Health Insurance plan in detail, including the drug pricing system and issues related to drug prices. Pharmaceutical companies contributing to healthcare security and Korea economic growth will receive preferential drug pricing The 2nd NHI plan announced on the 4th by the MOHW contains policy objectives of assessing preferential drug pricing differentially based on companies’ contribution to improvement in citizens’ healthcare, considering the sustainability of NHI and national economic growth The plan outlines a vision to provide preferential drug pricing to pharmaceutical companies that advance healthcare and establish a stable supply chain. This includes investing in R&D of innovative pharmaceuticals, such as new drugs and incremental new drugs, contributing to the supply of essential drugs, and creating new jobs opportunities. Director Oh emphasized that the 2nd NHI plan is focused on contributing to economic growth and healthcare security. Particularly, the plan includes various measures within the health insurance policy to encourage pharmaceutical companies to engage in the development of new drugs, incrementally modified drugs, and generics. “The current health insurance plan includes discussions on assessing ICER value flexibility and implementing measures to reduce drug pricing if a company positively contrivutes to Korean medical healthcare through substantial investment in R&D, as well as job creation,” said Oh. “Compared to the current incentive system, the revision may yield more improvements because the development of new drugs, incrementally modified drugs, and combination drugs can help healthcare finances.” Oh also mentioned that regardless of a company’s status as an innovative pharmaceutical company, the policy of higher drug pricing will apply to pharmaceutical companies that contribute to Korean economic growth. A reference criteria for preferential drug pricing will be set in the first half of this year after working with a public-private consultative body comprised of the MOHW and pharmaceutical companies, Oh answered. Oh stated that they plan to revise the qualification criteria for innovative pharmaceutical companies to make them less stringent. “Additionally, we will consider creating an administrative system that provides drug pricing benefits to companies that do not qualify as innovative pharmaceutical companies but have made significant contributions to the healthcare industry and health insurance finances through their R&D investments,” Oh said. “We will put our efforts into formulating the criteria of preferential drug pricing by the first half of this year.” “In the 2nd NHI plan, we have suggested a course of direction. We will hear from industry experts in a public-private consultative body to discuss drug pricing index, systemization, and ratios. We have not yet decided on the execution date, but we will implement the system soon,” Oh commented. The MOHW will look into the revision of the generic drug pricing system and the post-management system of drug pricing The MOHW will assess whether the post-management drug pricing system should be revised as well, in addition to enhancing administrative measures for better patient access and considering revision to the drug pricing system of generic drugs. Since July of last year, the MOHW has initiated research with a team led by Professor Dong-Sook Kim at Kongju National University under the government contract to work on evaluating the necessity of restructuring Korea’s drug pricing of generic drugs and to devise revision. The MOHW is currently finalizing the research. Comparing Korea’s drug pricing system for generics to the overseas drug pricing system, the research aims to evaluate whether the current step-wise drug pricing system is valid. Specifically, the research team will analyze whether it is appropriate to set the number of items, differentially priced at 53.55~38.69%, that receive differential drug pricing to 20, should drug prices of generics be maintained at 53.55% of the originals before the patent expires, and whether it is necessary to differentially set the drug prices of generics to 53.55% once the patent of the originals expires. The research includes the post-management methods, including the price-volume agreement. Oh has announced that they will begin working on amending the drug pricing system and the post-management of generic drugs this year after completing the research and a comprehensive review of the post-management system,. However, the execution date will be determined later “after gathering opinions from patients, pharmaceutical companies, and experts.”
- Policy
- Production and supply of Cifex Eye Drops is discontinued
- by Lee, Hye-Kyung Feb 08, 2024 05:49am
- Samil Pharm will suspend production and supply of its 2nd generation fluoroquinolone antibiotic eye drop, Cifex Eye Drops (ciprofloxacin hydrochloride hydrate). According to the Ministry of Food and Drug Safety's status report on the discontinued or supply shortage drugs, Samil Pharm had reported the discontinuation of its Cifex Eye Drops on the 6th. Samil Pharm said, "We are suspending production and supply due to low sales and increased amount of disposed products. There is a possibility of resuming production if there is a large demand in the future." Cifex Eye Drops was approved in 1995 and have been used to treat corneal ulcers and conjunctivitis. According to the Ministry of Food and Drug Safety's production performance report, sales of the drug have steadily increased from KRW 36.75 million in 2020, KRW 36.77 million in 2021, to KRW 40.94 million in 2022, but Samil Pharm believes that inventory is increasing due to low sales. The company added, "There are many quinolones such as ‘ofloxacin,' 'levofloxacin,' and 'moxifloxacin' available to substitute Cifex Eye Drops, so we do not expect any inconvenience to occur for the patients due to the discontinuation of Cifex Eye Drops. Currently, the only remaining second-generation quinolone antibiotics that contain ciprofloxacin like Cipex Eye Drops is Daewoong Pharmaceutical's Ciplus, and other ofloxacin products available include ‘Effexin,’ ‘Ocuflox,’ ‘Ofbella,’ ‘Quinovit,’ and ‘Tarivid.’ Other alternative antibiotic eye drops available include 3rd generation quinolone antibiotics like ‘Cravit,’ ‘Levofexin,’ which contains levofloxacin, and ‘Ozex,’ which contain tosufloxacin. Among 4th generation quinolone biotics, ‘Gatiflo,’ which contains gatifloxacin, and ‘Vigamox’ and ‘Vigaflo’ that contain moxifloxacin are available in the market.
- Opinion
- [Reporter’s View] Long-awaited, but not prescribed?
- by Eo, Yun-Ho Feb 08, 2024 05:49am
- Even though the only existing treatment on the planet has finally been approved for reimbursement in Korea, prescribers are hesitant to introduce the drug to their institutions due to concerns over incurring losses if the costly drugs are not used. These are drugs that have gained much attention since approval. The drugs showed outstanding efficacy in diseases with no or limited treatment options, but are expensive. Upon their entry into Korea, patients and their families had been desperately arising for their insurance reimbursement. In every stage of the process, from when the pharmaceutical company applied for reimbursement benefits to the Health Insurance Review and Assessment Service, to every step of the listing process by the National Health Insurance Service, attention was gained and petitions were filed, prompting its listing. However, to the public’s disappointment, the approval process for new drugs that bring heavy financial burdens on national health insurance is usually not smooth and takes a long time. But often, these new drugs that passed this rough and difficult reimbursement process are not being prescribed at most hospitals. And these aren’t all gene therapies that require specific facilities for their prescription. One drug, which was listed almost half a year ago, has only landed in a handful of medical centers in the country despite being an unprecedented and reimbursable treatment. This is because hospitals are reluctant to bear the loss that may occur if the government orders insurance cuts after the drugs are prescribed at the discretion of their physicians. The same is true for the distributors. If they incur a loss in the process of distributing these drugs, they lose a lot of money. The same goes for drugs that require preapproval. The preapproval system is a system established to review whether or not to reimburse expensive rare disease drugs for each patient in advance and is designed to improve patient access to treatments while protecting health insurance finances. It has two functions: prior review, which determines the eligibility of the patients before treatment, and concurrent review, which determines whether the patient may continue treatment with reimbursement after the preapproval. In other words, because the drug is so expensive, the authorities are using prior review to determine whether or not the drug can be reimbursed, case-by-case. The drugs that require prior review can also prescribed when there is an emergency at the doctors’ discretion. The problem lies in when the drug is prescribed but the authorities decided to reject its coverage. It’s not right to ask the hospitals and distributors to just bear the losses. But we all need to remember that much yearning and hard work went into reimbursing the drugs. Hospitals and distributors need to work with the industry and authorities to fulfill the purpose of the ‘risk-sharing’ scheme. This is not the time to be reluctant, it is rather the time to take a proactive step forward. The government also needs to understand this hesitation on-site in using drugs that have entered the system. ‘Landing’ shouldn't become one more barrier that contributes to ‘drugs that exist but can't be taken or administered’ in addition to reimbursement.
- Policy
- Preferential pricing possible for non-innovative new drugs
- by Lee, Tak-Sun Feb 08, 2024 05:48am
- The government has announced a plan allowing new drugs developed by pharmaceutical companies not designated as Korea’s innovative pharmaceutical companies to be eligible for preferential drug pricing. This has turned attention to whether Jeil Pharmaceutical’s new drugs will benefit from this plan. On the 4th, the Ministry of Health and Welfare (MOHW) announced the 2nd comprehensive National Health Insurance plan (2024~2028), stating that the ministry will establish a measure to provide preferential drug pricing to pharmaceutical companies, regardless of their innovative new drugs designation status, that advance healthcare and establish a stable supply chain. The current plan offers expanded support compared to the ‘the drug pricing system to ensure fair-value compensation for innovative new drugs’ announced by the Biohealth Innovation Committee, which is chaired by the Prime Minister. In ‘the drug pricing system to ensure fair-value compensation for innovative new drugs’, domestically developed new drugs, which were produced by innovative pharmaceutical companies and underwent confirmatory clinical trials targeting Koreans and received expedited approval by the Ministry of Food and Drug Safety (MFDS), were eligible for receiving the drug pricing measures. Previously, if a drug's clinical usefulness was assessed to be the same or less than that of its substitute, it was priced lower than the weighted average price of the substitute. However, from now on, it will be allowed to be priced between the weighted average price and the maximum price of the substitute. Following the announcement, the pharmaceutical industry welcomed the news, but expressed disappointment at the limited benefits for only innovative pharmaceutical companies. During last month’s public-private consultative body meeting, the pharmaceutical industry proposed that non-innovative pharmaceutical companies should also be considered for preferential drug pricing. It seems that such measures have been incorporated into the 2nd NHI plan. Particularly this year, there is anticipation surrounding the emergence of domestically produced new drugs developed by non-innovative pharmaceutical companies, raising interest in whether they will also receive drug pricing benefits. ‘Zastaprazan,’ developed by Onconic Therapeutics, a subsidiary of Jeil Pharmaceutical, is one of those drugs. Zastaprazan has applied for product approval form the MFDS. Zastaprazan, like Kcab, is a P-CAB class treatment for gastroesophageal reflux disease. Compared to PPI-class medications, it has a rapid onset of action and can be taken regardless of meals. Onconic Therapeutics conducted a Phase 3 trial enrolling 289 patients with gastroesophageal reflux disease at 28 medical institutions, demonstrating non-inferiority compared to Esomeprazole. The product approval is expected to be confirmed this year, followed by the reimbursement listing process. Based on current criteria, since it is considered a non-innovative new drug, it is expected to receive a price below the average weighted price of substitute drugs. Although the government announced ‘the drug pricing system to ensure fair-value compensation for innovative new drugs’ measure end of last year, Jeil Pharmaceutical and Onconic Therapeutics have been excluded from potential beneficiary because they are not designated as innovative pharmaceutical companies. With the 2nd NHI plan, these new drugs can receive higher prices if subjected to preferential drug pricing. DA-8010, which is a new drug being developed by Dong-A ST for treating overactive bladder (OAB), has been identified as a potential beneficiary. If the phase 3 trials of this drug are completed within the first half of this year, there is a high possibility that the company will apply for product approval by the end of the year. Previously, Dong-A ST has been excluded from drug pricing incentives as it is not designated as an innovative pharmaceutical company, despite the new drug development. The industry expects the government to formulate preferential drug pricing criteria for non-innovative new drugs in the first half of the year. During a meeting with the KSPA NEWS On the 5th, Chang-Hyun Oh, Director of Pharmaceutical Benefits, stated that “We will consider creating an administrative system that provides drug pricing benefits to companies that do not qualify as innovative pharmaceutical companies but have made significant contributions to the healthcare industry and health insurance finances through their R&D investments.” Oh explained, “We will put our efforts into formulating the criteria of preferential drug pricing by the first half of this year.” After the New Year holiday, the government is expected to begin discussing measures of preferential drug pricing with the pharmaceutical industry through a public-private consultative body.
- Company
- Yuhan Chemical completes FDA and ANVISA inspections
- by Nho, Byung Chul Feb 07, 2024 05:59am
- Yuhan Chemical’s manufacturing plant in Hwaseong. Yuhan Chemical (CEO & President: Sang-Hun Seo) has confirmed its global-scale capacity for manufacturing and quality management systems. Yuhan Chemical announced on the 5th that the company has successfully completed the inspections of the United States Food and Drug Associations (FDA) and the Brazilian Health Surveillance Agency (ANVISA). As a result, the current inspection likely verified that Yuhan Chemical has the global-scale capacity for manufacturing and quality management systems, firmly establishing its position as Korea’s top active pharmaceutical ingredient (API) manufacturing company. The current FDA inspection lasted five days, serving as a Pre-Approval Inspection and a routine inspection for APIs intended for U.S. exports. The FDA assessed the company’s compliance with stringent good manufacturing practice (cGMP) standards, and the inspection successfully concluded with only minor notifications issued. Yuhan Chemical also cleared Pre-Approval Inspection of Brazil’s ANVISA, known to be as stringent as the FDA approval, with no observations. Regarding the current inspections, Yuhan Chemical stated, “This round of inspections reaffirmed that Yuhan Chemical holds a strong position as an API company. We have demonstrated our superior manufacturing facility, quality system, and commitment to Data Integrity, utilizing an IT-based quality system while upholding the company’s values of honesty and integrity.” Yuhan Chemical, a subsidiary of Yuhan Corporation, is an API development and manufacturing company. Founded in July 1980, the company has been pursuing global quality standards. Yuhan Chemical received FDA approval for its Ansan manufacturing plant in 2002 and is certified to comply with the advanced GMP quality standards of regulatory agencies in various countries, including European EDQM, Japanese PMDA, Brazil ANVISA, and Australia TGA. In January 2016, the company established its second plant in Hwaseong, Gyeonggi Province. To expand its manufacturing capacity to achieve further growth, Yuhan Chemical completed the construction of a new facility, HB Dong, in November 2023. The facility has the capacity to produce 144,000 liters annually. With these developments, Yuhan Chemical has a total production capacity of 843,000 liters annually. The company expects to secure new contracts with potential clients with its expanded manufacturing capacity. With scheduled inspections by regulatory agencies and client companies, Yuhan Chemical aims to achieve high-quality growth and further development. “Yuhan Chemical is strengthening its competitive position in producing top-quality APIs. Our company is actively working to implement a Continuous Manufacturing system, which will become a new industry standard worldwide,” Yuhan Chemical stated. “Yuhan Chemical aims to overcome the difficulties posed by the diminishing domestic API manufacturing landscape due to low price competitiveness. The company will strive to become a global API CDMO leader.”
- Company
- Bayer partners with Chong Kun Dang to sell Kerendia
- by Nho, Byung Chul Feb 07, 2024 05:59am
- An upturn is expected in the KRW 20 billion markets for chronic kidney disease treatments, with Bayer and Chong Kun Dang joining forces to establish a joint sales front for its chronic kidney disease treatment, Kerendia Tab, According to industry sources, Bayer and Chong Kun Dang signed a joint sales agreement for Kerendia Tab today (February 6) and will challenge the market as a ‘first-line treatment’ for chronic kidney disease. Bayer's innovative new drug Kerendia Tab. 10-20mg (finerenone) was approved by the Ministry of Food and Drug Safety in April 2022 for indications including as chronic kidney disease and was listed for reimbursement on the 1st of this month. The drug price is KRW 1,670 for both the 10m and 20 mg doses. Although there had been some hypertension drugs, the CKD treatment market had been virtually dominated by HK Inno.N’s Kremezin and Daewon’s Renamezin. Although Kerendia (finerenone) and Kremezin (spherical sorbent) or Renamezin (spherical sorbent) do not contain the same active ingredient, in terms of their 'broad indications,’ Kerendia is likely to pull the brakes on the growth of existing products. Although the field of kidney disease treatment is not divided into first-line and second-line like diabetes or hypertension drugs, it is likely that Kerendia will be prescribed first due to its initial treatment efficacy. Kerendia is a treatment for adult patients with chronic kidney disease (CKD) and type 2 diabetes (T2D)that reduces the risk of end-stage kidney disease (ESKD) and a sustained decrease in estimated glomerular filtration rate (eGFR), and cardiovascular death, nonfatal myocardial infarction, and hospitalization for heart failure. Kremezin and Renamezin, on the other hand, has indications for improving uremia and delaying dialysis, which occurs in in later stage chronic kidney disease. However, the launch of Bayer's new treatment option Kerendia, which adds on to the previous options of Kremezin and Renamezin, is welcome news for the patients, given that the drug is intended to prevent hemodialysis, a major costly treatment that can cost up to KRW 30 million per year. In addition, the introduction of Daewon Pharmaceutical's new formulation, Renamezin Cap., is expected to quickly penetrate the existing market that consists of fine-grained and fast-acting tablets, building on its strength of improved dosing convenience. This, coupled with Chong Kun Dang’s strong sales and marketing capabilities, is expected to raise Kerendia into a dark horse in the market.
