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- 2026-03-11 21:57:56
- Policy
- Prostate cancer tx Xtandi·Zytiga, 5% pt copayment applied
- by Lee, Tak-Sun Oct 26, 2023 06:06am
- Mandatory coverage is applied to some treatments for prostate cancer treatments Xtandi soft capsule 40mg and Zytiga, which is expected to reduce the financial burden on patients. This is a measure of fairness as Erleada is subject to mandatory benefit as it was previously listed. The HIRA announced that it will revise the anticancer drug reimbursement standards including this information starting in November. Xtandi's pt copayment will be lowered from 30% to 5% due to expanded coverage for ADT combination therapy (first-line palliative treatment) for metastatic hormone-sensitive prostate cancer. Zytiga also lowers the pt copayment of prednisolone + ADT combination therapy (first-line, palliative treatment) from 30% to 5% for metastatic hormone-sensitive prostate cancer. HIRA said, "As Erleada, a drug in the ARTA (androgen receptor targeting agent) class, was recently applied for the same indication with a pt copayment of 5/100, issues such as confusion in actual clinical settings and patient equity were raised, so textbooks and guidelines were revised. · Referring to academic opinions, etc., it was judged to be a drug that needed expanded coverage, so the pt copayment was changed from 30% to 5%,” he explained. The upper limit amount was also adjusted according to the expansion of benefits. Zytiga has applied an ex officio adjusted upper limit amount as Hanmi Pharmaceutical's 'Abiteron 500mg', a generic drug, was listed starting this month. Accordingly, the upper limit will be reduced from 16,780 won per party, which is 70% of the previous highest price, to 11,746 won. After one year, it will drop to 8,986 won, which is 53.55%. For reference, Hanmi's first generic ‘Abiteron 500mg’ was listed at 8,537 won per tablet. The transition to mandatory coverage also greatly reduces the financial burden on patients. In the case of Xtandi, the cost per patient is reduced from about 5.84 million won to about 660,000 won per year, the NHIS said. Last year, based on IQVIA, domestic sales amounted to 29.1 billion won for Xtandi and 21.8 billion won for Zytiga.
- Policy
- Will restrictions be eased for vaccine clinical trials?
- by Lee, Jeong-Hwan Oct 26, 2023 06:06am
- Minister of Food and Drug Safety Yu-Kyung Oh promised to reduce or ease the mandatory participation rate of domestic clinical patients from the current 10% to 5% to strengthen sovereignty over domestically produced vaccines and increase self-sufficiency. The plan is to improve the current regulations by accepting the claims raised by domestic pharmaceutical companies that seek to develop domestic vaccines and agreeing with the National Assembly's suggestion to speed up development by lowering the domestic reference rate to reinforce actual vaccine self-sufficiency. On the 25th, Yu-Kyung Oh, Minister of Food and Drug Safety, responded as follows to an on-site inquiry made by Rep. Ki-Youn Kang of the People Power Party at the NA audit. Rep. Kang pointed out that vaccines to prevent diseases such as pertussis and cervical cancer are frequently sold out or out of stock domestically, thereby infringing on people's health and convenience. In particular, Rep. Kang pointed to the 10% domestic participation rate requirement set for clinical trials for vaccine development as the issue and urged it be lowered to 5%. Rep. Kang said, “South Korea, which ranks among the top 10 economies around the globe, is always low on vaccines. To secure sovereignty, the related R&D budget must be significantly increased. Also, the current 10% domestic participation rate required for vaccine clinical trials is very high compared to global standards. If this ratio is lowered to just 5%, the vaccine development period can be shortened by 2 to 3 years.” Rep. Kang added, “Please review the claim that the proportion of the Korean participants in the clinical trial should be lowered. The Ministry of Food and Drug Safety needs to ease regulations by actively listening to the pharmaceutical industry’s demands for vaccine development.” In response to Rep. Kang's criticism, MOHW Minister Kyoo-Hong Cho promised to secure the R&D budget necessary for vaccine development, and MFDS Minister Oh promised to push down the domestic participation rate requirement to 5% for vaccine clinical trials. Minister Cho said, “We will be able to better support vaccine sovereignty by introducing a new project called Korean ARPA-H in the 2024 budget. We will proceed according to plan.” Minister Oh said, “The 10% rate is not mandatory, but recommended. If the developer provides statistically valid evidence, the Korean participation rate can be adjusted flexibly.” When Rep. Kang requested easing of the regulation to 5%, Oh replied, “I will do so.”
- Policy
- Severe asthma txs Nucala and Cinqair are to be reimbursed
- by Lee, Jeong-Hwan Oct 24, 2023 05:22am
- Reimbursement treatment options for the treatment of severe eosinophilic asthma are expanded. GSK Korea's Nucala and Handok Teva Cinqair will be listed on the payroll simultaneously next month. Eisai's JAK inhibitor Jyseleca will also have new insurance coverage standards, and Novartis' JAK1/JAK2 inhibitor Jakavi will have coverage standards for Graft-versus-host reaction or disease (GVHD) added. Recently, the Ministry of Health and Welfare announced the details of the standards and methods for applying such nursing care benefits. We will begin collecting opinions until the 29th for implementation on the 1st of next month. Nucala and Cinqair are used in adult patients with severe eosinophilic asthma who are not adequately controlled despite high-dose inhaled corticosteroids - long-acting inhaled β2 agonists (ICS-LABA) and long-acting muscarinic antagonists (LAMA). In this case, salary is recognized. Benefits are recognized only when ▲the blood eosinophil level is more than 300 cells/㎕ within 12 months before starting treatment, ▲ four or more acute exacerbations of asthma requiring systemic corticosteroids within 12 months prior to starting treatment, or ▲if oral corticosteroids equivalent to 5 mg/day of prednisone have been administered continuously for 6 months prior to starting treatment or, only when the blood eosinophil level is 400 cells/㎕ or more within 12 months before starting treatment and when there have been three or more acute exacerbations of asthma requiring systemic corticosteroids within 12 months before starting treatment. Continued administration is recognized upon evaluating before and every year after drug administration to ensure that the frequency of acute exacerbations of poly asthma has decreased by more than 50% compared to before starting treatment, ▲for patients who require continuous oral corticosteroid treatment, the oral corticosteroid dose is reduced by more than 50% compared to before starting treatment while improving or maintaining asthma symptom control. Nucala is registered with RSA applied, and Cinqair is registered as a general salary. Accordingly, Nucala's sticker price (maximum price) is much higher, but the actual price is known to be similar. If Cinqair had previously been listed as general, it would have been difficult to apply the RSA for Nucala, but with the two drugs being listed at the same time, they were able to be listed under a different reimbursement procedure track. Jyseleca has a new reimbursement standard for rheumatoid arthritis and moderate-to-severe active ulceritis in adults. The standard for benefits is when the patient does not respond appropriately to or is intolerant to common medications for each disease. For those over 65 years of age, benefits may be recognized if the patient does not respond appropriately to or is intolerant to TNF-α inhibitors. Novartis' JAK1/JAK2 inhibitor Jakavi has additional coverage criteria for steroid-refractory GVHD for those aged 12 years or older. Reimbursement is recognized for acute patients for whom a response is confirmed in a monthly evaluation 2, 4, 6, or 8 weeks after the start of Jakavi administration, and for chronic patients for whom a response is confirmed for a monthly evaluation 3 months after the start of Jakavi treatment. do. However, only chronic patients who show a more than adequate response to a daily dose of 10 mg or less can be evaluated at a maximum of 3 months, and re-administration is permitted for patients who stopped after improving. The maximum administration period is up to 6 months for acute administration and up to 3 years for chronic administration. Chronic administration after completion of acute administration, cases where acute and chronic symptoms overlap, and cases where a patient who stopped treatment after improvement relapses and administration exceeds the maximum administration period are case-by-case. In addition, if GVHD progresses during administration (symptoms worsen or new symptoms appear), adverse reactions that prevent administration occur, or systemic treatments other than steroids and calcineurin inhibitors are used, supplementation will be discontinued. Meanwhile, a new reimbursement standard for Celebrex and Layla was also established. Reimbursement is permitted within the scope of approval, but concurrent use of other digestive tract medications to prevent symptoms such as gastritis is not permitted.
- Policy
- TZD combined DPP4i-SGLT2i complex
- by Lee, Tak-Sun Oct 24, 2023 05:21am
- Due to the expansion of the reimbursement standards for combination diabetes drugs, combination drugs combining TZD-based ingredients with DPP4i or SGLT2i are expected to be released in November. Most of these products are combination drugs combining the DPP4i series Sitagliptin. According to the industry on the 23rd, TZD combination drugs such as Mothers Pharmaceuticals Sitadion, Hyundai Pharmaceuticals Sitapio, Samik Pharmaceuticals Piosita, Medica Korea Pioglsita, Hutex Pharmaceuticals Piovia, Daewoo Pharmaceuticals Sita-Act, Jinyang Pharmaceuticals Januacto, and Daewon Pharmaceuticals Janupio will be listed on the payroll next month. These products are a combination of DPP4i-type Sitagliptin and TZD-type Pioglitazone. Boryung Trubuddy is also listed on the payroll. This drug is a combination of the SGLT2i series Dapagliflozin and Pioglitazone. The sudden emergence of Pioglitazone combination drugs is due to the expanded diabetes drug combination reimbursement standards last April and the impact of Sitagliptin with the patent expired in September. Last April, the combination of metformin + SGLT2i + TZD was approved for reimbursement. Accordingly, in the case of Boryung Trubuddy, which will be released in November, reimbursement is recognized when used together with metformin. The substance patent for Forxiga, the original product of dapagliflozin contained in Trubuddy, also expired on April 8. As the substance patent for Januvia expired on September 1, not only single drugs but also combination drugs are being released one after another. The Sitagliptin + Pioglitazone combination, which is being newly introduced this time, is the first combination drug developed quickly by domestic companies. These combination drugs have the advantage of reducing the risk of side effects and maximizing efficacy because each single drug has a different mechanism.
- Policy
- Announcement of dual pricing system
- by Lee, Jeong-Hwan Oct 20, 2023 05:32am
- The Ministry of Health and Welfare is expected to include the application of a refund-type risk-sharing system for innovative new drugs in the plan to provide appropriate information on the innovative value of new drugs to be announced soon. In order to improve accessibility to rare disease treatments, the company announced its position to carefully review the plan to expand the scope of drugs from children to adults by omitting the submission of economic evaluation data. In the case of reimbursement management for expensive new drugs, we plan to implement policies to minimize uncertainty in financial impact by applying a patient-based performance-based reimbursement system, implementing a prior approval system, and setting standards for discontinuation of medication. On the 19th, the Ministry of Health and Welfare responded as follows to a written inquiry from People Power Party lawmaker Lee Jong-seong on the government audit. ◆Application of the dual pricing system = Regarding the expansion of the refund-type risk-sharing system to prevent Korea from passing and promote the overseas expansion of domestically developed new drugs, the Ministry of Health and Welfare said, "We are reviewing a plan to improve the drug price system to appropriately compensate for the innovative value of new drugs." We also agreed on the need to ensure profitability and support the overseas export of R&D-invested new drugs, such as conducting domestic clinical trials. In particular, they announced that they will prepare appropriate measures, including the application of a risk-sharing system (dual pricing system), to the extent that they do not conflict with WTO trade issues in order to promote the overseas expansion of domestically produced new drugs and strengthen price competitiveness. ◆ Expansion of drugs subject to PE data = In order to strengthen patient accessibility to new drugs for serious diseases such as cancer and rare diseases, the Ministry of Health and Welfare has revised related regulations since January of this year to allow for rapid listing of new drugs with a small number of patients and clinically proven to improve quality of life. He explained that he is operating it by adding it as a PE omission target. Crysvita, a new drug for the treatment of hypophosphataemic rickets in children, was administered on May 1, an example of rapid reimbursement due to a revised regulation. At the same time, the Ministry of Health and Welfare expressed its position that social discussion is needed regarding the expansion of drugs subject to PE omission to adults and that it should be pursued with caution. It should be taken into account that the PE omission system is an exceptional operation in which the cost-effectiveness evaluation is determined based on the listed price of the excluded country. ◆Improvement of the orphan drug coverage rate = In relation to the improvement of the orphan drug coverage rate, the Ministry of Health and Welfare aims to strengthen coverage of treatments for expensive severe diseases and has launched two items to treat rare pediatric diseases with a life expectancy of less than one year, no alternative drugs, and sufficient improvement effect. They announced that they are conducting a pilot project to simultaneously conduct the Ministry of Food and Drug Safety approval evaluation, HIRA reimbursement evaluation, and NHIS drug price negotiation in the second half of this year. It was announced that reimbursement management would be strengthened by applying a patient-based performance-based reimbursement system for high-priced new drugs, implementing a prior approval system, and setting standards for discontinuation of medication to minimize uncertainty about financial impact.
- Policy
- Will a new Alzheimer’s drug be introduced in 20 yrs in KOR?
- by Lee, Tak-Sun Oct 20, 2023 05:31am
- New Alzheimer's disease treatments are accelerating their introduction into the country. Following Eisai's application for the approval of its ‘lecanemab’ in June, Lilly also received approval from the Ministry of Food and Drug Safety to initiate a multinational Phase 3 clinical trial for ‘donanemab’ in Korea. As Biogen applied to introduce 'aducanumab' to Korea in 2021 but withdrew its application for approval due to controversy over its effectiveness, attention is being paid to whether other new drugs may achieve success and make their way into Korea. The MFDS approved Lilly’s Phase 3 clinical trial for donanemab on the 18th. The trial will evaluate the safety and efficacy of donanemab inpatients with early symptomatic Alzheimer's disease. Donanemab is a new antibody drug that blocks amyloid beta plaque accumulation, which is overexpressed in early-stage Alzheimer's patients. The company submitted an application to the U.S. Food and Drug Administration (FDA) at the end of June and is anticipating its approval at the end of the year. In the Phase III trial results that were published in the Journal of the American Medical Association in July that observed the intermediate tau population, patients who were treated with donanemab showed that the drug slowed clinical decline by 35% compared to placebo. A clinical trial that was conducted for 76 weeks also confirmed the effect of delaying the progression of Alzheimer's disease. In the donanemab arm, 47% had no disease progression after 1 year, compared with 29% in the placebo arm After applying for FDA approval, the company also submitted data to Japan’s Ministry of Health, Labor and Welfare. With the approval of this clinical trial, the company is expected to soon begin the approval process in Korea as well. #iLilly had already applied for the approval of its ‘lecanemab,’ which has the same mechanism of action as donanemab, in June to treat mild cognitive impairment or mild dementia stage of disease arising from Alzheimer’s disease (AD). The drug, which was co-developed by Eisai and Biogen, was officially approved by the FDA in July. This is the third application the company has filed in Asia, following Japan and China. Clinical trial results showed that the lecanemab arm recorded a CDR-SB score of 1.21 at 18 months, which is a 27% reduction in clinical decline compared with the 1.66 recorded in the placebo arm. In Korea, no new drug for treating Alzheimer's disease has been approved since Ebixa (memantine) in 2003. Aricept, the original drug of the ingredient donepezil, which is the most commonly prescribed treatment for Alzheimer's disease in Korea, received domestic approval in 2000. The size of the domestic Alzheimer's disease treatment market is estimated to be near KRW 340 billion as of last year. As it has already been 20 years since the first treatment was released, the companies of the 2 new drugs are expected to competitively accelerate entry into the domestic market for market preoccupation.
- Policy
- HIRA ‘will discuss reimb obesity treatments with MOHW'
- by Lee, Tak-Sun Oct 19, 2023 05:29am
- HIRA President Jung-gu Kang In response to the claim that obesity should be recognized as a chronic disease and its treatment covered by Korea’s health insurance, President Jung-gu Kang of the Health Insurance Review and Assessment Service responded that he would discuss the request with the Ministry of Health and Welfare. Kang made this announcement at the National Assembly Health and Welfare Committee’s Health Insurance Service-Health Insurance Review and Assessment Service audit that was held at the National Assembly on the 18th. Rep Hyun-Young Shin from the Democratic Party of Korea said, " Obesity should be considered a chronic disease. According to the Korea Disease Control and Prevention Agency, 1 in 3 adults suffer from obesity.” Shin asked, “The Korean Society for the Study of Obesity, which recognizes not only severe obesity but general obesity as a chronic disease, claimed the need to provide everything from testing to drug treatment. What does HIRA’s president think about the claim that the whole course of obesity treatment from testing to pharmacotherapies should be reimbursed?” Kang answered “Early treatment is important due to the high follow-up care and treatment costs required for obesity. We will discuss the issue with the Ministry of Health and Welfare.” Shin said, “From a preventive medicine perspective, covering obesity will also help with the financial soundness of NHI finances. Please consider gradually expanding reimbursement for obesity.”
- Policy
- NA calls for prompt reimb of Ilaris during NA audit
- by Lee, Tak-Sun Oct 19, 2023 05:29am
- The National Assembly requested progress to be made in reimbursing ‘Ilaris (canakinumab, Novartis),’ a drug used to treat Hereditary recurrent fever syndromes that affect 13 patients in Korea. Rep. Sun-Woo Kang of the Democratic Party of Korea and member of the National Assembly Health and Welfare Committee suggested so at the Health Insurance Service-Health Insurance Review and Assessment Service audit held on the 18th. Mr. Lee, a parent of a pediatric patient whom Rep. Kang called as a witness, appeared before the National Assembly and said, "There are two palliative treatments. One is Kineret Inj, which needs to be administered daily, and my two-year-old child is suffering the pain of its daily injections every day." “Ilaris can administered once every 8 weeks, but it has not been reimbursed yet,” he said. He said, "If Ilaris is reimbursed, it can significantly improve my child's quality of life. " adding, "It is difficult to understand that this drug, which is covered by insurance in 30 other countries, is not covered by insurance in a developed country like Korea" appealed. Rep. Kang said that patients are spending between KRW 80 million to KRW 100 million per year to use non-reimbursed drugs, and requested that the registration of benefits be speeded up to improve the quality of life for children and ease the financial burden on patients' families. Regarding this, HIRA President Kang said, "Ilaris is administered once every 8 weeks, and it is so effective that 97% of patients responded to the treatment. We reviewed the reimbursement standards last September, and will continue to work to reimburse it as soon as possible."
- Policy
- Rep. Young-hee Choi ‘expenses surged after Moon Care’
- by Lee, Tak-Sun Oct 18, 2023 05:49am
- After the implementation of Moon Jae-in Care, which was implemented to strengthen health insurance coverage, KRW 5.272 trillion was found to have been spent on drugs for seriously ill patients over the 6 years and exceeded the expenditure target every year. According to data Rep. Choi Young-hee (People Power Party, proportional representation), a member of the National Assembly Health and Welfare Committee, received from the National Health Insurance Service on the 12th, the number of previously non-reimbursed drugs that are now reimbursed and categorized as pharmaceutical expenses for severe diseases increased from 529 in 2017 to 4,027 as of September this year, even though the NHIS granted 1306 non-reimbursed items reimbursement last year. In addition, Rep. Choi's office claimed actual expenditures spent on expanded non-reimbursed covered drugs rose 56.5 times from ▲ KRW 31.5 billion in 2017, ▲ KRW 309.8 billion in 2018, ▲ KRW 6854 billion in 2019, ▲ KRW 1.3 trillion in 2020, ▲ KRW 1.43 trillion in 2021, to ▲ KRW 1.77 trillion in 2022. Rep. Choi's office explained that patients frequented hospital visits even if they were only mildly ill due to improved medical access and the reimbursement of non-reimbursed drugs. Last year, 188,054 patients received treatment more than 150 times, and patients in their 50s showed excessive medical consumption, receiving treatment 3,009 times at 50 medical institutions. Due to this, it is pointed out that the current health insurance balance was in deficit of ▲KRW 177.8 billion in 2018, ▲KRW 2.82 trillion in 2019, then ▲KRW 353.1 billion in 2020. Afterward, the use of medical services decreased due to COVID-19, resulting in a surplus of ▲KRW 2.82 trillion in 2021 and ▲KRW 3.629 trillion in 2022. Rep. Young-hee Choi said, “Moon Jae-in's care is ultimately a ruined policy that only increased the burden on patients due to worsening health insurance finances and increasing non-reimbursed items," and she emphasized, "It is natural that the Yoon Suk-yeol government defined it as a 'populist policy' and declared its abolition." Representative Choi then urged the preparation of countermeasures, saying, “Although health insurance finances have recently become stabilized, we must work for efficient operation and normalization of health insurance finances in preparation for the low birth rate and aging population.”
- Policy
- Layla+Celecoxib coming soon
- by Lee, Tak-Sun Oct 18, 2023 05:48am
- a new osteoarthritis complex developed by PMG Korea.A compound that combines different osteoarthritis treatments based on natural products and synthesis is expected to be released on the 1st of next month. 20 companies are selling their products, and it is noteworthy whether it will create a new wind in the osteoarthritis treatment market. The original drug ingredient of Danggui, Mogwa, Bangpung, Sokdan, Ogapi, Wooseul, Wiryeongseon, Yukye, Jingyo, Cheongung, Cheonma, and Honghwa 25% Ethanol Yeonjo X is Layla of Korea PMG Pharmaceutical. PMG Pharmaceuticals Korea succeeded in developing a compound that combines the ingredient of Layla tablet with the ingredient of COX-2 inhibitor 'Serecoxib', and was approved for the item 'Reladisuine' in August. The drug demonstrated superiority to the control group in a phase 3 clinical trial of 356 patients with knee osteoarthritis (177 in the trial group and 179 in the control group) in a 100 mm pain VAS change in activity at week 8 compared to the baseline, the primary efficacy evaluation variable. In the same month, 19 items with the same ingredients were also licensed. These items are consignment items that have been approved through joint development with Korea PMG Pharmaceuticals. All product production is handled by PMG Korea Pharmaceutical. The items are Kyungdong Pharmaceutical's 'Selec Duojeong', Guangdong Pharmaceutical's Cox Duojeong', Daewoong Bio's Beacoxis Plus Jeong', Dongkuk Pharmaceutical's Selebron Jeong', Vascan Bio-Pharmaceutical 'Sebkan Plus Jeong', Samil Pharmaceutical 'Lecoxjeong', Samjin Pharmaceutical 'Asbon Plus Jeong', CMG Pharmaceutical 'Coks Plus Jeong', Anguk Pharmaceutical 'Cox2 Plus Jeong', Alico Pharmaceutical 'Raycelco Jeong', HLB Pharmaceutical 'Rex Duojeong', Unimed Pharmaceutical 'Bon Ekox', Ilhwa 'Sele Inajeong', Jenewon Science 'Sereduojeong', Jinyang Pharmaceutical 'Aduria Diess', Palm Genesis 'Sejoinjeong', Pungjeong', Korea Techon Pharmaceutical 'Unira-on Pharmaceutical 'Unira Plus These are expected to be priced by the compound calculation criteria. The compound is calculated at 53.55% sum of the single component before patent expiration. Both ingredients have expired patents, so it is likely that they will be set at the sum of the highest price of a single component. Then, the drug price is expected to be calculated at 567 won, which is the maximum price of ethanol Yeonjo X, which is 220 won for 25% ethanol Yeonjo X and 347 won for Celecoxib 100 mg 347 won. However, if the Ministry of Food and Drug Safety recognizes it as an improved new drug, the drug price will be added at 58.5% instead of 53.55%, so there is also interest in whether to designate an improved new drug. Some analysts say that in the case of eperison + aceclofenac complex in December last year, only Aju Pharm, a trustee, received an added-improved new drug, so there may be a difference in the drug price depending on whether it is above or not. Regardless, with a combination of the two ingredients, each pharmaceutical company has performance expectations in that it can receive a higher drug price than a single drug. In particular, PMG Pharmaceutical, which sells the original Layla, has seen a decline in earnings due to drug price adjustments since the appearance of Layla generic, so expectations for this product are different. Moreover, since it is also in charge of consignment production to 19 companies, it is expected to add CMO performance to its own product sales performance. The domestic osteoarthritis treatment market is estimated to be about 500 billion won. The launch of this complex is expected to be an opportunity to create a new competitive landscape.
