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- 2025-12-21 07:38:40
- Policy
- Final PVA improvement plan to be prepared soon
- by Lee, Tak-Sun Oct 27, 2023 05:33am
- The final plan to improve the price-volume linkage system is expected to be prepared soon. Most of the improvement plans are expected to reflect the research service results that were released last April. According to industry sources on the 26th, the National Health Insurance Service will complete the public-private working group activities that have been held since June will be completed with the last meeting held on improving the usage-drug price linkage system in early November The NHIS plans to prepare a final draft after the completion of working group activities and aims to revise the internal guidelines with the goal of implementing it on January 1 next year. Accordingly, the final draft is expected to be released at the end of the year. The revision to the internal guidelines is likely to raise the claims amount standard for drugs subject to PVA price cut negotiations from KRW 2 billion to KRW 3-4 billion. If this happens, lower-performing products will likely be relieved of the burden of relieving drug price cuts. However, the other measures that require notification will be implemented later. Industry experts expect the changes such as increasing the maximum reduction rate currently restricted to 10% and including items with an increase in claims amount of more than 10% and KRW 5 billion to be subject to PVA negotiations, to be made by the first half of next year. Meanwhile, changes to the PVA system as a preferential measure for innovative new drugs that had been discussed may also likely be included in the final draft. The price reduction rate for innovative new drugs that are subject to PVA will be reduced if the same drug is subject to PVA three times in a row. Last year, the NHIS carried out an external research service on practical measures to improve Korea’s drug expenditure management system, and its result report was released in April. Results of the ‘A study on the performance of the Price-Volume Agreement System and measures on its improvement’ that Professor SeungJin Bae from Ewha Womans University's College of Pharmacy participated as the principal investigator, showed that the selection and management of drugs with large financial impact should be identified and that a more efficient operation of the system is necessary.
- Policy
- Minister Cho will work to address shingles vaccine issue
- by Lee, Hye-Kyung Oct 26, 2023 06:06am
- The government responded that it would seek ways to ease the public burden in response to the request that shingles vaccines should be included in Korea’s National Immunization Program (NIP). Rep Young-Joo Kim of the Democratic Party of Korea pointed at the audit of the NA Health and Welfare Committee that was held on the 25th. She said, “There are medical institutions that charge up to KRW 400,000 for shingles prevention vaccine, whose supply price starts at KRW 8,400. In addition to adding the vaccines to NIP, we need to take measures such as a price disclosure system for suppliers.” According to the data Rep Kim received from the KDCA and HIRA, the average price of Zostavax Inj in 2022 was KRW 165,471, ranging from KRW 90,000 to up to KRW 400,000. In 2021, the average price of vaccination in SKYZoster was KRW 146,358. Its price ranged from KRW 40,000 to KRW 230,000, which is a sixfold difference. From 2021 to August of this year, the average supply price of SKYZoster was around KRW 77,000 every year. The places that received the vaccines at the highest price during this period were found to have received them at KRW 341,000, KRW 161,000, and KRW 150,000 in 2021, 2022, and 2023, respectively. Rep Kim said, “People are receiving shingle vaccinations like a lottery. The ex-factory price is being set randomly, and those who lack information are left to receive the vaccination for KRW 400,000,” requesting countermeasures. In relation to this, Minister of Health and Welfare Minister Kyoo-Hong Cho said, "We have been disclosing the price of non-reimbursed items first because it is difficult to control their price. We will investigate the cause of the sharp drop in price and the price difference. The issue of its reimbursement through NIP needs to be reviewed on its medical necessity and financial efficiency. It is difficult to say no, so we will seek ways to alleviate the public burden." HIRA President Jung-Gu Kang, said, “We have been disclosing the non-reimbursed prices of drugs, and will expand the disclosed items to more than 1,000 in the future. We will try to find other means (to disclose ex-factory prices).” Commissioner Young-Mee Jee of the Korea Disease Control and Prevention Agency said, “We are currently evaluating introducing shingles vaccine to NIP. We will apply it as soon as the results are available. If it is listed as an NIP drug, the method of purchasing the vaccine will also be improved and be priced appropriately.”
- 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."
