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- 2026-05-02 11:39:32
- Policy
- Will non-face-to-face prescriptions of Wegovy be banned?
- by Lee, Jeong-Hwan Oct 24, 2024 05:51am
- Yu-Kyoung Oh, Minister of the Ministry of Food and Drug Safety, said the ministry will discuss the issue of Wegovy, a new obesity drug, being prescribed through non-face-to-face treatment with the Ministry of Health and Welfare. The MOHW Minister Kyoo-hong Cho also responded that he would actively engage in Oh's request for discussions. On the 23rd, Rep. Joo Young Lee, a lawmaker from the Reform Party, asked Oh about the misuse of obesity drugs through non-face-to-face prescriptions. Rep Lee said, ‘The anticipated concerns regarding obesity treatment have become a reality. After the release of Wegovy on the 15th, in addition to the illegal sales and advertisements of the drug online, but also the issue of the drug being prescribed through non-face-to-face treatment platforms even if they are normal or underweight arose. The MFDS’s promotion is not enough, and I believe it is necessary to make it institutionally difficult to make the inappropriate access itself.” “There is a precedent of post-partum contraceptives being excluded from the list of possible prescriptions from non-face-to-face treatment platforms,” said Lee, adding, “Obesity management should start with lifestyle improvement. Adding Wegovy prescriptions to the list of allowed non-face-to-face prescription servrequiresquire more sensitivity and expertise. Bad practices such as using them in smaller doses are arising. Is there a countermeasure?” Oh replied that the ministry would seek measures to address the misuse of Wegovy and limit non-face-to-face treatment prescriptions. “The purchase of Wegovy online is a problem, and the cyber investigation team has been intensively monitoring this for a month,’ Oh said, adding, ’Overseas direct sales are also a concern due to poor temperature control. Since yesterday, we have been cooperating with the Korea Customs Service to block overseas direct sales and purchases of Wegovy.’ “Non-face-to-face treatment prescriptions are also a problem. We sent a letter asking them to refrain from excessively advertising the prescription of obesity drugs,” said Oh, adding, ’We will discuss whether to include prescriptions for non-face-to-face treatment (such as Wigobi) as it is the responsibility of the Ministry of Welfare.’ Minister Cho Kyu-hong also briefly responded to Oh's comment, saying that the MOHW would “cooperate.”
- Policy
- Overseas direct purchases of GLP-1 obesity drugs banned
- by Lee, Hye-Kyung Oct 23, 2024 05:50am
- The government has begun blocking direct purchases of GLP-1 obesity drugs overseas in the wake of the ‘Wegovy’ craze. The Ministry of Food and Drug Safety (Minister: Yu-Kyung Oh) and Korea Customs Service (Comissioner: Kwanghyo Ko) announced on the 22nd that they would block the direct purchase of recently launched GLP-1-based obesity drugs via overseas online platforms and bringing them into Korea. They also said they are actively cracking down on illegal sales and advertisements online and via social media. The MFDS has asked major online shopping malls to set ‘Wegovy,’ ‘Saxenda,’ ‘diet pills,’ and ‘slimming pills’ as prohibited words and requested their cooperation in self-monitoring and regulating the illegal imports. GLP-1-class obesity drugs such as Wegovy must be administered following a doctor’s prescription at a hospital and dispensing and medication guidance of a pharmacist at a pharmacy, according to the set dosage and administration method. If purchased directly from overseas, it is difficult to check the authenticity of the drug due to unclear manufacturing and distribution routes, and if it is an illegal counterfeit product, its safety cannot be guaranteed as it may contain harmful ingredients and is dangerous due to the possibility of misuse. The Ministry of Food and Drug Safety has requested major online shopping malls to prohibit the sales of obesity treatment drugs and conduct self-monitoring and requested the Korea Communications Commission to block access to posts on social media and online shopping malls that illegally promote or advertise sales of such drugs. Since Wegovy was released on the 15th to the 21st of this month, 12 violative posts were detected and taken action against. The Ministry of Food and Drug Safety and the Korea Customs Service will continue to share relevant information to prevent consumer damage caused by illegal direct purchases and advertisement of obesity treatment drugs overseas. They also warned that the obesity drugs sold on online platforms should never be purchased or administered and that they will do their best to strengthen the monitoring system for illegal sales and bait advertising in the future for the safe use of drugs by people in Korea.
- Policy
- New drug expenditure is 13.5% of NHI finance's drug spending
- by Whang, byung-woo Oct 23, 2024 05:49am
- It was found that the total expenditure on new drugs listed in the past six years since the Positive List System policy was implemented amounted to 13.5% of the National Health Insurance pharmaceutical spending, which is the lowest compared to the averages of A8 countries and OECD countries. The Korean Research-based Pharmaceutical Industry Association (KRPIA) announced the research outcome of 'Analysis of pharmaceutical spending on new drugs by disease,' conducted by Seung-Rae Yu, a Professor at Dongduk Women's University's College of Pharmacy, on October 22nd. The research evaluated new drugs listed from 2007 to 2022 when the Positive List System policy was implemented to allocate financial resources to drugs. The document compared the performance to 25 OECD countries besides South Korea. The research aimed to set the analysis period to the past 6 years (2017-2022) and to investigate financial analysis reflecting the outcome of the government's policy implementation to strengthen patient access to new drugs. It researched disease types contributing to patient deaths and compared domestic and overseas new drug expenditures in diseases with the highest financial burden, by analyzing pharmaceutical costs by disease. The percentage of new drug expenditures in South Korea (red), OECD countries (green), and A8 countries (blue). The percentage of new drug expenditure in South Korea Based on the research, the percentage of new drug expenditure in South Korea's total pharmaceutical cost amounted to 13.5%, which was below half of those in A8 countries, 38.0% on average, and in OECD countries, 33.9% on average. The analysis suggests that the figure would be the lowest among 26 countries. The analysis of the trend in the percentage of new drug expenditure from 2017 to 2022 indicates that the differences between Korea and the average for A8 countries grew significantly, amounting to almost a threefold difference in 2022. In particular, the total expenditure on new drugs was merely 15-25% of those in A8 countries, including the U.K., France, Italy, and Canada, which are similar in population and GDP per capita. The research analyzed the financial cost of disease by comparing a weighted index of disease·injury·risk factor, including death·disorder, by country, and new drug expenditure through the analysis of pharmaceutical cost by disease. The percentage of expenditure on new drugs for treating tumors was 46.2% for South Korea, not significantly different from 54.4% in the OECD on average. However, the percentage of expenditure on new drugs for treating cardiovascular diseases was 20.2% for the OECD on average and 2.4% for South Korea. Furthermore, the neurological disease category was 30.1% and 4%, respectively. The respiratory system category was 43% and 6.7%, respectively. They showed that Korea's percentages were merely 1/10th of the OECD countries' average, indicating relatively poor patient access to treatments. In other words, Korea showed significantly lower expenditures in the top-costing disease category, including the cardiovascular system, neurological system, and respiratory system, compared to those of the OECD and A8 countries. The analysis of the trend in the percentage of new drug expenditures in South Korea (red) and the average for A8 countries (blue). The research pointed out that despite a continuous increase in National Health Insurance reimbursement in the past, reimbursement for severe·high cost diseases started to decrease since 2022. The expenditure index of the number of new drugs and pharmaceutical cost by reimbursement category shows that the number of new drugs listed under the economic evaluation exemption program or essential program amounts to merely 11.6% and 3.6%, respectively. These drugs are needed to enhance patient access to severe disease treatments. The percentages of these drugs in the total pharmaceutical cost were 0.6% and 0.3%, which is relatively low. Additionally, the percentage of new drugs listed after undergoing economic evaluation out of the total number of listed new drugs was 26.8%. Excluding drugs in the antitumor category, it is merely 14.5%, indicating that the percentage of listed new drugs that are found to have values for improving clinical effectiveness is relatively small. "After implementing the Positive List System policy, the percentage of pharmaceutical cost in the total medical cost was aimed at about 24%, and it has been maintained. However, it seems that setting the new drug expenditure in the total pharmaceutical cost lacked specific aim and direction," said Yu. "From a financial viewpoint, we need to consider differences in the percentage of new drugs in Korea to other major countries and set the priority to strengthen reimbursement of treatments, including reimbursement of innovative new drugs, for diseases with high cost." "The percentage of new drugs in National Health Insurance-supported pharmaceutical cost is significantly lower than those of overseas, indicating that Korean patients are not fully benefiting from new drug treatments," Lee Young-shin, vice chairman of the KRPIA, said. "The system may need improvements, including the economic evaluation and expanding economic evaluation exemption and risk sharing agreement system, to enhance patient access to innovative new drugs and to allow them to have a better lifestyle."
- Policy
- Dongkook receives reimb for s-amlodipine triple-drug combo
- by Lee, Tak-Sun Oct 22, 2024 05:52am
- Olmevikar, a combination of s-amlodipine and olmesartan currently sold by Dongguk. The company will sell Olmevikar HCT from November, which contains Olmevikar and hydrochlorothiazide Dongkook Pharmaceutical has succeeded in becoming the first Korean company to receive reimbursement for a three-drug combination drug for hypertension that combines the CCB ‘s-amlodipine,’ ARB ‘olmesartan’ and diuretic ‘hydrochlorothiazide’. The combination therapy is expected to be useful for patients whose blood pressure is not adequately controlled with the company's combination product, s-amlodipine+olmesartan. Only Dongkook Pharmaceutical and Ahngook Pharm owns an s-amlodipine+olmesartan combination drug. According to industry sources on the 21st, Dongkook Pharmaceutical will start selling three types of Olmevikar HCT Tab beginning November, 1 with reimbursement. Olmevikar HCT Tab is a three-drug combination of S-Amlodipine Besylate 2.5 Hydrate, Olmesartan Medoxomil, and Hydrochlorothiazide. Compared to Daiichi Sankyo's existing Sevikar HCT, the only difference is the amlodipine and s-amlodipine ingredients. S-amlodipine is a component derived from only the S-enantiomer of amlodipine, which is the active isomer of amlodipine. Therefore, it is equally effective with half the dose of amlodipine with no difference in terms of stability. In Korea, there are 28 amlodipine 3-drug combination drugs like Sevikar HCT. However, Dongkook Pharmaceutical is the first to develop a 3-drug combination containing s-amlodipine. Olmevikar HCT is a combination of s-amlodipine besylate 2.5 hydrate and olmesartan medoxomil that was approved in late May for the treatment of essential hypertension, a condition in which blood pressure is not adequately controlled. It is indicated as a second-line treatment following amlodipine+olmesartan combination therapy as well as s-amlodipine+olmesartan. There are only two as s-amlodipine+Olmesartan combination drugs on the market, Dongkook Pharmaceutical ‘Olmevikar Tab’ and Ahngook Pharm’s ‘Levomos Tab.’ Last year, Olmevikar generated KRW 3.8 billion in outpatient prescriptions and Levomos KRW 1.2 billion, according to UBIST. “Looking at the indications, Olmevikar HCT tablets are expected to be useful for patients who are not sufficiently treated with Olmevikar Tab,” said a pharmaceutical industry insider. “Dongkook’s product competitivity by strengthening its hypertension combination product lineup.” The price has been set in line with the original Sevikar HCT. The company has applied for the 5 (s-amlodipine)/40 (olmesartan)/12.5 mg (hydrochlorothiazide) dose at KRW 821 per tablet, the 2.5/40/12.5 mg dose at KRW 765, and 2.5/20/12.5 mg dose at KRW 703 for, which is lower than the calculated price. This is the same as the price of the same dose Sevikar HCT.
- Policy
- MFDS grants EUA to COVID-19 variant vaccine for infants
- by Lee, Hye-Kyung Oct 22, 2024 05:51am
- The Ministry of Food and Drug Safety (MFDS) announces. The Ministry of Food and Drug Safety (Minister Oh Yu-kyoung, MFDS) announced on October 21st that it has granted Emergency Use Authorization for 'Comirnaty JN.1 Inj 0.033 mg/mL (bretovameran),' a SARS-coV variant (JN.1) vaccine for infants aged 6 months-4 years. Emergency Use Authorization is a system designed to respond appropriately to a public health crisis, including infectious disease pandemics. In this system, the MFDS minister enables the supply of medical products that do not have domestic approval by ordering manufacturers and importers to manufacture or import upon requests from the central administrative agency. The Korea Disease Control and Prevention Agency (KDCA) requested the Emergency Use Authorization to provide immunization for infants (6 months-4 years old), and the MFDS quickly reviewed it and granted approval. For Emergency Use Authorization, MFDS gathers expert opinions by reviewing company's submitted clinical and quality documents through the official posting of the emergency use authorization upon request from the central administrative agency. Then, after review and voting from the committee for the 'Public Health Emergency Preparedness and Responses for a Medicinal Product,' the MFDS makes a final decision. "We will continue to put efforts in enhancing public health by quickly supplying medical products that are effective in overcoming COVID-19, based on our scientific knowledge and regulatory expertise," the MFDS stated.
- Policy
- 2nd GIFT drug Nefecon’s approval imminent in Korea
- by Lee, Hye-Kyung Oct 21, 2024 05:48am
- Meditip's Nefecon (budesonide), which was designated as the 2nd Global Innovative Products on Fast Track (GIFT) drug last year, is close to receiving approval in Korea. According to industry sources on the 21st, the Ministry of Food and Drug Safety recently completed the safety and efficacy review for Nefecon. The completion of the safety and efficacy review in general leads to approval in Korea. Nefecon has been designated as a GIFT item as a drug that developed a new efficacy and effectiveness using the already marketed budesonide ingredient. A GIFT designation can also be given to a previously approved ingredient that has no treatment for a disease but can be used to treat a new patient population. Nefecon is a drug used to treat primary IgA nephropathy in adults with a urinary protein-to-creatinine ratio of 1.5 or greater who are at risk of rapid progression. In a presentation made at Kidney International, Nefecon was associated with a 27% lower urinary protein-to-creatinine ratio at 9 months of treatment compared to placebo. Glomerular filtration rate remained stable, with a difference of 3.87 ml/min/1.73 m2 compared to placebo. The drug was approved by the US FDA last year under the brand name Tarpeyo and by the European EMA under the trade name Kinpeygo. In China, the National Medical Products Administration (NMPA) designated Nefecon as a Breakthrough Therapy Designation (BTD) in 2020, and the Taiwan Food and Drug Administration granted it an Accelerated Drug Designation (ADD). IgA nephropathy is a disease caused by the deposition of immune complexes, including IgA, in the glomeruli of the kidneys, causing an inflammatory response. About 9,000 patients are known to be affected by IgA nephropathy in Korea. In clinical practice, antihypertensive drugs such as ARBs and ACEIs, immunosuppressants, and diuretics are used to treat IgA nephropathy. However, these drugs are symptomatic treatments that prevent the worsening of symptoms, and no drug fundamentally treats the condition. Meanwhile, drugs are given the GIFT designation if it is a ▲ drug aimed at treating serious diseases such as life-threatening cancer or rare diseases ▲ drug aimed at preventing or treating infectious diseases that may cause serious harm to public health, such as bioterrorism infectious diseases or pandemics of infectious diseases ▲ new drug developed by a Korea Innovative Pharmaceutical Company as designated by the Ministry of Health and Welfare ▲ a combination of a drug and medical device subject to fast-track review ▲ a case where there is no existing treatment or a drug showed clinically significant improvement in efficacy over existing treatments. The MFDS reviews the eligibility for the GIFT designation when a pharmaceutical company applies for expedited review and, if necessary, designates a drug as a GIFT item after consulting with the Medical Product Expedited Review Expert Council. Once designated, the review period is reduced by at least 25% (e.g. from 120 working days to 90 working days). Applicants will receive a variety of support for rapid commercialization, including rolling review, where the application data is reviewed on a rolling basis, close communication between the reviewer and the developer, such as item briefings and supplementary briefings, and expert consulting on regulatory matters.
- Policy
- How to stabilize supply of national essential medicines
- by Lee, Hye-Kyung Oct 18, 2024 05:49am
- While prescribing drugs by ingredient name and introducing international nonproprietary names (INNs) are being discussed as measures to stabilize the supply of drugs, voices have emerged calling for a system that allows the use of the same ingredient drugs as nationally essential medicines. The issue of stabilizing the supply of not only national essential medicine but also drugs that are constantly experiencing supply and demand instability is one of the most frequent questions asked by the National Assembly's Health and Welfare Committee's national audit this year. According to the written inquiries submitted by the MFDS to the National Assembly on the 17th, 7 lawmakers - Yoon Kim, Hee-Seung Park, Jong-Heon Baek, Mi-Hwa Seo, Young-Seok Seo, Byung-Hoon So, and In-soon Nam - inquired about stabilizing the supply of medicines. Representative Yoon Kim pointed out the unstable supply of national essential medicines and asked how the MFDS plans to promote the use of drugs with the same ingredient name. “Changing the method of prescriptions is the responsibility of the Ministry of Health and Welfare,” said the MFDS, adding, ’The MFDS will cooperate with the competent ministry, which is MOHW, if requested.” For national essential drugs, the Stable Supply Consultative Group is discussing comprehensive measures, improving the criteria for designating pediatric drugs as national essential medicines and the designation and removal national essential medicines. In particular, in the case of pediatric drugs, products that are essential for pediatric patients but have unstable supply are designated as national essential medicines. The MFDS said, “In the case of medicines whose supply is expected to be interrupted (shortage) due to insufficient production, we will jointly respond with the Ministry of Health and Welfare through the Public-Private Consultative body for Unstable Supply and Demand of Medicines, reviewing measures including raising drug prices.’ Representative Hee-Seung Park inquired about the reasons for the supply chain instability of national essential drugs, to which the MFDS responded, “We understand that the supply chain instability of national essential drugs is intensifying due to a combination of factors such as increased demand due to infectious diseases such as COVID-19 and deterioration of solvency due to rising production costs.” There was also an inquiry about the supply interruption report, which is required to be reported to the MFDS 60 days before the supply interruption. On this, the MFDS announced on the 4th of this month that the ‘Rules on the Safety of Drugs, Etc.’ will be amended to change the supply interruption reporting criteria from 60 days to 180 days in advance from April 5th next year. Until now, reporting drug shortages had been a recommended measure, but from next year, it will become mandatory. “In order to promptly receive drug supply interruption reports, the deadline for reporting supply interruptions has been moved up from 60 days to 180 days in advance,” said the ministry, adding, “If a pharmaceutical company has a plan to reduce production and imports below a certain standard, it must file a report within 1 month.” Representative Jong-Heon Baek called for a stable supply plan through the expansion of domestically produced drugs. “We support domestic pharmaceutical companies to develop manufacturing process technologies for national essential medicines that are highly dependent on imports and require stable supply and demand, and will continue to strive for the stable supply and self-sufficiency of raw materials and finished products for national essential medicines that are essential for healthcare,” the MFDS explained. Through the self-sufficiency of national essential medicines project, which has been underway since 2022 with the Korea Orphan & Essential Drug Center and the Korea Pharmaceutical and Bio-Pharma Manufacturers Association, the associations completed the development of 3 raw materials (amiodarone, ketoconazole, and benserazide) and 2 finished drugs (amiodarone injection and tablets) in the first phase (2022-2023). As the second phase (2024~2026) of the project, the company is developing 3 raw materials (acetaminophen, ipratropium, and furosemide) and 2 finished products (acetaminophen and furosemide). The MFDS also responded to Representative Young-Seok Seo’s inquiry about the need to monitor the process of distributing medicines that are difficult to supply to pharmacies and medical institutions. The MFDS said, “The MOHW is in charge of reporting on the supply of medicines, and the two ministries are responding to timely identification of supply and demand issues through smooth information exchange. We will continue such information exchange in the future so that the relevant ministries can jointly respond to drug supply insecurity.” It was also pointed out that compared to direct response measures such as emergency import or made-to-order production, the measures made by the ministries end at indirect measures such as monitoring and encouraging production. “There are many reasons for drug supply interruptions, such as production issues and raw material supply problems, and we are responding to each cause by reviewing the existence of substitute drugs and consulting with experts,” the MFDS said, adding, “We will prepare a response manual for drug supply interruptions in the future.”
- Policy
- 'Can the Yoon administration develop blockbuster drugs?'
- by Lee, Jeong-Hwan Oct 18, 2024 05:49am
- Criticism has been raised that the government's policy to create global blockbuster drugs is not working and has a dark future. It has been pointed out that the difficulty in raising funds to support the R&D costs for pharmaceutical and biotech companies and ventures is causing financial difficulties for bioventures, and that expert human resource training is not being done properly, either. On the 17th, lawmaker In-soon Nam of the Democratic Party of Korea questioned Soon-do Cha, President of the Korea Health Industry Development Institute, about the policy direction of the pharmaceutical bio-industry during the National Assembly audit of the agency. Rep Nam said, “At the beginning, there was some talk that Cha is closely communicating with President Suk-Yeol Yoon. I'm not pointing any fingers, but I was expecting the business of the KHIDI to progress better.” ‘The Yoon administration is saying that we should support the development of the pharmaceutical bio industry as a future growth engine, but not much speed nor progress is being made in the field. The administration said that it will support the creation of 2 blockbuster drugs by 2027, but can it really achieve this?” “We have set an implementation plan and are checking the implementation of the comprehensive plan every year,” Cha replied, “I know it is difficult, and there are no guarantees, but we are proceeding surely and cautiously.” Nam criticized Cha's tendency to give generalized answers and requested more specific result reports. “What I'm hearing is that biotech companies are facing financial difficulties,” Nam said, adding, “New investments should be flowing in, but they're decreasing. I wonder if the Yoon administration is really setting a policy direction for the pharma-bio industry as Korea’s future food.” “I heard that the pharma-bio fund has not been created yet. Are they fostering human resources? Please submit your progress in detail before the comprehensive audit,” said Nam.
- Policy
- Gov't opposes to suspending reimb·ingredient prescribing
- by Lee, Jeong-Hwan Oct 17, 2024 05:52am
- The government has opposed the proposed measure, which aims to minimize the chaos in prescription·dispensing by suspending insurance reimbursement or blocking prescription code of drugs when substitute drugs are available. Suspending reimbursement of drugs covered by insurance is a temporary measure implemented in the case of administrative meaures from the Ministry of Food and Drug Safety (MFDS), such as canceling marketing authorization. The government rationale is that suspending reimbursement due to drug shortages would only confuse patients and pharmacies. At the time of the separation of prescribing and dispensing of drugs, the government also opposed to the measure to allow active ingredient prescribing of drugs in shortages. The rationale for the opposition was that it violated the agreement between the government and the medical community. On October 15th, the Ministry of Health and Welfare (MOHW) announced this in response to written parliamentary questions submitted by Rep Seo Youngseok and Rep. Nam In-soon of the Democratic Party of Korea. Rep. Seo asked MOHW's opinion about suspending insurance reimbursement or blocking the prescription code of drugs when substitute drugs are available. To resolve the issue of drug shortages, Rep. Nam proposed the need to legalize the DUR notification, limit the number of days of prescription, temporarily suspend issuing reimbursement, and implement active ingredient prescription. The MOHW explained that they are reviewing drug pricing adjustments after receiving applications from pharmaceutical companies when the drug shortages consultative body requests that it is necessary to increase the supply by adjusting the ceiling price. The MOHW also answered that suspending reimbursement of drugs in shortages and implementing active ingredient prescription requires careful consideration. "Suspension of reimbursement is a limited measure when the MFDS' approval of the product is revoked," the MOHW stated. "Suspension of reimbursement for drugs in shortages may cause confusion in the field, such as patients and pharmacies, so careful consideration is required." "Currently, the drugs that have been reported to be out of supply are being directed to DUR. In addition, the DUR notification on additional drugs in shortages should be prioritized by establishing standards for drugs in shortages," the MOHW stated, adding, "We believe that limiting the number of prescription days for drugs in shortage is necessary in exceptional cases where it is difficult to increase production, such as a shortage of raw materials. It is necessary to prepare a relevant legal basis." Regarding the active ingredient prescribing for drugs that are in shortage, the MOHW stated, "It is necessary to be cautious by changing the agreement at the time of the separation." Regarding the MOHW's measures against the shortage of Imotun supply at clinical sites such as pharmacies, the MOHW staged that they would consider utilizing substitute drugs. In response to Rep. Suh's point that special measures such as restricting Imotun's salary are necessary, the MOHW expressed their position on careful consideration. The MOHW explained, "Imotun Cap is produced by receiving the supply of Avocado-Soya Unsaponifiables raw materials from France," adding, "As it is a herbal ingredient, the production of raw materials is constant. Therefore, there will be a small increase in supply in 2023 compared to 2022, but there will be a limit to sufficient supply." "The drug in question was discussed at a meeting between the public-private consultative body for drug shortages and the medical community," the MOHW added. "It was discussed as an adjunctive treatment for osteoarthritis, and it was discussed as a drug that is difficult to respond to first considering the possibility of using other drugs with similar effects. We will consider the use of alternative drugs in the future." "Imotun Cap was recognized for its clinical usefulness in the 2022 re-evaluation after the conditional reimbursement was maintained in the 2021 reimbursement appropriateness re-evaluation," the MOHW added. "The reimbursement restriction should be reviewed carefully considering the overall social needs. The supply of the drug has been maintained by 160,000 capsules annually, and it does not fall under the reason for the reimbursement restriction due to the recognition of usefulness."
- Policy
- HIRA President, "Copayment ratio needs to be adjusted
- by Lee, Tak-Sun Oct 17, 2024 05:51am
- HIRA President Jung-Gu Kang HIRA President Jung-Gu Kang said that the copayment ratio should be adjusted for anticancer drugs that lack verification of effectiveness. Kang said during the parliamentary audit by the Health and Welfare Committee, "We must lower the patient access hurdle and increase monitoring." Adding, "Especially because we evaluate high-cost drugs that have not completed phase 3 studies, copayment ratio needs to be adjusted to lower patient access hurdle for drugs that lack verification of effectiveness." It means that the current 5% ratio needs to be increased for anticancer drugs lacking verification of effectiveness. Rep. Juyoung Lee of the National Reform Party said, "I agree with differential ratio," adding, "But, the rationale to supply cheap does not meet the global standard." Rep. Lee has requested expanding reimbursement through fast track, investing in clinical trials, and specifying a monitoring plan for the alternative measure to the Korean passing of anticancer drugs.
