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Policy
Drug pricing adjustment guidelines to be established soon
by
Lee, Tak-Sun
Nov 14, 2023 05:49am
With the rise of drugs that show unstable supply and the consequent rise in drugs requesting pricing adjustments, the National Health Insurance Service plans to establish a guideline for smooth pricing adjustment negotiations and disclose it soon. The NHIS recently completed expert consultations and is currently revising the final draft. According to industry sources on the 13th, the NHIS had started establishing a guideline for the pricing adjustment negotiations to simplify materials requiring submissions and ensure accurate cost analysis. Also, the authorities had collected opinions from the industry after establishing a consultative body with the Korea Pharmaceutical and Bio-Pharma Manufacturers Association. Since October, the body has started to consult with experts to establish a guideline. Currently, the NHIS completed expert consultations, and final preparations to release the final draft are said to be in progress. An NHIS official explained, “We plan to release the pricing adjustment negotiation guidelines before the end of the year. Final work is currently in progress.” Due to the rise in the number of drugs with unstable supply and demand requesting pricing adjustments, the need for a clear pricing adjustment negotiation guideline has been increasing. Moreover, the drug subject to negotiations has also increased with the NHIS’s expansion of drugs subject to adjustment applications in 2021. Previously, only drugs that did not have alternative drugs or were necessary for medical treatment were able to apply for pricing adjustments, but from 2021, drugs with an administration cost lower than their alternatives and are necessary for medical treatment and drugs that only one other company owns a drug with the same administration route and ingredient can also apply for pricing adjustments. Recently, resolving the supply and demand instability has emerged as a government task, and drugs subject to pricing adjustment are being interpreted broadly. Starting with acetaminophen at the end of last year, prices of magnesium hydroxide and pseudoephedrine were also increased through pricing adjustment negotiations, and the application for the pricing adjustment of budesonide passed the Drug Reimbursement Review Committee, and will soon begin full-scale negotiations. The adjustment negotiations aim to facilitate a stable supply of drugs by conserving drug costs. However, there was much criticism around the large amount of data submissions required, as most of the data required aligns with those required for the Drug Shortage Prevention Program. In addition, there was an opinion that an accurate cost analysis is needed by setting a fixed ratio for the general management cost and profit. NHIS plans to comprehensively collect these opinions and reflect them in the guidelines. Once the guidelines are created, it is expected to simplify the required data submissions, clarify cost analysis, and facilitate smoother drug pricing negotiations. However, drugs with an unstable supply and demand that are currently undergoing drug negotiations undergo rapid negotiations within a month through prior consultation between the public and private sectors under the condition of increasing their supply, so attention is being paid to whether these will also be able to reach an agreement within the set guidelines.
Policy
Regeneron enters Phase 3 in Korea
by
Lee, Hye-Kyung
Nov 13, 2023 05:23am
FDA and EMA review begins in the second half of this year for CD20 and CD3 targeted treatments. Phase 3 clinical trials for Regeneron's new lymphoma treatment drug Odronextamab are being conducted in Korea. The Ministry of Food and Drug Safety recently submitted an application from ICON Clinical Research Korea for the efficacy and safety of Odronextamab (REGN1979), an anti-CD20/anti-CD3 bispecific antibody used in combination with Lenalidomide in subjects with relapsed/refractory follicular lymphoma and marginal zone lymphoma. A phase 3, open-label, randomized clinical trial (OLYMPIA-5) was approved to compare rituximab in combination with lenalidomide. It can be viewed as a clinical trial for approval of a wide range of indications as an initial treatment for lymphoma and additional treatment for B-cell non-Hodgkin lymphoma. Odronextamab is a type of CD20 Follicular lymphoma and diffuse large B-cell lymphoma are the most frequently occurring subtypes of B-cell non-Hodgkin lymphoma. The European Medicines Agency (EMA) received PanMAA in August for the treatment of adult patients with relapsed or refractory follicular lymphoma or relapsed or refractory diffuse large B-cell lymphoma that has progressed after at least two prior systemic treatments. Subsequently, the US FDA accepted the application for priority review approval as a third-line therapy for the same indication in September. The target date for final approval is reportedly March 31 next year. It is expected to be the fourth dual antibody treatment targeting CD20·CD3 to receive FDA approval, following Roche's 'Lunsumio', AbbVie's Epkinly, and Roche's Columvi. Lunsumio', the first CD20·CD3 targeting dual antibody treatment approved by the FDA, received product approval in Korea on the 3rd. Following Epkinly and Columvi, if Odronextamab receives FDA approval, it is expected to take steps for domestic approval.
Policy
Looking at the review date for GIFT No. 1 Lunsumio
by
Lee, Hye-Kyung
Nov 13, 2023 05:23am
"The goal of the GIFT program is to shorten the general review period by 25%. The statutory review period is 120 days for chemical drugs and 115 days for biopharmaceuticals, but GIFT items In the case of, the goal is to complete the review within 90 days.” Park Jae-Hyeon, head of the rapid review division of the Ministry of Food and Drug Safety, announced on the 3rd that the actual review period for Roche Korea's Lunsumio Injection, the first GIFT product to receive domestic product approval, took 86 working days. GIFT's goal was to shorten the general review period by at least 25%. However, if you look at the period from the expedited review designation on November 29th of last year to the actual approval, it took 11 months. At first glance, you may question whether the expedited review is appropriate. Manager Park said in a recent interview with Dailypharm, "Lunsumio was reviewed for about 86 working days. As it is GIFT's first product, the licensing manager worked together to process it quickly," adding, "It took 11 months from designation to approval. “When I looked at the reason why it took, it took about 7 months to supplement the new application’s data,” he explained. According to the 'Drug Rapid Review Report' published by the Ministry of Food and Drug Safety this year, the time taken for rapid review during the drug review period, which generally takes 120 days, was 26.9 days for COVID-19 vaccines and treatments, and 81.5 days for other products. However, this statutory review period does not include the data supplementation period. The Ministry of Food and Drug Safety does not include the supplementation period in the approval review period under the current legal system. Therefore, the Ministry of Food and Drug Safety's shortened expedited review period refers to the pure review period excluding the data supplementation period. Manager Park said, “Shortening the review period is not an easy task,” and added, “The key is how well the applicant understands the supplementary matters and prepares the materials.” In particular, this year's expedited review designation has more than tripled compared to last year, and Manager Park said, "The pharmaceutical industry is interested and is applying for expedited review designation." He added, "It officially takes 30 days to review the expedited review designation, but the current employees' “Through our efforts, we are completing the designation without completing 30 days,” he said. These days, it is said that an increasing number of pharmaceutical companies do not immediately submit applications for approval even after receiving expedited review designation. This is because each company has its own circumstances, such as taking the licensing step after understanding the global market. Manager Park said, “After being designated for expedited review, the applicant must submit all documents related to the permit to the permit general manager before they are forwarded to the expedited review department.” “It’s going on,” he said. As of November 6, there were 19 items designated as GIFT brands, but the rapid review department was newly established in 2020 and the number of items designated for rapid review is 44. Once designated as expedited review, the Ministry of Food and Drug Safety shares the overall review schedule and holds product information sessions and supplementary information information sessions. In addition, the review period will be shortened through 'rolling review', which reviews materials prepared through prior review. Manager Park said, "It is meaningful that Runsumio was the first to receive approval under the GIFT name. However, shortening the review period also requires efforts from the industry. When the Ministry of Food and Drug Safety delivered the first review opinion, the parts that were not understood were discussed with the person in charge. “I think it will be helpful if we communicate with each other to understand clearly and prepare materials,” he said. Currently, items subject to GIFT are ▲medicines intended to treat serious or rare diseases such as life-threatening cancer, ▲intended for the prevention or treatment of infectious diseases that are likely to cause serious harm to public health, such as bioterrorism infectious diseases or infectious disease pandemics. It is limited to ▲ new drugs developed by innovative pharmaceutical companies designated and announced by the Ministry of Health and Welfare ▲ combinations of drugs and medical devices subject to rapid review ▲ cases where there is no existing treatment or showing clinically meaningful improvement in effectiveness, etc. compared to existing treatments. Manager Park added, “We are receiving a request to expand the GIFT target as an industry suggestion,” and added, “It is not easy as we are conducting screening work with limited manpower, but we are making efforts.” .
Policy
Korean researchers develop 1st new substance for Alzheimer's
by
Lee, Hye-Kyung
Nov 09, 2023 05:43am
A Korean research team has developed a new substance (ALT001) that promotes mitophagy, and the recycling of damaged mitochondria, and presented a new door to treating Alzheimer's type dementia. The Korea Health Industry Development Institute (President: Soon-Do Cho) announced that a joint research team that consists of Jin-ho Yoon (College of Medicine, Dong-A University), Jong-Hyun Cho (Department of Medicinal Biotechnology, College of Health Sciences, Dong-A University), Ji-Hoon Jo (Chonnam National University), and Alt Medical (CEO: Eun-Hee Yoo) has succeeded in developing a new mitophagy promoting substance (ALT001) that can treat Alzheimer's type dementia. Summary of ALT001 ALT001 demonstrated low toxicity and safety that does not interfere with cell growth. Also, animal testing in vivo showed that the substance effectively improved damaged cognitive function, proving its value as a clinically applicable treatment substance for dementia. Previously, most studies for the treatment of Alzheimer's type dementia had focused on amyloid beta and tau proteins, but recent study results showed that mitochondrial dysfunction plays an important role in the development of dementia by interacting with amyloid beta, and promoting the mitophagy process that maintains mitochondrial function has been attracting attention as a new treatment strategy. However, due to the absence of mitophagy-promoting substances with proven clinical applicability, dementia treatment through mitophagy has not been implemented in practice. To improve this situation, the joint research team conducted a chemical library screening using an in-house mitophagy activity analysis system. Through the screening, the research team identified an isoquinolium scaffold for mitophagy induction and generated ALT001 through chemical optimization of the isoquinolium scaffold. ALT001 effectively promotes mitophagy and is safe as it does not interfere with cell growth, demonstrating its clinical applicability. The result of an experiment conducted to evaluate the learning and memory ability when using ALT001 for Alzheimer's type dementia in mouse models showed surprising results, where the learning and memory ability of the dementia mouse model was restored, and this therapeutic effect was also identified in a mouse model widely used in other dementia research. Professor Jin-ho Yoon, who led the research, said, “Thanks to the national support and helping hands, we researchers in Korea were able to develop a dementia treatment substance that can be clinically applied in the highly competitive mitophagy-based treatment development field. We are very grateful for the support. Our research will allow the development of a mitophagy-based dementia treatment that has been difficult to commercialize due to the lack of a drug with defined molecular mechanisms. We will devote ourselves to follow-up research with the goal of commercializing a dementia treatment using the results of this research.” The study was conducted with the support of the Korea Dementia Research Center, and its results were published in Theranostics, a world-renowned academic journal ranked among the top 5.8% in the field of medical research.
Policy
Drug pricing nego start in earnest for Tagrisso·Leclaza
by
Lee, Tak-Sun
Nov 09, 2023 05:43am
With drug pricing negotiations ongoing for the reimbursement of Tagrisso (AZ, osimertinib) and Leclaza (Yuhan, lasertinib) as a first-line treatment for non-small cell lung cancer, whether the two drugs will be applied the initial treatment refund-type RSA (risk-sharing agreement system) remains a variable. Leclaza, which is being supplied for free through the early access program (EAP), is not applied to the initial treatment refund type RSA and the National Health Insurance Service is conducting negotiations in consideration of this. According to industry sources on the 8th, Leclaza began drug pricing negotiations with the National Health Insurance Service at the end of last month. Leclaza was previously recognized as adequate for reimbursement in the first line at the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee meeting that was held on the 12th. Tagrisso had been conducting negotiations with the corporation since the end of September. Given that drug price negotiations are carried out within a 60-day deadline, Tagrisso and Leclaza are expected to complete negotiations in December at the earliest receive reimbursement listing in January. However, a tense tug-of-war between the government and companies is expected over the RSA refund rate. In particular, in the case of Leclaza, as the initial treatment refund type is not included in its RSA, the government is expected to adjust the other refund rates while taking this into account. The initial treatment reimbursement type RSA takes into account uncertainties in effect among others for the initial treatment period. The initial treatment reimbursement type RSA was not applied for Leclaza because the full amount is being supported without limit to patients until its reimbursement listing through the Early Access Program (EAP). However, from the NHIS’s perspective, the authorities would need to adjust the other refund rates as it has no choice but to consider treatment uncertainty and the required finances. Moreover, they also must consider equity with Tagrisso, which is also under negotiation. Due to high interest in the reimbursement of the two drugs, including the National Assembly, the NHIS is expected to speed up negotiations. However, it remains to be seen whether both drugs will succeed in receiving reimbursement together or whether only one drug will be listed for reimbursement. An industry official said, “Their reimbursement depends on how much the pharmaceutical company is willing to give up on the RSA refund rate. Since the government and pharmaceutical companies are all willing to reimburse both drugs, it is highly likely that negotiations will be concluded at an appropriate level.”
Policy
MFDS approves P3T for talquetamab in MM patients
by
Lee, Hye-Kyung
Nov 08, 2023 05:37am
Janssen Korea Janssen Korea received approval to initiate a Phase III trial for its first-in-class investigational bispecific antibody ‘talquetamab’ for multiple myeloma in Korea. The drug is ‘Talvey,’ which was approved by the US FDA in August. The FDA granted accelerated approval to Talvey based on its overall response rate and duration of response. Its continued approval will depend on the results of the Phase III confirmatory trial. The phase 3 drug trial approved in Korea this time is for the indication approved by the FDA. The FDA approved Talvay for the treatment of adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. The randomized Phase III conducted in Korea will enroll adults patients with relapsed or refractory multiple myeloma who have received one to four prior lines of therapy, and compare the effect of talquetamab+pomalidomide, talquetamab+ teclistamab, and investigator’s choice of elotuzumab combined with pomalidomide dexamethasone(EPd) or pomalidomide, bortezomib, and dexamethasone (PVd). The trial will be conducted at seven sites, including Seoul National University Hospital, Samsung Medical Center Chonnam National University Hwasun Hospital, Ulsan University Hospital, Seoul St. Mary's Hospital, and Pusan National University Hospital. Talvay is a bispecific T-cell engaging antibody that binds to the CD3 receptor on the surface of T cells and G protein-coupled receptor class C group 5 member D (GPRC5D) expressed on the surface of multiple myeloma cells, non-malignant plasma cells and healthy tissue such as epithelial cells in keratinized tissues of the skin and tongue. The Phase 2 MonumenTAL-1 study, which became the basis for its accelerated approval, was conducted on 187 patients who had received at least four prior lines of therapy and who were not exposed to prior T-cell redirection therapy Results showed that patients who received a biweekly dose of Talvay 0.8 mg/kg, 73.6% of patients achieved an ORR. At a median follow-up of nearly 6 months from the first response among responders, 58% of patients achieved a very good partial response (VGPR) or better, including 33% of patients achieving a complete response (CR) or better 73.0% of patients who received a once-weekly subcutaneous injection (0.4mg/kg) of Talvay also achieved an ORR, but their CR rate was 35%, lower than the biweekly arm. The duration of response was also favorable for the biweekly arm, which was why the drug was approved as a biweekly subcutaneous injection.
Policy
Daewoong starts developing XR formulation of tofacitinib
by
Lee, Tak-Sun
Nov 08, 2023 05:37am
Pfizer Daewoong Pharmaceutical has begun developing a product that can rival Pfizer's oral JAK inhibitor 'Xeljanz XR 11mg'. Xeljanz XR (tofacitinib citrate) is Prizer's latest tofacitinib product approved in December 2020. Daewoong Pharmaceutical, like the original company Pfizer, is building a lineup of immediate-release and extended-release tablets before entering the tofacitinib generic drug market. On the 3rd, the Ministry of Food and Drug Safety approved the Phase 1 clinical trial plan for DWJ1431, for intake with and without food. DWJ1431 is known to contain 10mg of tofacitinib. The trial will focus on confirming DWJ1431’s pharmacokinetic properties and safety compared with tofacitinib 11mg. The reference drug, tofacitinib 11mg appears to be Pfizer's Xeljanz XR Tab 11mg. Pfizer received approval for the once-daily Xeljanz XR Tab 11mg on December 1, 2020. With its approval, the company secured various prescription options, in addition to the twice-daily Xeljanz 5mg Tab (approved in April 2014) and Xeljanz 10mg Tab (approved in December 2018). Xeljanz XR Tab is used to treat rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. In particular, its extended-release tablet is expected to play a major role in protecting the market from its generics, which are scheduled to be released in November 2025. As of now, 56 generic versions of Xeljanz have been approved by the Ministry of Food and Drug Safety, most of which are tofacitinib 5 mg salt-modified drugs that have overcome the Xeljanz composition patent, and are immediate-acting tablets that are taken twice a day. Daewoong Pharmaceutical also received approval for its Zeltopa Tab 5mg, which contains tofacitinib aspartate, in September 2020 and is waiting to release the product. If it receives approval for its XR formulation as well, the company’s competitiveness is expected to double when the market for generics opens. Meanwhile, Pfizer's Xeljanz recorded outpatient prescriptions worth KRW 12.3 billion in Korea in 2022 based on UBIST.
Policy
PN injection benefit restriction suddenly halted
by
Nho, Byung Chul
Nov 08, 2023 05:37am
Intra-articular injection of PN ingredients reduces knee cartilage friction by maintaining physical restoration and high elasticity With the advent of the reevaluation period for selective coverage of intraarticular injections containing PN (sodium polynucleotide), health authorities are planning to adjust the patient copayment upward. Manufacturers and sellers have recently submitted opinions to HIRA, drawing attention to the future direction. The opinion is based on supporting papers and clinical evaluations, and it is expected that the issue of 'restrictions on reimbursement of related products' will be quickly resolved. According to the industry on the 7th, HIRA held a suitability evaluation committee and treatment material expert evaluation committee from early this year to September with the advent of the selective reimbursement period for PN preparations and agreed to increase the patient copayment from the existing 80 to 90%. The key issue in the selective reimbursement of PN drugs is evaluated as 'restriction of administration after 6 months from the start of treatment,' and if such a measure is actually realized, the related market may be in danger of virtually drying up. Currently, there are approximately 20 pharmaceutical companies manufacturing and selling intra-articular injections containing PN ingredients, and the market size alone amounts to a whopping 80 to 100 billion won. If all went as planned, the measure to restrict coverage of PN drugs around October to December would likely have been submitted to the review committee and then notified, but the brakes were put on hold as pharmaceutical companies' written opinions based on clinical usefulness, feasibility, and cost-effectiveness were delivered. The PN preparation is a new medical technology that has entered insurance coverage and has secured clinical results that are not inferior to the safety and effectiveness of the pharmaceutical collagen/sodium hyaluronate injection. The industry and academic community also believe that ex officio adjustments related to ‘withdrawal of insurance benefits’ are an abuse of administrative power when there is clinical data that is comparatively inferior to alternative drugs, regardless of whether it is a drug or medical device. An industry official said, "PN, collagen, and hyaluronic acid injections are usually administered 1 to 5 times every 6 months, and it is known that there is no significant difference in their effectiveness and safety. However, with the advent of selective coverage, PN injections are now available for life. He pointed out, “Limiting benefits to only one vaccination per cycle is highly problematic.” Regarding the overall situation, the legal profession's position is citing the precedent of Dong-A ST's Styrene Tablet, and it is highly likely that PN preparations and intraarticular injections will also present conditional clinical trials related to securing effectiveness within the next 2 to 3 years. In the case of Stillen, there is a precedent in 2011 of receiving reimbursement for about 2.5 years on the condition of securing an indication for the prevention of gastritis due to the administration of non-steroidal anti-inflammatory drugs (NSAIDs). At the time, the dispute over the reduction of styrene tablets' benefits, although it failed to secure clinical trial data to prove its usefulness, was evaluated as an exemplary case of protecting the authority and pride of an 80 billion won blockbuster domestic natural medicine, including indications for the treatment of acute and chronic gastritis, against the ex officio adjustment of health authorities. there is. The introduction of health insurance coverage for new medical technologies is an active patient consideration policy that limits the upper limit of indiscriminate treatment fees for similar non-covered products and can also be expected to have a savings effect on health insurance finances. In other words, with the development of private actual cost insurance, out-of-pocket expenses can be minimized, and the national health insurance financial loss can be reduced to only 1/4 of the level of registered drugs, killing two birds with one stone. This raises questions about the current benefit restriction measure. PN preparations have been proven to be safe and effective using DNA components, a safe biomaterial extracted from salmonid fish, and are a biomaterial for tissue repair recommended for patients whose knee cartilage is worn out due to aging or overweight by reducing knee joint friction. all.
Policy
A draft for reevaluation of overseas drug prices
by
Lee, Tak-Sun
Nov 08, 2023 05:37am
Advantages and disadvantages depending on the re-evaluation method. The HIRA has prepared a draft plan for comparative and reevaluation of overseas drug prices and will begin collecting opinions in earnest with the pharmaceutical industry starting this month. As the HIRA plans to conduct re-evaluation sequentially starting next year, it is expected to prepare a final plan by at least next month, and intensive discussions are expected to take place this month. According to the industry on the 7th, HIRA plans to hold working-level discussions with the pharmaceutical industry on the 10th to discuss ways to compare and reevaluate overseas drug prices. Depending on the method of reevaluating overseas drug prices, there is a high possibility that it will have a disadvantageous effect on the domestic pharmaceutical industry, so it is expected that it will be difficult to come up with a final plan during this working-level discussion. The overseas countries subject to comparison are eight: the United States, the United Kingdom, Germany, France, Italy, Switzerland, Japan, and Canada. The HIRA plans to sequentially re-evaluate chronic disease drugs whose patents have expired starting next year. In a recent government audit, he said, "We plan to carry out re-evaluation sequentially by the year starting in 2024," and added, "We will strive to secure the sustainability of health insurance finances by managing the drug costs of products listed with high drug prices compared to foreign countries." He said. Considering this, it is highly likely that a reevaluation will be carried out with the goal of reducing drug costs, so it is possible that the overseas drug price standard will be lowered and the upper limit amount may be adjusted. However, it appears that some modifications will be made while gathering opinions from the pharmaceutical industry, so we will have to watch the future discussion process. A HIRA official also explained, “The internal draft has been prepared, but the final draft may be revised during discussions with the pharmaceutical industry.” It is expected that some of the contents of the HIRA draft will be made public once the opinion collection process begins. In order for the reevaluation to proceed next year, the final draft must be confirmed in December, so intensive discussions with the pharmaceutical industry are scheduled to take place this month. A HIRA official added, “We plan to hold discussions with the pharmaceutical industry throughout November,” adding, “I don’t think it will end with one or two meetings.”
Policy
Drug price reduction delayed due to suspension of execution
by
Lee, Jeong-Hwan
Nov 07, 2023 05:34am
As the so-called 'Drug Price Reduction Litigation Recovery and Refund System' is about to be implemented in earnest from the 20th, it is expected that some pharmaceutical companies will be put on hold in their tricks to preserve the prices of their own drugs by nullifying or delaying the effect of the government's drug price reduction disposition. According to the Ministry of Health and Welfare on the 6th, according to the results of administrative litigation on drug price reduction, the amendment to the Health Insurance Act and subordinate laws to post-settlement the recovery and refund of drug costs between pharmaceutical companies and insurance authorities will take effect from the 20th. The amendment requires domestic and foreign pharmaceutical companies to collect losses and interest if they obtain unreasonable profits, such as collecting drug costs without reducing the litigation period by suing to suspend the execution of drug price cuts decided by the government through litigation procedures. Conversely, if the government loses the case and is found to have illegally lowered drug prices to a pharmaceutical company, it will be required to refund the pharmaceutical company's drug cost losses along with interest. This regulation applies to administrative trials or administrative lawsuits filed after November 20, when the amendment goes into effect. With the implementation of the system, the number of cases in which pharmaceutical companies protest against government drug price cuts and file 'applications for suspension of execution' and 'lawsuits for cancellation of administrative dispositions' without considering whether they win or not is expected to decrease. Until now, in most cases, suspension of execution of drug price reduction measures was cited until the court's final ruling, which resulted in drug prices not being reduced or only after the lawsuit was completed several years later. This is why criticism has been raised that patients had to take medicine at high prices during the period when drug prices were not reduced due to lawsuits, leading to a waste of health insurance funds. According to the health insurance authorities, the financial loss of health insurance resulting from the suspension of drug price cuts in 47 lawsuits in which suspension of execution was cited since 2018 amounted to approximately 573 billion won as of the end of March 2022. The Ministry of Health and Welfare plans to minimize health insurance financial losses by implementing the system and using related funds to strengthen patient access to rare disease treatments.
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