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- 2026-05-11 20:25:56
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- Prescription of Celltrion’s Takeda drugs fall for 2 yrs
- by Kim, Jin-Gu Feb 08, 2023 05:53am
- Prescription performance of the 3 major chronic disease treatments that Celltrion Pharm acquired from Takeda Pharmaceutical had fallen for 2 consecutive years since their acquisition. The ‘Nesina’ series, which account for the most proportion of sales among the acquired products, recorded KRW 28.2 billion in sales last year, recording a downward trend for 3 consecutive years since 2020. Sales of the other diabetes treatment ‘Actos’ series and the hypertension treatment ‘Edarbi’ series have also shown sluggish sales in terms of prescription performance over the past 2 years. According to the market research institution UBIST on the 8th, the total prescription amount of the 3 major chronic disease treatments that Celltrion acquired from Takeda Pharmaceutical was KRW 65.4 billion last year. This is a 5% decrease from the KRW 68.9 billion recorded by the same drugs in 2021. In June 2020, Celltrion signed an agreement with Takeda Pharmaceutical to acquire the rights of 18 prescription drugs and OTCs sold by Takeda’s Primary Care Business Unit in the Asia Pacific region for a total of USD 278.3 million (KRW 307.4 billion). Under the deal, the company acquired the diabetes treatment Nesina Actos, the hypertension treatment Edarbi, and OTCs Whituben, Albothyl, etc. The acquisition process was completed in December of the same year, and work to switch the domestic marketing authorization license had been ongoing until January last year. The products are now being sold by Celltrion in Korea. The decrease in sales was most significant in the sales of the Nesina series, the DPP-4 inhibitor class diabetes treatments. Total sales of Nesina, Nesina Met, and Nesina Act recorded KRW 28.2 billion last year. Ever since their sales peaked at KRW 35.9 billion in 2019, sales steadily declined to KRW 33.4 billion in 2020, then KRW 31.4 billion in 2021. In particular, sales fell below KRW 30 billion for the first time in 6 years since 2016 last year. In the case of the Nesina series, their prescriptions have been on a decline even before the drug was acquired by Celltrion due to fierce competition in the DPP-4 inhibitor class diabetes treatment market. In addition, the release of generic versions of its competitor Galvus and Tenelia further decreased the influence of Nesina in the market. The TZD class antidiabetic Actos series and the ARB class hypertension treatment Edarbi series had also shown a slowdown in sales recently. The total prescription amount of Actos, Actos Med, and ActosRyl was KRW 25.9 billion, which was a 3% increase from KRW 25.2 billion in 2020. However, the amount had decreased by 2% from KRW 26.6. billion in 2021. Total prescriptions of Edarbi and Edarbi klo had increased by 3% in the past 2 years from KRW 10.8 billion in 2020 to KRW 11.2 billion last year. The combined prescription amount of the three product groups rose steadily from KRW 62.9 billion in 2018 to KRW 69.5 billion in 2020. However, sales then fell to KRW 68.9 billion in 2021, then to KRW 65.4 billion last year. After Celltrion acquired the products, sales performance of the Edarbi and Actos series had improved slightly, but as the performance of the Nesina series, which accounted for the largest portion of sales among the acquired products decreased significantly, this is analyzed to have led to the decrease in the total prescription amount. In the case of the OTCs Whituben and Albothyl, their sales data has not been compiled yet. However, in the case of Whituben, sales are said to have increased twofold compared to the previous year due to the increase in demand for cold medicines following the rapid increase in confirmed cases of COVID-19 last year. Sales of the Whituben series in 2021 had been KRW 2.5 billion.
- Company
- The first reverse growth of NOAC worth 230 billion won
- by Jung, Sae-Im Feb 08, 2023 05:53am
- Eliquis·Pradaxa·Xarelto·Eliquis The NOAC market, which is worth 230 billion won, fell for the first time last year. This is because the generic market for some items was opened and drug prices were cut. Generics, which competed with the original "Xarelto," secured a market worth 9 billion won last year. According to Ubist, a pharmaceutical market research firm on the 8th, the size of the outpatient prescription market in the NOAC market last year was 227.6 billion won, down 1.8% from 231.8 billion won the previous year. NOAC has attracted attention as a drug that has a lower risk of bleeding side effects than warfarin, a conventional anticoagulant, and has a great thromboembolic effect. A total of four original products are on sale. Since the early 2010s, they have replaced warfarin and gained influence in the prescription field. The NOAC market, which had been increasing every year, saw its annual prescription reverse growth for the first time in 2022. With the emergence of generics of some items, the original drug price cut was made, and it entered a downward phase. The representative one is Bayer's "Xarelto." Last year, Xarelto's outpatient prescription amount was 46.8 billion won, down 22% from 59.6 billion won the previous year. Since its launch, Xarelto prescription solutions, which have continued to grow, have turned downward since last year. The biggest blow is the original drug price due to the generic salary registration. As of August 22 last year, the Ministry of Health and Welfare cut the drug price of all doses of Xarelto (2.5·10·15·20mg) by 30%. This is because the Seoul High Court sided with the Ministry of Health and Welfare in a lawsuit filed by Bayer against the Ministry of Health and Welfare to cancel the Xarelto drug price cut. The Xarelto price was scheduled to be lowered in May 2021, when generic was first listed, but the execution was suspended until the original ruling because Bayer filed a lawsuit that the drug price cut was unfair, saying that Generic was released before the patent expired. The ruling was made after about a year and two months, and the drug price cut was finally confirmed. Xarelto's quarterly prescription, which was between 14 billion won and 15 billion won, fell sharply to 11 billion won in the third quarter. In the fourth quarter, it was 7.4 billion won, which is half the level before the drug price cut. Compared to 2020, Xarelto's prescription in the second half of last year lost 40%. The decline is expected to be steeper as additional Xarelto drug price cuts are expected this year. The government will add the original drug price to 53.55% for the first time when generic is listed, and 70% for one year after adjusting it to 53.55%. As a result, Xarelto, which was cut by only 30% last year, is expected to be cut by 23.5% to 23.6% this year. The influence of Xarelto generic is also growing. Last year, Xarelto generic products received 9 billion won in outpatient prescriptions, more than five times higher than the 1.6 billion won in the previous year. Chong Kun Dang (2.9 billion won), Hanmi Pharm (1.5 billion won), and Samjin Pharm (1 billion won) are driving the growth of the generic market. ◆Lixiana and Eliquis increase without generic penetration, 160 Billion-scale Lixiana, the No. 1 in this market, raised its prescription amount by 89 billion won last year. This is an increase of 5% compared to the previous year. Lixiana is the latest NOAC formulation to enter the market. There is a five-year difference from other drugs. Despite being generic, Lixiana succeeded in reversing in 2019 by accumulating data through direct comparative studies with other drugs. Analysts say that aggressive sales strategies with domestic companies also affected rapid growth. Lixiana, which was 4.8 billion won in 2016, expanded its size from 20.9 billion won in 2017 to 39.5 billion won in 2018, 61.9 billion won in 2019, 72.9 billion won in 2020, and 84.8 billion won in 2021. As of last year, Lixiana accounted for 41% of the original NOAC market. BMS's Eliquis ranked second in the NOAC market. Equis' prescription amount last year was 70.6 billion won, an 8% increase from the previous year. The recent increase in Eliquis' sales is largely due to the withdrawal of generics. Eliquis' growth slowed in June 2019 as it faced competition with generics. Generic companies, which won the case until the second trial, preemptively released generic, and annual prescriptions rose by nearly 10 billion won in 2020. During this period, Eliquis was 50.6 billion won in 2019 and 55 billion won in 2020. Eliquis growth, which increased by 10 billion won every year, slowed down. However, in April 2021, the Supreme Court reversed the previous ruling in the patent lawsuit and sided with BMS, taking a new turn. Immediately after the ruling, the generics withdrew from the market en masse. This is because BMS announced a claim for damages due to patent infringement. The Mayor of Eliquis generic, which was 1.2 billion won in 2019 and 9.4 billion won in 2020, shrank to 5.4 billion won in 2021, when the Supreme Court ruled. Last year, the prescription amount was 0 won as the generic benefit was deleted and all distribution inventory was exhausted. Along with this, Eliquis' prescription amount, which had slowed down, recovered to 65.2 billion won in 2021, expanding by 10 billion won again. Last year, it surpassed 70 billion won. Generics that lost the lawsuit can only sell their products after September next year. ◆Pradaxa's sales have been on the decline for 5 years Sales of another NOAC, Pradaxa of Beringer Ingelheim, have been on the decline for the fifth consecutive year. Pradaxa's prescription amount last year was 12.2 billion won, down 20% from 15.2 billion won in 2020. Unlike other formulations, Pradaxa, which expanded its size in 2017, failed to exceed 20 billion won and turned downward. Pradaxa's sales, which were 21.6 billion won in 2017, showed a clear decline to 19.6 billion won in 2018, 18.7 billion won in 2019, and 16.5 billion won in 2019. Pradaxa, which has been pushed back from the competition with NOAC Original, is also out of the interest of generics. According to the Ministry of Food and Drug Safety, 10 domestic companies were licensed for Pradaxa Generics in 2018, but none of them have been released on the market. It seems that it is meaningless to compete in the Pradaxa market, which is only 10 billion won.
- Company
- Dong-A Forxiga loses the patent dispute
- by Kim, Jin-Gu Feb 07, 2023 05:48am
- A new method of avoiding material patents virtually fails the 'prodrug' strategy, which was drawing attention. Dong-A ST lost the Forxiga patent dispute alone. Dong-A ST pushed ahead with the release of Forxiga's late drug, Dapapro, on the basis of its victory in the first trial, but the ruling put considerable pressure on sales. ◆ Dong-A ST loses patent dispute alone, Dapapro sales variable The Supreme Court's special second division ruled in the morning of the 2nd that Dong-A ST would dismiss the appeal in an appeal filed against AstraZeneca. Forxiga is protected by two substance patents. The first substance patent (10-0728085) expires on April 7, 2023, and the second substance patent (10-1021752) expires on January 8, 2024. Dong-A ST alone challenged the first substance patent, which expires first. In April 2018, Dong-A ST requested a passive judgment on the scope of rights for the first substance patent. In the first trial, Dong-A ST won. The Korean Intellectual Property Trial and Appeal Board made a trial decision on the establishment of the claim in August 2020. AstraZeneca objected, and the ruling was overturned in the second trial. The patent court ruled in favor of AstraZeneca. This time, Dong-A ST filed an appeal with the Supreme Court in protest. However, the Supreme Court finally sided with the original company. Dong-A ST has already released Posh's generic Dapapro exclusively based on the first trial victory trial in December last year. However, the Supreme Court ruling put a burden on Dapapro's sales. However, Dong-A ST won the nullification lawsuit for the second substance patent issued on the same day, so there is no problem with sales after April this year when the second substance patent expires. Patent infringement related to the forced sale of Dapapro is treated separately as a lawsuit. Currently, Dong-A ST is proceeding with a separate lawsuit against AstraZeneca and Prodrug and a patent infringement lawsuit. ◆New method of avoiding material patents The 'Prodrug' strategy, which was drawing attention, has virtually failed Dong-A ST's challenge to avoid material patents has received considerable attention from the pharmaceutical industry. This is because Dong-A ST has come up with a new material patent avoidance strategy called "Prodrug." A prodrug is a drug in the pro stage of the drug. Until just before taking the drug after it is produced, the chemical structure of the original drug is partially different in the substituent part. When you take a drug, it acts like an original drug in your body. In the pharmaceutical industry, if Dong-A ST wins, it is predicted that the challenge of material patents using the Prodrug strategy will continue. However, Dong-A ST's prodrug strategy has virtually failed to see the light as it lost consecutive second and third trials. "The strategy of avoiding material patents by Prodrug has been put on hold by the Supreme Court for now," a pharmaceutical industry official said. "However, we have to wait and see the results because Dong-A ST is filing a separate lawsuit using Prodrug."
- Policy
- MFDS prepares a list of pre-requisite data for inspections
- by Lee, Hye-Kyung Feb 07, 2023 05:47am
- The Ministry of Food and Drug Safety has prepared a list of pre-requisite data for local inspections of overseas pharmaceutical manufacturing plants. A total of seven data submission lists, including the list of drug manufacturing over the past three years, have been prepared to enhance the predictability and consistency of administration during field inspections of overseas manufacturing plants. This list of data is one of the suggestions submitted by the pharmaceutical industry through the first meeting of the regulatory innovation industry in the pharmaceutical sector held in July last year. At the time, the pharmaceutical industry requested that data should be prepared at the site of due diligence and submitted and reviewed during the due diligence process instead of submitting data in advance of the on-site inspection of overseas manufacturing plants. The on-site inspection of overseas manufacturing plants is conducted in accordance with Article 695 of the Pharmaceutical Affairs Act, and specific procedures and methods are stipulated through the Prime Minister's Decree, but a detailed list of pre-requisite data has never been released. In response, the Ministry of Food and Drug Safety decided to disclose a list of pre-required data by reflecting some of the pharmaceutical industry's suggestions instead of not submitting prior data. According to the list of required data, ▲ List of pharmaceutical products (including manufacturing date, manufacturing number, shipment status, export volume, etc.), ▲ List of document management regulations and standards (including approval date and revision number), ▲ Comprehensive Process Validation Plan and Report (badge filling test, filter validation included), ▲ Quality Assessment Report (P) ▲ Manufacturing Material Report (Recent) For the last three years, the list except for the manufacturing list of medicines and the manufacturer's general list must be submitted only for items subject to field inspection. The Ministry of Food and Drug Safety plans to finalize the list of pre-requisite data for overseas manufacturing plants in the future by collecting opinions from the pharmaceutical industry on the list.
- Policy
- Further proposals made for reimb of diabetes combos
- by Lee, Tak-Sun Feb 07, 2023 05:47am
- SGLT-2 inhibitor class diabetes drugs (from the left: Forxiga, Jardiance, Xigduo, Jardiance Duo) The health insurance authorities have once again started analysis on the fiscal impact of reimbursing diabetes combination drugs. In the latest financial impact analysis, a red light was turned on in reimbursing the combined use of diabetes drugs as the reimbursement amount exceeded the government’s range of expectations. Whether the newly submitted price cut proposals will satisfy the government's expectations and finally allow reimbursement to be made for diabetes combinations is gaining attention. According to industry sources on the 6th, the Ministry of Health and Welfare collected the voluntary price cut rates submitted by 11 pharmaceutical companies related to the reimbursement of combination drugs for diabetes until last Friday (3rd) and began analyzing their fiscal impact. Discussions on the reimbursement of combination drugs for diabetes had previously come to a halt after the MOHW determined the fiscal impact of the drugs that submitted voluntary discount rates in November last year exceed the expected range. Accordingly, the MOHW held another meeting on the 11th of last month with related pharmaceutical companies and requested the companies to submit the voluntary discount rates again within two weeks. If the fiscal impact falls within the expected range with the voluntary reduction rate that was submitted this time, discussions on the reimbursement of diabetes drug combos will gain momentum. The combinations being discussed are triple therapy combinations such as metformin+SGLT-2+DPP-4, metformin+SGLT-2+TZD, and the combination of some SGLT-2 drugs+sulfonylurea or insulin. The Korean Diabetes Association has been requesting reimbursement of the combined use of diabetes drugs since 2016. However, due to their large impact on finances, discussions on their reimbursement have only been made in earnest since 2021 and were sluggish before then. In the market, companies have also released fixed-dose combinations that were designed to increase treatment efficacy through the combined use of diabetes drugs. However, if the government turns down the reimbursement listing, these new drugs are likely to be abandoned without proper use. It is said that the government is determined to make the decision quickly as discussions on the reimbursement of the combined use of diabetes drugs had been ongoing for a long time. The key will be the discount rate submitted by companies that own large drugs such as Forxiga. An official from a related company said, “What discount rate the companies such as AstraZeneca that owns Forxiga submitted will greatly affect the reimbursement listing of combination drugs. If the additional proposal cuts the drug price by only a small amount from the previous proposal, the discussion itself will likely be discontinued. Therefore, this is virtually the last chance."
- Policy
- Non-face-to-face treatment included as key policy task
- by Kang, Shin-Kook Feb 07, 2023 05:47am
- The Korean government is expected to make systemic improvements in the field of healthcare this year, with non-face-to-face treatment included as a key social policy. The Ministry of Education (Deputy Prime Minister and Education Minister Ju-Ho Lee) held the first Ministerial Conference on Social Relations at the Government Complex-Seoul on the 6th to deliberate and decide on a plan for implementing key social policies in 2023. The 2023 Key Social Policy Implementation Plan that was jointly established by 15 social government ministries contained the vision, goals, and major policy tasks for social policies and areas that the ministries will focus and collaborate on this year. Key social policy tasks for 2023 During discussions, the institutionalization of non-face-to-face treatment was included as a healthcare policy task. The policy is aimed at introducing non-face-to-face treatment mainly in primary medical institutions for the health management of patients residing in islands and isolated areas, overseas residents, infectious disease patients, and chronic disease patients. Also, the plans also include measures to expand emergency medical centers and expand healthcare in public health centers. Measures to expand essential healthcare and improve accessibility were also included as social policy measures. The plan is the same as the one announced by the Ministry of Health and Welfare, which aims to expand essential medical services, especially for severe emergencies, childbirth, and pediatric care, and to improve and strengthen public medical infrastructure Major social policy tasks for 2023 Also, the development of manufacturing and quality control technology to localize essential national medicines and the establishment of a national supply chain for medical devices that are rare or require urgent introduction were included as key tasks. Ju-Ho Lee, Deputy Prime Minister and Minister of Education said, “We have prepared the Key Social Policy Implementation Plan this year to bring hope of making a Korea that realizes the value of freedom through solidarity. We have established a pan-ministerial cooperation system to promote this.” Prime Minister Lee added, “The plan consists of 9 major tasks and 27 detailed policy tasks to achieve the social policy goals of ▲leaping towards the future, ▲ solidarity together, and ▲ensuring safe daily life.”
- Company
- SGLT-2 Market ↑3x in 3 years
- by Jung, Sae-Im Feb 07, 2023 05:47am
- The domestic SGLT-2 inhibitor outpatient prescription market has grown to 170 billion won. It has more than tripled in the past three years. It has been about 10 years since SGLT-2 inhibitors entered Korea. This year, a major change is expected as a number of "Forxiga" generics leading the market are released and new domestic SGLT-2 inhibitors are also released. ◆ SGLT-2, which has grown considerably, grows evenly According to UBIST, a pharmaceutical market research institute on the 6th, the total amount of outpatient prescriptions for SGLT-2 inhibitors in Korea last year was 172.3 billion won. This is an increase of 14.8% compared to 150.1 billion won in the previous year. The market, which was about 50 billion won in 2017, quickly grew in size by expanding its influence in diabetes. It recorded 70.3 billion won in 2018 and 96.9 billion won in 2019 and surpassed 100 billion won for the first time in 2020. It is now on the verge of surpassing 200 billion won. The SGLT-2 inhibitor was evenly grown by a single agent and a combination agent The combination refers to the addition of Metformin to the SGLT-2 inhibitor component. Last year, the single agent grew by 11.1% to 98.6 billion won, and the combined system increased by 20.1% to 73.7 billion won, respectively. By product, AstraZeneca's Forxiga, Xigduo, and Beringer Ingelheim's single Jardiance recorded more than 40 billion won last year. By the manufacturer, AstraZeneca is 91.4 billion won, higher than Beringer Ingelheim's 76.1 billion won. Forxiga was the highest prescription item, up 14% from the previous year to 48.5 billion won. Jardiance then increased by 10.5% to 45.2 billion won. The combined Xigduo increased by 16% to 42.9 billion won during the same period. Beringer Ingelheim's compound "Jardiance Duo" recorded a prescription amount of 30.9 billion won, up 26.2% from the previous year, although it fell short of Xigduo. ◆ Launch of new product and generic, SGLT-2 market upheaval this year This year, a big change is expected in the SGLT-2 inhibitor market. First of all, the release of domestic SGLT-2 inhibitors is imminent. Daewoong Pharmaceutical plans to release Envlo, which was approved by the Ministry of Food and Drug Safety in November last year, within the first half of this year. The company is also speeding up the approval of the complex system. A number of generics for Forxiga and Xigduo will also be released in April. The Supreme Court ruled in favor of Forxiga's Generics on the 2nd. The ruling will allow generic companies to release generic for exclusive use from April 7, when Forxiga's first substance patent expires. A total of 14 companies, including Kyung Dong, Kukje, Daewon Pharmaceutical, Dongwha, Boryung, Samjin, Sinil, Alvogen Korea, Yunjin, Ildong, Jeil, Chong Kun Dang, Hanmi, Han Wha, etc., have 39 items of generics for Forxiga.
- Policy
- The price of AbbVie Skyrizi is likely to be adjusted
- by Lee, Tak-Sun Feb 06, 2023 05:51am
- AbbVie's moderate-severe psoriasis treatment Skyrizi PFS has agreed to a PVA negotiation, which is expected to reduce the upper limit. The drug was registered in June 2020, and it is analyzed that it exceeded the expected claim agreed in advance with the NHIS from 2021. According to the industry on the 3rd, the NHIS has completed PVA negotiations with AbbVie which will be reflected in the list as of March 1. Skyrizi was also a PVA-monitoring drug in the third quarter of last year. As type A, this is the first upper limit under PVA negotiations. In patients with moderate to severe psoriasis lasting more than 6 months, if ▲Plaque psoriasis is more than 10% of the total skin area, ▲PASI 10 or higher, ▲ MTX or Cyclosporin is administered for more than 3 months, or if treatment cannot be continued due to side effects, ▲PUVA or UVB treatment. Psoriasis is an immune-mediated disease caused by abnormalities in the body's immune function, and redness and white dead skin cells occur throughout the body. Skyrizi has the convenience of taking it once every 12 weeks. It is evaluated to be excellent in terms of effectiveness, with skin improvement maintained even in the first year of administration in clinical trials. It was approved by the Ministry of Food and Drug Safety in December 2019, applied for benefits immediately, passed the Pharmaceutical Review Committee in March 2020, and was listed on the final list in June after the NHIS negotiations until May of that year. The annual financial requirement was expected to be 5.9 billion won, and the upper limit of insurance was set at 1,247,790 won per government office. According to IQVIA, Skyrizi sold only 1.5 billion won in its first year, but its performance jumped to 8.4 billion won in 2021. It is believed that the upper limit amount has been adjusted through PVA negotiations with the NHIS this time while exceeding the expected amount of claims.
- Company
- Does the Xospata dosing cycle limit disappear?
- by Eo, Yun-Ho Feb 06, 2023 05:51am
- The new leukemia drug Xospata is aiming to expand insurance benefit standards again. According to related industries, Astellas Pharmaceutical Korea submitted an application to expand the salary of Acute Myeloid Leukemia treatment Xospata at the end of last year and is currently discussing the schedule for the cancer disease review committee with the HIRA. Looking at the current benefit criteria, two-cycle benefits are recognized as induction therapy for patients who are non-responsive to existing treatments or can perform homogeneous hematopoietic stem cell transplantation among FLT3 mutation-positive AML patients. However, considering the preparation period for allogeneic hematopoietic stem cell transplantation, additional two cycles are recognized only if the same hematopoietic stem cell transplant is approved in advance (or equivalent evidence is presented). In other words, the administration of Xospata is limited to up to 4 cycles. In general, when the dose cycle of a drug is limited in the benefit standard, it is based on the design of clinical research of the drug or authoritative overseas guidelines. Blood cancer treatments such as Besponsa and Blincyto have limitations on administration, which are all based on evidence. In the case of Xospata, there is no specific reason to limit the dosage cycle. According to Xospata's ADMIRAL study, it is designed without limitation on the duration of administration, and the NCCN guidelines also recommend "Category 1" without limitation on the duration. Domestic permits are also allowed to be administered until severe toxic symptoms occur or clinical benefits do not appear. Of course, the salary standard does not necessarily have to be the same as the permit, but the academic community's position is that the limited standard of Xospata is problematic. As a result, it remains to be seen whether Xospata will expand its benefit standards this year and improve the prescription environment. Xospata is a drug that targets both FLT3-ITD and FLT3-TKD mutations, which are taken once a day orally, and can be treated on their own at home without frequent hospital visits. It also improved its effectiveness compared to conventional chemotherapy.
- Opinion
- [Reporter’s View] Improving NHI-related legislation
- by Lee, Jeong-Hwan Feb 06, 2023 05:51am
- The bill to remove the administrative drug price cut and reimbursement suspension dispositions that were imposed on illegal drug rebates from the current National Health Insurance Act and raising the penalty surcharge system has drawn industry attention and rose as an issue of focus this year. The bill aims to minimize third-party damage inflicted on patients, prescribing doctors, and dispensing pharmacists by the administrative dispositions imposed on rebate drugs, and to strengthen control over illegal rebates. The controversy over the irrationality of the drug price cuts and reimbursement suspension dispositions imposed on rebate drugs had been an issue for quite some time. The law was revised to improve the irrationality of reimbursement suspensions, where doctors and patients were left with no choice but to use more expensive drugs or experience other disadvantages in treating their diseases due to the reimbursement suspension dispositions. After the reimbursement suspension system on rebate drugs was implemented in July 2014, the revised National Health Insurance Act that applies drug price cuts according to the number of rebates and suspends reimbursement or imposes fines after 3 violations took effect in March 2018. The bill that proposed the reform of the National Health Insurance Act was submitted by NA Rep. Min-Suk Kim of the Democratic Party of Korea as representative. The bill attempts to improve the institutional irrationality of the current reimbursement suspension system. For this, the proposed bill not only contains measures that remove the price cut and suspension of reimbursement dispositions on rebate drugs and improve the standard for fines, but provisions to resolve the issue of drugs that have received reimbursement suspensions in the past. The supplementary provision of the proposed bill allows the law to be applied to drugs that received drug price cuts or reimbursement suspension dispositions or are undergoing administrative litigation at the time Rep. Kim’s bill was implemented. If so, it will be possible to retroactively apply the new system to drugs that were fined when the previous reimbursement suspension system was applied, reducing the risk of unreasonable cases and improving patient rights. The National Health Insurance Service agreed with Kim’s proposed bill that replaces reimbursement suspensions with fines. The NHIS said, “The reimbursement suspensions may violate the health rights of patients in need of the drug, so the NHIS agrees on the purpose of the amendment to impose a fine instead,” acknowledging the harm caused by the reimbursement suspension disposition. Although Kim’s bill cannot be completely flawless., the bill shows traces of multifaceted considerations made to improve the issue of the reimbursement suspension system as rationally as possible while strengthening control over rebates. Lee’s bill to revise the National Health Insurance Act is soon set to be reviewed by the Ministry of Health and Welfare soon. It is hoped that the efforts of the pharmaceutical industry and the National Assembly, which have been struggling to address the issue of reimbursement suspension for a decade, will be thoroughly reflected in the legislation during the review. Also, the legislation, which can allow three birds - preventing unnecessary damage to patients, doctors, and pharmacists, minimizing waste of health insurance finances, and strengthening punitive fines for rebates on pharmaceutical companies - to be caught with one stone, will be successfully implemented.
