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- 2026-04-17 15:11:30
- Opinion
- [Reporter’s View] Next year wishes for the industry
- by An, Kyung-Jin Dec 30, 2019 09:47pm
- “Last year, not one of Korean-made new drug was approved by the U.S. Food and Drug Administration (FDA). Ever since hemophilia treatment Aftyla was passed in 2016, Korean drugs have not been able to get a green light from the U.S. health regulator for two consecutive years. However, the industry is expected to bring a series of good news this year about Korean drugs entering the U.S. market.” In the beginning for the year, Daily Pharm had opened an article with the lead. And as predicted, Korean pharmaceutical and bio companies had a year filled with good news. Starting from Yuhan closing a license-out deal with Gilead Sciences on candidate medicine for non-alcoholic steatohepatitis (NASH), SK Biopharmaceuticals, OliX Pharmaceuticals, LegoChem Biosciences, Bridge Biotherapeutics, JW Pharmaceutical and Alteogen also scored license-out deals. Total nine license-out deals from January to November this year were closed by Korean pharmaceutical and biotechnology companies for 290 billion won. Also, other good news reported new pipelines developed with Korean-made technology have been approved in global markets. The U.S. FDA gave a nod respectively on treatment for excessive daytime sleepiness associated with narcolepsy, Sunosi (solriamfetol), and for partial-onset seizure, Xcopri (cenobamate) that SK Biopharmaceuticals licensed out to Jazz Pharmaceuticals. Led by botulinum toxin medicine Nabota developed by Daewoong Pharmaceutical, Samsung Bioepis and Celltrion’s biosimilars also had a notable achievement of grabbing foreign regulators’ approval this year. Although they were not first-in-class breakthrough drugs, Nabota and the biosimilars have been making profits from global markets in competition against other blockbuster drugs. Celltrion Healthcare has generated total of 800 billion won up to the third quarter with three biosimilars, Resima, Truxima and Herzuma. The volume surged by 60 percent from the same time last year. Samsung Bioepis selling three biosimilars—Benepali, Flixabi and Imraldi—in European market is expected to turn around for the first time in the year with accumulated net profit of 97.2 billion won up to the third quarter. Unfortunately, the industry had to endure a number of setbacks as well. Following the sales ban on Kolon Life Science’ Invossa, emerging biotechnology companies like Sillajen, Helixmith, and HLB Life Science released regretful news of failed clinical trials and left the public doubtful of the pharmaceutical and bio industry. Hanmi Pharmaceutical with the most aggressive R&D investment strategy in Korea had to give up on two R&D milestones from its license-out deal, whereas botulinum toxin companies like Medytox and Hugel stagnated with litigation over the source of strain and regulation on Chinese resellers. In contrast, the sluggish bio stocks growth having to turn around recently gave a hint of hope for next year. Investors are expecting the J.P. Morgan Healthcare Conference 2020 in January to be a catalyst to drive up the bio stocks. The J.P. Morgan Healthcare Conference is the one of the world’s most renowned conferences for the bio sector. It has been reported major pharmaceutical and biosimilar companies from Korea, such as Hanmi Pharmaceutical, Yuhan, Daewoong Pharmaceutical, JW Pharmaceutical, Dong-A ST, Celltrion and Samsung Biologics, as well as other bio companies like Medytox, Hugel and ABL Bio are planning to participate in the event. Moreover, the industry predicts SK Biopharmaceuticals going public in the first half of next year would also boost investors’ confidence. Hopefully, Korean pharmaceutical and bio industry would achieve even more R&D milestones in year 2020.
- Policy
- Impurity checks are left to the industry
- by Lee, Tak-Sun Dec 30, 2019 09:47pm
- As announced after the 2018 Valsartan incident, the MFDS focused on regulating generic entry this year. In the sense that all restrictions can be made, irrational systems were introduced as soon as possible to prevent the entry of generics. Generic regulatory measures, including restrictions on cooperative and entrusted activities, the introduction of three batches of commissioned generic trial production, and mandatory licensed generic DMF, have already been implemented or heralded. Among them, the joint and consignment limit is an administrative notice announced in April, and the domestic pharmaceutical industry is under pressure and is keen to implement it. Generic entry restrictions up to maximum aimed at consigned production items The restriction on the joint and entrusted bioequivalence test was cited as the most representative generic entry regulation when criticism was raised that there were many Valsartan preparations in which carcinogen NDMA was detected. Earlier this year, the MFDS held a meeting with CEOs to limit the number of items allowed for co-communication to 1 + 3 from 2020, and informed them that they will not allow it in 2022, three years later. In April, the government announced an amendment to the relevant regulations and is going to start at any moment. However, it is unreasonable regulation that the co-commission is not allowed. In 2010, the regulatory reform committee under the Prime Minister's Office was also braked. As the review of the proposed rule is delayed, it is noteworthy whether the 1+3 regulation, which was announced in the first half of next year, will be implemented on time. Currently, generic drugs of the same ingredient produced in the same plant through a consignment contract are replaced by a review of the existing Bioequivalence test by existing consignees. This has been criticized for the exponential increase in the number of generically approved generic ingredients. In November, it announced the introduction of another regulation. The contractor is obligated to produce three batches of licensed drugs that were exempted. The system, which disappeared in 2014, has also been revived in the name of preventing generic upheaval. Once this system is introduced, the consignor, who is entrusted with the production of the consignment company, must test and produce three batches as part of the GMP review, even at the time of generic approval. The domestic pharmaceutical industry is complaining of the burden of livestock costs due to the limitation of co-prosperity and the additional cost of trial production due to the revitalization of three batches. There are also new regulations that have already been announced as part of the ban on generics. In March, an amendment that mandates the submission of safety proof data on the genotoxicity or carcinogenic impurities and metal impurities of medicines will be announced in next September. In October, an amendment was announced to include licensed generics in stages for drug substance registration. ▲ Commercial drugs by December 31, 2021 ▲ High-cost drugs by December 31, 2022 ▲ Other drugs and drugs that require testing without a living body should register DMF by June 30, 2023. Since June 12, the pharmacological law revision has extended the restriction period for healthy people to participate in clinical trials to six months, making it difficult to conduct bioequivalence trials in the field. Ranitidine, Nizatidine Impurities Continue to Burst, direct assessment of all synthetic raw materials Even during the mobilization of generic regulations, the fear of impurities in pharmaceuticals did not go away. Following the hypertension Valsartan formulation, the carcinogen NDMA was continuously detected in the gastric ulcer therapeutic Ranitidine and Nizatidine formulations. Pharmaceutical industry officials attending the drug impurity response briefing held at Samjung Hotel on the 6th attended and showed interest.The MFDS banned sales and recovery of all Ranitidine products in September, and banned and recalled some Nizatidine products in November. In addition, as NDMA is detected in the anti-diabetic Metformin preparation in Singapore, some items are being recovered and impurity fears are still in shape. The MFDS instructed pharmaceutical companies to submit their own results of impurity evaluations to all synthetic materials by next May and test results on drugs concerned with impurities by May 2021 for self-examination of persistent impurity issues. Advanced Law Passes Parliament, laying grounds for fast track such as serious diseases Unlike generic regulation, new types of drugs have provided the basis for supporting rapid licensing. This is accelerated in August when the Act on Advanced Renewable Medical and Advanced Biologics Safety and Support passed the National Assembly. As a result, drugs that need to come to market early, such as serious illnesses, rare diseases, and pandemic infections, will be included in the expedited treatment for early approval. The organization and system are being set up by establishing the Convergence Innovative Product Support Group in the Korea Food and Drug Administration for the next August. However, the threshold for safety testing for advanced drugs has been strengthened due to the effects of ' Invossa', which was released in April due to the fact that the main component cells were changed and the license was revoked.
- Policy
- NHIS "providing reliable and reasonably priced generics"
- by Lee, Hye-Kyung Dec 30, 2019 06:19am
- Korea’s National Health Insurance Service (NHIS) has reported it would take over the generic management from next year. The Price-volume Agreement (PVA) system currently limited to new drug only would be also applied on generic pricing negotiation. The government agency plans to form a task force team to support Ministry of Health and Welfare (MOHW) making a related revision on the official notification. NHIS is focusing on the additional conditions required by side agreements for the generic pricing negotiation. The government body’s plan is to set a legal basis for imposing price reduction on rebate-providing drug as stated by the side agreement. President Kim Yong Ik of NHIS spoke at the end-of-the-year press conference for government correspondents convened recently, and stated “NHIS would endeavor managing generics next year,” and accordingly “we have acquired insights on generic supply structure through the recently completed research on prospective improvement on pharmaceutical supply and purchasing system.” The research is also known as the ‘All-around Pharmaceutical Product Research,’ initially led by then Professor Lee Eui-kyung of Sungkyunkwan University School of Pharmacy since November last year. The research was later passed on to her student Professor Lee Sangwon, as the former principal investigator was appointed as a new Minister of Food and Drug Safety, and it presented the final result of the research recently. The one-year-long study comprehensively delved into pharmaceutical development, manufacturing, supplying, distribution and consumption with key research topics, such as the present pharmaceutical industry status and regulatory policy in Korea; analysis on generic supply structure and efficient pharmaceutical expense management; new drug supply analysis and recommendation on improving efficiency in pharmaceutical distribution industry; recommendation on advancing pharmaceutical distribution transaction system; prospective vision and tasks of pharmaceutical supply structure. In particular, the research task of analyzing generic supply structure and improving efficiency in pharmaceutical expense management studied the present regulations and related improvements, and also analyzed generic manufacturing structure of Korean pharmaceutical companies. President Kim said, “80 percent of listed drugs at the moment are generics, and most of the health conditions are treated with generics. As we mentioned many times before, we, as an insurer, need inexpensive but good generics.” So far, the president has been emphasizing on amending the industry’s distribution structure for the ‘principle’ of providing the best drug with the lowest price. “We need reliable generics with reasonable price. But when it was announced NHIS would be managing the generics, the public thought we would recklessly lower the pricing. However, we see that consistent investment is needed to purchase even better quality of generics with even lower price,” said President Kim. In short, a ‘two-sided strategy’ is needed to purchase better priced but reliable generic with a consistent investment. President Kim stated, “We would make various plans for next year to figure out how to provide better quality but better priced generics.” Regarding the side negotiation for the generic pricing negotiation, Health Benefit Strategy Office Park Jong Heon mentioned, “A task force team would be formed early next year to support the process of amending the official notification. The amended negotiation procedure would not be in effect immediately from next year. The goal is to have the notification revised within next year.”
- Company
- Pharmaceuticals produced an average of 58 drugs 2018
- by Chon, Seung-Hyun Dec 30, 2019 06:19am
- Last year, Korean pharmaceutical companies produced 58 finished drugs on average. The amount produced per item was only ₩900 million. Among the three in 3 pharmaceutical companies, the proportion of small-scale pharmaceuticals are high, with the annual output of less than ₩1 billion. According to the '2019 Statistical Yearbook of Food and Drugs,' published by the Ministry of Food and Drug Safety on the 27th, the finished drug production totaled ₩18.5 trillion last year. It was 5.7% higher than 2017's ₩17.6 trillion. In 2010, it increased by 30.3% from ₩14,2 trillion in 2010. Last year, there were 19,239 products produced. In 2017, 52 fewer than 19,291, but 3,266 up from 15,973 in 2010. In 2018, the production performance of each drug product is calculated to be ₩ 963.86 million. Although it is gradually expanding from ₩891.17 million in 2010, it is still small scaled. Finished drug production in 2018 (left) and output per item (right) (Unit: ₩ million, Source: the Ministry of Food and Drug Safety) Last year, there were 329 drug manufacturers. Although 28 fewer than the previous year, 59 more than 270 in 2010. In 2018, an average of ₩56.4 billion of drug production was recorded per pharmaceutical company, and 58 items were produced on average. In general, domestic pharmaceutical companies handle various products and do not escape from department store management, which generates small sales per item. Drug producers (left) and number of items (right) in 2018 (Unit: numbers , Source: the Ministry of Food and Drug Safety) In fact, there were a lot of small companies that did not have a good record of finished drug production. Out of 329 drug product producers in 2018, the company recorded 32.5% of the total production of less than ₩1 billion. One out of three is a small company with less than ₩1 billion in drug production. 166 companies with less than ₩10 billion in production recorded more than half of the total. A total of 48 companies with over ₩100 billion in finished drug production were reported. More than ₩500 billion were in six places. Number of firms by size of finished drug production in 2018 (unit: Numbers , source: the Ministry of Food and Drug Safety)
- Company
- Boryeong’s copyright of anti-cancer drug,commercial value↑
- by An, Kyung-Jin Dec 27, 2019 06:28am
- The anti-cancer drug 'Zepsyre', which is owned by Boryeong in Korea, has entered the early stage of commercialization. PharmaMar, the original developer, is expected to secure the first FDA indication for small cell lung cancer by August next year. The company also won a large contract worth up to ₩640 billion to surpass the US copyright, which is expected to be released the fastest. Boryeong signed a domestic exclusive promotional license agreement for Zepsyre from PharmaMar in November 2017. In 2016, the company signed a monopoly on sales and development of a myeloma treatment drug, Aplidin, to build a strong partnership. According to the industry on the 26th, Borm Pharmaceutical's partner, Spanish PharmaMar, recently signed a monopoly license agreement with jazz pharmaceuticals’ Lurbinectedin. Lurbinectedin is the ingredient name of 'Zepsyre', an ovarian cancer drug introduced by Boryung in November 2017. It selectively exhibits anticancer activity by inhibiting the cause of cancer. It is a mechanism that selectively inhibits the oncogenic transcriptional processes activated in cancer cells and tumor-associated macrophages (TAM) and causes cell death by cutting DNA double strands. With the deal, PharmaMar secured a $200 million deposit (approximately ₩232.2 billion) from Jazz with no obligation to return. When Zepsyre is licensed to sell the US Food and Drug Administration (FDA), it will receive up to $250 million in additional technology charges (milestones). In the future, commercial milestones were guaranteed up to $550 million in technology fees and sales royalties ranging from late 10% to 30%. Jazz is a well-known company that is a partner of 'Sonosi (Solriamfetol)', a sleep disorder new drug exported by SK Biopharm. In the industry, Jazz has secured a huge short-term milestone from Zepsyre's US market potential. PharmaMar submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) on the 17th, based on the results of the second phase clinical trial of Zepsyre. According to PharmaMar's announcement of the American Society for Clinical Oncology (ASCO 2019) in June, patients with small cell lung cancer who received Zepsyre had a significant improvement in tumor response rate (ORR) of 35.2% compared to currently available Topotecan (16.9%). In addition to small cell lung cancer, various cancers including ovarian cancer, head and neck cancer, and BRCA mutation breast cancer are being actively researched. In recognition of this potential, the company signed a licensing agreement with Luye pharmaceutical of China (including Hong Kong and Macao) in April of this year. PharmaMar's executives are confident in the FDA's rapid approval. Small cell lung cancer monotherapy, a rare disease with high unmet demand, has secured positive clinical results. Zepsyre was designated by the FDA in August last year as a rare drug for small cell lung cancer. PharmaMar expects to receive the FDA's final approval in mid-August when the document is completed early next year and undergoes a six-month quick review process. Since then, the aim is to expand the indications to various carcinomas including ovarian cancer, head and neck cancer, and breast cancer. Bruce Cozadd, Chief Executive Officer of Jazz Pharmamaticals, said, “The treatment is limited in patients with advanced small cell lung cancer. The agreement is significant because it expands the jazz anticancer pipeline and later stage assets”.
- Company
- Discontinued sales of Champix generics
- by Kim, Min-Gun Dec 27, 2019 06:27am
- Anti-smoking drug Champix by Pfizer KoreaPfizer's Champix (Varenicline) salt-changing patent disputes have resulted in the loss of more than 20 domestic pharmaceutical companies, which has resulted in the suspension and recovery of generic drugs. According to the industry on the 24th, Hutecs Korea, C-tri, Danajen announced that they will be discontinued due to the result of a material patent evasion lawsuit by salt change of Champix This is because the patent court recently decided that “Champix generic anti-smoking drugs belong to products that differ from champix in the scope of the original material patent rights”. The ruling halted sales and prescriptions of generic products in response to a preliminary order to prohibit patent infringement. Increasingly, pharmaceutical companies are withdrawing from the market. Hutecs has discontinued its sales of 0.5mg (11 tablets, PTP packaging) and 1mg (28 tablets, PTP packaging) sold by the company. “It was due to the loss in the patent evasion litigation by changing the champix salt”, the company explained. In addition, Hutecs requested to block the code so that it is not sold to wholesale trade or nursing homes and to treat as a normal return although not subject to compulsory recall but due to discontinuation. C-tri has decided to discontinue the production of 0.5mg and 1mg of nicotine tablets. C-tri announced that there will be no future reproduction after the stock runs out and excluded from contract sales items. Danajen also stopped selling 0.5mg and 1mg of its Nicotine tablets on the 20th and began to collect all items. Danajen decided to complete the collection by the 15th of next month. In addition to coverage result of Dailypharm, the top domestic pharmaceutical companies that sell Champix generics have withdrawn from the market or are doing the same action. JW Shinyak, Chong Kun Dang, Daewoong Pharmaceutical, and Il Dong Pharmaceutical Co., Ltd ceased production and marketing. One of the pharmaceutical companies said, “We stopped prescribing and selling on the 23rd and will start returning products to pharmacies in the future, Other pharmaceutical companies also blocked both orders and sales”. An official from the PR team in Korea, who had completed the recall, said, “After the solicitation of Solifenacin, we finished preparations for the suspension and recovery early. Some pharmaceutical companies are quick to determine the profitability compared to marketing costs because they are unable to use the strategy to avoid salt changes”. On the other hand, there were some companies still watching the situation. A public relations executive at a mid-size pharmaceutical company said, “The sales department continues to sell, and we have not taken action yet”.
- Policy
- 'Brakes' on reimbursed drug’s listing process
- by Lee, Hye-Kyung Dec 27, 2019 06:27am
- This year, the insurance authorities were able to reorganize their drug price system to the organization of the person in charge of drug prices. Last year, The NHIS chairman Yong-ik Kim, who designed Moon Jae-in Care, was very active, and this year, there have been a number of institutional improvements that have been carried out by staff in charge of implementing the policy. In the drug sector alone, there were many big and small things happening, including the expansion of screening benefits and RSA drugs, and the creation of contracts that included supply obligations prior to drug price negotiations and patient protection and confidentiality. As the HIRA manages the health insurance finance, it has to focus on the income expansion to support the policy of strengthening security and the task of spending expenditure efficiency. If the focus has been on finding new drug-based follow-up management plans, next year, it will continue to seek ways to improve the 'price-volume agreement' that has been spinning the wheels with research services several years ago. The HIRA reviewed the revised economic evaluation guidelines and reference methods for foreign drug prices until the second half of this year to improve the drug listed system. In August, the RSA target was expanded from cancer and rare diseases to severe and intractable diseases, and the severe atopic dermatitis, Dupixent, will be paid from next January. ◆Enhancing Access to Medicines by Moon Jae-In Care= This year, the first case of drug screening benefits was released. In order to strengthen health insurance coverage, six types of anti-cancer drugs, which had no reimbursement standard or remained as 'baseline non reimbursement' at 100% of the copayment rate, were selected as a screening benefit. The protagonists of the first screening benefits include breast cancer treatments ‘Perjeta (Pertuzumab)’, ‘Halaven inj (Eribulin)’, Prostate Cancer Therapeutics, ‘Xtandi soft cap (Enzalutamide)’, and ‘Zytiga (Abiraterone)’. RSA targets for late-release drugs were also expanded. Dupixent, which was not an anticancer drug or a rare disease treatment drug, had difficulty in applying RSA expansion, but the health insurance policy review committee decided to complete the reimbursement registration process on the 23rd. The MOHW applies a special calculation to reduce the incurable cost of medical expenses (20~60% → 10%) for rare and incurable diseases, and expanded the target diseases. In January of this year, The MOHW identified 100 rare diseases and included them in the exception, and added 91 new rare diseases in the second half of this year. In the case of medicines, health insurance coverage is being expanded to focus on the treatment of serious diseases such as anticancer drugs and rare diseases. Compared to 2016, anti-cancer drug spending rose 41% from ₩1.47trillion to ₩1.46trillion in 2018, and rare disease treatment spending increased 81% from ₩235.2 billion to ₩4265 billion. During the same period, the drug cost growth rate exceeded 19%. This year, a new high-priced drug called Spinraza, which costs ₩560 million for the first year and ₩280 million from the next year, will cost ₩92.35 million per vial per patient. It is also a significant year for reimbursement listing under both total contracts system and RSA. ◆Reorganization of departments related to drug price in the HIRA=The organizational reform of the department in charge of drug prices in the HIRA, which was in charge of the implementation of Moon’s care, was an issue. The HIRA changed the existing insurance reimbursement division to the reimbursement strategy division from January 1 through amendment of the Order Regulations and the Enforcement Rules of the Order Regulations, and increased the departments related to drug prices from two to three. Dr. Jong-Heon Park, former researcher, was appointed as the head of the reimbursement strategy division. Since the establishment of the Drug Price System Division, it has also lowered the threshold of 'secret drug price negotiations' by opening a foreign drug price inquiry guidelines bulletin board and opening the drug price negotiation drug. In July, the glass ceiling of the 2nd level pharmacy occupation promotion of the HIRA broken. In order to guarantee the opportunity for promotion of pharmacy jobs, which was stopped at Level 3, the HIRA has been reorganizing its personnel and organizational regulations since 2017. As a result, Nam-sun Shin, the head of drug price negotiations, a second-level manager was produced from the pharmaceutical industry. ◆The HIRA, fix the drug price system= Last year, the Economic Evaluation System Improvement TFT was operated to revise the economic evaluation guidelines for medicines. TFT focused on the comparative drug, ICER, utility, and discount rate that the pharmaceutical industry has pointed out. Based on the TFT report, the HIRA is publishing commissioned research announcements to develop guidelines and conducting research. The economic evaluation system was created in 2007 following the introduction of a drug screening system. Over the past decade, the Economic Evaluation Subcommittee of the Committee on Drug Benefit Evaluation has reviewed data of approximately 190 ingredients (80 times) based on economic evaluation guidelines. However, since the guidelines used to evaluate the economic feasibility have been applied since the beginning of June 2006 and only one revision was made in December 2011, the pharmaceuticals complain that the reality is not reflected. At the Fifth Health Insurance Policy Review Committee held on April 3rd, there was a brake on the decision to skip negotiations. Another issue is the decision to delay negotiations to negotiate during the April 3 meeting of the Health Insurance Policy Review Committee. At the time of the face-to-face screening process, 90-100% of the weighted average price of alternative drugs was accepted and drug price negotiations were skipped. Among the drugs envisaged by the Health Insurance Policy Review Committee, there was a brake on reimbursement such as antidepressant Agotine tablet of Whanin, Faslodex of breast cancer treatment of AstraZeneca Korea, and Alunbrig tablet of non-small cell lung cancer treatment of Takeda. This is because members of the Health Insurance Policy and Deliberation Committee have put in place conditions for the drug price agreement. The conditional resolution was foreseen to some extent from the time the Ministry of Health and Welfare switched all the drugs proposed to the Health Policy Review Committee to face to face examination. The MOHW raised the CJ Healthcare's K-cap tablet for gastroesophageal reflux disease to the Health Insurance Policy Review Committee on February 26, and decided on an internal policy to turn the face-to-face examination of drugs that had been settled through price negotiations. From this point on, a subsidiary agreement on 'performance of supply obligations' will be drawn up for all drugs undergoing drug price negotiations with the HIRA, and the 'pre-counseling system' will be actively operated until the Minister of Health and Welfare 's order for drug price negotiations. The HIRA has signed and managed a contract containing the same provisions, including 'Supply Obligations and Patient Protection' on 172 drugs of 59 pharmaceutical companies by October this year. It is necessary to negotiate in advance whether there is a drug that can be replaced by itself and how the supply will proceed in the future. In the research process conducted by the HIRA, the foreign drug price standard referred to in the process of listing domestic drug benefits is added from A7 (USA, UK, Germany, France, Italy, Switzerland, Japan) to A10 (additially Taiwan, Canada, Australia). When the results of the study suggest that they should be expanded. The movement has begun to improve this. Recently, the HIRA also added 'Post-Pharmaceutical Evaluation' and 'Herbal Drugs' to the Subsidy Commission of the Pharmaceutical Benefits Evaluation Committee. The new Sub-Committee on Subsequent Drug Evaluation will conduct post-evaluation of those drugs that have extended their coverage by anticancer drugs, rare drugs, and clinical usefulness, which are expensive drugs. ◆Yang-ho Cho ’s issue=n last July, the prosecution filed a warrant for arrest of the chairman of Hanjin Group, Cho, Yang-ho, for fraud, embezzlement, and duties. He also illegally borrowed a pharmacist's license and ran a pharmacy to violate the pharmacist law, and retrieval process begins for ₩100 billion in insurance financing. Six criminal detectives at the Southern District Prosecutors' Office investigated Cho's suspicion of escaping the inheritance tax, and have been accused of running a pharmacy illegally as a nominee for over 20 years. But, on April 8, when President Cho suddenly passed away, the trial proceedings have been disrupted including violations of the Pharmaceutical Affairs Law. At present, Mr. Cho's illegal pharmacy trial continues against Mr. Won, a pharmacist Lee, and his spouse Mrs Ryu , who conspired to commit the crime. Sue was suspected of violating pharmacological law by opening a pharmacy on the first floor of the company's annex under the name of pharmacist Lee, through Mr. Won and Mrs Ryu. ◆Field survey=Since this year, the self-check system has been expanded. The autonomous check system was introduced to allow the reviewers to detect and report unfair claims by informing the appropriate nursing institution of the possibility of unfairness of the reimbursement expenses already paid before the on-site investigation. Trial project from December 2017 ▲ Temporary mandibular joint shooting (1st) ▲ Increase of claims after divided use of injection (2nd) ▲ Violation of breast biopsy calculation standard ▲Pharmacy differential index and night addition error claim based on the results of the autonomous inspections in turn, the autonomous inspection system was introduced in earnest from November 1, 2018. The HIRA noted that such a problem was also pointed out by the State Auditor last year. The HIRA feels the necessity of reviewing administrative measures for improvement based on the type and billing amount. On the other hand, the NHIS has argued that employees of the HIRA should have the special judicial police right to eradicate operated hospitals by office manager, not a doctor. ◆Bending of the first ₩1 trillion in history= The NHIS announced the average rate of increase in the conversion index for nursing institutions on the 1st of next year at 2.29% (bending ₩1.47 trillion). Although it was determined to be slightly lower than 2019 (2.37%) in consideration of the subscriber's ability, financial integrity, and medical expenses growth rate, it recorded the first ₩1 trillion in sales. Next year's budget is estimated at ₩1.4688 trillion, with ₩434.9 billion for hospitals, ₩93.5 billion for dentistry, ₩66.9 billion for oriental medicine, and ₩114.2 billion for pharmacies. The rate of increase was 3.5% in pharmacies, 3.1% in dentistry, 3% in oriental medicine, and 1.7% in hospital, but the order of the distribution of bending shares was reversed. ◆DUR Advancement Pilot Project=The Drug Utilization Review (DUR) Advancement Pilot Project, which has been in progress since August 1st, was completed this month. The HIRA conducted a pilot project for 20 medical institutions (2 senior general hospitals, 2 general hospitals, 1 hospital, 4 clinics, and 11 pharmacies) in the second half of this year. Based on the results of 2018 DUR Research Plan for Advancement of DUR, the pilot project was undertaken to establish a comprehensive management system before and after drug use as well as to establish a compensation system. And there are two types of systems in which pharmacies participate: aftercare, allergy, and adverse event monitoring. ◆Drug serial number system= From January 1, the serial number system has been implemented. The average reporting rate for the first half of all distributors released in August was 89.1%, at the time of shipment, 2591 companies (96.4%) had a serial number reporting rate of more than 50%, and 98 companies (3.6%) had less than 50%. The appeals of 18 wholesalers were cited as a result of the request by the HIRA to 98 companies for administrative disposal. 80 unappealed or rejected complaints were selected as the final administrative disposal request companies and notified to the public health center. In the second half of this year, the administrative reporting criteria for the distribution number serial number of distributors have been raised from 50% to 55%. From July to December this year, after the first half of this year's accounting period, requests for administrative disposal of manufacturing import companies are applied from the serial number reporting rate in the second half of this year.
- Policy
- Severe atopic drug Dupixent listed, first benefit from RSA
- by Kim, Jung-Ju Dec 26, 2019 06:34am
- Sanofi Aventis' treatment for severe atopic dermatitis, Dupixent PFS 300mg (Dupilumab), will be listed next month after all of its reimbursment hurdles. Although it was not an anticancer drug or a rare disease treatment agent, there was a difficulty in expanding the RSA, but the government and the health authorities were able to follow this track as they decided to expand the RSA disease. The MFDS held a Health Insurance Policy Deliberation Committee this afternoon, saying Dupixent's reimbursement was resolved. Dupixent was the first to be listed due to the expansion of RSA diseases. According to the resolution, the drug is listed on the first day of next month as an RSA with a combination of initial treatment refund type, refund type and total limit type. The reimubrsed price is ₩710,000 per syringe. The RSA initial treatment reimbursement type included in this drug contract is the reimbursement by the pharmaceutical company to the NHIS for the initial period of time. In addition, the refund type refers to the pharmaceutical company refunding a certain percentage of the drug bill to the NHIS, and the total limit contract is the mechanism by which a pharmaceutical company refunds a certain percentage of the amount to the NHIS if the actual amount exceeds the pre-set annual expected cap. Dupixent entered the domestic market in earnest with the approval of the MFDS on March 30 last year. Following the application for insurance registration on Feb 22 this year, the Pharmaceutical Benefits Evaluation Committee (Pharmaceutical Committee) was determined to be eligible for RSA on July 25. Later, on October 10, Formulary approval was recognized. The drug price negotiations with the NHIS were held from Oct 22 to Dec 17. At the time of deliberation, the textbook and clinical guidelines indicated clinical usefulness in severe atopic patients who were not adequately controlled or recommended by local or systemic immunosuppressants. Indeed, the cost of one-day administration is more expensive than alternative drugs, but the cost-effectiveness is considered to be acceptable through additional RSA and economic evaluation. Looking at the prices of major seven countries (A7) referring to the prices, they are listed in the United States, Italy, the United Kingdom, France, Germany, and Japan, and the A7 foreign drug prices (adjusted average price) are set at ₩ 971,661 per syringe. Meanwhile, the annual fiscal expenditures (estimated billings) presented during the drug price negotiations with the NHIS are about ₩76.2 billion.
- Policy
- Unpaid medical benefits “fully solved next month”
- by Kim, Jung-Ju Dec 26, 2019 06:31am
- The government reflected the unpaid medical benefits in the budget of ₩100 billion in next year's budget. Most of this year's unpaid payments have been resolved, and the unpaid payments of nursing institutions, which appeared at the beginning & the end of the year, are being resolved somewhat. However, dues are reflected in next year's budget, and may occur partially in some regions. The MFDS said in a recent question by the Professional Reporters Council that the unpaid medical benefits to be received by nursing homes this year have been resolved by supplementary budget, and the budget has been secured by reflecting the expected unpaid payments next year. The medical care budget for next year is about ₩7 trillion, an increase of ₩600 billion from ₩6.4 trillion this year. The reimbursement per capita has increased by more than 16%, the MFDS said that it was first reflected in the budget to prevent unpaid payments. Looking at the budget by year, it is increasing by ₩4.59 trillion in 2015, ₩4.81 trillion in 2016, ₩5.24 trillion in 2017, and ₩5.61 trillion in 2018. Nursing institutions, including pharmacies and other hospitals, have complained of difficulties in management due to the delayed payment of medical benefits for several months at the beginning & the end of the year. According to the MFDS, Ministry of Health and Welfare Committee Seung-Hee Kim's report presented at the National Audit, the unpaid medical benefit in 2018 was ₩869.5 billion, the highest ever. This is an increase of ₩430.9 billion (98%) compared to 2017, which is doubled compared to last year. As a result, the unpaid amount reflected in next year's medical benefit budget amounted to ₩108.7 billion. However, the MFDS explained that due to the portion reflected in next year's budget, the unpaid amount may be partially generated in some attempts. The Ministry of Health and Welfare said, “We expect little delay in payment every year, and the nursing institutions like pharmacies and hospitals would take a breather”.
- Product
- Oral treatment by Sanofi has the highest number of defects
- by Kim JiEun Dec 26, 2019 06:30am
- Ten defects were found in the same product of the same company a year The Seoul Pharmaceutical Society (Chairman Dong-ju Han), the pharmacy committee (Vice chairman Yong-seok Choi, Head Commissioner Woo-young Chang, Soo-hyun Byun, and Tae-seok Kang), and the Pharmacist Guidance Committee (Chairman Kyung-Jin Jeon and Soo-Yul Lim) announced the results of the submission of bad drugs this year. The Seoul Pharmaceutical Society has received reports from member pharmacies since this year by promoting the operation of the bad drugs report center. According to the Seoul Pharmaceutical Society, a total of 174 cases were received and processed at 70 member pharmacies in 24 Seoul branches. The most common types of defective drugs received were simple damages (33 cases), including ▲shortage of 17 cases, ▲poor PTP packaging, ▲12 poor tablets wear, ▲8 poor inspections, ▲8 poor tablet and poor coating, ▲ Seven PTP and bad inspection ▲4 bad inspection, ▲4 bad sealing, ▲4 bad containers, ▲Three poor granulation and bad tablets. In addition, there were discoloration and change of appearance, mixing of other products, mixing of foreign materials, poor filling, and excessive quantities. The Seoul Pharmaceutical Society received the most reports with 10 cases of oral infectious drugs by Sanofi. It recently announced that a recovery action was requested for the serial number and expiration date. In addition, a total of 136 items were reported. The Seoul Pharmaceutical Society receives a reception for defective drugs through text messages (Tel: 010-3568-5811), and the member pharmacy receives the name of the department, the name of the pharmacy, the name of the pharmaceutical company, the name of the drug, the manufacturing number/expiration date, and the bad drug picture. The pharmacy society asked for information from member pharmacies as it could be used as a basis for data accumulation even when pharmacies and pharmaceutical companies (wholesalers) provided their own drugs. They also pointed out that even though there are many cases of drug shortages in pharmacies, it is not easy to pass on because of lack of proof. In this case, they also asked for active reporting. Chairman Dong-ju Han said, “Defective drug notification serves as an important stepping stone to improve the quality and to ensure the safety of patients by identifying the cause and preventing recurrence and awaits the participation of member pharmacies”.
