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- 2026-05-09 17:28:01
- Policy
- ₩2.8 billion will be invested in AI drug development
- by Kim, Jung-Ju Jan 02, 2020 06:09am
- The government will greatly strengthen investment in innovation growth in the biohealth sector, which is called the future food industry, such as the pharmaceutical industry and increased the budget by 13% to ₩527 billion, and doubled the budget by building big data, new drug development platform, and support for the development of the pharmaceutical industry this year. The MOHW responded to pending questions on the Korean Special Press Association. First, this year's total budget is ₩82.5 trillion, an increase of 13.8% from last year. Among them, the MOHW’s budget increased ₩1.35 trillion by 11.7%. Looking at the biohealth sector, which includes pharmaceuticals, investment for innovation growth in the pharmaceutical, medical data, and medical device sectors will be greatly strengthened. This year's major R & D budget for health care is ₩527.8 billion, up 13% from ₩466.9 billion last year. The amount increased by 60.9 billion won. The government will establish a new drug development platform utilizing the 4th Industrial Revolution technology and discover core experts in pharmaceutical and biotechnology. The AI drug development platform was set at ₩2.8 billion, up ₩300 million(11.1%) from last year's ₩2.5 billion. In order to innovate biohealth technology, the budget of ₩15 billion was also reflected in the development of big data platform for genome and medical clinical information. Bio big data development is a pan-government project in connection with the Ministry of Welfare, the Ministry of Science and ICT, and the Ministry of Trade, Industry and Energy. In addition, the government invest ₩9.3 billion, will newly select and support five medical data-centric hospitals. As the Advanced Renewable Bio Act comes into effect in August, a budget will be invested in establishing a regenerative medical safety management system. The Ministry of Health and Welfare decided to reflect the budget of ₩1.2 billion to establish a clinical research system for rare and intractable diseases and to establish a safety management system. In the case of medical devices, the MOHW decided to support R&D to commercialization and expand investment to strengthen industrial competitiveness. A total of ₩30.2 billion was newly organized for full-cycle R&D development, and a budget of ₩8.6 billion was increased by ₩3.9 billion(82.4%) year-on-year to strengthen industrial competitiveness. In addition, the cosmetics industry plans to raise ₩7.74 billion to support localization of materials and development of technology to respond to market diversification to foster sustainable future growth engines.
- Policy
- Lipiodol’s gap recurrence prevention law is pushed forward
- by Lee, Jeong-Hwan Jan 02, 2020 06:06am
- A bill, which the government is obliged to conduct regular surveys on the state of supply of essential medicines, to build a stable supply environment will be promoted. The legislative goal is to prevent the gap of essential medicines to prepare for major national disasters such as terrorism and radioactive pollution. Representative Myung-yeon Kim of the National Assembly's Health and Welfare Committee (Danwon gu, Ansan, Liberty Korea Party) presented the proposed amendment to the pharmaceutical affairs law on the 30th. Under the current law, national essential medicines are necessary for health and medical services such as disease control and radiological disaster prevention, but they are difficult to supply in a stable manner due to lack of marketability. Related departments, such as the MFDS, are designating and managing 351 items. But Representative Kim criticized that the vast majority of emergency medicines for terrorism and radiological warfare were less than a tenth of statutory reserves. In particular, in 2018, the sale of special contrast agent 'Lipiodol', which is used to treat liver cancer, was stopped. In January of this year, anxiety arose due to unstable supply of essential drugs, such as the anti-cancer and glaucoma drug ' Mitomycin', which is in danger of being stopped. In order to solve the problem, Representative Kim said he proposed an amendment to the Pharmaceutical Affairs Law that strengthens the responsibility for the Agency to function as a national essential drug control center and specially manages the supply situation such as complete enumeration of the expiration date. Representative Kim said, “The current stockpile and stockpiling location of essential medicines are not well understood, and it is expected that this amendment will proactively respond to national emergency situations”.
- Policy
- Report find MFDS cleared 112 IMDs in past decade
- by Lee, Tak-Sun Jan 02, 2020 06:05am
- Apparently, more than half of incrementally modified drugs (IMDs) approved in the past decade were combination drug. And majority of them were approved for treating chronic disease. On Dec. 30, Korea’s Ministry of Food and Safety (Minister Lee Eui-kyung) published ‘IMD Approval Report’ reviewing current status and past cases of approved IMDs. The report was compiled to inform the IMD-developing companies of approval criteria, approval failed cases and a list of all approved IMDs in the past decade, since the IMD approval was implemented from 2008, to enhance the predictability of the approval system. The report found the total of 112 IMDs has been cleared from 2009 to last November. Breaking down the approval list, 62 items (55.4 percent) ‘improved effectiveness,’ 39 items (34.8 percent) ‘improved usability,’ seven items (6.3 percent) was ‘recognized with innovativeness of pharmaceutical technology,’ and four items (3.5 percent) ‘improved safety.’ 62 items, recognized with improved effectiveness, were all combination drugs (two or more active ingredients are combined as one item). Among which, 52 items were dual agent combination drug and ten items were triple agent combination drug. 39 items, recognized with improved usability, were approved with decreased dose or more convenient administration method providing better drug adherence. Approved IMDs from 2009 to Nov. 2019 Breaking down the list again by class, 47 items (40.4 percent) were for cardiovascular and circulatory system drugs (antihypertensive, anti-arteriosclerotic drug), while 16 items (14.3 percent) were anti-diabetic drugs. It was apparent the majority of IMDs were developed for chronic disease (hypertension, hyperlipidemia, diabetes and etc.). The key finding was that Korea entering the era of aging society is resulting in increased chronic disease, and accordingly, pharmaceutical companies have developed more drugs with simplified multiple drug dose or administration method for better drug adherence. Analyzing the drug development types, 70 items (62.5 percent) improved safety (reduced adverse reaction) or effective (increased treatment effect) and 29 items (25.9 percent) improved dose and administration by lessening frequency of administration (twice-daily to once-daily, or three times-daily to twice-daily). MFDS official explained, “We expect the report would provide practical information to Korean pharmaceutical companies currently developing or preparing drugs in different types. The ministry would continue to provide more useful information to the industry for developing new drugs.”
- Policy
- Keytruda-Lenvima already got 9 trials approved in Korea
- by Lee, Tak-Sun Dec 31, 2019 05:51am
- MSD Korea and Eisai Korea are conducting a series of clinical studies in Korea to confirm cancer-treating efficacy of combination therapy of immunotherapy Keytruda (pembrolizumab) and targeted therapy Lenvima (lenvatinib). In Korea alone, nine clinical protocols on the combination therapy have been approved. The pharmaceutical industry is keeping close eyes on how the immunotherapy market leading PD-1 inhibitor Keytruda and new targeted therapy for liver cancer after a decade-long wait would create synergy effect together. On Dec. 30, Korea’s Ministry of Food and Drug Safety (MFDS) granted approval on Phase 3 clinical trial protocol for Keytruda-Lenvima combination therapy treating patients with metastatic or recurrent head and neck squamous cell carcinoma (HNSCC). The trial would be conducted in 12 university hospitals in Korea comparing efficacy of Keytruda monotherapy. Two companies have reported already nine protocols of Keytruda-Levima combination therapy have been approved in Korea alone. Since Phase 3 trial for combination therapy treating patients with advanced hepatocellular carcinoma (HCC) was cleared, the pharmaceutical companies have conducted clinical trials for treating patient with advanced melanoma, solid tumor with previous treatment record, metastatic HNSCC non-small cell lung cancer (NSCLC), and for treatment-naïve metastatic NSCLC patients with tumor proportion score higher than one percent. Moreover, the Korean government body granted approval on the combination therapy’s trials confirming safety and efficacy on previously treated participants with metastatic NSCLC and progressive disease after platinum doublet chemotherapy and immunotherapy; participants with advanced or recurrent endometrial cancer; and cisplatin-ineligible participants with a Programmed Cell Death-Ligand 1 (PD-L1) or participants ineligible for any platinum-containing chemotherapy regardless of combined positive score with advanced unresectable or metastatic urothelial carcinoma. Eight out of nine trials are Phase 3, and two are targeting patients with a specific solid tumor. Co-commercializing the two treatments under a strategic collaboration, MSD and Eisai have also started their co-sales and marketing of the two treatments from January this year. The companies have been running transnational trials of the combination therapy since March 2018. The fruitful results from the trials are expected to expand Lenvima’s indication on other types of cancer, besides already-cleared indication for first-line treatment of liver and thyroid cancer, and raise cancer treatment success rate.
- Policy
- Maviret, liver & kidney transplant patients benefit extended
- by Kim, Jung-Ju Dec 31, 2019 05:51am
- Liver and kidney transplant patients will be expanded and added to the administration of adult chronic hepatitis C treatment drug, Maviret (Glecaprevir + Pibrentasvir), and the reimbursed period of administration will be divided. reimbursed indication of Jext inj (Epinephrine bitartrate)150μg is changed to anaphylaxis, and covered up to two pens a day. The MOHW recently revised some of the details of the 'applicable criteria and methods of reimbursement benefits'. The effective date is January 1 of next year. Looking at the major revisions, Reimbursement of liver or kidney transplant patients for Maviret have been extended and the dosing period has changed due to a change in permit. It is noted here that the permit changes to 8 weeks when patients with cirrhosis have genotypes 1 to 6 who have no previous treatment experience. The administration target is changed to anaphylaxis in 150 μg of Jext. This is possible when prescribing discharge after anaphylaxis treatment or when prescribing to patients with a history of anaphylaxis. In addition, the reimbursement will be extended to allow up to two pens at a time. The diagnostic criteria of Repatha inj(Evolocumab) for homozygous familial hypercholesterolemia has been changed to be the same as the registration standard for the exception. Benefits will also be extended to additional indications: hypercholesterolemia and mixed dyslipidemia and atherosclerotic cardiovascular disease. In the case of steroid injections, such as Jeil Dexamethasone inj, the allowance was exceeded and the benefit could be granted for the purpose of preventing fetal complications in pregnant women at risk of preterm birth. In addition, patients with Guillain-Barré syndrome with human immunoglobulin G injections, such as IV-Globulin SN inj 50ml, were changed to ‘unable to walk without aids or other people’ without the MRC score, and reimbursement is approved for the second dose to refractory Kawasaki disease and atypical Kawasaki disease.
- Policy
- IMD pricing reduction dispute to continue on
- by Lee, Jeong-Hwan Dec 30, 2019 09:48pm
- Pharmaceutical industry and lawmakers are reprehending the government for not laying down any specific plan, despite their demand for the government to abolish or revise the pricing reduction policy on new incrementally modified drugs (IMDs). The criticism is on the lack of any follow-up action from the government, although Minister of Health and Welfare Park Neung-hoo at the National Assembly annual audit session agreed with the lawmaker’s concern about reducing incrementally modified drug pricing and stated he would revisit the matter. According to the industry sources and a few of lawmakers of the National Assembly Health and Welfare Committee on Dec 29, Ministry of Health and Welfare (MOHW) has not disclosed a detailed policy revision plan as demanded. The industry and the lawmakers claim IMD is a uniquely competitive cash cow and stepping stone for the emerging Korean bio and pharmaceutical industry that would leverage Korea to become a new global pharmaceutical powerhouse. Ultimately, abolishing pricing benefit for IMD would impair pharmaceutical industry’s advancement and their commitment to develop new drug. Such point was clearly made when the Health and Welfare Committee-affiliated Democratic Party lawmakers, Nam In-soon and Oh Jae-sae, questioned Minister Park directly at the National Assembly audit session. The issue fired up the lawmakers and the industry when MOHW issued a notice on the generic pricing regulation revision, which would apply the same early pricing reduction regulation as generic on the IMD to reduce the pricing after maximum three years a same class generic is launched. Although the generic pricing reduction may be inevitable, the industry insists pricing benefit on IMD should be maintained as it is associated as a drug with innovativeness-recognized data. A Health and Welfare Committee lawmaker’s office official pointed out, “The National Assembly audit has raised the same issues on the IMD pricing reduction policy numerous times, and the minister has said he would look into the matter. But the ministry has now followed up with any plan for months now.” “The Special Act on Fostering and Support of Pharmaceutical Industry that passed the National Assembly plenary session clearly provides pricing benefit on IMD. Basically, the government is removing regulations the lawmakers have regulated. Recklessly lowering drug pricing would eventually harm the quality of drug product directly affecting the people’s health. We suspect the recent valsartan contamination issue broke out, partially because the companies were pushed to use competitively low-priced active ingredients due to the past drug pricing reduction,” the official elaborated. A director of drug development department at a medium-sized pharmaceutical company urged, “Fundamentally, we understand the government’s intent and logic behind the pricing reduction. They are trying to reform the Korean pharmaceutical industry’s present business model centering generic. Although we agree with the intent, their actions are too fast and too unrefined. Their message would come across fine regulating only against generics while maintaining the benefit for IMDs.” “The Korean pharmaceutical industry has already well-noted the government’s intent to redirect the industry’s effort on new drug development with the revised generic pricing reduction regulation. It would make a better sense for pharmaceutical industry and government to cooperate and together leap as an emerging pharmaceutical powerhouse than to strictly regulate IMD pricing,” said the director. However, MOHW begs to differ and argues drug pricing regulation is essential for Korea to become a new global pharmaceutical powerhouse. At a recently convened drug pricing-related policy seminar, the ministry reiterated its aim to significantly raise the proportion of new drug expenditure within the National Health Insurance (NHI)-covered drug expenditure breakdown. In other words, the ministry means to significantly cut down the NHI expenditure on expensive generic and IMDs. At a seminar convened last month by Korean Research-based Pharmaceutical Industry Association (KRPIA) about the social value of new drug and management of NHI, MOHW expressed its commitment to shift the NHI expenditure management towards new drug and explained, therefore, regulating the pricing of generic and IMD is unavoidable. A MOHW official at the seminar stated, “Other pharmaceutical powerhouses do not spend as much as Korea does on generics. Off-patent drugs should exit the market and inexpensive generic should fill up the market instead. While we needed to reconstruct the pharmaceutical expenditure structure itself, we happen to have reformed the generic pricing regulation first as a transitional step.” As a result, the pharmaceutical industry and lawmakers, and government would continue to clash about the IMD pricing benefit and regulation.
- 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.”
- 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.
