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- 2025-12-24 10:01:32
- Policy
- Recruitment of 733 COVID-19 cured patients was completed
- by Lee, Hye-Kyung Aug 03, 2020 11:06am
- 1098 patients who were cured revealed their willingness to participate in the development of COVID-19 blood plasma, of which 733 were recruited. At the regular briefing held on the 30th, Kwon Jun-wook, Deputy director of the Central Disease Control Headquarters said, “Recruitment of 733 plasma for cured patients was completed and recovery plasma collected from 6 medical institutions, apart from blood plasma treatment, were from 23 COVID-19 patients." In relation to reports from the foreign media that the duration of the COVID-19 vaccine will be limited to 1 year, he said, “In the case of DNA or mRNA vaccine, the immunity disappears quickly even if the immunity reaches a certain level after 2 doses. There are experts who argue that defense is possible to some extent by being stored in the so-called immunity of the so-called T cells, apart from the loss of immunity.” He said, “Depending on the platform of the four vaccines, the defense, level of defense, and persistence at the time of inoculation of each vaccine, and if it does not persist, whether or not additional vaccination should be given, such as influenza that must be continuously inoculated at regular intervals, it is a situation to do research and analysis." Regarding the point that vaccine development is being delayed while emphasizing stability unlike the United States, he said, “In the case of phase III clinical trials, it usually takes more than a year or two.” Kwon said, "One year, in some cases, in six months, and in some cases, in some countries, the practical use of the vaccine is mentioned even before phase III clinical trials." It is very likely that this is a temporary immunization of the consultation or through such an institutional procedure. In that case, safety is the biggest challenge, not to mention effectiveness.” There were 7 new COVID-9 confirmed patients in Korea, 11 cases of foreign inflows, and the total cumulative confirmed number was 14,269. Currently, 63 new quarantined patients were released and 837 are currently in quarantine.
- Policy
- The promotion for the KCDC are in progress
- by Lee, Jeong-Hwan Aug 03, 2020 11:05am
- On the 28th, the Public Administration and Security Committee held a general meeting without any member of the opposition party, and decided to amend the government organizational law, which included the introduction of multiple vice ministers by the MOHW and the promotion of the KCDC to the Disease Control and Prevention Service. As a result, multiple vice ministers and the promotion of the KCDC leave only the judicial review and review procedures of the Legislation & Judiciary Committee The core of this amendment is the introduction of multiple vice ministers including separate vice minister for health, to strengthen the expertise of the health service and to strengthen the ability to respond to new infectious diseases such as COVID-19 by promoting the KCDC to the Disease Control and Prevention Service. On this day, the Public Administration and Security Committee also decided to amend the Basic Act on Disaster and Safety Management, including expanding the scope and methods of financial support in relation to the COVID-19 economic crisis. The amendment contains provisions to indemnify public officials and employees of public and financial institutions for the consequences of aggressive administration in the financial support process. Members of the United Future Party objected and missed the meeting because the ruling party proposed without limitation the local tax exemption laws and government organization laws related to real estate.
- Policy
- MFDS to independently investigate data manipulation
- by Lee, Jeong-Hwan Jul 31, 2020 06:33am
- Director Kim Sang-Bong of Biopharmaceuticals and Herbal Medicine Bureau at MFDS (left) and Democratic Party Lawmaker Kang Byungwon “This day in K-Bio is a hurdle we have to overcome to become the new drug developing country that tackles unmet medical needs. But we have already started working on creating fertile grounds to leverage the Korean-made pharmaceuticals in the global market by utilizing this hurdle as an opportunity to tighten administrative investigational power.” On July 29, South Korea’s Ministry of Food and Drug Safety (MFDS) official declared relevant regulations would be tightened for the ministry to independently investigate data manipulation among approved and distributed pharmaceuticals without the help of prosecutors. A discussion panel on strengthening business ethics in pharmaceutical industry was convened by Democratic Party Lawmaker Kang Byungwon, where Director Kim Sang-Bong of Biopharmaceuticals and Herbal Medicine Bureau participated as a panel and presented the ministry’s plan to reinforce quality control in biopharmaceuticals. MFDS means to assertively extend administrative power to prevent previous scandals like revoking marketing licenses of Kolon Life Science’ Invossa and Medytox’ Meditoxin due to their accusation of manipulating data for their biopharmaceutical approval review. Director Kim addressed recent issues like Invossa and Meditoxin and said “ethics and morals in advanced biopharmaceuticals” are the crucial matters to contemplate on at the moment. And he said Korea’s pharmaceutical industry of today stepped on to a phase of developing drugs to treat disease that has never been cured before. The director urged, “The K-Bio is shooting for two key goals of growing the industry and curing diseases. In the process, we have forgotten ethics and morals as if they were like oxygen,” and “unfortunate events like data manipulation and license revocation occurred. We need to mark these events as a turning point.” Director Kim noted it was regrettable that MFDS’ investigation was unable to fully disclose the detailed causes of data manipulation incident, whereas the judicial authority did. Accordingly, the director promised to considerably strengthen the ministry’s current administrative investigational power. His vision is to improve the current macro approach of MFDS evaluation standards and system, to take micro approach to match the speed of advanced biopharmaceutical development, and to systematically enhance the competency of MFDS reviewers in charge. The director elaborated, “The existing segmentalized but short and simple evaluation standards have been expanded to cover 109 items. This would mark the beginning of enhancing administrative investigational power,” and “compared to synthetic pharmaceuticals, advanced biopharmaceutical needs frequent intervention of observer’s objective evaluation. As the future of the industry like cell therapy and gene therapy require close attention, the precedent data manipulation cases cannot be treated as a simple incident.” Director Kim said, “The ministry goal is not to target the judicial authority, but to build a system for the ministry, as an administrative authority, to directly investigate data manipulation,” and “it would require securing general investigational capability, instead of relying on a few reviewers’ specialty.” The director also pin pointed, “The pharmaceutical companies may feel that the ministry is taking a medical evidence-based approach. In the past, a company with archived record was able to dodge the penalty, but they would be penalized without photographed evidence from now on,” because “the ministry would consider it as data manipulation, if a company cannot retrospectively prove the evidence according to the disclosed approval standards agreed upon the industry.” This is the ministry’s effort to step away from the past of concentrating on enhancing the global credibility of the Korean-made drugs. But now the ministry aims to create a ground to develop new drug for the unmet medical needs. The ministry intends to take Invossa and Meditoxin incidents as an opportunity and ask the industry, government, academic societies and the people to play their roles in evolving the Korean pharmaceutical industry. The director concluded, “Expanding the evaluation standards up to 109 items is only a beginning. It would be fine-combed to eradicate any loophole of data manipulation.” He also stressed, “This is relevant to all bio and pharmaceutical industries, not just for specific company or incident.” Lawmaker Kang Byungwon, the organizer of the discussion panel, compared the Invossa and Meditoxin incidents to the Volkswagen’s scandal of cheating the pollution emission test and said he would fully support for the legislation of preventing unethical business practice. Based on his experience of passing the bill to prevent Volkswagen incident and imposing reasonable fine on the responsible company, Lawmaker Kang aims to create an environment for the pharmaceutical industry to never repeat the data manipulation incidents again. The lawmaker urged, “The Korean industries have been blindly advancing forward without looking back. The process did not matter as long as the outcome was satisfying. But such behavior cannot lead Korea to become a developed country, and achieving K-Bio is impossible.” He noted, “The consumers who purchased the imported automobiles did not realize how they were damaging their own body. But the company knew exactly. When the Korean pharmaceutical industry realizes the gravity of their responsibility, it would finally become a global pharmaceutical industry.”
- Policy
- “Primary care-based remote medicine as a supplement"
- by Lee, Jeong-Hwan Jul 30, 2020 06:20am
- Professor Hong Yun-chul at Seoul National University Hospital (left) and Secretary General Jeong Ji-yeon at Consumers Union of Korea To respond against novel infectious disease like COVID-19 and super-aged society, experts claim the South Korean society should prepare for an introduction to digital healthcare and remote medicine. In particular, the experts pointed out the remote medicine (non-contact medical care) would not replace the traditional medical care, but it should take root in the society as supplementary care for senior patients and other medically invulnerable community. The experts added the remote medicine should be limited to local clinics practicing primary care to balance out efficiency and equality. At a seminar convened at National Assembly Library on July 29, Professor Hong Yun-chul at Seoul National University Hospital and Secretary General Jeong Ji-yeon at Consumers Union of Korea (CUK) said the above while discussing about plans to strengthen local community primary care competency and digital healthcare. Professor Hong and Secretary General Jeong giving a presentation argued a foundation to utilize digital healthcare and remote medicine in the society should be built. Professor Hong stated COVID-19 and super-aged society have further extended the needs to bring digital healthcare into the social system. While the people and the society are demanding new responsive strategy amid pandemic, the post-coronavirus medical strategy is becoming increasingly more relevant to the society. Professor Hong named it the ‘Post-coronavirus Public-private Collaborative Medical System.’ The system aims to realize Smart medicine based on an integrated platform consisting of state university hospital, regional hospital, public healthcare center and local primary care provider. The professor elaborated the public-private collaborative medical system can be activated by comprehensively utilizing digital healthcare technology in society and medical system and focusing remote medicine on primary care. Professor Hong said, “Since the outbreak of COVID-19, we have actually been in the times of crucial societal changes. The current society is experiencing a historic increase in senior citizens,” and “the society would struggle to support the senior patients in two decades time. Basically, a system should be constructed for the digital healthcare to help senior citizens to maintain their good health.” The professor stated, “In the end, medical care in close enough proximity should be provided. The role of a personal doctor in the center of primary care would be the key.” The professor added, “Remote medicine is a hot potato. The entire competitive system would be faltered when remote medical practice in primary, secondary and tertiary healthcare institute is allowed; primary care providers cannot sustain the competition.” Professor Hong further explained, “Ultimately, the remote medicine should be supported by the government to be applied around local community primary care and utilize personal doctors for it,” and “face-to-face medical care is a principle that should not be shaken. Remote medicine is merely a supplementary tool.” Secretary General Jeong urged the remote medicine should be introduced as a medical system that enhances convenience for the consumers. Her point was healthcare consumer and providers should not blindly oppose against infection- preventive and beneficial remote medicine, but discuss where to put a safety tools in the system. Secretary General Jeong was also against providing non-contact medical service from the beginning of the medical care. She explained using remote medicine as a supplementary tool after a personal doctor sees a patient would be closer to the answer. Secretary Jeong insisted sufficient discussion should be conducted regarding opposing opinion or criticism against remote medicine like commercialization of medical service, and the government should draw up a reasonable means to adopt the system. The secretary general stated, “The remote medical service should be practiced for the consumers. Already experiencing COVID-19, the non-contact industry is rapidly permeating through the society,” and “remote medicine is not optional, but necessary for the society. But it should be a system to support the traditional medical service based on primary care.” Secretary General Jeong added, “Remote medicine should serve a role of completing the patient-centered medical service. The success of primary care-based remote medicine would be only possible, when medical service consumers’ trust is prioritized,” and “also, the introduction of the remote medicine should be discussed from the perspective of improving access to medical service in the age of digitization and aged society.”
- Policy
- Biosimilars are growing at 52% among pharmaceutical exports
- by Lee, Hye-Kyung Jul 30, 2020 06:18am
- Pharmaceutical exports in the first half of this year were $3.8 billion, up 52.5% from the previous year's $2.5 billion. Biosimilars account for 52% of export items ($1.98 billion). he KHIDI (Director, Deok-cheol Kwon) held a press conference at 11:00 am on the 29th and announced major performance trends such as health industry exports, jobs, and management performance in the first half of 2020. The announcement was made by the director of the Health Industry Innovation Planning Team, Dong-Woo Han. In particular, in the first half of this year, despite the deteriorating external conditions caused by the worldwide spread of COVID-19, the domestic health industry emerged as a growth export industry as it was rated as a 'K-defense' model country. Since the occurrence of COVID-19, exports of diagnostic devices and sanitary products have surged, and domestic biopharmaceutical exports have continued to expand, ranking sixth in the export rankings, rising four levels compared to the same period last year. ◆Export trends in the first half of this year=exports of the health industry in the first half totaled $9.6 billion, followed by pharmaceutical products of $3.8 billion, cosmetics of $3.4 billion, and medical devices of $2.3 billion. In the case of pharmaceuticals, exports of domestically produced disinfectants (Korea Customs Service's import and export classification HSK 3808940000) increased explosively ($3.35 million → $230 million) compared to the same period last year, and exports increased 52.5% year-on-year. Exports to the United States, where COVID-19 is continuously spreading, surged since March, accounting for 52.1% of total disinfectant exports, followed by 25.6% in Japan and 5.4%. in China. The countries that export biosimilars are Germany ($640 million), the United States ($350 million), Turkey ($320 million), and Belgium ($160 million). Exports of medical device diagnostic products have increased significantly since March, and have exported $730 million in the first half of the year to 173 countries such as the United States, Brazil, India, and Italy. This is 31.4% of total exports. However, despite increasing exports of diagnostic products, ultrasound imaging equipment (US$50.1 million → US$15 million) and implants (US$54.5 million → US$48.8 million), faced disruption in face-to-face operations in China, suspension of dental operations, and reduction in inpatients after COVID-19 For example, sluggish earnings also contributed to the decline in exports. The total number of workers in the health industry in the first half of this year was 931,000, an increase of 29,000 compared to the same period last year. By sector, drugs were 74,000, medical devices 52,000, cosmetics 37,000, and medical services 768,000. In the field of pharmaceuticals, the number of workers increased 4.2% compared to the same period last year due to the development and investment of influenza vaccines caused by COVID-19. Among the detailed industries, the number of drug manufacturing workers increased by 2,043 compared to the same period last year, the largest increase, and the manufacturing of pharmaceutical compounds and antibiotics increased by 533. ◆Management performance in the first quarter of this year=280 companies listed in the health industry, and the total sales amounted to ₩1.07 trillion, an increase of ₩1.1 trillion compared to the same period last year. In terms of sales growth by sector, pharmaceuticals are 20.5%, medical devices 28.2%, and cosmetics 5.6%. The R&D expenditure amounted to ₩800 billion, accounting for 41.5% of pharmaceuticals and 7.4% of medical devices. 156 companies were listed in the first quarter, with sales of ₩6 trillion. Despite the COVID-19, the domestic prescription drug market rose slightly, and the sales of pharmaceutical companies increased due to increased sales of biosimilar products to the European and US markets. n particular, Celltrion Healthcare's biosimilar products are accelerating to the U.S. (Inflectra, Truxima, Herzuma), and biosimilar products are continuing to be popular in Europe (Ramshima SC) and Chong Kun Dang's existing flagship items and the growth of newly introduced items (Kcab Prolia) has been strong. Sales growth by pharmaceutical companies increased by 159.6% for Celltrion Healthcare, 80.5% for Celltrion, 25.2% for Chong Kun, 65.3% for Samsung Biologics, and 41.1% for Dong-A ST. The KHIDI predicted that the domestic pharmaceutical industry will continue to maintain its competitive edge over global pharmaceutical companies by preoccupying the market by launching new products and expanding prescriptions for biosimilar products in Europe and the US. ◆Accelerated advancement into biosimilars =The creation of high value-added products through the expansion of global market share, such as the launch of new drugs in the global market and the expansion of overseas technology transfer, led to the export of medicines. Among domestic pharmaceutical companies, Celltrion and Samsung Bioepis are preoccupying the market by obtaining first biosimilars in Europe and the United States. In the European market, Ramsima accounted for 60%, Trukshima 39%, and Hersuma 19%. As of January of this year, the status of domestic and overseas biosimilar licenses obtained at domestic and international markets is as follows: Celltrion’s Remsima, Truxima, and Herzuma, Samsung Bioepis’ Benepali, Eticovo, Flixabi, Renflexis, Imraldi, Hadlima, Ontruzant, and Samfenet. “The global economy and supply chain uncertainty have increased due to the prolonged COVID-19, but the domestic health industry has maintained growth compared to other industries, such as exports, jobs, and management performance, until the first half,” said Dong-Woo Han. He emphasized, "In the future, the domestic health industry needs to support policy to preemptively prepare for the post COVID-19 era by accelerating the Korean version of the new deal, such as strengthening the D.N.A ecosystem and non-face-to-digital transformation."
- Policy
- NECA, the safety and effectiveness of Epidyolex & Sativex
- by Lee, Hye-Kyung Jul 30, 2020 06:17am
- The NECA announced on the 28th that it has drawn the first social consensus on the safety and effectiveness of Epidyolex and Sativex, a hemp-derived drug approved in Korea. Recently, With Byung-Joo Park, Professor of the Department of Preventive Medicine, Seoul National University, Young-Chul Kang, Professor of Department of Pediatrics, Severance Hospital, Ji-Eun Kim, Professor of Department of Neurology, Ewha Womans University Seoul Hospital , Won-Gu Lee, Professor of Kosin University Gospel Hospital, Jae-Moon Kim, Professor of Chungnam National University Hospital, Won-Chul Shin, Professor of Kyung Hee University Hospital, Chang-Woo Han, Professor of Gangnam Eulji Medical center, Dong-Kyung Hur, representative of the Korea Bureau for Epilepsy’s patients family, and Dong-Chan Cho, SBS Medical Journalist , a round-table conference was held with the theme of providing the right information on the hemp ingredient medicine. This round-table conference allowed limited use of hemp for medical purposes after the revision of the Act on the Management of Narcotics, but as information lacking evidence spread indiscriminately, it aims to present the correct information about the safety and effectiveness of hemp drug products and the potential for expansion of indications. The scope of the agreement is limited to Epidiolex (CBD) and Sativex (CBD and THC complex), which are approved for handling by the MFDS and used in domestic clinical trials. As a result of the round-table meeting, Epidiolex was evaluated to have side effects such as drowsiness, dizziness, and headache, but the potential dependence of the drug was not high. Sativex may also cause side effects such as headache and dizziness, but it is acceptable and the drug dependence is not high. However, it is necessary to fully discuss the benefits and risks of taking medicine with medical staff and patients, and that dependence should be followed up. In the case of effectiveness, Epidiolex has the effect of reducing seizures in some patients with epilepsy syndrome (Dravet's syndrome, Lennox-Gasto syndrome), and Sativex has the effect of improving stiffness and pain in patients with multiple sclerosis. In this agreement, the possibility of expansion of indications for hemp component drugs was examined, and the necessity of further research necessary for this was suggested. Based on the research findings that the hemp drug is effective against adult epilepsy, Alzheimer's disease, Parkinson's disease, neuropathic pain, Huntington's disease, Tourette's syndrome, sleep apnea, and brain tumors, participants of the roundtable agreed to the possibility of future indication expansion. They emphasized that the establishment of an effective management system for the accumulation of reliable clinical evidence observed over a long period of time and prevention of misuse should be preceded. “This round-table conference has great significance for improving the social prejudice or misconception about hemp-based medicines and suggesting the first milestones that can be prescribed to patients in need,” NECA Director Kwang-Hyup Han said, "We will make an active effort with various stakeholders to produce and spread the correct information based on."
- Policy
- Nesp, cheaper than biosimilar due to voluntary price cut
- by Lee, Tak-Sun Jul 29, 2020 09:45pm
- Original Nesp (top) and Biosimilar Nesbel (bottom)The second-generation EPO 'Nesp' (Darbepoetin alfa/Kyowa Kirin, Korea) has become cheaper than biosimilar through voluntary cuts in insurance premiums. According to the MOHW, as of August 1st, Nesp cut its insurance upper limit by 12.5% for each dose. Accordingly, in the case of Nesp PFS 20, it was lowered from \19,898 to \17,411. Last year, Chong Kun Dang, which released Korea's first biosimilar 'Nesbel', also voluntarily cut the price on the same month. However, the price was reversed because the difference in price cuts was less than that of Nesp. Nesbel PFS 20 was priced at about \17,908 from \19,898, about 500 won higher than Nesp. Insurance cap trend for Nesp and NesbelNesbel was registered at 80% of the original in April of last year. The 80% drug price compared to the original is the highest price that a biosimilar can receive. In Korea, biosimilars can receive an insurance premium of up to 70% of the original before expiration of patents, but up to 80% for innovative pharmaceutical companies. Chong Kun Dang was included in the innovative pharmaceutical company and received the highest price of 80%. In the case of the original drug, when the biosimilar is registered, the upper limit is lowered by 20% to 80% of the previous price. Accordingly, from May 8 of last year, Nesp and Nesbel were insured at the same price. However, the price difference occurred when both drugs were voluntarily cut, and the original company's cut was even larger, leading to a reverse phenomenon. Nesp is a second-generation anemia treatment drug based on Darbepoetin alfa. It is a drug that is frequently used for the treatment of anemia in a patient suffering from chronic renal insufficiency . Chong Kun Dang entered the market for the first generic in Korea after developing Nesp biosimilar in 2012. It was also approved in Japan last September. However, it is only a short time since it was released, and sales are largely different from the original. According to data from IQVIA, Nesbel recorded sales of \400 million in Korea in the first quarter, and Nesp posted a performance of \5.7 billion in the same period. However, Nesp suffered negatively 14.9% decrease in sales compared to the same period last year. The voluntary drug price cut is also determined to win the biosimilar competition. It is noteworthy how the market will react when the original becomes cheaper than the biosimilar.
- Policy
- Tecentriq combo wins coverage as first-line on NSCLC
- by Lee, Hye-Kyung Jul 28, 2020 06:37am
- Roche Korea’s Tecentriq (atezolizumab) is to receive coverage on treating patients with non-small cell lung cancer (NSCLC) as a first-line treatment. South Korea’s Health Insurance Review and Assessment Service (HIRA) disclosed the revised notice on anticancer treatment with the said update, which would accept public opinion on the revision until July 28. Combined with carboplatin and etoposide, Tecentriq has been indicated as a first-line treatment in patients with extensive NSCLC. HIRA apparently reviewed textbook, guideline and clinical literature to expand the reimbursement standard. The government body confirmed the National Comprehensive Cancer Network (NCCN) guideline prefers (Category 1) the combination therapy as a first-line treatment in patients with extensive NSCLC. Moreover, Phase III trial ‘IMpower 133’ confirmed the combination therapy showing statistical improvement in the median overall survival (mOS) by two months (12.3 months vs. 10.3 months) and median progression-free survival (mPFS) by 0.9 months (5.2 months vs. 4.3 months) compared to the control group. The coverage expansion was granted as most of patients with extensive NSCLC have short survival time (eight to ten months) and extremely limited anticancer treatment options. But in Korea, immunotherapy can be used only in healthcare institutes capable of responding on emergency cases of unpredicted adverse reaction, and administered by a well-experienced doctor with sufficient knowledge in anticancer therapies. Accordingly, a healthcare institute and patient using Tecentriq would have to submit information on using the treatment with coverage to the president of HIRA. A patient’s coverage would last for a year. HIRA has also decided to approve reimbursement on on-label use of Casodex (bicalutamide) in patients with prostate cancer as Category 1 single or combination anticancer treatment. As a measure to improve review expertise and transparency standard, a Category 1 single or combination therapy in prostate cancer newly added bicalutamide.
- Policy
- Copayment of Choline alfoscerate other than dementia is 80%
- by Kim, Jung-Ju Jul 28, 2020 06:36am
- The government's commitment to the re-evaluation of the already listed Choline alfoscerate was clear, and the results of the re-evaluation of Choline alfoscerate, which had strong social demands, eventually ended up maintaining the benefits only for dementia. The government left only the task of applying the revision after making an administrative notice to revise the relevant notice. If it proceeds sequentially, it may be implemented at the end of next month. The MOHW held the 13th general meeting of the Health Insurance Policy Deliberation Committee this afternoon (24th), and proposed and reported the Amendment of the Pharmaceutical reimbursed list and the upper limit table. The Pharmaceutical Benefits Evaluation Committee conducted a deliberation by the Pharmaceuticals Post-Assessment Subcommittee on the 4th of June and the 11th of the Committee, gathered industry opinions such as pharmaceutical companies from the 12th to the 13th of this month, held a round-table meeting with the Pharmaceuticals Association on the 16th In addition to 81 pharmaceutical companies, the Korean Neurological Association, the Korean Neurosurgical Society, and the Pharmaceutical Society for Health Society submitted different opinions surrounding Choline alfoscerate to the HIRA. Pharmaceutical companies generally lowered the copayment for selective benefit from 80% to 50% for brain-related diseases in consideration of social needs ▲submitted severe brain-related disease literature ▲high-priced alternatives had no effect on financial savings ▲Procedure lack of transparency ▲After deriving the results of clinical re-evaluation from the MFDS, it was suggested to adjust insurance benefits. Subsequently, the HIRA hled a subcommittee on the 21st of this month and decided to maintain the re-evaluation and put it up on the 23rd. As a result of the review by the Pharmaceutical Evaluation Committee ▲selective benefit is considered in social needs, but the minimum benefit rate is required because the clinical usefulness is insufficient. ▲The submitted documents are already reviewed as data on patients with dementia that may occur due to stroke, etc. Data ▲ Among 5~6 prescriptions for inexpensive alternative drugs ▲Procedures such as public hearings, deliberation and review of health ratings, and opinions from pharmaceutical companies are undergoing legal procedures. The MOHW plans to announce and revise the proposed amendment to 'a partial revision of Criteria for Adjustment and Method on Reimbursed services' during next month as the report of the Deliberation Committee is completed. In this case, it can be applied even at the end of August. Therefore, according to the government's will, it is expected that the reduction of Choline alfoscerate benefit will be implemented in late August or September. On the other hand, the efficacy of this drug is ▲ secondary symptoms due to cerebrovascular defects and deterioration in memory, confusion, and decreased concentration due to degenerative or degenerative cerebral stromal syndrome ▲ emotional and behavioral changes ▲ sensible pseudodepressiveness, for clinical usefulness. The dementia-related disease with evidence (within the efficacy effect) maintains benefit, and other diseases with insufficient evidence are converted into selective benefit (copayment rate: 30→80%) and reevaluate the appropriateness of reimbursed services for selective benefit after 3 years. Choline alfoscerate has a high rate of increase in claims, but there are social controversies over clinical evidence and are sold as health functional foods in major foreign countries. This ingredient, listed in 2007, has 232 items listed as of May this year. In 2016, it was claimed to be ₩167.6 billion, and in 2019, it exploded to ₩352.5 billion. So far, the National Assembly and civic groups have constantly raised concerns about the abuse of this drug and the appropriateness of insurance benefits.
- Policy
- Multiple myeloma drug Farydak was revoked after approval
- by Lee, Jeong-Hwan Jul 28, 2020 06:33am
- Farydak (Panobinostat), which can be used for patients who have failed to administer Velcade (Bortezomib), was revoked after three years of domestic marketing approval. There are many domestically licensed multiple myeloma medications, and the track listings, such as Risk-Sharing Agreement (RSA), have had an effect on the cancellation of the permit. On the 27th, the MFDS announced that Novartis Korea's approval for three items of 'Farydak capsules 10, 15, and 20 mg' has been revoked. Farydak was approved by the MFDS on February 6, 2017. Farydak is used as a combination therapy of Bortezomib and Dexamethasone in the treatment of patients with multiple myeloma who have previously received at least two treatments, including Bortezomib and an immunomodulatory agent. At the time of marketing approval, Farydak was evaluated as the first drug approved as a 'Histone Deactylase Inhibitor' that restores cellular function in patients with multiple myeloma with epigenetic activity. Nevertheless, the drug was not officially administered because it was not listed for health insurance for three years after the approval, and it was finally canceled. There were 7 multiple myeloma drugs that were marketed in Korea, including Janssen’s Darzalex (Daratumumab), Takeda’s Ninlaro (Ixazomib), Celgene’s Revlimid (Lenalidomide), Pomalyst (Pomalidomide), Amgen’s Kyprolis (Carfilzomib), BMS’ Empliciti (Elotuzumab), and Farydak. Of these, Revlimid, Pomalyst, Kyprolis, and Darzalex are being applied as risk-sharing (RSA) benefits. Empliciti, Farydak, and Ninlaro were not listed, and Farydak was canceled on the list of multiple myeloma drug approvals in Korea. Currently, RSA benefits are excluded from drugs that are considered as alternatives compared to existing drugs. Some point to this as a monopoly on the benefits. Farydak also seemed to lead to withdrawal of permission because it was difficult to launch market
