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- 2025-12-26 09:24:31
- Policy
- Marketing approval for major Ranitidines have been renewed
- by Lee, Tak-Sun Apr 02, 2020 06:26am
- The approval of Ranitidine formulations, such as Albis, Curan, and Zantac, which have been banned from the end of September last year due to the detection of carcinogenic substances NDMA, has been renewed. Accordingly, permits will remain in effect until March 31, 2025. It is noted whether sales can be resumed during this period. According to the Ministry of Food and Drug Safety, major items containing Ranitidine such as Albis (Daewoong), Curan (Ildong), and Zantac (GSK), whose expiration date was originally set until today (March 31, 2020), were successfully updated. As a result, the validity period for the next 5 years is granted and the permit is maintained until March 31, 2025. The renewal will continue the possibility of resuming sales. Some companies, such as Daewoong, are known to be preparing safety data for resuming sales. However, the MFDS believes that it is difficult to judge the safety for a long period of time because it is considered a problem with the structure of drugs because of concerns about carcinogenesis of Ranitidine. Therefore, there is much interest in the decision of the MFDS when the related companies apply for resumption of sales. This renewal is expected to pass if the company applied without returning the permit. When reviewing the existing renewal, whether or not to register for an overseas formulary is the key, The most important thing is whether or not to list in the foreign formularies, Ranitidine, which has passed the existing renewal review, is already listed in the foreign formularies. However, it is expected to act as a variable in the next update audit, as it plans to strengthen the renewal audit, such as mandatory regular reporting of safety information. If sales are not resumed within 5 years of validity, the marketing approval will likely be canceled.
- Policy
- NHIS to act on growing number of administrative litigations
- by Lee, Hye-Kyung Apr 02, 2020 06:26am
- National Health Insurance Service (NHIS) is setting down administrative litigation response strategy to handle pharmaceutical companies’ taking legal action against drug pricing reduction. NHIS has recently started a cosigned research on ‘Drug Pricing Reduction Related Litigation Case Study and Response Plan.’ The research would be conducted for four months with the budget of 50 million won. From 2015 to 2019, total 24 cases of drug pricing reduction-associated litigations have been filed by pharmaceutical companies against the Korean government. Only three cases were filed every year from 2015 to 2017, but the number soared to 13 cases in 2018 and eight cases in 2019 since the start of a case regarding pricing reduction on single-use eye drop. In last year, most of those litigations were filed due to the 30 percent cut in maximum reimbursed price from the point of a first generic launch. NHIS official said, “As the number of administration litigations against drug pricing reductions has surged, the government agency requires in-depth analysis of precedent cases,” so “the aim of the research is to seek improvements in legal principles and administration for the pricing reduction litigations.” The cosigned research would consist of analysis on drug pricing reduction related litigation in last ten years (litigation type, cause, outcome, ruling and impact on health insurance), proposed legislative revision based on litigation analysis, and legal response against litigation through case analysis and practical persuasion strategy for pharmaceutical industry.
- Policy
- HIRA clears 4 out of 5 Spinraza reimbursement pre-approvals
- by Lee, Hye-Kyung Apr 02, 2020 06:26am
- Korean health authority has passed four out of five preliminary applications submitted last month to treat spinal muscular atropy (SMA) with reimbursed use of Spinraza. Even the one denied case would likely to be cleared, if the applicant submits additional evidential data of patient’s onset symptoms of SMA. In every four months, Spinraza users receiving reimbursement have to submit monitoring report prior to maintenance administration. And the health authority has approved all ten monitoring reports submitted. On Mar. 31, Health Insurance Review and Assessment Service (HIRA, President Kim Seung-taek) posted the results of pre-administration approval on four listed items—Spinraza, Soliris, ventricular assist device (VAD) and hematopoietic stem cell transplantation (HSCT)—Treatment Review and Assessment Committee deliberated in February. Spinraza’s reimbursed use standard stipulates patients are eligible for reimbursement when qualifying all conditions—positive genetic testing of a deletion or mutation in the survival motor neuron 1 (5q SMN-1) gene, onset of SMA symptoms from age three or less and not on permanent ventilator (more than 16 hours a day for over 21 consecutive days). The reimbursed use of the drug has to be assessed before the initial administration, after administering initial dosage (four doses) but before the fifth dose, and every maintenance dose then after based on clinical evaluation (development stage, motor function and respiratory function). Before the Spinraza review, the committee reviewed pre-administration applications on reimbursed use of Soliris (eculizumab). All three to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) were cleared, but one case of atypical hemolytic uremic syndrome (aHUS) treatment was denied. The rejected aHUS case was to treat 67-year-old patient, who visited an emergency room for nausea and vomiting and was hospitalized due to acute renal failure and observation of symptoms like thrombocytopenia, anemia and schistocyte but continued to have thrombotic microangiopathy (TMA) despite receiving steroid and therapeutic plasma exchange (TPE). Nevertheless, it was ultimately rejected, as the doctor’s record of the patient’s schistocyte and thrombocytopenia did not coincide with the TMA described in the reimbursement standard notice. Other details of the Treatment Review and Evaluation Committee’s deliberation can be found on HIRA website.
- Policy
- Co-pay rate of advanced hospitals for cold patients to 80%
- by Lee. Chang jin Apr 01, 2020 06:21am
- As soon as the plan to reorganize the medical delivery system, which has shown a lull in the event of COVID-19, is expected to be presented to the Health Insurance Policy Deliberative Committee during this month. In particular, it is noteworthy that a plan to increase the outpatient co-payment rate of minor patients, such as simple colds using advanced hospitals, from 60% to at least 80%. As a result of covering on the 1st at the Medical Times, it was confirmed that the Ministry of Health and Welfare is preparing to propose The Health Insurance Policy Deliberative Committee, which will be held in April to improve the short-term countermeasures of patients with minor illnesses, which is a short-term measure, among the plans to reorganize the medical delivery system. The Ministry of Health and Welfare is considering a plan to increase the burden of co-pay for advanced hospitals for people with mild illnesses such as colds. This is the briefing of the director of the health department, Hong-in Noh.#Earlier, Noh Hong-in, head of the Ministry of Health and Welfare, announced the plan to improve the medical delivery system in September of last year. In order to prevent the use of advanced hospitals for mild patients such as colds, a strong penalty was given only to medical institutions. If so, what will happen to minor patients, such as colds, who are receiving outpatient treatment at an advanced hospital? According to the Enforcement Decree of the National Health Insurance Act, the rate and amount of the burden of partial co-payment (separate table), the co-payment rate of outpatient care for general patients at advanced hospitals is 60%, 50% for general hospitals, 40% for hospitals, and 30% for clinics. The Ministry of Health and Welfare is actively considering ways to increase the out-of-pocket rate of outpatient care for patients with mild illness from 60% to at least 80% in parallel with the penalty of senior general hospitals. Outpatient out-of-pocket rates for general patients at senior general hospitals specified in the National Health Insurance Act#The strategy is to increase the effectiveness of the plan to improve the medical delivery system only if the minor patient's burden is increased than the current situation. Personnel from the Ministry of Health and Welfare said that there is no change in the policy to improve the health care delivery system by applying 0% of the classification rate of senior general hospitals as a short-term measure and excluding medical quality evaluation support funds. He said that they are looking into ways to strengthen the current co-payment rate by more than 60% to minimize outpatient use of advanced hospitals for minor patients such as colds. In this case, the question is how to judge a mild patient. For first-time patients, the application of the classification rate and co-payment is the same as the present, and if the diagnosis is confirmed as a mild disease after examination, the method of applying the classification rate of 0% and the co-payment increase from the reign is predominant. The Ministry of Health and Welfare is planning to propose a plan to improve the medical delivery system through the Health Insurance Policy Deliberative Committee in April. #An official from the ruling party said that it was problematic to impose a penalty only on advanced hospitals when discussing plans to improve the medical delivery system between the administrations in September last year. Although there were objections from patient groups, he agreed that increasing the burden of minor patients such as colds would contribute to re-establishing the medical delivery system and improving consumer behavior. The plan to change the name of the senior general hospital to 'severe general hospital' will be promoted through a bill in the second half of the 21st National Assembly standing committee after the general election in April in that it is necessary to revise the medical law. Another official from the Ministry of Health and Welfare said that the importance of infection management has increased as a result of the COVID-19 incident, and that they are considering a medical delivery system and a separate infection management delivery system. He said that it could take some time for both the quarantine, infection and medical policies to be discussed.
- Policy
- Bioequivalence reevaluation may hinder drug license renewal
- by Lee, Tak-Sun Apr 01, 2020 06:21am
- Korean pharmaceutical industry is voicing their concerns about the Ministry of Food and Drug Safety’s (MFDS) plan to revive bioequivalence reevaluation and to toughen the item license renewal review procedure. Arguing the government’s redundant review could harm them, the industry claims the ministry should set down more consistent review approach to avoid having a series of contradicting review results. The industry sources reported on Mar. 31, MFDS has unveiled the first Master Plan for Pharmaceutical Safety Management (valid from 2020 to 2024) containing details of reviving bioequivalence reevaluation and strengthening license renewal review. The ministry means to enhance credibility of approved drug quality through strenghtened bioequivalence test system for prescription drugs. Basically, the ministry is bringing back the regular bioequivalence reevaluation that was removed in 2018 due to the newly implemented renewal system. MFDS would finalize a master plan for bioequivalence reevaluation by 2024, after compiling a list of reevaluation subjects within this year. Some of the pharmaceutical industry agrees that bioequivalence reevaluation on already-approved items would be unavoidable due to the expanded bioequivalence test policy. Oral drugs would be required submit bioequivalence test results from this year, injection and sterile medicinal products from 2021, and all drugs from 2022. Already-approved drugs without qualifying bioequivalence test result would need to submit the test result to maintain their original pricing. However, the industry points out reviving the bioequivalence reevaluation, after the government has replaced the old reevaluation procedure with the current renewal system, would become a redundant procedure. An insider in government affairs explained, “An item approved through bioequivalence reevaluation could fail to renew and lose its license, because it was not listed in a foreign pharmacopoeia.” At the movement, the item renewal review prioritizes listing on an overseas pharmacopoeia. Apparently, some drugs have had their license revoked unfairly, only because they were not listed on overseas pharmacopoeia. Pharmaceutical industry expert groups argue the renewal review should have its own review standards, instead of relying on pharmaceutical status in other countries. Another government affairs associate criticized, “The Korean government should step away from outdated style of depending on certificate of pharmaceutical product (CPP) issued by an advanced country, but rather it should set forth an independent review standards,” and “the safety management master plan does specify its objective, but it is missing detailed standards.” Seemingly conscious of these criticisms, MFDS has announced the license renewal review would be updated through the master plan. From 2021, the ministry would mandate submission of prompt and regular report on safety issues including adverse event, data analysis and evaluation result, and safety control report. And from 2023, the ministry would also mandate collection and analysis of safety issue data from home and abroad and submission of post-marketing safety management report. However, the pharmaceutical industry predicts that items with mediocre sales and limited safety profile data would have gap in data submission, compared to originals with high overseas sales. This is the reason why the industry is concerned possible discrimination in the renewal review procedure. The industry insider in government affairs said, “Amid COVID-19 outbreak, it is frustrating to see the communication channel between the government is cut, when we need to discuss about tools to fill up the gaps it unfolds the new policy.” The insider added, “The government should convene a meeting to exchange questions and answers instead of disseminating information.”
- Policy
- Coverage on COVID-19 treatments to last a year
- by Lee, Hye-Kyung Apr 01, 2020 06:20am
- Despite the expedited review, the health insurance reimbursement on the off-label drug would be reassessed a year after due to the COVID-19 outbreak. Korea’s Health Insurance Review and Assessment Service (HIRA) disseminated a press release on Mar. 30 and stated, “Taking in account the latest medical case studies and expert recommendation, the healthcare reimbursement listing standards on COVID-19 related treatments were reviewed in the shortest period. The decision was made to promptly provide treatments according to patient symptoms.” Interferon (including peg interferon), Kaletra (lopinavir plus ritonavir), hydroxychloroquine, ribavirin, human immunoglobulin G (IVIG), oseltamivir and zanamivir are currently used off-label with coverage to treat patients with COVID-19. The treatments are used on either confirmed or suspected cases for seven to 14 days. Typically, the reimbursement review takes approximately 80 days. Nevertheless for the COVID-19 treatments, HIRA reported to the Ministry of Health and Welfare (MOHW) the reimbursement standard set based on the recommendation made by Korean healthcare experts on Feb. 3. And immediately, the ministry issued related notice on the day after. The additional reimbursement standard was again reported to MOHW on the day after the healthcare experts submitted an additional recommendation on Feb. 19, and the related notice was issued immediately. The reimbursement standard set amid COVID-19 outbreak would be reassessed for reimbursement adequacy a year after according to MOHW’s notice (No. 2020-37). Director Kim Ae-ryun of Pharmaceutical Management Department at HIRA said, “Regular reimbursement standard review generally takes more than 80 days, but the review on COVID-19 treatments were rapidly processed due to the fast spreading infectious disease. The agency would do its best to provide safe and effective treatments to the people by promptly reviewing reimbursement standard at times of infectious disease outbreak.” Although there is no drug developed to specifically treat COVID-19, HIRA has established the standard based on latest medical case studies and expert’s advice, considering the urgency of the outbreak. Moreover, HIRA plans to accumulate evidential data in the future, and constantly accept related academic societies’ recommendations to consolidate adequacy of the current reimbursement standards. Meanwhile, HIRA is planning to swiftly review reimbursement listing and standard for Ministry of Food and Drug Safety (MFDS)-approved drugs, using the outcome of clinical trials conducted as a part of pharmaceutical rediscovery research project for COVID-19 treatment.
- Policy
- Renewal of Marketing Approval for drugs, will be reinforced
- by Lee, Tak-Sun Mar 31, 2020 06:29am
- Renewal System of Marketing Approval for Drugs ongoing since 2018 will be further reinforced. The system which gives a 5 year validity for each category respectively, renews allowance after reviewing safety and effectiveness. However, it is criticized that the screening does not properly evaluate the safety and effectiveness of pharmaceuticals. Accordingly, the MFDS decided to strengthen the renewal review by comprehensive review of ingredients and formulations, refrain from renewing unsold items, and compulsory submission of post-market safety data. According to the industry on the 30th, the MFDS recently released the first comprehensive plan for drug safety management (from 2020 to 2024). In the comprehensive plan of the MFDS, the drug renewal system is currently reviewing and evaluating safety, efficacy, and quality data for each drug, but the need for comprehensive review and evaluation by ingredient and formulation is increasing. The background of the plan to strengthen the item update was explained. Furthermore, the MFDS explained that worries exist because even though they have eliminated not produced or not imported items during the 5 year validity from the renewal objects, cases where after the minimum quantity is manufactured and imported for the purpose of passing through the renewal, in which the legal compliance (quality management, safety management after marketing) is not observed, are occuring. Accordingly, the MFDS suggested strengthening ▲the submission of safety data for items subject to renewal ▲ evaluating safety and effectiveness of each ingredient and formulation ▲ not being able to update drugs without sales within the expiration date. First, from 2021, it was decided to submit safety information promptly and regularly, including side effects during the expiration date, and to analyze and evaluate the information and data on safety management measures. In addition, from 2023, it is a policy to collect and analyze safety information at home and abroad for some items and to submit a comprehensive report on safety management after marketing. The MFDS also announced that when reviewing the renewed ingredients for the first time this year, the entire domestic review of the same ingredients and formulations will be conducted to prepare a comprehensive review and continuously update. In particular, from 2023, it was obliged to submit action plans, including comparison and analysis of domestic and foreign permits, and changes to permits for some items. Drugs without sales records could not be renewed. Currently, only the results of manufacturing and imports are reported during the renewal examination. The MFDS is planning not to renew even if it has not been manufactured, imported, or sold during the validity period (5 years) of the item permission and notification from 2021. It is expected that the burden of pharmaceutical companies will increase if it is mandatory to submit safety data after marketing and items without sales records are not allowed to be renewed.
- Policy
- Asthma inhaler Alvesco, clinical trial for COVID-19 patients
- by Lee, Tak-Sun Mar 31, 2020 06:28am
- Alvesco inhalers (Ciclesonide, AstraZeneca), which are being used as an asthma treatment, conduct clinical trials on COVID-19 patients. Institut Pasteur Korea (Director Wang-Sik Ryu) announced on the 29th that IIT for 'Alvesco' was approved based on the research results. IIT are led by Professor Woo-Joo Kim, Infectious Medicine of Korea University Guro Hospital, Professor Jung-Yeon Hur, Infectious Medicine of Ajou University Hospital, Professor Hye-Won Chung, Infectious Medicine of Chungbuk National University Hospital, and Professor Yu-Bin Seo, Infectious Medicine of HUMC-Kangnam. From this April to April next year, the clinical effectiveness of Alvesco will be evaluated in 141 mild COVID-19 infected patients over the age of 18 years for one year. Institut Pasteur Korea has been conducting drug repositioning study to verify the efficacy of COVID-19 treatment among existing drugs since February, and has confirmed that Ciclesonide, a major ingredient in Alvesco, has efficacy. Ciclesonide showed equivalent or superior antiviral activity in cell experiments compared to Remdesivir, Kaletra, and Chloroquine, which are currently in clinical trials at home and abroad. In Japan, there have been reports of recovery from administration to actual patients, and the Japanese Association for Infectious Diseases is conducting observational study. Institut Pasteur Korea announced that it will continue to pursue drug repositioning study to further discover other substances with excellent medicinal properties. Accordingly, through close cooperation with related organizations such as the KRICT and the KSID, it will create effective research results and continuously provide them to medical sites.
- Policy
- 5 out of 11 COVID-19 trials approved to speed up development
- by Lee, Tak-Sun Mar 31, 2020 06:28am
- Apparently, total 11 clinical trials in patients with COVID-19 have applied for the Korean health authority’s approval and five of them were cleared. The Korean government says pharmaceutical companies have sufficient stock of Kaletra and hydroxychloroquine used to treat COVID-19. On Mar. 27, Ministry of Food and Drug Safety (MFDS, Minister Lee Eui-kyung) officials reported the ministry is supporting rapid development of COVID-19 treatment and vaccine while managing stable supply of drugs used to treat patients with COVID-19. According to MFDS, it has formed ‘Commercialization Team’ under the COVID-19 Risk Management Support Headquarter on Feb. 3 to provide individual consulting for companies engaged in development of COVID-19 treatment and vaccine, and to expedite and prioritize the clinical trial review procedure. So far, 11 COVID-19-related clinical trial review applications have been submitted, and five of them were approved after consulting with experts from Korea Society of Infectious Disease (KSID) and Korean Society for Antimicrobial Therapy (KSAT). Currently, three clinical protocols using Gilead Sciences’ Ebola treatment remdesivir, one protocol with HIV-1 treatment Kaletra plus malaria treatment hydroxychloroquine and another protocol with hydroxychloroquine only have been approved for COVID-19. The ministry has also reportedly approved six cases of using clinical drugs under investigation as influenza treatment to treat COVID-19, and the ministry is continuing to review ten other cases. The six cases of using ImmuneMed’s HzVSF for treatment purpose have been approved at Seoul National University Hospital, Yeungnam University Medical Center, and Chungnam National University Hospital. Treatment-purpose approval allows MFDS to grant approval on using an unapproved investigational drug for urgent patients either with life-threatening condition or without alternative treatment. MFDS has informed Korea Association of Institutional Review Board (KAIRB) about expedited clinical trial with ‘considerations related to clinical trials on COVID-19.’ The consideration talks about Institutional Review Board (IRB) prioritizing clinical protocol review related to COVID-19, allowing video conference for deliberation, and asking for the trial participant’s consent via phone call. And MFDS official added the ministry would actively cooperate with Ministry of Science and ICT (MSIT) and Korea Centers for Disease Control and Prevention (KCDC) on the COVID-19 treatment development project to shorten the development period as much as possible. The project would mediate sharing information regarding clinical trial protocol from the initial stage and assessing scientific evidences to minimize error in the study. At the moment, MSIT is operating Pharmaceutical Rediscovery Project to explore and inform the medical industry of an effective medicine against COVID-19, out of drugs approved by the U.S. Food and Drug Administration (FDA), and to push on with the candidate medicine’s clinical trial. KCDC is currently running a research on clinical trial regarding expanding indications on approved drugs, antibody and plasma-derived therapies and vaccines to treat patients with COVID-19. Besides various efforts to drive forth clinical trials for the treatment, the ministry stated HIV-1 protease inhibitor drug Kaletra, currently unapproved in Korea, has been exceptionally imported three times to treat patients with COVID-19, upon KCDC’s request. Moreover, the ministry is apparently monitoring supply of Kaletra and hydroxychloroquine used against COVID-19 in Korea to prepare import or production on demand. As of Mar. 26, pharmaceutical companies in Korea have stocked Kaletra tablets for about 15,000 patients and hydroxychloroquine tablets for about 200,000 patients. MFDS official stressed, “The Korean government intends to actively aid companies to promptly develop COVID-19 treatment vaccine, and to maintain stable supply of drugs used for COVID-19 by closely cooperating with KCDC and related government agencies.”
- Policy
- Champix salt-modified drugs ready for launch in July
- by Lee, Tak-Sun Mar 31, 2020 06:28am
- The substance patent expiration on smoking cessation drug Champix is approaching in coming July, and more drugs with modified salt base are applying for market approval. Although the Korean court has ruled against salt-modified drugs launching before Champix’ patent expiration, new drugs are hectic preparing for their release immediately following the patent expiration. According to Ministry of Food and Drug Safety (MFDS), 12 drugs sharing the same active pharmaceutical ingredient varenicle as Champix but with a different salt (Champix has tartrate) have applied for approval. The most recent applications from two products were submitted on Mar. 20. The first salt-modified version of Champix has been released in November 2018. But most of the modified varenicle drugs have taken their products off the shelf after January last year, when the Supreme Court has ruled a salt-modified solifenacin drug had illegally infringed the original’s patent. Moreover, the court has also stated the modified varenicle drugs infringed Champix’ substance patent by launching before its term expiring, quoting the solifenacin precedent. Accordingly, all Korean companies with the modified drugs have completely suspended their marketing. Nevertheless, the modified drugs would be able to resume their sales again from July 20 as the Champix’ patent is to expire on July 19. From July 20, drugs evading or nullifying the original’s salt patent (to be expired on Jan. 31, 2023) would be able to market their products. The Champix market would likely to welcome new competitors. Yuhan, currently co-marketing Champix with Pfizer, is actually developing a modified version as well. As of Mar. 26, total of 74 varenicle drugs with modified salt have been approved. The Champix’ sales revenue has been falling recently with pricing reduction and decreased number of participants in smoking cessation campaign. Regardless, the Korean companies would join the market competition with fierce marketing as the original has still generated 23.8 billion won last year, according to IQVIA.
