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- 2025-12-26 09:24:31
- Policy
- Revised generic reimbursement regulation to get delayed
- by Lee, Hye-Kyung Mar 23, 2020 06:27am
- Apparently, the postponed action plan on the revised reimbursed generic pricing management, covering all procedures of the listing, would also likely to affect drug pricing negotiation schedule. As the Korea’s Ministry of Health and Welfare (MOHW) is preoccupied with response against COVID-19 outbreak and the main division director’s position still open, the preannouncement of revising ‘Regulation on National Health Insurance Reimbursement Standard’ is getting delayed. The National Health Insurance Service (NHIS), in charge of drug pricing negotiation, has been processing the legislative preannouncement with the government to apply the pricing negotiation terms, previously used on new drug and price-volume linkage system, on generic products as well. A draft of the preannouncement briefly posted on the Ministry of Government Legislation website in February stipulated generic exempted from pricing negotiation for reimbursement listing would be subjected to pricing negotiation track. A pharmaceutical company with generic product has to undertake pre-agreement terms with NHIS on negotiation and agreement compliance when applying for reimbursement to Health Insurance Review and Assessment Service (HIRA). When HIRA completes drug pricing calculation, the applicant company has to negotiate pricing with NHIS for 60 days before the Health Insurance Policy Deliberation Committee (HIPDC) deliberation. The initial plan was to pre-announce the revised regulation and to accept public opinion from February to April, and to start the pricing negation from June. As the negotiation takes at least about 60 days, NHIS had to create a legal foundation before the revised generic pricing system was enforced. However, NHIS’ plan to initiate the generic pricing negotiation by the end of June would be postponed as the legislative preannouncement has not been issued, yet. The NHIS’ key roadmap of the year originally aimed to finish off designing generic negotiation agreement and compliance management task process until coming May with the Generic Negotiation Management Task Force formed under NHIS Health Benefit Strategy Office in January, and also to start drug pricing negotiation and negotiation agreement compliance monitoring in June and July, respectively.
- Policy
- The Review Committee for Cancer Diseases postponed again
- by Kim, Jung-Ju Mar 20, 2020 06:27am
- COVID-19 crisis that spread around the world is prolonged and the face-to-face meeting of the Review and Assessment Committees within HIRA is also changing by choosing the second-best solution. Last month and this month, when the spread of infectious diseases in Korea was at the forefront, once it was postponed or canceled, it was no longer possible to postpone the reimbursement-related discussions. After the health policy deliberlate committee schedule was canceled this month, the affiliated committees were confirmed to have adopted a written or postponed method according to government policies. If the health policy deliberlate committee is the top legislative organization for health insurance, the sub-committees are specialized deliberations by field to introduce the health policy deliberlate committee. These committees, which examine, evaluate and deliberate on pharmaceuticals and medical practices, are under the HIRA, and have specialized discussions in each field. There are a total of seven committees, including the Pharmaceutical Benefits Advisory Committee, which is important for the supply of new drugs, as well as the Review Committee for Cancer Diseases, which is the center of discussions on anticancer drug benefits, the Medical service Expert Evaluation Committee, the Oriental Medical service Expert Evaluation Committee, the Treatment Materials Evaluation Committee, the Human tissue Expert Evaluation Committee, and the Disease Group Evaluation Committee. Among them, the representative drug-related committees that deal with the new drug's reimbursement and the expansion, the discussion of the high-priced drug reimbursement tracks such as RSA, and the general reimbursement standards, are the Pharmaceutical Benefits Advisory Committee and the Review Committee for Cancer Diseases. The Pharmaceutical Benefits Advisory Committee has already decided to conduct a full written review, and it is highly likely that the Review Committee for Cancer Diseases will be discussed in writing accordingly. In particular, the Review Committee for Cancer Diseases was postponed on the 26th of last month, and the government showed a willingness to discuss this month. the HIRA decided to hold a meeting of the Review Committee for Cancer Diseases on the 6th of next month. However, this is also scheduled, and the HIRA is struggling on a case-by-case basis regarding written, face-to-face, and face-to-face substitutions. The remaining five committees are also planning to adopt this month's written or the Review Committee for Cancer Diseases-like approach. The reason why the committee's face-to-face meetings are as important as the health policy deliberlate committee is that detailed deliberations and discussions are carried out in three dimensions for each area of expertise. Depending on the case, a doctor or external person in the clinical field attends to express specific opinions on the necessity of reimbursement and non-reimbursed benefits, and this is important in that it serves as a decisive influence and ground for deliberation. The HIRA, which operates all 7 committees, has already prepared video conferencing systems in Wonju and Seoul Smart Work Center to prepare for this unpredictable situation, and has the same level of face-to-face meetings so that committee members can view or collect opinions. However, even so, in some cases, members of the situation who cannot use video IT equipment must participate, so basically, a written meeting will be adopted and utilized. This is also in accordance with government guidelines. In fact, among the committee members, those who return to their home country after business trips, those whose fever has been confirmed for any reason, and those who belong to hospitals, schools, etc., may be unable to attend meetings due to government policies or organizational schedules. In response, the HIRA said, “Since the meeting cannot be postponed, the methodology will be different according to the trend. Since the distribution of written data is basically provided to all members before the meeting, there is a way to make a decision after internal review with a review opinion in writing. In the case of meetings on sensitive topics, additional meetings may be reviewed for feedback". The HIRA said, “It will be operated in a way to avoid possible face-to-face meetings, but if there are important issues that require face-to-face discussions, it will be selected the next best option such as video conferencing. It will not delay or delay important reimbursement discussions without missing the opinions of the committee members”.
- Policy
- Imfinzi available for reimbursed use from next month
- by Lee, Hye-Kyung Mar 20, 2020 06:25am
- From next month, reimbursed use of Imfinzi (durvalumab) would be available for non-small cell lung cancer (NSCLC) monotherapy. The new reimbursement standard set for Imfinzi would enable administering immunotherapy not only for palliative chemotherapy, but also as consolidation therapy. The reimbursement standard would be also applicable for patients using Opdivo (nivolumab), Keytrua (pembrolizumab) and Tecentriq (atezolizumab). Korea’s Health Insurance Review and Assessment Service (HIRA) has recently posted ‘Revised Notice on Prescription and Administration for Cancer Patients,’ and started accepting public opinion. Without any opposition, the newly changed reimbursed standard would come in effect from Apr. 1. ◆New and revised reimbursement standard for NSCLC immunotherapy: HIRA has decided to follow the study specifying Imfinzi’s applied therapy categorization, staging group and number of concurrent chemoradiation therapy (CCRT), and administration initiation point. And the agency would reflect all terms applied to other existing immunotherapies on Imfinzi as well. For NSCLC consolidation therapy, a doctor with sufficient knowledge and experience in anticancer therapy should administer the immunotherapy at a healthcare institute capable to respond to urgent events such as an unexpected adverse reaction. Also, information regarding the reimbursed use of the immunotherapy has to be submitted to HIRA. HIRA official affirmed, “The reimbursement listing period for Imfinzi would not expire in two years, generally used for immunotherapies, but would expire in a year based on its clinical evidences. When failed to result in effective treatment, another immunotherapy as a palliative therapy cannot be used with reimbursement.” Imfinzi has been approved by Korean health authority for treating patients with locally advanced, unresectable NSCLC that had not progressed after platinum-based chemotherapy and radiation therapy (CRT). The National Comprehensive Cancer Network (NCCN) guideline recommends Imfinzi as a category 1 consolidation immunotherapy for unresectable, Stage III NSCLC patients with no progression after two cycles of platinum-based CCRT. The Pan-Asian ESMO guideline recommends Imfinzi as a consolidation therapy within 42 hours after CRT on patients with unresectable Stage III NSCLC. The new reimbursement standard on Imfinzi would include Opdivo, Keytruda and Tecentriq, used as palliative therapy at second or later-line treatment, in the administration subjects. But, when Imfinzi treatment fails as post-CRT consolidation therapy, reimbursement would not be provided. ◆ New reimbursement standard for Venclexta as chronic lymphocytic leukemia monotherapy as third or later-line treatment: HIRA has decided there is no alternative option for a monotherapy for patients with relapsed or refractory chronic lymphocytic leukemia (CLL) as third or later-line treatment. During Phase 2 clinical study in adult patients with the indication, Venclexta has achieved overall response rate (ORR) of 65 percent (95% CI: 53-74), median progression-free survival (mPFS) at 24.7 months (95% CI: 19.2-NR) and confirmed that it is a necessary treatment. HIRA official explained, “There is no other option available at third or later-line treatment. As a result, the agency has changed the reimbursement standard reflecting the experts’ opinion to provide treatment opportunity to patients, who cannot use chemo-immunotherapy (rituximab, obinutuzumab) with Venclexta.” ◆Blincyto added as a monotherapy for patients with acute lymphoblastic leukemia: Blincyto has been approved to treat adult and pediatric patients with relapsed or refractory Philadelphia chromosome-positive and immature B cell acute lymphoblastic leukemia (ALL). NCCN guideline recommends Blincyto as category 2A treating adult patients with relapsed or refractory Philadelphia chromosome-positive ALL. And for pediatric patients, the guideline recommends the treatment as category 2A to treat relapsed, refractory or multiple relapse after transplanting stem cell. The indication was approved based on a Phase 2 single-group clinical study in adult patient, in which Blincyto achieved complete remission (CR) or complete remission with partial hematologic recovery (CRh) at 36 percent, and median overall survival (mOS) of 7.1 months. Moreover a Phase 2 single-group clinical study in pediatric patient confirmed Blincyto’s clinical efficacy with CR and CRh reaching 32 percent within week two of administration and mOS of 7.5 months. Based on the literature, HIRA has decided to grant reimbursement with 5-percent copayment for remission induction therapy (2 cycles). After reviewing feasibility of providing selective reimbursement on Blincyto, the government body has decided for ALL, stem cell transplantation is a standard of care when the patient reaches CR after remission induction. And the consolidation therapy is only clinically effective in case stem cell transplantation is unlikely after remission induction. Moreover, HIRA judged reimbursement (5-percent copayment) is not adequate for a high-cost use of Blincyto. However, the agency stated three cycles of the consolidation therapy is needed for patients who cannot receive stem cell transplantation due to donor’s issue, and selective reimbursement (30-percent copayment) would be provided for the consolidation therapy on patients who achieved CR or CRh after remission induction therapy and has received pre-approval for stem cell transplantation, as it does not have alternative option at the moment.
- Policy
- New reimbursed price for Imfinzi, Venclaxta and Blincyto
- by Kim, Jung-Ju Mar 20, 2020 06:25am
- From next month, health insurance reimbursement would be granted on AstraZeneca Korea’s locally advanced non-small cell lung cancer (NSCLC) treatment Imfinzi (durvalumab) and AbbVie Korea’s chronic lymphocytic leukemia (CLL) treatment Venclaxta (venetoclax). Two treatments have accepted risk sharing agreement (RSA) terms set down on the negotiation table by Korea’s National Health Insurance Service (NHIS). Amgen’s leukemia treatment Blincyto (blinatumomab) would lower its price by four percent considering the financial impact for increased reimbursed use with expanded indication. According to pharmaceutical industry, Ministry of Health and Welfare (MOHW) is planning to revise the ‘List of Reimbursed Drugs and Maximum Reimbursed Price’ with the said changes. The revision would come in effect from Apr. 1. ◆Imfinzi: The immunotherapy has been approved to treat unresectable, locally advanced NSCLC patients with no progression after platinum-based concurrent chemoradiation therapy (CCRT). The company has submitted an application to Health Insurance Review and Assessment Service (HIRA) for reimbursement listing on Dec. 21, 2018, immediately after receiving an approval from Ministry of Food and Drug Safety (MFDS) in the same month. At a Cancer Deliberation Committee meeting convened in early November last year, HIRA has decided it would be feasible to provide reimbursement on the drug. The committee’s decision was based on clinical study proven clinical efficacy improved than placebo, and also the committee judged its cost-effectiveness would accept ICER value better than the placebo. The refund and expenditure cap type RSA, proposed by the company, was at an acceptable level. The refund type and expenditure cap type of RSA stipulate the applicant company to pay back a set amount of drug reimbursement claim to National Health Insurance Service (NHIS), and to return a certain ratio of the claimed amount exceeding the expected cap. The drug negotiated drug pricing with NHIS from then on to last month As a result, the reimbursed price of the drug would be at 3,350,930 won per 0.5 g and 804,223 won per 0.12 g. ◆Venclaxta: Venetoclax is an orally administered anticancer treatment used to treat CLL as third or later-line treatment, and it is approved as a monotherapy for patients with relapsed or refractory chronic lymphocytic leukemia (CLL) who have been treated with chemo-immunotherapy and B cell receptor inhibitor, previously. From last May last year, the pharmaceutical company has submitted a reimbursement application to HIRA, immediately after MFDS’ green light, and received a nod from Drug Reimbursement Evaluation Committee (DREC) in last December. DREC official said the treatment has demonstrated clinical efficacy and is eligible for pharmacoeconomic evaluation (PE)-exemption track. The three PE-exemption track qualifications include; an anticancer used for treating life-threatening disease with no alternative option at the same level of treatment; a treatment approved by MFDS based on single-group clinical data without placebo and has difficulty producing evidential data with limited number of patients; a treatment listed for reimbursement in at least three countries out of the seven countries the committee has chosen to refer their adjusted average values. A drug can qualify for the PE-exemption track after qualifying all three conditions. Then after, the company has successfully reached an agreement with NHIS last month on pricing negotiation under the expenditure cap type RSA. The reimbursed price would be at 4,469 won per 10 mg, 22,341 won per 50 mg, and 44,682 won per 100 mg. ◆Blincyto: The anticancer treatment has been approved to treat adult and pediatric patients with relapsed or refractory Philadelphia chromosome-positive or negative immature B cell acute lymphoblastic leukemia (ALL). From October 2016, the treatment has been provided with reimbursement in Korea for patients at age over 18. The company has applied for expanded reimbursement to HIRA in February last year, after expanding its indication to treat adult and pediatric patients with relapsed or refractory Philadelphia chromosome-positive acute ALL in January last year. At the June meeting convened last year, Cancer Deliberation Committee said selective reimbursement would be granted for remission consolidation therapy to reduce non-reimbursed criteria. The treatment already has essential coverage on its remission induction therapy indication. Its expanded reimbursement was finalized by Drug Reimbursement Evaluation Committee (DREC) in last December. DREC’s decision was based on the treatment’s clinical efficacy and its cost-effectiveness qualification for PE-exemption track for the expanded reimbursement. In this month, the company has finally reached an agreement on negotiated pricing with NHIS. The key was to lower the price by four percent to lessen the financial impact. The negotiated price was decided at 2,346,000 won, reduced from the original price of 2,442,800 won.
- Policy
- Antiepileptic drug Fycompa may face follow-on drugs soon
- by Lee, Tak-Sun Mar 19, 2020 06:26am
- Antiepileptic drug Fycompa Drugs using same substance as Eisai’s Fycompa film coated tablet, used to treat patients with partial-onset seizure, is preparing for a market release. Myung In Pharm and Whan In Pharm recently requested for negative scope confirmation on Fycompa’s crystalline form patent (to be expired on Oct. 14, 2026) to evade infringement. As the prescription volume of Fycompa has been steadily increasing, follow-on drug manufacturers are keeping a close eye on the legal proceeding. According to pharmaceutical sources on Mar. 18, Myung In has requested for a negative scope confirmation on Fycompa’s patent on Feb. 28, followed by Whan In on Mar. 13. Myung In and Whan In, prominent in the Korean central nervous system (CNS) market, are seemingly preparing for the first generic of Fycompa. However, a follow-on drug would have to wait more than three years or so to fully commercialize the drugs as Fycompa still has ongoing post-marketing surveillance (PMS) and substance patent in effect. Fycompa is a non-competitive α-amino-3-hydroxy-5-methylisoxazole-4-propionic acid (AMPA) glutamate receptor antagonist. It has been approved by Ministry of Food and Drug Safety as a new mechanism to treat epilepsy but it is a subject for PMS for six years. During the PMS period, approval application from a latecomer drugs are rejected. Fycompa’s PMS period is to end on July 9 next year. For Myung In and Whan In to receive preferential sales approval for an exclusively launched generic, it would be more advantageous for them to apply for it after July 10 next year. But even after its approval, the follow-on drug would face the barrier of substance patent. The patent is to expire on Oct. 13 2023. Myng In and Whan In have challenged the crystalline form patent, but they have not taken any action on the actual substance patent. The U.S. Food and Drug Administration (FDA) has approved Fycompa in 2017 as a monotherapy for treating partial-onset seizures with or without secondarily generalized seizures in people with epilepsy aged four and older. According to UBIST, the treatment’s outpatient prescription volume, started at around 2 billion won in 2017, has been growing up to 2.7 billion won and 3.4 billion won in 2018 and 2019, respectively. The industry sees that this once-daily treatment has potential to grow further with medication convenience for the patients, which is why the two Korean companies are assertively challenging the original.
- Policy
- Boryung’s imported quadrivalent vaccine gets greenlit
- by Lee, Tak-Sun Mar 19, 2020 06:26am
- After receiving an approval on imported quadrivalent influenza vaccine, Boryung Biopharma now owns three manufactured or imported vaccine items. Sources predict the Korean company would choose an item to launch and its quantity based on the purchase price. On Mar. 16, Ministry of Food and Drug Safety (MFDS) granted an approval on Boryung Biopharma’s quadrivalent influenza vaccine Afluria prefilled syringe. The vaccine is used on people aged over five years to adults for prevention of influenza virus type A and influenza virus type B infection. The quadrivalent vaccine targets two type A viruses and two type B viruses. It prevents one more type of viruses than the existing trivalent vaccines. So far, MFDS has approved 11 quadrivalent vaccines from nine companies including SK Bioscience, GC Pharma, GlaxoSmithKline (GSK), Sanofi Pasteur, Boryung Biopharma, Korea Vaccine, Ilyang Pharmaceutical and Dong-A ST. And among them, two are imported complete vaccines—Fluarix Tetra by GSK and Vaxigrip Tetra by Sanofi Pasteur. The newly approved Afluria is an imported complete vaccine Boryung Biopharma, which is manufactured by Seqirus, an Australian-based biotechnology company CSL Limited’s subsidiary. Boryung Biopharma also manufactures other quadrivalent influenza vaccines, such as Boryung V Tetra Vaccine and Boryung VII Tetra Vaccine. The company brings the source solutions from GC Pharma and Sanofi and fills the syringe with the vaccine at Jincheon plant. As a result, the Korean company owns total of three quadrivalent line-ups with two manufactured and one imported. The company official commented on Afluria and said, “The release date has not been set, yet. As we have some time left until the beginning of flu season in September, we would review the market situation thoroughly and decided on the release schedule.” The pharmaceutical industry predicts quadrivalent vaccine supply price could fluctuate with the heated competition in the market, and because the vaccine type is now a part of National Immunization Program (NIP) distributed through Public Procurement Service. Especially for Boryung Biopharma, the solution purchase price from GC Pharma and Sanoif could be affected depending on the related policy changes. Considering the prime cost of three approved vaccines, the Korean vaccine company is expected to enter the market with strategic price. According to IQVIA data, Boryung Biopharma’s quadrivalent vaccine sales volume from last year has reached 7.2 billion won. Currently, SK Bioscience and GC Pharma that manufacture both the solution and complete vaccine are topping the marketing by generating 13.1 billion won and 12.4 billion won, respectively. Whereas GSK importing the vaccines are closely tailing the two top companies by making 7.9 billion won. The quadrivalent vaccine market would have to see if Boryung Biopharma with competitive line-up would bring an impressive impact on the market with forthcoming pricing policy.
- Policy
- MFDS “All Korean and U.S. COVID-19 test kits use RT-PCR"
- by Lee, Tak-Sun Mar 19, 2020 06:26am
- On Mar. 15, Korea’s Ministry of Food and Drug Safety (MFDS) has dismissed the news articles accusing Korea’s COVID-19 test kit is not even adequate for an emergency use, citing the U.S. Food and Drug Administration’s (FDA) review. According to earlier news reports by a number of Korean media, Rep. Mark Green has reportedly claimed during a congressional hearing that the test kit from Korea is unreliable by citing the U.S. FDA would not approve of using the kit in the U.S. Regarding the issue, MFDS confirmed the antibody test kit referred by the news article is not the kit the Korean health authority has cleared for emergency. The ministry official also elaborated the four emergency test kits approved by the U.S. FDA are also using the same reverse transcription polymerase chain reaction (RT-PCR) technique as the Korean kits. MFDS official stressed, “All five COVID-19 test kits approved for emergency in Korea use real-time RT-PCR technique that MFDS and Korea Centers for Disease Control and Prevention (KCDC) have verified. The Korean Society for Laboratory Medicine is continuously monitoring the accuracy of those kits, and we have not received any reports of an inaccurate diagnosis to this date.”
- Policy
- All traveler record accessible via DUR from Mar. 18
- by Lee, Hye-Kyung Mar 18, 2020 06:37am
- From 2 p.m., Mar. 18, information of all travelers entering Korea would be provided to healthcare providers via Drug Utilization Review (DUR) system and International Traveler Information System (ITS). Health Insurance Review and Assessment Service (HIRA) has been providing real-time information of travelers from China, Italy, Iran, Singapore, Japan, Thailand, Vietnam, Taiwan, Malaysia, France, Germany, Spain, the U.K., the Netherlands, Hong Kong, Macao, where COVID-19 has spread, and those who came in contact with confirmed cases through DUR system. However, as the outbreak has been spreading throughout the world, the Central Disaster and Safety Countermeasures Headquarters (CDSCH) has announced on Mar. 17, “Starting from Mar. 19, all travelers entering Korea from overseas would undergo special immigration procedure.” Accordingly, HIRA is also expanding its server to provide all inbound travelers’ information to healthcare providers using ITS. The traveler’s information would be disclosed on a real-time pop-up window in the DUR system, accessible to hospital, clinic, and pharmacy, as a part of the page with information regarding healthcare institute registration, medical counseling, and pharmaceutical prescription and dispense. To confirm the DUR system properly working and providing travelers’ information, a healthcare institute’s registration desk could type in test name and registration number on the National Health Insurance reimbursement billing software and check the pop-up window. Doctors can also access the information by inputting test name and registration number on the page for diagnosis and prescription, which would appear on a pop-up window when running DUR system. Pharmacists can input the test name and registration number on the dispensing software and check pop-up window when running the DUR system. Healthcare institutes, without an installed ITS, may download an update patch (‘Infectious Disease Related ITS version July 1, 2019’) available on HIRA Healthcare Institute Business Portal website (https://biz.hira.or.kr) under ‘Monitoring’ category.
- Policy
- Ranexa by Menarini was approved in Korea
- by Lee, Tak-Sun Mar 18, 2020 06:35am
- 'Ranexa', a new treatment for cardiovascular disease, has approved Ranexa is a Ranolazine-based drug that was approved by the US FDA in January 2006. The MFDS approved Menarini Korea's 'Ranexa' (Ranolazine) as a new drug to treat angina. Ranexa is a drug developed by CV Therapeutics, which was acquired by Gilead, and Menarini owns domestic rights. Ranexa attracted attention as an angina pectoris drug that was released over 20 years after the US FDA approval in January 2006. The mechanism of action of Ranolazine, the main component of the drug, is known to exhibit antianginal effects through inhibition of late sodium influx from heart cells. Currently, the primary treatment for angina pectoris is a beta-blocker or calcium antagonist (CCB), which is also used as a drug for hypertension. Ranexa is licensed as a combination therapy for symptomatic treatment of stable angina patients who are not adequately controlled or intolerant to primary angina treatment. In clinical trials, it was confirmed that the combination effect was high. In the core trial CARISA, Ranexa was added to the treatment of Atenolol 50 mg once a day, Amlodipine 5 mg once a day, or Diltiazem 180 mg once a day. 823 patients (23% of women) were randomized to receive Ranexa 750 mg twice a day, Ranexa 1000 mg twice a day, or placebo for 12 weeks. As a result, when the drug was used as an additional therapy, it was proved that it showed excellent efficacy in terms of prolonging exercise time after 12 weeks at both doses of Ranexa (Ranolazine) compared to placebo. Compared to placebo, the number of angina attacks per week and the amount of fast-acting Nitroglycerin was significantly reduced for one week. The ERICA test (565 subjects) added to Amlodipine 10mg once daily treatment also significantly reduced the number of angina attacks and fast-acting Nitroglycerin use for one week compared to placebo. Angina is acute pain or pain during exercise or activity. Atherosclerosis or atherosclerotic lesions are the causes. In Korea, there are data on the NHIS which has 645,000 patients as of 2017. The total medical expenditure spent on angina treatment was also very low at ￦771 billion in 2017. As a result, it is expected that it will be booming as new drugs have appeared in the domestic market after a long time. As of 2018, Ranexa's worldwide sales amounted to $ 760 million (about ￦915 billion).
- Policy
- Avigan is not imported for COVID-19
- by Lee, Tak-Sun Mar 18, 2020 06:35am
- AviganIt was found that the health authorities decided not to import special cases of 'Avigan' (Favipiravir), a new H1N1 flu treatment used in Japan as a treatment for COVID-19. This is because there is not enough clinical evidence to use COVID-19 as a treatment. It is said that the KCDC did not make any special requests to the MFDS to decide on special import through the emergency introduction system. According to the MFDS on the 16th, the Central Pharmaceutical Affairs Review Committee on Avigan's import exceptions concluded that Avigan'streatment efficacy base for COVID-19 is insufficient. Avigan is a drug developed by Fujifilm Toyama Chemicals, a subsidiary of Fujifilm in Japan, and is an antiviral agent with a mechanism to suppress RNA virus proliferation. In Japan, it has been approved for use when Tamiflu is not effective against influenza viruses. However, it has not yet received an item license in Korea. Lee Eui-kyung, the Minister of Food and Drug Safety, has been spotlighted on the 25th of last month by saying she was considering a special plan for imports from Avigan. In Japan, it is currently recommended for worsening symptoms in mild patients for COVID-19. However, the World Health Organization (WHO) is not raising Avigan as a candidate for clinical trials of COVID-19. It is known that the Central Pharmaceutical Affairs Review Committee also concluded that the efficacy data for COVID-19 patients is insufficient, and that it is negative for domestic patients because of the risk of side effects such as fetal toxicity. Officials from the MFDS said that drugs that have not obtained domestic permission can be imported through the emergency introduction system, but to use the emergency introduction system, the KCDC must make a request through Central Pharmaceutical Affairs Review Committee. However, there was no such request from the KCDC. He said, "Even if Avigan is not imported, the stock of domestic COVID-19 treatment is sufficient." Currently, in Korea, patients with COVID-19 are using HIV treatment, Kaletra (Lopinavir/Ritonavir), and an anti-malarial drug, Hydroxychloroquine, In addition, clinical trials of Gilead's antiviral drug 'Remdesivir' have been approved, and it has also begun to be administered to domestic patients.
