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- 2025-12-23 12:52:08
- Policy
- Delstrigo listed at ₩19,491 … Zejula’s price cut 6%
- by Kim, Jung-Ju Sep 29, 2021 05:53am
- MSD Korea’s fixed-dose combination product Delstrigo (doravirine·lamivudine·tenofovir disoproxil fumarate) will be listed with insurance benefit next month, at ₩19,491. Also, reimbursement for Takeda Korea’s Zejula cap. 100mg (niraparib) has been extended to cover monotherapy for ovarian cancer, upon which the price was cut by 6% and will be reimbursed at the price. The Ministry of Food and Drug Safety held a Health Insurance Policy Deliberation Committee (HIPDC) meeting today and passed the ‘proposed amendment to the drug benefit list and price ceiling table.’ The amended list and table will be effective from October 1st. ◆Pifeltro·Delstrigo tab.= MSD Korea’s Pifeltro tab(doravirine) and Delstrigo tab(doravirine·lamivudine·tenofovir) are oral HIV medications that are taken as one tablet, once daily. One year after receiving approval from the MFDS on November 22nd, 2019, the company applied for insurance listing of the two products in December last year and received deliberation for the insurance benefit by HIRA’s Pharmaceutical Benefit Assessment Committee in early June. Delstrigo tab(doravirine·lamivudine·tenofovir disoproxil fumarate르). At the time, the PBAC determined the drugs to be cost-effective, as they are recommended for the treatment of HIV infections in textbooks and clinical practice guidelines and accepted the price of less than 90% of the weighted average price of its alternatives. The alternatives to Pifeltro are the non-nucleoside reverse transcriptase inhibitors Stocrin and Edurant tablets. And alternatives to Delstrigo are 2 NRTI + NNRTI combo therapies such as Triumeq and ‘Troubadour+stocrin, ‘Descovy+Edurant’. Pifeltro is listed in all A7 countries abroad, and its weighted average price is ₩24,099 per tablet. Delstrigo is listed in the U.S, France, Germany, Italy, U.K, Switzerland among the A7 countries, and is its weighted average price is ₩36,483 per tablet. In the same month, the company had made negotiations with the National Health Insurance Service on the amount of expected claims of each drug. The NHIS expected no additional funds The final listed insurance price of each drug was set at ₩7,975/ tablet for Pifeltro and ₩19,491/tablet for Delstrigo. ◆Lynparza 100mg and 150mg = AstraZeneca Korea’s Lynparza tab(olaparib) is a treatment for ovarian cancer including fallopian tube cancer or primary peritoneal cancer. The drug was listed through the risk-sharing agreement scheme (RSA) in October 2017, using the pharmacoevaluation exemption system. However, its reimbursement was first only allowed for up to 15 months as maintenance therapy after chemotherapy, and then the restriction was lifted in May 2019 after discussions between the government and the company to extend reimbursement. After then, the company received MFDS approval on October 29th 2019 and applied for insurance benefits in January 2020. In June of the same year, the agenda was deliberated by HIRA’s Cancer Drug Review Committee, but the company had to reapply for reimbursement in October of the same year. The drug was finally put on the agenda for deliberation by HIRA’s PBAC in April this year. In April, the PBAC confirmed that the drug prolonged PFS compared to placebo from a clinical trial. Also, the committee decided that the ICER is at an acceptable level for use as first-line maintenance therapy and that the drug was cost-effective as second-line maintenance therapy as it cost less than its alternatives, Lynparza cap, and Zejula cap. The adjusted price of Lynparza tab that is listed in all A7 countries is ₩62,062 for the 100mg tab and ₩67,911 for the 150mg tab. Based on the calculated price, the company had been negotiating with the NHIS on the drug’s price and expected claims amount. During the pricing negotiations, both parties agreed on incorporating two types of reimbursement where the company pays back to NHIS a specific portion of the claims amount and a specific portion of the amount of claims that exceed the expected cap. The final price was set at ₩38,842 for 100mg and ₩48,553 for the 150mg dose. Zejula cap. 100mg (niraparib).◆Zejula cap. 100mg = Like Lynparza, Takeda Korea’s Zejula cap 100mg(niraparib) is also a treatment for ovarian cancer including fallopian tube cancer or primary peritoneal cancer that is already receiving reimbursement for the indication. 200mg of the targeted therapy is taken orally twice a day and has been reimbursed as second-line maintenance therapy for ovarian cancer since December 2019, and the reimbursement has been extended to treat patients with recurrent ovarian cancer who have received 3rd-line or higher chemotherapy since February this year. This time, discussions had been held to extend reimbursement to maintenance monotherapy in ovarian cancer for patients who have responded to first-line platinum-based chemotherapy. The company succeeded in adding the indication by MFDS on August 3rd last year and has requested an extension of reimbursement in the same month. In January, the drug has passed CDRC deliberations and was deliberated by the PBAC in June. At the time, HIRA had determined for reimbursement is appropriate as the drug is recommended as maintenance therapy in ovarian cancer patients who have responded to first-line platinum-based chemotherapy and is cost-effective as it is cheaper than alternative drugs. Also, it is listed in the U.S, France, Japan, Italy, U.K, Switzerland among A7 countries and its weighted average price is set at ₩129,886 per tablet Since then to earlier this month, the company had negotiated with the NHIS on the drug’s price and expected claims amount. Both parties had agreed that the company should pay back a specific portion of the amount of claims that exceed the expected cap, and the price to be set at 6% lower than the current cap of ₩74,184 and at ₩69,733.
- Policy
- Domestic venture introduces new imported breast cancer drug
- by Lee, Tak-Sun Sep 28, 2021 05:54am
- As domestic startup is imminent to introduce new breast cancer drug from overseas, Geo-Young is in charge of third-party logistics of the drug, drawing attention. This is because it is different from the existing anticancer drug distribution method that foreign pharmaceutical companies and large domestic pharmaceutical companies used to supply. According to the MFDS on the 27th, the screening of Nerlynx (Neratinib), a treatment for adult patients with early breast cancer positive for HER2, will be completed, and the final approval will be decided soon. It is introduced by Bixink, a subsidiary of KOSDAQ-listed company KPS, which focuses on OLED business, from Puma Biotech, Inc. in the U.S. Neratinib was approved by the U.S. FDA in July 2017 as an auxiliary treatment for HER2 positive early breast cancer adult patients under Trastuzumab-based therapy. Last year, it was additionally approved as a tertiary treatment for HER2 positive progressive and metastatic breast cancer patients through combination therapy with Capecitabine. The company explains that unlike conventional HER2 targeted anticancer drugs, it has been developed with a small molecular weight to penetrate blood vessel-brain barriers and overcome limitations in treating and preventing brain metastasis. If Nerlynx is approved, it is the first drug sold by Bixink. In addition to Nerlynx, Bixink also secured Asian copyrights for Mucosamin PO liquid, which helps prevent and treat oral mucosal inflammation caused by chemotherapy such as radiation and chemotherapy, from PDI, an Italian amino acid pharmaceutical company in December last year. Founded in 2016, the company is focusing on developing digital treatments in addition to the project to introduce anticancer and anti-cancer aids. KPS is looking forward to the synergy between IT and bio-business units. Bixink, which has no domestic distribution network as a new venture, will supply products through Geo-Young, the No. 1 pharmaceutical distribution company.
- Policy
- Will Rinvoq be approved for atopic dermatitis?
- by Lee, Tak-Sun Sep 28, 2021 05:54am
- Whether AbbVie Korea’s ‘Rinvoq SR,’ which has been prescribed with reimbursement as an oral rheumatoid arthritis treatment since last year, will add an indication for atopic dermatitis, is gaining attention. The industry believes it is highly possible, as the higher-dose formulation is soon to be approved in Korea, and the drug was approved for the atopic dermatitis indication in Europe in August last month. According to industry sources, the Ministry of Food and Safety’s review for AbbVie Korea’s ‘Rinvoq SR 30mg’ is now complete, and the drug is pending approval. Currently, only the 15mg dose is approved in Korea. Rinvoq SR 15mg is used to treat adults with moderate to severe active rheumatoid arthritis who had an inadequate response or are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). It is the 4th approved JAK inhibitor for rheumatoid arthritis. It is currently being prescribed at 21,085 won per tablet with reimbursement since November last year. In addition to rheumatoid arthritis, Rinvoq had verified its efficacy in atopic dermatitis through a clinical trial. Last year, the company had released the results of the Phase III study (Measure Up 2) that demonstrated Rinvoq’s efficacy and safety in moderate to severe atopic dermatitis patients. The drug was then approved as a treatment for atopic dermatitis in August in Europe and become the first JAK inhibitor to be approved for the atopic dermatitis indication. At that time, Rinvoq was approved in Europe for the treatment of moderate to severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy. The recommended dose of Rinvoq in adults patients was 15 mg or 30 mg once daily, and 15 mg once daily for adolescents. In this respect, industry experts believe that it is highly likely that the atopic dermatitis indication will concurrently be approved with the approval of Rinvoq SR 30mg. Analysts believe that oral JAK inhibitors have a competitive edge in the atopic dermatitis treatment market due to their better accessibility over the only biologic that has occupied the EU market, Dupixent prefilled syringe (dupilumab, Sanofi). The company may be more intent on adding the atopic dermatitis indication as oral JAK inhibitors are under the risk of being restricted as a second-line treatment to be used after TNF inhibitors. Eli Lilly’s ‘Olumiant’ has already been approved for the atopic dermatitis indication in May in Korea. Also, Pfizer is working to add the atopic dermatitis indication to its ‘abrocitinib.’ Whether AbbVie's Rinvoq, following Lilly Korea’s Olumiant, will open the era of JAK inhibitors for 'atopic dermatitis in Korea remains to be seen.
- Policy
- Pfizer vaccine for 1.67 million doses, about to be discarded
- by Lee, Jeong-Hwan Sep 28, 2021 05:53am
- Among the COVID-19 vaccines supplied in Korea, the vaccine with the most imminent expiration date was the Pfizer vaccine. Pfizer had about 1.67 million in stock and Janssen had about 720,000 in stock for supplies that remained within a month of expiration. Kang Ki-yoon, a member of the People Power Party, made the remarks in a data submitted by KDCA on the 23rd. The amount of pfizer left within one month of expiration date is about 1.67 million times, and Janssen had about 720,000 doses in stock. The Janssen vaccine also showed 719,600 doses left within a month of expiration, and 28,000 doses left between one and two months. He points out that products with an imminent expiration date had no choice but to ship them by marking the expiration date of the product itself, not the expiration date after thawing. Most of the products marked in this way were Pfizer vaccines. Among these products, 87,730 were delivered with only 10 days left, and 166,000 were delivered with 18 days left in Janssen's case. Representative Kang said, "Vaccines take about two weeks from the time of entry to delivery to medical institutions." In the case of vaccines with less than two weeks left, it is highly likely that they will lead to vaccination if they are not rushed, he pointed out. Looking at the cases of vaccinations that have passed the expiration date, AstraZeneca had 34 cases as of September 13, while Pfizer had 689 cases, indicating that Pfizer was overwhelmingly high. He said, "Most of the vaccines whose expiration date is imminent are Pfizer vaccines that have been received through Israel or Romania." He pointed out, "At the time of introduction, many people were concerned that they would be vaccinated against expired vaccines." He then said, "The expired Pfizer vaccine is overwhelmingly large." "With vaccine booster shots considered, the government should be extra careful not to receive vaccines from third countries that are about to expire due to failure in vaccine supply and demand," he stressed.
- Policy
- 129 drug price reduction starting in October
- by Kim, Jung-Ju Sep 28, 2021 05:53am
- Drugs that sell a lot or have a high price range will be lowered as of the 1st of next month. It will be reduced by up to 10%. It also included seven Choline alfoscerates that negotiated the redemption of drug costs for clinical revaluation. AstraZeneca's Lynparza 50mg, Kadcyla 100mg, and Kadcyla 160mg succeeded in risk-sharing contracts (RSA), respectively, with drug prices cut from 1% to 9%. According to the industry, it will be applied as of October 1 if the revision is finalized soon. This drug price cut corresponds to the type 'Na' and 'Da' of the Price-Volume Agreement. First of all, the type 'Na'' is a new drug which price has not been adjusted according to type 'Ka' and four years have passed since the date of registration, and the total amount of claims for the same product group has increased by more than 30%. Among them, the NHIS negotiates with the company if the amount of ▲ claims has increased by more than 60% from the previous year's claim, or if the amount of ▲ claims increases by more than 10% and the increase is more than 5 billion won. The type 'Na' drug, which will be applied as of the 1st of next month, is Bayer Korea's Eilea, which has been decided to cut 2.5% in the negotiations. There are as many as 128 items. In particular, some of the Price-Volume Agreement drugs include recently completed Choline alfoscerate negotiations. A total of three drugs have succeeded in renegotiating RSA and will be maintained at a reduced price next month. AstraZeneca's Lynparza 50mg will fall 9.1% from the existing drug price, while Kadcyla 100mg and Kadcyla 160mg by Roche will be reduced by 1.7%, respectively.
- Policy
- Is the third Avastin biosimilar coming out?
- by Lee, Tak-Sun Sep 27, 2021 05:51am
- Attention is focusing on whether another company will release an Avastin (Bevacizumab) biosimilar approved by Samsung Bioepis and Pfizer. This is because it was found that a new item was approved by the MFDS in August. If the item is approved, a total of four items, including the original Avastin by Roche and three biosimilars, are expected to compete. According to the MFDS on the 24th, a new biosimilar with Bevacizumab, the same ingredient as Avastin, was applied on August 30. The item was found to have applied for permission, excluding ovarian cancer-related indications that could cause patent disputes. Samsung Bioepis' Onbevezy and Pfizer's Jairabeve were also approved except for some of the ovarian cancer indications. This is because the patent will last up to March 2033. Onbevezy and Jairabeve were approved on March 11 and May 17 this year, respectively. Among them, Onbevezy has been on sale by Boryung since September. It is 37% cheaper than the original product, and the expiration date is 36 months long. Pfizer is also expected to release its products in the domestic market soon. The fact that another biosimilar is aiming for the domestic market also appeared in the recent patent challenge trial. Alvogen Korea filed a trial for invalidation of Avastin's ovarian cancer-related patent in August. Alvogen is reportedly planning to release biosimilars in Korea. However, it is analyzed that it may not be an item developed by Alvogen.Samsung Bioepis has also been participating in the patent invalidation trial. Celltrion has also terminated phase 3 clinical trials of "CT-P16," an Avastin biosimilar, and is in the process of product approval. Including Alvogen Korea and Celltrion, there are five domestic Avastin biosimilars. As Avastin is with a performance of about 120 billion won in Korea alone, competition for market share is expected to be fierce. Amgen, Samsung Bio, and Pfizer are already competing in the European market. On top of that, as Beringer Ingelheim and Celltrion are about to be approved, competition for biosimilars is expected to be fierce in the Avastin market.
- Policy
- The per capita GDP reference standard was deleted from ICER
- by Lee, Hye-Kyung Sep 27, 2021 05:51am
- The per capita GDP phrase was deleted from the ICER threshold used in the economic evaluation process of the first stage of new drug benefits. Although it has been changed to refer to the results of the existing deliberation, the phrase GDP per capita has been deleted, and the application of ICER values, one of the pharmaceutical industry's long-cherished projects, remains to be seen. On the 23rd, The HIRA unveiled the "Detailed Evaluation Criteria for Drugs Subject to Negotiation, such as New Drugs (Completed Amendment)." The revision of this standard includes the evaluation criteria deliberated and resolved at the 8th Pharmaceutical Benefit Appeal Committee held on September 3. The HIRA changed the standard, saying, "We will flexibly evaluate the disease by referring to the results of the existing deliberation considering its severity, social disease burden, impact on quality of life, and innovation." An additional content was added, "Refer to the results of the existing deliberation." The existing evaluation criteria will be applied first without linking GDP per capita in cost effectiveness. Kim Ae-ryeon, head of the drug management office, said, "We have decided to delete the application of per capita GDP standards to ICER values through meetings in the pharmaceutical industry, expert advice, and civic group opinions." She explained, "In the early days, expert advice was dominant that it was to apply health care priorities." She said,"Instead of deleting GDP standards to ICER, we need other standards." She added, "As we have accumulated experience while running the committee, the revision was carried out as opinions were gathered that it was reasonable to refer to the results of the existing deliberation." The pharmaceutical industry has been demanding expansion, pointing out that the domestic ICER threshold remains at the level of 25 million won, a reference to GDP in 2013.
- Policy
- Reimbursed generics pour in with Xarelto's patent expiry
- by Kim, Jung-Ju Sep 24, 2021 05:57am
- More than 100 reimbursed generics of Xarelto will be pouring into the market next month with the substance patent expiry of the novel oral anticoagulant (NOAC) Xarelto (rivaroxaban). Among the drugs, products that are subject to premium pricing for being drugs from innovative pharmaceutical companies, etc. are Chong Kun Dang’s Riroxia Tab. 15mg, and 20mg that was released earlier in May. The two drugs will receive premium pricing for 7 months based on the release date of the 20mg strength. According to industry sources on the 23rd, the Ministry of Health and Welfare is working to amend the ‘Drug reimbursement list and reimbursement ceiling price table’ to include such changes. The changes will be effective from October 1st. First, the price of Korea Prime Pharm’s Xaito Tab. 10mg has been set at 85% of the highest price of same ingredient drugs that are already listed as it met only one of the two standards set for pricing of generic drugs, and only one other same ingredient drug is currently listed and priced at 53.55% of the ceiling price of same ingredient drugs. Twelve products will be listed at the same price as the highest price set for same ingredient drugs, 6 of which are rivaroxaban products. Sixty-eight products will be listed at 85% of the highest price of already listed same ingredient drugs. Among these, 60 products, including Han Poong’s Rivarell tab. 15mg, Boryung Biopharma’s Xarox tab. 15mg, Daewoong Bio’s Varelto tab. 15mg and 20mg, are rivaroxaban products. Also, the price of 32 products was set lower than the ceiling price of its higher strength product that was filed for listing at the same time. Such drugs include Daewoong Bio’s Varelto tab. 10mg, GC Pharm’s Neoroxaban tab. 10mg, Yuhan Phram’s Yuhan Rivaroxaban tab. 10mg, Yuyu Pharm’s Yuvaro tab. 10mg, Dong Wha Pharm’s Rivacor tab. 10mg, Aju Pharm’s Zatol tab. 10mg, Kolmar Pharma’s Newroxban tab. 10mg, and Whanin Pharm’s Jaroban tab. 10mg. Also, a new 10mg strength product of Chong Kun Dang’s Riroxia tab. that was already released in May will be newly listed. The drug’s price had been set at a price lower than the ceiling price of its already listed higher strength product. The government sets the ceiling price of lower strength products at a lower price than the ceiling price set for its higher strength counterpart when a higher strength drug with the same company, route of administration, ingredient, and formulation is already listed. Therefore, Chong Kun Dang’s Riroxia tab. 10mg’s price was set at ₩1,312 per tablet. Thirty-four products were set at the expected sales price. The government allows a drug’s price to be set at the expected sales price submitted by the manufactuer·congisnged manufacturer·importer applicant when the price is lower than the price set according to standards. Drugs that will be listed at the expected price are Boryung Biopharma’s Xarox tab. 10mg, Yooyoung Pharm’s Yooroxaban tab.10mg, Yungjin Pharm’s Xarex tab. 10mg, Samjin Pharm’s Rivoxaban Tab. 10mg, Hanmi Pharm’s Riroxban tab. 10mg, GC Pharm’s Neoroxaban tab. 15mg, Yuhan Pharm’s Yuhan Rivaroxaban Tab. 15mg, and JW Pharmaceutical’s Livalozet tab., etc. Meanwhile, 11 rivaroxaban products from 4 companies will be listed with a premium. The premium will expire in 7 months, on April 30th, 2022. The government allows premium pricing for one year from the first generic was listed for some drugs. For innovative pharmaceutical companies, the premium is set at 68% of the original drug price in the first year, then subsequently lowered to 53.55% after the term is terminated. Products that benefit from this premium pricing are Chong Kun Dang’s Riroxia Tab 15mg and 20mg that was released first among generics in May. As the premium pricing period is set based on the 20mg strength drug, the premium will be in effect for only 7 more months.
- Policy
- Lynparza RSA renewed, adds reimbursement for ovarian cancer
- by Lee, Hye-Kyung Sep 24, 2021 05:56am
- In addition to the ongoing negotiations for RSA renewal, an insurance benefit standard will be newly established for ‘Lynparza (olaparib)’ as maintenance monotherapy. The Health Insurance Review and Assessment Service (HIRA) has announced that it has posted a public notice on the ‘Details of the standards and methods for applying insurance benefit to pharmaceuticals prescribed or administered to cancer patients,’ and will be reviewing opinions until the 27th. The amended details will be effective from October 1st. After reviewing the reimbursement standards for Lynparza in ovarian cancer, HIRA decided to allow its reimbursement as ‘first-line maintenance treatment for patients newly diagnosed with BRCA-mutated advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have responded to first-line platinum-based chemotherapy (partial or complete response)’; and ‘as second-line maintenance treatment for patients with BRCA-mutated advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have responded to second-line or higher platinum-based chemotherapy (PR or CR).” As for the administration period, reimbursement for maintenance treatment after first-line platinum-based chemotherapy will be allowed up to 2 years from initial treatment. For ovarian cancer, etc. that responds to second-line or higher platinum-based chemotherapy, reimbursement will be restricted to patients with a BRCA mutation. Details on the platinum-based chemotherapy that is administered immediately before the maintenance therapy will be specified in footnotes in consideration of the inclusion/exclusion criteria in its clinical trials, and eligible patients should have received platinum-based chemotherapy (excluding therapies that use bevacizumab) for at least 4 cycles with no history of PARP inhibitor use. Also, the increased scope of eligibility for ‘Zejula cap. (niraparib)’ in ovarian cancer and ‘Sprycel (dasatinib)’ in acute lymphoblastic leukemia led to an expansion in their reimbursement standards. For Zejula, a new reimbursement standard was added for BRCA mutated patients as ‘maintenance monotherapy for ovarian cancer (including fallopian tube cancer or primary peritoneal cancer) in adult patients who have shown response to first-line platinum-based chemotherapy (partial or complete response).’ For Sprycel, reimbursement standard was set for ‘use in combination with chemotherapy in pediatric patients aged 1 or older with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML)’
- Policy
- Rekirona are expanded to 50 years of age or older
- by Lee, Tak-Sun Sep 24, 2021 05:56am
- The MFDS approved the official approval based on the results report of phase 3 clinical trials of Celltrion's COVID-19 antibody treatment Rekirona, which completed phase 3 global submitted by the company. It has expanded the subject of administration. However, mild patients were not included. The MFDS announced on the 17th that it had carefully reviewed the results of a global phase 3 clinical trial of Rekirona (Regdanvimab), a domestic COVID-19 antibody treatment submitted by Celltrion on the 10th of last month, and approved the change to delete the permit conditions and expand the range of patients who can be administered. As the efficacy and effect of Rekirona was allowed to be changed to "treatment of mild and all secondary adult patients at high risk of COVID-19", the number of patients who can be treated increased. The previous high-risk patients were over 60 years old or with underlying diseases (one or more of cardiovascular disease, chronic respiratory disease, diabetes, and high blood pressure), which lowered the target's age to over 50 years old and added obese people (BMI index 30 or more), chronic kidney disease (including dialysis), chronic liver disease, bone marrow transplantation. The administration method also shortened the administration time from intravenous administration for 90 minutes to 60 minutes. The MFDS explained that the overall safety of Rekirona was good. In phase 3 clinical trials, the incidence of abnormal cases of Rekirona was similar to that of the placebo group, and most of the symptoms were mild or moderate. The most frequently reported abnormal cases included elevated liver enzyme levels and hyperglycermia, and significant abnormal cases were "injection-related reactions" (one patient), recovering within a few days. It has been confirmed that the effectiveness of Rekirona significantly reduces the duration of severe exacerbation and clinical recovery due to COVID-19. Among mild and secondary patients administered Rekirona, the rate of severe transmission from 446 high-risk patients decreased by 72% compared to placebo (434 patients), and the clinical recovery period was also shortened by 4.12 days compared to placebo (12.3 days). The MFDS explained that it consulted experts on the 3rd and the Central Pharmaceutical Affairs Council on the 10th on whether the results of Rekirona's phase 3 clinical trial could therapeutically confirm the effectiveness of the drug in the patient group that Celltrion applied for change. As a result, experts agreed that it is reasonable to delete the permit conditions and switch to formal permission, and that it is desirable to expand the scope of high-risk groups and apply them to high-risk mild and all secondary adult patients. However, in the case of mild symptoms other than high risk, the frequency of severe morbidity was low, and there was insufficient confirmation of effectiveness, so it was not included in the scope of use. In addition, it was suggested that it is reasonable not to include children over the age of 12 in the scope of use because they are not included in the clinical trial. The MFDS reviewed the results of the review and advisory opinions and decided on the scope of the drug's use as "all secondary adult patients in mild to high-risk groups" identified in the clinical trial.
