- LOGIN
- MemberShip
- 2026-05-12 21:11:14
- Company
- Keytruda has booked high sales in the domestic market
- by Chon, Seung-Hyun Nov 29, 2022 05:53am
- Keytruda, an immuno-cancer drug, has reserved a leading position in the domestic pharmaceutical market for 3 consecutive years. New drug products recently released by multinational pharmaceutical companies such as Gardasil 9 and Dupixent continued to be high. According to IQVIA, a pharmaceutical research firm, MSD Keytruda posted 161.6 billion won in sales in the first three quarters of this year, the largest among all medicines. Compared to the same period last year, it increased by 11.1%, firmly maintaining its leading position. Keytruda's sales in the first quarter were 40.4 billion won, down 8.4% from the previous year. At that time, the decline in sales was blamed for the drug price cut. Keytruda's insurance upper limit was lowered by 25.6% in March as the scope of health insurance benefits was expanded to primary treatment for non-small cell lung cancer. However, Keytruda recovered its upward trend from the second quarter. Sales in the second quarter rose 9.7% year-on-year to 53.9 billion won, and sales in the third quarter rose 28.8% to 67.2 billion won. It is analyzed that Keytruda's primary treatment benefit application effect occurred in earnest. In the case of sales in the third quarter, considering the drug price cut rate, it is calculated that usage increased by more than 60% compared to the same period last year. Keytruda, released in Korea in 2015, is an immune checkpoint inhibitor that treats cancer by inhibiting PD-1 protein on the surface of immune cell T cells to prevent binding to PD-L1 receptors and activate immune cells. In Korea, 21 indications were granted in 16 carcinomas, including melanoma, lung cancer, and head and neck cancer. Currently, the cancers that can use Keytruda have reached ▲ lung cancer, ▲ head and neck cancer, ▲ Hodgkin lymphoma, ▲ urinary epithelial cancer (Bladder cancer), ▲ esophageal cancer, ▲ melanoma, ▲ renal cell cancer, ▲ endometrial cancer, ▲ gastric cancer, ▲ small intestine cancer, ▲ pancreatic cancer, ▲ biliary cancer, ▲ cervical cancer 16, ▲ cervical cancer. It can be used in the largest number of cancer types among immuno-cancer drugs licensed in Korea. Keytruda's sales began to rise rapidly after insurance benefits were applied as a secondary treatment for non-small cell lung cancer in August 2017. Sales exceeded 10 billion won in the first quarter of 2018 and 30 billion won in the second quarter of 2019. In the first quarter of 2020, Lippito was brought down to the second place and ranked first overall, and since then, he has maintained the lead for 11 consecutive quarters. New drug products recently released by multinational pharmaceutical companies were strong at the top of drug sales. MSD's cervical cancer vaccine Gardasil 9 ranked third overall, with cumulative sales of 85.3 billion won in the third quarter, up 68.0% from the same period last year. Gardasil 9 saw its sales rise 39.2% year-on-year to 24.3 billion won in the first quarter, while sales in the second and third quarters grew 98.9% and 66.1% year-on-year, respectively. Gardasil 9 is an HPV (human papillomavirus) vaccine product that adds five serum types (31, 33, 45, 52, 58) to four serum types (6, 11, 16, and 18 types) owned by Gardasil. It includes most HPV types of cervical cancer vaccines. In addition to cervical cancer, the number of male vaccinations is also increasing every year due to word of mouth that Gardasil 9 can prevent HPV-related diseases such as anal cancer, reproductive demons, and precancerous lesions. Since July 2020, the recommended age for vaccination has expanded from 9 to 26 years old women to 27 to 45 years old women, and the rate of re-vaccination of adults who have previously been vaccinated against cervical cancer has also increased significantly. Sanofi's atopic dermatitis treatment Dupixent recorded 75.9 billion won in cumulative sales until the third quarter, up 45.2% from the previous year. Sales in the first and second quarters increased 77.0% and 47.6% year-on-year, respectively, while sales in the third quarter increased 23.8% from the previous year. Dupixent is the first targeted biological drug developed for the treatment of moderate to severe atopic dermatitis, where topical treatments are not recommended or symptoms are not properly controlled. It acts as a mechanism that selectively suppresses the signal transmission of interleukin-4 and interleukin-13, which are known to be the causes of atopic dermatitis. Dupixent, which received domestic permission in March 2018, has seen its sales expand rapidly since January 2020 when it was covered by salaries for severe atopic dermatitis. Dupixent's sales were only 3.3 billion won in the first quarter of 2020, but quadrupled to 13.5 billion won in the first quarter of last year. It has recorded sales of 20 billion won since the third quarter of last year. Ono's immuno-cancer drug Opdivo's cumulative sales in the third quarter were 79.8 billion won, up 32.6% from the previous year. Opdivo, which was licensed in 2015, began to see a significant increase in sales after it was listed as an insurance benefit in 2017. Opdivo surpassed 10 billion won in quarterly sales for the first time in the first quarter of 2018 and has recorded sales of 20 billion won since the third quarter of last year. Amgen's Prolia ranked fourth overall, with sales rising 28.6% from the previous year to 83.8 billion won in the first and third quarters. Released in Korea in November 2016, Prolia is a biomedical osteoporosis treatment that targets the protein RANKL, which is essential for the formation, activation, and survival of bone-destroying osteoporosis. Prolia began to see an upward trend in sales after salaries were applied only to secondary treatment therapy in 2017. Since April 2019, Prolia's sales have exploded as insurance benefits have been recognized in primary treatment. Among the new drugs developed by Korean companies, HK inno.N's anti-ulcer drug K-CAB ranked seventh overall with sales of 77.9 billion won in the third quarter, up 20.1% from the previous year. K-CAB, released in March 2019, is a new mechanism of action that inhibits gastric acid secretion by competitively combining proton pumps and potassium ions located in the final stage of acid secretion.
- Policy
- Avastin biosimilar will be reimbursed starting next month
- by Lee, Tak-Sun Nov 29, 2022 05:53am
- Celltrion VegzelmaCelltrion's Avastin biosimilar Vegzelma will be listed on the 1st of next month. As a result, Roche, which owns the original Avastin, has joined Alvogen Korea, a biosimilar company, Samsung Bioepis, and Celltrion, making the market competition a four-way race. According to industries on the 25th, Celltrion Vegzelma's 0.1g and 0.4g will be listed at 208,144 won and 677,471 won, respectively, on the 1st of next month. The price is the same as Samsung Bioepis' Onbevezy and Alvogen's Arimcis. Bevacizumab formulations are anticancer drugs used in various carcinomas, with the domestic market reaching about 100 billion won. The original Avastin recorded 38.1 billion won in the first half of last year based on IQVIA. In September last year, Samsung Bioepis Onbevezy received a salary and was released for the first time in Korea as a biosimilar. This product is currently being sold by Boryung Pharmaceutical. Onbevezy's one-year monopoly in the biosimilar market was broken when Albogen Korea released Arimcis last month. Arimcis is sold by Daewoong Pharmaceutical. Competition for Bevacizumab formulations is expected to begin in earnest as Celltrion joins in December. Although biosimilars are less popular in the domestic market, Celltrion is also looking forward to Bevacizumab as it is only Remsima that performs as well as the original. Since the drug price difference between the original and biosimilars is not significant, the performance difference is expected to appear depending on marketing and distribution capabilities. However, the fact that Alvogen Arimcis is limited in use in relation to ovarian cancer due to patent problems is considered a weakness in the indication. Although Samsung Bio and Celltrion are raising their stock prices with biosimilars overseas, it is true that they have been negligent in marketing in the domestic market, which is small in size. However, the Avastin biosimilar is expected to be active in investing in domestic sales due to its large domestic market size. Attention is focused on who will win the four-way race for biosimilars.
- Company
- First targeted PIK3CA Piqray reapplies for reimb
- by Eo, Yun-Ho Nov 28, 2022 05:51am
- An anticancer drug that targets the PIK3CA gene will once again attempt reimbursement listing in Korea. According to industry sources, Novartis Korea submitted a reimbursement application for the reimbursement of its breast cancer treatment Piqray (alpelisib) recently. The drug was unable to pass deliberations by the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee in February this year. Piqray, which was approved in Korea in May last year, is a 'PIK3Caα-inhibitor that blocks the overactivation of the PI3K enzyme which, when overactivated because of a mutation in the PIK3CA gene, stimulates cancer cells to divide and grow in an uncontrolled fashion. The targeted cancer therapy is prescribed in combination with Faslodex (fulvestrant) to treat metastatic and advanced-stage, hormone-receptor-positive/ HER2-negative breast cancer in patients who failed previous treatment. Piqray’s safety and efficacy were demonstrated in the SOLAR-1 trial, which was conducted on 572 postmenopausal women, and men, with HR+, HER2- advanced (locoregionally recurrent or metastatic) breast cancer whose disease had progressed or recurred on or after an aromatase-inhibitor-based treatment (with or without CDK4/6 combination) Results showed when used in combination with Faslodex, Piqray improved the median PFS (Progression- Free survival) of cancer patients with the PIK3CA mutation from 5.7 months to 11 months. The Objective Response Rate (ORR), which indicates the proportion of patients whose tumor size was reduced by over 30%, was 35.7% for the combination therapy group, which is twice more than the 16.2% in the fulvestrant monotherapy group. The secondary endpoint, Overall Survival (OS) in patients with PIK3CA mutations, was 39.3 months in the combination therapy group. This was 8 months longer than the 31.4 months in the fulvestrant monotherapy group but did not have statistical significance.
- Policy
- Actilyse's price to rise 15% from next month
- by Kim, Jung-Ju Nov 28, 2022 05:50am
- The price of Boehringer Ingelheim’s acute myocardial infarction treatment Actilyse Inj. (alteplase) will rise 15% from next month after applying for drug pricing adjustments. Aju Pharm’s acute back pain reliever (aceclofenac, eperisone hydrochloride) will newly receive a 10% premium for 1 year. Also, the 30.4% premium pricing for Hanmi Pharmacueetical’s allergic rhinitis treatment Potastine OD Tab (bepotastine calcium dihydrate) will be maintained due to the small number of companies producing the same product, and Kyowa Kirin Korea voluntarily opted for a 1.5% reduction in the price of its Romiplate 250μg (romiplostim). According to industry sources, the Ministry of Health and Welfare is working to amend the ‘drug reimbursement list and reimbursement ceiling price table’ to implement the changes above for implementation on December 1st. First, Aju Pharm’s Afexon Tab has been newly listed with premium pricing for 1 year. The premium pricing rate will be wet at 10%. For incrementally modified combined new drugs, the government applies a 59.5% premium for first generics for one year from listing. For drugs from 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. The premium pricing for Hanmi Pharmaceutical’s Potastine OD Tab will be maintained for the time being due to the small number of companies manufacturing the same item. The premium rate of the drug is set at 30.4%. The government applies premium pricing to drugs when there are 1 or less companies that produce a drug with the same route of administration, ingredient, and formulation as the first-listed incrementally modified new drug. However, if no other companies produce the same product even after the 5-year premium pricing period, the premium pricing is maintained until the number of companies becomes 2 or more. On the other hand, some companies have opted for strategic price reductions for marketing, etc. Kyowa Kirin Korea applied for drug pricing adjustments to reduce the price of its Romiplate 250μg by 1.5%, and the reduction will be applied from the next month. Boehringer Ingelheim Korea applied for a price increase for its Actilyse Inj. (alteplase), and after undergoing negotiations, the price of Actilyse will be raised by 15% for each strength from next month. The application to adjust the ceiling price for price increases can be submitted when the drug is ▲essential to the treatment of patients, ▲has no alternatives, ▲is supplied by one company and its administration is cheaper than its alternatives. After the drug passes deliberation by the Health Insurance Review and Assessment Service’s Drug Reimbursement Review and Assessment Service and undergoes drug pricing negotiations with the National Health Insurance Service.
- Opinion
- [Reporter's view]There should be no recurrence of COVID kit
- by Lee, Hye-Kyung Nov 28, 2022 05:50am
- Demand for self-examination kits is increasing rapidly as Twindemic, where COVID-19 and seasonal flu are prevalent at the same time, becomes a reality. According to the pharmacy site data analysis service Care Insight (www.careinsight.co.kr), 12,629 self-kits were sold at 396 pharmacies in the 47th week of this year (11/13-19), with daily sales of about 4.56 pharmacies. As the average daily sales per pharmacy in the 43rd week of this year increased every week from 2.45 to 2.87 (44 weeks) → 3.28 (45 weeks) → 3.91 (46 weeks), some are concerned about the recurrence of the supply shortage of self-kits in the first half of this year. The Ministry of Food and Drug Safety said it is continuously monitoring domestic production and inventory, adding that it is not at a stage where it is concerned about the reproduction of supply shortages. The reason is that as of November 15, the inventory of self-kits is 70 million people, which can produce about 40 million people a week. Front-line pharmacies are concerned that if the number of people looking for self-kits increases due to the Twindemic, the supply shortage that occurred earlier this year could be reproduced if demand suddenly increases more than supply. In particular, as pharmacies were confused by the Ministry of Food and Drug Safety's management system, which changes every day at the time of the supply of self-kits, they have no choice but to worry about securing inventory of self-kits in preparation for Twindemic. When the shortage of self-kits occurred in February, the government's policy changed several times in just 10 days. On February 11, the Ministry of Food and Drug Safety announced a ban on online sales on February 10, followed by then Prime Minister Kim Boo-kyum's "consideration of introducing the highest price system," limiting sales to pharmacies and convenience stores, allowing small sales, and limiting purchases. Pharmacists could not trust the government as they announced the designation of 6,000 won for each sale on Feb. 14, announced the application of 50 quotas per seller, and changed their words to abolish the 50 quota system on Feb. 16. The problem occurred once more last August. Complaints from pharmacies have increased as convenience stores that have not reported medical device sales businesses have been allowed to sell their own kits from July 20 to September 30. It is said that the supply of self-kits is sufficient now, but if there is a shortage again, the Ministry of Food and Drug Safety is expected to actively intervene as in the cases in February and July. However, if another unprepared policy and plan to ignore the existing system are announced, trust will eventually be broken. The Ministry of Food and Drug Safety should predict demand with experts in advance and create natural solutions together, not urgent measures so that there is no confusion and dissatisfaction at the site.
- Policy
- Crysvita, referred to the welfare committee
- by Lee, Jeong-Hwan Nov 28, 2022 05:50am
- A petition for national consent calling for quick approval of the rapid use of "Crysvita," a treatment for hypophosphatemia, a rare disease, was recently referred to the National Assembly's Health and Welfare Committee with 50,000 consent. Crysvita is a treatment for XLH hypophosphatemia rickets and osteomalacia supplied by Kyowa Kirin Korea in Korea. XLH (X-Linked Hypophosphatemia, X chromosome dominant hypophosphatemia) is a genetic disease and has a characteristic of severely bending legs. The prevalence of XLH is about one person per 20,000 to 60,000 people, and most of them are found after the disease has progressed considerably due to signs around the age of two. Early detection of XLH is essential for future treatment and management of patients. If you miss the timing of treatment, you may suffer from side effects such as limb deformity, growth delay, reduced height, increased risk of fracture, kidney calcification, and elevated parathyroid levels. In severe cases, you may not be able to walk. Kyowa Kirin Korea's Crysvita was approved by the Ministry of Food and Drug Safety in September 2020 as a treatment for XLH and osteomalacia. However, it has not been eligible for salary for two years since the permission. The petitioner, who introduced himself as the patient's mother, explained, "XLH chromosome-dominant hypophosphatemia is a disease that requires living in pain for the rest of your life because early detection is essential for the patient's future treatment and management. She appealed, "In Korea, it is excluded from the standard of fewer than two years of survival threat or life expectancy, so treatment cannot be used even before the eyes." The petitioner appealed, saying, "The mother of a patient who is having a hard time every day because health insurance is not covered even before the treatment for hypophosphatemia rickets, which has been waiting for more than 20 years." She said, "Since health insurance is not covered, individuals have to pay hundreds of millions of won in treatment costs." Crysvita was approved by the FDA in April 2018, is used as a treatment for adults and children over 6 months, and has been approved for sale in major countries such as Europe, the United States, and Japan.
- Policy
- IVI-Biovac has signed an agreement to develop an OCV
- by Lee, Hye-Kyung Nov 28, 2022 05:49am
- The International Vaccine Research Institute (IVI) announced on the 24th that it has signed a license and technology transfer agreement with Biovac, located in South Africa, for the local manufacture of IVI's OCV. This agreement is meaningful in securing the manufacturing capacity of raw materials, that is, the ability to produce antigens/raw materials necessary to actually manufacture vaccines, through the project. The agreement comes at a time when recent outbreaks of cholera have been triggered by climate change, armed conflict, and forced migration in countries such as Pakistan, Nigeria, and Malawi, seriously hurting already vulnerable health systems. This situation is already causing additional demand for the supply of cholera vaccines, which are in short supply worldwide. In recent years, the area of cholera outbreak has expanded further amid growing supply-demand imbalances caused by a lack of supply of cholera vaccines. The purpose of the agreement signed by IVI and Biovac is to permit and transfer vaccine manufacturing technologies, and ultimately to solve the shortage of vaccines by increasing vaccine production worldwide to prevent cholera. In addition, this technology transfer is expected to be an opportunity to establish and demonstrate the full capacity of GMP expansion, local manufacturing of clinical trial products, and production of vaccines available in Africa and around the world. The agreement is expected to be an important step in enabling vaccine production on the African continent decades later. In the African market, locally produced vaccine production is currently less than 1%, and infectious diseases are still one of the main causes of death, especially for children under the age of five. African leaders have expressed their commitment to creating a local vaccine industry, aiming to raise the proportion of vaccines manufactured in Africa from 1% in 2021 to 60% in 2040 The agreement is the first step in the project's launch and will receive $6.9 million in donations from the Wellcome Trust Foundation and the Bill and Melinda Gates Foundation. Through this agreement, Biovac will be able to expand its capabilities from vaccine vial filling and packaging to all areas of vaccine product development and raw material drug manufacturing. The technology transfer process begins in January 2023, and the first batch of vaccine prototypes for clinical trials is expected to be produced in 2024. The South African National Regulatory Authority (SAHPRA) approval for product use and the WHO Pre-Qualification Certification (PQ), which will take place immediately after approval, is scheduled to be completed in 2026.
- Company
- K-similars compete for Canada's ₩31 tril market
- by Nov 25, 2022 06:05am
- Biosimilars manufactured by domestic bio companies are targeting Canada, the world's 10th largest pharmaceutical market With an increasing number of provinces in Canada actively implementing policies to mandate the use of biosimilars, usage of biosimilars in the country, which had been in the 10% range, is expected to increase significantly. According to industry sources on the 25th, Samsung Bioepis launched its oncology drug ‘Avastin’ biosimilar ‘Aybintio’ through its partner company Organon. Aybintio is a VEGF inhibitor prescribed for metastatic colorectal cancer, metastatic or recurrent non-small-cell lung cancer, platinum-sensitive recurrent ovarian cancer, etc. With the approval, a total of 5 Samsung Bioepis biosimilar products have been released in Canada as of this month. When including the 4 Celltrion biosimilars, a total of 9 biosimilars from Korea are now in the Canadian market. Starting with its Enbrel biosimilar ‘Brenzys’ in 2016, Samsung Bioepis received approval for 6 biosimilars including its Remicade biosimilar ‘Renflxis’ in 2017, Humira biosimilar ‘Hadlima’ in 2018, Avastin biosimilar ‘Aybintio’ in 2021, Herceptin biosimilar ‘Ontruzant’ and Lucentis biosimilar ‘Byooviz’ in 2022. Among the products, Byooviz has not been released to the market yet due to patent issues. In the case of Celltrion, it received approval and has marketed 4 biosimilars including its Remicade biosimilar ‘Remsima,' Rituxan biosimilar ‘Truxima,’ and Herceptin biosimilar ‘Herzuma’ in 2014, and Humira biosimilar ‘Yuflyma’ in 2021. Among the 50 biosimilar products approved by the health authorities in Canada, 10 are Korean products. ◆Canada ranks 10th in the global market...receives attention for its policy pro-biosimilar policy The Canadian pharmaceutical market is worth UDS 23.8 billion (KRW 31.58 trillion) based on IQVIA in 2020, and is the 10th largest market in the world. The country has been pointed to as the ‘land of opportunity' by domestic biopharmaceutical companies with the government’s recent implementation of biosimilar-friendly policies in provinces to reduce the cost of prescription drugs. The Province of British Columbia after implemented a policy three years ago that only allows the use of biosimilars for certain diseases, with exceptions, to raise the usage of biosimilars that remained at the 8% level at the time. British Columbia has mandated that prescriptions be switched to biosimilars, except in exceptional cases for indications for autoimmune diseases such as plaque psoriasis, psoriatic arthritis, and Crohn's disease. Some provinces in Canada have a policy that mandates the use of biosimilars instead of originals for certain diseases. (Source: Northwest Territories website) The unconventional policy significantly increased the use of biosimilars in the province. As of the end of last year, the share of biosimilars in the private biopharmaceutical market, which had been 12% in other provinces, had reached 65% in the Province of British Columbia. From December last year to this year, other provinces including Alberta, New Brunswick, Quebec, Nova Scotia, Northwest Territory, and Saskatchewan also adopted policies to encourage the use of biosimilars, therefore, the biosimilar market is expected to grow further. The number of biosimilar approvals has also increased. Since approving 9 biosimilars last year, Health Canada additionally approved 7 products by November this year. In total, 50 biosimilars have now been approved in Canada so far, which is more than the 39 approved in the US. The Canadian government projects that it will be able to save about KRW 1 trillion (USD 768.7 million) a year with the implementation of the pro-biosimilar policy. An official from Samsung Bioepis said, “We have established a diverse product portfolio in Canada, the world's 10th largest pharmaceutical market, and plan to work more closely with our partners to expand their sales in the North American market."
- Company
- Janssen Korea to reduce workforce...conducts VSP
- by Eo, Yun-Ho Nov 25, 2022 06:05am
- Janssen Korea plans to restructure its labor force. According to industry sources, Janssen finalized its decision to conduct a Volunteer Separate Program (VSP) in its town hall meeting. The company will receive applications for VSP until the 30th of this month and does not have a fixed number of reductions planned. The specific terms of compensation for the VSP have not been disclosed. While conducting the VSP in 2015, the company had proposed ‘'years of service X2+2 months (average wage)+2 months (normal wage)' as compensation for early retirement. Also, Janssen’s VSP will exclude those in charge of market access (MA) and regulatory affairs (RA). Other multinational pharmaceutical companies including Novartis Korea, GSK Korea, and Sanofi Korea have also implemented early retirement programs in the second half of this year.
- Opinion
- [Reporter's view] Godex benefit adequacy will be further di
- by Lee, Tak-Sun Nov 25, 2022 06:05am
- At the Health Insurance Policy Deliberation Committee held on the 23rd, it was decided to further discuss the appropriateness of the salaries of Godex and Imotun at the next deliberation committee. Although the HIRA Drug Benefit Evaluation Committee recognized the appropriateness of the benefit, the final organization, the Health Insurance Policy Review Committee, put the brakes on it. The review committee plans to revisit whether it is appropriate to recognize the appropriateness of benefits just because drugs with unclear clinical usefulness are cost-effective. The decision of the Health Insurance Policy Review Committee should serve as an opportunity to look back on whether the re-evaluation of drug benefits, which has been underway since last year, is proceeding correctly. First of all, it is necessary to check whether the basis for judging the clinical usefulness being evaluated is playing its role. The HIRA first evaluates clinical usefulness based on the basis of evidence such as textbooks, clinical care and guidelines. Items with ambiguous clinical usefulness and unclear items are emerging. Godex and Imotun were those kinds of drugs. If so, it is necessary to look back on whether the data on which the evaluation is based lack of reliability or the threshold of evidence is too low. Unlike the salary re-evaluation, the Ministry of Food and Drug Safety's re-evaluation of efficacy is much clearer. If the effectiveness of the drug is unclear, the basis is provided through clinical trials. The permission also varies depending on the success of the clinical trial. The evaluation of the clinical usefulness of the HIRA is supposed to be skipped if it is ambiguous. In other words, if the clinical usefulness is unclear, the appropriateness of the salary is evaluated by considering the cost effectiveness. Even if the clinical usefulness is not accurately proven, there is a way to maintain the salary. In some ways, I don't know if it's effective or not, but it's cheap, so it can be seen as maintaining benefit. The deliberation committee also points out this point and asks if it fits the purpose of re-evaluation of benefit adequacy for the purpose of optimizing drug expenditure. Even if Godex and Imotun are recognized for their appropriateness as determined by the committee at the next hearing, the existing clinical usefulness evaluation part should be revised. It is necessary to provide clues that make it clear whether it is clinical useful without intermediate or if the clinical usefulness is unclear. In that respect, the current evaluation of benefit adequacy is not clear. It may be a way to leave drugs with unclear clinical usefulness to the Ministry of Food and Drug Safety to conduct clinical re-evaluation. I would like to ask again whether it is efficient to undergo double verification because the efficacy verified by the Ministry of Food and Drug Safety and the clinical usefulness evaluated by the HIRA are different. The HIRA should not dismiss the review committee's decision as a kind of distinction, but should use it as an opportunity to double-check whether the re-evaluation of salaries has been carried out correctly.
