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- 2025-12-21 13:28:17
- Policy
- MFDS amends medical device permit renewal regulations
- by Lee, Hye-Kyung Sep 07, 2023 05:31am
- The Ministry of Food and Drug Safety (Minister: Yu-Kyung Oh) issued a pre-announcement of administration on September 6th regarding the amendment of the ‘Regulations on Renewal of Medical Device Manufacturing Permits.’ and will be receiving opinions until September 26th. The amendment contains changes such as requiring different data submissions for each medical device in consideration of each device’s characteristics to ensure the smooth operation of the medical device product renewal system that will be implemented in 2025. The medical device permit renewal system was introduced to periodically check the safety and effectiveness of products that have already been approved, reported, and certified, and requires companies to submit the latest safety and efficacy data, manufacturing and import records, etc. every 5 years to the MFDS. After the MFDS review, companies can continue manufacturing or importing their devices. The main contents of the amendment made are: ▲reasonable application of data submission requirements according to the characteristics of each medical device subject to report production and import discontinuations, etc. ▲focus on maintenance of distributed products during 1st renewal, and full-scale comprehensive review of safety and efficacy during 2nd renewal. For ‘reported products' that are relatively low risk to the human body and medical devices that must submit production/import discontinuation reports because a stable supply of such is necessary for patient safety, companies would need to submit a declaration of conformity as proof that it had reflected the latest standards. Also, ‘maintenance products’ that do not require the application of the latest standards due to discontinuation, companies will only need to submit production/import performance records and safety information measures. In the first renewal period (2025-2029), the government plans to focus on reorganizing the products already in distribution, including reorganizing product names and grades to conform with the current regulations. In the second renewal period (2030-2034), the government plans to reflect the latest standards and comprehensively review the safety and efficacy of medical devices, including safety information actions details made by companies, etc. Also, to increase industry predictability, the renewal application deadline will be clearly defined as 270 to 180 days before the expiration date of the validity period, and specify that safety information and action details that have already been reported (submitted) do not need to be submitted separately. The MFDS had held continuous meetings to listen to opinions in the field on ways to improve the industry's predictability and acceptance of the new system and has actively reviewed the opinions for the amendment. The MFDS said that it expects the new amendment to support the rational operation of the medical device product permit renewal system based on regulatory science and expertise, and stated that it will continue to make efforts to create grounds for the public to use medical devices with greater peace of mind. Opinions submitted during the administrative notice period will be actively reviewed and reflected if necessary. For further information regarding the amendment, please visit the Ministry of Food and Drug Safety’s website (http://mfds.go.kr > Laws/Data > Legislation Data > Legislation/Pre-Announcement of Administration) for review.
- Policy
- What to expect from the upcoming 2-day HIRA DREC meeting
- by Lee, Tak-Sun Sep 07, 2023 05:31am
- The industry’s attention is focused on the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee meeting that is being held for an unprecedented 2 days this month. The industry predicts that the 2-day term reflects the difficulty the committee will have in reaching a conclusion on the agendas set for DREC review. In particular, the issues of interest are the reimbursement reevaluation of HA eye drops that have a market size of over KRW 200 billion and the review of reimbursement adequacy of the neurofibromatosis treatment ‘Koselugo Cap’ that was set to receive redeliberations. According to industry sources on the 6th, DREC will hold its 9th meeting on the 6th and then its 10th meeting on the 7th. In other words, the meeting will be held for two days. In the 2-day meeting, the committee members will be deliberating the drug reimbursement adequacy reevaluation results on one day, and the other to deliberate on the decision on long-term care benefits and whether to approve reimbursement for prescription drugs. The industry expects DREC will have difficulty making decisions this time, as the agendas are serious and important to the state and its deliberation requires 2 days. ◆Industry interest rises on whether the use amount of HA eye drops will be restricted In particular, whether the use amount of HA eye drops will be restricted as a result of reimbursement reevaluations remains an issue. The authorities have also been reviewing whether to drop reimbursement for extrinsic diseases, but limiting its usage is the key focus of industry interest. Moreover, the industry is concerned that if the annual limit is set at 4 boxes, their usage will be cut in half. As for the other ingredients subject to reevaluations, their deliberation is expected to proceed without issue as their reimbursement status will not change significantly. According to the industry, it is expected that reimbursement for rebamipide and levosulpiride may be maintained while reimbursement for limaprost alphadex, loxoprofen sodium, and epinastine hydrochloride may be restricted for secondary indications rather than primary indications. ◆Orphan drug Koselugo to be redeliberated for reimbursement, Will Leclaza’s competitor Tagrisso pass deliberations this time? Among newly deliberated drugs, whether Koselugo will pass review is the industry’s primary interest. The committee had decided to rediscuss Koselugo’s reimbursement at the 8th DREC meeting. As it has recently been reported that the HIRA and pharmaceutical companies have reached an agreement on a risk-sharing plan for this drug, attention is being paid to whether it will be able to pass the DREC review this time. Koselugo is the only drug that was judged non-reimbursable by DREC last year. On the 5th, the Korean Organization for Rare Diseases submitted a petition to the Human Rights Commission of the Republic of Korea, calling for coverage of 'Koselugo.’ After its reimbursement was discussed as an agenda item for DREC, patient groups have been strongly calling for its reimbursement. Also, whether the plan to extend reimbursement for Tagrisso to the first line for non-small cell lung cancer, which passed review by the Cancer Disease Review Committee in March, will be reviewed by DREC is receiving attention. The analysis is that if Tagrisso passes the DREC review this time, it could be listed for reimbursement faster than its competitor ‘Leclaza,’, which passed CDDC last month. The results of the DREC meeting will be announced through a press release on the evening of the 7th, the day the 10th meeting is scheduled to end.
- Policy
- Daewoong withdraws its Herceptin biosimilar Ogivri from mkt
- by Lee, Hye-Kyung Sep 06, 2023 05:36am
- Pic of Ogivri sold in the U.S. ‘Ogivri Inj. 150mg (trastuzumab),’ the third Herceptin biosimilar to be approved in Korea, is withdrawing from the Korean market. The Ministry of Food and Drug Safety announced on the 4th that Daewoong Pharmaceutical voluntarily withdrew its license for Ogivri in Korea. Ogivri was developed by the Indian pharmaceutical company Biocon. Alvogen Korea received domestic approval for the product on August 25, 2020, and the license holder was later changed to Daewoong Pharmaceutical. The company received insurance reimbursement for the drug on November 1, 2020, in preparation for releasing Ogivri. However, referring to its non-existent performance for 3 years since its approval and reimbursement, the company suddenly withdrew its reimbursement listing on May 1 and prepared to withdraw from the domestic market. Meanwhile, Sam-oh Pharm had received approval for a same-ingredient drug ‘Tuzepta Inj. 150mg, 440mg,’ which was also supplied by the Ogivri-producer Biocon on July 10th. This was why there were speculations that Daewoong Pharmaceutical may receive a transfer of domestic sales rights for Tuzepta from Samo Pharmaceutical. A Daewoong Pharmaceutical official said, "We decided to withdraw our license for Ogivri due to a change in our company’s global sales strategy. We plan to continue on our biosimilar business in the mid-to long- -term, but are considering conducting our own CDMO business rather than selling other companies' products." Meanwhile, the market share of Roche's original Herceptin, which was approved in Korea in 2005 as a biopharmaceutical for HER2-positive breast cancer and metastatic gastric cancer, has been decreasing since the release of its biosimilars. According to market research institution IQVIA, Herceptin's sales decreased by 25% from KRW 80 billion in 2018 to KRW 60 billion last year. The original's market share decreased from 91% to 63%. On the other hand, the market share of Herceptin biosimilar increased by 28% points in 4 years from 9% in 2018 to 37% last year. Looking at the domestic Herceptin biosimilar approval status, Celltrion received approval for ‘Herzuma’ in November 2014, and Samsung Bioepis obtained approval for ‘Samfenet’ in November 2017. Herzuma’s sales increased 3.7 times in 4 years from KRW 7.7 billion in 2018 to last year. Samfenet’s sales increased 2.5 times in 3 years from KRW 2.2 billion in 2019. Daewoong Pharmaceutical's Ogivri was the 3rd biosimilar to be approved, but the company withdrew its approval after 3 years without launching the product in the market. With the 4th biosimilar also approved in Korea, the production of Herceptin biosimilars continues. Last May, Prestige Biopharma held a preliminary meeting with the European Medicines Agency (EMA) to apply for product approval for its Herceptin biosimilar 'HD201', and in August, Aprogen and Aprogen Healthcare & Games signed an agreement for the joint development of a Herceptin biosimilar, AP063, and completed global Phase 1 clinical trials in the United States.
- Policy
- What about digital therapy devices awaiting approval
- by Lee, Hye-Kyung Sep 06, 2023 05:36am
- Younglim Lee, Head of the Medical Device Review Department In addition to digital treatment devices for improving insomnia, the Ministry of Food and Drug Safety is expecting applications for licenses for digital treatment devices No. 3 and 4 aimed at improving symptoms in the fields of neurology and psychiatry, respiratory rehabilitation, visual disturbances, and tinnitus. Lee Young-rim, head of the medical device review department at the Korea Food and Drug Safety Evaluation Institute, said in a press briefing for a specialized magazine on the 5th, "As of the end of August, there are 47 digital therapeutic devices for which clinical trial plans have been approved," and "among them, confirmatory clinical trials will be conducted in 2021 and 2022." “As there are 14 products for which the trial plan has been approved, it is expected that the application for approval will be made as soon as the clinical trials are completed,” he said. Digital therapeutic devices are software medical devices that provide evidence-based therapeutic intervention to patients to prevent, manage, and treat medical disorders or diseases. Instead of drugs or injections, digital therapeutic devices stimulate organs, tissues, and nerves with electric ultrasounds, etc. to treat diseases. It provides a treatment method different from Electroceutical, which refers to an electronic device that produces a treatment effect. Currently, there are two products approved as digital therapy devices in Korea, DTx/Digital Therapeutics Somzz and WELT-I, which treat insomnia by installing a mobile app on a smartphone after consulting a doctor. Since it has not yet been approved by health insurance, it has not yet been used in clinical settings, and the effectiveness of its actual use information, or performance has not been verified. Director Lee said, “Only when it is used in clinical settings will we be able to hear the opinions of doctors, patients, etc.,” and added, “As it has not yet been used in medical treatment, it appears that time will be needed to collect information or investigate its effects.” Regarding items expected to be approved after the digital treatment device for insomnia, 64% of products approved for confirmatory clinical trials also represent these fields, perhaps because items 1 and 2 are diseases in the neurological and psychiatric fields. Confirmatory clinical plans were approved for rehabilitation (respiratory, orthopedic) 21% and 15% other than neuropsychiatric fields such as generalized anxiety disorder, mild cognitive impairment, alcohol/nicotine disorder, depressive disorder, and eating disorder. Manager Lee said, “As two products have been approved for the treatment of insomnia, many people are waiting for digital treatment devices for various diseases.” He added, “Recruiting patients for clinical trials requires IRB approval, but recruiting patients has been difficult due to COVID-19. “There was an aspect. It is expected that clinical trials will be conducted for many products starting this year.” The expected digital therapy device is one aimed at improving rehabilitation, and clinical trials are underway for a variety of products, including devices for respiratory rehabilitation for elderly patients. He also added that he is conducting various discussions with IT companies called 'Big Tech' to improve regulations on cutting-edge medical products. Director Lee said, “We held on-site consultation meetings with big tech companies such as Naver, Kakao Healthcare, LGU+, KT, and Kakao Brain and identified requirements for regulatory improvement and support.” He added, “Considering the characteristics of generative artificial intelligence medical devices, they are approved as medical devices.” “We decided to prepare licensing and review guidelines that can be used when entering overseas markets and provide consulting and support for licensing, such as clinical trials and verification,” he explained. Regarding Naver, Lunit, Welt, etc. developing ChatGPT in the medical field and examining the possibility of using it for AIMD, Director Lee is working with industry-academic cooperation experts to develop the "Generative AIMD Permission/Examination Guidelines" by November 2024. “We will develop it,” he emphasized, adding, “We are trying to establish screening standards for safety and effectiveness when it is approved as a medical device.”
- Policy
- Reimb of HA eye drops will be restricted in KOR
- by Lee, Tak-Sun Sep 06, 2023 05:36am
- As a result of the government’s reimbursement reevaluations, patients will be unable to receive reimbursement when using hyaluronic acid eye drops for extrinsic diseases, and the amount of their use will also be restricted. The government has also been known to be discussing limiting reimbursement to 4 boxes per year. According to industry sources on the 5th, the Health Insurance Review and Assessment Service is said to have set such a direction regarding the reimbursement of HA eye drops after conducting reevaluations on the adequacy of their reimbursement this year. HA eye drops, rebamipide, limaprost oxiracetam, loxoprofen sodium, levosulpiride, and epinastine hydrochloride were subject to reevaluations on their reimbursement adequacy this year. Among them, the market for the HA eye drops that are used as artificial tears, has the largest market amounting to KRW 200 billion. Industry rumors are that the post-marketing subcommittee, which held a meeting before the Drug Reimbursement Evaluation Committee deliberations set for the 7th of this month, decided to focus on limiting the use amount of the HA eye drops. The plan was to restrict the amount of use to 4 boxes and set a separate reimbursement standard for additional use. In addition, it has been reported that the committee to remove the reimbursement for extrinsic diseases among extrinsic and intrinsic diseases. Currently, HA eye drops are used for intrinsic diseases such as Sjögren's syndrome, mucocutaneous ocular syndrome (Stevens-Johnson syndrome), and dry eye syndrome, as well as extrinsic diseases caused by surgery, drugs, trauma, or contact lens wear. The industry is regarding this as a win as its use for extrinsic diseases is relatively low. The argument that the amount of use of HA eye drops should be limited was raised by the National Evidence-based Healthcare Collaborating Agency in 2020. In the report, 'Post-marketing evaluation of Specialized OTC-ETC Classified Drugs: Focusing on Hyaluronic Acid Eye Drops (Shin Sang-jin)', NECA argued that 12 boxes of disposable eye drops should be set as the amount recognized for reimbursement and that the number of reimbursable prescriptions should be limited to a maximum of 5, like in Australia. However, as many have been arguing that the reimbursement of HA eye drops should be maintained, it remains to be seen whether a clear conclusion will be reached at the DREC meeting on the 7th. HIRA has decided to change its original policy of non-disclosure of the DREC meeting results and release the results through a press release on the same day.
- Policy
- Evaluating Tagrisso's primary benefit
- by Lee, Jeong-Hwan Sep 05, 2023 05:40am
- The Ministry of Health and Welfare announced that it is conducting a cost-effectiveness evaluation regarding the expansion of health insurance coverage for the first-line treatment of AstraZeneca's lung cancer drug Tagrisso. On the 4th, the Ministry of Health and Welfare responded as follows to a written question from People Power Party Rep. Choi Young-hee, a member of the National Assembly Health and Welfare Committee.
- Policy
- Drug crime regulation,
- by Lee, Jeong-Hwan Sep 05, 2023 05:40am
- It is expected that a bill that would impose an obligation on doctors and pharmacists who prescribe and dispense drugs with a risk of misuse, such as narcotics, to check medication history through the Drug Safety Information System (DUR) will quickly pass the National Assembly. This is because a large number of drug-related crimes have occurred, such as the so-called 'Rolls Royce Man on Drug Suspicion' incident, and social consensus on the need for stronger regulations has grown, and the Yoon Seok-yeol government has also announced mandatory DUR confirmation of medication history as a measure to strengthen surveillance of medical drugs. On the 4th, Jeon Hye-sook, an official from the Democratic Party of Korea's office, explained, "We have secured a consensus not only on the government but also on the ruling and opposition parties on the need to make it mandatory to check the medication history of patients who prescribed and dispensed narcotics through DUR." The amendment to the Medical Service Act and the Pharmaceutical Affairs Act, proposed this time by Rep. Jeon Hye-sook, are a method of establishing new regulations on medicine and pharmacists in the 'confirmation of drug information' provision commonly stipulated in both laws. Specifically, the 'confirmation of drug information' clause stipulated in Article 18-2 of the Medical Service Act and Article 23-2 of the Pharmaceutical Affairs Act will be revised. Rep. Jeon Hye-sook's bill stipulates that in order to ensure the safe use of medicines, the Minister of Health and Welfare or the Minister of Food and Drug Safety must check whether the same ingredients have been administered in the past when prescribing, directly dispensing, or dispensing medicines that are recognized as having a risk of abuse, such as narcotics. In addition, DUR was proposed as a method for doctors, dentists, and pharmacists to check a patient's medication history for the same narcotic ingredient, and a fine of up to 1 million won could be imposed if the verification obligation was not followed. The Yoon Seok-yeol government declared war on drugs last April and announced comprehensive government-wide measures. At that time, as the Gangnam Academy District drug drink incident and famous celebrities' drug use crimes such as propofol and methamphetamine continued to occur, the Office for Government Policy Coordination announced that it would be mandatory to check prescription drug history using DUR, starting with drugs with a high risk of abuse such as fentanyl. With administration consistent with the purpose of the bill proposed by former lawmakers, an environment has been created in which the speed of processing can be accelerated when the bill is later reviewed by the National Assembly. There is a possibility that the medical community will oppose legislation mandating drug use history DUR. In the past, medical and hospital groups strongly opposed the amendments to the Medical Service and Pharmaceutical Affairs Act in the 20th National Assembly, which mandated the use of DUR when prescribing and dispensing medicines and imposed fines on violators. At the time, the medical and hospital communities considered the fact that punitive regulations were created without support measures such as fees or compensation for medical institutions, that doctors' judgments regarding drug prescriptions and dispensing could be excessively restricted, and that there were limits to clinical usefulness. rebelled against. The Ministry of Health and Welfare, the responsible ministry, and pharmacists' organizations supported the bill to strengthen drug safety by increasing DUR utilization. Rep. Jeon Hye-sook, who proposed the bill, plans to speed up the review of the bill by putting legislative feasibility first in order to prevent drug crimes from becoming increasingly rampant. She plans to push for legislation mandating the use of DUR when prescribing and dispensing non-reimbursed high-risk drugs and narcotic psychotropic drugs, following legislation mandating DUR confirmation of narcotic medication history.
- Policy
- Why many choline alfoscerates accepted price cuts
- by Lee, Tak-Sun Sep 05, 2023 05:39am
- Pic Chongkundang Gliatirin Soft Cap (left) and Gliatamin(right), leading choline alfoscerate drugs Companies are reluctant to self-manufacture their brain function enhancer choline alfoscerates despite price cuts. Only 20% of the companies decided to protect their drug price by switching to self-manufacture, and the prices of the others that opted to continue manufacturing through contract manufacture organizations (CMOs) were cut. This fact was evident in the insurance price ceiling reevaluation results announced by the Ministry of Health and Welfare on the 1st. Among the 51 choline alfoscerate 0.4g capsule formulations, 40 of them received price cuts of up to 15% of the highest price (KRW 445/capsule). 11 products have maintained the original drug price, and 10 of them have maintained their drug prices by conducting self-bioequivalence tests of their self-manufactured (imported) products. The products that maintained their price are ▲Chong Kun Dang Pharmaceutical’s ' Chongkundang Gliatirin Soft Cap.’▲Daewoong Bio’s 'Gliatamin Soft Cap. ' ▲Korea United Pharm 'Glicetil Soft Cap.' ▲GuJu Pharma ' Cereforin Soft Cap.' ▲Cosmax Pharma 'Choline Max Soft Cap. 400mg' ▲Mothers Pharm 'Memoem Soft Cap.' ▲Korea Prime Pharm 'Gria Soft Cap.' ▲Hanmi Pharm’s ' Cholinate Soft Cap. 400mg' ▲Su-Heung’s 'Alfogreen Soft Cap.' ▲Kukje Pharm ' Cholencina Soft Cap. ' A majority of products gave up protecting their drug prices with self-bioequivalence tests due to high investment risk. In 2020, the government made the decision to reimburse choline alfoscerate preparations only for dementia and apply selective reimbursement and cover only 80% of the cost for its main indication, mild cognitive impairment. Also, starting in 2021, clinical re-evaluation is underway to verify the substance’s efficacy for dementia and mild cognitive impairment. If the clinical trials show bad results, their indication may be reduced or deleted. This is why the analysis is that companies have been passive in maintaining their drug price by conducting self-bioequivalence tests. Even products with annual outpatient prescriptions exceeding KRW 10 billion did not defend their drug prices. Based on UBIST, the capsule formulations that posted sales of over KRW 10 billion, such as Daewon Pharmaceutical's Alfocholine (KRW 21 billion), Arlico Pharmaceutical's Choliatin (KRW 18 billion), Yuhan Corp’s Alfoatilin (KRW 17.5 billion), Jeil Pharmaceutical's Glitin (KRW 16 billion), and HLB Pharmaceutical's Glitia (KRW 12.9 billion) and Hutex’s Silvercerin Tab. (KRW 11.7 billion), maintained consignment production, and the insurance price ceiling of the drugs fell to KRW 445. Some have also pointed out that companies decided to not defend drug prices to pursue a low-price strategy as competition is intensifying. Dongkoo Bio Pharm’s Glifos Soft Cap. already lowered its price to KRW 445 in September last year. Nevertheless, UBIST showed Glifos’s sales grew 36% from the previous year to KRW 14.8 billion in outpatient prescriptions last year. An industry official said, “Choline alfoscerate has significant product risk due to clinical reevaluations. Also, we did not take any action to defend drug price because we are pursuing a low-price strategy."
- Policy
- New GLP-1 RA stops reimb discussions in KOR
- by Lee, Tak-Sun Sep 04, 2023 05:04am
- Novo Nordisk The debut of a new GLP-1 analog used as an adjuvant to dietary and exercise therapy in diabetes patients has been postponed in Korea. This comes as a disappointment as only one single-agent drug is currently reimbursed in Korea, and the high global demand for the drugs has rendered domestic supply short. According to the Health Insurance Review and Assessment Service and the industry on the 1st, discussions for the reimbursement of Novo Nordisk’s single agent GLP-1 receptor agonist ‘Ozempic Pre-Filled Pen' have come to a stop. This drug was recognized as appropriate for reimbursement by the Drug Reimbursement Evaluation Committee in February under the condition that the company accepts a price below the evaluated amount. Afterward, the pharmaceutical company accepted the evaluated amount and began drug pricing negotiations with the National Health Insurance Service. However, the company withdrew its The speculation is that the excess demand in the global market rendered it difficult for the company to supply the drug to Korea as well, for at least one year. Currently, the only single-agent GLP-1 receptor agonist available with reimbursement in Korea is Dulaglutide (Trulicity). Exenatide (Bydureon, AstraZeneca), which had received new reimbursement standards, had withdrawn its approval in September 2021. Another same-class drug, LyxumiaR had also withdrawn its approval in 2020. All of the companies gave up selling their drugs in the Korean market after losing to the long-acting once-weekly Trulicity. Since its release in May 2016, Trulicity has continued to its sole lead in the domestic market. Based on IQVIA, Trulicity recorded sales of KRW 59.4 billion last year. As another long-acting once-weekly treatment, Ozempic was expected to serve as a rival to Trulicity. In the global market, Ozempic’s sales have already surpassed that of Trulicity. However, its unstable supply due to global demand hindered its domestic launch. Ozempic is listed in the US, Japan, Italy, France, Switzerland, and the UK among the A7 countries. The Korean Diabetes Association and the Korean Endocrine Society had recommended that it would be appropriate to reimburse Ozempic as a long-acting GLP-1 receptor agonist same as Trulicity, as a comparative study between the two same-class drugs has also been conducted. GLP-1 is a hormone that regulates glucose and appetite and has various effects on the cardiovascular system. Its effect on glucose and appetite is achieved through GLP-1 receptors in the pancreas and brain, and GLP-1 analog drugs selectively bind and activate these GLP-1 receptors.
- Policy
- Kanoa, the upper limit price was reduced further by PVA
- by Lee, Tak-Sun Sep 01, 2023 05:44am
- Ankook Pharm Daelim-dong office building It was found that the upper limit of the choline alposerate formulation Kanoa Soft Cap sold by Ahnook Pharm has been reduced more with PVA (use-drug linkage agent) than the Kanoa Soft Capre-evaluation of the upper limit. There are a total of 18 items that have been re-evaluated and reduced by both the PVA this time, and among them, Kanoa was the only one with a larger PVA reduction rate. According to the industry on the 31st, the upper limit of Angook Kanoa did not meet the BA directly in the re-evaluation of the upper limit amount, so the upper limit was decided to be reduced from 471 won to 445 won. According to the Ministry of Food and Drug Safety, Kanoa soft capsule is produced by Seoheung, and Kanoa tablets are commissioned by Vivozon. In this reassessment of the upper limit, the choline alfoscerate formulation was divided into 523 won if all the requirements were met, and 445 won if only one requirement was met. It is said that there are no items that do not meet both requirements, including DMF. Accordingly, the re-evaluation rate of Kanoa's cap was -5.5%. However, the actual upper limit, which will take effect from the 5th, is lower than this. The reason for this is that the cut rate of -9.3% was applied by the usage-drug linkage negotiations. The final cap is 427 won, which is the lowest price among the choline alposerate formulations. Kanoa's outpatient prescription amount was 6.8 billion won as of last year's Ubist, up 68% from the previous year. This time, there are a total of 18 items in which the drug price will be reduced at the same time according to negotiations on the re-evaluation of the upper limit and the PVA type. Among them, the results of the PVA with a large reduction rate of Kanoa have been applied. On August 23rd, the upper limit of the re-evaluation of the upper limit, which was disclosed earlier, was marked as 445 won. However, pharmacies and wholesalers seem to need to be careful because the upper limit of Kanoa is finally adjusted to 427 won.
