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- 2026-04-09 09:45:00
- Policy
- Advanced biologics to receive expedited review
- by Lee, Hye-Kyung Sep 08, 2023 05:33am
- Advanced biological drugs that have demonstrated a significant improvement in safety or effect compared to existing treatments will be regarded as ‘drugs with no alternatives’ and allowed to receive expedited review in Korea. Until now, only advanced biopharmaceuticals with limited scope of application (such as patients who have positive or negative biomarkers) compared to existing treatments or those for patients who are unresponsive to existing treatments were regarded as ‘drugs with no alternatives.’ However, the Ministry of Food and Drug Safety decided to expand treatment opportunities for patients with rare and incurable diseases by revising the regulations and allowing expedited processing for biopharmaceuticals that have proven improved safety or efficacy compared to existing treatments. On the 7th, the MFDS issued a pre-announcement of administration of the ‘Partial amendment of the marketing authorization and review regulations for advanced biopharmaceuticals' and announced that it will expand patient treatment opportunities and harmonize domestic and foreign standards and regulations. Article 21 of the regulations that will be amended contains the designation of subjects eligible for fast-track review, which includes cases where there are no alternative treatments. Such cases were defined as ▲ cases where there are no domestically approved drugs, and ▲ cases where the target of application is limited due to the existence of positive or negative biomarkers compared to existing treatments, or cases where existing treatments cannot be used. When targeting patients who could not receive it or were unresponsive, it was limited to cases where there were no alternative treatments. However, through the amendment, the government decided to designate advanced biopharmaceuticals that have proven to have significantly improved safety or effectiveness, as well as drugs where production, import, and supply have been suspended and supply has not been resumed, as those subject to fast track review. In addition, probiotics were included in the definition of biological drugs, and the legal basis for restricting marketing authorization for gene therapies was specified as 'Article 11 (1) 9 (c) and (1) of the Rules on the Safety of Drugs, etc.' Also, terms such as quality review and quality evaluation were unified into standards and test method review, and provisions based on submitted data for conditional approval were also revised. The MFDS is accepting opinion submissions about the pre-announced administrative notice until November 6.
- Policy
- Yooyoung will newly release repackaged flagship Pravafenix
- by Lee, Tak-Sun Sep 07, 2023 03:50pm
- Yooyoung Pharmaceutical has voluntarily withdrawn the marketing authorization for its product, ‘Pravafenix Cap’, as the product is due for a packaging renewal. As a flagship product, Pravefenix Cap has been recording annual sales of approximately 20 billion KRW. The newly self-packaged product is expected to be listed for reimbursement this upcoming October. According to the industry, Yooyoung Pharmaceutical voluntarily withdrew its permit for Pravafenix Cap (pravastatin+fenofibrate) on the 18th. This comes 11 years after the company first received approval in July of 2012. The drug is a treatment for dyslipidemia, imported from the Belgian pharmaceutical company, SMB. Since then, the drug has settled as a flagship item and has long served as Yooyoung's cash cow. Based on UBIST, the drug reached an outpatient prescription sales of 21.4 billion KRW last year. Considering Yooyoung’s total sales being approximately122.1 billion KRW last year, Pravafenix accounted for a high proportion of the company’s total sales. The company received approval for ‘Yooyoung Pravafen Cap’ in February before withdrawing its approval for the existing Pravafenix. In the past, Yooyoung imported Pravafenix from SMB as fully packaged finished goods under an import permit. The new manufacturing approval for Pravafenix allows for the company to import the capsules in bulk and package the products at Yooyoung’s manufacturing facility. The company explained that this decision was made to flexibly respond to market demands. The newly packaged drug is expected to be listed for reimbursement in October. A company official stated that Yooyoung voluntarily withdrew the import permit in order to use the trademark “Pravafenix Cap”, as for the MFDS would not allow two authorizations under identical names. The product name of the new manufactuiring approval has been changed from “Pravafen Cap” to “Pravafenix Cap”. He added, "The newly released Pravafenix Cap is expected to be reimbursed from October, however reimbusment may be claimed for the original Pravafenix Cap as well during a short overlapping period in order to minimize supply interruptions. Although some domestic companies are developing generic versions of Pravafenix, there has been no news of an item receiving marketing authorization yet.
- Company
- Ildong’s new GLP-1 analogue starts clinical trial
- by Chon, Seung-Hyun Sep 07, 2023 05:31am
- Pic of Ildong Pharmaceutical Ildong Pharmaceutical announced on the 6th that it recently received investigational new drug (IND) approval from the Ministry of Food and Drug Safety for its ID110521156’s Phase I clinical trial. ID110521156 is Ildong’s new GLP-1 receptor agonist drug candidate. Through the trial, the company plans to evaluate the tolerability, safety, and pharmacokinetic properties of ID110521156 in healthy adults. ID110521156 acts as an analog of the GLP-1 hormone, which regulates blood sugar levels by inducing insulin secretion in the body. GLP-1 hormone is produced in pancreatic beta cells and is known to be involved in insulin synthesis and secretion in the body, reduction of blood sugar level, regulation of gastrointestinal motility, and appetite suppression. Based on the clinical development and commercialization progress, the company plans to develop ID110521156 into an oral new drug targeting type 2 diabetes and obesity in the future. ID110521156 is a new compound that serves the same function as the GLP-1 hormone. Compared to biological agents such as peptides, it has a low molecular weight and is structurally stable. In an efficacy and toxicity evaluation of ID110521156 that was conducted using diseased animal models, the drug candidate has demonstrated superior efficacy in insulin secretion and glucose control, as well as superior safety compared to other same-class competitors. Ildong Pharmaceutical plans to develop an oral formulation that has advantages in terms of marketability and dosing convenience, unlike existing injection-type formulations, by utilizing the differences in effectiveness, safety, and stability resulting from the structural characteristics of its active substance. An official from Ildong Pharmaceutical said, “We have been actively discussing partnership opportunities with many global pharmaceutical companies, including licensing out our technology. To secure a favorable position in terms of promoting commercialization and securing rights, we have completed patent registration or applications in major market countries including Korea, the United States, Europe, China, and Japan.”
- 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.
- Opinion
- [Reporter's view] Massive drug price cuts
- by Kim, Jin-Gu Sep 06, 2023 05:36am
- Generic proliferation. It is the root of all evil. At least that's the case from the government's perspective. When the valsartan incident occurred in 2018 and the ranitidine incident the following year, everyone knew that the essence of the incident was impurities, but the government continued to point out that the proliferation of generics was the problem. The government said it would reduce the proliferation of generic drugs. A new drug pricing system was proposed in July 2020. The new rule set by the government was that the drug price would be reduced if one of the two was not done, whether it was conducting an in-house BA test or using registered raw drug products. It is an ambitious plan by the government to prevent the proliferation of generics. Finally, the time has come to reevaluate already registered generics. The government proposed qualifications such as its own BA testing and use of registered raw drug substances. They said they would reduce the price of drugs by up to 27% for drugs that do not have these two pieces of data. Approximately 23,000 generics suddenly underwent this qualification verification. Pharmaceutical companies face a moment of choice. More than 7,000 generic drugs accepted the fate of lower drug prices. As of September 5, the government lowered the prices of 7,355 generic products. The pharmaceutical industry is expected to lose more than 300 billion won per year. Can the government, which seeks to resolve the proliferation of generic drugs and further secure the financial soundness of health insurance, be free? Initially, the government proposed a new drug pricing system, saying it would solve the proliferation of generics, and at the same time gave a grace period of nearly two years. During the grace period, pharmaceutical companies approved generics as if it were their last chance. Pharmaceutical companies received approval for insurance use of drugs they had no intention of selling, and these products became the subject of this reevaluation of generic drug prices. It is time for generics to be sorted out. Many of the targets of this drug price cut were for insurance purposes, not for sales. The government is required to take a more responsible attitude. A sufficient explanation is needed to resolve the issue caused by incorrect policy judgment using a different logic. It is difficult to look at the direct and indirect losses to the pharmaceutical industry, distribution industry, and pharmacy prices resulting from the price reduction of 7,000 generic drugs as if it were someone else's problem.
- 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.
- Opinion
- [Desk’s View] Compensate for the value of novel drugs
- by Lee, Tak-Sun Sep 06, 2023 05:36am
- The Ministry of Health of Welfare plans to soon announce an appropriate compensation plan for the innovative value of new drugs, including novel homegrown drugs. The health authorities’ plan is to deliberate its plan by the Health Insurance Policy Review Committee within the month and release the results to the public soon. The domestic pharmaceutical industry is hoping that this measure will provide additional points to non-inferior new drugs. Non-inferior new drugs contain new active ingredients and have proven to be non-inferior to existing drugs. Most new drugs developed in the domestic pharmaceutical industry fall into this category. The novel homegrown drugs, No. 36 'Envlo Tab,' No. 34 'Fexuclue Tab,' and No. 30 'K-CAB' have all demonstrated their noninferiority to existing drugs in clinical trials. However, the insurance price ceiling for these drugs had been set below the weighted average price of their alternatives because they were unable to demonstrate superiority over existing drugs. As a result, the price of Envlo Tab was set below 90% of previously released SGLT-2 inhibitors in the same class, and Fexuclue Tab was priced below the weighted average price of previously released P-CAB class drugs and PPI class drugs. K-CAB, which was listed with reimbursement in March 2019, was able to receive a relatively high price as it had benefitted from the ‘global innovative new drug pricing premium’ that was applied at the time. However, the preferential pricing plan for global innovative new drugs arose as a discriminatory element during the Korea-US FTA negotiations and was nearly non-existent at the time. The pharmaceutical industry has been criticizing how the current price calculation method for domestically produced new drugs is not sufficient to compensate for the industry’s new drug development efforts. The MOHW’s compensation plan for the innovative value of new drugs under review this time is the result of the continuous efforts of the domestic industry that has continuously raised the need to provide preferential pricing for domestically produced new drugs. In 2013, the MOHW reported to the National Assembly that the development of a domestic new drug costs an average of KRW 22.2 billion and takes 9 years and 8 months. As these results were from 10 years ago, the average cost of new drug development would have only increased further since then. In Korea, where drugs are covered by health insurance, companies need to receive a high insurance drug price to make up for the enormous costs of developing new drugs. The companies can determine when they could retrieve their investment according to drug price. Moreover, as the companies that developed the homegrown new drugs seek to expand overseas after initial release into the domestic market, it is beneficial for the companies to receive a high insurance price for their drugs in Korea, as it will serve as a future reference price for their price abroad as well. Above all, if the government wants to foster and improve the competitiveness of Korea’s pharmaceutical industry, it has to provide preferential treatment to these homegrown new drugs. The profit margins of the domestic pharmaceutical industry have been dropping significantly as generic drugs, which had been the main driver of the industry until now, are not making enough profit as they are constantly subject to price cuts to ensure the financial soundness of the National Health Insurance. The losses arising from the price ceiling reevaluations that were conducted this time are expected to amount to KRW 300 billion. In this environment, who would want to develop a new drug and suffer the huge amount of costs incurred? If lowering the price of generic drugs, which companies depend on to fund new drug development, is inevitable, the value of new drugs must be recognized to create a virtuous cycle that encourages new drug development. In addition to providing preferential drug pricing at the time of initial listing, the government should fully compensate for the value of homegrown new drugs by ensuring that the prices are not later reduced through post-marketing control measures such as price-volume agreements. We need new drugs to raise the competitiveness of the Korean pharmaceutical industry in overseas markets. If the government has set its sights on fostering homegrown new drugs, it should focus on what it needs to support and stop being indecisive.
- 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.
