- LOGIN
- MemberShip
- 2026-03-12 01:02:46
- Policy
- BT public-private council will soon resume operations
- by Lee, Jeong-Hwan Sep 13, 2023 05:28am
- The Ministry of Health and Welfare is expected to soon resume the operation of the 'BT (breakthrough therapy) Public-Private Council', a pharmaceutical industry discussion body necessary for establishing and implementing BT price preference policies. The Ministry of Health and Welfare is expected to establish standards for preferential drug prices based on the results of discussions at the BT public-private consultative body held from February to April, and then finalize them after gathering opinions from the pharmaceutical industry at the public-private consultative body, which is scheduled to resume as early as this month. In the case of the public-private consultative body to reform the generic drug price system, there has been no concrete movement yet, and as the Ministry of Health and Welfare has begun research on the form of private contracts, the atmosphere is waiting until the research is completed and the analysis of the results is completed. According to the pharmaceutical industry on the 11th, the Ministry of Health and Welfare recently met with three pharmaceutical organizations along with NHIS and HIRA and held a public-private consultative body to discuss pending issues of reforming the drug price system. At this meeting, the Ministry of Health and Welfare reportedly announced plans to resume the public-private consultative body in the near future and confirm the BT preferential treatment standards in response to inquiries from the three pharmaceutical organizations regarding the BT preferential drug price policy. It has been reported that the Ministry of Health and Welfare's position is to partially accept the demands of the three pharmaceutical groups not to announce preferential policies without prior discussion or to immediately submit them to the Health Insurance Policy Deliberation Committee agenda. Pharmaceutical industry officials are observing that the Ministry of Health and Welfare has already reached the stage of completing the internal establishment of BT preferential standards and measures. It is explained that the Innovative New Drug Public-Private Consultative Body, which will be launched in September at the earliest or early October at the latest, will decide on what criteria and how to give preferential treatment to the prices of drugs made by innovative pharmaceutical companies. The Ministry of Health and Welfare and NHIS have announced plans to announce BT preferential measures within September at a National Assembly debate and press conference. The public-private consultative body that will discuss the generic drug price system, including comprehensive generic drug price cuts, is showing no significant movement. Previously, in July, the Ministry of Health and Welfare signed a private contract with Professor Kim Dong-sook of Kongju University's research team for a research project to 'prepare a plan to improve the generic drug price system', so the pharmaceutical industry predicts that the implementation of the system related to generic drug price reduction will be delayed until the study is completed and the results are analyzed. This is the consensus of experts. Last April, under the direction of Second Vice Minister Park Min-soo, the Generic Drug Price System TFT was formed and the reform of the drug price system was initiated. Compared to the time when the pharmaceutical industry expressed concern that the government might immediately move to reduce generic drug prices in batches, some portion of the system has not been implemented. It has been delayed. An official in the domestic pharmaceutical industry explained, “We requested the Ministry of Health and Welfare to publicly announce the drug price preferential treatment plan after going through the BT public-private consultative body and go through a sound review process, and they responded that they would accept it.” He explained, “Research on the generic drug price system reform plan, including generic drug price cuts, is scheduled to be studied until this year, and discussions are expected to begin only after next year.” This official said, “Fear or backlash over the wholesale price cut for generics has been delayed until the end of the study, but just reevaluating the comparison of overseas drug prices right now is a significant burden on pharmaceutical companies.” He added, “I hope that the Ministry of Health and Welfare will create the system together rather than unilaterally establish the system and then go through a formal opinion-gathering process.”
- Policy
- Will Enhertu pass PE evaluations for reimb in KOR?
- by Lee, Tak-Sun Sep 13, 2023 05:28am
- Due to delays in the review of the economic feasibility of the anticancer drug Enhertu (trastuzumab deruxtecan), the industry is seeing delays in its reimbursement agenda being submitted for deliberation to the Drug Reimbursement Evaluation Committee. The agenda had previously passed the Cancer Disease Deliberation Committee review after redeliberation in May. The company expects to receive positive results at the Pharmacoeconomic Evaluation Subcommittee meeting in October. According to industry sources on the 12th, Daiichi Sankyo recently submitted supplementary pharmacoeconomic evaluation data to HIRA for its Enhertu and expects to pass HIRA deliberations in October. Enhertu passed the CDDC review after redeliberations in May. The committee determined Entertu reimbursable for the treatment of ▲unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens (third-line or higher treatment), and ▲locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received two or more prior therapies including an anti-HER2-based regimen (third-line or higher treatment) As a result, the agenda was supposed to be submitted for deliberation by the Drug Reimbursement Evaluation Committee. However, it seems that the company and the government are having difficulty reaching a consensus in the pharmacoeconomic evaluation process. Daiichi Sankyo submitted the PE evaluation data in July, but was unable to reach an agreement with HIRA. The industry analysis is that Enhertu's superior effect is hindering economic evaluations. Currently, the Pharmacoeconomic Evaluation Subcommittee is evaluating the cost-effectiveness of Enhertu compared to Kadcyla. However, as Enhertu demonstrated an extension in progression-free survival (mPFS) by more than 22 months compared to existing drugs, and the increase in the administration period that followed, there have been limitations in proving the cost-effectiveness of the drug using the current economic evaluation method. Even so, Daiichi Sankyo has accepted most of the deliberation results from the last Pharmacoeconomic Evaluation Subcommittee’s deliberation in order to quickly receive reimbursement. The company had requested redeliberation on some aspects that are difficult to accept. Daiichi Sankyo recently submitted the supplementary materials and is expecting positive results at the Pharmacoeconomic Evaluation Subcommittee meeting that will be held in October. In the paper, ‘Analysis of Socioeconomic Indirect Cost of Premature Death in Patients with HER2-positive Metastatic Breast Cancer (MBC) using Nationwide Claims Data’ that was recently published on Yakhak Hoeji on August 31, research teams of Sungkyunkwan University’s School of Pharmacy and Samsung Medical Center showed that socioeconomic benefits were greater with the administration of Enhertu. The research teams identified the claims data of 2,212 patients with HER2-positive MBC who were prescribed trastuzumab-emtansine as a second-or-higher-line of treatment from January 2007 to May 2021 using nationwide insurance claims data to estimate the progression-free survival (mPFS) and the resulting socioeconomic benefits. As a result, the mPFS of trastuzumab-emtansine ranged from 7.1 months (age 65 or older) to 12.5 months (age 30s), and the mPFS of trastuzumab-deruxtecan (Enhertu) was more than three times longer for all ages, ranging from 23.4 months (age 65 or older) to a maximum of 41.1 months (age 30). Accordingly, the socioeconomic benefits brought about by the extended PFS with the use of trastuzumab-deruxtecan (Enhertu) compared to existing drugs were estimated to amount to KRW 261.4 billion, which is averages to KRW 118 million per patient. An official from Daiichi Sankyo Korea said, "We hope that the authorities will review Enhertu’s reimbursement more flexibly, in consideration of the various aspects such as social losses of breast cancer and the extension of patients' lives that can be expected through Enhertu treatment under the framework of Korea’s current pharmacoeconomic evaluation system.
- Policy
- Forxiga's generics, advertised for off-label indications
- by Lee, Hye-Kyung Sep 12, 2023 05:37am
- Forxiga's generic development companies that promoted 'chronic heart failure, chronic kidney disease' in their drug advertisements were subject to administrative sanctions. On August 18th and 22nd, the Ministry of Food and Drug Safety suspended Boryung and Aju Pharmaceuticals from advertising for products containing Dapagliflozin for three months, respectively. The objects of disposal are three items, including Boryung's Trudapa 10 mg (Dapagliflozin Bis L-proline), Trudapa M SR 10/500 mg (Dapagliflozin, Metformin), and Trudapa M SR 10/1000 mg (Dapagliflozin, metformin). and Aju Pharmaceutical's Daparil 5 mg (Dapagliflozin Propanediol Hydrate), Daparil 10 mg (Dapagliflozin Propanediol Hydrate), Daparil Duo SR 10/500 mg, Daparil Duo SR 10/1000 mg, etc. There are 4 items. They were subject to administrative action after it was discovered that they used pamphlets targeting doctors and advertised content other than the approved efficacy and effects. The original, AstraZeneca Korea's Forxiga, has three indications, including type 2 diabetes, chronic heart failure, and chronic kidney disease, but the generic developed by domestic pharmaceutical companies only has type 2 diabetes as an indication. In this situation, Forxiga's generic companies became subject to administrative action by producing and distributing promotional materials containing claims that the drug was effective against chronic heart failure and chronic kidney disease, which are unauthorized indications. The only companies to which the Ministry of Food and Drug Safety has issued administrative measures are Boryung and Aju Pharmaceuticals, but as the number of domestically approved products for Dapagliflozin reaches 222, the likelihood that other pharmaceutical companies will also be subject to administrative measures if they advertise for indications other than those approved has increased. The efficacy or performance of pharmaceuticals cannot be advertised unless permission or modification is granted in accordance with Article 68 of the Pharmaceutical Affairs Act. In the case of a first violation according to the standards for administrative disposition in Table 8 of the Rules on the Safety of Medicines, etc., the advertising business for the product concerned will be suspended for 3 months. As it became known that generic drug developers were promoting non-approved indications, AstraZeneca Korea sent a certificate of contents to the companies in question, leading to an inspection by the Ministry of Food and Drug Safety. Meanwhile, after Forxiga's substance patent expired last April, a total of 90 pharmaceutical companies entered the market with 105 single-drug products and 64 combination products approved. According to UBIST, a pharmaceutical market research firm, the outpatient prescription performance of Dapagliflozin single and combination drugs in May was 11 billion won. The sales of the original Forxiga were 4.7 billion won, and those of Xigduo were 4.1 billion won, accounting for about 80%. The remaining 2.2 billion won was accounted for by generics Forxiga and Xigduo. As of May, 60 pharmaceutical companies recorded a total of 1.436 billion won in prescriptions for single drugs, and 31 pharmaceutical companies recorded a total of 772 million won in prescriptions for combination drugs.
- Policy
- Pfizer’s ALL drug Besponsa renews RSA in KOR
- by Lee, Tak-Sun Sep 12, 2023 05:37am
- Pfizer Korea’s acute lymphoblastic leukemia (ALL) treatment ‘Besponsa (inotuzumab ozogamicin)’ has recently renewed its risk-sharing agreement (RSA) with the government. The company had signed an Expenditure Cap Type RSA for the drug in 2019. According to the National Health Insurance Service and industry sources on the 11th, Besponsa recently completed negotiations on renewing its RSA with the NHIS. This drug is reimbursed as a treatment for adult patients with relapsed or refractory ALL, regardless of their Philadelphia Chromosome mutation status. At the time of its reimbursement in October 2019, the drug was only approved for patients with Philadelphia chromosome-negative ALL, however, its reimbursement was extended to allow use regardless of Philadelphia Chromosome mutation status since February last year. Besponsa is the first antibody-drug conjugate introduced to ALL. It is a combination of an antibody, inotuzumab, which targets the CD22 antigen expressed on the surface of B cell precursor ALL cancer cells, and the cytotoxic drug calicheamycin to induce death and destruction of cancer cells. The company explained that the combination showed a stronger effect than existing chemotherapy and significantly improved the complete response rate compared to existing chemotherapy, helping patients successfully undergo hematopoietic stem cell transplantation. This drug, which signed a 4-year expenditure cap-type RSA at the time of reimbursement listing, will maintain its refund contract with the government for 5 more years until September 2028 through the RSA renewal. The contract term, which had been 4 years at the time of the first RSA signing, has now been extended to 5 years. Besponsa's current list price is KRW 11,445,800/vial. Based on IQVIA, it raised sales of KRW 5.6 billion in 2022.
- Policy
- Vytorin generics suffer blow from reevaluations
- by Lee, Tak-Sun Sep 11, 2023 05:30am
- The hyperlipidemia combination ‘Vytorin (ezetimibe+ simvastatin) suffered a direct blow from the insurance price ceiling reevaluations conducted in Korea. As a result, only two companies were able to maintain the highest insurance ceiling price for their generics. In particular, Genuone Sciences was the only company to maintain the highest ceiling price in the 10/10mg group. According to industry sources, the price ceiling of Vytorin generics had been reduced for 60 of the items (21 10/10mg dosage forms and 28 10/20 dosage forms) as a result of the price ceiling reevaluations. As a result, only Genuone Science’s Vyteb Tab was able to maintain its highest insurance ceiling price at KRW 784 among the 10/10mg dosage forms. Previously, 26 items had been sold at the highest price of KRW 784. In the case of the 10/20mg dosage forms that contain 20mg of simvastatin, the number of highest-priced drugs (KRW 1,095) was reduced to 2 - Genuone Sciences’ Vyteb 10/20mg and Korea United Pharm’s SImpex Duo Tab 10/20mg. Previously, 17 items had been sold at the highest price. The price of the original Vytorin fell from having the highest price due to a price cut made on January 1, 2022. Accordingly, Vytorin tablets 10/10 mg are priced at KRW 781, and 10/20 mg at KRW 1091. The insurance price ceiling set for products whose price was reduced by 15% because it does not meet one of the standard requirements is KRW 666 for the 10/10 mg dose and KRW 931 for the 10/20 mg dose. Of the 35 10/10mg products, 32 were priced lowest at KRW 666, and 28 of the 32 10/20mg products were priced lowest at KRW 931.
- Policy
- Next year's new drug R&D budget: 58 billion won
- by Lee, Jeong-Hwan Sep 08, 2023 05:34am
- The Ministry of Health and Welfare has set the national new drug development (R&D) budget for next year (2024) to 57.99 billion won, an increase of about 16.1 billion won from this year's budget of 41.19 billion won. 10.4 billion won was allocated to research to expand the new drug base, 16.5 billion won to research to build a new drug R&D ecosystem, 8.6 billion won to clinical development of new drugs, and 19.1 billion won to support the development of excellent new drugs to promote global expansion and partnerships. On the 6th, the Ministry of Health and Welfare submitted next year's budget plan to the National Assembly with these contents. National new drug development is a national task of the Yoon Seok-yeol administration. We have set a national scheme to become a global center for bio and digital health and to join the G5 in science and technology by fostering super-gap strategic technologies. The total budget for the project increased compared to the previous year, but most of the items have decreased if you look at the detailed project details. This is due to a decrease in the existing business budget as a new budget for promoting global expansion and partnership worth close to 20 billion won was established. Specifically, 10.465 billion won was earmarked for next year's budget for 'acid drug-based expansion research' to support researchers in deriving active substances and lead substances in order to continuously supply an early-stage new drug pipeline that is qualitatively and quantitatively excellent, compared to this year's 12.76 billion won. This is a decrease of 2.295 billion won compared to 10,000 won. Next year's budget for research on building a new drug R&D ecosystem is also 16.491 billion won, a decrease of 560 million won compared to this year's 17.051 billion won. The goal of the budget is to build an ecosystem that can smoothly connect basic research and clinical research and to intensively foster small and medium-sized enterprises and venture companies. Next year's budget for new drug clinical development has increased. 8.685 billion won was allocated, which is 645 million won more than this year's budget of 8.04 billion won. It is used to support phase 1 and 2 clinical trials for company-centered new drug development and global-level technology transfer. Next year's budget for new drug R&D commercialization support, which supports the resolution of barriers in significant stages of new drug development such as clinical trials, technology commercialization, and manufacturing/production, is 719 million won, a whopping 36.3% decrease from this year's 1.147 billion won. The amount was reduced by 428 million won. Next year's business unit operating expenses are 2.424 billion won, a 10.6% increase from this year's 2.192 billion won. The budget to support the development of excellent new drugs to promote global expansion and partnering, which will be deployed starting next year, is 19.125 billion won. The goal is to intensively foster and support next-generation new drugs that the global pharmaceutical and bio industries are paying attention to. KRW 2.363 billion is spent on lead drugs, 5.437 billion won on candidate drugs, 5.625 billion won on non-clinical trials, and 5.7 billion won on clinical trials. Specifically, the Ministry of Health and Welfare established a new budget to secure differentiated competitiveness and support new drug technologies that can actively advance into the global market. The intention is to strengthen global cooperation to intensively foster and develop next-generation food and new drugs such as ADC, TPD, new targets, and modalities, and to promote five projects that will be successfully carried out. The Ministry of Health and Welfare expects that after 2024, the expected effects will be to expand the domestic new drug development base by deriving excellent effective substances and lead substances, establishing a new drug R&D ecosystem, and enhancing company-centered new drug development capabilities.
- 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.
- 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.
