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- 2026-05-07 05:51:09
- Company
- Ilaris reimb passes DREC review, but again with a condition
- by Eo, Yun-Ho Apr 09, 2024 05:50am
- The orphan drug 'Ilaris' has again received a conditional reimbursement decision in Korea. Ilaris (canakinumab), Novartis Korea’s treatment for hereditary periodic fever syndrome, was quickly resubmitted to the Health Insurance Review and Assessment Service's Drug Reimbursement Evaluation Committee on the 4th after receiving a conditional reimbursement decision at the same level in February but faced the same results. However, whether the scope of additional data requested by the government was reduced compared to before remains key to the drug’s road to reimbursement. Novartis was unable to accept the conditions set by the DREC in February. However, it is unlikely that DREC would have set the same level of additional documentation requirements in its second conditional reimbursement decision. In other words, what the government took into consideration this time and whether the drugmaker accepts the new terms will determine the future fate of Ilaris. Since being approved in 2015, Ilaris has already failed two reimbursement attempts. With patients waiting more than 8 years, it will be interesting to see if the government and the pharmaceutical company can reach an agreement and move toward expanding coverage. Ilaris is indicated in Korea to treat ▲Cryopyrin-Associated Periodic Syndromes (CAPS), ▲Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS), ▲hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD), ▲ Familial Mediterranean Fever (FMF), and ▲ Systemic juvenile idiopathic arthritis (JIA). Among the indications, CAPS is further categorized into ▲Familial Cold Autoinflammatory Syndrome (FCAS)/Familial Cold Urticaria (FCU), ▲Merkle-Wells Syndrome (MWS), and ▲Neonatal Onset Multisystem Inflammatory Disease (NOMID)/Chronic Infantile Neurological Cutaneous Articular Syndrome (CINCA). With such a small patient population and complex indications, reimbursement discussions for the drug have not been easy. The number of patients for the many indications of Ilaris’ is extremely small. Some indications for Ilaris don't even have disease codes or have only recently been registered. Dr. Dae-Cheol Jeong, President of the Korean College of Pediatric Clinical Immunology (Department of Pediatrics, St. Mary's Hospital, Seoul, Korea), said, "There are many challenges to reimbursing Ilaris because due to its very specific indications and the very small number of patients each. The current situation is regrettable as some patients are even considering emigrating to countries where Ilaris can be prescribed with reimbursement."
- Company
- Two new CML drugs were granted reimbursement in one year
- by Eo, Yun-Ho Apr 08, 2024 05:46am
- (Upper picture)Scemblix, Bosulif The chronic myelogenous leukemia (CML) treatment market is starting to show activity again. According to industry sources, treatment options for CML have been expanded with the reimbursement of Novartis Korea's 4th generation CML treatment ‘Scemblix (asciminib) in July last year, and Pfizer Korea’s 2nd generation drug 'Bosulif (bosutinib)’ this year. Scemblix, a next-generation drug, made headlines when it finalized its reimbursement listing process within a year of its application. Although it is a fourth-generation drug, its estimated cost was comparable to its third-generation alternative, Korea Otsuka Pharmaceutical’s ‘Iclusig (ponatinib),’ and was listed without drug pricing negotiations by accepting a price less than 100% of the weighted average price (WAP) of its alternative. The reimbursement process for Bosulif was not so slow either. Bosulif, which was approved in Korea in January last year, is a 2nd generation-targeted anticancer therapy like Novartis Korea’s ’ ‘Tasigna (nilotinib),’ BMS Korea’s ‘Sprycel (dasatinib),’ Il-Yang Pharmaceutical’s ‘Supect (ladotinib)’. The drug, which was approved in January, has been commercialized later in Korea than in other countries as it was approved by the U.S. FDA in 2012 but submitted reimbursement applications immediately after receiving marketing authorization and smoothly became listed for reimbursement in January this year. However, the reimbursement standard for Bosulif is under controversy. The reimbursement standard for Bosulif was set as "second-line or later treatment for patients with Philadelphia chromosome-positive chronic myeloid leukemia aged 18 years or older in chronic phase, accelerated phase, or blast phase who are resistant or intolerant to prior therapy that contained imatinib,” which is narrower than the indication it was granted for by the MFDS. In response, the Korea Leukemia Patients Organization issued a statement calling for Bosulif’s reimbursement in the first-line and for pediatric patients. Pfizer is also known to be considering expanding reimbursement to those indications. Meanwhile, Scemblix was approved as a treatment for adult patients with Ph+ CML in the chronic phase previously treated with two or more tyrosine kinase inhibitors (TKIs) after demonstrating its safety and efficacy through the Phase III ASCEMBL trial. Study results showed that Scemblix improved the rate of major molecular response (MMR) compared to its comparator bosutinib by 2 times. Also, the rate of treatment discontinuation due to adverse reactions in the Scemblix group was 5.8%, about one-fourth of the control group's 21.1%, confirming its overall safety profile. Bosulif’s safety and efficacy were verified through the Phase III NCT02130557 trial that was conducted on patients with newly diagnosed Ph+ CML. The major efficacy outcome measure was the major molecular response (MMR) at 12 months. Results showed that MMR at 12 months was 47% in the Bosulif arm and 36% in the Glivec (imatinib) arm. MMR at 60 months was 74% in the Bosulif arm and 66% in the Glivec arm. The median time to MMR in respondents after 60 weeks of follow-up was 9.0 months in the Bosulif arm and 11.9 months in the Glivec arm.
- Company
- Early breast cancer treatments fail to get reimb in KOR
- by Eo, Yun-Ho Apr 08, 2024 05:46am
- It seems unlikely that a new reimbursed option will be introduced to the early breast cancer environment anytime soon. First, Lilly Korea again failed to overcome the barrier of the Health Insurance Review and Assessment Service's Cancer Disease Review Committee for its CDK4/6 inhibitor Verzenio (abemaciclib). This was the company’s second failed attempt to receive reimbursement for the drug in Korea. Verzenio was the only new drug available for HR+/HER2- breast cancer other than the endocrine therapy letrozole generic. In the field of early-stage breast cancer, Lilly Korea faced challenges in presenting Verzenio’s reimbursement to be deliberated by the Drug Reimbursement Evaluation Committee from its initial attempt. Verzenio’s reimbursement was presented as an agenda in May last year, 6 months after submitting its application, but received a 'no reimbursement standard established' result. The company resubmitted its to HIRA 5 months later in October. Following Verzenio's reapplication, a petition titled "Request for Reimbursement of Verzenio, a targeted therapy for early breast cancer," was posted on the Cheong Wa Dae National Petition Board the same month. Lilly added the 5-year monarchE data presented at the 2023 European Society for Medical Oncology (ESMO) Congress to reinforce its evidence but failed its second attempt as well. This makes Verzenio's reimbursement unlikely for the foreseeable future in Korea. There is another drug pending in the early breast cancer space that is seeking reimbursement in Korea as well. Bixlink Therapeutics' Nerlynx (neratinib maleate) is also struggling to reach the reimbursement stage. Nerlynx is used for HER2+ early breast cancer, just like Verzenio is used for HER2- breast cancer. Nerlynx is indicated for the extended adjuvant treatment of patients with early-stage hormone receptor-positive HER2-positive breast cancer and who completed adjuvant ‘trastuzumab-based therapy’ less than 1 year ago. However, reimbursement for Nerlynx has been pending after failing the first attempt in February last year and the reattempt in December of the same year, and no news of its reimbursement progress has been heard of since. However, in March 2023, the U.S. National Comprehensive Cancer Network (NCCN) treatment guidelines raised the level of evidence for Verzenio+endocrine therapy to Category 1 from Category 2A for adjuvant therapy in HR+/HER2- high-risk breast cancer patients. Nerlynx is also recommended in the NCCN guidelines as a treatment for early-stage and metastatic breast cancer.
- Company
- Sanofi’s Dupixent sales skyrocket after expanded indication
- by Nho, Byung Chul Apr 08, 2024 05:46am
- Cinqair, Dupixent, Xolair, and Fasenra (clockwise from top-left). Sanofi-aventis Korea’s Dupixent (dupilumab) has accomplished outstanding external growth in the market for asthma biologic treatments. Based on pharmaceutical drug sales performance, Dupixent generated sales of KRW 143.1 billion last year. It has been ranked as the top-selling drug for the past five years. Dupixent sales were around KRW 8 billion in 2019 but have grown 1688% in four years. Dupixent secured its position as the leading product in the market by having a wider range of indications than its competitors. It has been approved for efficacy and effectiveness in type 2 inflammatory asthma, severe eosinophilic asthma, corticosteroid-dependent asthma, and atopic dermatitis. Among biologic asthma therapies, it offers the most treatment options. Notably, prurigo nodularis is related to type 2 inflammatory diseases, including atopy and asthma, and almost half of the patients with prurigo nodularis also have atopic diseases. Dupixent is the only biologic to target this disease. Novartis’ Xolair (omalizumab) ranked second and generated KRW 5.0 billion, KRW 6.1 billion, KRW 11.6 billion, KRW 15.7 billion, and KRW 21.1 in the last five years. Xolair has also consistently shown an upward trend in the sales curve. According to analysis, it is due to Xolair’s wide range of approved indications, such as allergic asthma, chronic sinusitis, and chronic idiopathic urticaria. Cinqair (reslizumab), which followed Xolair, generated approximately KRW 1.6 billion in sales last year. GSK’s Nucala (mepolizumab) and AstraZeneca’s Fasenra (benralizumab) have each shown performances in 2023, approximately KRW 700 million and KRW 400 million, respectively. Currently, Cinqair, Nucala, and Fasenra have indications for severe eosinophilic asthma only. Asthma treatment sales performances in the market (Nucala, Dupixent, Cinqair, Xolair, and Fasenra). According to South Korea’s asthma treatment guidelines, low-dose inhaled corticosteroids (ICS) and formoterol are recommended as the first-line asthma treatment. When short-acting beta agonists (SABA) are used as an alternative strategy, low-dose ICS is combined. Therapies recommended in second-to-fourth-line treatment include ICS plus leukotriene receptor antagonist or ICS plus beta 2 agonist. Fifth-line treatment involves tiotropium, anti-IgE agents (omalizumab), anti-IL/5R agents (mepolizumab, reslizumab, benralizumab), or anti-IL-4R agents (dupilumab). However, reimbursement does not cover combination therapies using biologics, such as Xolair, Nucala, and Cinqair, in treating severe asthma patients.
- Policy
- 'Need patient engagement for reimb of high-priced drugs'
- by Lee, Tak-Sun Apr 08, 2024 05:46am
- A study has shown that there is a need for a formal process for patient organizations and patients to participate in discussions for the reimbursement of high-priced drugs in Korea. With the reimbursement of high-priced drugs rising as a social issue and patient organizations and others raising concerns, the opinion has risen on the need for an official window for the patients’ participation. These findings were presented in the Health Insurance Review and Assessment Service's own 'Comparative Research on the Reimbursement Management Systems for High-Priced Drugs in Korea and Abroad' (Principal Investigator: Associate Researcher Yoo-Jung Kim). The results of the study were released on HIRA's website on April 4. After reviewing the cases of high-priced drugs Spinraza, Hemlibra, Enhertu, and Jakavi that arose as issues through press conferences or public petitions by patients or patient organizations, and explained the need for an official window that allows patient participation. In the final report, the research team wrote, "While domestic patients are represented by members of the Drug Reimbursement Evaluation Committee, there is no formal process for patient organizations to participate in the decision-making process for drugs. There needs to be a formal administrative process for domestic patient organizations and patients to formally submit their opinions and participate in the decision-making process. "Until now, Korean patient organizations have made demands in a one-time, informal manner in the form of complaints or petitions. Due to the large amount of pressure the media puts on the government to accept such demands, and the fact that the Health Insurance Review and Assessment Service responds to complaints on a case-by-case basis rather than through a formal process, the one-time complaints increase the workload and stress of HIRA employees." The researchers added, “The lack of a formal process means that the opinions of all patient organizations cannot be objectively and fairly reflected, and only the demands of some patient organizations may be expressed.” Other countries had formal processes for patient organizations’ input. The UK, France, Germany, Canada, Australia, and Taiwan all had such processes, leaving only Italy and South Korea without. Excerpt from the As policy recommendations for managing high-cost drugs, the researchers suggested the need to internalize the price-volume agreement system, evaluate the effectiveness of high-priced drugs, and expand the outcome-based risk-sharing system in the short term. In particular, this should be preceded by the establishment of a high-priced drug follow-up management system. In addition, the research team added that a pharmacoeconomic evaluation exemption system needs to be changed into a pharmacoeconomic evaluation deferral system, and the existing PE exemption drugs should also undergo reevaluations. In addition, improving the pre-approval system was also cited as a short-term improvement task. Based on the research results, HIRA has recently started implementing the improvements. In the long term, the team emphasized that early access to rare diseases and anticancer drugs should be improved through a separate fund outside of health insurance finances to generate evidence to confirm the effectiveness and safety of new drugs.
- Policy
- Recalls of antiplatelet drugs containing 'clopidogrel'…
- by Lee, Hye-Kyung Apr 05, 2024 05:44am
- The recall of the products due to exceeding safety standards for miscellaneous impurities in safety tests for the antiplatelet drugs containing the ingredient 'clopidogrel' is expanding. The Ministry of Food and Drug Safety (MFDS) reported that a total of 29 items have been recalled until April 2, starting with Daewoong Bio’s 'Clovons Tab' on March 17. Products containing clopidogrel bisulfate and clopidogrel sulfate are recalled. As these products are primarily contract manufacturing items, recall measures are rising. Daewoong Bio manufacturing plant items, including Korea Syntex Pharmaceutical, Daewoo Pharm, Mirae Pharm, Rp Bio, Spc Pharm, Kwang Dong Pharmaceutical, Bukwang Pharm, and Guju Pharm, are recalled. The first instances of exceeding impurities standards were detected in 13 items of Daewoong Bio. Among these, the Daewoong Bio manufacturing plant items, including Korea Syntex Pharmaceutical, Daewoo Pharm, Mirae Pharm, Rp Bio, Spc Pharm, Kwang Dong Pharmaceutical, Bukwang Pharm, and Guju Pharm, are recalled. Hanlim Pharm and Kyongbo Pharmaceutical have recently switched their CMO partner to Youngil Pharm, but the recalled products were confirmed to be those previously manufactured by Daewoong Bio. Some CMO companies announced in a public statement that “We received an official letter from Daewoong Bio, which is responsible for contract manufacturing the whole process of clopidogrel, to voluntarily withdraw the product.” They added, “The reason for the voluntary recall is that products exceeded impurities standards in the safety test.” It appears that the products that exceeded impurities standards were confirmed during the safety test for long-term storage. Testing the long-term storage of medicines is a safety test for drugs with a maximum shelf life of three years. Medicines undergoing the test are stored for at least six months before the test. The MFDS sees that the drugs had no issues when manufactured, but impurities occurred during the long-term storage process. According to UBIST, a market research agency, the outpatient prescription amount for the market of antiplatelet drugs containing clopidogrel was KRW 532.7, up 7.9% from KRW 493.5 in 2022. The market of antiplatelet drugs containing clopidogrel topped KRW 400 billion in 2019. Despite the ongoing COVID-19 pandemic, this market maintained steady growth of around 7%. The drugs with clopidogrel ingredients are used to improve symptoms of atherosclerosis in patients with ischemic stroke and myocardial infarction. It is also prescribed as a maintenance therapy following stent surgeries.
- Company
- High dose Eylea approved in KOR… extends dosing interval
- by Son, Hyung-Min Apr 05, 2024 05:43am
- Bayer Korea announced that its Eylea 8mg, a treatment for macular degeneration, was approved in Korea on the 3rd. Eylea 8mg was developed to maintain the effective drug concentration in the eye longer than the already approved Eylea 2mg product, allowing for longer dosing intervals and fewer injections. Eylea is an intravitreal injection used to treat major retinal diseases, including vision impairment caused by neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME). Eylea 8mg is injected once monthly for the first 3 months, after which the dosing interval may be extended to up to 16 weeks based on the physician’s judgment of visual and/or anatomic examination results. Thereafter, the dosing interval may be extended to up to 20 weeks with a treat-and-extend dosing regimen with stable visual and/or anatomic findings. The approval of Eylea 8 mg is based on the results of the PULSAR trial, in patients with neovascular (wet) age-related macular degeneration, and the PHOTON trial, in patients with diabetic macular edema (DME). The PULSAR trial, which was conducted on 1,009 patients with nAMD, showed that Eylea 8mg administered every 12 and 16 weeks was non-inferior to Eylea 2mg administered every 8 weeks in terms of best corrected visual acuity (BCVA) changes. Eylea 8mg’s mean 48-week best-corrected visual acuity gain was 6.7 letters from baseline for its 12-week dosing regimen and 6.2 letters from baseline for its 16-week dosing regimen, demonstrating noninferiority to the 7.6 letters Eylea 2mg achieved at a fixed 8-week treatment interval. In the PHOTON study, which included 658 patients with DME, both dosing regimens of Eylea 8 mg achieved comparable visual improvement to Eylea 2 mg every 8 weeks. Eylea 8mg’s mean 48-week best-corrected visual acuity gain was 8.8 letters from baseline for its 12-week dosing regimen and 7.9 letters from baseline for its 16-week dosing regimen, demonstrating noninferiority to the 9.2 letters Eylea 2mg achieved at a fixed 8-week treatment interval. In terms of dosing intervals, 93% of patients receiving Eylea 8 mg maintained a dosing interval of 12 weeks or longer at Week 48. Sangok Seo, Head of the Specialty Medicine BU at Bayer said, “We are very pleased that this approval establishes Eylea as the only anti-vascular endothelial growth factor (VEGF) on the market that can offer an extended dosing interval of up to 20 weeks. Building on the efficacy and safety that we have established over the past decade and an improved dosing interval, we hope to improve long-term treatment adherence and help patients maintain a better quality of life with Eylea 8mg.”
- Company
- AbbVie Korea, 52% increase in sales last year…
- by Kim, Jin-Gu Apr 05, 2024 05:43am
- AbbVie Korea’s major performances, including sales and operating profit, have increased by about 50% in a year. The analysis attributes this to the integration with Korea’s Allergan. AbbVie headquarters initiated the integration process between both companies in June 2019. The analysis suggests that the company’s total assets have expanded due to the completion of the integration process between the Korean subsidiaries last year. According to AbbVie Korea’s audit report on April 4, the company generated sales of KRW 234.7 billion last year, up 52% in a year compared to KRW 154.6 billion in 2022. The operating profit of the same period increased from KRW 7.8 billion to KRW 11.5 billion, up 49%. AbbVie Korea reported consistently generating sales within the range of KRW 150 billion for the past five years, with KRW 157.3 billion in 2019, KRW 146.7 billion in 2020, KRW 140.4 billion in 2021, and KRW 154.6 billion in 2022. The operating profits were KRW 7.4 billion in 2020, KRW 7.1 billion in 2021, and KRW 7.8 billion in 2022, without significant changes. Notably, sales and operating profit increased by about 50%. The analysis attributes this to the integration of AbbVie Korea with Korea’s Allergan. Trends in AbbVie Korea’s sales & operating profits (Unit: KRW 100 million, Source: Financial Supervisory Service). On February 1, AbbVie Korea acquired 100% of the shares of Korea’s Allergan. Subsequently, it completed the merger with Allergan. As of the following day, the performance of existing Allergan began to be reflected in AbbVie Korea. AbbVie Korea’s total assets increased by 98% in one year, from KRW 89.9 billion in 2022 to KRW 177.7 billion last year. Similarly, the company’s payroll expenses rose from KRW 20.2 billion to KRW 32.7 billion, up 62%. Additionally, selling and administrative expenses, including payroll, increased from KRW 43.1 billion to KRW 70.4 billion, up 63%. The headquarters completed the acquisition in 2019. On June 25, 2019, AbbVie acquired Allergan for $63 billion (approximately KRW 73 trillion). The major products of AbbVie Kore are Humira, Mavyret, Rinvoq, and Skyrizi. Humira’s sales are seeing a decreasing trend due to patent expiration. Rinvoq and Skyrizi, which are follow-up drugs to Humira, are filling the gap of Humira. Korea’s Allergan had been selling Botox, a botulinum toxin.
- Policy
- Orphan drug Ilaris receives conditional pass for reimb again
- by Lee, Hye-Kyung Apr 05, 2024 05:43am
- Although the government restarted reimbursement discussions for Novartis Korea's orphan drug Ilaris Inj (canakinumab) after 2 months, the results were the same. According to the "Results of the 4th 2024 Drug Reimbursement Review Committee Deliberations," which was released on the 4th by the Health Insurance Review and Assessment Service, Ilaris was deemed adequate for reimbursement for the following indications: ▲Cryopyrin-Associated Periodic Syndromes (CAPS), Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS), ▲Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD), ▲Familial Mediterranean Fever (FMF), and ▲ Systemic Juvenile Idiopathic Arthritis (SJIA). However, the approval came with a condition. Further evidence for the three indications - CAPS, TRAPS, and FMF - must be submitted for the reimbursed use of the drug. At the DREC meeting in February, Ilaris was deemed adequate for reimbursement subject to submission of further evidence, but Novartis filed an appeal, putting the decision on hold. Novartis then requested a reevaluation and received another DREC review after 2 months, but the results remained unchanged. Ilaris, which was deemed adequate for reimbursement along with Enhertu Inj, is a treatment for a rare disease called periodic fever syndrome, which affects only 13 patients in Korea. It is a drug that HIRA President Jung-Gu Kang said he would make efforts for prompt reimbursement during the National Assembly audit in October last year. Ilaris is the only IL-1 inhibitor recommended by international guidelines for the treatment of hereditary periodic fever syndrome and is approved by both the U.S. FDA and the European EMA. Based on the efficacy and safety of the drug confirmed through clinical studies, it is being reimbursed in a total of 30 countries. However, it is facing difficulties in receiving reimbursement approval in Korea. Novartis made two previous attempts for Ilaris’s reimbursement in 2017 and 2022 but failed both attempts. This is its third attempt. Ilaris is also an expensive drug, costing KRW 8 million to KRW 100 million per year for once every 8-week dose. If Novartis accepts DREC’s decision this time, the reimbursement process for Ilaris will progress rapidly, but if it doesn't, its reimbursement will again be at a standstill. Meanwhile, ‘Orkedia Tab 1mg, 2mg, (Orkedia Tab),’ Kyowa Kirin Korea’s treatment of secondary hyperparathyroidism in patients on maintenance dialysis was deemed adequate for reimbursement by DREC at the same meeting. In the case of Santen Pharm Korea’s ‘Rhopressa Ophthalmic Soln. 0.02% (Netarsudil Mesylate),’ which is a treatment for open-angle glaucoma and ocular hypertension, the drug was deemed adequate for reimbursement if the company accepted a price lower than the evaluated price. Takeda Pharmaceutical Korea’s ovarian cancer treatment ‘Zejula Cap. 100mg (niraparib tosylate monohydrate)’ was reviewed for RSA coverage expansion, but DREC determined its adequacy to be unclear.
- Policy
- HIRA in final stages of preparing expense report survey
- by Lee, Tak-Sun Apr 05, 2024 05:43am
- The Health Insurance Review and Assessment Service is busy preparing a survey and public disclosure of the expenditure reports on economic benefits pharmaceutical companies and medical device companies provided to doctors and pharmacists. As the data submitted by pharmaceutical companies through the survey will be subject to public disclosure, HIRA is also planning to build a system for relevant data collection. However, it plans to receive the data through a temporary system this year and open a formal system next year. According to industry sources on the 3rd, HIRA informed pharmaceutical organizations about the survey on expenditure reports. The survey will be conducted for 2 months from June to July like in the past year. In June, drug wholesalers, and in July, drug licensees, importers, and promoters must submit their previous expenditure reports to HIRA's expenditure report management system, Korea Patient Safety Reporting (KOPS). This year, consignment sales organizations (CSOs), which are entrusted with the sales promotion duties, will also be subject to submit data. CSOs are also required to prepare their own expenditure reports. However, HIRA added that it is advisable for the drug suppliers to manage and supervise the expenditure reports prepared by CSOs. The survey will cover general information such as company information and expenditure report operation status, as well as the 1-year expenditure report prepared from January to December 2023. The expenditure report includes the provision of samples, support for conferences, support for clinical trials, product presentations, post-marketing surveys, and discounts based on payment terms. In last year's survey, pharmaceutical companies uploaded the data in an Excel format, but this year's survey will be conducted in two ways: companies can directly enter the information into the temporary system or upload the data in an Excel format. The results of the survey will be posted on the MOHW website in December, just like last year. Separately, the expenditure reports submitted by pharmaceutical companies in December through KOPS will be made public for 5 years. The disclosed data will be replaced with the data the companies submitted for the expenditure report survey. HIRA plans to database the submitted data and post it according to the open principle. Last month, the Ministry of Health and Welfare announced the 'Operational Guidelines for Public Disclosure of Information,' and explained that the names of recipients, including those of the medical practitioners whose personal information may be leaked, and clinical trial information that contains the companies’ business strategies will be de-identified, then disclosed. HIRA has additionally begun hiring personnel to support the disclosure of expenditure reports and surveys. It announced on Jan. 1 that it would hire 12 people for the service through an emergency bid announcement on 'management staff dispatch service'. A HIRA official said, "This year, we plan to temporarily build an expenditure report management system, and open an official system next year. We plan to make the public disclosure in December, and we will disclose the information after discussing the scope of the disclosure and databasing the data submitted by companies."
