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- 2026-04-17 11:08:07
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- Ilyang's Supect, good effect on leukemia cells reduction
- by Jung, Hye-Jin Feb 10, 2020 06:30am
- Ilyang announced that its phase III clinical trial of 'Supect', a leukemia treatment drug developed by the company, outperformed than Glivec. Ilyang Pharmaceutical (President Kim Dong-yeon) announced on the 6th that the clinical results were published in British journal of Hematology. In this trial, 241 patients with chronic myelogenous leukemia were administered to 24 hospitals in Asia (Korea, Thailand, Philippines, and Indonesia) for four years, and the results were followed by the administration of Supect, brand for Radotinib and the first generation of anticancer drugs 'Glivec'. According to the results, 86% of Supect administration group & 75% of Glivec administration group were the patients who received the major gene response who estimated to have reduced leukemia cells by more than 1000 times, and The complete gene response rate was 58% in the Supect-treated group and 49% in the Glivec group. According to Ilyang Pharmaceuticals, the treatment failure rate was 6% in the 300mg twice daily dose of SUPECT, more than three times less and 19% in the Glivec group. Kim Dong-Wook, Hematology Professor of Seoul St. Mary's Hospital, who led the clinical study and participated in the paper, said, “At 3 months after treatment, predicted long-term good genetic response rate was 86% in the Supect group and 71% in the Glivec group. The use of Supect is expected to result in a long-term treatment effect in a larger number of patients faster and significantly increase the number of patients who can stop drug treatment after using SUPECT for a period of time. Targeted anticancer drugs prescribed for patients with chronic myelogenous leukemia for the first time were Glivec, a first-generation anticancer drug, and a second-generation target anticancer drug, such as Supect from Ilyang Pharmaceutical, Tasigna by Novartis Switzerland, and Sprycel by Bristol Myers Squibb. Ilyang said, “The first diagnosis of chronic myelogenous leukemia patients showed faster and higher gene response rates in the 'Supect' group, and there was no new serious adverse reaction even after long-term follow-up, It was confirmed that the repair treatment could increase the possibility of Treatment Free Remission. And, the second generation of targeted anticancer drugs has been selected as the first treatment in many countries because of its superior efficacy than Glivec". In addition, "Supect, the second-generation targeted anticancer drug, is the inexpensive treatment cost, which can reduce the financial burden on patients and contribute greatly to the financial stability of national health insurance". A total of 20 researchers participated in the trial, including Professor Do Young-rok (first author), Department of Hematology and Oncology, Keimyung University Dongsan Medical Center and Professor, Dong-Wook Kim(corresponding author), Seoul St. Mary's Hospital.
- Policy
- HIRA to tighten personal data protection for committees
- by Lee, Hye-Kyung Feb 10, 2020 06:30am
- Drug reimbursement feasibility deliberating Health Insurance Review and Assessment Service (HIRA) plans to tighten operational regulation for its associated committees. The revised regulation would minimize collection of committee member’s private information and generally strengthen protection of personal information. HIRA’s Benefit Listing Department and Pharmaceutical Standards Department of Benefit Management Sector notified of revising operational regulation for ‘Drug Reimbursement Evaluation Committee (DREC)’ and ‘Cancer Disease Deliberation Committee (Cancer Committee),’ respectively. The current seventh DREC has a member pool of 100, where 19 of them are randomly selected to participate in regular meeting convened every first Thursday of a month. DREC decides listing of drug based on reimbursement standard, medical needs, clinical efficacy, cost-effectiveness and external reference country’s financial impact review result, when a pharmaceutical company applies for reimbursement covering a new drug. Six subcommittees associated under DREC—Drug Reimbursement Standards Subcommittee, Pharmacoeconomic Analysis Subcommittee, Risk Sharing Agreement Subcommittee, Financial Impact Assessment Subcommittee, Korean Herbal Drug Subcommittee, Drug Reevaluation Subcommittee—provide consultation on pharmacoeconomic analysis or review reimbursement standards for DREC to comprehensively evaluate feasibility of drug reimbursement. The eighth Cancer Committee has 43 members in its pool and regular meetings are convened on a Wednesday every month for two years from last Dec. 1. The committee deliberates standards of anticancer treatment reimbursement and off-label use of anticancer treatments. HIRA aims to revise their operational regulation to minimize collection of the 100 DREC members and 43 Cancer Committee members’ personal information and to clarify the personal data archiving period and third party personal data sharing record. Also, HIRA has decided to collect date of birth from the committee members, instead of Resident Registration Number. The revised regulation would remove the agreement for providing personal data and allowing personal identification information process, delete bank account number section on provided personal data, but substitute with ‘Consulting Fee and Travel Expense Certificate.’ The personal data archiving period would be stated as member’s term of two years, and the list of committee members would be posted on HIRA website.
- Policy
- Rucalo newly listed, Meqsel+Rafinlar expands reimbursement
- by Kim, Jung-Ju Feb 10, 2020 06:30am
- Healthcare reimbursement would be granted on Yooyoung Pharmaceutical’s chronic constipation treatment Rocalo tablet (prucalopride succinate) soon at a price of 100 won a unit. Used to treat BRAF V600E mutation-confirmed metastatic melanoma, Novartis Korea’s Meqsel (trametinib dimethyl sulfoxide) plus Rafinlar (dabrafenib mesylate) combination therapy would be additionally indicated for treating non-small cell lung cancer (NSCLC). But, only in condition of signing the expenditure cap type risk sharing agreement (RSA) for the financial issues. According to pharmaceutical industry on Feb. 5, the Korean government plans to reflect the said changes on ‘List of Reimbursed Drug and Maximum Reimbursed Price.’ ◆ Rucalo tablet: A selective serotonin 5-HT4 receptor agonist, Rucalo treats adults with chronic constipation, who does not respond to conventional laxative. After Ministry of Food and Drug Safety (MFDS) approved the drug as of Jan. 25 last year, the company immediately applied for reimbursement to Health Insurance Review and Assessment Service (HIRA) on Feb. 15 last year. Reimbursement on the drug was granted by Drug Reimbursement Evaluation Committee (DREC) in last October following the review by HIRA. Apparently, Korean Society of Neurogastroenterology and Motility’s claim that the doctors actually consider such prokinetic drug when a patient does not respond to first-line laxative (form-bulking or osmotic laxatives), has influenced the decision. In fact, the drug is listed in some of A7 countries like the U.K., Germany, Italy and Switzerland. Since then, the company successfully reached an agreement during pricing negotiation with National Health Insurance Service (NHIS) conducted from last November to early January, as ordered by MOHW. When the listing is completed, the drug’s maximum reimbursed price is predicted to be set at 127 won per 1 mg unit, and 191 won per 2 mg unit. ◆ Meqsel plus Rafinlar combination therapy expands reimbursement: Meqsel plus Rafinlar combination therapy has been indicated for treating metastatic melanoma in patient with confirmed BRAF V600E mutation. The combination has been receiving reimbursement since November 2017 in Korea. BRAF V600E mutation is a particular change in BRAF gene that affects growth and transmission of cancer cell and is frequently found in a number of specific cancers like melanoma. For the reimbursement review procedure, it took the pharmacoeconomic analysis exemption route. After a while, the pharmaceutical company added the therapy an indication to treat NSCLC patient with confirmed BRAF V600E mutation, and applied for expanded reimbursement to HIRA in February last year. HIRA’s Cancer Disease Deliberation Committee and DREC cleared reimbursement for the combination therapy in April and October last year, respectively. The combination therapy used on NSCLC, also recommended by clinical practice guidelines by National Comprehensive Cancer Network (NCCN) and European Society for Medical Oncology (ESMO), was evaluated to have improved clinical efficacy when reviewed by DREC. However, the government and NHIS laid down a condition of signing RSA to cover the financial impact caused by expanding reimbursement on the combination therapy’s NSCLC-treating indication (NHI estimates yearly claim would be approximately 20 billion won). During the negotiation with the company later, the maximum prices of Meqsel and Rafinlar were lowered by 23% and 13%, respectively. When the new reimbursement is finalized, the maximum reimbursed price per unit is expected to be set at 128,344 won and 32,086 won per 2 mg and 0.5 mg of Meqsel, and 24,751 won and 36,336 won per 50 mg and 75 mg of Ranfilar.
- Company
- MFDS to clear Forxiga’s heart failure indication soon
- by Eo, Yun-Ho Feb 10, 2020 12:17am
- Anti-diabetic treatment Forxiga is ready to be reintroduced as a heart failure drug in Korean market as well. According to pharmaceutical industry on Feb. 7, AstraZeneca’s sodium-glucose cotransporter 2 (SGLT-2) inhibitor Forxiga (dapagliflozin) would be soon indicated for reducing the risk of hospitalization by heart failure in patients with type 2 diabetes. Korea’s Ministry of Food and Drug Safety (MFDS) is expected to conclude the review within this month at earliest. AstraZeneca started the additional indication approval procedure immediately after the U.S. Food and Drug Administration (FDA) has cleared of the indication in back October 2019. The company also aims to quickly process expanding an indication to reduce the risk of heart failure in patients with reduced ejection fraction, with and without type 2 diabetes, the FDA has processed under Priority Review. Forxiga’s efficacy to reduce the risk of hospitalization of diabetic patients with heart failure was confirmed during Phase III DECLARE-TIMI 58 trial. The large-scale trial observed 17,000 patients around the world with co-morbid type 2 diabetes and either cardiovascular-related risk or heart failure to study the effect of the SGLT-2 inhibitor on cardiovascular conditions. The outcome found Forxiga lowering the risk of hospitalization or death from heart failure by 17 percent and, specifically, the risk of hospitalization was lowered by 27 percent. The tendency of reduced risk of hospitalization by heart failure or death by cardio vascular disease was consistently prevalent in patient groups with cardiovascular risk factors (hypertension, dyslipidemia, smoking), and previous record of cardiovascular disease. Executive Director Chae In Ho of Korean Society of Interventional Cardiology (Professor at Seoul National University Bundang Hospital) stated, “Although heart failure treatment options are available, its medical need is still highly unmet. The use of SGLT-2 inhibitor for treating heart failure would be significantly popular in Korea.” Another SGLT-2 inhibitor, Boehringer Ingelheim’s Jardiance (empagliflozin) also has ongoing clinical trials to test indication to treat heart failure. The drug is simultaneously conducting EMPEROR-Preserved trial on patients with preserved ejection fraction and EMPEROR-Reduced trial on patients with reduced ejection fraction. Based on EMPEROR and EMPERIAL studies particularly testing efficacy on heart failure, FDA has reportedly granted fast track status on Jardiance’ heart failure indication.
- Policy
- NIH, urgently promotes 2019n-CoV vaccine research
- by Kim, Jung-Ju Feb 07, 2020 06:32am
- Health authorities urgently push forward research to develop 2019n-CoV treatments and vaccines. After the MERS outbreak, it will strengthen its research capabilities and begin research on viral pathogenicity within this month. The National Institutes of Health (Director Hyun-Young Park), in the Centers for Disease Control and Prevention (Director Eun-kyung Chung), announced on the 5th that it is urgently pursuing research on the development of treatments and vaccines to cope with 2019n-CoV that threaten public health worldwide. The National Institutes of Health has conducted research on new and variant viruses in Korea through the development of antibody therapeutics and high-sensitivity gene diagnostics after the MERS outbreak in 2015. Based on the accumulated technology, the NIH will collaborate with domestic researchers to launch 2019n-CoV treatment, vaccine development, and viral pathogenicity research in February. In detail, the cost of this research is ₩800 million, which is divided into clinical, therapeutic, vaccines, and pathogenic analysis. In the clinical and therapeutic sectors, the hospital-centered network is used to study the clinical immunological characteristics of domestic patients and to develop a wide range of antigens and antibodies for the development of therapeutic antibodies. The vaccine division studies DNA vaccines, major antigen production, various types of vaccines including vaccine antigen carriers and inactivated vaccines, and development of efficacy evaluation techniques for vaccines. Pathogenicity analysis includes the analysis of the major genetic variants of the 2019n-CoV and the prediction of its evolution. In addition, the Ministry of Health and Welfare and the Ministry of Science and ICT will cooperate with relevant ministries and industry-university research institutes to expand preemptively prepare for and respond to the emergence of new and variant viruses including 2019n-CoV. In the case of the Ministry of Welfare, the Ministry of Science and ICT and the Ministry of the Interior and Safety will undertake the National Life Safety Emergency Response Study. Sung-soon Kim, director of the Center for Infectious Disease Research at the National Institutes of Health, said, "This urgent research project will play a pivotal role in the research of new and transformed infectious diseases and lay the groundwork for the development of 2019n-CoV treatments and vaccines at the national level". Meanwhile, there are no specific treatments or vaccines for 2019n-CoV infections, so countries around the world are using symptomatic therapy and existing antiviral agents and developing vaccines and treatments. Overseas funding and technology are supported by the international cooperation, the Coalition for Epidemic Preparedness Innovations (CEPI). Ebola virus treatment (Remdesivir) and HIV treatment (Lopinavir, Ritonavir) are also being evaluated for efficacy.
- Policy
- Feb shortage prevention drug list: 641 items with Vivaquine
- by Lee, Hye-Kyung Feb 07, 2020 06:32am
- Myung In Pharmaceutical’s Vivaquine tablet (primaquine phosphate) has been designated as a shortage prevention drug as compensation for high production cost. The maximum price is set at 309 won. Health Insurance Review and Assessment Service (HIRA) recently disclosed new list of shortage prevention drug as of February 2020. ‘Shortage prevention drug’ is defined as an essential drug the government designates to prevent pharmaceutical company from stop supplying the drug due to poor profitability. The drug is then categorized as ‘compensation for usage incentive and high production cost,’ ‘compensation for high production cost,’ or ‘compensation for usage incentive.’ All shortage prevention drugs added to the list this month would receive National Health Insurance benefit as compensation for high production cost. Along with Vivaquine, Shin Poong Pharm’s Malafree tablet (primaquine phosphate) and Richwood Trading’s Richnight tablet (doxepin hydrochloride) have been designated as shortage prevention drugs with maximum prices set at 309 won and 89 won, respectively. The designation was finalized on Jan. 22, when Ministry of Health and Welfare (MOHW) revised the ‘List of Reimbursed Drug and Maximum Reimbursement Price.’ As the mandatory reporting regulation of drug manufacturing, importing or suspending supply stipulates, pharmaceutical manufacturer or importer with approved drug planning suspend the drug supply is required to report the plan with justifiable reason to Minister of Food and Drug Safety 60 days prior to the estimated date. Companies not complying with the regulation would be imposed with administrative measure of manufacturing or business operation suspension—three months for the first offence, six months for the second and business license revocation for the third.
- Policy
- DREC to deliberate drug reevaluation as originally planned
- by Kim, Jung-Ju Feb 07, 2020 06:32am
- Although committee meetings and events by Korean government and associated agencies have been either canceled or postponed due to the novel coronavirus, Drug Reimbursement Evaluation Committee (DREC) plans to push on with its original schedules as it plays the role of the first threshold to drug reimbursement listing and criteria negotiation. Pharmaceutical industry insider reported Health Insurance Review and Assessment Service (HIRA) has decided to convene DREC meeting on Feb. 6 as initially planned. DREC’s objective is to deliberate and decide on issues regarding new and generic drug listing, alleviating or adjusting reimbursement criteria and other National Health Insurance reimbursement. The committee regularly convenes a meeting on every first Thursday of a month, and reports outcomes to Ministry of Health and Welfare (MOHW). The ministry then sort out drugs for listing to either report them to Health Insurance Policy Deliberation Committee (HIPDC) or order National Health Insurance Service (NHIS) to schedule further negotiations with the pharmaceutical companies, if need be. The industry carefully assumed DREC would also postpone its meeting schedule, as HIPDC meeting, as well as other government and public events and meetings, have been affected by the novel coronavirus outbreak. But the industry was still skeptical of the committee rescheduling the meeting as DREC consists of only about 20 or so members and its decision-making procedure is more urgent than any other committee’s as it affects company’s business schedule and patient’s treatment access. The industry is naturally quite keen on this specific DREC meeting as it the agenda includes the pharmaceutical reevaluation standard and method. HIRA has been hinting the industry of a plan to adopt reevaluation system for already-listed drug and accordingly adjust pricing and reimbursement conditions, but it has yet to finalize related guideline and subject drug list. The industry has been highlighting the finalization of the reevaluation guideline and subject list as reevaluating last year’s hot potato, choline alfoscerate, would be also decided at the same time. Overall, the industry is mostly convinced the upcoming DREC meeting would deliberate and decide on the guideline and the list considering the general flow and time needed of Comprehensive National Health Insurance Plan and revised drug pricing system.
- Company
- Opdivo retries expanding reimbursement without NSCLC
- by Eo, Yun-Ho Feb 06, 2020 06:31am
- Seemingly have given up on expanding reimbursement, Opdivo has turned around and started taking actions again. Nevertheless, its health coverage application excluded indication for lung cancer. According to industry sources, Ono Pharmaceutical and BMS have recently applied for expanding reimbursement on PD-1 inhibitor-based immunotherapy Opdivo (nivolumab). The application is for the use as second-line treatment for renal cell carcinoma, second-line treatment for relapsed or metastatic squamous cell carcinoma of the head and neck (SCCHN), and second-line treatment for typical Hodgkin’s disease. The issue-making indication treating non-small cell lung cancer (NSCLC) regardless of expressed PD-L1 was dropped from the new application. Although the companies may have left the NSCLC indication behind, they are determined to continue improving access to Opdivo. Since early 2019, the government has been negotiating with respective pharmaceutical companies on Opdivo, Roche’s Tecentriq (atezolizumab), and MSD’s Keytruda (pembrolizumab) all together for expanded reimbursement. In the process, Ministry of Health and Welfare (MOHW) engaged in preliminary negotiation with the companies and laid a condition to limit reimbursement only to patients showing response and the ‘trade-off’ initiative, which would reduce off-patent drug’s pricing as a compensation for recognizing value of new drug. The preliminary negotiation is a type of special procedure, not a part of regular deliberation process for reimbursement expansion, such as Cancer Disease Deliberation Committee, Drug Reimbursement Evaluation Committee (DREC) of Health Insurance Review and Assessment Service (HIRA) or drug pricing negotiation with National Health Insurance Service (NHIS). Immunotherapy has been a game changer that shifted the paradigm of anticancer therapy. However, it is extremely expensive and its indication can expand out indefinitely. Preliminary negotiation is a unique tool the Korean government has established to discuss easing reimbursement criteria for drugs necessary for treatment but comes with significant financial burden. The purpose of the tool is to expedite the procedure with DREC and NHIS by reaching an agreement on financial issues and reimbursement criteria prior to the regular procedure. But, only Roche reached an agreement with the government. Although the second round of negotiation fell through, MSD applied for reimbursement expansion again with another indication approved at the end of last year and is now waiting for Cancer Disease Deliberation Committee’s decision. Whereas, Ono Pharmaceutical and BMS have not taken any other actions after the first negotiation ruptured last May. Many suspected the companies have basically ‘given up’ on Korean market. For now, the industry is keeping close eyes on Opdivo putting aside the discrepancy experienced last year and yet again applying for expanding reimbursement without the NSCLC indication. Initially, Opdivo was indicated ‘regardless of expressed PD-L1,’ but it was listed in August 2017 with a set expression rate of PD-L1 under refund and expenditure cap type risk sharing agreement.
- Company
- Pelubi’s indication expansion, seeking for breakthrough
- by Kim, Jin-Gu Feb 06, 2020 06:30am
- Pelubi & Pelubi CR Daewon Pharm challenges the expansion of Pelubi's patented indication. Pelubi's indication for osteoarthritis is extended to dysmenorrhea. Recently, Pelubi CR’s phase III trial plan by Daewon was approved from the Ministry of Food and Drug Safety. This is a phase III clinical trial in Korea to evaluate the efficacy and safety of DW9801 in primary dysmenorrhea patients. Currently, Pelubi has indications for osteoarthritis, rheumatoid arthritis and low back pain. There are two related patents. There are formulation patents for Pelubi and formulation patents for Pelubi CR, respectively. The attempt to expand the indication is related to the recent patent challenge. Pelubi has been patented by six pharmaceutical companies since late last year. Yungjin Pharm filed a judgement on passive confirmation of the scope on the Dec 27 last year, followed by Futecs, Huons, Chong Kun Dang, Nexpharm, and Mother’s Pharmaceutical. This is why Daewon Pharm is attempting to expand the indications to Pelubi CR rather than Pelubi. The six companies' patent challenges are headed for Pelubi. Successful overcoming this patent, which expires in November 2028, will be available after September 2021, when the PMS expires. However, even if the patent is overcome, it can be prescribed only for the treatment of osteoarthritis, rheumatoid arthritis, and low back pain, which is an indication limited to Pelubi. Under the assumption that Pelubi CR is extends the indications, it cannot be used for the treatment of dysmenorrhea. So far, no patent challenge has been confirmed for the Pelubi CR. Last year, the combined Rx amount of Pelubi & Pelubi CR amounted to ₩ 28.9 billion. Prescriptions, which amounted to ₩4.6 billion and ₩5.7 billion respectively in 2014-2015, surged to ₩8.5 billion in 2016, ₩13.5 billion in 2017, ₩23.9 billion in 2018, and ₩28.9 billion in 2019. The rapid growth of Pelubi's prescription is analyzed that to there was not a little impact on the release of Pelubi CR. Pelubi was released in 2007 as the new domestic drug No.12. Since its launch. By the first half of 2015, the half-yearly prescription performance was just around ₩2.3 billion. However, since the launch of the Pelubi CR in June 2015, the semi-annual earnings have been on the rise, and since the second half of 2017, it has grown into a blockbuster drug with full-fledged operations by Daewon Pharm. Pelubi RX results (Unit: ₩100 million, Data:UBIST) for the past six years. Since the release of Pelubi CR tablet in June 2015, it has been on the rise.
- Policy
- 2019n-CoV was successfully isolated from infected patients
- by Kim, Jung-Ju Feb 06, 2020 06:30am
- Health authorities have successfully isolated the new coronavirus (wuhan pneumonia) from patients with infectious diseases, It is very good news for developing vaccines and treatments The KCDC(Director, Eun-kyung Chung) announced on the 5th that 2019n-CoV was isolated and will share with the scientific community for the development of vaccines and treatments. The new isolate of Korean coronavirus is BetaCoV/ Korea /KCDC03/2020. STR of isolated new Korean coronavirus The KCDC inoculated the patient's respiratory specimens (sputum, etc.) into cells and confirmed the growth of the new coronavirus and analyzed the viral gene sequences to prove the new coronavirus. The culture is to divide, grow and multiply the cells, which are the basic life units, so that the population increases. Viruses can be cultured only in living cells. According to the virus genetic information released by the KCDC, the isolated virus was identical in sequence (99.5 ~ 99.9%) with viruses isolated from China (Wuhan, Guangdong), France, Singapore, Germany, etc. No significant genetic variation was found. .The nucleotide sequence information of the new isolates of the new coronavirus is registered in the GISAID of the World Health Organization (WHO) and can be used by researchers at home and abroad .GISAID is WHO's world influenza surveillance network, which contains information on the gene sequence of new coronaviruses in each country .The director, Eun-kyung Chung said, "Isolated viruses will be distributed to relevant ministries and relevant competent institutions so that they can be used for research and development as an indispensable resource for the development of diagnostics, treatments, and vaccines, and distribution procedures and methods will be announced later".
