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- 2026-04-17 11:08:06
- Policy
- Meqsel+Rafinlar combination NSCLC indication reimbursed
- by Kim, Jung-Ju Feb 12, 2020 06:27am
- Korea’s top healthcare reimbursement decision-making body has passed listing of Yooyoung Pharmaceutical’s chronic constipation treatment Rucalo tablet (prucalopride succinate) and expanded reimbursement on Novartis Korea’s Meqsel (trametinib dimethyl sulfoxide) plus Rafinlar (dabrafenib mesylate) combination therapy. The revised List of Reimbursed Drug with the said changes came in effect from Feb. 10. Ministry of Health and Welfare (MOHW) has disclosed the outcomes on Feb. 6 of Health Insurance Policy Deliberation Committee (HIPDC) deliberating the changes on the List of Reimbursed Drug and Maximum Reimbursed Price. Rucalo tablet was released in Korean market in January last year as a treatment for adults with chronic constipation, who does not respond to conventional laxative The drug was waiting for the final call on reimbursement listing as Drug Reimbursement Evaluation Committee (DREC) under Health Insurance Review and Assessment Service (HIRA) has cleared reimbursement feasibility and pricing negotiation with National Health Insurance Service (NHIS) reached an agreement. The maximum price was set at 127 won per 1 mg tablet and 191 won per 2 mg tablet. Used to treat BRAF V600E mutation-confirmed metastatic melanoma, Meqsel plus Rafinlar combination therapy has been listed for reimbursement since November 2017. But as the combination therapy was additionally indicated for treating non-small cell lung cancer (NSCLC) patient with confirmed BRAF V600E mutation, the company applied for adjustment of maximum price and expanded reimbursement. The pricing negotiation of the combination therapy with NHIS immediately followed the reimbursement approval by HIRA’s Cancer Disease Deliberation Committee and DREC last year. However, the combination therapy was given a choice to get reimbursement with risk sharing agreement (RSA) in combination of expenditure cap type and induction therapy refund type, because the additional indication was estimated to cost approximately 20 billion won annually, according to NHIS’ estimated amount of claim. For the expenditure cap type RSA, when the actual amount claimed with reimbursement exceeds the cap of estimated amount of claim set during the pricing negotiation, the pharmaceutical company has to pay NHIS back the set ratio of exceeded amount. As for induction therapy refund type, the pharmaceutical company has to refund the cost of the treatment administration in induction therapy phase. The details of the agreement is undisclosed between NHIS and the company. The maximum reimbursed price for Meqsel was readjusted to 128,344 won per 2 mg tablet, 32,086 won per 0.5 mg tablet. Rafinlar’s price was set to 24,751 won per 50 mg capsule, and 36,336 won per 75 mg capsule.
- Company
- JAK-inhibiting oral antirheumatic drug market getting fuller
- by Eo, Yun-Ho Feb 11, 2020 06:31am
- Orally taken antirheumatic treatment, JAK inhibitor drug market in Korea would be soon led by four competitors. According to pharmaceutical industry, the close competition between Pfizer’s Xeljanz (tofacitinib) and Lilly’s Olumiant (baricitinib) would get even intensified as Astellas Pharma’s Smyraf (peficitinib) entered the competition last month and AbbVie’s upadacitinib is awaiting Ministry of Food and Drug Safety’s nod at the moment. Janus kinase (JAK) inhibitor has gotten the industry’s attention since its release, because it was first oral therapeutic option for autoimmune disease with equivalent treatment level as anti-TNF medicine. However, its position in the market is not as influential as other biologics. While anti-TNF drug and anti-interleukin drug have consolidated their positions in the market, JAK inhibitors’ indications have been too narrow except for rheumatoid arthritis. Global Sales Volume of Anti-TNF Drugs and JAK Inhibitor Drugs (Unit: KRW 100 million) In other words, JAK inhibitor still has much more potential. The first JAK inhibitor, Xeljanz was additionally indicated for treating ulcerative colitis and psoriatic arthritis, and other following drugs have ongoing trials to expand indications treating autoimmune diseases like atopic dermatitis, Crohn’s disease and ankylsoing spondylitis. Once Smyraf and upadacitinib enter the market, and Gilead Sciences’ filgotinib, currently under review in the U.S. and Europe, is commercialized in Korea, JAK inhibitor market with convenience of oral administration option would naturally grow. But also there is a drawback. JAK inhibitor recently had an adverse reaction issue regarding cardiovascular system safety when administering high dose. Although direct relationship of cause-and-effect has not been fully confirmed, warning has been labeled on the high-dose prescription of the three drugs. High-dose of the drugs is prescribed for rheumatoid arthritis and other major indications. JAK inhibitors block inflammatory cytokine cell’s family of Janus kinase enzymes (JAK1, JAK2, JAK3, and TYK2). Different kinds of JAK inhibitors share the same mechanism of actions but with some intricate differences. Xeljanz inhibits JAK1 and JAK3, Olumiant blocks JAK1 and JAK2, whereas Smyraf blocks JAK1, JAK2, JAK3 and TYK2. Upadacitinib and filgotinib interferes activity of JAK1.
- Opinion
- All the access in China must be cut off
- by Nho, Byung Chul Feb 11, 2020 06:30am
- Professor Young-Bong Kim2019n-CoV is a RNA virus belonging to beta corona, similar to SARS or MERS, and is a common infectious disease with high mortality due to the absence of vaccines and treatments. The mortality rate of SARS and MERS was 10% and 30%, respectively. This is due to the level of medical care, and because it has very high gene homology with SARS and the same cellular receptor uses ACE2, it can be regarded as a second SARS virus. Viral disease, like a fire, early response is very important. The first thing you need to do when it is fire is to scream. That way, you should alert your surroundings so you don't miss an initial response. It's better to stay a bit more fuzzy than a big accident. Already, China failed to respond early, putting the entire region at risk, not just Hubei. Soon there will be more than 100,000 official infections, and already they have grown exponentially, but the diagnostic system will not follow them, and statistics will be missing. However, the death toll continues to rise, with exponential growth at some stages, and mortality is expected to be higher than now. 2019n-CoV is not a strong viruse when tested for virus inactivation. The virus is exactly the same as the cold epidemic of RNA viruses with temperature- and humidity-sensitive envelopes. The strength of the virus' propagation is important, but it's more affected by the environment. In other words, SARS inactivation test results show that at 4 ℃, the phenomenon is relatively stable in pH 3 or chemical disinfectant (formaldehyde based), etc., and this phenomenon is maintained until at least the end of March. Korea has experience of MERS in 2015, so the monitoring management system and the negative pressure isolation ward facility of the KCDC have been prepared. There is no infection in the hospital and the initial response is still good. This is also a reward for MERS. However, as new inflows continue and the second and third epidemics increase, the domestic virus disease response system is bound to reach its limit. Fortunately, even if it doesn't spread to serious pandemics, if the situation lasts until the end of March or April, people's fatigue and economic impact will be hard to say. The current diagnosis system cannot completely diagnose the carriers, so if we do not block the entry of infected people from China, we can become like other parts of China, so more preventive measures are required. It should be borne in mind that the last domestic MERS outbreak was caused by only one super infected person. The winter is a pleasant environment for viruses. No 2019n-CoV without a drug or vaccine can be prevented by justice and can only be solved by scientific protection.
- Product
- It costs ₩867 million to become a physician
- by Kang, Shin-Kook Feb 11, 2020 06:29am
- It is estimated that it costs ₩867 million from entering medical school to obtaining professional qualification. The Korean Medical Association(KMA)'s research institute for healthcare policy (Director Deok-sun Ahn) announced on the 7th that it has published a research report on the estimation of doctor training costs and public support. According to the research report, the average cost of education per student in the basic medical education stage (1 year of premedical course and 1 year of regular course) was ₩64.97 million (minimum ₩54.12 million, maximum ₩77.62 million). Divided into premedical courses and medical courses, the average annual education cost per premedical student was ₩25.3 million (at least ₩14.93 million, up to ₩38.81 million). The average annual education cost per medical student was ₩39.95 million (minimum ₩3257 million, maximum ₩48.51 million). As a result of estimating the cost of internships, the average annual training cost per intern was ₩73 million (min. ₩55.5 million, max. ₩93.95 million). As a result of estimating the training costs of majors (5 departments: internal medicine, surgery, obstetrics, pediatrics, family medicine, etc.), the average annual training cost for each major is ₩146.04 million(minimum ₩111.18 million, max. ₩187 million). According to the results of estimating the cost of each doctor's training, the total cost of training one doctor (to become a specialist) is ₩887 million, and the total annual cost for training doctors is ₩2.7175 billion. On the other hand, in the US, UK, Germany, Japan, and Canada, the state and society share a large part of the cost of physician training. In the United States, for example, the share of medical costs needed to train doctors is shared by various organizations, including 23% in the state, 8% in federal research funds, 18% in medical schools, 28% in clinical care, and donations. According to the U.S. medical schools, 70% of the per capita training costs are shared by Medicare (20% direct, 50% indirect) and 30% by Medicaid and other private health insurance companies. Korea's budget is ₩72 trillion (₩60 trillion in social welfare and ₩12 trillion in health care) in 2019, and in the budget, the portion for training and aptitude and supply of medical personnel is ₩24.9 billion, of which, the budget for support for nurturing majors and qualification examinations for specialists is about ₩1.3 billion. The Research institute for healthcare policy said, "As the social interest in patient safety increases, the education and training environment for excellent doctor training is increasing, the study was meaningful in estimating the cost of training and total cost per doctor and suggesting the justification for public support". The research institute said, “Based on the results of the study on the estimation of the cost of doctor training and public support measures, it is necessary to form a consultative body for social discussion of the cost sharing of doctor training, and social councils should involve the important stakeholders in health care, the nation, the Korean Medical Association, medical schools, intern & training Centers, local governments, and the general public”.
- Company
- Pfizer recalling Lipitor and Caduet in defective packaging
- by Jung, Hye-Jin Feb 11, 2020 06:29am
- Pfizer Korea is recalling some of Lipitor and Caduet stocks, not because of the drug itself but because of defective packaging. On Feb. 6, Pfizer Korea disseminated official notice to vendors and requested them to suspend shipping of Lipitor and Caduet. The shipping is halted for Lipitor 10 mg in 90-tablet packaging with manufacturer’s serial number DA1448 (expired by Apr. 15, 2022), CY0992 (expired by Apr. 15, 2022), and DA0505 (expired by Oct. 24, 2021), and Caduet 5/ 20 mg in 30-tablet packaging with serial number CR4181 (expired by Aug. 5, 2022). Pfizer Korea explained the company has found potential risk on product quality, and said it would voluntarily recall the products. The official notice stated, “Any healthcare institute or distributor with the said packaging in the stock should suspend shipping, and return the products to supplier when the recall is initiated.” Currently, Pfizer is discussing about the recall with Ministry of Food and Drug Safety (MFDS), and is also planning to notify related vendors and healthcare institutes about the recall method as soon as possible when it is decided. Pfizer Upjohn Korea official said, “The shipping suspension has been decided, because we found some bottled products with a crack on the rim of bottle opening. However, the ratio of products with the crack among the to-be-recalled products is estimated to quite low.” The company elaborated the potential risk on patient is low, but the preemptive steps are taken voluntarily to ensure safety of the patients.” Lipitor is hypertension-treating drug with atorvastatin that made 176.2 billion won in Korea last year. Caduet is a combination drug treating hypertension and dyslipidemia with atorvastatin and amlodipine. It has raised 24.1 billion won last year from prescription.
- Policy
- Strensiq, a rare disease treatment, passed the Committee
- by Lee, Hye-Kyung Feb 11, 2020 06:28am
- Strensiq, a rare disease treatment , passed the Pharmaceutical Benefits Advisory Committee On the 6th, the HIRA (Director Seung-taek Kim) revealed the results of the review by the Pharmaceutical Benefits Advisory Committee on the adequacy of the medical benefits of the drug application. Only one drug has been evaluated for adequacy of reimbursement, and is used to treat bone symptoms in children with hypophosphatemia which is Strensiq. Strensiq is a medicine that Handok signed a domestic sales contract for Soliris to strengthen its strategic partnership with Alexion on November 17 2016. It is a long-term enzyme replacement therapy for treating bone symptoms in children with hypophosphatemia in childhood. Clinical results in neonates and infants with hypophosphatemia showed that the survival rate at 1 year of age for patients who received 48 weeks of strains was 95%, significantly higher than the survival rate of 42% for historical control. The Committee stated that "the adequacy of the benefits of the strain is recognized", and "The final evaluation result may be changed in the event of changes in the specific reimbursement range and standard items of the drug, changes in the permission of the requested item, and withdrawal (cancellation)".
- Policy
- Phase 3 trial for Korea-made DPP-4 + SGLT-2 approved
- by Lee, Tak-Sun Feb 10, 2020 06:31am
- Apparently, Phase III clinical protocols of two new Korea-made anti-diabetic treatments based on DPP-4 inhibitor, Suganon (evoglitin by Dong-A ST) and Zemiglo (gemigliptin by LG Chem), have been approved to test their combination efficacy with SGLT-2 inhibitor drug. Among nine new dipeptidyl peptidase 4 (DPP-4) inhibitor drugs competing in Korean anti-diabetic treatment market, the two investigational drugs are rare cases of Korea-developed drugs. But also two of them have not yet confirmed combined efficacy with sodium-glucose cotransporter-2 (SGLT-2) inhibitor drug. Currently, MSD’s Januvia, Bristol-Myers Squibb’s Onglyza, and Boehringer Ingelheim’s Trajenta are indicated in Korea as combination therapy with SGLT-2 inhibitor. And recently, a few DPP-4 inhibitor plus SGLT-2 inhibitor combination drugs have been approved, but none of them are developed by a Korean company. On Feb. 7, Ministry of Food and Drug Safety (MFDS) has approved Phase III protocols on Suganon plus metformin plus dapagliflozin combination therapy and Zemglo plus metformin plus dapagliflozin combination drug. The health authority green lit Dong-A ST Suganon’s multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase III trial that aims to test efficacy and safety of metformin plus evoglitin (brand name: Suganon) combination therapy added with dapagliflozin, treating type 2 diabetic patients with insufficient control of blood sugar level. LG Chem’s Phase III protocol on gemigliptin (brand name: Zemiglo) plus SGLT-2 inhibitor combination drug has been cleared to test efficacy and safety of metformin plus gemigliptin plus dapagliflozin combination therapy treating type 2 diabetic patients, who cannot sufficiently control blood sugar level after treated by metformin monotherapy. The Phase III trial would be multicenter, randomized, double-blind, double-placebo, active-control, parallel-group study comparing the investigational combination with dapagliflozin plus metformin combination therapy. Dapagliflozin apparent in both combination therapies is AstraZeneca’s SGLT-2 inhibitor anti-diabetic treatment, Forxiga’s active pharmaceutical ingredient. So far, Suganon has been indicated as monotherapy and combination therapy with metformin. And Zemiglo has been indicated as combination therapy with metformin, combination therapy with metformin plus sulfonylurea, and combination therapy with insulin. The most frequently used substance for anti-diabetic drug, DPP-4 inhibitor, controls blood sugar level by blocking enzyme dipeptidyl peptidase-4 to activate insulin-secretion stimulating hormone incretin. SGLT-2 inhibitor inhibits sodium-glucose transport protein 2 to prevent reabsorption of glucose in the kidney to lower blood sugar level. The medication is the newest drug in the anti-diabetic drug market rapidly increasing the volume in the market. Experts evaluate the combined use of two drugs would be more effective as both DPP-4 inhibitor and SGLT-2 inhibitor medications have confirmed outstanding efficacy of controlling blood sugar level and safety. But only limited number of drugs has been indicated as DPP-4 inhibitor plus SGLT-2 inhibitor combination therapy. Moreover, those drugs are all imported. The industry expects the Korea-made Suganon and Zemiglo to enhance their market competitiveness, when they win the SGLT-2 combination therapy indication. According to UBIST last year, Suganon has generated 7 billion won for outpatient prescription, and Sugamet, an evogliptin plus metformin combination drug, generated 8.6 billion. Moreover, Zemiglo has made 34 billion won, and its combination drug with metformin, Zemimet raised 63.5 billion won. The overall DPP-4 inhibitor market volume in Korea is approximately 500 billion won.
- Product
- Lyxumia by Sanofi stops supply in the second half
- by Kim, Min-Gun Feb 10, 2020 06:31am
- Sanofi-Aventis KoreaSanofi-Aventis Korea's supply of GLP-1 analog diabetes treatment ‘Lyxumia (Lixisenatide)’ will be discontinued from June this year. According to the distribution industry on the 7th, Sanofi recently announced that it has stopped supplying two formulations, such as 10μg and 20μg of Lyxumia pen, due to company circumstances. Sanofi said in an announcement that it is scheduled to withdraw its product license (from the Ministry of Food and Drug Safety) for the convenience of the company. If Lyxumia is withdrawn in March, the supply is expected to cease in June this year, when inventory held by wholesalers is exhausted. The remaining benefit period is expected to be up to six months from the date of withdrawal. As a result, benefits are expected to cease from October this year. The reason for the withdrawal of Lyxumia is unknown. However, the rapid decline in revenue after the advent of competitive products is believed to have had some effect on supply disruption. Licensed as a GLP-1 analogue in March 2013 by the Food and Drug Administration, the product was approved for glycemic control, diet and exercise therapy supplements in adult patients with type 2 diabetes. At the time of the market, once-daily administration showed attention for lowering blood sugar regardless of pre and post meal. However, Lixumia's sales declined sharply in 2016 because of Trulicity (Dulaglutide), which is administered once a week with the same GLP-1 analog family. According to drug market research institutes such as IQVIA, The sales fell to ₩500 million in 2018 and ₩300 million in 2019. The poor performance of the family of GLP-1 analogs administered once a day is not the only Lixumia. Victoza (Liraglutide) by Novonordisk and Byetta(Exenatide) by Astrazeneca also fell below ₩100 million. At present, the market size of the GLP-1 analogue is known to be about ₩30 billion. The industry believes that it is due to the convenience of once-weekly administration and Trulicity, which is recognized for its combination with basal insulin at the end of 2017. The long-lasting product has reduced the rejection of injections. This is a long-lasting product that has increased convenience. The market grew, but as Trulicity encroached, once-daily dosing products gradually disappeared.
- Company
- MSD’s Spin off completes within this year
- by An, Kyung-Jin Feb 10, 2020 06:31am
- Employees of Korean subsidiaries had begun to stir as Merck (US MSD) declares a division of business. Anxiety over future behaviors is heightening as the company announces the launch of an independent corporation to manage women's health-related products, patent expired drugs, and biosimilars within the year. #Decision to split MSD business, Transfer women's health and biosimilar products to a new corporation MSD held a conference call on the 5th and formulated a spin-off plan. The company plans to split the existing pharmaceutical division into two and set up a separate independent corporation (tentatively named NewCo) to focus on women's health-related products, cardiovascular diseases, respiratory and pain products, and biosimilar products. MSD has decided to focus its research and development (R&D) capabilities on remaining drugs, including anticancer drugs, vaccines, specialty products, and animal health. By item, About 90 patent-expired drugs such as ▲Biosimilars distributed by MSD headquarters such as Renflexis, Brenzys and Ontruzant through a contract with Samsung Bioepis ▲Etonogestrel implant Nexplanon franchise, birth control pills, maternity products, etc. ▲Hyperlipidemia drug, Zetia, Vytorin, respiratory disease drug Singulair, skin disease drugs, pain medicine, etc. will be transferred to the new corporation. Business split plan announced by MSD (Source: Merck Conference Call) Ken Frazier, CEO of Merck, said he decided to split the company to build a business model that fits the portfolio and expects both companies to focus on investment and growth in the first half of 2021. The company announced that it will proceed with the process of establishing a new corporation in the coming months. Based on the contraceptive and infertility related products currently owned by MSD, the goal is to foster new corporations as global leaders in women's health. The company also said it would seek opportunities for active partnerships with other pharmaceutical bio companies to maximize the value of cardiovascular and skin diseases, respiratory diseases, pain, and biosimilar products and to increase patient access. MSD plans to split the company within this fourth quarter, reorganization is imminent According to the headquarters policy, reorganization is inevitable even for a Korean corporation with 700 employees. MSD Korea held a town hall meeting for all employees on the 6th afternoon to share information on corporate division and had a Q&A time. According to officials who attended the Town Hall meeting, the management of the Korea MSD on the day set the standard that the employee's affiliation will follow the business unit to which the dedicated product portfolio belongs. Of the four divisions under the MSD of Korea, more than 100 employees from the DB (Diverse Brand) division dealing with respiratory and skin diseases such as Propecia and Singulair and some employees in the PC(Primary Care) with diabetes and cardiovascular diseases are influential. Since the new corporation is a completely independent company, the office will be operated separately after the spin-off. For example, sales marketing staff currently in charge of vaccine products such as Gardasil work at MSD, while sales marketing staff dedicated to DB business products such as Singulare are moved to a new corporation. The distribution criteria for employees who were in charge of both company's products or internal departments other than sales marketing department have not been specified yet. Since the company's affiliation may vary depending on the division's operating model, the company said that it would provide individual guidance on whether or not it belongs to the third quarter. The management of Korea MSD said, “It is expected that it will complete the spin-off within the fourth quarter of this year, regardless of the schedule of the headquarters. It is difficult to predict the number of employees who will be moving to a new corporation, except for clinical departments. Next week's departmental session will provide details”. Korean subsidiary's confusion aggravated, "no ERP implementation plan" by company Sudden decision adds confusion among employees. Employees attending the town hall are said to have asked questions about the succession of consecutive years of service and salary, benefits, and conditions of succession when they move to a new corporation. There is also anxiety that the ERP(Early Retirement Program) may be activated if the service years are not inherited or if the settlement of severance pay in the middle of business split. In this regard, a Korean MSD official said, “the company does not currently plan to settle interim severance pay or implement ERP. Years of service remain the same. Since the establishment of the new corporation, the company has not received any information from the headquarters regarding the sale and merger and acquisition plan”. He stressed, "It is not a cost reduction but a decision for long-term growth, so we plan to actively support the growth and career development of our employees after the division".
- Company
- AstraZeneca, decided to withdrawal from the KDPU
- by Kim, Jin-Gu Feb 10, 2020 06:31am
- AstraZeneca Korea decided to withdraw from the KDPU(Korea Democratic Pharmaceutical Union). The branches of the KDPU have been reduced to 18, including 17 multinationals and 1 domestic. According to the pharmaceutical industry on the 6th, the Branch of AstraZeneca Korea under the KDPU has voted for members whether or not to withdraw from the end of this January. As a result of the voting, More members were in favor of the withdrawal. After the withdrawal process, the union of AstraZeneka Korea will conduct collective bargaining with the company as an industrial union. AstraZeneca Korea's withdrawal from the KDPU is the third after Janssen Korea and Novonordisk. Prior to AstraZeneca Korea, the majority of members withdrew from the MSD Branch of Korea, but it did not lead to a complete withdrawal yet. At the end of last year, MSD Korea withdrew 300 members out of 380 members of the KDPU. There are currently two unions in the MSD Korea. Reasons for withdrawal include unequal voting rights and an increase in union costs. The KDPU are currently entitled to one vote per company regardless of the number of members. As a result, large companies continue to complain. It is reported that the union's executive department recently decided to raise union costs. In the case of large companies, the right to vote is limited and union costs have increased, which is a double burden. After the withdrawal of Jansen Korea, AstraZeneca Korea was the second largest after Novartis Korea. The KDPU was launched in 2012 by multinational companies under the Federation of Korean chemical Workers’ Unions. At the time, 8 companies including ▲Novartis Korea ▲Takeda Korea▲Sanofi-Pasteur ▲AstraZeneca Korea ▲Wyeth Korea ▲Zuellig Pharma Korea ▲ Bristol-Myers Squibb Korea and ▲Janssen Korea participated as founding members. Since then, ▲Baxter Korea ▲Merck KGaA ▲Ferring Pharmaceuticals, Korea ▲Allergan Korea ▲Fresenius Kabi Korea ▲Fresenius Medical Care ▲Abbvie Korea ▲Astellas ▲MDS Korea ▲Mundipharma Korea ▲Galderma Korea ▲Zuelligpharma services Korea joined as a new union branch. Among domestic companies, Kolon pharma has attracted attention by joining the union. Among them, Janssen Korea, Novonordisk and AstraZeneca Korea withdrew, and currently, there are 18 branches under the KDPU.
