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- 2026-04-11 21:14:16
- Policy
- Lorviqua reimb at ₩52,819, Emgality at ₩295,250
- by Kim, Jung-Ju Aug 30, 2022 05:55am
- ◆Lorviqua Tab= Lorviqua is a treatment that received domestic marketing authorization as monotherapy to treat adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small-cell lung cancer (NSCLC). The company applied for reimbursement after receiving approval from the Ministry of Food and Drug Safety on July 29th. The Health Insurance Review and Assessment Service deliberated the agenda at the Cancer Disease Deliberation Committee on January 12th, and at the Drug Reimbursement Evaluation Committee on April 7th. At the time, HIRA had determined the drug adequate for reimbursement and waived pharmacoeconomic evaluations. The drug is listed in 7 of the A7 countries. The agenda was then passed on to the National Health Insurance Service, where the company conducted negotiations on the drug price and expected claims amount until May. As a result, the parties agreed on employing the ▲Refund type where the company refunds a certain rate (reimbursement rate) of the amount of the claims to NHIS, and the▲Expenditure Cap type where the amount that exceeds a certain cap is refunded, of the RSA. The insured price will be set at ₩52,819 for the 25mg strength and ₩158,457 for the 100mg strength starting on the 1st of next month. ◆ Emgality 120mg prefilled pen·prefilled syringe inj = Emgality was approved by the MFDS as a migraine prevention treatment on September 5th, 2019. The industry applied for reimbursement to HIRA on March 31st, after which the agenda was listed and deliberated by DREC on May 12th. At the time, the economic evaluation subcommittee acknowledged the clinical need for the drug and that the drug is subject to cost-effectiveness analysis. After pharmacoeconomic evaluations, the cost-effectiveness ratio was determined to be in an acceptable range. In countries abroad, the prefilled pen inj is listed in 6 of the A7 countries, and prefilled syringe in 2 of the A7 countries. The agenda was passed on to the National Health Insurance Service, where the company conducted negotiations on the drug price and expected claims amount from May to July. Both the pen and syringe was listed for reimbursement at ₩295,250. However, in consideration of the fact that the drug is more expensive than its alternative (oral treatment), the discontinuation standard has been set so that patients discontinue treatment if the number of migraine days is not reduced by 50% or more from baseline (before administration) during response evaluations, and the administration period was set to a maximum of 12 months.
- Policy
- Zemimet’s price drops 9.7% in 5 years…discounted 5 times
- by Lee, Tak-Sun Aug 30, 2022 05:54am
- LG Chem’s incrementally modified new diabetes treatment, ‘Zemimet Tab,’ has once again been subject to Price-Volume Agreement negotiations this year and its price will be discounted as of the 1st of next month. This is the fifth price cut made through the PVA system for the drug since its reimbursement approval. Its price had fallen nearly 10% during the period. According to the industry on the 29th, Zemimet Tab was applied Type C of PVA negotiations, the ceiling price of all four strengths of Zemimet SR Tab were discounted. The discount rate varies by strength but was in the 1.1% to 1.5% range. This is already the fifth price discount made through the PVA system, indicating the exponential increase of Zemiglo users in Korea. Although the system was established to secure and expand NHI finances, on the company’s part, the company should inevitably feel frustrated as the system hampers product growth. In the case of Zemimet ST Tab 50/500mg, its price has been lowered every year from 2018 to this year through the PVA system. The ceiling price, which had been ₩815 during the initial listing, had fallen to ₩736. This is a 9.7% discount. The industry had been raising voices that PVA negotiations for drugs like Zemimet SR Tab need to be limited to reflect the R&D efforts made by homegrown new drugs. The industry suggested that a maximum number of negotiations should be limited to three, or other incentives are provided for new homegrown drugs from Korea Innovative Pharmaceutical Companies. However, the NHIS is negative about only granting incentives to domestically developed drugs for reasons of equity. During the correspondents’ briefing that was held on the 23rd, Haemin Jeong, Deputy Minister of NHIS Pharmaceutical Management Department, said, “The NHIS agrees on the need for Korea Innovative Pharmaceutical Companies to receive preferential treatment in consideration of the social and industrial values of such companies, but a more cautious approach is required to apply measures like easing price cuts to the PVA system.” He added, “The PVA system adjusts drug prices to share the financial risk held by drugs whose expenses exceed a certain level, and drugs that affect NHI finances must be managed, regardless of whether it is a drug produced by Korea Innovative Pharmaceutical Companies or not. Providing preferential treatment for such innovative pharmaceutical companies is difficult in reality in terms of equity due to international trade issues, and would require discussion with relevant organizations.” Although Jeong’s response was limited to the provision of incentives for Innovative Pharmaceutical Companies, the response can also be interpreted as that it is difficult to give preferential treatment to domestically-developed drugs through the PVA system.
- Policy
- Kyowa Hakogirtin Postelligeo 20mg is expected to be approved
- by Lee, Hye-Kyung Aug 30, 2022 05:54am
- Posteligeo 20mg, a rare two-type non-Hodgkin lymphoma treatment of Kyowa Hakogirin, is expected to be approved. It has been four years since the U.S. Food and Drug Administration (FDA) approved the treatment of mycosis fungoids (MF) or Sézary syndrome (SS) in August 2018. According to the pharmaceutical industry on the 26th, the Ministry of Food and Drug Safety recently completed Potseligeo's safety and efficacy review. It has been four years since the U.S. Food and Drug Administration (FDA) approved the treatment of mycosis fungoids (MF) or Sézary syndrome (SS) in August 2018. According to the pharmaceutical industry on the 26th, the Ministry of Food and Drug Safety recently completed Posteligeo's safety and efficacy review. Analysts say that as the review has been completed, it is highly likely to receive permission soon if there are no other variables. Posteligeo is a monoclonal antibody component that acts on C-C chemokine receptor-4 (CC chemokine receptor type 4) found in cancer cells to produce therapeutic effects. At the time of U.S. approval four years ago, it received the title of the first approval as an SS treatment. The duration of survival (PFS) without exacerbation of the disease in phase 3 clinical trials was more than twice as long in the Posteligo group (7.6 months) as in the Zolinza group (3.1 months). The proportion of patients whose tumor size was reduced to a specific level (ORR) was 28% in the Posteligo group and 5% in the Zolinza group. Abnormal cases caused by Posteligeo administration include rashes, injection site reactions, fatigue, diarrhea, and musculoskeletal pain. Meanwhile, Posteligeo was approved by the European Commission in November 2018 as a treatment for adult patients with Mycosis Fungoides and Sézary Syndrome who received at least one systemic therapy after FDA's approval.
- Company
- Piqray can be prescribed in 18 hospitals
- by Eo, Yun-Ho Aug 30, 2022 05:54am
- Piqray, an anticancer drug targeting the PIK3CA gene, can be prescribed at a general hospital. According to related industries, Novartis' Piqray passed the Drug Committee of 18 medical institutions nationwide, including Samsung Medical Center, Seoul St. Mary's Hospital, and Seoul Asan Medical Center, as well as Bundang Medical Center and Korea University Anam Hospital. Piqray, approved in Korea in May last year, is a PIK3CAα inhibitor that blocks excessive activity of the PI3K pathway by inhibiting overactivation of PI3K-α due to PI3CA gene mutation, and is a target anticancer drug prescribed in combination with Faslodex in previously failed HR+/HER2-transitive and progressive breast cancer patients. However, Piqray is still a non-reimbursed drug. It submitted an application for benefits at the end of last year, but failed to pass at the Cancer Disease Review Committee of the Health Insurance Review and Assessment Service in February. Novartis is currently working on a re-challenge to register insurance benefits. Piqray demonstrated efficacy through SOLAR-1 studies conducted on 572 menopause women and patients with advanced or metastatic breast cancer after receiving or receiving HR-positive, HER2 negative, and aromatase inhibitor (AI). Clinical results showed that when Faslodex and Piqray were used in tumor patients with PIK3CA mutations, the median value of PFS (Progress-Free Survival) in patients with PIK3 tumors improved by 5.7 months to 11 months. ORR, which represents the proportion of patients whose tumor size has decreased by at least 30%, also showed a combined therapy group of 35.7%, more than double the difference from the monotherapy group of 16.2%. The OS in PIK3CA mutant patients, a secondary evaluation variable, was 39.3 months in the combined therapy group, about 8 months longer than 31.4 months in the monotherapy group, but was not statistically significant. Sohn Joo-hyuk, a professor of oncology at Sinchon Severance Hospital, said, "we recommends a combination of Piqray and Fulvestrant therapy in category 1 for breast cancer patients with PIK3CA gene mutations in the NCCN guidelines. With the introduction in Korea, we can expect to overcome resistance to endocrine therapy."
- Company
- HIV tx Delstrigo is available in major national hospitals
- by Eo, Yun-Ho Aug 29, 2022 06:03am
- The HIV complex Delstrigo is available in general hospitals. According to related industries, Delstrigo, a fixed-dose HIV tx taken once a day by MSD Korea, has passed the D.C. of medical institutions such as Sinchon Severance Hospital, National Medical Center, Pusan National University, Kyungpook National University, Chonnam National University, and Seoul Medical Center. Due to the nature of HIV drugs, as prescriptions are mainly made at national hospitals, landing was conducted mainly at major national hospitals. The drug was approved in Korea in January 2020 and has been on the list since January last year. Delstrigo's indication is "treatment of human immunodeficiency virus (HIV-1) infection in adults who have no previous experience in antiretroviral treatment." As of November 22, 2019, 100 mg of Doravirine was approved by the Ministry of Food and Drug Safety under the product name Pifeltro, and is required to be administered in combination with other antiretroviral drugs. Both Pifeltro and Delstrigo received indications for the treatment of human immunodeficiency virus (HIV-1) infection in adult patients with no previous antiretroviral treatment. Delstrigo confirmed its validity through DRIVE-AHEAD clinical trials. In the clinical trial, Delstrigo demonstrated non-inferiority compared to Efavirenz, Emtricitabine, and Tenofovir therapy. The proportion of patients who reached viral inhibition (less than HIV-1 RNA 40copies/mL) at 48 weeks was 84% in the Delstrigo treatment group and 80% in the EFV/FTC/TDF treatment group. The treatment discontinuation rates due to abnormal reactions were 3% and 6.6%, respectively, which were lower in the Delstrigo treatment group. Meanwhile, in the domestic market, Gilead, GSK, MSD, Janssen, Abbvie, and BMS are competing in the HIV field, of which Gilead and GSK account for about 90% of the market.
- Company
- Pfizer Korea receives tax audit...files tax appeal
- by Aug 29, 2022 06:03am
- On why Pfizer Korea filed a “tax appeal” against the National Tax Service, the company said it had “duly instituted administrative procedures, judging that some of the imposed taxation standards were unreasonable,” refuting the allegations that the company was fined due to ‘cost overstatements.’ According to the pharmaceutical industry on the 26th, the National Tax Service levied fines on some Korean subsidiaries of multinational pharmaceutical companies including Pfizer Korea after tax audits. Pfizer Korea did not disclose the specifics on its amount, but the amount is estimated to be in the tens of billion won range. Pfizer Korea filed a tax appeal regarding the additional fine levied by the NTS on the company, claiming that the tax levied by the NTS was excessive. Pfizer Korea said, “A tax appeal can be filed based on the reasonability of the taxation standards, regardless of the amount. Judging that there were some unreasonable parts in the taxation standards, the company has been taking due process for the tax appeal.” The company stressed, “We have no intention to avoid taxes or exaggerate costs.” Pfizer Korea also drew the line on the so-called ‘cost overstatement’ allegations that were made, on the claim that the company had been writing the product's price higher than the existing price when importing products to increase profits for its headquarters. The company stressed that the imposed fines were irrelevant to sales of the company’s COVID-19 vaccine or oral treatment. The company explained, “the import price is set in consideration of various factors including the product’s cost and terms of transactions, etc.” The fines were imposed not due to cost exaggerations but as part of regular tax audits. In particular, the company added that “the fine was imposed on taxes paid in 2015-2020, at a time unrelated to COVID-19. The fines were levied as a result of a regular tax audit made every 5 years, regarding the taxes paid in 2015-2020, and has no relation to the company’s sales made related to COVID-19.” Pfizer Korea made nearly ₩1.7 trillion last year, ₩1.3 trillion of which is estimated to be from COVID-19 vaccines. In 2020, before COVID-19 vaccines were imported, Pfizer Korea’s sales had been in the ₩300 billion range. When adding the sales of its spin-off company, Viatris, the combined sales had been in the ₩600 billion to ₩700 billion range. Pfizer Korea said, “The company has been faithfully filing its tax returns and payments so far, and will be judged through due process of the taxation standards that are deemed unreasonable on the company’s part."
- Policy
- "Raise the prescription rate for high-risk patients to 50%"
- by Lee, Jeong-Hwan Aug 29, 2022 06:03am
- Experts have pointed out that high-risk patients with COVID-19 should be first administered oral treatments such as Paxlovid or Lagevrio etc. before hospitalization. In other words, if the prescription rate of oral COVID-19 treatments remains in the current 20% range, experts believe that the prescriptions will not be sufficient to prevent the increase in severe disease and deaths amid the resurgence of COVID-19. Therefore, the experts believe that the prescription rate in high-risk COVID-19 patients needs to be increased to at least 30% and to at most 50%. Gi-Seok Jeong, Director-General of Special Response of the Central Disaster and Safety Countermeasure Headquarters stated so at the regular briefing held on the 26th. Jeong added that there is no obstacle to providing prompt medical treatment for COVID-19 patients as over 10,000 one-stop medical institutions nationwide are in operation, and 1 out of 3 local hospitals and clinics are providing one-stop treatments. However, pointing out that in 25% of the medical institutions the progress to hospitalization is not smooth, Jeong expressed the view that this problem should be resolved quickly, and treatment be administered during the waiting period prior to hospitalization. Jeong said, “Smooth progress to hospitalization is of course important, but regardless of this, the high-risk group should unconditionally be administered prescription drugs. The prescription rate has been improved much, but the rate should not remain at the current 20% range." “The rate has improved much, from 4% last Spring to 20%, but the statistics need to be improved so that the rate is improved to 1 in 2 or 1 in 3 patients receiving prescriptions to implement the targeted, precision quarantine for high-risk patients that we hope to achieve. Achieving this goal will lead to a gradual decrease in the severity or fatality rate in COVID-19 patients in the future.”
- Company
- South Korea is looking forward to Xpovio's benefit
- by Aug 29, 2022 06:02am
- Xpovio, a treatment for multiple myeloma, succeeded in entering the benefit one after another overseas. Expectations are growing that the registration of overseas lists will have a positive effect on Korea, given that there has been no country to refer to drug prices. According to the pharmaceutical industry on the 25th, Canadian health authorities recently decided to reimburse for Antigen Pharmaceutical's new drug Xpovio, a multiple myeloma drug. Prior to this, it passed in Australia in March. Canada and Australia are not included in the A7 countries (US, UK, Germany, France, Italy, Switzerland, and Japan), which are drug reference countries. However, the domestic outlook is also bright as two countries with insurance registration systems similar to Korea have succeeded in registering insurance one after another. On top of that, last month, the European Commission (EC) approved Xpovio as a treatment for multiple myeloma. In the pharmaceutical industry, it is observed that benefits will be made in each country in Europe, starting with Germany and Switzerland. Xpovio received an item license from the Ministry of Food and Drug Safety in July last year. However, it has not passed the cancer disease review committee under the HIRA for a year. A review process, but was rejected. Because there is no suitable overseas country to refer to the drug price, Korea calculates the appropriate domestic drug price by referring to the drug price of seven overseas countries. Previously, xpovio was entered by permit only in the country, Medicaid and other benefits. But the drug price of the United States only appropriate that hard to calculate for the price of a position of the health authorities. That is currently released in January, the deliberative committee for the amjilhwan a xpovio, after failing to set wage did not meet the criteria number of benefits seven countries listed is sitting at a standstill, all the way. Multiple myeloma patients are asking for its speed in Australia and Canada for the price of a reference to benefits. Minhwan Back, the chairman of the KMPG said, "a third round of multiple myeloma after then developed an immunity to period is very quickly relapse. Xpovio is the only drug that can be used in the fifth round, but it is very economical because it can only be treated with non-reimbursement." He said, "Patients who failed the fourth treatment are waiting for the news of their benefits with the feeling of grasping at straws, Xpovio will be listed as soon as possible and give hope to patients who are in a difficult situation." The company position is to speed to the benefit is granted a measure of the station. The gimminyeong of Tianjin, the pharmaceutical representative said, "I am happy, and the results of a good rating agencies and other countries, waiting for a drug the molting season early to think I will try to local benefits can be made as soon as possible"
- Company
- NPU condemns the unilateral ERP of multinational companies
- by Aug 29, 2022 06:02am
- The NPU condemned global pharmaceutical companies' unilateral ERP moves. The NPU, which gathered 16 domestic and foreign pharmaceutical bio companies, issued a statement on the 24th, signaling a strong response, saying, "Some member companies have recently shown unilateral voluntary retirement, wage negotiations that do not fit common sense, and collective agreement negotiations." NPU claimed that even though global pharmaceutical company A made the largest sales ever with COVID-19 vaccines and treatments, it is trying to conduct forced restructuring under the guise of ERP for many sales department employees in the name of changing business models. Global B Pharmaceutical Company claims that it is conducting ERP without unilaterally breaking the agreement between labor and management on the logic that ERP is not a cut despite the agreement between labor and management regarding employee cuts. The NPU then noted, "Global Company C is shaking employees with rumors that they will inevitably take voluntary retirement as a global policy as if they were riding on this situation." Global companies D and E have a wage problem. Company D presented a very low wage increase rate of 1.5% in the unprecedented high price and high interest rate situation, and the NPU claims that Company E is changing employee performance pay disadvantageously and not providing fuel costs. Finally, Company F mentioned that it is attempting to neutralize the union so that the union cannot be involved in the collective agreement negotiations and that users can proceed unilaterally. The NPU said, "I'm sure that the reason why this happened is because there are forces that lead it, and I think that those forces are representatives of some HR's user interests." The NPU warned, "We will condemn the behavior of ignoring the union without recognizing it as a counterpart, and will carry out a campaign to step down so that the forces leading it will no longer be established in the industry." On the same day, the Korea GSK union also issued a statement condemning the management's unilateral voluntary retirement. GSK Korea announced on the 16th that it will conduct voluntary retirement for employees of the sales department. Applicants will be accepted by the end of this month. In response, the union said, "This voluntary retirement is due to outsourcing of certain departments, and according to Article 21 of the agreement, we agree with the union when the reduction is carried out due to unavoidable management," adding, "But the management notified the union 30 minutes ago." After the surprise announcement, they are pushing ahead with one-on-one interviews with the employees, and putting psychological pressure on early applicants within a week by applying additional payment conditions. The union said, "The union stopped the management's actions and demanded negotiations for discussions in accordance with the principle of good faith that has continued so far, but the ERP, which was able to proceed smoothly with avoidance, faced considerable conflict." The union urged "to immediately stop layoffs disguised as ERP."
- Company
- HK inno.N, Daewoong, & Jeil are competing to secure K-Cab
- by Kim, Jin-Gu Aug 29, 2022 06:02am
- HK Innoen K-Cab and Daewoong Pharmaceutical Fexclue Competition is expected to expand beyond P-CAB to PPI HK inno.N and Daewoong Pharmaceutical are competitively expanding the indication of P-CAB series gastroesophageal reflux disease treatment. On top of that, Jeil Pharmaceutical is planning to join the competition by operating two clinical trials at the same time to launch the third gastroesophageal reflux disease treatment. The pharmaceutical industry predicts that competition in the gastroesophageal reflux disease treatment market, including P-CAB-based drugs as well as PPI-based drugs, will intensify in the future. On the 22nd, Daewoong Pharmaceutical announced that the indication of Fexclue, a new drug for treating gastroesophageal reflux disease, has been added. Fexuclu, which previously received indication for treatment of erosive gastroesophageal reflux disease, added indication of "improvement of gastric mucosal lesions (10mg) of acute and chronic gastritis." In particular, acute and chronic gastritis is an indication that is not present in the competing drug HK Inno. N's K-Cab Daewoong Pharmaceutical plans to focus on highlighting such differences in competition with HK Inno.N. HK Inno. N is also focusing on expanding the indication of K-Cab. Currently, K-Cab has five indications, including erosive gastroesophageal reflux disease, non-irritating gastroesophageal reflux disease, gastric ulcer, combined antibiotic therapy for Helicobacter pylori eradication, and maintenance therapy (25 mg) after treatment of erosive gastroesophageal reflux disease. Phase 3 clinical trials are underway as a "preventive therapy for gastric and duodenal ulcers that induce nonsteroidal anti-inflammatory analgesics." The clinical trial began with the goal of recruiting 390 patients in October 2020. HK Innoen plans to complete clinical trials by the end of this year. Jeil, which aims to approve the third P-CAB-based gastroesophageal reflux disease treatment, also started two clinical phases at the same time. Jeil is developing a P-CAB-based gastroesophageal reflux disease treatment under the name JP-1366 through its subsidiary Oncherapeutics. In December last year, phase 3 clinical trials for patients with erosive esophagitis were launched, and in May this year, phase 3 clinical trials for patients with gastric ulcer were approved.
