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- 2026-05-07 18:03:06
- Company
- Hemgenix receives orphan drug designation in KOR
- by Eo, Yun-Ho Oct 10, 2023 05:26am
- The one-shot gene therapy for hemophilia, Hemgenix, has been designated as an orphan drug in Korea. On the 6th, the Ministry of Food and Drug Safety announced so through an orphan drug designation notice. Hemgenix (etranacogene dezaparvovec-drlb), which is the first and only one-time gene therapy approved for the treatment of adults living with hemophilia B, was first approved by the FDA in November last year. The drug can be used to treat adults with hemophilia B who: currently use Factor IX prophylaxis therapy, have current or historical life-threatening bleeding, or have repeated, serious spontaneous bleeding episodes. Hemgenix’s efficacy was confirmed through the pivotal HOPE-B study, the largest gene therapy study in hemophilia B to date. Study results showed that the mean factor IX activity of hemophilia B patients had increased to 36.9 IU/dL after infusion, and showed durable and sustained stable activity levels. Also, the drug reduced the annual bleeding rate (ABR) by 64%. Also, 9 96% of patients discontinued routine Factor IX prophylaxis and mean Factor IX consumption was reduced by 97% at 18 months post-treatment. The drug continued to show effect in the HOPE-B 24-month extension study. There were no serious treatment-related adverse events in the clinical study setting, and the drug was generally well tolerated. Hemophilia B is a congenital bleeding disorder caused by a single gene defect and is caused by a deficiency in coagulation factor IX (blood coagulation factor 9), a protein that helps blood coagulation and is mainly produced in the liver. Moderate-to-severe Hemophilia B is treated using prophylactic infusions of factor IX to temporarily replace or supplement low blood clotting factor levels. Although effective, patients are burdened with having to strictly adhere to a lifelong infusion schedule. Also, patients can experience pain, limited mobility, joint damage, and spontaneous bleeding due to the disease. When these patients are injected with Hemgenix intravenously, they can produce blood coagulation factor IX on their own, lowering the risk of bleeding.
- Policy
- Will Leclaza also begin drug price negotiations soon?
- by Lee, Tak-Sun Oct 10, 2023 05:26am
- The expansion of reimbursement for Leclaza, a third-generation EGFR TKI non-small cell lung cancer treatment developed by Yuhan Corporation, as a first-line treatment will be discussed at the HIRA Pharmaceutical Reimbursement Evaluation Committee on the 12th. If the Pharmaceutical Reimbursement Evaluation Committee recognizes the adequacy of the benefit on this day, the drug price will be negotiated with NHIS and placed on the final benefit list. According to the industry on the 6th, Leclaza is on the agenda for deliberation by the evaluation committee to be held on the 12th. The Pharmaceutical Review Committee deliberates on the registration of new benefits, expansion of benefits, and adjustment of the maximum amount of drugs. A total of 40 people, including 17 committee members and government officials, will attend. Leclaza was approved as a first-line treatment for non-small cell lung cancer last June. It is the second third-generation EGFR TKI treatment for non-small lung cancer, following Tagrisso. However, the speed of salary registration is almost the same as Tagrisso. While Tagrisso's reimbursement standards were set by the HIRA Cancer Disease Review Committee last March, five years after approval from the Ministry of Food and Drug Safety, Leclaza's reimbursement standards were established two months after approval last August. If it passes the Pharmacy Review Committee this time, the gap in registration speed with Tagrisso will be further reduced. Tagrisso passed the committee held on the 7th of last month. There is also a possibility that the two drugs may be listed on the insurance plan at the same time through NHIS drug price negotiations. Once the drug price negotiation is concluded, it will be included in the final benefit list after deliberation by the Health Insurance Policy Deliberation Committee of the Ministry of Health and Welfare. The domestic market size for first-line non-small cell lung cancer treatment is said to be approximately 300 billion won. If the third-generation treatment that has proven its excellence in effectiveness becomes the first-line treatment, it is expected to record high sales performance. Recently, Yuhan's stock price has risen by 40% in three months as expectations for Leclaza's expanded first-line treatment coverage and entry into the global market have grown.
- Company
- Dongkook succeeds P3T for its BPH combination drug
- by Chon, Seung-Hyun Oct 06, 2023 05:37am
- On September 25th, Dongkook Pharmaceutical announced that it had confirmed the safety and efficacy of its incrementally modified combination drug for benign prostatic hyperplasia (BPH), ‘DKF-313,’ through a Phase III trial. Based on the positive results, Dongkook Pharmaceutical plans to complete the Phase III trial result report within the year, then apply for its marketing authorizations and release. Pic of Dongkook Pharmaceutica HQ DKF-313 is the world’s first combination of dutasteride and tadalafil. According to Dongkook Pharmaceutical, its combo drug has a dual effect of reducing prostate size while improving urinary disorder symptoms from BPH and can bring better treatment effect than single-agent drugs. The company said, “We were able to confirm the superior effect of DKF-313 in the trial. The drug is expected to improve the convenience and quality of life for patients ailing from a condition that requires long-term medication, as the drug comes in a once-daily, one-tablet dosage form." The company received approval to initiate a Phase 3 trial for DKF-313 from the Ministry of Food and Drug Safety in July 2020 and began full-scale clinical trials to enroll about 650 patients from 18 hospitals nationwide in 2021. Dongkook Pharmaceutical took charge of the development of DKF-313, and three domestic pharmaceutical companies, including Dong-A ST, Shinpoong Pharm, and Dong Koo Bio & Pharma, shared the cost as participants. If the drug succeeds in commercialization, the partner companies will each gain marketing authorization and release it simultaneously. The incrementally modified version of this combination drug will be manufactured and supplied at a facility of the organizing company, Dongkook Pharmaceutical. Professor Choung-Soo Kim, Director of the Prostate Cancer Center at Ewha Womans University’s Mokdong Hospital, said, “The combination demonstrated superiority in improving the International Prostate Symptom Score (IPSS) compared to each agent alone, and there was no statistically significant difference between the combination and single-agent drugs in terms of adverse drug reactions. If the results lead to product launches, it may provide new and significant support in improving the treatment and quality of life of the patients.” A Dongkook Pharmaceutical official said, “We plan to strengthen our stronghold in the domestic market based on our domestic and overseas network and sales power and expand our scope overseas and penetrate the global market.”
- Policy
- Pfizer applies for reimb of its COVID-19 Tx Paxlovid
- by Lee, Tak-Sun Oct 06, 2023 05:36am
- Pfizer applied for the reimbursement of its COVID-19 treatment 'Paxlovid' in Korea. With the government planning to end the current free support system for COVID-19 treatments in the 1H next year, the company has begun the process of applying for reimbursement accordingly. According to the industry on the 5th, Pfizer Korea recently submitted a drug decision application for its COVID-19 treatment ‘Paxlovid Tab’ to the Health Insurance Review and Assessment Service. Paxlovid was first introduced to Korea through the Emergency Use Authorization system in December 2021. At the time, the need for oral treatment was raised due to the increased number of confirmed COVID-19 cases and critically ill patients and the spread of the Omicron variant, leading to the prompt introduction of Paxlovid. On July 18, the drug received official marketing authorization from the Ministry of Food and Drug Safety. Until now, Paxlovid had been provided 100% free of charge through government support. However, the government announced a provisional plan to convert COVID-19 into a level 4 infectious disease starting August 31 and end the free support for COVID-19 treatments from the 1H next year, raising the need for Paxlovid’s reimbursement. Without reimbursement, a single set of Paxlovid for 5 days will cost KRW 700,000. Also, Pfizer Korea announced at a press conference celebrating the official approval of Paxlovid in July that it was discussing with the government to quickly list the drug before 1H of next year. If reimbursed, patients will be able to use it cheaper through national health insurance support. The drug had established itself as Pfizer’s cash cow, posting global sales of $4.069 billion (KRW 5.4492 trillion) in Q1 last year.
- Product
- Investigation into companies refusing to supply animal med.
- by Kim JiEun Oct 06, 2023 05:36am
- The Korean Pharmaceutical Association (Chairman Choi Kwang-hoon) took out its sword against pharmaceutical companies that refused to supply veterinary medicines to pharmacies. Kang Byeong-gu, director of animal medicine at the Korean Pharmaceutical Association, appeared at Seoul Namdaemun Police Station as a complainant on September 26 and was investigated. Last August, the Pharmaceutical Association reported Boehringer Ingelheim Korea Animal Pharmaceuticals to Seoul Namdaemun Police Station on charges of violating the Pharmaceutical Affairs Act. This is a criminal complaint for violation of the Pharmaceutical Affairs Act, unlike the case of violation of the Fair Trade Act in 2013 when some animal drug manufacturers refused to supply products to animal pharmacies. The Pharmaceutical Association believes that Boehringer Korea Veterinary Pharmaceuticals' refusal to supply medicines violates Article 47 of the Pharmaceutical Affairs Act (Sales Order of Medicines, etc.) and Article 22 of the Rules for Handling Veterinary Medicines, etc. (Compliance Matters for Veterinary Medicine Manufacturers, etc.) The Pharmaceutical Association explains that Boehringer's actions interfere with the preparation and administration of medicines at veterinary pharmacies and are likely to encourage collusion by supplying veterinary medicines only to certain wholesalers and veterinary hospitals. In his appearance at this police investigation, Director Byeong-gu Kang stated that he had requested a thorough investigation into problems with Boehringer Ingelheim's veterinary drug distribution policy. Kang Byeong-gu, director of animal medicine, said, “An animal guardian who has been issued an out-of-hospital prescription by a veterinarian visits an animal pharmacy to dispense a prescription, but the animal pharmacy is unable to supply veterinary medicine for dispensing,” adding, “The Pharmaceutical Association has sent an official letter requesting product supply to the relevant pharmaceutical company.” However, we received a response from Boehringer refusing to supply,” he said. Director Kang said, “A thorough investigation must be conducted into pharmaceutical companies that violate the Pharmaceutical Affairs Act. Starting with this complaint, we will normalize the distribution channel of veterinary medicines while continuing to take action against manufacturers that refuse to supply veterinary medicines.”
- Policy
- Reducing criminal liability for essential healthcare
- by Lee, Jeong-Hwan Oct 06, 2023 05:36am
- The ruling party proposed legislation to reduce criminal liability for doctors embroiled in medical malpractice suits while providing essential health services, and for the state and local governments to support and foster essential healthcare personnel. The legislation is in line with the Yoon Suk Yeol administration's policies to strengthen essential healthcare. With regards to how the government considers it as the biggest agenda in health and welfare, the medical community, led by the Korean Medical Association, had been consistently requesting the legislation of 'exemption of criminal liability for doctors providing essential healthcare services.’ On the 5th, Rep. Suk-Joon Hong of the People Power Party proposed the ‘Bill for the Promotion and Support of Essential Healthcare’ as representative that contained the contents above. Rep. Hong pointed out that a gap existed in protecting the lives and health of the people in Korea due to the recent lack of essential healthcare infrastructure. In particular, some essential healthcare treatment departments are facing a serious shortage of personnel, so measures to foster and support essential healthcare are urgently needed. In addition, in fields that provide essential healthcare services such as childbirth, the risk of medical accidents is relatively high, and excessive criminal punishment places an excess burden on the doctors, leading to an increase in the doctors’ avoidance of essential healthcare services. Therefore, Rep. Hong proposed a bill to encourage the national and local governments to prepare and promote policies to support and promote essential healthcare, and to reduce criminal liability for medical malpractice suits in essential healthcare under strict requirements. The bill’s main purpose is to contribute to protecting and improving public health by resolving the avoidance of practicing essential healthcare and preventing the collapse of Korea’s essential healthcare system.
- Company
- SCD accelerates EU approval of Eylea biosimilar
- by Nho, Byung Chul Oct 05, 2023 05:27am
- SCD announced on the 4th that it had decided to proceed with final negotiations after receiving confirmation of the details of the due diligence conducted for three days from September 6th to 8th by the Eylea biosimilar European partner company. Inspectors designated by the European partner company visited the SCD Eylea biosimilar CMO production site and inspected production facilities and GMP regulations for three days. As a result, it was concluded that there were no problems with the application for European EMA approval, and it was reported that the first result was confirmed on September 26th. An SCD official said, “This extension of the Binding Term Sheet deadline is not because there was a problem with due diligence or negotiations, and we have not yet received the final report on the due diligence results, so we have inevitably extended the signing of this contract.” SCD explained, “The inspectors are comprised of experts with more than 20-30 years of experience in the European EMA approval review process, so it is almost the same level as the approval inspection.” He added, “Now that all preliminary work for the contract has been completed, we will strive to achieve results within the targeted time.” In addition, it was confirmed that SCD received $3 million (approximately 40.8 billion won) in down payment related to the previous Eylea biosimilar supply contract in Canada.
- Company
- New drugs only account for 8.5% of all drug spending in KOR
- by Eo, Yun-Ho Oct 05, 2023 05:27am
- A study revealed that the expenditures spent on new drugs account for only 8.5% of Korea's total drug cost. On the 4th, the Korean Research-based Pharmaceutical Industry Association (KRPIA) released the results of 'A study on the analysis and rationalization of drug expenditures for new drugs in Korea' conducted by Professor Jong-Hyuk Lee from Chung-Ang University’s College of Pharmacy. Study results showed that the expenditures spent on new drugs from the national health insurance finances accounted for 8.5% of total drug costs and 2.1% of the total national health insurance medical costs. In particular, the financial impact made by new drugs on national health insurance finances was among the lowest when compared with other OECD countries. This study was initiated in recognition of the growing need to strengthen coverage of innovative new drug treatments for domestic patients, and how the new innovative drugs were having difficulties being listed due to the perception that they are a significant burden on health insurance finances. Professor Lee's research team examined Korea's current drug expenditure structure by analyzing the expenditures made by 227 new drugs that were listed during the past 10 years (2012-2021). More specifically, the results showed that the annual drug expenditure spent per new drug product was about KRW 6.1 billion, with the total drug expenditure spent over the past 10 years being KRW 164.2 trillion. The study also analyzed the financial impact made by new drugs according to their cost-effectiveness verification method (economic evaluation, economic evaluation exemption, weighted average price, etc.), and the proportion of expenditures spent on new drugs listed under the risk sharing agreement (RSA) system, and the financial impact of new drugs according to their serious disease classification status. In this analysis, the financial expenditures spent on items that were waived pharmacoeconomic evaluation data submissions and were subject to RSA, which account for most of the new drugs used to treat serious diseases such as cancer and rare diseases, were low at 0.3% and 2.7%, respectively, of the total drug cost. In addition, when analyzing the financial impact of new drugs according to their serious disease classification status, drug expenditures spent on new drugs for severe and rare diseases (cancer, rare diseases) were found to be only account for 3.3% of the total drug costs, suggesting the low treatment access available for domestic patients with severe and rare diseases. Professor Lee said, “The 10-year financial expenditures spent on domestic new drugs that were analyzed in our study were lower than what was previously known, confirming that their impact on finances was lower than the general perception.” He added, "In particular, new drugs that are exempt from submitting from pharmacoeconomic evaluation data, which account for the majority of new drugs being introduced recently, not only have a low financial impact, but also have a low annual drug cost per item, and the ratio of finances spent for new drugs for severe rare diseases is also low. Therefore, the expenditure structure requires some improvement in terms of improving access to treatment." Meanwhile, PhRMA (Pharmaceutical Research and Manufacturers of America) also shared its report on the international comparison of accessibility and financial impact of new drugs in each country (based on IQVIA data) of 460 global new drugs approved in the U.S., Europe, and Japan over the past 10 years (2012-2021). According to PhRMA’s analysis results on the financial impact of new drugs of each OECD country, as of 2021, Korea's financial impact of new drugs was 4%, ranking 30th out of 32 countries, the third from the last, followed by Turkey, Greece, and Mexico. Korea’s financial expenditure structure for new drugs was at a similar level. In addition, compared to major developed countries, Korea had the lowest financial expenditure ratio for new drugs, with a 3~6 times difference from major countries such as the United States stands at 26%, Germany at 19%, the United Kingdom at 18%, and Japan at 14%.
- Company
- GSK Korea appoints Maurizio Borgatta as new General Manager
- by Oct 05, 2023 05:27am
- On the 4th, GSK Korea announced it appointed Maurizio Borgatta, former General Manager of GSK Portugal as its new general manager. After joining GSK in 2015, the new GM is known to have successfully launched and sold GSK’s treatments and vaccines in the European region, including Belgium, Spain, Italy, and the UK. Also, he contributed to increasing patient access to treatments in various countries including the United States, Japan, and Germany by launching a treatment for severe eosinophilic asthma and expanding indications. Since 2021, he served as general manager of GSK Portugal, where he successfully achieved the expansion of indications for 8 innovative drugs and enabled the market entry of 2 new vaccines. He said, “With employees and executives at GSK Korea, we will strive to strengthen access to GSK's broad vaccine portfolio and other innovative treatments for Korean patients and ensure stable supply to stay ahead of disease and contribute to improving the quality of life of patients in Korea.” Rob Kempton, who led GSK Korea since 2020 until recently, was appointed Head of the Vaccines Market in Europe.
- Company
- The reimbursement process for Cosentyx and Taltz
- by Eo, Yun-Ho Oct 05, 2023 05:27am
- The insurance reimbursement registration process for IL-17A inhibitors as first-line treatment for ankylosing spondylitis has been at a standstill for a long time. As a result of the investigation, the two IL-17A inhibitors approved in Korea, Cosentyx of Novartis Korea and Taltz of Lilly Korea completed discussions on expanding the HIRA level of coverage in February, but the application has not yet been implemented. These drugs simultaneously submitted applications for reimbursement expansion based on the ‘ASAS-EULAR axSpA treatment recommendations 2022’ in July last year. Interleukin drugs are already available for prescription as first-line treatment for ankylosing spondylitis in more than 30 countries. In Korea, both drugs are approved for reimbursement only as second-line therapy after a prescription for a TNF-α inhibitor. According to the ASAS-EULAR guidelines revised last year, IL-17A inhibitors were upgraded to the same recommendation grade (A) and level of evidence (1a) as TNF-α inhibitors. It was mentioned that both agents are currently being used as first-line biological agents for the treatment of ankylosing spondylitis, and it was officially confirmed that the therapeutic positions between the two agents are the same. Additionally, in the case of TNF-α inhibitors, there are concerns about tuberculosis. For this reason, treatment for latent tuberculosis must precede the use of TNF-α inhibitors. However, despite anti-TB treatment, the occurrence of tuberculosis due to the use of TNF-α inhibitors is still reported in several studies. Therefore, for some patients who are at high risk of infection, such as tuberculosis, or who have comorbid conditions, such as heart failure, for which it is difficult to prescribe TNF-α inhibitors, other treatment options are needed. Hong Seung-jae, insurance director of the Korean Society of Rheumatology (Department of Rheumatology, Kyung Hee University Hospital), said, "IL-17A inhibitors are already widely used as first-line treatments overseas, and the 2022 overseas treatment guidelines also state that for patients with ankylosing spondylitis accompanied by skin diseases such as psoriasis, IL-17A inhibitors are already widely used as first-line treatments overseas. “As 17A inhibitors are recommended with priority over TNF-α inhibitors, we hope that coverage for IL-17A inhibitors will be expanded in Korea as soon as possible so that we can provide customized treatment tailored to patient characteristics,” he said. Meanwhile, the number of ankylosing spondylitis patients has rapidly increased by nearly 50% over the past 10 years (35,592 in 2013, 52,616 in 2022). It is a disease that mainly develops at a young age, and domestic patients go through a waiting period of about 40 months until they receive an accurate diagnosis. In addition, the disability level of ankylosing spondylitis is the highest level 2, making it a serious disease that qualifies people with severe disabilities and even exemption from military service. Among domestic ankylosing spondylitis patients, 72.6% are male, and one in two male patients are in their 30s and 40s, and are most socially active, so there are concerns about a decline in occupational ability due to symptoms. In fact, in a study targeting domestic patients, patients were absent from work due to their symptoms, and the annual cost of lost productivity time due to this was approximately 14 million won, and this increased as disease severity and functional limitations increased.
