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- 2026-03-11 14:10:35
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- Greenlight for reimbursement of ' Tepmetko'
- by Eo, Yun-Ho Mar 10, 2025 05:51am
- Product photo of Tepmetko The MET-targeted anticancer drug 'Tepmetko' has gained the greenlight to the insurance reimbursement coverage. According to industry sources, Merck Korea has agreed to the drug pricing negotiations with the National Health Insurance Service (NHIS) for its Tepmetko (tepotinib), a treatment for patients with topically advanced or metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition factor gene exon 14 (METex14) skipping mutations. The company achieved this three after obtaining domestic approval. In December 2024, Tepmetko passed the Drug Reimbursement Evaluation Committee (DREC) review of the Health Insurance Review and Assessment Service (HIRA) and has undergone drug pricing negotiations since January. Tepmetko received domestic approval in 2021 at the same time as 'Tabrecta (capmatinib),' a drug with the same mechanism of action as Tepmetko, and proceeded with the reimbursement process. Until now, no MET anticancer drugs have been listed for reimbursement in South Korea. If Tepmetko receives the final approval for reimbursement, it will be the first treatment option. The reimbursement listing process of Tepmetko has not been easy. This drug failed to set the insurance reimbursement criteria twice, including the Cancer Disease Review Committee review of the HIRA in March. Afterward, the company voluntarily withdrew from the reimbursement process and reapplied for reimbursement in July. Finally, the company gained a result this time. NSCLC accounts for 80% of all lung cancer diagnosis. METex14 skipping occurs in 3-4% of patients with NSCLC. Based on the diagnosis of 1020 patients with NSCLC in South Korea, 1.9% of patients were confirmed to have METex14 skipping. The efficacy of Tepmetko was evaluated through the VISION study, which enrolled the largest number of participants than any other clinical trials that enrolled patients with NSCLC harboring METex14 skipping mutations. The clinical results showed that patients treated with the drug had a median progression-free survival (PFS) of 15.3 months and an objective response rate (ORR) of 56.8%, demonstrating significant life extension effects. The median duration of response (DOR) was 46.4 months, and overall survival was 25.9 months, demonstrating long-term and continued anti-tumor activity. During the 2023 international conference of the Korean Association for Lung Cancer (KALC), Professor Han Ji-Youn, affiliated with the Division of Hemato-Oncology of the Center for Lung Cancer at the National Cancer Center, presented analysis outcomes of 79 Asian patients enrolled in the clinical trial for Tepmetko. Based on the results, the ORR was substantially high, with 66.7%. The second round of patients treated with the drug showed a 48.1% ORR. Meanwhile, in the Phase 3 VISION follow-up study, Tepmetko also showed significant results in analyzing Asian patients. The analysis showed that Tepmetko-treated patients had an ORR of 56.6%, a median DOR of 18.5 months, a PFS of 13.8 months, and a median OS of 25.5 months. Notably, Asian patients with no prior therapy experience had an ORR of 64.0%, reconfirming the previous study results that the drug is effective in the first round of treatment. 39.6% of patients experienced adverse reactions over Grade 3, indicating that the safety-related issue has not been found. Furthermore, Tepmetko passed the drug committees (DC) of 'Big 5' tertiary general hospitals, including Samsung Medical Center, Seoul University Hospital, Seoul St. Mary's Hospital, Asan Medical Center in Seoul, Sinchon Severance Hospital, and 30 medical centers nationwide.
- Company
- The cardiomyopathy drug 'Vyndamax' is reimbursed
- by Whang, byung-woo Mar 10, 2025 05:50am
- 'Vyndamax,' a new drug for the treatment of transthyretin amyloid cardiomyopathy, has recently been added to the insurance reimbursement list after five attempts. Three years have passed since the company initially applied for the listing. Product photo of VyndamaxConsequently, the prescription of Pfizer Korea's Vyndamax (tafamidis 61 mg) is now covered with reimbursement for the treatment of ATTR amyloidosis with cardiomyopathy (ATTR-CM). Vyndamax was approved in August 2020 in South Korea. It has finally been added to the reimbursement listing after multiple rounds of challenges. At its first attempt at reimbursement in early 2021, Vyndamax failed to receive designation as an essential medicine. After that, the economic evaluation was conducted in the first half of the same year, and a second attempt was made through the Risk Sharing Agreement (RSA) program. However, it received the same result. In April 2022, the drug had not passed the reimbursement criteria committee of the Health Insurance Review and Assessment Service (HIRA). It passed the committee review in July of the same year. However, after 9 months, it received a non-reimbursement decision from the Drug Reimbursement Evaluation Committee (DREC) review. An agreement had not been reached between the government and the pharmaceutical company regarding the RSA. After that, Pfizer re-applied for the reimbursement process in June 2024. It passed the DREC review in October of the same year and reached an agreement with the National Health Insurance Service (NHIS) last month. Vyndamax's ceiling price has been set as KRW 100,000. Vyndamax is a product that received approval after adjusting a dosage of tafamidis, the same active ingredient in Vyndaqel, a treatment of Transthyretin Familial Amyloid Polyneuropathy (TTR-FAP). Some view that the company strategized this to aim at differential drug pricing. Reimbursement news is regarded as favorable since the company finally gained listing after five attempts over 4 years. Patients now only have to pay 10% of the drug price with the special exemption coverage. Meanwhile, the efficacy of Vyndamax was demonstrated through the Phase ATTR-ACT study, which showed Vyndamax reduced the occurrence of cardiovascular-related events and improved 6 minutes walking test in CM patients. In the ATTR-ACT study, 441 patients were randomly assigned at a 2:1:2 ratio to the tafamidis 80 mg treatment group, the tafamidis 20 mg treatment group, and the placebo group. The primary endpoint was hierarchical evaluation of all-cause mortality and cardiovascular-related hospitalizations. The study's secondary endpoints were changes in the 6 minute walk test and the 'Kansas City Cardiomyopathy Questionnaire-Overall Summary (KCCQ-OS)' score, which indicates better health conditions with a higher score from the baseline up to 30 months after treatment. The study results showed that the tafamidis treatment groups had statistically lower all-cause mortality or cardiovascular-related hospitalizations compared to the placebo group.
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- Reimb approval JAKi switching can change RA treatment in KOR
- by Son, Hyung Min Mar 07, 2025 05:56am
- Yun Sung Kim, Professor of Rheumatology at Chosun University Hospital “The realistic goal for treating rheumatoid arthritis is remission, not cure. With various treatment options introduced for the disease, patients can expect good results if they start treatment by administering the right treatment for them. In particular, since switching is now allowed for oral treatment options like JAK inhibitors, this may be of great help in improving the treatment environment for rheumatoid arthritis.” Yun Sung Kim, Professor of Rheumatology at Chosun University Hospital, explained so on the changes in the treatment environment for rheumatoid arthritis at a recent meeting with Dailypharm. Rheumatoid arthritis is one autoimmune disease that occurs when immune cells invade the joints that are part of our body. In the early stages, inflammation occurs in the synovial membrane surrounding the joints, causing pain, swelling, and deformation of the surrounding cartilage and bone. Inflammation mainly affects small joints such as the fingers, wrists, toes, and ankles, and can also occur in large joints such as the knees. It is a chronic disease that lasts for several months to several years, and the continuous inflammatory reaction of the synovial membrane can damage the cartilage of the joint, eventually leading to joint destruction, deformation, and dysfunction. It is also accompanied by symptoms of fatigue, low-grade fever, and generalized musculoskeletal pain. Professor Kim said, “Rheumatoid arthritis is a disease that requires continuous control, just like diabetes or hypertension. This is why we use the word remission rather than cure. The goal is to control the disease activity through medication.” In the early stages of rheumatoid arthritis, non-steroidal anti-inflammatory drugs (NSAIDs) are used to reduce inflammation and relieve pain, and steroids can be used temporarily if the inflammation is not controlled. However, such treatment can alleviate symptoms but not reduce disease activity, so treatment with disease-modifying antirheumatic drugs (DMARDs) such as methotrexate (MTX) may be needed depending on the severity of the symptoms. Kim explained, “Early diagnosis and treatment of all diseases is important, but in the case of rheumatoid arthritis, because it invades the joints, without an early diagnosis, not only inflammation but joint deformation can also occur, causing not just symptoms but also impairment in the joint function itself.” He went on to say, “If you have symptoms of rheumatoid arthritis such as numbness in your hands and leave them untreated, the risk of cardiovascular disease also increases, and if it invades the lungs, it can also cause interstitial lung disease. This is why early diagnosis and treatment are important.” Various treatment options have emerged in the field Rheumatoid arthritis treatment is one of the areas that has seen the most progress in the last 20 years. Treatment options have expanded with the introduction of steroids, anti-rheumatic drugs, biological agents, and Janus kinase (JAK) inhibitors. Kim said, “The 2022 European Congress of Rheumatology guidelines recommend reducing the dose or increasing the interval of anti-rheumatic drug administration, but the American College of Rheumatology recommends continuing the use of anti-rheumatic drugs.” In particular, with the recent inclusion of several JAK inhibitors, such as Jyseleca, Rinvoq, and Xeljanz in the National Health Insurance (NHI) reimbursement list, patients can now use oral drugs that are less burdensome to administer than injectable biologics. Until now, switching between JAK inhibitors was not allowed, so if a patient switched from a biologic to a JAK inhibitor and found no effect, there was no alternative but to switch back to other biologic drugs. In response to the demand for the allowance of switching between JAK inhibitors from patients and medical staff, the government has approved insurance reimbursement for switching between JAK inhibitors since December, reducing the patients’ burden of switching from biological agents to JAK inhibitors. Kim said, “JAK inhibitors are being used as a second-line treatment, but I think they may be used in the first-line in the future. Rather than preferring a particular treatment among JAK inhibitors, I think their usage in general will expand.” He went on to say, “Patients’ satisfaction level is higher with oral treatments. Since anti-rheumatic drugs must be taken when administering biological agents, the medication compliance for oral agents is high. Data shows that oral agents are a little safer, which may further increase their preference with the improvement in the reimbursement environment.” Although the reimbursement environment has improved, blind spots remain Kim stressed that patients with seronegative rheumatoid arthritis antibodies are facing difficulties because they cannot receive institutional benefits. About 80% of rheumatoid arthritis patients are diagnosed as seropositive, but the remaining 20% are seronegative. These seronegative patients are not eligible for the special calculation benefit. Therefore, there are many difficulties in treating seronegative rheumatoid arthritis patients due to restrictions on their use of JAK inhibitors and biological agents. Currently, patients may receive reimbursement for their treatment if their treatment with biological agents or JAK inhibitors is insufficient even after more than 6 months of treatment. Professor Kim said, “Although switching JAK is not yet covered by insurance for various inflammatory diseases, it is very encouraging that it is covered for rheumatoid arthritis. If there is one more thing I would like to see, I would like the reimbursement standards to be eased to cover patients with seronegative rheumatoid arthritis.”
- Company
- Roche adds expertise through leadership appointments
- by Whang, byung-woo Mar 07, 2025 05:56am
- (from the left) Jinyoung Jeong, Lead of Oncology·Hematology Cluster, and Hyunmi Kim, Lead of Specialty Medicines Cluster Roche Korea is strengthening its leadership by appointing new leads to its Oncology and Hematology cluster and Specialty Medicines cluster. The company announced on the 5th that it has appointed Jinyoung Jeong as the new head of the Oncology·Hematology Cluster and Hyun-mi Kim as the new head of the Specialty Medicines Cluster. By appointing two new leaders with extensive industry experience and expertise, Roche Korea plans to strengthen its portfolio across various therapeutic areas, including solid and hematological tumors, ophthalmic diseases, and neurological diseases, and solidify its innovative medicine leadership. Jinyoung Jeong graduated from the College of Pharmacy at Seoul National University and has accumulated experience in pharmaceutical marketing at Mundipharma Korea and Pfizer Korea since 2009. Prior to her new role, she was the Lead of the Lung Cancer Diseases Area in Roche APAC, where Jeong played a leading role in designing organizational operations and portfolio strategies and maximizing synergies by strengthening cross-country collaboration. Hyun-mi Kim first entered the pharmaceutical industry in 2004 when she joined Janssen Korea after graduating from the College of Pharmacy at Seoul National University and earning a master's degree from the same university. Since then, Kim has led business growth in a wide range of fields, including blood cancer, solid cancer, immunology, and neuroscience, and has demonstrated her ability to plan business strategies and develop new businesses in global markets, including Korea, the United States, China, and the Asia-Pacific (APAC) region. Jinyoung Jeong, Lead of Oncology·Hematology Cluster at Roche Korea, said, “Based on the experience and expertise I have accumulated in Oncology at Roche Korea, I will take the lead to promptly provide innovative treatment solutions to Korean patients suffering from cancer. We will continue to prioritize the extension of patients’ lives and improvement of their quality of life, and focus on expanding treatment access.” Hyun-mi Kim, Lead of the Specialty Medicines Cluster at Roche Korea, said “I am pleased to join Roche Korea, which has been driving innovation in the industry as a a global pharmaceutical industry leader. In the Specialty Medicines area, which includes ophthalmic and neurological diseases, it is very important to address unmet patient needs and reduce the burden of disease through innovation. I will make every effort to help more patients lead healthy and happy lives.”
- Company
- SK Chemical signs a joint sales agreement with Viatris
- by Lee, Seok-Jun Mar 06, 2025 05:58am
- SK Chemicals, which developed the first natural drug for osteoarthritis in Korea, ‘Joins Tab,’ has secured additional pain medications for its portfolio. SK Chemical (CEO Jae-Hyun Ahn) announced on the 5th that it has signed a distribution and sales agreement with Viatris Korea for △Lyrica, △ Neurontin, and △ Celebrex. Under the agreement, SK Chemicals will be responsible for the distribution of the three drugs to all hospitals and marketing to hospitals and clinics with less than 300 beds. Marketing to general hospitals with more than 300 beds will be handled by Viatris Korea. △ 'Lyrica', a treatment for peripheral and central neuropathic pain △ 'Neurontin', a treatment for neuropathic pain △ 'Celebrex', an anti-inflammatory analgesic, are products whose efficacy and safety have been confirmed through various clinical studies. SK Chemicals plans to maximize synergies with its existing products, such as ‘Joins’ and ‘Ultracet,’ by expanding its lineup of pain treatment products through this agreement. In the case of the osteoarthritis treatment drug, Joins, which is SK Chemicals' representative pain medication, and the non-narcotic anti-inflammatory analgesic drug, Ultracet, which is exclusively sold by SK Chemicals, the two are actively used in combination with the three Viatris products, so the collaboration is expected to bring synergy between the products. Hyunsun Park, Head of the Pharma Business at SK Chemicals, said, “The introduction of Lyrica, Neurontin, and Celebrex will provide patients and medical staff with a wider range of effective pain treatment options. We will continue to secure new pipelines that are highly linked to existing businesses and strengthen our expertise in specialized markets such as pain treatments.”
- Company
- Vyndamax is reimbursed for ATTR-CM in Korea
- by Whang, byung-woo Mar 06, 2025 05:58am
- Pic of Vyndamax Pfizer Korea announced on the 5th that its Vyndamax (tafamidis), a treatment for wild-type or hereditary transthyretin amyloidosis cardiomyopathy (ATTR-CM), has been granted reimbursement by Korea’s National Health Insurance. ATTR-CM is a progressive rare disease in which the naturally circulating transport protein in the blood, transthyretin (TTR), becomes unstable and separates into misfolded monomers, which accumulate in the heart and cause restrictive cardiomyopathy. According to this announcement, Vyndamax may be prescribed with reimbursement in adult patients aged 18 or older who have been diagnosed with hereditary ATTR-CM. Also, wild-type patients who satisfy all of the following conditions may receive the drug with reimbursement: those who ▲are Class I-III in the New York Heart Association (NYHA) heart failure severity classification for the last six months, ▲have received a diagnosis of heart failure and a history of one or more hospitalizations due to heart failure within the last six months, ▲has 600 pg/mL or higher level of pro-B-type natriuretic peptide (NT-proBNP, N-terminal pro-B-type natriuretic peptide level), and ▲have a left ventricular wall thickness at the end of diastole that is 12 mm or more. Vyndamax, which is the first and only approved treatment for adult patients with ATTR-CM in Korea, has secured clinical evidence through the ATTR-ACT study and the ATTR-ACT LTE study. In the ATTR-ACT study, which was conducted to compare the efficacy and safety of Vyndamax and placebo in 441 ATTR-CM patients, about 71% of patients in the tafamidis meglumine group were alive at the 30-month follow-up, showing improved survival compared to the placebo group (about 57%). It also reduced the relative risk of heart-related hospitalizations (0.48/year) by 32% compared to placebo (0.70/year) (95% confidence interval, 0.56-0.81). In addition, according to the results of the ATTR-CM LTE trial, which analyzed long-term survival rates of patients, the patient group that continued to receive tafamidis meglumine showed a reduction in all-cause mortality compared to the patient group that switched from placebo to tafamidis meglumine. Ji-Eun Lee, Head of the Specialty Care Business Unit at Pfizer Korea, said, ” We are pleased to be able to improve the access to treatment for our ATTR-CM patients who have had difficulty using the treatment due to financial constraints despite the availability of this option rather than heart and liver transplantation. We will continue to work to provide innovative treatments to patients with rare diseases, including ATTR-CM, and improve the treatment environment.”
- Company
- Novo Nordisk Korea appoints Kasper Roseeuw Poulsen as new GM
- by Whang, byung-woo Mar 06, 2025 05:58am
- Kasper Roseeuw Poulsen, Novo Nordisk Korea On March 5, Novo Nordisk Korea announced the appointment of Kasper Roseeuw Poulsen as the new General Manager starting March 2025. The new GM Kasper Roseeuw Poulsen joined Novo Nordisk in 2006 and served key roles in finance, strategy, organizational development, commercial partnership, and management across Europe, South America, and Asia-Pacific. Kasper Roseeuw Poulsen holds a bachelor's degree in Business Administration and a master's degree in Finance & International Business from Aarhus University's School of Business, Denmark. Until recently, he served as Vice President of Finance and Operations for Novo Nordisk's APAC region, overseeing more than 20 countries. Before that, he demonstrated outstanding strategy and executive ability as Vice President of a subsidiary in China. Kasper Roseeuw Poulsen said, "South Korea is a key market in the APAC region and a leading country for healthcare optimized for innovative medical settings. I'm excited to lead Novo Nordisk Korea." "By establishing closer partnerships with healthcare professionals and key healthcare partners in South Korea, we will strive to provide better benefits for patients based on Novo Nordisk's leadership in chronic diseases," he said. Meanwhile, the former GM Sasha Semienchuk was promoted to CVP Marketing in Novo Nordisk's subsidiary in China and will oversee commercial activities across the Chinese mainland. Since his appointment as Novo Nordisk Korea's GM in October 2022, Sasha Semienchuk had executed Novo Nordisk's patient-centered corporate value in the APAC region with his outstanding leadership. Sasha Semienchuk led the supply of products, such as Wegovy, for various treatment areas and fostered a corporate culture that embraces mutual growth between the company and its employees. He made significant contributions at Novo Nordisk, which earned international recognition as a 'Great Place to Work' and 'Best Workplace for Women' in two consecutive years.
- Company
- Pfizer launches JAK inhibitor for severe alopecia areata
- by Whang, byung-woo Mar 06, 2025 05:58am
- Pfizer Korea will launch a new Janus kinase (JAK) inhibitor treatment Litfulo (ritlecitinib tosilate), and set to challenge the market for severe alopecia areata. Previously launched Olumiant (baricitinib), the first drug approved in South Korea for treating adult patients with severe alopecia areata, has already settled in the market. The company will likely promote Litfulo's broader indication to treat adolescents over 12 years of age. Dr. Chong Hyun Won, Professor in the Department of Dermatology at Asan Medical Center in SeoulOn March 5, Pfizer Korea hosted a press conference celebrating the launch of the severe alopecia areata treatment Litfulo. The company highlighted the clinical significance of the drug. Litfulo is the first drug among alopecia areata treatments in South Korea to obtain approval for use in adolescent patients. Alopecia areata is an autoimmune disease that causes hair loss in the scalp, face, and body in patches or complete loss of hair. It is an inflammatory and immune-mediated disease caused by the immune system attacking the body's hair follicles, leading to hair loss. In South Korea, the number of patients treated for alopecia areata showed an increasing trend for the past 10 years, recording 154,380 patients in 2013 and 178,009 patients in 2023. In most cases, alopecia areata without severe symptoms naturally recover and respond well to treatments. However, it has a high relapse rate, with about 40-80% of patients experiencing relapse within a year. Dr. Chong Hyun Won, Professor in the Department of Dermatology at Asan Medical Center in Seoul, who attended the press conference, said, "About 100% of the patients with alopecia areata experience relapse within 20 years, so the disease has a high recurrence rate." Dr. Won explained, "It causes a substantial psychological burden on patients and is closely associated with mental health issues, such as depression, affecting the quality of life greatly." However, the introduction of JAK inhibitors like Litfulo has changed the treatment settings. Previously, severe alopecia areata was treated with corticosteroids or cyclosporine. Analysis suggests that aggressive treatment is possible after the introduction of a new option. "The launch of the new treatment provides hope for patients with unmet needs who suffered for a long time from alopecia areata. It is also meaningful to doctors, considering that a safe new option is now available," Dr. Won said. The basis of approval for Litfulo was the global clinical study Phase 2b/3 ALLEGRO. The analysis results evaluating the primary endpoint, the patient ratio with a Severity of Alopecia Tool (SALT) score of 20 or below, showed that at week 24, 23% of the patient group had a SALT score less than 20, which was statistically significant treatment effectiveness compared to a 2% in the placebo group. At week 48, the treatment group with a SALT score less than 20 was 43%, confirming significant treatment effectiveness than the placebo group (10%). This indicates that effectiveness increased over time. (from left) Dr. Chong Hyun Won, Professor in the Department of Dermatology at Asan Medical Center in Seoul, and SungBum Jung, Chief Medical Affairs at Pfizer When Olumiant was launched earlier, the alopecia areata had high unmet needs despite its non-reimbursed indication. It was evaluated that a higher-than-expected number of patients are opting for treatment. In other words, since Olumiant already dominates the market, the company must strategize to promote Litfulo. The most significant difference is the mechanism and indication. Unlike Olumiant, which targets JAK1 and 2, Litfulo primarily targets JAK3. Also, Olumiant is used for adults aged 18 and older, whereas Lifulo is used to treat adolescents aged 12 years and above. Dr. Won commented regarding this, "As of 2023, adolescents account for about 10% of the patients with alopecia areata, and the number can be lower with severity. However, the drug presents significance considering that earlier occurrence of alopecia areata may require longer treatment and has poor prognosis when relapse." Furthermore, Dr. Won mentioned that it is too early to determine drug switching between existing treatments and new treatments. "As drug switching requires the analysis of drug's effects and safety, a clear answer is not available at this point," he said. "We need confirmation of which patients can be better treated with existing treatment with longer safety."
- Company
- "COVID-19 response has changed to protect high risk groups"
- by Whang, byung-woo Mar 05, 2025 06:01am
- As COVID-19 transitioned to the endemic phase, an important issue has arisen regarding 'how' to prevent and respond to the disease, unlike the initial period focused only on response. One of the big changes was the reimbursement of treatments. On October 25, 2024, The Ministry of Health and Welfare (MOHW) approved the National Health Insurance reimbursement of the COVID-19 treatments, Veklury and Paxlovid. Based on the demands of clinical settings, the government aims to provide a stable supply of COVID-19 treatments to patients through the National Health Insurance system. In another point of view regarding infectious disease management in the endemic period, experts are highlighting the need to revisit the discussion of 'SARS-CoV-2,' which is one of the respiratory viruses other than COVID-19. Essy Mozaffari, Gilead Sciences Medical AffairsDuring the meeting with Daily Pharm, Essy Mozaffari, affiliated with the Gilead Sciences Medical Affairs, emphasized the role of antiviral therapy in protecting immune-compromised individuals and high-risk patients. In February 2020, the WHO officially announced the name for COVID-19, and at the same time, it assigned the name SARS-CoV-2 to the virus. It means that corona 19 (COVID-19) is typically used when discussing symptoms, whereas the SARS-CoV-2 virus causes the infection. Medical Affairs Mozaffari (hereafter, MA) said, "At the current endemic phase, it is crucial that we discuss SARS-CoV-2 infection rather than using the term COVID-19," adding that, "If SARS-CoV-2 is used to describe the virus, it will help remind that it is a virus that can make people ill every year." The latest COVID-19 responses have focused on immune-compromised individuals and high-risk patient groups, who can be relatively vulnerable to a disease. The approach has been limiting the spread of the disease through immunization and providing treatments to infected individuals in a timely manner. For instance, the COVID-19 treatment Veklury (remdesivir) is the first antiviral agent to receive approval from the U.S. FDA for the treatment of hospitalized adult patients with COVID-19. Veklury is now recommended as the standard therapy for adults and children who are hospitalized due to SARS-CoV-2 infection. Also, it is recommended for use in non-hospitalized patients with mild and moderate symptoms who are at risk of advancing to severe COVID-19. MA Mozaffari stated, "Although there are many antiviral therapies, Veklury has low drug interaction, so it is an important treatment option for patients who must take other medicines. Patients who have liver and spleen dysfunction can use the therapy without adjusting the dosage." "Veklury with real-world evidence demonstrated effects in high-risk patient group" MA Mozaffari particularly highlighted that Veklury has proven real-world evidence (RWE) in hospitalized patients due to COVID-19. "The Phase 3 PINETREE trial involving high-risk non-hospitalized patients infected with SARS-CoV-2 has shown that administering Veklury for three days decreased the hospitalization risk," MA Mozaffari said. "The recent real-world data (RWD) confirmed that the use of Veklury in the high-risk patient group, including immune-compromised individuals and older patients aged 65 and above, significantly lowered the death risk compared to the control group in all mutation periods. MA Mozaffari views that proper management of infection through treatments can benefit the efficient management of the medical healthcare system as medical healthcare system resources are being spent on managing immune-compromised individuals. "COVID-19 infection causes a significant burden to the medical healthcare system consistently, and it poses a risk of disease progression and death in older people aged 65 and above," MA Mozaffari said. "Antiviral therapies with proven treatment effects for various COVID-19 mutations will play a crucial role in future COVID-19 treatments." Now, Gilead Sciences is conducting research on the potential use of Veklury in a particular patient group with unmet needs for COVID-19 treatments. The company is evaluating the effects of Veklury treatment in new mutations as COVID-19 vaccines target changes. "Based on trial results so far, Veklury continued to maintain treatment effects on all mutations, including omicron sub-variants. Notably, there have been no key genetic changes affecting targeted RNA polymerase of the virus," MA Mozaffari explained. The results indicate that mutations to the virus will not cause significant changes to RNA structure and function, so the therapy can continue to work effectively," MA Mozaffari analyses. Lastly, MA Mozaffari mentioned the concern for effective responses amid COVID-19 settling down as an endemic disease. "COVID-19 is now transitioned to endemic disease, but SARS-CoV-2 continues to pose significant health risk worldwide," MA Mozaffari said. "The government, researchers, doctors, and individuals must strive to maintain the infection rate low and stay alert to respond to new mutations effectively."
- Company
- Ocrevus is reimbursed for relapsing multiple sclerosis
- by Whang, byung-woo Mar 05, 2025 06:00am
- Pic of Ocrevus On March 4, Roche Korea announced that its multiple sclerosis treatment drug Ocrevus (ocrelizumab) will be reimbursed by Korea’s National Health Insurance from March 1. According to the new announcement, Ocrevus will be covered as a monotherapy for patients with relapsing multiple sclerosis, which includes ▲patients with relapsing-remitting multiple sclerosis (RRMS) who are ambulatory and have failed or had insufficient response to first-line treatment (e.g., interferon beta-1b) and ▲patients with secondary progressive multiple sclerosis (SPMS). As a result, Ocrevus will be reimbursed for the relapsing-remitting type as a second-line treatment and the secondary progressive type as a first-line treatment. Relapsing multiple sclerosis (RMS) includes both relapsing-remitting and secondary progressive multiple sclerosis. Relapsing-remitting multiple sclerosis (RRMS) is the most common type of multiple sclerosis. The reimbursement application of Ocrevus was based on a wealth of clinical evidence on its utility, including the results of large-scale global Phase III clinical trial OPERA I & II and the 10-year analysis of the open-label extension study in patients with relapsing multiple sclerosis. In the OPERA I & II studies, the Ocrevus group showed a 40% improvement in the risk of confirmed disability progression (CDP) compared to the control group over 12 weeks and maintained a consistent effect over 24 weeks. The annual recurrence rate (ARR) was reduced by nearly half compared to the control group, and the average number of brain lesions per MRI scan was also significantly improved, confirming clinical efficacy. The clinical efficacy of Ocrevus was maintained even after 10 years of dosing. A 10-year follow-up analysis conducted in the open-label extension study of OPERA I & II showed that the Ocrevus-treated group achieved a steady decline in ARR over 10 years, with the 10-year ARR (0.017) being equivalent to approximately 1 relapse in 60 years. In particular, in both clinical studies, patients who received early treatment with Ocrevus in the early stages of the clinical trial showed more effective disease progression control and lower risk of disability compared to patients who started treatment later. No new adverse reactions or unexpected side effects were observed in patients who received Ocrevus for 10 years, confirming an overall favorable safety profile. “Recently, treatment for multiple sclerosis has been shifting to a strong initial treatment strategy that actively prevents disability by using high-potency drugs from the early stages,” said Professor Ho-jin Kim of the Department of Neurology at the National Cancer Center. ”With the reimbursement of Ocrevus increasing the treatment options, more patients can effectively prevent disease progression and disability from the early stages, ultimately improving treatment outcomes.” “Ocrevus, which has risen to record number one in global drug sales at Roche, is a representative multiple sclerosis treatment that has benefited more than 350,000 patients worldwide,” said Ezat Azem, General Manager of Roche Korea. “We expect that the reimbursement application will strengthen the accessibility of treatment for patients with relapsing multiple sclerosis in Korea and provide more patients with the therapeutic benefits of Ocrevus, which have been confirmed through a large number of clinical data and prescription experiences.” Meanwhile, in Korea, Ocrevus was approved by the Ministry of Food and Drug Safety in May 2024 for two types of patients: relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS).
