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- 2026-04-21 07:56:07
- InterView
- "High hopes for reimbursed Ilaris…a new treatment option"
- by Whang, byung-woo Feb 05, 2025 05:52am
- The Hereditary Periodic Fever (HPF) syndromes cause not just fever and pain but affect various aspects, such as patient's growth and development, psychological elements. The reimbursement coverage of a new treatment in nine years has increased patient satisfaction." Clinical practices have high hopes for changes to the treatment setting as Ilaris (canakinumab), a treatment for Hereditary Periodic Fever (HPF) syndromes, passed the reimbursement hurdle nine years after approval. Although doctors still face difficulties finding the appropriate dosage, analysis suggests that reimbursement will solve unmet needs for ultra-rare disease treatment where treatment options have been limited. Experts believe that systematic improvements are needed to overcome the limitations, such as genetic testing, in the long term. Dr. Soyoung Lee, Professor of Pediatric & Adolescent Medicine at Hallym University Sacred Heart HospitalDaily Pharm met with Dr. Soyoung Lee, a Professor of Pediatric & Adolescent Medicine at Hallym University Sacred Heart Hospital, with years of prescribing experience, and heard about changes to HPF syndrome treatment settings following reimbursement coverage of Ilaris. The HPF syndromes are rare autoinflammatory diseases that occur shortly after birth or in childhood. Unexplained and periodic episodes of full body fever and rashes characterize these diseases. The HPF syndromes are categorized into various disorders based on abnormal genes. Symptoms such as fever and rashes most commonly occur, but other symptoms vary by disorder. "In my opinion, it is more suitable to call this disorder periodic fever syndromes (PFS) rather than the HPF syndromes," Dr. Lee said. "In contrast to other autoimmune diseases, these disorders are categorized as autoinflammatory disorders. A single gene causes some of these disorders, whereas several genes are indicated to contribute to the disorder," Dr. Lee explained. In South Korea, common cases include Cryopyrin-Associated Periodic Syndrome (CAPS), Familial Mediterranean Fever (FMF), Tumor Necrosis Factor Receptor-Associated Periodic Syndrome (TRAPS), and Hyper IgD Syndrome (HIDS). These disorders are all single-gene disorders. According to Dr. Lee, the most common treatments for these disorders include nonsteroidal anti-inflammatory drugs (NSAIDs) and steroids to alleviate pain and fever. "In 2010, the introduction of the IL-1 inhibitor Anakinra allowed for the replacement of steroids, enabling most patients to discontinue unnecessary medications. However, since the injection had to be administered daily at a fixed time, patients faced significant challenges," Dr. Lee remarked. "Typically, the dosage of the medication must be increased depending on the severity of the disease/ Because of the limitation of dosage that can be administered at a single injection, patients often suffer serious pain, and the other problem is that the required dosage required two separate injections," Dr. Lee stated. In other words, Dr. Lee says that existing treatments had limitations in terms of long-term effects and patient quality of life despite the nature of HPF syndromes in affecting various aspects, such as patient's growth and development, psychological elements, and causing fever and pain. "Reimbursed Ilaris provides benefits in terms of treatment effects‧administration interval" Changes to the treatment setting have been apparent since August of last year, following reimbursement coverage of Ilaris for CAPS, TRAPS, and FMF." What changes have been made to the treatment setting with reimbursed Ilaris? Dr. Lee says only few cases can be compared because it is a rare disease, but reimbursed Ilaris provided significant benefits in symptom improvements and improved patient quality of life. "As patients switch to Ilaris based on insurance criteria, there have been no cases where patients gave up treatment despite the process being tough finding the appropriate dosage after starting with a low dosage," Dr. Lee said. "Since the administration interval is longer than the other treatments, patients can now be treated with more freedom." "Additionally, patients can get injections at the hospital, so they are now freed from the burden of being injected at home by non-experts," Dr. Lee added. "The half-life of Ilaris is about 26 days, which minimizes the burden of drug administration time. Consequently, Ilaris provides a crucial turning point for patients." While reimbursed Ilaris provides various benefits, the remaining issues are the dosage and managing side effects due to the longer administration interval. Depending on the type of HPF syndromes, Ilrais is given every 8 weeks or 4 weeks. Doctors are concerned about dosage adjustment or symptom management if symptoms occur during treatment. "The process of determining the appropriate dosage was not easy, but all five patients currently undergoing treatment have found their optimal dose and are continuing treatment stably," Dr. Lee said. "Although it has been just over four months since starting Ilaris, we now have more flexibility in adjusting the dosage for the next cycle while closely monitoring weight gain and symptoms." Adjusting treatment dosage remains a challenge…"We must consider a patient-customized treatment" Yet, another challenge is to help patients with HPF syndromes to receive reimbursement coverage. "Currently, Ilaris can only be used if a patient's genetic mutation is confirmed. However, genetic testing fails to provide a diagnosis in up to 40% of cases." Dr. Lee added, "According to foreign studies, despite advancements in genetic analysis technology, 20–30% of cases still rely solely on clinical diagnosis to initiate treatment, highlighting the need for further discussion on this issue." "Because the starting dosage is set too low, patients face challenges finding appropriate dosage. If the system is improved so that dosages can be flexibly determined under the doctor's supervision, patient-customized treatment will offer better treatment settings," Dr. Lee mentioned. Ultimately, Dr. Lee highlights the need for efforts to improve the diagnostic rate of the HPF syndromes, which is a rare disease, in the long term. "The number of patients with CAPS is recorded to be 2 plus 3 in 2022, but more undiagnosed patients likely exist," Dr. Lee said. "To provide more accurate and professional information, we hope academic organizations provide educational sessions for doctors interested in this field." Dr. Lee added, "Genetic testing is an important tool for diagnosing (very) rare diseases, but its usefulness assessment varies by how it is used. "In my opinion, it is more effective to conduct genetic testing only when doctors determine it is necessary, after thoroughly evaluating the patient's symptoms and diagnostic course."
- InterView
- Approval called for drug switching in atopic dermatitis
- by Whang, byung-woo Jan 24, 2025 05:51am
- Atopic dermatitis treatment settings are changing quickly. New treatment options are available as new drugs with fewer side effects and superior treatment effectiveness than existing therapies emerge. There is a growing interest in how atopic dermatitis can be treated rather than just treating it, as changes have been brought to the treatment paradigm. According to health experts, considering many factors contibute to the nature of atopic dermatitis, even if the same medication is used, the treatment effects may vary by patient. Dr. Yang Won Lee, Professor in the Department of Dermatology at Konkuk University Medical Center, who has the latest expertise in this field stresses, the importance of treatment choice based on potential treatment effects and side effects and the need for improvement to the system. "New drugs for atopic dermatitis have shifted the treatment paradigm" Dr. Lee says the most significant change he has experienced following the introduction of new drugs for atopic dermatitis is the treatment effects and patient awareness. Dr. Yang Won Lee, Professor in the Department of Dermatology at Konkuk University Medical Center"In the past, patients were reluctant to receive therapy or even avoid getting one because of the notion that atopic dermatitis treatment is not efficacious and long-term steroid therapy may result in side effects. However, the launch of biological agents and targeted therapies such as JAK inhibitors have changed the care settings," Dr. Lee says. New drugs for atopic dermatitis are good news because treatment effects vary greatly depending on the patient's sensitivity. "Atopic dermatitis is a multifactorial disease where it is not affected by just a single factor but caused by various contributing factors, such as genetic factors, skin barrier issues, and dysfunctional immune responses," Dr. Lee stated. "Due to varying patient sensitivity, even if the same medication is used, patients may experience varying treatment effects." For instance, it means that even if biological agents or JAK inhibitors of the same class are used, patient treatment can differ depending on the mechanism. More treatment options became available this year and will likely change the treatment setting. On January 9, Lily Korea's Ebglyss (ingredient name: lebrikizumab), used to treat moderate to severe atopic dermatitis, was launched. Ebglyss was launched six months after obtaining approval from the Ministry of Food and Drug Safety (MFDS) in August 2024. It is a new biologic treatment that selectively blocks interleukin (IL)-13. The efficacy and safety profile of Ebglyss have been confirmed in the Phase 3 clinical trials. Once a patient meets the clinical response after 16 weeks treatment, the drug can be administered every 4 weeks with a maintenance dose (250 mg). Dr. Lee focused on fewer side effects associated with Ebglyss compared to conventional therapies. "While long-term use of cyclosporine or steroids can lead to various side effects, Ebglyss, a biological treatment, is relatively free from such concerns in terms of side effects. It has the advantage of long-term prescriptions and greater efficacy than existing treatments," Dr. Lee says. The basis of approval for Ebglyss was ADvocate-1 and ADvocate-2 Phase 3 studies. According to the results, the most common adverse reactions are conjunctivitis (6.9%), injection site reactions (2.6%), allergic conjunctivitis (1.8%), and dry eye (1.4%). Although dupilumab, a representative treatment for atopic dermatitis, is effective, some patients may experience side effects, including worsening conjunctivitis or facial and neck dermatitis. Therefore, therapies like Ebglyss are seen as potential alternatives. "Compared to dupilumab, Ebglyss shows a relatively lower frequency and severity of side effects such as conjunctivitis or facial and neck dermatitis," Dr. Lee said. "Additionally, if clinical response is achieved, Ebglyss can be administered monthly after 16 weeks. If the efficacy and side effects are comparable, drug adherence can be considered to reduce patient burden." Switching drugs for atopic dermatitis treatment has limitations…"We must provide broader range of treatment options to provide patient-customized treatments" However, there are challenges to overcome to achieve this. The remaining issue is a 'drug switching' between treatments. Last year, the Korean Atopic Dermatitis Association (KADA) submitted a statement to the health authority illustrating that drug switching should be allowed in the field of atopic dermatitis. The government is reviewing this matter, but it is expected to take time. The reimbursement criteria for special cases of atopic dermatitis patients switching treatments are complicated. For example, if patients transition from a biological therapy to a JAK inhibitor, they must meet complicated eligibility requirements from the beginning. Similarly, the same applies when switching from a JAK inhibitor to a biological therapy. "Patients often feel discomfort from the side effects of their current treatments, but due to the reimbursement requirements, which mandate waiting periods of three to four months, they often give up on switching therapies," Dr. Lee explained. "Meeting these conditions is burdensome, leaving patients in a situation where they must continue treatments despite experiencing side effects." "From the patient's perspective, having a broader range of treatment options is essential, and from the doctor's perspective, it is crucial to have multiple tools to combat a disease like atopic dermatitis. Therefore, the drug switching is vital," Dr. Lee emphasized. "If drug switching becomes more accessible, doctors will have a wider range of options for treatment, and patients can look forward to achieving better therapeutic outcomes." Dr. Lee particularly mentioned that if drug switching for atopic dermatitis is approved, the treatment options among drug types and the number of limitations must be discussed. "Patients who do not respond to existing treatments should be able to switch medications immediately. They should be able to choose from the same drug type, such as a biological agent or JAK inhibitor," Dr. Lee says. "In my opinion, not limiting the number of possible drug switching will broaden the range of treatments." "Drug switching is permitted for psoriasis, which is the same inflammatory skin disease. However, unlike psoriasis, atopic dermatitis is significantly limited. Like psoriasis, the treatment setting for atopic dermatitis should improve quickly," Dr. Lee said. Ultimately, Dr. Lee advised actively treating atopic dermatitis with a wider range of treatment options. "In the past, patients treated for atopic dermatitis often experienced several side effects or did not fully benefit from their treatment. However, new drugs provide opportunities for patients. Because many opportunities are open for patients with severe disease who need treatment, we hope patients will participate in getting treatment," Dr. Lee said.
- InterView
- "Reimb granted to drug switching between JAK inhibitors"
- by Son, Hyung Min Dec 26, 2024 05:50am
- Dr. Seung-Jae Hong, a Professor in the Department of Rheumatology at Kyung Hee University Medical Center "Until now, drug switching between JAK inhibitors has not been reimbursed, so there have been unmet patient needs for rheumatoid arthritis patients who do not benefit from conventional biological agents. As reimbursement for drug switching will be granted starting in December, patients will be less burdened by switching from biological agents to JAK inhibitors. Also, patients will no longer resort to treatments they do not benefit from. The reimbursement approval will significantly change the treatment landscape for rheumatoid arthritis." Dr. Seung-Jae Hong, a Professor in the Department of Rheumatology at Kyung Hee University Medical Center, remarked on changes to the treatment landscape for rheumatoid arthritis during a recent meeting with Daily Pharm. Rheumatoid arthritis treatments are one of the fields that accomplished the most advances in the past 20 years. Treatment options for patients have broadened after the introduction of steroids, anti-rheumatic drugs, biological agents, and Janus Kinase (JAK) inhibitors. Since drug switching was not approved for reimbursement, patients required to switch from biological agents to JAK inhibitors had to revert to biological agents if the switch was ineffective. As patients and doctors demanded drug switching, the government granted approval of insurance reimbursement for drug switching between JAK inhibitors; starting in December, patients will be less burdened by switching from biological agents to JAP inhibitors. "At the early stage, nonsteroidal anti-inflammatory drugs (NSAIDs) can be used to suppress inflammation and reduce pain. Steroids can then be temporarily used if inflammation is not controlled. However, such a treatment regimen can reduce the alleviation of symptoms but does not lower disease activation. As a result, treatments using disease-modifying antirheumatic drugs (DMARDs), such as methotrexate (MTX), may be necessary," Dr. Hong said. "If sufficient treatment effects are not observed within several months, targeted treatments such as biological agents or JAK inhibitors can be used. Such targeted treatment works by suppressing substances that induce inflammation in rheumatoid arthritis or targeting the signaling pathways of inflammatory substances. The targeted treatments can reduce side effects, while high treatment effects can be expected. This is why switching medications is necessary for treating rheumatoid arthritis," Dr. Hong said. Rheumatoid arthritis is an autoimmune disease caused by immune cells attacking the joints, which are part of our own body. At the early stage of the disease, inflammation occurs in the tissue lining of joints, causing pain, swelling, and deformities in surrounding bones and cartilage. Inflammation primarily affects small joints such as the fingers, wrists, toes, and ankles but can also involve larger joints like the knees. As a chronic disease that progresses over months or years, persistent inflammation of the tissue lining of joints can lead to cartilage damage, causing joint destruction, deformation, and functional disability. Symptoms such as fatigue, low-grade fever, and generalized musculoskeletal pain are often accompanied. However, among patients treated with biological agents, only 56.5% achieve remission or a low disease activity state within the first year of treatment. Furthermore, 43.5% of rheumatoid arthritis patients treated with existing therapies fail to reach remission. Many patients reaching remission still have severe pain, indicating a significant unmet need for medications that can effectively improve both remission rates and pain management. "Rheumatoid arthritis is a condition that causes deformities in finger joints. Patients with such deformities often find it difficult to grasp and self-administer injectables. In one case, we prescribed an oral JAK inhibitor to a patient, but since the medication was not effective enough, we needed to switch back to an injectable. However, the patient refused and chose to continue with the oral medication instead," Dr. Hongexplained. "Oral medications are a good option for patients who fear injections and are also beneficial for those who frequently travel or go on business trips. While there are differences among medications, clinical research data indicates that oral therapies demonstrate high 'remission' rates, defined as a state with minimal symptoms, and are effective in improving morning stiffness, pain, and fatigue, offering significant benefits to patients," Dr. Hong added. Establishing patient-centered treatment landscape…"Supportive policies are needed" With drug switching between JAK inhibitors now granted reimbursement, effective treatments like Rinvoq may be quickly adopted in clinical practice. Dr. Hong remarks that doctors previously reserved highly effective therapies before drug switching approval, but due to changes in insurance reimbursement policy, this approach is no longer necessary. "Several argued that Rinvoq should be used as a second-line treatment because of its significant efficacy, but this was when drug switching was not possible, and only one JAK inhibitor was available. Now that drug switching is approved among multiple medications, there’s no reason to use a specific medication for later treatment. When medication changes are needed due to ineffectiveness, doctors prioritize choosing the most effective treatment first," Dr. Hong stated. Rinvoq, whether used as a monotherapy or combined with existing DMARDs, has demonstrated superior clinical remission and low disease activity rates compared to placebo, MTX, or the biologic adalimumab (product name: Humira). Additionally, Rinvoq's SELECT-BEYOND study, targeting patients with inadequate responses to biologic therapies, confirmed that patients maintained physical function while improving symptoms such as pain, fatigue, and morning stiffness in patient-reported outcomes (PRO) at Week 12. Dr. Hong shared that it is important to utilize available treatments, as new drugs are no longer being introduced. An education course may be necessary to enhance patient compliance. "Untreated rheumatoid arthritis can lead to disability, and the government may have to provide a lifelong support for patients with disability. By preventing disabilities, significant social costs that the government has to be responsible for patient support can be reduced. This is why doctors emphasize early diagnosis and treatment," Dr. Hong said. "Doctors have to care for patients, but having patients manage their diseases is also important. Education allows patients to enhance disease-management skills." However, education costs are not covered for rheumatoid arthritis. The government must provide education cost coverage to reduce social costs," Dr. Hong stated. "The pain mechanism and joint-destruction mechanism differ for rheumatoid arthritis, but patients simply associate the disease with joint pains. Patients who are young children or elderlies may not understand well, so an education session must be conducted for both patients and caregivers," Dr. Hong emphasized.
- InterView
- ‘New start at a law firm…will become a trusted expert’
- by Kim, Jin-Gu Dec 13, 2024 05:52am
- Expert Advisors Jung-Eun Kim (left) and Sol Kim (right) recently joined Shin & Kim The role of law firms has greatly expanded in the pharmaceutical bio and healthcare sectors recently. Whereas law firms used to provide piecemeal legal services in the past, law firms have now been providing comprehensive services over a long period of time, covering the whole course of a drug’s journey from pre-approval to reimbursement. As such, many talents in the pharma and biotech industry have been heading to law firms. This is the case with Sol Kim(35) and Jung-Eun Kim (34), who joined Shin & Kim's Healthcare team this year. “I want to become a trusted expert for the clients,” they said. Expert advisors from pharmaceutical companies and HIRA joint Shin&Kim Healthcare Team Sol Kim and Jung-Eun Kim Kim joined Shin & Kim's Healthcare Team in June and September of this year, respectively. Sol Kim was previously in charge of insurance drug pricing at the Korean subsidiaries of multinational pharmaceutical companies such as Pfizer Korea, AstraZeneca Korea, and BMS Korea. Before joining the firm, Jung-Eun Kim worked for over 6 years at the Health Insurance Review and Assessment Service, where she was responsible for evaluating drug reimbursement adequacy. The two pointed to the scope of their work as the biggest difference between their new jobs at the law firm. Whereas in their previous jobs, they were able to delve deeply into a relatively narrow scope of work, they said, their work at law firms requires them to be creative across a much wider range of areas. “The scope of collaboration is much larger at the firm, so you can be creative without being limited to a specific area,” says Sol Kim. ”In the past, when working in government affairs, I used to wonder about the government’s perspective. Here, there are many lawyers, advisors, and expert advisors from government and public organizations, which is very helpful.” For Jung-Eun Kim, a former HIRA member, the change is even greater. “When I was in HIRA, I only looked at the drugs I was in charge of. Here, I experience everything that happens before a drug enters the insurance landscape. I didn't realize how much work goes into the process, and it has broadened my perspective.” Deciding to join a law firm took a lot of thought...“The value of working for the patients remains constant” Both advisors had many concerns before joining the law firm. They explained how they contemplated the role of law firms in the pharma-bio-healthcare sector, why they wanted to join a law firm, and what they could do at a law firm. “No matter where you work, you work for patients,” was the conclusion made by both advisors. In addition, having the opportunity to be more proactively involved in pharmaceutical affairs in a much broader scope at a law firm was attractive. “I thought a lot about what I could do in a law firm,” said Sol Kim. ”After thinking about it, I concluded that it doesn't matter where you work, in drug pricing or others, as you’re still working for patients, and I think there's a lot more you can do in a law firm as Korea’s reimbursement regulations are becoming more and more demanding.” Jung-Eun Kim also said, “At HIRA, I was in charge of objectively looking at drug prices based on pharmacoeconomic evaluation results. Rather than just imposing price cuts, I had been reviewing the appropriate price. The same is true here. As the drugs come into our country the exchange rate changes. The same applies here, in that we want to make sure that these drugs come into Korea and are available to patients at the right price.” “Will become an ‘expert’ who trusts clients...will grow together with Shin & Kim's Healthcare Team” Both members emphasized their desire to grow with Shin & Kim’s Healthcare Team. With the addition of the 2 members, Shin & Kim's Healthcare Team has grown to over 30 people. The team is led by Sung Tae Kim, a former lawyer at the Ministry of Health and Welfare, and includes a number of people who have worked at the Ministry of Health Welfare, Ministry of Food and Drug Safety, Health Insurance Review and Assessment Service, and pharmaceutical and biotech companies. Jung-Eun Kim said, “Not only HIRA, but MOHW is also in charge of drug pricing based on the enforcement and implementation rules stipulated by law. This means that interpreting the law is a very important point. It is very helpful to have lawyers in the same space. In addition, the other experts and advisors provide different perspectives.” “I joined here as an expert advisor,” said Jung-Eun Kim, ”so I want to be true to my position and serve as an expert that clients can trust.” “I think the role of law firms is becoming more important as regulations related to drug prices are becoming more and more stringent,” said Sol Kim. ”As a former pharmaceutical industry member, I aim to become an expert who can better understand the needs of pharmaceutical companies and act as a bridge between pharmaceutical companies and law firms.”
- InterView
- ‘3 IBD treatment trends…early treatment is the first’
- by Kim, Jin-Gu Dec 02, 2024 05:49am
- The treatment method for a single disease can continue to change at a very fast pace. This is true for inflammatory bowel diseases (IBD) such as ulcerative colitis and Crohn's disease. In recent years, a variety of drugs have been developed to treat these diseases, and the treatment trend is changing as more research is conducted. Dr. Jun Lee, a professor of gastroenterology at Chosun University Hospital, recently cited 3 recent trends in the treatment of inflammatory bowel diseases - early treatment, strict observation, and precise targeting. "The most important thing is to use the drug as quickly as possible," said Lee, adding that a large-scale study that demonstrates this was recently published in the international journal Lancet. "A variety of drugs are emerging, expanding treatment options...more to consider" According to Lee, the classic treatment for IBD is using steroids and immunosuppressants. These drugs are still commonly used in the first-line treatment of IBD. In the 2000s, the market saw a major shift in the treatment of autoimmune diseases, including IBD. The advent of the first biologics changed the approach to the disease. In the past, the focus was on treating the disease with fewer drugs. The prognosis was so poor, and there weren't many good drugs available, that side effects and patient comfort had to be less prioritized. However, the emergence of several biologics, and more recently, oral treatments, has changed the treatment landscape. The choice of treatment depends on the severity of the disease, as well as safety, side effects, patient comfort, pregnancy, and infection concerns. "As a physician, it's a happy dilemma. There are so many things to consider in line with the increased treatment options," said Dr. Lee, "and because we don't yet have biomarkers that tell us in advance how well a patient will respond to a drug, it's important to know which position to use it in. "There are different drugs for different patients. Some patients respond to one drug for a long time, while others lose their response quickly," he said, adding, "At this point, a different treatment should be used. The only regrettable thing is that it is difficult to switch between different treatments in Korea." "New trend in IBD is early treatment...the sooner the drug, the better" With the wider treatment options available, new trends have emerged in the treatment of IBD. Dr. Lee summarizes them as three - early treatment, strict observation, and the use of precisely targeted drugs. Early treatment is the most important, Lee emphasized. "The most important thing is to use drugs as early as possible. There is a major study published in the Lancet that proves this, and I feel it in clinical practice.” Lee explained that it would be beneficial to administer the drug at an earlier time, especially for patients with a poor prognosis. "If you have a patient with a poor prognosis, such as a large lesion area or ulceration, the earlier you start the drug, the better," Lee said. Furthermore, these patients will benefit from "combination therapy" - the use of multiple drugs at the same time. The idea is that because the drugs are diverse and have different mechanisms of action, they will complement each other to increase the effectiveness of the treatment. "For example, in the case of HIV, the effectiveness of treatment has increased dramatically by using multiple drugs at once," said Lee. "We are just beginning to see this in IBD. So far, the results don't seem to have as many side effects as we feared. If enough studies are accumulated to confirm the effectiveness, combination therapy may become a new trend."
- InterView
- ‘Improve new drug access to treat rheumatoid arthritis'
- by Son, Hyung Min Nov 21, 2024 05:46am
- Dr.Sung Chul Shim, Professor of Rheumatology, Chungnam National University Hospital “Rheumatoid arthritis is not just a painful disease, but a disease that can cause direct damage to the joints. Patients need to start treatment with good treatments in a timely manner, but their access to new drugs is still limited. Switching between JAK inhibitors should be allowed freely so patients can receive personalized treatment.” Sung Chul Shim, Professor of Rheumatology at Chungnam National University Hospital, evaluated the current treatment landscape for rheumatoid arthritis as so during a recent interview with Dailypharm. Rheumatoid arthritis is a disease in which the synovial membrane becomes inflamed due to immune dysfunction. The disease initially starts with tingling and pain in the hands, but if left untreated, joint deformities can occur, accompanied by anemia, dryness, subcutaneous rheumatoid nodules, and pulmonary fibrosis. “People with rheumatoid arthritis don't realize that their joints are being damaged,” said Professor Shim. “They are often reluctant to start treatment early because they believe that taking pain medications is enough to relieve their symptoms.” “However, the molecules that cause pain are not the same molecules that are involved in joint damage. If you control the molecules that are involved in pain, such as prostaglandins, you can reduce the pain, but if you don't target the molecules that are involved in joint damage, your joints may continue to be damaged.” Professor Shim noted how rheumatoid arthritis has a poor early diagnosis rate. The golden time to treat rheumatoid arthritis is 2 years, and if treatment is not started within this period, joint deformity will begin, which is why early diagnosis and aggressive treatment are important. “The lack of early diagnosis in rheumatoid arthritis is due to low patient awareness,” said Professor Shim. If they recognize rheumatoid arthritis as a disease that destroys joints, they will start treatment sooner, but if they recognize it as just a painful disease, they will postpone treatment.” Multiple rheumatoid arthritis treatment options available...switching between drugs should be considered" The good news is that there are many treatment options available for the disease. From steroids to anti-rheumatic drugs to biologics to Janus kinase (JAK) inhibitors, there is a wide range of options available for prescriptions. “There are more treatments for rheumatoid arthritis than for any other disease, including oral and injectable medications,” says Dr. Shim, ”Yet as many as 10% of patients do not respond to the currently available treatment options. As such, having more treatment options doesn't necessarily mean they will work for everyone. Timely access to the right treatment requires an accurate diagnosis and a specialist who can switch medications at the right time for patients who have developed resistance. Currently, four JAK inhibitors are available, including Jyseleca, Xeljanz, Rinvoq, and Olumiant, but they cannot be switched between JAK inhibitors once started. Also, they cannot be switched to a biologic drug either. This is why the patients’ choices are limited despite the many treatment options available. In September, health authorities were expected to announce an amendment that allows switching between JAK inhibitors in rheumatoid arthritis but postponed it. The authorities are now expected to issue the amendment in December. “At this point, even with other therapies available for the same indications, we cannot use them,” said Professor Shim. There are patients who don't respond to one treatment, so we need to switch between drugs. There's no reason to keep them on the same drug when they're getting worse with it.” He added, “The goal of rheumatoid arthritis treatment should be to protect the joints, not control pain. For this, we need to be able to use the various treatment options available to us. It seems that governments are hesitant to allow switching because of the immediate budget impact. If the disease worsens and patients have to undergo surgery, this will be more costly in the long run.”
- InterView
- 'Early detection of RA can help prevent severe symptoms'
- by Whang, byung-woo Nov 14, 2024 05:51am
- "Rheumatoid arthritis not only induces permanent joint deformities and damages but also has a detrimental effect on quality of life due to many general symptoms. As effective disease management becomes possible following the recent introduction of various treatment options, early diagnosis and patient-customized treatment approach are crucial." New treatment options for rheumatoid arthritis have improved unmet needs in clinical practices and increased disease awareness. However, despite the rising diagnosis rate, some patients receive a diagnosis after the disease progresses to severe symptoms. Yunjung Choi, Professor in the Division of Rheumatology at Jeonbuk National University Hospital, has emphasized the importance of early diagnosis of rheumatoid arthritis, explaining the disease characteristics and the latest treatment advances. Yunjung Choi, Professor in the Division of Rheumatology at Jeonbuk National University HospitalRheumatoid arthritis is the most common autoimmune disease where abnormally activated immune cells invade joints, causing inflammation and pain. "Rheumatoid arthritis is mainly caused by inflammation in the thin tissue lining of joints. The disease symmetrically affects small joints in the hand and foot, damaging bones and cartilage surrounding the tissue lining of joints. It leads to joint deformities and loss of joint function." Choi added, "JAK inhibitors that can be orally administered and have almost similar effects now enable patients to manage arthritis effectively." The treatment options for rheumatoid arthritis broadened following the introduction of conventional disease-modifying antirheumatic drugs (cDMARDs), biological agents, and Janus Kinase (JAK) inhibitors. "Patients who have not reached treatment goals after being treated with cDMARDs in primary healthcare centers are often transferred to secondary healthcare centers or university hospitals," Choi said. "Many of them are moderate to higher patients who have poor prognosis factors, and they consider either biological agents or JAK inhibitors." "Customizing treatment to individual patient is necessary. For instance, adapting to patient conditions to prevent and manage side effects, ensure administration convenience, and evaluate drug compliance," Choi emphasized. The current clinical practices use cDMARDS, biological agents, and JAK inhibitors based on the 2021 American College of Rheumatology Guideline and the 2022 European Alliance of Associations for Rheumatology classification recommendations. With JAK inhibitors recently added to the reimbursement list, patients now have treatment options that offer the convenience of oral administration, less burden than injectables, and high efficacy comparable to biological agents. Choi said such a change has contributed to increased patient drug compliance and provided effective treatment options to medical practitioners. Regarding the benefits of JAK inhibitors, Choi said, "At first, there were concerns about JAK inhibitors for cardiovascular system-associated side effects, but follow-up research outcomes have shown that such risks are gradually alleviating." Choi added, "We hope more data in South Korea becomes available and anticipate safer drug use considering ages and existing health conditions." "There is a need for improvements in the rheumatoid arthritis system with blind spot" Furthermore, there is a need to improve a system regarding drug switching for rheumatoid arthritis treatment. For instance, switching to another JAK inhibitor is difficult when a patient does not respond to a JAK inhibitor. Some people have demanded systematic improvements. Positive changes are expected regarding this issue. The Health Insurance Review and Assessment Service (HIRA) has suggested a criterion for drug switching needs, establishing 'An assessment criterion for evaluating drug switching effects for rheumatoid arthritis.' In addition, Choi emphasizes the need to expand support for patients with serotype-negative rheumatoid arthritis. "About 80% of patients with rheumatoid arthritis are diagnosed with antibody positivity. But, the rest of the 20% are found to be antibody-negative, posing difficulty in receiving benefits," Choi said. "These patients require treatments their whole lives, experiencing joint damage and functional deficits. Because they are excluded from benefits, improvements to the policy may be necessary." Additionally, Choi pointed out that patients who use biological agents are recommended for immunization to prevent shingles, but many experience considerable cost burdens. "Shingles immunization is crucial for patient safety, but its high cost poses an additional burden to patients. Systematic support is required to lower the economical hurdle," Choi said. Lastly, Choi reiterates the importance of early diagnosis to seize the 'golden time' for treating rheumatoid arthritis. "Many patients endure symptoms thinking that they feel pain from using their hands frequently, but end up visiting hospitals once the disease has worsened. When an individual feels one's hand stiff and hard to grasp, and feels extensive pain in the body, one should not disregard it simply as fatigue," Choi advises. When morning stiffness lasts over 30 minutes on more than two occasions within two weeks, it may indicate early rheumatoid arthritis. Individuals must consult rheumatology specialists for an accurate diagnosis and a suitable treatment plan. "An early intervention makes a significant difference in preventing joint damages and preserving quality of life," Choi said. "Patients need to recognize disease early and proactively seek treatments."
- InterView
- "Recruiting a company to co-develop pitavastatin+ezetimibe"
- by Kim, Jin-Gu Oct 30, 2024 05:54am
- Seung Hee Baek, Shinil Pharmaceutical Shinil Pharmaceutical will collaborate with other biopharmaceutical company to co-develop a generic 'pitavastatin+ezetimibe' combination drug for treating hyperlipidemia. Through joint-collaboration, Shinil Pharmaceutical plans to improve not only the contract manufacturing of medicines but also cost savings and productivity. In the meantime, the company plans to teach its construction technology for active ingredients and production know-how to companies participating in joint development in addition to out-licensing. "The pitavastatin+ezetimibe combination drug is set to enter the generics market in 2027," Seung Hee Baek (52), Shinil Pharmaceutical's Executive Director who is directing the co-development·out licensing project, said. "We started to prepare for the current project amid searching for a new sales approach following the implementation of 1+3 bioequivalence regulation." 'pitavastatin+ezetimibe' combination drug sales are skyrocketing…Sinil has completed the bioequivalence test for its generic drug, set to enter the market The company's pitavastatin+ezetimibe combination drug for treating hyperlipidemia received approval under the name Livalozet (JW Pharmaceutical). Livalozet sales are skyrocketing in the prescription market. According to the pharmaceutical market research firm UBIST, Livalozet generated sales of KRW 70.4 billion in prescription sales, more than twice the previous year's growth. Up to September 2024, it generated KRW 66.8 billion in sales. It is expected to surpass last year's prescription record. It seems that Korean pharmaceutical companies have started to show interest in these generics, as Livalozet has shown strong sales in the prescription market. During 2020-2021, many generics containing pitavastatin+ezetimibe received approvals. Livalozet generics are currently subjected to reconsideration. When the reconsideration period ends after 2027, product launch is possible. Sinil Pharmaceutical focused on pitavastatin's low statin side effects and significant treatment effects. The company has already completed a bioequivalence test and is set to enter the market. "The advantage of pitavastatin is that it lowers the risk of diabetes than other statin agents," Baek said. "Sinil Pharmaceutical had selected the pitavastatin+ezetimibe combination as an in-house project. In April 2024, the company demonstrated the bioequivalence of the drug to the control drug through a bioequivalence test." "Searching for a company to co-develop…we will make a technology transfer, including active agent designing·production know-how" Sinil Pharmaceutical will begin technology marketing based on its completed bioequivalence demonstration. The company plans to secure a co-development company and make a technology transfer to the partner, including active agent designing·production know-how·how-to prepare documents for approval. Baek anticipated that such a co-development·technology transfer strategy would be a win-win for both Sinil Pharmaceutical and its partnering company. Baek explained that Sinil Pharmaceutical could benefit from improving its profitability by sharing the development cost. A co-development company can learn various know-how during the technology transfer process. In addition, a co-development company can appoint a CMO company. "Sinil Pharmaceutical conducts the process of product development·approval·production in-house. We can make a technology transfer of necessary technology for each stage up to launching a product," Baek emphasized. "Partnering company can secure various know-how, including the production technology needed in a plant and CTD documentation for applying for approval, in addition to active ingredient designing that made Sinil Pharmaceutical successfully complete the bioequivalence test." Baek emphasized that 'timing is a key to generics development.' Baek explained that the timely development of drugs secures high drug pricing and establishment in the market. Additionally, a company has to consider the cost-effectiveness of the development for an agent that is difficult to demonstrate bioequivalence. "Sinil Pharmaceutical has already demonstrated a bioequivalence of its pitavastatin+ezetimibe combination," Baek emphasized. "Considering cost-effectiveness, joining one of the three co-development companies will provide benefits." Changes occurred following the 1+3 bioequivalence regulatory policy…"It's our new sales strategy" Sinil Pharmaceutical strategized this approach following the 1+3 bioequivalence regulatory policy, which the government implemented in July 2021. The policy requires that a bioequivalence document can be used up to three times when a manufacturing plant produces a pharmaceutical that is equivalent to one for which a pharmaceutical company conducted a bioequivalence test. Only four generics can receive approval based on a single bioequivalence test. After the implementation of the policy, CMO companies faced significant changes, Sinil Pharmaceutical likewise. Concerns have risen in the company that profitability could be lowered because the company can appoint only three CMOs companies. "Sinil Pharmaceutical has been actively developing first-generics," Baek said. "After the implementation of the 1+3 policy, the company had to find a different sales approach for its CMO business." Baek explained, "Recruiting only three CMO companies can hinder development, but on the bright side, expanding to technology sales can be a win-win strategy for both CMO and consignment companies." Sinil Pharmaceutical plans to expand its business field based on the current joint development·technology transfer experience. "We have tried technology transfer of previously manufactured products after the implementation of the 1+3 policy. However, we had difficulty starting a business because too much information had already been shared," Baek said. "For a new product, it is different. We plan to pursue technology transfer sales for a new product actively."
- InterView
- "JAK inhibitors bring a paradigm shift to RA treatment"
- by Whang, byung-woo Oct 16, 2024 05:50am
- As patients with autoimmune diseases, including rheumatoid arthritis, have better access to medical care, early diagnosis and treatment have been pointed out as the key. Early diagnosis and treatments previously available in university hospitals are now possible in local clinics. As a result, patient-personalized therapies, even for patients with mild symptoms, through local clinics have become increasingly important. "More patients are visiting clinics at early stages compared to the past," Dr. Won-Suk Lee, Chief of Easy Rheumatis Clinic in Jeonju, said. "It is important to provide personalized treatments to improve patient's daily life." JAK inhibitors for treating rheumatoid arthritis…"We have observed fast treatment effects" Dr. Won-Suk Lee, Chief of Easy Rheumatis Clinic in JeonjuRheumatoid arthritis is an autoimmune diseases in which abnormally activated immune cells invade joints, causing inflammation and pain. In the past, it was regarded as a disease that required treatment at university hospitals. However, without properly treating it at an early stage, repeated inflammation over time can cause joint deformity, leading to loss of function. So, the importance of early diagnosis has been emphasized. Specialists in the field of rheumatoid arthritis have opened clinics all over the nation, improving patient access. "As more specialists in the field of rheumatoid arthritis have opened clinics, patients have better access. More patients now visit clinics at an early stage of the disease compared to the past,"Dr. Lee explained. "There may be differences in disease awareness depending on geographical location, but overall disease awareness has increased." Along with improved disease awareness, doctors have more treatment options to utilize. Janus Kinase (JAK) inhibitor has brought a significant paradigm shift to the treatment of rheumatoid arthritis. "Patients initially begin the treatment with DMARDs, a methotrexate (MTX)-based therapy, but when drug response lowers, patients resort to TNF-α inhibitors or JAK inhibitors," Dr. Lee said. "I have been employing a step-wise increasing prescription in patients of young age, according to the guideline." Dr. Lee quickly switches from prescribing conventional medicine to JAK inhibitors because of the 'effects' and 'convenience.' Compared to conventional medicines, JAK inhibitors have the advantages of requiring less use of steroids and pain killers. They also relieve the patient's administration burden because they are oral drugs. However, in 2021, an issue of cardiovascular system-related side effects of JAK inhibitor was reported, so there are 'safety'-related concerns. At the time, the U.S. Food and Drug Administration (FDA) issued warnings related to cardiovascular disease and cancer for JAK inhibitors. The Korean Ministry of Food and Drug Safety (MFDS) also posted safety documents. Ultimately, the FDA decided to include the safety information, including cardiovascular-related instances, thrombosis, and death, on the box warning label. Dr. Lee commented regarding this issue, "We cannot deny the research, but I have not had cardiovascular-related side effects issues during my years of prescription experience. In my opinion, side effects could be manageable, and the occurrence of shingles is seven times higher in Asia, I explain the vaccination option and prescribe it." Emphasizes the need to improve medication switching for personalized treatment The latest issue for rheumatoid arthritis treatment is obtaining insurance reimbursement authorized for switching between JAK inhibitors. Notification was expected within October, but it has been extended. Dr. Lee commented that we need to consider the criteria for using conventional medicines in addition to the issue of JAK inhibitor switching. "When medication switching is allowed, patients can choose better treatments, which is the most important point," Dr. Lee said. "The current criteria indicate that when a patient uses conventional medicine and does not benefit, one can use JAK inhibitor after six months. However, we should also consider three months amid the early intervention trend." Lastly, Dr. Lee emphasized the need for early diagnosis and personalized treatment for the management of rheumatoid arthritis. "For rheumatoid arthritis, early diagnosis and early treatment are most important, so we focus on treating patients without hindering daily lives, along with pain management," Dr. Lee said. "Rather than repeatedly prescribing the same drug, we need to consider complications and accompanying disease."
- InterView
- "An OTC drug increases lymphedema patient satisfaction"
- by Kim, Jin-Gu Sep 23, 2024 05:50am
- Lymphedema occurs when the body's flow of lymph fluid is disrupted. Due to a particular reason, the build-up of lymph fluid between cells causes swelling and hardening of fatty tissues in the arms and legs. Unfortunately, the number of medicines for treating lymphedema is limited. Therefore, there are unmet needs in clinical practices. Hence, Ha Suk Bae, Director of the Lymphedema Center at Ewha Womans University Mokdong Hospital, draws attention to 'Newbein (troxerutin).' Bae said, "We recommend this drug to patients with lymphedema who visit our hospital," adding, "Although it was approved as an over-the-counter (OTC) drug, we prescribe it because Newbein provides administration convenience and is more effective than the existing drugs." Despite a variety of treatment methods, the number of drugs is limiting…"in search for better drugs" Lymphedema commonly occurs in patients undergone cancer surgeries. For example, those who have breast cancer. During the procedure of removing cancer tissues, a portion of lymph nodes is removed, and this causes disruptions to the lymphatic system, leading to swelling of arms. Ha Suk Bae, Director of the Lymphedema Center at Ewha Womans University Mokdong Hospital. There are several treatment methods for lymphedema. Lymphedema bandaging, which applies a compression wrap to the lymphedema area, is combined with exercise therapy or massage therapy. It may be treated with surgeries. However, the number of medicines is limited. Medicines that help the vein and lymph circulation are often used, but there aren't many types. Most drugs cause patient inconvenience because they are orally administered three times a day. Such limitations have raised concerns for Bae. Bae attempts to find new medicines to assist in treatment courses. Bae explained, "For example, Breast cancer patients have to focus primarily on cancer treatment because cancer has to be immediately removed and to save their lives," adding, "This is the reason why there aren't many lymphedema medicines." Bae said, "However, patients have lives after the cancer treatment. When patients experience lymphedema after recovering from cancer, it substantially reduces the quality of life," adding, "I was hoping that medicines that can easily be administered are available considering that patients have to manage lymphedema their whole life." Drug containing troxerutin…"prescribing this drug raises patient satisfaction" Bae started reviewing drug approval documents in South Korea and overseas in search of a better drug. He sighted an OTC drug containing troxerutin. The Ministry of Food and Drug Safety (MFDS) approved the drug for the use of 'improving swelling and pain in lower part of the body (legs) due to vein and lymph circulation disruptions.' Although it is a vein circulation enhancer, Bae was hoping that it would be effective in lymphedema. Bae also reviewed research articles and found that troxerutin works in the inner wall of micro vessels, reducing permeability, and lowering the burden on the lymphatic system. Additionally, Bae found research showing that troxerutin can alleviate swelling by reducing the protein content rise that often occurs in lymphedema. Troxerutin prevents neutrophils and platelets from attaching to the inner wall and inhibits excessive aggregation of red blood cells. It also inhibits damaging substances in vascular endothelial cells and improves the elasticity of blood vessels. In this process, venous flow becomes smoother, and lymphatic circulation improves. Troxerutin seems adequate for lymphedema and edema of the lower body caused by varicose veins. After securing these grounds, Bae recommended an OTC drug containing troxerutin for patients with lymphedema. Bae explained that in addition to alleviating edema symptoms, the drug also increased patients' satisfaction compared to the existing drug. Bae said, "Because troxerutin drugs introduced in South Korea are in liquid formulation, taking these drugs is convenient. It has the advantage of taking the drugs once daily," adding, "Hence, patient satisfaction is high." "In our hospital, we recommend these drugs to patients with lymphedema. OTC drugs are not usually prescribed in hospitals, but we have been prescribing these drugs because troxerutin drug is quite effective in treating lymphedema," Bae added. This drug has been prescribed at four general hospitals and Ewha Womans University Mokdong Hospital. Bae emphasized that he hopes this drug will be used in more patients. Bae stated he would announce it through Ewha Womans University Mokdong Hospital. Bae said, "Not many doctors are familiar with this drug. I hope more patients can access this drug."
