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- 2025-12-22 16:51:15
- Policy
- Tadalafil, only concern for abuse in erectile dysfunction
- by Lee, Hye-Kyung Mar 11, 2025 05:54am
- ’Tadalafil,’ whose indications have been expanded to treat not only erectile dysfunction but also benign prostatic hyperplasia, is expected to partially get rid of the shackles of being a drug with concerns for misuse and abuse. According to the Ministry of Food and Drug Safety's “Partial Amendment to the Regulations on Designation of Drugs of Concern for Misuse and Abuse,” which was announced on the 7th, “tadalafil-containing drugs” that were designated as a drug of concern for misuse and abuse will be revised to “tadalafil-containing drugs for erectile dysfunction.” Tadalafil was designated as a drug of concern for misuse and abuse in 2003 due to concerns over its abuse as a sexual enhancer. In Korea, 3 dosage forms of tadalafil-containing drugs are currently approved (5, 10, and 20 mg) for a total of 187 items, and are indicated for the treatment of erectile dysfunction. However, since 2012, the indication for the low-dose 5 mg has been expanded, breaking the formula that tadalafil is only used for erectile dysfunction. In addition to erectile dysfunction treatment, Lilly Korea has added two indications for Cialis (tadalafil) 5 mg, including ▲benign prostatic hyperplasia and ▲benign prostatic hyperplasia. With the addition of the indications, Cialis 5mg has become a treatment that simultaneously improves the symptoms of erectile dysfunction and benign prostatic hyperplasia, the most common urological diseases in men over the age of 40. Cialis 5mg was the first and only treatment in the world to be approved by the FDA in 2011 for both the treatment of erectile dysfunction and benign prostatic hyperplasia. At the time, Korea was the 5th country to approve the additional indication. Since then, domestic companies have approved a series of generic versions of Cialis 5mg, and there are currently more than 60 low-dose tadalafil products available in the market. In addition, the development of a combination drug containing ingredients such as dapoxetine and tadalafil, following the sildenafil and clomipramine combination, has expanded the treatment options for patients with premature ejaculation and erectile dysfunction. In February, the first combination drug that contains dutasteride and tadalafil, which is used to treat benign prostatic hyperplasia, was approved in Korea. Dongkook Pharmaceutical has received marketing authorization for ‘Uresco Tab,’ an incrementally modified drug for enlarged prostate that contains dutasteride and tadalafil. Benign prostatic hyperplasia is a very common condition where the prostate enlarges with age, causing abnormalities in various urination functions. Drugs that reduce the size of the prostate (finasteride, dutasteride) are used, and various drugs are used in combination to improve symptoms.
- Company
- Besremi demonstrates effects in polycythemia vera
- by Whang, byung-woo Mar 11, 2025 05:54am
- "In polycythemia vera, 10–20% of patients develop resistance or intolerance to hydroxyurea treatment. Since no other treatment option is available, reimbursement for the new treatment option must be considered." Although the average survival for polycythemia vera is around 14.1 years, typically considered a comparatively lower mortality risk than other blood cancers, the abnormal overproduction of blood cells in the bone marrow can lead to severe cardiovascular complications such as thrombosis and embolism. Currently, the disease cannot be completely cured, and long-term management of complications is of utmost importance. However, treating the disease with the standard therapy hydroxyurea is limited because of its non-responsiveness or intolerance. Dr. Seong Yoon Yi, Professor of the Division of Hematology-Oncology in the Department of Internal Medicinea at Inje University Ilsan Paik HospitalDr. Seong Yoon Yi, Professor of the Division of Hematology-Oncology in the Department of Internal Medicinea at Inje University Ilsan Paik Hospital, emphasized the critical need to secure reimbursement for new treatment options that target the underlying pathology of polycythemia vera. Polycythemia vera is caused by somatic mutations in the bone marrow that abnormally activate hematopoiesis, resulting in excessive production of red blood cells, white blood cells, and platelets. Approximately 90% of patients with polycythemia vera have been found to harbor a mutation in the JAK2 gene. Dr. Lee explained, "Because polycythemia vera is a rare blood cancer, it is uncommon for patients to seek medical attention in its early stages. Most patients are diagnosed only after presenting with vague symptoms, followed by blood tests, bone marrow examinations, and genetic tests." Dr. Lee said treatment strategies are typically divided into low-risk and high-risk groups. Patients aged 60 or older or those with a history of thrombosis are classified as high-risk. Low-risk patients are generally treated with aspirin and phlebotomy, whereas high-risk patients receive these interventions in combination with hydroxyurea to help control excessive blood cell production. The problem with polycythemia vera, being an incurable condition requiring prolonged treatment, is the emergence of drug tolerance and adverse effects. Dr. Lee explained, "Polycythemia vera, like diabetes and hypertension, is a chronic condition that requires lifelong management, which means treatment lasts indefinitely," adding, "Over the long term, there are instances when blood counts are not stably controlled with hydroxyurea, and the disease can progress rapidly." "In some cases, patients develop tolerance to hydroxyurea so that it no longer provides therapeutic benefits, or they experience intolerable side effects that force them to discontinue treatment," He added. "Typical side effects include skin ulcers, a decrease in white blood cell counts leading to compromised immunity, and a decline in cardiac function, especially in older patients." Patient Lee Deok-hee, who joined the meeting with Dr. Lee, shared, "Since my diagnosis in 2010, I have been receiving both hydroxyurea and phlebotomy for 13 years. Initially, having hydroxyurea prescribed every three months was enough to maintain stable blood counts. However, since 2023, as I've developed resistance, I've had to visit the emergency room more frequently, and my daily life has become so restricted that I can no longer maintain my work." "Polycythemia vera's second-line treatment option poses a cost problem" According to research from the Myeloproliferative Neoplasms Research Group under the Korean Society of Hematology, approximately 10–20% of polycythemia vera patients develop resistance or intolerance to hydroxyurea treatment. Regarding this, Dr. Lee emphasized, "Although polycythemia vera is considered a rare blood cancer and may appear to affect only a small patient population, the number of cases continues to accumulate over time. As the disease progresses, low-risk patients often transition to a high-risk category, thereby increasing the likelihood of developing resistance or intolerance, presenting a challenge that cannot be overlooked." Following hydroxyurea treatment, two treatment options are considered: Besremi (ropeginterferon alfa-2b) and Jakavi (ruxolitinib). Besremi is a next-generation interferon that selectively targets and eliminates the JAK2 mutation, the primary cause of polycythemia vera. It was developed to improve the purity and tolerability compared to existing interferons, allowing for administration every two weeks for the initial 1.5 years and once every four weeks thereafter. Currently, Besremi is recommended as a polycythemia vera treatment in the National Comprehensive Cancer Network (NCCN) and European Leukemia Network (ELN) guidelines, regardless of a patient's prior treatment history. "Notably, the extent to which the allelic burden, which is the fundamental driver of the disease, is reduced," Dr. Lee said. "Clinical trials have demonstrated that Besremi significantly lowers the JAK2 mutation allelic burden. This means that Besremi alleviates symptoms and addresses the underlying cause of polycythemia vera." However, Besremi and Jakavi are currently not reimbursed, posing substantial cost hurdles. In practical terms, hydroxyurea remains the only treatment that patients can use without an economic burden. Consequently, there is growing attention on Besremi's multiple attempts to be considered for the Economic Evaluation Committee of Health Insurance Review and Assessment Service (HIRA). Given the apparent demand for new treatment options in clinical practice, industry observers are closely watching whether Besremi can pass through the subcommittee review and ultimately reach the final stage at the Drug Reimbursement Evaluation Committee (DREC). Dr. Lee said, "We know that patients with polycythemia vera want new treatment options to be reimbursed. In particular, Besremi has shown stable clinical data across risk groups and offers the potential for a fundamentally transformative approach, which has greatly raised patient expectations." He added, "While it would be ideal for every patient to access treatment without any economic burden, the realities of the National Health Insurance budget mean that securing reimbursement is especially urgent for patients who develop resistance or intolerance to hydroxyurea. These patients have no other treatment options once hydroxyurea becomes ineffective." Finally, Dr. Lee stressed that, given the unique characteristics of polycythemia vera as a rare blood cancer, reimbursement reviews should consider not only the number of patients and drug costs but also the broader societal burden. "Costs related to treating side effects of hydroxyurea, such as myocardial infarction or stroke, and the social costs when caregivers have to quit their jobs for patient care are often overlooked. I hope these factors will be partially reflected in the drug reimbursement decision-making process," Dr. Lee added.
- Company
- Celltrion’s Xolair biosimilar Omlyclo is approved in the US
- by Chon, Seung-Hyun Mar 11, 2025 05:54am
- Celltrion announced on the 10th that ‘Omlyclo,’ its biosimilar version of ‘Xolair’ has was approved by the US Food and Drug Administration (FDA). Xolair is an antibody biologic used for allergic asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), and chronic spontaneous urticaria (CSU). Xolair posted global sales of approximately KRW 6 trillion and over KRW 3 trillion in the US market alone. Celltrion applied for Omlyclo’s marketing authorization to the FDA based on the results of a global Phase III trial last year and was approved for all indications the original drug was approved for, including allergic asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), chronic spontaneous urticaria (CSU), and Immunoglobulin E (IgE)-mediated food allergy. Omlyclo was approved as the first Xolair biosimilar in the United States, following approvals in major global countries such as Europe (EC), South Korea, the United Kingdom, and Canada. As Omlyclo’s interchangeability was recognized in the United States, pharmacies will be able to substitute the original product with Omlyclo without the healthcare professional’s prescription change. Celltrion will sell Omlyclo through its local subsidiary in the US. With the approval, Celltrion has received approval for 4 products in the United States in the first quarter of this year alone – Omlyclo; the autoimmune disease treatment Avtozma; and biosimilar versions of the bone disease treatment Prolia-Xgeva. “Omlyclo has not only been approved as a first mover in the United States, the world's largest pharmaceutical market, but also secured an interchangeability designation, enabling it to take an advantageous position in the market upon its initial launch,” said a Celltrion official.
- Policy
- Keytruda will be considered for DREC next time
- by Lee, Tak-Sun Mar 11, 2025 05:54am
- Product photo of Keytruda The expanded use of scope application of the immune cancer drug Keytruda, which passed the Cancer Disease Review Committee, is expected to be considered for the Drug Reimbursement Evaluation Committee (DREC) review as soon as April. Previously, the 2nd DREC review for 2025, held on March 6, did not include Keytruda. As Keytruda's DREC review is imminent, the National Health Insurance Service (NHIS) has started to prepare for the next stage. According to industry sources on March 10, the NHIS has initiated a preliminary financial analysis of Keytruda, which is expected to undergo negotiations for an expanded reimbursement scope. Because the approval of the expanded scope of use for Keytruda is expected to cost substantial expenditure, the NHIS may aim to take the lead in negotiations through the preliminary financial analysis. It has been reported that the NHIS will conduct a financial analysis of Keytruda's expanded scope of use through internal meetings. After failing five times, the application of Keytruda for the expanded scope of use passed the Health Insurance Review and Assessment Service (HIRA)'s CDRC on the sixth attempt on the 12th of last month. Of the 17 applications considered for the review, 11 received reimbursement standards. The reimbursement will determined for these 11 indications with reimbursement standards once they pass the DREC and complete negotiations with the NHIS. Keytruda is reimbursed for seven indications in four cancer types, including non-small cell lung cancer, Hodgkin lymphoma, melanoma, and urothelial cancer. Keytruda's yearly claim amount exceeds KRW 400 billion. Therefore, if 11 indications are additionally reimbursed, it will substantially cost the National Health Insurance finance. Because of this, the key to the expanded scope of use negotiations will be the extent to which the pharmaceutical company will take a share of the finance. Consequently, the NHIS reportedly initiated preliminary analysis before negotiating even though the drug had not passed the DREC. The completion of the DREC review is expected in early April. Industry personnel said, "Although the drug was not considered for the DREC in March, it passed the CDRC in February, so there is a chance that it will be considered for the DREC soon," adding, "Because the CDRC carefully considered this item up to six times, the drug will likely to pass the DREC quickly." A drug under the Risk Sharing Agreement (RSA) with a claim amount over KRW 1.5 billion has to pass the DREC review to receive an expanded scope of use. The review outcome will be announced on that day.
- Company
- AbbVie’s Rinvoq to benefit most from changes in KOR
- by Whang, byung-woo Mar 10, 2025 06:05am
- Expansion has been growing on the expansion of related prescription markets with the government approving reimbursement for switching between atopic dermatitis treatments, which has been in high demand in the field. The industry expects an increased number of treatment options and an expanded scope of reimbursement to enable more effective treatment for patients. In particular, the presence of Rinvoq (upadacitinib) has been growing with its indication expansion to moderate to severe atopic dermatitis in adolescents aged 12 and older, and the grant for switching between JAK inhibitors. On the 7th, AbbVie Korea held a press conference on the latest clinical research of Rinvoq and changes in the treatment environment due to changes in the atopic dermatitis reimbursement coverage standards. Tae Young Han, Professor of Dermatology, Nowon Eulji Medical Center According to the Korean Atopic Dermatitis Association guidelines, patients with moderate-to-severe atopic dermatitis are highly recommended to consider switching to another biological agent or oral JAK inhibitor if they do not respond sufficiently to the biological agent or oral JAK inhibitor or if they cannot use them due to side effects. Until now, there have been limitations to treatment due to the fact that reimbursement coverage was not applied when the patient wanted to switch from biological agents to JAK inhibitors. However, from the 1st of this month, ▲if a patient is not responding to a biological agent or a JAK inhibitor, or ▲if the patient cannot continue taking the medication due to side effects (recommended to continue taking the replaced medication for at least 6 months), the patient will be eligible for reimbursement even if the patient has switched to a JAK inhibitor or biological agent. However, switching between the same class of drugs is not allowed. Professor Tae Young Han of the Department of Dermatology at Nowon Eulji Medical Center who made a presentation on this day, said, “Atopic dermatitis is a disease that has symptoms and manifestations depending on the characteristics of the patient, and a personalized treatment strategy is needed for each patient to receive appropriate treatment. The recognition of reimbursement coverage for switching has opened up new treatment opportunities for patients who have not seen sufficient treatment effects so far.” Han added, “Patients who have had side effects or showed an inadequate response to biological agents can be switched to a JAK inhibitor such as Rinvoq to achieve an appropriate treatment response. In addition, with the availability of reimbursement coverage, it is now possible to prioritize the use of treatments that are expected to be highly effective for each patient, from his or her initial treatment.” The reason why the expansion of Rinvoq’s influence is drawing attention is because of the Heads Up trial, which is a head-to-head trial between Dupixent (dupilumab), the biological agent with the most prescriptions, and Rinvoq. The results showed that 90% of patients who switched to Rinvoq (30 mg) after 24 weeks of dupilumab (300 mg) achieved EASI 90 (an almost clear skin condition) at Week 16 of Rinvoq treatment (40 weeks in total), and 56.1% achieved WP-NRS 0/1 (no or almost no itching). Yong Hyun Jang, Professor of Dermatology at Kyungpook National University said, “For moderate or more severe atopic dermatitis, the use of drugs that have quick and high efficacy in the early stages needs to be prioritized to quickly suppress severe itching. With switching between different classes of drugs granted reimbursement in Korea, the burden of choosing Rinvoq as the initial treatment option will be reduced as its long-term safety has been confirmed in clinical trials.” According to the results of the approximately 4-year follow-up of the extension study of Phase III clinical study on Rinvoq (Measure Up 1, Measure Up 2), among patients who received 15 mg and 30 mg Rinvoq, 69.8% and 72.9% of patients maintained EASI 90 and 44.9% and 47.2% of the patients maintained WP-NRS 0/1, respectively. Yong Hyun Jang, Professor of Dermatology at Kyungpook National University The indication expansion to adolescents aged 12 and older and the reimbursement expansion for Rinvoq also received positive evaluations. Professor Jang said, “Adolescents require sufficient sleep for growth and development, and lesions on visible areas such as the face and neck are especially stressful at that age. This is a very important period to prevent exacerbation of atopic dermatitis in adulthood, so the importance of early treatment is even greater. I expect the changes in the approval environment in Korea will help establish a flexible treatment strategy.” Jiho Kang, Country Medical Director of AbbVie Korea, added, “With the approval of switching and the approval for adolescents and the expanded insurance reimbursement coverage, we hope that the flexible dose strategy of Rinvoq will help improve the quality of life and enable patients to enjoy daily life that is no different from that of the general public through Rinvoq’s fast and strong treatment effect.” Meanwhile, due to the approval of switching, Rinvoq’s insurance price has been cut due to expected additional claims, based on the calculation formula. Due to this expansion of the scope of use, the insurance price ceiling of Rinvoq will be reduced from the previous KRW 18,740 to KRW 18,328 for the 15 mg product and from the previous KRW 29,850 to KRW 29,193 for the 30 mg product starting next month.
- Company
- 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.
- Opinion
- [Reporter's View] K-Bio's global entry and transparency
- by Whang, byung-woo Mar 10, 2025 05:51am
- The active overseas expansion of domestic bio companies is considered to be one of the essential strategies for continuous growth. News is coming in on domestic companies participating in overseas academic societies and conferences. This has become an important strategy for strengthening competitiveness and building trust in the global market, beyond simply expanding the scope of a company's international activities. However, efforts are also being emphasized to ensure that their activities on the international stage do not simply end at 'participation' and lead to 'substantial results'. First, the transparent disclosure of the participation results is necessary. Many companies participate in academic conferences and conferences held abroad, but information about what they have achieved or what challenges they have faced is often not disclosed. This lack of information can affect not only internal development but also the long-term building of trust with investors and partners. From the company’s perspective, it may not share subsequent information due to a lack of performance or substantial results. However, transparently disclosing the results of participation, regardless of the achieved results, can send a positive signal to stakeholders and contribute to increasing the credibility of the company. Many domestic companies are entering the global arena, so no one expects much with a single participation. It is more reasonable to look at the lessons and experiences gained in this process as the drive to move on to the next step. That is why experts emphasize transparency and continuity as a way to ensure the success of companies. One-time participation may generate short-term interest, but continuous participation is believed to help companies build in-depth networking and long-term partnerships in the global market. In fact, many biotech company representatives say that when they participate in events like BIO USA, discussions develop further and progress in the following years with continuous participation rather than in the first year. Until now, the word “continuum” has been used much when mentioning government support for the development of the domestic pharmaceutical and bio industry. As a later entrant to the global market, continuous government support is an indispensable element for the development of the domestic pharmaceutical and bio industry. However, fundamentally, individual companies must lay the groundwork for the domestic pharmaceutical and bio-industry to become competitive on the global stage. Many companies have been seeking to enter overseas markets from the beginning of the year. Participation in overseas academic societies and conferences is an important opportunity for domestic bio companies to achieve sustainable growth in the global market. To this end, companies need to make efforts to strengthen the transparency of the companies' attempts to enter overseas markets and their continuous participation.
- 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.
- Policy
- 734 SGLT2is add precautions for ketoacidosis
- by Lee, Hye-Kyung Mar 10, 2025 05:50am
- SGLT-2 inhibitors approved in Korea Precautions for antidiabetic SGLT2 inhibitors will be strengthened in the near future. 734 ertugliflozin, empagliflozin, and dapagliflozin drugs that have been approved in Korea are expected to be subject to the changed regulations. The Ministry of Food and Drug Safety will prepare an ‘Order for labeling changes (draft)’ based on the safety information of SGLT2 inhibitors by the 20th of this month and conduct an opinion inquiry thereafter. This draft order for changes was made based on the 'Results of the review of safety information on SGLT2 inhibitor-related drugs' by Health Canada (HC) and the US Food and Drug Administration (FDA). Representative products include AstraZeneca Korea's ‘Sidapvia Tab (dapagliflozin, sitagliptin)', HK Inno. N’s ‘DapaN Tab (dapagliflozin propanediol hydrate)', Boehringer Ingelheim Korea’s ‘Jardiance Tab (empagliflozin)', and MSD Korea’s ' Steglatro Tab (ertugliflozin L-pyroglutamic acid).’ The labeling changes for the SGLT2 inhibitor class will be made in the 'General Precautions' section. In all products that have been announced, the 'ketogenic diet' will be added as a factor that is likely to cause ketoacidosis. In addition, pancreatic disorders that cause insulin deficiency will include not only type 1 but also type 2 diabetes. Previously, risk factors for ketoacidosis included reduced insulin doses, acute febrile illness, calorie intake restriction due to illness or surgery, and alcohol abuse. The precautions for combination drugs such as dapagliflozin-sitagliptin, dapagliflozin-metformin, dapagliflozin-metformin-sitagliptin, dapagliflozin-glimepiride, dapagliflozin-pioglitazone, dapagliflozin-linagliptin, dapagliflozin-saxagliptin, dapagliflozin-evogliptin, dapagliflozin-evogliptin-metformin, and dapagliflozin-gemigliptin will become slightly stricter. The changes include the addition of a precaution about ketoacidosis: “Diabetes and ketoacidosis may persist longer than the expected duration and urine glucose excretion may persist for 3 days after discontinuation of administration. However, there have been post-marketing reports of diabetes and ketoacidosis persisting beyond 6 days and up to 2 weeks after discontinuation of SGLT2 inhibitor administration.” The Ministry of Food and Drug Safety has asked associations to notify their members of the changes so that review opinions can be submitted.
- Company
- 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.”
