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- 2026-05-01 23:17:57
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- Leqembi may be prescribed in general hospitals in Korea
- by Eo, Yun-Ho Jan 22, 2025 05:54am
- The new Alzheimer’s drug Leqembi is landing in general hospitals in Korea According to industry sources, Leqembi (lecanemab) has passed the drug committees (DCs) of top tertiary hospitals in Korea, such as Samsung Medical Center, Seoul Asan Medical Center, and Sinchon Severance Hospital, as well as medical institutions such as Busan Paik Hospital and Gachon Dae Gil Hospital. Since its official launch at the end of last year, the drug has been rapidly expanding its prescription area. Leqembi has been proven to reduce the rate of disease progression and slow cognitive decline by selectively binding to amyloid beta (Aβ) aggregates, which are a known cause of Alzheimer's disease. Due to the lack of treatments for the disease, the desperation of the patients and their families had been indescribable. In addition to public petitions, the MFDS's Korea Orphan & Essential Drug Center has been inundated with inquiries on the date of Leqembi’s approval and supply in Korea. However, the problem is the price of the drug. In the U.S., Leqembi costs about KRW 35 million per year; in Japan, it costs KRW 27 million. Due to its high price, it will take a while for the drug to be approved in Korea and be listed for reimbursement as it requires a tug-of-war between pharmaceutical companies and the government. In the Clarity AD study, Leqembi achieved statistically significant results in both its primary and secondary endpoints. Specifically, Leqembi delayed clinical decline in brain function by 27% at 18 months compared to placebo. While the market for amyloid-targeted therapies such as Leqembi is gaining recognition for its effect in delaying the onset of dementia, the use of the drug has been hampered by its characteristic side effects. The amyloid-related imaging abnormalities (ARIA) that are often mentioned as an issue, are abnormal signals observed on MRI scans, such as brain edema or microhemorrhage that are detected with the drug’s use. Depending on how the adverse event occurs, ARIA is classified as ARIA-E and ARIA-H. ARIA-E can be observed on MRI as brain edema or sulcal effusions, and ARIA-H as microhemorrhage and superficial siderosis. Meanwhile, a special committee composed of 11 members of the Korean Dementia Association recently announced guidelines on using Leqembi that are tailored to Korea’s condition. The guidelines include specific details on ▲ selection of eligible patients for the drug, ▲ necessary tests and preparations before administration, ▲ administration method, ▲ monitoring and response to adverse drug reactions, and ▲ counseling for patients and guardians.
- Policy
- MOHW to 'carefully review' post-dispensing notification law
- by Lee, Jeong-Hwan Jan 22, 2025 05:54am
- A bill to add the Health Insurance Review and Assessment Service to the post-notification subjects for dispensing substitute drugs by pharmacists is scheduled to be reviewed on the 21st, but the government's cautious stance is expected to be a hurdle. The Ministry of Health and Welfare has not changed its stance on the bill, saying it should be carefully reviewed considering the scope of the HIRA’s work and concerns about the safety of drug use caused by the increased notification term. Physicians and hospital organizations are also opposed to the expansion of post-notification, citing concerns that it would undermine the doctors' prescription rights and delay the time of notification to doctors. There are a total of three bills related to dispensing substitute drugs pending in the National Assembly as of the 19th. Rep Byung-Deok Min, Young-seok Seo, and Sujin Lee of the Democratic Party of Korea have separately introduced the 3 bills. The bills are to change the “dispensing substitute drugs” clause in the Pharmaceutical Affairs Act to “same-ingredient drugs” (Young-Seok Seo, Sujin Lee) and to expand the subjects for post-notification of substitute drug dispensing to include HIRA (Byung-deok Min, Young-Seok Seo, and Sujin Lee). MOHW-HIRA “Drug safety concerns arise due to increased notification period of dispensing substitute drugs” The MOHW has been showing a cautious stance on both the provisions to change the ‘dispensing substitute drugs’ clause and the post-notification to HIRA clause. This is a reversal of the opinion as the MOHW had expressed plans to accept the post-notification provision for the same Act mentioned in the bill introduced by Rep. Young-Seok Seo in the 21st National Assembly. The MOHW explained, “Changing the phrase to same-ingredient drug dispensing may be misunderstood as being able to substitute will all drugs that contain the same ingredients,” adding, “There are differences in perceptions and positions between the medical and pharmaceutical communities on dispensing substitute drugs, so careful review is necessary.” “We agree on the need to improve the convenience of the post-notification system, which is currently conducted via phone or fax.” It added, “However, stipulating that the review committee should receive the results of the dispensing substitute drugs and renotify the prescribing physician should be carefully reviewed considering the purpose of the organization's establishment, the scope of its work, and concerns about drug safety due to the increased notification period.” HIRA also expressed a cautious view. “The notification period would inevitably increase when post-notification is made through the review committee. If a weakening incident occurs in a situation without the doctor’s awareness, patient safety issues can also arise as a concern. Since HIRA can only perform the tasks entrusted by law, separate grounds for entrusting alternative notification-related tasks is necessary.” “A unique identification number in accordance with the Personal Information Protection Act, regulations based on handling sensitive information, and provisions on granting immunity for HIRA in the event of a weakening incident would also be necessary.” Doctors and hospitals oppose the revisions...only pharmacists are in favor In addition to the cautious stance expressed by MOHW and HIRA, there are many other expected legislative hurdles. The opposition of doctors and hospital organizations is one of them. In addition, legislation to promote dispensing substitute drugs is expected to be more difficult in the 22nd National Assembly. This is because the NA Health and Welfare Committee is composed of a large number of doctors. In the 21st National Assembly, the bill to promote dispensing substitute drugs failed to pass due to the strong opposition of a single lawmaker who was a physician, although a number of lawmakers, including 3 pharmacists (Young-Seok Seo, Jeong-sook Seo, and Hye-sook Jeon), emphasized the need for legislation. The ratio of doctors and pharmacists in the 22nd National Assembly's Welfare Committee was 5 (Yoon Kim, Myung-ok Seo, Jia Han, Sun-min Kim, Joo-young Lee) to 1 (Young-Seok Seo), which is a great increase in the cap compared to the 21st National Assembly. Just in the 1st Subcommittee of the Legislative and Judiciary Committee alone there are 3 physicians (Yoon Kim, Myung-ok Seo, and Joo-young Lee). Of course, it cannot be assumed that physicians will necessarily oppose the bill to enable dispensing of substitute drugs. However, it is widely believed that the majority of doctors will serve as a major obstacle to the bill's passage. The Korean Medical Association and the Korean Hospital Association also opposed the bill. The KMA said, “If the details of the dispensing substitute drugs are first sent to HIRA, pharmacists can arbitrarily change the drug without the consent of the doctor, which may undermine the doctor's prescription right. It will be difficult to respond quickly to the patient’s drug side effects and may cause liability problems for the prescriptions and side effects.” The KHA also said, “It may be difficult to share information on dispensing substitute drugs between doctors and pharmacists, which may delay the doctors' recognition of inappropriate substitutions and further actions required by the patients. Frequent changes to doctors’ prescriptions may affect treatment outcomes.” Only the Korean Pharmaceutical Association is in favor. “It is often difficult to notify the prescribing doctors and dentists due to lack of fax numbers or telephone connection failures,” said the KPA, ”Improving the process to electronically notify HIRA will eliminate administrative inconveniences and streamline the process to facilitate dispensing substitute drugs.”
- Company
- HK Inno.N and Roche will co-promote Avastin
- by Chon, Seung-Hyun Jan 22, 2025 05:54am
- Dalwon Kwak, CEO of HK Inno.N.(right), and Ezat Azem, General Manager of Roche Korea (left) HK Inno.N announced on the 21st that it has signed a co-promotion agreement with Roche Korea for Roche’s targeted anticancer drug Avastin (bevacizumab). Avastin is an anticancer drug indicated for the treatment of metastatic colorectal cancer, metastatic breast cancer, non-small cell lung cancer, advanced or metastatic renal cell carcinoma, glioblastoma, epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer, and cervical cancer. Under the agreement, HK. Inno.N will be responsible for marketing and sales of Avastin in colorectal and gynecologic cancers. Roche Korea will conduct sales and marketing of Avastin in areas other than colorectal and gynecologic cancers and conduct research and clinical trials to enhance the clinical value of Avastin. “This partnership is designed to address the unmet medical needs of patients in Korea and bring the clinical benefits of Avastin to more patients,” said the companies. “We are pleased to announce the co-promotion of Avastin following our agreement with Roche Korea to distribute and co-market the influenza treatments Xofluza and Tamiflu,” said Dalwon Kwak, CEO of HK Inno.N. ”The prevalence of colorectal and gynecologic cancers is rapidly increasing due to aging and lifestyle changes, and will work with patients and caregivers to help them overcome their cancers with Avastin.” Continuing innovation for the patients is a top priority for Roche Korea,” said Ezat Azem, General Manager of Roche Korea. “We look forward to leveraging the synergies of this agreement to further contribute to benefiting the lives of more people with cancer.” Avastin has been prescribed to more than 4.2 million cancer patients worldwide in the nearly 20 years since its FDA approval in 2004, treating 340,000 patients annually. In Korea, Avastin was first approved for metastatic colorectal cancer in 2005 and has since expanded to include 7 other cancer types, including non-small cell lung cancer, renal cell carcinoma, epithelial ovarian cancer, cervical cancer, and glioblastoma. When including the combination therapy with Tecentriq, it is indicated for the treatment of 8 cancers.
- Policy
- Yuyu seeks to expand the scope of its fexofenadine to ETC
- by Lee, Tak-Sun Jan 21, 2025 05:54am
- Yuyu Yuyu Pharma, which developed a 60mg OTC drug containing the antihistamine fexofenadine, is now seeking to enter the specialty drug market. Currently, only Handok, the original drugmaker, and Hanmi Pharm own a 180 mg fexofenadine product, but Yuyu Pharma is expected to barge in and pave its way into the two-drug market with its new product. According to industry sources on the 20th, Yuyu Pharma’s Fexoone Tab. 180mg (fexofenadine hydrochloride) will be reimbursed as of the 1st of next month. The upper insurance price ceiling was set at KRW 309 per tablet, which is cheaper than Handok’s Allegra Tab 180 mg (KRW 310) and Hanmi Pharmaceutical’s Fexonadine Tab 180 mg (KRW 314). Since there are two other drugs containing the same ingredient, and Yuyu Pharma met all the criteria for pricing premiums the company was able to receive the highest price of KRW 314, but Yuyu lowered its price to KRW 309 to become the lowest-priced drug in the market. Fexofenadine hydrochloride is a 2nd generation antihistamine. Depending on the dose, it is divided into over-the-counter and ethical-the-counter (specialty) drugs, with 60mg and 120mg classified as OTC and 30mg and 180mg classified as ETC drugs. However, Yuyu’s 60mg formulation recently received approval as an ETC drug. The 60mg dose, which was developed by Yuyu, has never been available before. The 120mg version is usually taken as a single pill before bed, but the effects do not last until the next day. In contrast, the company said that the 60mg version can as two pills a day to remain effective throughout the day. With Yuyu receiving approval for the 60mg formulation as an OTC, ETC, fexofenadine 60mg became an OTC/ETC drug. With the addition of Fexoone Tab 180 mg, Yuyu now has 4 fexofenadine products on Korea’s reimbursement list. The four items include Fexogien 60mg, an OTC drug, Fexogien 60mg, an ETC drug, and Alesta 120mg, a general drug. Of these, Fexozien 60mg and Fexoone 180mg have been or will be reimbursed. Yuyu’s focus on fexofenadine is likely influenced by the fact that the second-generation antihistamines olopatadine and bepotastine are undergoing reimbursement reevaluations this year. The company focused on developing fexofenadine as an alternative to these drugs. The original fexofenadine, Allegra, generated KRW 7.2 billion in outpatient prescription sales (UBIST) last year. It has the advantage of having steady market sales. It will be interesting to see if Yuyu’s fexofenadine expansion strategy will gain success.
- Policy
- CKD completes acquisition of diabetes drug 'Januvia'
- by Lee, Tak-Sun Jan 21, 2025 05:54am
- Chong Kun Dang has completed the sale transfer and takeover of 'Januvia (sitagliptin phosphate hydrate),' a diabetes drug that generates annual sales of KRW 23 billion in South Korea. Conseqently, what was previously labelled as MSD's is now labelled as Chong Kun Dang's in South Korea. According to industry sources on January 20, the pharmaceutical company label for three Januvia items (25 mg, 50 mg, 100 mg) registered in the National Health Insurance Service's reimbursement list will be changed from MSD Korea to Chong Kun Dang. The change is due to adjustments following the sale transfer and takeover. The insurance authority allows the final ceiling price to be the same as the transferred item if the acquired item holds the production rights. As a result, the prices will remain the same: KRW 200 for Januvia Tab 25 mg, KRW 301 for Januvia Tab 50 mg, and KRW 453 for Januvia Tab 100 mg. In 2023, Chong Kun Dang signed an agreement with the MSD headquarters to acquire all domestic rights for three items: Januvia, Janumet, and Janumet XR. Chong Kun Dang will acquire domestic sales and distribution rights, as well as approval, trademark, and production rights. The contract period is from July 15, 2025, to August 31, 2038. Chong Kun Dang has been selling the Januvia series since 2016 through joint promotion with MSD Korea. Now that Chong Kun Dang wholly owns Januvia's domestic rights, it has secured a stable cash cow. Januva recorded outpatient sales of KRW 23 billion in 20224, according to UBIST. The annual sales performance of Januvia, Janumet, and Janumet XR exceeds KRW 100 billion. Currently, Chong Kun Dang has completed the process for Januvia's permit and is expected to takeover the reimbursement permit soon. The company is proceeding with the sale transfer and takeover of Janumet XR Tab. Chong Kun Dang explained on the sale transfer and takeover of the Januvia series as "By securing the Januvia series in addition to previously acquiring Duvie, new drug for diabetes, we have stably expanded treatment options for patients."
- Policy
- MFDS approves Vyvgart for severe myasthenia gravis
- by Lee, Hye-Kyung Jan 21, 2025 05:54am
- The Ministry of Food and Drug Safety (MFDS, Minister Yu-Kyoung Oh) announced on the 20th that it has approved the orphan drug Vyvgart(efgartigimod alfa) for the treatment of adult patients with general myasthenia gravis (gMG) who are anti-AChR antibody positive. Myasthenia gravis is an autoimmune disease characterized by decreased neuromuscular signaling and generalized muscle weakness caused by IgG (Immunoglobulin G) autoantibodies that target components of the neuromuscular junction. Vyvgart Inj works by preventing the binding of autoantibody IgG to the neonatal Fc receptor (FcRn)*, which promotes the degradation of autoantibodies, bringing therapeutic benefit in patients with autoantibody-mediated myasthenia gravis. The neonatal Fc Receptor (FcRn) is specific for antibody IgG homeostasis in the body and prevents IgG from being degraded by lysosomes. This is the first drug to be approved in Korea with a new mechanism of action that binds to FcRn, and the approval is expected to broaden the treatment options for adult patients with myasthenia gravis. For reference, the MFDS designated the drug as the 22nd Global Innovative product on Fast Tracking (GIFT) (November 2023) and announced it would expedite its review so that it could be quickly introduced into the field for myasthenia gravis patients in Korea. “Based on our regulatory science expertise, we will continue to do our best to ensure that new therapies are quickly supplied to patients with rare diseases to expand treatment opportunities,” said the MFDS.
- Policy
- MFDS' pharma policy keyword, 'shorten time'
- by Lee, Hye-Kyung Jan 21, 2025 05:54am
- According to the business plan announced by the Ministry of Food and Drug Safety (MFDS) this year, support policy to facilitate quick market entry for new drugs and innovative products stands out. The 'Ministry of Food and Drug Safety's Major Policy Implementation Plan for 2025' announced on January 21 by the MFDS contains its aim to shorten the duration of development to commercialization using various systems. First, the MFDS will newly establish a dedicated review team this year to provide expert consultation services at each approval stage. Improvement of panel·process for approval·review. The new drug approval fee increased to KRW 410 million. The MFDS will prioritize document review and GMP site monitoring and plan to shorten the approval duration from 420 to 295 days. The MFDS will implement a priority review policy to expand the number of interview consultations (3→10) and prioritize the review of a document that requires supplementation as soon as it is completed. Additionally, the MFDS will improve the expetise of the review panel and regulatory capacity by continuosly expanding the percentage of experts within the review panel, including doctors and pharmacists, developing educational programs for the latest technologies, and conducting training programs customized to the panel's work experience (basic·core·intensive). Notably, companies can apply for a single pre-registration consultation session before applying for a new drug marketing authorization. It has been reported that two consultation sessions have been held to date. Kim Sang Bong, Director of the Pharmaceutical Safety Bureau, stated during the briefing held on January 20, "We have held two pre-registration consultation sessions until today." Kim added, "Yet, we do not have a record of the new drug application that was submitted." "The MFDS announced a documented plan for a procedure that is equivalent to the level of new drug assessment in advanced pharmaceuticals countries such as the U.S. and Europe," Kim said. "To efficiently run the annouced process, we will assign review panels and expand expert personnel with a strong background." Starting in April, the MFDS will implement a regulatory suitability review system where innovative product R&D research as part of government R&D projects will be selected and provide regulatory requirements, process, and commercialization strategy. The The MFDS will run a 'Path Program,' providing approval guidelines to support new technology-based product development, including gene diagnosis and antibody-drug conjugate technologies, and facilitating prior-registration consultation for each stage, such as clinical trials·approval, and expedited review. "The MFDS will implement a 'Path Program' linking the With-U prior-registration consultation, clinical trial review, and GIFT expedited review," Kim said. "Previously, we received a review that each program runs without smooth transition, so we designed a program to overlook the transition." The 'Path Program' is projected to shorten the time for innovative product development to commercialization. Kim stated, "We cannot guarantee that the time will greatly reduce, but the program has the advantage in terms of predictability and transparency." Kim Sang Bong, Director of the Pharmaceutical Safety BureauThe MFDS also plans to establish a stable pharmaceutical supply network this year. Starting in April, to prepare for the pharmaceutical supply shortage, the MFDS will set a preliminary report date of 180 days before the supply discontinuation of production and imports by pharmaceutical production·import companies and mandate reporting of supply shortage. "The government is in the process of establishing a safety network for efficient transaction between various policies, including national essential drugs, private-public committee for supply shortage, and consignment production·production by orders," Kim said. "Reporting of supply shortage is one of the advanced measures." "The pharmaceutical industry may take these updates as another regulatory measure, but the intent of these policies is to predict supply shortage in advance and to secure time for each policy measure to run smoothly," Kim said. "The MFDS aims to prevent supply shortage in advance and allow companies to receive administrative support."
- Company
- Astellas 'Xtandi' offers high efficacy with low side effects
- by Whang, byung-woo Jan 21, 2025 05:54am
- As more treatment options are covered by reimbursement, concerns about 'how' best to treat prostate cancer are increasing. Given the increasing number of prostate cancer patients increases each year, it is important to discuss which options to provide based on the patient's condition. Dr. Hong Koo Ha, Professor in the Department of Urology at Pusan National University HospitalThe specialist in the field, Dr. Hong Koo Ha, Professor in the Department of Urology at Pusan National University Hospital, emphasizes that there must be discussions about patient-customized treatment. The incidence of prostate cancer is rising among men diagnosed with cancer. The increase in diagnosis is attributed to factors such as aging, westernized dietary habits, and more frequent PSA (Prostate Specific Antigen) testing. "PSA testing was available in the past. However, prostate cancer surgery has increased 5-6-fold," Dr. Ha said. "Increased access to PSA testing due to heightened interest in changed dietary habits and disease has contributed to the increased incidence." Dr. Ha explained. What's different from the past is the variety of available treatment options. Dr. Ha analyzes that prostate cancer treatment options are extensive as new therapies continue to be introduced. "Most patients, when initially diagnosed, fall into the early-stage hormone-responsive prostate cancer where patients respond to hormone therapy. During diagnosis, metastasis affects the later treatment direction. The size of cancer also contributes significantly to prognosis and treatment response. The treatment course differs depending on the patient's condition, even in the mid-stage," Dr. Ha said. Hormone therapies play significant role…Extandi with extended reimbursement, 'positive sign' At the early stage of prostate cancer, surgery is recommended. When cancer progresses, combinations of surgery, radioactive therapy, and hormone therapy are used. And treatment outcomes have been reported to be similar to those received at the early stage. The issue arises when there is metastasis. According to Dr. Ha, a patient's survival period depends on the treatment selection in this case. Currently, when there is metastasis, the most common option is hormone therapy. Hormone therapy advanced after the first generation, and now three types of next-generation hormone therapy have been demonstrated to provide extended survival periods. One of the latest updates is approval of essential reimbursement to the use of Astellas Pharma's Xtandi (enzalutamide) in combination with an androgen deprivation therapy (ADT) for the treatment of hormone-responsive metastatic prostate cancer (HSPC). An expanded role of Extandi has been projected, as the drug can be used regardless of the presence of metastasis (whether in hormone-responsive prostate cancer or following biochemical relapse). Now that a year has passed since the expanded reimbursement, what would be Dr. Ha's opinion be on this? Dr. Ha focused on the effectiveness of Extandi and the low likelihood of side effects. "When outpatient patients with HSPC were treated with Extandi, the results were comparable to those of the ARCHES Phase 3 study, which demonstrated that Extandi significantly reduces disease progression and the death risk, were shown," Dr. Ha said. "As for side effects, Extandi is relatively free of side effects. Therefore, doctors prescribe this drug based on its proven safety and effectiveness." Previously, in the ARCHES Phase 3 study, a 'combination therapy of Extandi+ADT" has been shown to reduce radiographic Progression-Free Survival (rPFS) by 61%. "Extandi can be widely used in almost all patients with prostate cancer regardless of the presence of metastasis, and it is relatively free of side effects than other medications that are similar in administration methods and molecular formulation," Dr. Ha remarked. "As doctors, we are less burdened to explain side effects within the tight time of outpatient consultation." "Regional hospitals pay a crucial role in the treatment of prostate cancer, which requires continuous treatment" Also, Dr. Ha mentioned the role of regional medical centers where patients can continue to receive treatments for prostate cancer, which is diagnosed with increased age and patients have accompanying diseases. "Considering the nature of prostate cancer, we must discuss issues that arise during the continued treatment course. Continuance of treatment at initially diagnosed hospitals has the benefit of quick response when an unexpected issue arises and provides safe care for patients. Regional medical centers play an important role regarding this matter," Dr. Ha said. Dr. Ha recommends patient-customized therapy for the treatment of prostate cancer. Dr. Ha has been conducting collaborative research to develop methods for analyzing patient characteristics and diagnosing using Artificial Intelligence (AI). "Compared to data on prostate cancer surgery from 6-7 years ago, prostate cancer in South Korea had higher malignancy and stages than those in the United States. We are reviewing the proteomics data," Dr. Ha said. "Also, we are collaborating with a Korea-based AI company to use the latest trend AI for research on prostate cancer diagnosis." Additionally, Dr. Ha emphasizes that expanding reimbursement of prostate cancer treatment options and enabling government-funded PSA tests is essential. "Most prostate cancer treatments are costly. If government-funded insurance reimbursement is not applied, it is difficult for doctors to prescribe this medication to patients. We hope that a quick reimbursement process will provide practical and benefits for patients when new prostate cancer is introduced," Dr. Ha remarked. Dr. Ha added, "Cost-effectiveness is important for testing and screening. PSA test costs KRW 10,000 per session and can be done once every 1-2 years, which is relatively inexpensive." He added, "Conducting PSA tests more widely for early diagnosis of prostate cancer, early diagnosis of prostate cancer, can lead to efficient patient treatment and lower costs in the long run, which is projected to become the top cancer among men."
- Company
- Darzalex is granted reimb extension in Korea
- by Moon, sung-ho Jan 21, 2025 05:54am
- Multiple myeloma drug Darzalex (daratumumab) will enter the clinical field next month after successfully expanding its coverage. As new drugs such as bispecific antibody-based therapies are becoming the last treatment option in Korea, Darzalex’s success in expanding coverage has raised the prospect that combination therapy could emerge as the standard of care. # According to industry sources on the 18th, the National Health Insurance Service and Janssen Korea recently completed drug pricing negotiations on the multiple myeloma drug Darzalex for its reimbursement extension. Multiple myeloma is highly resistant and refractory to existing therapies and relapses frequently. Patients who have experienced triple-refractory multiple myeloma - those who have experienced three or more relapses or three or more failures to prior therapies - represent approximately 15% of all multiple myeloma patients and have a median life expectancy of only 5.1 months. Therefore, it is important to treat multiple myeloma with a combination of clinically proven agents from the earliest stage of diagnosis. In the global market, combination therapies that use Darzalex are regarded as the standard of care for the initial treatment of multiple myeloma. “Darzalex is used as a first-line treatment worldwide and is the first monoclonal antibody drug approved for the treatment of multiple myeloma,” said Dr. Chang-Ki Min, Professor of Hematology at St. Mary's Hospital in Seoul. ”Patients who are candidates for newer therapies such as CAR-T cell therapy and bispecific antibody therapy are those who have failed therapies using monoclonal antibodies such as Darzalex, proteasome inhibitors, and immunotherapies.” The DVTd regimen (Darzalex+Bortezomib+Thalidomide+Dexamethasone) is a 4-drug regimen that adds Darzalex to the VTd regimen (Bortezomib+Thalidomide+Dexamethasone). However, in Korea, Darzalex has been used only as a fourth-line monotherapy since it was approved for the treatment of relapsed or refractory multiple myeloma) that has received three prior therapies (fourth or later line). Among them, Janssen Korea has been actively promoting the reimbursement extension of Darzalex since last year and recently agreed to negotiate the drug price with the National Health Insurance Service, which is the final step. Following the conclusion of the drug price negotiations, the Health Insurance Review and Assessment Service has also started revising the anticancer drug reimbursement standards. In other words, HIRA has decided to establish reimbursement standards for DVTd therapy for multiple myeloma patients who have not previously received chemotherapy. HIRA explained that DVTd therapy is “mentioned in many textbooks, and is recommended as category 2A in the NCCN guidelines and as the new standard induction therapy in the ESMO guidelines ([I, A]). However, the ESMO guidelines state that there is no established standard of care for consolidation therapy.” It added, “This regimen consists of 4 cycles (induction) and 2 cycles (consolidation) before and after hematopoietic stem cell transplantation, however, the consolidation therapy is not yet a standard of care in this disease, so the reimbursement standard is set only for the 4 cycles of induction therapy, considering how maintenance therapy is also reimbursed after transplantation, reducing the medical need for consolidation therapy.” With the drug price negotiations settled and the HIRA’s reimbursement notice, it is likely that the reimbursement extension will take effect next month. In the clinic, when the Darzalex-containing DVTd therapy is reimbursed as a first-line therapy, subsequent treatment strategies will also likely be quickly revised. Bispecific antibodies and the CAR-T therapy Kymriah will likely become more prominent as fourth-line options for multiple myeloma. Bispecific antibody-based drugs include Janssen's Tecvayli (teclistamab), Talvey (talquetamab), and Pfizer's Elrexfio (elranatamab). These drugs have been approved and used in the field as the fourth-line therapy option for multiple myeloma in recent years. At the same time, Janssen also has a CAR-T treatment, Carvykti (ciltacabtagene autoleucel), approved in Korea. “Without Darzalex, the application of the latest therapies, such as CAR-T therapies and bispecific antibody drugs, may be delayed,” said a professor of Hematology at a tertiary hospital who requested anonymity. ”According to current standards, patients must first use Darzalex before receiving CAR-T cell therapy. This delays access to effective treatments.” “If Darzalex’s reimbursement is successfully extended, the reimbursement challenges of bispecific antibody drugs will rise as a hot topic this year.”
- Company
- Only half of the multiple myeloma drugs reimb in KOR
- by Eo, Yun-Ho Jan 20, 2025 05:54am
- Despite the increased number of treatment options, patient access to those multiple myeloma drug options has not changed much. Multiple myeloma remains an incurable disease, but in the past, survival rates were very low due to limited treatment options. In recent years, however, innovative treatment options such as monoclonal antibodies, CAR-T therapies, and bispecific antibodies have diversified the treatment options, improving survival. In fact, over the past 20 years, the five-year survival rate for multiple myeloma patients has increased from 29.8% in 2001-2005 to about 50.1% in 2017-2021. However, this is still less than the 60% survival rate found in developed countries such as the United States, and limitation in access to care is regarded as the major contributing factor. Only half of the guideline-recommended drugs are reimbursed in Korea In Korea, only 13 (52%) of the 22 drugs recommended in the NCCN guidelines for multiple myeloma are covered by reimbursement (based on the NCCN guidelines 2024 v2). For example, Darzalex (daratumumab) was approved in 2019 as a first-line combination therapy for multiple myeloma but was only granted reimbursement as a fourth-line monotherapy in Korea. In October last year, 5 years since the Drug Reimbursement Evaluation Committee recognized the appropriateness of expanding Darzalex’s reimbursement coverage under the Risk Sharing Agreement (RSA). Also, Xpovio (selinexor) was granted reimbursement in July 2024, after 4 reimbursement attempts after its approval in 2021. Burden of proving cost-effectiveness for rare cancers such as multiple myeloma One of the reasons why it takes longer to reimburse the crucial multiple myeloma drugs and hinders access is that multiple myeloma is a rare cancer, which renders it more difficult to prove cost-effectiveness than other cancer drugs. In order to apply for reimbursement of high-priced anticancer drugs, the companies must submit data that demonstrates the drug’s cost-effectiveness, as per the guidelines for pharmacoeconomic evaluations. In particular, due to the rising financial expense spent on anticancer drugs in recent years, the government has been setting higher standards for the submitted data to demonstrate the improvement in the effectiveness of new drugs over existing drugs. However, multiple myeloma is similar to rare diseases in that it has a limited number of patients that can enroll in clinical trials, and it is difficult to set a comparator drug. In the case of anticancer and rare disease drugs, clinical trials often have a single-arm design or are limited to Phase II studies, which introduces uncertainties and challenges in the reimbursement review process. Add to this, the number of new treatment options has been growing. Recently, bispecific antibodies, which are regarded as the next-generation biotechnology, have been approved and released for multiple myeloma. Bispecific antibody treatments are immune cell therapies that consist of two monoclonal antibodies that recognize the target antigens of multiple myeloma and T cells. Bispecific IgG2 kappa antibodies, which are composed of two monoclonal antibodies that recognize the target antigens of multiple myeloma, B-cell maturation antigen (BCMA) and CD3 antigen, respectively, are common and are a novel treatment that directly targets cytotoxic T cells to BCMA-expressing multiple myeloma cells. Despite their high clinical efficacy, the bispecific antibody therapies currently approved in Korea, including Pfizer's Elrexfio (elranatamab) and Janssen's Tecvayli (teclistamab) and Talvey (talquetamab), remain non-reimbursed. Suk Jin Kim, Professor of Hematology-Oncology at Samsung Medical Center and the President of the Society of Hematology said, “Although treatment outcomes have improved significantly with the active development of new drugs, the limited access to high-priced anticancer drugs have been preventing patients from receiving optimal treatment as needed.” Kim added, “Policy changes are needed, including flexibility in Korea’s reimbursement standards, to ensure that patients in Korea have access to treatment that meets global standards. We must urgently expand patient access to treatment through early adoption of innovative therapies to close Korea’s survival gap compared with other countries.”
