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- 2026-05-21 06:30:12
- Opinion
- [Reporter’s View] At least a guideline for ‘class effect’
- by Eo, Yun-Ho Jan 03, 2020 06:33am
- ‘Recognizing expected efficacy of drugs with same mechanism of action.’ It is definitely an unresolved conundrum. Experts have clashing opinions and each pharmaceutical company has different interests. In the end, what it comes down to is ‘case by case.’ Not that it needs an answer key, but obviously the prescribing doctor’s decision based on experience and medical knowledge is important. The problem is consistency in applying healthcare insurance reimbursement. For some classes, the effects are recognized regardless of the approved label and equivalent reimbursement criteria are applied, but some other classes have different scope of labels approved. Reimbursement expansion on combination therapy of sodium-glucose cotransporter-2 (SGLT-2) inhibitor, currently pending without much of progress from 2018, would be a good example. As Korean Diabetes Association (KDA) failed to settle a dispute over expanding reimbursement on off-label anti-diabetic combination therapies including SGLT-2 inhibitor, dipeptidyl peptidase-4 (DPP-4) inhibitor and thiazolidinedione (TZD), the government that initially had intention to expand reimbursement on the off-label use, is now hesitant to take a further step. An odd phenomenon of the doctors opposing on expanding reimbursement is happening because of the dispute over class effect. Originally, it was the medical industry that started the discussion of providing reimbursement on anti-diabetic combination therapy. Apparently, doctors had experiences of confusion in prescribing as each drug in same class had different indications, and eventually had reduced reimbursement. In 2013, expanding reimbursement on combination therapy with DPP-4 inhibitor and TZD went through the same ordeal. However, the results were different. The medical industry valuing clinical evidence and expert’s judgment over approved label and financial impact was unprecedented as well. Class effects of DPP-4 inhibitor and SGLT-2 inhibitor, as stated by Korea’s reimbursement standard on orally taken anti-diabetic treatment, have been polarized so far. However, the possibility is still out there. Some expects positive outcome of a former professor at Seoul St. Mary’s Hospital, Yoon Kun-ho, elected as the president of KDA. The former professor used to actively demand for reimbursement on the combination therapy in 2013. We are talking about prescription drug. It doesn’t hurt to be careful. Some might say it better be rather careful. But, if their agenda is to recognize the class effect, then they should set a guideline on ‘required time for properly building up prescription experience, or prescription volume.’ There may be an expectation in the current situation, but there is no promise. If properties of disease are different, then a manual on class effect by each disease is essential. There is no need for the government to worry about the industry getting too confident about class effect and lazy on clinical trial. They know very well that abundant academic data is more powerful in the field than qualifying for reimbursement criteria.
- Policy
- Only 6 out of 9 reimbursed use of Spinraza approved
- by Lee, Hye-Kyung Jan 03, 2020 06:31am
- Only 66.6 percent of preliminary approval applications for reimbursement submitted last month was cleared for the use of spinal muscular atrophy (SMA) treatment Spinraza (nusinersen). Six out of nine applications were approved, and other three applications were rejected with conditional approval, disapproval and required supplementary data. On Dec. 31, Health Insurance Review and Assessment Service (HIRA, President Kim Seung-taek) officially disclosed outcomes of reimbursement review on four items—Spinraza, Soliris, ventricular assist device (VAD), and hematopoietic stem cell transplantation—deliberated by Healthcare Review & Assessment Committee in November 2019. Spinraza has been listed for reimbursement since last Apr. 8, but a healthcare institute intending to use super-high-cost treatment priced at 92.36 million won per 5 ml has to apply for a preliminary approval for reimbursement. For reimbursement on the treatment, a patient has to qualify for all conditions of lacking 5q SMN-1 gene or being diagnosed with gene mutation; SMA related clinical symptoms and signs onset from age younger than three; and not in use permanent ventilator. A well-known unapproved case was a 14-year-old male patient with SMA, who could not clearly prove his age of SMA-related symptom and sign onset was younger than 36-month-old according to the submitted data. The committee did not approve the application without proper objective data. A conditional approval was granted on 24-year-old female patient with a record of scoliosis surgery as her myelogram result proved she is able to take continuous administration into her dura mater with lumber puncture. However, the approval condition was submission of the confirmed number of SMN2 copy with the monitoring report. Soliris (eculizumab) was available for preliminary approval for reimbursement prior to Spinraza, and had six applications submitted for treating atypical hemolytic uremic syndrome (aHUS). But only one was approved out of all. A 49-year-old male patient was approved with reimbursed use of Soliris as he had recurrent thrombotic microangiopathy and kidney dysfunction, despite he had conservative treatment after ABO-incompatible kidney transplantation. Although HIRA found, reviewing his medical record, thrombotic microangiopathy has occurred after the kidney transplantation and using immunosuppressant, it approved of the reimbursed use because the patient had clinical symptoms of aHUS and also continued to show thrombotic microangiopathy symptoms with no apparent response to hemodialysis and therapeutic plasma exchange. But the patient has been ordered to submit genetic testing result and two-month monitoring report. His feasibility of maintained reimbursement would be deliberated depending on the clinical result.
- Company
- Daewoong launches 'Nabota' Phase III clinical trial in China
- by An, Kyung-Jin Jan 02, 2020 11:26pm
- On the 28th, Sung-soo Park , Director of Nabota Business Division, Daewoong Pharm. Co., Ltd (Third left in front row) is taking commemorative photos with the researchers such as Yu-ri Pan, professor of dermatology (Fourth left in front row) of Zhejiang Provincial PeopleNabota, a botulinum toxin preparation developed by Daewoong Pharm. Co., Ltd (CEO Seung-ho Jeon), has begun preparations for clinical trials in China. Daewoong Pharm. Co., Ltd announced on the 31st that it held a researcher meeting for Nabota's phase III clinical trials in China at the Pullman Skyway Hotel in Shanghai on the 28th. Daewoong Pharm. Co., Ltd aimed to release the product in 2022 after acquiring Nabota's moderate to severe frown lines improvement indications in China. Daewoong Pharm. Co., Ltd plans to demonstrate non-inferiority and safety by comparing Nabota with the reference drug for 16 weeks in 500 patients with moderate or higher frown lines. The clinical trials will be conducted in 12 institutions, including the 9th Hospital of Shanghai Jiao Tong University, which is famous for its plastic surgery in China. Around 60 people attended the meeting, including professors in the 9th Hospital of Shanghai Chung-Ang University Hospital including the chief clinical officer of China, Chung Bong Lee, clinical researchers and hospital staff. In addition to the announcement of China's Phase III trial plan and questions and answers, Nabota products and clinical trial experiences were introduced. In order to improve understanding of the product and clinical trials, Dr. Won-Woo Choi, a dermatologist of the Wells Dermatology Center, conducted a training program to assist in the launching of clinical trials such as the method for evaluating the frown lines. Chung Bong Lee, Professor of the 9th Hospital of Shanghai Chung-Ang University Hospital said, “2020 is the most anticipated time of change in the medical beauty market. Many people are looking forward to new products, and Nabota will strive to become a successful importer of botulinum toxin in China”. Sung-Soo Park, director of Nabota Business Division, Daewoong Pharm. Co., Ltd, said, “China has the largest number of patients in the world, while its market penetration rate is as low as 2%. The market is expected to grow the most in the future because there are only two licensed drugs. If a high-quality, reasonably priced product, such as Nabota, is officially approved and supplied to the market, Chinese potential patients will be able to receive botulinum toxin procedures more easily and safely”.
- Policy
- Rare cancer reoccurred in patients with Allergan’s implants
- by Lee, Tak-Sun Jan 02, 2020 11:21pm
- Another patient with rare cancer developed after breast augmentation with Allergan’s coarse surface implants. This is the second time since it was first reported in Korea on August 14th. The Minister of Food and Drug Safety, Eui-Kyung Lee and the Korean Society of Plastic and Reconstructive Surgeon(Chairman, Kwang Seog Kim) announced on the 26th that an additional patient with breast implant-related anaplastic large cell lymphoma (BIA-ALCL) was reported on the 24th. Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a rare cancer associated with the immune system that is separate from breast cancer. Suspicious symptoms include changes in the size of the breast caused by serousomas, lumps or skin rashes on the skin. The patient, a woman in her 40s, underwent breast enlargement using rough surface implants from Allergan in 2013. After swelling in the chest recently, a pathology examination was performed at a university hospital. The patient was diagnosed with BIA-ALCL and reported to the MFDS and the Korean Society of Plastic and Reconstructive Surgeon. The patient visited the medical institution promptly and received the BIA-ALCL test in accordance with safety information, such as how to respond to suspected BIA-ALCL symptoms reported by the MFDS and medical institution. On the 26th after final confirmation with BIA-ALCL, additional tests such as positron emission computed tomography (PET-CT) confirmed that BIA-ALCL did not spread to other sites. The MFDS explained that the patient is currently working on a treatment plan, including removal of the implant. Meanwhile, according to the compensation plan for patients with rough surface breast implants on Sep 30, Allergan will pay medical expenses for the patient. The MFDS and the Korean Society of Plastic and Reconstructive Surgeon are conducting patient registration studies to minimize the difficulty of patients with breast implants and improve safety, and will continue to implement more rapid measures through continuous monitoring of adverse event information. In addition, They have repeatedly asked patients with breast implants to visit and see a medical professional if they have any suspected symptoms, such as a sudden change in breast shape.
- Policy
- Reimbursed Dupixent requires prior prescription record
- by Kim, Jung-Ju Jan 02, 2020 11:20pm
- The reimbursement criteria for patients taking now listed Sanofi Aventis Korea’s severe atopic dermatitis treatment Dupixent Pre-filled syringe 300 mg (dupilumab) were officially disclosed. Reimbursement on the treatment is granted for an adult patient age over 18 with chronic and severe atopic dermatitis symptoms continuing over three years, who has a record of topical treatment and systemic immunosuppressive therapy within six months. And when the patient has to resume treatment after a hiatus with a medical reason would also be granted with reimbursement under certain circumstances. Korea’s Ministry of Health and Welfare (MOHW) recently announced partially revised ‘National Health Insurance Reimbursement Listing Criteria and Method’ reflecting the details of the newly listed atopic dermatitis treatment. Dupixent is a first non-anticancer or rare disease treatment in Korea to have signed the risk sharing agreement (RSA) with the government. However, patients requesting for National Health Insurance reimbursement on the treatment have to qualify for a list of conditions. ◆ Patient condition = According to the announcement, the treatment is listed for treating chronic severe atopic dermatitis patient over the age of 18 with symptoms continuing over three years. Also, the adult patient should have symptoms unable to be managed after four-week topical treatment (corticosteroids or calcineurin inhibitor) as first-line treatment, and not showing more than 50 percent decrease of Eczema Area Severity Index (EASI) score after three-month systemic immunosuppressant therapy (cyclosporine or methotrexate), and have EASI score over 23 before administrating the treatment. Also, the patient has to have a record to receiving topical treatment and systemic immunosuppressant therapy within past six months. ◆ Reimbursement evaluation = Reimbursement is granted for six months more after 14 weeks of administration and the patient showing more than 75 percent decrease of EASI score at week 16. From then on, reimbursement would be granted continuously when the result of initial evaluation response is maintained in EASI evaluation every six months. By principle, the reimbursement is limited to in-patient prescription only, and an outpatient prescription for a patient discharged from hospital covers four-week of dose of the treatment at most. However, for patients demonstrating stable disease activity and no adverse reaction at week 24 after the initial administration, their outpatient prescription can cover up to eight to 12 weeks of dose. To confirm a patient’s self-injection record during the administration period, the patient has to document ‘daily administration log’ and their healthcare institute has to confirm and oversee the daily log. A doctor specializing in atopic dermatitis related department like a department of dermatology or allergy has to prescribe the treatment, and objective data of the prescribed patient and their response assessment result of multiple dose administration (past treatment record, EASI evaluation result, photos of patient body with symptoms) should be handed in. ◆ Reimbursement when resuming treatment after hiatus = Patients needs to pass a certain condition to receive reimbursement again when resuming the treatment after a hiatus for medical reason. Patients, who had a hiatus before the first response assessment at week 16, may receive reimbursement for resumed treatment if the patient qualifies for the initial administration standard (EASI score over 23). On the other hand, two conditions apply for a treatment-resuming patient, who took hiatus after the initial response assessment followed by multiple dose treatment. Resuming after a hiatus shorter than three months would be considered continuous administration. But a patient would have pass the initial administration standard (EASI score over 23) to receive the reimbursement again if the hiatus was longer than three months. MOHW plans to collect public opinion until Jan 30, and to finalize the revision on Jan 31. Contact Pharmaceutical Management Department of Health Insurance Review and Assessment Service (HIRA) for inquiries on the details of the announcement.
- Policy
- ₩2.8 billion will be invested in AI drug development
- by Kim, Jung-Ju Jan 02, 2020 06:09am
- The government will greatly strengthen investment in innovation growth in the biohealth sector, which is called the future food industry, such as the pharmaceutical industry and increased the budget by 13% to ₩527 billion, and doubled the budget by building big data, new drug development platform, and support for the development of the pharmaceutical industry this year. The MOHW responded to pending questions on the Korean Special Press Association. First, this year's total budget is ₩82.5 trillion, an increase of 13.8% from last year. Among them, the MOHW’s budget increased ₩1.35 trillion by 11.7%. Looking at the biohealth sector, which includes pharmaceuticals, investment for innovation growth in the pharmaceutical, medical data, and medical device sectors will be greatly strengthened. This year's major R & D budget for health care is ₩527.8 billion, up 13% from ₩466.9 billion last year. The amount increased by 60.9 billion won. The government will establish a new drug development platform utilizing the 4th Industrial Revolution technology and discover core experts in pharmaceutical and biotechnology. The AI drug development platform was set at ₩2.8 billion, up ₩300 million(11.1%) from last year's ₩2.5 billion. In order to innovate biohealth technology, the budget of ₩15 billion was also reflected in the development of big data platform for genome and medical clinical information. Bio big data development is a pan-government project in connection with the Ministry of Welfare, the Ministry of Science and ICT, and the Ministry of Trade, Industry and Energy. In addition, the government invest ₩9.3 billion, will newly select and support five medical data-centric hospitals. As the Advanced Renewable Bio Act comes into effect in August, a budget will be invested in establishing a regenerative medical safety management system. The Ministry of Health and Welfare decided to reflect the budget of ₩1.2 billion to establish a clinical research system for rare and intractable diseases and to establish a safety management system. In the case of medical devices, the MOHW decided to support R&D to commercialization and expand investment to strengthen industrial competitiveness. A total of ₩30.2 billion was newly organized for full-cycle R&D development, and a budget of ₩8.6 billion was increased by ₩3.9 billion(82.4%) year-on-year to strengthen industrial competitiveness. In addition, the cosmetics industry plans to raise ₩7.74 billion to support localization of materials and development of technology to respond to market diversification to foster sustainable future growth engines.
- InterView
- “Key to healthcare innovation is pharmaceutical industry"
- by Kim, Jung-Ju Jan 02, 2020 06:08am
- Korea’s Ministry of Health and Welfare (MOHW) has stated two core goals of the current administration are ‘creating an inclusive welfare state’ and ‘supporting innovative growth of emerging industry.’ The key is definitely the pharmaceutical industry. During a question and answer session with correspondents, Park Min-soo, a director of Health Insurance Policy Bureau under Office for Planning and Coordination at MOHW, said this year the ministry is committed to support all-around new drug development covering from basic science research to commercialization, and to strengthen industry competitiveness. Director Park, in charge of the ministry’s budget plan each year, allocated 12.9 trillion won on healthcare sector this year. The plan reflects the record-high National Health Insurance state funding of 1.86 trillion won, whereas 2.7 trillion won was allocated besides for healthcare. Director Park stressed the importance of pharmaceutical industry among the industries government is backing up. He elaborated, “Other than the goal of creating inclusive welfare state, the government is devoted to support innovative growth of emerging industry.” “The government is trying to find the hidden gem of the healthcare industry and create an environment to polish it. Among the emerging industries of IT, bio, pharmaceuticals, agriculture, and food the government is currently pushing on for innovation, the pharmaceutical industry is the most valuable key,” he continued. One of ongoing inter-ministerial programs supporting the key industry is the big data platform project. Director Park explained, “Big data utilization is expected to embody vast amount of data, but it needs the government to build a foundation to optimize utilization of the information, because it has a limitation of private information protection.” So apparently the director allocated budget to connect the dots between dispersed information. Government support for R&D is another highly expected project. He emphasized the investment value for R&D is high as Korea’s R&D investment rate against GDP is at worlds highest. “From basic science research to commercialization, we need to bridge the gaps to ultimately make a living out of the industry. To strengthen the industry competitiveness, the ministry would support new drug development in every step of the way and also train specialists to reinforce the industry strength,” Director Park said. He added, “Laying the groundwork for the R&D system would encourage more research activities and contribute on advancing technology further. The result may not be tangible immediately, but the government is committed to continue support it.” Moreover, Director Park explained about MOHW’s plan to open a tentatively named ‘Office for Health Policy’ that reinforces government’s preventive healthcare programs to reduce medical expense and solve the issue of increasing dependants in the aging society. Additionally, he emphasized the importance of preventive healthcare programs to get under way from this year. “The point of the policy in the end is to make people live their lives without dealing with serious health condition. Mobile Healthcare program providing high-risk chronic disease management would open 30 more centers this year, while the mental health sector would secure human resources and open Emergency Intervention Team with 39 percent increase in budget,” he said.
- Product
- Samsung completes Phase III of Lucentis Biosimilar
- by Lee, Seok-Jun Jan 02, 2020 06:08am
- Samsung Bioepis’ Lucentis Biosimilar (SB11)' phase III completed. Lucentis' global sales last year were about ￦4.2 trillion. Samsung Bioepis recently announced its last patient visit for the SB11 phase III trial was done. Phase III examined compared non-inferiority with the original Lucentis in a total of 705 patients with Wet Age-related Macular Degeneration from Mar 2018. Lucentis is a treatment for eye diseases such as macular degeneration and diabetic macular edema, jointly developed by Roche’s subsidiary Genentech and Novartis, multinational pharmaceuticals. Samsung Bioepis plans to announce the results of phase III next year and proceed with the marketing authorization application process in Europe and the United States. SB11 is Samsung Bioepis' first eye disease treatment project. Meanwhile, Samsung Bioepis recently signed marketing partnerships about two types of eye disease treatment pipelines (SB11: Lucentis Biosimilar, SB15: Ilia Biosimilar) with Biogen, including the US and Europe. SB15 is a case that recognized market value from partners even though it is a candidate for clinical preparation.
- Policy
- Lipiodol’s gap recurrence prevention law is pushed forward
- by Lee, Jeong-Hwan Jan 02, 2020 06:06am
- A bill, which the government is obliged to conduct regular surveys on the state of supply of essential medicines, to build a stable supply environment will be promoted. The legislative goal is to prevent the gap of essential medicines to prepare for major national disasters such as terrorism and radioactive pollution. Representative Myung-yeon Kim of the National Assembly's Health and Welfare Committee (Danwon gu, Ansan, Liberty Korea Party) presented the proposed amendment to the pharmaceutical affairs law on the 30th. Under the current law, national essential medicines are necessary for health and medical services such as disease control and radiological disaster prevention, but they are difficult to supply in a stable manner due to lack of marketability. Related departments, such as the MFDS, are designating and managing 351 items. But Representative Kim criticized that the vast majority of emergency medicines for terrorism and radiological warfare were less than a tenth of statutory reserves. In particular, in 2018, the sale of special contrast agent 'Lipiodol', which is used to treat liver cancer, was stopped. In January of this year, anxiety arose due to unstable supply of essential drugs, such as the anti-cancer and glaucoma drug ' Mitomycin', which is in danger of being stopped. In order to solve the problem, Representative Kim said he proposed an amendment to the Pharmaceutical Affairs Law that strengthens the responsibility for the Agency to function as a national essential drug control center and specially manages the supply situation such as complete enumeration of the expiration date. Representative Kim said, “The current stockpile and stockpiling location of essential medicines are not well understood, and it is expected that this amendment will proactively respond to national emergency situations”.
- Policy
- Report find MFDS cleared 112 IMDs in past decade
- by Lee, Tak-Sun Jan 02, 2020 06:05am
- Apparently, more than half of incrementally modified drugs (IMDs) approved in the past decade were combination drug. And majority of them were approved for treating chronic disease. On Dec. 30, Korea’s Ministry of Food and Safety (Minister Lee Eui-kyung) published ‘IMD Approval Report’ reviewing current status and past cases of approved IMDs. The report was compiled to inform the IMD-developing companies of approval criteria, approval failed cases and a list of all approved IMDs in the past decade, since the IMD approval was implemented from 2008, to enhance the predictability of the approval system. The report found the total of 112 IMDs has been cleared from 2009 to last November. Breaking down the approval list, 62 items (55.4 percent) ‘improved effectiveness,’ 39 items (34.8 percent) ‘improved usability,’ seven items (6.3 percent) was ‘recognized with innovativeness of pharmaceutical technology,’ and four items (3.5 percent) ‘improved safety.’ 62 items, recognized with improved effectiveness, were all combination drugs (two or more active ingredients are combined as one item). Among which, 52 items were dual agent combination drug and ten items were triple agent combination drug. 39 items, recognized with improved usability, were approved with decreased dose or more convenient administration method providing better drug adherence. Approved IMDs from 2009 to Nov. 2019 Breaking down the list again by class, 47 items (40.4 percent) were for cardiovascular and circulatory system drugs (antihypertensive, anti-arteriosclerotic drug), while 16 items (14.3 percent) were anti-diabetic drugs. It was apparent the majority of IMDs were developed for chronic disease (hypertension, hyperlipidemia, diabetes and etc.). The key finding was that Korea entering the era of aging society is resulting in increased chronic disease, and accordingly, pharmaceutical companies have developed more drugs with simplified multiple drug dose or administration method for better drug adherence. Analyzing the drug development types, 70 items (62.5 percent) improved safety (reduced adverse reaction) or effective (increased treatment effect) and 29 items (25.9 percent) improved dose and administration by lessening frequency of administration (twice-daily to once-daily, or three times-daily to twice-daily). MFDS official explained, “We expect the report would provide practical information to Korean pharmaceutical companies currently developing or preparing drugs in different types. The ministry would continue to provide more useful information to the industry for developing new drugs.”
