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- 2026-05-18 11:04:06
- Company
- Reimbursement for Olumiant in AD is being discussed
- by Eo, Yun-Ho Nov 05, 2021 05:24am
- Discussions on increasing coverage for atopic dermatitis treatments continue. According to industry sources, the authorities have completed collecting expert opinions on Lilly’s JAK inhibitor ‘Olumiant (baricitinib)’ Sanofi’s ‘Dupixent (dupilumab)’ and is awaiting deliberation by the Health Insurance Review and Assessment Service’s Insurance Benefit Standard Subcommittee. The progress comes 5 months after the company submitted its application in May. Discussions for another JAK inhibitor, Dupixent, had also started in earnest 7 months after its application. In this context, whether the addition of Olumiant will spur discussions on expanding coverage in atopic dermatitis remains to be seen. Olumiant is a new drug for moderate-to-severe atopic dermatitis that applied for reimbursement at a more economical price than the recently-listed new atopic dermatitis treatment, ‘Dupixent (dupilumab).’ The drug t selectively and reversibly inhibits JAK1 and JAK2 to reduce the expression of inflammatory cytokines and shows an overall anti-inflammatory effect. The efficacy and safety of Olumiant was identified in the three clinical trials - BREEZE-AD1, BREEZE-AD2, BREEZE-AD7 – as a monotherapy and combination therapy with a topical corticosteroid (TCS) in adult patients with moderate to severe AD. In particular, Olumiant rapidly improved itching that severely deteriorates the quality of life from Day 2 in the three clinical trials. Chang-Wook Park, Professor of Dermatology at Severance Hospital said, “Olumiant can bring hope to AD patients in Korea who have had limited treatment options, as the drug showed rapid symptom improvement in patient-reported outcomes from Day 2 of treatment.” Also, one other JAK inhibitor is attempting to expand its reimbursement to atopic dermatitis. Last month, Abbvie applied to expand reimbursement of its ‘Rinvoq (upadacitinib)’ to atopic dermatitis. Discussion for Rinvoq has not started yet, but its efficacy was verified through the Phase IIIb Heads Up study, a head-to-head trial between Rinvoq and Dupixent.
- Policy
- Taiwanese PharmaEssentia got a business license
- by Lee, Tak-Sun Nov 05, 2021 05:24am
- PharmaEssentia, a Korean subsidiary of PharmaEssentia, a Taiwanese pharmaceutical company, has obtained a drug business license. The first CEO of PharmaEssentia in Korea is Haksun Moon, former representative of Novartis Korea. The MFDS granted PharmaEssentia Korea a drug business license as of the 4th. The first factory is located on the 14920th floor of Sejong-daero, Jongno-gu, Seoul. On the 13th of last month, the company obtained a domestic product license for Besremi (Ropeginterferon alpha-2B), a treatment for rare diseases. Meditip, a licensing agency, was approved because PharmaEssentia was not granted business license. The drug is said to be manufactured at the PharmaEssentia plant in Science Park, Taiwan, and imported from Korea. Besremi also received European EMA approval in 2019, and in June, it applied for approval from the FDA. PharmaEssentia was founded in 2003 under the leadership of Taiwanese Americans and is currently headquartered in Taipei, Taiwan. It has branches not only in Korea, but also in the United States, China, and Japan, and has Asian branches in Hong Kong. orea PharmaEssentia The first CEO of PharmaEssentia Korea is Haksun Moon, former representative of Novartis Korea. CEO Moon, who graduated from Kyung Hee University (Dept. Biology) and obtained a Master of MBA from Sungkyunkwan University, joined Novartis Korea as a CRA in 1994 and worked for more than a decade as the first Korean to become a representative. However, Novartis Korea stepped down after a year as he was involved in illegal rebates, and was later recruited by Helixmith to serve as vice president. CEO Moon also served as the president of a Taiwanese subsidiary when he was in Novartis, so communication with PharmaEssentia's headquarters is expected to be smooth. PharmaEssentia Korea is also known to have recently acquired the domestic copyright of the new drug Klisyri (Tirbanibulin), which is expected to launch a business in Korea in earnest.
- Company
- LG Chem, developing a new drug that has never existed before
- by Lee, Seok-Jun Nov 05, 2021 05:24am
- LG Chem has started clinical development to develop next-generation osteoarthritis treatments that have not existed before. Osteoarthritis is a degenerative disease that causes pain and gait disorders due to inflammation in the joints and cartilage wear. LG Chem announced on the 4th that it has been approved for phase 1b/2 clinical trials of LG34053, a new drug candidate for osteoarthritis treatment. The company will conduct a study at SMC to evaluate indicators such as safety and drug resistance, pharmacokinetics (drug absorption, distribution, metabolism, and elimination) and select optimal doses for patients with mild and moderate knee osteoarthritis (K&L 2-3). LG34053 is an injection-type new drug that blocks inflammatory pathways of new mechanisms and inhibits cartilage cell death. Preclinical results have improved pain relief effects, as well as cartilage damage, the root cause of arthritis. LG Chem is planning to expand its region to Australia and conduct phase 1b/2 clinical trials to secure global clinical data. Since then, it plans to carry out Phase III global commercialization in the U.S. and other regions and start global commercialization from 2028. According to global market research data, the osteoarthritis market in seven major countries with large medical markets, including the United States, Japan, Germany, France, the United Kingdom, Italy and Spain, is expected to form KRW 2 trillion by 2028.
- Opinion
- [Reporter’s View] New drugs for Alzheimer’s in development
- by Nov 05, 2021 05:24am
- "I felt like it was all a dream. But I wasn't sure if I was young dreaming that I’m older, or I was old dreaming that I was younger. I have Alzheimer's." This is what Hye-Ja Kim, acting as a dementia patient in the “The Light in Your Eyes” TV drama two years ago, said as she revealed her condition to her friends. The drama gained much acclaim with the twist that the story depicted the world from an Alzheimer’s patient's view rather than being a common ‘time leap (time travel)’ story. The most common cause of dementia among the 840,000 dementia patients over the age of 65 in Korea is Alzheimer’s. The exact pathogenesis or cause of Alzheimer’s remains unknown, but it is being presumed that the condition is caused by Beta-amyloid and tau deposition. One of the reasons why Alzheimer’s was feared was because no drug could fundamentally treat the disease, and only drugs used to improve cognitive function were available. Countless global pharmaceutical companies had attempted to develop treatments to no avail. With no treatment available, prevention was considered as the only option for Alzheimer’s. However, the field has entered a new turning point this year with Biogen introducing a new treatment for Alzheimer's. Biogen's 'aducanumab (product name: Aduhelm),' was approved by the US Food and Drug Administration, and Eli Lilly is also preparing for the approval and review of its ‘donanemab.' When approved, two new treatment options will suddenly be available in the 'impregnable' field of Alzheimer's disease. Of course, many issues remain to be addressed despite the introduction of these new drugs. Both Biogen and Lilly’s new drugs target beta-amyloid plaques and reduce beta-amyloid to improve Alzheimer’s symptoms such as cognitive function, etc. However, the issue is that it is unclear whether beta-amyloid is the determining cause of Alzheimer’s. Recent studies have shown that the tau protein may be the main cause of Alzheimer’s, which raises mixed opinions on what needs to be targeted to treat Alzheimer’s. Also, the two new drugs will need to be further verified. The FDA had granted breakthrough therapy designation to both drugs and accelerated approval for aducanumab in consideration of the lack of treatment for Alzheimer's. Donanemab is also expected to go through the same accelerated approval process soon. Drugs that are approved with the accelerated approval system can receive faster approval than through traditional review processes but needs to demonstrate their clinical benefit through a confirmatory trial. Otherwise, their approval is revoked. In particular, Biogen’s aducanumab needs to justify its approval through further clinical trials as its two Phase III trials showed mixed results. On the positive side, the introduction of these new drugs has changed public perception. Alzheimer’s is no longer considered unconquerable. Pharmaceutical companies in Korea and abroad are eagerly racing to be the first to develop more and better drugs for Alzheimer's. Just earlier last year, the COVID-19 outbreak brought fear to the whole world. However, with the introduction of COVID-19 vaccines and the introduction of COVID-19 treatments soon to be expected, COVID-19 has now entered the realm of being 'manageable.' This is why countries are now gaining the courage to attempt to live ‘With COVID-19’ even if more than 2,000 patients are confirmed every day. Awaiting the second new Alzheimer’s drug to come, I have faith that Alzheimer's will soon become manageable, as with COVID-19 and the many other crises that we managed to overcome.
- Policy
- Gov needs to maintain patient benefits to the public
- by Lee, Jeong-Hwan Nov 05, 2021 05:23am
- Starting next year, the Korea Organization For Patient Group expressed regret to the MOHW and the HIRA, which triggered anxiety and confusion among cancer patients by announcing plans to exclude second-tier anticancer drugs from the coverage. The Korea Organization For Patient Group urged the MOHW and the HIRA to give confidence in ensuring the continuity of treatment for patients taking anticancer drugs, which have been subject to new comprehensive applications. The Korea Organization For Patient Group released a press release on the 2nd and said, "The government and pharmaceutical companies should actively cooperate and ensure that all cancer patients receive health insurance benefits to quickly register second-tier anticancer drugs such as targeted anticancer drugs and immuno-cancer drugs." They pointed out that the HIRA caused confusion among patients by saying that all second-tier anticancer drugs and rare drugs were decided as non-target items in an official letter to hospitals participating in the pilot project for the new comprehensive fee system next year. The official document that cancer patients, who have been treated for only 5% co payment so far, have to pay 100% of the drug price from January 1 next year is tantamount to telling the patient to give up treatment. The group introduced the Democratic Party of Korea, Kang Byeongwon and Nam In-soon, urging the government to take the lead in promoting the fact that anticancer drug benefits will be maintained regardless of the system improvement. The intention is to clarify the continuity of treatment for cancer patients through explanatory press releases. The Korea Organization For Patient Group said, "Targeted anticancer drugs and immuno-cancer drugs used to treat cancer patients must be approved by the MFDS and registered as health insurance quickly." The Patient Group pointed out that "second-tier anticancer drugs that have not yet been registered as health insurance are causing conflicts between the government and pharmaceutical companies due to high drug prices and financial sharing measures." "If pharmaceutical companies do not apply for health insurance registration, they should apply quickly, and the MOHW should consult closely with insurance benefits and insurance medicine departments to expedite health insurance registration," the group said. The patient group added, "All cancer patients who need second-tier anticancer drug treatment should receive health insurance benefits and should not have victims in good faith."
- InterView
- KYMRIAH, a good but expensive medicine
- by Eo, Yun-Ho Nov 04, 2021 05:56am
- The cost of a single injection is 500 million won, but the era has come when cancer can be expected to be cured with that "once." Ultra-high-priced, high-tech new drugs are already approaching us. Kymriah (Tisagencleucel), a CAR-T treatment called dream anticancer, is the new drug. Kymriah obtained approval from the MFDS in March as the first treatment of the Advanced Regenerative Bio Act. Kymriah dramatically improved the survival period of patients with recurrent and refractory end-stage blood cancer, who no longer had treatment options available with a single treatment, and even confirmed the possibility of long-term survival. ◆The essence of process-customized treatment required for each patient Kymriah is an innovative personalized one-shot treatment that utilizes the patient's immune cells, and is an anticancer drug with all the characteristics of cell, gene, and immune treatments. As it is a non-reimbursed treatment, it is different from previous treatments from the mechanism and manufacturing process of manufacturing. First, the patient's immune cells are extracted. Afterwards, a receptor that recognizes cancer cells is inserted into the cell surface to form a cell with strong power, that is, a chimera antigen receptor, and injected into the patient. Kymriah's indication is ▲the treatment of adult patients with recurrent or refractory diffuse large-B-cell lymphoma (DLBCL) after two or more systemic treatments and ▲ the treatment of post-transplantation recurrence or secondary recurrence and subsequent recurrence or refractory B-cell acute lymphocytic leukemia (B-ALL, B-Acute Lymphoblastic leukemia) in children and young adult patients under the age of 25. The number of DLBCL and B-ALL patients who refused or recurred to existing treatment was about 200 in Korea, and until Kymriah's approval, there were no alternative treatment options or standard treatment was not established, so life expectancy was only 6 months. In fact, the median survival period of DLBCL patients who failed secondary treatment in Korea is around 4.73 months, and about 70% of patients who failed secondary treatment repeatedly perform rescue chemotherapy. The Kymriah permit presented patients who were no longer in need of treatment with another hope for long-term survival. According to clinical trials in patients with recurrent or refractory DLBCL, the overall response rate in patients administered Kymriah was 53%, of which 39.1% reached complete remission. In addition, in the case of clinical trials in patients with recurrent or refractory B-ALL, 8 out of 10 patients (82%) reached complete response (CR), and 98% of patients who reached remission were negative. ◆ In Korea, more than 5 cases were administered. Kymriah Center was established Kymriah is still a non-reimbursed drug and it is difficult to say that sales have been activated in Korea. However, preparation work for prescription is active. In particular, Big 5 advanced general hospitals are moving rapidly. According to related industries, Big 5 general hospitals, including Seoul National University Hospital, AMC, Seoul St. Mary's Hospital, and Sinchon Severance Hospital, are undergoing management approval procedures such as human cells, and Samsung Medical Center has already completed approval. Among them, in the case of Seoul National University Hospital, Kymriah (Tisagenlecleucel) passed the Drug Commission (DC) in April, and Samsung Medical Center also began prescriptions in May. Novartis, a developer of Kymriah, allows to pay by establishing a general hospital and Kymriah center. Kymriah Center will open in May at Samsung Medical Center and Seoul National University Hospital, respectively, and the rest of the upper-level hospitals are expected to join the center later. In order to establish a center, hospitals must obtain permission for management businesses such as human cells under the newly established Advanced Regeneration Bio Act, which means that medical institutions are actively working on preparing all matters. according to the Dailypharm, more than five Kymriah doses have already been made, even though they are non-reimbursed, and 10 prescriptions will be made within this year. The era of CAR-T is certainly beginning. ◆The insurance benefit registration procedure is also an issue Kymriah's insurance benefit registration is also an issue. It is unusual for interest in one drug to increase to this extent because it is such an expensive drug and there are so many patients waiting. In March, the drug was approved by the MFDS using the Drug Approval-Benefit Linkage System. And it was first introduced to The HIRA's Cancer Drugs Benefit Appraisal Committee in September, but was put on hold. When the results were released through the media, the leukemia association criticized the government and pharmaceutical companies in a statement. The patient association earlier criticized Kymriah for the delay in the proposal of the Cancer Drugs Benefit Appraisal Committee. Eventually, Kymriah passed the Cancer Drugs Benefit Appraisal Committee in October. It is encouraging to pass this deliberation, but there is a high possibility that there was a burden as it was so focused on attention. Novartis' Korea subsidiary's plan to share finances and its willingness to persuade its headquarters are expected to be key. Kymriah, a drug that is too good but too expensive, is just the beginning.
- Policy
- The HIRA proceeds to improve the mediation system
- by Lee, Hye-Kyung Nov 04, 2021 05:56am
- The MOHW requests the promotion of research services for effective system operation. Improvement of the adjustment application system will be carried out to raise the upper limit of -reimbursed drugs. The HIRA recently made an open bid for a "request for research proposal on how to improve the drug adjustment application system" and announced that the project will be carried out within six months from the date of signing the contract. The study was conducted when the MOHW requested the promotion of research services to prepare specific measures to improve applications for coordination for effective system operation. Within the current positive list system, measures to increase the upper limit of the reimbursed drugs listed on the drug benefit list are limited, such as designation of Drug Shortage Prevention, cost preservation, and application for adjustment of the upper limit. The Drug Shortage Prevention designation and cost preservation system stipulates detailed standards such as cost analysis in the "Attachment 5 of Drug Determination and Adjustment Standards" through past research services, but the application system for an increase in the upper limit has not been reviewed overall. In addition, procedures and evaluation criteria are required to apply decision of application to the relevant laws and regulations, and detailed evaluation criteria are operated privately. The need to improve the system has emerged as drug prices related to this year's additional revaluation and drug price revaluation scheduled for next year are expected to surge. Through this study, The HIRA aims to diagnose and analyze the current mediation application system, compare the mediation application system with the Drug Shortage Prevention system, and derive a reasonable mediation application system improvement plan. Analysis of the current mediation application system is expected to be conducted on the recent mediation application status and operation details, identifying problems such as uncertainty in the reason for the application, ambiguity in evaluation standards, and the NHIS negotiations. The HIRA said, "We hope this study will come up with an improvement plan that will be used to improve the mediation application system." The HIRA said, "We hope for system development and efficient operation through objective and rational improvement."
- Policy
- MFDS to support Phase III trials of domestic COVID-19 Txs
- by Lee, Tak-Sun Nov 04, 2021 05:56am
- The Ministry of Food and Drug Safety has been supporting domestic companies that have entered Phase III trials for their domestic COVID-19 treatments through its ‘Development-focused Support Council.' The three items currently approved for Phase III trials and supported by the Support Council are: Chong Kun Dang’s ‘Nafabeltan (nafamostat),’ Daewoong Pharmaceutical's ‘Foistar(camostat),’ and Shin Poong Pharmaceutical’s ‘ Pyramax (pyronaridine/artesunate).’ The news was shared at an ‘Online briefing session regarding 2021 2H drug reviews ’ that MFDS held on the 3rd. Kyung-sook Choi, a researcher of the Oncology and Antimicrobial Products Division, said, “We have been operating a Development-focused Support Council since earlier this year to address the difficulties faced by domestic developers (of COVID-19 treatments) that are entering Phase III trials.” After completing the Phase II trial for ‘Nafabeltan,' Chong Kung Dang had applied for conditional approval earlier this year but was turned down in February. However, the company continued its pursuit and received approval for a Phase III trial in April and started the trial in July. Chong Kung Dang plans to conduct its clinical trial in Korea and 7 other countries - Ukraine, Argentina, India, Russia, Brazil, Peru, Thailand. In the Phase III trial, the company will enroll 600 patients with severe COVID-19 to verify the efficacy of its treatment candidate. Daewoong Pharmaceutical has been developing its Foistar tablet under the trademark name ‘Coviblock’ as a COVID-19 treatment. The Phase III trial protocol for the substance, DWJ1248, was approved twice - on December 31st last year and in January this year. Although the drug failed to meet the primary endpoint and reach statistical significance in its Phase II trial, its potential as a treatment still remains as the drug had shown to expedite recovery in patients who have a higher risk of progressing to severe COVID-19. The Phase III trial protocol for Shin Poong Pharmaceutical’s Pyramax tablet was approved last August. Like the other new drug candidates from Chong Kun Dang and Daewoong Pharmaceutical, Shin Poong Pharmaceutical’s Pyramax also failed to meet statistical significance for its primary endpoint in its Phase II trial. However, the drug also showed potential in reducing the rate of progression to severe COVID-19, based on which the company initiated a large-scale Phase III trial. The company plans to recruit around 1,400 participants for the trial. All three domestic COVID-19 candidates are repurposed drugs that were used to treat other diseases in the past. Chong Kun Dang’s Nafabeltan inj. was a blood anticoagulant, Daewoong Pharmaceutical's Foistar a treatment for chronic pancreatitis and reflux esophagitis, and Shin Poong Pharmaceutical’s Pyramax an antimalarial drug. The MFDS explained that it had held 16 Development-focused Support Council meetings to support the smooth progress of the companies' clinical trials. Choi said, “We first held meetings once a week, but then changed to a twice a week schedule. The council not only supports issues related to approval and reviews but also helps companies resolve non-MFDS issues by sharing such issues with the pan-government support group." The MFDS had shortened the clinical trial period for COVID-19 treatments from the previous 30 days to 7 days (15 days for new drugs) and organized an exclusive review team to shorten the review and approval process from the previous 180 days to 40 days. Currently, a total of 34 COVID-19 treatment candidates have entered clinical trials, including 25 antivirals (18 repurposed drugs, 7 new substances) and 9 immunomodulators (7 repurposed drugs, 2 new substances). Choi said, “We are doing our best to meet our promised deadline through priority and expedited review systems for COVID-19 treatments. We ask for your understanding as this may delay complaints filed for non-COVID-19 treatments."
- Policy
- NA asks NHIS to introduce the reference pricing system
- by Lee, Hye-Kyung Nov 04, 2021 05:55am
- The National Assembly raised the opinion that a reference pricing system should be introduced to induce price competition between generic drugs and encourage the use of cheaper generics. NA member Youngseok Seo of the Democratic Party of Korea inquired on introducing the reference pricing system to normalize the generic market and reduce NHI finances to the National Health Insurance Service through a written QA at the NA’s Health and Welfare Committee’s Comprehensive Audit The reference pricing system refers to a system in which a certain reimbursement level is set for all drugs with the same efficacy. Through the system, only a certain amount of a drug price is covered by NHI finances, and the patient bears the difference in high-priced drugs that exceed the set level. Seo said, “We need to prepare an institutional environment that induces price competition among generics and encourages the use of cheaper generics. The NHS should review introducing the reference price system that can prevent alliances between doctors and pharmaceutical companies, grant pharmacists the obligation to provide information, and allow patients to select medicines based on cost awareness.” Upon inquiry, the NHIS agreed on the need to prepare an institutional environment that can save NHI finances by inducing pricing competition and the use of cheaper generics. NHIS replied, “In addition to newly establishing a Pharmaceutical Pricing Management Office, we have made multilateral efforts to establish a management system that can cover the whole cycle of insured pharmaceuticals by expanding the Generic Management Department. We agree on the need to review measures to promote the use of high-quality inexpensive generic drugs and introducing a reference price system with reference to the economic burden borne by patients as well as cases overseas." The NHIS added, “We will discuss the measure with government ministries by collecting stakeholder opinions, etc."
- Policy
- Refund RSA may be set higher than the lowest price
- by Lee, Jeong-Hwan Nov 04, 2021 05:55am
- The HIRA said that the cost-effectiveness evaluation criteria for omitted drugs that submit economic evaluation data are less than 80% of the lowest A7 adjustment price. It also explained that the economical evaluation drug can be integrated into a risk-sharing system (RSA), which can set the indicator price higher than the lowest A7 price in case of refundable restrictions. On the 2nd, The HIRA responded like this to a written inquiry from Rep. Kim Mi-ae of the National Assembly. Rep. Kim Mi-ae pointed out that it is necessary to disclose the internal regulations of The HIRA on the criteria for lowering the level of cost-effectiveness evaluation of economic evaluation drugs. Rep. Kim also asked The NHIS' position on the basis of 80% of the lowest A7 price contradicts the NHIS' guidelines for drug price negotiations. The NHIS explained that the actual price was deliberated to evaluate the cost effectiveness at about 80% of the lowest A7 adjustment price, considering the clarity of the criteria for "considering the lowest price" and whether to apply the risk-sharing system to excluded countries. After this year's third Drug Reimbursement Evaluation Committee, it was added that it shared related information at an industry meeting on June 17 and a private consultative body on July 28. Regarding the 80% standard of the A7 lowest price, The NHIS replied with the intention that it does not contradict the industrial complex negotiations, but that it means that prices can be lowered further when negotiated if necessary. The NHIS said, "If the lowest A7 price risk-sharing contract is confirmed when determining the cost effectiveness of the economical evaluation drug, additional price cuts are needed due to uncertainty in the indicator price." It said, "Since October 8, 2021, the economic evaluation drug has also been integrated into a risk-sharing system," adding, "If the A7 lowest price is not subject to a risk-sharing contract, the A7 lowest price can be set higher."
