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- 2026-04-13 13:20:42
- Policy
- "Reference pricing will activate sales of generic drugs"
- by Lee, Jeong-Hwan Nov 08, 2021 05:51am
- A pharmacist-politician Seo Young-Seok of the Democratic Party of Korea criticized the generic drug policy failure of the government, saying that Korea should also aggressively implement the ‘reference pricing system’ used in the US and Europe to break collusive ties between doctors and drug companies and lead the generic policy system on the road to success. The basic notion is that the authorities should implement supply regulations to lower the price of generics while regulating the demand to encourage the increased use of cheaper generics and save NHI finances. Seo said that the pharmaceutical expenses can be drastically reduced by reducing the price of generics through reference pricing and profit control and drastically increasing the use amount through systems such as generic incentives for doctors and pharmacists’ generic substitution. On the 6th, Dailypharm analyzed the joint policy report ‘Suggestions on pharmaceutical policies’ that Seo published with a social co-op ‘GungangBut.’ In the report, Seo said that as of 2019, the finished product market accounts for 19.8 trillion won’s worth of the 22.3 trillion won domestic pharmaceutical industry (finished·API drugs). In particular, only 1.7% of the domestic pharmaceutical companies that manufacture finished products produced more than 500 billion won’s worth of products, and the most, 31.9%, produced less than 1 billion, followed by 20.1% that produced 10 billion to 50 billion won’s worth of products. Seo believes that generics can be the source for reducing NHI finances as it has a lower price with the same efficacy. In this sense, Seo stressed that supply-side regulations that set the price of generic drugs as low as possible, as well as demand-side regulations that encourage the use of inexpensive generic drugs, should be implemented together. For this, Seo said that a mechanism in which a lower price ensures market share is essential for market competition between generic developers to work and encourage pricing competition between the companies. More specifically, Seo asked the government to impose demand regulations so that products that voluntarily cut prices are used in the market instead of the current supply regulations that set generics’ prices in the order of entry. Under the current structure, the lowest-priced generic drugs are not used much because the doctors prescribe a drug from a specific pharmaceutical company regardless of the price level. “The reality is that it is more advantageous for the pharmaceutical companies to maintain their high drug price and give rebates to doctors rather than lower their drug prices. This is why there is no pricing competition between generics, and no health insurance savings are taking place.” As a solution, Seo proposed using the reference pricing system as a policy to reduce NHI expenditures by activating the use of generics. The reference pricing system refers to a system in which a certain reimbursement level is set for all drugs with the same efficacy and that level of the drug price is covered by NHI finances, while the patient bears the difference in high-priced drugs that exceed this. To implement the reference pricing system, Seo said we would first need to establish a decision-making system that goes from doctor's prescriptions - pharmacist's generic substitution and information provision - patient’s information acceptance and selection. She pointed to various reasons such as low trust in generic drugs, quality distrust about low-priced drugs, and infringement of doctors' prescriptions’ rights as to why the generic drug policies have failed and financial savings are not being achieved due. If the reference pricing system is implemented, patients will be prescribed drugs in need regardless of brand or ingredient name, and pharmacists will be required to provide generic substitutions, and patients will be given pricing information based on the reference price. Seo also said that the reference pricing system allows patients to express their opinion in choosing their prescription drugs, and pay an additional fee when choosing a drug that exceeds the reference price or receives an incentive of paying no out-of-pocket cost when choosing a drug below the reference price. “The reference pricing system will ultimately allow the government to reduce NHI finances by inducing pricing competition by breaking collusive ties between doctors and pharmaceutical companies and activating the use of drugs that are priced at the reference price level. It also has the advantage of preventing the mushrooming of generics, regaining the public’s trust, and providing an opportunity to make patient-focused decisions," said Seo. Seo added, “We can also expect the system to eradicate negative pharmaceutical sales activities and contribute to diversifying the domestic industry that is currently focused on generic production without competition. Also, the system will allow Korea to achieve substantiality by diversifying and enriching the industry with R&D-focused companies and generic companies.
- Policy
- Will RWD drive accessibility to ultra-high-priced drugs?
- by Kim, Jung-Ju Nov 08, 2021 05:51am
- Korea’s RSA system is moving to become more of a performance-based mechanism rather than a finance-based system. Performance-based RSA means that the system will be using real-world data (RWD) from clinical practice as real-world evidence (RWE). Ultra-high-priced drugs like Kymriah inj. (tisagenlecleucel) have had difficulties in reimbursement, and the government's RSA expansion attempt may be an important tool that can increase patient accessibility. Ji-Hye Byun (Ph.D. in Social Pharmacy), Head of Evidence-based research at the Health Insurance Review & Assessment Service, presented on ‘Plans for reimbursement management in Korea, including pharmaceuticals using RWD, etc’ at the Innovation Research Symposium, ‘Establishing measures for RWD collection to manage pharmaceutical reimbursement management,' that was hosted by HIRA today (4th). Innovative anticancer therapies like Kymriah are ultra-high-priced drugs with much demand for prompt listing from patients and requests for high prices from pharmaceutical companies. The insurance authorities are having difficulty allowing reimbursement for these innovative drugs that have an ultra-high price despite uncertainties in their effectiveness, safety, and cost-effectiveness. This issue is not just a concern for Korea alone, as the trend in new drug development now turned to focus on high-priced drugs that innovatively treat rare diseases. Advanced countries in insurance or new drug development have also been facing the same issue and pursuing the use of RWD to suit each country. According to ‘The UK’s integrated management and use of RWD (Current and future role of RWE in NICE)' that was presented by the copresenter, Jihyung Hong, Professor of College of Social Science at Gacheon University, the UK has been rapidly reinforcing the state-led data integrated system. Patient accessibility to anticancer drugs or rare disease drugs that have a high uncertainty has been reinforced through the "Managed Access Scheme (MAA)" during which additional data (including RWE) are collected. Under the Cancer Drug Fund (CDF), a separate fund for high-priced anticancer drugs, NHS England and pharmaceutical companies collect additional data to agree upon the details on reimbursement. The reimbursement level and degree of uncertainty collected in over 2 years of managed access are used as a basis to conduct further reassessment, based on which NICE will decide on whether to make a final recommendation. In France, reimbursement for rare disease drugs that have uncertain clinical grounds is not deliberated immediately, but applied a temporary use system ‘ATU,’ and allowed conditional use upon reassessment. The UK, France, Germany, Italy, and Spain are all using RWE to resolve the uncertainty in the decision-making process for Kymriah. Spain uses an RWD (patient registration) system that it established that considers the ‘post-marketing safety-economic evaluation analysis.’ In Korea, HIRA has also been operating an expert advisory council since 2019 and had studied RWD cases in partnership with the Korean Cancer Study Group in the process. Another co-presenter and KCSG president, Professor Dae Young Zang (Division of Hematology-Oncology, Hallym University), presented on the ‘Study on efficacy and safety of gastric cancer drugs using electronic medical records (EMR),’ on the RWD items of ramucirumab (Cyrmanza). As such, Korea is also seeking to manage the whole lifecycle of reimbursed drugs using RWE. RWE is a viable alternative that can overcome the limitations of the current system, including the fact that there is no cost-effectiveness benefit management mechanism for applying results that have changed since reimbursement, lacks data collection suited to the purpose of collecting clinical data for HTA (economic feasibility assessment), and the fact that reassessment will only take place after a certain period passes after the submission due to prospective data collection based on reimbursement notices. During the presentation, Byun proposed several measures for systematically managing reimbursed drugs using RWD. One key example was using an RSA system based on patient unit performance. Korea is currently using an RSA mechanism that is overwhelmingly focused on finances when reimbursing high-priced drugs. The main point of a performance-based RSA that uses RWD is in that the pharmaceutical company's responsibility increases with the high price of its drugs in order for the authorities to meet the continued challenge of reimbursing ultra-high-priced drugs with limited finances.
- Company
- K-Rare Disease Drug Hunterase that is more popular overseas
- by Chon, Seung-Hyun Nov 08, 2021 05:51am
- Hunterase, developed by GC Pharma, is speeding up its efforts to target global markets. It is successful as a treatment for rare diseases developed in Korea, generating more than three times more sales than domestic demand in overseas markets. According to GC Pharma on the 4th, Hunterase's sales rose 77.7% year-on-year to 23.1 billion won in the third quarter. It more than doubled from 11 billion won in the previous quarter. In the third quarter of this year, cumulative sales jumped 63.9% year-on-year to 47.2 billion won. Sales exceeded 46.2 billion won recorded over the past year. Hunterase, which was approved in Korea in 2012, is the world's second treatment for Hunter syndrome. Hunter syndrome, called Mucopolysaccharidosis type II, is a rare disease known to occur in the remaining 100,000 to 150,000 people. Hunter syndrome, a congenital metabolic abnormality disease, is a genetic disease that shows unpredictable symptoms such as skeletal abnormalities and decreased intelligence, but dies early around the age of 15 in severe cases. The number of patients in Korea is only about 70 to 80. Hunterase's recent steep growth is based on a high rise in overseas markets. Hunterase's export performance in the third quarter was 17.4 billion won, more than doubling from 7.8 billion won in the same period last year. It tripled in one quarter from 5.8 billion won in the previous quarter. Hunterase's domestic sales in the third quarter rose 9.6% year-on-year to 5.7 billion won, which means that it has realized a significant growth in overseas markets. Exports accounted for 75.3% of Hunterase's third-quarter sales. The company explained, "The use of Hunterase abroad has increased significantly and demand has soared in Russia." Hunterase is on sale in 14 foreign countries, including Russia, Egypt, Turkey, and Brazil. It is analyzed that Hunterase's competitive drugs are not many, and that it is recording stable sales growth due to the characteristics of rare disease treatments that are expensive and must be administered for a lifetime. Prior to the appearance of Hunterase, Eleapase was the only treatment. GC Pharma is also speeding up Hunterase's entry into the Asian market. In October last year, it obtained an item license for Hunterase from the NMPA. Earlier this year, it received permission for Hunterase ICV items from the MHLW. Hunterase ICV is a new formulation that inserts a device into the head and administers the drug directly to the ventricle. It has the advantage of overcoming the limitations of existing intravenous formulations that do not improve symptoms of intelligence degradation because drugs cannot penetrate the cerebrovascular barrier (BBB). China's licensed item is a Hunterase intravenous injection (IV) formulation, and the market preoccupation effect is expected in that there was no previously approved Mucopolysaccharidosis type II treatment in China. It is predicted that it will serve as a catalyst for overseas sales growth as it starts selling to China and Japan, which have large markets.
- Policy
- The introduction of a double price system is empty talk
- by Lee, Jeong-Hwan Nov 08, 2021 05:51am
- When the government responded that it was introducing a double price system instead of opposing the National Assembly's criticism that incentives such as exclusion and suspension of PVA should be given to new domestic drugs, the domestic pharmaceutical industry negatively evaluated it as an "empty talk-style administration." Critics say that PVA has virtually no complementarity and that there are no cases of new domestic drugs that benefit from the double price system. On the 2nd, the domestic pharmaceutical industry is disappointed with the MOHW's position on the issue of "Exclusion and Suspension of New Drugs for Development of Innovative Pharmaceutical Companies," which has become a hot topic during this year's parliamentary audit. Multiple domestic pharmaceutical companies that have domestic new drugs or are about to be released in the future in the development stage are in a position to minimize cases in which domestic new drugs receive reverse discrimination from global new drugs. PVA should reflect the specificity of domestic new drugs that complete the sequential lineup with years of R&D investment after electing the most marketable or fastest-to-market indications. When the health insurance authorities, led by the MOHW, answered that they were already implementing a double price system to support exports of new domestic drugs or innovative pharmaceutical drugs, the domestic pharmaceutical community criticized, saying, "It is a rigid attitude." In particular, the National Health Insurance Service said, "There are many cases in which PVA drug prices have been lowered consecutively for multinational companies other than domestic pharmaceutical companies." When he replied, "There is no reverse discrimination," Korean companies countered, "It is a generalization error of simple statistics." The intention is that it is meaningless to simply compare the number of consecutive PV negotiations with the reverse discrimination of domestic new drugs that actually contributed to reducing health insurance finances. In particular, he pointed out the government's position that domestic companies are supporting domestic new drugs through a double price system instead of PVA incentives. The PVA incentive is a policy for domestic new drugs to grow successfully in the domestic pharmaceutical market, and the government has pushed for a double price system that has no impact on the domestic market. HK inno.N's K-CAB is the only drug currently implementing the double price system, and MA officials in Korea say that most of the new domestic drugs and new domestic drugs to be developed and released are unlikely to benefit from the double price system. They also said that the double price system is not a huge preferential treatment or incentive system because it has to maintain the existing drug price and return the drug price through post-settlement, but there is also administrative work necessary for it. Critics say that the double price system is actually a "nothing burger" for a new domestic drug that has to make profits in the domestic market unless it is a new domestic drug developed for overseas exports. An official from Company A, who owns a new domestic drug, said, "The double price system requires administrative work for both the industrial complex and the pharmaceutical company. In particular, it is a system that does not require applying for a double price system for new domestic drugs, where the domestic market is important, he said. "This is a representative case in which Kanarb quit in the middle because there was no real benefit after implementing the double price system. In the end, there is no double price drug other than K-CAB," he pointed out. An official from Company A said, "PVA incentives are policies for the domestic market, but seeing that they are suddenly pushing for a double price system and supporting new domestic drugs, I felt that it was an inevitable repetition of empty talk." He criticized, "If it is difficult to exclude or suspend PVA, other alternative methods should have been devised, so the double price system is out of the blue."
- 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.
