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- 2026-04-09 21:05:42
- Opinion
- [Reporter’s View]Kudos to Keytruda for filing 13 reimb apps
- by Eo, Yun-Ho Jul 05, 2023 05:45am
- A truly extraordinary case has emerged. MSD Korea has applied for the reimbursement of 13 Keytruda indications at once. This is an unprecedented event, the first time such a large amount of applications had been filed for a single drug since the positive list system was implemented for drug reimbursement in Korea. After submitting the applications, MSD explained “Cancer is in itself an aggressive and life-threatening condition, and we saw that there was a dire need for improved access to Keytruda in the field due to the lack of alternatives or reimbursed latest treatment options. To address the need, the company decided to apply for the extended reimbursement of Keytruda to cover indications with high clinical need or reimbursement. We seek to improve treatment access to all patients that can benefit from Keytruda.” We should first applaud the company for its effort. Considering the rising number of non-reimbursed immuno-oncology drug indications piling up in the field, MSD duly served its mission as a pharmaceutical company by applying for the reimbursements, regardless of success or failure. Keytruda is currently reimbursed for 7 indications in 4 cancer types in Korea. Applying for the reimbursement of 13 indications is not an easy task. As a drug under the Risk Sharing Agreement scheme, its each and every indication must undergo an evaluation process comparable to that of a new drug to extend reimbursement. Pharmacoeconomic evaluations must be performed for indications that were approved based on a Phase III trial to demonstrate cost-effectiveness, and those approved based on a Phase II trial must undergo negotiations to receive pharmacoeconomic evaluation waivers. The relevant health authorities including the Ministry of Health and Welfare and the Health Insurance Review and Assessment Service also have a lot on their hand as they must concurrently evaluate numerous indications of a single drug. Therefore, the reimbursement extension process will also require considerable effort on the government’s part. Considering how this is an unprecedented situation and that the pharmaceutical companies would not have applied for the reimbursement of 13 indications without prior discussion with the government, anticipation is rising on how the results will turn out for Keytruda. In an era where a single drug owns multiple indications, I hope Keytruda’s case will set a milestone and serve to resolve the rising issues in Korea’s reimbursement extension process. Meanwhile, the 13 indications Keytruda applied for were: ▲ early-stage triple-negative breast cancer; ▲locally recurrent or metastatic triple-negative breast cancer, ▲metastatic or with unresectable, recurrent head and neck squamous cell carcinoma, ▲ locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) carcinoma, ▲adjuvant treatment of patients with renal cell carcinoma, ▲non-muscle invasive bladder cancer, ▲persistent, recurrent, or metastatic cervical cancer, ▲ advanced endometrial carcinoma, ▲metastatic endometrial carcinoma that is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) ▲ unresectable or metastatic MSI-H or dMMR colorectal cancer ▲metastatic MSI-H or dMMR small bowel cancer, ▲ metastatic MSI-H or dMMR ovarian cancer, and ▲ metastatic MSI-H or dMMR pancreatic cancer.
- Company
- Samsung Biologics signs 2 CMO contracts with Pfizer
- by Chon, Seung-Hyun Jul 05, 2023 05:44am
- Exterior perspective view of Samsung Biologics Samsung Biologics signed two contract manufacturing organization agreements with Pfizer. The contracts, including the largest single contract ever made that is valued at KRW 922.7 billion (approximately USD 818 million), have been successfully concluded, totaling the amount to KRW 1.2 trillion (approximately USD 1.06 billion). On the 4th, Samsung Biologics announced that it has signed a contract manufacturing agreement for pharmaceuticals with Pfizer, worth KRW 922.7 billion. This amount represents 30.7% of the recent revenue. Samsung Biologics had first signed a letter of intent for the contract manufacture of Pfizer's biopharmaceuticals worth KRW 536 billion (approximately USD 411.38 million) last month. A part of the initially agreed USD 411.38 million contract that was worth USD 218.63 was increased by USD 485.76 million to become worth USD 704.39 million. nearly doubling the overall contract. This contract manufacturing agreement is the largest single contract ever signed by Samsung Biologics. On the same day, Samsung Biologics also signed a contract to expand its existing contract manufacturing agreement it had made with Pfizer in March. Initially valued at KRW 241.0 billion, this contract was also increased to KRW 495.3 billion. The amount Samsung Biologics secured through the new and expanded contracts with Pfizer nears USD 897 million (approximately KRW 1.2 trillion). Samsung Biologics explained, "We signed a contract manufacturing agreement with Pfizer in March for a product. Under the contract, we will be manufacturing Pfizer's various biosimilar product portfolio in our recently completed Plant 4 until 2029, which includes pharmaceuticals for tumors, inflammation, and immune therapies." The total contract Samsung Biologics signed with Pfizer this year totals at USD 1.08 billion (approximately KRW 1.418 trillion). Samsung Biologics is currently operating 4 biopharmaceutical plants. Plant 4, which commenced partial operation in October of last year with a capacity of 60,000 liters, has a production capacity of 256,000 liters, marking it the largest scale plant ever. With the operation of Plant 4, Samsung Biologics will secure a total production facility capacity of 618,000 liters, along with its existing 3 plants (30,000 liters for Plant 1, 152,000 liters for Plant 2, and 180,000 liters for Plant 3). A Samsung Biologics representative said, "We are increasing long-term agreements in large quantities based on our outstanding competitiveness in securing orders. So far, we have 13 of the top 20 global big-pharma companies as clients."
- Company
- Samsung Bioepis launches Humira biosimilar in the US
- by Lee, Seok-Jun Jul 04, 2023 05:37am
- On July 3rd, Samsung Bioepis announced that it had released its Humira biosimilar ‘Hadlima (project name: SB5, ingredient: adalimumab) in the US through its partner Organon. Hadlima is a treatment for autoimmune diseases including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and plaque psoriasis. The drug is now available in the US in two formulations – low concentration (50 mg/mL) and high concentration (100mg/mL) – and is supplied in a carton containing two pre-filled pens or two pre-filled syringes. Samsung Bioepis has received approval for its low-concentration and high-concentration Hadlima in 2019 and 2022, respectively. The drug, which is approved as Imraldi in the European Union, has been supplied in Europe since October 2018. In addition to the European market, Samsung Bioepis has been supplying SB5 to 24 markets around the globe. The company owns real-world study data on over 5,100 patients across rheumatologic, dermatologic, and gastroenterological conditions. Meanwhile, Humira raised annual sales of KRW 2.7 trillion (USD 21.2 billion) last year. Among them, the US market accounts for about 88% at KRW 23 trillion.
- Company
- Celltrion seeks approval for Stelara biosimilar in the US
- by Kim, Jin-Gu Jul 04, 2023 05:37am
- Celltrion announced on the 3rd that it has submitted an application for the approval of its Stelara (ustekinumab) biosimilar to the U.S. Food and Drug Administration (FDA). Its indications are the same as its original - plaque psoriasis, pediatric plaque psoriasis, psoriatic arthritis, pediatric psoriatic arthritis, Crohn's disease, and ulcerative colitis. Celltrion conducted a Phase 3 clinical trial of Stelara biosimilar under the development name "CT-P43." The study evaluated the efficacy and safety of CT-P43 compared to Stelara, in 309 patients with moderate to severe plaque psoriasis aged 18 and older. According to the Phase III clinical trial results that were announced in September last year, CT-P43 demonstrated its equivalence in both efficacy and safety after 12 weeks of drug administration. Celltrion applied for the marketing authorization of Stelara's biosimilar in Europe in May, as well as the marketing approval in Korea in June. Celltrion plans to continue acquiring approvals from more countries following the U.S. application. Celltrion stated, "The application includes all indications approved for the original Stelara. We expect the biosimilar to provide treatment opportunities to more patients in the future and reduce the financial burden on the health insurance system.”
- Company
- Discussion on whether Vabysmo benefit is possible
- by Eo, Yun-Ho Jul 04, 2023 05:37am
- Attention is focusing on whether Vabysmo, a macular degeneration treatment, will be able to be listed on the insurance benefit list. According to related industries, it is expected that Vabysmo, a Bispecific antibody treatment in Roche Korea, will be presented to the Drug Benefit Evaluation Committee this month (July). This drug passed the Drug Benefit Standards Subcommittee in May. Vabysmo, licensed as a treatment for neovascular or wet-related macular degeneration (nAMD) and vision damage by diabetic macular edema, is a new drug with a differentiated mechanism that targets both VEGF-A and Ang-2, the main path of disease. Based on the new mechanism, it is the first intraocular injection that enables administration every 4 months (16 weeks) through licensed clinical studies, and a small number of injections can reduce the patient's treatment burden. Vabysmo is administered in the recommended dose of 6 mg (0.05 ml) into the vitreous once a month (4 weeks) for the first 4 doses. After that, nAMD patients who do not have disease activity are administered once every 4 months (16 weeks). In patients with diabetic macular edema (DME), the administration interval can be increased to four weeks, extending up to four months (16 weeks), at the discretion of the medical staff. Vabysmo proved its validity through a total of four Phase 3 studies, including clinical studies related to nAMD treatment TENAYA and LUCERNE and clinical studies related to DME treatment YOSEMITE and RHINE studies. TENAYA and LUCERNE studies are Non-inferiority trials compared to Vabysmo and Eylea in nAMD treatment. As a result of the study, Babismo treatment at intervals of up to 4 months (16 weeks) in the first year of treatment showed Eylea at intervals of 2 months (8 weeks) and treatment and a mean level of vision improvement. In the first year of treatment, about 80% of the Vabysmo administration group maintained an administration interval of more than 3 months (12 weeks). In the recently released second year of treatment, more than 60% of patients maintained a four-month (16 weeks) administration interval, which was expected to provide continuous clinical benefits to patients.
- Opinion
- [Reporter’s View] Gvn't policies hinder KOR pharma growth
- by Lee, Tak-Sun Jul 04, 2023 05:37am
- It seems that the pro-business policy the new administration has been implementing to promote Korea’s industries is not benefiting the domestic pharmaceutical companies at all. Rather, the companies have expressed their regrets on how the authorities have been implementing policies that hinder their corporate activities, such as those that lower generic drug prices. Although the policy to reduce the price of generics has not been implemented yet, the industry believes the policy will surface with the release of the 2nd Comprehensive National Health Insurance Plan in the second half of this year. In particular, the drug price-reducing policy is expected to come to the fore because Professor Jinhyun from Seoul National University who has been at the forefront in arguing for generic drug price reductions, has been appointed the joint head of the 2nd Comprehensive National Health Insurance Plan Promotion Team with Korea’s 2nd Vice-Minister of Health and Welfare, Minsoo Park. Therefore, the industry also expressed concerns about the rumors that Vice Minister Park is revamping the drug pricing system to reduce the number of generic items on the market. All in all, it seems that a series of policies unfavorable to domestic pharmaceutical companies will be introduced to Korea in the near future, along with the reorganization of the generic drug pricing system, the complete revision of the actual transaction price discount system, and comparison with overseas generic drug prices. Therefore, it is only natural that domestic pharmaceutical companies are expressing their dissatisfaction regarding the changes being made. The companies have pointed out that the policies are in direct contrast to the government’s goal of becoming one of the 6 global biohealth powerhouses and developing two homegrown new blockbuster drugs that can bring in annual sales of over KRW 1 trillion in 5 years. The Korean pharmaceutical industry has constantly stressed that Korea’s generic drug industry is the driving force behind the self-sufficiency of Korea’s pharmaceutical market. Therefore, adopting a direct comparison model that compares Korea’s situation with other countries that gave way to cheap imported generics is illogical. Also, the companies implored that they cannot fund the long-term research and development required for the introduction of new blockbuster drugs if the government reduces the sales revenue from generic drugs, as it is the major driving force for R&D in most domestic pharmaceutical companies. Therefore, the Korean pharmaceutical industry plans to take action and relay its message on the need to protect the domestic industry before the government implements its generic drug price reform plan. Policies to reduce generic drug prices have been steadily proposed by every administration, regardless of their political tendencies, liberal or conservative. However, the impact made by the conservative governments has been stronger. One leading example is the lump-sum drug price cuts in 2012 made during the Lee Myung Bak administration. The industry, therefore, is more worried that the Yoon Suk Yeol administration will also come up with a policy similar to Lee’s lump sum drug price cut. Of course, the companies are also welcoming some policies that they have longed for, such as regulatory reform. However, most domestic pharmaceutical companies seem to believe that the positive effects of other policies are offset by the generic drug price cut that will inevitably affect most pharmaceutical companies. The Korean pharmaceutical industry is not understanding why the government is so obsessed with measures to reduce Korea’s drug use volume and generic drug prices. One official emphasized, “The company needs to first do well for it to pay the corporate taxes and contribute to the national wealth. However, domestic pharmaceutical companies are applied the lowest rate for corporate taxes due to low revenue. In this context, are policies that further reduce profit really right and necessary? With pharmaceutical companies that have no money to pay corporate taxes, and the unwavering government pushing to cut their profits, this reporter must ask, are pharmaceutical companies included in the government’s business-friendly policies?
- Company
- Forxiga expands its benefit through heart failure
- by Jung, Sae-Im Jul 04, 2023 05:36am
- Domestic and foreign cardiac societies recommend SGLT-2 for preserving exudation rates Forxiga, a blockbuster treatment with an annual prescription of 90 billion won, has expanded its scope to the entire heart failure. AstraZeneca Korea held a press conference at The Plaza Hotel in Jung-gu, Seoul on the 3rd to commemorate the expansion of chronic heart failure indications, including preservation of SGLT-2 inhibitor Forxiga ejection rate. At the meeting, Yoon Jong-chan, a professor of cardiology at Catholic University Seoul St. Mary's Hospital, and Oh Jae-won, a professor of cardiology at Yonsei University Severance Hospital, led by Kang Seok-min, chairman of the Korean Heart Failure Association (Cardiology at Severance Hospital). Heart failure is divided into reduction, mild reduction, and preservation according to the heart rate. Usually, less than 40% of the ejection rate is regarded as HFrEF, 41-49% as HFmrEF, and 50% or more as HFpEF. Unlike heart failure, which reduces the rate of exudation, there has been no suitable treatment for mild reduction and preservation of exudation. Many new drugs have challenged this area but failed clinical trials. SGLT-2 inhibitors have succeeded in advancing into exudate conservation heart failure. Following last year's SGLT-2 inhibitor Jardiance, Forxiga also secured the indication this year. With the expansion of this indication, Forxiga can be used in all chronic heart failure patients, including heart failure conservation at the rate of exudation. Phase 3 DELIVER study conducted by the company is a global phase 3 clinical trial that evaluates the effectiveness of Forxiga compared to placebo in heart failure patients with a withdrawal rate of more than 40% (hardness reduction-preservation) regardless of type 2 diabetes. Professor Oh Jae-won said, "About half of the patients without a history of type 2 diabetes were included, and relatively high-risk patients were included in the clinical trial, such as those who were hospitalized or have been hospitalized for heart failure. In addition, most of the patients were using various drugs, and at the time of registration of the study, patients with an improved exudation rate of more than 40% were also registered. " As a result of clinical trials, Forxiga reduced the risk of developing complex evaluation variables evaluated as cardiovascular death or worsening heart failure (unscheduled hospitalization and hospital visits due to heart failure) by 18% compared to the placebo group. Forxiga was 23% lower than the placebo group in overall heart failure exacerbation and cardiovascular death risk, and the symptom evaluation score also improved by an average of 2.4 points over the placebo group. In a sub-analysis according to the ejection rate, Forxiga also confirmed a consistent improvement trend in the patient groups of 49% or less, 50-59%, and 60% or more. Professor Oh explained, "The results of the DELIVER study are an important basis for patients and actual clinical trials as Dapagliflozin can be considered for patients with heart failure who can be prescribed by working regardless of the exudation rate." With the performance of Jardiance and Forxiga, guidelines for treating CHF have also changed. In the 2022 revised heart failure guidelines jointly published by ACC, AHA, and HFSA, the three major cardiac societies in the United States, SGLT-2 inhibitors such as Fosiga were recommended as HFmrEF·preserved heart failure treatments (recommended level 2a). The Korean Heart Failure Society also recommended SGLT-2 inhibitors to reduce hospitalization or cardiovascular death from heart failure in patients with preserving exudation rates, with or without diabetes (recommended grade 1). Professor Yoon explained, "Furthermore, this year's ACC recommended that all patients with preserving exudation rates start treatment with SGLT-2 inhibitors in the amendment to the Expert Consensus Decision Pathway." Professor Yoon said, "Half of the patients died within five years of diagnosis, so active treatment is needed from an early stage to improve the prognosis, and SGLT-2 inhibitors have provided the basis for their role." From the left, Professor Kang Seok-min, Professor Oh Jae-won, and Professor Yoon Jong-chan Professor Kang, who headed the team, explained, "It is very meaningful that the DELIVER study confirmed the effectiveness and safety of SGLT-2 inhibitors in patients who take other drugs as well as the entire ejection rate spectrum of chronic heart failure." He added, "In the meantime, new treatment options have been limited in patients with preservation and mild reduction of exudation rates, so we hope that many patients will benefit by registering their benefits as soon as possible."
- Policy
- Mounjaro, a weight loss effect for DM pts, has been approved
- by Lee, Hye-Kyung Jul 03, 2023 05:47am
- Eli Lilly's 'Mounjaro PFS', known overseas as a game changer for obesity treatment, has been approved in Korea. In Korea, it has been approved as a treatment for diabetes. Mounjaro is a synthetic peptide with a mechanism that can selectively bind to both the GIP and GLP-1 receptors for the first time in Korea. The Ministry of Food and Drug Safety (Ministry of Food and Drug Safety, Minister Oh Yu-Kyoung) has tested the content of 6 Mounjaro (2.5, 5, 7.5, 10, 12.5, 15mg/0.5ml) used as an adjuvant for diet and exercise therapy to control blood sugar in adult type 2 diabetic patients. It was confirmed on the 28th. This drug selectively binds to the GIP receptor and the GLP-1 receptor to induce insulin secretion promotion, insulin resistance improvement, and glucagon secretion reduction, thereby causing pre- and postprandial blood glucose reduction. GLP-1 agonists act on GLP-1, a hormone that makes you feel full by acting on the brain's hypothalamus, activates incretin, an intestinal hormone, and promotes insulin production to lower blood sugar levels. It slows down the movement of food from the stomach to the small intestine, increases satiety, and has proven its effectiveness, becoming a very popular obesity treatment in the United States. Mounjaro is a successor to Lilly's blockbuster diabetes treatment Trulicity and was approved by the US FDA in May of last year as a dietary and exercise supplement to improve blood sugar control in patients with type 2 diabetes. It can be used as a monotherapy or as a combination therapy with Metformin, SGLT2 inhibitor, Sulfonylurea, and Insulin glargine. The Ministry of Food and Drug Safety said, “We will continue to do our best to expand treatment opportunities for patients by making efforts to promptly supply treatments whose safety and effectiveness are sufficiently confirmed based on regulatory science expertise.”
- Company
- Lagevrio was voluntarily withdrawn from Europe
- by Kim, Jin-Gu Jul 03, 2023 05:47am
- Merck has voluntarily withdrawn its European approval application for Lagevrio, an oral COVID-19 treatment. The pharmaceutical industry is paying close attention to whether the global supply of this drug will continue. Celltrion and Hanmi Pharmaceutical, which had already decided to produce and supply Lagevrio generics to developing countries, have withdrawn their plans. Foreign media including Reuters reported on the 28th (local time) that Merck voluntarily withdrew its application for permission from the European Union (EU) for Lagevrio, an oral COVID-19 treatment. It is an analysis that Europe is in fact stepping out of the process. The EMA-affiliated CHMP recommended banning Lagevrio approval in February this year. At the recommendation of the CHMP, Merck eventually voluntarily withdrew its application for authorization in the EU. In the pharmaceutical industry, attention is focused on whether Lagevrio's exit will spread to other countries, including the United States. Lagevrio is being supplied as a corona treatment in more than 25 countries, including Korea, the US, Japan, the UK, Australia, and China. Regarding this, Merck drew a line, saying, "This decision will not affect the use of Lagevrio in countries where licensing or approval has already been completed." Lagevrio appeared in 2022, in the midst of the Corona-19 crisis. Together with Pfizer Paxlovid, it was widely used as an oral corona treatment. However, this year, the global pandemic situation has ended and its use has declined significantly. In the pharmaceutical industry, there is an analysis that Merck has decided to withdraw from the European market due to declining marketability. It is analyzed that the lower effect compared to Paxlovid also influenced the decision to withdraw voluntarily. Lagevrio is a mechanism that inhibits viral replication. Unlike Paxlovid, which lowered the risk of hospitalization and death due to corona by 89%, Lagevrio only reduced the risk of hospitalization and death by 30%, as shown in phase 3 clinical trials. It is said that the treatment effect is low and the marketability is greatly reduced, and global demand is said to have decreased significantly. After generating $5.684 billion in global sales last year, Lagevrio's sales have plummeted this year. As a result, domestic biopharmaceutical companies that were trying to produce and supply Lagevrio generics to low- and middle-developed countries are also stepping back. Celltrion Pharmaceuticals recently passed the bill to terminate the license agreement for Lagevrio generic production at the board of directors' meeting. The company originally planned to produce Lagevrio generics at its Cheongju plant but decided to terminate the contract as the COVID-19 situation eased compared to the time of the contract. Hanmi also signed a contract to produce Lagevrio generics last year but canceled it earlier this year. Likewise, Hanmi Pharm explained that this is because demand has significantly decreased as the corona crisis turned endemic. In the pharmaceutical industry, attention is focused on alternatives to Lagevrio, which is in the process of being virtually phased out. Potential alternative drugs include Xocova, developed by Japan's Shionogi Pharmaceutical, and Xafty, which is being developed by Hyundai Bioscience. Xocova is an oral COVID-19 treatment developed by Japan's Shionogi Pharmaceuticals. Xocova is currently being supplied only in Japan with EUA. Xocova recorded sales of close to 1 trillion won in Japan for four months from November last year to March this year. The Japanese government purchased 2 million doses of Xocova for 104.7 billion yen under a supply contract with Shionogi. In Korea, Ildong Pharmaceutical started the joint development of Xocova with Shionogi Pharmaceutical. Earlier this year, Ildong Pharmaceutical applied for product approval of Xocova to the Ministry of Food and Drug Safety. The review is still ongoing after 6 months. Hyundai Bioscience is developing niclosamide, which was previously used as an insect repellent in Korea, as an oral corona treatment through drug re-creation clinical trials. In phase 2 clinical trials, it was found that the time taken for improvement of corona symptoms was shortened by 4 days. Hyundai Bioscience plans to proceed with EUA and product approval to the Ministry of Food and Drug Safety.
- Company
- Leclaza and Tagrisso compete for reimb in the first line
- by Jung, Sae-Im Jul 03, 2023 05:47am
- (From the left) Pic of Leclaza and Tagrisso Yuhan Corp’s EGFR-targeted anticancer drug ‘Leclaza (lasertinib)’ has been approved as a first-line treatment in Korea and is competing for reimbursement with its competitor ‘Tagrisso (osimertinib).’ As reimbursement review for Tagrisso’s first-line indication is already in progress, Yuhan is also expected to hasten its steps to receive reimbursement for its Leclaza. On June 30th, the Ministry of Food and Drug Safety approved the change in Leclaza’s indication to ‘the treatment of patients with advanced or metastatic non-small-cell lung cancer harboring EGFR mutation exon 19 deletions or exon 21 substitution.’ With the approval, Leclaza, which had been used as a second-line treatment until now, is now available as a first-line treatment in Korea. As a result, 2 third-generation TKIs – Tagrisso and Leclaza – are now available for the treatment of EGFR-mutated NSCLC in the first line. However, as the first-line indication for the drugs is yet to be reimbursed in Korea, the drugs are mainly used as subsequent therapy following initial treatment with first and second-generation drugs. Leclaza PFS data(Data: ESMO Asia) Results of the Phase III LASER301 trial that was presented in December last year showed that Leclaza achieved its primary endpoint and improved progression-free survival (PFS) over its comparator (gefitinib) by 9.7 months. Also, Leclaza reduced the risk of disease progression and death by 55% compared to the control group (HR=0.45). Also, its benefit was consistently observed in ▲patients with brain metastasis, ▲patients with L858R mutation, and▲ Asians. Although a uniquely high incidence of paresthesia was observed in the Leclaza-treated group, most were mild and manageable. ◆Tagrisso and Leclaza compete for first-line reimbursement With the approval, Leclaza is now on a level playing field with Tagrisso. Leclaza quickly closed the gap during the 4 years Tagrisso struggled and failed to pass its first step to receiving reimbursement in the first line. Therefore, how the competition will end will now depend on which drug becomes reimbursed in the first line. In the case of Tagrisso, its adequacy for reimbursement in the first line was finally recognized in March by the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee (CDDC) after 5 attempts. AstraZeneca had attempted to pass CDDC review with its global FLAURA trial data that was the basis of Tagrisso’s fist-line indication and the FLAURA China trial data that confirmed an improvement in overall survival (OS) in Asians, to no avail. The CDDC had deemed that the data was not sufficient to recognize the drug’s effect on Asians. The company had strategically narrowed its reimbursement standards, but that attempt was also turned down by the CDDC. The situation turned in favor of Tagrisso at the end of 2022 after large-scale real-world data on Tagrisso’s effect as a first-line treatment in Asia and Europe was released. Analysis of the real-world data of 660 Japanese patients confirmed a progression-free survival of 20.0 months and overall survival of more than 3 years (40.9 months), which was longer than that found in its Phase III clinical trial. Based on the data, the company put an end to Tagrisso’s efficacy controversy in Asia. However, the problem is that the company has only now passed the first step to its reimbursement. Tagrisso’s reimbursement agenda needs to pass HIRA’s Drug Reimbursement Evaluation Committee (DREC) review, drug pricing negotiations with the National Health Insurance Service, and the Ministry of Health and Welfare’s Health Insurance Policy Deliberation Committee (HIPDC) to complete the reimbursement process in Korea. As a risk-sharing agreement (RSA) drug, Tagrisso must also pass pharmacoeconomic evaluations. HIRA’s statuary evaluation period is set at 120 days or less, but it is common for HIRA to exceed the set deadline if the company is required to submit supplementary data. In fact, 3 months have passed since Tagrisso passed the CDDC review, but no schedule for the subcommittee for its pharmacoeconomic evaluation has been set yet. Although the statutory period set for the reimbursement process sets the timing for Tagrisso's reimbursement extension at the end of this year, there is a strong possibility that the period will be delayed somewhat. Unlike Tagrisso, Leclaza’s reimbursement agenda is expected to pass CDDC review without difficulty as the drug demonstrated its effectiveness in the Asian subgroup with a hazard ratio of 0.46. The fact that it is the only homegrown new drug is also expected to work in favor of Leclaza. Therefore, if Leclaza passes the CDDC review in July or August, the drug may also be deliberated by DREC with Tagrisso. Yuhan Corp plans to apply for reimbursement in the first line as soon as possible. Also, the company has also prepared an Early Access Program (EAP) that provides Leclaza free of charge until the drug is granted reimbursement. The move shows Yuhan Corp’s confidence that it will be able to rapidly receive reimbursement. Yuhan Corp said, “With Leclaza’s approval, we are pleased to be able to provide a new treatment option for patients with EGFR mutation-positive NSCLC, which is highly prevalent in Korea. We are preparing to apply for the reimbursement extension for Leclaza in the first line and provide our drug for free to the patients until it is reimbursed through our Early Access Program (EAP).”
