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- 2025-12-23 09:48:32
- Company
- Public opinion grows on if PO kidney tx should be covered
- by Nho, Byung Chul Oct 31, 2023 05:35am
- Bayer chronic kidney disease treatment Kerendia. This drug is a disease-related disease that has emerged for the first time in 20 years As first-in classes related to kidney disease are blocked by insurance registration review barriers, it seems urgent to improve the system through social consensus. A drug related to this is Kerendia, Bayer's chronic renal failure treatment that was newly introduced for the first time in 20 years. Renal anemia that occurs due to abnormal kidney function can be mentioned, including the recently approved AstraZeneca Evrenzo (2021), JW Pharmaceutical Eronai (2022), and Mitsubishi Danabe Vadanem (2023). The reasons why a rapid registration process for innovative new drugs related to kidney disease is required are to expand patient treatment options and reduce health insurance finances. According to the NHIS data, the number of chronic kidney disease patients in Korea increased by 36.9% from 206,061 in 2017 to 282,169 in 2021, and in particular, those in their 80s surged by 82.8%. The number of hemodialysis patients is also showing an exponential increase, and the health insurance budget currently spent on approximately 100,000 patients is close to 3 trillion won. Compared to existing renal anemia treatments that are distributed only as injections, it is expected that patient compliance will also significantly increase because it is in the form of an oral pill. The news that Kerendia has been submitted to the pharmaceutical review committee provides some hope for the insurance listing of these drugs related to comprehensive kidney disease. This is a result of approximately one and a half years after approval (May 2022) due to the expression of opinions from all directions, including not only the developer, but also the nephrology society, the National Assembly, and patient groups. Therefore, discussions on drug price negotiation for Kerendia, which was recognized as appropriate for coverage of chronic kidney disease with type 2 diabetes at the 11th pharmaceutical reimbursement evaluation committee, are gaining momentum, giving strength to the justification for listing renal anemia treatment drugs. The reason why health authorities actively reviewed the adequacy of Kerendia's benefits was to reduce social costs. When chronic kidney disease progresses to end-stage renal failure, treatment progresses to hemodialysis, peritoneal dialysis, kidney transplantation, and surgery, which costs around 30 million won per year, which goes against public opinion to overcome this by actively intervening in drug therapy in the process. We are doing it together. AstraZeneca, JW Pharmaceutical, and Mitsubishidanabe obtained approval from the Ministry of Food and Drug Safety for tablet-type renal anemia treatments Evrenzo, Eronai Tablet, and Badanem in 2021, 2022, and 2023, respectively. These drugs are expected to have equivalent effects compared to injectable drugs and contribute to reducing health insurance costs but are still pending HIRA review As can be seen in the Kerendia case, tablet-type renal anemia treatments also require an emphasis on drug efficacy and cost-effectiveness and a quick reimbursement process is required. It is known that tablet-type renal anemia treatment drugs can achieve financial savings of about 10 to 20% compared to existing injection drugs, based on clinical data on anemia treatment in dialysis patients, even if patients with general kidney disease are excluded. Some are concerned about issues related to blood clots, but according to the industry, existing drugs appear to be in a similar situation, so it is almost a logical contradiction to use this as an issue to put a brake on drug price negotiations. The only treatment for renal anemia is EPO, which was developed about 30 years ago, and recently, even third-generation injectable drugs with extended administration intervals have been released. As the number of patients who do not respond to existing medications is gradually increasing, new treatment mechanisms are required due to side effects such as blood pressure changes and nausea and vomiting. It is understood that JW Pharmaceutical's Eronai and Mitsubishi Badanem are attempting to be listed at the average price among alternative drugs. AstraZeneca Evrenzo appears to have virtually suspended all proposals for PE and alternative drug weighted average prices based on the headquarters' high orphan drug price policy.
- Company
- Zavicefta nears final negotiations for reimb in KOR
- by Eo, Yun-Ho Oct 31, 2023 05:35am
- Whether the next-generation antibiotic ‘Zavicefta’ will be successfully listed for reimbursement is gaining attention. Under the Ministry of Health and Welfare’s order to proceed to drug pricing negotiations, Pfizer Korea is soon set to begin pricing discussions for ‘Zavicefta’ (ceftazidime-avibactam). The drug passed the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee review last September. However, unlike other drugs that almost immediately started negotiations, the company wasn’t able to start drug pricing negotiations for the drug right away. With the negotiations soon to begin, it remains to be seen whether a new antibiotic drug will be listed in an area where no other drug than MSD Korea's Zerbaxa (ceftolozane-tazobactam) has brought results. Zavicefta was developed to address the urgent need for new antibiotics in severe infections that cause serious problems such as multidrug-resistant pseudomonas aeruginosa or carbapenem-resistant gram-negative Enterobacteriaceae and extended-spectrum-lactamase (ESBL) producing intestinal bacteria. Zavicefta is used to treat adult patients suffering from complicated intra-abdominal infections (cIAI); complicated urinary tract infections (cUTI), including pyelonephritis; hospital-acquired pneumonia (HAP); and the treatment of aerobic Gram-negative infections in adult patients who have limited treatment options. Zavicefta was originally developed by AstraZeneca. In 2016, Pfizer acquired the drug while acquiring AstraZeneca’s antibiotic business. Securing a new treatment alternative for carbapenem is a global health issue publicized by the WHO. Multidrug-resistant Gram-negative bacteria are increasing worldwide and have recently become a serious problem in healthcare-associated infections. This is why the WHO had designated carbapenem-resistant Pseudomonas aeruginosa as a Priority 1: Critical pathogen that requires research and development of new antibiotics. Korea’s pseudomonas aeruginosa resistance rate to carbapenems is 30.6%, the second highest among the surveyed countries after Greece. Also, the ESBL (extended-spectrum beta-lactamases)-producing Enterobacteriaceae are also showing resistance to cephalosporin antibiotics that are effective against a wide range of gram-negative bacteria. Currently, new antibiotics available in Korea include MSD’s anti-infective Zerbaxa (ceftolozane-tazobactam) and Pfizer’s antifungal ‘Cresemba (isavuconazonium).’
- Company
- Jyseleca to be launched in earnest next month
- by Eo, Yun-Ho Oct 30, 2023 05:30am
- A fifth entrant has joined the competition in the JAK inhibitor market. The Japanese pharmaceutical company, Eisai Korea’s ‘Jyseleca’ will be listed for reimbursement starting next month (November). Its first reimbursed indication is rheumatoid arthritis and moderate to severe active rheumatoid arthritis. Patients eligible for reimbursement are those aged 65 or older who do not respond adequately to or are intolerant to existing treatments or those who show inadequate response or are intolerant to TNF-α inhibitors. Jyseleca received a conditional reimbursement decision for rheumatoid arthritis and ulcerative colitis indications from HIRA’s Drug Reimbursement Evaluation Committee in July. At the time, DREC judged that reimbursement was adequate if the company accepted a price less than the evaluated amount. As such, Eisai Korea appears to have accepted a price below the assessed value. The company skipped negotiations on the insurance price ceiling that requires negotiation with the National Health Insurance Service by accepting a price that is below 90% of the weighted average price of its alternative, thereby jumping into the JAK inhibitor drug competition. JAK inhibitors currently available in Korea are Xeljanz (tofacitinib), Olumiant (baricitinib), and Rinvoq (upadacitinib).’ These drugs have received a lot of attention upon introduction as the first oral drug options to demonstrate equivalence to anti-TNF agents in the field of autoimmune diseases. These drugs have been steadily expanding their indications and reimbursement standards since their launch. Xeljanz, which was the first to be developed, secured additional indications for ulcerative colitis and psoriatic arthritis last year, and later entrants, including Rinvoq, have also been expanding their prescriptions to autoimmune diseases such as atopic dermatitis, Crohn's disease, and ankylosing spondylitis. Meanwhile, Jyseleca (filgotinib) is an adenosine triphosphate (ATP) a competitive and reversible inhibitor that selectively inhibits JAK1. JAK1 is a substance that transmits inflammatory cytokine signals and is considered a major treatment target for rheumatoid arthritis. Some of the recent treatments inhibit JAK2 or JAK3 by indication, but there is some opinion that both mechanisms are involved in immune cell proliferation and homeostasis regulation, and may cause adverse reactions. The drug's efficacy was demonstrated through Phase III trials, including FINCH1, FINCH2, and FINCH3. In the FINCH1 study, the drug improved arthritis symptoms by more than 20% at 12 weeks when administered to patients with moderate-to-severe active RA (rheumatoid arthritis) despite continued methotrexate (MTX) treatment.
- Company
- Heart failure drug Entresto continues to grow rapidly
- by Kim, Jin-Gu Oct 30, 2023 05:30am
- Entresto Novartis' heart failure treatment Entresto continues to grow rapidly thanks to increased benefits. Although it has been six years since it was launched in Korea, prescriptions are increasing by more than 30% every quarter compared to last year. However, Entresto faces challenges from several successor products. Recently, Verquvo, a new heart failure drug with a new mechanism, was released, and SGLT-2 inhibitor diabetes treatments are expanding their indications to the heart failure area. Additionally, generic companies are actively challenging Entresto's patent evasion and invalidation. Quarterly prescription volume approaching 15 billion won, still growing rapidly 6 years after launch. According to UBIST, a pharmaceutical market research firm, on the 28th, Entresto's out-of-hospital prescriptions in the third quarter were KRW 14.8 billion. It increased by 36% in one year compared to 10.9 billion won in the third quarter of last year. Six years have passed since its release in the fourth quarter of 2017, but it is still showing high growth. It grew by more than 30% every quarter compared to the same period last year. It exceeded 5 billion won in the first quarter of 2020, and expanded to more than 10 billion won in the second quarter of 2022. If the current trend continues, it is expected to exceed 15 billion won in the fourth quarter of this year. The analysis is that there was no suitable treatment for heart failure before the launch of Entresto and that the company was able to quickly increase prescriptions by enjoying a monopoly position without competing drugs after the product launch. The steady expansion of the salary range is also considered a factor in maintaining high growth. Entresto's coverage has been expanded to 'first-line treatment of HFrEF with a left ventricular ejection fraction of 40% or less' since July of this year. Domestic chronic heart failure patients can now use Entresto from the first treatment, even if they do not take a stable dose for more than 4 weeks in combination with standard treatment such as ACE inhibitors or ARBs. In March last year, coverage was expanded to primary treatment for hospitalized patients with acute decompensated heart failure. For patients who were hemodynamically stabilized after hospitalization for acute decompensated heart failure, benefits were recognized when administered Entresto even if ACE inhibitors or ARB drugs were not administered. Competition is expected with follow-up new drugs, SGLT-2 diabetes drugs, generic drugs, etc. However, opinions differ on how long this growth trend will continue in the future. This is because we face challenges from a variety of competing products. First of all, Verquvo, another heart failure treatment from Bayer, was released last September with insurance coverage. It is expected that full-fledged prescriptions will be made once the drug passes the Pharmacist Committee (DC) at major general hospitals. Verquvo is a treatment for chronic heart failure with a new mechanism. It is a mechanism that promotes the synthesis of cyclic guanoic acid monophosphate (cGMP) within cells. Unlike existing ACE I or β-blockers, which suppress the activation of the neuro-hormonal system due to myocardial and vascular dysfunction, it improves myocardial and vascular function by directly stimulating sGC to promote cGMP synthesis. In the pharmaceutical industry, as it is a treatment option with a new mechanism that has emerged for the first time in a long time since Entresto, it is predicted that prescriptions will rapidly expand in clinical settings in the future. SGLT-2 inhibitor-type diabetes treatments such as Forxiga and Jardiance are also expected to pose a challenge. Both drugs recently received approval for expanded indications for heart failure. Subsequently, an application was made to expand benefits based on efficacy and effectiveness. Forxiga was applied for reimbursement for heart failure with reduced cardiac output and chronic renal failure, and Jardiance was applied for heart failure with reduced cardiac output and heart failure with preserved left ventricular ejection fraction. In the case of Forxiga, as it has also obtained indications for heart failure with preserved left ventricular ejection fraction and reduced mildness, it is expected that applications for reimbursement in this area will continue in the future. Last year, related academic societies in the United States and Korea successively recommended Forxiga and Jardiance as treatments for heart failure. The American College of Cardiology (ACC), American Heart Association (AHA), and Heart Failure Society of America (HFSA) jointly recommended SGLT-2 inhibitors, such as Farxiga, as a treatment for mild or preserved heart failure in the 2022 revised heart failure guidelines (recommendation level) 2a). The Korean Society of Heart Failure also recommended SGLT-2 inhibitors in patients with preserved ejection fraction, regardless of the presence or absence of diabetes (recommendation grade 1). Entresto is also facing patent challenges from generics. (From left) Product photos of Verquvo, a new heart failure drug, and Forxiga and Jardiance, SGLT-2 inhibitor diabetes drugs. All three products are evaluated as competitors to Entresto Domestic pharmaceutical companies, including Hanmi Pharmaceutical, Chong Kun Dang, Samjin Pharmaceutical, Hana Pharmaceutical, and Angook Pharmaceutical, are pursuing lawsuits to avoid the Entresto patent. Last year, Hanmi Pharmaceutical was the first to succeed in capturing all five Entresto-related patents. Afterward, 9 additional companies won. Novartis disagreed with the first trial result and appealed. We are currently awaiting the patent court's ruling. The Patent Court announced November 9 as the date for the second trial of the Entresto crystalline patent lawsuit. The verdict was originally scheduled to be handed down in September but was postponed for about two months. In the case of two pharmaceutical patents expiring in 2029, the first trial victory for generic companies has been confirmed. If the patent challengers win in the second trial and succeed in neutralizing the remaining patents, the launch of the generic Entresto is expected to come closer.
- Company
- Nic Horridge resigns as CEO of Roche Korea
- by Eo, Yun-Ho Oct 30, 2023 05:29am
- CEO Nic Horridge According to related industries, CEO Nic Horridge will step down as CEO of Roche's Korean subsidiary at the end of this month and become CEO of the Australian subsidiary. CEO Nic Horridge was appointed as CEO of Roche Korea in October 2018 and led the company for approximately five years. During his tenure, he achieved the expansion of primary lung cancer coverage of the immunotherapy drug Tecentriq, as well as the listing of new items such as spinal muscular atrophy treatment Evrysdi, eye disease treatment Vabysmo, and cancer-regarding cancer drug Rozlytrek. In addition, he promoted Agile Transformation, which was carried out at the headquarters level to quickly and flexibly make the organization's work methods and operating model. Unlike general pharmaceutical company employees who are responsible for each product, employees are responsible for diseases, or specific indications. However, in the process, quite a few issues of personnel adjustment and departure occurred. Meanwhile, CEO Nic Horridge has served as the leader of the marketing division in several countries around the world, including the headquarters, since joining Roche's New Zealand branch in 2005, and served as Roche's Vietnam branch manager from May 2016 until recently. Before joining Roche, he had extensive business experience in sales and marketing for 3M Healthcare and received a bachelor's degree in cell biology and a doctorate in molecular biology from the University of Canterbury in New Zealand.
- Company
- Nephoxil can be prescribed at general hospitals
- by Eo, Yun-Ho Oct 27, 2023 05:33am
- Nephoxil, a hyperphosphatemia treatment drug, is entering the prescription range of general hospitals. According to related industries, Kyowa Kirin Korea's Nepocsil has passed the Drug Committee of about 50 hospitals across the country, including Sinchon Severance Hospital. Nephoxil was developed as a new iron-based phosphorus binder with high solubility, and through clinical trials, it not only has a phosphorus control effect but also has an additional anemia correction effect, reducing the dosage of hematopoietic hormones and iron injections. In addition, the capsule formulation is evaluated to not only improve medication compliance but also contribute to the economical treatment of hyperphosphatemia patients among hemodialysis patients. Nephoxil was approved for improving hyperphosphatemia in chronic kidney disease patients receiving hemodialysis and was listed on the health insurance coverage list on July 1. It is imported and sold by Kyowa Kirin Korea, the Korean subsidiary of Japanese Kyowa Kirin, but it was developed by a Taiwanese pharmaceutical company, not Japan. This can be seen as a rare case where a Taiwanese new drug was imported domestically and even applied for reimbursement. In particular, this drug was not listed in the A7 reference country, but it was cheaper than alternative drugs and took only 1 year and 2 months from approval to reimbursement. Non-calcium drugs currently on the market include Sanofi Renvela, SK Chemicals Invela, and JW Pharmaceuticals Fosrenol. In particular, several generic Renvela drugs have recently come out and are competing with it.
- Company
- Livtencity aims to enter the reimbursement market
- by Eo, Yun-Ho Oct 27, 2023 05:33am
- According to related industries, Takeda Pharmaceutical Korea's Livtencity submitted a benefit application in the third quarter of last year, has completed PE, and is currently submitting it to the HIRA Pharmaceutical Reimbursement Evaluation Committee. Accordingly, it remains to be seen whether an alternative treatment option can be developed for patients resistant to existing drugs. CMV is a type of herpes virus that infects more than 60% of adults worldwide at least once in their lives. It is a typical disease that occurs in patients who use immunosuppressants after hematopoietic stem cell (HSCT) transplantation. The risk is such that 30-70% of hematopoietic stem cell transplant patients experience CMV viremia. In hematopoietic stem cell transplant patients, CMV disease causes multi-organ diseases such as pneumonia, hepatitis, gastroenteritis, retinitis, and encephalitis, of which pneumonia has a mortality rate of up to 60%. Because CMV in immunocompromised patients is fatal, preemptive treatment is generally administered, mainly ganciclovir, valganciclovir, foscarnet, and cidofovir, and hospitalization is essential. Additionally, because these drugs have similar mechanisms if resistance to one drug develops, it is highly likely to not respond to other treatments. With the advent of Livtencity, there is hope for secondary treatment. Livtencity has almost no side effects compared to existing drugs and can provide an alternative in cases where resistance to these treatments develops. The antiviral activity of this drug, Livtencity, inhibits CMV proliferation and migration through a differentiated multi-modal mechanism of action that inhibits the protein kinase of the HCMV enzyme UL97. It not only inhibits DNA from coming out of cells but also inhibits DNA replication and virus encapsulation. Livtencity was approved by the US FDA as the first treatment for CMV-infected patients in November 2021 and was approved in Korea in December last year.
- Company
- The Key to Competitiveness is 'OS·Brain metastasis'
- by Oct 26, 2023 06:07am
- The combination therapy of major EGFR variant lung cancer treatments has yielded results at the annual conference of the European Society of Oncology (ESMO 2023). Combination therapy of Lexraza + Rybrevant has succeeded in improving major clinical evaluation indicators compared to Tagrisso monotherapy. Lexraza is a lung cancer treatment that targets the EGFR variant Exxon 19 and Exxon 21 L858R developed by Yuhan. We are confirming the possibility of a primary treatment for lung cancer in combination with Janssen's Exxon 20 target Rybrevant. Tagrisso, in combination with platinum-based chemotherapy, has released clinical results in which encephalon has been effective in lung cancer patients. Tagrisso is a third-generation tyrosine kinase inhibitor (TKI), such as Leclaza, which is used to treat primary and secondary lung cancer with EGFR mutations. After the failure of third-generation TKI treatment, platinum-based chemotherapy, which is mainly used for secondary treatment, is being used in combination with Tagrisso to evaluate its effectiveness. Published clinical results showed that one side did not show overwhelming results. The overall survival (OS) data to be released at a later date and the effectiveness of brain transfer in patients have become important. Leclaza+Rybrevant Improves key evaluation indicators for Tagrisso therapy. At ESMO 2023 on the 23rd, the results of an interim analysis of the MARIPOSA Phase 3 clinical study evaluating the efficacy of Leclaza+Rybrevant combination therapy were released. The clinical trial was conducted in 1074 patients with EGFR variant locally advanced or metaplastic non-small cell lung cancer. The patient age (median) was 63 years old and Asian patients accounted for more than half (59%). Among them, the rate of brain transfer was 41%. Patients were randomly assigned to a 2:2:1 ratio for Leclaza+Rybrevant combination therapy, Tagrisso monotherapy, and Leclaza monotherapy. The primary evaluation variables included no-progress survival (PFS), and the secondary evaluation variables included the OS, PFS (PFS2) after the first subsequent treatment, and ORR. As a clinical result, the PFS (median) of the Leclaza+Rybrevant group was 23.7 months and the Lexa monotherapy group PFS was 18.5 months, which was longer than the 16.6 months recorded by the Tagrisso monotherapy group. The Leclaza+Rybrevant group was found to have a 30% lower risk of disease progression and death than the Tagrisso group. ORR showed similar numbers, with Leclaza+Rybrevant groups and Tagrisso monotherapy groups at 86% and 85%, respectively. In the interim OS analysis, the Leclaza+Rybrevant group showed a favorable tendency over the Tagrisso monotherapy group. PFS2 results show that the Leclaza+Rybrevant group had a 25% lower risk of disease progression or death compared to the Tagrisso monotherapy group. In terms of safety, EGFR and MET-related adverse reactions have been more commonly reported in the Leclaza+Rybrevant group. Level 3 adverse events were reported at 75% and 43% in the Leclaza+Rybrevant and Tagriso monotherapy groups, respectively, and serious adverse events were reported at 49% and 33%. The adverse events that led to death were similar at 8% and 7%. Presenters at Presidential Session 3 held on the 23rd. Yonsei Cancer Hospital Professor Cho Byeong-cheol (left) introduced the results of the MARIPOSA phase 3 clinical trial. Photo source = ESMO DAILY REPORT Professor Cho Byung-cheol of Yonsei Cancer Hospital, who was in charge of the presentation on this day, said, "Recraza + Libribant combination therapy was effective regardless of race or race. In particular, as favorable tendencies have been confirmed in the OS mid-analysis, Leclaza+Rybrevant has suggested the possibility of becoming a new standard treatment for the new EGFR variant primary treatment for non-small cell lung cancer.” In the case of Tagrisso, data from a follow-up study of the FLAURA2 clinic was released. In the FLAURA2 clinical study, PFS of Tagriso+Platinum-based chemotherapy was recorded at 29.4 months. In ESMO 2023, the results of a subgroup analysis of patients were released. The results of a study released on the 21st showed that the combination of Tagrisso + chemotherapy for patients had a stronger inhibitory effect on intracranial progression compared to Tagrizo monotherapy. The clinical trial included 557 patients with EGFR-positive metaplastic non-small cell lung cancer who had no previous experience in general therapy. Among them, there were 222 patients with brain war. Patients were assigned to the combination therapy group (279 people) and the monotherapy group (278 people), respectively. As a clinical result, intracranial ORR in the co-therapy group was 73%, similar to 69% for monotherapy. However, the complete response (cEAS) in the two was 59% in the co-use group and 43% in the monotherapy group. The median intra-two non-progress survival (PFS) assessed by the Independent Review Committee (BICR) was 30.2 months for the combination therapy group and 27.6 months for the monotherapy group. The risk of disease progression or death in combination therapy was found to be 42% lower. The key evaluation element of combination therapy, 'OS·brain transfer effect' Leclaza+Rybrevant, Tagrisso +, and chemotherapy all differed in PFS. The OS data was still immature, but favorable tendencies were observed for both combination therapies. As the PFS difference is not significant, the OS data that will be released in the future will be the key to becoming the primary treatment for EGFR mutations for non-small cell lung cancer. It is also noteworthy that the two combination therapies have an effect on patients. PATIENTS WITH CEREBRAL EMBRACTION INCLUDED 43% IN THE MARIPOSA CLINICAL AND 40% IN THE FLAURA2 CLINICAL. It is known that anticancer drugs fail to pass through the Blood Brain Barrier (BBB) if the cancer has spread to the brain. Especially since encephaly occurs frequently in patients with lung cancer, the proportion of patients with epilepsy including epilepsy is emphasized in the two clinical trials that evaluate the effectiveness of combination therapy. The utilization of Leclaza+Rybrevant, Tagrisso + chemotherapy is analyzed and effective data will play a decisive role in patients with OS and Brain metastasis, which will be released at a later date.
- Company
- Seo Jeong-jin, targets sales of 5 trillion won for new drugs
- by Kim, Jin-Gu Oct 26, 2023 06:06am
- Celltrion Group Chairman Seo Jeong-jin is explaining future plans at a press conference on the 25th Seo Jeong-jin, Chairman of Celltrion Group, presented a goal to increase global new drug sales to 5 trillion won by 2030, focusing on 'Zymfentra', which was recently approved as a new drug in the United States. Chairman Seo made this announcement at a press conference held at NH Investment & Securities in Seoul on the 25th. Previously, Celltrion set the group's total sales target of 12 trillion won in 2030. The plan is to increase sales by adding new drugs as well as existing biosimilars. Chairman Seo predicted that Zimfentra would play a pivotal role here. Zymfentra is the subcutaneous (SC) formulation of Remsima. On the 20th (local time), it received sales approval as a new drug from the U.S. Food and Drug Administration (FDA). Previously, it was approved as a new formulation biosimilar in Europe, but in the United States, it took the route of new drug approval through a separate phase 3 clinical trial. Celltrion explains that since it has obtained approval as a new drug, it can set a higher sales price than existing biosimilars. Chairman Seo said, “We expect superior profits in the U.S. market compared to Europe, where RemsimaSC was previously approved as a biosimilar.” Chairman Seo said, "When RemsimaSC was sold in Europe, it was confirmed that 40% of patients who had previously used the intravenous formulation switched to the SC formulation within one year." He added, "If we apply this to patients in the United States, many patients will move to the SC formulation." “We expect that Zymfentra alone will be able to achieve global sales of 3 trillion won within 3 years,” he emphasized. He explained that he has also begun drug price negotiations with several insurance companies in the United States. It was expected that the drug price in the US market would be at the level of ‘competitive products’. He pointed out the competing product as Takeda Pharmaceutical's Entyvio. Entyvio is a treatment for autoimmune diseases such as ulcerative colitis and Crohn's disease. In the United States, it was previously approved as an intravenous injection formulation, but recently a subcutaneous injection formulation was also approved. It is said to be similar to Jim Pentra in many ways. Chairman Seo predicted, “Negotiations with insurance companies began in earnest yesterday. Negotiations will be completed within the year,” and added, “The US price of Zympentra is expected to be similar to that of Entyvio, a competing product.” Chairman Seo said, “Next year, we will also conduct a comparative clinical trial with Entyvio,” and added, “Entyvio conducted a comparative clinical trial with Humira, but not with Remsima. The existing animal clinical trials yielded meaningful results.” Chairman Seo said, "In addition to Zympentra, we have four new drug platforms. The related pipelines amount to 20," and added, "We expect that there will be no problem with global new drug sales of 5 trillion won by 2030, centered on Zympentra." He emphasized.
- Company
- Verzenio reattempts reimb for early breast cancer in KOR
- by Eo, Yun-Ho Oct 26, 2023 06:06am
- Verzenio, the first CDK4/6 inhibitor to attempt reimbursement listing for early breast cancer, has begun its second journey toward reimbursement in Korea. This attempt is being made 5 months after the first failure. The news of Lilly Korea's Verzenio (Abemaciclip) reapplication for reimbursement was made known through a written inquiry made by Rep. Young-Seok Seo (Democratic Party of Korea) of the National Assembly Health and Welfare Committee to the Ministry of Health and Welfare during the NA audit. Rep Seo inquired about the status of reimbursement of drugs approved to prevent relapse in patients with early breast cancer and the MOHW’s position and plans regarding the application of coverage to related new drugs. Verzenio was mentioned as one of the 17 drugs that own an indication for early breast cancer in the response submitted by the MOHW. Other than the letrozole generic that is used as endocrine therapy, it is the only new drug for the HR+/HER2- type. The drug was first approved on November 18th, 2022 as an adjuvant treatment for adult patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-), node-positive, early breast cancer (EBC) at high risk of recurrence in combination with endocrine therapy. More specifically, a very limited range of patients with ▲ patients with 4 or more positive axillary lymph nodes, ▲ 1-3 positive axillary lymph nodes, and tumor size of 5 cm or larger, or ▲histological grade 3 disease. However, the drug struggled from the first step to its reimbursement at HIRA's Cancer Disease Review Committee level. After a long wait of 6 months after submitting the application, the agenda was finally reviewed at the 3rd CDDC meeting that was held on May 3rd. However, Verzenio had unfortunately many contestants. A total of 9 items were reviewed in the 3rd CDDC meeting. This was the largest amount of subjects among the 7 cancer screening meetings held this year. 5 months after failing the first CDDC review, Lilly filed for reimbursement again on October 4th to HIRA. The company was equipped with new supporting data presented at the 2023 ESMO Congress that had been held in Madrid, Spain recently. The 5-year morachE data that was released was a follow-up study of the 4-year data released at the San Antonio Breast Cancer Symposium published in Lancet Oncology in December 2022. Study results showed that the differences in the major clinical indicators - invasive disease-free survival (IDFS) and distant relapse-free survival (DRFS) rates – widened more distinctively between the Verzenio arm and the control arm (endocrine therapy alone) at 5 years compared to 4 years. At 5 years, the primary efficacy endpoint IDFS differed by 8%. This means that even after completing Verzenio treatment during the limited period of 2 years after surgery, its treatment effect continued until the 5th year. This data is even more significant as the term, ‘cure,’ is generally used 5 years after cancer treatment. Powered by the reinforced data, the key now lies in the hands of the MOHW. In response to Rep. Seo's written inquiry regarding the coverage of new drugs to prevent early breast cancer recurrence, the MOHW’s Pharmaceutical Benefits Division said, "We strongly agree with the direction of helping early breast cancer patients receive timely treatment and enjoy a better life. We are committed to preventing early breast cancer recurrence. When drugs with indications to prevent early breast cancer recurrence apply for reimbursement, we will review them in accordance with procedures, taking into full consideration their cost-effectiveness, etc..”
