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Opinion
[Reporter's View] Suspension of drug price cut
by
Kim, Jin-Gu
May 08, 2023 05:41am
The price of Forxiga, an SGLT-2 diabetes drug, remains unchanged despite the release of a generic version. AstraZeneca applied for suspension of drug price cut execution along with an administrative lawsuit, and the court accepted it. AstraZeneca cited the reason that Forxiga's indications include not only diabetes but also heart failure and kidney disease. A generic Forxiga was released as a treatment for diabetes, and the government's price cuts that affect other indications are unreasonable. Unlike the US, Switzerland, and Australia, Korea does not differentiate drug prices by indication. In other words, unless the current drug pricing system changes in a broader framework, it is very likely that the administrative lawsuit filed by AstraZeneca will not be accepted by the courts. There is no way that AstraZeneca did not know about this situation. Nevertheless, AstraZeneca applied for a suspension of execution of Forxiga's drug price cut. It is a very clever decision from AstraZeneca's point of view. Considering that it usually takes more than three years for the Supreme Court to make a final decision, it can prevent expected losses of tens of billions of won every year for more than three years. However, at the same time, it cannot be free from criticism that it abused the suspension system. Coincidentally, the day Forxiga's drug price cut enforcement suspension was cited was the day the 'Drug Price Cut Refund and Refund Act' passed the National Assembly. This law is about the collection and refund of pharmaceutical expenses paid or unpaid during the period of suspension or execution of drug price cuts. The government has emphasized the necessity of this bill. Biopharmaceutical companies complained that the judiciary's decision to suspend the execution of drug price cuts caused a loss in health insurance finances. The biopharmaceutical industry criticized that it was concerned about violating the constitutional right to sue. Regarding the government's claim that the pharmaceutical industry abuses the judiciary's suspension of execution, he protested that it was only a "partial problem." The face of the biopharmaceutical industry, claiming the injustice of the drug price reduction/refund law, has become meaningless. Rather, it has strengthened the government's argument that has emphasized the necessity of the bill. According to the government's logic, health insurance financial losses of tens of billions of won are expected over the next few years. Neither the government nor the biopharmaceutical industry can view this positively. On the day the bill to correct the problem was passed, he did that very problematic act. Criticism comes from the pharmaceutical industry that the degree of cleverness is too much. The bill will come into effect six months after promulgation. After 6 months, such an application for suspension of execution is burdensome. If the Forxiga drug price cut had been six months later, would AstraZeneca have made the same decision as it is now?
Company
New polycythemia vera drug Besremi may be prescribed
by
Eo, Yun-Ho
May 08, 2023 05:40am
The Taiwanese pharmaceutical company PharmaEssentia’s first new drug ‘Besremi’ can now be prescribed in general hospitals in Korea. According to industry sources, PharmaEssentia’s polycythemia vera treatment, Besremi (Ropeginterferon alfa-2b) passed drug committee reviews of tertiary hospitals in Korea including Seoul National University Hospital and Asan Medical Center. The company submitted an application for the reimbursement of its drug on March 28 and is undergoing the reimbursement process in Korea. If listed, the drug is expected to quickly lead to actual prescriptions in the field. Polycythemia vera is a rare blood disorder where a somatic cell mutation in the bone marrow abnormally activates bone marrow function and produces excessive red blood cells. It has a short survival period and is so fatal that 10~15% of patients with polycythemia vera develop myelofibrosis or leukemia within 10 years. Although hydroxyurea had been used as the standard of care, it was difficult to fundamentally cure the disease with hydroxyurea, and patients who could not be treated with hydroxyurea had limitations as there were practically no drugs available for them in Korea’s domestic reimbursement environment. Besremi is an interferon treatment that selectively removes JAK2 mutations that cause polycythemia vera. In Korea, the drug received approval in October 2020 to treat low-risk and high-risk patients with polycythemia vera without symptomatic splenomegaly. The drug demonstrated its potential as a radical treatment for polycythemia vera in patients who had not received cytoreduction therapy or received less than 3 years of treatment with hydroxyurea. Therefore, whether the only interferon treatment option approved for polycythemia vera will be born in Korea is receiving attention. Besremi demonstrated its efficacy and safety in the Phase III PROUD/CONTINUATION-PV trial that was conducted on polycythemia vera patients. Trial results showed that 53% of the patients in the Besremi arm achieved a complete hematological response, an improvement compared with the hydroxyurea patient arm (38%). The hematologic and molecular response rates at 72 months were also high, at 80.4% and 65.3% in low-risk and high-risk patients, respectively. Regardless of their risk, patients treated with Besremi did not require phlebotomy even 6 years after administration. Sung-Soo Yoon, Professor of Hemato-Oncology at Seoul National University Hospital, said, “Polycythemia vera is currently left unattended in the blind area of reimbursement in Korea. Patients that show no response to hydroxyurea, the current standard of care, had no appropriate treatment and had no option but to wait for their condition to progress further.” He added, “Korea’s clinical practice guidelines recommend interferon and ruxolitinib as second-line treatment for patients who show intolerance or are refractory to hydroxyurea, but both drugs are currently unreimbursed, and other interferon treatments have withdrawn from the Korean market. Therefore, as the only treatment option available, Besremi is in urgent need of reimbursement.” Besremi is recommended as a first-line or second-line treatment for polycythemia vera in the National Comprehensive Cancer Network (NCCN) and European Leukemia Network (ELN) guidelines, regardless of previous treatment experience.
Company
Merck establishes a bio-production facility in Daejeon
by
Jung, Sae-Im
May 08, 2023 05:40am
(From left) Minister of Trade, Industry and Energy Lee Chang-yang, Merck Life Science CEO Matthias Heinzel, Daejeon Metropolitan City Mayor Lee Jang-woo Merck Life Sciences establishes a bio raw material production facility in Korea. Merck Lifesciences announced on the 3rd that it has signed a memorandum of understanding (MOU) with the Ministry of Trade, Industry and Energy and Daejeon Metropolitan City to establish a production facility for raw and subsidiary materials used in the new Asia-Pacific bioprocess in Korea. The bio-process production facility scheduled to be established in Daejeon will support the pharmaceutical/bio ecosystem in the Asia-Pacific region and focus on producing products for biotech and pharmaceutical customers. Along with this, the company and the city of Daejeon will support biotech companies that have moved into the Daedeok Research Complex in Daejeon and will expand research cooperation with leading universities in Korea. Matthias Heinzel, CEO and Member of the Board of Directors of Merck Life Sciences said, "Korea is an emerging world leader in the biotechnology industry, and this MOU is a commitment to actively support our customers in the Asia Pacific region through close cooperation with the government. "The production facility being tested will play an essential role in meeting the demand for bioprocessing in the Asia-Pacific region, while also serving as an important hub for the development of Korea's biopharmaceutical industry." said. Minister of Trade, Industry, and Energy Lee Chang-yang said, "This cooperation is expected to serve as an opportunity for our biopharmaceutical industry to take a leap forward as a national high-tech industry."
Company
AbbVie Korea merges with Allergan Korea
by
Jung, Sae-Im
May 07, 2023 08:37pm
AbbVie Korea announced on the 2nd that it will complete the integration of domestic corporations with Allergan Korea on May 1st and launch as a single corporation. The domestic corporation merger is a follow-up to the announcement of the merger and acquisition of Allergan by the global headquarters in May 2020. It plans to integrate the entire business operation management system and take a new leap forward with 'one AbbVie'. As part of the integration process, AbbVie Korea recently expanded its existing office space and renovated it into a smart office to integrate the two companies workspaces. Since the announcement of the global acquisition of Allergan in 2020, the two companies have been operating employee programs such as Culture Week, company-wide training program, and Possibilities Week together every year, integrating corporate culture into a unified AbbVie. With this domestic corporation integration, the total number of AbbVie Korea employees will be about 330 as of May. As a leader in the field of immunology, AbbVie has successfully launched Humira, a treatment for autoimmune diseases, Skyrizi, a treatment for psoriasis, and Rinvoq, which is expanding its treatment to include rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, atopic dermatitis, and ulcerative colitis. introduced domestically. In addition, it is supplying innovative treatments such as Maviret, a treatment for hepatitis C, and Venclexta, a treatment for chronic lymphocytic leukemia and acute myeloid leukemia. The integration will include Allergan's Ozurdex treatment for diabetic macular edema and uveitis, Combigan treatment for glaucoma, Ganfort and XEN Gel implant medical devices for eye diseases, as well as Botox for stroke-related upper extremity spasticity and chronic migraine headache treatment, which will be included in AbbVie's specialty medicines business. widen Allergan esthetic provides differentiated brand programs and educational opportunities in the medical esthetic business, such as botulinum toxin preparation Botox, hyaluronic acid filler Juvedern, and coolsculpting, and provides new growth opportunities. Kang So-young, CEO of AbbVie Korea, said, "We are pleased to have successfully completed the operation management system and corporate integration process of both companies." We expect that we will be able to maximize the synergy effect by integrating each other's professional capabilities and experiences, as well as expanding the treatment area."
Company
BeigeneKR's hematologic cancer drug Brukinsa, covered from M
by
Jung, Sae-Im
May 04, 2023 05:50am
BeigeneKR announced on the 2nd that Brukinsa, a treatment for Waldenstrom's macroglobulinemia (WM), will be covered from this month. Brukinsa reimbursement applies to monotherapy in adult patients with Waldenstrom's macroglobulinemia who have received one or more prior therapies. Brukinsa is a second-generation BTK inhibitor that targets BTK. Existing patients with Waldenstrom's macroglobulinemia were treated with chemotherapy that damages normal cells as well as cancer cells. Brukinsa improved both efficacy and side effects by targeting the BTK protein through the malignant B-cell receptor (BCR). Waldenstrom's macroglobulinemia is a rare type of non-Hodgkin's lymphoma. It mainly occurs in the elderly. The main pathogenesis is the infiltration of lymphoid plasma cells secreting monoclonal immunoglobulin M (IgM) into the bone marrow. Increased IgM causes blood viscosity to rise, resulting in symptoms such as blood flow disorders, headaches, nosebleeds, retinal hemorrhages, and cerebral hemorrhages. Anemia, thrombocytopenia, and neutropenia due to bone marrow involvement are also common. Some patients experience fever, night sweats, or unexplained weight loss. Brukinsa reduced median IgM levels by 79% in a phase 3 trial in patients with WM. The event-free rate at 18 months for patients who achieved a complete response (CR) or very good partial response (VGPR) was 93%. Brukinsa also has indications for ▲MCL and ▲MZL. However, the two indications failed to pass the Cancer Disease Review Committee of the Health Insurance Review and Assessment Service.
Company
Erleada can be prescribed at general hospitals in Korea
by
Eo, Yun-Ho
May 04, 2023 05:50am
The new prostate cancer drug ‘Erleada’ can now be prescribed at general hospitals in Korea According to industry sources Janssen Korea’s metastatic hormone-sensitive prostate cancer (mHSPC) treatment Erleada (apalutamide) passed the drug committees (DCs) of tertiary hospitals in Korea including the Seoul National University Hospital and Asan Medical Center, including emergency DC meetings, a total of 60 medical institutions generated a prescription code for Enhertu. With the drug’s reimbursement listing last month, the approval is expected to quickly lead to actual Erleada prescriptions in the field. Erleada is an androgen receptor targeted agent and a latecomer that belongs to the same class of drugs as Zytiga (abiraterone)’ and ‘Xtandi (enzalutamide).’ The drug safety and efficacy in the Phase III TITAN trial in 1,052 patients with mHSPC. Despite the fact that about 40% of the patients assigned to the placebo group continued treatment with Erleada during treatment, the risk of death in the Erleada group was 35% lower than that of the placebo group. Overall survival (OS) at 48 months was 65% in the Erleada group and 52% in the placebo group. Also, when excluding the effect of patients who switched medication from the placebo group to Erleada, the risk of death in the Erleada group was 48% lower than that of the placebo group. Meanwhile, according to the National Cancer Registration Statistics Program, the number of patients diagnosed with prostate cancer in 2020 was 16,815, ranking third in men following lung cancer (19,657) and stomach cancer (17,869). The number surpassed that of colorectal cancer (16,485). In addition, among the 5 major male cancers (lung cancer, stomach cancer, prostate cancer, colorectal cancer, and liver cancer), only the rate of prostate cancer has been increasing, and at an annual average rate of over 5%.
Company
Daewoong is accelerating its global expansion
by
Kim, Jin-Gu
May 04, 2023 05:50am
A view of Daewoong Pharmaceutical’s Hyangnam factory (above) and Daewoong Bio’s Hyangnam factoryDaewoong Pharmaceutical Group is speeding up CAPA expansion. In order to speed up its global expansion, it decided to invest 250 billion won in establishing two new factories this year alone. Daewoong Pharmaceutical plans to expand its botulinum toxin production capacity to 3.6 times the previous level by constructing a third plant for Nabota. Daewoong Bio will expand its scope from the production and sales of raw materials and finished pharmaceuticals to the global CDMO business by establishing a new microorganism-only plant. ◆Production capacity increased 3.6 times with the establishment of the 3rd factory in Nabota, Will the utilization rate decrease to 150%? According to the pharmaceutical industry on the 4th, Daewoong Pharmaceutical has begun construction of a third plant exclusively for producing Nabota, a botulinum toxin. Daewoong Pharmaceutical plans to complete the construction by 2024 at a cost of 103.6 billion won. The third factory located in Hyangnam-eup, Hwaseong-si, Gyeonggi-do has an annual production capacity of 13 million vials. The production capacity of the existing Nabota Plants 1 and 2 was 5 million vials. This means that after 2024, Nabota production capacity will expand to 3.6 times the current level. Daewoong Pharmaceutical explained that it is setting out to establish a new plant to respond to the expanding global demand for Nabota. Daewoong Pharmaceutical achieved sales of 142.1 billion won with Nabota last year. It increased by 79% compared to 79.6 billion won in 2021. In particular, exports of Nabota increased 2.3 times in one year to 109.8 billion won. The production capacity of Daewoong Pharmaceutical's Hyangnam plant, including Nabota, has steadily expanded since 2018. It more than doubled in four years from 5.8 billion won in 2018 to 6.2 billion won in 2019, 9.3 billion won in 2020, 10 billion won in 2021, and 14.4 billion won last year. The utilization rate has already exceeded 100%. 159% in 2018, 156% in 2019, 149% in 2020, 143% in 2021, and 165% last year. The utilization rate of the entire Hyangnam plant is also steadily maintained at 150-160%. This means that even though factories are operating beyond their limits, the situation continues to be difficult to meet demand. In particular, in February 2021, Daewoong Pharmaceutical's US partner, Evolus, signed a three-way agreement with Medytox and AbbVie to eliminate risks associated with local sales of 'Jubo (Nabota's US product name)', and exports are rapidly increasing. Daewoong Pharmaceutical launched Nabota in the UK in September of last year, aiming to enter the European market in earnest. Daewoong Pharmaceutical obtained product approval from the EC in October 2019. It has been registered in 62 countries around the world so far and plans to release products in 9 European countries, China, Egypt, Chile, Australia, New Zealand, Singapore, and Malaysia. Daewoong Bio, entering the global CDMO business with the construction of a new plant, expects synergy with Daewoong Pharmaceutical. Daewoong Bio also announced an expansion of its production capacity recently. Daewoong Bio announced in January that it would build a microbe-based plant. At the same time, it announced that it would enter the global CDMO business. It plans to expand its business area from the production of existing raw materials and finished drugs. Daewoong Bio is operating its Hyangnam and Anseong factories in Korea. The production capacity of the Hyangnam plant is 200,000 liters per year. It has production lines dedicated to raw materials, UDCA, and Fexuclue, which are raw materials for Ursa. The Anseong plant has an annual production capacity of 400 million tablets and produces Gliatamine, Atorvastatin, and Clopidogrel. The new plant, with an investment of 146 billion won, is expected to serve as an outpost for the global CDMO business. In the pharmaceutical industry, there is a prospect that the CDMO business structure from Daewoong Pharmaceutical to Daewoong Bio will be completed. Daewoong Pharmaceutical obtained permission for an advanced regenerative medicine cell processing facility from the Ministry of Food and Drug Safety in July last year. Daewoong Pharmaceutical has been able to speed up the development of cell and gene therapy products by obtaining permission for cell processing facilities in addition to the existing high-tech biopharmaceutical manufacturing and management businesses such as human tax cells. If Daewoong Pharmaceutical's Yongin Bio Center provides services such as the development and quality testing of cell and gene therapy products, it is expected that Daewoong Bio's new plant will be able to complete the CDMO business structure in charge of the production of related products. It is analyzed that both Daewoong Pharmaceutical and Daewoong Bio made a bold investment decision at the group company level in the construction of a new plant. The 103.6 billion won invested in Daewoong Pharmaceutical's new plant construction amounts to 14% of its equity capital (741.2 billion won) at the end of last year. Daewoong Bio plans to invest 40% of its equity capital (365.1 billion won) in the construction of a new plant at the end of last year.
Company
Rare diseases still left neglected in Korea’s healthcare
by
Eo, Yun-Ho
May 04, 2023 05:49am
Patients with rare diseases suffer due to the rarity of their disease. Even when treatments are available, the drugs have difficulty receiving reimbursement as it is difficult to prove cost-effectiveness and predict financial expenditures for the drugs due to the small number of patients. The government is well aware of such difficulties. This is why it has attempted to improve access to rare disease treatments through various systemic improvements. However, the situation has not improved much. Among the 6,000 to 7,000 rare diseases known worldwide, only about 6% have available treatments developed. This is because it is difficult to secure statistical significance of the data due to the small number of patients and limited clinical data. This is why even the small number of rare diseases for which treatments have been developed is a pie in the sky in terms of reimbursement. In this sense, the ‘Study on the current status of access to rare disease treatments in Korea and measures to strengthen their coverage' that was recently announced by Professor Jong-Hyeok Lee of Chung-Ang University College of Pharmacy is attracting attention. Results of the study suggest that there are still many blind spots that remain unattended for rare disease treatments. Reimbursement rate remains at 33% for orphan drugs ineligible for special calculation exemptions First, when analyzing the reimbursement status of the total of 136 orphan drugs that were approved over the past 10 years (2012-2021), the reimbursement rate for anticancer drugs rose to 58% after measures were implemented to strengthen coverage for 4 major severe diseases that began in 2013. In the case of rare disease treatments, the rate is only 51%. In particular, the rate for orphan drugs that are not subject to special calculation exemptions is only 33.3%, indicating the existence of the neglected areas, or blind spots that remain, in the area of rare diseases. In addition, the period required for reimbursement was about 22 months for drugs subject to special calculation exemptions, while it was 34 months for those ineligible for special calculation exemptions, showing the significant difference. Such results show that Korean patients' access to rare disease drugs is still limited, and the process is time-consuming. ◆Lacks application of RSA and PE exemptions The RSA (Risk Sharing Agreement) and the pharmacoeconomic evaluation exemption (PE exemption) system, which are special systems established for the reimbursement of new drugs, were also found to be rarely applied to rare diseases. Reimbursement evaluation results of the drugs analyzed in the study showed that the special systems were mainly applied to anticancer drugs. The RSA and PE exemptions were only applied to 30% and 22% of the rare disease drugs, respectively. All in all, the limited scope of application of the special systems was affecting access to treatments for patients with rare diseases. Supported by such study results, the industry has been requesting that the government allow individual deliberations to be made for drugs that are not subject to the special calculation exemption but are chronically debilitating diseases as orphan drugs not subject to the special calculation exemption system cannot receive the systemic benefits for reimbursement (only 2 products have received benefits from the system). Meanwhile, the Ministry of Health and Welfare held public-private consultative body meetings to improve the drug pricing system with the National Health Insurance Service, Health Insurance Review and Assessment Service, and three pharmaceutical organizations. After 5 meetings, the MOHW is known to be preparing to announce the final measure to improve the drug pricing system. The ultimate purpose of preparing the 'Innovative New Drug Compensation Plan' by the 2nd Vice Minister Min-soo Park of the MOHW for the implementation of ‘Yoon Administration’s National Policy Tasts’ is not on increasing the value of drugs that are already reimbursed, but to fulfilling the fundamental purpose of allowing drugs that have not yet entered the system (received reimbursement benefits) to enter the system. Therefore, to expand access to rare disease treatment as listed as a national task by the Yoon administration, it is hoped that a practical and effective systemic improvement will be made rather than superficial attempts.
Opinion
[Reporter's View] Patent expired original
by
Lee, Tak-Sun
May 03, 2023 05:38am
For original drug patents that have expired, the upper limit is adjusted under the authority of the Ministry of Health and Welfare when a generic drug with the same product appears. Original drugs will be reduced to 70% of the previous price for one year, and from the second year onwards, the price will drop to the same 53.55% level as generic drugs. If the price drops by half, sales are likely to drop in proportion to him. That's what we call performance cut in half. Therefore, from the company's point of view, it is necessary to devise a strategy to prevent generics from being produced. First, it is to delay the expiration of the patent. In order to further guarantee the validity of a 20-year substance patent, the patent period can be extended by requesting an extension of the duration. In Korea, there is no limit on the extension of the duration. Therefore, pharmaceutical companies have been delaying the expiration of patents by extending the duration in consideration of the drug registration period. Another is to register subsequent patents. Commonly referred to as an evergreening strategy, it is to delay the release of generics by additionally registering salt patents, formulation patents, composition patents, and use patents. Domestic pharmaceutical companies sometimes make salt-modified drugs to avoid extending the duration or subsequent patents. However, as the Supreme Court disallowed it as a means of avoiding extending the duration, it is now widely used to neutralize subsequent patents. However, the salt-modified drug is not the same drug as the original drug because the salt is different. Therefore, even if a salt-altering drug comes out, the upper limit of the original drug does not fall. Maybe the original drug's evergreening strategy worked. Last year, generics were also released for diabetes treatment Tenelia, but the price ceiling did not fall because they were all salt-modifying drugs. Despite this patent strategy, generics are bound to come out. Last month, generics of Forxiga, a diabetes treatment, were poured out in heaps. Therefore, the original drug price was scheduled to be adjusted ex officio this month. The drug price cut was temporarily postponed because AstraZeneca, a pharmaceutical company, applied for suspension of execution to the court, and this was tentatively quoted. AstraZeneca applied for suspension of execution to the court because Forxiga, unlike generics, has indications other than diabetes. The company claims that it is unreasonable to cut drug prices that affect all other indications for which benefits have been applied, such as heart failure and kidney disease. It is interpreted that AstraZeneca pulled out a suspension card as a last resort when generics came out and drug price cuts became a reality. If the company suffers huge property damage, the possibility of suspension of collection increases. As mentioned earlier, the original drug's original drug price cut is halved, so property loss is inevitable. As a result, the rate of suspension of execution is also high. Once a suspension of execution is cited, price adjustments are not made until the outcome of the trial on the merits, so pharmaceutical companies can buy time for a long time. The longer the drug price adjustment period is, the more it will inevitably lead to financial losses for health insurance. As this problem has emerged, there is a movement to crack down on the door through revision of the law. The amendment to the Health Insurance Act, which provides for the recovery and refund of drug expenses paid or unpaid during the period of suspension of enforcement following the outcome of administrative litigation to cancel drug price cuts by pharmaceutical companies, passed the National Assembly on the 27th of last month. It is expected that if this law goes into effect six months after the government promulgation, the number of indiscriminate applications for suspension of enforcement by dissatisfaction with drug price cuts will decrease. A partial amendment to the Patent Act was proposed to limit the extension of the patent term to 14 years after approval and limit the number of patent rights that can be extended. If this law is passed, it is expected that generics will be more likely to be released earlier than before. I would like to think about introducing a more active reduction strategy, such as applying the ex officio adjustment condition limited to generics of the same product to late-release drugs with the same active ingredient after the expiration of the substance patent. There may be many things to consider, such as resistance from the pharmaceutical industry, laws and principles, and equity, but if the mechanism for adjusting authority is narrowly designed as it is now, strategies or tricks that abuse it will inevitably continue.
Company
Will Verzenio succeed in expanding benefits
by
Eo, Yun-Ho
May 03, 2023 05:38am
Attention is focusing on whether Verzenio will succeed in expanding early breast cancer insurance benefits. According to the related industry, the agenda to expand reimbursement for early breast cancer with a high recurrence risk of Verzenio, a breast cancer treatment with CDK4/6 inhibitory mechanism of Lilly Korea, is expected to be presented to the Cancer Disease Review Committee of the Health Insurance Review and Assessment Service next month. Verzenio was approved by the Ministry of Food and Drug Safety in November last year as an adjunctive treatment for early breast cancer patients at high risk of recurrence of positive HR+/HER2- type lymph nodes, as an indication for combined administration with endocrine therapy. The clinical efficacy of this drug was confirmed through the monarchE study, a clinical study conducted on patients with HR+/HER- lymph node-positive early breast cancer who had a high risk of recurrence. In this clinical trial, Verzenio was conducted on patients with a low survival rate due to a high risk of recurrence among early breast cancer patients. Specifically, a very limited group of patients with ▲ four or more lymph node metastases, ▲ one to three lymph node metastases with a tumor size of 5 cm or more, and ▲ a grade 3 histological grade participated in the study. MonarchE 4-year follow-up data was announced at the San Antonio Breast Cancer Symposium Annual Conference in December last year. As a result of the study, Verzenio + endocrine therapy reduced the risk of recurrence and death by about 34% compared to endocrine therapy alone, and the risk of distant recurrence and death was also reduced. reduced by about 34%. Early breast cancer has a high risk of recurrence in the first 1 to 2 years after surgery. Therefore, unlike metastatic breast cancer, which requires continuous treatment, active treatment early after surgery minimizes the risk of recurrence and improves long-term prognosis. Verzenio is also administered only 2 years after surgery. The reason why the 4-year follow-up data announced in December of last year drew attention is that the IDFS and DRFS improvement results of Verzenio in the 4th year compared to the 2nd and 3rd years were more strengthened. Professor Joo-Hyeok Son of the Department of Oncology at Severance Hospital said, "The gap in invasive disease-free survival rate and remote recurrence-free survival rate between Verzenio + endocrine therapy and endocrine therapy alone continued to widen until the 4-year follow-up period, which was consistent with Verzenio even after completing adjuvant therapy after surgery for 2 years. "This suggests that Neo's treatment benefits may continue." Verzenio's benefit is recognized in HTA countries such as the UK and Canada.
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