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- 2026-04-10 21:59:51
- Company
- SGLT-2 Market ↑3x in 3 years
- by Jung, Sae-Im Feb 07, 2023 05:47am
- The domestic SGLT-2 inhibitor outpatient prescription market has grown to 170 billion won. It has more than tripled in the past three years. It has been about 10 years since SGLT-2 inhibitors entered Korea. This year, a major change is expected as a number of "Forxiga" generics leading the market are released and new domestic SGLT-2 inhibitors are also released. ◆ SGLT-2, which has grown considerably, grows evenly According to UBIST, a pharmaceutical market research institute on the 6th, the total amount of outpatient prescriptions for SGLT-2 inhibitors in Korea last year was 172.3 billion won. This is an increase of 14.8% compared to 150.1 billion won in the previous year. The market, which was about 50 billion won in 2017, quickly grew in size by expanding its influence in diabetes. It recorded 70.3 billion won in 2018 and 96.9 billion won in 2019 and surpassed 100 billion won for the first time in 2020. It is now on the verge of surpassing 200 billion won. The SGLT-2 inhibitor was evenly grown by a single agent and a combination agent The combination refers to the addition of Metformin to the SGLT-2 inhibitor component. Last year, the single agent grew by 11.1% to 98.6 billion won, and the combined system increased by 20.1% to 73.7 billion won, respectively. By product, AstraZeneca's Forxiga, Xigduo, and Beringer Ingelheim's single Jardiance recorded more than 40 billion won last year. By the manufacturer, AstraZeneca is 91.4 billion won, higher than Beringer Ingelheim's 76.1 billion won. Forxiga was the highest prescription item, up 14% from the previous year to 48.5 billion won. Jardiance then increased by 10.5% to 45.2 billion won. The combined Xigduo increased by 16% to 42.9 billion won during the same period. Beringer Ingelheim's compound "Jardiance Duo" recorded a prescription amount of 30.9 billion won, up 26.2% from the previous year, although it fell short of Xigduo. ◆ Launch of new product and generic, SGLT-2 market upheaval this year This year, a big change is expected in the SGLT-2 inhibitor market. First of all, the release of domestic SGLT-2 inhibitors is imminent. Daewoong Pharmaceutical plans to release Envlo, which was approved by the Ministry of Food and Drug Safety in November last year, within the first half of this year. The company is also speeding up the approval of the complex system. A number of generics for Forxiga and Xigduo will also be released in April. The Supreme Court ruled in favor of Forxiga's Generics on the 2nd. The ruling will allow generic companies to release generic for exclusive use from April 7, when Forxiga's first substance patent expires. A total of 14 companies, including Kyung Dong, Kukje, Daewon Pharmaceutical, Dongwha, Boryung, Samjin, Sinil, Alvogen Korea, Yunjin, Ildong, Jeil, Chong Kun Dang, Hanmi, Han Wha, etc., have 39 items of generics for Forxiga.
- Policy
- The price of AbbVie Skyrizi is likely to be adjusted
- by Lee, Tak-Sun Feb 06, 2023 05:51am
- AbbVie's moderate-severe psoriasis treatment Skyrizi PFS has agreed to a PVA negotiation, which is expected to reduce the upper limit. The drug was registered in June 2020, and it is analyzed that it exceeded the expected claim agreed in advance with the NHIS from 2021. According to the industry on the 3rd, the NHIS has completed PVA negotiations with AbbVie which will be reflected in the list as of March 1. Skyrizi was also a PVA-monitoring drug in the third quarter of last year. As type A, this is the first upper limit under PVA negotiations. In patients with moderate to severe psoriasis lasting more than 6 months, if ▲Plaque psoriasis is more than 10% of the total skin area, ▲PASI 10 or higher, ▲ MTX or Cyclosporin is administered for more than 3 months, or if treatment cannot be continued due to side effects, ▲PUVA or UVB treatment. Psoriasis is an immune-mediated disease caused by abnormalities in the body's immune function, and redness and white dead skin cells occur throughout the body. Skyrizi has the convenience of taking it once every 12 weeks. It is evaluated to be excellent in terms of effectiveness, with skin improvement maintained even in the first year of administration in clinical trials. It was approved by the Ministry of Food and Drug Safety in December 2019, applied for benefits immediately, passed the Pharmaceutical Review Committee in March 2020, and was listed on the final list in June after the NHIS negotiations until May of that year. The annual financial requirement was expected to be 5.9 billion won, and the upper limit of insurance was set at 1,247,790 won per government office. According to IQVIA, Skyrizi sold only 1.5 billion won in its first year, but its performance jumped to 8.4 billion won in 2021. It is believed that the upper limit amount has been adjusted through PVA negotiations with the NHIS this time while exceeding the expected amount of claims.
- Company
- Does the Xospata dosing cycle limit disappear?
- by Eo, Yun-Ho Feb 06, 2023 05:51am
- The new leukemia drug Xospata is aiming to expand insurance benefit standards again. According to related industries, Astellas Pharmaceutical Korea submitted an application to expand the salary of Acute Myeloid Leukemia treatment Xospata at the end of last year and is currently discussing the schedule for the cancer disease review committee with the HIRA. Looking at the current benefit criteria, two-cycle benefits are recognized as induction therapy for patients who are non-responsive to existing treatments or can perform homogeneous hematopoietic stem cell transplantation among FLT3 mutation-positive AML patients. However, considering the preparation period for allogeneic hematopoietic stem cell transplantation, additional two cycles are recognized only if the same hematopoietic stem cell transplant is approved in advance (or equivalent evidence is presented). In other words, the administration of Xospata is limited to up to 4 cycles. In general, when the dose cycle of a drug is limited in the benefit standard, it is based on the design of clinical research of the drug or authoritative overseas guidelines. Blood cancer treatments such as Besponsa and Blincyto have limitations on administration, which are all based on evidence. In the case of Xospata, there is no specific reason to limit the dosage cycle. According to Xospata's ADMIRAL study, it is designed without limitation on the duration of administration, and the NCCN guidelines also recommend "Category 1" without limitation on the duration. Domestic permits are also allowed to be administered until severe toxic symptoms occur or clinical benefits do not appear. Of course, the salary standard does not necessarily have to be the same as the permit, but the academic community's position is that the limited standard of Xospata is problematic. As a result, it remains to be seen whether Xospata will expand its benefit standards this year and improve the prescription environment. Xospata is a drug that targets both FLT3-ITD and FLT3-TKD mutations, which are taken once a day orally, and can be treated on their own at home without frequent hospital visits. It also improved its effectiveness compared to conventional chemotherapy.
- Opinion
- [Reporter’s View] Improving NHI-related legislation
- by Lee, Jeong-Hwan Feb 06, 2023 05:51am
- The bill to remove the administrative drug price cut and reimbursement suspension dispositions that were imposed on illegal drug rebates from the current National Health Insurance Act and raising the penalty surcharge system has drawn industry attention and rose as an issue of focus this year. The bill aims to minimize third-party damage inflicted on patients, prescribing doctors, and dispensing pharmacists by the administrative dispositions imposed on rebate drugs, and to strengthen control over illegal rebates. The controversy over the irrationality of the drug price cuts and reimbursement suspension dispositions imposed on rebate drugs had been an issue for quite some time. The law was revised to improve the irrationality of reimbursement suspensions, where doctors and patients were left with no choice but to use more expensive drugs or experience other disadvantages in treating their diseases due to the reimbursement suspension dispositions. After the reimbursement suspension system on rebate drugs was implemented in July 2014, the revised National Health Insurance Act that applies drug price cuts according to the number of rebates and suspends reimbursement or imposes fines after 3 violations took effect in March 2018. The bill that proposed the reform of the National Health Insurance Act was submitted by NA Rep. Min-Suk Kim of the Democratic Party of Korea as representative. The bill attempts to improve the institutional irrationality of the current reimbursement suspension system. For this, the proposed bill not only contains measures that remove the price cut and suspension of reimbursement dispositions on rebate drugs and improve the standard for fines, but provisions to resolve the issue of drugs that have received reimbursement suspensions in the past. The supplementary provision of the proposed bill allows the law to be applied to drugs that received drug price cuts or reimbursement suspension dispositions or are undergoing administrative litigation at the time Rep. Kim’s bill was implemented. If so, it will be possible to retroactively apply the new system to drugs that were fined when the previous reimbursement suspension system was applied, reducing the risk of unreasonable cases and improving patient rights. The National Health Insurance Service agreed with Kim’s proposed bill that replaces reimbursement suspensions with fines. The NHIS said, “The reimbursement suspensions may violate the health rights of patients in need of the drug, so the NHIS agrees on the purpose of the amendment to impose a fine instead,” acknowledging the harm caused by the reimbursement suspension disposition. Although Kim’s bill cannot be completely flawless., the bill shows traces of multifaceted considerations made to improve the issue of the reimbursement suspension system as rationally as possible while strengthening control over rebates. Lee’s bill to revise the National Health Insurance Act is soon set to be reviewed by the Ministry of Health and Welfare soon. It is hoped that the efforts of the pharmaceutical industry and the National Assembly, which have been struggling to address the issue of reimbursement suspension for a decade, will be thoroughly reflected in the legislation during the review. Also, the legislation, which can allow three birds - preventing unnecessary damage to patients, doctors, and pharmacists, minimizing waste of health insurance finances, and strengthening punitive fines for rebates on pharmaceutical companies - to be caught with one stone, will be successfully implemented.
- InterView
- SGLT-2 I is a great help in the treatment of heart failure
- by Kim, Jin-Gu Feb 06, 2023 05:51am
- SGLT-2 inhibitors developed for the purpose of treating diabetes are speeding up the expansion into the area due to heart failure. The use of SGLT-2 inhibitors targeting heart failure is expanding not only in university hospitals but also in the local area. This trend has been expanding since the revision of the domestic heart failure guidelines last year. Although benefits are still limited, expectations for the drug are said to be very high at the front-line prescription site. Jung Young-jin (37), head of the cardiovascular center at Yongin Myeongju Hospital, said, "SGLT-2 inhibitors are very helpful in treating heart failure. He said, "The effect of improving major symptoms of heart failure, including difficulty breathing, is visible," adding, "Personally, we are more actively prescribing SGLT-2 inhibitors to heart failure patients than in the past." ◆SGLT-2 Inhibitor, Improvement of Heart Failure Symptoms Visibly The Korean Heart Failure Association revised the guidelines for heart failure treatment in July last year. The revised guidelines recommended SGLT-2 inhibitors as the main treatment for heart failure treatment regardless of the presence or absence of diabetes. It was used limitedly only to reduce heart rate and mildness during heart failure, but the revision of the guidelines added an area to preserve heart rate. The pharmaceutical industry predicts that SGLT-2 inhibitors will become the basic treatment for heart failure. SGLT-2 inhibitors have previously been known to be diabetes treatments that benefit cardiovascular diseases. Still, their status has risen significantly as the results of solo clinical trials on heart failure patients were announced in 2019. Expectations for this drug are high even at the front-line prescription site. Jung Young-jin, head of the cardiovascular center at Yongin Myeongju Hospital, said, "It is prescribed a lot to patients with heart failure who do not have diabetes," adding, "Improvement of major heart failure symptoms, including difficulty breathing, is visible." Jung, head of the center, said, "It was often used in heart failure patients in the past, but I have been using it more actively since a paper was published last year that it is effective in heart failure patients whose heart function is preserved." He added, "We are seeking consent from patients and prescribing them because the salary has not yet been applied." The pharmaceutical industry also predicts that SGLT-2 inhibitors will be able to further expand their areas in the future. SGLT-2 inhibitors are mechanisms that selectively inhibit SGLT-2 transporters involved in the reabsorption of glucose. Through this, blood sugar is controlled by blocking the reabsorption of glucose discharged into the urine into the bloodstream. In this process, SGLT-2 inhibitors also inhibit the secretion of inflammatory cytokines, which has the effect of treating heart failure. Considering this mechanism alone, it is estimated to be effective not only for heart failure but also for cardiovascular disease as a whole. This means that SGLT-2 inhibitors can be used to treat heart failure and other cardiovascular diseases such as myocardial infarction. Already in the United States and Europe, a paper has been published on the effect of SGLT-2 inhibitors on the treatment of myocardial infarction. AstraZeneca and Beringer Ingelheim, which have major drugs, are undergoing phase 3 clinical trials for myocardial infarction. The two clinical results are scheduled to be released this year. He also agreed with the possibility. Since the most common cause of heart failure is ischemic heart failure, I think it will be effective in other cardiovascular areas, said he, head of the center. "There is a possibility in terms of the mechanism."
- Company
- Mavyret occupies 85% of HCV market...sales fall 36% in 3 yrs
- by Kim, Jin-Gu Feb 06, 2023 05:51am
- Pic of Abbvie Abbvie’s Mavyret has dominated the oral hepatitis C treatment market. Last year the drug increased its market share to 85%. Despite this increase in market share, the drug’s prescription performance fell 36% over the past 3 years. The analysis is that the absolute size of the Hepatitis C treatment market, which has a limited number of patients, has been decreasing due to the near-cure effect of the treatments in the market, which eventually led to a reduction in the overall market size. ◆Mavyret occupies 85% of the HCV market...prescription performance drops 36% in 3 years According to the market research institution UBIST on the 4th, Abbvie’s oral HCV treatment Maryret’s outpatient prescriptions recorded KRW 29 billion last year. This was a 10% increase compared to 2021 and is considered to be due to Maryret’s scope of reimbursement being expanded from adults to adolescents aged 12 years or older. With the reimbursement extension, its market share increased to 85%. Mavyret had quickly expanded its influence in the market since its release in September 2018, with its benefits of being pan-genotypic and short treatment period. In 2019, its market share increased to 70% and then to 75% in 2020 and 2021. However, in the long term, the reduction in prescription performance is clear. Outpatient prescriptions fell from KRW 45.6 billion in 2019 to KRW 35.7 billion in 2020, then to KRW 26.3 billion in 2021. This amounted to a 36% decrease in prescription performance compared to 2019. The reason for the decrease in prescription performance despite the increase in market share is because of the reduced overall market size. The size of the oral HCV treatment market has steadily decreased from KRW 135.3 billion in 2017 to KRW 73.7 billion in 2018, to KRW 65.1 billion in 2019, to KRW 47.4 billion in 2020, to KRW 35.1 billion in 2021, then to KRW 34.2 billion in 2022. Compared to 2017, when the market had expanded to its maximum, the market had shrunk to one-fourth its size in 5 years. ◆Increased cure rate had contracted market size...All HCV drugs other than Mavyret·Harvoni earn less than KRW 100 million In the pharmaceutical industry, the cause of market contraction is due to the characteristics held by HCV treatments. Before the introduction of direct-acting antivirals (DAAs) like Mavyret, HCV had been a very critical condition. However, the treatment effect of HCV drugs had increased dramatically with the introduction of BMS’s Daklinza and Sunvepra. Then, Gilead Sciences' Sovaldi and Harvoni. MSD’s Zepatier and Abbvie’s Mavyret followed, enhancing the treatment effect With the treatment effect high enough to be close to a complete cure, the market size quickly contracted with the number of patients being prescribed the drug increasing within the finite number of patients in the market. With the rapid contraction of the market, some drugs that once dominated the market decided to withdraw from the domestic market. In March 2021, BMS voluntarily withdrew the authorization for its for Daklinza and Sunvepra. In June, Roche also voluntarily withdrew its injectable HCV treatment Pegasys from the domestic market. The situation is also similar for drugs other than Mavyret. Prescription performance of drugs that had occupied the market after Daklinza and Sunvepra, such as Zepatier, Sovaldi, and Harvoni are converging to nearly 0. In the case of Zepatier, its prescription sales had recorded KRW 19.9 billion in 2018, but then fell rapidly to record less than KRW 50 million last year. Sovaldi’s sales had also fallen to less than KRW 10 million last year from the KRW 84.3 billion in 2017, and Harvoni’s sales had fell to KRW 5 billion from the 40.9 billion in 2016. ◆Gilead releases a new drug for the first time in 5 years...makes winning bid with low price Pic of Gilead ScienceThe market contraction is expected to continue in the market. The variable is the new HCV treatment released by Gilead Science. Gilead had released Epclusa and Vosevi, its next-generation HCV treatments in November last year. These were the first new drugs for HCV released by Gilead in 5 years after Sovaldi and Harvoni. Epclusa is a pan-genotypic treatment like Mavyret. Although its treatment period is 12 weeks, 1 month longer than Mavyret, it has a more convenient means of administration of one pill once daily compared to three pill once daily administration of Mayvert. Its price had been set lower than Mavyret. Epclusa is priced at KRW 117,030 per tablet and Vosevi at KRW 120,836 per tablet. In terms of total treatment cost, Epclusa costs KRW 9,830,520 and Vosevi 10,150,224. This is cheaper than the KRW 10,922,352 of Mavyret. Gilead plans to regain the glory it occupied in the past with treatments and Harvoni with its more competitive price than Mavyret.
- Company
- EXKIVITY, PO lung cancer treatment, is released
- by Jung, Sae-Im Feb 03, 2023 08:51am
- Differences between oral medication and long-lasting effects "Further study needed to find suitable patient population" The second new drug targeting EGFR mutations, which are rare in non-small cell lung cancer, has been released in Korea. Takeda Pharmaceutical's Exkivity is expected to compete with oral drugs and long reaction duration. Takeda Pharmaceutical Korea held a press conference at The Plaza Hotel in Jung-gu, Seoul on the 1st and officially announced the launch of the new non-small cell lung cancer drug 'Exkivity'. Exkivity is a targeted treatment for EGFR Exxon 20 inserted mutated non-small cell lung cancer and can be used as a secondary treatment in patients who have previously been treated with platinum-based chemotherapy. EGFR Exxon20 insertion mutation is rare enough to account for about 10% of EGFR-mutated non-small cell lung cancer and about 2% of all non-small cell lung cancer. The survival period is about twice as short as that of the Exxon19 defect and the Exxon21 (L858R) substitution mutation, which accounts for most of the EGFR mutations. It is known that the existing EGFR mutation target treatment does not work well with the Exxon 20 insertion mutation. Ahn Myung-joo, a professor of hemato-oncology at Samsung Medical Center, said, "Exon 20 mutant patients had a significantly lower prognosis and survival rate than common EGFR mutant patients," adding, "We knew the existence of Exxon 20 mutant for about 20 years, but the demand was high because there were no suitable drugs." Last year, two new drugs targeting this biomarker appeared. Janssen Rybrevant and TakedaIt's pharmaceutical Excitivity. Rybrevant is a dual antibody that targets both the EGFR Exxon20 insertion mutation and the MET mutation. On the other hand, Exkivity is the only oral drug that intensively targets the Exxon20 insertion mutation. It is expected to compete with Rybrevant with the launch of Exkivity in February. Exkivity recorded an objective response rate (ORR) of 28%, a median overall survival period (mOS) of 24.0 months, and a median progressive survival period (mPFS) of 7.3 months in clinical trials of 114 patients, respectively. The median reaction time after administration was 1.9 months, showing a rapid medicinal effect. The safety profile was also shown to be good. The most common adverse reactions were diarrhea, rash, and fatigue, which could be managed through dose reduction. In particular, Exkivity showed a long reaction duration of 17.5 months. Kim Tae-min, a professor of hematologic oncology at Seoul National University Hospital, said, "One of the important indicators when confirming the effectiveness of targeted anticancer drugs is the duration of the reaction from the first reaction to the time when the reaction lasts longer, which can ultimately lead to the patient's survival." It is expected that Exkivity will show its strength in that it has increased the convenience of taking oral drugs, unlike Rybrevant, an intravenous injection, along with a long duration of the reaction. Experts agreed that further research is needed to find a suitable patient group for each drug. Professor Kim said, "Each patient has different reactions to the drug. Some patients respond only to Exkivity or Rybrevant, and some respond to both. It is necessary to analyze it through additional data, he said. "In addition, the two drugs differ in formulation and adverse reactions, so we need to determine the appropriate drug through close communication with patients." Professor Ahn also said, "It is dangerous to compare and judge the two drugs based on this data because the number of patients currently participated in the clinical trial is only about 100," adding, "It is clear that it is more effective than conventional drugs, but more data should be accumulated."
- Policy
- The aftermath of the COVID-19 Pandemic
- by Lee, Hye-Kyung Feb 03, 2023 05:54am
- There is a need to convert COVID-19 vaccines and treatments, which had been designated for rapid screening, to general screening to cope with the COVID-19 pandemic situation. This is because it is argued that screening personnel should not be wasted due to rapid screening of COVID-19 vaccines and treatments in a situation where the world is concerned about COVID-19. In addition, there are voices that COVID-19 vaccines and treatments should be excluded from the rapid screening in order to focus on the Global Innovation Product Rapid Review Support System (GIFT) prepared by the Ministry of Food and Drug Safety last year. In this regard, an official from the Ministry of Food and Drug Safety said, "The Ministry of Food and Drug Safety is keeping an eye on the COVID-19 pandemic discussion. As it has been taken based on laws to cope with the COVID-19 public health crisis, we will take measures related to the rapid screening process for COVID-19 vaccines and treatments. Since August 31, 2020, the Ministry of Food and Drug Safety has established a rapid screening department and is conducting rapid screening only for innovative products such as life-threatening diseases or treatments for rare and incurable diseases and drugs that respond to public health crises. From September 2020 to July 2022, 23 items were designated for rapid examination of medicines, and 17 items were designated and subject to rapid approval review. According to the items that have been approved, COVID-19 vaccines accounted for the largest number of items with 10, followed by five chemicals, one biopharmaceutical, and one biopharmaceutical. The rapid screening period aims to shorten the general screening period to 75% of the general screening period, and the number of working days required for the rapid screening of the COVID-19 vaccine was short, averaging 26 days. This is because the screening period was shortened by using preliminary reviews in consideration of urgency, and 5 out of 10 COVID-19 vaccines that were approved were pre-reviewed and frequently reviewed in areas such as clinical, non-clinical, and quality. However, while the workload has increased, some say that the structure of drug screening personnel's work should be reorganized due to the rapid screening system of COVID-19 vaccines and treatments in order to properly utilize the GIFT system in the future. An official from the pharmaceutical industry said, "The seriousness of COVID-19 has decreased to the extent that even the obligation to wear indoor masks is lifted," adding, "The Ministry of Food and Drug Safety should also consider ending the rapid screening system for COVID-19 vaccines and treatments." Some say that all permits and screening personnel have been put into a rapid screening of COVID-19 vaccines and treatments, and other tasks have been pushed back by nearly a year, he said. "To solve the problem, we need to think about completing the system that was applied to a crisis." The United States recently declared that it would end the COVID-19 public health emergency from May to November. Subsequently, there is an opinion that Korea will be able to completely lift its obligation to wear a mask in May.
- Policy
- CDDC sets reimb standards for Inrebic Capsule
- by Lee, Tak-Sun Feb 03, 2023 05:54am
- A green light has been turned on for the reimbursement of the myelofibrosis treatment Inrebic Cap. (fedratinib, BMS Pharmaceutical Korea) with the Cancer Disease Deliberation Committee setting reimbursement standards for the drug. Also, the reimbursement standards for the ovarian cancer treatment Zejula Cap (niraparib, Takeda Pharmaceutical) have been extended. The drugs will be approved and listed for reimbursement after passing review by the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee and drug pricing negotiations with the National Health Insurance Service. HIRA announced that it had held the 1st Cancer Disease Deliberation Committee (CDDC) meeting in 2023 on the 1st and announced it had deliberated as such. Inrebic is indicated as a treatment for enlarged spleen or other symptoms related to ▲ primary myelofibrosis ▲ post-polycythemia vera myelofibrosis, and ▲ post-essential thrombocythaemia myelofibrosis in adult patients that have been previously treated with ruxolitinib. The CDDC determined that setting the salary standard in line with the indication was appropriate. The 1st CDDC deliberation results in 2023 Also, the CDDC determined it appropriate to extend reimbursement and set additional reimbursement standards for Zejula Cap as ‘maintenance monotherapy in adult patients with HRD-positive ovarian cancer (including fallopian tube cancer or primary peritoneal cancer) who have shown response to first-line platinum-based chemotherapy (partial or complete response).’ On the other hand, no reimbursement standard had been set for the MET exon 14 skipping mutation treatments Tabrecta and Tepmetko. At the same meeting, the CDDC declined Kyowa Kirin Korea’s application to set reimbursement standards for ‘Poteligeo Inj’ to treat adult patients with mycosis fungoides (MF) or Sézary syndrome (SS).
- Company
- Enhertu quickly lands at general hospitals in Korea
- by Eo, Yun-Ho Feb 03, 2023 05:53am
- Prescription of the next-generation new antibody-drug conjugate 'Enhertu' has started in earnest. According to industry sources, Enhertu (trastuzumab deruxtecan), AstraZeneca and Daiichi Sankyo Korea’s new antibody-drug conjugate drug for HER2-positive breast cancer have passed the drug committees (DCs) of 20 medical institutions in Korea, including Samsung Medical Center, Seoul National University Hospital, Sinchon Severance Hospital, Kangbuk Samsung Medical Center, and Chonnam National University Hwasun Hospital. Most hospitals held an emergency DC meeting to generate a prescription code for Enhertu, suggesting the healthcare professional’s high interest in the drug. The drug was approved by the Ministry of Food and Drug Safety in September last year based on the DESTINY-Breast01 and DESTINY-Gastric01 trials. In Korea, Enhertu is indicated to treat ▲ unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting’ and ▲ locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen. Also, in December, based on the DESTINY-Breast03 trial, the drug’s indication was expanded to treat patients with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2-based regimens. Enhertu is an ADC that combines ‘trastuzumab,’ a monoclonal antibody that binds to specific target proteins, and ‘deruxtecan,’ a strong cytotoxic agent, by a linker. ADCs act selectivity on antibody targets and apoptosis of target tumor cells allows the drug to work selectively only on the tumor cells, increasing its therapeutic effect and minimizing side effects. However, Enhertu has not been reimbursed yet in Korea. AstraZeneca and Daiichi Sankyo applied for reimbursement listing in December last year and are awaiting review by the Health Insurance Review and Assessment Service. If listed, the drug’s prescriptions are expected to increase rapidly. Sun-Young Rha, Professor of Medical Oncology at Yonsei Cancer Center, said, “Enhertu is the first and only HER2-targeted therapy that demonstrated a survival period of over one year as a treatment for advanced gastric cancer after treatment with a trastuzumab-based regimen. We hope reimbursement will be applied as soon as possible in consideration of the small number of patients.” Enhertu demonstrated a significant improvement in progression-free survival (PFS) in the head-to-head DESTINY-Breast03 trial that compared Enhertu with trastuzumab emtansine (T-DM1) in patients in patients with HER2-positive unresectable or metastatic breast cancer previously treated with one or more anti-HER2 therapy. The interim analysis results that were updated in 2022 showed that Enhertu also continued to demonstrate a clinically meaningful improvement in progression-free survival (PFS) with a 22-month improvement in median PFS over T-DM1. The median PFS for patients in the Enhertu arm was 28.8 months compared to 6.8 months for T-DM1. Also, in terms of OS, the key secondary endpoint in the trial, Enhertu demonstrated a statistically significant 36% reduction in risk of death versus T-DM1. Also, in the DESTINY-Breast01 trial, Enhertu demonstrated continued anticancer effect in patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens that include T-DM1, trastuzumab, and pertuzumab. Results showed that Enhertu met its main efficacy outcome with an objective response rate (ORR) of 60.9%. The median duration of response (DoR) was 14.8 months, and the drug showed a continued anticancer effect in severe patients with a median of 6 previous lines of treatment (range 2-27).
