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- 2025-12-20 21:53:36
- Policy
- Remote GMP inspections not recognized from April
- by Lee, Hye-Kyung Jan 29, 2024 06:05am
- The GMP inspections, which were temporarily allowed non-face-to-face due to the difficulty of on-site evaluations during the COVID-19 outbreak, are gradually returning to ordinary procedures. After switching the pre-approval GMP item inspections back to full on-site inspections in December last year, the Ministry of Food and Drug Safety (MFDS) now decided to recognize only on-site reports rather than the written reports, which had been recognized for a limited time due to difficulties in conducting on-site inspections. From April 25, the only written reports the MFDS will accept are vendor audit results from on-site inspections. In order to import active pharmaceutical ingredients (API), the company must submit a GMP certificate of API issued by the government or public institution of the country of manufacture. However, when the company seeks to receive a supply of the APIs for the manufacture of finished pharmaceutical products, vendor audit results based on an on-site inspection of the finished pharmaceutical product manufacturer are also recognized as a GMP certificate. Due to the COVID-19 pandemic, It had been difficult to conduct on-site inspections, which was why the MFDS had recognized written inspection result reports. The MFDS stated, "During the COVID-19 pandemic, it was difficult to conduct on-site inspections, which was why we temporarily recognized written inspection reports. However, with the end of the COVID-19 pandemic, we will give a 3-month grace period and then recognize only on-site GMP inspection reports from April." Previously, the MFDS had replaced GMP on-site inspections with remote inspections such as by reviewing PIC/S report data during the COVID-19 outbreak, but since September last year, it has been phasing out the flexibilities that were put in place and started on-site inspections for some items, new drugs, or aseptic preparations, conducting a phased transition back to on-site inspections. As regulatory agencies such as the U.S. and PIC/S have announced that non-face-to-face inspections cannot replace on-site inspections, the MFDS is also converting some parts of the non-face-to-face inspections back to on-site inspections.
- Policy
- Lilly’s UC drug Omvoh is soon to be approved in KOR
- by Lee, Hye-Kyung Jan 26, 2024 05:51am
- Lilly's ulcerative colitis treatment Omvoh (mirikizumab-mrkz) is nearing approval in Korea. Omvoh received U.S. FDA approval in October last year and settled as the first and only interleukin-23p19 (IL-23p19) antagonist for the treatment of moderately to severely active ulcerative colitis (UC) in adults. According to industry sources, the Ministry of Food and Drug Safety recently completed a safety and efficacy review for Omvoh’s marketing authorization in Korea. MFDS’ completion of the safety and efficacy review means that marketing authorization for the drug is imminent. Omvoh is the only ulcerative colitis treatment that selectively binds to the p19 subunit of IL-we and inhibits interaction with the receptor. Ulcerative colitis is a chronic inflammatory disease of unknown cause characterized by inflammation localized in the mucosal or submucosal layers of the large intestine, and the p19 subunit plays an important role in the development of inflammation associated with ulcerative colitis. The FDA’s approval was based on results from the LUCENT program, which included two randomized, double-blind, placebo-controlled Phase 3 clinical trials consisting of LUCENT-1 - a 12-week induction study (UC-1) - and LUCENT-2 - a 40-week maintenance study (UC-2) for 52 weeks of continuous treatment. All patients in the LUCENT program had past treatments, including biological treatments, that did not work, stopped working, or that they could not tolerate. After 12 weeks of treatment with Omvoh, 65% of patients achieved clinical response and 24% achieved clinical remission compared to placebo (43% and 15%, for clinical response and clinical remission, respectively). Among those who achieved clinical response at 12 weeks, one-half (50%) achieved steroid-free clinical remission at one year, compared to placebo (27%). Per a post-hoc analysis, 99% of patients who achieved clinical remission at 1 year were steroid-free. Patients in steroid-free clinical remission were steroid-free for at least 3 months prior to the end of the 52-week assessment. In 2018, a Phase III trial for Omvoh was approved by the Ministry of Food and Drug Safety under the same details as the LUCENT program, and completed in Korea. Omvoh was approved in Japan in March and in Europe in June last year.
- Policy
- P2T for LG Chem’s obesity drug LB54640 approved in Korea
- by Lee, Hye-Kyung Jan 26, 2024 05:51am
- LG Chem’s generic obesity treatment, 'LB54640,' has been approved for a Phase II clinical trial in Korea. On the 24th, the Ministry of Food and Drug Safety approved LG Chem’s application to initiate a randomized, placebo-controlled, double-blind Phase II study with an open extension period to evaluate the efficacy and safety of LB54640 in patients with acquired hypothalamic obesity. Hypothalamic obesity is a type of syndromic obesity that results from abnormalities in endocrine, hypothalamic, genetic, frontal, and metabolic systems. It is classified as a rare form of obesity that occurs in approximately 1% of pediatric obesity patients. The Phase II study will be conducted at Seoul National University Hospital until March 1, 2025. Global clinical trials for LB54640 had previously been approved in the U.S. and Europe. LB54640 is a once-daily (oral) treatment for obesity that targets the action pathway of the MC4R (melanocortin-4-receptor) protein, which is known to deliver satiety signals. According to LG Chem, results of the Phase I study showed LB54640’s potential with up to 3% reduction in body weight in the highest-dose group over 28 days of treatment. The drug received orphan drug designation from the U.S. Food and Drug Administration (FDA) as a treatment for LEPR deficiency in September 2020 and for POMC deficiency in June 2022. Meanwhile, LG Chem signed an agreement with Rhythm Pharmaceutical to transfer the global development and marketing rights for its orphan drug LB54640 on the 5th. The agreement, which amounts to USD 350 million (KRW 400 billion), includes an upfront payment of USD 100 million (KRW 130 billion). Upon successful commercialization, the company will receive separate sales royalties based on annual sales.
- Policy
- MOHW “Drug pricing for listed drugs is set to be reduced"
- by Lee, Jeong-Hwan Jan 26, 2024 05:50am
- The Ministry of Health and Welfare (MOHW) In February, the government will post the outcomes of notifications of the second-round review & assessment, analyzing the upper limit of standards and requirements associated with the drug pricing reduction of currently listed generics. The adjusted prices will take effect on March 1st. The drug pricing reduction related to market-based actual transactions will be determined in the next round of implementation due to an incomplete review of national essential drugs and drugs in short supply. On the 24th, the Ministry of Health and Welfare (MOHW) representative explained the notifications mentioned earlier during a meeting with KSPANEWS. The MOHW initially planned to implement the drug pricing reduction in January, following re-assessment of reimbursement listed drugs and a survey of prices in actual transactions. However, this implementation was postponed. The MOHW has decided to implement the drug pricing reduction, reflecting the outcomes of the second-round reassessment of listed drugs, beginning on March 1st, following the notification process in February. Yet, the reduction related to the actual transaction will be postponed until further notification. There are approximately 1,000 items related to drug pricing reductions for listed drugs. However, the MOHW has clarified that considering the significant changes in drug pricing for a substantial number of drugs, they have included a preparatory period to minimize misunderstandings between pharmacies, marketing companies, and pharmaceutical companies. The MOHW has sought the opinions of companies to prevent the recurrence of the confusion that occurred during the first-round reevaluation of drug pricing reduction for listed drugs. In the initial round, the simultaneous processing of drug pricing reduction related to the volume-price linkage negotiations led to confusion among pharmacies and pharmaceutical companies. "We have not yet finalized the implementation date of price reduction associated with actual transactions due to ongoing reviews related to essential drugs and concerns surrounding the drugs in short supply," a representative of MOHW explained.
- Policy
- Chong Kun Dang cuts price of its Lucen BS by half
- by Lee, Tak-Sun Jan 25, 2024 05:50am
- Chong Kun Dang is offering a bargain price for its biosimilar. The company has decided to cut the price of its 'Lucen BS', a biosimilar of the macular degeneration treatment Lucentis (ranibizumab, Novartis), by half from next month. As a result, the price difference between it and the original product, as well as it and Samsung Bioepis’s biosimilar, has widened significantly. According to the industry on the 23rd, Chong Kun Dang will voluntarily reduce the insurance price ceiling of its biosimilar 'Lucentis' by half from next month. Accordingly, the price of Lucen BS Inj 10mg/ml and Lucen BS Prefilled Syringe will be reduced from KRW 300,000 to KRW 150,000. Lucen BS was launched in January last year and is the first biosimilar of the macular degeneration treatment Lucentis in Korea. At the time, Lucen BS and Samsung Bioepis ‘Amelivu’ were listed simultaneously. The two companies set the price of their generic drugs at a much lower price than the original, at a price lower than the calculated amount. At the time of its reimbursement listing in January, the price of Lucen BS was KRW 300,000, which was 37% of the original drug’s price at the time. The price difference between it and the original drug as well as Samsung Bioepis’s product has become even greater now that Lucen BS’s price has been cut by half. Currently, the original Lucentis costs about KRW 580,000 per vial, while the biosimilar Amelivu costs KRW 350,000 per vial. With Lucen BS’s price set at KRW 150,000, patients will be able to access the biosimilar at 25% of the original price. Lucen BS’s price difference with another biosimilar, Amelivu, is KRW 200,000, making Lucen BS even more competitive in the market. Chong Kun Dang conducted a Phase III trial for Lucen BS from September 2018 to March 2021 at 25 hospitals, including Seoul National University Hospital on a total of 312 patients with neovascular (wet) age-related macular degeneration. Analysis of the primary efficacy endpoint, which compared the best-corrected visual acuity (BCVA) in 3 months after drug administration, showed that the proportion of patients with vision loss of less than 15 letters was 97.95% (143/146 patients) in the Lucen BS arm and 98.62% (143/145 patients) in the original drug arm, meeting the range of equivalence between the two drugs.
- Policy
- Handok-Sanofi launches hypertension combo drug Aprovasc
- by Lee, Tak-Sun Jan 24, 2024 05:45am
- Aprovasc, a hypertension combination drug co-developed by Handok and Sanofi Aventis Korea, will enter the market in earnest with reimbursement on the 1st of next month. The product is a combination drug of ARB-class irbesartan, which was developed by Sanofi, and CCB-class amlodipine besylate. This is the first irbesartan-amlodipine combination released to the market. It was approved in Korea in November last year and completed the reimbursement listing process time. According to industry sources on the 23rd, three dosage forms of Aprovasc Tab will be listed starting on Feb. 1. The drug is indicated for essential hypertension in adult patients in whom blood pressure is not adequately controlled on irbesartan or amlodipine monotherapy. Aprovasc received premium pricing as an incrementally modified new combination drug and for being a product of Handok’s, a company designated as a Korea Innovative Pharmaceutical Company. As a result, Aprovasc Tab 300/5mg will be listed at KRW 119.2/tablet. Aprovasc Tab 150/5mg and Aprovasc Tab 150/10mg also received a 68% premium in their pricing, but Handok listed them at lower prices, at KRW 854 and KRW 988, respectively. Aprovasc has gained industry attention as the two companies - Sanofi and Handok had partnered on the drug from development to sales. irbesartan (brand name: Aprovel) is an ARB-class hypertension drug developed by Sanofi. The two companies signed a license agreement in October 2019 for the development, manufacture, and licensing of Aprovasc in Korea. Since then, Handok has conducted domestic clinical trials and confirmed superior blood pressure-lowering effects compared with irbesartan monotherapy in two Phase III trials. The two companies will also collaborate on sales activities. Handok will be in charge of the manufacturing, and the two companies will copromote the drug in the highly competitive domestic hypertension combination drug market. Currently, the ARB+CCB hypertension combination drug market is crowded with products such as Hanmi Pharmaceutical’s Amosartan, Boehringer Ingelheim’s Twynsta, Novartis’s Exforge, Daiichi Sankyo’s Sevikar, and Chong Kun Dang’s Telminuvo that post annual prescriptions (based on UBIST) of more than KRW 50 billion. With such viable competitors already occupying the market, the industry expectation is that Handok and Sanofi will have difficulty generating high sales in the short term as a late entrant. However, the industry also predicts that the product will be able to secure basic demand from patients who had difficulty controlling their blood pressure while being on Aprovel, as the irbesartan monotherapy drug Aprovel is the best-selling antihypertensive drug with an annual prescription volume of KRW 10 billion.
- Policy
- New drug Zavicefta Inj, and more completed drug pricing nego
- by Lee, Tak-Sun Jan 23, 2024 06:02am
- Pfizer Korea’s new drug The two drugs Pfizer Korea’s ‘Zavicefta Inj’ and ‘Dulackhan Easy Syrup,’ which were in negotiations for a drug pricing increase due to short supply, have reached agreements in negotiations with the National Health Insurance Service (NHIS), and they are expected to receive reimbursements starting next year. The chronic kidney disease treatment ‘Kerendia Tab’ and genetic retinal disease treatment ‘Luxturna’ have completed drug pricing negotiations and are awaiting reimbursement next month. According to industry sources on the 19th, NHIS recently updated the listing of pharmaceuticals that have completed the drug pricing negotiations. The updated listing of new drugs that have completed negotiations included Kerendia Tab 10 mg/20 mg (finerenone, Bayer Korea), Luxturna (voretigene neparvovec, Novartis ), Zavicefta Inj 2g/0.5g (ceftazidime/avibactam). Among the drugs, Zavicefta Inj has omitted the upper limit amount negotiations and proceeded to the negotiations of the estimated amount of claim. Kerendia was approved by the Ministry of Food and Drug Safety (MFDS) in May 2022 as a treatment for chronic kidney disease in adult patients with type 2 diabetes. According to the American Diabetes Association’s (ADA) Standards of Care in Diabetes, Kerendia is suggested for use in combination with SGLT-2 inhibitor in patients who have an increased risk of cardiovascular events or sustained chronic kidney disease progression or those who are unable to use the SGLT-2 inhibitor. Accordingly, it is expected that Kerendia will be used more frequently in combination with SGLT-2 inhibitors, including Forxiga and Jardiance, which are used in treating chronic kidney disease. Starting next month, Chong Kun Dang Pharmaceutical will be responsible for sales and marketing of Kerendia. Luxturna is indicated for use in pediatric and adult patients who have sufficient surviving retinal cells but lost vision due to inherited retinal dystrophy caused by biallelic RPE65 mutations. Luxturna, a gene therapy, is a ‘one-shot treatment’ that can be administered as a single dose. The drug has garnered attention to whether it would pass the hurdle of insurance benefit due to its high price, with a non-reimbursement price of up to 1 billion won. Finally, the company secured the reimbursement listing through a risk-sharing agreement (RSA) with the NHIS, reducing the burden of insurance benefit expenses. Pfizer's Zavicefta Inj is a combination drug that combines "ceftazidime," a third-generation cephalosporin antibiotic, with "avibactam," an enzyme inhibitor that inhibits the function of beta-lactamase enzymes responsible for breaking down beta-lactam antibiotics, to maintain its antimicrobial potency. Zavicefta Inj has emerged as an alternative treatment option for treating multi-drug-resistant gram-negative bacteria or carbapenem-resistant intestinal bacteria, which previously had limited available treatment options. Two products that contain Lactulose Solution as their active ingredient have successfully reached an agreement in drug price negotiations, namely "Lactuse Syr" by Access Pharma and "Dulackhan Easy Syrup" by Chong Kun Dang Pharmaceutical. These Lactulose-based formulations, used for pediatric constipation, have been known as chronic shortage drugs due to limited supply compared to demand. Lactuse Syr, an imported item facing shortages, is anticipated to see increased availability in the market due to a rise in its drug price. Dulackhan Easy Syrup production is expected to increase following another drug pricing increase after 2022. Gilead Science Korea's Biktarvy Tab has completed the price-volume agreement type 'Na', which is expected to result in a reduction in drug pricing.
- Policy
- Samsung Bioepis receives approval for its Soliris biosimilar
- by Lee, Hye-Kyung Jan 23, 2024 06:02am
- Samsung Bioepis Samsung Bioepis has received approval for its Epysqli (eculizumab),’ a biosimilar of the ultra-high-priced rare disease treatment Soliris (eculizumab) in Korea. At the same time, it was granted first generic exclusivity until October 19th of this year, allowing Samsung Bioepis to market its biosimilar exclusively for the next nine months. In Korea, Soliris only has a patent for its 'method of treating hemolytic disease' that expires in February 2025, but the Patent Court of Korea cited a ruling by the Intellectual Property Trial and Appeal Board on December 22 last year and ruled IPTAB’s ‘invalidation ruling as legitimate.’ Among eculizumab biosimilars, Epysqli has become the first to receive approval in Korea, but Amgen’s ‘Bekemv’ was granted marketing authorization from the European Medicines Agency (EMA) in April last year. On the 19th, the Ministry of Food and Drug Safety approved Epysqli for paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). Epysqli is a biosimilar of Soliris, which posts annual sales of about KRW 5 trillion ($3.76 billion) around the globe, and conducted a global Phase III trial on PNH patients from August 2019 to October 2021. It received final approval in June 2022, 19 months after applying for domestic marketing authorization. Soliris is an orphan drug, which means patents for each indication are protected separately. The patent for Soliris’s PNH indication, which is prescribed the most, expired in April 2020 in Europe and will expire in the U.S. in March 2027. Therefore, only the patent for the ‘method of treating hemolytic disease' that is set to expire in February 2025 remains for Soliris. In June 2022, Samsung Bioepis filed a patent invalidation trial against Soliris’s developer Alexion to the IPTAB while applying for the Epysqli trademark and marketing authorization, and received an invalidation ruling. Eculizumab is mainly prescribed for PNH, a condition that causes patients to pass blood-colored urine at night due to hemolysis, a phenomenon in which hemoglobin is released from red blood cells. It can be caused by mutations in the X chromosome, which is involved in the production of proteins that make up the red blood cell membrane. The exact incidence of PNH remains unknown. It mainly affects adults in their 20s and 30s. About 10% of all patients are children. Without treatment, 20% to 50% of patients die within 6 years of diagnosis, signifying its high treatment demand.
- Policy
- Korean patients pay ₩10.5M for ₩300M Luxturna
- by Lee, Tak-Sun Jan 23, 2024 06:02am
- Novartis Luxturna (voretigene neparvovec-rzyl, Novartis), the first gene therapy for Inherited Retinal Dystrophy (IRD), is set to be reimbursed from the 1st of next month and is expected to significantly reduce the burden of those suffering from IRD in Korea. Although the price limit for Luxturna had been set at KRW 325.8 million per vial, the out-of-pocket cost borne by each patient is expected to be about KRW 10.5 million with the insurance reimbursement. According to industry sources on the 22nd, Luxturna will be listed for reimbursement under the risk-sharing system with a price cap of KRW 325.8 million per vial from next month. Novartis has signed 3 types of risk-sharing agreements with the National Health Insurance Service, including the refund type, expenditure cap type, and performance-based refund type RSA. The drug is used for adult and pediatric patients who have sufficient viable retinal cells but have lost vision due to IRD caused by a mutation in the RPE65 gene. The number of affected by IRD is estimated to be around 9 per year. Novartis’s Luxturna is a one-shot treatment that can treat a disease with a single administration, and the third among one-shot treatments to receive reimbursement approval in Korea, following Kymriah and Zolgensma. Currently, Luxturna is listed in 6 of the A8 countries – the US, France, Japan, Italy, Switzerland, and the UK. The A8 adjusted average price is KRW 875.11 million for both eyes. In Korea, Luxturna will be listed at a lower price of KRW 652 million. If used on one eye, the total cost is KRW 325.8 million. If you apply the 10% copayment rate, the cost is KRW 32.58 million, but if you apply the out-of-pocket maximum system, the cost borne by the patient drops to KRW 10.5 million. The estimated claims amount for the drug in the first year is about KRW 5.86 billion based on the list price, but the NHIS expects the actual financial expenditure to be less than this, considering the risk-sharing agreement signed for the drug. In addition, to ensure cost-effectiveness, Novartis needs to submit long-term follow-up data from Phase III clinical studies. The data will be evaluated at the end of the risk-sharing agreement period. Luxterna applied for reimbursement upon its approval in September 2021 and received insurance reimbursement in 2 years and 4 months. Meanwhile, Novartis decided to lower the price of its chronic heart failure treatment ‘Entresto Film Coated Tab’ from KRW 1,690 to KRW 1,683 per tablet upon Luxturna’s reimbursement.
- Policy
- Luxturna, Kerendia, & Raspirin will get new reimb standards
- by Lee, Jeong-Hwan Jan 22, 2024 05:49am
- On the 19th, the Ministry of Health and Welfare (MOHW) gave an administrative notification on the “Partial amendment to the details (pharmaceuticals) on the application standards and methods of medical reimbursements.” New reimbursement standards will be established for Novartis’s Luxturna, a one-shot retinal dystrophy treatment, Hanmi Pharmaceutical’s Raspirin Cap, and Bayer’s Kerendia Tab 10 mg, as they are set to be listed for reimbursement. Reimbursement standards will be set for Takeda’s Obizur, a treatment for acquired hemophilia A, and Pfizer’s Zavicefta Inj, a new antibiotics drug, as they are in the process of reimbursement listing. On the 19th, the Ministry of Health and Welfare (MOHW) gave an administrative notice on the “Partial amendment to the details (pharmaceuticals) on the application standards and methods of medical reimbursements” and will collect opinions by the 29th. ◆Luxturna Inj= an ophthalmic drug Luxturna will be eligible for reimbursement for pediatric and adult patients with inherited retinal dystrophy caused by biallelic RPE65 mutations who meet all of the following conditions and have sufficient surviving retinal cells. Patients must have a genetic diagnosis of biallelic pathogenic or likely pathogenic RPE65 mutations. Reimbursement will be approved for patients who are aged four years or older but younger than 65 years at the time of administration. The maximum corrected visual acuity in both eyes should be 0.3 or less, or the visual field in both eyes should be less than 20 degrees. In addition, there must be enough surviving retinal cells, and all the following conditions must be met. The thickness of the posterior part of the retina in optical coherence tomography findings should exceed 100 μm. Based on fundus examination, the area in the posterior part of the retina without atrophy or pigment degeneration should be at least three times the size of the optic disk. The visual field measured with Goldmann III4e isopter or its equivalent should remain within the central 30 degrees of vision. Patients who have undergone intraocular surgery within the past six months or have had infections in or around the eyes will be excluded from the treatment group. Luxturna, a gene replacement therapy given as a single dose, is eligible for reimbursement once in a lifetime. It should be administered exclusively by a retinal specialist experienced in macular surgery. According to the revised standards for managing reimbursement of high-cost drugs, patients receiving Luxturna must provide reimbursement information on the reimbursement statement for four years, adhering to the specified reimbursement claim procedure, assessment claim form, statement format, and preparation guidelines. ◆Raspirin Cap= Reimbursement will be approved for patients who are being treated with a combination therapy of Aspirin and rabeprazole, meeting reimbursement standards. ◆Kerendia 10 mg= Reimbursement will be approved for adult patients with chronic kidney disease associated with type 2 diabetes who are receiving the drug in combination with a standard therapy (ACE inhibitor or angiotensin II receptor blocker) and meet all conditions, even if they have been stably treated with the maximum tolerated labeled dose of angiotensin-converting enzyme inhibitor (ACEi) or angiotensin II receptor blocker for more than four weeks. However, patients in NYHA class II~IV with consistent symptoms will be excluded from reimbursement eligibility. ◆Obizur= Reimbursement for Obizur will be applied for the treatment of bleeding episodes in adults with acquired hemophilia A. The treatment is intended for patients who meet one of the following conditions: who have an antibody titer of greater than 5 Bethesda Units (BU), who have antibody titer of less than 5BU and a lack of clinical response to high doses of antihemophilic factor, or who have a recent history of an antibody titer of less than 5BU and who had a clinical response to Obizur after having a lack of clinical response to high doses of antihemophilic factor. Obizur can be administered to hospitalized patients and outpatients in hospitals. Treatment costs can be reimbursed when the drug is used according to the recommended methods of administration and dosage. Patients should also refer to precautions, including warnings, adverse reactions, and general precautions. Patients should be diagnosed and receive prescriptions by hematologists specializing in hematology-oncology in the department of internal medicine or hematology-oncology specialists in the department of pediatrics. ◆Zavicefta Inj= Reimbursement will be approved for patients with documented cases of complicated intra-abdominal infections, complicated urinary tract infections, or when carbapenem antibiotics have failed in treating hospital-acquired and ventilator-acquired pneumonia, or when multi-drug-resistant gram-negative bacteria or carbapenem-resistant intestinal bacteria are present. Additionally, a prescription recommendation must be attached. ◆Forxiga and Jardiance= Reimbursement for Forxiga (ingredient: dapagliflozin) 10 mg and Jardiance Tab (ingredient: empagliflozin) 100 mg, which are SGLT-2 inhibitor-mediated diabetes treatments, will be expanded for patients undergoing treatment for chronic heart failure. Specifically, reimbursement will be approved for patients having chronic heart failure with reduced left ventricular ejection function, falling into NYHA class Ⅱ∼Ⅳ, having a Left Ventricular Ejection Fraction (LVEF) of ≤ 40%, and undergoing a standard treatment with a stable dose.
