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- 2026-05-01 13:13:48
- 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.
- Policy
- Forxiga withdraws from the Korean mkt despite reimbursement
- by Lee, Tak-Sun Jan 22, 2024 05:48am
- The SGLT-2 inhibitor ‘Forxiga Tab,’ which its company plans to withdraw from the Korean market in the first half of the year, will now be reimbursed for chronic heart failure. However, the withdrawal of the drug from the market has put a damper on the reimbursement expansion. Even if it is reimbursed from next month, there will inevitably be a gap in the use of the treatment when stocks run out due to the discontinuation of its supply. Therefore, patients with heart failure in Korea are at risk of losing access to the treatment option of Forxiga despite the coverage expansion. The Ministry of Health and Welfare announced in a preliminary notice of revisions to the drug reimbursement standards that it will expand reimbursement for SGLT-2 inhibitors such as Forxiga and Jardiance to chronic heart failure from the 1st of next month. With the revision, Forxiga and Jardiance will be reimbursed for patients with chronic heart failure and a left ventricular ejection fraction of 40% or less who are receiving a stable dose of standard therapy. Here, standard therapy is defined as an ACE inhibitor or angiotensin Ⅱ receptor blocker (ARB) or sacubitril-valsartan in combination with a beta-blocker or aldosterone antagonist. Forxiga and Jardiance can also be used in combination with other standard therapies for heart failure. As a result, the treatment scope of Forxiga, which had mainly been used to treat patients with diabetes, was been extended to chronic heart failure. However, the reimbursement extension was overshadowed by the company's withdrawal from the domestic market in the first half of this year. AstraZeneca announced late last year that it would be withdrawing Forxiga from the domestic market in the first half of this year. Given the upcoming domestic supply disruption, patients with heart failure may be hesitant to use Foxiga even with the reimbursement extension. The patients will have to discontinue use of Forxiga the day the remaining stock runs out, On this, AstraZeneca Korea said, "We are in multi-faceted discussions with the health authorities on how to continue treatment for patients with chronic heart failure and chronic kidney disease who are using Forxiga. We currently have secured sufficient quantities for domestic supply for the year.” The problem is, other than Forxigna, none of the same-ingredient generics that have been released since April last year own the chronic heart failure indication. Upon Forxiga’s market withdrawal, generic versions of the same drug would have to be used, but this is difficult because the generic versions are not authorized or reimbursed for the chronic heart failure indication. This is because Forxiga’s patent for chronic heart failure does not expire until March 2040. Due to this, the reimbursement extension granted for SGLT-2 inhibitors is likely to benefit Boehringer Ingelheim Korea's Jardiance. Jardiance has yet to launch a generic, and other SGLT-2 inhibitor generic drugs do not have a chronic heart failure indication. Therefore, whether the health insurance authorities will find a way to maintain the use of dapagliflozin, Forxiga’s main ingredient, available for chronic heart failure, remains to be seen.
- Policy
- P3T for chin fat reduction injection ‘AYP-101’ approved
- by Lee, Hye-Kyung Jan 19, 2024 05:45am
- A Phase III trial for Amipharm's 'AYP-101', an injectable drug for submental fat reduction, will be conducted in Korea. On the 16th, the Ministry of Food and Drug Safety approved a Phase III clinical trial to ‘evaluate the efficacy and safety of AYP-101 in reducing submental fat in adults with moderate-to-severe convexity or fullness associated with submental fat. Amipharm had previously conducted a Phase II trial for the injection on 96 Koreans from August 2021 to June 2023 and will initiate the Phase III trial in Korea with the MFDS approval. AYP-101 is an injectable for submental fat reduction that selectively induces fat cell apoptosis and lipolysis. Its main ingredient is polyene phosphatidylcholine (PPC), a natural substance extracted from glycine max. merr (soybeans) at high purity. In 2018, Amipharm obtained a patent from the Korean Intellectual Property Office for "Composition and Manufacturing Method of Local Fat Reduction Injectable (AYP-101) without Pain, Edema and Side Effects. If commercialized, Amipharm expects AYP-101 will become the first new incrementally modified drug to be developed in Korea in the aesthetic field. AYP-101’s composition improves the disadvantages of existing PPC injections, which cause pain and swelling through a mechanism of action that brings about cell necrosis. PPC injections have previously been approved for cell membrane binding and regeneration in areas such as liver disease and dementia as ‘Lipobin Inj,’ but have been used off-label as lipolysis injections. Current treatment options for submental fat, also known as a double chin, are limited. Existing methods include off-label, mesotherapy cocktail injections performed under general or local anesthesia and surgical liposuction performed under general anesthesia. AYP-101 is expected to help expand the therapeutic area for the injection to patients who are interested in the non-surgical injectable method of localized fat reduction. Meanwhile, AMI Investment, an investment company established through a 6:4 joint venture between KPM Tech and Telcon, invested KRW 10 billion and acquired 810,000 shares (24.2% stake) of AmiPharm, and became the second largest shareholder. Amipharm holds a patent for 'Composition and Manufacturing Method for Injectable Drug Containing PPC without deoxycholic acid sodium’ that it obtained in Korea in 2014 and a patent for 'Composition and Manufacturing Method for Fat Decomposition Substance that contain PPC' in the United States in 2015.
- Policy
- Emerging candidate for Dir. of the Pharmaceutical Benefits
- by Lee, Jeong-Hwan Jan 19, 2024 05:45am
- Secretary Jung-min Yu (Left), Director Chang-Hyun Oh (Right). Chang-Hyun Oh (55/College of Pharmacy, Chung-Ang University), the incumbent director of the Pharmaceutical Benefits at the Ministry of Health and Welfare (MOHW), is expected to be succeeded by Jung-min Yu (passed the 51st civil service exam/Ewha Womans University), who is currently serving as Secretary in the Office of the Senior Secretary to the President for Social Policy while being transferred to the Presidential Secretariat. Oh is expected to rejoin the Ministry of Food and Drug Safety (MFDS) after his promotion. According to the sources in the pharmaceutical industry on the 17th, MOHW will make personnel changes for the position of Director of Pharmaceutical Benefits soon. The Division of Pharmaceutical Benefits is responsible for various aspects of domestic pharmaceutical reimbursements. Specifically, its responsibilities include conducting cost-effectiveness evaluations and setting the upper limit of healthcare benefits (insurance drug pricing) for pharmaceuticals seeking reimbursements, reassessing the drug prices of previously listed insured drugs, developing comprehensive plans for post-insurance management of insured drugs, and conducting research and investigations related to the insurance reimbursement system for pharmaceuticals. If Yu assumes the position of the Director of the Pharmaceutical Benefits, she will also oversee the practical implementation of the revised drug pricing system to ensure fair-value compensation for innovative new drugs, which was announced in December of last year, in addition to Yu’s responsibilities related to the division. Secretary Yu initially started her career in the MFDS, then moved to the Office for Governmental Policy Coordination, and later joined the MOHW. Subsequently, Yu was transferred from working as the Director of healthcare security management in May 2022 to take the position as Secretary in the Office of the Senior Secretary to the President for Social Policy and continued to work in that position. Yu has an extensive background in roles within the MOHW, including working in the Division of National Pension Policy, Committee on Low Birthrate, and the Division of Healthcare Policy. After serving as the Head of the Healthcare Delivery System Task Force, Yu was promoted to the position of Director of healthcare security management. In March 2021, while serving as Secretary at the MOHW, Yu was recognized from the Prime Minister for her proactive administration, which included implementing temporary telephone counseling and prescriptions to prevent the spread of Covid-19 outbreak in Korea. Director Oh is expected to rejoin the MFDS after his promotion. Oh, who graduated from Chung-Ang University, is a government official responsible for pharmaceutical matters. He previously transferred to the MOHW from the MFDS through a personnel exchange program.
- Policy
- Celltrion rebrands and sells self-manufactured drugs
- by Lee, Hye-Kyung Jan 19, 2024 05:44am
- Celltrion Pharm will discontinue importing the original diabetes and hypertension drugs that it has successfully self-manufactured after acquiring all the rights, including sales rights and patents, from Takeda Pharmaceutical. According to the list of supply discontinuation drugs reported to the Ministry of Food and Drug Safety, the soon-to-be-discontinued drugs include Celltrion's diabetes drug ‘Nesina Tab (alogliptin benzoate),’ 12. 5mg and 25mg; ’ as well as ‘Nesina Act Tab (pioglitazone hydrochloride-alogliptin benzoate)’ 25/30mg, 25/15mg; and the hypertension drug ‘Edarbi Tab (azilsartan medoxomil potassium)’ 40mg, 80mg; and Edarbyclor (chlorthalidone-azilsartan medoxomil potassium) 40/25mg. Also, the company will discontinue sales of ‘ActosRyl Tab (glimepiride- pioglitazone hydrochloride)’ 30/4mg and 30/2mg due to deteriorating product profitability from decreased sales volume. In December 2020, Celltrion acquired all rights, including sales and patents, of Takeda Pharmaceutical's 12 ETC drug brands including ‘Edarbi’ and 'Nesina,' as well as 6 OTC drugs such as ‘Whituben Q’ and ‘Albothyl’ in 9 Asia-Pacific countries for USD 278.3 million (approximately KRW 30.74 billion), and has been preparing to self-produce and sell these products to ensure stable product distribution. The diabetes drug Nesina that is being discontinued was rebranded to ‘Celltrion Alogliptin Met’ and Nesina Act to ‘Celltrion Alogliptin Benzoate.’ In addition, the hypertension treatments Edarbi Tab and Edarbyclo Tab were approved as 'Celltrion Azilsartan Medoxomi Tabl' and 'Celltrion Azilsartanclo Tab,’ and have been localized. Celltrion Pharmaceutical said, "We have discontinued imports due to self-production. We will supply our own products to the market before the stock of imported products is exhausted, and we will establish a manufacturing plan according to market needs." In the case of its diabetes drug ActosRyl, the company said that it would terminate its sales due to the decline in sales volume with prescriptions of around 100,000 tablets per year, and because there are many existing single-agent drugs that contain glimepiride and pioglitazone. Meanwhile, the Celltrion Group announced in January that it will separately sell the sales rights to ETCs in all of the Asia-Pacific region excluding Korea, and OTCs in the Asia-Pacific region, that it had acquired from Takeda Pharmaceutical in 2020. The business rights for the ETC in the Asia-Pacific region is about KRW 209.9 billion, and Celltrion Group is expected to make a significant return on the KRW 138 billion investment it had made at the time of acquisition. However, the items that reported discontinuation of original imports due to in-house conversion and self-manufacture were excluded from the sale and will continue to be sold in Korea by Celltrion Pharm. Celltrion Group excluded the Asia-Pacific rights for Nesina, Actos, and Edalbi from the list of products it will sell.
- Policy
- Moderna will only supply Spikevax Duo 2 in Korea
- by Lee, Hye-Kyung Jan 18, 2024 06:07am
- Moderna Korea has discontinued the supply of all other vaccines, leaving only its latest version, Spikevax Duo 2 (elasomeran, davesomeran) in circulation among the 5 COVID-19 vaccines it had received approval for in Korea. On the 17th, the Ministry of Food and Drug Safety (MFDS) received a report on Moderna’s supply discontinuation of ‘Moderna Spikevax Inj,’ ‘Moderna Spikevax 2 Inj,’ ‘Spikevax inj,’ and ‘Spikevax 2 Inj.’ Moderna stated that it is “producing, importing, and supplying a new updated vaccine in response to the emergence of new coronavirus variants," and that it has been “supplying the latest updated version of Spikevax Inj that protects against the latest variants since October 2023.’ Moderna’s most recently updated version is called ‘Spikevax Duo 2 Inj', and its entire domestic supply is contract manufactured by Samsung Biologics. Spikevax Duo 2 Inj was granted Emergency Use Approval by the MFDS on September 27th last year for adolescents and adults aged 12 years and older against the XBB.1.5 subvariant of the SARS-CoV-2 virus. In preparation for the winter vaccination season, national regulatory agencies and international public health organizations have recommended countries update their COVID-19 vaccines to monovalent vaccines that include protection against the XBB.1.5 variant. Moderna has published clinical data confirming that its XBB.1.5 targeted monovalent vaccine provides neutralizing antibody responses to the variants BA.2.86, EG.5, and FL.1.5.1 in addition to XBB subvariants XBB.1.5, XBB.1.16 and XBB.2.3.2. The most common local adverse reaction following the use of Spikevax Duo 2 was injection site pain. The most common systemic adverse reactions were headache, fatigue, myalgia, and chills. Its safety profile was consistent with what is known for the original Spikevax vaccine. Meanwhile, Moderna has been ranked as the No. 1 domestic pharmaceutical company in terms of production volume in 2022 with its COVID-19 vaccine alone. According to the '2023 Food and Drug Statistics Yearbook', Moderna's production volume amounted to KRW 1.2756 trillion in 2022, driven by the production of 2 dosage forms of its Spikevax Inj vaccine.
- Policy
- Drug price cuts will be applied in bulk next month
- by Lee, Tak-Sun Jan 18, 2024 06:07am
- A number of products are expected to receive price cuts next month as a result of the second round of reevaluations the government conducted on the insurance price ceiling of listed drugs. The drug price adjustments, which were initially set to be applied in January, were pushed back to February. Also, in consideration of the returns and difference settlements that need to be made by pharmacies, sufficient time is expected to be given between the announcement and the effective date of the pricing adjustments. According to industry sources on the 17th, the second round of negotiations after reevaluation of the insurance price ceiling of listed drugs will be completed this month and be reported to the Health Insurance Policy Deliberation Committee (HIPDC). About 3,220 products were subject to the second round of negotiations. As this includes all of the evaluated items, some that are not subject to pricing adjustments are also included in the negotiations. Therefore, it is expected that the actual number of products that receive price cuts will be fewer than this. In the first round of reevaluations that were conducted in September last year, 12,800 items were subject to negotiations, but 7,400 items were applied pricing adjustments. The second round of price ceiling reassessment will cover some specialty oral drugs and aseptic drugs that were included in the bioequivalence demonstration by the Ministry of Food and Drug Safety in 2020. The second round of reevaluations included some prescribed oral drugs and aseptic drugs that were required to demonstrate bioequivalence by the MFDS in 2020. Initially, the Ministry of Health and Welfare had planned to apply the drug price adjustments in January after reporting the results to HPIDC in December last year. However, it was postponed in February due to concerns about the burden borne by pharmacies. Also, drug price ceiling adjustments following the investigation into actual transaction prices had been set to be applied in January at the time. However, this was also postponed thereafter. Therefore, the adjustment period will likely be further delayed to after March, as the results were not reported to HIPDC’s meeting this time. The pricing adjustment date for the second round of price ceiling reevaluations is also expected to be a few days after the first of next month, just as it had been in the first round of price ceiling reevaluations. In the first round, the adjustments were announced on Aug. 23 last year, notifying its implementation on Sept. 1, but the actual implementations were made on Sept. 5 to account for return and settlement confusion among pharmacies. Meanwhile, the reevaluation of the price ceiling of listed drugs is being conducted to maintain or reduce the price of listed drugs depending on whether the drug meets the requirements of self-bioequivalence testing and DMF listing. If the listed drug satisfies both requirements, the ceiling price is maintained as is; however, if the drug satisfies only one of the two requirements, the price is reduced to 85%, and to 72.25% if both requirements are not met.
