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Policy
Why Galvusmet is priced same as salt-modified and generics
by
Lee, Tak-Sun
Apr 13, 2022 06:03am
Prices of DPP-4 inhibitor Galvus (vildagliptin) and Galvusmet (vildagliptin+metformin) latecomers show that the original Galvus’s price is still set high, but the price of the original Galvusmet (50/500mg) is set at the same level as its salt-modified and generic versions. Also, Galvus’s price had fallen 30% with premium pricing after the introduction of generics, but Galvusmet’s price fell only 25.3%. Why the difference? This is due to the different standards in pricing between single-agent and combination drugs. Galvusmet’s pricing did not follow the general formula. First, combination drugs are not applied the premium pricing formulas. For original single agent drugs, the drugs’ price falls 30% in the first year due to premium pricing, then to 53.55%, same as generics after 1 year. Reimbursement listing status of vildagliptin(50mg)/metformin(500mg) However, original combination drugs are not provided a premium and therefore are discounted and set at 53.55% like its generics at the time of entry. If so, why did Galvusmet’s price drop only 25.3%? It was because its price had been set at a lower level during its initial listing. This is why the drug’s price was set at ₩310, which is a sum of ₩240, the ceiling price of Galvus before premiums, and ₩70, the ceiling price of metformin 500mg. The price of KB Pharma’s salt-modified drug Vildamet tab 50/500mg was also set at ₩310 under the same calculations. Also, United Pharma Korea’s generic version of Galvusmet, ‘Healusmet tab’ was listed at ₩310 like the adjusted price of Galvusmet by satisfying both the direct bioequivalence testing and Regulation on Registration of Drug Substances (DMF) requirements. This is why the original, salt-modified drug and generics were set at the same price upon market entry. On the other hand, the price of generics from companies that were not able to satisfy the direct bioequivalence testing requirements – those from Samjin, Ahn-gook, Ahn-gook New Pharm, and Shinpoong- were set at ₩264. Meanwhile, Hanmi Pharmaceutical’s ‘Vildaglmet 50/500mg,’ which was allowed the same price as KB Pharma’s at ₩310, was voluntarily listed at a lower price of ₩300. Yoon-Hee Choi, Team Head of the Health Insurance Review and Assessment Service’s Drug Pricing Department, said, “No premium is provided for combination drugs, therefore, the price of original combination drugs may be set at the same level as its generics upon entry of generics. However, as Galvusmet’s price had been set at a lower price in its initial listing, the price was not discounted 53.55%, but under a different standard.”
Company
“NOAC Eliquis is safe for use in high-risk groups”
by
Apr 13, 2022 06:02am
The bleeding safety of the novel oral anticoagulant (NOAC) ‘Eliquis (apixaban)’ was reaffirmed through clinical practice guidelines of major academic societies. On the 12th, BMS Korea and Pfizer Korea announced that they have hosted a ‘VMC Master of Masters Webinar’ on the 11th to share the latest advances in preventive therapies for atrial fibrillation and Eliquis’ effect and safety with healthcare professionals in Korea. The webinar was prepared to share the latest advances in stroke prevention for atrial fibrillation patients by sharing the revised clinical practice guidelines from major international societies, and highlighted the stroke prevention effect and bleeding safety of Eliquis. Professor Gregory YH Lip at the University of Liverpool, Professor Jan Steffel at the University of Zurich, and Professor Eue-Keun Choi of the Cardiology Department at Seoul National University Hospital participated as lecturers to introduce the updated guidelines of the ▲European Society of Cardiology (ESC), ▲European Health Rhythm Association (EHRA), and ▲Asia-Pacific Heart Rhythm Society (APHRS). According to Professor Steffel, the EHRA revised its guidelines last year to mention apixaban as one of the preferred NOACs in patients weighing less than 60kg, as it has shown consistent effect and safety compared to VKA in low-weight patients. Apixaban was also mentioned as a NOAC that reduced the risk of major bleeding in high-risk patients such as the elderly and patients with renal impairment. Professor Steffel added, "Special attention is required during anticoagulation therapy, especially in underweight patients, as such treatments are frequently accompanied by conditions that can increase the risk of stroke and bleeding, such as advanced age, cancer, and decreased renal function." Professor Lip introduced an integrated atrial fibrillation management strategy based on ESC guidelines. The integrated management of atrial fibrillation in the ‘Atrial fibrillation Better Care (ABC)’ pathway defines the use of anticoagulant therapy to prevent strokes as the first treatment step. Professor Lip said, “ESC is recommended over non-vitamin K antagonist oral anticoagulants or VTKs in patients with atrial fibrillation that can be administered oral anticoagulants.” Professor Choi highlighted stroke prevention therapy in Asian patients with atrial fibrillation and the use of NOACs in specific patient groups. Professor Choi said, “Patients after atrial fibrillation diagnosis grow older and develop comorbidities such as heart failure, high blood pressure, and diabetes, which continuously increases the risk of strokes. This is why the APRHS guidelines recommend patients to reevaluate their risk of strokes every 4 months.” In particular, Professor Choi focused on the stroke prevention therapies that were newly added for specific patient groups such as those with old age, underweight, liver failure, etc in the updated guidelines. Analysis of major clinical data on 4 types of NOAC (apixaban, dabigatran rivaroxaban, edoxaban) by age showed that apixaban was the only drug to show a reduction in risk of stroke, major bleeding, and intracranial hemorrhages in those between 65 to 74 and over 75 years of age compared to warfarin. On this, Choi said, “The company has steadily accumulated clinical data on various patient groups for Eliquis. The clinical practice guidelines on atrial fibrillation were updated based on real-world data on Eliquis that shows that the drug has consistent effect and safety profile even in specific patients groups, including high-risk group and Asians.”
Policy
Korea loses $9 billion a year in exports
by
Lee, Jeong-Hwan
Apr 13, 2022 06:02am
If low- and mid-income countries such as Africa and Central America fail to raise their collective immunity levels sufficiently, it will have a negative impact on the economy, such as a decrease in export profits of high-income countries. This is because countries around the world are linked to each other by trade and investment, and the country that is expected to lose the most is expected to hit the U.S. with $50 billion a year, while Germany is expected to hit $30 billion a year as the second country to lose. Korea is also expected to lose $9 billion a year, and it is analyzed that having an international cooperation system that can fairly inoculate the COVID-19 vaccine will eventually bring economic benefits to rich countries. On the 11th, Kim Joo-kyung, a legislative investigator at the National Assembly's legislative investigation office, made the announcement through the "significance and task of international cooperation to respond to the pandemic of infectious diseases." The main point of the analysis is that in order to minimize economic losses caused by the COVID-19 pandemic, vaccine inequality between countries should be minimized and international cooperation should be strengthened. According to the international statistics site Our World in Data, the rate of COVID-19 vaccine booster shots per 100 people as of the 4th was very low in African continental countries and some Central American countries. Chile (83.3%) and Singapore (70.7%) finished booster shots, and Korea had a high vaccination rate along with 64.6% of Korea, Iceland (67.9%) and Italy (64.9%). Gabon and Cameroon accounted for 0.1% and Ethiopia 0.3%, with most of the African continent countries and Central American countries such as Jamaica (1.1%). The Legislative Research Service pointed out that vaccine nationalism poses health risks such as increasing death and morbidity by continuing the public health crisis situation, while also seriously affecting the global economy. Countries around the world are interconnected by trade and investment, leading to a decrease in economic demand in low- and medium-income countries leading to negative effects such as a decrease in exports to the economies of high-income countries. Kim explained, "If low-income countries fail to raise their collective immunity levels sufficiently, the cumulative economic cost to 30 high-income countries is estimated to be $216 billion in 2022-2023 alone and $258 billion in 2023-2024. Kim added, "The country that is expected to be hit the hardest among the 30 countries will incur $41.3 billion in 2022-2023 and $493 in 2023-2024, and Germany will lose $26.1 billion in 2022-2023 and $31.1 billion in 2023-2024. Korea is expected to suffer economic losses of $8.2 billion from 2022 to 2023 and $9.7 billion from 2023 to 2024, he said. "Quick vaccination is important because potential economic costs arising from the lack of vaccines to poor countries increase over time." Kim stressed that vaccine inequality should be improved through international cooperation. In particular, as Korea has been selected as a "global bio-human resource training hub," it said that it should start seeking international cooperation measures. The global bio-human resources training hub, organized by the World Health Organization (WHO), is a project that provides education and training across the production of vaccines and biopharmaceuticals. Korea will be selected alone and conduct vaccine and biopharmaceutical manufacturing training for 370 global bio-workers from July. Kim said, "The way to solve the COVID-19 pandemic is to improve the current vaccine and vaccinate the most vulnerable people," adding, "To this end, the WHO is trying to supply vaccines fairly through COVAX Facility and transfer vaccine technology to low-income countries." Kim said, "Korea did not have the original technology for COVID-19 vaccines, so it was difficult to supply and demand vaccines in the early days of the pandemic. In response, we have the task of becoming a leading country in the bio-pharmaceutical industry. As Korea has been selected as a global bio-human resource training hub, we need to seek international solidarity and cooperation to contribute to health security around the world."
Company
Propecia is sold in a new package
by
Apr 13, 2022 06:02am
Organon Korea announced on the 11th that it will introduce a new package of the oral male hair loss treatment Propecia (Finasteride). As for the new package, it applied CI of Organon Korea company. Propecia, which has been sold by MSD Korea for more than 20 years since its launch in Korea in 2000, was officially launched and relocated by Organon Korea, which was spun off from MSD in June last year. Organon will consolidate its position as a major product, Propecia, with its new package. Currently, Propecia is on sale in two packaging specifications: 28 tablets and 84 tablets. Organon Korea will supply changed packages for Propecia 84 tablets first in April, and will supply 28 tablets sequentially from May. Depending on the pharmacy, It sells new packages as the old packages are sold depending on the pharmacy. Han Soo-young, head of marketing at Organon Korea's Propecia, said, "This package change means that Propecia is once again announcing its official departure as a major item of Organon, and only the company name has been changed, but the quality of Propecia's production and packaging is the same as before, and Organon Korea Propecia is the No. 1 oral hair loss treatment in Korea, and we will continue to strive for its original value."
Policy
Galvusmet latecomers face a price war since launch
by
Lee, Tak-Sun
Apr 12, 2022 06:05am
How price will affect sales of the DPP-4i antidiabetic treatment Galvusmet’s latecomers is gaining attention. Hanmi Pharmaceutical, which had been the first to release a drug to the market, had opted to set its price lower than planned, and the price of the original Galvusmet had also fallen due to the introduction of generics. The price of the generics had also been set accordingly. According to industry sources on the 11th, starting with Hanmi’s Vildaglmet, sales of Galvusmet generics had started in earnest in February, along with sales of KB Pharma’s salt-modified drug in March, all of which as latecomers of Novartis’s Galvusmet (vildagliptin/metformin). The latecomers have been eyeing the Galvusmet market as this fixed-combination drug has been prescribed more than the single-agent Galvus. According to UBIST, Galvus sold ₩8.5 billion and Galvusmet ₩38 billion last year in Korea. Among the latecomers that were newly introduced, only a generic version of the Galvusmet’s main dose - vildagliptin 50mg/metformin 500mg – was released in the market. The introduction of Galvusmet 50/500mg generic had reduced the price of the original by 25.3%, leaving no difference in price between it and the latecomer drugs. In particular, KB Pharma’s salt-modified Vildamet tab 50/500mg, and Korea United Pharm’s Healusmet tab, which received a pricing premium as an innovative pharmaceutical, were listed at ₩310, which is the same price as its original drug. However, Hanmi Pharmaceutical opted to set the price of its salt-modified Vildaglmet tab 50/500mg ₩300, and how this will affect market competition is receiving attention. 빌다글립틴(50mg)/메트포르민(500mg) 동일제제 급여등재 현황 Galvusmet latecomers were able to enter the market earlier after successful patent challenges. Although the original's substance patent was set to expire on March 4th this year, Hanmi and Ahn-gook succeeded in invalidating part of the extended term of the patent and released their generics earlier than the patent expiry date. On this, Novartis has filed an active trial to confirm the scope of its patent against companies other than Hanmi – KB Pharma, Korea United Pharm, Ahn-gook Pharmaceutical, Ahn-gook New Pharm, and Samjin Pharm – on grounds of patent infringement. With patent and drug prices so intricately intertwined, who will be the last to smile in this ₩40 billion market is expected to continue to draw attention.
Company
KRPIA BOD meets Oh Chang-hyun, the new head
by
Eo, Yun-Ho
Apr 12, 2022 06:05am
KRPIA BOD will hold its first face-to-face meeting with Oh Chang-hyun, director of the MOHW's insurance pharmaceutical dept. According to related industries, KRPIA Board of Director (BOD) will hold a meeting with Oh Chang-hyun, the new manager, and members of the MOHW's Insurance and Pharmaceutical Affairs on the 15th. The meeting is expected to be accompanied by Oh Dong-wook, CEO of Pfizer Korea, Lee Young-shin, a full-time vice chairman of KRPIA, and some members of the board of directors. Through the discussion meeting, KRPIA BOD is a plan to deliver grievances, policies, and pledges from the perspective of pharmaceutical companies within the agenda of "expanding new drug coverage." As the industry has recently emphasized the need for the introduction of the "post-evaluation of lights" system, it remains to be seen how to proceed with discussions with the changed head of the insurance drug department. KRPIA is also discussing with the 20th Presidential Transition Committee to expand the guarantee of new drugs.
Company
No. of employees decline sharply due to restructuring/reorgs
by
Apr 12, 2022 06:04am
The number of employees at multinational pharmaceutical companies has declined sharply due to their active restructuring and reorganizations. Over 200 employees have been laid off in just 4 companies - Roche Korea, Lilly Korea, Sanofi-Aventis Korea, and Zuellig Pharma Korea. According to the Financial Supervisory Service, the number of employees at Roche Korea, Lilly Korea, Sanofi-Aventis Korea, and Zuellig Pharma Korea was 1,109, which was a 16% decrease from the 1,326 of the previous year. Approximately 80 employees left Sanofi-Aventis Korea last year. The number of employees in the company had been 492 at the end of 2020 but was reduced to 413. In the same period, the number of Zuellig Pharma Korea employees decreased by 58, from 293 to 235. Roche Korea’s employees decreased by 52 from 309 to 257. Lilly Korea’s employees decreased by 28 from 232 to 204. The companies above have all actively carried out restructuring and reorganizations last year, influenced by the business model reorganizations conducted to remove or reduce non-core departments by the companies’ global headquarters. Also, the sales department became the main target of restructuring due to the increasing preference for online-based, non-face-to-face sales activities due to COVID-19. The number of employees at Sanofi-Aventis Korea decreased greatly following the split-off and merger of its consumer healthcare business with Opella Healthcare Korea. Before the spilt-off, the company had also offered an early retirement program for its CHC and GenMed divisions. The GenMed division is in charge of non-core prescription drugs of the company other than vaccines (Pasteur), and specialty care (Genzyme). Zuellig Pharma Korea had reduced the number of employees while withdrawing its local pharmacy retail business. The company had notified employees of its plans to dissolve the pharmacy retail business and large-scale restructuring in March last year. The company had decided to undergo such measures due to continuous operating deficits brought on by the lower distribution fees and intensified market competition. The company aimed to lay off about 80 people by eliminating direct sales and leaving only a small number of personnel in online sales services, Lilly Korea had downsized its offline sales services while increasing its online sales. For this, the company had carried out a large-scale ERP since November 2020. At the time, the company explained that its purpose was “The purpose of the reorganization is to increase the productivity and efficiency of the sales division and reinforce various multi-channels including digital programs.” The company had expected 25% of the 100-something employees in its sales division to opt for the ERP, and it is analyzed that a corresponding number of employees have voluntarily retired. Roche Korea had also conducted two ERPs at the end of 2020 and in the previous year. The main subject of the ERP was the sales department. Although around 20% of the 60-70 workforce in sales were expected to opt for ERP, the number that left had exceeded expectations. The number of employees at Roche Korea, which had exceeded 300, was reduced to 250 after ERP.
Company
Lutathera’s partner ‘LysaKare’ may be prescribed at GHs
by
Eo, Yun-Ho
Apr 11, 2022 05:58am
‘LysaKare’, the drug concomitantly used with the neuroendocrine tumor treatment ‘Latathera’ may soon be prescribed at general hospitals. According to industry sources, Novartis Korea’s ‘LysaKare (L-arginine hcl/L-lysine hcl) has passed the drug committee (DC) reviews at 3 of the Big 5 general hospitals – Samsung Medical Center, Seoul National University Hospital, Seoul Asan Medical Center - in Korea. LysaKare was approved as a drug to be used concomitantly with Novartis’s orphan drug Lutathera (lutetium), a neuroendocrine tumor treatment that was approved in July 2020. Lutathera is a radioactive targeted therapy that increases the dose of radiation in the tumor areas. It is an ultra-high-priced but highly effective drug used to treat a very small number of patients. The drug was listed for insurance benefit in March last year and cost ₩104 million for 4 injections before then. LysaKare is used to reduce damage caused by renal radiation exposure during the use of Lutathera. The Ministry of Food and Drug Safety had also designated LysaKare as an orphan drug recently. Specifically, LysaKare is indicated for ‘reduction of renal radiation exposure during peptide-receptor radionuclide therapy (PRRT) with lutetium (177Lu) oxodotreotide in adults.’ Meanwhile, Lutathera’s efficacy had been demonstrated through the Phase III NETTER-1 trial and Phase I/II ERASMUS studies. The primary efficacy endpoint of the NETTER-1 study was progression-free survival (PFS). At the time of primary analysis, the median PFS was not reached for Lutathera and was 8.4 months for the control group, showing that Lutathera reduced disease progression and death by 82% compared to the control group. In particular, the drug had significantly prolonged PFS in patients regardless of tumor size, including those with liver tumors, and demonstrated the possibility of effectively treating various types of patients.
Policy
The adverse drug reaction rate of Trulicity is 19%
by
Lee, Hye-Kyung
Apr 11, 2022 05:58am
As a result of a six-year post-marketing survey of Type 2 diabetes treatment Trulicity in Lilly Korea, 15 cases of serious adverse drug reactions that cannot be excluded from causal relationships were reported. The permit will be changed as 62 unexpected adverse drug reactions, which cannot exclude causal relationships, also occurred. The MFDS recently announced that it will pre-announce and reflect the order to change the permission according to the results of the re-examination of Trulicity 1.5 mg/0.5ml and Trulicity 0.75 mg/0.5ml disposable pens from July 6. Trulicity was developed as a disposable syringe formulation as a long-acting GLP-1 analog and obtained domestic permission in 2015. As a result of a post-marketing survey of 3,022 people for 6 years for re-examination in Korea, the incidence of abnormal cases was reported to be 19.49% (589/3,022 people, total 819 cases), regardless of causality. Significant adverse drug reactions were found to be 0.46% (14/3022 patients, 15 cases), with occasional blood sugar increases and rare dizziness, poorly controlled diabetes, diabetic gastritis, gastroesophageal reflux disease, acute kidney damage, and diabetic kidney disease. In the case of unexpected adverse drug reactions such as weight loss, weight gain, sensory degradation, and gastroenteritis, 1.99% (60/3,022 cases, 62 cases) occurred. Trulicity is administered as an adjuvant to dietary and exercise therapy to improve blood sugar control in adult type 2 diabetes patients. Among patients who have difficulty controlling sufficient blood sugar with Metformin and Sulfonylurea combination therapy, insurance benefit is being applied to the combination therapy of patients who cannot perform body mass index ≥25kg/㎡ or insulin therapy. Last year, it recorded 47 billion won in outpatient prescriptions based on UBIST, up 23% from 38.2 billion won in the previous year.
Policy
NHIS to study measures on improving the PVA system
by
Lee, Tak-Sun
Apr 11, 2022 05:58am
With a study on improving the price-volume agreement (PVA) system in plan, the possibility that the improvement may increase drugs subject to PVA is being raised. According to industry sources on the 8th, the National Health Insurance Service is preparing to conduct a research to ‘evaluate the performance of and improve the Price-Volume Agreement system’ and will post a bid for its research services soon. Its plan, as disclosed by the NHIS, indicates that the study will be conducted for 6 months from the period of its initiation and be completed at the end of the month. Through the study, the authorities plan to establish a mid-to-long-term roadmap for the PVA system and ensure the appropriateness of the drug expenditures to save excess resources and strengthen Korea’s NHI coverage. Feasibility reviews on alternatives that go beyond the existing agreement system and reference formulas will also be developed in the study. For example, the current system applies the rate of increased claims in the formula, but the study will review the application of a reference formula that considers the absolute claims amount and the amount of increase. In addition, the study will be used to prepare a reasonable plan that considers the fiscal impact of the selection/exclusion criteria that were already revised this month, and review diversifying the method used to make PVA. Based on the research results, NHIS also plans to hold public hearings with relevant institutions to improve the PVA system to prepare a system improvement plan that can enhance both acceptability and negotiation power, and propose a mid-to-long-term development direction for the PVA system based on legal and institutional review. NHIS announced its plan to research measures to improve the PVA system earlier this year. At a policy roundtable meeting on the ‘Rational improvement of the PVA system’ that was held by the National Assembly in January, Hyun-Deok Kim, Director-General of the Pharmaceutical Management Department, said, “We are aware of the issue caused by reviewing only the rate of increase without consideration of the absolute increase in claims amount. We agree that there is a need to conduct a comprehensive review on the PVA system and prepare improvements, and will be posting a bid for research services within the year.” As the main purpose of the study is to save NHI pharmaceutical expenses, friction with pharmaceutical companies seems inevitable in the process of its implementation. An industry official expressed regrets, "Contrary to the pharmaceutical industry’s opinion of reducing or deferring the PVA system, the government’s only plan seems to be to reduce its expenses. By the contents of the study alone, it seems that subject drugs and discount rate would only increase further."
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