- LOGIN
- MemberShip
- 2026-05-03 10:13:34
- Policy
- GC Biopharma’s Livmarli approved as first ALGS Tx in KOR
- by Lee, Hye-Kyung Mar 02, 2023 05:53am
- The Ministry of Food and Drug Safety (Minister: Yu-Kyoung Oh) announced that the ministry approved GC Biopharma’s ‘Livmarli (maralixibat chloride)’ on the 28th. Livmarli is an imported rare disease drug used to treat cholestatic pruritus in patients with Alagille syndrome who are 1 year of age and older. Alagille syndrome is a rare genetic disorder in which bile builds up in the liver and does not flow out due to reduced number of bile ducts inside the liver. It can also cause cardiovascular, skeletal, ocular, and dermatological complications. According to the Health Insurance Review and Assessment Service data, there were currently 136 patients diagnosed with Alagille syndrome in Korea in 2021. The newly approved Livmarli interrupts bile acid recirculation through inhibition of the apical sodium-dependent bile acid transporter, increasing fecal excretion and reducing the amount of bile acids in the body. As the first treatment available for use to treat cholestatic pruritus in patients with Alagille syndrome, the drug is expected to be of great help to patients who have previously suffered from itchy skin due to this condition. Minister Oh said, “The MFDS will continue to promptly review the safety and efficacy of rare disease drugs and seek innovation in safety to expand and ensure treatment opportunities for people with rare or intractable diseases. This effort will also contribute to realizing the government’s national goal of ‘accompanying the people to realize a happy society.’ The MFDS said it will continue to make the best effort to expand treatment opportunities to patients by promptly supplying treatments with verified safety and efficacy based on its expertise in regulatory science.
- Policy
- Negotiations on the Brukinsa price have begun
- by Lee, Tak-Sun Feb 28, 2023 05:52am
- Crysvita and Dupixent are also negotiating drug prices. It has been found that Chinese pharmaceutical company BeiGene Korea has entered into drug price negotiations with the NHIS for Brukinsa capsules 80mg sold domestically. When the NHIS drug price negotiation is completed, the drug will be covered through a report to the Health Insurance Policy Deliberation Committee of the Ministry of Health and Welfare. According to the industry on the 27th, The NHIS recently disclosed this fact on its website. Since April 2019, The NHIS has been disclosing the drugs ordered by the Ministry of Health and Welfare to NHIS for drug price negotiations on its website for the public's right to know. According to the Ministry of Health and Welfare's negotiation order, the drug price negotiations will be carried out within 60 days between the NHIS and pharmaceutical companies. At the HIRA held on the 9th, this drug was judged to be eligible for reimbursement for WM. WM is a rare blood cancer in which the bone marrow produces many abnormal white blood cells that crowd out healthy blood cells. Previously, the US FDA approved Brukinsa as a WM treatment in September 2021. Meanwhile, the NHIS said Crysvita 10, 20, and 30mg were also included in the drug price negotiations. This drug also passed the committee on the 9th, and the negotiation period was shortened from 60 days to 30 days after prior consultation with The NHIS as a drug to improve the quality of life for children. Crysvita is used for 'FGF23-associated hypophosphatemic rickets and osteomalacia'. The NHIS also said that drug price negotiations are underway for Dupixent, which passed the committee in January. Dupixent, which is currently receiving reimbursement for adult atopic dermatitis, is undergoing reimbursement procedures for pediatric atopic dermatitis.
- Policy
- The value of pharmaceutical bio innovation is reflected
- by Lee, Jeong-Hwan Feb 24, 2023 05:53am
- Second Vice Minister Park Min-sooSecond Vice Minister of Health and Welfare Park Min-soo promised to support the biopharmaceutical sector by implementing drug pricing policies that reflect innovative values and improving the certification system for innovative pharmaceutical companies. Vice Minister Park also asked biopharmaceutical companies to make efforts to create blockbuster new drugs and jobs through bold technology development investment and open innovation. Vice Minister Park made this announcement at the '78th KPBMA regular general meeting' held at the KPBMA on the 21st. Vice Minister Park said, “The biopharmaceutical industry is at a very important juncture in leaping into the global market by having the capacity to develop innovative new drugs and to produce and export high-quality, large-scale medicines.” “We will support our biopharmaceutical industry to grow to the level of sixth in the global market through the establishment of mid- to long-term strategies such as a roadmap for regulatory innovation in the health sector and manpower training plans,” he said. Vice Minister Park said, "We will strive to improve related systems such as drug prices and innovative pharmaceutical company certification systems to appropriately compensate for the value of corporate innovation and ensure a stable supply of essential medicines." Please create blockbuster-level new drugs and create more jobs." Afterward, Vice Minister Park presented the Minister of Health and Welfare Commendation to five people of merit and expressed gratitude for their hard work in the pharmaceutical bio industry.
- Policy
- Expansion of insurance coverage for diabetes drugs
- by Lee, Tak-Sun Feb 24, 2023 05:52am
- SGLT-2 inhibitory antidiabetic drugs (from left: Forxiga, Jardiance, Xigduo XR, Jardiance Duo)While the combination benefit between SGLT-2 diabetes treatment and other treatments is expected to be applied from April, the two-drug regimen between SGLT2 and DPP4, which was omitted from the current discussion, is also expected to be reviewed. It is expected that if the SGLT2+DDP4 complex is applied for reimbursement, it will naturally be sorted out through discussion. According to the industry on the 23rd, some SGLT2+DPP4 combinations have applied for reimbursement to the HIRA. It is known that AstraZeneca's 'Qtern', Boehringer Ingelheim's Esglito, and LG Chem's SGLT-2 inhibitory antidiabetic drugs (from left: Forxiga, Jardiance, Xigduo XR, Jardiance Duo) applied for benefits. MSD's Steglujan is also expected to apply for benefits sooner or later. These items are being promoted to be registered as a benefit in time for April when the benefit is expanded. This is because they are products developed by the original developer of original ingredients, so they can be registered as products regardless of patents. However, 82 products of Dapagliflozin + Sitagliptin approved by domestic pharmaceutical companies are scheduled to be registered after September 1, when the substance patent for Sitagliptin (Januvia) expires. While pharmaceutical companies with combination drugs welcome the news of an increase in reimbursement, attention is focused on whether reimbursement for two-drug combination therapy is also applied. The concomitant benefit drugs currently being discussed for benefit expansion are triple therapy such as metformin + SGLT-2 + DPP-4, metformin + SGLT-2 + TZD, and some SGLT-2 items + sulfonylurea or insulin combination therapy. This is because the 2+DPP-4 two-drug regimen is missing. If the benefit expansion plan is applied as planned, the two-drug combination of SGLT2 + DPP4 should be used as a three-drug regimen with Metformin. As SGLT2 or DPP4 drugs are currently used alone, the pharmaceutical industry insists that these two-drug therapies should also be covered. The HIRA believes that if the SGLT2+DPP4 complex is applied, it is highly likely that the second drug will also be reviewed. An official from The HIRA said, “If a two-drug combination drug is applied for, we will not organize traffic regarding whether or not the second drug will be covered.” There is," he explained. If the review of whether or not to pay for the second system is prolonged, it cannot be ruled out that the third system will be started first, and whether or not the second system will be covered will be discussed later. Judging from the discussion so far, the three-drug combination of metformin + SGLT2 + DPP4 is advantageous in terms of ease of administration, but there are currently no domestically approved drugs.
- Policy
- Daewoong also enter the Vemlidy late-stage drug market
- by Lee, Tak-Sun Feb 23, 2023 05:46am
- Gilead’s hepatitis B treatment Daewoong Pharmaceutical and Chong Kun Dang will also enter the late-stage drug market for Vemlidy, a chronic hepatitis B treatment previously occupied by Dong-A ST. Daewoong and Chong Kun Dang's products received a month's delay in obtaining approvals, and their benefits were also applied a month later. According to the industry on the 20th, from March 1, Daewoong Pharmaceutical's Vemlidy and Chong Kun Dang's Tenofobell-A will be covered. The two products are salt-modifying drugs of Gilead Sciences' 'Vemlidy'. Daewoong Vemlidy has Tenofovir Alafenamide HemiFumarate as the main ingredient, and Chong Kun Dang Tenofobell-A has Tenofovir Alafenamide Succinate as the main ingredient. These products succeed in the patent challenge through salt change, obtain generics for exclusivity, and are released before generics when the patent has not expired. The drug price calculation standard for salt-changing drugs is 90% of the original. Daewoong Vemliver costs 2828 won, which is 80% of the original Vemlidy (3,535 won). Chong Kun Dang Tenofobell-A costs 2,439 won, which is 69% of the original price. This amount is cheaper than Donga ST Vemlia's 2,474 won, which was previously applied for benefits. Each generic has a different drug pricing strategy, and it is noteworthy how it will affect market sales. Meanwhile, Jeil Pharm's 'Tecavir-D', which was licensed in the same month as Daewoong's and Chong Kun Dang's, is not on the March reimbursement list. Vemlidy is an upgraded version of Gilead's existing hepatitis B treatment 'Viread'. The patent is scheduled to expire on August 15, 2032, and a generic drug with the same ingredient will have to wait another nine years. Last year, Vemlidy's outpatient prescriptions (based on UBIST) were 47.1 billion won, up 18% YoY.
- Policy
- 9 bepotastine besilate antihistamines listed for reimb
- by Lee, Tak-Sun Feb 23, 2023 05:46am
- Leading bepotastine besilate product Sustained-release antihistamine drugs that contain bepotastine besilate will be listed for reimbursement for the first time in Korea. The original bepotastine besilate product developed by Mitsubishi Tanabe Pharma Corporation is Tarion. Tarion was sold by Dong-A ST in 2004 in Korea, and the company withdrew from the Korean market in December 2017 after the drug’s patent expired. Therefore, only its generics that contain the same ingredients and salt-modified products are currently being sold in the Korean market. According to industry sources on the 21st, 9 sustained-release antihistamine products will be listed for reimbursement at a ceiling price of KRW 326 from March 1st. Companies that own related products are the CMO Dongkoo Bio&Pharma, and Mother’s Pharmaceutical, Eden Pharma, Yungjin Pharm, Kukje Pharma, Shin Poong Pharm, Hutecs Korea Pharmaceutical, Myungmoon Pharm, and Union Korea Pharm. This is the first time a sustained-release product that contains bepotastine besilate was listed, and currently ninety-two 10mg bepotastine besilate is taken twice a day, and one once-daily 5mg product is available in the market. Currently, the ceiling price for all the 10mg products is KRW 148 per tablet. By daily dose, the 10mg short-acting drugs cost KRW 296, which is cheaper than the sustained-release drugs, which cost KRW 326. In addition to bepotastine besilate, bepotastine salicylate products that contain a different salt is also available. Also, there are sustained-release products available for bepotastine salicylate. 5 short-acting products and 6 sustained-release products are available each. The ceiling price for these drugs is also KRW 148 for the short-acting product and KRW 326 for the sustained-release products. However, bepotastine besilate products have been showing better performance. Among the major items, Dong-A ST’s Twolion sold the most, recording KRW 9.5 billion in outpatient prescriptions (UBIST), followed by the KRW 4.6 billion made by Daewon Pharmaceutical’s Bepostarbi, then KRW 3.2 billion by Dong Kook’s Bepotan. Among the three products, Twolion and Bepostarbi are bepotastine besilate products and Bepotan is a bepotastine salicylate product. Although the salt-modified sustained-release tablets did not perform so well in the market until now, as sustained-release tablets that contain the same ingredient as the original were released, attention is being paid to whether they will break the existing market structure and drive the market. Antihistamines work as antagonists to excess histamine caused by antigen-antibody reactions and is used for allergic conditions and early cold treatment. In the early days of COVID-19, the market size shrank with the decline in the number of respiratory patients, but last year, it was also used for COVID-19 patients, which led to an upward trend. However, it is difficult for individual companies to develop their products into blockbusters. Competition is fierce in the market with over 100 generics and salt-modified products, and there are several second- and third-generation antihistamines including bepotastine, therefore, it is not easy to foster one product. However, even if the drugs cannot become a blockbuster, the drugs show performance continuously, therefore, industry officials expect the sustained release products can also successfully settle in the market, with sales and marketing activities.
- Policy
- SGLT-2 DM Combi Benefit Expansion Expected to be applied
- by Lee, Tak-Sun Feb 23, 2023 05:45am
- Expansion of reimbursement for the combination of SGLT-2 diabetes treatment and other treatments is expected to be applied from April. It is said that the government accepted the wage increase after receiving details of voluntary reductions from related companies earlier this month. According to the industry on the 20th, it was reported that the Ministry of Health and Welfare, which is discussing the expansion of the combined benefit of SGLT-2 diabetes treatment, has set up a plan to apply for the benefit in April. Currently, the concomitant benefit drugs being discussed are triple therapy such as metformin + SGLT-2 + DPP-4, metformin + SGLT-2 + TZD, and some SGLT-2 items + sulfonylurea or insulin combination therapy. The Ministry of Health and Welfare estimates that these combined benefits will cost tens of billions of won. The Ministry of Health and Welfare induced 11 companies with benefits expansion drugs to voluntarily lower the maximum amount in order to share finances as it requires enormous financial resources. However, in November of last year, the government received a voluntary cut rate and started an analysis of the fiscal impact, but there was no further progress as it exceeded the expected range. As a result, by the beginning of this month, the voluntary reduction rate was once again received, but this time it is interpreted that the financial range was satisfied. It is said that the companies have expanded the reduction rate and submitted it to the Ministry of Health and Welfare. For drugs that are voluntarily reduced to expand the range of use, benefits can be applied quickly because only a quality supply contract is required with the NHIS, bypassing the review by the Drug Evaluation Committee of the HIRA. In response, the government is said to be planning to apply for benefits from April through a report to the deliberation committee next month. As related combination drugs are currently waiting for approval, it is expected that the expansion of the combination benefit will become a new trend in the diabetes treatment market.
- Policy
- The ruling party promotes the establishment of a serious dz
- by Lee, Jeong-Hwan Feb 22, 2023 05:54am
- In order to strengthen health insurance coverage for anticancer drugs and treatments for severe rare diseases, legislation will be promoted to separately establish "severe disease accounting." On the 20th, Rep. Lee Jong-sung of the People's Power proposed a partial amendment to the National Health Insurance Act. Rep. Lee Jong-sung argued that health insurance coverage for treatments for severe and rare diseases has been reduced over the past five years of the Moon Jae In government. Lee explained that President Yoon Suk Yeol pledged to expand the application of health insurance for treatments for severe and rare diseases and adopted "relaxing the burden of high-priced medical expenses, such as the rapid registration of treatments for severe and rare diseases." Lee included a clause in the bill to establish a separate accounting for severe diseases for the benefit of treatments directly related to the lives of severely ill people in the health insurance finance. It is a method of using the finances saved by the re-evaluation of drug benefit adequacy and the risk-sharing system (RSA) as financial resources for accounting for severe diseases. Specifically, provisions such as grounds for the establishment and operation of accounting for serious diseases and financial resources for accounting for serious diseases were included. He said, "It is a plan to cover the necessary funds for the treatment of severe diseases without additional financial investment. Since the inauguration of the Yoon administration, expensive anticancer drugs and rare disease drugs have improved the lives of severely ill patients, but they are still suffering from double burdens of disease and economic burden. He added, "If the law is revised, the blind spot of the current medical expense support system for severely ill patients will be partially resolved."
- Policy
- Lucentis biosimilar Ameliebou prices cut 24.5% voluntarily
- by Kim, Jung-Ju Feb 22, 2023 05:54am
- Samsung Bioepis lowers the insurance drug price of its sixth biosimilar Ameliebou 10 mg/mL (Ranibizumab) by nearly 25%. It's been two months since the benefit was released. AbbVie Skyrizi PFS and Amgen Korea Repatha are used a lot, so they will conduct PVA with the NHIS and reduce drug prices to 3-6%. According to the industry on the 20th, the Ministry of Health and Welfare plans to revise the list of drug benefits and the upper limit and is pushing to apply it as of the 1st of next month. First of all, there are a total of six drugs that companies will voluntarily cut next month. Samsung Bioepis' biosimilar Ameliebou 10mg/mL will lower its price by 24.5% within two months of its launch. This drug is a biosimilar of Lucentis and is used to inhibit the formation of new blood vessels by binding to Vascular Endothelial Generating Factor (VEGF)-A. Samsung Bioepis signed a domestic distribution and sales contract with Samil Pharmaceutical with the launch of the product and launched it in January. In addition, products containing 20 mg and 10 mg of Yungjin Fluoxetine Cap will be lowered by 53.4% and 38.4%, respectively, while products containing Revlimid's generic, Lenaldo 10 mg and 5 mg of Kwangdong Pharmaceutical will be lowered by 21.1% and 21.2%, respectively. A total of two drugs will be reduced to PVA next month, subject to type "Ka" and "Na", respectively. If looking at the product, AbbVie Skyrizi PFS belongs to the type "Ga" and is on the negotiating list, agreeing to a 6.1% cut. Amgen Korea Repatha PFS will be lowered by 3.7% from next month as a result of PVA negotiations with the corporation.
- Policy
- Chong Kun Dang's Tamivir is listed as the lowest price
- by Lee, Tak-Sun Feb 22, 2023 05:54am
- Chong Kun Dang, which has stopped selling the flu treatment "Tamiflu" since this year, was immediately covered by the salary of its generic drug. Chong Kun Dang has been selling Tamiflu for more than a decade in partnership with Roche Korea since 2012 and has not released its own generics with only permission. According to the industry on the 20th, Tamivir 30, 45, and 75mg per Chong Kun Dang will be listed as salary at 524, 907 won, and 1063 won, respectively. Tamivir was approved in December 2009 and was the earliest Korean generic to be approved. Chong Kun Dang has been unable to come to the market since 2012 because it has sold the original Tamiflu capsule in partnership with Roche Korea. Instead, Chong Kun Dang has been selling suspension powder products that are not in the original under the Tamivir brand. At the beginning of the year, Chong Kun Dang sent an official letter to the distribution industry and officially announced the suspension of Tamiflu sales, saying that the salesperson of 75, 45, and 30mg of Tamiflu capsules had been changed from Chong Kun Dang to Roche Korea as of January 6. As a result, the registration of Tamivir is interpreted as a measure following the suspension of sales of Tamiflu by Chong Kun Dang. The Tamivir capsule is currently the lowest price on the same system. In the case of Oseltamivir capsule 30mg, the highest price is 854 won and the lowest price is 790 won, which is 266-330 won more expensive than Chong Kun Dang Tamivir products. 45 mg and 75 mg also differ in price from Chong Kun Dang products. Analysts say that Chong Kun Dang is likely to settle in the market for a short period of time as it has experience in selling Tamiflu and has price competitiveness. As COVID-19 subsides, the flu is on the rise again, and some predict that it could exceed the expected sales in March without supply issues. Attention is focused on how much sales Chong Kun Dang, which changed its product from original to generic, will make in the market.
