LOGIN
ID
PW
MemberShip
2026-05-03 22:10:31
All News
Policy
Company
Product
Opinion
InterView
검색
Dailypharm Live Search
Close
Policy
Crysvita, referred to the welfare committee
by
Lee, Jeong-Hwan
Nov 28, 2022 05:50am
A petition for national consent calling for quick approval of the rapid use of "Crysvita," a treatment for hypophosphatemia, a rare disease, was recently referred to the National Assembly's Health and Welfare Committee with 50,000 consent. Crysvita is a treatment for XLH hypophosphatemia rickets and osteomalacia supplied by Kyowa Kirin Korea in Korea. XLH (X-Linked Hypophosphatemia, X chromosome dominant hypophosphatemia) is a genetic disease and has a characteristic of severely bending legs. The prevalence of XLH is about one person per 20,000 to 60,000 people, and most of them are found after the disease has progressed considerably due to signs around the age of two. Early detection of XLH is essential for future treatment and management of patients. If you miss the timing of treatment, you may suffer from side effects such as limb deformity, growth delay, reduced height, increased risk of fracture, kidney calcification, and elevated parathyroid levels. In severe cases, you may not be able to walk. Kyowa Kirin Korea's Crysvita was approved by the Ministry of Food and Drug Safety in September 2020 as a treatment for XLH and osteomalacia. However, it has not been eligible for salary for two years since the permission. The petitioner, who introduced himself as the patient's mother, explained, "XLH chromosome-dominant hypophosphatemia is a disease that requires living in pain for the rest of your life because early detection is essential for the patient's future treatment and management. She appealed, "In Korea, it is excluded from the standard of fewer than two years of survival threat or life expectancy, so treatment cannot be used even before the eyes." The petitioner appealed, saying, "The mother of a patient who is having a hard time every day because health insurance is not covered even before the treatment for hypophosphatemia rickets, which has been waiting for more than 20 years." She said, "Since health insurance is not covered, individuals have to pay hundreds of millions of won in treatment costs." Crysvita was approved by the FDA in April 2018, is used as a treatment for adults and children over 6 months, and has been approved for sale in major countries such as Europe, the United States, and Japan.
Policy
IVI-Biovac has signed an agreement to develop an OCV
by
Lee, Hye-Kyung
Nov 28, 2022 05:49am
The International Vaccine Research Institute (IVI) announced on the 24th that it has signed a license and technology transfer agreement with Biovac, located in South Africa, for the local manufacture of IVI's OCV. This agreement is meaningful in securing the manufacturing capacity of raw materials, that is, the ability to produce antigens/raw materials necessary to actually manufacture vaccines, through the project. The agreement comes at a time when recent outbreaks of cholera have been triggered by climate change, armed conflict, and forced migration in countries such as Pakistan, Nigeria, and Malawi, seriously hurting already vulnerable health systems. This situation is already causing additional demand for the supply of cholera vaccines, which are in short supply worldwide. In recent years, the area of cholera outbreak has expanded further amid growing supply-demand imbalances caused by a lack of supply of cholera vaccines. The purpose of the agreement signed by IVI and Biovac is to permit and transfer vaccine manufacturing technologies, and ultimately to solve the shortage of vaccines by increasing vaccine production worldwide to prevent cholera. In addition, this technology transfer is expected to be an opportunity to establish and demonstrate the full capacity of GMP expansion, local manufacturing of clinical trial products, and production of vaccines available in Africa and around the world. The agreement is expected to be an important step in enabling vaccine production on the African continent decades later. In the African market, locally produced vaccine production is currently less than 1%, and infectious diseases are still one of the main causes of death, especially for children under the age of five. African leaders have expressed their commitment to creating a local vaccine industry, aiming to raise the proportion of vaccines manufactured in Africa from 1% in 2021 to 60% in 2040 The agreement is the first step in the project's launch and will receive $6.9 million in donations from the Wellcome Trust Foundation and the Bill and Melinda Gates Foundation. Through this agreement, Biovac will be able to expand its capabilities from vaccine vial filling and packaging to all areas of vaccine product development and raw material drug manufacturing. The technology transfer process begins in January 2023, and the first batch of vaccine prototypes for clinical trials is expected to be produced in 2024. The South African National Regulatory Authority (SAHPRA) approval for product use and the WHO Pre-Qualification Certification (PQ), which will take place immediately after approval, is scheduled to be completed in 2026.
Policy
SGLT2+DPP4 standards expanded, will it be over again?
by
Lee, Tak-Sun
Nov 24, 2022 05:51am
from left to left, Forxiga, Jardiance, Xigduo XR, Jardiance Duo The expanded application of salary standards for the combination of diabetes treatment SGLT-2 inhibitor-based drugs and DPP-4 inhibitor-based drugs is expected to pass another year. Since the Korean Diabetes Association requested expansion in 2016, there have been expectations for application within this year as full-scale discussions have been underway, but in fact, it is unlikely to be applied this year. According to the industry on the 23rd, the Ministry of Health and Welfare is expected to receive a voluntary cut rate from related companies by this week and conduct a financial impact analysis based on it. If the expected financial scope is satisfied by the weak reduction, it will be reflected in the salary through a report by the Health Insurance Policy Review Committee. Analysts say that it is difficult to apply this year because each company has a different position and the constitutional review was held on the 23rd to reflect benefits in December. The Ministry of Health and Welfare held a meeting with pharmaceutical companies last week regarding the expansion of the benefit standards for diabetes treatments and asked each company to suggest ways to voluntarily cut them. As a result, pharmaceutical companies are expected to submit data on how to cut the upper limit through their own analysis to the Ministry of Health and Welfare by this week. The Ministry of Health and Welfare's mention of the option of voluntary cuts is interpreted as a move to quickly conclude that the expansion of salary standards has a greater impact on finances than expected. In June, the HIRA announced that it is currently analyzing the financial direction while reviewing the salary standards for three drugs such as Metformin+SGLT-2+DPP-4, metformin+SGLT-2+TZD, and some items of SGLT-2+sulfonylurea or insulin combination. It was necessary to complete the change in standards and drug price evaluation after completing the financial impact and deliberation by the Drug Benefit Evaluation Committee. The drug price is determined by the standard according to the increase in the expected amount of claims. Drug prices will be lowered by a maximum of 5%. However, the Ministry of Health and Welfare encouraged pharmaceutical companies to voluntarily cut the price before deliberation by the committee. This is because the voluntary reduction drug to expand the scope of use can be applied through the report of the Health Policy Review Committee immediately after skipping the committee's deliberation. Analysts say that this is because even if the upper limit is cut by up to 5% according to the set procedure, it far exceeds the expected fiscal range. Accordingly, it is known that the government plans to reduce the level of fiscal input as much as possible by inducing a larger range of voluntary cuts. In particular, the Ministry of Health and Welfare reportedly ordered pharmaceutical companies with SGLT-2 drugs, which are expected to see a high rise in claims, to make a large cut. The pharmaceutical companies that accepted the proposal are in different positions. It is said that some pharmaceutical companies with low-claimed items have already voluntarily replied that they will not cut drug prices. On the other hand, pharmaceutical companies with large claims are expected to accept voluntary weak cuts and present a cut rate to the Ministry of Health and Welfare. Some analysts say that if the voluntary cut rate falls short of expectations through financial impact analysis, it may be difficult to expand the combined salary. On the other hand, if the cut-rate meets expectations, the pace of salary application is expected to accelerate. The overall atmosphere is that it will be difficult to apply this year. In addition, it is unknown at the moment whether to apply expansion to items that have not chosen voluntary cuts. The HIRA official said, "We know that we will receive voluntary cuts from each company and then examine whether it is appropriate to expand benefits through financial impact analysis." He said, "I understand that nothing has been decided yet about the subsequent procedure."
Policy
COVID vaccine side effects proven by the Government
by
Kim, Jung-Ju
Nov 24, 2022 05:50am
In order to prevent new infectious diseases such as COVID-19, a revision to the related law will be promoted to allow the government to receive medical and nursing expenses first if it is damaged by side effects after being vaccinated. Chung Chun-sook, a member of the Democratic Party of Korea's Health and Welfare Committee, proposed today (22nd) a bill to partially revise the Infectious Disease Prevention and Management Act. The revision aims to prevent damage as most of the people voluntarily participated in vaccination for community safety when new infectious diseases such as COVID-19 are prevalent around the world, but some people suffer from diseases, disorders, or deaths due to abnormal reactions caused by vaccination. The application of this amendment is limited to cases where new infectious diseases are prevalent. It also includes special cases such as expanding the scope of compensation for existing vaccination damage, providing medical and nursing expenses first, and ensuring that the state is responsible for proving the causality with vaccination to compensate the public for damage caused by new infectious diseases. Lawmaker Chung's office explained, "The main purpose is to apply the revised law from the beginning of vaccination due to COVID-19 and to compensate the public as much as possible by applying it even when compensation for vaccination is set." Meanwhile, it included Kang Byung-won, Kang Hoon-sik, Kim Won-i, Kim Han-kyu, Yang Kyung-sook, In Jae-geun, Choi Hye-young, Huh Jong-sik, Kang Eun-mi of the Justice Party, and independent Kim Hong-gul.
Policy
The government are in full swing discussing support
by
Lee, Jeong-Hwan
Nov 24, 2022 05:50am
The ruling party and the government's move to expand access to patients with severe and rare diseases, which was President Yoon Suk Yeol's presidential pledge, is notable. On the 21st, the People's Power, the Ministry of Health and Welfare, and the Ministry of Strategy and Finance will hold a policy meeting at the National Assembly to prepare measures to support the treatment of severe and rare diseases. The move is aimed at collecting opinions from private experts on the establishment of nursing hospitals specializing in severe and rare diseases and supporting medical expenses for new drugs for rare diseases and reflecting them in related policies and budgets. The policy meeting will be attended by People's Power figures, including Sung Il-jong, chairman of the policy committee, Lee Chul-kyu, secretary of the Special Committee on Budget and Accounts, and Lee Jong-sung, a member of the Health and Welfare Committee. In the government, Park Min-soo, the second vice minister of welfare, Hwang Soon-kwan, the Ministry of Economy and Finance, and the director of chronic disease management at the Korea Centers for Disease Control and Prevention will attend. In the private sector, the co-CEO of the Seungil Hope Foundation, permanent directors, and chief-level officials will be present. Ahead of the review of the Special Committee on Budget and Accounts, the People's Power announced that it would set up a regional specialized institution to deal with rare diseases of children and adolescents, establish a nursing hospital for rare incurable diseases such as amyotrophic lateral sclerosis(ALS), and increase the budget by 34.5 billion won to support medical expenses for non-reimbursed new drugs. Analysts say that it is unusual for the ruling party's policy committee to directly mention medical expenses for new drugs for severe and rare diseases. It is interpreted as a move to fulfill President Yoon's presidential campaign pledge and meet the demand for access to new drugs for incurable diseases raised by the private sector. President Yoon has made a pledge to resolve policy blind spots on treatments for severe and rare diseases and inject finances where practical guarantees are needed.
Policy
Gov’t to increase drug price reference countries
by
Lee, Tak-Sun
Nov 23, 2022 06:04am
The Health Insurance Review and Assessment Service made a preannouncement of a revision plan to expand the number of reference countries used to evaluate new drugs from 7 to 9 (US, UK, Germany, France, Italy, Switzerland, Japan, Canada, Australia·A9). After opinion inquiries, the revised plan will take effect in January next year. Although the reference countries are used to evaluate the adequacy of reimbursement of new drugs that are waived submission of pharmacoeconomic evaluation data, domestic pharmaceutical companies that own more generics than new drugs are also voicing opposition due to concerns over the next step HIRA will take afterward. According to industry sources on the 22nd, HIRA is also preparing reevaluations on listed drugs based on the revised plan to expand the number of price reference countries. Therefore, it is analyzed that reevaluations will be carried out sequentially from 2024 at the earliest after making preparations next year. The industry had expressed concerns about the very low price of generic drugs in Australia, which was added as a drug price reference country in the revision. Australia is known to introduce the cheapest drugs through competition. According to research, some generic drugs in Australia are set at one-fifth of the price in Korea. Therefore, using the drug price of 9 countries including Australia when conducting reevaluations on the adequacy of listed drugs will likely reduce the price of listed drugs in Korea. In other words, it will have the same effect as the unilateral price cut that had been made in 2012. Another industry concern is that such reevaluations are also being driven by policies after the ruling party pointed out that generic prices in Korea are high at the last NA audit. An industry official said, “If the expanded reference countries are used not only for pricing of new drugs but also reevaluations of all listed drugs, the price of generic drugs will inevitably be cut.” The reevaluation plan of listed drugs was also discussed with the expansion of pricing reference countries at the public-private working group meeting that had been held previously. Thus, HIRA is expected to start preparations after including the reevaluation plan for listed drugs in the 2nd Comprehensive Plan of National Health Insurance according to the expansion of reference countries. As a result, the industry believes that the criteria will be set next year and the drug price of listed drugs adjusted after sequentially receiving reevaluations from 2024.
Policy
MFDS recruits companies to develop 6 National Essential Drug
by
Lee, Hye-Kyung
Nov 23, 2022 06:04am
The government is busy recruiting institutions to develop domestic manufacturing technology for items that are heavily dependent on imports and have unstable supply to achieve self-sufficiency of national essential medicines. The Ministry of Food and Drug Safety had recently selected 11 products, including 5 raw materials and 6 finished products, as candidates for Stage 1 development after deliberation by the Product Selection Committee, and posted an open recruitment for developers on the webpages of research institutions including Korea Orphan & Essential Drug Center and the Korea Pharmaceutical and Bio-Pharma Manufacturers Association. The government will additionally recruit developers for items only a single company had applied for, which include 2 finished products (‘Amiodarone Inj,’ ‘stiripentol Cap’) and 4 APIs (‘amiodarone (amiodarone tablet, injection),’ ‘ibuprofen (ibuprofen injection 5mg/ml),’ ‘ketoconazole (ketoconazole tablet),’ ‘benserazide (levodopa, benserazide tablets)’). Although there is no limit to the number of development projects each institution may apply for, if the same applicant applies to develop the APIs that are candidates for a stable supply of national essential drugs and use them for the development and production of the finished drugs, the items will be recognized as two separate items and be supported separate R&D expenses. The MFDS selected drugs that are heavily dependent on imports and have unstable supply to achieve self-sufficiency of national essential medicines and has been carrying out the ‘Research Project for Managing Stable Supply of National Essential Drugs’ from this year until 2026. Despite the need to maintain a stable supply of national essential drugs at all times, there recently has been a shortage of raw materials as well as finished drugs internationally due to the COVID-19 outbreak. In particular, Korea is heavily dependent on imported drugs, therefore criticism had been raised on the need to prepare a supply chain for essential drugs in case of the rise of public health crises in the future. in The MFDS will invest a total of KRW 5 billion for 5 years - KRW 1 billion each year- to build a stable supply system for national essential drugs that have supply concerns and will aim to develop raw materials and finished drug production technology for domestic production. In the first stage (first-second year) of the project, the development targets will be selected and over 40% of the technology for the target drugs will be developed. In the second stage (third-fifth year), the remaining technology will be developed and be subject to comprehensive assessments. The MFDS said, "In addition to developing the technology for the localization and self-sufficiency of API manufacturing, we will also expand the recognition of multiple specifications of APIs when adding API manufacturers to diversify the supply chain for APIs. Also, if a disruption in supply is expected, we will promptly handle related complaints including adding drug substance manufacturers, etc."
Policy
Forxiga Prodrug will be reimbursed for five months
by
Lee, Tak-Sun
Nov 23, 2022 06:04am
ForxigaProdrug of Forxiga, an SGLT-2 diabetes treatment drug that Dong-A ST succeeded in avoiding patents through the development of drugs, will be listed on the 1st of next month. It is five months before the expiration of the patent. Earlier this month, it was possible because it succeeded in avoiding the duration of the material patent, which ends in April next year. The Ministry of Health and Welfare recently disclosed this fact through an administrative notice of the revision of some details on the criteria and methods for applying for medical care benefits. Dong-A ST's "Dapapro 10mg" will be newly registered on the 1st of next month and added to the standard for diabetes treatment. Dapapro was granted permission on 23 August. At that time, it was unclear whether Dapapro would be released before the expiration of its patent. This is because Dong-A lost the second trial of a patent suit against AstraZeneca, a patent holder of Forxiga, in February. Dong-A challenged the patent that Dapapro, a prodrug with a different chemical structure from the original, was not within the scope of Forxiga's material patent rights, but it was blocked in the second trial. The Korean Intellectual Property Tribunal, which is the first trial, decided that it was not within the scope of rights as requested by Dong-A. The ruling could have put Dong-A ST's early launch efforts in vain. This is because there is not much time left until the patent expires. However, Dong-A succeeded in avoiding patents on the 2nd of this month through a new patent lawsuit. This time, it was argued that Dong-A ST products were not included in the rights on the 917th day of the duration added to a material patent for Forxiga. For now, Dong-A ST is reportedly coordinating internally with the goal of releasing it before February next year if it is paid on the 1st of next month. Currently, the Ministry of Food and Drug Safety has approved 225 products containing Dapagliflozin. However, among them, only seven items from AstraZeneca, the original company, are on the market. It is virtually difficult to sell the remaining items until the patent expires in April next year. Dong-A ST is launching early alone. It is the first SGLT-2 generics in Korea. However, there is a possibility that the direction of patent litigation will emerge as a variable. It is not known whether AstraZeneca, who lost the patent tribunal, will appeal. If AstraZeneca expresses her intention to appeal, it will have to fight again in the patent court. If the ruling is overturned in the patent court, the sale of the product must be stopped. If there is a record of selling before then, AstraZeneca can also file a compensation suit based on this. It is highly expected that Dong-A ST will not miss this opportunity to dominate the market. Although it actively responds to patent lawsuits, it is expected to focus its efforts on marketing to preoccupy the market regardless of the outcome. It is reported that Dong-A ST believes that the patent issue has been resolved and judges the early release before the expiration of the patent.
Policy
Reimb standards will be newly established for Coagadex
by
Kim, Jung-Ju
Nov 22, 2022 06:04am
Reimbursement standards for the hemophilia treatment Coagadex (Human coagulation factor X) that had been granted urgent introduction in Korea have been newly established. Also, oral eperisone hydrochloride as well as oral and ophthalmic solutions that include syrup and oral suspension forms of sodium alginate that were subject to reevaluations on their reimbursement adequacy will be applied new reimbursement standards according to their reevaluation results. The Ministry of Health and Welfare announced its partial amendment to the ‘Details on the standards and methods for application and method (pharmaceuticals)‘ and is opinion inquiry until the 24th. The new reimbursement standards are set to be applied on December 1st. First, the MOHW recognized the need for reimbursement for the hemophilia treatment Coagadex (Human coagulation factor X) in patients confirmed with hereditary Factor X deficiency and willy newly establish reimbursement standards. Patients with hereditary Factor X deficiency will be allowed the administration of Coagadex. In terms of a single administration (single dose), 40 IU/kg in patients aged less than 12 years, 25 IU/kg in patients aged 12 years or older will be allowed, with up to 4 courses recognized per visit. Under the doctor’s discretion, such as when the patient's condition is stable, up to 8 courses of administration will be reimbursable if a patient visits once every 4 weeks. If Coagadex is administered in the hospital, those administered in hospitals are also counted. However, if bleeding occurs in the patient even after administering 8 courses for 4 weeks, an additional 2 courses per visit may be covered, but the doctors’ medical opinion in the medical record needs to be attached. Also, oral eperisone hydrochloride, oral, and ophthalmic solutions including syrup and oral suspension forms of sodium alginate that were subject to reevaluations on their reimbursement adequacy this year will be applied new reimbursement standards according to their reevaluation results. Eperisone hydrochloride drugs including CHodang Pharm’s Mulex Tab will be reimbursed for painful muscle spasms associated with musculoskeletal disorders such as cervicobrachial syndrome, periarthritis, and lower back pain. Sodium alginate preparations including Taejoon Pharm’s Lamina-G solution etc will be granted reimbursement for improving subjective symptoms of reflux esophagitis. For ophthalmic solutions including syrup and oral suspension forms, a new reimbursement standard will be set under oral sodium alginate products according to the reimbursement reassessment results, and be deleted under general principles for ophthalmic solutions. The restrictions set on the number of administrations for Hanmi Pharmaceutical’s Maqaid Inj (triamcinolone acetonide) will be deleted based on approvals in Korea and abroad, textbooks, clinical practice guidelines, clinical literature, and opinion from related societies, but readministration will only be applied reimbursement when administered in intervals that exceed 3 months. Also, Hanmi Pharmaceutical’s Esomezol Cap 10mg (oral esomeprazole 10mg) will be newly listed next month and be added to the list of proton pump inhibitors. Reimbrusement standards for oral proton pump inhibitors include omeprazoles like Yuhan Losec Cap, lansoprazoles like Lanston Cap, pantoprazole like Pantoloc Tab, rabeprazoles like Pariet Tab, and esomeprazoles like Nexium Tab. However, as Esomezole DR Cap 10mg was not approved for the treatment of H.pylori infections, this indication is off-label and excluded from reimbursement. Reimbursement for Kyowa Kirin Korea’s Romiplate Inj 250μg (Romiplostim) will be extended to the treatment of refractory or relapsed aplastic anemia following immunosuppressive therapy based on approvals in Korea and abroad, textbook, clinical practice guidelines, and clinical literature. Reimbursement standards for vedolizumab injections that are applied to Takeda Pharmaceuticals Korea’s Kynteles Inj (vedolizumab) will newly include Kynteles refilled Pen Inj to account for its new listing. However, in consideration of the differences between existing formulations and the approvals (dose and usage), the evaluation method for ulcerative colitis will be changed and new standards for self-injection and long-term prescription will be set. According to the new details, considering how Kynteles Prefilled Pen Inj is a self-injection formulation, the patient should fill out a 'patient dosing diary' to monitor the administration period of the drug for the management of medical care institutions. Also, for long-term prescriptions of Kynteles Prefilled Pen Inj, a single prescription period shall be up to 2 weeks upon discharge from the hospital and up to 3 weeks for outpatient prescriptions and shall be prescribed in hospitals in principle. Patients who show no side effects and stable disease activity 24 weeks since initial administration.
Policy
Phase 3 of Fitusiran, an all-around tx for hemophilia
by
Lee, Hye-Kyung
Nov 22, 2022 06:04am
Phase 3 clinical trials of Fitusiran, a treatment candidate substance that is effective for both hemophilia A and B, are also being conducted in Korea. The Ministry of Food and Drug Safety approved a phase 3 clinical trial of Sanofi-Aventis Korea on the 18th. This clinical trial is a phase 3, single group, multi-organ, multinational clinical trial to investigate the efficacy and safety of Fitusiran prevention therapy in male severe type A or type B test subjects over the age of 12 with or without inhibitory antibodies to coagulation factor VIII or IX. In phase 3 of multinational clinical trials targeting 75 male hemophilia patients around the world, Korea has been approved for clinical trials in five patients. Clinical trials are conducted at Kangdong Kyung Hee University Hospital, Severance Hospital, and Inha University Hospital. The Fitusiran global clinical trial was voluntarily suspended by Sanofi in October 2020 after non-fatal symptoms of thrombosis were found in phase 3 clinical trial participants. Sanofi also stopped all studies in September 2017 when one patient died of thromboembolism in the brain during phase 2 clinical trials. Hemophilia is a congenital hemorrhagic disease caused by a lack of blood clotting factors, and the incidence rate is estimated to be around one per 10,000 people. Depending on the type of insufficient coagulation factors, it is divided into two types: hemophilia A and hemophilia B, with type A accounting for 80% of the total and type B accounting for the remaining 20%. Fitusiran is a small interference RNA (siRNA) treatment that targets antithrombin, which is a treatment for hemophilia type A and type B patients and promotes thrombin production by lowering the level of antithrombin to prevent hemophilia's hemostasis and bleeding. Currently, Hemlibra, which is used for hemophilia type A, ranks first in the hemophilia treatment market, and Sanofi and Novonordisk's Concizumab are the development treatments used for both hemophilia type A and type B patients.
<
131
132
133
134
135
136
137
138
139
140
>