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- 2026-05-05 07:23:17
- Policy
- The gov's all-out efforts to promote EUA for overseas drugs
- by Lee, Jeong-Hwan Mar 28, 2022 06:10am
- The government will make all-out efforts to expand the total amount of supply by expanding the production and import of regular medicines such as antipyretic painkillers and cold medicines used to alleviate COVID-19 symptoms. It will even review the emergency introduction of foreign drugs with the same composition as domestic licensed items, quickly review them to prevent disruptions in production due to administrative procedures such as permits, and continue administrative support. The government expressed its willingness to make active efforts with the pharmaceutical industry to stabilize the supply of COVID-19, while also asking the medical and pharmaceutical sectors for cooperation such as prescribing an appropriate amount of solid drugs instead of syrup. Park Hyang, head of the Central Disaster and Safety Countermeasures Headquarters, made the announcement at a regular briefing on the 23rd. As a result of receiving a report from the MFDS on the supply and demand status and action plans for COVID-19, the Central Disaster and Safety Countermeasures Headquarters decided that supply needs to be stabilized. The shortage of some products of antipyretic pain relievers and cold medicines used to alleviate COVID-19 symptoms continues. Accordingly, the government will expand the total supply of COVID-19 medicines. Specifically, it expands production and imports and encourages rapid shipment. It will consider promoting the emergency introduction of overseas drugs with the same composition as domestic licensed products. The government plans to do its best to prevent disruptions in production by providing support for rapid processing such as changing the raw materials and manufacturing plants of standing medicines, quick import approval of drugs and raw materials contained in cold medicines, and convenience of other administrative procedures. It also asked the medical and pharmaceutical sectors to prescribe an appropriate amount of prescription and a solid drug rather than a syrup drug. The government announced its intention to maintain and strengthen support for clinical trials of COVID-19 vaccines and treatments. Currently, eight vaccine companies and 17 treatment companies (18 candidate substances) are conducting clinical trials in Korea. SK Bioscience vaccine has completed recruiting and inoculating phase 3 clinical participants with the aim of completing development in the first half of this year. Subsequently, the procedure for confirming the efficacy of the vaccine through sample analysis is in progress. The treatment is developing an additional antibody treatment (Celltrion) that can respond to mutant viruses, and Ildong Pharmaceutical is jointly conducting clinical trials by securing domestic copyright for Shionogi's developed and edible treatments. The government announced that it is supporting the development of domestic COVID-19 vaccines and treatments with all its might by operating the pan-government support committee for the development of COVID-19 treatments and vaccines. The government said, "For the rapid development of treatments and vaccines, clinical trials are more important than anything else," adding, "We ask the public to actively pay attention to and participate in clinical trials."
- Policy
- Kymriah's benefit standard has been established
- by Lee, Tak-Sun Mar 25, 2022 05:48am
- The worldChimeric antigen receptor-T cell therapy, which can be effective only once by using cancer patient T cells, is expected to be given to patients after receiving health insurance benefits for the first time in Korea from April. Novartis' Kymriah will enter the benefit range a year after being approved in Korea. The HIRA announced that it will conduct an inquiry on the "Amendment of Public Notice according to Drugs Prescribed and Prescribed to Cancer Patients" from the 24th to the 30th, including the establishment of Kymriah's standards. The amendment will take effect on April 1 unless there is a disagreement. In this amendment, standard was established to allow Kymriah to be administered to an adult (DLBCL) Diffuse Large B-cell Lympoma and B-cell acute lympneumonia (ALL), one of the non-Hodgkin lymphoma. Specifically, after two or more systemic treatments, it is newly established as a tertiary or more monotherapy for DLBCLs in adults who are recurrent or refractory. The recognition period is once in a lifetime per patient, and should be administered by a doctor with sufficient knowledge and experience in chemotherapy at medical institutions capable of responding to emergencies in preparation for unexpected side effects of CAR-T cell therapy. There was a condition that data on the status of medical care benefits should be submitted to the director of the HIRA. Accordingly, a form related to follow-up management should be submitted to the director of the HIRA at the time of administration of Kymriah, 6 months after administration, and 12 months after administration. It is also recognized if Kymriah is administered in post-transplantation recurrence or secondary recurrence and subsequent recurrence or refractory B-cell acute lymphatic leukemia (ALL) treatment in children and young adults under the age of 25. The administration stage should be secondary or tertiary or higher. It can also be administered under the direction of a medical institution suitable for treatment and an educated doctor, and the recognition period is once in a lifetime per patient. Kymriah is the world's first approved CAR-T treatment. CAR-T treatment is an immune cell therapy anticancer drug made by combining genetic information that expresses chimeric antigen receptors specific to cancer cells in patients' T cells. It is in the spotlight as a next-generation anticancer drug that can have a high effect with just one administration. However, insurance authorities have been agonizing over the difficulty of accessing patients due to high costs. Kymriah passed Drug Benefit Evaluation Committee of the HIRA in January and has been negotiating drug prices with the NHIS. Roche's Rozlytrek (Entrectinib), and Bayer's Vitrakvi (Larotrectinib Surfate) also included a new standard. Rozlytrek is newly established as a primary treatment for solid cancer in adults and children over 12 years of age with neurotic tyrosine receptor kinase (NTRK) gene fusion without known acquisition-resistant mutations. Vitrakvi is similar. However, there is no age limit for children. Non-Hodgkin lymphoma combination therapy (secondary or higher) of Rituximab+Revlimid and combination therapy of Bortezomib +Revlimid + Dexamethasone for newly diagnosed for multiple myeloma is newly established for multiple myeloma.
- Policy
- Yoon’s transition team prepares for digital platform govnt
- by Lee, Jeong-Hwan Mar 25, 2022 05:48am
- President-elect Suk-Yeol Yoon’s presidential transition committee announced a policy with the state-led public prescription system in mind. In the process of announcing the creation of a task force (TF) to bring the digital platform government into reality, the committee made a remark that it would be possible that the TF will establish a one-stop hospital treatment and prescription to pharmacy dispensing system. In the transition committee’s press conference that was held at Samcheong-dong, Seoul on the 23rd, the committee announced the creation of a Digital Platform task force (TF). The digital platform government was Yoon’s administration’s pledge to improve administrative efficiency by expanding cooperation between ministries as a state administration system that focuses on digital transformation, artificial intelligence (AI), and big data utilization. The committee’s goal is to ultimately reduce and simplify the steps in the administrative service through data integration by fully disclosing and linking public data owned by government ministries, in principle. The committee said that a site that allows a one-stop, paperless process from hospital treatment and prescription to dispensing in pharmacies needs to be prepared as one case of the digital platform government. This was a statement that can directly affect the establishment of the government-led public prescription system. The Korean Pharmaceutical Association had proposed the establishment of a public prescription issuance system to policy head Hee-Ryoung Won and the healthcare policy promotion director Jeong-Sook Seo during a policy roundtable that was held with Yoon’s policy coordination team last month. Il-Hee Won, senior deputy spokesperson of the transition committee, said, “the TF will consist of 10 members, with the Planning and Coordination Division holding the key and the Science and Technology Education Division and the Political Affairs and Judicial Administration Division working together with private ICT experts. The data is ultimately the public’s asset, therefore it needs to be given back to the people.” Deputy spokesperson Won added, “For example, you now need to receive treatment at a hospital and submit prescriptions to a pharmacy to receive medication. In order for this to become a paperless process, data must be shared, linked, and integrated. We are planning to establish a one-stop, one-site service so that these documents can be issued online." In addition, he said, “If the current government’s system ended at linking the ministries together, the digital platform government pursued by the new government will achieve integration of the ministries We will remove the barriers between ministries and open and release the data to the public, the rightful owners of the data.”
- Policy
- Corona tx Largevrio has been urgently approved
- by Lee, Hye-Kyung Mar 24, 2022 05:54am
- The MFDS (Director Kim Kang-rip) announced on the 23rd that it has decided on the EUA of Largevrio developed by Merck and imported by MSD Korea. Largevrio can be used in patients with severe liver and kidney disorders who are difficult to use injection-type treatments, and patients who cannot take Paxlovid, a conventional PO treatment, for taking certain ingredient drugs. Largevrio, which is inserted instead of RNA in the process of replicating the COVID-19 virus as an RNA-like substance, can be taken twice (every 12 hours) for five days, 800 mg (200 mg x 4 capsules) a day. It should be administered as soon as possible within five days after being diagnosed positive for COVID-19, and mild symptoms with a high risk of developing severe corona due to age and underlying diseases. It targets adult patients with moderate symptoms. Pregnant women or children and adolescents under the age of 18 are prohibited from taking them. On November 17 last year, the KDCA requested Lagevrio's EUA to the MFDS, and the MFDS decided after deliberation by the Public Health Crisis Response Medical Product Safety and Supply Committee. As a result of consultation with external experts (11 people) in various fields such as infectious medicine, toxicology, and virology, it was agreed that the need for emergency use approval of Lagevrio was recognized considering the results of non-clinical and clinical tests and the COVID-19 pandemic in Korea. Considering the results of reviewing animal test data and clinical test data, it was recommended to partially restrict the target patient group, such as not administering it to pregnant women and children and adolescents under the age of 18. The Public Health Crisis Response Medical Product Safety and Supply Committee also acknowledged the validity of emergency use approval by comprehensively considering expert advice, the increase in COVID-19 confirmed patients in Korea, access to treatment for patients who cannot use existing treatments, and medical staff's options. The MFDS will strengthen the collection of side effect information and additional safety use measures in the process of using Largevrio. It has established a system that allows domestic importers to actively collect and report domestic and foreign safety information, and allows medical experts and patients (family members) to report side effects over the phone or online.The government will continue to analyze and evaluate domestic and foreign safety information to promptly take necessary safety measures such as guidance, suspension of use, and recovery of serious side effects, and to evaluate causality and compensate for them. Side effects that occurred after using Lagevrio can be reported to drugsafe.or.kr, and side effects can be reported directly by phone (1644-6223) or related consultations can be made. It is a DUR used by medical experts for prescription and preparation that it cannot be used for pregnant women and children and adolescents under the age of 18, and plans to provide cautionary information on women, men and lactating women planning to get pregnant. In cooperation with the MOHW, the KDCA, and the Korean Pharmaceutical Association, guide patients (guardians) using Largevrio for safe use will be provided, and thoroughly managed not to be prescribed and administered to excluded patients, such as pregnant women and children and adolescents under 18.
- Policy
- Ahn to tap on “domestic production of Paxlovid generic”
- by Lee, Jeong-Hwan Mar 24, 2022 05:54am
- Transition Committee Chair Cheol-Soo Ahn (Source: National Assembly Picture Corp) President-elect Suk-Yeol Yoon’s transition committee is pursuing the manufacture of a generic version of the oral COVID-19 treatment, Paxlovid. The government plans to ask Pfizer whether it would be possible to produce generic copies of Paxlovid in exchange for royalties. At a press conference of the transition team that was held in Samcheong-dong Seoul on the 22nd, transition committee chair Cheol-Soo Ahn said, “Although it is unprecedented, there is a need to review the possibility of domestically manufacturing generic COVID-19 pills by making a deal with pharmaceutical companies for their patents in exchange for a royalty." Such a decision is interpreted as one of the changes that Chairman Ahn is preparing after criticizing the current government's COVID-19 measures as political and announcing policy reorganization for scientific quarantine at a meeting of the Special Committee for the Emergency Response to COVID-19 the day before (21st). Ahn said, “We are experiencing a severe shortage of Paxlovid and other oral COVID-19 treatments, and may completely run out of stock by April. So we need to do our best to secure oral pills to minimize those who die due to lack of treatments.” Ahn also announced his idea of conducting a public survey to investigate the rate of positive antibodies in the general public. Ahn said, “Although the confirmed cases amount to 300,000 cases a day, we estimate that the actual number of those infected is around twice that due to those who are unaware of their condition or uncounted for in the statistics. If we regularly investigate the positive rates among the general public, we can better grasp how much of the public was infected and is recovering, based on which we can establish a more accurate quarantine policy by age and region.” Regarding vaccinations and the vaccine pass system, Ahn believes it is appropriate to maintain the current measures as is, and that it is reasonable to allow people to decide upon themselves to receive vaccinations Ahn said, “although vaccinations are not mandatory even now, we all saw consensus on the fact that it should be left to the decision of individuals and parents. Some have also discussed the use of vaccine passes, but the passes have already been discontinued by the present administration, and we believe it is no longer necessary.” Meanwhile, Ahn presented 7 recommendations regarding the COVID-19 response to the government that included: ▲ Face-to-face treatment at local clinics ▲ Fast track treatment of high-risk confirmed patients ▲ Transparent disclosure of vaccine’s side effects and confirmed patient data ▲ Voluntary vaccination for 5-11 years old ▲ Procurement of oral COVID-19 treatments ▲ Extension of small business loans and deferment.
- Policy
- The price of Biktarvy will be lowered next month through PVA
- by Lee, Jeong-Hwan Mar 24, 2022 05:54am
- Gilead Science Korea's HIV treatment drug Biktarvy will be reduced by signing PVA negotiations. The price will be adjusted from 24,631 won to 23,900 won and the new drug price is expected to take effect from April 1. According to the industry on the 21st, the MOHW is pushing for a "revision of the drug benefit list and upper limit table" with such contents. The PVA adjustment item, Biktarvy, is a new drug registered as a drug negotiation, up more than 30% from the expected amount of drug negotiations, making it the subject of negotiations. The company and the NHIS will negotiate drug prices to agree on a reduction rate within up to 10% below the current upper limit. Biktarvy is leading the HIV treatment market with annual sales exceeding 10 trillion won last year. Biktarvy's price will be applied in April based on the results of PVA negotiations.
- Policy
- EUA of Lagevrio imminent…interest focused on its treatment
- by Lee, Jeong-Hwan Mar 23, 2022 05:51am
- Whether the US company Merck (MSD)’s oral COVID-19 treatment Lagevrio (molnupiravir) will settle in Korea as an alternative to Paxlovid (nirmatrelvir, ritonavir) is gaining attention. The company had applied for the emergency use authorization of molnupiravir to the Ministry of Food and Drug Safety in November last year but has not been granted EUA as of yet. On the reason for the delay, some had evaluated that the delay was due to the lower efficacy of Lagevrio, whose rate of preventing hospitalization and deaths is 30% as compared to the 88% demonstrated by Paxlovid. The MFDS had announced that it will decide upon Lagevrio’s EUA by 24th at the latest. However, as the disease control and prevention authorities had already announced that it will bring in 100,000 courses of Lagevrio within the week, the prevailing view is that Lagevrio will be granted EUA. Lagevrio is an RSA analog containing molnupiravir that induces virus deaths by being inserted in the place of the normal ribonucleic acid needed in the viral replication process. Four 200mg capsules (800mg) of Lagevrio are to be taken twice a day for 5 days, totaling up to 40 capsules. As for the period of administration, the drug is used in patients with mild symptoms of COVID-19, within 5 days of symptom onset. The FDA had announced in December last year that Lagevrio’s rate of preventing hospitalization and deaths was 30%. The drug is contraindicated in pregnant women, and some leukemia treatments are known to cause drug-drug interactions. In the current situation, whether Lagevrio can show practical effect in treating COVID-19 as a substitute to Paxlovid in the case of its shortage is gaining attention. The authorities believe that Lagevrio can be useful as Paxrovid, which is currently used in patients of all ages over 60, the immunocompromised, and those over 40 with underlying diseases, has many contraindications and is difficult to use in patients with impaired renal and liver function. Eun-Kyeong Jeong, the commissioner of the Korea Disease Control and Prevention Agency (KDCA), had said, “The National Infectious Disease clinical committee had discussed on the need to introduce Lagevrio in patients that are ineligible for Paxlovid. The WHO had also authorized limited use of Lagevrio in patients who cannot be prescribed Paxlovid.” Although Lagevrio’s prevention rate of hospitalization and deaths is at 73% that of Paxlovid,’ the need for its introduction has been growing due to the upsurge of new confirmed COVID-19 cases and the strict conditions required for Paxlovid’s administration. The need for an alternative to Paxlovid has been increasing with the rising demand for oral tablets due to the upsurge of new COVID-19 cases in the medical field. In particular, compared to Lagevrio, which is only contraindicated in pregnant women, and some leukemia treatments, the use of Paxlovid is much more restricted. Paxlovid in patients with severe renal, liver impairment, and not allowed for use with 23 medicinal products including hypertension drugs, analgesics, angina drugs, arrhythmia drugs, gout drugs, sedatives, anticancer drugs, anticonvulsants, and some antifungal drugs. The fact that one of the main ingredients of Paxlovid, ritonavir, has many contraindications and drug-drug interaction has affected the change in attitude towards Lagevrio. As a result, after the Ministry of Food and Drug Safety decides on the emergency use of Lagevrio, how the drug will be used is expected to be determined according to the trend of new COVID-19 patient development and the prescription and medication status of Paxrovid. Whether Lagevrio can broaden the range of options for patients who cannot take Paxlovid is also expected to affect the response of confirmed COVID-19 patients in the medical field. The government has already signed an advance purchase agreement for 242,000 courses of Lagevrio.
- Policy
- Rozlytrek & Vitrakvi are likely to be listed in April
- by Lee, Tak-Sun Mar 22, 2022 05:54am
- Bayer Korea's Vitrakvi and Roche Korea's Rozlytrek completed drug price negotiations and are likely to register their benefits in April. Both drugs are used to treat solid cancer in adults and children with confirmed NTRK gene fusion. If NTRK gene fusion is confirmed, it can be administered regardless of cancer. According to the industry on the 21st, the two drugs are likely to complete drug price negotiations with NHIS and register their benefits in April. Rozlytrek and Vitrakvi were granted permission in April 2020 and May 2020, respectively. Rozlytrek and Vitrakvi are equally used in adult and pediatric solid cancer treatments with neurotic tyrosine receptor kinase (NTRK) gene fusion. Rozlytrek also has a local progressive or metastatic non-small cell lung cancer indication that is positive for ROS1 in adults. Rozlytrek showed 56.9% ORR in a clinical trial (STARTRK-2) conducted in patients with solid cancer positive for the NTRK fusion gene. More than half of the subjects were confirmed to have decreased tumors. Vitrakvi also showed 75% ORR in clinical trials of 55 people whose NTRK gene fusion was confirmed. The two drugs passed the HIRA's Cancer Disease Review Committee in May last year and were reviewed by the Drug Benefit Assessment Committee in November of the same year. As a result of the deliberation, Vitrakvi recognized the appropriateness of the benefit, but in the case of Rozlytrek, the appropriateness was recognized if the conditions for an additional drug reduction and an appropriate refund rate were accepted. Vitrakvi was also recognized for adequacy, but there was also a clue that Rozlytrek's cost-effectiveness evaluation results need to be further considered. The two drugs with the same efficacy were simultaneously placed on the same line and the evaluation was conducted. Since then, the two drugs have been negotiated with NHIS. However, they failed to reach a conclusion within 60 days, the deadline for negotiations, and began additional negotiations. The NHIS posted on its website that negotiations on the two drugs have been completed. An industry official said, "As announced by NHIS, negotiations on the two drugs have been completed and we understand that they will be reimbursed in April." If the two drugs are reimbursed, it is expected that new treatment benefits will be given to cancer patients whose NTRK gene fusion has been confirmed.
- Policy
- Actemra is likely to be reimbursed for managing CRS
- by Kim, Jung-Ju Mar 21, 2022 05:55am
- Actemra (Tocilizumab 200mg), imported by JW Pharmaceutical and used to treat rheumatoid arthritis, is also expected to be paid for CRS management. The MOHW announced on the 18th some amendments to the "Details on the Application Criteria and Methods of Nursing Benefits" containing such contents. Actemra is a drug approved for adult rheumatoid arthritis treatment, systemic childhood idiopathic arthritis, and multi-articular childhood idiopathic arthritis. CRS develops symptoms due to excessive release of cytokines from immune cells in the process of killing cancer cells. The MOHW plans to recognize benefits when administering Actemra to CRS management. The government plans to conduct an industry opinion inquiry by the 27th with the aim of implementing it on the 1st of next month. Meanwhile, Actemra recently received EUA from the MFDS to be used for the treatment of severe COVID-19 patients over the age of 2. The drug is approved as a COVID-19 treatment in the United States, Japan, and Europe.
- Policy
- In/outpt Rx for Paxlovid are available in nursing hospitals
- by Lee, Jeong-Hwan Mar 21, 2022 05:55am
- Nursing hospitals will be able to prescribe outpatient & inpatient Rx for Paxlovid, a COVID-19 treatment. Both outpatient prescriptions that prepare and supply oral drugs at pharmacies in charge and inpatient prescriptions that receive oral drugs from hospitals dedicated to infectious diseases that supply treatments have become possible. The KDCA made the announcement at a regular briefing on the 17th. The KDCA judgment that group infections in nursing hospitals are continuing and timely administration of PO treatments for the elderly affected the permission of outpatient & inpatient prescriptions in nursing hospitals. Kim Ok-soo, head of the resource management team at the quarantine countermeasures headquarters, explained, "The nursing hospital originally tried to prescribe Paxlovid as outpatient Rx, but there was a shortage of supplies at pharmacies in charge of cities, counties and districts. Team leader Kim Ok-soo added, "The nursing hospital has improved the system since the 14th so that inpatient and outpatient Rxs can be made in a timely manner," adding, "It is a new application." Since the 14th, KDCA has taken measures to prescribe Paxlovid, a treatment to be taken when training rapid antigen tests, for those aged 60 or older, and it is necessary to secure the amount of treatment. According to the KDCA, Paxlovid for 163,000 people was supplied to Korea as of the 16th, and the inventory was 96,000 people. In addition, it is scheduled to be introduced in Korea at the end of March. The KDCA said, "We will promote the prevention of seriousness and the burden of the medical system through active administration to the elderly," adding, "We will ensure that timely administration of treatments can be made."
