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- 2025-12-24 12:42:40
- Policy
- Moderna vaccine by Samsung Biologics is supplied worldwide
- by Kim, Jung-Ju Jul 27, 2021 05:36am
- Prime Minister Kim Bu-gyeom briefly mentioned in a radio media interview today (the 26th) when Samsung Biologics' moderna COVID vaccine will be released, and quarantine authorities said that hundreds of millions of doses of Samsung Biologics products will be supplied to the world except the U.S. next year. The KDCA made the announcement in a regular "COVID-19 briefing" this afternoon. Earlier, Prime Minister Kim Bu-gyeom appeared on radio media and said, "I know that Samsung BioLogics' Moderna vaccine will be released in late August or early September." Regarding the production schedule, the KDCA said, "We understand that Samsung Biologics is doing its best to produce this year, and will supply hundreds of millions of Doses to the world except for the U.S. by next year."
- Policy
- When will Phase 3 trials of K-COVID-19 vaccines begin?
- by Lee, Tak-Sun Jul 27, 2021 05:35am
- Development of domestic COVID-19 vaccines has come to a standstill before entering the final stages - the phase 3 trials. Cellid, which had shown the fastest progress in development, is planning to reenter phase 1 trials with an improved version of its vaccine. Due to such changes, the industry has a negative outlook on the commercialization of domestic vaccines by the first half of next year. According to the Ministry of Food and Drug Safety on the 26th, there are currently 10 candidate COVID-19 vaccines in clinical trials in Korea. The Phase 1 clinical trial for HK Inno.N’s recombinant vaccine, ‘IN-B009,’ was approved on the 22nd to increase the count to ten. 5 are recombinant vaccines, 3 are DNA vaccines, 1 is a viral vector-based vaccine, and 1 is an RNA vaccine. 자료제공 : 식약처The only viral vector-based vaccine, Cellid’s 'AdCLD-CoV19,’ was approved for a new Phase 1 clinical trial on the 23rd. The trial will evaluate the candidate vaccine’s safety and immunogenicity on 40 healthy adults. Cellid’s candidate vaccine is no different from the vaccine that was approved for a clinical trial in December last year. However, the vaccine’s production yield was improved to allow mass production. Cellid plans to proceed with Phase 3 trials for its improved vaccine candidate immediately after completing the Phase 1 trial, as a Phase 2 trial for its previous vaccine candidate is already in progress. Clinical trials can be divided into 3 parts: Phase 1 trial that assesses the safety of a drug, Phase 2 that determines the dosage, and Phase 3 trial to confirm the drug’s effectiveness in a large number of patients. However, no domestic COVID-19 vaccines have been verified for their efficacy yet. Many trials have been approved since SK Bioscience received approval for the first clinical in November last year, but all are still in their early stages. However, SK Bioscience had submitted a Phase 3 clinical trial protocol for its recombinant vaccine ‘GBP510’ last month and is awaiting MFDS approval. The vaccine received support from the Bill and Melinda Gates Foundation and CEPI. SK Bioscience plans to start its Phase 3 trial for its candidate vaccine as early as August. The MFDS has approved companies to conduct Phare 3 trials in comparison with previously authorized vaccines to reduce the burden of the large-scale Phase 3 trials. As a result, the trial is expected to assess the candidate vaccine’s efficacy and immunogenicity using currently marketed vaccines as comparators such as Pfizer, Moderna, AZ, and Janssen vaccines in around 3,000 healthy adults. However still, as a Phase 3 trial takes a long time from participant recruitment to analysis, there are growing concerns about whether Korea will be able to produce a domestic vaccine soon. Even if the candidate vaccines enter Phase 3 trials in the second half of this year and completes it successfully, experts believe that it will be difficult to commercialize the vaccine in the first half of next year.
- Policy
- Onivyde listed at ₩672,320 as RSA refund type
- by Kim, Jung-Ju Jul 26, 2021 05:50am
- Servier Korea’s 'Onivyde injection(irinotecan liposome),’ which is used in second-line or higher treatment of pancreatic cancer, will be available with insurance benefits at ₩672,320 per vial starting next month. The Ministry of Health and Welfare announced today(23rd) that the Health Insurance Policy Deliberative Committee deliberated and passed the ‘amendment to the drug benefit list and the maximum ceiling price table’ containing the amendment mentioned above. The drug was approved by the Ministry of Food and Drug Safety as a ‘second-line treatment for metastatic pancreatic cancer,’ on August 29th, 2017. In the same year, the company applied for its reimbursement to HIRA, on October 31st. Although HIRA had held a Review Committee for Cancer Disease meeting to review its reimbursement on January 24th, 2018, the company withdrew its application in June, putting a stop to all discussions. On July 24th, 2020, the company reapplied for the insurance benefit listing. On April 8th of this year, HIRA held a Review Committee for Cancer Disease meeting and ruled that the drug is appropriate for reimbursement. At the time, the committee recognized that the clinical practice guidelines then had recommended Onivyde in combination with fluorouracil and leucovorin for patients whose disease had progressed after first-line cancer therapy and that Onivyde had an improved clinical benefit compared to the control group in clinical studies. Academic societies had also suggested compared to existing second-line treatments for pancreatic cancer that lacked evidence on their clinical usefulness, Onivyde had demonstrated its benefit through clinical studies and is being recommended as a preferred option in clinical practice guidelines for pancreatic cancer. Afterward, the government ordered pricing negotiations to NHIS, and the NHIS made negotiations with the company from April 23rd to June 21st. Among the A7 countries, the drug is currently listed in four countries - Japan, Germany, the United Kingdom, and the United States, and the A7 adjusted average price of Onivyde is ₩1,562,643. Based on the price, the company and the NHIS had drug negotiations with the company to reimburse Onivyde as a refund type under the RSA scheme. The refund type is a type of RSA agreement where the company refunds a certain proportion of the claimed drug cost. In consideration of the fiscal impact and the foreign drug price, the NHIS and the company agreed to set Onivyde’s price at ₩672,320 per vial starting next month. Through the reimbursement, approximately ₩12.1 billion of NHI finances is expected to be spent on Onivyde. Additional finances spent due to the nonavailability of an alternative drug are estimated to be approximately ₩9.6 billion.
- Policy
- New PBAC members to make big reimbursmeent decisions in 2H
- by Lee, Hye-Kyung Jul 26, 2021 05:50am
- From September, new members of the Drug Reimbursement Evaluation Committee (DREC) of the Health Insurance Review and Assessment Service will be conducting evaluations on the adequacy of pharmaceutical reimbursements. PBAC members that will start committee activity from the second half of this year, will carry out major deliberations and tasks from whether the ultra-high-priced new drug ' Kymriah' is eligible for reimbursement to the coverage expansion of 'Keytruda' that has recently passed the Review Committee for Cancer Disease deliberations. HIRA received recommendations from relevant organizations to pool around 100 experts from relevant fields for the committee until the 23rd of last month. The 8th PBAC members are appointed among a double pool of candidates who are recommended from relevant organizations, who undergo qualification review. The number of recommendations requested by HIRA requested to relevant organizations was 192, including 112 from the Korean Academy of Medical Sciences (4 or more per society, 28 societies); 18 from The Pharmaceutical Society of Korea (6 or more per society, 3 societies); 10 from medical and pharmaceutical associations (6 or more per society, 3 societies); and 24 from civic and consumer groups (2 or more per group, 12 groups). Among the recommendations, HIRA will select 96 members in consideration of each member's professionalism, diversity, and connectivity to agendas. ▲Those performing pharmacoeconomic evaluation-related services for pharmaceutical companies; ▲executives, private practitioners, or private pharmacists in the recommended medical and pharmaceutical organizations; ▲those who are judged unfit to perform fair work during pre-diagnosis of work ethics ▲those subject to administrative disposition or punishment under the Medical Service Act, Pharmaceutical Affairs Act, National Health Insurance Act or Medical Care Assistance Act within the last 5 years; ▲ those who have served as a member of the PBAC for two or more consecutive terms, were excluded from recommendations. In the case of ‘two or more consecutive term’ standard' that was prepared to limit long-term appointment and duplicate appointments, reappointment is possible for members who have served as an advisory member or who are in specialized fields in consideration of their unique circumstances In case of data submitted for PE evaluations. the characteristics of each drug and disease are difficult to regularize or standardize due to various assumptions, methodologies, and models involved. To address this, appointment standards have been slightly relaxed to ensure continuous participation of certain committee members, which is necessary for maintaining consistency in PBAC review. The 8th PBAC will consist of 102 members. In addition to the 96 recommended members, HIRA plans to add one member from the Ministry of Health and Welfare, one from the Ministry of Food and Drug Safety, the Department head of the HIRA Pharmaceutical Benefit Department, and 3 panels from the Healthcare Review and Assessment Committee to compose the 8th PBAC. The PBAC meetings will be held by 3 fixed members from MoHW, MDFS, and HIRA, and 17 other members (19 for agendas related to oriental medicine) from the 120 members.
- Policy
- Controversy over the manufacturing location of QTP104
- by Lee, Tak-Sun Jul 26, 2021 05:50am
- The location of COVID vaccine, which was approved for phase 1 of clinical trial by South Korea's bio-venture Quratis on the 19th, is controversial. Quratis vaccine is the first of its kind in South Korea, similar to Pfizer and Moderna. However, the MFDS says the vaccine is an overseas development product and discriminates against other domestic development products. On the 20th, the MFDS approved Phase 1 clinical trial plan for QTP104. The clinical trial will be conducted for 36 people at Gangnam Severance Hospital, which is aimed at increasing capacity, multiplying institutions, disclosing and phase 1 of clinical trials to evaluate the safety of vaccines to prevent COVID-19 among healthy adults. QTP104 is a self-replicating mRNA-based vaccine, which is known to produce more antigen proteins by inserting replication genes involved in self-explosion, unlike conventional mRNA vaccines. QTP104 is the first RNA vaccine in Korea. The COVID-19 vaccine, which is currently undergoing clinical trials in Korea, is a DNA vaccine from Genexine and Geneone, a virus vector vaccine from Cellid, and a recombinant vaccine from SK Bioscience and EuBiologics. The RNA vaccine was first developed by Curatis. The MFDS also marked Quratis' vaccine as a domestic development shortly after clinical approval. However, since QTP104's original developer is a foreign company, it has changed to foreign development. There was no press release that was distributing approval of vaccine for domestic development. According to the clinical trial approval information, the original developer of QTP104 is HDT Bio Corp in the U.S. But, HDT Bio also failed to commercialize the vaccine. Quratis explains that QTP104 is a development vaccine in Korea. A company official said, "Vaccines are manufactured at the Osong plant, and it is a vaccine developed in Korea. We also asked the MFDS to change it to domestic development." However, the MFDS said, "No data related to domestic manufacturing have been submitted, and nothing has been officially applied for domestic development." There is also a new drug developed in Korea by bringing substances from overseas. K-CAB (Tegoprazan), which was approved as Korea's new drug No. 30, is also said to have been introduced from Japan. However, it is called a new drug developed in Korea because CJ Healthcare conducted a clinical trial for commercialization. QTP104 can be said to be a new domestic development drug if Quratis gets permission first in Korea and has never been commercialized overseas. The standards for overseas development are also unclear. Until now, overseas development products are known to refer to multinational clinical trials by global pharmaceutical companies that are conducted not only in Korea but also in other foreign countries. However, it is questionable whether the QTP104 will be considered multinational clinical even if partner companies are receiving clinical approval from the U.S. and India and product development is underway. This is because individual companies are conducting clinical trials in each country. Quratis is a company that participates in the "Vaccine Business Council" led by the MOHW, and is also supported by the government. Therefore, even if Quratis vaccine is commercialized later, controversy over whether it is a domestic or overseas vaccine is expected to continue.
- Policy
- Tamsulosin and Donepezil insurance cuts were most objected
- by Lee, Hye-Kyung Jul 23, 2021 05:57am
- It was found that most amount of objections were filed for examination fees and outpatient prescription drugs after the Health and Insurance Review Service's adjustments such as cutbacks on items that do not meet the review criteria for insurance benefits. HIRA had recently held a ‘2021 Briefing session on filing objections’ for medical care institutions. In the session, HIRA introduced cases of 1st adjustments after review that received the most amount of objections. By each treatment category, objections filed for examination fees accounted for 23%, followed by outpatient prescription drugs 20%, emergency aid and operation fees 17%, and injection fees 12%. Among outpatient prescription drugs, adjustment on the oral tablets ‘Tamsulosin’ and ‘Donepezil,’ and the denosumab injection received the most objections. Results of objections filed for adjustment made showed that Tamsulosin was being applied insurance benefit for its indication, ‘dysuria from benign prostatic hypertrophy,’ and for the off-label use in neurogenic bladder. However, in many cases, adjustments were made for unconfirmed benign prostatic hypertrophy or bladder disease diagnosis. When the medical institution files an objection regarding the adjustment, the institution needs to attach a medical record that shows proof of diagnosis related to benign prostatic hypertrophy. Cases of adjustments made to the denosumab injection showed that cuts were made due to unconfirmed osteoporosis disease, unconfirmed BMD test results, and an excessive number of follow-up tests results, among others. Applicable medical institutions need to confirm the eligible subjects and period of administration as specified in the notification, and when filing an objection, medical records that can confirm osteoporosis, period and frequency of administration, etc. or radiation reading sheets, bone density test results that can confirm osteoporotic fractures need to be attached to the objection. Most adjustments were made for Donepezil oral tablets due to unconfirmed Alzheimer-type dementia diagnosis, unconfirmed test results including CDR, MMSE, and errors in description format. To avoid insurance cuts, medical institutions need to check the subject eligible for administration, evaluation method and enter the dementia test results under the specific classification code ZT007 as specified in the instructions on how to write up the claim for benefits. In filling out the Donepezil claim form, the test results should be listed in the order of MMSE, CDR, and GDS, then the test dates should be listed. When filing an objection, the diagnosis and test results that can confirm Alzheimer’s must be attached. Meanwhile, HIRA has been operating inspection services including the pre-inspection service that allows for inspection, modification, and remedies before submitting the claim and a claims error service that allows for corrections and supplements to be made within 2 days after filing the claim. Medical institutions may check for errors identified before claiming benefits through the pre-inspection service to prevent adjustment of medical expenses, minimize supplementary claims, and prevent filing objections.
- Policy
- Moderna vaccine shows 94% prevention in overseas trial
- by Kim, Jung-Ju Jul 23, 2021 05:57am
- Moderna’s COVID-19 vaccine was found to be 94.1% effective in preventing COVID-19. The results were analyzed and presented by the disease prevention and control authorities based on the results of the observation made on 420,000 people who receive their first vaccination in Canada. In Korea, 290,000 doses of the Moderna vaccine were introduced on the 22nd. The COVID-19 Vaccination Response Team (Head: Eun Kyeong Jeong) explained the vaccine’s prevention effect as workers in hospital-level medical institutions were administered the Moderna vaccine from June to July, and people in their 50s will be receiving the Moderna vaccine from the 26th. ◆Effect of vaccination = Results from a Phase III clinical trial on 30,420 people showed that the Moderna vaccine was 94.1% effective. In its effect against preventing variants that were conducted on 421,073 people in Canada who received their first dose of the Moderna vaccine, the vaccine had an 83% effect on the Alpha variant, 77% effect on the Beta/Gamma variant, and 72% effect on the Delta variant. In addition, the vaccine’s effectiveness in preventing hospitalization and deaths after the first dose, the vaccine had a 79% effect on the Alpha variant, 89% effect on the Beta/Gamma variant, and 96% effect on the Delta variant 로나19 모더나 백신 변이주에 대한 백신효능. The authorities also provided guidelines on how to respond to adverse reactions for a safe vaccination with the Moderna vaccine. People who are vaccinated should stay at the institution for 15 to 30 minutes after vaccine administration to be observed for adverse reactions and should be closely monitored for over 3 hours even after returning home. The vaccinated person should be observed with special attention for at least 3 days after vaccination, and people with a high fever or abnormal physical symptoms must immediately seek medical attention. In particular, the Vaccination Response Team added that people who are suspected of symptoms of myocarditis or pericarditis after vaccination, and people with facial fillers who show facial swelling should seek immediate medical attention, and requested the institutions to report the adverse reactions. ◆Vaccine introduction status and plan = On the 22nd, the KDCA announced that a total of 24.92 million doses of COVID-19 vaccines, including the 290,000 doses of the Moderna vaccine that were introduced to Korea. In addition, approximately 31 million doses will be additionally introduced until late August, and the detailed schedule for each vaccine will be provided to the extent allowed as soon as the discussions are finalized with the relevant pharmaceutical companies. Meanwhile, the COVID-19 Vaccination Response Team said 77.2% (5,847,769) of the subjects eligible for vaccination completed their reservations as of midnight on the 22nd. 83.2 % of the subjects aged 55 to 59, and 72.3% of the subjects aged 50 to 54 completed their vaccine reservations.
- Policy
- Onivyde reimb. to be expanded to 2nd-line pancreatic cancer
- by Lee, Hye-Kyung Jul 22, 2021 05:53am
- From next month, Servier Korea’s 'Onivyde (irinotecan liposome injection)' will be available with insurance benefits for use in second-line or higher treatment of pancreatic cancer. However, patients eligible for the insurance benefit are limited to patients with an ECOG(European Cooperative Oncology Group) of 0 to 1. The Health Insurance Review and Assessment Service recently disclosed the 'Revision of notice according to medicines prescribed or administered to cancer patients' that contain the changes mentioned above and is reviewing opinions until the 26th. If no objections are made, the agenda will be deliberated and passed by the Ministry of Health and Welfare's Health Insurance Policy Deliberative Committee this week and applied reimbursement from the 1st of next month. Onivyde was first approved in August 2017 'in combination with fluorouracil and leucovorin, for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy.' HIRA's review of the drug for reimbursement showed that Onivyde was recommended as Category 1 in the NCCN guidelines and as 'II, B' in ESMO guidelines for the second-line treatment of metastatic pancreatic cancer in patients who were previously treated with gemcitabine-based therapy. Its efficacy in second-line treatment was verified through the open-label, randomized Phase III NAPOLI-1 study conducted on patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) over the age of 18. In the study, Onivyde demonstrated its clinical efficacy over the '5-FU + Leucovorin' combination. In relation to the policy to 'cover non-benefits for items that exceed the scope of coverage,' which is being implemented as part of the coverage enhancement policy, the benefit for G-CSF injections will also be expanded. The 'Neulasta prefilled syringe inj.', 'Neulapeg prefilled syringe inj.'Dulastin prefilled syringe inj.'', and 'Longquex' prefilled syringe inj.' were only be applied insurance benefit for cancer patients over the age of 19 years that belong to certain cancer types and in combination with anticancer therapies specified in the benefit standards. For coverage enhancement, the authorities reviewed whether to expand the benefit standards to the scope currently being paid in full by the patient as an out-of-pocket cost. As a result, the benefit was expanded to hyper CVAD, R-hyper CVAD, and ifosfamide + etoposide + mitoxantrone therapy in non-Hodgkin lymphoma that was confirmed to 'have an over 20% risk of neutropenic fever', as well as to Hyper CVAD therapy in acute lymphoblastic leukemia with an over 20% risk of neutropenic fever, in consideration of the risk of neutropenic fever found in clinical studies. The 'Neulapeg prefilled syringe inj.'Dulastin prefilled syringe inj.'', and 'Longquex' prefilled syringe inj' were not approved for acute lymphoblastic leukemia, however, G-CSF injections that prevent neutropenia are applied the same expansion of benefit as there is no clear difference in their effect in each cancer type.
- Policy
- The administration monitoring cycle of Samsca is changed
- by Kim, Jung-Ju Jul 22, 2021 05:53am
- The administration monitoring cycle of Samsca (Tolvaptan) is changed in more detail. Psoriasis arthritis treatment Ixekizumab, which have been used as secondary drugs, and Secukinumab such as Cosentyx will be expanded to primary biological treatments. The MOHW announced on the 20th a partial revision of the "Details on the Standards and Methods of Medical Benefits," which is based on this information, and began to inquire opinions by the 27th. The new drug standards will be applied as of August 1. ◆Samsca, a treatment for upper chromosomal polycystic kidney disease, changes the monitoring cycle for administration by reflecting the permission. The MOHW and the HIRA decided to change the monitoring cycle of ADPKD patients and electrolyte levels in consideration of domestic and foreign permits, textbooks, clinical care guidelines, and related academic opinions. Specifically, monitoring, which was conducted once a month before and after the initial administration of this drug, is changed to monthly for the first 18 months before and after the initial administration, and every three months after that. ◆Cosentyx and Taltz Prefilled Syringe = Taltz Prefilled Syringe and Cosentyx, which can be used as secondary treatment drugs for psoriasis arthritis, are expanded to primary biological treatments and cautions regarding the risk of tuberculosis infection of biological agents are specified. These drugs will be expanded to the DMARDs non-compliance activities and primary biological sanctions by referring to domestic and foreign permits, textbooks, clinical care guidelines, clinical research documents, and related academic opinions. It was added to implement the late tuberculosis test in the same way as the TNF- in inhibitor, reflecting precautions for use and expert opinions regarding the risk of tuberculosis infection in biological agents. Based on the conditions under administration, the benefits can be applied if two or more types of DMARDs have been treated for more than six months (each three months), or if they meet the conditions as active and progressive arthritis patients who have discontinued treatment due to side effects of drugs. There shall be at least three compressed joints and at least three edema joints, and shall be the result of two consecutive measurements at intervals of one month. The treatment guidelines for late tuberculosis should be followed when using the TNF- in inhibitor. The MOHW plans to inquire about the revision by the 27th and implement it as of August 1st if there is nothing special.
- Policy
- GSK & SK Bio also stopped supplying TD vaccines
- by Lee, Tak-Sun Jul 21, 2021 05:51am
- Greencross TD Vaccine Prefilled Syringe InjSK Bioscience will also withdraw its products from the TD vaccine market that prevents diphtheria and tetanus in adults. GSK, which had been importing and supplying TD vaccines last year, also stopped supplying them in the Korean market. As a result, GC Pharma, which is manufacturing domestic drugs, is expected to strengthen its position in the TD vaccine market. According to the MFDS on the 16th, SK Bioscience said it will stop importing SK Td Vaccine, which it is supplying, after the 18th of next month. It said, "As the company that was supplying the undiluted solution stopped supplying the finished product, the company also stopped supplying the finished product." Sk Td Vacine is known to have imported the undiluted solution from GSK in Germany and made it into a finished product in Korea. Last year, GSK announced that Novartis will stop supplying TD vaccines in the process of integrating and maintaining production lines for business efficiency after acquiring the vaccine business unit. Therefore, it is observed that this effect may have been caused by the discontinuation of Sk Td Vacine. The adult TD vaccines now available in Korea are GC Pharma's "Greencross TD Vacine Prefilled Syringe Inj" and Accesspharm's "diTeBooster SSI". GC Pharma's position is expected to be strengthened as GSK and SK Bioscience have stopped supplying TD vaccines. GC Pharma succeeded in domesticizing the TD vaccine in 2016 and contributed to reducing its dependence on imports. The product developed by GC Pharma has been commercialized for the first time in six years since 2010 with consulting support from the MFDFS. At the time, the MFDS said that the localization of the TD vaccine is expected to replace the import of 450,000 people every year. In terms of sales by IQVIA last year, Greencross TD Vacine Prefilled Syringe Inj was about ￦1.4 billion in sales. SK Td Vacine's sales were only about ￦900 million. GSK's products were discontinued, reaching only about ￦300 million, and Accesspharm's products also reached ￦300 million. Accesspharm is said to be imported from SSI in Denmark as complete products. The only domestic product is Greencross TD Vacine Prefilled Syringe Inj. An official from the pharmaceutical industry said, "As a result of the localization of TDI vaccines for adults, we can respond to the suspension of supply of imported products." "It seems that there will be little impact on the market because there is domestic product even when SK Bioscience products are not imported."
