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- 2025-12-23 16:23:27
- Policy
- Pfizer aims to commercialize PF-07321332 by the end of 2021
- by Lee, Tak-Sun Aug 03, 2021 08:09pm
- On the 29th, the MFDS approved 3 multi-national clinical plans for "PF-07321332," a candidate for COVID-19 oral treatment applied by Pfizer. The first clinical trial was the oral administration of PF-07321332 to prevent postmortem infections in adults who had contact with people with COVID-19, and the validity and safety of Ritonavir's two methods. The total number of test subjects is 2,634 and 22 people will be recruited in Korea. The test is conducted at Chilgok Kyungbuk National University Hospital. The second clinical trial assesses the mediated validity and safety of oral administration PF-07321332/Ritonavir in comparison to placebo in non-admission-bearing adult participants with severe cases and low risk of progression. The total number of test subjects is 800, and the number of subjects in Korea is 14. The test will be conducted at Busan National University Hospital, Seoul Medical Center, Boramae Hospital, Chonnam National University Hospital and Chilgok Gyeongbuk National University Hospital. The third clinical trial assesses the mediated validity and safety of oral administration PF-07321332/Ritonavir compared to placebo in non-admission-bearing adult participants with severe cases and high risk of progressive coronavirus. The total number of test subjects is 2,260, and the number of domestic recruitment subjects is 62. It is carried out in the same institution as clinicians earlier. Pfizer launched a clinical trial of PF-07321332 in the United States in March. It aims to release a treatment at the end of the year after going through a large-scale clinical trial. Ritonavir, administered in conjunction with PF-07321332, is the original of the antiviral drug Norvir of AbbVie in Korea.
- Policy
- Peramivir has earned its generic exclusivity
- by Lee, Tak-Sun Aug 02, 2021 08:41pm
- JW Life Science is the first known Peramivir drug to win a generic for exclusivity. It is known to have been applied by JW Life Science's premium technology. Premix preparation is an injection that does not need to be diluted with saline water and is convenient to use. However, GC Pharma and Chong Kun Dang were also allowed to impose premix sanctions in May, signaling competition. The MFDS approved JW Life Sciences' Fluenpera on Wednesday. It is a premix formulation that does not require dilution, and can be used once. In particular, JW Life Science's premix technology is applied, and it is a multi-layered film plastic container filling injection. Peramivir is a single intravenous treatment for the flu. Oseltamivir (Tamiflu) preparation requires for five days PO. Peramivir premix was approved first by GC Pharma and Chong Kun Dang. In May, the two companies introduced the first Peramivir premix formulation, with Peramiflu Premix Inj and Peraonce Inj, respectively. Both products are produced in Chong Kun Dang. JW's "Fluenpera" is different in appearance, indication and doses from products licensed by GC Pharma and Chong Kun Dang. Therefore, JW has acquired generic for exclusivity this time, but it does not affect the sales of products of GC Pharma and Chong Kun Dang because it is not the same formulations. It will take effect from yesterday (28th) to April 28th next year. It also reflected the cited invalidation of the JW Life Science's claim to Peramiflu's patent on the original product.
- Policy
- Reimbursement criteria for Cosentyx and Taltz inj. expanded
- by Kim, Jung-Ju Aug 02, 2021 06:06am
- Secukinumab injections such as Novartis Korea’s Cosentyx injection and Ixekizumab injections such as Lilly Korea’s Taltz prefilled syringe injection will be covered as first-line biologics for active and progressive psoriatic arthritis refractory to DMARDs. Also, the monitoring cycle of liver and electrolyte levels in patients for orally administrated Tolvaptan spray-dried powder, such as by Otsuka Korea Pharmaceutical's Samsca Tablet 15mg, will be changed to match the indication. On the 30th, the Ministry of Health and Welfare revised and issued the details regarding the criteria and methods for applying pharmaceutical benefits that contained the abovementioned changes. The revision is effective from August 1st. ◆Cosentyx and Taltz PFS Inj. etc.= ◆ The insurance benefit criteria for secukinumab injections such as Cosentyx injection and Ixekizumab injections such as Lilly Korea's Taltz prefilled syringe injection will be expanded. The Health Insurance Review and Assessment Service has decided to expand the reimbursement of first-line biologics to DMARD refractory active and progressive psoriatic arthritis after reviewing domestic and foreign indications, textbooks, clinical treatment guidelines, clinical research papers, related academic opinions and etc. Also, reflecting the experts' opinions and the precautions in the use of biologics issued for the risk of tuberculosis infection, the phrase to test for latent tuberculosis was added like for the TNF-α inhibitor. In addition, the phrase directing three-time administration of the injections was deleted. Specifically, the reimbursement criteria now stipulate that patients eligible for administration are those who saw insufficient treatment effect with two or more types of DMARDs for over 6 months (3 months or more for each) or patients with active and progressive psoriatic arthritis who discontinued treatment due to side effects of the abovementioned drugs. Also, the conditions in the revised details specifically state that the patient should have 3 or more joints with tenderness and 3 or more joints with edema, and that the results should be from two consecutive examinations taken at a 1-month interval. In the evaluation method, the phrase to administer the drug '3 times’ has been deleted from the '3 times in 6 months' condition. In addition, a new criterion has been newly added, stating that the 'Guidelines for treating latent tuberculosis when using TNF-α inhibitor' should be followed when using such drugs. ◆Samsca Tablet = The monitoring cycle of liver and electrolyte levels in patients with autosomal dominant polycystic kidney disease (ADPKD) for orally-administrated tolvaptan such as Otsuka Pharmaceutical Korea's Samsca Tablet 15mg, will be changed to match the drug's indications. Looking at the changes in the detailed approval criteria, values such as AST, which were to be measured before the first administration and 'once a month' after administration, were changed 'to be examined before the first administration and every month for the first 18 months and once every three months thereafter during administration.' In addition, the criteria for blood test results that were limited by 'monthly' results when filing claims for reimbursement, was changed to 'according to monitoring' results to match the indications.
- Policy
- Teva's new migraine drug Fremanezumab is released in Korea
- by Lee, Tak-Sun Jul 30, 2021 05:47am
- Teva's new migraine treatment drug Fremanezumab is released in Korea. It was approved by the U.S. Food and Drug Administration (FDA) in May 2018 in the calcitonin gene-released peptide (CGRP) family. The MFDS approved two items of Handok Teva's migraine prevention drug Ajovy on Wednesday. Two formulations of Ajovy Prefilled Syringe and Ajovy Auto Injector have been approved. These drugs can be used to prevent migraines in adults, and subcutaneous injections can be made every 1 month or 3 months. It is a CGRP-based antibody treatment drug such as Emgality which was approved by the MFDS in September 2019. Clinical trials of Fremanezumab was conducted to confirm the effect of reducing the average number of migraine days per month compared to placebo. There have been beta-blockers and antidepressants for migraine treatments. However, the medical community has been looking forward to customized new drugs due to different treatment choices and severe adverse reactions depending on the patient's characteristics. CGRP-based new drugs are emerging as expected drugs to meet this unfulfilled demand. The first product approved in Korea is Lilly's Emgality (Galcanezumab). Emgality was released in December 2019. It costs about ₩500,000 to ₩700,000 per dose. The medical community says Emgality should be reimbursed. In addition to Fremanezumab, Amgen's Aimovig is also aiming for a domestic release. Competition is expected to be fierce if CGRP-based treatments are paid.
- Policy
- MSD's Sinemet products have been withdrawn
- by Lee, Tak-Sun Jul 29, 2021 05:52am
- All three items of MSD's Sinemet (Carvidopa-Levodopa) were withdrawn as of Monday. Accordingly, the same active ingredient containing product in Korea is Perkin by Myungin. It is analyzed that Sinemet has lost its competitiveness since the launch of Stalevo (Carvidopa, Entacapone, Levodopa). The MFDS dropped Sinemet CR, Sinemet 25/100 and Sinemet as of Thursday. Sinemet is a best-selling Parkinson's disease treatment approved in 1995. Since the launch of Stalevo, Sinemet's copyright has been changed and discontinued. In 2013, Sandoz Korea brought domestic copyright, and in 2019, it reported to the MFDS that it had been out of stock for a long time. As a result, sales of outpatient prescriptions based on UBIST last year remained at ₩10 million, combining Sinemet and Sinemet CR. Perkin by Myungin, unlike Sinemet, recorded ₩3.6 billion in outpatient prescription last year. Perkin's sales are expected to continue in the future as Sinemet withdrew completely from the domestic market with the cancellation. The market for Parkinson's disease treatment in Korea is about ₩50 billion. However, it is expected that new drugs such as Ongentis (Opicapone) and Equifina (Safinamide Mesilate) have recently been released in the domestic market.
- Policy
- Regulations are required on GMP violations
- by Lee, Jeong-Hwan Jul 28, 2021 05:54am
- The National Assembly is discussing legislation with health authorities on health insurance finances for the recovery of drug benefits from pharmaceutical companies, which filed a lawsuit to cancel the disposal of drug price cuts for fraudulent purposes. It is also discussing ways to enhance stability of quality of domestic manufactured medicines by supporting and strengthening GMP regulations. The National Assembly, the MOHW, and the MFDS are discussing the proposed revision of the Health Insurance Act and the Pharmaceutical Affairs Act. As the National Assembly recently completed the review of the supplementary budget bill and agreed to form a legislative body including the chairman of the Legislation and Judiciary Committee, it is expected that the bill will begin in earnest next month. The two bills are expected to have a significant impact on drug benefits and drug manufacturing and production sectors in the domestic pharmaceutical industry. Kwon Deok-chul, Minister of Health and Welfare, also acknowledged the need for a bill to recover reimbursed drug benefits from pharmaceutical companies that filed administrative lawsuits to delay or disable the government's drug price reduction and suspension. When a pharmaceutical company deliberately filed an administrative lawsuit to avoid the government's legitimate drug reduction, it will impose the right to plan for the recovery of drug benefits and penalties. There is a possibility that the government will compensate for the damage caused by pharmaceutical companies when they finally won the government's drug price lawsuit and the drug price reduction has been proven unfair. Choline alfoscerate, which was confirmed to reduce the benefit due to some of its indications last year, is still showing a large amount of prescription in 2020, with a prescription amount of ₩42,574,1.53 million. Choline alfoscerate recorded more than ₩200 billion in prescriptions in the first half of this year. Nam In-soon, a memver of the Democratic Party of Korea, criticizes, "Even though the benefit reduction by adaptation has been confirmed, pharmaceutical companies are wasting hundreds of billions of won a year in health insurance finances." The bill is expected to have the effect of preventing a recurrence of such controversy through legislation. The purpose of legislation for GMP support and regulation of domestic pharmaceutical manufacturers is to prevent GMP serial violations. It plans to significantly increase the level of punishment for pharmaceutical companies that violate GMP and cancel GMP certification or item permission for pharmaceutical companies that violate GMP regulations even once by introducing the so-called "one strike out" system. In addition to the GMP legislation, which focuses solely on strengthening punishment of pharmaceutical companies, the government is also preparing legislation to prevent violations of GMP by strengthening the authority of the chief manufacturer. The current law neglects the situation of violating GMP even though it is aware of the illegal fact because the authority of drug manufacturers such as director of Pharmaceutical Manufacturing is relatively unclear or weak. Attention is focusing on what kind of legislation the National Assembly and regulatory authorities will finally come up with to support and regulate domestic pharmaceutical GMPs An official of the National Assembly's Health and Welfare Committee said, "The bill to prevent drug cuts has formed a consensus between the welfare committee members and the MOHW." "The two bills will be discussed in earnest when pending issues such as the second supplementary review are dealt with," he added.
- Policy
- The weighted average price may vary when charging Xarelto
- by Lee, Hye-Kyung Jul 28, 2021 05:54am
- When pharmacies claim Bayer Korea's Xarelto, they need to reconfirm the purchase price. This is because the weighted average price may change due to changes in drug prices due to lawsuits such as suspension of the execution of notification on drug price cuts. In particular, if a pharmacy claims a drug price change without checking it, it needs to be careful because it can be disposed of as a claim mismatch through "regular confirmation of the purchase price" in the future. The HIRA conducted a "Guidance on Xarelto's Suspension Claims" on Sunday. Following the Seoul High Court's decision to suspend the execution of the revised Xarelto (2.5/10/15/20 mg), the MOHW suspended the notice as of July 2. The existing upper limit price was reduced by 30% from June 8 to July 1, but returned on July 2, causing a change in the price of medicine. Since it is a period that is reflected in the calculation of the purchase price of medical treatment in August and October of this year, the medical institutions should check once more when they claim it. The purchase price will be calculated based on the "quarterly weighted average price" divided by the total purchase amount of the drug purchased quarterly. It will be the purchase price for the treatment that lasted from the beginning of the second month of next quarter to the third month. If Xarelto is charged from August 1 to October 31, the weighted average price will be the average of the purchase price in the second quarter of this year. It is accurate if checking the medical expenses claim → medication management → pre-weighted average price → weighted average price by medication on the website of the medical institution's task portal. The history of the purchase can be managed by registering the purchase details of the drug in → claim for medical treatment → medication management → purchase medicine calculation management in the pharmacy's task portal screen.
- 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.
