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- 2025-12-24 12:41:36
- Policy
- Will changes be made to Hemlibra’s reimbursement standards?
- by Lee, Jeong-Hwan Aug 04, 2021 06:01am
- As the Anti-Corruption & Civil Rights Commission (ACRC) in addition to the National Assembly raised the need to ease the reimbursement standards for the hemophilia treatment Hemlibra (emicizumab), the growing sense of urgency on the Ministry of Health and Welfare (MOHW) and the Health Insurance Review and Assessment Service (HIRA)’s behalf to take follow-up actions is expected to increase. The NA and ACRC requested the standards be changed so that pediatric patients under the age of 12 can use the subcutaneous injection Hemlibra immediately without prior use of the intravenous drug treatment ‘immune tolerance induction (ITI) therapies. Sun-Woo Kang of the Democratic Party of Korea had first criticized the inappropriateness of Hemlibra’s reimbursement standards in June, then the ACRC had also made recommendations to the MOHW to change the reimbursement standards. The NA member pointed out that the existing reimbursement standards that acknowledge reimbursement of Hemlibra in pediatric patients aged under 12 only after they fail intravenous injections that accompany great pain should be changed. The ACRC also decided that it was harsh to recognize insurance benefits for Hemlibra only after the pediatric patients that have weak blood vessels undergo ITI therapy that require intravenous injections for 2-3 years. The NA and ACRC’s move was influenced by the appeals made by guardians of pediatric patients with hemophilia that were posted on the National Petition board of Cheong Wa Dae. A total of 4 requests to change the reimbursement standards of Hemlibra had been posted on the national petition board from November 2019 to date. 2019 was when JW Pharmaceutical had received marketing authorization for Hemlibra. JW Pharmaceutical received approval for Hemlibra from the Ministry of Food and Drug Safety on January 20th, 2019. In the earlier petitions, the request was focused on approving reimbursement for Hemlibra, but from last year, the content of the petitions changed to request modification or ease of reimbursement standards for patients aged less than 12 years. Recently, the caregivers of patients (parents) had requested MOHW and HIRA to delete the mandatory ITI therapy prerequisite for Hemlibra’s reimbursement in pediatric patients aged 1 to 12 years old. They criticized that the current reimbursement standards violate human rights by forcing pediatric patients to receive intravenous injections even though Hemlibra, a subcutaneous injection option, is available. Upon receiving such criticism, the MOHW and HIRA are making a move to improve the reimbursement standards. HIRA had held an expert advisory meeting on the efficient operation of ITI therapies for hemophilia A, and the MOHW is planning to amend the reimbursement standards for pediatric patients based on HIRA’s discussion results. In particular, the need to improve the standards grew with the NA strongly criticizing Hemlibra’s reimbursement standards as “standards that approve reimbursements based on the pain and suffering of our children.” Also, the fact that other countries do not limit reimbursement of Hemlibra by age raises the validity on the need for the health authorities to improve the benefit standards. The U.K .approves reimbursement of Hemlibra when the patient satisfies any one of the following conditions: those who fail ITI therapy, or cannot control bleeding, or administers the drug as maintenance therapy or bleeding therapy with bypassing agents, or as maintenance therapy to prevent bleeding symptoms during ITI therapy. In response to the continued criticism from the NA, ACRC, and caregivers of pediatric patients, the MOHW and HIRA are expected to present a bill to revise the benefit standards in the near future. On Sun-Woo Kang’s criticism, the Minister of Health and Welfare Kwon Deok-Cheol said that he would “comprehensively review the issue with experts and discuss how to improve the reimbursement standard of Hemlibra in consideration of the characteristics of pediatric patients.”
- Policy
- Daewoong has added a line-up of osteoporosis treatments PO
- by Lee, Tak-Sun Aug 03, 2021 08:27pm
- Daewoong's Evimax 45mg was approved on July 29. It is generic for Raloxifene HCl 45mg. The original for Raloxifene HCl is Evista from Alvogen Korea. Evista contains Raloxifene HCl 60 mg. Raloxifene HCl 45mg was first developed by Yuhan. In September 2019, Yuhan was granted 'Raboni 45mg', a product containing Raloxifene HCl 45mg. The company explains that safety has been increased by lowering the content of Raloxifene HCl by improving its bioavailability. Daewoong's approved product is also manufactured and supplied by Yuhan. In June, Daewoong was previously granted "Evimax D," a combination of Raloxifene HCl 45mg and a concentrated vitamin D powder. This is also an item produced by Yuhan. As a result, Daewoong will have three Raloxifene preparations, including Daewoong Raloxifene HCl 60mg, which was approved in March last year. Daewoong has been selling Daewoong Zoledronic Acid as a treatment for osteoporosis and Ricen Plus as an oral medicine. The performance is not bad either. Based on IQVIA last year, Daewoong Zoledronic Acid recorded ₩11.2 billion and Ricen Plus, which is a combination of Risedronic acid and Cholesterol, recorded ₩1.5 billion. In terms of sales, oral products are less competitive than injection products. For this reason, Daewoong needed the latest treatment for oral osteoporosis. It is believed that the company introduced Raloxifene HCl 45mg developed by its competitor Yuhan first. In the past, Daewoong sold original osteoporosis drugs such as Fosamax Plus D and had the largest share in the oral market. However, due to the termination of the contract for MSD's Fosamax, it suffered from losing its main items. Zoldronic Acid, which had little sales at the time, was successful by co-promoting with Sandoz. Since then, the Zoldronic Acid injection has been manufactured by Daewoong by purchasing copyrights. Considering Daewoong's business competitiveness in the osteoporosis treatment market, the introduction of Raloxifene HCl 45mg is also likely to be successful. Attention is focusing on how much sales Daewoong will make in the osteoporosis treatment oral market through the launch of a new product.
- Policy
- The number one treatment for mild COVID is Kaletra
- by Kim, Jung-Ju Aug 03, 2021 08:24pm
- The number one drug used to treat mild COVID in the first half of this year was AbbVie's Kaletra, which amounted to ₩596 million. The total amount of drugs spent on the entire treatment, including severe cases, amounted to ₩12.1 billion. Among the data on "COVID-19 Treatment Expenditure in the first half of the year," the "Status of Drug Administration by severe cases" showed this. According to the current status, the amount of drugs used to treat COVID-19 in the first half of this year amounted to ₩12.1 billion, or 2.5% of the total medical expenses. AbbVie's Kaletra (₩596 million) is the number 1 based on drug costs . Then, Chong Kun Dang's Tazoperan 4.5g , ₩107 million, Samsung's Combicin 3g, ₩98 million, Ukchemipharm's Trison Kit 2g is ₩88 million, Boryung's Maxipim 1g is ₩83 million, SK Chemical's Huthan 50mg is ₩72 million, Bayer Korea Avelox 400mg, ₩68 million, and Yuhan's Meropen 0.5g, ₩65 million. Following oxygen, cost of AbbVie's Kaletra is the most at ₩128 million, Yuhan's Meropen 0.5g, ₩112 million, Chong Kun Dang's Tazoperan 4.5g, ₩99 million, Maxipim 1g, ₩72 million, Huthan, ₩51 million, Avelox 400mg, ₩47 million, and Clexane, ₩45 million, Vfend 200mg, ₩4400 million. Excluding oxygen, Fresofol 2% of Fresenius Kabi Korea was the most used, followed by Meropen 0.5g of Yuhan with ₩238 million and Huthan 50 with ₩1.9 million. Greencross Human Serum Album 20%, ₩173 million, Human Serum Album 20%. ₩127 million, Vfend 200mg, ₩120 million, Boxter's Phoxilium Phosphate Solution 1.2 mmol/L, ₩85 million, and JW Life Science's Winuf, ₩83 million, respectively.
- 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.
