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- 2025-12-19 23:49:31
- Policy
- Reimb for Paxlovid still pending amid COVID-19 resurgence
- by Lee, Tak-Sun Aug 12, 2024 05:55am
- Product photo of Paxlovid. As the COVID-19 treatment supply becomes an ongoing issue amid a virus resurgence, clinical practices are frustrated by delayed reimbursement coverage of 'Paxlovid (nirmatrelvir‧ritonavir, Pfizer Korea).' The drug reimbursement application for Paxlovid was submitted to the Health Insurance Review and Assessment Service (HIRA) in early October of last year. After that, HIRA has yet to finish the evaluation. On August 8th, Paxlovid was not considered for HIRA's Drug Reimbursement Evaluation Committee (DREC) review. Initially, Pfizer aimed to acquire reimbursement for Paxlovid for the first half of the year, but it has yet to be considered for the DREC review 10 months after submission. During this period, Pfizer submitted response letters to HIRA six times. The company recently requested HIRA an extended response letter due date. While the reimbursement for Paxlovid is being delayed, the Korean Disease Control and Prevention Agency (KDCPA) discontinued the free-of-charge program in May. Now, patients are required to pay KRW 50,000, which is approximately 5% of the drug price, for the drug. However, it is still provided free of charge for medical reimbursement benefit recipients and those eligible for co-payment reduction due to having the second-lowest income. When the drug became available for co-payment, some clinical practices prescribed Paxlovid to adult patients under different conditions. The basis for Paxlovid approval in South Korea is its efficacy and effectiveness in treating adults with mild to moderate symptoms who are at a high risk of developing severe COVID-19, including hospitalization and death. As a result, prescribing it to adults with mild symptoms still meets the efficacy and effectiveness criteria. However, when the government provided Paxlovid free of charge, it was only used for patients who were senior-aged and had severe symptoms. It seems that when the drug became available for co-payment, clinical practices mistakenly thought it had reimbursement criteria and prescribed it as approved. Recently, the Korea Disease Control and Prevention Agency (KDCPA) officially requested that clinical practices prescribe oral COVID-19 medicines, including Paxlovid, only to high-risk patients who show symptoms. Those who can be prescribed are patients over 60 years old and 12 years old (Paxlovid) or 18 years old and older (Lagevrio) who are immune compromised or with underlying diseases. Additionally, it must prescribed within 5 days of showing symptoms and for patients not needing oxygen therapy. The KDCPA said, "There are no changes to who can be prescribed COVID-19 medicines before or after issuing co-payment in May." They explained, "It can only be prescribed in clinical practices designated for COVID-19 medicines prescription." To prevent such confusion, some have pointed out the necessity of prescription criteria through reimbursement coverage, as well as agreements with pharmaceutical companies for the efficient supply of drugs. A HIRA official said, "Paxlovid will be internally evaluated soon and considered for the DREC review."
- Policy
- 4th PVA negotiations complete for Prolia
- by Lee, Tak-Sun Aug 08, 2024 09:25am
- The government completed price-volume agreement (PVA) negotiations for Prolia Prefilled Syringe (denosumab), the leading product in the domestic osteoporosis treatment market, with Amgen Korea. Whether the drug’s price will be adjusted for the 4th time under the PVA is gaining attention. According to industry sources on the 4th, Amgen Korea and the National Health Insurance Service recently agreed on PVA negotiation terms for Prolia. The current upper insurance price for Prolia is KRW 156,100. Prolia is a biological drug that targets the RANKL protein, which forms osteoclasts that destroy the bone. The drug is co-marketed by Amgen Korea and Chong Kun Dang in Korea. Ever since the drug was granted reimbursement in October 2017, the drug immediately dominated the domestic osteoporosis drug market. In April 2019, the drug was granted extended reimbursement, covering its use as a first-line therapy, which rapidly increased its use. According to IQVIA, Prolia’s domestic sales in Q1 amounted to KRW 41.2 billion, ranking second among all drugs. With sales rising steadily, the company inevitably had to negotiate Prolia’s price under the price-volume agreement system. Prolia's price has already been adjusted 3 times through negotiations. The first was a "Type A" negotiation in December 2020, which resulted in a 6.5% reduction. Type A negotiations are applied when the drug’s expected use amount increases by over 30%. The second was a "Type B" negotiation that was applied in August 2022. Type B negotiations are applied when the expected use amount increased by 60% or more compared to the previous year or increased by 10% or more but the total amount exceeds KRW 5 billion. The third was also a ‘Type B’ negotiation, which resulted in a 3.7% price cut in Prolia’s insurance price ceiling in August last year. If the drug price is adjusted this time, it will be the 4th PVA price reduction. In May, Prolia's insurance price ceiling was lowered from KRW 162,600 to KRW 156,100 due to the reimbursement extension. Prior to the reimbursement extension, patients with a bone mineral density measurement of -2.5 (T-score) or less were eligible for 1 year of benefits, but after the reimbursement extension, patients with a T-score of -2.0 or less and to -.2.5 are eligible for up to 2 years of reimbursement.
- Policy
- Topiramate XR generics may be released soon
- by Lee, Tak-Sun Aug 08, 2024 09:24am
- 국내 유일 토피라메이트 서방캡슐 Generic companies have applied for approval of new follow-on drugs of 'Qudexy XR Cap,’ an extended-release topiramate formulation used for epilepsy, to the Ministry of Food and Drug Safety. The follow-on drugs that applied for approval this time are film-coated tablet formulations rather than capsule formulations, and whether the generic companies will be able to avoid Qudexy’s patent with the changed formulation is gaining attention. According to industry sources on the 5th, 2 products with the same ingredient (topiramate) as 'Qudexy XR Cap have recently applied for approval to the MFDS. The MFDS notified the original company upon the generic companies’ application because the original company has a patent (extended-release topiramate capsules) registered on the list in accordance with the approval-patent linkage system. Generic companies have also applied for approval of their Qudexy XR Cap generics in December last year and in May this year. The industry is looking at Introbiopharma as the likely developer of a follow-on Qudexy XR Cap. This is because Introbiopharma conducted a bioequivalence test for its Topimed XR tablet (tentative name) with Qudexy XR Cap as a control drug. Qudexy XR Cap, which is supplied by SK Chemicals in Korea, is the first extended-release topiramate formulation in Korea. While the existing immediate-release topiramate formulation is taken twice a day, the extended-release formulation is absorbed slowly into the body and can be taken once a day, improving the patients’ convenience in administration. The drug was developed by the U.S. pharmaceutical company Upsher-Smith Laboratories and approved by the FDA in 2014. In Korea, it was approved by the Ministry of Food and Drug Safety in August 2017. Qudexy XR Cap is indicated to treat epilepsy ▲as monotherapy for the treatment of partial-onset seizures with or without secondary generalized seizures in children and adults 6 years of age and older; ▲partial-onset seizures, primary generalized tonic-clonic/convulsive seizures, and seizures associated with Lennox-Gastaut Syndrome with or without secondary generalized seizures in children and adults 2 years of age and older that are not adequately controlled by existing first-line antiepileptic drugs. The drug had been granted reimbursement since February 2018. Last year, outpatient prescriptions amounted to KRW 3.5 billion based on UBIST. As a single item, its sales are not very high. However, topiramate-based formulations account for KRW 30 billion of the KRW 80 billion antiepileptic drug market and are the most prescribed ingredient. This is why analysts saw high potential for the XR formulation. This explains the rapid move among generic companies to develop extended-release formulations. The patent for Qudexy XR Cap, which is registered on the MFDS Green List, is expected to last until January 2034. The patent covers the extended-release topiramate capsule. As the generic companies applied for film-coated topiramate tablet formulations, it is analyzed that the generics will likely be released to the market apart from the registered patent. "The patent currently registered for Qudexy XR Cap protects the capsule form, but the follow-on extended-release formulations the generic companies applied for are film-coated tablet formulations, so companies will likely be able to avoid the patent," said a pharmaceutical industry insider. "It seems that the generic companies have adopted a patent avoidance strategy to quickly develop their respective products.”
- Policy
- Price-Volume Agreement negotiations to be finalized soon
- by Lee, Tak-Sun Aug 08, 2024 09:24am
- The ‘Type C’ price-volume agreement (PVA) negotiations are expected to be completed next week. When the negotiations are complete, the insurance price ceiling of the subject items is expected to be adjusted from September after passing the Health Insurance Policy Review Committee review this month. According to the industry sources on the 6th, negotiations for the PVA ‘Type C’ items started in July and are expected to be finalized next week. The negotiations involved 60 product groups that contain identical ingredients. The Type C negotiation is conducted for drugs that do not fall under 'Type A' or 'Type B', which are negotiated upon listing, and whose claims for the same product group from the 4th year of listing have increased by more than 60% from the claims of the previous year, or by more than 10% but exceeds KRW 50 billion. Most Type C drugs are generic drugs that have received a set price upon listing. The National Health Insurance Service conducts Type C negotiations every year with the goal of adjusting the insurance price ceiling of subject drugs by September of the same year. During this year's negotiations, in particular, the pharmaceutical companies enjoyed increased options due to the amendment made to the details of the operating standards. For example, drugs whose usage has temporarily increased due to inevitable reasons such as the COVID-19 pandemic can choose to refund part of their claims instead of lowering the price. In the first round of negotiations that were given the option, several companies reportedly opted for the refund option. In addition, innovative pharmaceutical companies or companies with an R&D ratio of 10% or more, which have been subject to PVA negotiations 3 times within 5 years, will be eligible for a 30% less price reduction than the amount calculated via the reference formula rate in its third time. Although small, there are reportedly a small number of companies that have agreed to negotiate their price using this option. The pharmaceutical industry had previously expressed concerns to the government on how drugs that have completed bioequivalence tests for the price ceiling reevaluations may be subject to larger price cuts during PVA negotiations. The logic is that the price difference between a drug that has maintained its price through bioequivalence testing and the weighted average price of the same-ingredient drug becomes larger than the weighted average price of drugs with the same ingredient, resulting in a larger price reduction during PVA negotiations. In response, the pharmaceutical industry requested price adjustments for drugs that underwent bioequivalence tests for a prior reevaluation, considering how the companies have followed government policy. In response, the NHIS is said to have partially accepted the industry's opinion and reflected it qualitatively during negotiations. As a result, it is observed that all the negotiations will be completed within the deadline this year. "We understand that the negotiations will be completed by next week," said an industry official, "and the results will be announced after being reported to the HIPDC this month."
- Policy
- Approval of abortion drugs at a halt in KOR
- by Lee, Jeong-Hwan Jul 31, 2024 05:52am
- The Ministry of Food and Drug Safety has gained attention for stating that the Criminal Code and the Mother and Child Health Act must be amended before the approval of abortion drugs in Korea. The process of gaining marketing authorization for abortion drugs that the pharmaceutical companies applied for has been at a halt for 4 years, as follow-up legislation has not been enacted since the constitutionality of abortion was ruled unconstitutional. On the 29th, the Ministry of Food and Drug Safety responded so to a point raised by Representative Sun-min Kim of the National Assembly's Health and Welfare Committee regarding the domestic approval of abortion drugs. Kim raised the need for expedited approval of abortion drugs, questioning why the abortion drug has not yet been approved despite repeated applications submitted in 2021 and 2023. Hyundai Pharm applied for the marketing authorization of Mifegymiso in 2021 after signing an exclusive marketing and distribution agreement for its supply in Korea with the UK-based Linepharma International. However, the company voluntarily withdrew its application upon the MFDS’s data supplement request. The company then reapplied for the license last year (2023) and received another data supplementation request. Mifegymiso is a combination pack that contains 1 200mg mifepristone tablet and 4 misoprostol 200ug tablets. The drug inhibits the action of progesterone, the progestational hormone that sustains pregnancy, while misoprostol works to contract the uterus. It is only indicated for use in the first trimester of pregnancy, up to 9 weeks, and is typically prescribed as one tablet of mifepristone followed by 4 tablets of misoprostol 36-49 hours later. The MFDS’s position is that the Criminal Code and the Mother and Child Health Act must be amended before Mifegymiso, which the company has reapplied for approval, can be approved in Korea. The logic is that the abortion period should be established first so that a risk management plan can be submitted for the approval of abortion drugs like Mifegymiso. "Currently, there are permit data that can only be submitted after the amendment of the Criminal Code and the Mother and Child Health Act, which is why the review process has been temporarily suspended upon mutual recognition of the applicant and the MFDS,” said an MFDS official. "If the relevant laws are amended and the applicant submits data accordingly, we plan to resume the review without delay and decide whether to approve or reject the application.” Meanwhile, when the amendments will be made to the Criminal Code and Mother and Child Health Act remains unclear. In April 2019, the Constitutional Court ruled the criminal offense of abortion (termination of pregnancy) unconstitutional, citing respect for women's right to bodily self-determination. As of January 1, 2021, abortion was effectively legalized. The Constitutional Court ordered the National Assembly to come up with alternative legislation to reflect the decision, but 4 years have passed without such legislation being enacted. In the 21st National Assembly, 7 bills to abolish the abortion law were introduced, including amendments to the Criminal Code and the Mother and Child Health Act, but were never properly discussed until the end of the 21st NA period.
- Policy
- GSK receives administrative disposition in KOR
- by Lee, Hye-Kyung Jul 30, 2024 05:51am
- The global pharmaceutical company GlaxoSmithKline (GSK) has received administrative dispositions for failing to report changes to the specifications of the main ingredient of its active pharmaceutical ingredient and for issues relating to the drug containers. The Ministry of Food and Drug Safety recently imposed a fine of KRW 52.2 million in substitution of the 15-day suspension on the sale of ‘Duac Gel 5%,’ a 6-month import suspension on ‘Flixoteide Junior Evohaler 50 micrograms,’ and a 6-month import suspension on ‘Seretide 100-250-500 Diskus.’ Duac Gel is a gel-type mild-to-moderate treatment for acne that contains clindamycin phosphate and benzoyl peroxide. It is prescribed as an alternative that can alleviate concerns about the development of resistance that may arise from the use of antibiotics. However, an investigation by the MFDS found that the direct containers of the drug were imported and sold with the lot numbers and expiration dates switched with each other. As a result, the MFDS announced it will suspend the sales of Duac Gel 5% from August 1. Also, 1 item, which was suspended for six months, and 3 items, for which the company decided to pay fines instead of the suspension, were found to have failed to report changes in the specifications of the active pharmaceutical ingredient in the drug substance. The company will pay a fine of KRW 52.2 million for 3 items - Seretide 100 Diskus, Seretide 250 Diskus, and Seretide 500 Diskus - imposed in place of the 6-month suspension. Sales of Flixoteide Junior Evohaler 50 micrograms, a preventive treatment for asthma, are suspended for 6 months from August 1 to January 31, 2025.
- Policy
- Daewoong secures generic Xigduo through a transfer
- by Lee, Tak-Sun Jul 29, 2024 05:48am
- Daewoong Pharmaceutical has secured a generic version of the diabetes treatment Xigduo XR Tab (metformin hydrochloride/dapagliflozin propanediol hydrate) through a transfer and acquisition deal. The drug will be covered by reimbursement and introduced to the market in August. With the addition of generic Xigduo XR Tab, Daewoong Pharmaceutical now completes the product lineup, as its generic Forxiga 10 mg (dapagliflozin propanediol hydrate) is listed for reimbursement this month. According to industry sources on July 26th, Daewoong Pharmaceutical's Forxilomet XR Tab 10/1000mg, Forxilomet XR Tab 10/500mg, and Forxilomet XR Tab 5/500mg will be listed for reimbursement starting in August. These products' upper-limit prices are KRW 435, KRW 402, and KRW 342, respectively. Daewoong Pharmaceutical acquired these products already on the reimbursement listing through a transfer and acquisition deal. Daewoong Pharmaceutical acquired products from Jinyang Pharm and Huons. As a result, these products are manufactured by different contract manufacturing organization (CMO) sites. Kukje Pharm manufactures Forxilomet XR Tab 5/500mg and Forxilomet XR Tab 10/500mg, and Samik Pharmaceutical manufactures Forxilomet XR Tab 10/1000mg. Dongkoo Bio&Pharma manufactures Daewoong Pharmaceutical's monotherapy Forxilo tab 5mg and 10mg. Most pharmaceutical companies have listed their products immediately after the substance patent expiration on April 7th last year, but Daewoong Pharmaceutical was unable to do so. At the time, Daewoong was in a joint-sales agreement with the original company, AstraZeneca, to sell Forxiga and Xigduo. From 2018 to the end of last year, Daewoong Pharmaceutical was jointly selling Forxiga and Xigduo. As Forxiga is set to discontinue sales in South Korea, it was canceled for approval and deleted from the reimbursement listing. HK inno.N has been jointly selling Xigduo with AstraZeneca under a joint sales agreement since January. The ceiling price of Xigduo has been reduced by mandate since July 20th, after the introduction of generics. It was reduced after a year and three months after the generic entry. Although delayed, the price of Xigduo was reduced after AstraZeneca withdrew from filing a suit to cancel the mandatory reduction. Following a price reduction, sales reduction is inevitable. Therefore, AstraZeneca and HK inno.N as a team will likely put more effort into marketing. As a result, they are expected to compete fiercely against Daewoong Pharmaceutical. Although Boryung and Hanmi Pharm are now leading the generic market for dapagliflozin, Daewoong Pharmaceutical's entry will likely intensify competition among companies vying for the top spot. Companies aiming to dominate the market, including HK inno.N, which gained Forxiga's indication, are set to begin.
- Policy
- P3T for new insomnia drug will be conducted in KOR
- by Lee, Hye-Kyung Jul 29, 2024 05:47am
- New drug candidate for insomnia The Swiss biotechnology company Idorsia will conduct a Phase III clinical trial in Korea for ACT-541468 (daridorexant), its new drug candidate for insomnia. The Ministry of Food and Drug Safety (MFDS) approved Nxera Pharma Korea's application for a "multicenter, randomized, double-blind, placebo-controlled, parallel-group, Phase III clinical trial to evaluate the efficacy and safety of ACT-541468 (daridorexant) in adults and older adults with insomnia disorders” on the 26th. Daridorexant was previously approved by the U.S. FDA on January 10, 2022, and the European Commission on May 3, 2022, for the treatment of adult patients with insomnia who have difficulty initiating and maintaining sleep. In the second half of 2022 alone, the company reported sales of approximately KRW 100 billion in the U.S. and Europe. The FDA approval was based on an extensive clinical program involving 1,854 adult insomnia patients across 18 countries worldwide. Unlike existing therapies, daridorexant treats insomnia by blocking the binding of orexin, which promotes wakefulness, thereby inhibiting excessive wakefulness. This reduces the inconvenience of daytime sleepiness in daily life. Insomnia is a prevalent condition that affects up to 10% of all adults worldwide. It is defined as a symptom of hyperarousal that is characterized by dissatisfaction with sleep and its negative impact on daytime functioning. A person is classified as having insomnia if he or she is dissatisfied with their sleep and experiences difficulty falling asleep or staying asleep at night at least 3 times per week for at least 3 months. Daridorexant induces sleep by reducing arousal without altering the rate of sleep cycles. The recommended dose consists of a 50 mg tablet taken orally within 30 minutes before bedtime in the evening. However, in certain cases, such as patients with moderate hepatic impairment or those taking CYP3A4 inhibitors, a 25 mg dose may be recommended.
- Policy
- KDCA "Will secure budget for domestic mRNA vaccine dev."
- by Lee, Jeong-Hwan Jul 26, 2024 05:47am
- The Korea Disease Control and Prevention Agency (KDCA) plans to secure national budget for developing domestic mRNA vaccines. The Korea Disease Control and Prevention Agency (KDCA) announced that they will focus on securing national budget to develop Korea-made mRNA vaccines and secure platforms, supporting up to phase 3 trials. Its vision is to secure domestic mRNA technology based on Japan's case. Japan designated companies that could develop domestic vaccines during the COVID-19 pandemic from 2020 to 2023 and invested KRW 930 billion in the entire process from the beginning of the development, clinical trials, and production. The KDCA has submitted this plan to the Health and Welfare Committee of the National Assembly on July 24th. The KDCA explained that they set a government-wide policy to develop mRNA vaccines and secure platforms. They are in the process of allocating the relevant budget. They also planned this project to allocate a sufficient budget by continuing to communicate with fields, including experts, conferences with companies, and interviews. In particular, the KDCA emphasized that they prioritize securing a multi-KRW 100 billion budget so that they could support up to phase 3 trials by referencing Japan's domestic mRNA vaccine development case. The agency aims to support companies by acquiring budgets based on Japan's KRW 930 billion investment in the development. Additionally, they stated that they are continuing to hold meetings with the Ministry of the Interior and Safety to set up a support team for mRNA vaccine development. Furthermore, they stated that discussions and communications, including conferences with companies and interviews, to establish a system for technology collaboration. The KDCA said, "We will work to secure a sufficient budget with an aim to complete mRNA vaccine development." They added, "As the budget allocation is in progress and the project details are being discussed, we will quickly organize a supporting team within the second half of the year." "When the project takes off, we will officially organize an operating committee with public-private experts and company officials," the KDCA added. "It will allow companies to share their difficulties in their field. We will also supply various technology support packages for vaccine development to research agencies such as the National Institute of Infectious Diseases."
- Policy
- Will Rinvoq’s pediatric indication be expanded in KOR?
- by Lee, Hye-Kyung Jul 26, 2024 05:47am
- AbbVie Korea will conduct a clinical trial in Korea to expand the indication of its atopic dermatitis drug Rinvoq (upadacitinib) to children aged 2 to 12 years old. On the 24th, the Ministry of Food and Drug Safety (MFDS) approved AbbVie’s application to initiate a Phase III, open-label, blinded trial (START UP) to compare the safety and efficacy of Dupixent (dupilumab) vs RInvoq in children aged 2 to 12 years with moderate-to-severe atopic dermatitis. The trial will be conducted at Gangnam Sacred Heart Hospital, Chung-Ang University Hospital, Konkuk University Medical Center, Korea University Ansan Hospital, Soonchunhyang University Hospital Bucheon, and Seoul National University Hospital. RInvoq can currently be administered once a day to adolescents aged 12 to 17 years weighing 40 kilograms or more. The MFDS-approved label does not recommended for adolescents under 40 kilograms because it has not been studied in the patient population. Other JAK inhibitors used for atopic patients include Eli Lilly’s ‘Olumiant (baricitinib)’ and Pfizer’s ‘Cibinqo (abrocitinib).’ While both are reimbursed for adult patients, only Rinvoq and Cibinqo (for patients 12 years of age and older) and Dupixent (for patients 6 years of age and older) have been available for pediatric and adolescent patients since April of last year. Starting next month, Dupixent will also be reimbursed for infants and children with severe atopic dermatitis aged 6 months and older. In particular, Dupixent is the only pediatric atopic dermatitis treatment that confirmed symptom control and a consistent safety profile in infants, children, and adolescents with moderate-to-severe atopic dermatitis aged 6 months and older through a Phase III clinical study. If the company can generate significant clinical data in children and adolescents aged 2 to 12 years through the new trial, this will allow pediatric atopic dermatitis patients to have broader treatment options. The dosing regimen differs for the two drugs. While Rinvoq is an extended-release tablet that can be taken orally once a day, Dupixent is a subcutaneous injection that is injected into the fatty layer under the skin. Meanwhile, Korean companies are also intent on developing atopic dermatitis drugs in Korea. LG Chem changed the indication o itsf LC510255, a new drug candidate for autoimmune diseases, to atopic dermatitis in the second phase of domestic clinical trials. JW Pharmaceuticals transferred the technology of its atopic drug candidate JW1601 to LEO Pharma in Denmark, but the contract was terminated after the candidate failed to meet the primary endpoint in the initial results of the global Phase IIa/b clinical trial.
