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- 2025-12-22 17:52:46
- Policy
- nAMD & DME tx Vabysmo is about to be approved in Korea
- by Lee, Hye-Kyung Jan 09, 2023 06:10am
- The domestic approval of Vabysmo, the first and only dual-specific antibody biological drug related to eye diseases developed by Roche, is imminent. Vabysmo has been approved as an nAMD treatment and DME treatment in more than 40 countries around the world, including the United States, Japan, the United Kingdom, and the European Union, and was approved by the U.S. FDA in January last year. According to industries on the 5th, the Ministry of Food and Drug Safety recently completed a safety and effectiveness review of Vabysmo. If the review is completed without any problems, product approval is expected to take place soon. Vabysmo is the first and only ophthalmic injection approved by the FDA for nAMD and DME simultaneously. Depending on the patient's anatomical evaluation and vision results, vision can be improved and maintained by administering it every one to four months after the first four monthly administrations. It is estimated that more than 40 million patients suffer from one of the neovascular age-related nAMD treatments and DMEs worldwide, and the number of patients is gradually increasing as the population ages and the prevalence of diabetes increases. Until now, the standard therapy for the two diseases had to be administered every one to two months. However, in phase 3 of the Vabysmo global clinical trial, the patient group receiving Vabysmo at intervals of up to 4 months was found to have achieved a non-mean level of vision improvement compared to the patient group receiving Eylea every 2 months. It is evaluated that the convenience of patients has been improved by improving the administration cycle for up to four months. The international journal Nature Review Drug Discovery expects Babysmo's estimated sales to reach $1.129 billion within five years. Currently, four new nAMD drugs licensed in Korea are Avastin, Lucentis, Eylea, and Beovu.
- Policy
- PMS standards lowered for Sanofi’s hemophilia drug
- by Lee, Hye-Kyung Jan 06, 2023 05:57am
- The post-marketing surveillance (PMS) term for Sanofi’s hemophilia treatment ‘Eloctate’ and ‘Alprolix’ has been extended, and the number of subjects reduced. With the risk that the items may be canceled if the company fails to complete PMS for the drugs within the term set within the year, the authorities decided to extend the reevaluation term, including the submission of the risk management plan (RMP), by 3 years to collect more cases in consideration of the need for various hemophilia treatments and how they are being used in the field. The Ministry of Food and Drug Safety recently disclosed the results of the Central Pharmaceutical Affairs Council’s Drug Reexamination Subcommittee meeting to adjust the PMS period and the number of subjects for hemophilia treatments. Alprolix and Eloctate received marketing authorization in May and August 2017, respectively, and each is subject to reexaminations by May and August this year, respectively. According to the new ‘Notice on the Standard for Drugs subject to Reexaminations including New Drugs, etc.,’ the company may apply to adjust the number of surveillance subjects after at least half of the period elapses from the date of marketing authorization to the expiration date of the reexamination period until at least one year remains to the expiration date of the reexamination period. Sanofi was unable to sell the half-life extending hemophilia A treatment Eloctate and hemophilia B treatment Alprolix in the market for 3 years due to the transfer and acquisitions process between the previous license-holder UCB Korea and Sanofi, and due to the need to prepare inspection laboratories according to Korea's regulations on imported drugs. The two hemophilia treatments were not designated as rare disease treatments at the time of their approval and were required to collect 600 cases according to the set standards. However, due to their deferred sales in the market and difficulty collecting hemophilia patients, etc., Sanofi applied to adjust the number of surveillance subjects. The MFDS explained, “The company had applied to collect even fewer cases during initial discussions. The 65 and 35 case adjustments the company applied for this time show efforts on the company’s part as well.” According to the grounds for adjustments described by the company, the rate of adverse events was 10%, and the committee members' opinion was that the 65 and 35 people set for PMS would be the minimum target number. Other committee members said, “Hemophilia treatments are mainly used specifically by the Korea Hemophilia Foundation, therefore, it is difficult to collect a lot of cases. Patients mostly visit KHF clinics rather than university hospitals, therefore, not many patients can be enrolled. Therefore, the company seems to have applied to enroll a realistically possible number of subjects for PMS.” The MFDS also said, “The number of subjects for PMS under review will apply when the drugs are not registered as KHF drugs. If the drugs are registered as KHF drugs, the company will be able to collect more information.” Also, the reexamination period for the two drugs will be extended by 3 years each from the previous 6 years. As a result, the PMS period will be 9 years, and the subject number of patients 65 and 35 for Eloctate and Alprolix, respectively. Hemophilia is a rare intractable disease that develops in 1 in 10,000 people worldwide and is a disease that causes hemostasis issues when one of the coagulation factors in the blood is deficient or insufficient. As of 2019, there were 2,509 hemophilia patients in Korea. Among them, the most – 1,746 patients (69.6%) - had factor VIII deficiency, or Hemophilia A, followed by 434 patients (17.3%) with factor IX deficiency, or Hemophilia B.
- Policy
- Termination of PVA research services
- by Lee, Tak-Sun Jan 06, 2023 05:56am
- With the completion of the study that derived the improvement plan for PVA, attention is being paid to how it will be reflected in the actual policy. The industry expects the maximum cut rate, which is currently limited to 10%, to change. The NHIS also said it would come up with measures to improve the maximum reduction rate through research services. On the 2nd, the "Research on the Performance Evaluation and Improvement of the PVA System" was posted on the Public Institution Management Information Disclosure System (ALIO), which the National Health Insurance Service provided to Ewha Womans University Industry-Academic Cooperation Group (Professor Bae Seung-jin). The study was conducted from June 29 to December 29 last year. The contents of the study consisted of the background of the study, the status of the PVA system, overseas case review, in-depth interviews with stakeholders, scenario analysis, review, and conclusion. The original text was not disclosed. The reason for the non-disclosure is that it contains information on the size of claims, price cuts, and cost-effectiveness of certain drugs, which includes a number of confidential in management and business, and the research results are not disclosed because careful internal review and consultation with related agencies are needed to improve PVA. The results of the study are private, but the study is expected to be reflected in the actual system improvement policy. An NHIS official said, "The research results will be used and reflected in actual policies," and explained, "When the review is completed in the future, the research results can be converted to public." The study is known to have proposed an improved maximum reduction rate and a reference formula reduction rate. The maximum reduction rate of PVA is 10%, and the formula is set based on the rate of increase in actual claims compared to the previous year or expected claims. The average cut rate remained at 4-6%. It was 4.6% in 2017, 4.2% in 2018, 5.6% in 2019, 5.5% in 2020, 6.2% in 2021, and 5.2% as of August last year. In August, Jeong Hae-min, head of the NHIS' drug management office, said, "Research services are being conducted to analyze the overall PVA and come up with a reasonable system improvement plan. It includes adjusting the maximum cut rate and developing a reference formula considering the increase in billing amount." Accordingly, the study is expected to adjust the maximum reduction rate and develop a new reference formula. Meanwhile, PVA was introduced in December 2006 as part of the follow-up management of drug cost optimization measures. The main goal is to prepare a mechanism for lowering the upper limit through negotiations with pharmaceutical companies in order to share financial risks if drug costs have increased at a certain level. Through this, the NHIS is securing the soundness of insurance finances and inducing the proper use of drugs.
- Policy
- Approval of Pfizer’s JAK inhibitor Xeljanz Srup imminent
- by Lee, Hye-Kyung Jan 04, 2023 05:32am
- Pfizer’s JAK inhibitor ‘Xeljanz Syrup (tofacitinib citrate) 1mg/mL’ may soon receive marketing authorization in Korea. According to industry sources on the 3rd, the Ministry of Food and Drug Safety completed the safety and efficacy review for the marketing authorization application Pfizer Korea submitted for Xeljanz Syrup. Generally, items receive marketing authorization soon after MFDS completes the safety and efficacy review. Three items, 5mg and 10mg strengths of ‘Xeljanz Tab’ and 11mg strength of ‘Xeljanz XR,’ which are tablet formulations, are currently approved in Korea. The drug that completed the safety and efficacy review this time is a syrup formulation that can be used to treat polyarticular course juvenile idiopathic arthritis (pcJIA) in pediatric patients and adolescents ages 2 years or older. By weight, patients with pcJIA weighing 10kg-20kg will take 3.2mL of Xeljanz Syrup twice a day, those weighing 20kg-40kg will take 4mL of Xeljanz Syrup twice a day, and those weighing 40kg or more will take 5mL of Xeljanz Syrup twice a day. The tablet formulation of Xeljanz was only prescribed to pediatric patients weighing 40kg or more, but the syrup formulation has the benefit of being allowed to be prescribed regardless of weight. Xeljanz is the first and only JAK inhibitor in Europe to be approved to treat polyarticular JIA and pediatric psoriatic arthritis (PsA). The drug is currently approved by the EU to treat adults with moderate to severe rheumatoid arthritis, adults with psoriatic arthritis, adults with moderate to severe ulcerative colitis, children from 2 years of age with active polyarticular juvenile idiopathic arthritis (pJIA) or juvenile psoriatic arthritis.
- Policy
- Koselugo is the only non-reimbursed drug among 21
- by Lee, Tak-Sun Jan 03, 2023 05:41am
- The Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee (DREC) reviewed 21 items last year, among which only 1 failed to pass deliberations and be determined non-reimbursable. This non-reimbursed drug was the neurofibroma treatment ‘Koselugo Cap.’ Among the other 20, 9 were recognized to be adequate for reimbursement, and 11 received a partial nod under the condition that reimbursement is adequate if the company accepts a price lower than the assessed price for their drugs. Upon review of the products that filed applications for reimbursement based on results of the 12 DREC meetings that were held in 2022 on the 2nd, Dailypharm found that only 1 of the 21 products that received review was determined non-reimbursable. Koselugo Cap failed to pass the DREC review last March. Since then, AstraZeneca submitted supplementary data and reapplied for Koselugo’s reimbursement, and is expected to undergo receive another DREC review in the near future. The 9 items that were deemed adequate for reimbursement were: Kymriah Inj, 5 items including Resyno-ONE Inj, Loviqua Tab, Zogensma Inj, Emgality, Zerbaxa Inj, 10 items including Azelblock Tab, Ajovi Prefilled Syringe Inj·Auto Injector Ing, and 2 items including Reba-eye Eye Drops 2%. Other than the 10 azelnidipine-containing items including Azelblock Tab and the 2 items including Reba-eye Eye Drops 2%, all other drugs that passed the DREC review succeeded in reimbursement listing. In the case of the 2 items including Reba-eye Eye Drops 2%, the reimbursement agenda for the drugs passed DREC review in December and is undergoing NHIS pricing negotiations. 11 Items that received conditional approval last year were: Ryaltris Sanal Spray Sol, Sonazoid Inj, Dopa Check Inj, 4 items including Fexclue Tab, Dorenion Patch·Dohesive Patch, Reyvow Tab, Epclusa Tab, Bosevi Tab, Doveprella Tab, Trimbow Inhaler, and Erleada Tab. Among the drugs, all 8 drugs other than Reyvow Tab, Trimbow Inhaler, and Erleada Tab succeeded in reimbursement. Reyvow Tab was found to have not accepted DREC’s condition. In the case of Trimbow Inhaler, and Erleada Tab, the drugs received the conditional nod from DREC in October and December, respectively, therefore final results on their reimbursement are expected to be heard soon.
- Policy
- The fast track of tx for serious dz without a substitute
- by Lee, Tak-Sun Jan 03, 2023 05:40am
- Prior consultations will be newly established before the main negotiation to quickly register anticancer drugs without alternative drugs and treatments for severe and rare diseases. Accordingly, the negotiation period for the drug will be reduced from 60 days to 30 days. The NHIS announced on the 30th some revisions to the drug price negotiation guidelines containing such information. According to the amendment, among PE drugs, drugs that are evaluated as RSA (Expenditure Cap drugs or Refund) will have a negotiation period of 30 days. These drugs, etc. can be consulted in advance before the main negotiation if ordered by the Minister of Health and Welfare. Accordingly, the target drugs may undergo prior consultation by providing data to the NHIS 15 days before submission to the HIRA Drug Benefit Evaluation Committee to determine their benefit adequacy. Therefore, in this negotiation, the negotiation period will be reduced from 60 days to 30 days. The NHIS has decided to apply the guidelines from January 1 next year. Earlier, the HIRA also supported the introduction of a preliminary consultation system by specifying drugs that can omit submission of economic evaluation data through the "revision of regulations on evaluation criteria and procedures such as whether drugs are eligible for medical care benefits." According to the revision, the standard for PE omission drugs is established that "the target patients are few." There are no products or treatments with equal therapeutic positions as drugs used in children, and cases of clinically significant improvement in quality of life have been added to be recognized by the committee. As Canada is included in the drug price reference country, PE can be omitted for drugs that are publicly paid in more than three of the eight foreign countries (Japan, France, Germany, Italy, Switzerland, the United Kingdom, the United States, and Canada). This was also applied to the detailed evaluation criteria for drugs subject to negotiation, such as new drugs, which are the HIRA internal guidelines. All of them will go into effect on January 1 next year.
- Policy
- Will Koselugo, a new neurofibroma drug be reimbursed next ye
- by Lee, Tak-Sun Jan 03, 2023 05:40am
- "Koselugo (Selumetinib, AstraZeneca), the first drug used for childhood neurofibromatosis, a rare disease, is stepping up its challenge." Although he had a hard time at the HIRA in March, efforts to register health insurance have continued since then, such as supplementing data and reapplying for benefits. Starting next year, expectations for the registration are growing as the drug price negotiation period for drugs designated as drugs subject to rapid screening, such as Koselugo, is shortened. According to the industry on the 30th, Koselugo has continued its efforts to register benefits by submitting supplementary data since it was non-reimbursement in March. Since then, the HIRA has also conducted a review by listening to related academic opinions and reviewing standards. It is known that Koselugo's existing drug decision application was recently withdrawn and a new drug decision application was submitted. Koselugo is interpreted as a willingness to continue its efforts to register benefits next year. Starting next year, drugs designated by the Ministry of Food and Drug Safety as life-threatening or critical treatments such as Koselugo will speed up benefit screening and negotiations. The HIRA and the NHIS recently revised related guidelines to provide data to the NHIS in advance for drugs used for life-threatening diseases from next year, moving the negotiations forward by about 30 days. As a result, if Koselugo retries and passes the drug evaluation committee, the pace of registration is expected to accelerate. Patients' opinions on Koselugo are also greater than ever. Neurofibroma has relied on symptomatic treatment without proper treatment. About half of Type 1 patients experience PN, which can occur anywhere in the body along the nerves, and the range of motion is limited depending on the location and size of the nerve or causes pain and appearance problems. If a tumor develops inside, it compresses the internal organs, and most of the tumors are positive and grow slowly, but some are malignant or are likely to lead to breast cancer in women. The prevalence is around one in 3,000 people. Koselugo achieved the primary evaluation index ORR by reducing tumor size by more than 20% in 68% of administered patients in clinical trials. In addition, 82% of patients who showed partial reactions continued to respond for more than 12 months. Half of the patients who did not receive treatment suffer from disease progression after 1.5 years, and only 15% of the patients who used Koselugo developed the disease up to 3 years ago. As the drug approaches 200 million won a year, it is urgent to register health insurance benefits to reduce the economic burden on patients. Insurance authorities are cautious about analyzing cost effects as high drug prices have a significant impact on their finances.
- Policy
- Largest-ever drug pricing reeval to be conducted this year
- by Kim, Jung-Ju Jan 02, 2023 06:04am
- The health and pharmaceutical industry is busy preparing various systems and policies for the new year. The reimbursement adequacy reevaluations for listed drugs that had been initiated as a pilot project on choline alfoscerate products settled as an annual policy project and are expected to start full-scale reevaluations on previously notified products. High-priced drugs for pediatric patients will now be eligible for pharmacogenomic evaluation data exemptions (PE exemptions) and subjects for the special calculation system will also be expanded. In addition, the 3rd Comprehensive Plan to Foster the Pharma and Bio Industry will be initiated, and the task force for the development of the service industry that includes the healthcare industry will also be launched within the month and impact the medical and pharmaceutical industry. The National Assembly will discuss the abolition of the sunset clause on state funding for national health insurance and legislation for public late-night pharmacies. Dailypharm prepared a summary of notable changes in the system as well as policy projects that will be made in 2023 in the pharmaceutical and biopharmaceutical industry. First, the conversion factor for medical care facilities will be raised with the start of the new year. The increase rate is 1.6% for hospitals, 2.1% for clinics, 3.0% for oriental medicine hospitals, and 3.6% for pharmacies. Along with this, the health insurance rate will also rise to 7.09% based on those employed. For drug pricing coverage and control, high-priced drugs for pediatric patients may be allowed PE exemptions starting this month. PE exemption may be allowed for drugs used to treat pediatric patients that are therapeutically equivalent or has no available treatment option; and demonstrates improvement in quality of life or are otherwise approved by the committee. The adjustment in the reference countries used to calculate the foreign adjusted drug price that raised concerns in the pharma and bio industry has been made. The government added Canada to the existing A7 (Japan, France, Germany, Italy, Switzerland, the UK, and the US) to A8. Australia, the country that the industry worried would be included as a reference country, was excluded. The reimbursement reevaluations planned for the year are expected to be the largest ever. The government announced that HIRA will be reevaluating reimbursement on a total of 8 ingredients - Rebamipide, Limaprost alpha-cyclodextrin, oxiracetam, acetyl L carnitine, loxoprofen sodium, levosulpiride, epinastine hydrochloride, sodium hyaluronate eye drops. When adding the efficacy reevaluation set to be conducted on sterepto drugs that received conditional approval for 1 year, the number of drugs subject to reevaluation is increased to 9. The discount rate for the drugs will be finalized in the coming December. In February this year, ingredients subject to reimbursement reevaluations in 2024 will be decided upon and reviewed by the Health Insurance Policy Deliberation Committee. Also, a performance evaluation procedure and management plan for high-priced drugs such as Kymriah and Zolgensma, the so-called 'one-shot treatments', will be prepared within the month. Also, the negotiation period for drugs eligible for the Risk Sharing Agreement (RSA) among PE exemption drugs will be shortened by 30 days through the introduction of a prior discussion system, improving accessibility. Also, the scope of drugs eligible for special calculations will be expanded. A total of 42 new rare diseases and artificial kidney dialysis patients with chronic renal failure will also be applied to special calculations. Also, the administrative dispositions used for the drug serial number reporting system will be raised. From January, HIRA will raise the serial number reporting rate standard for administrative dispositions from 85% to 90% at the time of shipment by wholesalers (including manufacturers and importers that supply third-party licensed items). Therefore HIRA will request administrative dispositions to be made to local governments if the reporting rate becomes less than 90%. Also, the ‘ Regulation on Manufacture and Sales Management of Biological Products, Etc.’ that applied to all biological products will not be categorized into 3 product types. The MFDS plans to make the amendments to the regulation before the 17 of this month. The 3rd Comprehensive Plan to Foster the Pharma and Bio-Industry which had been set as a 5-year project will be implemented this year to support all areas ranging from R&D to business development, investment exports, job creation, and institutional infrastructure. The 'Service Industry Development TF', which sets policy directions to revitalize the service industry, including the field of healthcare, will also be launched in earnest this month. The Ministry of Economy and Finance that oversees the project plans to disclose its 5-year plan for innovating the service industry in March through the TF. During the H1 of the year, a pilot project for the ‘Approval Evaluation-Negotiation Linkage System' will be carried out, and subject drugs will simultaneously undergo three tracks of the drug approval process – MFDS’ safety and efficacy evaluations for marketing authorizations, HIRA’s reimbursement adequacy evaluations, and NHIS’s drug pricing negotiations. In the same period, the National Assembly will discuss whether to abolish the sunset clause for state support of health insurance finances and whether to legislate public late-night pharmacies. Although the contract sales organization (CSO) reporting system is expected to be discussed at the plenary session in the H1 of the year, as the effective date for the law is 1 year and 6 months after the promulgation, its actual application is expected to be possible only in the 2024 2H at the earliest, even if the revisions are made rapidly.
- Policy
- SK Chemicals Riluzole is listed
- by Lee, Tak-Sun Jan 02, 2023 06:04am
- Only tablet type is available for Riluzole, and suspension type is expected to be an alternative for patients with difficulty in swallowing. According to industries on the 1st, SK Chemical's Teglutik Suspension was listed at 134,970 won per bottle. Riluzole, the main ingredient of Teglutik, is used in the treatment of Amyotrophic Lateral Sclerosis (ALS), which is known to delay symptoms by several months. Riluzole is the first drug approved for Lou Gehrig's disease and is most commonly used. There are two products in Korea: Rilutek and Yooritek by Riluzole. Based on IQVIA in 2021, Rilutek showed sales of 3.7 billion won and Yuritech 2.5 billion won. Despite such identical products, Teglutik is introducing them to the domestic market because there is a demand for suspension. Patients with Lou Gehrig's disease have early symptoms of weak tongue and neck muscles, making it difficult to chew and swallow. It was difficult for patients who felt these symptoms to take two tablets of Riluzole daily. Teglutik is a suspension that can be easily taken through oral injections. Patients who are difficult to take directly can be injected through a PEG tube. The drug was developed by the Italian pharmaceutical company Italco Pharma and approved by the U.S. Food and Drug Administration (FDA) in 2018. SK Chemicals has completed patent registration since it was introduced in Korea. The upper limit of the benefit 134,970 won per bottle, is 15 days' worth, which is the same as the existing refining price (4,499 won per day) when converted into daily doses. Since there is no price difference, Teglutik is expected to be useful for patients with symptoms of dysphagia. On the other hand, Sanofi and Yoo Young, which divided the market, are expected to focus on protecting the market this year because they have difficult competitors.
- Policy
- High conc Ultomiris Inj 100mg/mL also approved in Korea
- by Kim, Jung-Ju Jan 02, 2023 06:04am
- Handok received marketing authorization for the orphan drug ‘Ultromiris 100mg/mL(ravulizumab)’ that is used to treat Paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uraemic syndrome (aHUS) and made a step towards supplying the drug in Korea. On the 28th, the Ministry of Food and Drug Safety announced that it had granted marketing authorization for the drug. The drug is a humanized monoclonal antibody (mAb) that specifically binds to the C5 protein and inhibits complement-mediated inflammation and hemolysis, etc. More specifically, the drug is indicated for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH), and as a treatment for adult and pediatric patients with atypical hemolytic uraemic syndrome (aHUS) and inhibits complement-mediated thrombotic microangiopathy (TMA). The MFDS explained that the product approved this time is a high-concentration version of the already-approved Ultomiris Inj and has the benefit of being able to reduce the IV infusion time in patients. The MFDS said, “We will continue to make efforts to allow for the prompt provision of treatments with confirmed safety and efficacy based on regulatory science."
