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- 2025-12-26 13:07:30
- Policy
- Early market entry of Gabsmet salt-modifying drugs are noted
- by Lee, Tak-Sun Jan 06, 2020 06:21am
- The salt-modifying drug 'Galvusmet', a DPP-4 inhibitory diabetes drug, applied for approval for the first time in Korea on the 24th of last month. It is therefore noteworthy whether it will be released to the market early. According to the MFDS on the 24th, Vildagliptin HCl-Metformin HCl combination was applied for the first time to the patent holder, Novartis. The salt is different from the original 'Galvus', which is a combination of Vilagliptin-Metformin HCl. Therefore, the industry has made an observation that Hanmi which has been developing Galvus salt modification drugs, has applied for a license. Hanmi also reportedly filed an application for a license for the Vildagliptin HCl formulation, a Galvus' monolithic salt change product, in July. However, it has not yet obtained a product license. On November 22, last year, Anguk received the first approval of generic drugs and obtained a exclusivity for generic product following the successful patent challenge. However, since the company succeeded in invalidating part of the extended period of the patent, the exclusivity for generic product of sale is not applied immediately, and it is enforced for nine months from August 30 2021. Galvusmet's salt-modifying drug, one of material patent is also likely to be on the market at this time. This is because Anguk and Hanmi have succeeded in invalidating patents that survive after August 29, 2021. Nevertheless, Galvusmet, a latecomer of DPP-4 diabetes, is expected to be the fastest case to enter the market. Galvus recorded outpatient prescriptions of ₩9 billion on UBIST basis in 2018, and Metformin-included Galvusmet is a blockbuster drug with a record earnings of ₩35.1 billion. If first-latecomers enter the market early through patent challenge, they will benefit from the preemptive effect.
- Policy
- Announcement of drug price reform is delayed
- by Kim, Jung-Ju Jan 04, 2020 08:47pm
- The reform of the drug price system, which the government plans to announce last month, is delayed somewhat. The pharmaceutical industry is all on edge because of the reorganization of generic drug prices, improved risk-sharing contract (RSA), economic exemption system, and insurance policy supplementary agreement (sub-contract). ◆Generic price restructuring= Among the many cases where drug price restructuring is expected, the focus of the industry is on the final revision of the 'Determination and Adjustment Criteria for Drug Price Revision', which contains the generic price restructuring. The government planned to announce the final announcement no later than last month, but it was slightly delayed, with some revisions to the earlier this month. It is essential to calculate this system by linking the MFDS' item permission to the Ministry of Health and Welfare’s drug price system. It is largely divided into generic cascade drug price reform and cut line system. The requirement for a cascading drug price reform is to conduct its own bioequivalence test and to meet the registered use of the Drug Master File (DMF). If both criteria are met, the price is estimated at 53.55% of the cost of the original drug (before generic listing). However, if one or not met, then the price is multiplied by 0.85 based on 53.55%, depending on the level of fulfillment of the criteria. They are cut by 15%. In addition, the 'cut line system' is a price condition that is lowered separately from the permit linkage. Starting from the 21st order of health insurance, the drug price is estimated at 85% of the lowest price regardless of whether the criteria are met. For example, the 21st generic is estimated at 85% of the lowest price in 20 products, while the 22nd generic is 85% of the 21st generic price. The government has announced that the drug price reform will be finalized by the middle of this month and planned to be implemented in July. ◆Completion of RSA, reimbursement decision, the economic evaluation exemption system and additional contract creation subjects=In the current drug price system, issues that require expansion or reorganization of the reimbursement gateway stage are also overhauled. The government has continually improved the drug price system without changing the fundamentals of the system since the implementation of the positive list system. However, as the groundbreaking reinforcement of security continued, the awareness of the need to reorganize and upgrade the positive list system continued. The improved drug price system can be divided into: ▲expanding the scope of RSA coverage ▲complementary details of reimbursement determination ▲complement of economic evaluation exemption system ▲expansion of generics for writing subsidies when reimbursement listed. First of all, in the case of RSA improvement, one of the new drug listing tracks, it is important to expand the gateway to be able to apply the RSA target criteria that could be applied only to the current selection drugs. In the meantime, drugs that have the same therapeutic position but have not been covered by RSA just because of late-release drugs will have a wider benefit opportunity. In addition, high-priced drugs that are subject to phase III conditional approval are considered to have greater uncertainty, and thus, improvements are made in the direction of raising benefits by reimbursed them within the framework of the RSA. In the case of reimbursement determination, some socially disturbing reimbursed priorities are supplemented. The government is currently making reimbursement in consideration of medically feasible or medically significant materiality and treatment effects, as well as patient costs and social benefits. In the future, it will be added to determine detailed principles or priorities in consideration of the financial status of health insurance. In other words, it reflects the decision of reimbursement to the financial level that health insurance can cover, along with the characteristics of pharmaceuticals and the necessity of the times. The economic evaluation exemption system will also be supplemented. The government plans to improve the system by adding antibiotics, tuberculosis treatment, and emergency detoxification drugs, which are difficult to evaluate, to reflect the voice of expanding the scope of drugs that are difficult to evaluate. Lastly, it is a revised plan that includes a generic agreement that is included when insurance is listed. The contracting parties are the Korea Health Insurance Corporation and pharmaceutical companies. The main contents of the contract are to fulfill supply obligations and accept price cuts when disposing of rebates. The government aimed to implement the midterm this year after outlined this month's reorganization plan based on improving the positive list system and promoting administrative notice. Evaluation adopted by the government during the maintenance of the list of registered agreements from 2007 to 2011 ◆Re-evaluation of listed drugs=The government is currently setting up a 'post-evaluation of pharmaceuticals', that is, a re-evaluation guideline for already listed reimbursed drugs and collecting expert opinion. The evaluation is based on the revised List of Contracts, which was carried out 12 years ago, but the standard is expected to be more detailed. Reevaluation targets are selected from anti-cancer drugs, rare disease drugs, and drugs of uncertain clinical usefulness. Of these, ▲drugs that need to confirm clinical usefulness through effects re-evaluation ▲drugs that need to be managed due to increase in population structure and usage ▲other drugs that require evaluation taking into account social impacts and other effects on health care at ex post evaluation Sub-committees become standards. The government plans to announce the final reassessment soon and finalize the system within the year.
- Policy
- Only 6 out of 9 reimbursed use of Spinraza approved
- by Lee, Hye-Kyung Jan 03, 2020 06:31am
- Only 66.6 percent of preliminary approval applications for reimbursement submitted last month was cleared for the use of spinal muscular atrophy (SMA) treatment Spinraza (nusinersen). Six out of nine applications were approved, and other three applications were rejected with conditional approval, disapproval and required supplementary data. On Dec. 31, Health Insurance Review and Assessment Service (HIRA, President Kim Seung-taek) officially disclosed outcomes of reimbursement review on four items—Spinraza, Soliris, ventricular assist device (VAD), and hematopoietic stem cell transplantation—deliberated by Healthcare Review & Assessment Committee in November 2019. Spinraza has been listed for reimbursement since last Apr. 8, but a healthcare institute intending to use super-high-cost treatment priced at 92.36 million won per 5 ml has to apply for a preliminary approval for reimbursement. For reimbursement on the treatment, a patient has to qualify for all conditions of lacking 5q SMN-1 gene or being diagnosed with gene mutation; SMA related clinical symptoms and signs onset from age younger than three; and not in use permanent ventilator. A well-known unapproved case was a 14-year-old male patient with SMA, who could not clearly prove his age of SMA-related symptom and sign onset was younger than 36-month-old according to the submitted data. The committee did not approve the application without proper objective data. A conditional approval was granted on 24-year-old female patient with a record of scoliosis surgery as her myelogram result proved she is able to take continuous administration into her dura mater with lumber puncture. However, the approval condition was submission of the confirmed number of SMN2 copy with the monitoring report. Soliris (eculizumab) was available for preliminary approval for reimbursement prior to Spinraza, and had six applications submitted for treating atypical hemolytic uremic syndrome (aHUS). But only one was approved out of all. A 49-year-old male patient was approved with reimbursed use of Soliris as he had recurrent thrombotic microangiopathy and kidney dysfunction, despite he had conservative treatment after ABO-incompatible kidney transplantation. Although HIRA found, reviewing his medical record, thrombotic microangiopathy has occurred after the kidney transplantation and using immunosuppressant, it approved of the reimbursed use because the patient had clinical symptoms of aHUS and also continued to show thrombotic microangiopathy symptoms with no apparent response to hemodialysis and therapeutic plasma exchange. But the patient has been ordered to submit genetic testing result and two-month monitoring report. His feasibility of maintained reimbursement would be deliberated depending on the clinical result.
- Policy
- Rare cancer reoccurred in patients with Allergan’s implants
- by Lee, Tak-Sun Jan 02, 2020 11:21pm
- Another patient with rare cancer developed after breast augmentation with Allergan’s coarse surface implants. This is the second time since it was first reported in Korea on August 14th. The Minister of Food and Drug Safety, Eui-Kyung Lee and the Korean Society of Plastic and Reconstructive Surgeon(Chairman, Kwang Seog Kim) announced on the 26th that an additional patient with breast implant-related anaplastic large cell lymphoma (BIA-ALCL) was reported on the 24th. Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a rare cancer associated with the immune system that is separate from breast cancer. Suspicious symptoms include changes in the size of the breast caused by serousomas, lumps or skin rashes on the skin. The patient, a woman in her 40s, underwent breast enlargement using rough surface implants from Allergan in 2013. After swelling in the chest recently, a pathology examination was performed at a university hospital. The patient was diagnosed with BIA-ALCL and reported to the MFDS and the Korean Society of Plastic and Reconstructive Surgeon. The patient visited the medical institution promptly and received the BIA-ALCL test in accordance with safety information, such as how to respond to suspected BIA-ALCL symptoms reported by the MFDS and medical institution. On the 26th after final confirmation with BIA-ALCL, additional tests such as positron emission computed tomography (PET-CT) confirmed that BIA-ALCL did not spread to other sites. The MFDS explained that the patient is currently working on a treatment plan, including removal of the implant. Meanwhile, according to the compensation plan for patients with rough surface breast implants on Sep 30, Allergan will pay medical expenses for the patient. The MFDS and the Korean Society of Plastic and Reconstructive Surgeon are conducting patient registration studies to minimize the difficulty of patients with breast implants and improve safety, and will continue to implement more rapid measures through continuous monitoring of adverse event information. In addition, They have repeatedly asked patients with breast implants to visit and see a medical professional if they have any suspected symptoms, such as a sudden change in breast shape.
- Policy
- Reimbursed Dupixent requires prior prescription record
- by Kim, Jung-Ju Jan 02, 2020 11:20pm
- The reimbursement criteria for patients taking now listed Sanofi Aventis Korea’s severe atopic dermatitis treatment Dupixent Pre-filled syringe 300 mg (dupilumab) were officially disclosed. Reimbursement on the treatment is granted for an adult patient age over 18 with chronic and severe atopic dermatitis symptoms continuing over three years, who has a record of topical treatment and systemic immunosuppressive therapy within six months. And when the patient has to resume treatment after a hiatus with a medical reason would also be granted with reimbursement under certain circumstances. Korea’s Ministry of Health and Welfare (MOHW) recently announced partially revised ‘National Health Insurance Reimbursement Listing Criteria and Method’ reflecting the details of the newly listed atopic dermatitis treatment. Dupixent is a first non-anticancer or rare disease treatment in Korea to have signed the risk sharing agreement (RSA) with the government. However, patients requesting for National Health Insurance reimbursement on the treatment have to qualify for a list of conditions. ◆ Patient condition = According to the announcement, the treatment is listed for treating chronic severe atopic dermatitis patient over the age of 18 with symptoms continuing over three years. Also, the adult patient should have symptoms unable to be managed after four-week topical treatment (corticosteroids or calcineurin inhibitor) as first-line treatment, and not showing more than 50 percent decrease of Eczema Area Severity Index (EASI) score after three-month systemic immunosuppressant therapy (cyclosporine or methotrexate), and have EASI score over 23 before administrating the treatment. Also, the patient has to have a record to receiving topical treatment and systemic immunosuppressant therapy within past six months. ◆ Reimbursement evaluation = Reimbursement is granted for six months more after 14 weeks of administration and the patient showing more than 75 percent decrease of EASI score at week 16. From then on, reimbursement would be granted continuously when the result of initial evaluation response is maintained in EASI evaluation every six months. By principle, the reimbursement is limited to in-patient prescription only, and an outpatient prescription for a patient discharged from hospital covers four-week of dose of the treatment at most. However, for patients demonstrating stable disease activity and no adverse reaction at week 24 after the initial administration, their outpatient prescription can cover up to eight to 12 weeks of dose. To confirm a patient’s self-injection record during the administration period, the patient has to document ‘daily administration log’ and their healthcare institute has to confirm and oversee the daily log. A doctor specializing in atopic dermatitis related department like a department of dermatology or allergy has to prescribe the treatment, and objective data of the prescribed patient and their response assessment result of multiple dose administration (past treatment record, EASI evaluation result, photos of patient body with symptoms) should be handed in. ◆ Reimbursement when resuming treatment after hiatus = Patients needs to pass a certain condition to receive reimbursement again when resuming the treatment after a hiatus for medical reason. Patients, who had a hiatus before the first response assessment at week 16, may receive reimbursement for resumed treatment if the patient qualifies for the initial administration standard (EASI score over 23). On the other hand, two conditions apply for a treatment-resuming patient, who took hiatus after the initial response assessment followed by multiple dose treatment. Resuming after a hiatus shorter than three months would be considered continuous administration. But a patient would have pass the initial administration standard (EASI score over 23) to receive the reimbursement again if the hiatus was longer than three months. MOHW plans to collect public opinion until Jan 30, and to finalize the revision on Jan 31. Contact Pharmaceutical Management Department of Health Insurance Review and Assessment Service (HIRA) for inquiries on the details of the announcement.
- Policy
- ₩2.8 billion will be invested in AI drug development
- by Kim, Jung-Ju Jan 02, 2020 06:09am
- The government will greatly strengthen investment in innovation growth in the biohealth sector, which is called the future food industry, such as the pharmaceutical industry and increased the budget by 13% to ₩527 billion, and doubled the budget by building big data, new drug development platform, and support for the development of the pharmaceutical industry this year. The MOHW responded to pending questions on the Korean Special Press Association. First, this year's total budget is ₩82.5 trillion, an increase of 13.8% from last year. Among them, the MOHW’s budget increased ₩1.35 trillion by 11.7%. Looking at the biohealth sector, which includes pharmaceuticals, investment for innovation growth in the pharmaceutical, medical data, and medical device sectors will be greatly strengthened. This year's major R & D budget for health care is ₩527.8 billion, up 13% from ₩466.9 billion last year. The amount increased by 60.9 billion won. The government will establish a new drug development platform utilizing the 4th Industrial Revolution technology and discover core experts in pharmaceutical and biotechnology. The AI drug development platform was set at ₩2.8 billion, up ₩300 million(11.1%) from last year's ₩2.5 billion. In order to innovate biohealth technology, the budget of ₩15 billion was also reflected in the development of big data platform for genome and medical clinical information. Bio big data development is a pan-government project in connection with the Ministry of Welfare, the Ministry of Science and ICT, and the Ministry of Trade, Industry and Energy. In addition, the government invest ₩9.3 billion, will newly select and support five medical data-centric hospitals. As the Advanced Renewable Bio Act comes into effect in August, a budget will be invested in establishing a regenerative medical safety management system. The Ministry of Health and Welfare decided to reflect the budget of ₩1.2 billion to establish a clinical research system for rare and intractable diseases and to establish a safety management system. In the case of medical devices, the MOHW decided to support R&D to commercialization and expand investment to strengthen industrial competitiveness. A total of ₩30.2 billion was newly organized for full-cycle R&D development, and a budget of ₩8.6 billion was increased by ₩3.9 billion(82.4%) year-on-year to strengthen industrial competitiveness. In addition, the cosmetics industry plans to raise ₩7.74 billion to support localization of materials and development of technology to respond to market diversification to foster sustainable future growth engines.
- Policy
- Lipiodol’s gap recurrence prevention law is pushed forward
- by Lee, Jeong-Hwan Jan 02, 2020 06:06am
- A bill, which the government is obliged to conduct regular surveys on the state of supply of essential medicines, to build a stable supply environment will be promoted. The legislative goal is to prevent the gap of essential medicines to prepare for major national disasters such as terrorism and radioactive pollution. Representative Myung-yeon Kim of the National Assembly's Health and Welfare Committee (Danwon gu, Ansan, Liberty Korea Party) presented the proposed amendment to the pharmaceutical affairs law on the 30th. Under the current law, national essential medicines are necessary for health and medical services such as disease control and radiological disaster prevention, but they are difficult to supply in a stable manner due to lack of marketability. Related departments, such as the MFDS, are designating and managing 351 items. But Representative Kim criticized that the vast majority of emergency medicines for terrorism and radiological warfare were less than a tenth of statutory reserves. In particular, in 2018, the sale of special contrast agent 'Lipiodol', which is used to treat liver cancer, was stopped. In January of this year, anxiety arose due to unstable supply of essential drugs, such as the anti-cancer and glaucoma drug ' Mitomycin', which is in danger of being stopped. In order to solve the problem, Representative Kim said he proposed an amendment to the Pharmaceutical Affairs Law that strengthens the responsibility for the Agency to function as a national essential drug control center and specially manages the supply situation such as complete enumeration of the expiration date. Representative Kim said, “The current stockpile and stockpiling location of essential medicines are not well understood, and it is expected that this amendment will proactively respond to national emergency situations”.
- Policy
- Report find MFDS cleared 112 IMDs in past decade
- by Lee, Tak-Sun Jan 02, 2020 06:05am
- Apparently, more than half of incrementally modified drugs (IMDs) approved in the past decade were combination drug. And majority of them were approved for treating chronic disease. On Dec. 30, Korea’s Ministry of Food and Safety (Minister Lee Eui-kyung) published ‘IMD Approval Report’ reviewing current status and past cases of approved IMDs. The report was compiled to inform the IMD-developing companies of approval criteria, approval failed cases and a list of all approved IMDs in the past decade, since the IMD approval was implemented from 2008, to enhance the predictability of the approval system. The report found the total of 112 IMDs has been cleared from 2009 to last November. Breaking down the approval list, 62 items (55.4 percent) ‘improved effectiveness,’ 39 items (34.8 percent) ‘improved usability,’ seven items (6.3 percent) was ‘recognized with innovativeness of pharmaceutical technology,’ and four items (3.5 percent) ‘improved safety.’ 62 items, recognized with improved effectiveness, were all combination drugs (two or more active ingredients are combined as one item). Among which, 52 items were dual agent combination drug and ten items were triple agent combination drug. 39 items, recognized with improved usability, were approved with decreased dose or more convenient administration method providing better drug adherence. Approved IMDs from 2009 to Nov. 2019 Breaking down the list again by class, 47 items (40.4 percent) were for cardiovascular and circulatory system drugs (antihypertensive, anti-arteriosclerotic drug), while 16 items (14.3 percent) were anti-diabetic drugs. It was apparent the majority of IMDs were developed for chronic disease (hypertension, hyperlipidemia, diabetes and etc.). The key finding was that Korea entering the era of aging society is resulting in increased chronic disease, and accordingly, pharmaceutical companies have developed more drugs with simplified multiple drug dose or administration method for better drug adherence. Analyzing the drug development types, 70 items (62.5 percent) improved safety (reduced adverse reaction) or effective (increased treatment effect) and 29 items (25.9 percent) improved dose and administration by lessening frequency of administration (twice-daily to once-daily, or three times-daily to twice-daily). MFDS official explained, “We expect the report would provide practical information to Korean pharmaceutical companies currently developing or preparing drugs in different types. The ministry would continue to provide more useful information to the industry for developing new drugs.”
- Policy
- Keytruda-Lenvima already got 9 trials approved in Korea
- by Lee, Tak-Sun Dec 31, 2019 05:51am
- MSD Korea and Eisai Korea are conducting a series of clinical studies in Korea to confirm cancer-treating efficacy of combination therapy of immunotherapy Keytruda (pembrolizumab) and targeted therapy Lenvima (lenvatinib). In Korea alone, nine clinical protocols on the combination therapy have been approved. The pharmaceutical industry is keeping close eyes on how the immunotherapy market leading PD-1 inhibitor Keytruda and new targeted therapy for liver cancer after a decade-long wait would create synergy effect together. On Dec. 30, Korea’s Ministry of Food and Drug Safety (MFDS) granted approval on Phase 3 clinical trial protocol for Keytruda-Lenvima combination therapy treating patients with metastatic or recurrent head and neck squamous cell carcinoma (HNSCC). The trial would be conducted in 12 university hospitals in Korea comparing efficacy of Keytruda monotherapy. Two companies have reported already nine protocols of Keytruda-Levima combination therapy have been approved in Korea alone. Since Phase 3 trial for combination therapy treating patients with advanced hepatocellular carcinoma (HCC) was cleared, the pharmaceutical companies have conducted clinical trials for treating patient with advanced melanoma, solid tumor with previous treatment record, metastatic HNSCC non-small cell lung cancer (NSCLC), and for treatment-naïve metastatic NSCLC patients with tumor proportion score higher than one percent. Moreover, the Korean government body granted approval on the combination therapy’s trials confirming safety and efficacy on previously treated participants with metastatic NSCLC and progressive disease after platinum doublet chemotherapy and immunotherapy; participants with advanced or recurrent endometrial cancer; and cisplatin-ineligible participants with a Programmed Cell Death-Ligand 1 (PD-L1) or participants ineligible for any platinum-containing chemotherapy regardless of combined positive score with advanced unresectable or metastatic urothelial carcinoma. Eight out of nine trials are Phase 3, and two are targeting patients with a specific solid tumor. Co-commercializing the two treatments under a strategic collaboration, MSD and Eisai have also started their co-sales and marketing of the two treatments from January this year. The companies have been running transnational trials of the combination therapy since March 2018. The fruitful results from the trials are expected to expand Lenvima’s indication on other types of cancer, besides already-cleared indication for first-line treatment of liver and thyroid cancer, and raise cancer treatment success rate.
- Policy
- Maviret, liver & kidney transplant patients benefit extended
- by Kim, Jung-Ju Dec 31, 2019 05:51am
- Liver and kidney transplant patients will be expanded and added to the administration of adult chronic hepatitis C treatment drug, Maviret (Glecaprevir + Pibrentasvir), and the reimbursed period of administration will be divided. reimbursed indication of Jext inj (Epinephrine bitartrate)150μg is changed to anaphylaxis, and covered up to two pens a day. The MOHW recently revised some of the details of the 'applicable criteria and methods of reimbursement benefits'. The effective date is January 1 of next year. Looking at the major revisions, Reimbursement of liver or kidney transplant patients for Maviret have been extended and the dosing period has changed due to a change in permit. It is noted here that the permit changes to 8 weeks when patients with cirrhosis have genotypes 1 to 6 who have no previous treatment experience. The administration target is changed to anaphylaxis in 150 μg of Jext. This is possible when prescribing discharge after anaphylaxis treatment or when prescribing to patients with a history of anaphylaxis. In addition, the reimbursement will be extended to allow up to two pens at a time. The diagnostic criteria of Repatha inj(Evolocumab) for homozygous familial hypercholesterolemia has been changed to be the same as the registration standard for the exception. Benefits will also be extended to additional indications: hypercholesterolemia and mixed dyslipidemia and atherosclerotic cardiovascular disease. In the case of steroid injections, such as Jeil Dexamethasone inj, the allowance was exceeded and the benefit could be granted for the purpose of preventing fetal complications in pregnant women at risk of preterm birth. In addition, patients with Guillain-Barré syndrome with human immunoglobulin G injections, such as IV-Globulin SN inj 50ml, were changed to ‘unable to walk without aids or other people’ without the MRC score, and reimbursement is approved for the second dose to refractory Kawasaki disease and atypical Kawasaki disease.
