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- 2025-12-24 09:59:33
- Policy
- MFDS-EMA, temporary confidentiality agreement for COVID-19
- by Lee, Jeong-Hwan Jul 02, 2020 06:08am
- The MFDS announced on the 30th that it had temporarily signed a confidentiality agreement with the European Medicines Agency (EMA) when exchanging information for the diagnosis, prevention and treatment of related infectious diseases including COVID-19. This agreement has the significance of establishing a close information exchange system for external non-public information such as clinical trial information, examination data, and safety issues of drugs used or developed for COVID-19 treatment. On this day, the MFDS and the EMA will also discuss ways to collaborate, such as cooperation in the field of health and defense related to COVID-19 and international solidarity in vaccines and therapeutics development, through a videoconference summit. "We will support the rapid development of therapeutic drugs and vaccines through mutual cooperation in the global COVID-19 panthemic crisis," said Lee Eui-kyung. "With this agreement, we will establish a formal confidentiality agreement in the future to solidify our cooperation."
- Policy
- Pharmaceutical coverage list updated with Xolair and Akave
- by Kim, Jung-Ju Jul 02, 2020 06:08am
- As an allergic asthma treatment Xolair injection (omalizumab) was newly listed, the detailed criteria for healthcare reimbursement was also updated. Also the reimbursement standard on hypertension and hyperlipidemia combination drug added new ‘fimasartan plus atorvastatin’ combination due to the new listing of Akave tablet. Korea’s Ministry of Health and Welfare (MOHW) revised and updated the detailed pharmaceutical reimbursement criteria and method with the said changes coming in effect from July 1. ◆Xolair injection: The updated list added detailed standards and method of granting reimbursement for using Xolair injection listed from this month. A patient aged 12 and above with moderate to severe persistent asthma, whose symptoms are inadequately controlled despite administering inhaled-corticosteroid-and-long-acting beta agonist (ICS-LABA) or long-acting muscarinic receptor antagonists (LAMA) should qualify all following criteria to receive reimbursement; demonstrating immunoglobulin E (IgE) level over 161 IU/ mL prior to the treatment, skin test exhibiting positive or in vitro reactivity to a perennial aeroallergen, having a baseline forced expiratory volume in one second (FEV1) less than 80 percent, and has experienced acute asthma attack requiring systemic corticosteroid more than twice in 12 months before the treatment. A pediatric patient from age six to 12 with moderate to severe persistent asthma, whose symptoms are inadequately controlled with ICS-LABA or LAMA should qualify all following criteria to receive reimbursement; demonstrating IgE level over 76 IU/ mL prior to the treatment, skin test exhibiting positive or in vitro reactivity to a perennial aeroallergen, and has experienced acute asthma attack requiring systemic corticosteroid more than twice in 12 months before the treatment. For patients prescribed with Xolair injection before the listing (July 1), the reimbursement would be provided if all the required criteria are met and confirmed by medical record and healthcare provider’s diagnosis. The eligibility would be evaluated, according to the criteria in effect from July 1, by reaction assessment at week 16 followed by a series of continuous reaction assessments in every three to six months. ◆Akave tablet: A ‘fimasartan plus atorvastatin’ combination drug Akave tablet is also newly listed from this month, adding a new criteria on reimbursement standard for hyperlipidermia. The four combinations of hyperlipidermia treatments including ‘amlodipine plus atorvastatin,’ ‘amlodipine plus rosuvastatin,’ ‘candesartan plus rosuvastatin,’ and also ‘fimasartan plus atorvastatin’ are now covered.
- Policy
- α-GPC can be adjusted in advance up on to clinical plan
- by Lee, Tak-Sun Jul 01, 2020 05:56am
- The MFDS briefed on the clinical evaluation of Choline alfoscerate on the 30th.The MFDS announced its position for the first time in the clinical re-evaluation of 'Choline alfoscerate', a brain function improving agent. The MFDS said there were no procedural issues related to this evaluation, and the duration or number of tasks will be decided after the clinical plan is received. However, it emphasized that approval could be adjusted even before clinical re-evaluation. The drug safety evaluation department, the main department of clinical re-evaluation of Choline alfoscerate, held a briefing for reporters at the headquarters in Osong on the morning of the 30th. The briefing was attended by Kim Jung-yeon, director, and Yoo-bin Lee, Secretary of the Department of Pharmacy Safety Evaluation, and Kim Mi-jung, who conducted internal review of Choline alfoscerate formulations. The MFDS actively explained the suspicion of protests surrounding clinical re-evaluation on the day, but was cautious about specific schedules and methods. When the clinical re-evaluation decision was later than the reimbursement re-evaluation, Kim Jeong-yeon said, “The drug price re-evaluation and drug efficacy re-evaluation were operated separately.” Although communication between agencies was different, the timing of the decision was different because the decision range was different. She added, "When conducting a clinical reevaluation, we do not consult with the MOHW regarding the drug price." The Central Pharmaceutical Affairs Review Committee said, it was not true that there was no vote. "The committee asked whether the clinical re-evaluation of Choline alfoscerate approval was conducted, and all agreed," said Kim. "We plan to open a committee on the validity of the proposal and decide whether to target it." The committee decides when a majority (2/3) or more agree, and the clinical re-evaluation of Choline alfoscerate is 'all agree'. However, the MFDS explained that the future schedule and direction should be reviewed by reviewing clinical plans from companies by December 23. "The number of clinical tasks for each indication and the time period to set the plan must come in and it is difficult to determine whether or not dementia is present even in the first indication," said Lee Yu-bin. "Choline alfoscerate is an old item that has been approved for 95 years, and its efficacy and effectiveness are wide in current standards. If the company prepares a clinical plan with specific indications, it will be possible to adjust the permit even before re-evaluation." "When conducting clinical trials for patients with dementia, it can be done alone or in combination with other drugs, and although there are some standards internally, it is necessary to look at the data submitted by the company," she said. She said that if there is a new overseas basis among domestic clinical reevaluation, it can be used as a reference. The MFDS plans to clarify the special reevaluation target in the future. In this regard, it is an explanation that the details of the reasons for selection have not been detailed in the past, and have not been conducted in connection with the re-evaluation of Choline alfoscerate. "In the future, we will select a special reevaluation target by reviewing it according to standards," said Kim Jeong-yeon. "Choline alfoscerate needs to be validated by the current standards even if there were no problems 25 years ago according to the standards at the time," he said.
- Policy
- MFDS lifts nizatidine sales ban, Alvogen cancels license
- by Lee, Tak-Sun Jul 01, 2020 05:54am
- Alvogen Korea has reportedly cancelled the item license on its nizatidine drug, although its sales ban for containing the unacceptable level of cancerous NDMA was listed. The case proves lifting the sales ban and a company’s will to sell the product are two different matters. On June 25, Korea’s Ministry of Health and Welfare (MOHW) has announced the reimbursement suspension on Alvogen Korea’s seven nizatidine items including Zanitidine tablet 75 mg was listed as notified by Ministry of Food and Drug Safety (MFDS). But apparently Alvogen Korea has cancelled the sales license on Zanitidine tablet 75 mg as of June 24. Ironically, the company returned the license of the product cleared from sales ban. The license cancellation would take Zanitidine tablet 75 mg off the shelf, unless the company reapplies for the license. Technically, such odd situation occurred as the sales ban was lifted not because the responsible company followed through with the process to resume selling the product. Once the pharmaceutical company completes the suspended nizatidine product recall, MFDS allows the product sales to be resumed. But the company has to test NDMA level by each production serialization, and only the acceptable products can be released. The test results are not for MFDS submission, but to be archived by the company. The recall on Alvogen’s Zanitidine tablet 75 mg has been done, but the company’s action could be interpreted that it has no intention to immediately resume sales. Currently, the sales ban on eight out of 13 nizatidine products has been cleared and they can be prescribed normally. MFDS lifted the ban on the products as the responsible companies have fully recalled the products. The other five items cannot be prescribed as the process is unfinished.
- Policy
- Korea Passing Novartis Xolair listed for reimbursement
- by Kim, Jung-Ju Jun 30, 2020 06:10am
- The Korean health authority has decided to grant healthcare benefit from next month on Xolair (omalizumab), the controversial ‘Korea Passing’ drug that withdrew the reimbursement application amid the pricing negotiation to avoid lowering the global price, from next month. The listing of the novel severe asthma treatment Xolair took three months from the first threshold, or the Drug Reimbursement Evaluation Committee (DREC). However, the benefit would be valid only for the Xolair injection first from next month due to the company’s internal supply issue. The 11th Health Insurance Policy Deliberation Committee (HIPDC) meeting was convened on June 26, where Korea’s Ministry of Health and Welfare (MOHW, Minister Park Neung-hoo) has deliberated and decided the approval on new drug reimbursement listing. An image of Xolair injection (Source: DrugInfo) The supplier of the drug Novartis Korea has abruptly withdrew from drug pricing negotiation with National Health Insurance Service (NHIS) on Dec. 20, 20218, after DREC has passed the drug. The company was apparently concerned of the drug pricing in the Chinese market. As the Chinese health authority tends to refer reimbursed drug pricing in Korea, the company unavoidably felt the pressure during the pricing negotiation. Novartis Korea withdrawing the reimbursement application on Xolair was recorded as the first case of ‘Korea Passing’ phenomenon, where a multinational pharmaceutical company discards drug reimbursement in Korea. Since then, the drug was listed for reimbursement in China and it repeated the economic evaluation procedure in Korea for reimbursement listing. In last March, the drug was approved by DREC and successfully completed the pricing negotiation. The maximum reimbursed price of Xolair injection and Xolair prefilled syringe injection in 150 mg dose would be at 271,700 won, and Xolair prefilled syringe injection in 75 mg dose at 143,000 won. But the reimbursement provision period would differ by doses due to the supply issue the company is going through. MOHW stated the reimbursement would be granted on Xolair injection from July 1, whereas the reimbursement on Xolair prefilled syringe injection 75 mg and Xolair prefilled syringe injection 150 mg would be provided from Jan. 1 and Oct. 1 next year, respectively. MOHW official said, “The latest decision on the healthcare benefit for patients with moderate to severe persistent asthma would improve their access to new drug treatment and lessen their medical expense.”
- Policy
- “KRW 10 bln COVID-19 vaccine budget plan unclear and vague"
- by Lee, Jeong-Hwan Jun 30, 2020 06:09am
- The voice of criticism is raised against weak and vague ‘budget plan on COVID-19 treatment and vaccine manufacturing facility establishment support (R&D)’ worth 10 billion won the Korean government included as a part of the third contingency budget plan. They point out a detailed business plan has to be set down first as the budget can be used differently depending on the development of the treatment vaccine. On June 29, the National Assembly Budget Office analyzed and made such comment on the third contingency budget plan of 2020. The treatment and vaccine manufacturing facility establishment support program mainly aims to financially boost the set up of the pharmaceutical manufacturing facility to respond against the COVID-19 pandemic. The program was not included in the original 2020 budget plan, and first and second contingency budget plans of 2020. The National Assembly Budget Office pinpointed the Ministry of Health and Welfare’s (MOHW) budget plan missing a specified business plan although the ministry plans to preemptively support setting up the manufacturing facility for the Korean-developed COVID-19 treatment and vaccine. The National Assembly officials also said the budget could be repurposed depending on the status of treatment and vaccine development. The 10 billion won budget plan appropriated 4.5 billion won and 5.5 billion won on constructing vaccine and treatment manufacturing facilities, respectively. The Budget Office claims the contingency budget plan lacks a clear basis of calculation for the budget appropriation. In detail, MOHW calculated 4.5 billion won would be needed for manufacturing 8.2 million doses of vaccine short from total 62.2 million doses of the two-dose vaccine required for immunizing 60 percent of the overall population (herd immunization threshold). The budget office stated the calculation only considered the required dose for herd immunity, and overlooked the feasibility of execution. The estimated treatment volume was also not properly projected, but apparently the ministry is to prepare it by the end of June. The Budget Office also commented the basis of calculation is weak as the specifics, such as the list of equipment to be funded or the number of pharmaceutical companies to be funded, were not decided. MOHW plans to allocate 2 billion won in constructing manufacturing facility for complete vaccine and 4.8 billion won on constructing treatment manufacturing facility. But the Budget Office sees these figures are inexact and the ministry has not made the decision on the subject pharmaceutical companies, yet. The contingency budget was reprimanded by the Budget Office as it could be used in other purposes besides the initial purpose, based on the development status of the COVID-19 treatment and vaccine. And the Budget Office was disapproving of MOHW suggesting the budget possibly reallocated to manufacture active pharmaceutical ingredient for symptomatic treatment in patients with COVID-19. Apparently, it is not clear if the ministry would withdraw the support plan depending on the high or low possibility of successfully finding COVID-19 treatment or vaccine within this year. The National Assembly Budget Office official stressed, “The ministry’s budget plan lacks a detailed business plan with the list of beneficiary, list of supported equipment, and subject designation standard,” and “The budget execution feasibility would be impacted significantly based on the development progress of the COVID-19 treatment and vaccine. The ministry should thoroughly draw out a business plan to achieve the objective of the program”
- Policy
- Insurance benefits of Dupixent PFS 300mg will be possible
- by Lee, Hye-Kyung Jun 30, 2020 06:08am
- After the approval of the MFDS on April 1, insurance benefits of 'Dupixent PFS 300mg (dupilumab)' will be possible when the adolescent patients are over 18 years old. As a patient with chronic severe atopic dermatitis who is over 18 years of age and has symptoms that persist for more than 3 years, ▲ it is not adequately regulated even after administration of a topical treatment agent (moderate or higher corticosteroid or calcineurin inhibitor) for 4 weeks or more. Reaction even after inhibitor (Cyclosporine or Methotrexate) was administered for 3 months or more (EASI (Eczema Area), and Severity Index) (over 50% reduction), or cannot be used due to side effects, etc. ▲ before starting the administration of the same drug, conditions such as EASI 23 or higher must be satisfied to receive benefits. The HIRA announced on the 26th QnA regarding the application of patient-related reimbursement criteria that began to administer Dupixent in youth. Dupixent has been reimbursed to adult atopic dermatitis since January 1st. Since April 1, the approval age of the MFDS expanded from 'adults' to 'adults and adolescents (over 12 years old)', and it is now possible for adolescent patients to administer drugs at their own expense. The HIRA said, "If adolescent patients over 12 years of age meet the administration target at the beginning of the first dose of Dupixent, they are judged to satisfy the administration target even when they become adults." "It is only possible to be reimbursed if it has been completed." Chronic atopic dermatitis, which persists for more than 3 years, means that the past history of atopic dermatitis diagnosed 3 years prior to the start date of Dupixent's administration is confirmed through the medical records. After the first topical treatment, if Dupixent is administered without systemic immunosuppressants, the patient must bear the full cost of the drug. However, if systemic immunosuppressive drugs cannot be administered due to medical contraindications such as renal failure, uncontrolled hypertension, uncontrolled infectious disease, malignant tumor, and severe liver disease, health benefit may be reimbursed if conditions such as EASI are satisfied. When re-administered after a drug break due to medical reasons, etc. ▲Re-administration of a patient who has been withdrawn prior to the first response evaluation (week 16) corresponds to the initial administration acceptance criteria. ▲ If the holiday period is less than 3 months, it is recognized as continuous administration, and if the holiday period is more than 3 months, the requirements such as the initial acceptance criteria must be met.
- Policy
- α-GPC clinical reevaluation requires ₩50 billion
- by Lee, Tak-Sun Jun 29, 2020 06:13am
- Gliatamin (Daewoong Bio) and Gliatilin (Chong Kun Dang)The industry estimates the cost of clinical re-evaluation of the brain function improving agent 'Choline alfoscerate' to ₩50 billion. This is the amount calculated when conducting clinical trials for all licensed indications. As the amount is large, the cost per company will be determined according to the number of companies participating. According to the industry on the 25th, it is expected that it will cost ₩50 billion to re-evaluate the clinical trial for the indication for the approval of Choline alfoscerate. This is the expected amount when three indications are divided into four clinical tasks. The indication of Choline alfoscerate formulation is ▲1. Secondary symptoms and degeneration or degenerative cerebral stromal psychological syndrome due to cerebrovascular deficiency: decreased sense of memory and confusion, decreased motivation and spontaneity due to motivation and spontaneous decline, decreased concentration, ▲2. Emotional and behavioral changes: emotional anxiety, irritation irritability, indifference, ▲3. Senile pseudodepression; Among the indications, the clinical evaluation for the purpose of alleviating dementia symptoms and the clinical for mild cognitive impairment are four reevaluation clinical tasks. The situation is different depending on the size of product sales by companies, but the top companies are showing that they are going through all four tasks. However, companies with low sales are expected to participate only in clinical trials or give up products. There are only 134 companies subject to clinical re-evaluation of Choline alfoscerate. if 100 companies participate and share the cost, it will cost about ₩500 million. However, this is only a simple calculation, and the situation is different for each company, so the cost of co-clinical trial is expected to be confusing. In the industry, Daewoong Bio and Chong Kun Dang, which have the largest sales, are paying more and expecting to divide the indications and lead clinical trials. An official from a mid-sized pharmaceutical company said, “Clinical cost of ₩50 billion seems to be a large amount, but Daewoong Bio and Chong Kun Dang have annual sales of about ₩70 billion, and assuming that clinical trials last up to 7 years, only 10% of sales are spent.” "We are willing to pay and participate in clinical trials because the indications are maintained during the clinical re-evaluation period and sales can continue."
- Policy
- SNUH started a clinical trial of Remdesivir+Baricitinib
- by Lee, Jeong-Hwan Jun 29, 2020 06:12am
- Seoul National University Hospital announced on the 25th that it will be conducting a follow-up clinical trial of Remdesivir, which has proven effective as a treatment for COVID-19. This is a clinical trial that seeks drug efficacy and safety when Remdesivir is administered alone or when Baricitinib & Remdesivir are administered. Seoul National University Hospital has participated in a global clinical trial hosted by the National Institute of Health (NIH) in the United States and confirmed the therapeutic effect of Remdesivir on COVID-19. This study (ACTT-1) was conducted from February to April, and 73 hospitals from 10 countries participated in a total of 1063 people. As a result, it was confirmed that patients using Remdesivir recovered 30% faster than patients receiving placebo. Remdesivir was recognized as the only antiviral drug that was confirmed to be effective as a COVID-19 treatment, but further investigation of drugs to control active inflammation after viral infection was needed. Accordingly, the international research team is conducting a follow-up study (ACTT-2), and in Korea, Seoul National University Hospital and Bundang Seoul National University Hospital are participating in this study. This study evaluates stability and efficacy by administering a combination of Remdesivir and anti-inflammatory Baricitinib, which have been previously proven effective. Patients are divided into 'Remdesivir + placebo' group and 'Remdesivir + Baricitinib' combination group. The research team is targeting a total of 1032 patients and enrolling patients worldwide. To date, 17 people have registered in Korea. It will be possible to confirm whether recovery time can be further shortened when a combination of Remdesivir and Baricitinib is administered to COVID-19 severe patients with this study. Baricitinib is an oral medication used for rheumatoid arthritis patients who do not respond well to existing treatments and has a mechanism of suppressing inflammation by regulating immune cells. Professor Park Wan-beom (Infectious Internal Medicine) at Seoul National University Hospital recently said that the development of treatments for severe patients is urgent in Korea as the infection of COVID-19 increases in the elderly. Also he said, it is expected that this study will be able to find an effective anti-inflammatory treatment for severe COVID-19 patients.
- Policy
- Boryung's Akave will be newly listed
- by Kim, Jung-Ju Jun 26, 2020 06:42am
- Boryung's Akave 30/10mg will be newly listed next month. This drug is a combination of Fimasartan and Atorvastatin. Guerbet Korea's 14 listed pharmaceutical products, such as Lipiodol ultra liquid (Iodized oil), have a lower price. The MOHW confirmed and revised the list of drug benefits and the upper limit. It will take effect from July 1st. The price of 653 items including Boryung's Akave 30/10mg, is automatically calculated and placed on the reimbursed list. Handok Aricept Chong Kun Dang Dilatrend SR cap 16mg Menarini Facpent Nasal Spray Akave 30/10mg is set at ₩902 and Akave 60/10mg at ₩1,013. Handok’s Aricept 23mg is ₩3,952, Chong Kun Dang’s Dilatrend SR 16mg is ₩544, and Menarini’s Facpent nasal spray 100mcg is at ₩43,920. Dong-A ST’s Sivextro 200mg will be removed from the list. The total number of transferable items is 77. The average price of 14 pharmaceutical products including Huon's Zopista 1mg drops by 18.1%. Changes in drug prices in July for added items (cuts) Guerbet Korea's Lipiodol ultra liquid has a lower price limit from ₩190,000 to ₩133,000, Zopista 1mg is ₩108 to ₩92, Samjin’s Serocover is from ₩603 to ₩590, and Nexpharm Korea’s Cloren is from ₩1,209 to ₩1,004, Jeil's Eldoten is cut from ₩196 to ₩189. PMG’s Rabepran 10mg drops ₩534 to ₩519, Astellas’ Betmiga PR tab 50mg from ₩712 to ₩498, Hanmi’s Ripratin 5mg/ml from ₩371,786 to ₩317,627, Yuhan's Anagre 0.5mg falls from ₩2,748 to ₩2,167, and Shire’s Agrylin 0.5mg falls from ₩2,832 to ₩2,167, respectively.
