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- 2026-05-20 07:16:29
- 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”
- Company
- Spravato, a nasal spray for TRD entered the domestic market
- by Eo, Yun-Ho Jun 30, 2020 06:09am
- Spravato is the first nasal spray medication, taken along with an oral antidepressant, for adults with treatment-resistant depression (TRD) and it enters the domestic market. According to the related industry, Janssen’s Spravato nazal spray (Esketamine HCl) as a treatment for moderate to severe major depressive disorder (treatment-resistant depression) in adults who do not adequately respond to at least two different oral antidepressants from the MFDS on the 23rd has been approved for oral antidepressant use in combination. Treatment-resistant depression refers to a case in which patients who are currently suffering from major depressive disorder (MDD) have taken two or more other antidepressants at appropriate doses for a sufficient period of time, but do not improve their symptoms due to inadequate response. In general, it is estimated that about one-third of patients with depressive disorder correspond to treatment-resistant depression. Spravato is a new mechanism of nasal spray treatment that first appeared in the field of treatment-resistant depression and 30 years in the major depressive disorder. The main component of Spravato, Esketamine, improves the symptoms of depression by regulating the activity of glutamic acid receptors called NMDA receptors in the brain to restore synaptic connections and increase neurotrophic signaling. The efficacy of the drug has been demonstrated in a phase III clinical trial consisting of short-term and long-term clinical trials in more than 1700 adult patients with treatment-resistant depression. In a short-term clinical trial of treatment-resistant depression between 18 and under 65 years of age, the combined group of patients with Spravato and oral antidepressants showed a decrease of 19.8 points on the Montgomery-Asberg Depression Assessment Scale (MADRS) over a 4-week treatment period. On the other hand, the group of patients receiving placebo and oral antidepressants in combination showed a decrease of 15.8 points, and statistically, it was confirmed that the symptoms of the group of patients receiving combination of Spravato and oral antidepressants were improved. In a long-term clinical study, patients who had stable remission by using Spravato and oral antidepressants were found to have a 51% reduction in the likelihood of recurrence of depressive symptoms compared to those who received placebo and oral antidepressants. Deok-in Jeon, Chairman of the Korean Society for Affective Disorders, said, "Resistant depression, which has a longer duration of disease and more severe symptoms than normal depression, causes serious pain to patients and their caregivers. Approval of Spravato is an innovative treatment option for new mechanisms in the field of depression that have not had new drugs in the past decades."
- 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.
- Company
- Prevymis by MSD is noted whether it is listed
- by Eo, Yun-Ho Jun 29, 2020 06:13am
- It is noteworthy whether the coverage for prevention of cytomegalovirus, infection in allogeneic hematopoietic stem cell transplant patients will be expanded. According to related industries, 'Prevymis (Letermovir)', a preventive treatment for cytomegalovirus (CMV) infection in allogeneic hematopoietic stem cell transplant patients, which passed the Pharmaceutical Benefits Advisory Committee of the HIRA last month, will enter into drug price negotiations with the NHIS. It is interpreted that the evaluation of the adequacy of Prevymis is clinically useful and cost effective compared to the case which is not prevented. This is similar to the government's policy to strengthen health insurance coverage. Allogeneic hematopoietic stem cell transplantation is essential for the treatment of severe hematologic cancer patients such as acute myelogenous leukemia and acute lymphocytic leukemia The government has increased the age limit for the payment of hematopoietic stem cell transplants from under 65 to under 70 in 2019 as a policy to strengthen health insurance coverage. Efforts have been made to revitalize transplants and reduce costs, including recognizing primary allograft as a nursing care benefit. When cytomegalovirus (CMV) is reactivated in patients with hematopoietic stem cell transplantation, diseases such as pneumonia, hepatitis, myocarditis, gastroenteritis, and encephalitis develop. Even if the level of CMV is low, it has an effect on mortality. In the case of hematopoietic stem cell transplantation patients with CMV infection, there is a report that the mortality rate during initial hospitalization is 3.5 times higher than that of non-infected patients, and the risk of death is 2.6 times higher in patients with CMV viremia at the early stage of transplantation (within 60 days). However, CMV treatment in allogeneic hematopoietic stem cell transplantation patients is currently relying on pre-emptive administration of antiviral agents when the concentration of virus in the blood exceeds a certain level. Sung-Soo Yoon (SNU), Chairman of the Korean Society of Hematology said, "The limitations of current preemptive treatments that can only be started after the CMV blood level reaches the threshold are clear. In particular, the demand for treatment sites for Prevymis is increasing, as it is an important drug treatment option for survival of high-risk patients.." Prevymis clinically demonstrated the inhibition of CMV reactivation and the reduction of mortality. Also, no adverse reactions related to myelotoxicity and nephrotoxicity occurred. Previmis is recommended as a prophylactic agent for allogeneic hematopoietic stem cell transplant patients with CMV seropositivity in the 2019 guidelines of the National Comprehensive Cancer Network (NCCN) and the European Conference on Infections on Leukemia (ECIL).
- Company
- Boycott Japan: Drug import rather increased in a year
- by Kim, Jin-Gu Jun 29, 2020 06:13am
- During a year of the Koreans boycotting against Japanese-made products, the total imported Japanese pharmaceutical sales have increased even more. But the trade balance has improved as the Korean-made pharmaceuticals exporting to Japan surged as well. Daily Pharm analyzed Korea Customs Service today and found the Japanese-made pharmaceutical import volume has increased by 2.1 percent from the time before the boycott. From the start of the boycott against Japanese product in June last year to May this year, the overall USD 390 million (approximately 469.6 billion won) of Japanese-made pharmaceuticals were imported in the year. Compared to the year before (June 2018 to May 2019), the figure jumped 2.1 percent (approximately 459.9 billion won) from 382 million dollars. The pharmaceutical import contrasts greatly against the overall Japanese product import volume plummeting by 11.8 percent from 51.54 billion dollars to 45.48 billion dollars. However, the trade balance has apparently improved with a steep increase in Korean-made pharmaceutical export to Japan. A year prior to the boycott, the export to Japan generated 193 million dollars, but during the year of boycott the figure leapt by 56.1 percent recording 310 million dollars. Due to the boycott, the trade deficit with Japan was dropped by about 100 million dollars from 189 million dollars to 89 million dollars. The change in pharmaceutical import and export with Japan from a year before (June 2018 to May 2019) and after (June 2019 to May 2020) the boycott against Japan. The Japanese-made pharmaceutical import rose (left) slightly, whereas the overall Japanese product import plunged by over 10% (Unit: USD 1 million) Source: Korea Customs Service The statistics show Korea has made trade surplus with Japan in January, April and May this year. For last two years, the pharmaceutical trading with Japan has never marked a monthly trade surplus. The pharmaceutical trade surplus with Japan generated 10 million dollars (exported 35 million dollars, imported 26 million dollars), 2 million dollars (exported 34 million dollars, imported 31 million dollars) and 3 million dollars (exported 24 million dollars and imported 21 million dollars) in January, April and May, respectively. The changes in trade balance with Japan in last two years. Korea made surplus in January, April and May this year (Unit: USD 1 million won) Source: Korea Customs Service The rare trade surplus aside, the Koreans boycotting against Japanese products does not seem to have brought a dire impact on the pharmaceutical sector. The monthly pharmaceutical import from Japan has been fluctuating from June to December last year, respectively marking 32 million dollars, 46 million dollars, 24 million dollars, 32 million dollars, 37 million dollars, 31 million dollars and 33 million dollars. The impact of boycotting was insignificant in pharmaceutical import this year as Korea imported 26 million dollars, 38 million dollars, 38 million dollars, 31 million dollars, and 21 million dollars of Japanese-made pharmaceuticals in January to May, respectively. Changes in Japanese pharmaceutical import from June 2018. Since June 2019 when the boycott movement started, the import volume fluctuated noticeably (Unit: USD 1 million) Source: Korea Customs Service The trend is also apparent in the outpatient prescription drug sales of top Japanese pharmaceutical companies in Korea until May. A pharmaceutical market research firm UBIST found Astellas Korea, Daiichi Sankyo Korea, Eisai Korea, Takeda Pharmaceutical Korea, Santen Pharmaceutical Korea and Korea Otsuka Pharmaceutical have generated total of 663.9 million won from outpatient sales within a year (June 2019 to May 2020). Compared to the outpatient drug sales performance in the year before (June 2018 to May 2019) at 662.7 million dollars, the figure only grew by 0.2 percent. Basically, the boycott has not affected the prescription drug sales. The change in prescription sales of Japanese pharmaceutical company product from a year before (June 2018 to May 2019) and after (June 2019 to May 2020) the boycott against Japan. Six companies did not demonstrate significant difference. (Unit: KRW 100 million) Source: UBIST The Koreans have revved up the boycott against Japanese products from June last year. When the Japanese government has reportedly decided to restrict the export of key material used in semi-conductor manufacturing, a large number of Korean consumers responded back by boycotting against Japanese-made beer, automobile, and consumer products. Regardless, the consumer boycott was unnoticeable in the pharmaceutical industry. The industry experts claim the boycott would have unlikely to target prescription drugs as they are, unlike OTC drugs, directly related to the people’s health. The majority of Japanese-made prescription drugs are original drugs with no alternative options used for highly severe diseases, which is why the switching drugs for the sake of boycotting would be unconvincing. In fact, Korean pharmacist groups have assertively participated in the boycott, but healthcare professionals did not openly join the movement.
- Company
- Dong-A ST is first to evade antidiabetic Forxiga patent
- by Lee, Tak-Sun Jun 29, 2020 06:13am
- For the first time in Korea, Dong-A ST has successfully evaded pharmaceutical patent on sodium-glucose co-transporter-2 (SGLT-2) inhibiting antidiabetic treatment Forxiga (dapagliflozin) by AstraZeneca. According to the pharmaceutical industry on June 25, Dong-A ST’s request for the negative scope confirmation on two Forxiga patents was accepted on June 23. The original drug has two substance patents to expire on Apr. 7, 2023 and Jan. 8, 2024, respectively. Following the legal proceeding, Dong-A ST would be the first company to knock on the follow-on dapagliflozin drug market. Dong-A ST is the only company that either evaded or nullified the original’s patent expiring on Apr. 7, 2023. The company would be able to launch a dapagliflozin product immediately after receiving the government’s approval. Other companies cannot launch a follow-on drug until Apr. 7, 2023 when the patent actually expires. The key to Dong-A ST’s patent evasion was modifying the original drug structure. For the patent-evaded dapagliflozin drug, the Korean company plans to conduct a Phase I trial and apply for item approval in the second quarter next year. If the product gets released next year, it would be two years earlier than other competitors. In the current antidiabetic treatment market dominated by DPP-4 inhibitor and SGLT-2 inhibitor, Dong-A ST would significantly expand its pie in the market with its independently developed new dipeptidyl peptidase 4 (DPP-4) inhibitor Suganon and the SGLT-2 inhibitor.
- 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.
- Policy
- Hanmi's Cossac was voluntarily withdrawn
- by Lee, Tak-Sun Jun 26, 2020 06:23am
- Cossac, which was once a representative medicine of sinus cold, disappeared. It was predicted when Hanmi switched marketing to 'Cossac-L', an upgraded item when it switched to Pseudoephedrine combination drug. However, since products converted to precription drugs at that time did not recover sales during OTC, it is understood that the re-classification of Pseudoephedrine combinations has weakened competitiveness. According to the industry on the 25th, 'Cossac' (Cetirizine HCl + Pseudoephedrine HCl) was voluntarily withdrawn on the 24th. As Hanmi strategically launched the upgraded drug 'Cossac-L' (Levocetirizine HCl + Pseudoephedrine HCl) in 2014, targeting the Prescription drug market, Cossac’s sales was decreased. However, Cossac is the first licensed product among the combinations of Cetirizine HCl and Pseudoephedrine HCl, and it is a pity that it was a popular item in the pharmacy market before switching to prescription drugs. At the end of 2013, the MFDS switched the combination drug containing Pseudoephedrine 120 mg from OTC drug to prescription drug. Cossac was a product of ₩2 billion at the time. Hanmi has been keeping in the lead in related items, considering the conversion of prescription drugs and switching marketing to 'Cossac-L', an upgraded item. Cossac had no outpatient prescription sales last year. 34 out of 50 Pseudoephedrine combinations that have been converted from OTC to are considered to have retained permission in 2013. 16 items were withdrawn from the market. An official in the pharmaceutical industry said, "Re-classification in 2013 became a bad news as items like Cossac lost competitiveness when switching to prescription drugs."
