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- 2026-05-20 12:38:13
- Opinion
- [Reporter’s view] Pharmacist's role to meet post COVID-19
- by Kim, Min-Gun Apr 29, 2020 04:59am
- COVID-19 is changing our lives and culture itself with more powerful infectious power than any other epidemic. Telecommuting and video conferencing, represented by social distance, began in earnest, and online shopping malls are booming. It is a daily routine of non-facing contact. Hong Nam-ki, Deputy Prime Minister and Minister of Economy and Finance also pointed to non-face-to-face meetings such as teleconference and video conferencing for economic policy since COVID-19 outbreak. In order to prevent the spread of infection in medical institutions, the government even allowed non-face-to-face treatment for people with chronic diseases and the elderly. The U.S. FDA also issued a deregulation guideline that lowered the barrier to entry into telemedicine during the COVID-19 epidemic in March. This is to activate telemedicine to prevent infection between face-to-face contacts. Non-face-to-face treatment is an issue directly related to the delivery of prescription medicines. The Korean Pharmaceutical Association is concerned about this. The government reassured that there was no expansion of telemedicine beyond the current law, saying that non-face-to-face care is needed to protect medical institutions and patients from COVID-19, a highly contagious infection. However, it is a sign that non-face-to-face counseling, such as telemedicine, will become necessary in the future in response to infectious diseases. However, the current social distance is accompanied by economic losses. There are also a lot of people who are tired of restraining outside activities. Accordingly, the government is considering the future health care system. There will be active discussions regarding non-face-to-face contact policies. The government is preparing to switch to a non-face-to-face, life-prevention system. It becomes social distance campaign in life. The most important countermeasures against the epidemic have been proved that quarantine measures through rapid inspection and confirmation, and that essential quarantine supplies should be supplied in a timely manner. This means that the diagnosis and prevention of infectious diseases is not the only role of medical institutions. Through the 5-day rotation mask distribution system, it was recognized that the pharmacy's role in the daily life prevention system is important. As the interest in the role of the pharmacist's skill that has been overlooked has been refocused, the pharmacist society should not be left behind by the post-COVID-19 era that will change in the future rather than clinging to telemedicine issues. The role of the pharmacist's function in the era of infectious diseases and the future are even more important. Masks, hand sanitizers, and disinfectants can also be bought at marts, but an expert who can explain the exact range of use and how to do it can be done by a pharmacist at the pharmacy. The role of the pharmacist in the daily life prevention system is inevitable. The pharmacist should conduct specialized training to cope with infectious diseases, and the trained pharmacist should be more professional in the prevention of life. In addition, specialized pharmacists in the prevention of infectious diseases should be fostered in accordance with the legislation of the specialized pharmacist system. If the pharmacist's skill is specialized, the opinion that pharmacists should be included in the health care providers will be more supported. In this case, expansion of the pharmacist's competency may also be considered. It can be considered that if the patient's care and prescription are stopped in response to an infectious disease that occurs simultaneously in a specific local medical institution, it is considered to be in accordance with the exhibition situation. If patient care and prescriptions are stopped in response to infectious diseases that occur simultaneously in certain local medical institutions, it will be like wartime situation. Before separation of prescribing and dispensing drugs, the pharmacy directly diagnosed the patient and took the role of prescribing and dispensing. In order to prevent the collapse of the health care system in the epidemic area, Measures for prescribing medicines temporarily by local pharmacies may be considered. Systematic protection measures should be prepared, such as storing personal protective equipment (PPE) for each pharmacist society and distributing it to member pharmacies when an epidemic occurs.
- Policy
- CSL, Australian company, licensed for business in Korea
- by Lee, Tak-Sun Apr 28, 2020 06:24am
- CSL, an Australian global pharmaceutical company, conducts full-scale marketing in Korea. It was the first time in the domestic pharmaceutical industry to acquire a business license and an item license. CSL Behring Korea, a subsidiary of CSL, received a drug import license from the MFDS on the 16th. General manager, Ji-Young Sohn, who has served as the marketing and strategy planner of Korea Pfizer Pharmaceuticals and the head of the department of anti-cancer drugs at Roche Korea. Sohn is a pharmaceutical management expert who graduated from the College of Pharmacy at Ewha Womans University and Korea University (MBA) Along with the business license, CSL Behring Korea also brought permission to approve ‘Afstyla’, a type A hemophilia treatment. This product, which was licensed in January, was the first subsidiary of Zuellig Pharma Korea Ltd. to be registered as a license holder. This is because CSL Behring Korea did not obtain a business license, so Zanovex Korea acted as an item license. However, recently, Afstyla's license for item approval has been changed to CSL Behring Korea. Afstyla is now owned by CSL because it is generally assumed that the licensed company holds the copyright. However, Afstyla will be sold by SK Plasma. Unfortunately, Afstyla is a product developed by SK Chemicals, a subsidiary of SK Plasma, to preclinical and technically exported to CSL. In March, it was approved for the marketing of the type B hemophilia treatment drug 'Idelvion'. Janovex Korea is also registered as a license holder. Idelvion will also be transferred to CSL Behring Korea in the near future. CSL Behring is a global pharmaceutical company with hemophilia treatment and rare disease treatment, and is a subsidiary of the Australian CSL Group. It has expanded into 60 countries worldwide and is headquartered in Pennsylvania, USA. Afstyla and Idelvion, which have been licensed this time, are evaluated as drugs with a significantly improved half-life than conventional hemophilia drugs. However, it is unlikely that the domestic market will be settled. The size of the domestic hemophilia treatment market is about ₩180 billion, of which Type A treatment accounts for 80%, and the Green Cross is dominated. In the case of Shire's highest-selling Adbate, Green Cross sells, and the second-largest product, 'Greengene F', is a product of Green Cross. Pfizer's Benefix has the largest share of type B drugs. In the case of hemophilia treatment, the Koham has great influence, so pharmaceutical companies with high contribution are currently leading the market. In this situation, it is unclear whether CSL, a latecomer, will settle into the domestic market with only upgraded products. This is because SK Plasma, a sales agent, is not a very influential pharmaceutical company in the domestic hemophilia treatment market.
- Company
- General hospitals ready to prescribe Verzenio
- by Eo, Yun-Ho Apr 28, 2020 06:24am
- The general hospitals in Korea have started entering the anticancer treatment Verzenio’s prescription code. According to pharmaceutical industry sources, drug committees at major general hospitals like Seoul National University Hospital, National Cancer Center, Ajou University Hospital and Chonnam National University Hwasun Hospital have recently cleared Lilly’s Verzenio (abemaciclib). When the company successfully completes the pricing negotiation with National Health Insurance Service (NHIS), Verzenio would be prescribed more consistently with the insurance reimbursement. The medication is in process of settling a risk sharing agreement (RSA) to receive reimbursement to treat patients with HER2- advanced breast cancer in combination with AstraZeneca’s Faslodex (fulvestrant). Cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor Verzenio can be prescribed to perimenopausal women with HR+/HER2- advanced or metastatic breast cancer either for first-line endocrine therapy combined with an aromatase inhibitor, or for combination therapy with Faslodex after receiving endocrine therapy. The first-in-class CDK4/6 inhibitor Ibrance by Pfizer requires seven days of off treatment after 21 consecutive days of once-daily 125 mg administration, whereas Verzenio can be administered every day. Ibrance is also negating with the government over the pricing, at the moment. Ibrance’ efficacy of significantly improving progression-free survival (PFS) as a second-line therapy has been confirmed during PALOMA-3 study. Besides patients with early stage breast cancer, the CDK4/6 inhibitor showed consistent effect on patients with stage 4 metastatic breast cancer that affected their lungs and bones. Verzenio has recently attracted the industry’s interest, when it completed MONARCH2 study as it not only improved PFS, but also improved overall survival (OS). The achievement was unprecedented for a CDK4/6 inhibitor. As a part of secondary endpoints, the OS of both pre and postmenopausal women was observed.
- Company
- Boryung records new quarterly operating profit
- by Chon, Seung-Hyun Apr 28, 2020 06:23am
- Boryung showed good results in the first quarter. Despite COVID-19, operating profit was the largest ever. Sales also rose from last year. The self-developed drug 'Kanarb Family' led the improvement. Boryung announced on the 24th that its operating profit in the first quarter increased by 42.1% year-on-year to ₩13.4 billion. During the same period, sales increased by 13.0% year-on-year to ₩134.2 billion, and net profit decreased 6.1% to ₩8.3 billion. 1Q operating profit is the largest ever. It surpassed ₩11.9 billion recorded in the third quarter of last year. After the spread of COVID-19, patients' concerns about sluggish sales due to a decrease in visits to medical institutions were dispelled. Kanarb Family led the rise in earnings. According to pharmaceutical research firm UBIST, Kanarb recorded an outpatient prescription amount of ₩12.3 billion in the first quarter. It increased 5.8% from the same period last year. Kanarb (Fimasartan), is an ARB (Angiotensin II receptor blocker) type hypertension treatment developed by Boryung. The growth trend of combination drugs using Kanarb was remarkable. 'Dukarb', a combination of Kanarb and calcium channel blocker (CCB) drug 'Amlodipine', was prescribed in the first quarter of ₩8.4 billion, an increase of 26.2% from the same period last year. 'Tuvero', which combines Kanarb with 'Rosuvastatin', an ingredient for hyperlipidemia treatment, was prescribed amount of ₩1 billion. The four combination drugs including Kanarb, such as Dukaro (₩200 million) combination of “Fimasartan, Amlodipine, and Rosuvastatin” released in February, jointly totaled ₩21.9 billion in the first quarter alone. The anti-ulcer drug “Stogar” also contributed to the increase in earnings. Stogar's prescription performance in the first quarter was ₩5.1 billion, up 64.5% from the previous year. Stogar is the same H2 receptor antagonist that was discontinued last year due to excessive detection of impurities, and prescriptions surged due to reflex benefits from Ranitidine withdrawal. The growth trend of new drug products, which have been licensed by multinational pharmaceutical companies, also contributed to the expansion. 'Trulicity', a diabetes treatment drug introduced and sold by Boryung from Lily, recorded an outpatient prescription amount of ₩8.3 billion, up 19.4% YoY in 1Q. The company explained that the spread of COVID-19 contributed to improved profitability. The decrease in sales management expenses due to the contraction of operating activities contributed to the increase in operating profit.
- Company
- Flu drug prescription plummets by 21% due to COVID-19
- by Kim, Jin-Gu Apr 28, 2020 06:23am
- The general prescription volume of influenza medications treatment has gone down drastically. Compared to the previous season, this season’s volume has plummeted by 21.0 percent. The flu treatment prescription seems to have been affected by the COVID-19 outbreak. The threat of the virus has particularly raised the awareness of personal hygiene nationwide, which ironically ended the flu season earlier than expected. ◆Lowest prescription volume in last six seasons, generics got impacted worse than the original According to the data released by pharmaceutical market research firm UBIST on Apr. 23, total 15.3 billion won was generated from prescribed flu medications in Korea from November 2019 to March 2020. Compared to 19.4 billion won made in the previous flu season (November 2018 to March 2019), the volume fell significantly by 21.0 percent. Since the 2014-2015 season six years ago, the prescription volume has hit the lowest point. (Left) Prescription volume of Tamiflu and generic in last six influenza season (Unit: KRW 100 million) Source: UBIST. (Right) Number of influenza patients in last six seasons* (Unit: 10,000 people) Source: Health Insurance Review and Assessment Service. *Accurate number of patients has not been reported, yet, for the 2019-2000 season. Most of the 38 medications in Korea took the steep fall. Even the prescription volume of Roche’s Tamiflu, the original oseltamivir, was decreased by 18.3 percent from 6.2 billion won to 5.0 billion won. The 37 oseltamivir generics had even steeper fall of 22.5 percent and the volume plunged from 13.2 billion won in the previous season to 10.3 billion won this season. Major generic products like Hanmi Pharmaceutical’s Hanmi Flu prescription volume had a 31.0 percent dip from 4.7 billion won to 3.2 billion won, while the volumes of Kolon Pharmaceutical’s Comyflu, Yuhan’s Yuhan N Flu and Jeil Pharm’s Flu-one were loweredl by 8.4 percent (from 1.3 billion won to 1.2 billion won), 25.7 percent (from 1.1 billion won to 800 million won) and 16.8 percent (from 600 million won to 500 million won), respectively. In this season, on the contrary, the prescription volumes of Arlico Pharm’s Tamipro (30.8 percent), CTC Bio’s Easy Flu (16.9 percent) and Boryung Biopharma’s Boryung Flu (1.8 percent) have surged, regardless of the decrease in general patient size. Comparing prescription volume of major flu treatment in 2018-2019 season and 2019-2020 season (Unit: KRW 1 million) Source: UBIST ◆Flu season ends 84 days shorter, “Infection was well-controlled due to COVID-19”” The flu medication prescription volume is heavily affected by the severity and patient size of the respective flu season. In the 2017-2018 flu season that reach the highest flu treatment prescription volume at 30.7 billion won, the flu patient size also reached the highest at 2.24 million. And this season has ended earlier than usual with far less patient size. The Korea Centers for Disease Control and Prevention (KCDC) has lifted the influenza alert on Mar. 27, after 134 days. Considering the 2018-2019 flu season lasted for 218 days, the last season lasted 84 days shorter. Apparently, the severity of the influenza was not so potent. Only average of 5.9 out of 1,000 people was infected by the flu, which is the lowest figure in the latest six seasons. In the previous season, the average rate was at 6.3 out of 1,000 people. Duration of flu seasons and average patient number in 1,000 people. Source: KCDC The pharmaceutical industry experts claim the COVID-19 outbreak has ironically help the flu season to end faster. As the novel coronavirus spread through the country, majority of the people in Korea stayed at home and paid an extreme attention to their own personal hygiene, which prevented severe spread of the influenza. A pharmacist with a pharmacy in the metropolitan area commented, “Even in last January, three or five Tamiflus were sold a day, but since the COVID-19 outbreak the number dropped to zero. As so many people are avoiding outdoor activity and paying a close attention to personal hygiene, the number of patients with influenza and common colds has gone down significantly.”
- Company
- Rx amount for Ezetimibe·Statin increased 5 times in 4 years
- by Chon, Seung-Hyun Apr 28, 2020 06:23am
- The combination of Statin and Ezetimibe in the hyperlipidemic drug market is rapidly increasing. Over the past four years, outpatient prescription amount has increased five times. It was prescribed more than ₩100 billion in the first quarter. The prescription scale of the combination of 'Rosuvastatin·Ezetimibe' such as Hanmi's 'Rosuzet', MSD's 'Atozet', and Yuhan's 'Rosuvamibe' has expanded rapidly. According to UBIST, a pharmaceutical research institute on the 23rd, the outpatient prescription scale of the combination of Ezetimibe and Statin in the first quarter was ₩109.1 billion, an increase of 23.3% from the previous year's ₩885 billion. The combinations of Statin·Ezetimibe have become increasingly popular in recent years. In the first quarter of 2016, the prescription amount of Statin·Ezetimibe was only ₩23.8 billion, but it expanded 4.6 times in four years. Quarterly Statin·Ezetimibe outpatient Rx amount (Unit: ₩100 million, Source: UBIST) The combinations of Statin·Ezetimibe have an excellent effect on lowering low-density low-protein cholesterol (LDL-C), and it is not expensive, so it seems to have a high preference. In recent years, it is analyzed that the market size has expanded as domestic pharmaceutical companies have competitively released combination drugs combining Rosuvastatin and Ezetimibe. In Korea, a combination of Ezetimibe and Statins such as Simvastatin, Rosuvastatin or Atorvastatin is on the market. The growth of 'Rosuvastatin and Ezetimibe' combinations has been outstanding. In the first quarter, the prescription size of 'Rosuvastatin and Ezetimibe' combinations amounted to ₩80.9 billion, accounting for 74.1% of the prescription amount of 'Statin and Ezetimibe' combinations. At the end of 2015, Hanmi’s Rosuzet, the combination of 'Rosuvastatin and Ezetimibe' first released on the market. The combination of 'Rosuvastatin and Ezetimibe' continued to rise sharply after exceeding ₩10 billion in prescriptions in the second quarter of 2016. In the first quarter of 2017, it soared from ₩27.4 billion to three times in three years. Currently, the competition is fierce, with 29 pharmaceutical companies offering 'Rosuvastatin·Ezetimibe' combinations. Rosuzet's 1Q prescription amount was ₩22.8 billion, up 27.4% from the previous year. After recording the prescription amount of ₩80 billion last year, this year is expected to exceed ₩100 billion. Outpatient Rx amount of Statin·Ezetimibe by month (Unit: ₩1 million, Source: UBIST) Hanmi secured the right to use Ezetimibe from patent holder MSD, and the strategy that entered the market before competitors was effective. Since October last year, Rosuzet has continued its monthly prescription amount of ₩7 billion and recorded ₩8 billion last month. Among the combinations of 'Rosuvastatin·Ezetimibe', Yuhan's Rosuvamibie recorded a prescription amount of ₩13.3 billion in the first quarter. It has risen 27.9% YoY and has established itself as the company's flagship product. HK inno.N's 'Robazet' was prescribed by ₩5.3 billion in the first quarter, up 21.5% from the same period of the previous year, leading the rise in the combination of 'Rosuvastatin·Ezetimibe'. The rise in the combination of Atorvastatin·Ezetimibe is also noteworthy. The MSD's Atozet, combination of Atorvastatin·Ezetimibe, which was ₩10.8 billion in the first quarter, up 20.8% from the previous year. Atozet is being sold jointly by MSD and Chong Kun Dang. On the other hand, the prescription amount of Simvastatin·Ezetimibe was somewhat low. In the first quarter, the prescription amount of Simvastatin·Ezetimibe was ₩10.3 billion, a 3.9% decrease from the same period last year. The combination of Simvastatin·Ezetimibe released first among the combination of statin·ezetimibe, but its share was the lowest. The original product MSD's 'Vytorin' prescription amount in the first quarter was ₩5.3 billion, down 19.8% from the previous year. Vytorin is analyzed to have significantly lowered its market share due to advances such as Rosuvastatin· Ezetimibe combinations.
- Company
- Xarelto-Eliquis follow Lixiana dominating NOAC market
- by Kim, Jin-Gu Apr 27, 2020 06:11am
- Lixiana has reaffirmed its dominance in the non-vitamin K antagonist oral anticoagulant (NOAC) market. Eliquis has gotten close to taking over the second place from Xarelto with ever more intense competition in the market,. First released in last June, generic products of Eliquis are expanding their pies. Currently, 12 products are released and their total prescription volume takes about 11.1 percent of Eliquis’. ◆Lixiana tops again, Xarelto and Eliquis head-to-head over the second place According to pharmaceutical market research firm UBIST on Apr. 22, Lixiana has generated 15.8 billion won from prescription in the first quarter. The figure was up by 15.1 percent than last year’s first quarter at 13.7 billion won. After taking over the top place in January last year, the drug has been leading the market for last 15 months straight. Although it followed into the market after the first-in-class, Lixiana’s prescription volume skyrocketed with a boost from a co-marketing deal with Daewoong Pharmaceutical. And the long-term stock-out period of Xarelto, caused by the maintenance work at Bayer’s German manufacturing facility, has probably affected Lixiana’s successful run. Quarterly prescription volume trend in major NOAC products (Unit: KRW 100 million) Source: UBIST On the other hand, Xarelto and Eliquis were battling over the second place. Both drugs actually made 12.3 billion won from prescription in the first quarter. But at the end, Xarelto made 12,283,260,000 won and Eliquis made 12,280,810,000 won, ranking them on the second and the third, respectively, with the difference of 2.45 million won. Their prescription volumes compared to last year’s first quarter were increased by 2.3 percent and 6.8 percent, respectively. Xarelto had to give up its top spot to Lixiana in January 2019, and now its second place is threatened by Eliquis. From last November to past February, Eliquis topped over Xarelto in prescription volume. ◆Apixaban generic’s prescription volume grows over 2.7 times in six months The apixaban generics would eventually affect the fierce competition between Eliquis and Xarelto. Since June last year, generic version of Eliquis like Chong Kun Dang’s Liquisia, Yuhan’s Yuhan Apixaban, Samjin Pharm’s Elxaban, Hanmi Pharamceutical’s Apixban, Aju Pharm’s Eliban and YooYoung Pharmaceutical’s Yupix have entered the NOAC market. In the first quarter, Liquisia has generated the most at 394.56 million won and Yuhan Apixaban, Elxaban, Apixban, Eliban and Yupix followed with 226.64 million won, 222.0 million won, 145.14 million won, 131.06 million won and 114.67 million won, respectively. The generic prescription volume has not been so overpowering to threat the originals, yet. The total volume took up 11.1 percent of the original’s, generating approximately 1.4 billion won. But the volume has increased steeply by 2.7 times since the last third quarter making 400 million won, while the original Eliquis’ volume growth has been sluggish. Considering other generics jumping into the NOAC market, the apixaban generic pie would grow even further. So far, the Ministry of Food and Drug Safety (MFDS) has approved of 42 apixaban generics. Quarterly Apixaban generic prescription volume in last one year (Unit: KRW 1 million) Source: UBIST ◆Eliquis pricing reduction postponed yet again Another variable in the market is pricing reduction in Eliquis. According to the court’s decision, the government-authorized Eliquis pricing reduction has been suspended temporarily. In January, the Seoul High Court has ordered the Ministry of Health and Welfare (MOHW) to temporarily halt the pricing reduction execution on Eliquis. The court ruled the pricing reduction should be postponed until the current proceeding of litigation is concluded. Initially, Eliquis’ pricing was supposed to be reduced by 30 percent from July last year after the generics’ launch in June. But the enforcement of the new pricing was halted as Bristol-Myers Squibb (BMS) has filed for an administrative litigation. Although the first trial was rejected as the court ruled in favor of the ministry and the pricing reduction, the ministry’s action was halted again as BMS filed for an appeal. The appeal is expected to be concluded in the latter half of the year. If the court rules favorable for MOHW again, Eliquis’ pricing would be reduced by 30 percent and its prescription sales would drop, accordingly.
- Company
- “Considering treatment options for ankylosing spondylitis”
- by Eo, Yun-Ho Apr 27, 2020 06:10am
- Professor Nam Seoung Wan In the autoimmune disease area, where tumor necrosis factor alpha (TNF alpha) inhibitor is leading the prescription market, various options of oral Janus kinase (JAK) inhibitors have been released so far. Guidelines on treating ankylosing spondylitis and spondylarthritis in Korea and other countries have a tendency to emphasize starting the first-line treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) in patients showing symptoms. And for patients not sufficiently benefiting from NSAIDs, the treatment guidelines recommend using biologics like TNF alpha inhibitor, considering the patient’s disease activity. And in 2016, a guideline by Assessment of Spondyloarthritis International Society/ European League Against Rheumatism (ASAS-EULAR) recommended using TFN alpha inhibitor for first-line biologics with the most amount of clinical data accumulated, but also recommended switching to other TNF alpha inhibitor or interleukin (IL)-17 inhibitor options when showing no response to the initial option. Moreover, American College of Rheumatology (ACR) and Spondyloarthritis Research and Treatment Network (SPARTAN) updated their guidelines last year and made a notable recommendation of using oral JAK inhibitor Xeljanz (tofacitinib) with an ongoing Phase III clinical study, besides using biologics like TNF alpha inhibitor (injection) and IL-17 inhibitor. Also, instead of using Cosentyx (secukinumab) that received approval first, the updated recommendations mentioned of using Taltz (ixekixumab) and TNF alpha’s biosimilars approved for use in Korea recently. Professor Nam Seoung Wan of Rheumatology Department at Wonju Severance Christian Hospital explained “Other than tofacitinib, various JAK inhibitors like upadacitinib have been tried on treating patients with ankylosing spondylitis. Compared to other biologics, JAK inhibitors have a great advantage in medication convenience with oral administration.” However, the professor stated the treatment’s limitation is its underperforming response rate at week 12 compared to existing TNF alpha inhibitor and IL-17 inhibitor options, regardless of its better effect confirmed in head-to-head Phase II study. Professor Nam stressed, “Continuous search for more treatment options in diverse biologics are encouraging for patient treatment, because each biologics have different effects on various symptoms apparent in many organs including ankylosing spondylitis, and also they bring out respective adverse reaction like risk in tuberculosis relapse.” However, the professor claimed the prescribers should be well aware of issues regarding tolerance development when using biologics for a long term. Professor Nam said, “Repetitive use of biologics could possibly diminish the effect of the drug gradually due to patient’s immune response on the drugs like developing an antibody on specific medicine. As for rheumatoid arthritis, there was a report claiming such tolerance is less likely to be developed when combining TNF alpha inhibitor and methotrexate (MTX). But there has not been any clinical evidence reported on the benefit of using MTX combination therapy on ankylosing spondylitis.” The professor added, “However, a number of treatment strategy could be considered depending on the patient’s clinical state, as various biologic treatment options have been recently introduced to treat patients with ankylosing spondylitis. And each biologics show different rate of antibody development and reaction depending on the patients.”
- Policy
- 19 new drugs & 1 new medical device were approved
- by Lee, Tak-Sun Apr 27, 2020 06:10am
- In the first quarter, 19 new drugs and 1 newly developed medical device were approved. The MFDS (Minister Eui-kyung Lee) made the announcement on the 23rd, when it released a list of new medical products that were first approved in Korea, such as new drugs and newly developed medical devices, in the first quarter of 2020. Previously, the status of new medical products could not be checked at a glance, but it will be announced quarterly so that anyone can easily check the current status of new medical products in the future,. Looking at the details, a total of 22 new medical products were approved in the first quarter, including 19 new drugs, 1 domestically developed vaccine, and 1 newly developed medical device. In the case of new drugs, the number of items increased compared to 13 items approved in the first quarter of last year, and various drugs, such as antihypertensive drugs, anticancer drugs, rheumatoid arthritis drugs, and ulcerative colitis drugs, have been approved. 'Xospata', which is used for acute myeloid leukemia, has been approved as an orphan drug, and 'Varycella shot', which was developed in Korea, is expected to contribute to the stable supply of chickenpox vaccine, which was dependent on imports. In addition, INFUSE ™ Bone Graft, a medical device used for intervertebral fusion, was designated as a newly developed medical device. This is a product that induces new bone production by soaking the genetically modified bone-forming protein in a collagen sponge and transplanting it into the intervertebral body. An official from the MFDS said that it would strengthen the right for the public to know by periodically distributing useful information, such as items of high social concern, to the public periodically in relation to the approval information for new medical products.
- Policy
- It has been successful in expanding the coverage of new drug
- by Lee, Jeong-Hwan Apr 27, 2020 06:09am
- It was evaluated that the government has achieved success in strengthening generic management, such as strengthening guarantees like new drugs for anticancer and rare diseases last year, and announcing plans to revise the generic drug pricing system. In the case of Ranitidine, a gastrointestinal drug containing carcinogenic substance NDMA, it was also diagnosed that DUR information system prevented further damage such as pre-blocking prescriptions and dispensing and shortening recovery procedures. The MOHW said in a report on the results of the self-evaluation of major policies in 2019. According to the report on the 22nd, the MOHW first gave a rating of 'slightly insufficient' for policy to advance drug distribution structure, 'regular' for strengthening insurance drug coverage and appropriate management policy for drug costs, and 'moderate' for policy strengthening pharmaceutical, medical device, and cosmetics industry competitiveness. ◆Advancement of drug distribution structure = Specifically, in the case of the policy of advancing drug distribution structure, it was mentioned that DUR information system and drug distribution information system were used to block prescribing and dispensing Ranitidine prescriptions and to shorten the recovery process. It was considered that the improvement and supplementation needs to actively collect patient and consumer opinions and develop performance indicators that will specifically include the results of the advancement of the drug distribution structure. In particular, it is said that performance indicators are needed to evaluate the advancement of the distribution structure of safety-related drugs. The intention is that there are no indicators that can actually represent the advancement of the distribution structure of safe medicines. In addition, the MOHW also considered that the rebate structure of pharmacies and hospitals was needed as a way to investigate the reality of the development of a dedicated pharmacy into hospital admission fees and cash rebates. It is not only to limit rebates between wholesalers and hospitals, but also to establish a rebate investigation method for the number of prescriptions between hospitals and pharmacies. ◆Enhancement of insurance drug coverage and appropriate management of drug costs = The MOHW evaluated that it has achieved enhanced security, such as new drugs for anticancer and rare diseases, which have high social demands and high medical expenses. Strengthening generic management by announcing plans to reorganize the generic drug pricing system was also a major achievement. However, the MOHW said there was a need to further increase the goal for policy enhancement and reducing drug costs. The MOHW says that a reduction in the proportion of drug costs may be a natural decrease as the overall rate of increase in health care increases, so it sets more aggressive goals. The MOHW said that in order to properly manage the drug cost, it is necessary to take various measures, such as managing generic drug prices, improving the irrational distribution structure of hospitals, and managing rational drug use. The ratio of drug costs was decided by the contents suggested by the evaluators, but it was necessary to raise the target. In terms of suitability for on-site monitoring and response to changes in the situation, the rapid response to NDMA detection was highly appreciated. It was diagnosed that the new drug listing guarantees were strengthened and the goals were achieved. ◆Strengthening competitiveness in the pharmaceutical and medical device industry = the MOHW cited strengthening competitiveness as enacting the 'Medical Device Industry Fostering and Innovative Medical Device Support Act', nurturing professional manpower, and opening AI new drug development support centers. However, it is said that it is necessary to strengthen the qualitative performance indicators based on the pharmaceutical and medical device industries. The MOHW said that the pharmaceutical and medical device industry is a higher value-added business and has high future-oriented importance. It was said that the expert networking was also excellent, so that the opinion gathering was appropriate when carrying out the policy. Furthermore, although the achievement index of the policy to strengthen the competitiveness of the pharmaceutical and medical device industry was achieved, it was evaluated that it was evaluated that it was not the promotion effect of last year alone. In addition, the overseas market expansion and the national recognition of the nation's technological power were raised, and the HOHW's leadership in the medical device industry across the government was highly appreciated.
