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- 2026-05-11 20:25:48
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- Reimbursement talks on first CMV prophylaxis soon to begin
- by Eo, Yun-Ho May 07, 2020 06:01am
- The reimbursement approval talk is about to get started for Prevymis, a medicine to prevent cytomegalovirus (CMV) infection in stem cell transplant recipient. Korean pharmaceutical industry sources reported MSD’s Prevymis (letemovir) that was passed by Economic Evaluation Subcommittee last month would be deliberated by Health Insurance Review and Assessment Service (HIRA) Drug Reimbursement Evaluation Committee (DREC) on May 7. Reactivation of CMV in patients, who have undergone a stem cell transplant, could cause diseases like pneumonia, hepatitis, myocarditis, gastroenteritis and encephalitis. Despite a low level of CMV viral load in blood, it could increase the risk of mortality. A study found that in early hospitalization stage of CMV-positive patients who had stem cell transplant, the risk in overall mortality could be 3.5 times higher than in non-infected patients, whereas the mortality rate in patients with CMV viremia have 2.6 times greater risk of overall mortality than patients with no viremia up to 60 days after the transplant. However, the current CMV treatment in allogenic hematopoietic stem cell transplantation (HSCT) recipients mostly relies on pre-emptive therapy, which injects antiviral medication when the viral load exceeds a certain level. In 2018, Korean Ministry of Food and Drug Safety (MFDS) has approved of Prevymis to be used to help prevent CMV infection and disease in adults who have received an allogenic HSCT. The treatment has both injection and tablet formulation options and it can be administered once-daily from the day of or within 28 days of HSCT for up to 100 days after the transplant The U.S. Food and Drug Administration (FDA) has approved the use of Prevymis in 2017 and also designated it as a Breakthrough Therapy, Priority Review Drug and Fast Track Drug. President Yoon Sung-soo of Korean Society of Hematology (Department of Internal Medicine at Seoul National University School of Medicine) explained, “The limitation of the existing pre-emptive therapy is clear as it initiates treatment only when the CMV viral load reaches the threshold level. The medical demand on Prevymis is surging as it is a crucial treatment option for the survival of high-risk patients.” Clinical studies have confirmed Prevymis hindering the reactivation of CMV and lowering the risk of mortality. The studies reported no observation of adverse reactions like myelosuppression or renal toxicity. In the 2019 guidelines published by the National Comprehensive Cancer Network (NCCN) and European Conference on Infections on Leukemia (ECIL), Prevymis has been recommended as a prophylaxis in CMV-seropositive allogeneic HSCT recipient.
- Company
- Temptation to reduce the cost of DMF
- by Kim, Jin-Gu May 07, 2020 06:01am
- About 7 out of 10 DMF that pharmaceutical companies have registered for use are from India and China. Compared to 10 years ago, the share of DMF in India and China is also increasing significantly. It is an analysis that pharmaceutical companies have increased demand for inexpensive Indian·Chinese drug products to cut costs. According to the MFDS on the 4th, the number of DMF last year was 601. Excluding 71 cases in Korea, 530 cases were registered overseas. By country, India had the largest number of DMFs. The total number was 254, accounting for 42.3% of the total. China was followed by 153 cases (25.5%). The share of the rest of the countries was less than 5%. India and China combined account for 67.7% of the total. 7 out of 10 DMF were made in India or China. Top 10 countries for DMF in 2019. Of the total 601 cases, 407 cases were from India and China (67.7%) (Source: the MFDS) Cumulative number of DMF in 2009-2019. Of the 5,523 cases, India·China accounted for 61.5% (the MFDS)From 2009 to 2019, a total of 5,523 DMF were registered for 11 years (including re-registration). Of these, Korea had 875 cases (15.8%) In the cumulative DMF, India was the largest with 2,066 cases (37.4%). China was followed by 1,329 cases (24.1%). Excluding Korea, 227 cases in Italy (4.1%), 183 cases in Spain (3.3%), and 84 cases in Germany (1.5%) were followed. Looking at the changes for the past 10 years since 2009, the proportion of registration of DMF from India·China is increasing. In 2009, only 17.9% of Indian·Chinese ingredients were registered. Then, it increased to 39.4% in 2010, and has remained in the mid to late 60% since 2011. Compared to 2012, when DMF notification system was changed to a registration system, the share of DMF in India and China increased by 9.8% p from 57.9% to 67.7%. On the contrary, the proportion of Korean DMF is generally small. It decreased from 47.4% in 2009 to 11.8% last year, down to a quarter level in 10 years. The share of DMFs in India·China over the past 10 years (Source; the MFDS) It is analyzed that the biggest reason for the increase in the share of DMF registration in India and China is the low price. It is known that Indian and Chinese ingredients are about 20 to 30% cheaper than domestic ones. As pharmaceutical companies are looking for inexpensive DMF to cut costs, registration of drug products from India and China seems to have increased. There are also some institutional reasons. In 2011, the MFDS changed the regulations to register as a DMF if salts or hydrates are different even if the same active ingredient is used. As a result, the number of DMF registrations exploded. In the process, registration of DMF from India and China has also increased significantly. At that time, 377 cases were made in India and 194 cases in China in one year.
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- Cancer Committee lets down both Keytruda and Tagrisso
- by Eo, Yun-Ho May 07, 2020 06:01am
- Apparently, neither one of Keytruda and Tagrisso won the Cancer Deliberation Committee’s nod. According to the pharmaceutical industry sources on May 1, Health Insurance Review and Assessment Service (HIRA) Cancer Deliberation Committee convened a meeting after postponing it twice due to COVID-19, and decided to ‘defer’ the reimbursement decision on MSD’s Keytruda (pembrolizumab) and ‘unapproved’ AstraZeneca’s Tagrisso (osimertinib). Basically, the reimbursement expansion on immunotherapy Keytruda and targeted therapy Tagrisso would unlikely to happen any time soon in Korea. The Cancer Deliberation Committee reviewed granting reimbursement on Keytruda’s five indications, including as a first-line treatment (monotherapy and combination therapy) for non-small cell lung cancer (NSCLC), monotherapy for second or later-line treatment in bladder cancer, and monotherapy for third or later-line treatment in or refractory classical Hodgkin lymphoma. In March 2017, Keytruda monotherapy has been approved as a first-line treatment in patients with NSCLC. And the MSD Korea has submitted an application for reimbursement approval on the monotherapy indication to be used as a first-line treatment in September 2017, and continued the talk with the government for over two years. Regardless of the effort, the talks fell through in September last year. Considering the health authority’s decision, MSD showed its commitment by submitting unasked-for economic evaluation data on the first-line treatment in NSCLC to seek for the reimbursement expansion. But the Cancer Deliberation Committee rather demanded additional data on reducing the cost and deferred the decision. As for Tagrisso, the result was even grimmer. AstraZeneca Korea has submitted a reimbursement expansion application for the first-line indication of its osimertinib treating epidermal growth factor receptor (EGFR)-mutated NSCLC. Although the company has expressed its assertive intention to reduce the financial burden as proposed by the government, the committee members (oncologists) raised the issues on the treatment’s clinical efficacy and insisted on not approving the reimbursement. The anticancer treatment has been deferred by the committee once already in last October. The committee’s decision then was due to the Asian subset analysis result of the FLAURA Phase 3 trial in Tagrisso, specifically confirming the overall survival (OS) value. The study found the median OS with osimertinib was 38.6 months, 6.8 months longer than first generation EGFR-TKIs, Iressa (gefitinib) and Tarceva (erlotinib). However, hazard ratio (HR) in the Asian subset analysis recorded a value of 0.995. Compared to the standard value of ‘1,’ the value difference of 0.005 meant no significance. Regarding the study result, some academics have questioned the efficacy of Tagrisso as a first-line therapy in Asian race. Meanwhile, others have raised concern over the committee applying double standard as first and second generation EGFR-TKIs, Iressa, Tarceva and Giotrif (afatinib), have been listed for reimbursement as first-line therapies without concrete evidence on the OS. Some also argued the solution is in drug pricing adjustment. Based on the speculations, AstraZeneca also persuaded its headquarters and expressed its intention to adjust the pricing, but the deliberation result was a let-down.
- Company
- Toujeo passed DC of big 5 general hospitals
- by Eo, Yun-Ho May 06, 2020 06:32am
- Next-generation insulin Toujeo can be prescribed at the Big 5 General Hospitals. According to the related industry, 'Toujeo inj Solostar (gene recombination insulin Glargine)' recently passed DC of Seoul National University Hospital, Seoul St. Mary's Hospital, Samsung Medical Center, and AMC including Severance Hospital. In addition, it has been approved for indications for type I and type II diabetes in children and adolescents over 6 years of age in the US and Europe. Toujeo's expansion of pediatric indications was based on the results of the EDITION JUNIOR clinical trial. The EDITION JUNIOR study compared Toujeo to Gla-100 in 463 children and adolescents (aged 6 to 17 years) treated for type I diabetes for at least one year and with HbA1c between 7.5% and 11.0% at screening. Participants continued to use their existing mealtime insulin. The study met its primary endpoint, confirming non-inferior reduction of HbA1c with Toujeo vs Gla-100 after 26 weeks. An official from the KDA said that next-generation insulins that solved existing adverse effects such as hypoglycemia would be a useful treatment option for children and adolescents with diabetes, as they have excellent drug effects. Meanwhile, Toujeo was listed on the insurance benefits list in November after domestic approval in August 2015. Toujeo's insurance premium per insulin unit is about ₩153 (₩15,306 per 100 units).
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- 902 trials around the world seeking for COVID-19 treatment
- by Kim, Jin-Gu May 06, 2020 06:32am
- 100 days have passed since the first confirmed case of COVID-19 was reported in Korea. While Korea seems to have flattened the curve, other countries like the U.S. and European countries are still enforcing strict emergency orders. Meanwhile, the global community is unprecedentedly speeding up the treatment and vaccine development. As of Apr. 27, total 902 cases of COVID-19 related clinical trials are reportedly in process. Compared to 66 cases reported in early March, the number has multiplied by 13.6 times. The world’s largest clinical trial registry by the U.S. National Institutes of Health (NIH), ClinicalTrials.gov has been keeping up with the number. Among those trials, 404 cases are testing pharmaceuticals. 190 drugs or candidate medicine are undergoing clinical trial to be labeled as a COVID-19 treatment. Most of the ongoing studies around the world are for drug repurposing. Instead of testing new candidate medicine, the studies aim to reevaluate existing drugs as a COVID-19 treatment. COVID-19 related clinical trials conducted around the world as of Apr. 27 (Source: ClinicalTrials.gov) Currently, hydroxychloroquine has been the most popular medicine to be tested. Total 114 cases are confirming hydroxychloroquine’s efficacy and safety profile (including redundant cases). And axithromycin is the second most popular medicine with 28 cases. Industry sources see that the U.S. President Donald Trump’s comments have heavily affected the number of studies in hydroxychloroquine and axithromycin. At the White House press conference, President Trump has expressed his optimism for those two drugs to be the game changer amid pandemic. Unlike his words, however, the outcome seems to have been rather disappointing. An interim report of a U.S. study found the treatment did not demonstrate significant effect, but almost doubled the mortality rate. Following those two drugs, AbbVie’s HIV treatment Kaletra (lopinavir plus ritonavir) is running 21 clinical trials. But Kaletra also had a number of studies reporting no significant effect on COVID-19 treatment. The sources say the drug would unlikely to be labeled as a COVID-19 treatment, unless it reports otherwise in other studies. Tocilizumab (Brand name: Actemra) used for treating multiple myeloma has ranked itself on the fourth spot with 20 ongoing trials. The interleukin-6 inhibitor is expected to prevent the cytokine storm. As a majority of the COVID-19 patients experience cytokine storm, a form of systemic inflammatory response syndrome, pharmaceutical experts have high hopes for the treatment. Interestingly, a number of hypertension treatments were included in the COVID-19 treatment related studies. 12 studies are testing losartan and other angiotensin II receptor blockers (ARBs), eight studies are testing angiotensin-converting enzyme (ACE) inhibitors, and calcium-channel blockers (CCB) and diuretic each have one study in progress. In total, there are 22 antihypertensives in testing. Among ARBs, losartan (6), telmisartan (2), candesartan (1) and valsartan (1) have the most number of ongoing tests, in the order. Two other studies have undisclosed substances in trial. Other drugs like myelofibrosis treatment ruxolitinib (Brand name: Kakavi) and a corticosteroid methylprednisolone have 11 and 10 clinical trials in progress, respectively. Remdesivir, a highly anticipated potential COVID-19 treatment, has total of nine trials in progress at the moment, which the three of them are conducted in Korea. The results of remdesivir clinical trials would be unveiled next month at earliest. Also, Japanese-made favipiravir (Brand name: Avigan), a rheumatoid arthritis treatment sarilumab co-developed by Sanofi and Regeneron, and an antiprotozoal medicine nitaxosanide respectively have eight trials in process. While a gout treatment colchicine and a rheumatoid arthritis treatment anakinra have seven and six ongoing trials, a Soviet-developed flu drug Arbidol and a corticosteroid medication dexamethasone each have five ongoing clinical trials.
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- 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.
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- 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.
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- 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.”
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- 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.
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- 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.
