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- 2026-05-08 13:04:41
- Company
- Celltrion applies for approval of its Eylea biosimilar in KR
- by Jung, Sae-Im Jul 27, 2023 05:40am
- On the 26th, Celltrion announced that it had completed applying for the marketing authorization of 'CT-P42,' its biosimilar to the eye disease treatment ‘Eylea (aflibercept).’ Based on its global Phase III trial, Celltrion applied to be approved for all Eylea indications including as a treatment for wet age-related macular degeneration (wAMD) and diabetic macular edema (DME). Celltrion confirmed the bioequivalence and similarity of CT-P42 in a Phase III trial that was conducted on 348 patients with diabetic macular edema in 13 countries, including the Czech Republic, Hungary, Poland, and Spain. In June, the company submitted an aBLA (abbreviated biologic license application) for CT-P42 to the US Food and Drug Administration. Starting with Korea, Celltrion plans to apply for approval in major global countries including Europe. Eylea is Regeneron’s blockbuster eye drug that posted global sales of USD 9.76 billion (KRW 12.7 trillion). Eylea’s exclusivity in the US is set to expire in May 2024, and in November 2025 in Europe. A Celltrion official said, “We have confirmed the bioequivalence and similarity of CT-P42 through a global Phase III trial, and applied for marketing authorization to the Ministry of Food and Drug Safety in Korea. In addition to the U.S. and Korea, we will apply for approval in major countries including Europe, and continue to make efforts to expand our biosimilar portfolio in ophthalmology.”
- Company
- Atozet market, ↑ 225% in 2 years
- by Chon, Seung-Hyun Jul 27, 2023 05:40am
- The hyperlipidemic complex drug Atozet prescription market has grown significantly. It more than tripled in two years due to the entry of generic drugs. About 100 generic products increased their market share to 60%, leading the market expansion. Jeil and HK inno. N stood out among generic products. According to UBIST, a pharmaceutical research institute, on the 27th, the outpatient prescription amount of ezetimibe/atorvastatin combination drug in the first half of last year was KRW 126.5 billion, up 33.7% from the previous year. Prescriptions for ezetimibe/atorvastatin combination drugs increased 35.4% YoY to 61.2 billion won in the first quarter and rose 32.1% to 65.3 billion won in the second quarter. Compared to 30.2 billion won in the second quarter of 2021, the prescription amount of the ezetimibe/atorvastatin combination drug in the second quarter more than doubled in two years. As Atozet's generics entered the market in droves, the market size expanded rapidly in a short period of time. Until 2020, the Ezetimibe/Atorvastatin complex was one of Organon's Atozet products. From 2021, more than 100 domestic companies entered the Ezetimibe/Atorvastatin market simultaneously, increasing the market size. In October 2020, Chong Kun Dang received permission for Lipilouzet, a combination drug with the same ingredients as Atozet, after clinical trials. At this time, 22 companies received permission for Lipilouzet's delegated generic products and were listed on the reimbursement list from April 2021. From February 2021, 88 additional pharmaceutical companies received approval for Atozet generics, and they were listed as payroll in May, a month later than Lipilouzet delegated generics. In June 2021, as two additional companies received approval for Atozet generic products, the number of domestic companies entering the Atozet market increased to 113 in total. In the first quarter of 2021, Atozet's prescription amount recorded 20.1 billion won, but as generic products poured in, the ezetimibe/atorvastatin combination market expanded 50.2% to 30.2 billion won in the first quarter. In the second quarter of last year, the prescription volume of the Ezetimibe/Atorvastatin combination soared by more than 224.9% in two years compared to before the introduction of generics. Generic products led the growth of the Ezetimibe/Atorvastatin combination drug market. In the second quarter of last year, Atozet's prescription amount was 25.1 billion won, up 25.0% from the first quarter of 2021, before entering the generic market. This means that the original drug was not affected even by the containment of generic products. In the second quarter of last year, prescriptions for Atozet's generic products were 40.2 billion won, up 46.0% from the same period last year. The share of generics in the ezetimibe/atorvastatin combination drug market reached 61.6%. Atozet's generic products overtook Atozet's prescription volume in the first quarter of last year, one year after its release, and the growth rate accelerated even more this year. The entry of ezetimibe/atorvastatin combination drugs by domestic companies is the result of a competition to preoccupy high drug prices after the implementation of the revised drug price system. According to the stepped drug pricing system, which was implemented as a result of the drug price reform in July 2020, when there are more than 20 identical products listed, the price of generics that enter as latecomers will be lowered by 15%. If there are more than 20 identical drugs already listed, regardless of whether or not the highest price requirement is met, the drug price will be lower between “85% of the drug price that does not meet the two requirements” or “85% of the previous lowest price”. In April 2021, Lipilouzet was listed at the same upper limit as Atozet, the first product with the same ingredient listed. The upper limit of Lipilouzet 10/10mg was registered at 1037 won, the same as Atozet at the time. Of the 21 delegated generics listed at the same time as Lipilouzet, 20 were priced at an upper limit of 85% of the highest price. This is because it did not meet the requirement of the ‘direct bioequivalence test’, which is the highest price requirement for generic products. Generic products must satisfy both the 'direct performance of bioequivalence test' and the 'use of DMF' in order to maintain a 53.55% upper limit compared to original drugs before patent expiration. Each time one condition is not met, the cap is reduced by 15%. Lipilouzet delegated generic 10/10mg 20 products were listed at 881 won, 15% lower than 1037 won. However, all 78 Atozet generic 10/10mg items listed one month later were set at the upper limit of 637 won. The highest price stayed at 61.4% of 1037 won. As ‘85% of the price of drugs that do not meet the two requirements’ is applied according to the step-type drug pricing system, the upper price limit is about 30% lower than that of Lipilouzet’s commissioned generic, which entered the market a month earlier. Among Atozet's generic products, Jeil Pharm's Lipitor Plus stood out with prescriptions of 6.3 billion won in 2Q. Among generic products, Lipitor Plus' share reached 15.7%. Lipitor Plus is jointly marketed by Viatris.
- Company
- Reimb discussions imminent for Obizur in Korea
- by Eo, Yun-Ho Jul 27, 2023 05:40am
- Takeda Pharmaceuticals Korea is quickening its steps to receive reimbursement listing for ‘Obizur,’ its treatment for bleeding episodes in patients with acquired hemophilia A (AHA). According to industry sources, Takeda Pharmaceuticals Korea’s bleeding treatment for adults with acquired hemophilia A may soon be introduced for deliberation at the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee meeting in August. As reimbursement evaluations for Obizur have been ongoing immediately after receiving approval in March, the reimbursement process is progressing relatively quickly. Obizur has been designated as an orphan drug in Korea in July 2021. Unlike existing bypass factor drugs, this drug replaces blood coagulation factor VIII with AHA indications. As a gene recombinant therapy that was produced by deleting the B-domain from a porcine factor VIII that is comparable to human Factor VIII, inhibitory antibodies do not readily recognize the treatment. Therefore, Obizur can replace the inactivated human coagulation factor VIII to help blood clotting and control bleeding. The unique mechanism of action allows Obizur to be the only AHA drug that can stably monitor patients’ blood factor VIII levels using standard assays, enabling individually tailored dosing. In a prospective, non-randomized, open-label Phase II/III study of 28 patients with AHA that evaluated the safety and efficacy of Obizur, all patients that were treated with Obizur had a positive response to treatment at 24 hours after initial dosing. A positive response was one where the bleeding had stopped or was reduced, with clinical improvement or with factor VIII activity above a pre-specified target. The treatment success rate after administration of the final dose (within 2 weeks of administration) was 85.7% (24/28), and the rate was higher in patients treated with Obizur as first-line therapy. The treatment success rate was 94% (16/17) in patients treated with Obizur as first-line therapy, and 73% (8/11) in patients treated with Obizur as second-line therapy. No serious adverse events or deaths were observed with Obizur in the study.
- Policy
- NHIS extends Bavencio’s reimb...adds KRW 20 bil sales
- by Lee, Tak-Sun Jul 27, 2023 05:40am
- Merck Korea's 6th immuno-oncology drug, 'Bavencio Inj,’was granted a reimbursement extension and will be covered for the first-line treatment of urothelial cancer from next month. With the reimbursement extension, the drug is expected to secure annual sales worth more than KRW 10 billion like the other immuno-oncology drugs. 'Bavencio is the first drug to be granted reimbursement as a first-line treatment for urothelial cancer. The Health Insurance Review and Assessment Service announced the news through the 'Opinion Inquiry on Amendment to Public Notice for Drugs Prescribed and Administered to Cancer Patients (Draft),’ effective as of August 1st. Bavencio Inj (avelumab) was approved in Korea as the 6th immuno-oncology drug in March 2019. As an anti-PDl-L1 immunotherapy drug, the drug was granted reimbursement for the rare condition, metastatic Merkel cell carcinoma (MCC) in 2020. Currently, a total of 8 immuno-oncology drugs, starting with BMS’s ‘Yervoy (ipilimumab)’ in December 2014, followed by MSD’s ‘Keytruda (pembrolizumab),’ Roche’s Tecentriq (atezolizumab),’ AstraZeneca’s ‘Imfinzi (durvalumab),’ Merck’s Bavencio (avelumbab),’ GSK’s ‘Jemperli (dostarlimab),’ then AstraZeneca’s ‘Imjudo (tremelimumab).’ All immunotherapy drugs other than Jemperli and Imjudo are reimbursed in Korea. Immuno-oncology drugs are breaking new sales records every year, receiving reimbursement extensions based on groundbreaking effects on various types of cancer. Last year, based on IQVIA, Keytruda posted sales of KRW 239.6 billion, Opdivo KRW 109.9 billion, Tecentriq KRW 81.8 billion, Imfinzi KRW 52.4 billion, and Yervoy KRW 14.2 billion. Only Bavencio failed to meet the blockbuster criteria, posting KRW 500 million won in sales last year, but reimbursement as first-line treatment for urothelial cancer approved this time is expected to enable the drug to raise over KRW 10 billion in sales. Urothelial cancer is a common term used to refer to malignant tumors originating from the lining of the urinary system that constitutes the mucosal layer of the urinary tract. It includes bladder cancer, renal pelvic cancer, ureteral cancer, and urethral cancer, with the most frequently occurring cancer being bladder cancer. Platinum-based chemotherapy has been used as the standard first-line treatment, and when the disease progresses or recurs, platinum-based chemotherapy is re-administered or drugs such as Keytruda and paclitaxel were used as second-line treatments. Bavencio is the first immuno-oncology drug to be used as monotherapy for the first-line maintenance treatment of adult patients with locally advanced or metastatic urothelial cell carcinoma who have not progressed on platinum-based chemotherapy. The NHIS estimated the number of urothelial cancer patients that would use Babencio to be about 670 per year and agreed with the pharmaceutical company on the estimated claims amount of KRW 21.65 billion. In other words, the reimbursement extension guarantees additional sales of KRW 20 billion won per year. However, actual sales are expected to be less as the company signed a refund type and expenditure cap type risk-sharing agreement (RSA). Bavencio also lowered its insurance price ceiling by 30% with the reimbursement extension, from KRW 1,226,243 per vial to KRW 854,864 per vial. However, Bavencio’s reimbursement extension is not expected to significantly affect insurance finances. Rather, it is expected to have the effect of saving NHI finances. This is because of the amount of Keytruda used. NHIS expects the use of Keytruda, which is being used as a second-line treatment for urothelial cancer, will decrease with the reimbursement extension of Bavencio. Immunotherapy drugs cannot be administered in the second line if another immunotherapy drug is used as first-line maintenance therapy. Therefore, the NHIS estimated that the actual amount of fiscal spending, unlike the expected claims amount, will range between KRW -1.84 billion to KRW 5.57 billion. Currently, Keytruda is granted reimbursement for 7 indications in 4 cancer types, including as a first-line treatment for metastatic non-small-cell lung cancer. In addition, as it has recently applied to extend reimbursement to 13 indications, its use in cancer is expected to expand further in the future. Therefore, the reimbursement authorities will have to continue to contemplate ways to minimize the spending of health insurance finances while expanding the reimbursement of effective immuno-oncology drugs.
- Company
- Astellas launches urothelial cancer drug Padcev
- by Kim, Jin-Gu Jul 26, 2023 05:41am
- Astellas officially launched 'Padcev' in Korea as a drug to treat locally advanced or metastatic urothelial cancer. Astellas Pharmaceutical Korea held a press conference to commemorate the launch of Padcev in Korea at the Intercontinental Hotel in Seoul on the 19th. Urethral carcinoma is a type of bladder cancer. It is estimated that 90% of bladder cancers are urothelial carcinomas. The survival prognosis is not known to be good. Non-muscle invasive bladder cancer that does not invade the bladder muscle has a 5-year relative survival rate of 80%. However, if the cancer invades the bladder muscle, the 5-year relative survival rate drops sharply to 50%. In particular, about half of them lead to distant metastasis. At this time, the 5-year relative survival rate is further reduced to 5%. Patients receive platinum-based chemotherapy as first-line treatment and PD-1 or PD-L1 inhibitors as second-line treatment. However, in the case of platinum-based chemotherapy, which is the first-line treatment, low tolerance and high possibility of disease progression were cited as problems. Immunotherapy that can be considered as a second-line treatment showed that only 13-28% of patients responded to treatment regardless of PD-L1 status. As a result, most of the disease progressed within 3 months of treatment. Padcev is a treatment that can be used for patients whose cancer has progressed or relapsed after chemotherapy (first-line treatment) and immuno-anticancer drugs (second-line or first-line maintenance therapy) in situations where treatment options are not feasible. Padcev is an antibody-drug conjugate (ADC) that targets nectin-4. In March of this year, it was approved as monotherapy by the Ministry of Food and Drug Safety. It is first recommended as Category 1 in the NCCN Guidelines. The Padcev phase 3 trial was conducted by comparing and evaluating Padcev with existing chemotherapy drugs in 608 patients with locally advanced or metastatic urothelial cancer. As a result, it was found that the Padcev administration group reduced the risk of death by about 30% compared to conventional chemotherapy. The median overall survival (OS) of the Padcev-administered group was 12.9 months, which was 3.97 months longer than the chemotherapy group, demonstrating a significant improvement in survival time. In addition, the median PFS of the Padcev-administered group was 5.6 months and that of the control group was 3.7 months, indicating a 37% reduction in the risk of disease progression. Kim Mi-so, a professor of oncology at Seoul National University Hospital, said, "Platinum-based chemotherapy is mainly based on cisplatin. However, the PFS ranges from 7.7 to 9.5 months, so most of the disease progresses within a year." Professor Mi-So Kim said, “Second-line PD-1/L1 inhibitors are recommended for patients whose disease has progressed after the first-line platinum-based chemotherapy, but most patients do not respond to treatment.” Park Kyung-ah, director of Astellas Pharmaceuticals Korea, said, "We will operate the patient program until Padcev is covered by reimbursement." Kim Joon-il, CEO of Astellas Pharmaceuticals Korea, said, “We are delighted to be able to release Padcev as early as possible.” "With Padcev, we will be able to provide innovative treatment options to patients with locally advanced or metastatic urothelial cancer in Korea," he said.
- Company
- Acetaminophen prescriptions at a record high
- by Chon, Seung-Hyun Jul 26, 2023 05:41am
- The single-agent antipyretic analgesic ‘acetaminophen’ recorded the largest-ever sales in outpatient prescriptions. The prescription market for acetaminophen has increased significantly due to the unceasing number of confirmed COVID-19 cases arising despite the end of the COVID-19 pandemic and the increase in flu and cold patients. The rise in the insurance drug price of acetaminophen the government made to stabilize acetaminophen supply has also contributed to the market expansion. According to the market research institution UBIST, the outpatient prescription market for single-agent acetaminophen drugs in Q2 was KRW 14.1 billion, up 89.2% YoY. The increase in the prescription amount was 5.5% YoY to KRW 11.8 billion in Q1, which grew further in Q2. The acetaminophen market broke its record for 2 consecutive quarters in Q2. In the first half of the year, acetaminophen prescriptions rose to KRW 26 billion, up 38.9 % from the same period last year. The acetaminophen prescription market had fallen to the KRW 4 billion-5 billion range by Q3 2021 after recording KRW 9.2 billion in Q4 2019 and KRW 7.8 billion in Q1 2020. At the time, COVID-19 was considered the direct cause of the contraction of the acetaminophen prescription market. The stricter personal hygiene practices that followed the spread of COVID-19, including washing hands and wearing masks, had greatly reduced cases of infectious diseases such as flu and colds, thus contracting relevant treatment markets. The acetaminophen prescription market rebound to KRW 6.7 billion in Q4 2021 and then soared to KRW 11.2 billion in Q1 last year. At the beginning of last year, the demand for acetaminophen increased significantly with hundreds of thousands of COVID-19 cases being confirmed a day. Then, prescriptions decreased to KRW 7.5 billion and KRW 8.2 billion in the Q2 and Q3 of last year, respectively. However, it made a rebound again to KRW 10.9 billion in the Q4 of last year and continued on its rise this year. The industry analysis is that the acetaminophen prescription market has grown further as the number of confirmed COVID-19 cases continues to occur by tens of thousands even after the end of the pandemic, and the number of flu or cold patients has also increased after the mandatory mask-wearing regulation was lifted this year. Quarterly outpatient prescriptions of acetaminophen single-agent drugs (Unit: KRW 100 million, Data: UBIST) The number of flu patients has continued to exceed the epidemic standard from the beginning of this year to June. According to the Korea Disease Control and Prevention Agency, the number of suspected influenza patients per 1,000 outpatients dropped from 52.5 in Week 1 of 2023 to 11.7 in March. However, the number of suspected flu cases rose again from April. For 6 consecutive weeks from the 17th week (fourth week of April) to the 22nd week last week of May), the number of suspected influenza patients per 1,000 outpatients continued to be over 20. This greatly exceeds the flu epidemic standard of 4.9 set by the KDCA. The raised insurance drug price of acetaminophen was also pointed out as another factor that contributed to the expansion of its prescription market. The Ministry of Health and Welfare raised the insurance price ceiling of 18 acetaminophen 650mg items by up to 76.5% since December last year. The insurance price limit for 650mg acetaminophen was only KRW 43 to 51 before then but was raised to KRW 90. The government made an unprecedented decision to raise the price of all acetaminophen together when pharmaceutical companies expressed reluctance to increase production due to the drug’s poor cost structure. However, it is a temporary increase that will be adjusted to KRW 70 from December this year. Affected pharmaceutical companies had promised to increase production of acetaminophen in line with the price hike. The upper ceiling price for acetaminophen drugs was determined through negotiations between pharmaceutical companies and the National Health Insurance Service based on manufacturing/import costs and factors that render the price increase necessary, production/import volume, etc. Janssen Korea’s Tylenol 8 Hour received the highest price hike of 76.5%, from KRW 51 to KRW 90. Prices of Bukwang Pharm’s Tacenol 8 Hours and Chong Kun Dang's Penzal were each raised from KRW 51 to KRW 88, a 72.5% hike. Price of Hanmi Pharm’s Suspen 8 Hours increased by 70% from KRW 50 to KRW 85. The price of Kolon Pharmaceutical's Tramol rose 66.7% from KRW 51 to KRW 85, while Genu Pharma’s Anispen 8 Hour and Hana Pharm's Tylicol 8 Hour rose 62.7% each to become KRW 83. The price of Sama Pharm’s Setopen and Yoong Poong Pharmaceutical’s Tifen 8 Hours rose 56.9% each to become KRW 80 from KRW 51. Also, 8 items including Boryung Biopharma’s Cetaphen 8hr were raised to the KRW 70 range. The price increase of acetaminophen resolved the unstable supply issue, and the increase in cold and flu patients has led to an unprecedented boom in the acetaminophen prescription market.
- Company
- MSD Korea appoints Albert Kim as new managing director
- by Eo, Yun-Ho Jul 26, 2023 05:41am
- General Manager Albert Kim On the 25th, MSD Korea announced that it has appointed Albert Kim (pic) as the new managing director, effective August 1st. The new managing director Kim is a seasoned pharma and bio expert who has served in global and Korean pharmaceutical bio companies for more than 25 years, accumulating extensive experience in local and global markets, including Korea. Kim has majored in Biochemistry at McMaster University and acquired an MBA at Schulich School of Business at York University, Canada. In various leadership positions, Kim led teams and groups in various countries and regions other than Korea, including the U.S., EU, Canada, Brazil, Switzerland, Sweden, Thailand, Singapore, Malaysia, and Taiwan. Before being appointed as a managing director of MSD, Kim served as the Vice President of the Commercial Division at Samsung Bioepis, where he oversaw the launch and growth of key major product portfolios in the U.S. and EU, in charge of global commercial strategy and operations. Kim had also served as the Chief Financial Officer (CFO) at Novartis, and as the founding General Manager of Menarini Korea where he led the establishment and growth of the Korean branch. GM Albert Kim said, “We will continue to live true to MSD's long-standing mission of saving and improving lives by improving medical access to MSD Korea's innovative medicines, vaccines, and pipelines.”
- Policy
- All Sandoz products removed from Korea’s reimb list
- by Lee, Tak-Sun Jul 26, 2023 05:41am
- All products that were registered by Sandoz Korea will be removed from Korea’s reimbursement list. The company had withdrawn from the Korean market in June. With the removal, the name Sandoz will no longer be visible in the Korean market. However, a grace period of 6 months has been granted for some items, and reimbursement for such drugs is valid until February 1 next year. Its CNS (central nervous system) items that have solidified their position in the domestic market will be transferred to Samil Pharmaceutical, and be changed accordingly in the reimbursement list. According to industry sources on the 25th, 18 products from Sandoz Korea will be removed from the reimbursement list as of August 1st. The company had voluntarily withdrawn the licenses of the 18 products. Currently, there are no effective Sandoz products on Korea’s drug approval list. All of them were withdrawn or were deleted in line with the company’s business closure in June. Sandoz withdrew from the Korean market following its spin-off decision made by its parent company, Novartis. Sandoz will be focusing on the biosimilar business in Europe. The license of some of the CNS (Central Nervous System) products sold by Sandoz in Korea has already been transferred to Samil Pharmaceutical. Samil received the sales and distribution rights to the antidepressant ‘Mirtax,’ ‘Sandoz Estical Opram,’ ‘Sandoz Paroxetine,’ the schizophrenia treatment ‘Sandoz Olanzapine Tab,’ and insomnia treatment ‘Sandoz Zolpidem.’ Accordingly, the name of the pharmaceutical company on the reimbursement list will also be changed from Sandoz to Samil Pharm. As a result, no Sandoz products will be left on the reimbursement list. Sandoz Korea had first established its branch in Korea in 2003 as Hexal Korea. Afterward, the company name was changed to Sandoz Korea, and it remained active in the generic market for 20 years thereafter, which is rare for a foreign pharmaceutical company, showing strength in the CNS and anticancer drug markets. Meanwhile, reimbursement for some generic items of its parent company, Novartis Korea, was also removed from the reimbursement list along with the deletion of the Sandoz products.
- Company
- Two types of JAK inhibitors start a full-scale competition
- by Eo, Yun-Ho Jul 26, 2023 05:40am
- The competition between two types of JAK inhibitors in the field of juvenile atopic dermatitis has begun in earnest. Following AbbVie Korea's Rinvoq last April, Pfizer Korea's Cibinqo was covered by insurance for the indication of atopic dermatitis in children and adolescents from this month (July). Cibinqo stopped the reimbursement process after passing the Pharmaceutical Reimbursement Criteria Subcommittee of the Health Insurance Review and Assessment Service in August last year, and at the beginning of this year, it expanded the scope from adults to teenagers over 12 years of age and resubmitted the application for reimbursement. After passing the Pharmaceutical Reimbursement Evaluation Committee in March, the drug price negotiations were concluded with HIRA in June. In terms of atopic dermatitis as a whole, the competition for JAK inhibitors is a three-way battle, but Lilly Korea's Olumiant has no indications for children and adolescents. Therefore, Rinvoq, Cibinqo, and Sanofi Korea's Dupixent, an interleukin drug, are expected to compete in this area. However, as Dupixent is relatively expensive and there are detailed differences in indications, competition among JAK inhibitors is expected to be fiercer. The prescription price of Rinvoq15mg for severe atopic adolescents aged 12 to 17 is 59,493 won, and the prescription cost of Cibinqo for the same age group is 53,217 won. The case of adults is similar. Rinvoq 30mg is 94,884 won and Cibinqo 200mg is 77,826 won, which is a similar drug price. The general hospital prescription environment is also stable on both sides. Both Rinvoq and Cibinqo have passed drug committees (DCs) of major medical institutions nationwide, including the big five tertiary hospitals, including Samsung Seoul Hospital, Seoul National University Hospital, Seoul St. Mary's Hospital, Asan Medical Center, and Shinchon Severance Hospital. In the case of Rinvoq, the high-dose (30mg) formulation has also been coded at 30 medical institutions, including Seoul Asan Medical Center, Shinchon Severance Hospital, Seoul St. Mary's Hospital, and the National Medical Center. The two drugs can be applied for insurance coverage among adults (18 years of age or older) and adolescents (12 to 17 years of age) patients with chronic severe atopic dermatitis who have symptoms lasting for more than 3 years ▲ who are not properly controlled even after administering a topical treatment for 4 weeks or more as the first treatment, ▲ there is no response or cannot be used due to side effects, etc. even after administering systemic immunosuppressants for more than 3 months, ▲ and ▲ have an EASI of 23 or higher before starting administration.
- Policy
- Yuhan’s low-dose atorvastatin combo receives reimb
- by Lee, Tak-Sun Jul 25, 2023 05:46am
- Just as Hanmi Pharm preoccupied the market with its low-dose (2.5mg) rosuvastatin, Yuhan Corp has its hopes for its low-dose (5mg) atorvastatin to do the same. The companies’ strategy is to reduce the risk of side effects while maintaining efficacy with low-dose statins. According to industry sources, Yuhan Corp’s ‘Atovamibe Tab 10/5mg’ will be listed for reimbursement starting on August 1st. The drug is a combination of atorvastatin calcium trihydrate 5mg and ezetimibe 10mg and is the first fixed-dose combination drug for hyperlipidemia that combines 5 mg of atorvastatin with ezetimibe. No other atorvastatin 5mg product – as a combination drug or a single agent- has been listed for reimbursement until now. The atorvastatin+ ezetimibe combination is well known for the original Atozet (MSD Korea). The rosuvastatin+ ezetimibe combo market is estimated to be at KRW 500 billion, and the atorvastatin + ezetimibe combo market about KRW 200 billion. Recently, the popularity of low-dose statins has been rising in this market. In December 2021, Hanmi Pharmaceutical introduced Rosuzet Tab. 10/2.5mg which contains rosuvastatin 2.5mg, and fostered it as a blockbuster worth KRW 10 billion a year, after which Daewoong Pharmaceutical, Yuhan Corp, Samjin Pharm, and Shinpoong Pharm joined the market. The rosuvastatin+ ezetimibe combinations were evaluated to be more effective than statin monotherapies while minimizing the risk of side effects such as diabetes and myopathy that arise from the use of existing high-dose statins. Yuhan Corp’s Atovamibe 10/5mg is also similar in concept to the rosuvastatin 2.5mg + ezetimibe combo. The drug demonstrated a superior LDL-C change rate to treatment with atorvastatin 5mg monotherapy and the ezetimibe 10mg monotherapy at 8 weeks. The insurance ceiling price of Atovamibe 10/5mg is KRW 637 and was listed at a price lower than the calculated price. At KRW 637, it is priced at the same level as Atovamibe 10/10mg. Therefore, patients can choose 10/5mg or 10/10mg Atovamibe Tab as their initial dose without burden. Yuhan Corp is also currently the first in Korea to receive approval for an atorvastatin 5mg single-agent drug as well. With those products, Yuhan Corp is expected to bring a sensation as a pioneer in the low-dose atorvastatin market.
