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- 2026-05-07 23:25:56
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- Will Enhertu pass the fiscal barrier and be reimb in KOR?
- by Eo, Yun-Ho Apr 19, 2023 05:50am
- The reimbursement progress of the anticancer drug that received 50,000 consents in a national petition is gaining attention. According to industry sources, the reimbursement review data for Enhertu, AstraZeneca and Daiichi Sankyo’s HER2-directed antibody-drug conjugate (ADC), has been supplemented and submitted to the authorities on the 14th. No reimbursement standard had been set for Enhertu at the Cancer Disease Review Committee (CDRC) meeting that was held in March. At the time, there was no disagreement among experts about the clinical usefulness of Enhertu. In other words, the reason why a standard had not been set was considered to be because of its potential financial burden on national health insurance finances. In addition, as the drug was accepted for review at the Petition Review Subcommittee held yesterday (15th), the possibility that the agenda will be deliberated at the Health Insurance Review and Assessment Service’s CDRC meeting that will be held on the 26th is rising. With the reattempt gaining a lot of attention, the pharmaceutical company is also determined to make the cut this time. Daiichi Sankyo was known to have prepared various plans to reduce the financial burden, such as by presenting the drug price of Enhertu at the lowest level in the world and considering applying the risk-sharing agreement (RSA) scheme. A company official said, “The seconds and minutes we waste here may be the matter of life and death for the metastatic breast cancer patients. We will also do our best to save all the time we can to Enhertu's reimbursement to save at least one more patient.” Meanwhile, based on DESTINY-Breast01 and DESTINY-Gastric01 trials, Enhertu was approved by the Ministry of Food and Drug Safety in September for the treatment of ▲unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens (third-line or higher treatment); and ▲locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received two or more prior therapies including anti-HER2-based regimens. Also, in December last year, its indication was expanded based on the results of the DESTINY-Breast03 trial to be used to treat patients with unresectable or metastatic HER2-positive breast cancer who have received one or more anti-HER2-based regimens.
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- Never-ending patent dispute over Galvus
- by Kim, Jin-Gu Apr 18, 2023 05:38am
- In a patent dispute over Galvus, a DPP-4 inhibitor-type diabetes treatment, Novartis received a dismissal from the Intellectual Property Tribunal. Apart from this trial decision, the Galvus patent dispute is expected to continue for some time. This is because the dispute between Novartis and the generic company regarding the extension of the duration has not yet been resolved, even though the substance patent expired in March of last year. According to the pharmaceutical industry on the 14th, the Intellectual Property Tribunal recently made a decision to dismiss Novartis in a trial to confirm the scope of its rights filed against a generic company. A dismissal is a trial decision in the sense that the claim does not meet the appropriate requirements. In January 2022, Novartis had previously requested a judgment to confirm the scope of its rights against Kyongbo Pharmaceuticals, United, Ahn-Gook, and Ahngook Newpharm. It was a judgment requesting a judgment on whether they infringed on some of the Galvus material patent claims. Generic companies released generics for Galvus one after another after the Supreme Court ruling in October 2021. Novartis argued that the validity of the Galvus material patent is also valid as the Supreme Court issued a ruling on remand overturns, but the dispute was not finalized as the first trial appealed. Accordingly, it was argued that the early release of generics by generic companies also has room for patent infringement. While this trial was in progress, the Galvus material patent expired (March 4, 2022). In the end, it is analyzed that the Intellectual Property Trial and Appeal Board made a decision to dismiss the trial, judging that the active trial for confirmation of the scope of rights requested by Novartis did not meet the appropriate requirements as a trial. In 2017, Ahn-Gook and others requested a judgment against Novartis that part of the Galvus material patent duration was invalid. In the first trial, the generic company won, and in the second trial, Novartis won. The Intellectual Property Trial and Appeal Board determined that 187 days of Galvus material patents were invalid, and the Patent Court ruled that 55 days were invalid. After the second trial, Novartis appealed. However, the Supreme Court judged that Novartis, which won in the second trial, had no right to appeal, and remanded the case to the first trial. In May of last year, the Intellectual Property Tribunal sided with Novartis. This time, generic companies appealed. The Patent Court opened its defense in January this year. On the 20th of this month, the second defendant has been announced. According to UBIST, a pharmaceutical market research institute, the combined prescription of Galvus and Galvusmet last year was 32.4 billion won. It decreased by 30.7% compared to 46.6 billion won in 2021. Generic products such as Kyongbo, Hanmi Pharm, and Ahn-Gook, which were released early last year, recorded a combined prescription record of 14.5 billion won.
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- Sales of Pfizer, Gilead, and MSD soared last year
- by Jung, Sae-Im Apr 18, 2023 05:37am
- Last year, Korean subsidiaries of multinational pharmaceutical companies made external growth in general. Pfizer Korea, MSD Korea, and Gilead Sciences Korea have enjoyed an increase in sales of COVID-19 vaccines and treatments. The high sales growth of new drugs such as Keytruda, Gardasil 9, and Prolia also contributed to the increase in sales. According to the Financial Supervisory Service on the 18th, combined sales in 37 of the 38 Korean subsidiaries of major multinational pharmaceutical companies, excluding Viatris totaled at KRW 11.72 trillion, up 27.7% from the previous year's KRW 9.18 trillion. During the same period, operating profits increased by 9.8% from KRW 361.2 billion to KRW 396.5 billion. The figure excludes Viatris Korea, which changed its settlement date from the end of November to the end of December last year. About 80% - 30 of 38 Korean subsidiaries of multinational pharmaceutical companies - increased sales. More than half (21) also saw an improvement in their operating profit. The sales expansion of multinational pharmaceutical companies' Korean subsidiaries can be attributed to the high sales growth of new drugs. The companies enjoyed the special procurement demand that arose due to the COVID-19 pandemic by developing vaccines and treatments for COVID-19. New drugs for diseases other than COVID-19 have also shown even growth in sales. According to the market research institution IQVIA, 9 of the top 10 drug sales last year were products from multinational pharmaceutical companies. MSD, Viatris, Amgen, AstraZeneca, Sanofi, and Roche evenly placed their names on the ranking list. Pfizer Pharmaceuticals Korea, which posted the highest sales last year, recorded an overwhelming annual sales of KRW 3.23 trillion last year. This is the highest figure recorded among pharmaceutical and bio companies in Korea. The company made more sales than Samsung Biologics, which recorded KRW 3.13 trillion last year. Operating profit also increased significantly to KRW 120.1 billion, a 102.8% increase from the KRW 59.2 billion won in the previous year. The COVID-19 pandemic drove the high growth for Pfizer Korea. Pfizer is the only one among domestic and foreign companies that supply both a COVID-19 vaccine and treatment. The COVID-19 vaccine ‘Comirnaty’ and the treatment ‘Paxlovid’ that was developed by Pfizer had been supplied through Pfizer Korea in Korea. Thanks to this, sales in its Korean subsidiary soared from KRW 391.9 billion in 2020 to RKW 1.70 trillion in 2021, then to KRW 3.23 trillion in 2022. As distribution and marketing for COVID-19 vaccines and treatments were virtually conducted by the government, the company was able to generate high profits thanks to low SG&A expenses. Pfizer Korea’s operating profit, which suffered a loss of KRW 7.2 billion in 2020, succeeded in turning a profit in 2021 and exceeded KRW 100 billion last year. Gilead Sciences Korea showed the second most growth in sales after Pfizer Korea. Last year, Gilead's Korean subsidiary posted KRW 565.4 billion in annual sales, a 96.1% increase from the previous year's KRW 288.4 billion. Gilead Sciences Korea, whose sales did not belong in the Top 10 among Korean subsidiaries of multinational pharmaceutical companies, jumped to 5th last year. Operating profit increased by 84.1% from KRW 12.5 billion to KRW 23 billion. Sales of its COVID-19 treatment ‘Veklury (remdesivir)’ is deemed to have contributed to Gilead Sciences Korea’s marked growth. The number of COVID-19 patients increased significantly last year, and the number of critically ill patients also increased. Veklury was approved for use in hospitalized patients with severe COVID-19 whose oxygen saturation level is less than 94% or who need supplemental oxygen treatment. MSD Korea also posted an all-time high in terms of annual sales by making KRW 820.4 billion last year. Overtaking AstraZeneca Korea, the company ranked second in sales among multinational pharmaceutical companies’ Korean subsidiaries. Sales of the COVID-19 treatment ‘Lagevrio,' the immuno-oncology drug ‘Keytruda,’ and the cervical cancer vaccine ‘Gardasil 9’ drove the company’s growth. Last year, the government purchased 242,000 courses of LAgevrio from the company. If the contracted amount was introduced last year as planned, sales of KRW 169.4 to KRW 193.6 billion (KRW 700,000 to KRW 800,000 per person) were generated. In addition, sales of Keytruda, the lead product among domestic drug sales, and Gardasil9, which ranks 3rd, reached KRW 356.6 billion based on an IQVIA. On the other hand, the company’s operating profit halved to KRW 28.6 billion due to the rise in the price of finished products the company had purchased from its headquarters and a large amount of money spent on SG&A expenses. In addition, Organon Korea (20.8%), Sanofi-Pasteur (19.9%), Ipsen Korea (19.2%), Abbott Korea (17.6%), Merck (16.8%), Roche Korea (16.6%), Novo Nordisk (16%) %) achieved high sales growth. In particular, sales of Sanofi Pasteur Korea, the vaccine division of the Sanofi Group, surpassed KRW 100 billion in annual sales for the first time last year thanks to strong sales of influenza (flu) vaccines last year. In other words, more than half of the 38 Korean subsidiaries of multinational pharmaceutical companies saw an improvement in their operating profit. However, except for Pfizer Korea, which marked an explosive growth in operating profit last year, the operating profit of the remaining companies fell 8.7% from KRW 302.9 billion in 2021 to KRW 276.5 billion in 2022. This means that the deuteration experience by the other companies was greater than the improvement in operating profit seen by 20 companies other than Pfizer Korea. Also, 5 companies whose operating profits turned to or continued to be a loss. In particular, MSD Korea (-50.7%), Sanofi-Aventis Korea (-60.4%), Jansen Korea (-47.2%), GSK Korea (conversion to a deficit), Abbott Korea (increased deficit), Mandipharma Korea (conversion to a deficit), and Menarini Korea (conversion to a deficit) were among the companies that saw a significant drop in operating profit last year.
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- Mitsubishi and Sanofi signs agreement to sell Rilutek in KOR
- by Jung, Sae-Im Apr 18, 2023 05:36am
- On the 17th, Mitsubishi Tanabe Pharma announced that the company had signed a domestic marketing agreement with Sanofi Aventis Korea for Sanofi’s amyotrophic lateral sclerosis (ALS) treatment ‘Rilutek (riluzole)’ on the 12th. Rilutek is the first treatment for ALS approved by the US FDA. The drug is used to extend survival or delay the need for a tracheostomy in ALS patients. Under the marketing agreement, Mitsubishi Tanabe Pharma Korea will own exclusive marketing rights for Rilutek. The company was able to offer a broader treatment option for the disease with the ALS injection treatment 'Radicut (ingredient: edaravone)' that was approved in the US in June 2016. ALS, which is better known as Lou Gehrig's disease, is a serious rare incurable disease that causes progressive paralysis and atrophy of the whole body muscles due to the degeneration of motor neurons. As the disease progresses, it can lead to paralysis of the limbs and respiratory muscles, leading to death within years. Mitsubishi Tanabe Pharma Korea’s General Manager Tae-hwan Ryu said, “Through sales of the injectable Radicut and the oral treatment Rilutek, we will now be able to offer diverse and effective treatment options for ALS patients in Korea. We are pleased to be starting this relationship with Sanofi-Aventis Korea.”
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- Pay attention to the animal drug market worth 3 trillion won
- by Nho, Byung Chul Apr 17, 2023 05:58am
- Traditional pharmaceutical bio companies are entering the companion animal medicine and feed market worth 2.5 trillion won, attracting attention as they seek new growth engines and external expansion. Yuhan Corporation, Daewoong Pharmaceutical, Donghwa Pharmaceutical, Dongkuk Pharmaceutical, Kwangdong Pharmaceutical, Ildong Pharmaceutical, and CMG Pharmaceutical are among the companies that have declared their entry into the pet market and are taking active steps. These companies are expanding their brands by launching veterinary professional treatment and prescription animal medicines such as injections, antibiotics, and anthelmintics, as well as zoonotic medicines, nutritional supplements, and feed. For this reason, a significant number of biopharmaceutical companies have the intention to preoccupy the market by mobilizing their strengths in formulation development, sales, and marketing to launch 'veterinary medicine/feed' variants of 'drugs/health functional foods' in the rapidly growing pet market. In particular, animal medicines and feed conversion products of OTC and health-functional foods are produced in so-called human-grade raw materials and human-grade manufacturing facilities and are competitive as they secure quality enough to be consumed by humans. In addition, China's pet market, which raises about 200 million pets, reaches 38 trillion won (feed 21 trillion won) as of 2020, making it an attractive industry because it can secure infinite cash cows if it is pioneered only in export markets. is evaluated as First of all, Yuhan Corp.'s veterinary medicine division (AHC), which is achieving external sales of 30 billion won, is leading the related market by increasing the number of veterinary hospital customers. One product that draws attention is GedaCure, a treatment for cognitive dysfunction in dogs launched in May 2021. Crisdesalazine, the main ingredient of GedaCure, is a new drug for Alzheimer's disease discovered with support from the Ministry of Science and ICT. The drug was approved as a domestic synthetic new drug for animals in February 2021 after its efficacy and safety were proven in dogs suffering from cognitive dysfunction syndrome similar to Alzheimer's dementia in humans. Currently, more than 1,300 veterinary hospitals through Yuhan Corp. prescribe it. The fact that GedaCure is effective for canine cognitive dysfunction syndrome as well as meningitis was disclosed at the Fall International Conference of the Korean Veterinary Society held at the Jeju International Convention Center in November 2022. It is expected to grow as a blockbuster drug in the future. In September 2021, Dongkuk Pharmaceutical entered the pet market by introducing Canidol, a veterinary medicine for periodontal disease, for the first time in Korea. Canidol is a pet-only product of Insadol, a 50-billion-dollar blockbuster over-the-counter gum treatment. Canidol contains herbal medicine ingredients, corn unsaponifiable quantitative extract, and silver leaf extract, and the composition of the ingredients is the same as that of insadol. The unsaponifiable corn extract helps to promote the formation of gum bone and strengthens the periodontal ligament. According to Canidol clinical trial results, clinical indicators of the gingival index and bleeding index improved immediately before scaling and 4 to 8 weeks after scaling for 40 dogs who visited the hospital with periodontal disease. In June 2022, Guangdong Pharmaceutical expanded the 20 billion-strong general medicine Kyungokgo brand to pet products. Gyeonokgo Bow, a nutritional supplement for dogs, has been approved and registered as a compound feed for animals, and in the form of pellets, the unique scent of pharmaceuticals is masked. The main ingredients include the mixed concentrate of Sukjihwang and Bokryeong, the main ingredients of Kyungokgo, as well as hydrolyzed duck, sweet potato, and red ginseng concentrate Gold CAD. Among them, MSM, Glucosamine, and Sukjihwang can help dogs' joint and cartilage health, and ginsenosides Rg1, Rb1, and Rg3 can help immune function. Kwangdong Pharmaceutical is building a pet-friendly brand image by conducting activities such as providing pet amenities in partnership with domestic 4-star or higher hotels that allow pets. Through this business agreement, the two companies plan to develop companion animal nutrients that are effective in reducing body fat and improving skin diseases by using the Akkermansia muciniphila EB-AMDK19 strain. Akkermansia is a strain that lives in the intestinal mucosa of the body and is one of the microorganisms important for health. According to numerous domestic and foreign studies, the number of Akkermansia muciniphila is significantly lower in patients with skin diseases such as atopy, intestinal diseases, and obesity compared to normal people. In particular, Enterobiome proved that Akkermansia is also effective for pet obesity. In a study conducted with a research team at the College of Oriental Medicine at Dongguk University, the weight of beagle dogs that consumed Akkermansia decreased by 15.1% compared to non-ingested beagle dogs. In addition, non-clinical toxicity tests are underway for Akkermansia muciniphila raw materials, and based on the data, the US Food and Drug Administration (FDA) New Food Ingredient (NDI) and European Food Safety Authority (EFSA) new raw material (NOVEL) along with registration of food raw materials in Korea. FOOD). In January of this year, CMG Pharmaceuticals acquired Ingmedix, a company specializing in animal nutritional supplements, and entered the companion animal nutritional supplement market. With excellent R&D technology, production capacity, and marketing know-how, we are developing and producing our own brand nutritional supplements for companion animals, and we are also conducting OEM (Original Equipment Manufacturer), ODM (Original Equipment Manufacturer), and OBM (Manufacturer Brand Development and Manufacturing) businesses. It is expected that synergistic effects will emerge when the distribution network is expanded, such as combining offline channels such as veterinary hospitals owned by Ingmedix with online channels such as home shopping and open markets owned by CMG Pharmaceuticals. After laying the groundwork for entering the market as nutritional supplements for companion animals, the company plans to proceed with the development of veterinary medicines. Donghwa is making a strategic investment of 5 billion won in Fitpet, a companion animal healthcare solution company, on the 21st of this month, and is paying attention to related industries. Through this strategic investment, Dongwha Pharm plans to research and develop animal medicines with its 126-year tradition of drug development know-how and large-scale drug manufacturing capabilities by utilizing Pipett's hundreds of thousands of companion animal healthcare databases. In addition, it has secured priority negotiation rights for the commercialization of medicines developed with this investment. Fitpet is a companion animal total healthcare solution company that has attracted more than 60 billion won in accumulated investment and is leading the market.
- Company
- Will the leukemia ADC Mylotarg be reimb this time?
- by Eo, Yun-Ho Apr 17, 2023 05:58am
- whether the new drug for acute myeloid leukemia (AML), ‘Mylotarg’ will be reimbursed in its second attempt is gaining attention. Mylotarg (gemtuzumab ozogamicin), which submitted an application for reimbursement listing earlier this year, is likely to be presented to the Cancer Disease Review Committee of the Health Insurance Review and Assessment Service this month. Also, another ADC drug, Enhertu (trastuzumab deluxtecanis also expected to be presented for review at the CDDC meeting. Mylotarg was deliberated by the HIRA’s CDDC in May last year but was unable to pass review and set reimbursement standards at the time. Therefore, whether Mylotarg will be able to pass CDDC this time and start on its journey to receiving reimbursement in Korea remains to be seen. The drug is an antibody-drug conjugate (ADC) approved as a first-line treatment for patients with newly-diagnosed CD33-positive AML. The drug, which received marketing authorization in Korea in December 2021, is an ADC composed of a CD33-targeting monoclonal antibody linked to calicheamicin, a potent cytotoxic agent. The drug works on cells that express the CD33 antigen, which is expressed on more than 90% of AML patients. This blocks cancer cell growth and induces apoptosis. Mylotarg’s approval was based on a clinical trial (ALFA-0701) conducted on 271 patients aged between 50 to 70 with newly-diagnosed AML with no prior treatment experience. The ALFA-0701 trial was an open-label, randomly assigned, multicenter Phase III study that compared the existing standard front-line chemotherapy, daunorubicin+cytarabine combination therapy, with Mylotarg+ daunorubicin+ cytarabine combination therapy. Results showed that the median event-free survival (EFS) in the Mylotarg+daunorubicin+cytarabine combination arm was 17.3 months, a 7.8-month extension compared to the 9.5 months in the daunorubicin+cytarabine combination arm. Also, the Mylotarg combination therapy reduced the risk of induction failure, relapse, or death by 44% compared to chemotherapy alone. Also, the median relapse-free survival (RFS) was 28.0 months in the Mylotarg+daunorubicin+cytarabine combination arm and 11.4 months in the daunorubicin+cytarabine combination arm, showing a significant difference of 16.6 months. In the case of median overall survival (OS), the median OS was 27.5 months in the Mylotarg+daunorubicin+cytarabine combination arm and 21.8 months in the daunorubicin+cytarabine combination arm, and the difference was not statistically significant.
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- Sales of cepha antibiotics make a rebound
- by Kim, Jin-Gu Apr 14, 2023 05:49am
- Biopharmaceutical companies that produce the so-called ‘cepha antibiotics' have taken a breather with the increased demand for related products due to the rapid increase in confirmed COVID-19 cases last year. This is in stark contrast to the situation of the previous year when many companies were contemplating whether to withdraw their cepha businesses. However, the dominant opinion is that the sales increase last year was a temporary phenomenon due to the rapid increase in confirmed COVID-19 patients. The frontline companies unanimously agree that they are still contemplating whether to reduce or discontinue their cepha business amid the recent trend of a steady decline in antibiotic prescription rates and a steady rise in production costs. ◆Sales of cepha antibiotics make a rebound...influenced by the surge in confirmed COVID-19 patients According to the Financial Supervisory Service on the 13th, Yungjin Pharm's antibiotic-related sales increased 15% in one year from KRW 59.6 billion in 2021 to KRW 68.6 billion last year. Sales of products it directly produces and sells such as Clamonex, Cefaclor, and Ceftazidime have increased 40% from KRW 30.6 billion to KRW 42.7 billion. In the same period, special sales of Cepha antibiotic APIs soared from KRW 200 million to KRW 1.8 billion. However, exports of cefcapen, cefditoren, and ceftazidime fell 16% from KRW 28.9 billion to KRW 24.2 billion. Yungjin Pharm's antibiotic-related sales have steadily declined until 2021. Its related sales, which reached KRW 102.2 billion in 2019, decreased 42% in two years to KRW 85.6 billion in 2020, then to KRW 59.6 billion in 2021. However, sales made a successful rebounded last year. It is analyzed that this is due to the increase in prescriptions to relieve COVID-19-related symptoms in line with the surge in confirmed COVID-19 patients in Korea. According to the market research institution UBIST, prescriptions of oral cephalosporins last year were KRW 259.6 billion, up 33.4% from the previous year. The ‘cepha antibiotics,’ or cephalosporins are widely used antibiotics for pneumonia, laryngopharyngitis, tonsillitis, and bronchitis. The situation has turned drastically from the first and second years of COVID-19. The cephalosporin antibiotic prescription market, which was worth KRW 271.1 billion in 2019, shrank to KRW 211.5 billion in 2020, then to KRW 194.6 billion in 2021. In the early phases of COVID-19, the market shrank greatly with the plummeting number of cold and flu patients, but last year, along with cough and cold preparations, their use for the purpose of relieving COVID-19 symptoms increased explosively. ◆Presciptions rise 33% in 1 year...companies that pondered market withdrawal breathe a sigh of relief Other cepha antibiotic manufacturers also experienced a similar situation. In particular, companies that had been considering withdrawing their businesses due to a steady decline in sales until the previous year were able to take a breath of relief. Boryeong's sales related to cepha antibiotics shrank from KRW 25.3 billion in 2019 to KRW 20.4 billion in 2020. However, sales rebounded to KRW 21.7 billion last year. Korus Pharm has been manufacturing cepha-class antibiotics such as Korus Cefaclor, Korus Ceftriaxone, K Axone, Cefozol, etc. The company’s combined antibiotic sales decreased 24% in 2 years from KRW 6 billion in 2019 to KRW 4.5 billion in 2021, but rebound to 5.3 billion last year. Withus Pharm’s Withus Cefaclor Cap’s sales fell to KRW 0.6 billion in 2020 from KRW 1.5 billion in 2019, then increased over threefold in 2 years to reach KRW 2.1 billion last year. Withus Pharm’s antibiotic sales, including Cefaclor Cap, increased 2.5 times in 2 years from KRW 2 billion in 2020 to KRW 5 billion last year. Daewoong Bio also saw its cepha antibiotic Ceclor’s sales increase 32% from KRW 7.4 billion in 2021 to KRW 9.8 billion last year. In addition, finished cepha antibiotic products from Kyungbo Pharmaceuticals, Kukje Pharm, and Jeil Pharm increased last year. However, Kyungbo’s sales of cepha-class antibiotic APIs decreased 4% from KRW 37.6 billion in 2021 to KRW 36.3 billion. ◆”Rise in cepha-class drugs temporary...still not profitable” This is in contrast to the years 2020 and 2021 when many companies were contemplating whether to withdraw their cepha antibiotic business. In 2020, a large pharmaceutical company A decided to discontinue consignment production of cephalosporin antibiotics. Company A has stopped manufacturing products contracted by other pharmaceutical companies and is only currently producing only its products. Another large pharmaceutical company, B, put up its cephalosporin antibiotic manufacturing plant for sale last year. A few companies considered taking over, but pharmaceutical company B withdrew its intention to sell. Company C, a mid-sized pharmaceutical company, also contemplated withdrawing from the cepha antibiotics business last year. On the surface, the company pointed to the decrease in prescriptions of cephalosporin antibiotics in the process of prolonged COVID-19, but the analysis was that the chronic deterioration of profitability caused them to consider withdrawing from the business. In line with the trend, the industry anticipates the companies’ withdrawal from the cepha antibiotics business will be repeated this year. Front-line companies all agree that the deteriorating profitability of antibiotics will not improve due to the rising cost of APIs day by day, while supply prices are unchanged under Korea’s health insurance. The price of APIs of cephalosporin antibiotics imported from China and India has risen by 10-20% during the past 2 years. On the other hand, the reimbursed product prices have stayed the same for a long period of time. The fact that the government is constantly trying to reduce antibiotic prescriptions is also cited as a reason for the deteriorating profitability. The antibiotic prescription rate for acute upper respiratory infections has decreased from 52% in 2010 to 36% in 2020. An official from a pharmaceutical company that produces cepha antibiotics said, “We have almost no profit gain from the manufacture of 1st and 2nd generation cephalosporin antibiotics. Labor costs have also risen significantly, so it is difficult to make any profit.”
- Company
- “Reimb standard for hemophilia should align with approvals"
- by Jung, Sae-Im Apr 14, 2023 05:49am
- Young-Sil Park, Treasurer of KSH The Korean Society of Hematology has set out to narrow the gap between the approved indication and reimbursement standards for hemophilia treatments. Through the amendment, KSH aims to apply the optimal dose and dosing schedule for each patient as personalized treatment strategies have settled as the standard for maintenance and prevention therapies. Therefore, whether the government will accept the new reimbursement standard plan proposed by the KSH remains the focus of attention. Young-Sil Park, Treasurer of KSH (Department of Pediatrics, Kyung Hee University School of Medicine), met with reporters on the 13th and said “We have submitted a proposal for the amendment of the reimbursement standards for hemophilia drugs in the Fall last year and is awaiting results. Although there are several steps left to final reimbursement extensions, I heard that HIRA has shown a positive response." The amendment to the reimbursement standards that KSH proposed can largely be divided into two parts. Increasing dose amount and frequency of administration. Currently, the reimbursement standard is set narrower than the approved maximum dose and number of administrations. For this reason, it has been pointed out that the treatment effect may be reduced due to insufficient single dosage amount depending on the patient. Therefore, KSH’s argument is that the maximum level in the reimbursement standard should be set at the same level as each drug’s indication. Drug reimbursement standard improvement plan, reconstituted by Dailypharm Specifically, KSH requested the dosage allowed for administration with each reimbursement to be increased from the current 20-25 (IU/kg) to a maximum of 50. The amendment would allow the dose to be increased flexibly according to the patient's condition, with the dose for standard half-life formulations to range from 20 to 40 (20 to 50 for children under 6 years of age) and extended half-life formulations to range from 40 to 50. These are the scope of dosages specified in the label for each formulation. The KSH also suggested the reimbursed number of monthly administrations allowed for patients should be expanded. According to the current reimbursement standard, patients can visit the hospital once or twice a month and receive a total of 10 doses of standard half-life treatments. Severely ill patients are allowed up to 12 doses. A total of 7 doses (8 doses for severely ill patients) are reimbursed for extended half-life drugs during the 1-2 visits per month. Drug reimbursement standard improvement plan, reconstituted by Dailypharm This means that standard half-life drugs can be administered three times a week for severe patients. However, experts pointed out that it is often necessary to adjust the frequency of administration depending on the patient's condition. Accordingly, the proposed amendment stipulates that 'if the trough concentration level cannot be maintained at 1% or higher 48 hours after setting and administering the maximum dose allowed according to the individual pharmacokinetic test result, administration of an additional dose up to the maximum dose permitted in the label may be accepted.’ Treasurer Park said, “Currently, patients are administered treatments three times every 7 days, on Day 2, Day 4, and Day 7. In some cases, almost no clotting factors remain in the body on the third day for some patients. Our proposed improvement to the plan offers an increased number of administrations so that the optimal effect can be achieved for those whose minimum coagulation factor level is not maintained on the second day.” The KSH is requesting another revision 4 years after the reimbursement standards for hemophilia treatment were revised because the hemophilia treatment has now been expanded to maintenance and preventive therapies. In the past, treatment of hemophilia was centered around ‘replacment therapy', in which clotting factors were administered when bleeding occurred. In recent years, the treatment paradigm has evolved to 'maintenance and prevention therapy', which prevents bleeding in advance by regularly administering clotting factors even without bleeding events. Furthermore, ‘personalized treatment', where a patient’s administration cycle and dose are customized in consideration of the patient's symptoms, living environment, and pharmacokinetics, has emerged as a trend. Currently, the treatment goals for patients with severe hemophilia consist of maintenance and prophylaxis therapies. Also, the introduction of drugs with extended half-life has reduced the required number of regular administrations, and an application that allows patients to determine their pharmacokinetic levels has been introduced, customized maintenance and prevention therapy have settled as the standard of care. However, the reimbursement standards that have been set in the past are narrower than the scope approved, which limits the realization of customized maintenance and prevention therapy. Park added, “The reimbursement standards for hemophilia have improved a lot compared to the past. I believe that a change in the reimbursement standard is necessary to achieve the optimal effect for patients in line with the changes made to the domestic treatment environment and the hemophilia treatment environment. I look forward to the government's positive decision that can allow personalized treatment for each individual in consideration of each patient’s factors."
- Company
- “Olumiant rises as a new option for alopecia areata”
- by Jung, Sae-Im Apr 13, 2023 05:46am
- A new treatment option has emerged in the field of severe alopecia, an area where no option other than local steroid therapy had existed until now. The drug gained attention from patients with severe circular hair loss due to its safe and high therapeutic effect. However, it remains unclear whether the indication for circular hair loss will be able to rise to the right to benefit. Lilly Korea held a press conference at The Plaza Hotel in Jung-gu, Seoul on the 12th and explained the meaning of expanding the indication for severe circular hair loss of the JAK inhibitor 'Olumiant (ingredient: baricitinib)'. Oh-sang Kwon, professor of Dermatology at Seoul National University Hospital, and Bark-Lynn Lew, Professor of dermatology at Kangdong Kyunghee University Hospital, explained the current state of alopecia areata in Korea, the disease burden, and the effects of Olumient. Professor Kwon served as the vice president of the Korean Hair Research Society and Professor Lew serves as the Academic Director of her academic society. Professor Oh-sang Kwon (left) Professor Bark-Lynn Lew (right) According to Professor Lew, as of 2021, about 170,000 patients visit the hospital with alopecia areata a year in Korea. Young patients in their 20s to 40s account for about 60% of the AA population. Unlike general hair loss caused by hormones, alopecia areata is classified as one of the symptoms of an autoimmune disease. The immune system mistakenly recognizes part of one’s hair as a foreign substance, and the hair falls out. Unlike general hair loss, in which the hair gradually thins, the forehead widens in the shape of an M, and the hair loss expands, in alopecia areata, one or several circular bald areas with clear boundaries occur on the scalp. Bald spots can occur not only on the scalp, but also anywhere on the hair, such as eyebrows, beard, armpit hair, and pubic hair. Professor Lew added, “Most hair loss is naturally cured and responds well to treatment, but about 40% of patients experience recurrence within a year, and in severe cases, all hair on one’s scalp or body falls out and progresses to widespread alopecia. Alopecia areata is a chronic autoimmune disease, which has a high risk of autoimmune disease complications such as atopic dermatitis at the same time and can have a significant impact on the quality of life of patients. Its lifetime prevalence of the psychiatric disorder is up to 74%." he explained.” Before Olumiant, there was no treatment approved for severe alopecia areata. Instead, topical steroids were used off-label for patients with mild symptoms. However, the efficacy evidence was limited on its use while the risk of side effects was high from long-term steroid use. The efficacy of Olumiant was demonstrated through the Phase III BRAVE-AA1 and BRAVE-AA2 trials that were conducted on a total of 1,200 patients with severe alopecia areata. Koreans participated in both studies. The trials’ primary efficacy endpoint was a SALT score of 20 or less. SALT stands for Severity of Alopecia Tool score. 41%, and 37% in the group treated with Olumiant for 52 weeks in AA1 and AA2, respectively, achieved the primary efficacy endpoint. At the time, improvements in eyebrow and eyelash coverage were also observed. The company plans to further confirm the effectiveness and safety of Olumiant treatment for up to 200 weeks. Professor Kwon said, "What is noteworthy in the 52-week extension study is that the regrowth effect of scalp, eyebrows, and eyelashes continued to improve for up to 52 weeks when treated with Olumient 4mg. This shows that long-term treatment may be required to achieve maximum benefit in AA patients." Patients’ responses were also positive. Professor Lew said, "Although it is reimbursed yet, about 60% of patients were willing to use Olumiant when it was recommended. This is twice more than my expectations, indicating the high willingness to treat among the patients.” However, it is expected that the AA indication will not be covered for the time being. Lilly Korea said, "It's only been a month since the indication was added, so nothing has been decided or progressed related to reimbursement yet. We will make efforts to expand access to Olumiant in AA patients with high unmet needs.”
- Company
- Supreme Court dismissed again
- by Chon, Seung-Hyun Apr 13, 2023 05:44am
- Pharmaceutical companies won a complete victory in the 2nd round suspension of execution of the lawsuit to cancel the reduction of benefits for the brain function improving Choline alfoscerate. Following Daewoong Bio Group, Chong Kun Dang Group also issued a ruling in the Supreme Court to suspend the implementation of wage reduction until the main lawsuit in the second trial is over. According to the industry on the 7th, the 3rd Special Division of the Supreme Court dismissed the decision of the Ministry of Health and Welfare to suspend the enforcement of choline drug benefit reduction. It is a decision to suspend the effect until the 30th day from the date of adjudication of the cancellation case of the ‘Announcement of Partial Revision of Details on the Application Criteria and Methods of Medical Care Benefit’, which contains the reduction of health insurance benefits for choline preparations. This means that 26 pharmaceutical companies including Chong Kun Dang and 8 individuals will not be able to reduce benefits until the end of the second trial in progress with the Ministry of Health and Welfare to cancel benefit reduction for choline drugs. This means that the benefit reduction will not be implemented until the end of the second trial of the ongoing lawsuit against the Ministry of Health and Welfare between 24 pharmaceutical companies such as Daewoong Bio and one individual to cancel the benefit reduction of choline drugs. In August 2020, the Ministry of Health and Welfare issued a partial revision notice of ‘Details on the Application Criteria and Methods of Medical Care Benefits’, which contains the content of reducing the scope of benefits for choline preparations. It is content that increases the cost burden rate from 30% to 80% when patients who have not been diagnosed with dementia use cholinergic drugs. After the Ministry of Health and Welfare issued a notice, a lawsuit began all at once. Pharmaceutical companies filed a lawsuit to cancel the notice of reduction in benefits. The lawsuit was filed in two groups according to the legal representative. Law firm Shin & Kim filed a lawsuit on behalf of 39 companies, including Chong Kun Dang, and eight individuals, while Lee & Ko, a law firm, took on the lawsuit for 39 companies, including Daewoong Bio, and one person. However, the Chong Kun Dang Group lost in July of last year, and Daewoong Bio also received a ruling in November of last year. The pharmaceutical companies filed an appeal and also requested a suspension of execution of the reduction in benefits. The suspension of execution requested by Daewoong Bio Group was cited in December of last year. The Ministry of Health and Welfare requested an appeal for suspension of execution, but the Supreme Court also sided with the pharmaceutical companies last month. The Chong Kun Dang Group’s request for suspension of execution also received a ruling in November of last year, “Suspend the enforcement of the public notice until the 30th day from the date of the second trial judge.” Pharmaceutical companies have all led to the suspension of execution in the first trial of the lawsuit for cancellation of benefit reduction. Pharmaceutical companies filed a lawsuit to cancel the reduction in benefits in 2020 and requested suspension of execution to suspend the implementation of the reduction notice until the main lawsuit. The lawsuit for suspension of execution was also filed in two groups according to the legal representative. The suspension of payroll reduction enforcement requested by Chong Kun Dang and others was completed until the Supreme Court ruling in April 2021. In September 2020, the Seoul Administrative Court made a decision to suspend execution, and in the appeal trial in December of the same year, the court sided with the pharmaceutical companies. The Supreme Court upheld the decision of the lower court even in the appeal of the suspension of execution. The suspension of execution of choline drugs, which was raised by Daewoong Bio and others, was cited in October 2020, and nine months after the Ministry of Health and Welfare appealed, the second trial also issued a decision citing the suspension of execution. In October of last year, a ruling was dismissed in an appeal filed by the Ministry of Health and Welfare. From the pharmaceutical company's point of view, it means that they have won all 10 cases of suspension of execution of choline drug benefit reduction. Looking at the ruling in the case of suspension of execution, the court judged that "there is no reason to admit that there is a concern that the suspension of choline drugs may have a significant impact on public welfare." The court pointed out that due to the reduced reimbursement for cholinergic drugs, patients may find themselves in a situation where they have to continue to be prescribed the drug or give up taking it while bearing a considerably higher co-payment than before. The court judged that if benefits were reduced because the clinical usefulness of choline preparations was not proven, the trust and reputation of choline preparations and the reputation of pharmaceutical companies could be damaged, and the related market could suffer a major blow.
