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2026-05-08 14:31:39
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Company
₩200 bil schizophrenia treatment market is changing
by
Kim, Jin-Gu
Jan 14, 2022 05:50am
Change is in the air in the schizophrenia treatment market that was once led by global pharmaceutical companies such as Otsuka Pharmaceutical and Janssen. Domestic companies are acquiring rights of originals and introducing new products to chase the multinational leaders in the market. In response to the change, the global pharmaceutical companies are also preparing strategies such as adding a new dose to their product line for the first time in 6 years. ◆ Boryung rises to the rank as No.3 after securing ‘Zyprexa’ According to industry sources on the 13th, the schizophrenia treatment market in Korea is estimated to be around ₩200 billion. The market had been led primarily by multinational pharmaceutical companies, with Korea Otsuka Pharmaceutical, Janssen Korea, and Lilly Korea owning the top 3 items in the market. Pic of Zyprexa. Boryung acquired the rights, including sales and licensing for Zyprexa from Lilly in October last yearHowever, a change has been forewarned in the market with Boryung’s acquisition of ‘Zyprexa (olanzapine).’ Boryung Pharmaceutical had acquired all sales and licensing rights for Zyprexa in Korea from Lilly in October last year. At the same time, the company announced its plans to reinforce its CNS (central nervous system) treatment portfolio around Zyprexa. The company’s goal is to raise its CNS sales, which are currently around ₩30 billion to ₩50 billion by 2025. Boryung’s confidence in setting such an aggressive sales goal lies in its securement of an original drug. Preference for originals is very high in the CNS treatment market that includes schizophrenia treatments. In the case of olanzapine, Whanin Pharm, Myung In, Hanlim Pharm own generic versions of olanzapine, but the companies had earned very little. In 2020, Whanin’s ‘Zyrepin’ earned ₩5.9 billion, Myung In’s ‘Neurozapine’ ₩3.1 billion, and Hanlim’s ‘Zyzapine’ ₩2.7 billion. In other words, the original drug that has been in the country for 25 years since its approval in 1997 holds an overwhelming influence over the market. This is why Boryung Pharmaceutical also made the decision to acquire the license of Zyprexa rather than release a generic version. ◆ Whanin plans to introduce ‘Cariprazine’…first new drug to be introduced in 11 years After acquiring original schizophrenia drugs, Boryung and Whanin are preparing to chase its leaders in the market This is why other Korean companies are also intent on securing their own originals. In this sense, Whanin Pharm set a strategy to introduce a new drug for schizophrenia to Korea. For the past decade, no new drugs had been introduced in the schizophrenia treatment market. ‘Abilify(aripiprazole),’ the No.1 leader in the market, was approved in 2002, and the No.2 ‘Invega (paliperidone) was also first approved in 2010. Whanin’s new drug ‘Cariprazine’ therefore is the first new drug to be introduced to the Korean market in a decade. Cariprazine is an atypical antipsychotic developed by the Hungarian company Gedeon Richter. The drug is being sold under the brand names Vraylar in the United States and Reagila in the European Union Whanin Pharm received approval to conduct a bridging study for the introduction of the drug to Korea in April last year. The trial is being conducted on 342 patients who have acute-phase schizophrenia at 30 institutions including the Seoul National University Hospital. Considering that it takes around a year for a bridging study to be complete, it is expected that the company will be completing the study within the year and receive marketing authorization for the drug. Samil Pharm has also jumped into the schizophrenia treatment market with an original of its own. In December last year, Samil Pharm had entered into a co-promotion agreement with Viatris Korea for the sale of three drugs - schizophrenia treatment ‘Zeldox (ziprasidone),’ antidepressant ‘Zoloft,’ and anxiolytic ‘Xanax’- to expand its CNS business. Dong Wha Pharmaceutical had previously been selling and distributing the drugs for the past 6 years. Samil is known to have set up a team dedicated to CNS to increase the influence of the three drugs. ◆MNCs in defense…Otsuka receives approval for a new dosage for the first time in 6 years With the entry of such new contestants companies that are already in the lead are preparing measures to defend their ranks in the market. Korea Otsuka Pharmaceutical newly received approval for its ‘Abilify 1mg’ in December last year. Previously, the company had 2mg, 5mg, 10mg, 15mg dosages of Abilify in the market. This is the first change made to the pipeline in 6 years since ‘Abilify Maintena Inj.’ was introduced in 2015. When limiting the product to the table formulations, it is the first new dosage to be introduced in 13 years, since the company received approval for the 2mg product in 2008. The industry believes this move was made conscious of the competition with domestic pharmaceutical companies that entered with original drugs at their forefront. Otsuka expects the ultra-low-dose product to play a positive role in securing their lead in the market as prescriptions of low-dose products are increasing in practice. No.1 and 2 in the schizophrenia treatment market, Abilify(left), Invega(right) According to the market research institution IQVIA, Korea Otsuka Pharmaceutical’s Abilify series makes the most sales among all domestic schizophrenia treatments. It recorded sales of ₩50.9 billion in 2020 with its three products -Abilify Tab, Abilify OD Tab, and Abilify Maintena Inj. Last year, in the first half year alone, the company had made ₩27.4 billion with the product line. The runner-up in the ranks is Janssen Korea’s Invega series. Janssen Korea recorded sales of ₩25.3 billion with Invega ER Tab, Invega Sustenna Inj, and Invega Trinza Inj in 2020. The company had sold ₩13.1 billion in the first half of last year. The third-most sold is Zyprexa, which sold ₩14.2 billion in 2020.
Company
One clinical trial of NeoImuneTech's new immuno-cancer drug
by
Ji Yong Jun
Jan 14, 2022 05:50am
NeoImuneTech has suspended one clinical trial for the treatment of COVID-19 of NT-I7 (efineptakin alfa), which is being developed as a new immuno-cancer drug. According to ClinicalTrials.gov operated by NIH in the U.S. on the 12th, it was confirmed that NeoImuneTech withdrew one phase 1 clinical trial related to NT-I7 in the second half of last year. Earlier, NeoImuneTech was approved by the U.S. Food and Drug Administration (FDA) in June 2020 for two clinical trials related to COVID-19. The withdrawn clinical trial corresponds to a pilot study. Pilot research is a small-scale study conducted to minimize errors before entering large-scale clinical trials of new drugs. Regarding the reason for the suspension of clinical trials, the company explained, "We withdrew it because the situation in the United States changed rapidly due to the emergence of vaccinations and treatments because it did not match the planned clinical design in the early stages of the COVID-19 incident." NeoImuneTech attempted to develop NT-I7 treatments as the number of patients increased rapidly due to the COVID-19 pandemic. From June 2020, 30 adult patients with mild COVID-19 were recruited and NT-I7 was administered as muscle injection to conduct clinical trials for treatment effectiveness and safety evaluation by dose with the NIH. A month later, an additional phase 1 clinical trial of NT-I7 was approved to obtain more detailed data than the existing clinical trial. The study was conducted by Jian Campian of Washington University in St. Louis. This clinical trial planned to confirm the immune effect of COVID-19 due to an increase in lymphocytes in the blood after NT-I7 administration. However, the additional clinical trial was withdrawn due to Professor Jian Campian's resignation without registering a single subject for more than a year since it was approved. In addition, the clinical trial conducted with NIH is in the process of recruiting patients. NT-I7 is a hyleukin-7 T cell amplifier developed by NeoImuneTech as a new immuno-cancer drug. NT-I7 has a mechanism to remove cancer cells and infected cells by increasing the number of T cells in the body. According to NeoImuneTech, NT-I7 was clinically confirmed to amplify and activate T cells in cancer patients and patients with lymphocytopenia. Currently, NeoImuneTech is examining clinical effects with a combination of immuno-cancer drugs such as Merck's Keytruda, Roche's Tecentriq, and BMS' Opdivo and NT-I7. There are only 10 global clinical trials aimed at securing indications for various carcinomas such as gastric cancer, breast cancer, and non-small cell lung cancer.
Company
SK Bioscience, speeding up its development of COVID Vaccine
by
Kim, Jin-Gu
Jan 13, 2022 06:05am
SK Bioscience is speeding up the commercialization of its own COVID-19 vaccine. In particular, it is predicted that the approval of the Novavax vaccine will have a positive effect at a time when the GBP510 is aimed at licensing items in the first half of this year. On the 12th, the MFDS approved Nuvaxovid PFS, NovaVax's COVID-19 vaccine. The item approval of this vaccine was carried out by SK Bioscience, not Novavax. Novavax handed over the right to sell Novavax vaccines to SK Bioscience in Thailand and Vietnam, including Korea, through an expansion contract with SK Bioscience late last year. ◆Nuvaxovid-GBP510 The pharmaceutical industry believes that this experience of product approval will be of great help to SK Bioscience. It is evaluated that SK Bioscience succeeded in solving similar types of practice questions before applying for GBP510, which is expected in the first half of this year. SK Bioscience is developing its own COVID-19 vaccine GBP510, which is similar to Novavax vaccine. Phase 3 clinical trials are currently underway. The goal is to obtain item permission within the first half of this year. GBP510 adopted a gene recombination vaccine platform. It is a method of inducing antibody production that can respond to viruses by injecting antigen proteins directly. Nuvaxovid, which was approved this time, was also developed as a gene recombination platform. Item licensing strategies are similar, such as obtaining "basic inoculation" permission first and "additional inoculation (booster shot)" permission later. SK Bioscience started clinical trials for GBP510 booster shots in December last year. The target number of test subjects is 550. When the clinical trial is completed, the company plans to apply for a change in permission to inoculate GBP510 with booster shots after completing the second vaccination of Pfizer and Moderna. ◆ NovaVax vaccine stock solution + finished product and sales are expected to be 200 billion won+ SK Bioscience is also expected to benefit from the approval of Novavax vaccine items. At the end of last year, the government decided to pre-purchase 10 million doses of SK Bioscience's vaccine. To this end, the company plans to invest 192 billion won in the budget allocated to the KDCA. Fees for consignment production of NovaVax vaccine stock solution (DS) and finished product (DP) are also profits that SK Bioscience can earn. SK Bioscience signed an expansion contract with Novavax in December last year regarding consignment production of vaccines. The contract period is until December this year. SK Bioscience uses three out of nine lines of Andong L House to produce Novavax vaccines. Of the three lines, two are responsible for the production of undiluted solutions and one is responsible for the production of finished products. SK Bioscience receives consignment fees based on undiluted production and sales fees based on complete sales from NovaVax. The undiluted solution produced in L House is supplied to Korea, Thailand, and Vietnam. If SK Bioscience receives additional item permits in Thailand and Vietnam, SK Bioscience's profits are expected to increase further from 192 billion won purchased by the Korean government. The finished vaccine is expected to adjust production at the request of NovaVax. Novavax has announced its vaccine production at 2 billion doses this year. Among them, SK Bioscience is also said to account for a considerable portion. It is expected to be responsible for most of the supply to Asian countries except Japan. Depending on how many Novavax requests for consignment production, SK Bioscience's fees are expected to increase. According to SK Bioscience, L House's production capacity is up to 450 million to 500 million doses per year. Arithmetically, it is possible to produce 50 million to 55 million doses of vaccines per year on one line.
Company
A single tech export brings in 11 times the annual revenue
by
Chon, Seung-Hyun
Jan 13, 2022 06:05am
The biotechnology company ABL Bio signed a mega-deal and secured 11 times its annual revenue through a single license agreement. Its upfront payment by itself ranks in the top 5 among the technology export deals made by pharmaceutical and biopharmaceutical companies in Korea. When excluding the ones that have returned the rights, ABL Bio’s deal is the third-largest in upfront payments. According to the Financial Supervisory Service on the 12th, ABL Bio signed a license agreement with Genzyme for ABL301, a bispecific antibody candidate for the treatment of Parkinson's disease and other neurodegenerative diseases. Genzyme is a fully owned subsidiary of Sanofi. Under the agreement, after ABL Bio completes the preclinical and Phase I clinical trial for ABL301, Sanofi will be responsible for further clinical development and receive worldwide exclusive development and commercialization rights to ABL301. ABL will receive up to $1.06 billion (approx. ₩1.3 trillion) under the agreement. ABL will first receive $75 million (approx. ₩90 billion) in upfront payment with no obligation for return and will be eligible to receive up to $45 million in near-term milestones, as well as up to $985 million (approx. ₩1.2 trillion) based on the achievement of predefined development, regulatory and commercialization milestones. ABL301 is a novel drug candidate that inhibits aggregation of α-synuclein, which causes Parkinson’s disease. Through the agreement, ABL Bio secured an amount 11 times that of its sales revenue of ₩8.1 billion in 2020 through a single technology export. ABL Bio’s ₩8.1 billion in 2020 were also profits made from technology transfer. ABL Bio posted sales of ₩1.3 billion and ₩4 billion in 2018 and 2019, respectively, both of which were also profits made from technology transfers. The upfront payment secured by ABL Bio this time ranks the company in the Top 5 among all technology exports made by domestic pharmaceutical companies. The amount shows how highly Sanofi considers the commercial value of ABL301. Hanmi Pharmaceutical holds the largest record of upfront payment made through technology export deals in Korea. In November 2015, Hanmi Pharmaceutical had entered into a license agreement with Sanofi to transfer the license of its 3 new diabetes drugs (Efpeglenatide·long-acting insulin·Efpeglenatide+long-acting insulin). The upfront payment, which was first set at 400 million euros and later reduced to 240 million, still ranks first among all upfront payments made for technology exports in Korea. Hanmi Pharmaceutical’s deal with Janssen for its long-acting diabetes-obesity drug ranks second in upfront payments ($150 million). Third is SK Biopharm’s epilepsy treatment cenobamate, which has received $100 million in upfront payment upon signing an agreement with Able Therapeutics. Fourth is again Hanmi Pharmaceutical, which had received $80 million through a licensing agreement with Genentech for its RAF inhibitor in 2016. ABL Bio’s ABL301 ranked fifth with $75 million in upfront payments. One unfortunate aspect is that 5 of the top 10 items that received the most in upfront payments were returned. In December 2015, Sanofi had discontinued development and returned the rights for the long-acting insulin among the 3 candidate drugs it acquired from Hanmi for its Quantum Project. Also, the agreement was then changed so that Hanmi develops the long-acting insulin combo (long-acting insulin+ efpeglenatide) for Sanofi’s acquisition in the future, but Sanofi did not take over in the end. The rights for Hanmi Pharmaceutical’s new candidate drug for obesity/diabetes 'JNJ-64565111,’ which accrued the second-most amount in upfront payment, has also been returned in September 2019. The license for Hanmi’s ‘olmutinib’ was also returned in 2016, and the immune disease treatment that was handed to Eli Lily was also returned in 2019. Dong-A ST’s partner company also gave up the development of Dong-A ST’s Mer tyrosine kinase inhibitor (Mer TKI). Among technology export agreements still in effect, SK Biopharm’s cenobamate has received the most amount in upfront payment with $100 million. ABL Bio’s ABL301 ranks third among technology exports that are still in effect.
Company
Viatris & J&J hired female executives
by
Eo, Yun-Ho
Jan 12, 2022 06:05am
Executive Director Kim Ji-young (left) and Executive Director Hwang SeonghyeExecutive-level personnel in charge of multinational pharmaceutical's external cooperation department are active. According to related industries, Viatris Korea appointed Kim Ji-young (52 years old), former executive director of Janssen Korea, as the head of the dept. of Foreign Cooperation in December last year, while Johnson & Johnson Korea (J&J) will appoint Hwang Sung-hye (50), former executive director of Pfizer, this month. Viatris Korea recruited Kim Ji-young, executive director of Corporate Affairs & Market Access, as her predecessor Lim Hyun-jung (45) moved to the head of the marketing department. Executive director Kim led Janssen Corporation and Patient Affairs for 10 years and was in charge of overall communication in the pharmaceutical industry, including disease communication, environmental creation and patient support, and CSR. Graduated from the Department of Archaeological Art History at Seoul National University, she obtained a master's degree in communication at the University of North Carolina in 2000 and also oversaw the promotion and external cooperation teams of Janssen in Taiwan and Hong Kong. Previously, she worked as a reporter for Maeil Business Newspaper and Hankook Ilbo for 20 years. As former Vice President Song Young-joo (62) became an advisor to BKL as of the 7th, J&J recently decided to appoint Hwang Sung-hye as executive director of Government Affairs & Policy. Hwang joined Pfizer Public Affairs in 2008, served as the General Manager of Corporate Affairs and Market Access of the dept. of Foreign Cooperation, and has even marketing experience. Graduated from Yonsei University's Department of Newspaper Broadcasting, she earned a master's degree in economics at Sogang University and a master's degree in business administration at Rouen ESC in France and worked as a reporter for the Chosun Ilbo. Until just before the turnover, executive director Hwang led Pfizer's MA team. Meanwhile, with Kim's move, Janssen is looking for a new general manager of the external cooperation team, and Pfizer also started hiring Market Access with Hwang's resignation.
Company
Keytruda-Renvima has been approved as the primary treatment
by
Jan 12, 2022 06:05am
MSD Korea announced on the 11th that a combination therapy of anti-PD-1 immuno-cancer drug Keytruda (Pembrolizumab) and Lenvima (Lenvatinib) has been approved by the MFDS as the primary treatment for advanced new cell carcinoma. Combination therapy of Keytruda and Lenvima in renal cell cancer treatment recorded 23.9 months of mPFS and improved OS in a phase 3 clinical CLEAR study. Studies have shown that Keytruda-Lenvima reduced the risk of disease progression or death by 61% (HR=0.39) compared to Sunitinib. The risk of death was reduced by 34% (HR=0.66). The overall survival period did not reach the median value. Keytruda-Lenvima's objective response rate (ORR) was 71%, significantly higher than that of the Sunitinib group of 36%. CR recorded 16%, 4%, and PR recorded 55%, and 32%, respectively. The most frequently observed adverse reactions in clinical practice are diarrhea and high blood pressure. In addition, clinical evidence for Keytruda's endometrial cancer indication was added. Phase 3 clinical data that succeeded in progressive endometrial cancer for the first time in 50 years has been added. Phase 3 KEYNOTE-775/Study 309 study found that Keytruda-Lenvima reduced the risk of death by 32% (HR=0.68) compared to chemotherapy (Doxorubicin or Paclitaxel). The risk of disease progression or death decreased by 40% (HR=0.60). In addition, the median survival period of the combined group was 17.4 months, which was statistically significantly improved to 12 months of the chemotherapy group. The median PFS was significantly longer at 6.6 months and 3.8 months, respectively. Kim Sung-pil, executive director of MSD Korea anticancer drug division, said, "This permit is a result of proving the excellent clinical profile of Keytruda-Lenvima."
Company
Reducing # of sales positions of pharmaceutical companies
by
Moon, sung-ho
Jan 12, 2022 06:04am
It was found that the number of personnel engaged in the control and bio industries has steadily increased over the report showed. However, amid the boom in pharmaceuticals and bio, the position of sales workers is decreasing day by day. Analysts say this is because it is concentrated on the development of online sales and marketing and contract manufacturing organizations (CMO). According to the KPBMA on the 11th, the number of people engaged in the pharmaceutical and bio industries has steadily increased over the past 10 years, reaching 1,398 companies and 114,126 in 2020. Considering 823 companies and 74,477 people in 2011, it doubled. Such an increase in pharmaceutical and bio-industry workers was led by production workers. The number of production workers exploded from 23,539 in 2011 to 46,166 in 2020. As a result, the proportion of production workers among all pharmaceutical and bio-industry workers also increased from 31.6% to 40.5%. Analysts say that this was an opportunity for large bio companies such as Celltrion, Samsung Biologics, and SK Bioscience to expand their CMO businesses by increasing production facilities before and after the COVID-19 pandemic. Sales positions, which have been key in pharmaceutical and bio-industry jobs, have been greatly reduced over the past 10 years. This is because the size of the sales position remained in place while the number of production workers doubled during the same period. The total number of sales jobs in 2020 was 25,317. Considering that there were 24,535 people in 2011, it is safe to say that it remains the same. The percentage of sales positions decreased from 32.9% in 2011 to 22.2% in 2020. In fact, as the proportion of production workers has increased, the proportion of sales workers has decreased. The industry seems to predict that the proportion of sales jobs will decrease over the years. They say that the position will inevitably decrease as consignment production of medicines, utilization of Contracts Sales Organization (CSO) by mid-sized pharmaceutical companies, and the spread of online sales and marketing are major factors. Some predict that large-scale movements of pharmaceutical sales workers will take place amid the growth of the digital healthcare industry. This is because in the digital healthcare sector, like in the pharmaceutical and bio sectors, hiring sales personnel is essential as its use in hospitals and clinics is directly related to the increase in sales. Digital healthcare companies that develop EMR or medical AI solutions are increasing their employment as sales workers at pharmaceutical companies. Company A, which is developing EMR, is hiring "someone who wants to sell data technology, not oral drugs," while company B is hiring people with experience in sales at university hospitals at the team leader level. An executive of a domestic pharmaceutical company, a former doctor who asked for anonymity, said, "It is now difficult to grow with the operation method of a traditional pharmaceutical company that relies on generic sales centered on face-to-face sales." As consignment production of medicines is suggested as an alternative to growth, traditional pharmaceutical companies are also focusing their capabilities on developing new drugs and producing drugs, he explained.
Company
Pharmaceutical bio jobs to be reorganized
by
Chon, Seung-Hyun
Jan 12, 2022 06:04am
Jobs in the pharmaceutical bio industry have increased by more than 50% in the past nine years. The number of production workers surged. In recent years, it is analyzed that many jobs have been created in production jobs as pharmaceutical bio companies have greatly increased production facilities and expanded their CMO business. The proportion of sales jobs in all jobs dropped sharply. According to the 2021 Pharmaceutical Bio Industry Data Book published by the KPBMA on the 10th, the total number of employees in the pharmaceutical bio industry in 2020 was 114,126, an increase of 10.9% year-on-year. It increased 53.2% in nine years from 74,477 in 2011. # of employees in the pharmaceutical bio-industry by year (unit: # of employee, data: the KPBMA) Jobs in the pharmaceutical bio industry have increased every year since 2011. Analysts say that the pharmaceutical bio-industry has recently shown growth and is playing a significant role in creating jobs. Looking at the current status of jobs by major task, the number of production workers has increased significantly. In 2020, the number of production employees was 46,166, an increase of 24.1% from the previous year. It doubled in nine years from 25,539 in 2011. The share of production workers in the entire pharmaceutical bio industry expanded from 31.6% in 2011 to 40.5% in 2020. In 2011, sales workers accounted for the largest portion of all employees, but in 2020, the proportion of production employees exceeded 40%. It is analyzed that the number of production jobs has increased significantly recently as production facilities have increased significantly and CMO businesses have expanded, especially among bio companies. Founded in 2011, Samsung Biologics is currently operating three biopharmaceutical plants in Songdo, Incheon. Samsung Biologics is building its fourth plant with the aim of operating it in 2023. The fourth plant is the largest ever with 256,000 liters of production. When the fourth plant is in operation, Samsung Biologics will secure a total of 618,000 liters of production facilities along with its third plant (3,000 liters of first plant, 152,000 liters of second plant, and 180,000 liters of third plant). As of the end of 2020, the number of production workers at Samsung Biologics was 1,255, an 87.6% increase from 669 in 2016. In other words, the number of production jobs has nearly doubled in four years. Celltrion and SK Bioscience also saw a significant increase in the number of production workers due to the recent surge in biopharmaceutical production. Samsung Biologics, Celltrion, and SK Bioscience all surpassed 100 billion won in quarterly operating profit, leading the growth of the entire pharmaceutical bio industry. The proportion of sales jobs in the pharmaceutical bio industry has decreased significantly. In 2020, the number of sales employees was 25,317, down 1.0% from the previous year. Sales jobs were the only ones among all jobs that saw a year-on-year. The number of sales employees increased only 3.2% over the past nine years from 24,535 in 2011 to 25,317 in 2020. Sales accounts for more than 10% of all jobs from 32.9% in 2011 to 22.2% in 2020. Although the pharmaceutical bio-industry is growing, the proportion of sales jobs is also expected to decrease as sales activities are relatively less important. Analysts say that sales activities based on scientific evidence have increased significantly rather than salespeople's supply offensive. Some say that the need for salespeople to visit medical institutions in person has been reduced as the proportion of non-face-to-face work such as online marketing has decreased significantly since the recent spread of COVID-19. The proportion of office and research jobs did not change significantly. The proportion of office workers increased by 1.5% from 19.4% in 2011 to 20.9% in 2020, while the number of research workers decreased by 0.1% from 11.8% to 11.7% during the same period.
Company
Soliris at risk of price cuts amid increasing PA rejections
by
Moon, sung-ho
Jan 12, 2022 06:04am
The National Health Insurance Service has selected ‘Soliris (eculizumab)’ as a ‘subject for PVA monitoring’ and began monitoring its claims amount, believing that its use has increased over a certain level. However, all of the prior authorization applications for the same drug had been rejected last month. In other words, the drug is double trouble as it is being assessed for price cuts due to its increased claims amount while being rejected for reimbursement in its prior authorization applications. According to the industry on the 6th, the NHIS had selected and informed companies of the drugs under the Price-Volume Agreement that will be evaluated in the first quarter of 2022, including Soliris. The PVA system is a means for the NHIS and the pharmaceutical company to share the amount of rising drug cost that is applied to drugs whose usage increases rapidly. After negotiations with the NHIS, the company needs to maintain the use volume that it has agreed upon to avoid price cuts. Therefore, drugs that are found to have been used over that certain level according to the NHIS’ claims amount may be subject to price cuts, being subject for the adjustment of its upper limit. Soliris is also known to have been caught under NHIS’ radar for exceeding the claims amount. If the NHIS deems that Soliris’ use volume has increased after monitoring its case, the authorities will conduct negotiations with its company, Handok, and push for price cuts. An NHIS official said, “We will be selecting subjects for negotiations after monitoring the evidence. Soliris is also one of the drugs being monitored. The drugs up for monitoring this time are those whose claims have increased by 30% or more or those that have increased over 60% annually during the compared period or by over 10%‧5 billion won.” However, one thing to note is that Soliris’s applications for prior authorization are being being continuously disapproved for reimbursement by the NHIS. Soliris is currently indicated for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). However, due to the high price of the drug – which costs 5.13 million won per vial – the MOHW and HIRA had set a hurdle that requires prior authorization for insurance benefit when approving the drug for reimbursement. And according to HIRA, all 3 of the prior authorization applications (2 new, 1 re-deliberation case) made for Soliris that were deliberated by the Healthcare Review and Assessment Committee in November last year were rejected. All 3 applications were for the use of Soliris in aHUS. For aHUS treatment, only 3 of the 47 applications filed for prior authorization last year were approved and administered to patients. As a result, although Soliris is not being administered much due to the series of disapprovals by NHIS during the prior authorization review, the drug is still subject to monitoring for price cuts due to its expanded indication that raised the claims amount. HIRA explained, “The applications were denied after reviewing the supplementary medical records that were submitted because the subjects were not eligible for administration as specified in the notice and were determined to have secondary thrombotic microangiopathy that was caused by drugs such as immunosuppressants.”
Company
Ultra-high-priced ‘Kymriah’ is up for DREC deliberations
by
Eo, Yun-Ho
Jan 11, 2022 06:29am
Whether the new CAR-T therapy ‘Kymriah’ will be applied insurance benefit is receiving wide attention. According to industry sources, the world’s first chimeric antigen receptor T-cell (CAR-T) therapy ‘Kymriah' will be deliberated as an agenda by the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee on the 13th of this month, 3 months after the agenda passed the Cancer Disease Deliberation Committee in October last year. Specifically, the drug is indicated for ▲ adult patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL) after two or more lines of systemic therapy, and ▲ patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (B-ALL) that is refractory or in second or later relapse Reimbursement listing of Kymirah is currently the biggest and hottest issue in the industry as this ‘one-shot’ treatment may cure cancer with a single administration but costs up to 500 million won per shot. The company had been going through the reimbursement process for Kymriah since it was approved in March last year through the ‘approval-reimbursement review linkage system.’ Although it was first set an agenda for CDDC deliberation in September, the committee deferred their decision. Immediately upon the news of deferral, the Korea Leukemia Patients Organization strongly criticized the government and the pharmaceutical company. The KLPO had before criticized the authorities over the delay in Kymriah’s agenda being put up for deliberation by the CDDC. Despite overcoming the CDDC obstacle, whether Kymriah will be able to complete its reimbursement journey to the end remains unknown. The CDDC may have passed the Kymriah agenda to DREC pressured by the intense attention focus around the agenda. Therefore DREC’s role is expected to be an important observation point that will play a key role in the listing process. Meanwhile, the CDDC had set the reimbursement standards for Kymriah so that the following conditions should be met for its reimbursement: ▲the company should bear a higher-level risk in consideration of the price level in other countries, ▲a risk-sharing system based on a performance-based payment model that pays according to treatment performance of each patient for relapsed or refractory diffuse large B cell lymphoma (DLBCL) as it has a poorer clinical outcome compared to acute lymphoblastic leukemia, and ▲an expenditure cap should be set on the total expenditure allowed for Kymriah. In other words, the key to the reimbursement listing of Kymriah depends on the fiscal sharing plan submitted by Novartis’ Korean subsidiary and its determination in persuading its head office.
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