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- 2026-03-19 04:10:02
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- Teva gave Celltrion ₩200 billion in copyright deposit
- by An, Kyung-Jin May 12, 2020 06:27am
- 허쥬마(왼쪽)와 트룩시마 제품사진 Celltrion group surpassed the exclusive rights of the two biosimilars in North America, and it was found that it generated a technology fee of nearly ₩200 billion. In a report submitted to the Securities and Exchange Commission (SEC) on the 7th (local time), multinational pharmaceutical company Teva revealed the history of a biosimilar copyright agreement signed with Celltrion Healthcare in the past. According to the report, the company confirmed that in October 2016, it paid out $160 million to Celltrion Healthcare under the condition of exclusive supply of 'Truxima' and 'Herzuma' in the United States and Canada. At the time, both products were subject to a condition of being refundable for $60 million of the down payment because they were prior to obtaining official approval. At present, both 'Truxima' and 'Herzuma' have been approved by the FDA and Health Canada, and their condition has expired when they start selling products. This is the first time that Celltrion Healthcare has revealed the amount of license revenue received from handing over biosimilars' exclusive overseas distribution rights. Celltrion Healthcare was an unlisted company when it signed an agreement with Teva, and did not disclose details of the contract. In the business report submitted to the Financial Supervisory Service by Celltrion Healthcare, only the timing of the contract (October 4, 2016) and distribution countries (USA, Canada, Puerto Rico) were mentioned for the 'Truxima' and 'Herzuma' supply contract' with Teva. The main thing to note in this contract is the size of the down payment. The $160 million secured by Celltrion Healthcare is the third largest among technology transfer contracts signed by domestic pharmaceutical bio companies. In 2015, three types of diabetic new drugs, which Hanmi exported to Sanofi, received the largest contract amount of €204 million. Hanmi's long-lasting obesity diabetes treatment drug ($105 million) was handed over to Janssen for the second largest down payment. SK Biopharmaceuticals signed a technology transfer contract with Able Therapeutics of Switzerland in February last year for a new drug candidate for encephalopathy, 'Cenobamate'. 'Truxima' is a biosimilar product of 'Mabthera' (Rituximab), a flagship product of multinational pharmaceutical company Roche. Mabthera is prescribed for autoimmune diseases such as rheumatoid arthritis, including blood cancer. In the U.S. alone, it is forming a market of about ₩5 trillion (based on 2018 IQVIA). Celltrion Healthcare and Teva were approved for FDA sales of Truxima in November 2018, and launched in the U.S. market starting in November 2019. In February this year, the product was launched in Canada. 'Herzuma' is a biosimilar product of Roche's anti-cancer drug 'Herceptin' (Trastuzumab), which is prescribed for breast cancer, stomach cancer, etc. Herzuma was approved by the FDA in December 2018, and began selling in the US in March this year. In Canada, it was released in January this year. Under the agreement, Teva and Celltrion Healthcare share revenue from product sales in the United States and Canada. An official of Celltrion Healthcare said, "The $ 160 million that Teva released was a pre-paid deposit when it signed a biosimilar license transfer agreement in October 2016. There was a provision that Teva would refund $ 60 million if it did not get FDA approval." "There is no obligation to return when we start selling locally." "Other details cannot be mentioned at a public expense," he said.
- Company
- Samsung Biologics, ranked No.1 in the market cap
- by An, Kyung-Jin May 11, 2020 06:19am
- Samsung Biologics (left) & Celltrion headquarters Samsung Biologics is taking third place in the market capitalization of KOSPI with the reflex profit of COVID-19. Difference in market capitalization with Celltrion is about ₩10 trillion, and it has been holding a position as a bio leading stock for 7 months. According to the Korea Exchange on the 8th, Samsung Biologics closed the transaction at ₩588,000, up 3.6% from the previous trading day. Compared to last year's closing price of ₩433,000, the stock price jumped 71.6% in five months. Celltrion's closing price on this day was ₩21,500, up 3.2% from the previous trading day. Although it increased 16.3% from the closing price last year, it did not significantly exceed Samsung Biologics' share price growth during the same period. Changes in market cap of Samsung Bioepis & Celltrion (Unit: ₩100 million, Source: the Korea Exchange) As of 8th, Samsung Biologics' market capitalization is ₩38.90 trillion, ranking third in the KOSPI market. It surpassed Celltrion's market capitalization of ₩28.36 trillion by more than ₩10 trillion, recording the largest market capitalization among pharmaceutical bios. Samsung Biologics' market ranking dropped to 12th place in May last year due to the prosecution investigation by suspicion of fraudulent accounting. However, after the third quarter of last year, the share price turned to a recovery, reflecting good earnings and expectations for growth of subsidiary Samsung Bioepis. Prospects that demand for contract manufacturing organization (CMO) will increase with the spread of COVID-19 this year increased market cap. After signing a CMO contract worth $360 million with Vir Biotechnology in the US last month, as the possibility of market reorganization was raised with regard to additional contract manufacturing organization (CMO) for COVID-19 treatment, it served as a trigger for the share price rise. Samsung Biologics completed the technology transfer process with Vir Biotechnology this year and will start production next year. It is said that the CMO work has been addressed at the 3rd plant, which resolved the concerns about utilization rates raised by some people. On the 10th of last month, when the contract was signed with Vir, Samsung Biologics' market capitalization jumped to more than ₩500 million a day, at ₩3.7 billion. Since then, the market cap continues to rise, and the market capitalization approaches ₩40 trillion at its peak. During the same period, Celltrion's market cap fell slightly from ₩27.17 trillion to ₩26.89 trillion (₩128.3 billion), and the gap with Samsung Biologics widened by more than ₩10 trillion. At the end of last year, Celltrion's market capitalization rose by more than ₩5 trillion over the past five months from ₩23.23 trillion to ₩28.36 trillion. Celltrion, like Samsung Biologics, is on the rise following the COVID-19 crisis, but its growth is far less than that of Samsung Biologics, and falls short of a bio leading stock. The securities firm predicts that this year, the two companies will have the highest performance ever. FnGuide, a financial information company, predicted that Celltrion would record an operating profit (stock price estimate average) of ₩569 billion, up 58.1% from the previous year based on separate financial statements. It is predicted that Samsung Biologics will increase operating profit by ₩228.4 billion, an increase of 149.1%.
- Company
- COVID-19 affected off-patent drug market share plunge?
- by Chon, Seung-Hyun May 11, 2020 06:18am
- Although off-patent originals have been consistently expanded their market shares in recent years unaffected by the army of generics entering the market, the original’s market share shrunk in last first quarter. The Korean pharmaceutical industry experts analyze the originals struggled to grow in the market against intense marketing of generics amid COVID-19 pandemic. ◆Lipitor and Crestor market shares stagger in the first quarter On May 10, pharmaceutical industry research firm UBIST stated Pfizer’s antihypertensive Lipitor (atorvastatin) has generated 47 billion won from outpatient prescription in the first quarter showing 0.2 percent decrease from the same time last year. Its prescription volume has been surging for last few years, but the growth seems to have slowed down. Compared to the first quarter last year, the prescription volume has increased only by 5.5 percent. The overall prescription volume of individual atorvastatin drugs in the first quarter reached 138.2 billion won with 2.3 percent increase from the year before. The overall market volume has grown but the original’s prescription volume has gone down. Quarterly prescription volume (left) and market volume (right) of Lipitor (Unit: KRW 100 million) Source: UBIST In the individual atorvasatin drug market, Lipitor’s pie took up 33.98 percent, which was reduced by 1 percent point compared to last year (34.83 percent). Even compared to the fourth quarter (34.92 percent) last year, the first quarter’s volume fell by 1 percent point. Since the third quarter of 2016 (33.66 percent), Lipitor’s quarterly market share has hit the lowest point in 42 months. Regardless of over 100 generics entering the market from 2009 as Lipitor’s patent was expired, the original has been constantly growing in the market. Lipitor’s market share steeply expanded from 31.70 percent in the first quarter 2015 to 34.92 percent in the fourth quarter last year. Although it maintained the market share over 34 percent since the fourth quarter of 2016, the figure plummeted this year at around 33 percent. Besides Lipitor, many of off-patent drugs that showed off their strong growth until last year saw their market share drop, simultaneously. Quarterly prescription volume (left) and market volume (right) of Crestor (Unit: KRW 100 million) Source: UBIST In the first quarter, Crestor (rosuvastatin) has made 22.5 billion won, recording a 5.1-percent drop from the same time last year (23.7 billion won). Compared to the previous year, Crestor had an 11.8-percent growth in last year’s first quarter, generating 23.7 billion won. The overall individual rosuvastatin drug market in the past first quarter has generated 84.1 billion won, jumping 5.2 percent from the same time last year. Despite the general growth in the market, Crestor’s first quarter market share has gone down significantly from 29.67 percent last year to 26.76 percent this year. Even against the last fourth quarter, this year’s first quarter market share fell by 2 percent point from 28.63 percent. Although it defended the market share of around 30 percent against over 100 generics for a while, this year’s first quarter market share has hit the lowest point. ◆Prescription volumes in Plavix, Aricept and Exforge also plunge The anticoagulant agent clopidogrel’s market also demonstrated similar trend. The first quarter prescription volume in Plavix (clopidogrel) was at 23.0 billion won with 1.4 percent increase than the previous year. The growing tendency continued but it was sluggish. In last year’s first quarter, Plavix generated 22.7 billion won, increased by 10.7 percent from the year before. In the first quarter of 2018, the drug’s prescription volume was 6.8 percent higher than the previous year. The overall individual clopidogrel drug market generated 2.6 percent more in the first quarter this year at 89.8 billion won, compared to 87.6 billion won in 2019. In the first quarter clopidogrel market, Plavix’ share was brought down to 25.65 percent by 0.38 percent point from 25.93 percent in last year. Compared to the fourth quarter last year at 26.27 percent, this year’s first quarter share was decreased by 0.62 percent point. The drug’s quarterly market share recorded the lowest in 18 months since the third quarter of 2018. Quarterly prescription volume (left) and market volume (right) of Plavix (Unit: KRW 100 million) Source: UBIST Moreover, other major off-patent drug market manifested noticeable plunge in original’s market share. The overall market of an Alzheimer’s disease-associated symptom treating agent donepezil has made 58.2 billion won this past first quarter with 1.0 percent increase from the same time the year before. Compared to 21.6 billion won made last year, the original brand drug Aricept has only made 23.0 billion won in last first quarter, recording 6.0 percent fall. In 2017 and 2018, Aricept’s first quarter prescription volume marked 18.9 billion won and 20.9 billion won, respectively, and showed a continuous growth but it turned downward this year. Aricept’s market share in the first quarter within the donepezil market has hit the lowest at 37.21 percent. Compared to last year at 39.99 percent, the first quarter share this year fell by 3 percent point. And from the fourth quarter last year, the number was again dropped by 0.3 percent point. Quarterly prescription volume (left) and market volume (right) of Aricept (Unit: KRW 100 million) Source: UBIST An amlodipine and valsartan combined antihypertensive, Exforge has also slipped. The first quarter prescription volume was at 20.2 billion won marking 1.6 percent drop from the year before. In the first quarter of last year, Exforge has generated 22.0 percent more in prescription volume against the year before. Influenced by the impurity found in valsartan in July 2018, the prescription volume of Exforge has surged but it has been stagnating recently. Taking up 41.54 percent of the combination drug market in this year’s first quarter, Exforge’s share has plummeted by over 3 percent point from 44.91 percent last year. Quarterly prescription volume (left) and market volume (right) of Exforge (Unit: KRW 100 million) Source: UBIST ◆Despite showing continued growth until last year, off-patent drugs crippled this year, possibly affected by COVID-19 In fact, patent-expired novel drugs continued to show strong growth up until last year, regardless of the generics intensely tackling the market. The industry experts claim the originals have advantages in market share growth due to Korea’s unique drug pricing system. When a generic is first released to the market, the original’s reimbursed price is reduced down to 70 percent of its initial pricing. And after a year from then, the pricing is again adjusted to 53.55 percent of the pricing before the patent expiration. The maximum pricing of a generic can be up to 59 percent of the original’s price before the patent expiration, and a year later the price also drops to 53.55 percent of the original’s pre-patent expiration price. The experts argue the prescribers seemingly prefer originals as it gets priced on par with generic pricing before the patent expiration. In this year, however, generics’ market share has gone up significantly. In this first quarter, the overall generic outpatient prescription volume has reached 3.70 trillion won with a 2.7-percent surge from last year at 3.60 trillion won. The industry experts analyze most of the original market has been engulfed by generics. Trend in monthly outpatient prescription volume (Unit: KRW 100 million) Source: UBIST Some experts carefully question if the COVID-19 pandemic has affected the dull growth of overall off-patent drugs. When multinational pharmaceutical companies have halted their salespeople from visiting healthcare institute amid COVID-19 outbreak, Korean companies could have assertively approached the healthcare providers and convinced them to prescribe generics. Since the first confirmed case of COVID-19 in Korea on Jan. 20, a growing number of pharmaceutical companies have refrained from visiting healthcare institutes, starting from the multinational companies. Most of the pharmaceutical company salespeople have started working from home as the number of confirmed cases skyrocketed since the discovery of the 31st confirmed case on Feb. 19. The experts also speculate many of chronic disease patients could have received prescription for a longer period of time at once to avoid visiting their healthcare providers. They also noted more clear trend in prescription drug market would be visible after April or May, when the pandemic heavily influenced the prescription volume.
- Company
- Zolgensma & Kymriah will be entered the Korean market
- by Eo, Yun-Ho May 08, 2020 06:34am
- Two very expensive new drugs by Novartis enter the Korean market. According to a related industry, Novartis Korea submitted an application for the approval of a treatment for Spinal Muscular Atrophy (SMA), Zolgensma (Onasemnogene abeparvovec) & CAR-T (Chimeric Antigen Receptor T cells) cell gene therapy, Kymriah (Tisagenlecleucel) earlier this year. The two drugs are expected to be approved in Korea in the second half of the year as soon as they have obtained approval in Japan following the United States. Zolgensma is an SMA treatment such as Biogen's Spinraza (Nusinersen), which has attracted attention as an expensive drug, but it was also priced very expensive. Currently, it costs about ₩2.5 billion per dose. The United States has approved the world's highest price for $2.1 million as a single treatment. For reference, Spinraza's domestic insurance upper limit is ₩92,359,131 per bottle. However, Spinraza is administered six times in the first year and three times each year from the following year, whereas Zolgensma is administered only once. Zolgensma is a gene therapy product designed to produce SMN proteins that do not function properly in patients with spinal muscular atrophy in specialized motor neurons that can regulate muscle contraction. The indications for the first CAR-T drug Kymriah are 'recurrent or refractory B-cell Venous Lymphoma in patients under the age of 25' and 'relapsed or refractory diffuse large B-cell lymphoma after two or more adult systemic treatments'. In Korea, it was already designated as an orphan drug in March last year. Novartis prepared a document based on ELIANA data, a global phase II clinical trial, and submitted a New Drug Application (NDA) in Korea. Kymriah was first commercialized in the United States in the world in August 2017, and approved in Europe in 2018. However, CAR-T is also very expensive. Although this drug is approved for domestic market with a cost of about ₩500 million per dose, it is judged that it will be difficult to be placed in the reimbursement list. For reference, Kymriah is administered once. Meanwhile, Novartis is also preparing to commercialize the macular degeneration treatment drug Beovu (Brolucizumab) in Korea. Beovu has proved its effectiveness through the HARRIER trial that directly compares to Eylea (Aflibercept).
- Company
- Jeil got a domestic exclusive promotion for Amitiza
- by Lee, Seok-Jun May 08, 2020 06:34am
- Jeil distributes FDA-approved constipation drugs in Korea. Jeil announced on the 6th that it has signed an exclusive promotional contract (distribution, marketing, and sales rights) in Korea with Amitiza soft capsule (Lubiprostone), a chronic constipation treatment for Takeda. Amitiza received FDA approval in 2006. In Korea, the approval process was completed in May last year. It is a type II chlorine ion channel local accelerator in small intestinal lining cells, and it has indications for the treatment of narcotic analgesic (opioid)-induced constipation △in adult patients with chronic non-cancerous pain, and △in adults patients with chronic idiopathic constipation. Amitiza is expected to be released this year. As of 2018, global sales amounted to ₩680 billion.
- Company
- Pharmaceutical companies ended telecommuting
- by Kim, Jin-Gu May 07, 2020 06:02am
- The 45-day “social distance campaign” ended. The government has announced that instead of ending social distance on the 5th, it will start “distancing in daily life” from the 6th. According to the government guidelines revision, pharmaceutical companies are also returning to normal business one after another. Most pharmaceutical companies ended telecommuting on the 6th. Pharmaceutical companies that are still working from home are expected to return to normal business starting next week. Existing guidelines such as wearing a mask or checking fever are still applied. Meetings and events are also encouraged to refrain. From the 6th, the government changed the COVID-19 response guidelines to keep distancing in daily life instead of social distance. (Data: the KCDC) ◆Chong Kun Dang, telecommuting ends in a month, major domestic companies return to normal business Among domestic companies, Chong Kun Dang began telecommuting from sales offices in Daegu, Gyeongbuk at the end of February, and all employees worked telecommuting at the end of March. Telecommuting, which has continued for more than a month, has ended entirely on the 6th. It is said that the salesperson entered normal work from Monday (April 27) last week, and from 6th immediately after the holiday was over. Other pharmaceutical companies are in a similar situation. in the case of HK inno. N and Kolmar Korea, the field work of the salesperson will resume from next week. So far, salespeople have seen live education or web seminars through office work instead of on-site visits. GC Pharma and Ildong Pharmaceutical have also resumed their sales activities in a limited manner since mid-March. However, it is also flexible for employees raising young children. If you are an employee who has entered normal work, but in the case of employees whose children have not started school yet, the flexible work schedule allows them to adjust their time to work. Most foreign pharmaceutical companies that have actively responded to the COVID-19 crisis than domestic companies have either ended or will end their telecommuting. Amgen Korea, which started work at home for the first time in Korea, will start work next week. Pfizer Pharmaceuticals of Korea and Abbvie Korea are also expected to commence normal work next week. Novartis Korea has been working normally since last week, and Roche Korea has started on the 6th. ◆Distancing in daily life campaign is still ongoing However, all of them are acting cautiously to prevent any possible infections, including 'distancing in daily life' according to government guidelines. Checking the fever in the lobby of Hanmi This includes running a thermal camera at the doorway and wearing a mask indoors. In some places, after long telecommuting, ventilation and quarantine of the entire building were carried out. As before, meetings and business trips should be avoided as much as possible. It is same for in-house events. Ildong Pharmaceutical held the 79th anniversary of its foundation on the 6th and attended the event with minimal attendance. Some pharmaceutical companies have a system in place to automatically switch employees to telecommuting if they go to the area where the confirmed person is located or if there are confirmed patients or people with symptoms. An official from a domestic company said that they returned to normal business, but they was more concerned with daily life prevention according to government guidelines and was carefully resuming normal business with thorough prevention. ◆Expectations that may improve in May At one time, some hospitals advised to refrain from visiting salespeople A domestic salesperson A, who is responsible for pharmacies in Gyeonggi-do, said that pharmacists are brighter than before, it seems that the number of patients who visited pharmacies has increased again since the end of last month's disaster aid was paid. He added that the situation was very bad in March and April, but he expects the situation to improve after May. A domestic salesperson B, who is responsible for clinics in Seoul, said that the mood was very bad for about two months after facing the damage caused by the COVID-19 incident directly, however, it has been improved since the end of last month. He said that more and more places were allowed to return to salespeople, and he said they were encouraging each other, mentioning the end of the COVID-19 outbreak.
- Company
- Reimbursement talks on first CMV prophylaxis soon to begin
- by Eo, Yun-Ho May 07, 2020 06:01am
- The reimbursement approval talk is about to get started for Prevymis, a medicine to prevent cytomegalovirus (CMV) infection in stem cell transplant recipient. Korean pharmaceutical industry sources reported MSD’s Prevymis (letemovir) that was passed by Economic Evaluation Subcommittee last month would be deliberated by Health Insurance Review and Assessment Service (HIRA) Drug Reimbursement Evaluation Committee (DREC) on May 7. Reactivation of CMV in patients, who have undergone a stem cell transplant, could cause diseases like pneumonia, hepatitis, myocarditis, gastroenteritis and encephalitis. Despite a low level of CMV viral load in blood, it could increase the risk of mortality. A study found that in early hospitalization stage of CMV-positive patients who had stem cell transplant, the risk in overall mortality could be 3.5 times higher than in non-infected patients, whereas the mortality rate in patients with CMV viremia have 2.6 times greater risk of overall mortality than patients with no viremia up to 60 days after the transplant. However, the current CMV treatment in allogenic hematopoietic stem cell transplantation (HSCT) recipients mostly relies on pre-emptive therapy, which injects antiviral medication when the viral load exceeds a certain level. In 2018, Korean Ministry of Food and Drug Safety (MFDS) has approved of Prevymis to be used to help prevent CMV infection and disease in adults who have received an allogenic HSCT. The treatment has both injection and tablet formulation options and it can be administered once-daily from the day of or within 28 days of HSCT for up to 100 days after the transplant The U.S. Food and Drug Administration (FDA) has approved the use of Prevymis in 2017 and also designated it as a Breakthrough Therapy, Priority Review Drug and Fast Track Drug. President Yoon Sung-soo of Korean Society of Hematology (Department of Internal Medicine at Seoul National University School of Medicine) explained, “The limitation of the existing pre-emptive therapy is clear as it initiates treatment only when the CMV viral load reaches the threshold level. The medical demand on Prevymis is surging as it is a crucial treatment option for the survival of high-risk patients.” Clinical studies have confirmed Prevymis hindering the reactivation of CMV and lowering the risk of mortality. The studies reported no observation of adverse reactions like myelosuppression or renal toxicity. In the 2019 guidelines published by the National Comprehensive Cancer Network (NCCN) and European Conference on Infections on Leukemia (ECIL), Prevymis has been recommended as a prophylaxis in CMV-seropositive allogeneic HSCT recipient.
- Company
- Temptation to reduce the cost of DMF
- by Kim, Jin-Gu May 07, 2020 06:01am
- About 7 out of 10 DMF that pharmaceutical companies have registered for use are from India and China. Compared to 10 years ago, the share of DMF in India and China is also increasing significantly. It is an analysis that pharmaceutical companies have increased demand for inexpensive Indian·Chinese drug products to cut costs. According to the MFDS on the 4th, the number of DMF last year was 601. Excluding 71 cases in Korea, 530 cases were registered overseas. By country, India had the largest number of DMFs. The total number was 254, accounting for 42.3% of the total. China was followed by 153 cases (25.5%). The share of the rest of the countries was less than 5%. India and China combined account for 67.7% of the total. 7 out of 10 DMF were made in India or China. Top 10 countries for DMF in 2019. Of the total 601 cases, 407 cases were from India and China (67.7%) (Source: the MFDS) Cumulative number of DMF in 2009-2019. Of the 5,523 cases, India·China accounted for 61.5% (the MFDS)From 2009 to 2019, a total of 5,523 DMF were registered for 11 years (including re-registration). Of these, Korea had 875 cases (15.8%) In the cumulative DMF, India was the largest with 2,066 cases (37.4%). China was followed by 1,329 cases (24.1%). Excluding Korea, 227 cases in Italy (4.1%), 183 cases in Spain (3.3%), and 84 cases in Germany (1.5%) were followed. Looking at the changes for the past 10 years since 2009, the proportion of registration of DMF from India·China is increasing. In 2009, only 17.9% of Indian·Chinese ingredients were registered. Then, it increased to 39.4% in 2010, and has remained in the mid to late 60% since 2011. Compared to 2012, when DMF notification system was changed to a registration system, the share of DMF in India and China increased by 9.8% p from 57.9% to 67.7%. On the contrary, the proportion of Korean DMF is generally small. It decreased from 47.4% in 2009 to 11.8% last year, down to a quarter level in 10 years. The share of DMFs in India·China over the past 10 years (Source; the MFDS) It is analyzed that the biggest reason for the increase in the share of DMF registration in India and China is the low price. It is known that Indian and Chinese ingredients are about 20 to 30% cheaper than domestic ones. As pharmaceutical companies are looking for inexpensive DMF to cut costs, registration of drug products from India and China seems to have increased. There are also some institutional reasons. In 2011, the MFDS changed the regulations to register as a DMF if salts or hydrates are different even if the same active ingredient is used. As a result, the number of DMF registrations exploded. In the process, registration of DMF from India and China has also increased significantly. At that time, 377 cases were made in India and 194 cases in China in one year.
- Company
- Cancer Committee lets down both Keytruda and Tagrisso
- by Eo, Yun-Ho May 07, 2020 06:01am
- Apparently, neither one of Keytruda and Tagrisso won the Cancer Deliberation Committee’s nod. According to the pharmaceutical industry sources on May 1, Health Insurance Review and Assessment Service (HIRA) Cancer Deliberation Committee convened a meeting after postponing it twice due to COVID-19, and decided to ‘defer’ the reimbursement decision on MSD’s Keytruda (pembrolizumab) and ‘unapproved’ AstraZeneca’s Tagrisso (osimertinib). Basically, the reimbursement expansion on immunotherapy Keytruda and targeted therapy Tagrisso would unlikely to happen any time soon in Korea. The Cancer Deliberation Committee reviewed granting reimbursement on Keytruda’s five indications, including as a first-line treatment (monotherapy and combination therapy) for non-small cell lung cancer (NSCLC), monotherapy for second or later-line treatment in bladder cancer, and monotherapy for third or later-line treatment in or refractory classical Hodgkin lymphoma. In March 2017, Keytruda monotherapy has been approved as a first-line treatment in patients with NSCLC. And the MSD Korea has submitted an application for reimbursement approval on the monotherapy indication to be used as a first-line treatment in September 2017, and continued the talk with the government for over two years. Regardless of the effort, the talks fell through in September last year. Considering the health authority’s decision, MSD showed its commitment by submitting unasked-for economic evaluation data on the first-line treatment in NSCLC to seek for the reimbursement expansion. But the Cancer Deliberation Committee rather demanded additional data on reducing the cost and deferred the decision. As for Tagrisso, the result was even grimmer. AstraZeneca Korea has submitted a reimbursement expansion application for the first-line indication of its osimertinib treating epidermal growth factor receptor (EGFR)-mutated NSCLC. Although the company has expressed its assertive intention to reduce the financial burden as proposed by the government, the committee members (oncologists) raised the issues on the treatment’s clinical efficacy and insisted on not approving the reimbursement. The anticancer treatment has been deferred by the committee once already in last October. The committee’s decision then was due to the Asian subset analysis result of the FLAURA Phase 3 trial in Tagrisso, specifically confirming the overall survival (OS) value. The study found the median OS with osimertinib was 38.6 months, 6.8 months longer than first generation EGFR-TKIs, Iressa (gefitinib) and Tarceva (erlotinib). However, hazard ratio (HR) in the Asian subset analysis recorded a value of 0.995. Compared to the standard value of ‘1,’ the value difference of 0.005 meant no significance. Regarding the study result, some academics have questioned the efficacy of Tagrisso as a first-line therapy in Asian race. Meanwhile, others have raised concern over the committee applying double standard as first and second generation EGFR-TKIs, Iressa, Tarceva and Giotrif (afatinib), have been listed for reimbursement as first-line therapies without concrete evidence on the OS. Some also argued the solution is in drug pricing adjustment. Based on the speculations, AstraZeneca also persuaded its headquarters and expressed its intention to adjust the pricing, but the deliberation result was a let-down.
- Company
- Toujeo passed DC of big 5 general hospitals
- by Eo, Yun-Ho May 06, 2020 06:32am
- Next-generation insulin Toujeo can be prescribed at the Big 5 General Hospitals. According to the related industry, 'Toujeo inj Solostar (gene recombination insulin Glargine)' recently passed DC of Seoul National University Hospital, Seoul St. Mary's Hospital, Samsung Medical Center, and AMC including Severance Hospital. In addition, it has been approved for indications for type I and type II diabetes in children and adolescents over 6 years of age in the US and Europe. Toujeo's expansion of pediatric indications was based on the results of the EDITION JUNIOR clinical trial. The EDITION JUNIOR study compared Toujeo to Gla-100 in 463 children and adolescents (aged 6 to 17 years) treated for type I diabetes for at least one year and with HbA1c between 7.5% and 11.0% at screening. Participants continued to use their existing mealtime insulin. The study met its primary endpoint, confirming non-inferior reduction of HbA1c with Toujeo vs Gla-100 after 26 weeks. An official from the KDA said that next-generation insulins that solved existing adverse effects such as hypoglycemia would be a useful treatment option for children and adolescents with diabetes, as they have excellent drug effects. Meanwhile, Toujeo was listed on the insurance benefits list in November after domestic approval in August 2015. Toujeo's insurance premium per insulin unit is about ₩153 (₩15,306 per 100 units).
