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- 2026-03-18 10:27:54
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- Generics for Eliquis are sold out
- by Apr 20, 2021 09:13am
- The production and sales of generics that lost Eliquis(Apixaban)' patent dispute were halted. According to the drug distribution industry on the 16th, generic for Eliquis companies stopped producing and selling items at once after the Supreme Court ruling. There is some inventory that has been passed to wholesalers. Generics for Eliquis have been released since June 2019 ▲Chong Kun Dang's Liquisia ▲Yuhan’s Yuhan Apixaban ▲Samjin's Elxaban ▲Hanmi’s Apixban ▲Yooyoung’s Yupix, and ▲Huons’ Apiquis. The Supreme Court overturned the court case on the 8th and sided with the patent holder, BMS. Distribution was stopped in preparation for compensation for damages in the final judgment. The Supreme Court overturned the court case on the 8th and turned to the side of the patentee, BMS. Unless a new allegation is raised, the judgment of the superior court is usually followed. Accordingly, domestic companies began to stop sales in preparation for a lawsuit for damages that BMS will file. They sent an official letter to the retailer, saying, ``We will stop production and sales after it is sentenced according to the decision to abolish the court's judgment in the court below. Most of the pharmacy-only online malls were sold out, except for some wholesalers that had left stock. Representatively, Chong Kun Dang’s Liquisia 2.5mg is out of stock, and only 8 of Liquisia 5mg are in stock. Since the amount of damages is determined in proportion to the amount of sales, it seems that generic companies have quickly stopped selling. Generic for Eliquis market has grown significantly over the past year. The generic market, which had sales of \1.2 billion in 2019, expanded 622% to \8.3 billion in 2020. This contrasts with the 2.6% decline in sales of original Eliquis. However, if the Supreme Court verdicts at the remand of revocation, the generic can only be released after September 2024. Due to the Supreme Court ruling, generic drugs are being sold out at online malls dedicated to pharmacies
- Company
- SG&A ratio fell in 3 out of 4 MNCs...a COVID-19 Impact?
- by An, Kyung-Jin Apr 20, 2021 06:03am
- Korean subsidiaries of multinational pharmaceutical companies have lowered their selling, general & administrative (SG&A) to sales ratio last year due to the prolonged COVID-19 crisis. Analysts predict that the cost-cutting measure was made in response to the disruptions in face-to-face sales and marketing activities caused by the pandemic. According to the Financial Supervisory Service (FSS) on the 19th, the SG&A expense of 34 major subsidiaries of multinational pharmaceutical companies in Korea last year amounted to 1.7 trillion won, a 0.8% increase from the previous year. The result is based on audit reports of the 34 subsidiaries that submitted reports to FSS. 31 companies that close accounts in December - Sanofi-Aventis Korea, Novartis Korea, AstraZeneca Korea, GlaxoSmithKline Korea, Bayer Korea, Roche Korea, Zuellig Pharma Korea, Baxter Korea, Janssen Korea, Merck, Korea Otsuka Pharmaceutical, BMS Korea Pharmaceutical, Amgen Korea, Boehringer Ingelheim Korea, GSK Consumer Healthcare Korea, Lilly Korea, AbbVie Korea, Mundipharma Korea, Menarini Korea, Novo Nordisk, Fresenius Medical Care Korea, Galderma Korea, Sanofi Pasteur, Alcon Korea, Kyowa Kirin Korea, Lundbeck Korea, Ferring Korea, Teva-Handok, UCB Korea, Guerbet Korea, Leo Pharma - as well as Servier Korea (closes account in September), Pfizer Korea · Viatris Korea (closes account in November) were included for analysis. Despite the increase in the total amount of SG&A expenses, The SG&A to sales ratio of the companies had declined 1.9% points from the previous year’s 23.6% to mark 21.7%. At the same time, sales of the 34 companies have increased 9.6%. The SG&A to sale ratio declined as the SG&A expense of the companies did not increase as much as their sales. 15 of the 34 companies reduced their SG&A expense compared to the previous year. Alcon Korea's SG&A expense was 17.4 billion won last year, which was 71.3% lower than the previous year. During the same period, the company's sales revenue increased 22.1% from 165 billion won to 201.4 billion won, decreasing the SG&A to sales ratio by as much as 28.0% points. Guerbet Korea spent 8.7 billion won as SG&A expense last year. Guerbet Korea’s SG&A to sales ratio last year was 21.8%. Although its SG&A expense fell greatly, its sales also fell by 6.9%, resulting in a decrease in SG&A to sales ratio of only 2.4% points. Merck Korea and Teva-Handok also cut costs by reducing their SG&A expense by over 15%. 19 companies, which accounts for over half of the surveyed companies, increased their SG&A expense. SG&A expense of Lilly Korea, GSK Healthcare Korea, Leo Pharma, BMS Korea Pharmaceutical, Sanofi-Aventis Korea, Abbvie Korea, Roche Korea, Pfizer Korea, and Amgen Korea increased over 5% compared to the previous year. Viatris Korea, which officially launched last November, reported its SG&A expense as 72.5 billion won. The amount is an aggregate of its performance from December 2019 to November of last year. However, as the SG&A expense written for the previous year - 39.9 billion won - was expense spent from May to November 2019, the change in SG&A to sales ratio (81.5%) cannot be considered significant. 25 of the 34 companies showed a reduced SG&A to sales ratio. This means 3 out of 4 MNC companies lowered their SG&A to sales ratio. Amgen Korea is known to have a relatively higher SG&A to sales ratio in the industry. Until 2019, its SG&A to sales ratio was 59.9%, however, the ratio fell to 41.6% last year. As its sales revenue increased by 51.6% but its SG&A expense only increased by 5.4%, the overall SG&A to sales ratio fell 18.2% points. Merck Korea reduced SG&A expenses to 15.9% while increasing sales revenue by 20.9%. As a result, its SG&A to sales ratio fell 8.0% points from 26.2% to 18.2%. In companies like Galderma Korea and GSK Consumer Healthcare Korea, their SG&A to sales ratio decreased because their sales growth exceeded their SG&A expense. Galderma Korea had increased its SG&A expense last year by 1.9% from the previous year to mark 26.2 billion won, however, as its sales revenue grew 16.6%, its SG&A to sales ratio fell 6.7% points. For GSK Consumer Healthcare Korea, although its SG&A expense increased 13.4%, its sales revenue increased by 33.5%, resulting in a 6.2% point decrease in its SG&A to sales ratio. The SG&A to sales ratio varies greatly from company to company. Menarini Korea’s SG&A to sales ratio decreased by 1.5% point from the previous year, however, its ratio still exceeded half of its sales revenue. On the other hand, Zuellig Pharma Korea and Alcon Korea’s SG&A to sales ratio fell short of 10%.
- Company
- Rx drug market recovers after flu season
- by Chon, Seung-Hyun Apr 20, 2021 06:02am
- The outpatient prescription drug market, which was slow in winter, is showing a recovery trend. Since the end of last year, the total prescription drug volume has been on a decline compared to the previous year, but in March it turned to an upward trend. It is analyzed that COVID-19 showed sluggishness due to a sharp decline in infectious disease patients due to the prolonged aftermath of the prolonged aftermath, but rebounded at the end of the flu season. According to the drug research institute UBIST on the 18th, the total outpatient prescription amount in the first quarter of the year was ₩3.5697 trillion, down 3.6% from the same period last year. Compared to the first quarter of 2019, it also decreased by 0.9%. The prescription size has increased every year, but this year has decreased. The prescription size in the first quarter of last year was ₩3.701 trillion, an increase of 2.7% from the previous year. In the first quarter of 2018 and 2019, prescriptions rose 8.9% and 5.5%, respectively, compared to the previous year. This is the aftermath of the sluggish prescriptions in January and February. The prescription size in January was ₩1,166.6 billion, down 7.0% from the previous year, and 5.6% in February compared to the same period last year. Monthly outpatient prescription amount trend (Unit: ₩100 million, Source: UBIST) However, the prescription performance in March was ₩1.253.7 trillion, up 1.9% from the previous year. Since December of last year, the total prescription drug volume has declined compared to the previous year for three consecutive months, and then turned to an upward trend in April. The sluggish prescription market in January and February was largely attributed to the prolonged COVID-19. Since the spread of COVID-19, it is highly likely that the incidence of infectious diseases has greatly decreased due to reinforced personal hygiene management such as hand washing and wearing a mask, leading to a decrease in visits to medical institutions. Since the end of last year, no flu pandemic warning has been issued this winter. According to the KCDA, the number of suspected flu patients per 1,000 outpatients during the 1st to 8th week of this year is 2.4, 2.4, 2.6, 2.3, 1.9, 1,9, 1.9, 2.0, etc. Compared to 49.1, 47.8, 42.4, 40.9, 28.0, 16.4, 11.6, and 8.5 outpatients per 1,000 outpatients during the 1st to 8th week of last year, there have been few recent flu cases. Since the end of last year, it is possible that visits to medical institutions have further decreased as the social distancing stage has been elevated due to the rapid increase in the number of COVID-19 confirmed patients. As more than 300 confirmed cases occurred from November 18 last year, the government raised the social distancing from November 24 to the second stage from the previous 1.5 stage. From then on, only packaging and delivery were allowed for cafes regardless of business hours, and only packaging and delivery were allowed after 9 pm for restaurants. Nevertheless, as the number of COVID-19 confirmed rapidly increased, the government raised the social distance in the metropolitan area to 2.5 steps from December 8 last year. Accordingly, in the metropolitan area, the operation of singing practice centers and indoor sports facilities in addition to the existing five types of entertainment facilities such as entertainment bars was additionally suspended. Shops, marts, department stores, movie theaters, PC cafes, and other facilities that are closely related to life must also close after 9 pm. Despite the rise in social distancing, the number of COVID-19 confirmed exceeding 1,000 and hitting a daily high, the Seoul Metropolitan Government implemented a super-precipitation measure that banned ``private gatherings with more than 5 people'' from December 23 last year, and such measures have been taken across the country since. Was applied to spread. Since last February, the social distancing step in the metropolitan area has been eased to two stages, but strengthened distancing measures are being implemented, such as “private gatherings for more than 5 people” are still banned. However, as the flu season ended in March, it is analyzed that the growth rate of the previous year has recovered. The number of suspected flu patients per 1,000 outpatients during the 9th to 13th week of this year was 1-2, similar to that of January and February. There is no significant difference from the 9th to 13th week of last year. Last year, it recorded 6.3 in the 9th week, but as the flu season ended, it decreased to 3.9 in the 10th week, 2.9 in the 11th week, 3.2 in the 12th week, and 2.8 in the 13th week. The industry diagnoses that the prolonged COVID-19 will inevitably hurt the prescription market for drugs used by flu or cold patients. However, as the use of medicines continues to increase due to the increase in the elderly population and the number of chronic diseases, the overall prescription market is expected to show an increase at the level of previous years. Although social distancing is still in place, it is observed that unlike the tourism and cultural industries that fell into extreme crises after COVID-19 outbreak, the pharmaceutical industry is affected by the demands of patients rather than the external environment, so it is difficult to lead to a sudden downturn.
- Company
- Domestic Sputnik V CMO meets with MOHW for discussions
- by Kim, Jin-Gu Apr 20, 2021 06:02am
- Photo of Sputnik V With the possibility of using ‘Sputnik V' rising in Korea, various industry sources have confirmed that a Korean CMO of this Russian vaccine has had a meeting with Korea's Ministry of Health and Welfare (MOHW). According to industry officials, one of the companies that signed a CMO deal for Sputnik V has recently had a meeting with an official from the Vaccine Procurement Task Force at the MOHW Sejong Office. The meeting was held at the request of the MOHW, during which the CMO company briefly explained its production volume, schedule, and agreement process for Sputnik V. Future meetings between the company and MOHW have not been scheduled yet. An industry official said, "A director-level personnel of the pan-government vaccine procurement task force and one of the CMO companies of Sputnik V has recently had a meeting at the MOHW Sejong Office. During the meeting, the MOHW official looked over the basics of the CMO deal." On this, an official from the CMO company said, "It is true that a meeting was held. At the meeting, the MOHW simply verified the progress of the CMO deal, and nothing else was discussed. However, we cannot disclose any more specifics about the meeting." Recently, the possibility of using Sputnik V in Korea has been rising due to the global shortage in vaccine supply and the issue of blood clots in AstraZeneca and Janssen vaccines. The demand to introduce a new vaccine to Korea has never been stronger. Based on the same idea, the industry speculates that the meeting is the government's attempt to get a grasp of the present state of Sputnik V under the premise of introducing the vaccine to Korea. However, several steps are required for the government to introduce Sputnik V to Korea. First, the government needs to make a deal with the Russian Direct Investment Fund (RDIF). Like any other vaccines, the amount and schedule of the vaccines should be negotiated with the supplier. Also, a formal approval by the MFDS is required. The key to whether Sputnik V will be approved by MFDS may partially depend on the European Medicines Agency (EMA) decision. EMA is currently conducting a formal review of Sputnik V. The results are expected to be announced in May at best. If EMA approves Sputnik V, this may also speed up the process of introducing the vaccine to Korea. In Korea, the Hankook Korus Consortium and Huons Global Consortium have each signed a CMO agreement for Sputnik V. Under the agreement, the Hankook Korus Consortium will be producing 500 million doses and Huons Global Consortium will be producing 100 million doses. The consortia have already completed the transfer of technology from Russia for the production of Sputnik V. Mass production of the vaccine will become possible as soon as the production facilities are completed. Another industry official said, “If the government wishes to officially introduce Sputnik V to Korea, they have to first negotiate the terms with RDIF, as it has made the CMO agreement with the domestic companies. With the possibility of introducing Sputnik V rising in Korea, it seems that the government trying to get a grasp of the current state of affairs through working-level meetings." Sputnik V is a COVID-19 vaccine developed by Russia. Like AstraZeneca and Janssen vaccines, it is a viral-vector vaccine. Earlier this year, the vaccine was found to be 91.6% effective against COVID-19 according to a Phase III clinical trial results published in the Lancet.
- Company
- Hemophilia B tx, Benefix, took the lead with weekly therapy
- by Apr 20, 2021 06:02am
- Pfizer Korea's Benefix (nonacog alfa)', which has been used for the treatment of hemophilia B patients in Korea for 15 years, has taken the lead as a once-a-week prophylaxis. The strategy for treating hemophilia has now become routine prophylactic therapy. The World Federation of Hemophilia recommended prophylaxis as standard treatment in its guidelines revised last year. In the past, the concept of prophylaxis was also aimed at preventing simple bleeding, but now, the goal is to lead a similar life to the general public and achieve a quality of life. In February, Benefix added an indication of daily prophylaxis with a weekly dosage. What was previously administered 2-3 times a week can now be administered only once a week. As a result of clinical studies, once-a-week prophylaxis reduced the annual bleeding rate to 94% compared to supplementary therapy. There was no significant difference in the annual bleeding incidence between the once-weekly prophylaxis and the twice-weekly prophylaxis. A similar effect can be obtained by administering Benefix 100IU/kg once a week instead of Benefix 50IU/kg twice a week. From the patient's point of view, fewer visits to the hospital can increase compliance and lower the risk of infection. In particular, once a week prophylaxis is most recommended for children under 6 years of age, where it is difficult to secure medical staff through intravenous infusion. In celebration of 'World Hemophilia Day (April 17)', Pfizer Korea held an online press conference on the 15th of 'The Present and Future of Hemophilia Type B Treatment Through Benefix' once-a-week prophylaxis. At the meeting, Professor Eun-jin Choi of Catholic University of Daegu Hospital said, "About half of patients with hemophilia B in Catholic University of Daegu Hospital are receiving Benefix once a week." Pfizer Korea's 'Benefix (nonacog alfa)', which has been used for the treatment of hemophilia B patients in Korea for 15 years, has taken the lead as a once-a-week prophylaxis. With the new indication, Benefix will be able to extend the range of half-life extension formulations. Benefix is a factor 9 standard half-life treatment. With the release of a half-life extension formulation, the relatively large number of doses is a disadvantage. For example, the half-life extension drug Alprolix 50IU/kg is administered once a week, and Alprolix 100IU/kg is administered once every two weeks, which is less frequent than Benefix twice a week. Benefix also expanded its area as weekly therapy became possible and occupied the first place in the hemophilia B market. Professor Choi said, "With the development of half-life extension drugs, drugs that fit once every two weeks and once every three weeks are emerging, depending on the patient's lifestyle. In some cases, the peak level is considered more important than the lowest coagulation factor activity level." If a patient wants to exercise such as soccer, he needs more than a certain percentage of the coagulation factor that the patient has, but if a patient has a peak level and shows low activity for 2 to 3 weeks (half-life extension drugs), it may not be suitable for that patient." She explained. There is no difference in the total dose for the twice-weekly or once-weekly therapy. Professor Choi said, "The current benefit is recognized as 30~40 IU, and if there is joint bleeding, it is possible up to 50 IU twice a week. Since there is no case written, 100 IU once a week is expected to be sufficient.”
- Company
- Novartis Korea surpassed ₩500 billion in annual sales
- by An, Kyung-Jin Apr 19, 2021 05:55am
- Novartis Korea has surpassed ₩500 billion in annual sales for the first time since entering Korea. Despite the confusion of COVID-19, representative medicines and new products generated synergy, which led to the highest sales ever. According to the Financial Supervisory Service on the 15th, Novartis Korea last year recorded ₩532 billion. With a 7.8% increase in sales compared to the previous year, it achieved the most sales among multinational pharmaceutical companies that entered Korea for the second consecutive year following 2019. This is the first time Novartis Korea has exceeded the annual sales of ₩500 billion since the inauguration of Novartis Korea in 1997. Operating profit was aggregated to ₩5.3 billion, down 12.4% from the previous year. Novartis Korea Novartis Korea is a foreign-invested company established in September 1984 under a joint venture agreement between Dongwha and Swiss pharmaceutical company Sandoz (now Novartis AG). In April 1997, the company changed its name from Sandoz Korea to Novartis Korea. Novartis AG and Novartis Pharma AG own 98.3% of the shares, while Dongwha owns the remaining 1.7%. Among the bad news for Corona 19, new products that were recently released showed high growth, generating the largest sales ever. According to IQVIA, a drug market research organization, the sales of Entresto, a chronic heart failure treatment, were ₩21.7 billion last year, up 64.7% from the previous year. Entresto is a combination drug consisting of two ingredients: Valsartan, an angiotensin receptor blocker (ARB) family, and Sacubitril, a neprilysin inhibitor (NEPI). It is prescribed to reduce the risk of death from cardiovascular disease and hospitalization due to heart failure for chronic heart patients with decreased left ventricular contractile function (NYHA class II-IV). In Korea, since October 2017, it has been receiving benefits as a treatment for chronic heart failure patients whose left ventricular ejection rate has decreased to 40% or less. Psoriasis treatment Cosentyx (Secukinumab) has established itself as a blockbuster product with annual sales of ₩20 billion by introducing a self-injectable pen in addition to the existing PFS. The two types of Cosentyx and Cosentyx Sensoready Pen made a joint venture of ₩20.9 billion, with a 51.5% increase in sales from the previous year. The metastatic breast cancer drug Kisqali (Ribociclib), launched at the end of last year, made the first sales of ₩1.7 billion. Existing representative products are also performing well. ARB-based hypertension combination drug Exforge (Amlodipine Besylate/Valsartan) sold ₩71.4 billion last year. Novartis has the largest sales volume among products sold in Korea. In July 2018, the impurity isuue gave a reflective profit. Macular degeneration treatment Lucentis (Ranibizumab) is also on the rise in sales with the release of PFS type. Last year's sales of Lucentis were ₩37 billion, up 23.0% from the previous year. The DPP-4 inhibitor-based diabetes combination drug Galvusmet (Metformin HCl/Vildagliptin) sold worth ₩31.5 billion last year. Glivec, a leukemia drug, posted sales of ₩41.2 billion. In the process of launching new products, expenditures increased and profitability decreased slightly, but it is evaluated that the sales of existing products and new products harmonized, resulting in stable performance. Novartis Korea is focusing on improving earnings by sorting out some items with relatively low profitability. It handed over the domestic copyright of the anti-epileptic drug Trileptal and the Alzheimer-type dementia treatment Exelon to Handok, and also stopped investing in sales marketing for the rest of the items, including the anti-epileptic drug Tegretol and Parkinson's disease treatment Stalevo and Comtan. It is expected to focus on introducing biologics known as ultra-high-priced drugs such as Zolgensma, a treatment for spinal muscular atrophy (SMA), starting with Kymriah, the first licensed CAR-T treatment in Korea.
- Company
- Will ‘Keytruda’ be reviewed for reimbursement in May?
- by Eo, Yun-Ho Apr 16, 2021 06:03am
- MSD Korea threw a game-changer for the reimbursement expansion of the immunotherapy drug ‘Keytruda.’ According to industry sources, the company has once again submitted a revised cost-sharing proposal to the Health Insurance Review & Assessment Service (HIRA) to expand the reimbursement of ‘Keytruda (pembrolizumab)’ to cover first-line treatment of non-small cell lung cancer (NSCLC). With the submission, the industry’s eyes are on whether the issue will put on the agenda for deliberation by the Cancer Drug Review Committee in May. If selected, this will be the 8th discussion held by the Committee for Keytruda. The decision for the drug was put on hold at the committee meeting in August last year as the committee determined that MSD Korea’s proposal lacked compromise on the company’s part. In September of the same year, HIRA handed the proposal back to MSD Korea and requested a 're-revision.' A month later, MSD Korea submitted a re-revised proposal, which was discussed by the Reimbursement Standard Sub-committee meeting but to no avail. The agenda of Keytruda’s reimbursement was not discussed by the Cancer Drug Review Committee. So, once again, MSD Korea submitted a cost-sharing plan to HIRA this year. The proposal submitted by MDS this time contains an offer equivalent to the company ‘covering the initial 3 cycles’ worth of administration cost’ through measures including adjusting the reimbursement rate. If the new cost-sharing proposal is reviewed and, again, rejected by the Cancer Drug Review Committee, expanded reimbursement for Keytruda will likely be difficult to achieve. An MSD official said, “Although we cannot share details as discussions with the government are still ongoing, we will do our best so that our patients in Korea can promptly receive the global standard-of-care treatment.” Meanwhile, MSD Korea has submitted additional applications to expand the indication of its PD-1 inhibitor Keytruda (pembrolizumab) ▲ as first-line treatment in patients with microsatellite instability-high (MSI-h) or mismatch repair deficient (dMMR) advanced colorectal cancer; and ▲ as first-line treatment in combination with platinum-based chemotherapy for patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma that is not amenable to surgical resection
- Company
- Celltrion-Icure applied for permission for Donepezil patch
- by Chon, Seung-Hyun Apr 16, 2021 06:02am
- Celltrion announced on the 13th that it has applied to the MFDS for an item license for the “Donerion patch” for the treatment of Alzheimer's dementia jointly developed with Icure. Donerion patch (Donepezil) is a product jointly developed by bio-venture Icure and Celltrion. In June 2017, after Icure developed and completed the non-clinical and phase 1 clinical trials, it signed a joint domestic copyright contract with Celltrion. Together with Icure, we conducted phase 3 clinical trials in about 400 patients with mild and moderate dementia in 4 countries including Korea, Taiwan, Australia, and Malaysia. Donerion patch is an IMD developed by attaching the oral Donepezil once a day twice a week. Compared to oral drugs, it is evaluated as a product that improves medication compliance and improves convenience. Donepezil is the original medicine by Eisai's Aricept. Celltrion said, "Donepezil is currently only commercialized for oral administration due to the difficulty in formulation development. If the Donerion patch is approved by the Ministry of Food and Drug Safety, it will become the world's first Donepezil patch." Both companies are aiming to commercialize next year after acquiring an item license. The clinical phase 3 of the Donerion patch was conducted for a total of 24 weeks in patients with mild and moderate Alzheimer's dementia. Oral Donepezil or Donerion patch was administered by dividing into a group taking oral Donepezil 5 mg or 10 mg and a group who had never taken Donepezil. Donepezil for oral administration by setting the Alzheimer's Disease Assessment Scale–Cognitive Subscale (ADAS-cog), a representative standard tool for dealing with memory, language, reconstruction, behavior, and mentality, as a primary efficacy endpoint in mild and moderate Alzheimer's Contrast the Donerion patch proved its non-inferiority. The non-inferiority of the Donerion patch compared to the oral Donepezil was also confirmed in the secondary efficacy endpoints CIBIC-plus, MMSE, CDR-SB, and NPI, which were additionally set to comprehensively evaluate the drug effect in terms of both cognitive and functional improvement. did. Donepezil is the most commonly prescribed ingredient in Alzheimer's dementia treatments. According to UBIST, a drug market research organization, Donepezil accounts for about 30 billion won, 80% of the domestic sales of Alzheimer's dementia treatments in 2020, of about 290 billion won. A Celltrion official said, "As Donerion was developed as the world's first Donepezil patch, it is expected to enter the market quickly with competitiveness differentiated from existing formulations if it obtains approval from the MFDS by improving patient convenience."
- Company
- Vyndamax tries RSA after failing essential drug designation
- by Eo, Yun-Ho Apr 15, 2021 05:56am
- Once again, attempts are in progress to receive reimbursement for 'Vyndamax,' a new drug for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM). Industry sources said that Pfizer Korea had recently submitted an application for the reimbursement of its new ATTR-CM drug, Vyndamax (tafamidis 61mg). This time, the company conducted the PE assessment and aims to receive reimbursement through the risk-sharing agreement (RSA) scheme. After failing to receive designation as an essential drug earlier this year, the company has quickly supplemented the data to try for reimbursement once again, which shows the company’s determination to be listed for reimbursement. So once again, the industry is keenly eyeing whether Vyndamax, virtually the only ATTR-CM treatment option available in Korea, may finally list its name on the benefits list. Compared to Vyndaqel (tafamidis 20mg), which was listed in October 2018 for the treatment of the hereditary transthyretin amyloid polyneuropathy (ATTR-PN) and therefore targets a very small number of patients, Vyndamax’s indication for the treatment of ATTR-CM includes patients with both hereditary and the wild-type form associated with aging and therefore has a high prevalence. So, these many patients, who have this fatal disease that has a survival period of 2 to 3.5 years without treatment, are currently left unattended as ATTR-CM is known as a disease with a poor treatment performance due to the lack of available treatment options and is commonly mistaken for simple heart failure. However, the efficacy of Vyndamax was demonstrated through the Phase III ATTR-ACT study by reducing the number of cardiovascular events in patients and improving functional athletic ability in the six-minute walk test. Based on the findings, healthcare professionals in Korea are stressing the need to prescribe Vyndamex. As it is a fairly expensive drug, the determination and will of the government and the pharmaceutical company may play a crucial role in the listing. As Pfizer showed the effort to conduct the PE assessment despite its difficult situation demonstrating the drug’s cost-effectiveness, expectations are rising that the two sides will be able to reach an agreement. In the ATTR-ACT study, 441 patients were randomly assigned in a 2:1:2 ratio to receive 80 mg of tafamidis, 20 mg of tafamidis, or placebo. The primary endpoint of the study was hierarchically assessed all-cause mortality, followed by frequency of cardiovascular-related hospitalizations. The secondary endpoint of the study was a change in the 6-minute walk test from baseline to month 30 and the score on the 'Kansas City Cardiomyopathy Questionnaire-Overall Summary (KCCQ-OS),' in which higher scores indicate better health status. Study results showed that all-cause mortality and cardiovascular-related hospitalizations rates were statistically significantly lower in patients who received tafamidis than those who received placebo.
- Company
- Measures for the reimbursement of advanced therapies
- by Apr 15, 2021 05:56am
- The release of the CAR-T treatment ‘Kymriah (tisagenlecleucel)’ in Korea was met with both anticipation and concerns. The drug itself is undeniably an innovative drug that can offer new opportunities to blood cancer patients with short life expectancy. However, the challenge lies in how this innovative new drug that costs 500 million won per dose should be listed for reimbursement in Korea’s healthcare system. Clearly, these advanced drugs cannot be evaluated under the same standards as existing drugs. The development trend of new drugs has already shifted towards the treatment of severe or rare diseases, and gene and cell therapies that combine new science and technology occupy a large proportion of development. Therefore, a new model that may reasonably evaluate the price of ultra-expensive drugs is necessary to accommodate the changing environment. Then, what limitations and changes has the industry seen and desired in Korea’s reimbursement environment? To hear the voices in the field, Dailypharm held its 41st Pharmaceutical Industry Future Forum, "Finding the correct solution for the ultra-expensive drug listing system," at its Moonjeong-dong office. Dr. Hyung-Ki Lee, Professor of Clinical Pharmacology and Therapeutics at the Seoul National University Hospital, chaired the event. Also, various industry and government officials including Kyung-Ho Choi, Deputy Director of the Division of Pharmaceutical Benefits at the Ministry of Health and Welfare; Min-Young Kim, Director at Korean Research-based Pharma Industry Association (KRPIA); Hyeon-Seok Na, Senior Manager at JW Pharmaceutical Corp.; and Jae-Ho Jeong, Department Head at Novartis Korea attended the event to share their views on the matter. (from the left) Dr. Hyung-Ki Lee, Professor of Clinical Pharmacology and Therapeutics at the Seoul National University Hospital; Kyung-Ho Choi, Deputy Director of the Division of Pharmaceutical Benefits at the Ministry of Health and Welfare; Min-Young Kim, Director at Korean Research-based Pharma Industry Association (KRPIA); Hyeon-Seok Na, Senior Manager at JW Pharmaceutical Corp.; and Jae-Ho Jeong, Department Head at Novartis Korea attended Dailypharm’s 42nd Future Forum. ◆'Advanced therapies that cost hundreds of millions of won may deliver value beyond their cost = Kymriah was tagged as an ‘ultra-expensive' drug as its single injection costs 500 million won. However, Jae-Ho Jeong, Department Head at Novartis Korea, expressed his opposition to the view. Unlike conventional drugs that should be taken annually or on a regular cycle, one can expect a full cure with a single injection of Kymriah, which ultimately would reduce the total cost invested in treatment. “We need to consider whether Kymriah is really an ultra-expensive drug from the financial aspect,“ said Department Head Jae-Ho Jeong. “Other orphan drugs that cost 400–500 million won per year are also listed as reimbursement. The only difference is, with Kymriah, one can expect to reach complete remission with a single injection.” He added, “The value of Kymriah lies in that it can provide the return to daily lives for patients who were non-responsive to existing treatments and therefore left with only several months of to live at most. We need to reconsider drawing the line just because a drug is expensive.” In fact, Kymriah achieved complete remission (CR) in 82% of the young adult and pediatric patients with acute lymphoblastic leukemia (pALL) within 3 months of its administration. The patients were relapsed and refractory patients with a life expectancy of only 6 months. Emily, a pediatric patient who participated in the first trial of Kymriah, is currently living a normal life after receiving Kymriah 9 years ago. Like Kymriah, advanced therapies such as CAR-T cell therapies and gene replacement therapies allow patients to dream of the long-awaited ‘cure.’ ‘Zolgensma,’ a gene replacement therapy, can cure the rare disease spinal muscular atrophy (SMA) with a single dose. ◆The need for a personalized reimbursement system = Rather than introducing a completely new system, industry experts have suggested implementing measures that may allow for more flexible use of the existing system, in other words, a personalized reimbursement system. KRPIA director Min-Young Kim referred to the U.K. as an example. For rare diseases that are chronic, severely disabling, and require life-long treatment, the U.K.’s Highly Specialised Technologies (HST) evaluation system weighs the quality-adjusted life-year (QALY) gain and allows a QALY index of 3 if the gain is 30 QALY or more. Also, the Patient Access Scheme (PAS) and Confidential Commercial Arrangement (CCA) implements a kind of risk-sharing system for drugs that have not been able to receive an ultimate value judgment from NICE or drugs with a large difference in ICER due to different health benefits per drug or indication. Also, a Cancer Drug Fund (CDF) system provides funding for oncology drugs that are not recommended by NICE for reasons of clinical uncertainty during the drug's data collection period “Like the U.K., Korea also needs segmentized, personalized policies so as to provide the opportunity for a full cure to patients with severe rare and incurable diseases,” said Kim. He continued, “In terms of patient accessibility, we may consider using systems like the ‘pre-listing post-evaluation' system. Financial uncertainty can be resolved by collecting information on the use amount based on real-world data during the pre-listed period, and then evaluating once the period is over. Also, customized systems that price drugs by indication or the trade-off system may also be used.”
