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- 2026-04-13 14:48:09
- Company
- Qtern will be released in Korea after 4 years of approval
- by Eo, Yun-Ho Oct 29, 2021 05:53am
- The DPP-4 inhibitor and SGLT-2 inhibitor diabetes complex Qtern will be released four years after approval in Korea. According to related industries, AstraZeneca Korea will start promotional activities for Qtern, a product that combines Onglyza and Forxiga, on the 1st of next month (November). Qtern was approved in Korea in March 2017, but its launch in Korea was delayed as the problem of insurance benefits for diabetes combined therapy was not resolved. However, a change in the market is expected as insurance authorities have recently discussed recognizing the combined benefits of SGLT-2 inhibitors. A meeting of diabetes experts convened by the HIRA integrated the benefits of a combination of DPP-4 inhibitors and SGLT-inhibitors. The reason for the decision to release Qtern is also believed to have reflected this. Currently, in addition to Qtern, combinations of DPP-4 inhibitors and SGLT-2 inhibitors are licensed in Korea, Beringer Ingelheim's Esglito and MSD's Sitagliptin+Ertugliflozin. It has been confirmed that they are also preparing to launch as the benefit issue has been resolved. On the 25th, GC Pharma's GC2123A received approval from the MFDS for a biological equivalence test plan. The active ingredient of this product candidate is known as the same ingredient drug Empagliflozin+Linagliptin. In addition, Dongkoo Bio applied for permission for a combination drug of Januvia (Sitagliptin) and Forxiga in March. LG Chem is conducting commercialization clinical trials for Zemiglo and SGLT-2 inhibitors, while Aju is conducting commercialization clinical trials for a combination drug of Jardiance and Forxiga. Meanwhile, the PMS period of the DPP-4 inhibitor and SGLT-2 inhibitor combination is now less than two years away. The PMS period ends in March 2023. Since March 2023, news of generic development has continued as it is possible to apply for a generic license.
- Policy
- KDCA “will monitor development of oral COVID-19 treatments"
- by Lee, Hye-Kyung Oct 29, 2021 05:53am
- The government expressed its determination to introduce a safe treatment with verified efficacy by continuously monitoring the COVID-19 treatment trends, including the US Merck & Co. (MDS)'s oral COVID-19 treatment, 'molnupiravir .' That was the KDCA's response to when NA member Young-seuk Seo of the Democratic Party of Korea asked in via a written inquiry about verifying the efficacy of molnupiravir after the NA audit that was held by the Health and Welfare Committee. Seo asked,” The published results show patients who took placebo or molnupiravir until Day 5 and had no virus detection. Authorities need to consider whether a drug this potent is necessary to increase relief among the public and as well as for disease containment." Regarding Seo’s inquiry, the KDCA said, “We have been reviewing the indications and clinical trial results from various countries." For the approval of an oral COVID-19 treatment the government plans to purchase, the authorities have been comprehensively reviewing various clinical trial results with various measures including the virus detection results, improvement in clinical symptoms, safety assessment, and the drug's approval status in advanced countries such as the United States.” In addition to the publsihed paper, Merck also announced the interim results of its clinical trial on mild-to-moderate patients at high-risk on October 1st. Results showed that 28/385 of the patients who received molnupiravir were hospitalized or died within 29 days of administration compared to the 53/377 in the placebo group. Deaths were reported in 0 patients that were administered molnupiravir and in 8 patients in the placebo group. Also, the drug showed a consistent effect in all mutations, including the gamma, delta, and Mu variants. Based on such results, the company has applied for the Emergency Use Authorization after discussions with the US FDA. KDCA said, “we will continue to monitor COVID-19 treatments and endeavor to introduce safe and verified treatments to Korea."
- Policy
- The government needs to create a sovereign wealth fund
- by Lee, Jeong-Hwan Oct 29, 2021 05:53am
- The National Assembly's Health and Welfare Committee urged both ruling and opposition parties to create tens to hundreds of trillion won worth of sovereign wealth funds to develop blockbuster vaccines and new drugs. As COVID-19 Pandemic has confirmed high demand in the global market for pharmaceutical and bio sectors such as vaccines and new drugs, Korea is also aiming to properly foster global big pharma like Pfizer. On the 27th, Rep. Seo Jung-sook of the People Power Party and Rep. Kang Byeongwon, affiliated with the Welfare Committee, strongly appealed to the MOHW that it is necessary to create a mega-level sovereign wealth fund to foster bio and pharmaceuticals in Korea. According to data submitted by the MOHW to the National Assembly, Korea's national R&D industry budget (2011-2021) totaled 173.7 trillion won, with an annual average of 17.3 trillion won. Among them, the investment budget in the pharmaceutical and bio sectors is 3.2 trillion won, which is being invested in 20,000 projects. In other words, the allocated budget per project is around 160 million won. Korea's budget for supporting the development of COVID-19 vaccines and treatments totaled 120.3 billion won, investing 40.2 billion won in vaccines and 80.1 billion won in treatments. The problem is that Korea's R&D budget in pharmaceutical and bio sectors is far short compared to global cases such as the United States. The United States is investing a total of 8.6 trillion won in vaccines alone. Compared to Korea, it is 70 times higher. The U.S. invested 2.182 trillion won only in Pfizer, a developer of the mRNA coronavirus vaccine and the world's No. 1 Big Pharma. The CEPI is investing 45.4 billion won in SK Bioscience. Lawmakers from the ruling and opposition parties of the Welfare Committee pointed out that it is urgent to create a "developmental sovereign wealth fund" to continue long-term investment while ensuring autonomy in the pharmaceutical and bio sectors. Rep. Seo Jung-sook said, "Korea should foster big pharma like Pfizer." Rep. Seo Jung-sook of the People Power Party pointed out that the government's investment in R&D in the pharmaceutical and bio sectors is too small. It is pointed out that in order to foster pharmaceutical companies that manufacture blockbuster vaccines or treatments that the global market finds first, efforts to innovate Korea's pharmaceutical and bio national budget by actively analyzing overseas cases are needed. In particular, Rep. Seo said that if it is difficult for the government to generate pharmaceutical and bio budgets alone, it should create a sovereign wealth fund in which the government and the private sector work together to have investment power of hundreds of trillion won to hundreds of trillion won. In Korea, the government and the private sector should actively cooperate to create a global big pharma like Pfizer. Representative Seo said, "Pfizer, which developed the COVID-19 vaccine, succeeded in producing PCN itself and secured capital power as it was used in large quantities in World War II and grew into a global pharmaceutical company." She said, "Pharmaceutical and bio cannot grow into a large company like Pfizer without a special opportunity. This is why fostering at the government level is essential, she explained. Rep. Seo said, "The current government is different from blockbuster-class with a distributed investment of 160 million won per project. The U.S. provided KRW 2.182 trillion to Pfizer alone for the COVID-19 vaccine, and the total investment in pharmaceuticals and bio exceeded KRW 8.6 trillion. It is more than 70 times that of 120.3 billion won in Korea, she added. "Domestic vaccines and new drugs are not being developed due to institutional problems." The government is controlled annually and cannot provide large-scale support by using budgets and funds for pharmaceutical and bio investments, it said. "In order to invest large-scale funds in pharmaceutical companies in the long run, we need to actively consider creating development-type sovereign wealth funds." Kang Byungwon said, "Mega funds are urgently needed in Korea" Following the last parliamentary audit, Kang also said it should support phase 3 clinical trials of domestic pharmaceutical companies that started developing blockbuster vaccines and new drugs with "10 trillion megafunds." In particular, Kang said, "Korean pharmaceutical bio companies' technology exports are at the top of the world with 11.6 trillion won, and it is regrettable that they cannot lead to final commercialization." Currently, government-private joint mega funds are essential to overcome the reality that the Korean government only supports R&D support in the pharmaceutical and bio sectors up to Phase 1 and Phase 2 clinical trials. Furthermore, Kang said the government should also take the lead in linking the technology of bio-ventures with the experience of large companies. Rep. Kang said, "The government should actively support the good ideas of pharmaceutical and bio venture companies to lead to the development of final new drugs somehow. The key to the development of new drugs depends on the success of late clinical trials, he said. "We need to create a mega fund in cooperation with the private sector so that the government can support up to phase 3 beyond phase 1 and 2 clinical trials to avoid WTO trade friction." Representative Kang said, "One way is to match and commercialize technology and capital power between bio ventures and large companies, and to support phase 3 clinical trials only for the development of new drugs for public interest purposes." He said, "In order to develop pharmaceutical and bio industries into new industries in the future, now is the most appropriate time when the world is paying attention to vaccines and new drugs due to COVID-19."
- Product
- PO treatment for COVID-19 "Molnupiravir" will be released
- by Whang, byung-woo Oct 29, 2021 05:53am
- The emergence of Molnupiravir of MSD, known as the first oral treatment for COVID-19, is drawing attention to how it will affect the war against COVID-19. While it is compared to Tamiflu and is evaluated as a game changer, there are mixed views on the other side that its role may be limited due to price limitations. According to the interim results of phase 3 clinical trials of MOVe-OUT, which evaluated the efficacy of the oral corona treatment Molnupiravir by MSD on the 1st, 775 patients with mild and moderate symptoms had reduced hospitalization and mortality by about 50%, satisfying the primary evaluation index. At this time, the dose of Molnupiravir was taken twice a day, 10 times for 5 days, and as a result, 7.3% of patients worsened to severe and there were no deaths. 14.1% of patients taking placebo worsened to severe and 8 died. Based on these clinical results, MSD terminated the clinical trial early without the registration of additional clinical patients originally planned and submitted an application for emergency use approval to the FDA. Considering the trend so far, Molnupiravir, which has been effective in clinical trials, is cheaper than conventional injections, so it will not be too much to win the title of the first oral treatment for COVID-19. The FDA will closely review safety and effectiveness data to determine whether to approve or not, and a final conclusion is expected within a few weeks. "The reason for getting a vaccine is to prevent it from going from mild to severe, that is, how severe it is even if it is a breakthrough infection," said Kang Jinhan, head of the Vaccine Bio Research Institute at Catholic University. "In the case of flu, the prevention rate is only about 50%, but the oral treatment of COVID-19 will be meaningful in that way." Director Kang said, "There is a need for oral treatments as a strategy to go to the so-called With Corona like the flu," adding, "I think it will be a concept that prevents medical confusion by administering it early so that mild patients do not get serious." Can Molnupiravir, which has been proven effective, be like Tamiflu? One question here is whether Molnupiravir can play the same role as Tamiflu or Xofluza, a flu treatment, at a time when many experts predict that COVID-19 will become endemic like the flu in the future. According to the most recently developed CAPSTONE-1 clinical study by Xofluza, the median time required for the Xofluza administration group to relieve symptoms after administration was about 2.3 days (Tamiflu 3.3 days). In addition, the median time it took to fever was about 1 day (Tamiflu 1.8), and the effect of reducing virus levels was reduced by half in about 1 day (Xofluza about 4 days). Choi Young-joon (pediatric infection), a professor at Korea University Anam Hospital, said, "I remember that Tamiflu was first introduced as an endpoint and gradually expanded to shorten the duration of symptoms," adding, "Molnupiravir aims to treat death and severe infections in public health and may expand the scope of treatment in the future." In fact, according to the MOVe-OUT clinical evaluation index that evaluated the efficacy of Molnupiravir, the primary evaluation index is the rate of hospitalization, death, and side effects, but the second evaluation index is the decomposition or improvement time of the coronavirus, so the possibility remains. Another variable is that the expected price of Molnupiravir is set at about 830,000 won ($700). As a result, the current market for oral treatments for COVID-19 is expected to form from about 7 trillion won (6 billion dollars) to about 8 trillion won (7 billion won).
- Company
- Bayer’s ‘Nubeqa’ can be prescribed at general hospitals
- by Eo, Yun-Ho Oct 28, 2021 05:59am
- The new prostate cancer drug ‘Nubeqa’’ can now be prescribed at general hospitals in Korea. According to industry sources, Bayer’s oral androgen receptor inhibitor for the treatment of men with non-metastatic castration-resistant prostate cancer (nmCRPC), ‘Nubeqa (larotrectinib)’ has recently passed the review of drug committees (DC) in three major hospitals - the Samsung Medical Center, Asan Medical Center, and Gangnam Severance Hospital. Nubeqa is an androgen receptor inhibitor with a distinct chemical structure that binds to the receptor and exhibits strong antagonistic activity, thereby inhibiting the receptor function and the growth of prostate cancer cells. The drug was approved based on the Phase III ARAMIS study that assessed the safety and efficacy of Nubeqa in combination with androgen deprivation therapy (ADT) compared to ADT alone. Study results demonstrated a highly significant improvement in the primary efficacy endpoint of metastasis-free survival (MFS) in Nubeqa +ADT, with a median of 40.4 months, compared to the 18.4 months for placebo+ADT. Also, Nubeqa+ADT reduced the risk of death by 31%. Also, the full overall survival (OS) results from the pre-specified final OS analysis of the Phase III ARAMIS trial were published in the New England Journal of Medicine (NEJM) on the 9th. Results showed that Nubeqa+ADT showed a statistically significant improvement in OS compared to placebo plus ADT, with a 31% reduction in risk of death. The results hold significance as the OS improvement was achieved despite 55% of patients that taking placebo received subsequent Nubeqa or other life-prolonging therapy after the trial was unblinded at data cut-off for final analysis (November 15, 2019). Meanwhile, Nubeqa has not been added to the insurance benefit list yet. The drug has been determined inappropriate for reimbursement by the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee in February, and the company has supplemented the data and is again undergoing the listing process.
- InterView
- Patients with severe diseases don't really like Mooncare
- by Lee, Jeong-Hwan Oct 28, 2021 05:59am
- Health insurance authorities should recognize that as universal health and welfare increases the coverage of mild diseases, the access to drugs for severely rare and intractable diseases is greatly reduced. It is nonsense that policies to strengthen coverage such as herbal medicine benefits are implemented without economic evaluation today, when there are many serious drugs that cannot be reimbursed due to the adequacy of benefits." This year's parliamentary audit of the National Assembly's Health and Welfare Committee also dealt with the issue of accessibility to patients with ultra-high-priced one-shot treatments, which cost hundreds of millions of won per dose. Technologies for treating severe rare and intractable diseases such as cancer and autoimmune diseases are rapidly developing, but health insurance finances for benefit-applied drugs are not keeping up. On the 27th, Dailypharm met Professor Lee Hyung-ki (57), a professor of clinical pharmacology at Seoul National University Hospital, and asked about the direction of Korea's health insurance benefit system for expensive drugs. Professor Lee Hyung-ki said the so-called "Moon Jae In Care" implemented by the current government is not welcome at all to patients with severe rare and incurable diseases. While it is strict for drugs developed by global pharmaceutical companies or domestic pharmaceutical companies, it is unreasonable to enter the insurance right without any problems. Professor Lee said the government should adopt a selective differential welfare method. The basic direction for the government is to focus on expanding the benefits of ultra-high-priced treatments that are inaccessible even with average or high benefits, leaving treatments or diagnoses for mild diseases that can be spent on average annual income. According to a survey of 787 domestic companies by Job Korea, the annual salary of new college graduates this year is 41.21 million won for large companies and 27.93 million won for small and medium-sized companies. According to the analysis of business reports by each company of the top 100 companies in market capitalization, the average annual salary of employees of large companies is 83.22 million won. In addition, this year's average annual salary for small and medium-sized workers is 28 million won for employees and 57 million won for managers. Professor Lee points out that it takes about two years for one new drug to enter the benefit range, although the government claims to be completing the benefits evaluation about 300 days. Professor Lee said, "In the case of anticancer drugs, it takes about two years to receive health insurance benefits. In this case, pharmaceutical companies that have developed treatments and patients waiting for insurance will suffer from double regulations, he explained. Professor Lee added, "Since we mainly focus on price control, it becomes difficult to be reimbursed and patient difficulties increase." Asked by a reporter if it would be difficult to apply new drug insurance benefits that did not take into account health insurance finances at all, Professor Lee said, "There are too many policies such as herbal medicine benefits to put health insurance finances as a justification." Professor Lee criticizes that health insurance benefits are often made without standards or principles in areas that are difficult to accept from the perspective of new drug development pharmaceutical companies and severely ill patients. Professor Lee said, "The ultra-high-priced drug itself is, in the end, an innovative drug. Patients who have been confirmed to be effective will have an experience of changing their lives and not losing their lives. "Kymriah treatment costs hundreds of millions of won. It is a level that individual patients cannot bear, he pointed out. Professor Lee said, "The national health insurance funding alone will inevitably reach the limit of the medical insurance drug cost support system." Professor Lee said, "It is necessary to consider raising a third fund and financial source. The government should show leadership to expand fiscal sources, he said. Professor Lee also criticized the lack of economic evaluation tools for ultra-high-priced one-shot treatments. There is no additional system other than RSA, and ICER are too low. Professor Lee said, "I understand that the benefit evaluation tool has become more flexible than before. The problem is that health insurance authorities rely only on ICER. In particular, if the standard treatment is already expensive, no matter how innovative the new drug is, accessibility will not increase, he stressed.
- Company
- “Prolia·Evenity drives the osteoporosis treatment market”
- by Oct 28, 2021 05:59am
- Amgen has long been considered the company that has changed the osteoporosis treatment paradigm with potent new drugs. After sweeping over the osteoporosis treatment market with ‘Prolia (denosumab),’ a bone resorption inhibitor, the company then presented a new treatment strategy with ‘Evenity (romosozumab),’ a bone builder with a dual mechanism of action that increases bone formation and inhibits bone resorption. The sequential therapy strategy of using Evenity then Prolia is regarded as the top-priority treatment option in patients at very high risk of fractures. Prolia recorded 75 billion won (based on IQVIA) in domestic sales in just 4 years after its release, and Evenity, which has been rapidly approved for reimbursement, is also settling well in the market. Behind such great success are the hidden efforts of three Amgen Korea’s three PMs in charge of marketing Amgen’s osteoporosis treatments. The PMs Yoochae Park, Ga-eul Lee, and Saim Shin, who have an average of 10 years of experience in the industry, work to make known the importance of treatment to those at high risk of osteoporosis that were left unattended while introducing the effect and treatment strategy of Prolia and Evenity to HCPs. Dailypharm met with the three Amgen Korea PMs that have been driving the growth of Prolia and Evenity to hear about the marketing strategies of the two products and the changing paradigm in osteoporosis treatment. (From the left) PMs Yoochae Park, Ga-eul Lee, Saim Shin in charge of Amgen’s osteoporosis treatments -Could you tell us about your roles in marketing Amgen’s osteoporosis treatments? PM Yoochae Park (hereinafter “Park”)= I joined the marketing team as a PM for Prolia in Januarya last year. My main tasks include strategy establishment, planning, and material production to strengthen Prolia's position as a market leader in osteoporosis treatment. PM Saim Shin (hereinafter “Shin”)= I joined Amgen ahead of Prolia’s launch in 2016 and worked at its sales team until 2019 when I started to work as a PM for Prolia. I am mainly responsible for overall branding activities such as the development of Prolia messages as well as HCP support activities such as symposiums and webinars. PM Ga-eul Lee (Hereinafter “Lee”)=I am a PM for Evenity. I joined Amgen in March last year and prepared for and executed the non-reimbursed launch of Evenity. My marketing activities are similar to those done by the Prolia team, but more focused on branding activities such as message development and market positioning to promote Evenity, as Evenity is still in the early stages of its launch. -Prolia holds a solid position in the osteoporosis treatment market, recording an annual sales of 75 billion won in Korea. What factors do you believe contributed to Prolia's rapid growth? Shin=In the past, an unmet need among HCPs had existed as there had been insufficient clinical grounds to support the need for long-term treatment in osteoporosis. In other words, treatment efficacy, such as the continued reduction in risk of fractures and continuous increase in bone density from long-term treatment, were not established for the long-term treatment. The long-term data of Prolia in the 10-year FREEDOM clinical study demonstrated the drug’s effect in improving bone density and reducing the risk of fractures. The longer-term between treatments, with a single shot every 6 months, had also improved convenience in administration in patients, allowing them to more realistically receive long-term treatments. Such characteristics that differentiated Prolia from other existing treatments for HCPs and patients were the biggest factor that pushed the growth of Prolia. Park=We were able to directly see the patients’ bone health and density improve after being prescribed Prolia. The HCPs prescription experience and trust in our product has allowed for the continuous growth of Prolia. -With Evenity recently approved for reimbursement, there must be a lot on your plate. What are you most focused on for Evenity? There must be some regrets due to the somewhat limited conditions for Evenity’s reimbursement. Lee=The most important activity for us now is to position Evenity to be used as a first-line treatment after fractures. In this regard, we are focusing more on expanding the market for anabolic agents so that patients who have already experienced fractures can prevent additional fractures. Our focus is on delivering the personalized treatment message to more very-high-risk patients so that they can receive the appropriate treatment to prevent osteoporosis fractures, rather than is limited reimbursement -How have HCPs in the field responded to Prolia-Evenity? Shin=The most difficult issue that the HCPs had faced was that patients were unable to receive continuous treatment despite the HCP’s strong will for their treatment. However, the doctors have acknowledged that continued osteoporosis treatment became a lot easier with the introduction of the once-every-6-months injection, Prolia. According to research, the reduction in fracture risk is lessened if the patients miss 1 of the 2 osteoporosis treatments. In this sense, the high medication adherence in Prolia is a great advantage Lee=With expectations also high for Evenity overseas, HCPs in Korea have shown much interest in the therapeutic benefits of Evenity. In this sense, the most feedback I receive is about how much the HCPs expect a good effect. In addition, the continuous treatment rate of Evenity in HCPs who have previous prescription experience has been maintained high. Also, we were able to confirm successful treatment cases where patients were able to act and return to daily life without protective gear only 3-4 months after receiving surgery for their fractures. -Were there any difficulties in switching the previous face-to-face marketing methods to online due to COVId-19? Shin=At first, digitalizing all marketing directions came as a great burden. All the pharmaceutical companies had launched similar online marketing activities in the same period, and we paid special attention to the online materials that we prepare to increase the mail check rate and the number of webinar viewers. As a result, we have hosted the 24th webcast symposium for osteoporosis experts this year, which has been running for 4 years now. An average of 500 HCPs accessed the symposium live in real-time. It was a difficult but rewarding year in which our symposium was recognized for its quality lectures that address the questions made by HCPs on Prolia and Evenity. Park=Switching all our work to online had increased our load, and also brought concern whether the messages that need to be effectively delivered to the HCPs are being sent one-way. In the field, many HCPs seem to have a positive view of online marketing activities. The HCPs immediately check the material online and request additional material, if necessary. We have been better utilizing the advantages of online communication than our initial concerns, and our message and the advantages of our product are being well delivered online. Lee=Evenity was approved for reimbursement after the COVID-19 pandemic, and the launch symposium for the drug was held as a hybrid event, increasing the need for marketing activities in the online environment. Therefore we considered various measures to organically utilize the brochures, emails, and iPad contents on and offline. Due to our continued efforts, we saw high viewer numbers and e-mail checks from HCPs from the start of the launch.
- Company
- Samsung BioLogics' sales surpassed ₩1 trillion
- by Chon, Seung-Hyun Oct 28, 2021 05:58am
- View of Samsung BioLogics Plant 3Samsung BioLogics surpassed 1 trillion won in sales in three quarters. Sales exceeded 1 trillion won in nine years after its establishment last year, and it showed a steeper rise this year. Samsung Biologics announced on the 26th that its operating profit as of the third quarter was 167.4 billion won, up 196.12% from a year earlier. Sales amounted to 408.5 billion won, up 104.02% from the previous year. Both sales and operating profit are the largest ever. It broke new records of sales (412.2 billion won) and operating profit (166.8 billion won) set in the second quarter again in one quarter. Samsung Biologics' cumulative sales in the third quarter amounted to 1.1237 trillion won, up 42.34% from the previous year. Founded in 2010, Samsung Biologics recorded sales of 1.1648 trillion won last year, exceeding 1 trillion won for the first time in nine years. This year, it surpassed 1 trillion won for the second consecutive year in three quarters. The company's cumulative operating profit in the third quarter was 408.5 billion won, up 104.02% from a year earlier. The operating profit ratio to sales reached 36.4%. The company explained, "In the third quarter, sales increased 64% year-on-year due to the rise in the utilization rate of the third plant due to the performance of new product orders, and operating profit increased significantly due to the operating leverage effect of the third plant operation rate." Samsung Biologics is currently operating three biopharmaceutical plants. As the world's largest (180,000 liters) three plants as a single factory were in full operation in October 2018, the volume of consignment contracts is also soaring. Samsung Biologics signed consignment production contracts with global pharmaceutical companies such as Roche and MSD in the third quarter of this year alone, surpassing $7.1 billion in cumulative orders. 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).
- Policy
- Multinational companies have more drugs for PVA
- by Lee, Hye-Kyung Oct 28, 2021 05:58am
- The NHIS made an official position that it cannot accept the criticism that new domestic drugs are being reversely discriminated within the PVA. After the parliamentary audit of the National Assembly's Health and Welfare Committee on the 15th, The NHIS replied, "It cannot be regarded as reverse discrimination in domestic new drugs," when asked about reverse discrimination by People Power Party lawmaker Lee Jong-sung. For this reason, as a result of analyzing drugs applied more than three times in a row since the reorganization of the PVA system in 2014, seven drugs were included in the case of "Type Ka and Na" and six drugs in the case of "Type Da." However, among them, only six types of drugs (type Da) were domestic, and all of the other drugs (type Da) and seven drugs (type Ka and type Na) were from multinational companies. Eight multinational companies had PV negotiations more than three times in a row. In addition, in the case of items that have been cut more than three times, the price has changed due to drug prices and changes in the alternative drug market. The NHIS selected 14,888 drugs as targets for monitoring drug analysis for negotiations on type Da in April this year. Among them, 14,097 drugs from domestic pharmaceutical companies and 791 drugs from multinational pharmaceutical companies were applied, and the final number of drugs subject to negotiation was 55 (0.39%) from domestic pharmaceutical companies and 4 (0.51%) from multinational pharmaceutical companies. Although domestic new drugs seem to be overwhelmingly subject to PVA negotiations, multinational companies are higher when calculating the ratio selected for negotiation. The NHIS explained, "PVA is a system that cuts the upper limit through drug price negotiations between the NHIS and pharmaceutical companies when drug costs increase to a certain level, and the rate of increase in claims affects insurance finances." The NHIS emphasized, "Drugs subject to continuous drug price cuts through PVA continue to affect finances." Rep. Lee Jong-sung also said in the data, "In the case of multinational history, most of them go through PVA in Type Ka and Na, and most of the domestic pharmaceutical companies in Type Da are applied, so it is understood that there is no reverse discrimination overall." Rep. Lee said, "New drugs developed by multinational pharmaceutical companies and entering the domestic market are also subject to PVA measures, but domestic new drugs seem to have been repeatedly cut by PVA." "The government is creating a structure that cuts prices when sales of drugs that have a positive impact on health insurance finances," he said, urging the promotion of motivation for the development of new domestic drugs. The NHIS said, "There was a preferential policy for new domestic drugs, but the related system was changed due to the Korea-U.S. FTA trade dispute," adding, "As soon as the MOHW comes up with research services on preferential measures for domestic pharmaceutical companies, we will review them."
- Company
- 'Vyndamax' fails reimbursement listing once again
- by Eo, Yun-Ho Oct 27, 2021 05:49am
- The new transthyretin amyloid cardiomyopathy (ATTR-CM) drug, 'Vyndamax,’ is suffering hardships in its process of being listed for insurance benefit. According to industry sources, the application Pfizer Korea submitted for the reimbursement of its new ATTR-CM drug, Vyndamax (tafamidis 61mg), was unable to pass the insurance benefit standard subcommittee. After the company failed to receive designation as an essential drug earlier this year, the company had applied for reimbursement once again through the Risk Sharing Agreement (RSA) scheme. Being deemed inappropriate after submitting data for PE evaluation, reimbursement of Vyndamax is facing difficulties. The problem is that this delay in reimbursement is affecting the patients. ATTR-CM is a fatal condition with a poor treatment outcome due to a lack of specific treatment and is often mistaken for simple heart failure. If not treated properly, patients with ATTR-CM have a survival period of only 2 to 3.5 years. Vyndamax is the only drug that demonstrated its survival benefit in ATTR-CM (ATTR amyloidosis with cardiomyopathy) and is virtually the only drug available as there are no alternatives. The subcommittee’s decision left much room for disappointment as experts have submitted a consistent opinion on the clinical benefit of Vyndamax at the government’s inquiry on the need to apply reimbursement to Vyndamax. Usually, another reason would have to exist for a drug that demonstrated clinical efficacy, has no alternative, and received a positive opinion from the academic society to not pass the insurance benefit standard subcommittee, and for Vyndamax, the reason is assumed to be its fiscal impact. However, separate subcommittees such as the economic evaluation subcommittee and the fiscal impact subcommittee do exist to assess the economic feasibility and fiscal impact of a drug. Therefore, the industry has been voicing complaints about the redundancy of the subcommittee reviews, by the insurance benefit standard subcommittee that is in charge of reviewing the insurance benefit standards conducting assessments on a drug’s fiscal impact. Jungwoo Son, Professor of Cardiology at Wonju Severance Christian Hospital said, “Early diagnosis and continued treatment is important for patients with the progressive ATTR-CM disease. Last year, the domestic ATTR-CM treatment environment has made rapid progress with the approval of Vyndamax, the only drug that provides practical survival benefit to ATTR-CM patients, however, the continued non-reimbursement of the drug has brought on the unfortunate situation where patients cannot start treatment even after being diagnosed.” Son stressed, “The insurance reimbursement system needs to be operated in a flexible manner for drugs like Vyndamax that has clear clinical benefit and no alternatives in consideration of the characteristics of rare diseases so that the patients’ right to treatment is not obscured by economic logic.”
