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- 2026-04-16 04:58:38
- Company
- Can novel bone-builder Evenity win reimbursement this year?
- by Eo, Yun-Ho Oct 20, 2020 06:34am
- Apparently, a novel bone-builder Evenity is making its last push to nab the National Health Insurance (NHI) benefit by the end of the year. The South Korean pharmaceutical industry sources reported, Amgen Korea and National Health Insurance Service (NHIS) have recently initiated a pricing negotiation on an osteoporosis drug Evenity (romososumab) indicated to promote bone formation and inhibit bone resorption. As the 60-day negotiation is due next month, the drug could be listed for reimbursement within this year if the administrative procedure rushes on. After receiving an approval for the South Korean market in May last year, the drug applied for reimbursement listing after a year. The Health Insurance Review and Assessment Service (HIRA) Drug Reimbursement Evaluation Committee (DREC) green lit the listing after confirming the feasibility. The drug is indicated for the treatment of osteoporosis in postmenopausal women at high risk for fracture, and for bone formation in men with osteoporosis at high risk for fracture. The specialists have been anticipating for the novel drug as it is the only bone-builder to have proven the effect of lessening hip fracture. As any of novel osteoporosis drugs had struggled through most of their reimbursement listing process in South Korea, Evenity would have to see if it could successfully get listed. For about a decade, 70 percent to 80 percent of osteoporosis patients in South Korea have been using bisphosphonate, which was tackled on its strict limitation for drug administration and efficacy lacking sufficient data. In fact, a bone formation medicine Forsteo (teriparatide) has taken a decade from item approval to reimbursement listing. Amgen’s Prolia was also approved for the South Korean market in 2014 and launched as a non-reimbursed treatment in November 2016, but finally got to list its name in October 2017. President of Korean Society for Bone and Mineral Research (KSBMR) Chung Ho-yeon noted, “Osteoporosis treatment prioritizes prevention of bone fracture. So a treatment option preventing bone loss while forming new bone would induce prompt treatment benefit.” The efficacy of Evenity has been confirmed during Phase III FRAME and ARCH studies, as well as in Phase III 3 BRDIGE study for the indication treating male patients. In the Phase III placebo-controlled FRAME study, Evenity has demonstrated effect of reducing the risk of new vertebral fracture in postmenopausal women with osteoporosis at risk for fracture resulting in bone mineral density (BMD) T-score of -2.5 to -3.5 at the total hip or femoral neck. Compared to the placebo group after 12 months, the Evenity group had 73 percent lower risk of new vertebral fracture. The patient group that switched to Prolia (denosumab) at year 2 after 12 months of using Evenity showed 75 percent lower risk of new vertebral fracture, compared to the placebo group switching to Prolia. And in Phase III alendronate-controlled study ARCH, Evenity confirmed preventive effect of reducing risk of vertebral fracture and clinical fracture superior than alendronate. Compared to the patient group treated only with alendronate, the patient group switched to alendronate after being treated with Evenity for 12 months had 50 percent lower risk of new vertebral fracture at 24 months.
- Company
- The government restricted the exemption to antibacterials
- by Eo, Yun-Ho Oct 19, 2020 06:19am
- The government restricted the exemption from economic evaluation to only antibacterial agents. There is great backlash. The HIRA confirmed the amendment to the regulations regarding evaluation standards and procedures, such as whether or not drugs are eligible for medical care benefits, by publicizing internal regulations on the 8th. The revised bill was announced, narrowing the scope of exemption from economic evaluation from 'antibiotics' to 'antibacterials'. Initially, the plan to expand the exemption from economic evaluation related to antibiotics was supported by both industry and academia. However, there was controversy in terms of 'the definition of antibiotics'. The medical concept of antibiotics refers to 'antimicrobial medicines' that encompass antibacterial agents (treatment of bacterial infections), antifungal agents (treatment of fungal infections), and antiviral agents (treatment of viral infections). The continued increase in antimicrobial resistance (AMR) is one of the most important public health agendas worldwide. The issue is that the concept of antibiotics is generally confined to 'antibacterial agents'. In fact, the government clarified the definition of antibiotics as the government announced its intention to apply limited inquiries to the related inquiries of the Korean Research-based Pharmaceutical Industry Association (KRPIA). ◆Antibiotic Resistance Problems and the International Community's Approach=The WHO defines the concept of AMR as 'a threat to effective prevention and treatment of continuously increasing infections caused by bacteria, parasites, viruses and fungi'. AMR is not limited to the well-known superbacterial outbreak. Antibiotic resistance, also called ``superbugs,'' is a change that occurs when microorganisms (fungi, viruses, parasites, etc.) that cause infection, including bacteria, are exposed to antibiotics and antibacterial drugs such as antifungal and antiviral drugs. AMR is a public health agenda that should be approached, including the risk of resistance to fungi such as Candida and Aspergillus, as well as so-called 'super bacteria' such as Carbapenem-resistant bacteria and Vancomycin-resistant bacteria. The revelation of AMR makes it difficult to treat infections, increases the risk of spread of infectious diseases, occurrence of severe infectious diseases, and death. As a result, the effectiveness of the drug decreases, and the risk of continued infection in the body increases the risk of transmission to others. Worrying about the mutation of COVID-19 even before the development of COVID-19 vaccine is in the same as worrying about the emergence of resistant bacteria that are currently being developed or the treatment does not work. In fact, in the early days of the 'Global Antimicrobial Resistance Surveillance System (GLASS)', which was started to implement the Global Action Plan for AMR in 2016, the focus was on human bacterial (bacteria) infection, but in 2018 Since then, efforts have been made to narrow the information gap in other types of AMR, such as the development of a global surveillance frame for AMR of invasive fungal infections. ◆ Increased risk of secondary infection in COVID-19 confirmed patients = Cases and results of secondary infections caused by these fungi are being published in patients with COVID-19. It is known that the risk of secondary infection in the hospital increases when long-term hospitalization or long-term use of a ventilator, such as a severe COVID-19 patient. There is a need to secure sufficient infectious disease drugs in preparation for new infectious diseases and secondary infections in hospitals. Analysis of the results of a retrospective multicenter cohort study of 191 COVID-19 patients at two hospitals in Wuhan, China, found that 15% of all patients (28/191) and about 50% (27/54) of deaths were secondary infections. According to a study analyzing the prevalence of invasive aspergillosis in COVID-19 patients, about 5% of COVID-19 patients were in critical condition requiring intensive treatment, and these severely ill patients have been shown to have an increased risk of secondary infection with Invasive Aspergillosis. Jeong-Hyun Choi, Chairman of the Korean Society for Antimicrobial Therapy (Department of Infection and Internal Medicine, Eunpyeong St. Mary's Hospital, Catholic University) said, "If patients are hospitalized for a long time or use a ventilator for a long time, such as a severely ill patient with COVID-19, the risk of secondary infection in the hospital increases. In contrast to the opinion of the Society, it is very unfortunate that the concept of antibiotics has been arbitrarily reduced, contrary to the opinion of the Society, while the necessity of securing sufficient drugs for infectious diseases in preparation for new infectious diseases and secondary infections in hospitals is being raised. In addition, he expected that the 'Antibiotic Resistance Management Division' within the Korea Disease Control and Prevention Agency would be established to enable active management of antibiotic resistance. However, the problem of accessibility is on the contrary. I hope that the government will listen to the voices of the infection control site so that it is not limited to only antibacterials.”
- Opinion
- [Editor’s View] Why still linger on bioequivalence test?
- by Chon, Seung-Hyun Oct 19, 2020 06:19am
- The South Korean government seems to be still lingering on the notion of restricting the joint bioequivalence test the Regulatory Reform Committee has put a brake on. At the recently convened National Assembly Annual Audit, Minister Lee Eui-kyung of Food and Drug Safety stated that she “fundamentally agrees with the restricting the ‘one-plus-three’ joint bioequivalence test.” The minister’s agreement was expressed on the regulatory bill introduced to the National Assembly to only approve of up to three generics using a single source of consigned bioequivalence tests. With the lawmaker’s boost, the ministry is rekindling the effort to legislate the restriction on joint bioequivalence test that was halted by the Regulatory Reform Committee. The restriction on joint bioequivalence test is viewed as a strict measure to prevent saturation of the generics market. When the number of consigned bioequivalence test per original test can be limited, the number of generic launched in the market could also be contained. Regardless of the Regulatory Reform Committee objecting to the restriction twice, the Ministry of Food and Drug Safety (MFDS) is relentlessly, and incomprehensibly, trying to reinforce the regulation without clear explanation as to why. Regarding the bioequivalence test restriction, the Regulatory Reform Committee concluded, “It is difficult to see it as an effective measure to achieve the objective of the regulation. And restricting pharmaceutical companies entering the market seems unlikely to directly improve the pharmaceutical quality and safety, or to promote R&D in the industry.” The committee also pointed out the restriction on joint bioequivalence test has been abolished by them in 2010, and no specific changes in the scene have been occurred to overturn their decision. MFDS is maintaining its stance on the toughening the joint bioequivalence test regulation without a clear justification, although the committee has reviewed that the restriction is an unfair regulation. The previous restriction on joint bioequivalence test was stipulated temporarily in distrust of Korean-made generics. When a number of drugs have been uncovered to have manipulated the joint bioequivalence test in 2006, total 307 items were revoked of approval. MFDS judged the heated competition in the generic market was also caused by the manipulated test results, and the ministry implemented the regulation on joint bioequivalence test from May 2007 to restrict the number of participating companies to two. But only after five years, in November 2011, MFDS removed the restriction on the joint bioequivalence test as recommended by the Regulatory Reform Committee. During the October Regulatory Reform Committee meeting in 2010, some criticized the unjustifiable restriction on joint bioequivalence test by claiming “Such non-scientific and irrational regulations should be abolished.” Also some argued, “Regulating the excessive competition is unreasonable, and besides the safety issue, the government intervening the market is a stretch.” And it is still a mystery if the restriction on bioequivalence test would hinder the generic market to get extremely saturated. The new drug pricing system has already demotivated new generics to enter the market. The newly revised drug pricing system effective from last July has put a lower cap on the generic pricing for those that did not individually conduct a bioequivalence test. Since the valsartan contamination incident, the Ministry of Health and Welfare (MOHW) put down the limitation on the drug pricing to solve the excessive generic competition. However, the unprecedentedly heated competition among the generic has already begun thanks to the South Korean government strengthening the regulation. As the government disclosed its plan to toughen the regulation, over 5,000 generics have been released to the market since last year. Some are even saying the government has instigated the excessive competition. Nevertheless, the government is still pointing its finger at the joint bioequivalence test for the cause of the phenomenon. About the regulation on joint bioequivalence test, a MFDS official at a Regulatory Reform Committee meeting stated, “Encouraging an individual bioequivalence test aims to raise the level of pharmaceutical quality and safety management.” Does it mean a generic that receives an approval based on results of consigned bioequivalence test has an issue? Could it mean the government granted an approval regardless of the risk of quality and safety management? For the government to set a policy, it needs its deserving justification. Moreover, it needs to persuade the stakeholders. And side effects of implementing a new policy should be checked beforehand. The voices from the industry should be heard to set an intricate policy. When it disregards the industry’s voice, the legitimacy of the policy is lost.
- Policy
- President Moon Jae-in visited the SK Bio Research Institute
- by Lee, Jeong-Hwan Oct 19, 2020 06:19am
- President Moon Jae-in visited the COVID-19 vaccine/treatment development site on the 15th and promised to become a 'strong supporter' that helps the final development while encouraging researchers to check the development status and participate in clinical trials. President Moon urged domestic COVID-19 vaccine and treatment developers to devote all their efforts so that the people can return to their daily lives as soon as possible. On this afternoon, President Moon visited the SK Bioscience Research Center in Pangyo, Seongnam-si, Gyeonggi-do, toured the laboratory according to the vaccine development process (cultivation→purification→fermentation→quality test), and he attended the conference named 'To the end! must! Let's apply and make'. Park Neung-hoo, Minister of the MOHW, Lee Eui-kyung, head of the MFDS, and Kwon Jun-wook, director of the Korea National Institute of Health participated. Science and technology advisor in Cheongwadae, Park Soo-kyung was present. SK Chairman Taewon Choi, CEO Jeongjin Seo of Celltrion, Jaeyong Ahn, CEO of SK Bioscience, and Secretary General of the International Vaccine Institute participated. In the medical field, Professor Won-seok Choi of Korea University, Professor Byung-min Sung of Yonsei University, researcher Hee-sook Lee, a nurse for infectious diseases at the National Medical Center, and Genexine·Gene One Life Science·GC Pharma officials also attended. This is the second time President Moon's on-site visit to COVID-19 vaccine and treatment was followed by Institut Pasteur Korea in last April. At the time of his visit to Institut Pasteur Korea, President Moon promised government support for the development of vaccines and treatments. Since then, 'Corona 19 Treatment and Vaccine Development Pan-Government Support Group' has been established and operated, centering on the MOHW and the Ministry of Science and Technology. President Moon has emphasized the need for vaccines and treatments since the COVID-19 outbreak, and has promised continuous interest and active government support for the development of vaccines and treatments by domestic companies. On the 7th, SK Bioscience, which President Moon visited, applied for approval for a phase I clinical trial for its own developed COVID-19 vaccine. President Moon observed the experiment and encouraged researchers by observing the cultured cells directly through a microscope in the cell culture room that produces corona vaccine antigens by culturing cells at high concentration on a tour of the SK Bioscience Lab. At the on-site meeting, they watched a video of an interview with a researcher who is engaged in the development of therapeutic agents and vaccines. President Moon said, "In order to end the long fight against COVID-19, it is necessary to develop vaccines and treatments." He then expressed his gratitude for the hard work of the companies and researchers, saying, "The government will be a supporter of vaccine and treatment development." Meanwhile, President Moon received a report on the development trends of COVID-19 vaccines and treatments in Korea and abroad from the head of the Korea Drug Development Fund and the head of the Korea National Institute of Health. Currently, in the case of vaccines, phase III clinical trials for 10 substances are in progress overseas, and SK Bioscience, Genexine, and Gene One Life Science are respectively developing vaccines in Korea. In addition to drug repositioning research, Celltrion is developing antibody treatments and blood plasma-based treatments at GC Pharma. Celltrion's CT-P59 was approved by the MFDS on the 8th as a clinical trial phase III (IND) as COVID-19 antibody treatment, and GC Pharma's COVID-19 blood plasma-based treatment was approved for a phase II clinical trial on August 20.
- Policy
- KHIDI “COVID-19 drug grants checks feasibility first"
- by Lee, Jeong-Hwan Oct 19, 2020 06:19am
- The Korea Health Industry Development Institute (KHIDI) noted the contingency budget on seeking the COVID-19 treatment and vaccine can only be provided for drugs submitted an application with realistic anticipation to result in treatment performance. At the National Assembly Health and Welfare Committee audit session on Oct. 15, President Kwon Deok-cheol of KHID answered so for the question raised by Lawmaker Jeon Bongmin. Lawmaker Jeon initially pointed out the South Korean government not properly executing the contingency budget after receiving the budget to urgently develop the COVID-19 treatment and vaccine. The lawmaker said only 40 percent of the budget has been used so far, which is 37 billion won out of total 94 billion won. Regarding the criticism, President Kwon Deok-cheol answered the execution of the budget would take a while as the government body has to verify performances and select businesses (pharmaceuticals) accordingly to grant the budget. The president explained, “The agency has currently opened the second round of the grant application submission. KHIDI would support development of the businesses with proven performance,” and “Surely, it is a difficult task. Either an existing drug should prove the repurposing efficacy, or find a new vaccine.” “The Minister of Science and ICT and the Minister of Health and Welfare are backing the program with a collaborative team,” and “We predict the treatment to be developed in the U.S. or Europe by the end of the year or the beginning of the next year. The Korean-made treatment has also initiated the Phase 3 clinical trial,” the KHIDI president added.
- Policy
- CKD-516, clinical approval for combined use of 'Imfinzi'
- by Lee, Tak-Sun Oct 19, 2020 06:19am
- Chong Kun Dang Chong Kun Dang's new anticancer drug candidate'CKD-516' is in a clinical trial to determine the effectiveness of the combination of immunotherapy for cancer ‘Imfinzi’ (Durvalumab, AZ). At the American Cancer Society (AACR) 2019 that was held last year, the possibility of combined use of immuno-cancer drugs was highlighted, and then the clinical phase I was immediately approved in Korea. On the 14th, the Ministry of Food and Drug Safety approved the clinical trial protocol of CKD-516 and Durvalumab (Phase 1 clinical trial) requested by Asan Medical Center in Seoul. This is a phase I test for the AMC. CKD-516 is better than after Chong Kun Dang's anticancer drug. It is known as an oral vascular disrupting agent (VDA) that selectively acts on tumor blood vessels as a mechanism to inhibit microtubule polymerization. In October last year, a phase III clinical trial was approved in Korea to compare efficacy and safety with Stivarga monotherapy as a combination therapy with Irinotecan, an existing anticancer drug, for colon cancer patients. Prior to this, in the American Society of Clinical Oncology held in April last year, the mechanism of co-administration of CKD-516 and immunotherapy and pre-clinical trial data were published. Imfinzi, which is administered together this time, is AstraZeneca's anticancer drug. It has a mechanism by which tumor cells disguise as normal cells and inhibit the protein PD-L1 that helps growth. In Korea, after platinum-based simultaneous chemoradiotherapy (CCRT), it was approved as a treatment for patients with unresectable local advanced non-small cell lung cancer, and the application of the benefit was decided in March. As a result, it recorded 5.3 billion won in sales (based on IQVIA) in the second quarter alone. Immunotherapy cancer drugs have emerged as a trend in cancer treatment due to their high patient response rate. Accordingly, many new drug candidates are expecting a better effect through combination with anticancer drugs. It is noteworthy whether CKD-516 will increase its commercialization potential as a new anticancer drug through combination with immunotherapy.
- Policy
- Immune checkpoint inhibitors require many considerations
- by Lee, Tak-Sun Oct 17, 2020 06:37am
- The MOHW showed a cautious attitude toward the expansion of the benefits of the primary lung cancer treatment for immune checkpoint inhibitors. This is because the patient's treatment opportunities expand, but enormous insurance finances may be required. The MOHW made this statement in a written answer to a question related to Jongseong Lee of a member of People Power Party at parliamentary audit of the administration on the 8th. The MOHW said, "If the benefit is expanded as a primary lung cancer treatment of immunotherapy drugs, the treatment opportunities for lung cancer patients can be expanded, but it is expected that enormous insurance finances of hundreds of billions of dollars will be required." and The MOHW explained, "We will try to make an insurance benefit by deriving a reasonable plan through active mutual efforts with pharmaceutical companies in the future." Currently, immuno-cancer drugs such as Keytruda are negotiating with the government to expand the benefits of primary lung cancer treatments. In addition, the MOHW explained to the 'non-reimbursement conversion problem when combined treatment of chemo-anticancer drugs and immuno-anti-cancer drugs' raised by Jongseong Lee. It is explained that the clinical utility and cost-effectiveness are reviewed for each therapy, not for individual drugs according to the approval of the MOHW in the case of anticancer drugs. The MOHW said that it would make an effort to provide insurance benefits as soon as possible for immunotherapy and combination therapy by devising a rational financial sharing plan through active mutual efforts with pharmaceutical companies. The MOHW responded to an inquiry from Chun Bong-min of the same party to strengthen the coverage of anticancer drugs that we are continuing to strengthen our coverage, focusing on treatments for severe diseases such as anticancer drugs, but the anticancer drug expenditure increased by 59% (₩1 trillion → ₩1.6 trillion). The MOHW said, "While maintaining the basic principles of health insurance, we will endeavor to ensure patients' treatment opportunities as much as possible and expand the application of insurance benefits along with measures to improve expenditure efficiency such as drug re-evaluation in the future. When asked Choi Hye-young, a memeber of Democratic Party of Korea, to use the National Health Promotion Fund to support the provision of anti-cancer drugs, the MOHW replied: "We agree with the need to support medical expenses including therapeutic drugs to expand treatment opportunities for cancer patients." In addition, the MOHW said that the National Health Promotion Fund provides annual health insurance funding for the amount prescribed by law, and that a careful review is necessary, taking into account the target, scope and required financial resources within the scope of the support.
- Company
- Issues to look into when pricing drug by each indication
- by Eo, Yun-Ho Oct 17, 2020 06:37am
- Amending a regulatory system is not a simple work. Moreover, introducing the indication-specific drug pricing would have to entirely change the premise of the National Health Insurance (NHI) system that grants ‘unified insured pricing on a single drug.’ Regardless of the final result, the government would need to have detailed discussions and survey the public opinion. As for the industry, it is positive that the government is still open to the idea to discuss it further. In fact, Vice Minister Kang Do-tae at Ministry of Health and Welfare (MOHW) spoke during an interview with the industry news media and noted, “The indication-specific pricing could help strengthening the treatment access in severe disease patients. But the feasibility of realizing the novel payment system within the current billing structure and payment system the NHI system uses should be confirmed. And also various views of stakeholders, such as related government bodies, pharmaceutical industry and civic group, should be sufficiently surveyed as well.” And there is already a number of issues raised regarding the subject. Following are the concerned voices on adopting the indication-specific pricing; ◆Issuing a variety of drug codes and the risk of abuse: Inconvenience in administration work is inevitable. Using the indication-specific pricing would mean giving two to three unique codes on a single drug. And the Health Insurance Review and Assessment Service (HIRA) and the National Health Insurance Service (NHIS) would undergo big changes in their billing system, which could cause confusion in healthcare institutes when inputting the main or sub disease code. Nevertheless, these are literally some ‘inconvenience’ that can be handled. When the government implemented the NHI coverage enhancement initiative and lowered the copayment rate of anticancer treatment expense to 5 percent and differentiated the billing, unique code for the variant copayment rate code was issued. In other words, issuing unique code for each indication on a single drug could be bothersome, but not impossible. However, the issue of the system abuse should be looked into. For instance, a drug could be priced at 100,000 won or 150,000 won when prescribed as a stomach cancer or liver cancer treatment, respectively, according to the indication-specific pricing. Then a healthcare institute may falsely report the drug as a prescription for treating liver cancer, when it was prescribed to a patient with stomach cancer to make profit from the difference. Actually, there are drugs containing same substance but priced individually. Regardless of the same substance, each item is approved under different name with a variety of doses and formulation. An immunosuppressant Certican and anticancer treatment Afinitor both containing everolimus, and enlarged prostate treatment Proscar and hair loss treatment Propecia sharing finasteride are prescribed under different pricing. Recently, Pfizer won separate approvals on Vyndaqel and Vyndamax sharing tafamidis and started the reimbursement listing procedure (Vyndamax). But even with these drugs, there were reported cases of abusing the drugs. People with hair loss receiving prescription of Proscar, instead of non-reimbursed Propecia, are apparently breaking the tablet into pieces to take them in smaller dose. But considering the anticancer treatment prescription scene and the initial talks on indication-specific pricing limited to RSA drugs only, it would be unlikely for the system abuse to be apparent widely. Nevertheless, the regulatory measures to manage such system abuse would be accompanied when implementing the indication-specific pricing. An official from NHIS said, “Even if it is a same drug, a pricing reasonable in one country or payment model could be inappropriate in other countries. Ultimately, it would be wise to select optimized payment model taking in account of unique situations in each countries. We need to have talks on the possibility of realizing the novel payment system within the current billing data structure and payment system.” ◆Patient acceptance and social consensus: The most fundamental issue and the core of the conflict is the patients’ reaction. Literally, the indication-specific pricing would differentiate the price of a drug a patient has to pay depending on the disease they have. And for a cancer patient, it may be difficult to accept the fact that the specific cancer they are fighting against is costing them more. In the end, the public should be aware and create a social consensus recognizing that the indication-specific pricing would ‘accelerate the reimbursement listing for anticancer treatment, and be a solution to drugs struggling to expand reimbursement on additional indication after its first.’ Patients could feel the burden of pricing, but ultimately receiving reimbursed treatment would be a better than no option at all. Also the actual price is subject to change when adjusting refund rate, but the gap would be narrowed when the copayment rate is applied. A market access personnel in a multinational pharmaceutical company urged, “Beyond the issue regarding the international reference pricing (IRP) system, the Korean offices are having more difficulties in getting the headquarters’ approval during the reimbursement expansion process. A company has to give up on expanding the coverage when a drug’s actual price, despite the labeled price, is making a loss. We want the public to understand that what the industry wants from the indication-specific pricing is not to burden the patients, but to improve treatment access for them.”
- Policy
- Pirespa·Kanarb are the targets of drug price negotiations
- by Lee, Hye-Kyung Oct 17, 2020 06:37am
- Ildong's 'Pirespa 200mg (Pirfenidone)' and Boryung's 'Kanarb 30, 60, 120mg (Fimasartan potassium)' and other drugs with increased usage were targeted for the price-volume agreement negotiation system monitoring. Roche Korea's 'Zelboraf 240mg (Vemurafenib)', Pfizer Korea's 'Inlyta1·5mg (Axitinib)', and Ipsen's 'Dysport (Clostridium botulinum toxin type a)' are also monitored. The NHIS recently released 'the price-volume agreement negotiation system (Type A and B) monitored drugs for the fourth quarter of 2020 on its website. The price-volume agreement negotiation system is a method by which The NHIS and pharmaceutical companies share the risk of health insurance finances. For drugs with a sharp increase in usage, drug prices are reduced through negotiations with The NHIS. The targets for monitoring in the fourth quarter are 131 items in 75 drug groups. The monitoring targets include 'Kynteles (Vedolizumab)' from Takeda Korea, 'Repatha injection prefilled pen (Evolocumab)' from Amgen Korea, 'Taltz (Ixekizumab)' from Lily Korea, and 'Cosentyx (Secukinumab)' from Novartis Korea. Gilead Science Korea's 'Biktarvy', Guerbet's 'Lipiodol ultra soln (Ethyl esters of the iodised fatty acids of poppyseed oil)', Shin Poong's 'Inisia (Ulipristal acetate)' and 'Pyramax', and Young Poong's 'Zaronti (Ethosuximide)' are also subject to the price-volume agreement negotiation system. The price-volume agreement negotiation system type A is when the bill for the same product group with the expected billing amount agreed upon by the NHIS and drug price negotiations, the expected billing amount negotiations, the drug price increase adjustment negotiations, the scope of use expansion negotiations, etc. increased by 30% or more. Type B is the case of the same product group that has been negotiated for Type A, or four years have passed since the date of initial registration without Type-I negotiation. This is the case when the previous type is increased by 60% or more than the previous year's bill every year from the day after the end of the analysis target period, or 10% or more and ₩5 billion or more. Drugs with an annual billing amount of less than ₩1.5 billion, drugs with an upper limit lower than the arithmetic average price of the same ingredient, low-cost drugs, and shortage prevention drugs are excluded from the price-volume agreement negotiation system.
- Policy
- Atozet latecomer CKD Atoezy wins approval without PMS
- by Lee, Tak-Sun Oct 17, 2020 06:36am
- 종근당 충정로 본사 Chong Kun Dang has reportedly received the South Korean health authority’s approval on a follow-on drug of MSD’s dyslipidemia treatment Atozet. The approval preceded Atozet’s post-marketing surveillance (PMS) end date on Jan. 22 next year by three months, putting the latecomer on an advantageous position. However, the estimated launch date is still unknown as the South Korean company is to call for a CMO to manufacture the same substance drug. Chong Kun Dang’s Atoezy is not pressured to meet the PMS conditions as Atozet’s outstanding PMS period did not carry over. On Oct. 13, the Ministry of Food and Drug Safety (MFDS) green lit three doses of Atoezy by Chong Kun Dang. The drug shares the same substance (atorvastatin calcium hydrate plus ezetimibe) as Atozet. But Atoezy dropped the hydrate but contains atorvastatin calcium, instead. In a Phase 1 trial, the Korean drug proved the bioequivalence to its reference drug, Lipitor plus Ezetrol. And also it confirmed statistically significant reduction of low-density lipoprotein cholesterol (LDL-C) level in a group taking the drug against the control group during a Phase 3 trial conducted on 366 patients with primary dyslipidemia for eight to 12 weeks. Although it was predicted the outstanding PMS would be carried over to the Korean drug as it shares the same substance with Atozet, MFDS designated the drug as a subject to submit risk management plan (RMP) to verify its safety after the market release. Similar to PMS, RMP subjects have to hand in use-result surveillance outcomes after the market release. But for pharmaceutical companies, PMS could feel more burdensome as a certain period of use-result surveillance is set as an approval condition. For instance, it would have been almost impossible for Atoezy to meet the 600 cases of use-result surveillance until Jan. 22 next year to apply Atozet’s outstanding PMS. MFDS official explained the condition was replaced with RMP as the outstanding PMS period was only three months and the ministry has a precedent to refer to. As Atoezy was able to dodge the outstanding PMS carryover, consigned companies that applied for authorized generic approval last month seem to be relieved. Atoezy would be able to launch the product in January next year at earliest. But the Korean company could be releasing the product around April next year, as the company has reportedly agreed with consigned companies to release the product along with authorized generic. Even if the launch date gets scheduled in next April, it would be still earlier than other generics entering the market after Atozet’s PMS period. Moreover, the industry is unsure of Chong Kun Dang directly handling the sales, as the Korean company has been co-marketing MSD’s original drug Atozet. Some speculates Atoezy’s license could be transferred to other company.
