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- 2026-05-20 03:12:21
- Policy
- Teribone's price will be cut from the 26th
- by Kim, Jung-Ju Sep 28, 2020 06:20am
- The price cut was finally decided in an administrative lawsuit to cut the drug price of Teribone inj 56.5 μg (Teriparatide). Since the company voluntarily withdrew the lawsuit due to lack of profit, no other drug price changes are expected in the future. The Seoul Administrative Court recently ruled against a lawsuit for cancellation of drug price cuts (revision of the 'Pharmaceutical Benefit List and Upper Limit Table No. 2020-38) filed by Dong-A ST. Accordingly, the suspension of execution, which the company requested and accepted by the court along with the lawsuit, also ended and price cut was imminent. According to the court, the suspension of enforcement of the notice will end in 25th. Accordingly, from the next day, the 26th, the price will drop to the price planned by the government through ex officio adjustment. The lawsuit came when the MOHW included the drug in the drug price cut list last month. The MOHW applies the so-called `half-price drug price' when a generic is registered for the first time, and is listed at a price of 53.55% of the original. However, if the number of companies with the same product is less than 3 even after a year has passed, the addition is maintained until the number of companies with the same product reaches 4 or more, and when the conditions disappear, the drug price is lowered through ex officio adjustment. Initially, Teribone inj was listed on the reimbursement list at 90% level in conjunction with the drug price of Forsteo in accordance with the 'Pharmaceutical Determination and Adjustment Criteria.' The cut was decided, and in conjunction with this, the drug price of Teribone inj 56.5μg was also reduced. Accordingly, the company has filed a lawsuit against the MOHW. The expected reduction is 22.2% from the current ₩73,287 to ₩57,001. In August, Lilly lost to Daewon in a lawsuit to cut the drug price of Forsteo, and the drug price cut of Dong-A ST Forsteo was finally decided without appeal. In other words, Teribone inj is automatically reduced in price separately from litigation. Due to such circumstances, Dong-A ST decided that the lawsuit was not profitable and decided to withdraw. Medical institutions should take care when making a claim, reflecting the drug price cut.
- Company
- Targeted therapy Tagrisso back on track expanding coverage
- by Eo, Yun-Ho Sep 25, 2020 06:06am
- A third generation targeted therapy Tagrisso is getting back on its track to seek reimbursement as a first-line treatment for patients with lung cancer. The pharmaceutical industry sources confirmed, AstraZeneca Korea has submitted an application to expand reimbursement on its epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) Tagrisso (osimertinib) as a first-line treatment. After failing to pass the Health Insurance Review and Assessment Service (HIRA) Cancer Deliberation Committee in last May, the company is resuming the process in five months. Adding the first-line treatment indication in December 2018, Tagrisso sought after the reimbursement expansion in 2019, but the South Korean health regulators deferred the decision by claiming the decision should be made when the Phase III FLAURA study reveals full data on overall survival (OS) as a first-line therapy. Although the company handed in additional data from the FLAURA study and accepted the government-proposed financial burden sharing plan, the Cancer Deliberation Committee members argued the treatment demonstrated issues in clinical efficacy and denied the reimbursement expansion. AstraZeneca’s new weapon of choice is the FLAURA China extension cohort study unveiled as a poster presentation at European Society for Medical Oncology (ESMO) conference convened online recently. The study provides specific OS data in Asian race. The toughest barrier that hindered Tagrisso from expanding the reimbursement was the Asian subset analysis. The study found Tagrisso’s OS was at 38.6 months, which improved OS in Iressa (gefitinib) and Tarceva (erlotinib) by 6.8 months. The findings were encouraging as Tagrisso was the first EGFR TKI, and the researchers counted even the cross over prescription on patients with confirmed T790M mutation. However, the subset analysis on Asian race showed skeptical hazard ratio (HR). Among the Asian participants, the HR was only around 0.995. The figure was basically within the margin of error from the value 1, which meant the targeted therapy failed to show meaningful improvement compared to the controls. Based on the unsatisfying result, the scholars claimed “The Tagrisso OS in Asian race, also covering the South Koreans, is not credible,” and the claim eventually influenced the Cancer Deliberation Committee’s decision. Now that Tagrisso has prepared the study results from China, the previous decision on reimbursement expansion could be overturned. The FLAURA China study incorporated a total of 71 participants using Tagrisso and 65 participants using control in China cohorts. The control group participants were allowed to cross over to Tagrisso as a second-line treatment, once they advanced as T790m-positive, in which 22 out of 65 patients were the case. As a result, Tagrisso group’s OS median reached 33.1 months, or 7.4 months longer compared to the control group with 25.7 months, while the risk of death was reduced by 15.2 percent.
- Policy
- More than 20 companies, to apply for Atozet's generics
- by Lee, Tak-Sun Sep 25, 2020 06:05am
- Atozet by MSDIt is reported that more than 20 pharmaceutical companies have contracted to produce generics for Atozet (Ezetimibe/Atorvastatin) with Chong Kun Dang. Accordingly, it is expected that the number of drugs applied for permission after PMS through bioequivalence test will be lowered by about 15% compared to Chong Kun Dang products. Chong Kun Dang signed contracts with consignment companies on the 22nd. According to the industry, contrary to the concerns of the participating companies, it is reported that more than 20 companies have signed contracts. In the new cascaded drug price system, up to 20 items in the order of listing will receive 53.55% of the drug price compared to the original if the condition of DMF-self-biological equivalence is satisfied. On the other hand, starting from 21st generics, drug prices are calculated at 85% of the lowest price, so generics are more advantageous the sooner they are listed. If there are no more than 20 contractors entrusted to Chong Kun Dang, including the original company and Chong Kun Dang, the companies applying for permission after the end of the PMS in January of next year could receive the drug price at the same level. Accordingly, some of the consignment companies that undertake Chong Kun Dang's contracts also commented that it would be better to entrust the same drug price to a bioequivalence generic company that has low production costs. However, it is reported that Chong Kun Dang responded to the consignment company to not worry because there are more than 20 contractors. Chong Kun Dang's drugs for data-based re-evaluation are expected to be approved next month, and the consignees are planning to apply within this week. From September 30, when applying for permission, it is mandatory to submit data on the possibility of causing genotoxicity of impurities. The evaluation data on the possibility of inducing genotoxicity of impurities is a system introduced by the MFDS in order to strengthen management in the subsequent NDMA incidents of carcinogenic substances. An industry official said, "In consideration of the MFDS’ confirmation schedule, Chong Kun Dang's consignment companies decided to apply for a permit within 25 days at the latest. It is likely that the exact number of consignment contractors will be disclosed after applying for permission." If more than 20 Atozet consignment contractors are confirmed, the demand for the restriction on the number of delegated generic licenses is expected to increase. This is because generics that have been tested for bioequivalence may suffer damage from the drug price due to late listing. Therefore, some in the industry have come up with an opinion that the number of delegated generic licenses should be limited.
- Policy
- The post-assessment system has many problems
- by Lee, Hye-Kyung Sep 25, 2020 06:05am
- The necessity of introducing post-assessment system for prior registration was raised to expand patient access to new drugs, but the government said it needed complex concerns. Choi Gyeong-ho, an official at the insurance pharmaceutical department of the MOHW, said at the 'Non-face-to-face discussion for enhancing patient accessibility of new drugs in the era of COVID-19' held at 2 p.m. on the 23rd hosted by member of the National Assembly, Lee Yong-ho and hosted by the Future Health Network. "The post-admission evaluation system is theoretically very good, but there are a lot of concerns." In the process of reducing Choline alfoscerate’s benefit, the notice was suspended due to lawsuits, etc., and Choi said, "we tried to subtract the ineffective Choline alfoscerate from reimbursement, but it is suspended." He said, "The post-admission evaluation system may have complex problems such as what to do with patients who have been taking it if there is a situation where they have to leave." "I have no choice but to have doubts whether pre-listing at temporary prices is a system that can actually work." Lee Hyung-ki, a professor of clinical pharmacology at Seoul National University Hospital, who was in charge of the topic presentation on the day, said that there is no simple approach to the increase of the ICER threshold. He said, “If we raise the price of ICER, it will help with positive aspects and high-priced new drugs or listings, etc. in terms of reinforcement of security, However, it is bound to be accompanied by an increase in drug prices. Therefore, there are many opinions, and there are opinions that the current value is okay, so a lot of discussion is needed.” It was also said that the law will be revised sooner or later regarding the listing of drugs after risk sharing (RSA). He said, "There are plans to improve the RSA system, such as generic drugs system, but it is a matter that needs to be revised and linked in practice and it will be implemented soon."
- Policy
- Better new drug access with pre-listing reimbursement
- by Lee, Hye-Kyung Sep 25, 2020 06:04am
- Pharmaceutical affairs expert argues, to enhance patients’ access to new drugs, the government should induce pharmaceutical companies to voluntarily set and lower generic pricing on their own, while also considering flexible ICER threshold and pre-listing reimbursement. And the expert criticizes the upcoming pilot program, effective from October to provide coverage on Korean herbal medicine, as ‘medical service coverage without sound evidence of cost-effectiveness,’ and urges the government to revisit the matter and review appropriately allocating the National Health Insurance (NHI) finance. A non-contact discussion panel on enhancing access to new drug amid COVID-19, convened by Lawmaker Lee Yongho and ‘Future Health Network’ on Sept. 23 The said claims were made at a non-contact discussion panel on enhancing access to new drug amid COVID-19, convened by Lawmaker Lee Yongho and ‘Future Health Network’ on Sept. 23. Professor Howard Lee at Seoul National University Hospital Department of Clinical Pharmacology presented his analytic findings on recommended policies to improve patients’ access to new drugs. Professor Lee proposed four policies on reinforcing the accessibility to new drugs. First, the professor urged the incremental cost-effectiveness ratio (ICER) threshold should be based off of the national income level, disease severity and properties, and patients’ need for the treatment. Currently, the Health Insurance Review and Assessment Service’ (HIRA) ‘Detailed Evaluation Standards of New Drug and Negotiating Drugs’ do not clearly state ICER threshold, but it refers to GDP per capita (36 million won as of 2019). Professor Lee said, “If the reference subject is used in combination with a high-cost standard therapy or other drugs, it is difficult to prove the cost-effectiveness,” and “ICER threshold should be flexibly applied in brackets for pharmaceuticals challenged to conduct pharamacoeconomic (PE) analysis, or cancer or severe disease treatments.” The second proposal is to seek alternatives for PE analysis. Professor Lee pointed out, “The risk sharing agreement (RSA) system was initially introduced, because proving cost-effectiveness was difficult,” but “these new drugs still take 746 days until the listing and 729 days with RSA, making not much of a difference. Nevertheless, there is no alternative option other than RSA.” Based on his criticism, he argued the mindset on enhancing new drug accessibility should be shifted and suggested adopting ‘pre-listing reimbursement.’ The third recommendation is to adequately appropriate NHI finance. His argument is that the price competition-induced generic pricing reduction and coverage on medical service, which cannot prove cost-effectiveness, should be taken into account again. The professor reprimanded, “South Korea’s generics are usually expensive but their markets generate more than sufficient sales. It means the true market functions is missing,” and “in case of Japan, where drug pricing controlled, its government decides the generic pricing preventing the price competition. But South Korea is different.” Regardless of the government’s pricing control, the generic sales are high, as well as the sales profit. So the professor stated, “Rather than the government-forced pricing control, voluntary generic pricing by companies is more effective to motivate generic pricing reduction.” The fourth proposal was opening a separate fund for the new drugs. He emphasized the government should seek for the social consensus to create an independent fund for the new drug coverage that can be operated regardless of NHI financial status.
- Policy
- The generic competition of Circadin PR is intensifying
- by Lee, Tak-Sun Sep 25, 2020 06:04am
- Circadin PR by KuhnilGenerics for Circadin PR, a melatonin-based insomnia treatment drug, began to be approved on the 22nd. Kuhnil's Circadin PR was removed from data protection due to the expiration of PMS in June. With the end of PMS, applications for permission for generic drugs were followed, and product approval was finally received this month. Prior to the release of generics, the entrusted generics, which signed a contract with Kuhnil, were pre-released, and attention is focused on the competitive structure. On the 22nd, the MFDS approved generics of the same ingredients as Circadin PR, such as SK Chemicals' Raton 2mg. Seven companies were approved on the 22nd and more companies are expected to receive approval for generic drugs within this month. On the 22nd, generic drugs produced by Inist and Mothers Pharm were approved. The original, Kuhnil's Circadin PR, obtained an item approval in June 2014. It is an item developed by NEURIM, headquartered in Israel, and imports and sells items produced by SwissCo Services AG located in Switzerland. In a domestic clinical trial for insomnia patients over 55 years of age, Kuhnil said that after taking Circadin, the quality of sleep, time to fall asleep, total sleep time, sleep efficiency and activity during the day were improved, but no special side effects occurred. In addition, while existing sleeping pills are limited to 3-4 weeks per time as psychotropic drugs, Circadin PR is a non-psychotic drug that can be prescribed for up to 13 weeks at a time. Circadin PR which was released as a non-reimbursement drug in July of that year, continued to increase in sales, but last year, it was evaluated that it successfully settled in the market at ₩6.5 billion based on IQVIA. However, with the end of PMS, which releases new drug data protection this year, it has become difficult to maintain market share due to the entry of generic drugs. Accordingly, Kuhnil has devised a strategy to increase its side through delegated generics. In February and March, before the expiration of the PMS, Kuhnil provided data to four companies, including Jeil, Penmix, Hanlim, CMG pharm and helped with the authorization of the delegated generic type. These four delegated generics, like the original, are drugs produced by SwissCo Services AG. The intention is to preoccupy the generic market with delegated generics manufactured in the same producer before generics are released. Sales of delegated generics released six months earlier are still not good. The fact that this drug is a non-reimbursement Rx drug, but it is an unpredictable indicator of how the market competition will flow. It is noteworthy how well domestically produced generic generics will perform.
- Company
- Janssen MA Director Lim Kyunghwa promoted to Janssen APAC
- by Eo, Yun-Ho Sep 24, 2020 11:59am
- Director Lim Kyunghwa Market Access (MA) Director Lim Kyunghwa at Janssen Korea is to be promoted to Janssen Asia Pacific. The pharmaceutical industry sources reported, Director Lim would be appointed as a new MA Director at Janssen Asia Pacific from coming October. Temporarily, Lim would be remotely working from South Korea amid COVID-19, but she would be working at the Asia Pacific Region Office later. Director Lim, currently leading the MA at Janssen Korea, has earned her master’s and doctorate degrees from Sookmyung Women’s University, as well as MBA from Korea University. Her career in MA started when she joined Chong Kun Dang, and she gained rich MA experiences from Boehringer Ingelheim and Novartis. Moreover, Director Lim is currently serving as a Co-chair of MA Committee at Korean Research-based Pharmaceutical Industry Association (KRPIA). Due to her promotion, KRPIA is to appoint a new co-chair on Sept. 28. KRPIA is also readying for a series of new personnel changes in Board of Directors, as the current Chairman Avi BenShoshan and Vice-Chair Julien Samson are returning back to the headquarters.
- Policy
- The answer is to improve the drug price system
- by Lee, Hye-Kyung Sep 24, 2020 06:20am
- The drug price system should be improved in order to enhance patient access to new drugs such as cancer and rare disease treatments. Through the 'non-face-to-face discussion to enhance patient accessibility of new drugs in the era of COVID-19' hosted by Lee Yong-ho, a member of the National Assembly and hosted by the Future Health Network on the 23rd, clinical field experts, patients, and pharmaceutical companies gathered opinions about ▲Flexible application of ICER values ▲ Risk-sharing system and expanded exemption from economic feasibility evaluation ▲ Post-priority evaluation ▲ Generic drug price cut ▲ Separate fund. The government also acknowledged the need to improve the drug price system, but emphasized that limited in reality. Lee Hyung-ki, a professor of clinical pharmacology at Seoul National University Hospital, who was in charge of the topic presentation, said, "Economic evaluation is difficult or the ICER value should be flexibly applied in the form of a band for cancer and severe disease treatments, and it still took 746 days for the total drug to pay and 729 days for the risk-sharing system, so there is no difference, but there is no alternative to the risk-sharing system." Choi Young-hyun, honors professor at Korea national university of Welfare (former head of the Department of Welfare) also said, "In the case of anticancer drugs, it takes 757 days to pay. Patients and their families have no choice but to mourn." After paying, in the process of negotiating a drug price with the NHIS, the method of adjusting the amount of use through drug price linkage can be an alternative." Choi In-hwa, managing director of Roche Korea (Chairman of the KRPIA reimbursement improvement Subcommittee) said that under the current situation, listing new drugs with Korea as a priority would be difficult for global pharmaceutical companies. Managing Director Choi added, "Korea is a country that can invest in new drugs because of the late payment of reimbursement and the high prices. We need to secure various solutions such as improving the drug price system such as total amount or positive list system for new drugs.“ On behalf of the patient, Baek Min-hwan, the representative of the Korea Multiple Myeloma Patients Association, asked about the government's measures to improve the RSA system and pay ultra-high-priced anticancer drugs. CEO Baek suggested, "It takes too long to be registered for benefits after approval. Patients are told to increase accessibility through positive list system altogether rather than waiting for them to die." The health authorities also sympathized with this, but said that there were some differences in perception. "The flexible application of the ICER value is simpler or not easier than expected, and it is good in terms of reinforcing guarantees, but we have to consider rising drug prices." said Choi Gyeong-ho, the secretary of the MOHW's insurance drug department. However, he said that the system could be supplemented by continuously collecting opinions. Kim Ae-ryeon, head of the pharmaceutical management department of the HIRA, said that she would release a proposal to improve the ICER value sooner or later. Kim said, "We are conducting a study on the ICER threshold, and we will be able to disclose the improvement plan once it is finished." Regarding the expansion of the economic evaluation exemption, she explained that as of June this year, 17 ingredients and 28 items were registered as an economic evaluation omission system. The NHIS also promised to prepare a mechanism for transparency in drug price negotiations by the second half of this year so that it can escape from 'drug price negotiations that are not known at all'. While negotiating drug prices, Park Jong-heon, head of the NHIS' reimbursement strategy department, said that we should have disclosed data such as the status of reimbursement and price hikes due to increased usage, and transparently disclose data to review if there is a disagreement. He said, “Until now, there were restrictions due to personal information protection or infringement of third party rights, and we will make a track on the part that can be shared as much as possible until the second half of the year so that there is no talk of negotiating without knowing anything.” On the other hand, the MOHW mentioned re-evaluation of registered materials regarding the expansion of insurance finances to strengthen access to new drugs. Choi said, "The overall health care budget is about ₩19 to 20 trillion, but it is impossible to set a budget for how much to spend in a certain field, through a reasonable increase in health care costs or re-evaluation of drugs such as Choline alfoscerate, and it will be possible to expand the coverage of cancer or rare diseases." In connection with the point of YouTube viewers that the Severe Disease Deliberation Committee of the HIRA is struggling to pay for cost-effectiveness, Choi said, “We cannot help but consider the overall cost of health care while judging the usefulness of the new drug in cancer, and tt any stage, we have to judge the cost.”
- Product
- Comedian Kim Chulmin, doesn’t recommend taking Fenbendazole
- by Kim, Min-Gun Sep 24, 2020 06:20am
- Comedian Kim Chulmin, who aroused hope by taking animal repellent 'Fenbendazole' for anticancer purposes, said, "I will never go back because my condition has deteriorated. I don't want to recommend it to my family." He said that it was over. In an interview with CBS' Kim Hyun-jung's NEWS SHOW on the morning of the 22nd, Kim, who is struggling with cancer, revealed that he does not take animal repellents anymore because his LFT level has increased and tumor spread to his throat. On this day, Mr. Kim said, "Recently, the cancer has spread to the neck (cervical spine No. 5), so I received radiation treatment, and the bone was removed and an artificial bone was inserted into the neck to protect the neck." Kim, who was diagnosed with lung cancer in August last year, became an issue by publicly revealing the challenge of taking Fenbendazole. He recently stopped taking both Fenbendazole for animal and human Albendazole for human. He revealed his condition in the interview that day for the purpose of hope that it will help other patients. He said, "At the beginning, the pain seemed to go away a little. The LFT level came out to normal, and it improved after two months," he said. When his appetite and voice returned and he had hope, he started posting experiences on social media. However, Mr. Kim said, "Because of my greed, I took Albendazole in the morning and Fenbendazole in the afternoon, and increased the dose. After about 5 months, the LFT level gradually increased and the cancer metastasis part appeared little by little. It got better and worse, but there were (tumor) spread in 3 places in the liver." Mr. Kim said, "They were a burden to the liver. Joe Tppens (a person who claimed a cure after taking anthelmintic repellent in the US) ate for 3 months and healed it, but I couldn't kill the cancer even though there was a temporary improvement." After months, the cervical spine cancer became larger and metastasized, and the liver level rose. The cancer tumor level peaked at 570-580, but I was scared to get to 1,650, so I thought this was not.” Mr. Kim said, “They hope since patients with stage 4 feels like holding something. I also did, and if Joe Tppens hadn't participated in the development of a new drug, I would have felt more trusting and effective repellents.” Mr. Kim, who is currently receiving only chemotherapy, said, "There are 1.6 million cancer patients. Many people look at me with interest and some will take it, so I said at the beginning, I will tell them clearly it gets better if it gets better and or it doesn’t get better if it doesn't." Mr. Kim said, "I have definitely failed and I do not want to recommend it because it has worsened. If I go back to that position, I will not do it. If my family has such a thing, I will object to not taking." Lastly, Mr. Kim said, "I think every time of the day is a gift. It is true that a small prayer gathering will be of great help." Meanwhile, Kim revealed that he had been taking Fenbendazole, an veterinary repellent, after being diagnosed with lung cancer in August last year, according to the claim that the cancer was treated with dog repellent in the United States. As a result, the issue of anti-cancer drug repellents has increased, as Fenbendazole sold out at pharmacies. When it became a social problem, the KMA and the KPA urged that there is no evidence for the efficacy and safety of animal repellents." The Ministry of Agriculture and Forestry also asked pharmacies to confirm its use when selling Fenbendazole.
- Company
- Suganon by Dong-A ST, approved for Phase II/III in the US
- by An, Kyung-Jin Sep 24, 2020 06:19am
- Suganon Dong-A ST announced on the 22nd that the diabetes treatment 'Suganon' (Evogliptin) has been approved by the US Food and Drug Administration (FDA) for Phase IIb/IIIa clinical trial plan (IND) for aortic heart valve calcification. Suganon is a diabetes treatment based on DPP-4 inhibitor developed by Dong-A ST. In order to use Suganon other than diabetes, Dong-A ST transferred the technology of a substance patent for Suganon and a patent for the treatment of aortic heart valve calcification of Asan Medical Center in Seoul, and established a joint venture Rednvia. In January of last year, Rednvia signed a technology transfer contract with Dong-A ST for the development and sale of aortic heart valve calcification treatment for Suganon and has been developing it. In June 2019, the MFDS approved Phase II Clinical Trial Plan (IND) for aortic heart valve calcification, and initiated Phase II clinical trial in Korea for 225 patients. In July of this year, the FDA received Phase IIb/IIIa clinical trial IND. Researchers from renowned medical institutions in the United States, such as Mayo Clinic and Massachusetts General Hospital, have confirmed participation in this clinical trial. Rednvia has unveiled its plan to accelerate product commercialization as much as possible by working closely with researchers from these institutions and receiving clinical research funding from the National Institutes of Health (NIH). Dong-A ST Chairman Eom Dae-sik said that this clinical trial is an attempt to re-create a drug for a new drug that has been successfully developed and we will work closely with us to complete the development of the treatment. Rednvia CEO Hoonmo Lee said, "I am very pleased to be able to obtain the approval of Sugarnon's US clinical IND after collaborating with excellent researchers and institutions, and we will do our best to successfully perform clinical trials." According to the data provided by the company, the treatment of aortic heart valve calcification is entirely dependent on surgery as there is currently no cure. In particular, elderly patients have a high risk of death during surgery, and there is a problem that reoperation should be considered every 10 years. If the oral drug Suganon completes clinical trials in Korea and the United States and succeeds in commercialization. High marketability is expected if commercialization is successful. Rednvia is known to be examining the discovery of a combination drug candidate targeting fibrosis in order to develop Suganon as a treatment for not only aortic heart valve calcification, but also non-alcoholic steatohepatitis (NASH).
