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- 2026-05-20 02:51:16
- Policy
- Nicobreak ODF was approved for the first time in Korea
- by Lee, Tak-Sun Apr 16, 2021 06:02am
- CTC Bio's'Nicobreak ODF', a smoking cessation treatment that melts and eats, was approved for the first time in Korea. this. This product has been confirmed to be equivalent to the existing Champix (Varenicline, Pfizer), which is the same ingredient product. The Ministry of Food and Drug Safety approved two items of Nicobreak ODF1mg/0.5mg of CTCBIO on the 13th. This product is a varenicline, such as Pfizer's Champix, and is used as an adjuvant therapy for smoking cessation. In particular, this drug is the first ODF formulation in Korea that can be dissolved with the tongue without water. Conventional Varenicline tablets should be swallowed with water. Patients with difficulty swallowing or refusal to rehydration feel uncomfortable with the tablets. ODF formulations are expected to increase ease of use by covering the disadvantages of these tablets. After a smoking cessation date is set, this drug should be administered one week before the designated date. Smoking can be started within 35 days from the 8th day after the drug administration. For 1~3 days, 0.5mg once a day, 4~7 days 0.5mg twice a day, 1mg twice a day until the end of the administration after the 8th day. Champix ▲ Pfizer's anti-smoking treatment This drug has been compared to Champix to confirm its equivalence. As a result of measuring the plasma concentration of varenicline in 28 healthy adults taking THIS DRUG and Champix, it was demonstrated that the 90% confidence interval of the mean difference was bioequivalent from log 0.8 to log 1.25. Nicobrec's oral melting film is also different from Champix' salt. This drug differs from Champix's tartrate because it has salicylate. Champix's sales based on IQVIA last year were 20.7 billion won, and it is 10 billion blockbuster drugs despite the decrease in the number of nationally supported smoking cessation. Equivalence check with Champix CTCBIO Nicobreak ODF, a dissolving smoking cessation treatment, succeeded in obtaining approval for the first time in Korea. This product has been confirmed to be equivalent to the existing Champix (Varenicline, Pfizer), which is the same ingredient product. On the 13th, the Ministry of Food and Drug Safety approved two items of Nicobreak ODF 1mg/0.5mg of CTCBIO. This product is a varenicline, such as Pfizer's Champix, and is used as an adjuvant therapy for smoking cessation. In particular, this drug is the first ODF formulation in Korea that can be dissolved with the tongue without water. Conventional Varenicline tablets should be swallowed with water. Patients with difficulty swallowing or refusal to rehydration feel uncomfortable with the tablets. ODF formulations are expected to increase ease of use by covering the disadvantages of these tablets. After a smoking cessation date is set, this drug should be administered one week before the designated date. Smoking can be started within 35 days from the 8th day after the drug administration. For 1~3 days, 0.5mg once a day, 4~7 days 0.5mg twice a day, 1mg twice a day until the end of the administration after the 8th day. This drug has been compared to Champix to confirm its equivalence. As a result of measuring the plasma varenicline concentration of 28 healthy adults taking THIS DRUG and Champix, a 90% confidence interval of the mean difference was within log 0.8 to log 1.25, demonstrating bioequivalence. Nicobreak ODF is also different from Champix' salt. This drug differs from Champix's tartrate because it has salicylate. Champix's sales based on IQVIA last year was 20.7 billion won, which is a 10 billion blockbuster drug despite the decrease in the number of nationally supported cessation cessation applicants.
- Opinion
- [Reporter's view]Controversy over Novavax vaccine
- by Lee, Tak-Sun Apr 16, 2021 06:02am
- The government explained that the Novavax COVID-19 vaccine, which had signed a technology transfer contract with SK Bioscience on the 12th, could be supplied as soon as possible in June. The release of this announcement raised controversy over the introduction of the Novavax vaccine, which has not yet been licensed abroad. Eventually, the conservative opposition party criticized using the people as clinical maruta. As the controversy continued, the government was controversial over the introduction of the ax vaccine before approval the day after the announcement. The government explained that the Novavax COVID-19 vaccine, which had signed a technology transfer contract with SK Bioscience on the 12th, could be supplied as soon as possible in June. The release of this announcement raised controversy over the introduction of the Novavax vaccine, which has not yet been licensed abroad. Eventually, the conservative opposition party criticized using the people as clinical subject of experiment. As the controversy continued, the government refuted the day after the announcement that it had never considered pre-licensing the Novavax vaccine. After reading this controversial article, I couldn't help but laugh. It is not possible at all for Korea to introduce a vaccine developed abroad first. There has not been a case of using overseas drugs developed first under the approval of Korean health authorities. All drugs can be sold only after obtaining approval from the MFDS. The same goes for vaccines. However, the MFDS has so far required to attach a certificate of manufacture and sale of the exporting country when applying for a new drug for import. This is to refer to the case of approval of the exporting country. In early April, the MFDS revised the regulations so that the approval results from exporting countries are not attached when applying for a permit for biological products such as vaccines. The reason is that the MFDS can also be independently screened. According to the regulations, domestic permits were possible without the need for overseas approval. However, there is no possibility that an overseas development company such as Novavax will first apply for a license in Korea instead of in large markets such as the US or Europe. SK Bioscience, which has transferred the technology, can also be approved if it has data from a clinical trial conducted by Novavax. Prior to application for overseas approval, clinical trial results are not shared with other companies in which the technology has been transferred. Among the COVID-19 vaccines, the only basis for the special import of Pfizer vaccine was the case of overseas approval such as the United States and Europe. In order for Novavax vaccine to be introduced in Korea before overseas approval, Novavax should prioritize the small market in Korea, and health authorities or experts must approve the introduction of the vaccine without referencing overseas approval. It is unlikely that this will happen. Health authorities are conservative. If safety or effectiveness is uncertain, it will not be introduced. The safest way is to consult foreign cases, especially FDA or EMA. Pfizer and AstraZeneca vaccines will be the same, and will be introduced in the future. Through this controversy, I feel that the media and politics are too concentrated on the success or failure of the government vaccine introduction. Anyway, in a situation where vaccine development with our technology has not been made, it is inevitable to be attracted to foreign companies. Japan, which has a lot of Big Pharma, does not have a vaccine developed in-house, so it is the same situation as Korea. Accordingly, the timing of the introduction and the overall supply and demand issue are uncertain. It seems pointless to question whether the policy is successful or not. The government should also be honest about the current situation and demand patience from the people. The media should also not criticize the government's policy of introducing vaccines. And we have to reflect on why we didn't make the vaccine on time.
- Company
- Celltrion-Icure applied for permission for Donepezil patch
- by Chon, Seung-Hyun Apr 16, 2021 06:02am
- Celltrion announced on the 13th that it has applied to the MFDS for an item license for the “Donerion patch” for the treatment of Alzheimer's dementia jointly developed with Icure. Donerion patch (Donepezil) is a product jointly developed by bio-venture Icure and Celltrion. In June 2017, after Icure developed and completed the non-clinical and phase 1 clinical trials, it signed a joint domestic copyright contract with Celltrion. Together with Icure, we conducted phase 3 clinical trials in about 400 patients with mild and moderate dementia in 4 countries including Korea, Taiwan, Australia, and Malaysia. Donerion patch is an IMD developed by attaching the oral Donepezil once a day twice a week. Compared to oral drugs, it is evaluated as a product that improves medication compliance and improves convenience. Donepezil is the original medicine by Eisai's Aricept. Celltrion said, "Donepezil is currently only commercialized for oral administration due to the difficulty in formulation development. If the Donerion patch is approved by the Ministry of Food and Drug Safety, it will become the world's first Donepezil patch." Both companies are aiming to commercialize next year after acquiring an item license. The clinical phase 3 of the Donerion patch was conducted for a total of 24 weeks in patients with mild and moderate Alzheimer's dementia. Oral Donepezil or Donerion patch was administered by dividing into a group taking oral Donepezil 5 mg or 10 mg and a group who had never taken Donepezil. Donepezil for oral administration by setting the Alzheimer's Disease Assessment Scale–Cognitive Subscale (ADAS-cog), a representative standard tool for dealing with memory, language, reconstruction, behavior, and mentality, as a primary efficacy endpoint in mild and moderate Alzheimer's Contrast the Donerion patch proved its non-inferiority. The non-inferiority of the Donerion patch compared to the oral Donepezil was also confirmed in the secondary efficacy endpoints CIBIC-plus, MMSE, CDR-SB, and NPI, which were additionally set to comprehensively evaluate the drug effect in terms of both cognitive and functional improvement. did. Donepezil is the most commonly prescribed ingredient in Alzheimer's dementia treatments. According to UBIST, a drug market research organization, Donepezil accounts for about 30 billion won, 80% of the domestic sales of Alzheimer's dementia treatments in 2020, of about 290 billion won. A Celltrion official said, "As Donerion was developed as the world's first Donepezil patch, it is expected to enter the market quickly with competitiveness differentiated from existing formulations if it obtains approval from the MFDS by improving patient convenience."
- Company
- Vyndamax tries RSA after failing essential drug designation
- by Eo, Yun-Ho Apr 15, 2021 05:56am
- Once again, attempts are in progress to receive reimbursement for 'Vyndamax,' a new drug for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM). Industry sources said that Pfizer Korea had recently submitted an application for the reimbursement of its new ATTR-CM drug, Vyndamax (tafamidis 61mg). This time, the company conducted the PE assessment and aims to receive reimbursement through the risk-sharing agreement (RSA) scheme. After failing to receive designation as an essential drug earlier this year, the company has quickly supplemented the data to try for reimbursement once again, which shows the company’s determination to be listed for reimbursement. So once again, the industry is keenly eyeing whether Vyndamax, virtually the only ATTR-CM treatment option available in Korea, may finally list its name on the benefits list. Compared to Vyndaqel (tafamidis 20mg), which was listed in October 2018 for the treatment of the hereditary transthyretin amyloid polyneuropathy (ATTR-PN) and therefore targets a very small number of patients, Vyndamax’s indication for the treatment of ATTR-CM includes patients with both hereditary and the wild-type form associated with aging and therefore has a high prevalence. So, these many patients, who have this fatal disease that has a survival period of 2 to 3.5 years without treatment, are currently left unattended as ATTR-CM is known as a disease with a poor treatment performance due to the lack of available treatment options and is commonly mistaken for simple heart failure. However, the efficacy of Vyndamax was demonstrated through the Phase III ATTR-ACT study by reducing the number of cardiovascular events in patients and improving functional athletic ability in the six-minute walk test. Based on the findings, healthcare professionals in Korea are stressing the need to prescribe Vyndamex. As it is a fairly expensive drug, the determination and will of the government and the pharmaceutical company may play a crucial role in the listing. As Pfizer showed the effort to conduct the PE assessment despite its difficult situation demonstrating the drug’s cost-effectiveness, expectations are rising that the two sides will be able to reach an agreement. In the ATTR-ACT study, 441 patients were randomly assigned in a 2:1:2 ratio to receive 80 mg of tafamidis, 20 mg of tafamidis, or placebo. The primary endpoint of the study was hierarchically assessed all-cause mortality, followed by frequency of cardiovascular-related hospitalizations. The secondary endpoint of the study was a change in the 6-minute walk test from baseline to month 30 and the score on the 'Kansas City Cardiomyopathy Questionnaire-Overall Summary (KCCQ-OS),' in which higher scores indicate better health status. Study results showed that all-cause mortality and cardiovascular-related hospitalizations rates were statistically significantly lower in patients who received tafamidis than those who received placebo.
- Policy
- SK's Cosca 25mg was first approved
- by Lee, Tak-Sun Apr 15, 2021 05:56am
- SK Chemical introduces generic for Losartan 25mg earlier than the original. At one time, SK Chemicals had the experience of selling delegated generics of the original Cozaar, so it is drawing attention. On the 14th, the MFDS approved SK Chemical's Cosca25mg (Losartan potassium). Losartan potassium 25mg has been widely used, but it has not been approved so far. Originally, only Cozaar (MSD) 50mg and Cozaar (MSD) 100mg, which are representative products, are available. However, Cozaar (MSD) 25mg is used a lot in certain age groups as an initial dose. For example, Cozaar 25mg is recommended as an initial dose for the elderly over 75 years, dialysis patients, children and adolescents over 6 years old, and patients with excessive blood pressure reduction. Until now, Cozaar 25mg was not available, so Cozaar 50mg had to be split in half for the first dose prescription for that age group. This is uncomfortable for pharmacists when dispensing them, and there is a risk of contamination. The reason why this product is attracting attention is also that SK Chemicals sold entrusted generics through co-marketing with MSD in the past. SK chemicals received products from MSD Korea from 2008 to 2012 and sold them under Cosca. It was delegated generic for Cozaar. However, the partnership was ended in 2012, and after that, through a change of license, the company's factory is producing generics that have been verified to be equivalent to the original. It became a competitor to MSD. Cozaar and Cosca are long-established drugs among ARB-based hypertension drugs. Since many new drugs of the same series have been released so far, sales have decreased significantly compared to the initial release. Based on UBIST last year, Cozaar recorded ₩27.9 billion and Cosca recorded ₩3.4 billion. Before the release of generics, Cozaar exceeded ₩70 billion, and Cosca was the only generic over ₩10 billion. It is noteworthy whether SK Chemicals will recover Losartan's past sales through this product.
- Company
- Measures for the reimbursement of advanced therapies
- by Apr 15, 2021 05:56am
- The release of the CAR-T treatment ‘Kymriah (tisagenlecleucel)’ in Korea was met with both anticipation and concerns. The drug itself is undeniably an innovative drug that can offer new opportunities to blood cancer patients with short life expectancy. However, the challenge lies in how this innovative new drug that costs 500 million won per dose should be listed for reimbursement in Korea’s healthcare system. Clearly, these advanced drugs cannot be evaluated under the same standards as existing drugs. The development trend of new drugs has already shifted towards the treatment of severe or rare diseases, and gene and cell therapies that combine new science and technology occupy a large proportion of development. Therefore, a new model that may reasonably evaluate the price of ultra-expensive drugs is necessary to accommodate the changing environment. Then, what limitations and changes has the industry seen and desired in Korea’s reimbursement environment? To hear the voices in the field, Dailypharm held its 41st Pharmaceutical Industry Future Forum, "Finding the correct solution for the ultra-expensive drug listing system," at its Moonjeong-dong office. Dr. Hyung-Ki Lee, Professor of Clinical Pharmacology and Therapeutics at the Seoul National University Hospital, chaired the event. Also, various industry and government officials including Kyung-Ho Choi, Deputy Director of the Division of Pharmaceutical Benefits at the Ministry of Health and Welfare; Min-Young Kim, Director at Korean Research-based Pharma Industry Association (KRPIA); Hyeon-Seok Na, Senior Manager at JW Pharmaceutical Corp.; and Jae-Ho Jeong, Department Head at Novartis Korea attended the event to share their views on the matter. (from the left) Dr. Hyung-Ki Lee, Professor of Clinical Pharmacology and Therapeutics at the Seoul National University Hospital; Kyung-Ho Choi, Deputy Director of the Division of Pharmaceutical Benefits at the Ministry of Health and Welfare; Min-Young Kim, Director at Korean Research-based Pharma Industry Association (KRPIA); Hyeon-Seok Na, Senior Manager at JW Pharmaceutical Corp.; and Jae-Ho Jeong, Department Head at Novartis Korea attended Dailypharm’s 42nd Future Forum. ◆'Advanced therapies that cost hundreds of millions of won may deliver value beyond their cost = Kymriah was tagged as an ‘ultra-expensive' drug as its single injection costs 500 million won. However, Jae-Ho Jeong, Department Head at Novartis Korea, expressed his opposition to the view. Unlike conventional drugs that should be taken annually or on a regular cycle, one can expect a full cure with a single injection of Kymriah, which ultimately would reduce the total cost invested in treatment. “We need to consider whether Kymriah is really an ultra-expensive drug from the financial aspect,“ said Department Head Jae-Ho Jeong. “Other orphan drugs that cost 400–500 million won per year are also listed as reimbursement. The only difference is, with Kymriah, one can expect to reach complete remission with a single injection.” He added, “The value of Kymriah lies in that it can provide the return to daily lives for patients who were non-responsive to existing treatments and therefore left with only several months of to live at most. We need to reconsider drawing the line just because a drug is expensive.” In fact, Kymriah achieved complete remission (CR) in 82% of the young adult and pediatric patients with acute lymphoblastic leukemia (pALL) within 3 months of its administration. The patients were relapsed and refractory patients with a life expectancy of only 6 months. Emily, a pediatric patient who participated in the first trial of Kymriah, is currently living a normal life after receiving Kymriah 9 years ago. Like Kymriah, advanced therapies such as CAR-T cell therapies and gene replacement therapies allow patients to dream of the long-awaited ‘cure.’ ‘Zolgensma,’ a gene replacement therapy, can cure the rare disease spinal muscular atrophy (SMA) with a single dose. ◆The need for a personalized reimbursement system = Rather than introducing a completely new system, industry experts have suggested implementing measures that may allow for more flexible use of the existing system, in other words, a personalized reimbursement system. KRPIA director Min-Young Kim referred to the U.K. as an example. For rare diseases that are chronic, severely disabling, and require life-long treatment, the U.K.’s Highly Specialised Technologies (HST) evaluation system weighs the quality-adjusted life-year (QALY) gain and allows a QALY index of 3 if the gain is 30 QALY or more. Also, the Patient Access Scheme (PAS) and Confidential Commercial Arrangement (CCA) implements a kind of risk-sharing system for drugs that have not been able to receive an ultimate value judgment from NICE or drugs with a large difference in ICER due to different health benefits per drug or indication. Also, a Cancer Drug Fund (CDF) system provides funding for oncology drugs that are not recommended by NICE for reasons of clinical uncertainty during the drug's data collection period “Like the U.K., Korea also needs segmentized, personalized policies so as to provide the opportunity for a full cure to patients with severe rare and incurable diseases,” said Kim. He continued, “In terms of patient accessibility, we may consider using systems like the ‘pre-listing post-evaluation' system. Financial uncertainty can be resolved by collecting information on the use amount based on real-world data during the pre-listed period, and then evaluating once the period is over. Also, customized systems that price drugs by indication or the trade-off system may also be used.”
- Policy
- Moderna's COVID-19 vaccine has been applied for approval
- by Lee, Tak-Sun Apr 15, 2021 05:56am
- Moderna's COVID-19 vaccine has begun to be approved in Korea. If Moderna vaccine is approved, it will be the fourth vaccine after AstraZeneca, Pfizer and Janssen vaccines. The MFDS announced on the 12th that GC Pharma has applied for approval as an import item for COVID-19 vaccine from Moderna in the US. Moderna vaccine is one of the vaccines announced by the government and was developed in a two-doses (28 days apart). It is the same platform as Pfizer’s Comirnaty, which is approved in Korea as a 'mRNA vaccine' that induces an immune response by injecting the antigenic gene of COVID-19 in the form of mRNA to generate antigenic protein in the body. The government announced that it signed a supply contract for 20 million people with Moderna in January. The MFDS carefully reviews the submitted quality, non-clinical, clinical, and GMP data, and undergoes triple consultation from the COVID-19 vaccine safety and effectiveness verification advisory group, the Central Pharmaceutical Affairs Review Committee, and the final inspection committee to ensure the safety and effectiveness of the product. It said that it was going to check whether or not to grant permission. Meanwhile, Moderna vaccine has been Emergency Use Authorization in the United States and the United Kingdom, and CMA has been required to submit additional data after approval in the European Union (EU), Canada, and Switzerland. An official from the MFDS said, "We will do our best to ensure that safe and effective vaccines are quickly supplied to our people in the future."
- Opinion
- [Reporter's view] Expensive vaccine sovereignty
- by Apr 15, 2021 05:56am
- The cervical cancer vaccine is Gardasil 9, and the rotavirus vaccines RotaTeq and Rotarix. Vaccines that are considered essential vaccinations, but consumers are less accessible. Foreign pharmaceutical companies are raising prices all at once. Gardasil 9 and RotaTeq's supply prices rose by 15% and 17%, respectively, from this month. RotaTeq will also become about 12% more expensive from next month. As supply prices rise, consumer vaccination prices also rise. Already, some hospitals are demanding additional costs from consumers who have made a prepayment. Gadasil 9 is already a vaccine that was burdensome at ₩450,000~600,000. Since 2016, women and adolescents aged 12 have been vaccinated free of charge for cervical cancer, but men and women born before 2003 have to get the vaccine at their own expense. Parents who have to give their newborns the rotavirus vaccine are also feeling not good. Due to the increase in supply prices, most hospitals have increased their vaccination prices since April, resulting in an average increase of 50,000 to 60,000 won for parents. Rotavirus vaccine is considered an essential vaccine for newborns, but in Korea it is not included in the national vaccination (NIP) program, so it is unconditionally non-reimbursement benefit. It should be inoculated with. The price of cervical cancer and rotavirus vaccines are rising, which is causing consumer dissatisfaction. In the case of Gardasil 9, even a national petition against the price increase appeared. There is a growing recognition that the cervical cancer vaccine is a vaccine that men as well as women should get. MSD Korea, a manufacturer, also announced the need for male vaccination by using male comedians such as Jo Se-ho and Yoo Byung-jae as advertising models. It is unreasonable to pay more than ₩600,000 and hope that the male vaccination rate will increase. Unfortunately, there is no basis for restricting pharmaceutical companies from raising the price of non-paid items. However, from the perspective of public health, the nation can expand NIP and support localization of vaccines. The former is the most obvious way to directly reduce the cost of the public, but the fiscal burden is high. In addition, the former has a problem that it is not possible to make a virtuous cycle in domestic demand because the invested finances go only to foreign companies. There is also an indirect method of inducing price cuts by increasing supply by supporting commercialization of domestic vaccines. Of course, it is difficult to predict how much the price cut effect will be in the market, but when a domestic vaccine is released, supply and demand and management are more stable. This is the same opinion as the government that it will secure'vaccine sovereignty' by increasing the self-sufficiency rate of domestic vaccines. Currently, both cervical cancer vaccines and rotavirus vaccines are only products from multinational pharmaceutical companies, so there is no way to deal with them even if prices rise or sell out. It is necessary for the government to make active efforts so that a domestic vaccine can appear as soon as possible and help improve the health rights of the people.
- Company
- “The framework to list ultra-expensive new drugs exists"
- by Eo, Yun-Ho Apr 14, 2021 06:07am
- We are living in an era where a single injection may completely cure cancer. The catch is that the 'single dose' would cost 500 million won. Such ultra-expensive advanced new drugs are not an item of our dreams – it is already within our reach. In addition to the CAR-T (Chimeric Antigen Receptor T cells) therapy Kymriah (tisagenlecleucel) that was approved in Korea, dozens of other gene therapy and cell therapy candidate drugs are also under development, some of which are being developed by domestic biopharmaceutical companies. The regulatory authorities have also passed the ‘Act on Safety and Support for Advanced Regenerative Medicine and Advanced Biopharmaceuticals’ in 2019 to reflect the changes in the new era. However, for these paradigm-shifting advanced medicines that overturn the existing concept of drug therapy to be used in real life, the lingering issue of their ultra-high ‘drug price’ needs to be resolved. How should the company that wants rightful compensation for the innovation, and the government that needs to take care of the public’s health with a limited budget, reach a consensus on the matter? Professor Hyung Ki Lee, SNUH In search of the answer, government and industry officials gathered at the 41st Pharmaceutical Industry Future Forum, "Finding the correct solution for the ultra-expensive drug listing system," held by Dailypharm at its Moonjeong-dong office. Dr. Hyung-Ki Lee, Professor of Clinical Pharmacology and Therapeutics at the Seoul National University Hospital, chaired the event. Various industry and government officials including Kyung-Ho Choi, Deputy Director of the Division of Pharmaceutical Benefits at the Ministry of Health and Welfare; Min-Young Kim, Director at Korean Research-based Pharma Industry Association (KRPIA); Hyeon-Seok Na, Senior Manager at JW Pharmaceutical Corp.; and Jae-Ho Jeong, Department Head at Novartis Korea participated as panelists for discussion. ◆ Now is the time to fully implement the Pre-listing Post-evaluation system = The key to pre-listing and post-evaluation is ‘speed.’ The system allows drugs to skip the deliberation on the appropriateness of reimbursement and be listed first, then decide whether to continue its reimbursement by evaluating the efficacy, use amount, etc. based on real-world data. The system would speed up the listing process, however, it may also cloud the transparency of the process. People are voicing concerns about whether the cancellation mechanism of already-listed drugs would definitely work, and whether the patients will be able to accept the reimbursement discontinuation of drugs they have been taking. There also lies the controversy over the method of accumulating RWD or RWE data and its and reliability. Officer Kyungho Choi, MOHW At the event, Deputy Director Choi said, “The ‘continuity of care’ issue of pre-listing post-evaluation drugs cannot be ignored from the government’s perspective. There are problems such as difficulties in adjusting drug prices when the pharmaceutical companies do not accept the evaluation results, as well as the issue of the system weakening the drug negotiation power of NHIS.” However, the industry had a strong aspiration to implement the system as a means to ‘introduce ultra-expensive drugs to Korea.’ Of the three industry panelists that participated in the forum, KRPIA director Min-Young Kim, and Novartis's Departement Head Jae-Ho Jeong pointed to the pre-listing post-evaluation system as the top priority solution. Kim explained, “The system can be well-managed. We already have had experienced similar cases like ‘Evoltra,’ the first therapy to be listed under the Risk Sharing Agreement (RSA). The government was unable to evaluate the cost-effectiveness of Evoltra at the time of its listing, and the drug was listed under conditional coverage with evidence development. After 4 years, the company underwent data collection and a re-evaluation process maintains its reimbursement.” “The pre-listing post-evaluation system needs to be accepted as a type of RSA. The industry has long conducted negotiations and signed agreements with HIRA and NHIS for the stable supply of its products," added Jeong. "The government should show some trust based on its accumulated experience with the companies. The potential risks and countermeasures can be discussed while conducting a pilot project.” Executive Director Minyoung Kim, KRPIA The government has consistently maintained a conservative attitude on implementing the pre-listing post-evaluation system. However, at the forum, MOHW did not rule out the possibility of implementing such a system. Deputy Director Choi said, “I agree that now is the time to seriously consider the implementation of such systems. If the industry proposes a detailed action plan, we will review the plan with HIRA and NHIS. However, one thing that I hope the industry also bears in mind is that the continuity of care is not an issue that impacts the listing or delisting of a single drug product; It is an issue that needs to be considered collectively for the sustainability of NHI finances.” ◆ Considerations on ‘cost-effectiveness,’ the first criteria considered in drug evaluations = Cost-effectiveness is central to Korea’s reimbursement listing system. Industry officials agree that is an essential criterion for the system while pointing out that too much stress is being laid solely on cost-effectiveness. In addition to cost-effectiveness, the Principles on Determining Eligibility of Long-term Care Benefits list factors such as medical significance (clinical utility) and social benefits as factors for consideration. However, industry officials say that these other factors are not sufficiently reflected during reimbursement evaluations. At the forum, Director Hyeon-seok Na from JW Pharmaceutical Corp. said, “The industry does feel that the government is too focused on cost-effectiveness. Such focus on cost-effectiveness would lead so many drugs to be not approved for reimbursement listing. We hope that the weight of other factors such as social benefit should be increased” Senor Manager Hyeon-seok Na, JW Pharm. Professor Hyung-Ki Lee who chaired the event added, “This reminds me of a paper published by HIRA. It was a 2006 study that tracked the standards used by HIRA in deciding reimbursement for drugs. Results showed that drugs that had lower prices were listed and at a faster rate than those with high clinical utility.” Cost-effectiveness is a staple topic in the discussion of improving the domestic drug reimbursement system. The difficulty in demonstrating cost-effectiveness leads to requests for improving the ICER threshold and the exemption of PE assessment. On this, the government’s response is that considerations of cost-effectiveness are just a matter of order. “The government does not solely focus on cost-effectiveness in the reimbursement decision-making process. For a drug to receive reimbursement, it first needs to prove its clinical utility,” said Choi. ”Only drugs that are determined to be clinically effective are then evaluated for their cost-effectiveness. The strict evaluation criteria may be worth discussing; however, it does not mean that we have had made no efforts to resolve the issue.”
- Company
- Generic for Eliquis, stop selling after supreme court loss
- by Kim, Jin-Gu Apr 14, 2021 06:07am
- Eliquis (Apixaban)’s generic companies stop selling one after another. This is a strategy after the Supreme Court ruled in favor of the original company BMS in the Eliquis patent dispute. This is a measure to reduce the risk even a little in preparation for future lawsuits for claiming damages. According to the pharmaceutical industry on the 13th, Chong Kun Dang, Yuhan Corporation, Samjin Pharm, and Hanmi Pharm, which are selling Eliquis generics, have either stopped or stopped selling the product. An official from a company selling generics said, "We have already stopped selling them." An official from another pharmaceutical company also said, "We are actively considering a plan to stop the sale." Another pharmaceutical company official, whose sales performance of generics is not large, said, "We will follow the choices of other companies." The reason they stop selling is because of the burden of a lawsuit for damages in the future. Claims for damages are proportional to product sales. This is because the more sales, the more compensation. In preparation for this, the sale is stopped in an effort to reduce the amount of compensation even a penny. BMS officially announced a claim for damages immediately after the Supreme Court ruling. Korea BMS Pharmaceutical CEO Kim Jin-young said, "As the validity of the Eliquis patent has been confirmed, we will take all possible legal actions, including claims for damages, for any act that infringes on the patent." ◆"The amount of damages will be less than the actual sales. Fierce legal disputes expected" In the pharmaceutical industry and the legal community, damage compensation is expected to be calculated less than the actual sales of generic products. According to the drug market research institute UBIST, the cumulative combined prescription amount of generic items is a little less than 10 billion won as of the end of last year. Since its launch in July 2019, it has been prescribed 1.2 billion won that year and 8.3 billion won last year. By item, Chong Kun Dang Liquisia 3 billion won, Samjin Pharmaceutical Elxaban 1.8 billion won, Yuhan Apixaban 1.3 billion won, etc. Typically, the amount of damages due to patent infringement is determined from operating profits, not from sales of the generics. This is because the'profit' obtained as a result of patent infringement is calculated as the amount of compensation. However, it goes through a very complicated calculation process as to how much the actual profit will be viewed. For example, raw material prices are generally excluded from damages. If the generic had not been released, the raw material would not have been bought, so it is subtracted from the damages. An official in the legal profession said, "Other items are added or subtracted from the calculation of damages," and "Another legal dispute between BMS trying to receive even a penny more in relation to the calculation of damages and a generic company trying to reduce even a little will develop very fiercely." . Generic companies are also preparing for destruction and repatriation along with the suspension of sales. This is because the legal battle has not yet ended. Earlier, the Supreme Court remanded the case to the Patent Court while making a decision on the side of BMS. In general, the remand of revocation is based on the judgment of the superior judge. However, if a new allegation is raised at the remand of revocation trial, the opposite decision may be made. Accordingly, generic companies are looking for new logic to deny Eliquis' material patent.
