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- 2025-12-24 13:21:13
- Policy
- Chloroquine was approved for export due to COVID-19
- by Lee, Tak-Sun May 26, 2020 06:06am
- #iUnder the influence of COVID-19, the approval of Chloroquine for export used as a therapeutic agent has been followed. It seems that domestic pharmaceutical companies are targeting overseas exports and making items due to the worldwide pandemic phenomenon. According to the MFDS on the 25th, permission to Chloroquine and Hydroxychloroquine for export reached 12 items in five companies this year. Starting with Korea Prime Pharm, on the 4th, CTC Bio, Korea United Pharm, Ahngook Pharm, and Unimed have obtained export licenses. They seem to have been granted permission for the purpose of developing and exporting formulations by importing raw materials from overseas. An industry official said, "The MFDS' export permits simply by the documentation." Countries that require Chloroquine will be licensed for export, and later approved by local countries. " In Korea, 27 items have already been approved, so there is no problem with the supply and demand of Chloroquine. However, companies believe that there is a high likelihood of a treatment gap in a sudden infectious disease abroad, especially in developing countries. Chloroquine has been used since the early days of COVID-19 along with Kaletra ( Lopinavir + Ritonavir), an AIDS treatment, and is in high demand as it is encouraged in some countries. Although this agent is used for the treatment and prevention of malaria, it is used as the primary treatment for COVID-19 in the medical field. In Korea, the Central Clinical Committee recommends Chloroquine as a standard treatment through literature review, and thus Hydroxychloroquine is used. However, there is a controversial situation about the actual effect. Trump believes Hydroxychloroquine could be a "game-changer" against the coronavirus, there are reports that the death rate has increased. On the other hand, other studies have shown that there are few side effects and there is an actual effect of preventing COVID-19. Nevertheless, it is an analysis that demand from overseas countries is increasing. PMG Pharm decided to export about 2 million dollars worth of Hydroxychloroquine to South America. CTC Bio, which has been granted permission for export, said, "The global demand has surged, so there are a lot of needs in existing countries as well as in overseas customers." It is known that domestic pharmaceutical companies are considering exporting not only Chloroquine, but also generic for Kaletra. Kaletra, in particular, has opened up opportunities for generic companies as Abbvie, the original developer, abandoned the patent. It is said that some domestic companies are currently pursuing export licenses while importing raw materials from India and developing formulations.
- Policy
- Will Vyleesi known as Viagra for women be released?
- by Lee, Tak-Sun May 26, 2020 06:05am
- A product known as Viagra for Women conducts clinical trials in Korea. It is Vyleesi (Bremelanotide, injection type) introduced by Kwangdong Pharmaceutical. The MFDS approved a clinical trial phase III bridging study plan by Kwangdong Pharmaceutical on the 22nd. Bridging study is a test to prove whether new drugs developed in foreign countries have the same effect on Korean people. Vyleesi conducted a phase III clinical trial in 1,267 premenopausal women who were diagnosed with underactive sexual desire disorder in the United States after being approved by the US FDA in June last year. At the time, the clinical results showed an effect in improving sexual desire and reducing pain associated with low sexual desire. The clinical trial will verify whether this effect is the same for domestic patients. The domestic patient population is 146, and is limited to pre-menopausal women with or without hypoactive sexual desire disorder (HSDD). The clinical trial will be conducted at Korea University Hospital in Seongbuk-gu. In 2017, Kwangdong Pharmaceutical signed a license agreement with Palatin Technologies, an American developer of Vyleesi, and obtained a sales right in Korea. The drug is a disposable pen-type subcutaneous injection, which is self-administered medication. The company has passed the bridge study and aims to release it in Korea around 2022. An official from the company said, "We expect Vyleesi to greatly contribute to improving the quality of life for women."
- Policy
- Virtual academic conferences consider e-booth as alternative
- by Kim, Jung-Ju May 25, 2020 06:26am
- Corporate booth participating in an offline academic conference (Source: Daily Pharm DB) Academic conferences in Korea are going through changes as many of academic events around the world are either canceled or postponed amid COVID-19 outbreak. While the medical experts predict the outbreak would not end anytime soon, a number of medical academia have either convened virtual conference or are planning on one to replace their offline conference. But as the regulations related to virtual conferences are not yet specified, the government, pharmaceutical industry and the affected academic societies have decided to revise the relevant regulations. On May 20, officials from the government, industry and academic societies held a press conference and announced the regulations would be amended within this month for the fall conferences to refer to. According to Ministry of Health and Welfare (MOHW), the current Fair Competition Agreement only stipulates offline sponsorship of academic conference by pharmaceutical companies, which does not reflect the recent circumstances. In fact, Korean Diabetes Association has already conducted an online conference, but the pharmaceutical company sponsorship was not properly managed by the relevant regulation. Medical academic conferences are essential events to share the latest medical findings and to educate healthcare professionals. Pharmaceutical and medical device companies make significant financial contribution to the conferences as they use the events to showcase their products in development or latest clinical outcomes through presentations by medical professionals. The academic societies spend the most on labor, venue rental, food and beverage and other out-of-pocket costs, which were usually covered by the companies’ donation, advertisement fee and incidental expenses. Regardless, from now on virtually formatted events would be more sought after as recently the conventional offline conferences have been restricted amid COVID-19 outbreak. The shift in the format of local and international conferences would inevitably result in change in method of sponsorship. The most mentioned method of sponsorship is virtually provided ‘e-booth.’ Already the pharmaceutical companies are inquiring their associated organization about the feasibility of sponsorship through e-booth and relevant method and level of contribution. The Korean government and industry officials elaborated, under the code of Fair Competition Agreement set by the Fair Trade Commission, the healthcare product suppliers are supposed to receive approval on the academic conference sponsorship, but the details on online sponsorship is still ambiguous. Meanwhile, MOHW, medical industry and pharmaceutical and medical device industry organization have recently established ‘Revised Academic Conference Sponsorship Standard’ to ban redundant sponsorship of providing donation and other advertisement fee and incidental expense. In other words, the advertisement fee and incidental expense can be provided if the company does not give donation. Medical academia “Confusion may get worse for the fall conferences without regulatory preparation” Academic societies struggling with offline conferences now fear the sluggish preparation of online event sponsorship regulation would eventually delay the fall conferences and cause turmoil. Korean Society for the Study of Obesity (KOSSO), for instance, is organizing an international conference in coming September. But it is now greatly challenged with inviting foreign speakers. The societies urge more attentions are also needed for international conference as well. KOSSO official commented with concerned voice that “The government should acknowledge the online attendance and quickly establish regulation on virtual or video conference, or even consider temporarily alleviating related regulations,” if not, “the academic societies would experience confusion with the conference management until next year.” Korean Academy of Medical Sciences is having similar concerns. The academy noted, “If the COVID-19 would continue to affect fall conferences, the academic societies would experience a massive confusion,” and “the societies are even considering on opening an option of ‘double booth.’ Also, we are expecting the government to allow banner and in-stream ads spots as well as sponsored product introduction time for the virtual conference.” Pharmaceutical industry “Needs to quickly work on long-term plan,” and Government “Newly revised regulation would be available next month” Regarding the situation, the pharmaceutical industry representatives firmly stated relevant regulation should be established as soon as possible, however, they should be constructed in efficient and reasonable fashion. Korea Pharmaceutical and Bio-pharma Manufacturers Association (KPBMA) official said, “We are getting endless inquires from the member companies. As sponsoring the academic conference is integral in sharing the latest developments and findings to healthcare professionals, it should be provided in any form or style,” and “the organization would closely cooperate on figuring out the feasible form of alternative sponsorship and appropriate level of the sponsorship.” Korean Research-based Pharmaceutical Industry Association (KRPIA) officials also stated, “We have task force discussing the matter in-depth. The organization is closely collaborating with the government to stipulate operating virtual booth and to work on other essential details through the Fair Competition Agreement,” and “We expect the discussion to efficiently build the framework for alternative sponsorship that can minimize the impact of COVID-19 on academic activities.” Accordingly, the government, medical industry and supplier organizations have recently convened a meeting and agreed on the necessity of the online conference sponsorship regulation. The meeting also concluded that another meeting should be convened early next month to finalize the amendment to the regulation. MOHW official said, “Based on the prospective that Post-Corona Era would prefer holding local and international conferences virtually, everyone agreed online sponsorship like ‘e-booth’ should be deliberated.” The official added, “The details would be decided in next month’s meeting. The alternative sponsorship would be sorted out promptly for the fall conference to utilize.”
- Policy
- Concerta OROS'll be moved overseas to complete registration
- by Lee, Tak-Sun May 22, 2020 06:16am
- Janssen Korea, which decided to operate a domestic factory by 2021, is in a hurry to convert imports of licensed items. Following the transition to an overseas manufactory earlier this year, six items have been changed in permission, and in June, the manufacturing plant of the ADHD treatment, Concerta OROS ER will also be moved overseas to complete registration. According to the industry on the 21st, Janssen Korea plans to change the permit in June as the location of the manufacturing plants that manufacture Concerta OROS ER 18 mg and 27 mg has been changed. Concerta OROS ER 36mg and 54mg were imported and approved in 2015. Concerta OROS ER 18mg and 27mg were approved as domestic manufactured items in 2008 and have been produced at the Hyangnam Plant. However, with the decision to withdraw the Hyangnam Plant, the company plans to move the manufacturing of Concerta OROS ER 18mg and 27mg to the Janssen plant in Puerto Rico. Janssen said it is expected to change the permit in June, and has sent an official letter to the distributor saying that it may be difficult to supply items temporarily due to the administrative process following the import conversion. Imported products will be supplied normally in October. Janssen changed permission by converting six items to imports this year. Jurnista 4mg, Topamax Sprinkle cap 25mg & 50mg, Invega ER 3mg, 6mg & 9mg were converted from Hyangnam factory to imported factory. Janssen is expected to push forward the conversion of domestic manufacturing items to the manufacturing plant until the operation of the Hyangnam plant ceases in the future. Currently, products such as Ultracet are known to plan to transfer manufacturers to domestic pharmaceutical companies like Handok. Currently, there are 33 remaining manufacturing license items at Hyangnam Plant.
- Policy
- COVID-19 vaccines/quarantine items road map details released
- by Kim, Jung-Ju May 22, 2020 06:16am
- Kwon Joon-wook, deputy general manager of the Central Quarantine Headquarter for quarantine managementThe quarantine authorities will release a detailed road map for 'COVID-19' vaccine and quarantine products next week. Regarding vaccines, the area of greatest interest, R & D of nucleic acid vaccines, such as those under development by Moderna, is also actively being conducted in Korea. Kwon Joon-wook, deputy general manager of the Central Quarantine Headquarter for quarantine management, answered the related questions at the regular briefing of the Central Quarantine Headquarter for quarantine management held on the afternoon of today (19th). th the successful formation of a neutralizing antibody as a candidate for the COVID-19 vaccine, which is currently being developed by Moderna, USA. Eight out of 45 trials confirmed the formation of neutralizing antibodies. This vaccine is called the 'nucleic acid vaccine'. In response, deputy general manager Kwon said, “This nucleic acid vaccine is capable of rapid development and mass production or utilization within a short period of time, and many research and development developers are fiercely challenging.” With regard to the clinical trials by Moderna, deputy general manager Kwon said, "As we understand now, Moderna aims to produce about 1 billion doses per year for mass production in the first half of next year, and the schedule could be much faster," also he added that in this regard, the President and the Minister of Health and Welfare of the Republic of Korea also spoke through the WHO General Assembly, but if developed anywhere in the world, every country should make every effort to use it without deficiency." In particular, he said the quarantine authorities are currently setting up a road map for vaccines and quarantine products. "The quarantine authorities will release the vaccine and quarantine road map in detail next week," said deputy general manager Kwon. He said that he will do his best in Korea, and even if the time is delayed, he will make more efforts to use our vaccine with COVID-19 as an opportunity. Lastly, he said, There are great achievements at home and abroad in relation to the development of vaccines. Right now, because we can't avoid sporadic infections other than" putting it in distancing in daily life. He asked, "Please keep distancing in daily life and the prevention of infectious diseases more thoroughly."
- Policy
- There are 17 cases of COVID-19 tx with stem cells worldwide
- by 박상준 May 21, 2020 06:01am
- As world-renowned pharmaceutical bio companies such as Gilead Sciences Korea, Novartis, and Pfizer have announced the development of COVID-19 treatment and vaccines, domestic pharmaceutical companies are also revealing their intentions through various mechanisms and strategies. In particular, it has attracted attention by offering various possibilities from cytokine anti-inflammatory drug candidates through stem cells to drug repositioning and therapeutics that directly target the RNA genome of COVID-19 using RNA interference technology. On the 20th, Bio Korea set up a special session on the development trend of COVID-19 treatment, and provided a place to promote the development of new drugs by sharing precautions for clinical and non-clinical development for treatment development and sharing cases of treatment development by domestic companies. Six sessions of industry-academia, including academic research institutes such as the Institut Pasteur Korea and the Korea Research institute of Chemical Technology (KRICT), and Cellivery, which received attention as an in vivo transport technology for pharmacological substances, participated in this online session. .Soon-wook Song, vice president of SCM Life Sciences, which first published a case study on the development of a stem cell therapy for treatment of COVID-19 (SCM-AGH), explored the possibility that stem cells could be used for COVID-19 treatment through anti-inflammatory functions .▲Stop cytokines, Stem cell anti-inflammatory mechanism "There is a worldwide search for ways to use stem cells for the treatment of COVID-19," said vice president Song ."Currently, clinical trials registered with stem cells called Mesenchymal Stem Cells (MSCs) have been registered worldwide." The number of cases reached 17," he said .Soon-Wook Song Vice President, SCM Life Sciences#"In the first clinical trial of stem cell therapy in China, 10 COVID-19 confirmed patients participated, 7 were included in the stem cell treatment group, and 3 were included in the control group." "Patients who participated in this trial received 1x106 cells / kg stem cells once, and usually started to respond after 2-4 days," he said .It has been found in animal experimental models that stem cell administration reduces inflammatory cytokines that cause cytokine storms and activates immune T cells that are effective in suppressing viruses .COVID-19 confirmed patients are exposed to the immune system's cytokine when the virus penetrates the human body, and the 'cytokine storm' phenomenon that attacks normal cells is expressed ."We have our own original technology for separating stem cells with high purity, and we are producing high-efficiency and low-cost stem cell therapies based on this technology," said Song ."We have already demonstrated its effectiveness in animal models of mild and severe acute pancreatitis with these high-efficiency stem cell therapies," he explained .He said, "In particular, stem cells reduce the inflammatory cytokines TNF-alpha, INF-gamma, IL-1beta, and IL-6, which cause cytokine storms, and increase the anti-inflammatory cytokines IL-4 and IL-10 .And activated T cells ." Also he said, "The expected therapeutic effects of SCM-AGH stem cell therapy are also cytokine storm control," In addition, "regulatory T cells are activated to increase IL-10 secretion, so immune cells such as abnormally activated T- and B-cells can also be regulated." It is expected to induce efficacy .Stem cell therapy is expected to induce the long-term treatment efficacy by rapidly normalizing the patient's immune system," he added .Cellivery, which has recently emerged as a technology for in vivo transport of pharmacological substances, is also developing therapeutic agents with a focus on anti-inflammatory properties .▲Regulate the signal of nuclear location in cells, Possible to suppress hyperinflammatory reaction Dae-Woong Cho, CEO of Cellivery, who announced 'Development of iCP-NI treatment for acute inflammation suppression', said, "Intracellular transmission of a nuclear localization signal can suppress inflammation by regulating the expression of cytokines / chemokines." "COVID-19 induces a cytokine storm, leading to death, and excessive inflammatory cytokines and chemokines can lead to destruction of bronchial and alveolar tissue, leading to permanent lung damage, such as lung fibrosis," he said .Dae-Woong Cho, CEO of Cellivery#"The iCP-NI, which we are developing, aims to regulate the expression of excessive inflammatory cytokines and chemokines," he said ."The nuclear location signal transmitted into the cell prevents stress-responsive transcription factors (SRTFs) from moving from the cytoplasm to the nucleus .It is a mechanism to limit and suppress the inflammatory response." As a result of animal experiments, iCP-NI showed the effect of regulating the expression of chemokines (MCP-1: -89%) and a cytokine (TNF-α: -79%, IL-6: -91%, IL-12: -110% & IL) in bronchial-alveolar fluid in an inhaled pneumonia model similar to RNA virus infection .-10: + 574%) .In addition, Bleomycin-induced pulmonary fibrosis in animal models reduced pulmonary fibrosis by 50% and iCP-NI protects leukocytes in staphylococcal enterotoxin B and acute pneumonia animal models (CD3+ T cell: 100%, CD4+/CD3+ T cell: 96%, B220+ B cell: 85%, CD45+ macrophage: 100%), and splenocyte cell apoptosis was reduced by 97% .These results indicate that iCP-NI is a potential as a new treatment for inflammation of various infectious diseases such as COVID-19, which is accompanied by cytokine storms and severe sepsis .▲Mutable RNA virus, solved by RNA interference Dong-ki Lee, CEO of Olix, announced the current status of COVID-19 RNA interference treatment .The challenge for COVID-19 is the high rate of RNA-based mutations .This is because vaccine development is not easy due to the possibility of mutation as well as resistance to therapeutic agents ."We are developing treatments for various diseases through our own RNA interference technology .Among domestic companies, only Olix is entering clinical trials with RNA interference technology." said CEO Lee .He explained that RNA viruses have a high variability, so they can easily develop resistance to therapeutic agents, but RNA technology can be used to directly target the viral RNA genome .RNA interference technology has advantages such as targeting a region that is not prone to mutation, or minimizing the possibility of mutation by allowing multiple asymmetric small-interference ribonucleic acids (siRNA) to target the genome at once .In addition, the Institut Pasteur Korea focused on 'Drug Repositioning' that utilize existing treatments in COVID-19 ."There are currently no vaccines or treatments available for COVID-19, and drug repositioning is the only alternative," said Dr .Seung-Tak Kim, researcher at the Institut Pasteur Korea ."To discover, we first screened about 3,000 antiviral drugs against the SARS coronavirus, which was prevalent in 2002 to 2003." He said that 48 FDA-approved drugs were selected and the drugs were tested for SARS coronavirus-2 antiviral activity again .As a result, a total of 24 drugs with significant antiviral efficacy against SARS coronavirus-2 were found.
- Policy
- Lilly’s Baricitinib begins clinical trial of COVID-19
- by Lee, Tak-Sun May 21, 2020 06:00am
- Global pharmaceutical company Eli Lilly's rheumatoid arthritis treatment, 'Baricitinib' (Olumiant) is conducting sponsor-investigator trials on COVID-19 patients. So far, 10 drugs have been approved for clinical trials in COVID-19 patients, including Baricitinib. The MFDS approved a sponsor-investigator trials investigating COVID-19 for Baricitinib submitted by Seoul National University Hospital on the 18th. The trial will be conducted from May 2020 to March 2023, and will target 1032 COVID-19 confirmed patients worldwide. In Korea, it will be held at Seoul National University Hospital and Bundang Seoul National University Hospital for 100 patients. Baricitinib is the ingredient name of rheumatoid arthritis treatment drug 'Olumiant', which was released in December 2017 by Lilly Korea. Baricitinib is expected to be a potential COVID-19 treatment and is being tested in clinical trials worldwide. The anti-inflammatory effect of Baricitinib may help to suppress the COVID-19's reaction in the human body, Lilly said. In addition, the National Institutes of Health (NIH) recently launched sponsor-investigator trials to see if Gilead's Remdesivir and Baricitinib can be used to treat COVID-19 infection. With the clinical approval of Baricitinib, the number of drugs that have been approved for clinical trials in COVID-19 patients has increased to 10. In Korea, starting with Remdesivir, Abbvie's AIDS treatment Kaletra, Hydroxychloroquine praised by US President Trump, asthma treatment Alvesco inhaler, Shinpoong's malaria drug Pyramax, EC-18 by Enzychem, SK Chemicals' Futhan, Young Poong’s Ferodil, and Bukwang’s Levovir are conducting clinical trials on COVID-19 confirmed patients. However, no treatment has been proven to be effective in Korea.
- Policy
- Consult with PM from the development to post-marketing stage
- by Lee, Tak-Sun May 20, 2020 06:11am
- The MFDS (Minister Eui-kyung Lee) expanded the role of the 'product manager (PM)', which has been limited to the permitting step, from the drug development to the post-marketing cycle, in order to increase the predictability of the approval and review process and safety management expertise. Announced on the 18th that it will switch to a one-stop support and management system Accordingly, the 'Product Manager', established in 2009, will manage the entire drug lifecycle, including pre-examination at the development stage, re-examination and risk management after approval. PM is the general manager of the pharmaceutical products of the MFDS, and it manages the history of each stage, such as permits and reviews, operates communication channels between reviewers and developers, and acts as an early recognition of problems to strengthen permit efficiency and predictability. Regulatory authorities such as the United States and Europe also operate item managers and are expanding their role. PM will be managed by the headquarters of the MFDS and new and orphan drugs or high-risk items will be classified as 'Special Management Items', and designated managers with expertise and experience will be differentially managed. Pharmaceutical companies can receive the necessary consultation from the drug development stage to the post-marketing stage through the designated 'PM', and the person in charge can be found on the website of the MFDS. "The expansion of the role of PM is a policy that the MFDS is pursuing with a strong will to advance to an international level of regulatory authority, so we will try to settle early," said Minister Eui-kyung Lee, while communicating with experts such as doctors and pharmacists, we will create an environment where people can use it more safely. ”
- Policy
- “Neglecting cost-effectiveness is dereliction of duty"
- by Kim, Jung-Ju May 19, 2020 06:07am
- Answering to the criticism that National Health Insurance (NHI) coverage enhancement initiative is toughening the barrier of pharmaceutical reimbursement listing and standard, Korean health authority officials urged the cost-effectiveness should be further reinforced. Recently appointed Director Yang Yoon Seok of the Pharmaceutical Benefits Division at Ministry of Health and Welfare (MOHW) hinted, “We want to put more filters, if possible.” The ministry officials also noted the government would pay a close attention to what pharmaceutical and bio industry, as well as patient groups, have to say, but they are planning to make policies weighing more on rationality and predictability. Regarding the listed drug reevaluation pilot program announcing last week that choline alfoscerate would be the first, the government officials stressed unlike the approval system, the cost-effectiveness comes first in listed drug reevaluation. On the questions directed to the final outcome of reevaluation—reimbursement removal or reduction, the officials shortly commented adequate actions would be taken and avoided providing further details. Director Yang elaborated during a press conference held immediately after the Health Insurance Policy Deliberation Committee (HIPDC) meeting on May 15. Appearing for the first time at an official press conference, Director Yang expressed his philosophy in insured drug policy, prospective approach, and his commitment to them. Senior Deputy Director Lee Seon-joo and Deputy Director Choi Kyung-ho, playing significant roles in the Pharmaceutical Benefits Division, also joined Director Yang during the question and answer session. (From left) Senior Deputy Director Lee Seon-joo, Director Yang Yoon Seok and Deputy Director Choi Kyung-ho ▶The Ministry of Food and Drug Safety (MFDS) is reportedly considering on reevaluating the approval standards on choline alfoscerate. Has the listed drug reevaluation been discussed with MFDS? If not, then it could cause confusion when reevaluations each conducted by MFDS and MOHW (Health Insurance Review and Assessment Service, HIRA) result in contrasting outcomes. Deputy Director Choi Kyung-ho (“Choi”) “MFDS’ approval evaluation and MOHW’s reimbursement listing evaluation are different. The previous negative listing system used to list most of the approved drugs, but the current positive listing system reviews cost-effectiveness. The listed drug reevaluation is to be introduced within the framework, and such reevaluation, specifically for the price, is nothing new.” ▶Can the listed drug reevaluation ultimately result in reimbursement standard reduction or removal? Director Yang Yoon Seok (“Yang”) “Depending on the outcome, adequate actions would be taken accordingly.” ▶The reevaluation mentioned in the first NHI Comprehensive Plan was about introducing more general drug reevaluation covering clinical efficacy, financial impact and contract compliance. While selecting choline alfoscerate for the pilot program does not exactly explain how it is covering the said factors. Is there a possibility that the pilot program could include other subject drugs during or after the first pilot program? And what is the reason behind only selecting choline alfoscerate? Yang “The lawmakers and media have raised issues over choline alfoscerate last year, and even civic health organizations have requested for an audit. As we have already promised for a reevaluation, it cannot be delayed anymore. The actual regulation would be set down based on the pilot program, but the pharmaceutical industry seems to be concerned about the [government policy] being spontaneous or arbitrary. [By understanding those concerns] the Ministry intends to enhance predictability.” Choi “A number of pharmaceutical substances were listed up as the pilot program candidates. Selecting the urgently demanded choline alfoscerate seemed appropriate. In fact, differentiating the pilot evaluation and the actual evaluation would be meaningless.” ▶According to the information from HIPDC, the pharmaceutical expenditure saved from the reevaluation would be used for listing severe and rare disease treatments. The previous director of Pharmaceutical Benefits Division mentioned about opening an account for pharmaceutical expenditure on severe disease treatment. Has it been reviewed any further? Choi “The limited resources, despite so many expenditures to cover, is our concern for the system. So basically, the talk came about as a means to accumulate resources for coverage on severe disease treatment by cutting out expenditure on drugs with weak efficacy or unnecessary reimbursement. Regardless, if the pharmaceutical expenditure can be saved, the ministry would have more resource to utilize on much needed reimbursement to cover severe disease treatments. The issue is still under review.” ▶Again, the HIPDC information explains the reason behind choosing choline alfoscerate for the pilot program, which referred to A8 external pricing reference countries. Does this mean that the existing list of A7 countries would be updated to A8 countries including Canada? Choi “[The external pricing reference countries] is set by HIRA. The A8 mentioned here is not so significant. The eight countries were picked as reasonable references. It would be better to interpreted like that.” ▶Some criticize that the financial issue of anticancer treatment reimbursement listing or expansion have been evaluated through ‘triple-filtering (Cancer Deliberation Committee, DREC and drug pricing negotiation)’ as the Cancer Committee started reinforcing financial impact management. Some even go further and say the triple-filtering is deferring deliberation on many of anticancer treatment coverage and affecting the patient’s access to treatment. Yang “They call it the ‘triple-filtering,’ but to be honest, we want more filtering if possible. For this time around, we had the applicant company to submit a financial impact management plan on their immunotherapy. Nevertheless, we would need to construct a system for the patients to receive more benefits.” Choi “It does not mean the previous evaluations were insufficiently done. Anyway, healthcare reimbursement review has to take account of cost-effectiveness at each step. “In some cases, HIRA first projects comparatively lower cost, when NHIS projects the cost higher. As a health authority, such cases should be prevented. Neglecting cost-effectiveness is as irresponsible as dereliction of duty. “Attempting to catch a mosquito with a sword would be nonsensical, but the related experts can talk about it at every step. And if each step can be a filter, we expect the next step would be able to bring even better outcome. “Pharmaceutical companies may feel these steps are excessively straining them, but demanding the health authority to review listing without the filtering would mean they are demanding us to work blindly. And in clinical scene, doctors judge the use of a drug, and these doctors are part of the committees. Financial experts are there to add more on the financial aspect. We are definitely not putting down one-fifth resource for the necessary expenditure.”
- Policy
- Reimbursement on Ibrance-Faslodex available from June
- by Lee, Hye-Kyung May 19, 2020 06:07am
- From June 1, the healthcare reimbursement would be granted on the combined use of Pfizer Pharmaceutical Korea’s HER2-negative breast cancer treatment Ibrance (palbociclib) capsule and Faslodex (fulvestrant). National Health Insurance Service (NHIS) has settled on a negotiation over an indication expansion of the already listed drug and listed Ibrance 75 mg, 100 mg and 125 mg under refund type risk sharing agreement (RSA). Each capsule would be priced at 125,900 won with the healthcare benefit. On May 15, Korea’s Ministry of Health and Welfare (MOHW) held the seventh Health Insurance Policy Deliberation Committee (HIPDC) meeting of the year. Convened for the first time in the year, the HIPDC members passed the Ibrance listing as a part of the revised list of reimbursed drugs and maximum reimbursement price. The negotiation on Ibrance was not a new drug pricing negotiation, but a reimbursement standard expansion according to the change in indication. Initially indicated to treat postmenopausal female patients with hormone receptor positive (HR+) or human epidermal growth factor receptor 2-positive (HER2+) advanced or metastatic breast cancer as an endocrine therapy, Ibrance is additionally indicated to treat, in combination with Faslodex, female patients with hormone receptor positive (HR+) or human epidermal growth factor receptor 2-positive (HER2+) advanced or metastatic breast cancer who has been treated with endocrine therapy. The indication expansion on Ibrance’ combination therapy has been demanded for over three years, as its indication was expanded to a first-line endocrine therapy combined with letrozole to treat postmenopausal women in 2017. Since Pfizer applied for the new indication to treat female patient with advanced breast cancer after endocrine therapy as a combination therapy with Faslodex on Apr. 26 last year, Health Insurance Review and Assessment Service (HIRA) has been reviewing the revised reimbursement standard. The revised reimbursement standard on Ibrance has undergone deliberations by Cancer Deliberation Committee in last September and Drug Reimbursement Evaluation Committee (DREC) in last February, and was negotiated for reimbursement pricing with NHIS from Mar. 7 to May 6. Due to the cost-effectiveness issue raised by NHIS, Pfizer has agreed to refund a set ratio of claimed cost of Ibrance to NHIS, and also to lower the reimbursed price by 10.8 percent to lessen the financial impact. The Korean health authority projected the expanded reimbursement standard on Ibrance, in effect from June 1, would additionally cost them 16.5 billion won a year.
