- LOGIN
- MemberShip
- 2026-04-11 09:37:17
- Policy
- PVA, financial resources to register new drugs, not penaltie
- by Lee, Jeong-Hwan Oct 17, 2022 10:52pm
- Regarding the criticism that PVA imposes penalties on pharmaceutical companies that produce drugs with high public demand, the Ministry of Health and Welfare countered that it is a system that contributes to improving patient accessibility through new drug insurance. The Ministry of Health and Welfare also said that it is impossible to temporarily suspend the implementation of PVA until the time when exchange rates and prices stabilize. On the 17th, the Ministry of Health and Welfare responded to written questions about PVA by Baek Jong-heon and Lee Jong-sung of the National Assembly's Health and Welfare Committee. Lawmaker Baek Jong-heon pointed out that cutting drug prices as usage increases is contradictory to imposing penalties on pharmaceutical companies with high public demand. It also said it could hinder cooperation between domestic and global companies. The Ministry of Health and Welfare did not agree with the National Assembly's criticism, explaining in principle the purpose of introducing the system. However, he said he would review improvement measures according to the results of the ongoing policy research service. The Ministry of Health and Welfare said, "PVA was introduced in 2006 as part of a plan to optimize drug costs. Drugs that have excessively affected health insurance finances are subject to negotiation, he said. "We will cut drug prices within a range of up to 10%." The Ministry of Health and Welfare explained, "The finances saved by PVA are used as financial resources to improve patient accessibility through the registration of new drugs." The Ministry of Health and Welfare said, "We are conducting policy research services under the auspices of the NHIS. "We will present reasonable improvement measures through collecting opinions from stakeholders," he said. Rep. Lee Jong-sung said the system should be suspended until the time when exchange rates and prices stabilize from next year, but the Ministry of Health and Welfare opposed it, saying it needs to be carefully reviewed. The Ministry of Health and Welfare said, "The purpose of the system is to pursue the rationality of drug spending. The drug price cut also has the effect of reducing the cost of patient's copy, he said. "The temporary suspension of PVA needs to be carefully reviewed."
- Policy
- “No considerations made to protect generics” at NA audit
- by Lee, Jeong-Hwan Oct 17, 2022 10:52pm
- After the Ministry of Health and Welfare revealed its plan to lower the price of generics step by step at the 2022 NA Audit, the domestic pharmaceutical industry has been expressly expressing their displeasure on how pro-government the regulation is and criticized how the plan does not consider the realities of the industry. The industry relayed its concerns on how the MOHW had opted to save NHI finances by regulating the price of generics rather than protecting the domestic industry, even though the sales of generics are a major means for profit generation used by domestic pharmaceutical companies to invest in R&D of new drugs. Also, suggestions that policies to preserve drug prices or preferential pricing should be considered and pharmaceutical support for new drug development should be increased substantially if the government plans to implement such drug price-reducing policies. On the 16th, the domestic industry has been reacting sensitively to the issue of generic drug price cuts raised that had been raised at the NA Audit by the NA Health and Welfare Committee. During the NA Audit for MOHW, Rep. Jae-Hyung Choi of the People Power Party raised the need to reduce NHI expenditures through drug price cuts and expand R&D investments for new drugs, pointing out how generic drug prices in Korea are excessively high compared to those in other advanced countries overseas. MOHW Minister Kyu-Hong Cho agreed with Rep. Choi and said he will seek measures to lower the price of generics in Korea step-by-step as the price of generics in Korea is higher than overseas. On this, the domestic pharmaceutical companies have complained that the government has opted to unilaterally reduce the price of generic drugs, which is the easiest way to save NHI finances. Although financial management of insurance in other advanced countries cannot be simply compared with Korea's situation, the government is pushing this fragmentary logic, vaguely comparing the price of generic drugs to original drugs to hold as a reason to lower drug prices. The industry also claimed that the NA and MOHW’s argument that the higher price of generic drugs in Korea compared to overseas undermines the willpower to develop new drugs. In particular, they criticized how critical an issue it is that the MOHW does not properly recognize the "generic Industry as part of the domestic industry.” While many foreign countries, including the US’s Biden administration, are devising multifaceted measures to protect their own pharmaceutical bio-industry, Korea is repeatedly laying out measures that cut the price of generic drugs in its own industry to “secure financial soundness” of NHI finances. Reducing the price of generic drugs in the single-payer NHI system will only reduce the share of the pie held by the domestic industry, which in turn will increase the market share of foreign pharmaceutical companies and cause difficulties for domestic pharmaceutical companies from market contraction. Moreover, the industry demanded that MOHW should proactively consider measures to preserve generic drug prices in various situations as much as for the reduction of the same, and develop policies to provide preferential pricing for innovative new drugs and budget support for new drug development, etc. Without a drug price preservation policy that partially exempts or suspends post-drug price cuts for generic drugs that have contributed to saving NHI finances, the generic drug price cuts will only impede drivers of new drug development in pharmaceutical companies. An official from Company A said, “Pounding on generics may be the easiest way to reduce NHI finances on the government’s part, but generics are the root and cash cow of the Korean pharmaceutical industry. Not many companies are reluctant to invest in new drug development because the price of generics are so high.” “Companies that continue to invest in new drugs and IMDs despite the burden of sunken costs will face a lack of financial resources to continue the research if the price of generic drugs is reduced. In addition, Korean companies have continuously contributed to national health crises with their generics, such as in resolving the Tamiflu shortage during the swine flu incident.” “Korea has a tendency to undervalue generic drugs, undermining the social contribution that had been made by the generic drugs and periodically reducing their price. The US uses private insurance, not a single-payer system like Korea. This is one of the reasons why generic drug prices of different countries should not be compared simply.” Another domestic pharmaceutical company official from Company B also said, "President Biden has recently issued an executive order to protect the pharmaceutical and bio-industry in the US. If the Korean market is attractive because of the high generic drug prices, why wouldn’t the foreign generic companies be entering the Korean market?"
- Company
- Shingrix costs 600,000 won
- by Kim, Jin-Gu Oct 17, 2022 10:51pm
- The inoculation price of Shingrix, a shingles vaccine scheduled to be supplied in December, is expected to be around 600,000 won. It is four to five times the existing inoculation price. According to the pharmaceutical industry on the 15th, GSK and GC Pharma recently officially signed a domestic joint sales contract for Shingrix. The two companies agreed to supply the next-generation shingles vaccine at around 160,000 won. The inoculation price reflecting the supply price is expected to be around 300,000 won. In the case of Shingrix, considering that immunity is completed with two vaccinations, the total vaccination price to be paid by the patient is around 600,000 won. The existing vaccines MSD Zostavax and SK Bioscience SKY Zoster were sold for 150,000 won to 200,000 won at the front-line opening price. In the case of Shingrix, vaccination prices have been set at four to five times the level of existing vaccines. GSK and GC Pharma plan to start distributing Shingrix nationwide in December. The first volume is 360,000 degrees, which can fit 180,000 people. GSK obtained Shingrix permission from the Ministry of Food and Drug Safety in September last year. It was originally planned to be released in February this year, but the schedule was delayed day by day. Shingrix is a vaccine used to prevent herpes zoster in adults over the age of 50 and immunocompromised people over the age of 18. When Shingrix is released, it is expected to be the third shingles vaccine in Korea after MSD Zostavax and SK Bioscience SKY Zoster. It is evaluated that the effect of preventing shingles confirmed in clinical trials is superior to that of the two existing vaccines. In Shingrix clinical trials (ZOE-50) for adults over the age of 50, the effect of preventing shingles was 97% at 3.2 years after vaccination. In clinical trials (ZOE-70) for those aged 70 or older, it was 90% at 3.7 years after vaccination. In the case of Zostavax, a competitive product, it has a preventive effect of 51% for those over 50 and 41% for those over 70. SKY Zoster demonstrated Zostavax and specific heat in clinical practice. It is analyzed that there is no significant difference from Zostavax in terms of prevention rate. GC Pharma has experience in co-selling MSD's herpes zostavax vaccine in the past. GC Pharma co-sold Zostavax for eight years until 2020 through a contract extension once after signing a co-promotion contract with MSD since 2013. In the process, Zostavax has grown into a large item with annual sales of 80 billion won. However, SK Bioscience launched its competitive product SKY Zoster at the end of 2017, and sales have decreased significantly since 2020 as the overall market size has shrunk due to the prolonged Corona crisis. According to IQVIA, a pharmaceutical market research firm, Zostavax sales last year amounted to 27 billion won, down 68% in four years from 83.7 billion won in 2017. This year, sales were only 11.6 billion won until the first half of the year. The pharmaceutical industry expects Shingrix to lead the domestic shingles vaccine market to rebound. In the global market, Shingrix's sales, which had already been dampened by the Corona crisis, began to recover in the second half of last year. In the first half of this year, Shingrix's global sales were £1.429 billion, more than doubling compared to the same period last year.
- Shingrix, a shingles vaccine, will be released in December
- by Oct 17, 2022 06:03am
- Shingrix, a new shingles vaccine that boasts overwhelming preventive effects, will be officially released in December. It is expected to shake the game of shingles vaccines by showing a 97% prevention effect, which is twice that of existing vaccines, and proving long-term effectiveness and safety. On the other hand, prices are more than four times higher and small initial supplies are considered barriers. According to the pharmaceutical industry on the 17th, GSK will release a new shingles vaccine, Shingrix, in Korea in December. It has been a year and three months since it was approved by the Ministry of Food and Drug Safety in Korea. Shingrix is an antigen of Glycoprotein E, a protein component of chickenpox and shingles virus. It combines AS01B, an immune enhancer that improves the immune response to the antigen, to exhibit a strong and continuous immune response. Shingrix is the third shingles vaccine and the first vaccine in Korea. Previously, it was a two-tier system of SKY Zoster by MSD Zostavax and SK Bioscience. Both products are live vaccines, which transformed parts of viruses or bacteria, eliminating the ability to produce toxicity, and leaving only self-breeding and immune-inducing capabilities. On the other hand, Shingrix, a four-vaccine vaccine, is a special treatment that deactivates all or part of a virus or bacteria and can be inoculated even to those who have difficulty getting a live vaccine due to reduced immunity. ◆The prevention rate of herpes zoster among those in their 50s and older is 97% The biggest advantage of Shingrix is by far the prevention rate. Unlike Zostavax and SKY Zoster, which showed a 51% prevention effect in patients over the age of 50, Shingrix had a 97% prevention rate. According to Shingrix Phase III clinical trial ZOE-50, Shingrix has a 97.2% preventive effect over an average 3.2-year follow-up period. In the results of separately selecting and analyzing ZOE-70 clinical trials and participants in the ZEO-50 study for patients aged 70 or older, Singrix maintained a preventive effect of more than 90%. Specifically, Shingrix had a 91% prevention rate in both 70s and 80s. This is in contrast to existing vaccines, which have fallen to 41% of the prevention effect among those aged 70 and older. Even if you have shingles after vaccination with Shingrix, the probability of preventing "shingles post-shingles neuralgia," a representative complication, was 91% for those over the age of 50 and 89% for those over the age of 70. The long-term effects of Shingrix are also being demonstrated. Currently, GSK is conducting a long-term follow-up study on clinical participants to see the long-term safety and effectiveness of Shingrix. According to the current confirmation, 91% of preventive effects were maintained for 7.1 years after Shingrix vaccination in all age groups over the age of 50. While maintaining a stable response to immunogenicity and cell-mediated immunity, the antibody concentration was found to be more than six times higher than the level before vaccination until eight years after vaccination. ◆ Two inoculations and expensive price barriers…The disadvantage is that 180,000 units are small In addition to the preventive effect, Shingrix differs from existing vaccines in terms of the number of vaccinations and price. Unlike Zostavax and SKY Zoster, which are one inoculation, Shingrix is two inoculations. You should get another vaccine between 2 and 6 months after the first vaccination. The cost of vaccination is expected to be 4 to 5 times higher than that of existing vaccines. According to the industry, GSK recently set the supply price of Shingrix at around 160,000 won per dose. The inoculation price, which reflects the supply price, is expected to be around 300,000 won. Considering that it is a total of two vaccinations, the total vaccination price that the patient has to pay is around 600,000 won. Currently, the inoculation price of Zostavax and SKY Zoster is about 150,000 won to 200,000 won. In other words, it becomes as expensive as four times at least, and five times at most. Despite the high inoculation price, Shingrix is expected to change the market landscape due to its unique preventive effect. The U.S. has already been overturned as a soloist, accounting for 98% of the market share within a year of its launch. Shingrix's U.S. sales reached 2.5 trillion won in 2019 and about 3 trillion won in 2020. Sales fell last year when COVID-19 was severe, but the company predicted a more significant rebound this year However, it is expected that it will be difficult to meet Shingrix in front-line hospitals and clinics immediately after its launch in December due to insufficient initial supplies. According to the industry, the initial volume of Shingrix is 360,000 doses, which can only fit 180,000 people. The initial volume will also be introduced sequentially according to the domestic inspection schedule such as the national lot release, and the supply is expected to be supplied from general hospitals.
- InterView
- “AstraZeneca’s sincerity in oncology drives cont. growth"
- by Eo, Yun-Ho Oct 17, 2022 06:03am
- AstraZeneca is known for its ‘sincere attitude’ towards R&D. Not only is the company in the top ranks in terms of its investment amount, but it has also always been at the forefront in terms of R&D-to-Total-revenue ratio as well. In 2021, AstraZeneca’s R&D-to-Total-revenue ratio stood at 26%, the highest in the industry. Due to their invested interest, the company is rarely behind in recognizing new drug development trends. More often, AstraZeneca has led the trend, releasing first-in-class drugs. AstraZeneca developed the antidiabetic SGLT-2 inhibitor ‘Forxiga,’ a drug that has recently been receiving attention for demonstrating cardiovascular benefit, and the oral antiplatelet ‘Brilinta,’ the only contender of Plavix (clopidogrel). Also, 'Crestor (rosuvastatin)’ which had threatened the sales of ‘Lipitor (atorvastatin),’ and the ICS/LABA combination ‘Symbicort’ are also some of AstraZeneca’s well-known products. Building on this solid foundation, AstraZeneca is now busy reinforcing its Oncology pipeline. In addition to the third-generation epithelial cell growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) ‘Tagrisso (osimertinib),’ the company has added the PD-L1 inhibiting immuno-oncology drug ‘Imfinzi (durvalumab)’ to its portfolio. In other words, the company's oncology pipeline is no longer represented by its first-generation EGFR TKI “Iressa (gefitinib).” Dailypharm met with Susan Galbraith, Executive Vice President of Oncology Research & Development at AstraZeneca to hear about the company’s oncology drug development. Trained as a clinical oncologist and Ph.D., EVP Galbraith has been leading Oncology R&D at the company for the past 12 years. -Which product were you most deeply involved in developing? I would have to say that I am most fond of Tagrisso. AstraZeneca aspires to become a leader in Oncology. When I joined the company, hormonal treatments such as Faslodex, as well as Iressa were already developed, and Tagrisso was in the development stage. My first work after joining AstraZeneca was to organize the company’s research portfolio. At the time, I suggested that we should focus on products with higher potential rather than products that have less chance of success. This was even before a project name had been coined for the development of Tagrisso, but I believed in the potential of the substance and made the decision to accelerate its development. Many patients who were treated with existing targeted therapies at the time had been developing resistance or intolerance to their treatments. They developed secondary mutations, and the drugs were not binding well in their targeted sites. I saw the potential of Tagrisso in addressing this unmet need. So Tagrisso was first administered to a patient in 2013. The Seoul National University Hospital in Korea also participated in our Phase I clinical trial, and tumor size was reduced in 2 of the 4 patients that were administered Tagrisso at the time. Resistance to existing treatment options -the T790M mutation - is found in around 50% of all EGFR-mutated lung cancer patients. Although we weren’t testing for the T790M mutation at the time, the tumor size reduction in 2 of the 4 patients raised hopes on how the drug targets the T790M mutation and brings therapeutic benefits. I still remember telling the chemist that developed the substance the good news about how promising the substance was. AstraZeneca was able to gain such insight based on solid collaboration with healthcare professionals in Asia. Our collaboration with healthcare professionals in Korea, Japan, and Taiwan greatly contributed to our discovery by helping us secure information on the resistance mechanism in advance. -As you mentioned, AstraZeneca’s oncology pipeline is rising in prominence. The pipeline, which had already existed for a while, seems to be getting stronger. You already own extensive product lines in Respiratory, Cardiovascular, and Endocrinology, does this mean you will be focusing on oncology drugs in the future? That’s not so. Rather than concentrating on either part, we are making efforts to build a balanced portfolio that can cover various treatment areas. Although 40-50% of our R&D budget is being invested in oncology drugs, we also have pipelines in various other treatment areas including Cardiovascular (CV), Renal, Respiratory, Immunology, Vaccines, etc. Oncology drugs do take up much of our interest, but it is not our sole area of interest. We have recently seen reports on how Forxiga, our antidiabetic drug, has significantly improved the risk of cardiovascular death. -It is also impressive that the company collaborated with Asian researchers from early phase trials for Tagrisso. Contrary to how Korea actively attracts Phase III trials, there has been criticism on how global pharmaceutical companies lack investment in early phase trials in Korea. I hope more opportunities will come in the future for Korea to collaborate with AstraZeneca. We are very interested in seeking opportunities in Korea. South Korea has been an innovation hub in developing new drugs for quite a long while and is leading in clinical trials. It is number three in contribution to global oncology clinical trials worldwide. In fact, involvement in the early phase clinical trials is something we have been doing with South Korea for many years and has built on year-on-year. -AstraZeneca’s competitivity has been further reinforced with the addition of the PARP inhibitor Lynparza to the pipeline. On the other hand, your immuno-oncology drug Imfinzi has been showing less impressive performance. Do you believe there is an opportunity for its comeback? We were excited to present data on the first improvement seen in biliary tract cancer for many years with Imfinzi. Biliary tract cancer is quite prevalent in Asia, and the addition of Imfinzi to first-line chemotherapy improved the treatment effect. The Imfinzi combination therapy was approved in the US based on this TOPAZ study, and we look forward to its approval in Japan as well. We also presented data earlier this year for the HIMALAYA study in liver cancer, in which the combination of Imfinzi with ‘Tremelimumab (anti-CTLA4 antibody)’ in a regimen where just one higher dose of Tremelimumab in order to improve the tolerability profile showed an improvement in the long-term survival benefit in liver cancer patients. I hope to hear from the US FDA on an indication based on the HIMALAYA study within the year. In addition, we have also submitted data in the first-line and non-small cell lunger cancer setting for the combination of Imfinzi with Tremelimumab added to chemotherapy.
- Policy
- 780,000 doses of Comirnaty 2 will be national lot released
- by Lee, Hye-Kyung Oct 17, 2022 06:03am
- The Ministry of Food and Drug Safety (Director Oh Yoo-kyung) announced that the mRNA COVID-19 vaccine imported by Pfizer Pharmaceutical Co. released 780,000 doses of Comirnaty 2 for two weeks on October 14. National lot release refers to a system that comprehensively evaluates the results of tests and testing results for each lot before vaccines are distributed on the market to check the quality once more. The Ministry of Food and Drug Safety thoroughly conducted a national lot release based on scientific evidence, putting safety first. As a result of conducting a test on 780,000 doses of 0.1 mg/mL of Comirny 2 and reviewing the manufacturing and test data of the manufacturer, it was determined that it met the approved quality standards and decided to release the national lot. The Ministry of Food and Drug Safety said it expects COVID-19 to help prevent COVID-19 as the vaccine is national lot released, and it will do its best to ensure a stable supply of quality vaccines by quickly and thoroughly verifying the COVID-19 vaccine.
- Policy
- Hemlibra's benefit speeds up to strengthen accessibility
- by Lee, Jeong-Hwan Oct 17, 2022 06:03am
- Kim Sun-min, director of the HIRA, promised to speed up the Hemophilia treatment Hemlibra benefit screening to strengthen accessibility for patients. On the 13th, Kim Sun-min, director of the HIRA, answered the on-site questioning of Kang Sun-woo, a lawmaker of the Democratic Party of Korea, at the NHIS parliamentary audit. Lawmaker Kang Sun-woo stressed that Hemlibra dramatically increases the quality of life of hemophilia patients and their families compared to other treatments that need to be intravenously administered as a subcutaneous injection. In particular, he stressed the need to expand the current standard for applying for Hemlibra benefits only to hemophiliac antibody holders to those who do not have antibodies. Director Kim Sun-min replied that she would speed up the ongoing screening of expanding Hemlibra benefits for non-antibody patients. Director Kim said, "I express my deep regret for the pain of hemophilia patients and their families."Director Kim said, "We are reviewing the clinical usefulness, safety, and cost-effectiveness of Hemlibra's expansion of non-antibody benefits. "We will try to strengthen accessibility by speeding up the screening process as much as possible," she said.
- Company
- Pfizer Korea leaves its beloved 15-year Myeongdong office
- by Eo, Yun-Ho Oct 14, 2022 05:53am
- Pfizer Korea will be soon leaving its Pfizer Tower in Myeongdong where it had resided for 15 years. The company will relocate to the nearby Namsan State Tower later this month. In other words, the company’s lease contract for the Myeongdong Pfizer Tower will expire on the 30th. The new office building may be smaller in size, and executive rooms including the one for the CEO will be removed. Also, the smart office format will be expanded in line with the recent trend of multinational pharmaceutical companies' increased telecommuting, etc. The Pfizer Tower, which had been under sale, is now back on the market. GRE Partners, the owner of Pfizer Tower recently suspended the sales process that it had started in May. Although the company had selected JLL Korea as its sales agent and started a bid, the bid price reportedly fell short of the seller's desired amount. A Pfizer official said, “Our new office was designed to be more efficient, modern, and an inspiring workplace for our executives and employees, based on which we expect to provide an environment that can realize our purpose of ‘delivering breakthroughs that change patients’ lives.’” Pfizer had relocated from Gwangjang-dong in Gwangjin-gu, Seoul to the Myeongdong office in June 2007. Before then, in June 2006, the company bought the Myeongdong office at KRW 58 billion. According to real estate agents, the price of Pfizer Korea’s Myeongdong office is estimated to be around KRW 100 billion to 120 billion. This is a profit of over KRW 60 billion generated in 13 years. The sales and relocation of the previous Pfizer office are being made due to the spin-off of Viatris, which was formed through the merger of Patent’s off-patent drug division and Mylan.
- Company
- Xofluza, is aiming for a rebound in sales
- by Oct 14, 2022 05:53am
- As soon as it was released, Xofluza, an unfortunate flu treatment that had little sales due to COVID-19, is seeking to rebound. As the flu pandemic warning has been issued for the first time in three years and the number of flu patients is increasing, Roche will also start selling Xofluza in earnest. ◆ New drug Xofluza for the first time in 20 years Xofluza is the next generation of flu treatment that Roche will succeed inTamiflu. Tamiflu is the only drug for new influenza and is a representative flu treatment for 20 years. Developed as a new mechanism of action in 20 years, Xofluza inhibits polymerase acid endonuclease, which is essential for cloning influenza viruses, preventing the progression from the early stages of virus replication. Xofluza dramatically reduced the number of doses. Unlike Tamiflu, which requires taking twice a day for five days, Xofluza only needs to be taken once within 48 hours of symptoms. In other words, 1 tablet of Xofluza can replace 10 tablets of Tamiflu. Xofluza, which received a lot of attention even before its approval and was approved by the Ministry of Food and Drug Safety in November 2019, had low sales due to the massive outbreak of unexpected COVID-19. As expected, sales of Xofluza had to rise from the 2020-2021 season, there were few opportunities for Xofluza to be used due to the unusually low flu epidemic for two consecutive years. This is because the entire nation is obligated to wear masks and social distancing has been strengthened. According to IQVIA, a pharmaceutical market research firm, Xofluza's quarterly sales were less than 100 million won. In the fourth quarter of 2020, which had the most sales, was only 75 million won. Despite sluggish sales, Xofluza has steadily expanded its indication. In January 2021, an indication of influenza prevention therapy was added. Xofluza can be taken as a preventive measure if in contact with an influenza-infected patient. In addition, in the United States this year, the indication has been expanded so that children aged 5 to 11 can use Xofluza. In Korea, only adolescents or adults aged 12 or older are subject to administration. Based on related research data, the age at which administration can be administered is expected to expand in Korea in the future. ◆Re-examination of Xofluza in the flu pandemic warning Xofluza, which has not been seen for two years due to COVID-19, is expecting a full-fledged increase in sales this year. This is because the flu is expected to be prevalent in the 2022-2023 season. The Korea Centers for Disease Control and Prevention issued a national flu pandemic warning for the first time since the COVID-19 pandemic. From the 4th to the 10th of last month, the proportion of influenza doctors (patients with suspicious symptoms) met the epidemic standard at 5.1 per 1,000 people and issued a pandemic warning earlier than usual. Trends in the proportion of suspected flu patients in the 2022-2023 season (Data: Korea Centers for Disease Control and Prevention) In fact, the number of patients with suspected symptoms per 1,000 outpatients is rapidly increasing. In the last week of September (September 25 to October 1), the number of patients showing suspicious symptoms per 1,000 outpatients was 7.1 per 1,000 patients, up 44.9% from the previous week. In preparation for the increase in the number of flu patients, Roche has also secured enough supplies of Xofluza. The Xofluza effect was demonstrated in phase 3 clinical trials (CAPSTONE-1, CAPSTONE-2, BLOCKSTONE). In a CAPSTONE-1 clinical trial of 1,436 patients aged 12 and over, Xofluza shortened the duration of influenza-related symptoms by more than one day compared to a placebo. It had a slight edge over Tamiflu. Xofluza significantly reduced the time to improve symptoms compared to placebo in high-risk groups aged 65 or older with a high risk of accompanying influenza complications (CAPSTONE-2). Subsequently, as a result of prophylactic administration of Xofluza to family members in contact with influenza-infected patients, the risk of developing influenza was reduced by 90% compared to the placebo (BLOCKSTONE). In order for Xofluza to be widely used like Tamiflu, it must be made. Roche attempted to register Xofluza salary in 2020 but received conditional non-payment at HIRA, the first gateway. The Pharmaceutical Evaluation Committee attached the condition that benefits are possible if the evaluation amount is less than or equal to the evaluation amount. Xofluza is still non-reimbursed as it ran parallel in the drug price negotiation process. It is not expected to be easy to apply for benefits during the 2022-2023 flu season. If Xofluza is prescribed as a non-payment, the price of the drug that the patient has to pay is known to be around 80,000 won to 90,000 won.
- Policy
- Proposal for improvement of omission of PE data submission
- by Lee, Jeong-Hwan Oct 14, 2022 05:53am
- Critics said the HIRA's plan to improve the PE data submission system is actually reducing the scope of application of drugs that can be omitted. It is pointed out that the amendment should be fully reviewed as an amendment to destroy President Yoon Suk Yeol's pledge to expand the coverage of severe and rare diseases. On the 13th, Kang Sun-woo of the Democratic Party of Korea criticized the plan to improve the PE system submitted by the Ministry of Health and Welfare and the HIRA. In August, The HIRA announced a partial amendment to the "Regulations on Evaluation Standards and Procedures, such as whether drugs are eligible for medical care benefits," which calls for shortening the processing period of drugs that can be omitted and expanding drugs that can be used for PE biological drugs. The reason for the revision of the regulations explained by the HIRA is to expand the number of medicines that can be omitted from submitting PE data. Kang argued that contrary to the HIRA explanation, when the amendment is applied, the drugs subject to the PE system will be rather reduced. It is pointed out that the standard for "minority of target patients," which has been one of the conditions for medicines that have been omitted from submitting PE data, will be changed to the basic condition in the revision, reducing the scope of major drugs. "Developed countries such as the U.S. and the EU have 5 and 6.4 patients per 10,000 people, respectively," Kang said. "Korea should also recognize exceptions considering the disease characteristics to expand or flexibly apply the number of PE patients in line with advanced countries." Rep. Kang said, "If the meaningful quality of life improvement is proven in children, it is considered meaningful, but even in this case, the expected number of patients is limited to 200, and drugs that can prove the meaningful quality of life improvement in children are still excluded."
