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- 2025-12-18 08:19:54
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- Korean-made new drug Rolontis readies for FN drug market
- by Moon, sung-ho Mar 24, 2021 05:45am
- Hanmi Pharmaceutical is readying for the febrile neutropenia (FN) treatment market for its first bio new drug Rolontis (eflapegrastim), as it finally received the South Korean health authority’s market authorization. This could be an opportunity for the South Korean company to take over the domestic drug market, currently led by global pharmaceutical companies. # On Mar. 18, South Korea’s Ministry of Food and Drug Safety (MFDS) approved the marketing of Hanmi Pharmaceutical's 'Rolontis' as the 33rd new drug developed in the country. At the same time, Hanmi Pharm entered the countdown of Rolontis' entry into the U.S. market. The U.S. Food and Drug Administration’s (FDA) `pre-approval inspection (PAI),’ previously delayed due to COVID-19 pandemic, has been scheduled in May. A ‘long-term use' new drug, is it a blockbuster drug material? FN refers to an abnormal decrease in neutrophils, which must occupy 50 percent to 70 percent of white blood cells. There are many factors that cause FN, but it is typical that most cancer patients develop FN due to several anticancer treatments. For this reason, treatments are mostly prescribed for the prevention or treatment of FN caused by anticancer treatment. It has been prescribed for all carcinomas in recent years, including leukemia and breast cancer. Professor Park Inkeun of Oncology Department at Gachon University explained, “Neutrophils are a type of white blood cell and, in simple terms, are responsible for defending against bacterial infection. When chemotherapy is performed, the number of neutrophils decreases, but it recovers over time. However, a treatment is prescribed because there is a risk of infection occurring at the stage of decreasing neutrophils.” The professor added, “Just as people drink differently, the amount of neutrophil reduction is different for each patient. In particular, it could be fatal for elderly patients. For this reason, FN treatments are also administered for prevention purposes every chemotherapy cycle. It's not a one-off shot.” Then, how about the competitiveness of Rolontis in the market? #The FN treatment market in the past used to be dominated by granulocyte colony-stimulating factor (G-CSF) drugs, but recently next generation G-CSF drugs for preventive purpose are expanding in the market. At the moment, the market is dominated by Amgen’s Neulasta (pegfilgrastim), which Kyowa Kirin Korea is supplying to the South Korean market. Meanwhile, Hanmi Pharmaceutical disclosed the data collected from two global Phase II trials (ADVANCE and RECOVER) facilitated by the company’s partner Spectrum Pharmaceuticals. The two trials conducted on 643 early-stage breast cancer patients with FN caused by anticancer treatment confirmed the safety and efficacy of Rolontis. Within total four treatment cycles, Rolontis, compared against its competitor Neulasta, demonstrated non-inferior duration of severe neutropenia (DSN) and superior reduction of risk. Healthcare providers reserve opinion on Rolontis dominating the market Hanmi Pharmaceutical is planning to go through an official domestic market release process as it obtains the world's first approval for Rolontis in South Korea, regardless of the approval by the U.S. FDA. The size of the domestic market for FN drug is estimated at 80 billion won. The figure is the sum of the annual sales of the first and second generation G-CSF drugs, but Rolontis would compete directly against the second generation G-CSF drugs. The top-selling drugs are Neulasta (Kyowa Kirin Korea), Neulapeg (GC Pharma), Lonquex (Teva Handok) and Dulastin (Dong-A ST). A pharmaceutical market research firm IQVIA reported, the sales of these four second-generation G-CSF drugs have been steadily increasing since 2017, reaching about 46 billion won last year. Meanwhile, in the healthcare providers mostly predict, even if Rolontis is released in South Korea, highly unlikely the drug would dominate the market easily. The market size is relatively small, while already-commercialized products have stable presence in the medical field. Ultimately, the company would have to target the overseas market. Currently, the global market is estimated at 3 trillion won.
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- This situation of mixing Lyrica with other doses is absurd
- by Kang, Shin-Kook Mar 22, 2021 06:16am
- When it was confirmed that Pfizer Korea's Lyrica had mixed drugs with different doses, The Korean Pharmaceutical Association urged a countermeasure to prevent recurrence. The KPA(Chairman Dae-eop Kim) made a statement on the 17th, saying, "The case where different doses of pharmaceuticals are mixed & packaging in the bottle is a serious problem that should not exist in the GMP process." "The basics of quality control have not been observed," he pointed out. The KPA said, "The government has achieved success in joining the Pharmaceutical Inspection Co-operation Scheme (PIC/S) to enhance the international reliability of the quality of domestic drugs, but paradoxically, the management of overseas manufacturing facilities of multinational pharmaceuticals has been neglected. In the year, the quality problems of imported medicines have been constantly being raised.” The KPA said, "As the manufacturing facilities for imported drugs are overseas, it is limited to check the problems of the manufacturing process. It is necessary to prepare intensive measures related to imported drugs, such as expanding due diligence at overseas manufacturing facilities and strengthening customs clearance procedures. As the 20th National Assembly has implemented a registration system for overseas manufacturing companies to strengthen safety management of imported drugs, and amendments to the Pharmaceutical Affairs Act, which established the grounds for taking measures to suspend imports according to the results of local due diligence, thorough supervision and expansion of specialized overseas investigators." In addition, The KPA said that it was necessary to improve the quality of imported drugs and to cooperate in prompt handling of complaints with the suspension of the sale and collection of imported drugs. The MFDS confirmed that Pfizer imported and distributed Lyrica bottles with different doses mixed with medicines, and issued an urgent sales suspension and recall order.
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- KMA recommends Tylenol for fever after AZ vaccination
- by Kang, Shin-Kook Mar 10, 2021 06:26am
- After the AstraZeneca COVID-19 vaccination, the frequency of fever or muscle pain was found to be 20-30%, and the KMA recommended taking Tylenol. The KMA (Chairman Choi Daejip) released a recommendation containing countermeasures after the COVID-19 vaccine vaccination to the public on the 6th. The KMA said, "In the case of the AstraZeneca vaccine that will be vaccinated this time, the frequency of fever (more than 38°C) or muscle pain after vaccination is known to be 20% to 30%. It's better not to take antipyretics if patient doesn't have a hard time." The KMA said, "There is a concern that taking antipyretic drugs will reduce antibody formation, and patient doesn’t have to go to treatment only with fever symptoms." It recommend Acetaminophen (Tylenol), which has little effect on antibody formation, in case of more than 38.5°C. The KMA said, "In case of fever within 24 hours of less than 38.5 °C, please take a break at home instead of visiting ER. If patient is having a lot of trouble and anxiety due to a high fever of 38.5°C or higher and muscle pain, consider outpatient treatment at a clinic during the day and an ER visit in the evening and at night. In the case of a fever of 38.5°C or more or a fever that lasts more than 24 hours, it is recommended to receive medical treatment."
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- Frequently consumed OTC drug prices differ in pharmacies
- by Kang, Shin-Kook Feb 03, 2021 06:09am
- The price gap of Tyrenol ER, Gelfos and Tak-Sen widened up to 150 percent among different pharmacies selling the drugs, which contrasted against high-priced bundle-packaged drugs showing barely any gap. Daily Pharm surveyed 22 pharmacies in Incheon for their frequently sold over-the-counter (OTC) drug retail prices as of February, and it found Tyrenol ER Tablet (6 tablets per package) is sold at maximum 2,500 won and minimum 1,600 won showing around 156 percent, or 900 won difference in prices. The average price for the product is 2,176 won. Gelfos M Suspension (4 packets per package) is sold at maximum 4,500 won and minimum 3,000 won, which also showed about 150 percent, or 1,500 won difference among pharmacies. The average is at 3,940 won. Average priced at 2,976 won, Tak-Sen Soft Capsule (10 tablets per package) are sold at maximum 3,000 won and minimum 2,000 won with 1,000 won (150 percent) price gap. A bundle of Insadol Plus Tablet (100 tablets per package) is priced at maximum 34,000 won and minimum at 31,000 won with an average price of 32,000 won. Insadol’s competitor Igatan F Capsule (100 tablets per package) is also similarly priced at maximum 34,000 won and minimum at 30,000 won showing insignificant price difference among pharmacies. Igatan’s average price is 32,500 won. The pharmacies seem to have found the stabilized price for Aronamin Gold Tablet (100 tablets per package) as they are sold at maximum 28,000 won and minimum at 24,000 won. Also Beecom-C Tablet and Comp Urusa Tablet’s price gap among pharmacies are 4,000 won and 3,000 won, respectively. .Ranging from 70,000 won to 50,000 won, B-max Meta Tablets (120 tablets per package) are sold with about 20,000 won difference (140 percent) .And Impactamin Premium Tablet (120 tablets per package) prices ranged from 60,000 won to 50,000 won with 10,000 won gap .The drug’s average price is 59,000 won .Meanwhile, there are frequently consumed drugs with no price gap .Low-priced drinks like Gas Whal Myung Su-Q and Benachio-F Solution had no price difference across all pharmacies .The detailed OTC drug prices across the Incheon region surveyed by Daily Pharm can be found in the following website: (Click HERE for the website) Daily Pharm monthly surveys and discloses frequently consumed OTC drug prices to promote stabilized pricing of the OTC drugs .As frequently consumed OTC drugs are sold with low margin rate, the fair pricing of these drugs is an integral issue for the pharmacist society .Even regional pharmacist organizations are campaigning ‘Fair Pricing for OTC Drugs.’ To make frequently consumed OTC drugs a boost for pharmacy business and not marketing bait for consumers, the fair pricing with adequate rate of margin should be enforced .
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- Efficacy vs. More inoculation? Vaccination plan in dilemma
- by Choi-sun Jan 22, 2021 06:26am
- The public is questioning the actual efficacy of the alternative regimen of the COVID-19 vaccine that reduces dose or delays the booster dose due to the vaccine shortage, Relevant experts give conflicted opinions. Some argue the government should maximize the efficacy with the limited resource, whereas some claim medical evidence is integral before making a hasty decision. ▲Three conflicts: delaying second dose, switching vaccine type and reducing dose volume The main considerations on the vaccine inoculation plan are spacing out the vaccine interval designed at the clinical phase, switching between vaccine types, and lessening the vaccine dose instead of delaying the interval. All conflicts are caused by the shortage in the COVID-19 vaccine. The health authority means to distribute the limited vaccines as much as feasible. Professor Kim Woo-joo at Korea University Hospital Department of Infectious Diseases said, “Delaying the second dose timing, although it has not been scientifically proven, would be cost-effective to immediately block off the COVID-19 transmission and to minimize the damage. But it does not have to be considered as South Korea’s situation is as not urgent as the situation in the U.K.” ▲Experts OK delaying second dose Vaccine and infectious disease experts show open stance on the longer vaccine interval. As the second dose serves as a booster for the first dose, they claim taking the two doses is more important than the timing. Professor Choi Yong-jun of Hallym University College of Medicine explained, “When it comes down to vaccine inoculation, a short interval can be problematic, but delaying it does not raise a concern. This is one of basic principles of vaccine inoculation.” The booster dose activates the immunocytes and antigen memory inducing the antibody reaction after the first dose. The second dose is only needed as a single shot of vaccine cannot guarantee 100-percent immunogenicity. In other words, the longer interval does not drastically affect the efficacy of the vaccine. ▲On switching the vaccine types, ”Absolutely not” Meanwhile, the experts are leaning towards an absolute negative stance on mixing the vaccine types. The U.K. authority considered inoculating Pfizer vaccine for the first dose and AstraZeneca vaccine for the second, but they had to withdraw the plan after the public criticism that there is not enough clinical evidence to ensure safety in the switch. Director Kang Jin-han at the Catholic University of Korea Vaccine and Bio Research Center firmed noted “The vaccine type switching is definitely not advisable. There is no evidence and it is unethical.” With a concerned voice, he added, “The clinical trial protocol on confirming the efficacy of a COVID-19 vaccine was conducted twice with the same vaccine type. Nobody knows what would happen when using two types of vaccines.” ▲Unsure of the low-dose inoculation Then, how about inoculating a lower dose vaccine, instead of a full dose? The experts carefully say the efficacy should be verified first. Theoretically, the full-dose inoculation would be idealistic to confirm the efficacy, but strangely there was a case a vaccine performed better with lower dose. During the Phase II/III trial on AstraZeneca’s vaccine candidate AZD1222, about 10,000 participants aged over 18 were inoculated twice with a month-long interval, and their prevention effect was checked after two weeks. The result found 2,741 people who received one dose achieved 90 percent of the effect, whereas 8,895 people with the two full doses only reached 62 percent. The vaccine efficacy improved by 28 percent-point with the one dosing regimen. Moderna disclosed research findings that half a dose of vaccine demonstrating similar effect with a full dose. Generally, lesser dose should show equivalent or inferior efficacy than the full dose, but AstraZeneca’s vaccine performed better with reduced dosing. Korean Society of Infectious Diseases (KSID) official pointed out, “The appropriate evidence of a lower dosing performing better than higher dosing cannot be found. We need a large scale clinical trial for more credible source of evidence.” ▲The health authority’s decision based on vaccine supply " The daily confirmed case count of COVID-19 in South Korea has dropped under 500. Taking account of the situation, the radical inoculation plan to switch the vaccine type or delaying the booster dose sound unrealistic at the moment. The Ministry of Food and Drug Safety (MFDS) official stated, “Except for an alarming crisis in the pandemic control, vaccination should be based on the label approved by the clinical evidence. The research data on lower dosing regimen and longer vaccine interval could be used for the inoculation plan, if need be.” Korea Disease Control and Prevention Agency (KDCA) plans to review all possibilities, as there is some time left until the vaccine supply arrives and the inoculation starts. The agency official also added, “The detailed would be unveiled later, but the agency is carefully setting up the vaccination plan by referring to experts’ opinions.”
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- What are the latest COVID-19 drug guidelines?
- by Choi, sun Jan 08, 2021 06:19am
- As COVID-19 pandemic has passed a year, the guidelines for drug use are being updated a lot. As the evidence was accumulated, the differences in the guidelines for use by each country decreased, and detailed recommendations for practical use were derived with recommendations for use and refraining from various cases even with the same drug. Based on the latest academic research, the KSID (The Korean Society of Infectious Diseases) also presented a guideline for drug treatment for COVID-19 infection on the 31st. Based on this, guidelines for drug use and changes in each case were summarized. Remdesivir, approved in Korea in July, has detailed use cases for each patient's condition. The example applied when oxygen therapy is required in patients hospitalized with COVID-19 is different. First of all, Remdesivir can be used (level of evidence: moderate, grade of recommendation: B) for patients with COVID-19 who require oxygen therapy but do not need a ventilator or ECMO treatment, the KSID judged. If this is not the case, the recommendation for administration of Remdesivir was withheld (level of evidence: moderate, grade of recommendation: I). Efficacy and safety of Steroid were also summarized in the latest research. In the early days of COVID-19 epidemic, controversy about the suppression of the immune system and the growth of the virus was raised by steroid administration, but recently, it is being placed on the effectiveness in severe patients. The KSID recommended the administration of Steroids to patients with severe or severe COVID-19 by severity (level of evidence: moderate, grade of recommendation: A). As a clinical consideration for Steroids, Dexamethasone 6mg per day is administered for 7-10 days, and other steroids such as Hydrocortisone 150-200mg, Prednisone 40mg, Methylprednisolone 32mg can be substituted. Steroid administration was not recommended for non-severe corona19 patients (level of evidence: moderate, grade of recommendation: C). Interleukin inhibitors that control inflammation-inducing factors are also classified according to their components and patient severity. Interleukin-6 (IL-6) inhibitors include Tocilizumab and Sarilumab. Interleukin-6 inhibitors can be used within the scope of clinical trials in patients with severe COVID-19 (level of evidence: moderate, grade of recommendation: B), but not recommended for patients with mild COVID-19 (level of evidence: moderate, grade of recommendation: C). Recommendations for the administration of Interleukin-1 (IL-1) inhibitors to COVID-19 patients have been withheld (level of evidence: low, grade of recommendation: I). Plasma treatment, which caused controversy over the effectiveness of treatment, was also put on hold. Plasma therapy is a method of using the immunity of a person who is cured after viral infection. It is a method of collecting COVID-19 antibodies present in the plasma of a cure and administering them to other infected people to fight against the virus, but the effectiveness is still controversial worldwide. As the study that presented the effect and the study that showed no effect were sharply mixed, the lack of clinical participants and the poor clinical design of the study were pointed out as the cause. As a result of combining several studies, the KSID decided to withhold the recommendation for recovery plasma treatment for patients with COVID-19 in the blood system fee (level of evidence: low, recommendation grade: I). General intravenous immunoglobulin (IVIG) administration was also not recommended for patients with COVID-19. However, it suggested that the use of immunoglobulins should not be excluded in the treatment of complications (level of evidence: low, grade of recommendation: C). Chloroquine was actually scheduled to be withheld as a COVID-19 treatment. Chloroquine suppresses the maximum effective concentration of the virus by half in laboratory studies, but in actual studies involving SARS and MERS, there has been no high-quality evidence of efficacy. The KSID also concluded that based on the latest studies, it does not recommend either the administration of Hydroxychloroquine alone or in combination with Azithromycin for COVID-19 patients (level of evidence: high, recommendation grade: C). The KSID concluded that it does not recommend AbbVie's antiviral drug Kaletra (Lopinavir/Ritonavir) for COVID-19 patients. The level of evidence is high. In fact, it means that even the use of the drug is ineffective or that statistically significant differences cannot be identified. Administration of other drugs known to have antiviral effects such as Favipiravir, Ribavirin, Umifenovir and Baloxavir marboxil is not recommended except for clinical trials (level of evidence: low, grade of recommendation: C).
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- “The lower the income, the later the cancer diagnosis”
- by Eo, Yun-Ho Dec 16, 2020 06:13am
- A survey found a clear correlation between the income level and the level of tumor development and metastasis when a patient with cancer is diagnosed. A not-for-profit organization advocating the improvement in inefficiency in cancer treatment environment, ‘All.Can Korea’ kicked off on Dec. 10 and disclosed a survey result on 495 cancer patients. All.Can Korea said the objective of the survey was to explore inefficiency a cancer patient in South Korea experiences during their treatment, and to seek detailed solution for the patient-centered cancer treatment environment. The survey was conducted with cancer patient organizations via an online platform, and the questionnaires were categorized into four areas—cancer diagnosis, cancer treatment, post-treatment management, and exposure to cancer treatment information and financial impact. The lower the income, the later the patient finds out about the cancer As a result, the majority of patients said they had ‘first discovered the cancer, when they detected the symptoms.’ The majority of the respondents (38.1 percent) answered they were diagnosed with cancer after experiencing detectable symptoms, even for the six major cancer types (stomach, colon, liver, breast, ovarian and lung cancers) examined by the national health check up program. And the phenomenon was more apparent when the monthly household income was lower. Also the level of tumor development and metastasis differed vastly depending on the cancer patient’s monthly income level. 35.5 percent of the respondents were earning less than 3 million won a month when diagnosed at stage I, whereas 57.8 percent of patients earning more than 6 million won a month were diagnosed at the initial stage. So the higher the income, the earlier the patients discover about the cancer. Comparatively more patients with lower monthly income were diagnosed at stage IV. And 18.2 percent of the respondents with income less than 3 million won had their tumor already metastasized at the point of initial diagnosis, which doubled the rate of respondents making over 6 million won at the 8.4 percent. Cancer patients do not see the need to manage their mental health Regardless of their mental distress during diagnosis and treatment, the patients seemed to be unaware of the necessity of mental support due to the imminent financial complications they face in daily life. The top two factors the respondents answered they were most concerned about when diagnosed with cancer were ‘the fear of possible death (36.8 percent)’ and ‘concerns for the family (36.8 percent).’ They picked ‘financial aid for expensive non-reimbursed examination cost’ as the most wanted improvement (48.3 percent). The difficulties during cancer treatment showed more than 20 percent point differences ranging from 46.5 percent of answering ‘physical pain’ to 45.5 percent ‘mental distress,’ 41.3 percent ‘faltering mental state,’ 26.9 percent ‘financial complications’ and 21.5 percent ‘burden of treatment cost.’ But the most sought after answer to solve the difficulties was ‘financial support for treatment and sharing information related to the system’ with 24.5 percent. However, a patient’s mental health is a crucial factor that also affects the cancer treatment outcome. Accordingly, other countries even include counseling sessions in the cancer treatment process starting from the diagnosis, but South Korea has not implemented such multidisciplinary treatment and the patients even have negative perception on psychological therapy. Representing All.Can Korea, Choi Sung-chul said, “The survey holds an integral meaning as it has confirmed the inefficiency the patients experience during the entire cancer management process starting from diagnosis through post-treatment phase. All.Can Korea is to create a patient-centered efficient cancer treatment environment by focusing on the most important parts that help the patients to fight against cancer.”
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- Instructing Tamiflu users on neurological side effect
- by Kang, Shin-Kook Dec 11, 2020 06:14am
- “Have you heard of that incident two years ago, where a middle school student took a fall after taking Tamiflu?” The importance of influenza treatment administration instruction is reiterated due to the reported neurological adverse reaction after the administration. On Dec. 9, the Korean Pharmaceutical Association (KPA) notified and warned the regional offices of the neurological adverse reactions like spasm and delirium, especially in children and adolescents, who have administered influenza treatment by oral (oseltamivir), inhalation (zanamivir) and injection (peramivir) route. The Ministry of Food and Drug Safety’s (MFDS) safety alerts reported adverse behavior of a user taking a lethal fall. But a similar adverse reaction can be found in patients who did not take the drug. Accordingly, the influenza treatment administration instruction highlights the healthcare provider to inform the patient and their guardians of the risk of adverse behavior and ensure the guardians to not leave the influenza patient alone for at least two days, regardless of taking the treatment or not. And the patients’ guardians should also be guided to lock windows, veranda windows and entrance door to prevent any adverse behavior by the influenza patient and closely monitor them. In December 2018, a female middle school student in Busan took a fall after taking Tamiflu, which raised an issue with the hallucination-related adverse reaction from the drug. The investigation on the healthcare provider and pharmacist who prescribed and dispensed Tamiflu to the deceased student confirmed both of them never explained about the adverse reaction, and as a result the pharmacist was fined.
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- What’s it like to have ATTR-CM in Korea
- by won, jong-hyuk Dec 10, 2020 06:09am
- A few years ago, a 50-year-old man visited a hospital when he experienced shortness of breath and edema. But he had to visit a number of hospitals for years for examination as he struggled to pin point the name of the disease. And one day, he felt tingling sensation in his toes and examined the heart. That was the time he had to face his rare disease called hereditary transthyretin amyloid cardiomyopathy (ATTR-CM). Typically categorized as either wild type or hereditary, ATTR-CM is an ultra rare disease that has extremely limited patient size and the prevalence rate in South Korea has not been estimated. To this date, about over 120 types of genetic mutation have been reported, and apparently some of them show qualities of endemic disease in specific regions. But the biggest issue is that the disease is easily diagnosed as other disease. Some of the major symptoms of ATTR-CM include congestive heart failure, shortness of breath, edema, fatigue and more. And because of these symptoms, the rare disease is often misdiagnosed as unexpected restrictive cardiomyopathy, heart failure, irregular heartbeat and heart failure with preserved ejection fraction (HFpEF). According to the researches done by academic societies so far, ATTR-CM is identified as a critical advanced rare disease resulting in restrictive cardiomyopathy caused by extracelluar deposition of transthyretin (TTR), normally involved in the transportation of the hormone thyroxine and retinol-binding protein, in the myocardium Moreover, these patients’ prognosis could be worsened rapidly due to accumulated amyloid, and in fact, the survival period from the point of diagnosis is only about two to 3.5 years. Considering the dire conditions, experts reiterate “An accurate early diagnosis is crucial for adequate disease management and improved treatment in patients with ATTR-CM.” ATTR-CM treatment manages heart failure and irregular heartbeat, and uses treatments” Even for ATTR-CM treatment scene with an absence of adequate treatment, a new door to treatment option was opened from August. For the South Korean market, Vyndamax (tafamidis) is now indicated to treat adult patients with ATTR-CM based on its evidence of reducing the risk of heart-related death and cardiovascular issue-related hospitalization. The drug is the first and only treatment for the disease in South Korea. The American Heart Association (AHA) recommends three treatment types for ATTR-CM—managing heart failure and irregular heartbeat, and using treatments. Before the new indication approval, the only treatment was to manage the organ failure symptoms and to slow down the disease progress. But ultimately, Vyndamax became a breakthrough treatment that patients can expect to reduce risk of cardiovascular-related death or hospitalization as the health authority cleared the drug. The U.S. Food and Drug Administration (FDA) approved the treatment for patients with wild type or hereditary ATTR-CM, and more specifically the patients categorized as New York Heart Association (NYHA) Heart Failure Class I through III. The U.S. health authority reflected the recommendation of the drug contributing in delaying the disease progress when consuming Vyndamax at early stage. Also, the Summary of Product Characteristics on tafamidis, published by the European Medicines Agency (EMA) mentions “To seek for more accurate clinical benefit in progress of ATTR-CM, tafamidis treatment should be initiated as soon as possible.” Rate of misdiagnosis high in South Korea and delays actual treatment The approval on Vyndamax was based on the results of a multicenter, placebo-controlled Phase III ATTR-ACT study with 441 patients with ATTR-CM. The 441 patients were randomly assigned to administrating 80 mg or 20 mg of tafamidis or placebo. The primary endpoint evaluated the frequency of cardiovascular related death and hospitalization. The secondary endpoint was the change in the Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS) score from 6-minute walk test taken and compared among the baseline time to 30-month point. The study found 264 people, who were administered with two different doses of tafamidis, had 29.5 percent and 42.9 percent lower risk of death by all causes, respectively, than the 177 in the placebo group and the risk of hospitalization also improved statically. Moreover, the KCCQ-OS score and the 6-minute walk test at the 30-month point were improved significantly with the drug. The president of the Korean Society of Heart Failure and a cardiology professor at Seoul National University Bundang Hospital, Dr. Choi Dong-ju emphasized, “ATTR-CM has high rate of misdiagnosis, which usually delays the diagnosis process. The ATTR-CM patients tend to only survive at least two to 3.5 years after the diagnosis, so an early diagnosis and aggressive treatment are important.” Dr. Choi elaborated, “Although the studies and investigation on the disease is insufficient in South Korea, an effective treatment Vyndamax is already approved for prescription. If the patients can quickly get diagnosed, they would be able to manage their prognosis better. But because the drug is not listed for reimbursement, the financial burden on ATTR-CM patients in Korea is unfortunately very high. I hope the treatment access improve even by a bit as the disease has to be both urgently diagnosed and treated.” Regardless of all efforts by the government and other organization, the only treatment option Vyndamax is still not listed for reimbursement in South Korea.
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- COVID-19 vaccine almost there, how about cost-effectiveness?
- by Choi,sun Dec 07, 2020 06:05am
- The anticipation for the COVID-19 vaccines in development is soaring as a number of global pharmaceutical companies have announced successful clinical trial results. The health authority and the public would closely follow the vaccines’ further development to confirm their effect, safety and reasonable pricing. ▲The COVID-19 vaccine candidates currently in Phase III trial Total 11 candidate vaccines have initiate their Phase III clinical trials globally, categorized in three major types of mRNA, virus vector and inactivated vaccine. BNT162, in development by Pfizer and BioNTech, and mRNA-1273 by Moderna are mRNA vaccines. Instead of an attenuated vaccine that reduces virulence for the injection, mRNA vaccine uses mRNA strand from a virus to manufacture the vaccines fast. On the contrary, AstraZeneca, Janssen, Gamaleya (Russia) and CanSino Biologics (China) are developing viral vector vaccines. The type of vaccine injects viral vector to transport the viral gene. AstraZeneca’s candidate vaccine uses chimpanzee adenovirus-based vector to combine the spike-like protrusions on COVID-19 virus. Moderna has also applied for the use approval on Nov. 30 in the U.S. and EU for its 100-percent effective vaccine proven through Phase III trial findings. The U.S. Food and Drug Administration (FDA) scheduled the vaccine approval review on Dec. 11 and 17 for Pfizer and Moderna, respectively. ▲Clinical results for each vaccine disclosed but AstraZeneca leaves questionable findings On Nov. 23, AstraZeneca presented the results of Phase II/III on its developing vaccine AZD1222. The clinical protocol was to confirm the COVID-19 prevention effect shown two weeks after two doses of vaccine administered in one-month interval on 10,000 volunteer subjects aged 18 and over. The trial found the vaccine was 90 percent effective in 2,741 subjects who were administered with a half-dose, whereas it was 62 percent effective in 8,895 subjects who had a full-dose. Total 131 subjects were reportedly infected with the virus. AstraZeneca claimed the vaccine is average 70 percent effective by combining the two trial findings from 11,636 volunteers. Apparently, the company had no reports of severe adverse reaction. The medical experts are clashing over the AstraZeneca’s vaccine; they are conflicted over the facts that the half-dose was more effective and the company insisting on the average efficacy deducted from using two different doses. Also the experts are suspecting the use of half-dose could have been an unintentional error in the trial. An insider from the Korean Society of Infectious Diseases (KSID) commented, “It is odd to calculate average by adding the results from two different dose groups, but also we are questioning the credibility in the efficacy data extracted from only 2,741 people. FDA requires data analysis from at least 30,000 people.” Regarding the skepticism, Dr. Kim Woo-joo at Korea University Guro Hospital Department of Infectious Disease said, “A half-dose vaccination showing higher efficacy is an exceptional result. A lot of news media is reporting it as an error, but a clinical trial cannot possibly have such error.” ▲mRNA vaccine competition, Moderna 94.5% vs. Pfizer 95% An interim analysis of Moderna’s COVID-19 vaccine Phase III COVE study was announced on Nov. 16. The protocol targeted 30,000 people administering two doses in four-week interval to confirm the COVID-19 infection after two weeks. In the first interim analysis, total 95 people were infected, including 90 people receiving placebo and five people receiving the mRNA vaccine. The vaccine was 94.5 percent effective. The reports on the adverse reactions were of mild cases, such as pain around the injected area and fatigue. The second endpoint was the number of COVID-19-infected people after using the vaccine. The placebo group had a total of 11 severe cases, but none of the mRNA vaccine group reported a severe case. Based on the findings, Moderna claims their vaccine is 100-percent effective against severe case of COVID-19. Pfizer administered two doses of their vaccines on 43,661 people in 21-day interval. Total 10 cases were confirmed with the virus, where nine were from the placebo group and one was from the vaccine group. Analyzing the result, the company states the vaccine is 95-percent effective. The vaccine had no reports of adverse reaction so far. Dr. Kim Woo-joo mentioned, “In regards to the efficacy, Moderna and Pfizer’s vaccine demonstrating 94.5 percent and 95 percent efficacy is outstanding. Now the problem is distribution of these vaccines.” ▲Taking account of cost-effectiveness, which could be accessible from South Korea? The experts say all three vaccines are over 90-percent effective, if they were to directly quote AstraZeneca with their 90-percent effective vaccine trial result. However, the three vaccines have widely contrasting distribution methods and pricing. First, Pfizer’s vaccine requires to be stored at minus 70 degrees Celsius. The vaccine is priced at USD 19.50 (approximately 21,600 won) per dose (requires two-dose administration). And as the vaccine distribution would need a cold chain to maintain the minus 70 degrees Celsius, the actual administration cost would be much higher. Considering South Korean flu vaccine distribution struggled to maintain 2 to 8 degrees Celsius, distributing Pfizer’s vaccine soon may be out of question. The Ministry of Food and Drug Safety (MFDS) official commented, “Pfizer’s COVID-19 vaccine requires an ultra-cold chain to deliver them at minus 70 degrees Celsius. It is questionable a company in South Korea would be able to handle mass distribution of Pfizer vaccine in such challenging environment.” Moderna vaccine, on the other hand, has to be stored at minus 20 degrees Celsius. As normal refrigerated distribution is kept at around minus 20 degrees Celsius, the vaccine distribution would be more manageable by private companies. But the issue is its pricing. Moderna says it would be priced at 32 to 37 dollars, or approximately 35,500 won to 41,000 won. For the two-dose administration, it would cost more or less 80,000 won. Meanwhile, AstraZeneca’s vaccine can be distributed at around 2 to 8 degrees Celsius and is priced at around 4 dollars per dose (approximately 4,400 won). The experts argue the vaccine would be most preferred with the cost of about 10,000 won for two-dose administration. Regardless of the emergency approval given to the vaccine in other countries, the company would be able to start the distribution in the first quarter next year at earliest as it would need to wait for the MFDS approval, vaccine procurement contracting and manufacturing. MFDS official added, “We would have to wait and see first if the actual vaccination result would match its clinical finding, as it started its emergency use approval application procedure in other countries. If AstraZeneca can prove the low-dose vaccine efficacy through additional clinical trials, their vaccine would be most adequate to be used in South Korea.”
