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- 2025-12-23 16:24:58
- Policy
- Aduhel has been applied for permission in Korea
- by Lee, Tak-Sun Jul 19, 2021 05:56am
- Recently, Aduhel (Aducanumab), a new drug for Alzheimer's disease approved by the U.S. Food and Drug Administration (FDA), has applied for permission in Korea. Aduhel is a new drug for Alzheimer's disease approved by the U.S. FDA in 18 years, the first drug to target the amino acid peptide β-amyloid known to be involved in the disease. The FDA approved after much meandering last month, but controversy still persists. According to industry sources on the 15th, Biogen Korea recently applied for Aduhel's approval from the MFDS. Aduhel was approved by the U.S. Food and Drug Administration on the 7th (local time) on condition that a post-marketing investigation would prove its effectiveness. The FDA determined that Aduhel's therapeutic benefits over risk for Alzheimer's patients. Aduhel did not meet the primary evaluation variables in EMERGE and ENGAGE clinical trial studies. Accordingly, in November last year, the FDA advisory committee decided that there was insufficient evidence to prove its effectiveness. However, Biogen further analyzed the clinical data and applied for approval from the FDA based on validation in the high dose group. Aduhel was approved, but the controversy continues. Three FDA advisors who opposed Aduhel's approval resigned, raising controversy over the appropriateness of the permit. The FDA recently asked the Office of Independent Inspectors (OIG) to investigate Aduhel's approval. Some say that indications may have been reduced as the FDA suggested prescription guidelines and added that patients with mild cognitive impairment or early Alzheimer's should start using Aduhel. The MFDS has been reviewing new drugs approved by the U.S. FDA and European EMA by applying advantage. Therefore, most of them were granted without difficulty. It is expected that Aduhel will not be able to gather consensus during the screening process as controversy continues even after approval. However, it is believed that the demand for new drugs for Alzheimer's disease will be actively reflected in the licensing review. In June last year, Aduhel was approved for clinical 3b in Korea and tested its efficacy on 41 patients.
- Policy
- Once 'out of stock' Bayer Aspirin 100mg to be discontinued
- by Lee, Tak-Sun Jul 16, 2021 05:54am
- Bayer decided to discontinue domestic supply of its antipyretic analgesic, ‘Bayer Aspirin 100mg.’ Despite the company’s explanation that the decision was made due to poor sales, the pharmacys’ eyes are not so kind on the company's decision as they have suffered shortages of stock issues regarding the product. According to the Ministry of Food and Drug Safety on the 15th, Bayer has decided to discontinue the supply of its Bayer Aspirin 100mg tablet on the 31st of this month. Bayer Korea explained, “We made the difficult decision to discontinue import of the product due to a decline in sales. We will discontinue supply with the last import of the product on December 29th last year." However, the company will continue to import and sell the Bayer Aspirin 500mg tablet. The company plans to inform wholesalers and HCPs with an official notice at the time of discontinuation. As the indication, effect, dosage, and regimen of the 100mg and 500mg doses are identical, it seems unlikely that the market withdrawal of the 100mg dose will cause a supply shortage. Bayer Asprin tablets are used to reduce and relieve mild to moderate pain from the common cold and other conditions such as headaches, toothaches, sore throats, menstrual pain, muscle and joint pain, backache, and minor arthritis pain. Patients aged 15 and over may take 500mg~1000mg orally once every 4 hours. As the starting dose is 500mg, it is true that the 100mg tablets are sold less. However, as the dose is increased or reduced according to the patient's age, condition, and symptoms, and a lower dose is required for pediatric patients without an indication, the 100mg tablet does have its use. The Aspirin Protect tab. is also a 100mg product but it has a totally different indication as it is used for the prevention of cardiovascular diseases. Pharmacies have been less trusting of Bayer Aspirin products due to their frequent out-of-stock issues. In particular, in 2017, the company's relocation of its manufacturing plant from Germany from Indonesia had halted sales of the drug for over a year. The company resumed sales in November 2018, but the instability in supply and demand continued with the 100mg product later becoming temporarily out-of-stock. A pharmaceutical industry official said, “The Bayer Aspirin 100mg tablet was out of stock in June, but I didn’t expect the company to stop importing the drug completely. Due to the long-term out-of-stock issue of the 500mg product, I have lingering distrust in the company’s ability to provide a stable supply.” Bayer Aspirin was made by chemist Felix Hoffman in 1897 using acetylsalicylic acid based on a willow bark extract. The product, which has been sold for over 120 years, was released in Korea in 1980. According to IQVIA, the Bayer Aspirin tablet sold around 1.7 billion won in sales in Korea last year.
- Policy
- 2nd AZ·Pfizer·Moderna shot prevents variants by 80%
- by Lee, Hye-Kyung Jul 16, 2021 05:54am
- Study results on the preventive effect of the AstraZeneca, Pfizer, and Moderna vaccine against variants showed that the vaccines had a preventive effect of over 80% after completing the two-dose regimen. The prevention effect was greater against the Alpha variant than the Delta. In preventing symptomatic infections, the vaccines had a similar prevention effect against variants and the original virus. Mixed vaccination using the AstraZeneca and Pfizer vaccine showed a neutralizing antibody response that was similar or higher than that of those using two shots of the same vaccine and the systemic reaction was at an acceptable level. The National Evidence-based Healthcare Collaborating Agency (NECA, President: Kwang-hyub Han) and the Korean Academy of Medical Sciences (KAMS, President:Ji-Tae Choung) jointly presented the results of the "Rapid review on issues regarding COVID-19 vaccines" study on the 15th. On the preventive effect of the current COVID-19 vaccines against variant strains such as the Alpha, Beta, Gamma, and Delta strains, the vaccines demonstrated a clinically significant effect (prevention of symptomatic infections, hospitalizations, and death). Regarding the preventive effect of the vaccines against variants, the vaccines were slightly less effective against the variants compared to the original virus, but still, the vaccine had a preventive effect of over 80% when subjects completed the two-dose regimen. The vaccines had a stronger preventive effect against the Alpha variant than the Delta. In preventing symptomatic infections, the preventive effect was of the vaccines was at a similar level for variants and the original virus. When completing a single shot of vaccination, the risk of hospitalization and deaths from variant infection was reduced by 78-96%, and after the second shot, by 86-96%. Also, the vaccines' effect on reducing hospitalization and deaths was not largely different against different types of variants, however, the data available as of now were insufficient to discern the severity of the events. Mixed vaccination using the AstraZeneca and Pfizer vaccine showed a neutralizing antibody response that was similar or higher than that of those using two shots of the same vaccine. Systemic reactions increased after the use of mixed vaccines, but at an acceptable level. On the immunogenicity after receiving mixed vaccinations, the study showed that receiving mixed vaccinations also elicited a neutralizing antibody response against the COVID-19 virus. In general, immune response increased after mixed vaccinations compared to two doses of the AstraZeneca vaccine, and was similar or higher than that measured after two doses of an mRNA vaccine (Pfizer, Moderna). The mixed vaccination had increased systemic response compared to two doses of the same vaccine, but was tolerable and at an acceptable level. However, as only short-term safety studies existed on mixed vaccination, it was difficult to evaluate the adverse events that have a low incidence using studies based on the current scale. The mixed vaccination regimen had increased immune response against the variants compared to two shots of the AstraZeneca vaccine and had an increased or reduced effect compared to two shots of the Pfizer vaccine, depending on the type of variant. But the limitation was that only small-scale studies with limited results existed for review. No direct studies on preventing infections were available and only studies with immunogenicity results existed for review. Mi-young Choi, head of Clinical Evidence Research Team at NECA said, “This study was the first systemic literature review conducted on the use of mixed dose vaccinations and activities against the variant strains. As most of the reviewed literature were studies in progress or unpublished, quantitative and qualitative limitations do exist in our study.” KAMS Policy Director Ho-kee Yum (Chair of the Expert Committee for COVID-19 Response, Korean Medical Association) said, "We can predict and respond to new infectious diseases to a certain extent by studying existing clinical data. I believe the release of reliable study results from a medical society and the government like this will contribute greatly to reducing the public anxiety that has been rising recently and in overcoming the pandemic.”
- Policy
- Patients with SCLS shouldn't get Janssen vaccine
- by Lee, Tak-Sun Jul 16, 2021 05:54am
- The MFDS said Janssen COVID-19 vaccine should not be vaccinated for people with a history of Systemic Capillary Leak Syndrome (SCLS). This is in accordance with the European EMA recommendation and is similar to the action that was taken on the AstraZeneca vaccine on the 14th of last month. The MFDS released the Dear Healthcare Professional Letter on the 12th. EMA's PRAC announced that Systemic Capillary Leak Syndrome should be added as a new side effect of the Janssen vaccine. It reviewed three cases of Systemic Capillary Leak Syndrome in Janssen COVID-19 vaccine recipients, one with a history of Systemic Capillary Leak Syndrome and two with fatalities. Systemic Capillary Leak Syndrome is a rare and serious condition that causes fluid leakage in small blood vessels (moscevascular), mainly resulting in edema in arms and legs, hypoglycemia, blood concentration, and hypoglycemia (critical blood protein). The MFDS said it will add related precautions to the manual by compiling the current status and safety information at home and abroad, stressing that people with a history of Systemic Capillary Leak Syndrome should not be vaccinated against Janssen vaccine.
- Policy
- Generic for Galvusmet was first approved
- by Lee, Tak-Sun Jul 16, 2021 05:54am
- The timing of the sale varies depending on the results of the Supreme Court's lawsuit against the validity of the patent. Hanmi has been approved for the first time in Korea as a generic for Galvusmet, a diabetes complex affiliated with Novartis' DPP-4 inhibitor. Hanmi developed Vildagliptin HCl and licensed both single and multi-drugs including Vilagliptin. Attention is focusing on whether it will preoccupy markets as it has made efforts to commercialize them early. The MFDS approved Hanmi's Metformin HCl-Vildagliptin HCl. Vildaglmet is the first generic for Galvusmet to be licensed in March 2008. It contains the same Vildagliptin HCl as the single Vildagle approved by Hanmi in February this year. The original Galvusmet is a salt-free Vildagliptin. Vildaglmet is the first licensed Galvusmet in Korea, so it is likely to be released first in the market. Material patent of Vildagle can be released earlier than other companies. The material patent expires on 4 March 2022. An-Gook and Hanmi have reduced the term of 187 days on the Intel Property Trial and Appeal Board and 55 days on the Patent Court through a lawsuit against the extension of the patent. It was shortened in the second trial. If the Patent Court cites the Intellectual Property Trial and Appeal Board's verdict, both companies' products can be released within the year and can be released next year according to the Patent Court. However, the Supreme Court may not recognize the claim for invalidation of the extension. If Supreme Court accepts the an extension of patent term, Ahn-Gook and Hanmi, which filed a patent suit, can be the first to put the product on the market before other companies. Hanmi can release both products at the same time because both single and comination drugs are licensed. This is because all patents related to compound drugs have been avoided. Hanmi has experience in co-selling Galvus with Novartis from 2014 to 2016. After the expiration of the copromotion, Hanmi worked on generic development and set up a strategy to preoccupy the market. It sought early release only with permission for efficacy and effects that did not violate patents, but lost a patent lawsuit. Since then, the product has been withdrawn. Outpatient prescription for Galvus and Galvusmet amounts to ₩8.1 billion and ₩36.4 billion, respectively. Hanmi does not have DPP-4 inhibitors. Therefore, early release of Vildagle and Vildaglmet is expected to expand in the diabetes market.
- Policy
- Kymriah's benefit is urgently needed
- by Lee, Jeong-Hwan Jul 15, 2021 07:07pm
- Leukemia patients have urged rapid health insurance registration of the first end-stage leukemia-Lymphoma CAR-T treatment, Kymriah. Korea Leukmia patients organization asked the government to register Kymriah's benefit and pharmaceutical companies to come up with reasonable financial burdens to strengthen access to medicines for leukemia patients. In a statement, the Korea Leukemia patients organization repeatedly called on the government to push for rapid health insurance benefits, including the introduction of Kymriah, at the fifth Cancer Drugs Benefit Appraisal Committee to be held on the 14th. The organization called for a rapid health insurance registration system for new drugs directly linked to life, such as Kymriah. It also added that Novartis Korea should come up with reasonable financial sharing measures to prevent the recurrence of some immuno-cancer drugs, which have delayed health insurance benefits due to controversy over high-dose financial sharing. "Even if Kymriah is passed at the Cancer Drugs Benefit Appraisal Committee on the 14th, the health insurance benefit will not be completed until November this year at the earliest because the NHIS' negotiations and health insurance policy committee procedures are required," said the Korea Leukemia patients organization. It said, "Most patients with recurrent or end-stage acute lymphocytic leukemia or lymphoma die within three to six months. If Kymriah is covered by health insurance in November, many of the 200 patients expected to be treated annually." It said, "It is a pity that patients who cannot afford to pay about 460 million won (non-reimbursed medical expenses disclosed on Samsung Medical Center's website) have to die while waiting for health insurance to be applied." "The government should complete health care benefits within six to seven months, just like Leclaza, the late-stage lung cancer treatment," the organization said. The organization said, "In the case of Kymriah, the scope of 'new drugs directly related to life' should be determined through social discussions, and health insurance should be applied first by the HIRA." The organization also said that "the HIRA's Cancer Drugs Benefit Advisory Committee, the NHIS' Pharmacological Benefit Advice Committee, and the Health Insurance Policy Committee will take the lead." "Glibec, the world's first targeted treatment for chronic myeloid leukemia, was approved by the MFDS on June 20, 40 days after the FDA approved it in May 2001. "In November, five months after the approval, the MOHW announced health insurance benefits. Twenty years later, the Kymriah process should not be delayed than Glivec. "Since August 30, 2017, when Kymria was approved by the U.S. FDA, the issue of high-priced drug prices has been raised."
- Policy
- Benefit plan of Keytruda & Tecentriq will be discussed
- by Moon, sung-ho Jul 13, 2021 11:08pm
- Keytruda (Pembrolizumab) and Tecentriq (Atezolizumab) from global pharmaceutical companies are challenging to expand their benefits as primary drugs for lung cancer. According to the pharmaceutical industry and the medical community on the 10th, the HIRA's Cancer Drugs Benefit Apparel Committee will discuss ways to expand the benefits of the two drugs at its fifth meeting in 2021. In the case of MSD Korea's Keytruda, five benefit expansion proposals were proposed at the fourth Cancer Drugs Benefit Appraisal Committee meeting in May, and two of them were passed. Benefit needs for urinary epithelial cancer secondary therapy and Hodgkin's lymphoma non-responsive secondary and recurrent fourth or higher therapy were acknowledged. Three strongly desired primary care treatments for lung cancer have been put on hold ▲ Primary treatment of progressive non-small cell lung cancer positive to PD-L1 and free from EGFR or ALK mutations (Solo therapy)▲ Primary treatment of metastatic non-flat cell lung cancer without EGFR or ALK mutation (Combination of Pmetrexed and Platinum)▲Transferable squamous non-small cell lung cancer primary treatment (Parclitaxel/Carboplatin combination). The government has put on hold all the expansion of benefits to primary treatments, which require a lot of funding for health insurance, and analysts say it did not recognize the financial sharing plan proposed by MSD. The Cancer Drugs Benefit Appraisal Committee will discuss expanding the benefit of rival drug Roche Korea's Tecentriq at its fifth meeting scheduled to take place on the 14th. According to a senior official at the Cancer Drugs Benefit Appraisal Committee, it was originally planned to be discussed with Tecentriq in this order regardless of Keytruda's introduction to the conference. In a related development, Roche Korea is said to have applied for Tecentriq (Atezolizumab)'s first solo treatment for non-small cell lung cancer shortly after obtaining a certificate of adaptation in April. Not only the pharmaceutical industry but also the medical community are watching this with interest. The ministry also suggested Keytruda be discussed at the Cancer Drugs Benefit Appraisal Committee in July. According to the report, members of the Cancer Drugs Benefit Appraisal Committee believe that Tecentriq's initial treatment financial sharing plan in the past would be the basis for benefit expansion. Health authorities estimate that refunds of initial treatments are equivalent to 25 to 30% of the effect of a reduction in drug prices. It seems impossible to increase benefit unless the pharmaceutical company presents another corresponding sharing plan. "An analysis of Roche's initial financial sharing plan has shown tremendous effect in terms of health insurance finance," said a member of the Cancer Drugs Benefit Appraisal Committee. "Based on clinical trials, the application of three of the nine cycles as a way for pharmaceutical companies to share, actually has a significant cost-cutting effect," he explained. "Moreover, real world data is difficult to produce the efficacy and effectiveness of drugs equivalent to clinical trials. "Like clinical trials, pharmaceutical companies pay for three cycles for drugs that only work for seven weeks, not nine." "The latecomers should come up with corresponding measures, given that the starter accepted the benefit at the expense of considerable damage," he stressed. Another concern is whether combination therapy of Keytruda and Tecentriq will be passed. This is due to Avastin (Bevacizumab), which also affects the patent expiration. The Cancer Drugs Benefit Appraisal Committee is also interested in which of Keytruda's and Tecentriq's primary use of lung cancer can be more effective. "No matter how much Tecentriq lowers its price, Avastin makes it difficult to match Keytruda's combination therapy," said a member of the Cancer Drugs Benefit Apparel Committee. "In the end, we have no choice but to determine which of the two combination therapies can contribute to insurance."
- Policy
- Evrenzo has been approved in Korea
- by Lee, Tak-Sun Jul 12, 2021 06:11pm
- A new oral drug that can treat anemia, one of the complications of patients with chronic kidney disease, has been approved in Korea. Until now, the standard therapy for treating the disease has been administered with a red blood cell production stimulating injection called EPO (Erythropoietin) or ESA (Erythropoiesis stimulating agent), and attention is being paid to whether a new oral drug with high convenience will replace ESA. The MFDS approved AstraZeneca Korea's (Roxadustat) 5 items on the 9th. This drug is used to treat syndrome anemia in patients with chronic nephropathy. In particular, patients who are or are not on dialysis can also be used. It can also replace the ESA injections that have been used. People with chronic nephropoientin develop anemia due to fewer kidney-generated Erythropoientin. This is because hematopoietic hormones are involved in the process of making red blood cells in the bone marrow. The hematopoietic hormone preparation made by recombination technology is ESA. The first generation of ESA required injections every two to three days, but the latest ESA has been improved to allow injections once a month. One of the most popular injections is Roche's Mircera. Mircera is a blockbuster drug that sold ₩18.8 billion (IQVIA) in South Korea last year. Other ESAs are also being used in addition to Mircera. Since oral oral medicine is more convenient to take than injections, attention is being paid to whether Evrenzo, which is approved this time, will replace existing ESA drugs. Roxadustat has a mechanism to activate hypoxia-inducible factors (HIFs) that regulate gene expression by engaging in red blood cell formation. By reversibly inhibiting HIF-PH, which targets HIFs and decomposes them under normal oxygen conditions, Roxadustat induces a response similar to the body's natural response to hypoxia. High efficacy was confirmed in three clinical trials (ANDES, OLYMPUS, and ALPS) and maintained the hemoglobin concentration in patients switching from conventional ESA therapy. Roxadustat, co-developed by AstraZeneca and FibroGen, was first approved in China in December 2018, and was also approved in Japan the following year. European EMA and the U.S. FDA are also likely to approve it soon. Attention is expected to continue to be paid to whether the existing market structure will be reorganized with the release of the drug.
- Policy
- MFDS orders minimized use of varenicline
- by Lee, Tak-Sun Jul 12, 2021 05:58am
- The Ministry of Food and Drug Safety ordered minimized use of the smoking-cessation treatment, ‘varenicline.’ The measure was announced 3 weeks after safety investigations had started for the products, from the 22nd of last month. The MFDS announced that it has issued a Dear Healthcare Professional Letter regarding the precautions to take when prescribing and using smoking cessation treatment aids using ‘varenicline,’ with regards to the recall of these products abroad due to N-nitroso-varenicline impurities found in some of its products. The MFDS explained that the letter was issued as a precautionary measure for domestic HCPs and patients, as the possibility of nitrosamine impurities cannot be completely ruled out, although the results of the safety investigations that started on the 22nd of June have not been released yet. Measures to recall some of the finished drug products containing ‘varenicline’ are already in force in Canada and the U.S. In the letter, the MFDS informed the experts and patients of the types of finished drugs and their related information. To HCPs including doctors and pharmacists, the ministry recommended minimizing the use of finished drug products that contain ‘varenicline’ and asked experts to consider other treatment methods, if possible, according to the patient’s condition, until the investigation results regarding the nitrosamine impurities are announced. To patients who are using affected products, the ministry advised them to continue using the treatment until the HCPs provide an alternative treatment, and to consult with doctors and pharmacists if any health concerns arise while using the medications. The ministry also added that it is working closely with relevant companies to ensure that the ongoing investigation for impurities is completed as soon as possible and that it will announce measures as soon as the key results are released. Also, products that do not complete testing by August 31st will be suspended from sales as a precautionary measure until it is confirmed that no impurities are detected in the products. An official from MFDS said, “Public safety is of our utmost priority, and we plan to quickly implement necessary measures including completing the development of test methods for impurities and collecting and inspecting related products if necessary.” The letter was issued in the midst of the confusion arising in the field as the Korean health authorities had made no measures after ordering investigations for impurities despite ongoing product recalls for some varenicline products in the U.S. and Canada.
- Policy
- Ultra-high-priced drugs(Kymriah) need coverage within a year
- by Lee, Jeong-Hwan Jul 11, 2021 07:05pm
- In order to commercialize high-tech biopharmaceuticals, which are evaluated as ultra-high-priced new drugs, it has been argued that a policy to recognize insurance benefits should follow beyond Expedited Review within at least a year of approval. It is pointed out that although the enactment of the Advanced Regenerative Bio Act in 2019 established a quick marketing permit system for serious and rare diseases without alternative treatments, there is still no system to register benefit. Professor Kim Won-seok of the Department of Blood Tumor Medicine at Samsung Medical Center will present the presentation at the National Assembly's debate on how to improve accessibility of patients with advanced biopharmaceuticals on the 9th. The debate was hosted by Kim Min-seok, chairman of the National Assembly's Health and Welfare Committee, and Choi Hye-young, a member of the Democratic Party of Korea. Professor Kim Won-seok, who is in charge of the presentation, announced the "Status of Advanced Biopharmaceutical Development and Treatment in Advanced Countries." Advanced bio-medicine is a drug based on cells, tissues, and genes, and many treat the source of the disease and show a full recovery effect with a single dose. Anti-cancer drugs are leading research and development of advanced biopharmaceuticals. Cancer diseases have a large number of unmet demand and indications with fewer patients with symptoms than the stage of disease development. Professor Kim said advanced bio drugs are a new alternative to the treatment of recurrent non-responsive incurable blood cancer, which currently has no cure. Kymriah (Tisagenleucel) using CAR-T cells was cited as an example. Professor Kim said Kymriah has been performing in the actual medical environment, with a total response rate of 53% in the follow-up analysis for about 40 months. Due to the characteristics of treatments that utilize human cells, there are many problems that need to be solved for commercialization, such as preparing a new system for medical institutions and establishing standards. In fact, CAR-T treatment in Korea requires permission, manpower, system, and standards from the management industry, and professional support such as infectious medicine, neurology, circulatory medicine, and critical patient medicine for comprehensive management after treatment. In particular, there are no advanced biopharmaceuticals called Marketing Authorization Under Exceptional Circumstances (MAEC). Looking at Kymriah's global status, Japan and Europe (France, Italy, Germany and Switzerland) recognized the benefit at the same time as the permit. Australia, Britain, Canada and Scotland, which have similar insurance benefit registration systems to Korea, applied their benefits after a quick review within a year of permission. Professor Kim believes that although Korea approved Kymriah on March 1, there is no insurance review program comparable to overseas countries. He said, "High-tech bio drugs are drugs that change the treatment paradigm. Patients waiting for Kymriah is less than 200 a year, and have only three to six months to wait for insurance benefit, and high-tech bio drugs need not only quick approval but also quick insurance registration."
