- LOGIN
- MemberShip
- 2025-12-18 05:33:11
- Product
- Actinum is a troublemaker?
- by Kim JiEun Feb 07, 2022 05:57am
- Actinum is out of stock due to lack of inventory. The key is to return distribution inventory after the 11th. Multivitamin Actinum, which ambitiously entered Korea, is in a position to become a headache. It is not expected to be easy to order at pharmacies for the time being. According to an official at Dongwha Pharm on the 14th, Actinum's sales ended in November. As of this day, the sales authority of Donghwa Pharmaceutical has expired. The problem is that domestic pharmaceutical companies that will take over the copyright of Actinum after Donghwa Pharmaceutical have not been decided, making it virtually unclear whether they will sell it in the future. Actinum is a domestic generic of Arinamin sold by Takeda. Immediately after its launch, aggressive marketing was conducted, such as conducting public advertisements through famous celebrities. However, it was directly hit by the boycott of Japanese pharmaceutical companies' drugs in 2019, and was pushed back by a series of competitive products. The industry believes that this situation has a direct impact on the selection of pharmaceutical companies after Dongwha Pharm. An official from Dongwha Pharm said, "I think Takeda is looking for a partner in a domestic pharmaceutical company." He said, "We also asked the headquarters to discuss inventory or settlement issues when the pharmaceutical company to be acquired is decided ahead of the end of the contract, but we are in a difficult situation as there has been little talk so far. The contract ended at the end of December, and we have agreed to sell it only until January 11th, he said. This situation has recently been reflected in front-line pharmacies. At major drug online malls, Actinum EX is currently out of stock and cannot be ordered. According to local pharmacy pharmacists, only a small amount of products can be ordered from some wholesalers. A local pharmacy pharmacist said, "Actinum is not a popular item, but we have secured inventory because there are cases where patients who have taken it before are looking for it, but it has not been easy to order recently," adding, "We have only ordered a small amount of it by asking the wholesaler." Dongwha Pharm said it is difficult to return or settle distribution inventory at the company level since the 11th when the sales contract expired. An official from Dongwha Pharm said, "It is frustrating that the copyright has not been clearly cleared up by the company," adding, "It will be difficult to settle or return inventory as it does not have its own authority on distribution inventory after January 11th. However, we plan to deal with all distribution products as much as possible in November, he said.
- Product
- The gov is pushing to supply COVID-19 PO tx with pharmacies
- by Kang, Shin-Kook Jan 12, 2022 06:04am
- The government is taking full-fledged steps to supply COVID-19 PO treatment to pharmacies. The Central Disaster and Safety Counters Headquaters (CDSCHQ) will hold an online meeting this afternoon (10th) with drug organizations participating and discuss oral corona treatment prescriptions and dispensing. In other words, the direction of the CDSCHQ has been virtually determined from prescription, preparation, and drug delivery. The CDSCHQ will then provide online education on preparation, medication guidance, and precautions to 270 pharmacies nationwide that are in charge of supplying oral corona treatments. The decision is based on the judgment that education is needed because the method of taking the medicine is complicated. The main dosage of Paxlovid should be taken Nimatrelvir 300 mg (2 pink tablets of 150mg) and Ritonavir 100mg , twice a day (12 hours) for 5 days. According to the CDSCHQ, Pfizer's Paxlovid is expected to enter Korea around the 13th, with initial supplies expected to be less than 50,000 people. According to the current status of government contracts, treatments for a total of 1 million and 44,000 people have been secured, including Paxlovid foe 762,000 people and MSD Molnupiravir for 242,000 people. Oral treatments can be used in mild and moderate patients with high probability of severe illness. However, as the volume is limited, it is highly likely to be administered to elderly patients aged 60 or older in hospitals or life treatment centers. People with underlying diseases such as chronic lung disease, diabetes, cancer, and obesity can also be targeted. The method of delivery of the drug has not been decided yet. More than 270 pharmacies nationwide, which are in charge of preparing drugs for home care patients, prepare and supply oral treatments as regional bases. Now, when a doctor gives a prescription, the pharmacy dispenses medicine, and public health centers and local government employees deliver the medicine to home treatment patients. Discussions are still underway over whether oral treatments will follow this method or whether pharmacies will be in charge of delivery. An official from the MOHW said, "We discussed with the Pharmaceutical Association on the 7th about the delivery method, but it was not concluded," adding, "In the beginning, it could be a direction to expand the role of pharmacies in the future."
- Product
- Lee’s pledge to reimburse hair loss drug creates buzz
- by Jung, Heung-Jun Jan 06, 2022 06:09am
- The news that presidential candidate Lee Jae-Myung's is considering reimbursement of hair loss treatments as his election pledge is drawing attention for days. However, as many unresolved issues including creating empathy on its need, budgetary projections, and review of beneficiaries remain, it is unclear whether this may be practically enforceable. Although most pharmacies are welcoming the pledge, the expectation is that some pharmacies that have been selling non-reimbursed hair loss drugs at a lower price will not be welcoming the reimbursement. Lee’s vow to review reimbursement of hair loss treatments has generated continuous buzz in online communities. Since the drugs cost over ₩30,000 every month and require continuous administration, their reimbursement is raising expectations of reducing the burden. However, the reimbursement of hair loss treatments may not benefit all those affected. Reimbursement will apply depending on the type of hair loss, cause, and degree of reimbursement. Therefore, unlike the rumors on social media, not all will be able to receive reimbursement. In Seok Oh, Pharmaceutical Benefit Director of the Korean Pharmaceutical Association, said, “Hair loss treatments are non-reimbursed, therefore their prices are set at a higher level. In general, patients pay over ₩30,000 every month for the drugs. If these drugs are reimbursed, a price ceiling will be set on the drugs, and a budgetary projection must be made. Also, reimbursing hair loss means that hair loss is recognized as a disease, thus specific classifications must also be made for this disease for insurance.” Oh added, “Also, not all people will be able to receive reimbursement, since the condition and type of hair loss vary greatly by person. Some may be due to stress, some due to skin irritation, and some may be at a stage where taking a drug may no longer be effective” If reimbursed, patients who had avoided treating their condition will also visit clinics and hospitals, increasing the number of patients. Consequently, pharmacies are also expected to see more hair loss patients. However, some local pharmacies that have attracted customers by selling hair loss drugs at a lower price may not welcome the change. Pharmacists A from Gyeonggi-do said, “It is good news for pharmacies that have not sold hair loss products before in the sense that their shares of the pie will increase. However, for pharmacies that specialize or sell many hair loss drugs that have attracted patients with a very low price, the harm may outweigh the benefits. Meanwhile, according to the market research institution IQVIA, the top-grossing hair loss treatments (finasteride, dutasteride) in Korea in 2020 were Propecia (₩41.3 billion), Avodart (₩38.4 billion), Monad (₩6.2 billion), Mypecia (₩ 5 billion), Damodat (₩3.3 billion), Finated (₩2.3 billion), Neodart (₩1.7 billion), Zygard (₩1.4 billion), Duted (₩1.2 billion) Jdart (₩1.3 billion).
- Product
- Is the price of Paxlovid reasonable?
- by Jan 03, 2022 05:55am
- On the 27th, Paxlovid, an oral treatment for COVID-19, was approved for EUA by the MFDS, and the Pharmaceutical Association for Health Society asked questions about the insolvency and effectiveness of the screening process on the 30th. The Health Pharmaceutical Association said, "Paxlovid is expected to be used in patients with high risk among mild and moderate coronavirus patients, and is known to have side effects such as taste abnormalities, diarrhea, and elevated blood pressure, and to be careful of various drugs such as anti-antibodymetic drugs." The Pharmaceutical Association said it would inquire about ▲ the inadequacy of the Ministry of Food and Drug Safety's examination process, ▲ possibility of effectiveness in the field, ▲ whether there is a treatment benefit for the use of mild patients, ▲ lack of efforts to solve the supply shortage problem,▲ in the absence of fair price negotiations, and▲ the lack of review of the supply of North Korean treatments. ▲How did Paxlovid finish its evaluation in 6 days?= Other new drugs also undergo a preliminary review process and have an average approval review process of 10 months. In addition, the data on the approval of new drugs are so vast that it is impossible to review all of them in six days. Therefore, there is a concern about insolvency screening, or it is doubtful whether it is a permit review relying on foreign regulators. ◆Is the restriction on clinical subjects actually effective?= Subjects of EPIC-HR, an important clinical trial of Paxlovid, were mainly mild and moderate patients who were not hospitalized, those with a high risk of COVID-19, those with one or more symptoms within 5 days, those who were not vaccinated, and those who participated as soon as possible after diagnosis.However, in actual clinical trials, those who have been vaccinated, those who are not at high risk, those who have passed five days of onset of symptoms, those who have been delayed from diagnosis to treatment, and patients with moderate or higher can also take medicine. Further research is needed on the effect of this. ◆Is it an appropriate treatment to administer to mild patients= So far, the proven effect of Paxlovid is the effect of lowering the risk of hospitalization and death. And the actual price is unknown, but the U.S. transaction price is said to be approximately 630,000 won. It is necessary to examine whether it is an appropriate price to administer 630,000 won to treatments to lower the risk of hospitalization and death of COVID-19 patients. The Institute for Clinical and Economic Review analyzed Remdesivir in a traditional cost-effectiveness method, and assessed that it had a therapeutic benefit of $2470 when used for secondary and severe patients, but only $70 when used for mild patients. The current COVID-19 is a global public health crisis. The Dominican government is considering generic for Paxlovid to respond to COVID-19. And it is known that this drug can be produced without any special technology. The government should prioritize public protection, not Pfizer's interests, to cope with infectious diseases. ◆Is the price of Paxlovid at the disposal of the seller? = Originally, drug pricing needs sufficient negotiation efforts between the government and pharmaceutical companies. Excessively high prices can undermine the patient's right to treatment and too low prices can undermine pharmaceutical companies' motivation for development. In order to simultaneously achieve patient accessibility and promotion of R&D in the pharmaceutical industry, fair drug prices should be considered. Drug price information should be disclosed as transparently as possible, but Pfizer continues to undermine price transparency with a public health crisis as a weapon in the COVID-19 situation. ◆Why don't we discuss the supply of Paxlovid to North Korea= North Korea is one of the few countries that have yet to start getting vaccinated against COVID-19. There are many reasons why vaccines are not supplied to North Korea, but it is known that there is a heavy burden on the storage conditions below the freezer and the exemption of side effects that occur in healthy people. Since Paxlovid is used in patients with COVID-19 symptoms, side effects can be avoided and storage can be done at room temperature for a long time, thereby overcoming these limitations. Since Pfizer doesn't apply Paxlovid patents in 95 low-income countries, including North Korea, the South Korean government will be able to consider producing and supplying generic for Paxlovid to North Korea using domestic pharmaceutical facilities for humanitarian purposes.
- Product
- Losartan's re-prescription & re-dispensing are imminent
- by Jung, Heung-Jun Dec 06, 2021 05:54am
- While the government's follow-up measures based on the results of Losartan impurity detection are expected to be announced this week, attention is being paid to the work guidelines for re-prescription and re-prevention. Items with problems with all manufacturing numbers are expected to be re-prescribed and re-manufactured, and items with problems with some manufacturing numbers will be exchanged. Earlier, the MOHW and the MFDS held two meetings with the Korean Medical Association and the KMA, the KHA, and the KSHP. In addition, meetings with the KPBMA and the KPDA were held and plans were made for follow-up measures such as cost settlement. According to the government's discussions with organizations so far, exchanges are likely to take the same measures as the detection of Azido impurities in September. If exchanged at a pharmacy according to patient needs, it will be changed to a normal lot number, and 110% of the drug price will be added to the drug price to settle by the pharmaceutical company. Since the Korean Pharmaceutical Association already has a related system and the exchange rate was low earlier, it is expected that there will be few problems with the exchange again this time. In the case of re-prescription, it will be a method in which the pharmaceutical company that received the claim details is reimbursed to the nursing institution every month. When a hospital or clinic re-prescribes the remaining amount of the patient's possession, the pharmacy proceeds with the claim through the existing claim program. It plans to assign a specific code to claims for re-dispensing. The HIRA and the NHIS check and deliver them to pharmaceutical companies every month. Since then, pharmaceutical companies have to pay hospitals, pharmacies, etc. within a set period (about a week). Detailed guidelines for the payment of expenses to nursing institutions of pharmaceutical companies are expected to be guided by the government through a confirmed guide. If mixed preparation is performed with powdered medicine, it is expected that drugs other than those subject to recovery will be exchanged. The size of the impurity detection items finally announced by the migrant government is expected to determine the impact on pharmacies.
- Product
- Why Tagrisso and Opdivo failed reimbursement expansions
- by Moon, sung-ho Dec 06, 2021 05:53am
- The 3rd generation targeted therapy for lung cancer, ‘Tagrisso (osimertinib)’ once again failed to expand reimbursement to first-line treatment. The reason was that the drug was more appropriate as a second-line treatment in terms of cost-effectiveness. By failing to expand reimbursement at the last Cancer Drug Review Committee meeting held this year, the two drugs will not have to wait until the next year to reattempt reimbursements. #According to the industry on the 26th, the National Health insurance Service held the 8th Cancer Drug Review Committee meeting on the 24th to deliberate on the reimbursement standards for drugs used by major cancer patients. As the last meeting planned for the year, the blockbuster drugs that were delayed deliberation due to data submissions from pharmaceutical companies and collecting academic opinions, the agenda of expanding reimbursement of the drugs was finally put on the table for deliberation. One representative drug that was put on the agenda for discussion was ‘Tagrisso (Osimertinib).’ With Tagrisso, which failed to extend reimbursement 3 times after adding an indication as a first-line treatment in lung cancer in December 2018, its company, AstraZeneca had attempted to receive approval once more with a more progressive cost-sharing plan. However, the company once again ‘failed.’ AstraZeneca had presented results from Phase III clinical studies conducted in China among others to support the need for extended reimbursement, however, the evidence provided by the company was not sufficient enough to convince the CDRC members. At the same time, the reimbursement approved for Tagrisso’s competitor, Yuhan Pharm’s ‘Leclaza (lasertinib),’ from the second half of this year as second-line treatment had also influenced the CDRC results. A CDRC official who requested animosity said, “We concluded that the use of Tagrisso or Leclaza as second-line treatment in line with the current reimbursement standards was more cost-efficient than using Tagrisso first-line as proposed. The cost-sharing proposal submitted by AstraZeneca was also adjusted and improved than before, it was not satisfactory. “ He added, “The discussions had been put on hold in the first half of this year because the level proposed by the company was not satisfactory in terms of cost-effectiveness. The other data submitted, such as the Chinese trial, were just referenced.” The CDRC also postponed the reimbursement extension for the cancer immunotherapy ‘Opdivo(nivolumab).’ Its company had applied to extend its reimbursement standards for melanoma, non-small-cell lung cancer, renal cell carcinoma, Hodgkin lymphoma, head, and neck cancer (240mg 2 weeks/480mg 4 weeks), but was unable to pass CDRC review. The CDRC official said, “Opdivo’s dosage was increased based on Europeans. Opdivo’s 240mg dose may be applied to Europeans in consideration of the 1kg/3mg dose recommendations as they weigh over 80kg.” He continued, “However, the average weight of Koreans is different from that of Europeans. They do not exceed 80 kg. Therefore calculating the dose by kg/3 mg is more cost-effective, but the company is attempting to expand reimbursement at a higher price.”
- Product
- Organon aims to resume Cozaar XQ supply from 2022 Q1
- by Nov 25, 2021 05:56am
- 'Cozaar XQ,' an antihypertensive combination drug that contains losartan, may be resupplied to pharmacies within the first quarter of next year, at the earliest. The company had made preparations to change the API source of Cozaar XQ to be the same as the one for Cozaar, which uses a losartan API from a different overseas manufacturer (France), and explained that it will start manufacturing in December next month to supply the market in the first quarter of 2022. The company had stopped the shipment of Cozaar XQ after impurities that exceed the standard level were detected in the API of Cozaar XQ during the company’s independent inspections. Currently, the supply of Cozaar XQ 5/50mg, 5/100mg, 10/50mg has been temporarily suspended. Organon recently announced through medical and pharmaceutical associations that “Cozaar tab., Cozaar 100mg tab., Cozaar Plus tab, Cozaar Plus Pro tab, and Cozaar Plus F tab are imported after being manufactured using a losartan API from an overseas manufacturer. After an internal review that included an assessment of the overseas manufacturer’s API manufacturing process, impurity impact, and the European regulatory agency's laboratory results, we have submitted the review results to the MFDS. Also, we are in the process of developing a testing method according to MFDS instructions." Also, the company explained that it is preparing to change the API manufacturing source of Cozaar XQ to be the same as for its Cozaar products and plans to start supply in the first quarter of next year. Organon said, “We will actively follow MFDS instructions to enable the smooth supply of our products without inconveniencing the patients and HCPs.” Meanwhile, prescriptions of Cozaar XQ had recorded 7.2 billion won.
- Product
- α-GPC can't be replaced with other drugs in the field
- by Kim, Jin-Gu Nov 25, 2021 05:55am
- Apart from the steady increase in the number of patients over the past 20 years, there has been no significant change in dementia treatments used in Clinic sites. However, two major changes have been predicted in the past two years. One is the controversy over the preparation of Choline alfoscerate in Korea, and the other is the controversy surrounding Aducanumab, a new dementia treatment drug that has been released for more than 20 years. The controversy is whether the drug is effective enough. The solution to the controversy is quite similar. Regulators in South Korea and the U.S. have instructed the controversy surrounding the two drugs to properly verify their validity through "clinical re-evaluation." What do the front-line prescription sites think about these controversies? Regarding the controversy over Choline alfoscerate, Ha Sang-wook, head of On Hospital, said, "It seems to help clinically improve cognitive function in early dementia," adding, "There will be positive results that re-verify the effectiveness of clinical re-evaluation." ◆ The prescription amount is similar to the previous one in reducing the benefit of Choline alfoscerate The core of the controversy is the effectiveness of Choline alfoscerate. This is because drugs were recognized as medicines in Italy, where drugs were developed, while in other countries they were sometimes used as health functional foods. In the end, the Ministry of Food and Drug Safety ordered a "clinical re-evaluation" last year to re-evaluate the safety and effectiveness of Choline alfoscerate on its own. 57 companies, including Daewoong Bio and Chong Kun Dang, have begun clinical re-evaluation. The Ministry of Health and Welfare has reduced the benefit of the Choline alfoscerate. Since August last year, when patients who have not been diagnosed with dementia use Choline alfoscerate, the drug price rate has risen from 30% to 80%. Pharmaceutical companies have actively taken legal action. Currently, a lawsuit for revocation of administrative disposition is underway. Regarding the controversy over the effectiveness of Choline alfoscerate, manager Ha Sang-wook explained, "There are many studies that improve cognitive function when dementia or dementia drugs are not activated in the early stages." He said, "Clinically, when replaced with Choline alfoscerate from other drugs, it is observed that it leads to cognitive improvement." For this reason, he explained that despite the reduced benefit, the prescription amount is almost the same as before. Manager Ha Sang-wook said, "First of all, it is a drug that patients are very satisfied with. Even if the prescription is changed to another drug, it is often prescribed again as Choline alfoscerate, he said. "I understand that it is prescribed steadily not only in our hospital but also in other places." He said there was no suitable drug to replace Choline alfoscerate. He said, "Except for Choline alfoscerate, there is virtually no drug to prescribe to patients." He said, "In particular, in the case of vascular dementia, Donepezil is not applied, so it cannot be used. Choline alfoscerate is the drug to be used, and if this drug is not allowed to be used, it is quite difficult for patients and doctors to use it, he said. He was also optimistic about the results of clinical re-evaluation. Manager Ha Sang-wook explained, "The key will be how many patients with hidden cognitive impairment are discovered." He said, "I think more patients with cognitive impairment will get good enough results if they participate in clinical trials. The Dementia Association is also formed in a positive direction". ◆"Patients' interest in Aducanumab is increasing rapidly Expectations were high for the new dementia treatment "Aducanumab" recently approved in the United States. In June this year, the U.S. Food and Drug Administration (FDA) approved Aducanumab, co-developed by Biogen and Eisai, as a treatment for Alzheimer's dementia. It has been about 20 years since Allergan's Namenda in 2003. However, controversy over the validity of this drug has continued since the approval process. Conflicting results were found in two clinical trials conducted by Biogen. For this reason, the FDA Advisory Committee issued a non-approval recommendation in November last year. The FDA did not accept the advisory committee's opinion. However, in consideration of the controversy over its validity, the condition of "reevaluation after clinical trials" was attached. Biogen should reevaluate Aducanumab through post-marketing clinical trials. If the efficacy of Aducanumab is not proven in the re-evaluation, the approval will be revoked. In terms of controversy alone, it is almost similar to the case of Choline alfoscerate in Korea. Many patients ask a lot about this drug, he said. "The success of Aducanumab will significantly change the direction of dementia treatment itself. If proven effective, dementia will turn into a conquerable disease. On the contrary, if clinical trials fail, follow-up drugs of the same mechanism are likely to fail, he said. Since the approval of Aducanumab, several pharmaceutical companies have been developing drugs with beta-amyloid blocking mechanisms. In June this year, Eli Lilly's "Donanemab" and "Lecanemab," co-developed by Eisai and Biogen, were designated by the FDA for breakthrough therapy designation one after another. Both drugs are undergoing phase 3 global clinical trials.
- Product
- AstraZeneca vaccination is expected to end as of this year
- by Nov 24, 2021 05:53am
- The first inoculation will end at the end of November, and for the second inoculation, all inoculations will end on the 31st of next month. Medical institutions that have AstraZeneca vaccines should provide primary vaccinations with vaccines they have, and inform the inoculated that secondary vaccinations should be cross-vaccinated with Pfizer vaccines. However, if the vaccinated person want to have AZ shot, the AstraZeneca vaccine can also be vaccinated until December 31 of this year. The KDCA recently guided medical institutions entrusted with COVID-19 vaccination on the end of the AstraZeneca vaccination. Those who have already been scheduled for the second vaccination with AstraZeneca vaccine will be vaccinated according to their reservation details, but if they wish, cross-vaccination is also possible through the health center. However, those who are scheduled for the second vaccination with AstraZeneca vaccine in 2022 will be changed to cross-vaccination. The KDCA urged consigned medical institutions to cooperate to ensure safe vaccination by familiarizing themselves with the expiration date of the vaccine they have and how to inoculate them. The COVID-19 vaccination response promotion team explained, "There are no plans to introduce additional AstraZeneca vaccines, and the validity period of the previously introduced inventory is imminent, so it is necessary to review the inoculation plan considering the amount available."
- Product
- Expansion of non-face-to-face tx little by little
- by Nov 18, 2021 05:54am
- Despite opposition from the KMA to expand non-face-to-face treatment using regulatory sandboxes, it is judged that the satisfaction of overseas Koreans is high and it will help resolve medical blind spots. However, concerns about allowing regulatory special cases are also expected to increase, taking advantage of regulatory sandboxes. Ministry of trade, industry and energy deliberated and resolved a total of 14 cases such as on-face-to-face overseas Koreans' care services including digital switching of tasks and tasks, such as carbon neutral through the 5th Industrial Convergence Regulation Special Deliberation Committee. Temporary permission for the non-face-to-face overseas Koreans' care and counseling is a major medical foundation Myongji. Myongji Hospital provides services such as medical counseling and medical treatment to overseas Koreans through telephone and video using an online platform, and medical staff judges and issues prescriptions when requested by patients. This is the same as the approval agenda for Life Semantics Corp. and Inha University Hospital from 20 to 2021. There are many people who have difficulty using medical services due to language and medical accessibility problems or are excluded from access to local hospitals due to their citizens' priority policy abroad. In particular, temporary permission was granted through sandboxes with the aim of "protecting the Korean people to the end," saying that SOS is lined up from overseas workers in the Middle East, where the number of COVID-19 confirmed cases is soaring. This year, Ministry of trade, industry and energy said, "Under the current medical law, telemedicine is only allowed for doctor-medical people, and medical practices such as doctor-patient diagnosis and prescription are prohibited in principle. The Special Regulatory Committee approved additional temporary permits." However, to prevent diplomatic and trade problems, services were provided to the extent that they did not violate local laws, and the same conditions as the existing approval agenda, such as medical mediation, were added. Ministry of trade, industry and energy "non-face-to-face overseas Koreans ' care services, currently on projects on the table is high user satisfaction." said. The Ministry expected that in the future, overseas Koreans will be able to use various non-face-to-face medical services at more domestic medical institutions, which will increase their medical options. Last year, the KMA pointed out in a statement that telemedicine for overseas Koreans is ineffective. At the time, the KMA argued, "Telemedicine is likely to trigger competition between companies and industries that provide platforms and increase unnecessary demand, abandoning the basis of face-to-face treatment and the people's right to health."
