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- 2026-04-09 14:41:32
- Product
- Hugel’s 'Licellvi Webinar' Successfully Completed
- by 어윤호 Aug 24, 2023 09:00am
- Hugel held a webinar for Thai healthcare professionals (HCPs) on Licellvi (Product name in Korea - Blue Rose Forte). The topic of the webinar was the "Combination of Thread Lifting and Botulinum Toxin", which was attended by over 300 local HCPs. The first speaker, Dr Choi Hosung (Piena Clinic), presented "Exploring the Mid & Lower Face Lifting Using PDO Threads Through Personalized Approach," which took into account individual patient characteristics. The next talk was given by Dr Lim Soo-sung (Balance Lab Clinic) who explained 'Brow Thread Lift - What to Consider', in line with the local trend of high interest in treating the forehead and brow area. A company representative said, "We will carry out various academic marketing activities aimed at local medical professionals with the goal of successfully settling down the Licellvi brand in the market. As the first company in Thailand to enter the PDO suture, botulinum toxin, and HA filler markets, we will increase the Hugel's corporate value in the local market."
- Opinion
- [Reporter's view] Hemophilia drug war of nerves
- by Kim, Jin-Gu Aug 24, 2023 05:46am
- GC Pharma snipes JW Pharmaceutical. Hemlibra, a hemophilia treatment that JW Pharmaceutical is introducing and selling in Korea, became the target. GC Pharma distributed a press release on the 21st. It is a press release titled, 'The report rate of abnormal blood clots in Hemlibra was 2.8 times higher than Factor XIII.' This press release was written based on the information presented at the American Society for Bleeding Disorders Conference. Based on the U.S. Food and Drug Administration (FDA) adverse event reporting system, JW Pharma's Hemlibra and GC Pharma's XIII formulation were compared. As a result, Hemlibra's thrombotic adverse event reporting rate was 4.07%, which was 2.83 times higher than Factor XIII's 1.44%. it was the content. It is unusual. It is true that cases of sending a press release directly mentioning and comparing competing drugs to the company's official e-mail address were rare, except for a few biopharmaceutical companies. In the biopharmaceutical industry, rather than directly mentioning the product name of a competing drug, it used to be expressed in terms of ingredient names. It was read with the intention of highlighting the side effects of competing drugs and finding fault with them, rather than revealing the advantages of the company's products and comparing them with competing drugs. Moreover, it was completely omitted from the press release that GC Pharma's Factor XIII drug showed a higher number of total adverse event reports and serious adverse event reports in the same data. There are many cases in which the pharmaceutical industry directly compares two drugs. However, this is based on the results obtained through elaborately designed clinical trials. This is because there are many external variables to evaluate the superiority or inferiority of the two drugs based on the simple reporting rate, as in the GC Pharma press release. JW Pharma expressed strong displeasure. In a separate statement, he said, "I am very sorry for the act of officially disparaging a competitor's drug." GC Pharma responded, saying, “There is no intention to disparage,” and that it was “to monitor the side effects of blood clots.” The dominant evaluation is that GC Pharma did something useless over the untimely war of nerves between the two companies. GC Pharma already dominates the domestic hemophilia treatment market through the Korea Hemophilia Foundation. There is no need to distribute press releases with poor comparison results. You just need to confidently compete with clinical data and sales power. Rather, there are opinions that this press release had an adverse effect. This is because the awareness of Hemlibra has increased as a result of this nerve war. At the same time, with Hemlibra accelerating its pursuit, GC Pharma has admitted to being nervous.
- Policy
- Verquvo will be listed for reimb at KRW 2,867 in KOR
- by Kim, Jung-Ju Aug 24, 2023 05:46am
- The 3 doses of Bayer Korea’s chronic heart failure treatment Verquvo Tab will be newly listed at KRW 2,867. The price of Abbott Korea’s Depakote Sprinkle Cap (divalproex sodium) will be raised by nearly 22% upon the company’s request and negotiations. According to industry sources on the 22nd, the Ministry of Health and Welfare is working on the ‘Amendment to the drug reimbursement list and reimbursement ceiling price table’ that contains the abovementioned changes that will become effective as of the 1st of the next month. First, 5 new that contain 3 ingredients are waiting to be listed after successful negotiations with the NHIS. The 2.5mg, 5mg, and 10mg formulations of Bayer Korea's Verquvo tablets will be listed at KRW 2,867. Two new melphalan hydrochloride drugs, a treatment for multiple myeloma, will also be newly listed. The price of Ace Pharma’s Megval Inj. 50mg and Korea HO Pharm’s Melpspal Inj. 50mg were set at KRW 110,000 per vial. A total of three drugs have succeeded in negotiations and will receive raise in drug prices. Among the drugs notified on the reimbursement list, these are drugs that successfully negotiated with the NHIS after requesting a price increase (application for adjustment) and passing deliberations by the Drug Reimbursement Evaluation Committee, and succeeded in negotiations with the NHIS. In order for the price adjustment application to be accepted, all of the following conditions must be met: the drug must be▲ essential for patient care ▲ no alternative drug exists ▲ the cost of administration is lower than its alternatives, and is supplied by a single company. In terms of the price increase by drug, Abbott Korea's Depakote Sprinkle Cap (divalproex sodium) will be supplied at a price of a 21.5% increase. In addition, Korea Orphan & Essential Drug Center’s Xenazine Tab (tetrabenazine) will be priced at a 19.6% increase, and DID Bio’s Leclean Solution (sodium phosphate enema) will be set at a 28.7% increase in price and supplied.
- Policy
- Generics for Januvia are deleted from the reimbursement list
- by Lee, Tak-Sun Aug 24, 2023 05:46am
- 6 While 239 drugs containing Sitagliptin, the active ingredient of DPP-4 diabetes treatment Januvia, will be registered for benefit on the 2nd of next month, six existing supplementary items will be deleted from the benefits list. It is interpreted that five items were excluded from the medical care benefit due to the newly created negotiation process. According to the industry on the 23rd, six supplementary items among sitagliptin generics will be deleted from the benefit list on the 1st of next month. These items were listed before June 2020, when the provisional registration system disappeared. The provisional listing system is a system in which generics approved by the Ministry of Food and Drug Safety are listed on the reimbursement list in advance during the original patent period. Through this, 9 items of sitagliptin phosphate hydrate were tentatively listed, but 6 items were deleted this time. In the case of Kwangdong Sitagliptin Phosphate Hydrate Tab 100mg, the pharmaceutical company expressed that it had no intention to sell it, and the list of benefits was deleted according to the last deliberation. Starvia 100mg, Janulinin S 100mg, Sitaliptin 25mg, 50mg & 100mg were not agreed upon as a result of the negotiations, so they are excluded from the medical care benefit after deliberation by the Health Insurance Policy Deliberation Committee. For these items, it seems that no agreement was reached in the negotiations related to the stable supply and quality control of drugs. Negotiations on this content were introduced in October 2020 for drugs subject to calculation, such as generics. It is interpreted that the provisional items had to be negotiated for stable supply on the premise of the actual launch, but this was not met. Instead, Kwang Dong, Daewon, and Vivozon are scheduled to be listed on the 2nd of next month as other items of sitagliptin. Among the tentatively listed items, only three items from Shinpoong Pharmaceutical Sitaglu will be listed on the 2nd of next month.
- Company
- Will the new NMOSD drug Enspryng be reimbursed in KOR?
- by Eo, Yun-Ho Aug 24, 2023 05:46am
- Whether the new drug for neuromyelitis optica spectrum disorder (NMOSD) can be reimbursed in Kore is gaining attention. Dailypharm found that Roche Korea is carrying out pricing negotiations with the National Health Insurance Service for the reimbursement of its NMOSD treatment Ensprying (satralizumab). The drug passed the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee review on the 3rd of this month. The issue is whether the ‘fourth or later lines of therapy’ that were set as the standard for reimbursement listing will be accepted during pricing negotiations. Enspryng first aimed to receive reimbursement by accepting the weighted average price (WAP) of its alternative ‘Soliris (eculizumab),’ but the company redirected its strategy and sought the PE exemption track when the listing process was delayed for Soliris in NMOSD. However, the government limited Enspryng’s reimbursement to fourth or later lines of therapy, restricting the scope of prescriptions. Currently, the immunosuppressant azathioprine is used as first-line maintenance therapy for NMOSD. If a patient fails treatment with azathioprine, mycophenolate, or rituximab is prescribed with reimbursement as second-line therapy. Both mycophenolate and rituximab are off-label drugs that do not have NMOSD indications. In other words, Enspryng can only be used as a third or later-line therapy in patients who fail treatment with rituximab. Of course, no discussion is made regarding the reimbursement standard in the drug price negotiation stage, but it remains to be seen whether Enspryng will be listed on the reimbursement list based on the currently discussed reimbursement standard. Meanwhile, Enspryng’s efficacy was demonstrated through SAkuraStar and SAkuraSky clinical trials that were conducted on adult patients with anti-aquaporin(AQP4) antibody-positive NMOSD. In the SAkuraStar monotherapy study’s AQP4 antibody-positive subgroup, 76.5% of ENSPRYNG-treated patients were relapse-free at 96 weeks, compared to 41.1% with placebo. In the SAkuraSky study, which evaluated Enspryng when used concurrently with standard immunotherapy, 91.1% of Enspryng-treated AQP4 antibody-positive subgroup patients were relapse-free at 96 weeks, compared to 56.8% with placebo.
- Policy
- Conflict rise over the need of the PE exemption system
- by Lee, Jeong-Hwan Aug 24, 2023 05:45am
- Experts are showing a sharp conflict of opinion over the effectiveness and need for the existence of Korea's system that exempts new drugs from receiving pharmacoeconomic evaluations. The PE exemption system, which was introduced in 2015, was implemented to improve access to new drugs for patients with severe and rare diseases. However, conflict has been rising on whether to abolish/reduce or continue the operation of the system after making improvements. Those who are in favor of the PE exemption system argue that the system should be more actively implemented but the process strengthened to increase patient access to treatments, while opponents argue that the system makes overseas drug prices be reflected as they are, wasting health insurance finances and only benefitting the pharmaceutical companies. On the 22nd, the pros and cons of the PE system were discussed by medical and pharmaceutical experts at a forum hosted by NA Rep. Hye-Young Choi of the Democratic Party of Korea to improve the PE exemption system that allows drugs to waive submission of pharmacoeconomic evaluation data during the reimbursement review process. Borami Kim, Co-chair of the Market Access Committee at KRPIA (Korea Research based Pharmaceutical Industry Association), which represents the global pharmaceutical industry, said that the PE exemption system has many advantages in expanding patient access to drugs within the limited health insurance budget. In other words, Kim’s point is that abolishment of the system is out of the question as it would impede patient access to new drugs. Kim said, “It is much more beneficial to operate the current system well according to its purpose, and it is also in line with the direction of the current government policy, which stresses the proper use of limited resources and the abolition of regulations. If we dismiss the benefits of the system and discuss its abolition or bring in more post-marketing control regulations than now, the door of opportunity for patients will only get narrower and narrower.” Dr. Young Chul Moon, Professor of Hemato-Oncolgoy at Ewha Womans University Mokdong Hospital, who actively treats patients in the field, also supported the improvement and maintenance of the PE exemption system. In particular, Moon’s diagnosis was that Korea’s new drug reimbursement speed was too slow despite the existence of the PE exemption track. His concern was that the speed of new drug reimbursement could be further delayed with the removal of the PE exemption system. Therefore, Moon proposed an improvement plan that raises the standards for submitting the PE exemption plan while further activating the system for its better management. Moon said, “New drugs that are in need of rapid reimbursement are not being introduced fast enough, even with the PE exemption system in place. It took over 6 months for Kymriah’s reimbursement, and patients and doctors are all concerned that reimbursement will further be delayed with the removal of the PE exemption system.” "Also, tighter pharmacoeconomic evaluations are made for drugs like anticancer drugs that are reimbursed through the PE exemption track. The Cancer Disease Deliberation Committee requests the companies to submit PE data to determine the price and request price cuts. Many drugs give up reimbursement even after applying for PE exemptions.” “We should encourage faster introduction of innovative drugs that improve patients’ lives, even if we bear the cost to some extent, and instead, we should establish a system to conduct reevaluations every 2-3 years. There is also a need for a policy to secure health insurance finances and stabilize drug prices by lowering the price of generics and biosimilars while encouraging their use.” Dong-Geun Lee, Director of the Korean Pharmacists’ Association for Healthy Society, objected to the system, claiming that it had changed into a system that maximized the benefits of pharmaceutical companies. Just as concerns were raised when the system was introduced in 2015, the price of new drugs has been set at a higher price due to the PE exemption system, and the system is becoming a chronic go-to regulation for companies rather than an exception. Lee said, "When the system was introduced during the Park Geun-Hye administration, civic groups opposed it because the system will accept the drug prices of advanced countries as is. We were concerned that it would have the effect of increasing the price of new drugs that should have been reimbursed through the positive listing system. We need to find out how much of these concerns have been resolved today.” “The purpose of the PE exemption system is to enhance patient access but it is used as a beneficial system for pharmaceutical companies that exempts the submission of safety and efficacy review data that pharmaceutical companies are required to submit. It was an exception at the time of introduction, but as it improved, the number of such exemptions continued to increase, and 17 drugs that have comparator drugs took the PE exemption track." Eun-Young Bae, Professor of Pharmacy at Gyeongsang National University also claimed the need to minimize the use of the system. Bae said the government should reduce the use of the PE exemption track to only when necessary to resolve its side effects such as how it adversely affects the reimbursement of of latecomer drugs.” In particular, Professor Bae dismissed concerns that access to new drugs for patients will decrease if the PE exemption system is abolished, saying, "We need to regard the two separately.” Professor Bae said “I do not mean that the PE exemption drugs should be non-reimbursed. "However, there is no decision-making measure available to use when clinical evidence is accumulated for PE exemption drugs that were approved through a simplified pathway. In order to make the best decision, we have to decide based on sufficient grounds, but the problem is that the PE exemption system does not allow this to happen.” “I don't think abolishing the PE exemption system will act as the main obstacle that hinders prompt reimbursement of new drugs. There are other ways to speed up patients' access to new drugs by conducting rolling evaluations even before the data is complete." Chang-Hyun Oh, Director of Pharmaceutical Benefits at MOHW, said that he agrees that there is a need to evaluate the pros and cons of the PE exemption system, and will collect various opinions and make efforts to make the best decision. Oh said, “The PE exemption system was established through social consensus, and the side effects of the system are just being discussed now, 6-7 years after its implementation. We conducted a preceding study last year, and we would need to simulate various scenarios after a system improvement plan is proposed based on the study, such as by adding a risk-sharing condition to the Pe exemption system, etc.”
- Company
- The report distorted the side effects of JW Pharma Hemlibra
- by Kim, Jin-Gu Aug 23, 2023 05:46am
- Rather, JW Pharma's official position is that the total number of adverse events, including thromboembolism, is more than three times greater in factor VIII. JW Pharma issued a statement on the 22nd and refuted the press release distributed by GC Pharma the previous day (21st). GC Pharma participated in the Bleeding Disorders Conference and distributed a press release stating that "Hemlibra's thrombosis adverse event reporting rate was 2.8 times higher than factor VIII" based on the analysis results of adverse events reported in the FDA Adverse Event Reporting System. Factor VIII is a hemophilia treatment sold in Korea by GC Pharma and Hemlibra by JW Pharmaceutical. JW Pharmaceutical explained in the press release that the FDA drug adverse event reporting system, which is the source of data, is based on voluntary reports, and that all adverse events of all drugs are not collected, and duplication and omission may occur. In order to accurately identify adverse reactions between products, it is necessary to measure the number of adverse events compared to the total number of patients administered for each product, which means that GC Pharma's press release is based only on voluntary reports without any such content. Accordingly, JW Pharma emphasized that GC Pharma's claim of 'thrombotic adverse events 2.8 times' is a leap forward and may cause confusion to patients. In particular, JW Pharma countered that factor VIII was significantly higher than Hemlibra in terms of the total number of adverse events. According to JW Pharma, the current market share of Hemlibra and factor VIII is similar at 51% to 49%, and the total number of adverse events of factor VIII is 9324, which is more than three times higher than the 2,383 cases of Hemlibra. In addition, in the case of 'serious adverse events (SAEs)' in the same data as GC Pharma, Hemlibra accounted for 1545 cases (64.8%) out of 2383 cases, whereas factor VIII accounted for 7675 cases (82.3%) out of 9324 cases, indicating that factor VIII was abnormal. It was emphasized that the number of reactions and the rate were higher. JW Pharma explained, "Hemophilia treatment has a reason for its existence to protect patients' lives and improve their quality of life." JW Pharma said, "We are very sorry for this act of causing unnecessary confusion to patients by directly mentioning and officially disparaging a competitor's drug without considering the differences in the time of release, mechanism of action, and reporting standards of each product." said.
- Policy
- 157 single and 82 combo Januvia generics reimbursed in KOR
- by Lee, Tak-Sun Aug 23, 2023 05:46am
- TA total of 239 new drugs that contain ‘sitagliptin,’ the active ingredient of the DPP-4 inhibitor class drug Januvia (MSD), will pour out onto the market on the 2nd of next month. In terms of the number of companies, 59 companies will be releasing their single-agent generics and 63 will be releasing their fixed-combination generics. According to industry sources on the 22nd, a total of 239 items (157 single-agent drugs, 82 fixed-combination drugs) will be listed for reimbursement on September 2, the day after the expiration of sitagliptin’s substance patent. In the case of the single-agent drug, 157 items from 59 companies will be reimbursed. The highest insurance price for sitagliptin 25mg was set at KRW 261, and 37 items received the price. only 3 items have a price below KRW 261. The highest insurance price set for the 50mg formulation was KRW 393 and was applied to 55 items, with 4 items having a lower price. The highest insurance price set for 100mg was KRW 592, and 57 items received the price, with 4 items having a lower price In the case of the fixed-dose combinations, 82 items from 63 companies will be listed. Among them, there are 9 triple fixed-dose combination drugs. Hanmi Pharm, Daewon Pharmaceutical, and Chong Kun Dang will release a three-drug fixed-dose combination that contains sitagliptin. The remaining 73 items are two-drug combinations, most of which are sitagliptin (DPP4i) + dapagliflozin (SGLT2i) combinations. Only Chong Kun Dang and Hanmi Pharm’s generic Janumet (metformin HCI + sitagliptin phosphate hydrate) are listed this time. The other Janumet latecomers have a different salt and hydrate formation. Therefore, single-agent drugs that contain the same ingredient will be listed this time, and other combination drugs are expected to be listed in October.
- Policy
- 'No other country has a PE exemption system'
- by Lee, Jeong-Hwan Aug 23, 2023 05:46am
- Professor Eun-Young Bae “Korea is the only country that has introduced the use of the pharmacoeconomic evaluation exemption system. As an academic, I do not understand the logic of the PE exemption system. It is also difficult to explain to other countries. If a particular drug has received reimbursement at a non-cost effective price due to the system, it will continue to affect latecomers in the indication." An expert has pointed out that the use of the PE exemption system in place for the reimbursement of drugs approved in Korea should be reduced to a minimum. The analysis is that if a drug has demonstrated a significant level of clinical benefit or is an ultra-rare disease, the specificity of the drug, such as its impact on health insurance finances, should be closely reviewed to determine whether to apply for PE exemptions. Also, suggestions that the current standard, which allows drugs that should not be subject to PE exemptions to receive exemptions, should be reformed and a separate reimbursement standard should be set for National Essential Medicines were raised. Eun-Young Bae, Professor of Pharmacy at Gyeongsang National University expressed her opinion at a forum that was held on the 23rd to seek ways to improve the PE data waiver system (PE exemption system) of pharmaceutical economic evaluation data. The PE exemption system, which was introduced in 2015, reviews the listing status and listed prices of a drug in A8 countries (that the government uses to calculate the foreign adjusted average price of drugs) during the reimbursement review process rather than its cost-effectiveness. As of July 2022, 26 drugs have been reimbursed under the PE exemption system. Professor Bae pointed out that it is necessary to review how to resolve the uncertainties that arise due to the cost-effectiveness of PE exemption drugs. Bae explained that the issue should be resolved because high uncertainties remain about the clinical grounds of drugs that were reimbursed through the PE exemption system, and affects the evaluation of its latecomers. Bae stressed, “An initial evaluation should be made on PE exemption drugs. The effectiveness of the reevaluations that are conducted after the application of the PE exemption system is low because of the lack of initial evaluation. If a drug has been reimbursed through the system at a high price and is not cost-effective, this will continue to affect latecomers.” She added, "We also need to look at whether to keep the initial registration conditions during the 5 years until reevaluations said. "We need to check how to evaluate the latecomers of PE exemption drugs and what the appropriate price level should be for the PE exemption drugs." "The justification for the use of the system is weak. If the government seeks to maintain the system nevertheless, its use should be minimized to the extent necessary. The PE exemption drugs should submit pharmacoeconomic evaluation plans in advance and receive deliberations that can be used as the basis for price reevaluation or readjustments in the future.” The forum was cohosted by NA Rep. Hye-Young Choi of the Democratic Party of Korea and the Korea Alliance of Patients Organization
- Policy
- Envlomet SR is priced at 611 won, the same price as Envlo
- by Lee, Tak-Sun Aug 23, 2023 05:46am
- Daewoong Pharmaceutical's self-developed SGLT2i ingredient, Enavogliflozin, combined with Metformin hydrochloride will be released in September. In particular, even though metformin hydrochloride is added, the price is the same as the existing single drug Envlo. This is related to the drug price calculation structure for combination drugs. According to the industry on the 22nd, Daewoong Pharmaceutical's Envlomet SR 0.3/1000mg will be listed as a benefit at 611 won per party from the 1st of next month. This drug is a combination drug that combines metformin, an ingredient for treating diabetes, with Envlo, a new domestic SGLT2i drug released last May. Envlo It contains Enavogliflozin 0.3mg and Metformin HCl 1000mg and is administered as an adjunct to diet and exercise therapy to improve blood sugar control in type 2 diabetic patients for whom combined administration of Enavogliflozin and Metformin is appropriate. The price is the same as the single drug Envlo. The combination drug is calculated as the sum of 68% of the single drug, and even if you add 418 won, which is 68% of the single drug Envlo, and 119 won for metformin 1000mg, it costs 537 won, which is cheaper than the single drug. As this reversal phenomenon appeared, the same calculation was made with the single drug price. As a result, even if Envlo is administered at 611 won per tablet and then switched to Envlomet for blood sugar control, the patient does not have an additional financial burden. Compared to the same series SGLT-2 series Forxiga and Xigduo XR, Envlo or Envlomet are at a high level. This is because the patent for Dapagliflozin of Forxiga expired in April, and generics have appeared. Looking at the adjusted price, Forxiga 10mg is 734 won to 514 won, Xigduo XR 10/1000mg is 736 won, 512 won, and Xigduo XR 10/500mg is 736 won to 473 won. Forxiga and Xigduo's direct adjustment price is cheaper than Envlo or Envlomet. In the future, Daewoong Pharmaceutical plans to continue expanding its lineup of complex drugs, starting with Envlomet, as demand for complex drugs continues to increase in the domestic diabetes treatment market.
