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- 2026-05-07 14:20:37
- 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.
- Company
- FST measure remains the issue for Luxturna's reimb
- by Eo, Yun-Ho Aug 23, 2023 05:46am
- Whether the differences in opinion over the ‘performance-based standard’ that has risen as an issue during reimbursement discussions for the one-shot retinal dystrophy treatment ‘Luxturna’ will be reconciled is gaining attention. Dailypharm found that the full-field sensitivity threshold (FST) has been set as the standard for evaluating the efficacy of Luxturna (voretigene neparvovec). This means that the FST result will become the standard that determines the reimbursement of Luxturna under the Risk Sharing Agreement (RSA) scheme. However, it seems that a difference of opinion exists between the government and Novartis Korea over on what FST value should be accepted as an improvement and be eligible reimbursement. So, what should the appropriate FST value be? Currently, Luxturna is reimbursed in all A8 reference countries, and among countries that conduct HTAs, a total of 4 countries are restricting its administration subjects: Switzerland, Italy, Canada, and the United States. These 4 countries have put some restrictions on age, visual acuity, visual field, and the existence of sufficient viable retinal cells rather than limiting the administration subjects as a whole. Publicly available documents showed that in Australia, Luxturna was approved under the performance-based FSA, and the government considered an improvement of 0.3 log10[cd.s/m2] or higher in FST during one efficacy assessment 60 days after administering Luxturna as appropriate for reimbursement. Some insurance companies in Australia and the US that conduct performance-based efficacy evaluations as a condition for reimbursement, also evaluate improvement with the 0.3 log10[cd.s/m2] threshold. This means that one patient experienced a twofold improvement in the sensitivity to light after treatment compared to before treatment. In addition, the Consensus Paper on RPE65-IRD that was published in the Korean Journal of Ophthalmology, an English journal published by the Korean Ophthalmological Society, suggested that changes exceeding 0.3 log should be considered clinically significant. Suk Ho Byun, the corresponding author of the Consensus Paper and Professor of Ophthalmology at Severance Hospital, said, “ 0.3 in FST is a meaningful difference beyond the test's margin of error. All tests bring different results no matter how many times they are performed on the same spot, and if the results show a consistent difference that exceeds 0.3 in FST, this can be accepted as an indicator that the patient has detected darker light than in his/her previous test.” He added, “It is difficult to define FST of 1 or higher as the absolute value that separates the success or failure of the treatment. Retinal dystrophy is an area with no treatment options. I have one patient who has been treated for one eye and is waiting for treatment for the other eye, and 3-4 additional patients are also waiting to be treated with the drug.”
- Company
- What to do with the loss of drug price cuts?
- by Chon, Seung-Hyun Aug 22, 2023 05:31am
- Pharmaceutical companies are in deep trouble ahead of the end of generic drug price re-evaluation. As each pharmaceutical company announces drug price cuts for as many as 100 or more products, the atmosphere is concentrating on figuring out the size of the loss. Dissatisfaction with the government's indiscriminate re-evaluation of drug prices is also growing. According to the industry on the 21st, from September 5th, the insurance upper limit of 7,677 generic drugs will be cut by up to 27.75%. The drug price of 7677 items will be reduced by 15% and 256 items will be cut by 27.75%. As the generic drug price re-evaluation, which has been pursued for the past three years, has ended, drug price cuts are imminent. In June 2020, the Ministry of Health and Welfare announced a plan to re-evaluate the upper limit on pharmaceuticals, stating that generics that do not meet the highest price requirement will maintain the previous drug price if they submit data on 'biological equivalence test' and 'registered raw material use' by the end of February this year. The generic drug price re-evaluation is a policy to apply the new drug price system, which came into effect in July 2020, to already-listed generics. In the reformed drug pricing system, generic products can receive the highest price only when they meet both the requirements for direct bioequivalence testing and the use of registered drug substances. Each time one condition is not met, the cap is reduced by 15%. If both requirements are not met, the price is reduced by 27.75%. The submission of generic drug price re-evaluation data was divided into two parts. Among the targets for re-evaluation of generic drug prices, drugs newly included in the equivalence test, such as sterile preparations such as injections, submitted data by the end of July. Initially, a total of 23,630 items were subject to drug price re-evaluation. Among them, about 20,000 products were designated for evaluation, excluding thousands of drugs subject to exclusion from drug price re-evaluation, such as reference drugs, drugs to prevent withdrawal, low-cost drugs, biological drugs, and first-listed products. Among them, as a result of reviewing 16,723 items for which data was submitted by February as they were classified as targets for the first evaluation, 7,677 generic items to be reduced starting next month were decided. This means that one out of two data submission targets has been classified as a drug price reduction target. Pharmaceutical companies are on the verge of losing money due to drug price cuts. As many as 100 or more companies are included in the target of drug price cuts, significant losses are unavoidable. Monthly number of BA test plan approvals (Unit: cases, Data: Ministry of Food and Drug Safety) Pharmaceutical companies calculated the amount of loss that would occur if drug price cuts were applied, and began to come up with countermeasures. It is expected that there will be no fatal loss because drug availability has been carried out through BA testing for flagship generic drugs with large sales in the pharmaceutical industry as a whole. After the announcement of the re-evaluation of generic drug prices, pharmaceutical companies simultaneously jumped into bioequivalence tests on licensed products. It is a strategy to avoid drug price cuts by creating generics through pharmaceutical research, conducting bioequivalence tests, and obtaining equivalent results by obtaining permission for changes. At this time, if the license is changed while consignment manufacturing is converted to in-house manufacturing, it is a strategy to meet the requirement of ‘conducting BA test’. The health authorities expected an effect of reducing health insurance by 297.8 billion won a year with the drug price cut in September. This means a loss of about 40 million won per item per year. From the perspective of the pharmaceutical industry, the annual operating profit of 297.8 billion won is tantamount to evaporation, so performance deterioration due to drug price cuts is inevitable. It is expected that medium-sized and small-sized pharmaceutical companies that have a lot of consignment-type generics will have many products with reduced prices. In other words, the losses experienced by pharmaceutical companies are bound to be even greater. Moreover, pharmaceutical companies are willing to accept price cuts for many of their products by abandoning bioequivalence testing of consigned generics. Pharmaceutical companies have already predicted huge losses as they inevitably accept drug price cuts when it is difficult to change manufacturers of consigned generics to their own. Expenditures have also increased significantly as bioequivalence tests are conducted at a considerable cost to maintain drug prices. The number of BA test plan approvals increased by 24.7% from 259 in 2019 to 323 in 2020. In 2021, it soared to 505 cases. In order to make up for the losses caused by drug price cuts, the sales field is already fiercely competing. An official from a pharmaceutical company said, “The only way to make up for the loss from drug price cuts is to increase sales. We are in a position where we need to encourage the strengthening of our sales force at the company level.” As a result of the generic drug price re-evaluation, products with 27.75% cuts appeared one after another because they did not meet both standard requirements and pharmaceutical companies are clearly in a panic. It has been reported that despite the efforts of pharmaceutical companies to keep up with the price of generic drugs, products that are classified as targets for drug price cuts have appeared one after another. For example, it is known that there have been quite a few products that have been notified of drug price cuts for not submitting a change permit even though they have completed the BA test and completed their conversion. Some products were classified as subject to price cuts because they could not complete the change approval due to a delay even though BA tests were carried out at a cost of hundreds of millions of won. It is known that some products are classified as subject to price reduction due to a lack of documentation even though the requirements for using registered raw materials have been proven. The use of registered raw materials is a requirement that can be easily met, but the fact that hundreds of products do not meet the price is also a variable that pharmaceutical companies did not expect. An official from a pharmaceutical company said, "We have already incurred a huge investment in BA testing of licensed generics, and if the drug price of products that have not undergone BA testing is lowered, a significant loss will become a reality." “In a situation where profitability is deteriorating due to recent raw material price cuts, if drug prices drop by 20%, products that are contemplating withdrawal from the market are expected to appear one after another,” he said.
- Company
- JW Shinyak will resume sales of flu vaccine SKYCellflu
- by Kim, Jin-Gu Aug 22, 2023 05:31am
- On the 21st, JW Shinyak announced that it will resume sales of SK Bioscience’s flu vaccine ‘SKYCellflu Quadrivalent Prefilled Syringe.’ The company signed a joint marketing agreement for ‘SKYCellflu Quadrivalent Prefilled Syringe’ in 2016, and has been responsible for the sales and marketing of the drug at specialized dermatology, urology, and plastic surgery clinics and hospitals. SKYCellflu Quadrivalent Prefilled Syringe is the first cell culture-based influenza vaccine developed by SK Bioscience. It can protect against four types of influenza viruses, including 2 types of influenza A viruses and 2 types of influenza B viruses. SK Bioscience has discontinued production of SKYCellflu Quadrivalent Prefilled Syringe for the past 2 years to ensure smooth supply of its COVID-19 vaccine. The company has only recently resumed production of the SKYCellflu Quadrivalent Prefilled Syringe in preparation for the sharp increase in flu cases that might arise this year due to eased social distancing and indoor mask regulations. Accordingly, JW Shinyak will resume sales of the flu vaccine that it had discontinued in line with the normalized supply of SKYCellflu Quadrivalent Prefilled Syringe and will increase its presence in the flu vaccine market based on its own sales and marketing competitivity. A JW Shinyak official, said, “The number of suspected flu patients per 1,000 outpatients has exceeded 15.0 recently, which is three times the flu epidemic standard (4.9) set by the Korea Disease Control and Prevention Agency. We will make our best efforts to ensure a stable supply of SKYCellflu by October in response to the expected surge of flu cases.”
- Company
- Luxturna, a one-shot gene therapy product
- by Eo, Yun-Ho Aug 22, 2023 05:31am
- Attention is focusing on whether progress will be made in the discussion on insurance benefits for Luxturna, a one-shot retinal disease treatment. As a result of the coverage, Novartis Korea recently submitted additional supplemental data for Inherited Retinal Dystrophy treatment Luxturna requested by the HIRA. The drug submitted an application for reimbursement in September 2021, but there was no progress in the listing process, and it was presented to the Pharmaceutical Reimbursement Evaluation Committee in March but failed to set reimbursement standards. It is known that during the evaluation process of Luxturna, there was a difference of opinion over the terms of the Risk Sharing Agreement (refund rate, etc.). As Novartis submitted supplementary data and both the government and pharmaceutical companies are showing their will to be listed as Luxturna, it remains to be seen whether this re-challenge will be successful. Luxturna restores the function of the defective or defective RPE65 gene, one of the causes of IRD, by replacing it with a normal gene with just one administration. This means that the fundamental treatment of the disease is possible. This drug was designated by the US FDA for Breakthrough Therapy in 2014, Orphan Drug in 2016, and Priority Review in 2017, and obtained expedited approval in 2017. Meanwhile, Luxturna proved its effectiveness through a phase 3 clinical trial targeting patients with hereditary retinal diseases in which a biallelic mutation in the RPE65 gene was confirmed. As a clinical result, the functional vision of patients treated with Luxturna improved statistically significantly compared to the control group who did not receive treatment for 1 year. As a result of evaluating the average score of the Multi-Luminance Mobility Test, which assesses the ability to pass through an obstacle course of various heights in various lighting levels by reproducing a daily walking environment, as the primary evaluation variable at the time of 1 year of treatment, Luxturna treatment group The score change was 1.8 points, which was 1.6 points higher than the control group's score change of 0.2 points.
