- LOGIN
- MemberShip
- 2026-05-13 22:00:59
- Company
- Dupixent's child benefit expands after over 1 1/2 yrs
- by Eo, Yun-Ho Oct 13, 2022 06:08am
- Discussions on expanding insurance benefits for children and adolescents of Dupixent, a treatment for atopic dermatitis, have been slow. According to related industries, Sanofi-Aventis Korea's Dupixent 200mg passed the Drug Benefit Standards Subcommittee in May, but has yet to be submitted to the Drug Benefit Evaluation Committee. The drug was applied for benefit expansion in March last year, but it is still in the early stages of the registration process. Earlier, Dupixent spent seven months until the expert opinion inquiry began last year. As it is an expensive new drug and it was not easy to register for the first time, it is believed that difficulties are also being followed in the discussion of expansion. Although detailed indications are different, there is a clear difference in speed compared to JAK inhibitors such as Lilly Oluminant and Abbvie Rinvoq, which belatedly submitted applications for expansion of atopic benefits. JAK inhibitors are also relatively inexpensive. Both drugs have been reimbursed since May. Since it is a risk-sharing agreement drug and a separate dose of 200mg has been added, it has to go through negotiations with the NHIS as well as HIRA's cost-effectiveness review process in the future. It remains to be seen whether Dupixent will be able to reach an agreement with the government and expand child benefits. Dupixent's health insurance coverage criteria are both 23 or higher EASI (Extremely severe eczema) even if symptoms are not controlled and systemic immunosuppressants are administered for more than 3 months, or if Dupixent is not available due to side effects. This corresponds to 300 mg.
- Company
- Status of antidiabetic SGLT-2 inhibitors rise with use in HF
- by Oct 13, 2022 06:08am
- SGLT-2 inhibitors that were initially released as a diabetes treatment have expanded their scope and risen as a representative heart drug. In addition to Heart Failure with reduced EF (HFrEF) and Heart Failure with mildly reduced EF (HFmrEF), SGLT-2 inhibitors have also demonstrated an effect in Heart Failure with Preserved Ejection Fraction (HFpEF), transforming heart failure guidelines in Korea and abroad. The heart failure treatment effect of SGLT-2 inhibitors, which was first demonstrated with Jardiance (empagliflozin), was confirmed with Forxiga (dapagliflozin). In the EMPEROR-Preserved clinical trial on HFpEF patients, Jardiance succeeded in reaching the primary efficacy endpoint. Then, Forxiga demonstrated its effect in HFrEF and HFpEF patients in the DELIVER trial. Based on such grounds, the Korean Society of Heart Failure (KSHF) published a newly revised Heart Failure Clinical Practice Guidelines and recommended SGLT-2 inhibitors as a main treatment regardless of the patient’s diabetic status in all areas of heart failure including HFrEF, HFmrEF, and HFpEF. The US has also recommended SGLT-2 inhibitors as the main drug in the guidelines for the treatment of heart failure. Some have compared the SGLT-2 inhibitor to a '21st-century statin' and predicted that it will become a standard of care in heart failure. Dailypharm met with professor Javed Butler from the University of Mississippi Medical Center in Jackson and Professor Seok-Min Kang from the Yonsei University College of Medicine (Chair of KSHF) to highlight the changes SGLT-2 inhibitors brought to the heart failure treatment paradigm. -Among SGLT-2 inhibitors, Jardiance was the first to present data demonstrating an effect on all heart failures including HFpEF. What significance does this hold and how was Jardiance able to become the first SGLT-2 inhibitor to demonstrate such data? ? Prof. Butler: Jardiance marked two milestones in the history of heart failure treatments. First, the drug was the first to demonstrate a reduction in cardiovascular deaths in diabetes patients in 2015 through the EMPA-REG OUTCOME trial. Also, the drug holds significance for being the first to demonstrate clinical efficacy in HFpEF, an area where no treatment option exists, through the EMPEROR-Preserved trial. In patients with HFpEF, Jardiance reduced the relative risk of hospitalization from HF or cardiovascular deaths by 21% and reduced the relative risk of all hospitalization from HF by 27%. This is significant because it can be felt in the field while treating patients, beyond being simply statistical figures. Although the cardiac ejection fraction rate will continue to serve as a key indicator in determining the type of heart failure and the according treatment method, it will not hold much meaning in determining the use of SGLT-2 inhibitors. Furthermore, when discussing treating heart failures, we usually discuss treatment in the spectrum of HFrEF to HFpEF. However, as SGLT-2 inhibitors have also demonstrated a relative risk reduction in the development of new heart failure events in patients with Type 2 diabetes, I would like to expand the spectrum and discuss extending its use to prevention as well. For patients with diabetes or chronic kidney disease (CKD), the best time for them to start treatment with SGLT-2 inhibitors is at the ‘pre-heart failure’ stage. -When comparing the two representative SGLT-2 inhibitors Jardiance and Forxiga, Jardiance showed a slight reduction in effect in the patient group with an ejection fraction rate of 65% or higher, but recent data on Forxiga showed that its effect remained constant in these patients. How should we interpret this difference? Professor Javed Butler Prof. Butler: It would be difficult to say that the results signify any difference between the two drugs. Based on the primary efficacy endpoint, it is difficult to say that the drugs show different efficacy in different ranges of ejection fraction rate. Only in the secondary efficacy endpoint does Jardiance show a slight reduction in effect in the group with an ejection fraction between 65-70%. However, as the drug’s efficacy rises again in the group with an ejection fraction rate of 70% or higher, the measure in the EF of 65-70% group has to be considered a noise that arose in the process of conducting the subgroup analysis. Even when taking into account the biological mechanism and principle of action of SGLT-2 inhibitors, it is difficult to provide a reasonable explanation on why its effect decreases in the EF of 65-70% group and rises again in the EF of 70% or higher group. When looking at the trend lines of clinical trials conducted on Forxiga and Jardiance, although the two may seem contrasting, it is difficult to see the difference as a clear signal indicating a significant difference when comprehensively analyzing the overall data. Also, a comprehensive meta-analysis of these data shows a fairly consistent effect across the entire cardiac ejection fraction rate spectrum. -Then, rather than discuss which drug is better, should we understand that SLGT-2 inhibitors have a class effect? Prof. Butler: It is too soon to consider it a class effect. Of course, the clinical trials of the two drugs that were conducted on patients with HFrEF and HFpEF showed consistent results. However, as we saw in various cases where the results were different after expecting such a class effect in the past, it is hard to prescribe SGLT-2 inhibitors while expecting a class effect. In other words, it would be difficult to put other SGLT-2 inhibitors on the same line other than the two drugs that have proven their treatment effect in heart failure. -The 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure gave a Class 2A recommendation for SGLT-2 inhibitors to treat HFpeF. How was the recommendation for the guideline determined at that level? Prof. Butler: There had been no other treatment option recommended in HFpEF before then. We used diuretics to treat congestion or were at the level of dealing with comorbidities. The US was the first to revise the major practice guidelines for heart failure in HFpEF after the Jardiance trial results were presented. The recommendations were changed based on the convincing trial results. However, the US guidelines require at least 2 related studies to recommend a treatment as Class 1 when revising guidelines. At the time of the revision, only one study - EMPEROR-Preserved – existed for SGLT-2 inhibitors, which was why it was not given a Class 1 recommendation. In Korea, SGLT-2 inhibitors have a Class 1 recommendation in HFpEF. I believe this is a more reasonable and advanced decision than the one made in the Us guidelines. With more relevant data being presented, I believe the US and European guidelines will also be revised to follow Korea’s guidelines. -Until now, the Korean practice guidelines mostly followed those in Europe and the US. What enabled your society to make such a bold decision this time? Prof. Kang: Korea lacks the conditions to conduct large-scale randomized clinical studies like Europe or the United States. This is why Korea commonly sets guidelines by adopting or accepting results from foreign clinical studies. We underwent various voting and debates to determine the level of evidence for several drugs before releasing our heart failure guidelines on July 22nd. Also, the DELIVER trial on Forxiga was scheduled to be presented at the European Society of Cardiology (ESC) Congress 2022 in August. We already knew the top-line results and were able to analyze the results to some extent. Considering how the prevalence of heart failure in Korea will continue to increase rapidly, the prevailing opinion was that it is reasonable to defiantly recommend a good treatment option as soon as possible. -You also mentioned SGLT-2 inhibitors should be used for prevention as well. At what scope are SGLT-2 inhibitors being prescribed in the US? Prof. Butler: As SGLT-2 inhibitors were first introduced to treat diabetes, it was mainly used by primary care doctors or endocrinologists that commonly treat diabetes. In cardiology, there is still a perception that SGLT-2 inhibitors are used to treat diabetes. Therefore, several heart failure-related societies are making efforts to raise awareness of SGLT-2 inhibitors as a treatment that can reduce cardiovascular risk, regardless of the patient’s diabetic status SGLT-2 inhibitors are being moderately used as a treatment for heart failure. However, compared to ARNis, its usage is increasing relatively quickly. -In Korea, the drugs would need to also receive reimbursement in the indication, but setting the reimbursement standards for SGLT-2 inhibitors may also be a difficult task. Even when basing the standards on the cardiac ejection fraction rate, it would be difficult to apply for reimbursement benefits according to the specific ejection rate. Prof. Kang: I cannot say what would be the clear standard for reimbursement, and this area would need to be considered further. When using the level of ejection fraction as a standard, we could set an arbitrary level and reimburse all substandard drugs for other class drugs, but for SGLT-2 inhibitors, we would need to contemplate what should be considered a normal ejection fraction rate. - So SGLT-2 inhibitors are now set in the forefront of heart failure treatment. Are there any tasks we need to solve to select patients that will benefit more from the use of SGLT-2 inhibitors or any precautions that need to be taken? Prof. Butler: SGLT-2 inhibitors are more of a supplement than a replacement of existing drugs. We need to first focus on starting drug treatment as soon as possible, and take into consideration the patient's condition, including blood pressure, cardiac and kidney condition, to start administration of drugs in the appropriate order so that patients can receive all 4 drugs within 3-4 weeks of initial administration. In most cases, we can add SGLT-2 inhibitors without regulating the use of the existing drugs, however, patients who are old, have hypotension, or dehydration may need to reduce their diuretic dose, etc. Prof. Kang: As there are many phenotypes of HFpEF, more follow-up studies on the use of SGLT-2 inhibitors in these various patients would be needed. Some may oppose the prospect that SGLT-2 inhibitors may be beneficial across the entire cardiac ejection fraction rate spectrum. Therefore, data supporting how effective SGLT-2 inhibitors are for the various characteristics of heart failure is needed.
- Policy
- National lot release for Moderna's bivalent COVID-19 vaccine
- by Lee, Hye-Kyung Oct 13, 2022 06:08am
- The 1.57 million courses of the bivalent vaccine manufactured by Samsung Biologics have been approved for national lot release. The Ministry of Food and Drug Safety (Minister: Yu-Kyung Oh) announced that it had approved the national lot release for 1.57 million courses of Moderna Korea’s domestically manufactured mRNA bivalent COVID-19 vaccine, ‘Spikevax 2’ on the 11th. The national lot release system was implemented to reaffirm the quality of a vaccine through a comprehensive evaluation of the state’s national test and the manufacture and test results of the manufacturer for each manufacturing unit (lot) before they are distributed on the market. Spikevax-2 is manufactured in Korea (by Samsung Biologics) through fill-finish processes after being supplied the API of the same Spikevax-2 vaccine that has been approved for import on September 8th from overseas. The MFDS expects the national lot release approval of the bivalent COVID-19 vaccine will contribute to the prevention of COVID-19 and will continue efforts to ensure a stable supply of quality vaccines through thorough and swift verification of COVID-19 vaccines to come.
- Policy
- The loss of health insurance is close to 200 billion won
- by Lee, Jeong-Hwan Oct 13, 2022 06:08am
- Rep. Nam In-soon said, "The Legislation and Judiciary Committee's pending bill to recover the reduction will be dealt with." Over the past decade, health insurance benefit losses amounted to 19.7 billion won for 17 cases in which pharmaceutical companies lost lawsuits related to weak cuts and re-evaluation. Critics point out that the revision of the Health Insurance Act, which calls for the recovery and refund system of drug prices, should be handled as soon as possible to prevent pharmaceutical companies from suing lawsuits to cancel drug prices. On the 6th, Rep. Nam In-soon of the Democratic Party of Korea said, "We should pass the National Assembly's Health and Welfare Committee and deal with the revision of the Health Insurance Act pending at the Legislation and Judiciary Committee as soon as possible to minimize the loss of health insurance finances and achieve pharmaceutical rights." Regarding the claim that some pharmaceutical companies are concerned that the regulation on redemption within the revision of the Health Insurance Act may neutralize the effect of suspension of execution, a principle of litigation law, Rep. Nam insisted that "it is not persuasive." Considering the ongoing administrative litigation of pharmaceutical companies, administrative trials, and applications for suspension of execution for the drug reduction, and accumulated financial losses on health insurance, she believes the National Assembly should wrap up the legislation as soon as possible. She said, "The provisions for the redemption and refund of the amendment do not limit the application for administrative litigation or suspension of execution itself." She emphasized, "It is a system operated on the premise of filing administrative litigation and administrative trial, and the purpose is to post-calculate losses incurred in the NHIS or pharmaceutical companies during the suspension period according to the characteristics of the profitable health insurance drug price system." Rep. Nam said, "If legality is recognized after the decision to suspend execution, it is similar to the purpose of the Supreme Court ruling in September 2020, which judged that the administration should take active measures the same as if there was no decision to suspend execution," adding, "It is expected to minimize health insurance financial losses and protect pharmaceutical companies' rights." "The loss of health insurance benefits for 17 cases lost by the plaintiff pharmaceutical company out of 49 administrative lawsuits is estimated to be 19.7 billion won, but the financial loss of health insurance due to the difference in drug prices before and after the decision to suspend execution of 49 administrative lawsuits," she added.
- Company
- The third PD-1 immuno-cancer drug is about to enter Korea
- by Eo, Yun-Ho Oct 12, 2022 05:50am
- It is predicted that additional immuno-cancer drugs with PD-1 inhibitory mechanisms will enter the domestic market. According to related industries, the Ministry of Food and Drug Safety is reviewing the final approval of PD-1 inhibitor Jemperli, which GSK Korea submitted an application for permission in March. Approval is possible as early as this year. If Jemperli is approved, it will be the third PD-1 inhibitor after Opdivo and Keytruda. Unlike the two drugs that took the first indication as a treatment for melanoma, this drug was first approved in the United States in April last year as a treatment for "reoccurring or progressive endometrial cancer" indicating a defect in platinum-based therapy or subsequent inconsistency recovery. Jemperli demonstrated its validity through a multi-cohort clinical trial GARNET study involving patients with recurrent or progressive dMMR/MSI-H endometrial cancer that progressed during or after platinum-based chemotherapy. As a result, RR was 43.5% and DCR was 55.6% after Jemperli treatment. The duration of the reaction has not yet reached the median value, and the rates at which the reaction lasted for 6 months and 12 months were 97.9% and 90.9%, respectively. In addition, in August of the same year, Jemperli obtained additional approval for recurrent or progressive solid cancers of adult replication error recovery defects (dMMRs) that did not reach satisfactory results with existing treatment. Jemperli recently confirmed its efficacy in non-small cell lung cancer. GSK announced positive headline results on the 5th that it met the primary evaluation variables RECIST and ORR goals in a phase 2 PERLA clinical study. The study compared Jemperli and chemotherapy combinations and Keytruda and chemotherapy combinations in primary care patients with NSCLC.
- Policy
- 99 items were granted generic exclusivity, none reimbursed
- by Lee, Tak-Sun Oct 12, 2022 05:50am
- ▲ Boehringer Ingelheim diabetes combo drug Although 99 items were granted generic exclusivity, none of the items were granted reimbursement during the period. This was what happened to generics of Boehringer Ingelheim’s Jardiance Duo (empagliflozin+metformin hcl). Although a large number of products were approved and even obtained generic exclusivity, the drugs were unsellable in the market, and the exclusive rights granted for the products became obsolete. According to industry sources on the 11th, the generic exclusivity granted to 99 Jardiance Duo generics ended on August 15th. However, none of the items were listed for reimbursement and sold in the market during the period. This was not unexpected. Although the Jardiance Duo generics succeeded in avoiding subsequent patents and obtained generic exclusivity, they were unable to release their drugs to the market due to a substance patent that was not registered with the Ministry of Food and Drug Safety. The MFDS patent list serves as the standard for granting generic exclusivity. A substance patent for the single ingredient Jardiance is currently listed, but none is listed for Jardiance Duo. Based on the patent list, companies that manufacture Jardiance Duo generics were allowed to release their drugs after approval as they have overcome all of the registered patents by avoiding subsequent patents that are terminated after the substance patent. Thus, all Jardiance Duo latecomers that were approved from November last year to April this year were allowed to be marketed upon approval under the drug approval-patent linkage system, and their generic exclusivity period was also set based on the approval date. The end date was set until August 15th based on the products that were approved in November last year. However, substance patents need to be observed due to the risk of a dispute with the patentee regardless of whether or not it is registered on the MFDS patent list. The substance patent for Jardiance Duo is set to expire on October 23rd, 2025. Ironically, the generic exclusivity of the single-ingredient Jardiance is set to start on October 24th, 2025. In other words, generics of the combination drug Jardiance Duo were unable to be sold in the market even with the generic exclusivity. Then how were 99 items allowed to receive this obsolete generic exclusivity? This is because the restrictions set for the 1+3 consigned bioequivalence tests were implemented in July last year. Pharmaceutical companies that conducted bioequivalence tests after July 2012 could only consign manufacture of same-ingredient drugs for up to 3 pharmaceutical companies. As a result, pharmaceutical companies had entered into consignment agreements before the enforcement of this law and rushed the development of their generics, which resulted in the manufacture of such large number of Jardiance Duo generics. According to the MFDS, Dongkoo Bio&Pharma is currently manufacturing empagliflozin+metformin hcl products on consignment for 24 pharmaceutical companies (71 items in total). Such large-scale consignment manufacture was possible because the generic was developed before the enforcement of the consigned bioequivalence test restriction law. As the approved items may only be sold after 4 years from now, it seems inevitable that all of the test products manufactured for approval will have to bd discarded. This means that much social cost was wasted due to the new regulations. Couldn't the generics rather be regulated through drug prices? The Ministry of Health and Welfare had announced a drug pricing system in July 2020, one year before the enforcement of the consigned bioequivalence test restriction law. The system focused on reinforcing the standard requirements for self-bioequivalence tests and a stepped drug pricing system. Under the new system, generics are required to conduct self-bioequivalence tests and be listed within the 20th in the reimbursement list to maintain its base price, which is 53.55% of the insurance ceiling price of the original drug. However, the system could be bypassed as many items that apply for reimbursement at the same time are listed at the same time and considered a single group, and not discounted their price even if the number exceeds 20. Jardiance Duo generics will also be able to avoid the stepped pricing system by applying for the insurance price at the same time before patent expiry. However, such waste from large-scale approvals will not be made for items that were developed after the bioequivalence restrictions were set last year, as only 4 companies at most will be approved at once.
- Policy
- Ponesimod's Domestic Item License
- by Lee, Hye-Kyung Oct 12, 2022 05:50am
- Ponesimod of Janssen Korea, a rare drug for treating multiple sclerosis, has been approved for domestic items. The Ministry of Food and Drug Safety (Director Oh Yoo-kyung) announced on the 11th that it has approved Ponesimo for the treatment of recurrent dysplasia in adults. The drug has been shown to reduce inflammatory reactions by blocking lymphocytes from being separated from lymphatic organs and inducing the number of lymphocytes in peripheral blood to decrease rapidly. Ponesimo is expected to reduce the occurrence of new diseases in patients with multiple sclerosis and prevent additional disorders from occurring and accumulating due to repeated and continuous symptoms. Ponesimo was designated as a rare drug in Korea on October 1 last year after being approved by the U.S. FDA in March last year as a treatment for adult patients with recurrent multiple sclerosis, including clinical solitary syndrome, recurrence-relaxation disease, and active secondary progressive disease. The Ministry of Food and Drug Safety said, "We expect that this rare drug license will contribute to improving the quality of life of patients by expanding their treatment opportunities and options." The Ministry of Food and Drug Safety said, "We will do our best to expand treatment opportunities to patients such as rare and incurable diseases by quickly supplying treatments that have been sufficiently confirmed in safety and effectiveness based on regulatory science expertise."
- Policy
- Alvogen’s Alymsys reimbursed...compete with Avastin similar
- by Lee, Tak-Sun Oct 12, 2022 05:50am
- Samsung Bioepis’s Avastin biosimilar Competition for biosimilars of the anticancer drug Avastin (bevacizumab) is intensifying in the domestic market. Alvogen’s ‘Alymsys’ is making a bid against Samsung Bioepis’s ‘Onbevzi,' which had been dominating the Avastin biosimilar market. With the entry of Alymsys, the original Avastin and its two biosimilars will be competing in the market. According to industry sources on the 11th, Alvogen Korea’s ‘Alymsys inj.’ will be included on the NHI reimbursement list starting this month. The maximum reimbursement price for the 0.1g dose will be KRW 208,144 per vial, the same as Samsung Bioepis’s ‘Onbevzi inj.’ The price of the 0.4g dose was also set at KRW 677,471, the same as Onbevzi. The price of its original, Roche’s Avastin inj is set at KRW 218,782 for the 0.1g dose and KRW 712,098 for the 0.4g, which is slightly higher than its biosimilars. Onbevzi enjoyed a monopoly in the biosimilar market for 1 year after being approved for reimbursement in September last year, and enjoyed a significant preoccupation effect in the market. Its sales, which reached KRW 0.5 billion in Q4 last year based on IQVIA, had continued rising to KRW 1.8 billion in Q1, and then KRW 4.1 billion in Q2. At this rate, its sales is expected to exceed KRW 10 billion only one year since its launch. With the launch of Onbevzi, Avastin’s price was also discounted. With the price reduction, its sales also dropped by KRW 20 billion from the KRW 58.9 billion in 1H of the previous year to KRW 38.1 billion in the 1H this year. Avastin is a targeted therapy monoclonal antibody that is widely indicated for the treatment of various cancers including ▲metastatic colorectal cancer, ▲metastatic breast cancer ▲non-small-cell lung cancer ▲advanced or metastatic renal cell carcinoma, ▲glioblastoma, ▲epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, ▲uterine cervical cancer, etc. Its market size exceeds KRW 100 billion in Korea. Due to its potential, biosimilar companies that had mainly stayed abroad have been launching large-scale marketing activities in the Korean market. However, Avastin’s patent emerged as a variable. Due to the patent, biosimilars were restricted from being used like the original drug, in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin for the ovarian cancer indication. Samsung’s Onbevzi was also unable to obtain this indication due to unresolved patent issues earlier in its release. On the other hand, Alvogen’s Alymsys was approved with the said indication. This is why the release of Alymsys was expected to weaken the competitiveness of Onbevzi in the market. But the situation was once again reversed with Samsung reaching an agreement on patent issues with the original developer Genentech, and Alvogen failing to do so. Samsung recently reached an agreement with Genentech for the patent suit on Avastin, which had been ongoing since June 2020. As a result, the company was able to obtain an additional indication for epithelial ovarian cancer last month. Alvogen, on the other hand, had to delete the indication in August due to a patent dispute and received reimbursement approval for the remaining indications. This is why the reimbursement approval period was delayed by one month. Despite some indication-related issues, many experts expect biosimilars to succeed in the domestic market, considering the high usage rate of bevacizumab in various other cancers as well. Samsung Bioepis entrusted sales of its product to Boryung Pharmaceutical, which is showing prominence in the anticancer drug market, and Alvogen to the large domestic pharmaceutical company Daewoong Pharmaceuticals for its early settlement in the market. In addition, Celltrion also received approval for its ‘Vegzelma inj’ on September 28th and is working to release the drug with reimbursement within the year. Celltrion also reached an agreement on Avastin’s patent with Genetech in May and was approved for the same indication as the original, including ovarian cancer related indication. Until now, Remsima was the only product that showed a good performance in the domestic biosimilar market. It is analyzed that the domestic biosimilar market is also entering full-fledged growth, starting with the Avastin biosimilar.
- Company
- Reimb for Ilaris unclear... benefits 13 patients in Korea
- by Eo, Yun-Ho Oct 11, 2022 05:51am
- As well expected, no progress has been made in reimbursing ‘Ilaris,’ an orphan drug that affects 13 patients in Korea. According to industry sources, reimbursement discussions for Ilaris (canakinumab), Novartis Korea’s Hereditary recurrent fever syndrome treatment that the company applied for in the first half of the year is making slow progress. The company had reapplied after receiving a non-reimbursement decision from the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee in 2017, but the government nor the company seems to be finding a way. Among the various specific syndromes that accompany a hereditary recurrent fever, Ilaris is approved in Korea to treat ▲Cryopyrin-Associated Periodic Syndromes (CAPS), ▲Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS), ▲Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD), ▲ Familial Mediterranean Fever (FMF) due to contraindication, intolerance or lack of efficacy. Although the drug had demonstrated an improvement in quality of life and convenience in administration with its 6-times-a-year administration in CAPS patients, the drug had difficulty proving its cost-effectiveness, being a treatment for an ultra-rare condition and because a relatively cheaper option ‘Kineret (anakinra)’ is being supplied through the Korea Orphan & Essential Drug Center. In fact, Novartis first applied for reimbursement in 2017 after it was initially approved in 2015. However, the company did not proceed with the reimbursement process again until recently after the setback in 2017. Anticipation had risen for its reimbursement with the reapplication filed this time but to no avail. Unlike Kineret which is administered every day, Ilaris offers a more convenient option to patients and carers alike, as it is administered every 8 weeks. Dae-Chul Jeong, Professor of Pediatrics at Seoul St.Mary’s Hospital, said, “Access to such treatments needs to be improved so that patients with hereditary recurrent fever in Korea are guaranteed the same right to receive treatment as other patients with rare diseases. In addition, “Patients with hereditary recurrent fever are diagnosed after a difficult journey. We need to provide social attention and support so that patients can maintain the quality of life with their families without being discouraged at the threshold of treatment." Meanwhile, in a clinical study, 97% of the patients that were administered Ilaris 150mg achieved a complete clinical response by Week 8 through a single administration during the open-label study period. In the double-blind, placebo-controlled study period, all patients who were administered Ilaris 150mg every 8 weeks maintained their complete response without relapse for over 6 months. Also, in a real-world study that was conducted in France that compared 68 adult and pediatric patients that received at least one dose of Ilaris at baseline, at 6 months and 12 months, over 40% of patients with CAPS who were treated with Ilaris showed an improvement in vitality such as social function, human relationship, and sexual activity, and the patient care period of carers reduced significantly.
- Company
- Hemlibra, emerged as an issue of the National Audit Office
- by Nho, Byung Chul Oct 11, 2022 05:50am
- As the administration of non-antibody patients has been delayed for more than three years since Hemlibra, an innovative new drug for hemophilia A, is expected to emerge as a topic of the parliamentary audit. Representative Kang Sun-woo (Democratic Party of Korea), a member of the Health and Welfare Committee, will question the issue of the benefit of hemophilia new drug Hemlibra at a parliamentary audit of HIRA held on the 13th of this month. Kim Kyung-Hwa, a mother of a hemophilia patient with type A as a representative of the Korean Hemophilia Association, will attend as a reference. She is expected to urge health authorities to apply for Hemlibra's delayed health insurance benefits, explaining the problems of existing treatments that should be used to prevent bleeding and why subcutaneous injections are needed at the National Audit Office. Hemlibra is used as a new innovative treatment for many hemophiliac patients, achieving the No. 1 global market share, but the application of benefits is being delayed in Korea. Hemlibra, a type A hemophilia treatment imported by JW Pharm in charge of domestic permission and sales, was first approved for sale as a treatment for antibody patients in January 2019 and was first listed in May 2020, and limited standards have been resolved several times since then. In September last year, the Anti-Corruption and Civil Rights Commission recommended a review of the standards, allowing young children to be prescribed Hemlibra without undergoing two to three years of intravenous treatment. The problem is that 90% of about 1,800 hemophilia A patients are non-antibody patients. Hemlibra added an indication for non-antibody patients in March 2020 and applied for benefits in July of that year, but health insurance benefits have not been used even after two years. According to the academic society and replotting organizations, the expansion of Hemlibra's standards was confirmed at the third subcommittee held at the Review Board in July. Looking at the clinical usefulness, Hemlibra judged that it was also worth paying for non-antibody patients. However, the future is a problem. Even if it has passed the subcommittee, it must go through the HIRA Drug Benefit Evaluation Committee and negotiate drug prices and usage with NHIS. Currently, the Drug Benefit Evaluation Committee does not know when it will be held. Hemlibra is the only existing hemophilia A treatment that has been approved for use as a preventive therapy for both antibody and non-antibody patients. It imitates the mechanism of action of the coagulation factor VIII with the first-in-class applied with the technique of simultaneously binding to the coagulation factors VIIII and X, Unlike conventional treatments that supplement the 8th coagulation factor with such a mechanism, antibody production is not risky. The patient's pain was dramatically improved when taking existing drugs with subcutaneous injections up to once every four weeks. In the case of conventional hemophilia treatments, intravenous injections should be performed at least twice a week. In August, the results of phase 3 clinical trials were published in Blood advises that hemophilia A patients with hemophilia administered with Hemlibra had fewer side effects of bleeding during surgery. The result is that the risk of bleeding during surgery is low in a situation where efficacy and safety have been proven as a law.
