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- 2026-04-08 03:35:26
- Opinion
- [Reporter’s View] Need momentum to boost investments
- by Kim, Jin-Gu Mar 12, 2024 05:49am
- Investment in the domestic pharma-bio industry is slowly rising, awakening from its long winter slumber. Although it is still too early to call it a full spring compared to the boom the industry had enjoyed in 2021-2022, however, significant signs of recovery are being shown through various indicators. Such change is usually most often noted first in the stock market. The KRX Healthcare Index, a leading index for the pharma and biotech sector, has been consistently above 3,000 since the start of the year. This is in contrast to last year when the score remained in the low 2000 range for most of the year. On the 8th, the index reached 3441.04. This is the highest index reached since January 13, 2022, when it reached 3556.92. The market has begun to rebound from the sluggish performance it had shown throughout the past year. Investment in the unlisted sector is also active. According to the Korean startup database TheVC, 37 investments in unlisted pharma and biotech companies had been made in the first 2 months of this year, totaling KRW 907.9 billion. This is a significant change from last year's 29 deals and KRW107.9 billion. The average investment per company also soared from KRW 3.7 billion to KRW 24.5 billion. The IPO market also saw a number of successful IPOs. Osang Healthcare, which is set to go public on the 13th, finalized an offering price of KRW 20,000, which exceeded the upper end of the price band (KRW 13,000-15,000) in its demand forecasting for institutional investors last month. The company continued the success in subscriptions for public shares for general investors, at a competition ratio of 2126 to 1. The deposit for subscription exceeded KRW 5 trillion. Such success continues to be seen in companies that have been listed on KOSDAQ since November last year, such as U2Bio, Curocell, YBiologics, and BlueMTech. A similar change can be detected in the phishing text messages that induce stock investment. While secondary battery-themed stocks were mainly used as bait until last year, several pharmaceutical and biotech stocks have started to be included this year. The texts recommend a few stocks that have risen sharply in recent years and promise high returns based on “non-public information.” In and out of the legal boundaries, the psychology for investment in the pharmaceutical and bio sectors has been showing signs of recovery. This is in stark contrast to the sharp decline in investments over the past 2 years. Although external factors do have a significant impact, it is analyzed that the domestic pharmaceutical bio industry's efforts have also played a role in overcoming the crisis. At the end of last year, Orum Therapeutics, Chong Kun Dang, LegoChemBio, and LG Chem signed a series of large technology export contracts. GC Biopharma secured marketing authorization for its immunoglobulin drug Alyglo from the U.S. Food and Drug Administration (FDA) in December last year, while Yuhan Corp is awaiting FDA approval for its non-small cell lung cancer drug Leclaza. However, the upcoming events that can keep the momentum going are as important. We are in desperate need of an event that will add momentum to the recent uptrend. If established, these events are expected to connect the dots and eventually lead to an improved investment flow for the industry as a whole. Events in the next few months will be crucial in determining whether the industry will emerge from its long winter hibernation and enter full bloom, or whether it will once again be left to freeze in the cold.
- Company
- Quadrivalent meningococcal vaccine MenQuadfi approved
- by Eo, Yun-Ho Mar 12, 2024 05:49am
- The quadrivalent meningococcal vaccine MenQuadfi has landed in Korea. The Ministry of Food and Drug Safety granted marketing authorization for Sanofi's invasive meningococcal disease (serogroups A, C, Y, W) vaccine, MenQuadfi (MenACYW-TT) on the 6th. MenQuadfi is a fully liquid quadrivalent meningococcal vaccine that protects against meningococcal serogroups A, C, W, and Y. It was approved as a single-dose vaccine for persons aged 2 to 55 years. MenQuadfi is administered intramuscularily as a single 0.5ml into the deltoid region or anterolateral thigh depending on the recipient's age and muscle mass. When evaluating immunogenicity and safety with other existing meningococcal quadrivalent vaccines, MenQuadfi demonstrated non-inferiority across all four serogroups. The seroprotection rates were 94.7% for serogroup A, 95.7% for serogroup C, 96.2% for serogroup W, and 98.8% for serogroup Y in people aged 10 to 55 years that were vaccinated with MenQuadfi. Also, compared with the company’s previous meningococcal vaccine that used the diphtheria protein, MenQuadfi uses a tetanus protein and contains more antigens. Meningococcal disease, which can be prevented with MenQuadfi, has been regarded as a global public health concern. Meanwhile, meningococcal disease is a Class 2 infectious disease with a fatality rate ranging from 10-14%. The disease affects 500,000 people worldwide each year. Symptoms include headache, fever, neck stiffness, vomiting, and decreased consciousness, and are often accompanied by petechiae or purpura fulminans. 11-19% of recovered patients suffer from sequelae such as hearing loss, cognitive impairment, and neurological disorders, underlining the importance of its prevention In particular, as meningococcal disease is transmitted person-to-person by respiratory droplets or secretions, vaccination is recommended for those who are about to enter a group setting. For example, new recruits at companies and college students who will be living in dormitories may want to consider meningococcal vaccination.
- Opinion
- [Reporter’s View] Potential drawbacks of expanding RSAs
- by Lee, Tak-Sun Mar 12, 2024 05:49am
- It has been announced that more drugs will be added to the Risk Sharing Agreements (RSAs) track, which will help to improve patient access and reduce uncertainties. In December, the ‘Improvement of the Drug Pricing System to Ensure Fair-value Compensation for Innovative New Drugs and Healthcare Security’ was announced. Under this system, drugs to treat ‘Irreversible Chronic and Severe Diseases’ will be eligible for the RSAs track. The current RSAs only applies to anticancer and orphan drugs, which treat life-threatening and severe diseases that cannot be treated with substitute drugs. In the future, the RSAs will cover drugs that are used to treat chronic and severe diseases that cannot be treated with substitute drugs and result in irreversible deterioration in the quality of life. For example, RSAs will provide coverage for treatments for generalized pustular psoriasis, interstitial lung disease, hereditary angioedema, and severe asthma. The improvement in the drug pricing system will also likely include implementing a dual price system through RSAS to support the export of domestically developed new drugs. The plan is for new drugs granted preferential pricing due to domestic clinical trial status to be listed for the RSAs with essential reimbursement pricing if confirmed to be intended for foreign market distribution and technology export. The RSAs were introduced to South Korea ten years ago. Starting in December 2013, RSAs became available for orphan drugs or anti-cancer drugs without substitutes. Since then, the scope of RSAs has continued to expand through revisions and amendments. In 2020, the coverage was extended to include tuberculosis treatments, antibiotics, and emergency antidotes. Additionally, RSAs were made applicable to subsequent therapeutically equivalent and cost-effective drugs. The advantages of the RSAs are evident. Pharmaceutical companies and insurance authorities can expedite reimbursement inclusion by sharing the uncertainty of drug efficacy and the financial risk burden on health insurance. Expedited listing enables patients to access new treatments. Pharmaceutical companies can overcome the disadvantage of information disclosure in international drug price negotiations by differentiating between the list price and the actual price. However, implementing a dual price system may negatively affect price transparency, potentially disadvantaging patients. For example, patients who paid the total cost of drugs under the RSAs or those who receive selective reimbursement may be eligible for a refund of a portion of the drug cost from pharmaceutical companies, but only if they apply. Patients who are not properly informed may miss out on reimbursement. If the contract renegotiations fail, the drug may be transitioned to non-reimbursable status, potentially increasing the financial burden on patients who were previously covered. The issue of price transparency is being raised internationally. Recently, in Spain, a citizens' group filed a lawsuit demanding the disclosure of actual drug prices under a risk-sharing scheme, and the court accepted the case. Administrative burden is also a concern. Regarding patient refunds, the National Health Insurance Service (NHIS) directly handles the process. For example, a patient was charged KRW 1 million for a cancer drug, and they paid a 5% co-payment rate, which was KRW 50,000. In this case, if a refund rate of 30% is applied according to the contract, and the NHIS receives KRW 300,000 from the pharmaceutical company, the final burden on the patient is not just KRW 50,000, but 5% of KRW 700,000, which is KRW 35,000. Therefore, the NHIS should refund the difference of KRW 15,000. The issue is that the government bears the total burden of this administrative process. With increasing medications subject to RSAs, the workload is only getting heavier. The situation is worsened by the shortage of officials with pharmaceutical expertise due to the drug department's relocation to local areas. It is reported that in advanced countries such as France, medications subject to RSAs are not refunded at all. Because Korea’s initial system included patient refunds, administrative burdens have yet to be relieved in South Korea. While hiring dedicated personnel could help minimize administrative burdens, it would result in additional costs. Experts say expanding RSAs should be handled delicately due to administrative costs and price transparency issues. However, recent government policies appear to be focusing on improving patients' access to new drugs without considering the administrative burden, leading to an increase in drugs subject to RSAs. The government should strengthen the review process to ensure RSAs are applied only to essential drugs. It is important to establish measures to minimize administrative burden to create sustainable policies.
- Company
- Ilaris’s reimb again at a standstill… bumpy road ahead
- by Eo, Yun-Ho Mar 12, 2024 05:48am
- The road to reimbursement for ‘Ilaris,’ a treatment used by around ten patients in Korea, continues to be bumpy ahead. According to Dailypharm’s coverage, the government’s ‘reimbursement adequacy’ decision made for Novartis Korea’s Ilaris (canakinumab) has been put on hold after the company failed to meet the government's request for additional data. The drug, which is a treatment for hereditary recurrent fever syndrome, had previously received conditional approval from the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee. Novartis has since requested the government to revisit the data submission requirements to the extent possible, and has recently filed a request with HIRA for Ilaris’s reimbursement. Ilaris is indicated 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), and ▲ Systemic juvenile idiopathic arthritis (JIA). The indications for CAPS, TRAPS, and FMF were deemed conditionally adequate for reimbursement by the DREC last month. At the time HIRA set out evidence submission and follow-up management as conditions for the reimbursement of these indications. In general, the condition set out by DREC is ‘accepting a price below the appraised value'. It is rare for a drug to be approved with such strict conditions. Given the circumstances, the government's requirements are likely to be difficult for the company to meet. The question is to what extent Novartis can accommodate the additional data requested by the government, and whether HIRA will accept the amount of data that the company believes it can submit rather than all of the data and grant reevaluations. Since being approved in 2015, Ilaris has already failed two reimbursement attempts. With patients waiting more than eight years, it will be interesting to see if the government and the pharmaceutical company can reach an agreement and move toward expanding coverage. A Novartis official said, "We are fully aware of the patients’ wait. As this is our third reimbursement attempt, we are exploring all measures available for reimbursement listing, and requested reevaluation so that the post-submitted evidence requirement presented by HIRA be adjusted to a realistically achievable level.
- Company
- SK Bioscience breaks ground on vaccine plant expansion
- by Chon, Seung-Hyun Mar 11, 2024 05:55am
- From the left, Dong-ho Oh, CEO of SK ecoengineering, Ki Chang Kwon, Mayor of Andong, Cheol-Woo Lee, Governor of Gyeongsangbuk-do, Jaeyong Ahn, CEO of SK bioscience, Pascal Robin, General Manager and Representative Director of Vaccines at Sanofi Korea, and other distinguished guests are commemorating a major expansion of Andong L HOUSE in South Korea. SK Bioscience announced on the 7th that the company broke ground on a vaccine plant, ‘Andong L HOUSE,’ located in Andong, Gyeongsangbuk-do, South Korea. The plant will be expanded to install new equipment. This expansion aims to increase vaccine production capacity for global supply by raising the existing vaccine plant within L House from one floor to three floors, securing a new space of approximately 4,200 ㎡. SK Bioscience and global pharmaceutical company Sanofi have made a large-scale joint investment to expand this facility. The facility will be used to commercially produce the next-generation pneumococcal vaccine candidate product, called "GBP410." SK Bioscience and Sanofi jointly developed GBP410, which includes 21 serotypes. In March 2014, SK Bioscience signed a joint development and sales agreement with Sanofi for the next-generation pneumococcal vaccine. Last June, SK Bioscience and Sanofi announced positive results from Phase 2 clinical trials evaluating the safety and immunogenicity of "GBP410" in infants. Based on the positive results from Phase 2 clinical trials, both companies are preparing for global Phase 3 clinical trials to submit an approval application in 2027. SK Bioscience plans to swiftly secure cGMP, the United States standards for pharmaceutical manufacturing and quality control, alongside the facility expansion, to enhance the global market competitiveness of GBP410. "With the expansion, the Andong L-HOUSE, which has proven its global production capacity, will solidify its position as a global vaccine hub," SK Bioscience CEO Jaeyong Ahn stated. "We are dedicated to creating and distributing highly effective vaccines with the potential to be blockbusters," Ahn added.
- Company
- Jemperli can be prescribed at general hospitals in KOR
- by Eo, Yun-Ho Mar 11, 2024 05:55am
- Jemperli, the first immuno-oncology option introduced to the field of endometrial cancer, can now be prescribed in general hospitals in Korea. According to industry sources, GSK Korea’s PD-1 inhibitor Jemperli (dostarlimab) has passed the drug committee (DC) reviews of tertiary hospitals in Korea. Including the Seoul National University Hospital and Seoul Asan Medical Center. The company has been gradually expanding its prescribing area after receiving reimbursement for Jemperli in December last year. While the number of hospitals that granted use of the drug is still small, GSK has been working to create an enabling environment for Jemperli prescriptions even before the reimbursement process, implementing an Expanded Access Program (EAP) in 15 major medical institutions in Korea. In the multi-cohort Phase 1 GARNET study that was conducted on patients with recurrent or advanced solid tumors, Jemperli demonstrated efficacy with the Cohort A1 analysis results, which enrolled patients with recurrent or advanced dMMR/MSI-H endometrial cancer who progressed during or after platinum-based systemic chemotherapy. The cohort was among the largest conducted for PD-1 inhibitor monotherapies in advanced dMMR/MSI-H endometrial cancer to date. The primary efficacy outcome measures of the study were Objective Response Rate (ORR) and Duration Of Response (DOR) as determined by a Blinded Independent Central Review (BICR) according to (Response Evaluation Criteria Solid Tumors) RECIST v 1.1. As a result of analyzing a total of 108 patients with a median follow-up of 16.3 months, Jemperli demonstrated durable antitumor activity with a manageable safety profile. In the cohort, the ORR was 43.5% and the median DOR was not yet reached. The Disease Control Rate (DCR) was 55.6%, and the proportions of responses lasting 6 and 12 months were 97.9% and 90.9%, respectively. On the 7th, Jemperli was additionally approved as a first-line treatment in combination with platinum-based chemotherapy for patients with Mismatch Repair Deficient/Microsatellite Instability-High (dMMR/MSI-H) recurrent or advanced endometrial cancer.
- Company
- Hemlibra shows big sales rise, Advate loses ground
- by Kim, Jin-Gu Mar 11, 2024 05:55am
- Hemlibra, introduced to South Korea by JW Pharmaceutical, is a drug used to treat Type A hemophilia. The market for Type A hemophilia has shifted significantly, with JW Pharmaceutical's 'Hemlibra' expanding sales considerably after receiving reimbursement expansion. However, Takeda Pharmaceutical’s 'Advate,' which has been recording the highest sales in the market for an extended period, lost ground. Advate sales decreased by over 20%, recording sales lower than Hemlibra’s. Hemlibra sales KRW 7.6 billion → KRW 19 billion…As a result of acquiring reimbursement expansion According to a pharmaceutical market research company IQVIA on the 8th, the market size of Type A hemophilia last year was KRW 77.1 billion, up 17% from KRW 66.2 billion in 2022. In this figure, sales data from hospitals run by the Korea Hemophilia Foundation were not included. JW Pharmaceutical's Hemlibra sales increased about 2.5 times year-over-year (YoY), surpassing the annual sales of KRW 10 billion for the first time. Its sales last year were KRW 19 billion. Hemlibra, introduced to South Korea by JW Pharmaceutical, is a drug used to treat Type A hemophilia. It utilizes dual-specific antibody technology that binds simultaneously to clotting Factors IX and X. Unlike traditional Factor VIII treatments, Hemlibra is the first non-Factor VIII medication that can be administered subcutaneously up to once every four weeks. JW Pharmaceutical secured the domestic development and sales rights for Hemlibra from Chugai Pharmaceutical in 2017. It acquired Korean BLA in January 2019 and launched in May 2020. After recording KRW 2.1 billion in sales in the first year of launch, its sales expanded to KRW 7.2 billion in 2021 and KRW 7.6 billion in 2022. The significant increase in Hemlibra’s sales last year may be attributed to its reimbursement expansion. Since May, Hemlibra has been reimbursed for ‘patients over the age of one with Type A hemophilia who do not have Factor VIII antibodies.’ In just three years, Hemlibra has expanded its reimbursement for non-antibody patients following its initial insurance coverage for patients with severe Type A hemophilia. Top Type A hemophilia drugs by sales statistics. Moreover, an increase in sales of Hemlibra may be due to its improved administration methods compared to existing treatments. Hemlibra is the first subcutaneous injection formulation, offering patients a more convenient option. Previous treatments required patients to locate a vein and self-administer injections, which was inconvenient and difficult for many patients, especially for children and teenagers. Advate sales, down 22%... Adynovate and Greengene F show weakness in sales overall On the other hand, Takada Pharmaceutical's Advate, which has established a strong position in the market, experienced a significant decrease in sales. Advate's sales last year were KRW 15.1 billion, down 22% compared to KRW 19.5 billion in 2022. Expanding the periods further, it has steadily declined since 2019. Sales of Advate, which stood at KRW 27.7 billion then, decreased to KRW 25.8 billion in 2020, KRW 22.9 billion in 2021, and KRW 19.5 billion in 2022. Advate has demonstrated a strong presence in the hemophilia A market for an extended period. By jointly selling products with GC Biopharma, which significantly influences the domestic hemophilia treatment market, Advate consistently recorded annual sales of over KRW 20 billion. However, Advate is gradually losing its strength as Hemlibra rapidly expands its influence. During the same period, Novo Nordisk Pharma's Novoseven RT sales increased from KRW 5.5 billion to KRW 17.3 billion, exacerbating Advate's decline. Another hemophilia A treatment from Takeda Pharmaceutical, Adynovate, also saw a 20% decrease in sales from KRW 6.8 billion to KRW 5.4 billion. GC Biopharma's GreenMono slightly increased from KRW 6.6 billion to KRW 6.7 billion, while another GC Biopharma's Greengene F, decreased by 35% from KRW 2.7 billion to KRW 1.8 billion. Including joint sales, three out of four products sold by GC Biopharma experienced a more than 20% drop in sales over the past year. However, GC Biopharma is still reported to maintain significant performance in the hemophilia treatment market through the Korea Hemophilia Foundation . The industry expects that Hemlibra's upward trend will continue in the future. This year, we expect to see more prominent effects from expanded reimbursement. It is estimated that there are around 1,700 hemophilia A patients in South Korea. Among them, it is estimated that 60% of non-inhibitor patients with hemophilia A in South Korea are eligible for Hemlibra reimbursement. A critical factor in the current situation is the renegotiation of Hemlibra's reimbursement terms. The risk-sharing agreement (RSA) contract for Hemlibra is scheduled to expire on the 30th of next month. JW Pharmaceutical had previously entered into an RSA contract with the government for Hemlibra, operating under a total expenditure cap model.
- Company
- AZ’s EGPA drug Fasenra receives orphan drug designation
- by Eo, Yun-Ho Mar 11, 2024 05:55am
- AstraZeneca's antibody drug Fasenra has been designated as an orphan drug in Korea for its eosinophilic granulomatosis indication. The Ministry of Food and Drug Safety announced so through an official orphan drug designation notice on the 7th. More specifically, the drug received an orphan drug designation as a treatment for eosinophilic granulomatosis with polyangiitis (EGPA) Fasenra (benralizumab)’s EGPA indication was granted an orphan drug designation by the US FDA in 2018. AstraZeneca recently presented results from its MANDARA trial at the American Academy of Allergy, Asthma, and Immunology (AAAAI) Annual Meeting, showing the drug’s potential. The MANDARA trial is a head-to-head trial that directly compared Fasenra to GSK's antibody drug Nucala (mepolizumab). In the trial, patients with relapsing or refractory EGPA were given one 30mg subcutaneous injection of Fasenra or three 100mg injections of Nucala every four weeks for 52 weeks to compare the efficacy and safety of the two drugs. 140 adults with difficult-to-treat EGPA who were receiving oral corticosteroids, with or without stable immunosuppressive treatment enrolled in the study. The mean age of the patients was 52 years, and 60% were women. Of these patients, 66% had relapsing disease and 60% had refractory disease. Study results showed that the rate of patients who achieved remission at weeks 36 and 48 was 59% in the Fasenra(benralizumab) group and 56% in the Nucala (mepolizumab) group. Although the rate was slightly higher in the Fasenra group compared with the Nucala group, the difference was not statistically significant. However, the results demonstrated Fasenra’s non-inferiority to Nucala. The secondary endpoints, duration of remission and the time to first relapse, were similar in both treatment groups. The mean reductions in blood eosinophil count from baseline to week 52 were comparable between the two groups, the Fasenra group showing reductions from 306.0/µL to 32.4/µL and the Nucala group showing reductions from 384.9/µL to 71.8/µL.1 EGPA is a systemic vasculitis associated with asthma, eosinophilia, sinusitis, pulmonary infiltrates, and neuropathy. EGPA can result in damage to multiple organs, including the lungs, skin, heart, gastrointestinal tract, and nerves, which accumulate over time and can be fatal if left untreated. Fasenra is a monoclonal antibody that binds directly to IL-5 receptor alpha on eosinophils and attracts natural killer cells to induce rapid and near-complete depletion of blood and tissue eosinophils in most patients via apoptosis (programmed cell death). Fasenra is currently approved as an add-on maintenance treatment for severe eosinophilic asthma in the US, EU, Japan, and other countries, and is approved for self-administration in the US, EU, and other countries. In Korea, the drug is being reviewed for reimbursement coverage as a treatment for severe eosinophilic asthma and the agenda has passed the Health Insurance Review and Assessment Service's Drug Reimbursement Evaluation Committee review recently.
- Policy
- 1st KOR trial of 'STX-721' to treat EGFR mutant NSCLC begins
- by Lee, Hye-Kyung Mar 11, 2024 05:55am
- The US pharmaceutical company Scorpion Therapeutics has started conducting the first clinical trial of its new EGFR-targeted therapy, 'STX-721,' on patients in South Korea. The Ministry of Food and Drug Safety (MFDS) has approved ‘The first human clinical trial of STX-721 enrolling patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) driven by EGFR exon 20 insertion mutations.’ The currently available targeted anti-cancer therapies for NSCLC (Source: Korea Bio-Economic Research Center of Korea Bio). The Phase 1/2 clinical trial of STX-721 will be conducted at Seoul National University Hospital. Scorpion Therapeutics and Pierre Fabre, a French pharmaceutical company, have entered an exclusive collaboration and license agreement to co-develop STX-721 and STX-241, two new drug candidates for next-generation mutant epidermal growth factor receptor (EGFR) inhibitors. According to Scorpion Therapeutics, STX-721, an orally administered treatment, is designed to selectively target mutations and optimize tolerability and efficacy compared to conventional treatments. “Conventional treatment options face significant limitations associated with the inhibition of wild-type EGFR in healthy tissues, including serious side effects often leading to dose reductions or interruptions, stated Michael Streit, Chief Medical Officer of Scorpion Therapeutics. “STX-721 demonstrated a compelling preclinical selectivity profile,” he added. The Phase 1/2 clinical trial of STX-721 started in October 2023, with the first patient receiving treatment. The company aims to complete the research, involving all 120 patients, by June 1st, 2028. Furthermore, the Phase 1/2 clinical trial is a multi-center, open-label study designed to evaluate the safety and tolerability of multiple dose escalation in patients with advanced or metastatic NSCLC. In the Phase 1/2 clinical trial, the first patient received STX-721 in October. The company is evaluating the drug as a monotherapy for patients with advanced or metastatic NSCLC driven by EGFR exon 20 insertion mutations. About 80-90% of all lung cancers are NSCLC. Early NSCLC detection can lead to a cure through surgery. However, only about 15% of patients with NSCLC are eligible for surgery and the recurrence rate after surgery is between approximately 20 to 45%. The most used targeted anticancer drugs for treating NSCLC are inhibitors that target EGFR, ALK, ROS1, and BRAF/MEK. EGFR mutations are reported to occur most frequently in non-smoking Asian lung cancers.
- Policy
- Fasenra's reimb application passes DREC review
- by Lee, Tak-Sun Mar 11, 2024 05:55am
- Fasenra, the last of 3 antibody drugs used for severe asthma to apply for reimbursement in Korea, has now passed the Drug Reimbursement Evaluation Committee (DREC) stage, increasing the likelihood of its reimbursement. The drug, like Nucala, is seeking reimbursement through the risk-sharing arrangement (RSA) scheme. The industry is paying attention to Fasenra’s progress because its same-class drug Cinqair has been reimbursed through the general listing process and Fasenra is going through the RSA process Nucala went through. The Health Insurance Review and Assessment Service announced on the 7th that it passed the applications for the reimbursement of new drugs such as Fasenra, Idelvion, and reimbursement extension of Brukinsa at the 3rd 2024 Drug Reimbursement Evaluation Committee. The reimbursement adequacy of Fasenra Prefilled Syringe Inj 30mg (benralizumab, AZ), a treatment for severe eosinophilic asthma, was deemed adequate at the recent DREC meeting. Fasenra had received a non-reimbursement decision at the previous DREC meeting that was held in September last year. Therefore, the company passed HIRA’s review in its second attempt. In particular, Fasenra is receiving attention for the fact that 2 other drugs with the same mechanism of action have already been approved. In October last year, 2 interleukin (IL)-5 antagonists used for severe eosinophilic asthma, like Fasenra, were granted reimbursement. The 2 other drugs are Cinqair (reslizumab, Teva-Handok) and Nucala (mepolizumab, GSK). Cinqair was approved through the regular reimbursement process, and Nucala was approved through the RSA process. This is the first time a drug in the same class has been approved through two different reimbursement schemes. In this sense, DREC’s recognition of Fasenra's reimbursement adequacy is even more unusual. The fact that the company is undergoing the reimbursement process through the RSA track is not exceptional, as latecomers can also apply for RSA since 2020, but no drug has attempted reimbursement listing through the RSA track after a same-class drug was listed through the general track. This is because if a drug in the same class is listed through the general listing process, it is disadvantageous for the latecomer to apply for RSA. However, since one of the drugs -Nucala – was listed through the RSA scheme, it is likely that the company referred to Nucala’s case when applying for Fasenra’s reimbursement through the RSA track. Moreover, as RSA applications were limited to anticancer drugs and rare diseases, Fasenra and Nucala are regarded as exceptions because they are severe chronic diseases. However, the Health Insurance Review and Assessment Service is expected to apply RSA to drugs for severe chronic diseases for which there are no alternatives and which irreversibly cause a significant deterioration in the quality of life, such as systemic pustular psoriasis, interstitial lung disease, hereditary angioedema, and severe asthma. At the meeting, DREC also recognized the reimbursement adequacy of CSL Behring’s ‘Idelvion Inj,’ which is used to treat hemophilia B. As it can extend the dosing cycle by up to 3 weeks, it is expected to be in high demand if it is approved for reimbursement. BeiGene Korea's Brukinsa Cap, which also sought to expand reimbursement, has been deemed adequate for reimbursement in Mantle cell lymphoma (MCL), Chronic lymphocytic leukemia (CLL), or small lymphocytic lymphoma (SLL). Burkinsa was first approved reimbursement as a treatment for Waldenström’s macroglobulinemia (WM) in May last year.
