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- 2026-05-07 06:48:00
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- Cinqair continues to land in general hospitals in Korea
- by Eo, Yun-Ho Apr 18, 2024 05:54am
- The biologic therapy for asthma, ‘Cinqair,’ is actively expanding its prescription area in Korea. According to industry sources, Teva-Handok’s monoclonal antibody Cinqair (reslizumab), which targets interleukin (IL)-5, has passed the drug committees (DC) of tertiary hospitals in Korea such as the Gangnam Severance Hospital, Samsung Medical Center, Seoul National University Hospital, and Seoul Asan Medical Center. The drug has been landing in hospitals in Korea after being listed for reimbursement in October last year. Cinqair has been granted reimbursement 8 years after failing its first attempt to enter the reimbursement system when it was approved in Korea in 2017. GSK's Nucala (mepolizumab), an antibody drug that has the same mechanism of action as Cinqair, was reimbursed with Cinqair through the risk-sharing agreement (RSA) system, while reimbursement for AstraZeneca's Fasenra (benralizumab) is being negotiated under the RSA track. These drugs are interleukin (IL)-5 antagonists, which work by reducing levels of blood eosinophils, a type of white blood cell involved in the development of asthma exacerbation. The drugs attracted attention upon their approval as a valid treatment option that hadn’t existed before. With reimbursed treatment options finally available for asthma, how the three drugs compete in the future is also receiving attention. Teva-Handok is currently co-promoting Cinqair with Teva-Handok. Meanwhile, Cinqair’s efficacy had been demonstrated through five placebo-controlled clinical studies that evaluated the safety and efficacy of Cinqair 3mg/kg in 1,028 adult and adolescent asthma patients that were uncontrolled with currently available therapies. In three Phase III clinical trial programs that were conducted on asthma patients with high blood eosinophil counts, Cinqair reduced the frequency of asthma exacerbations by up to 59% and significantly improved lung function, symptoms, and asthma-related quality of life. Also, Cinqair received attention for releasing the post-hoc analysis results of asthma patients who require Step 4 and Step 5 treatment among all patients who participated in the Phase III trial. Cinqair reduced the clinical degree of asthma exacerbations in patients classified as Step 4 or 5 under the Global Initiative for Asthma guidelines by 53% and 72%, respectively, and increased the level FEV1 (forced expiratory volume in 1 second) by 103ml in Step 4 patients and by 237ml in Step 5 patients, demonstrating that the benefit was found to be greater in Step 5 patients.
- Policy
- Will Fasenra be applied RSA for reimbursement in KOR?
- by Lee, Tak-Sun Apr 18, 2024 05:54am
- AstraZeneca has entered into drug price negotiations with the National Health Insurance Service for its ‘Fasenra Prefilled Syringe Inj (benralizumab, AZ),’ a severe eosinophilic asthma treatment that passed the Health Insurance Review and Assessment Service's Drug Reimbursement Evaluation Committee review in March. With other drugs with the same mechanism of action such as Cinqair and Nucala already listed for reimbursement in Korea, whether Fasenra will also be granted reimbursement in Korea is gaining attention. According to an industry source on the 16th, the National Health Insurance Service is in drug price negotiations with AstraZeneca for Fasenra. In particular, Fasenra’s reimbursement is receiving attention in particular for the fact that 2 other drugs with the same mechanism of action – Cinqair (reslizumab, Teva-Handok) and Nucala (mepolizumab, GSK) - have already been approved in Korea. In October last year, the 2 interleukin (IL)-5 antagonists were granted reimbursement at the same time. However, Cinqair was approved through the regular reimbursement process, and Nucala was approved through the RSA process. This was the first time a drug in the same class had been approved through two different reimbursement schemes. Fasenra is also seeking reimbursement through the RSA track, which is likely to rise as a new case. In principle, it is possible for latecomers to be listed through the RSA track, but there have been almost no cases of drugs being listed through RSA after a same-class drug was listed through the general track. Moreover, as RSA was limitedly applied to anticancer drugs and rare diseases, Fasenra is regarded as an example of its expanded application, being a treatment for severe asthma. Meanwhile, the Health Insurance Review and Assessment Service is also conducting drug pricing negotiations for ‘Idelvion Inj (CSL Behring),’ which is used to treat hemophilia B.
- Company
- Targrisso+chemo approved as 1st-line Tx for NSCLC in KOR
- by Son, Hyung-Min Apr 17, 2024 06:07am
- AstraZeneca Korea announced today that its Tagrisso in combination with platinum-based chemotherapy has been approved for the first-line treatment of EGFR-mutated non-small cell lung cancer. The approval marks the first time a combination therapy has been approved for the first-line treatment of EGFR-mutated lung cancer. The approval is based on the Phase III FLAURA2 trial in 557 patients with locally advanced or metastatic NSCLC who had received no prior systemic therapy and were positive for EGFR exon 19 deletion or exon 21 mutation. The study evaluated the efficacy and safety of the Tagrisso combination therapy versus Tagrisso monotherapy. Results showed that Tagrisso plus platinum-based chemotherapy reduced the risk of disease progression or death by 38% compared to Tagrisso monotherapy. Median progression-free survival (PFS) by investigator assessment was 25.5 months for patients treated with Tagrisso plus chemotherapy, an 8.8-month improvement versus Tagrisso monotherapy (16.7 months). Also, PFS results from blinded independent central review (BICR) were consistent with the results by investigator assessment, showing 29.4 months median PFS with Tagrisso plus chemotherapy, a 9.5-month improvement over Tagrisso monotherapy (19.9 months). In addition, in patients with the L858R mutation, the median PFS of Tagrisso plus platinum-based chemotherapy was 24.7 months, a 10.8 months extension over Tagrisso monotherapy (13.9 months.) Also, the benefits were consistent in patients with a greater unmet need, such as those with brain metastases or the L858R mutation. Dr. Sang-We Kim, professor of medical oncology at the Seoul Asan Medical Center who served as the principal investigator of the FLAURA2 trial in Korea, said, “The treatment of EGFR-positive lung cancer patients with brain metastases or the L858R mutation is challenging, their prognosis poor. We believe the approval has great significance in that patients will now be able to choose between two first-line treatment options, Tagrisso monotherapy or Tagrisso combination therapy.” Misun Yang, Director of the Oncology Business Unit at AstraZeneca, said, “We are pleased to see the Tagrisso+chemotherapy option approved this year, in addition to the reimbursement of Tagrisso in the first-line. With this reaffirmation of Tagrisso's value as a global standard of care in EGFR-mutated NSCLC, we will continue to work to ensure that more patients can benefit from Tagrisso’s value."
- Company
- Will DREC recognize Trodelvy’s reimbursement adequacy?
- by Eo, Yun-Ho Apr 17, 2024 06:06am
- Will another ADC breast cancer drug, ‘Troldelvy,’ follow the footsteps of ‘Enhertu’? According to industry sources, Gilead Sciences Korea's triple-negative breast cancer (TNBC) drug Troldelvy (sacituzumab govitecan-hziy), which passed the Health Insurance Review and Assessment Service's Cancer Disease Review Committee in November last year, is yet to be presented from the Drug Reimbursement Evaluation Committee for review. Therefore, whether the agenda will be discussed at the upcoming DREC meeting is gaining attention. Trodelvy is an antibody-drug conjugate (ADC) that consists of a monoclonal antibody that binds to the cell surface antigen Trop-2 and ‘SN-38,’ a TOP1 inhibitor payload. The drug received approval from the Ministry of Food and Drug Safety in May last year to treat adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies, including at least one prior therapy for metastatic disease. Trodelvy is the only non-cytotoxic chemotherapy approved as a second or higher line of treatment for the entire TNBC patient population that has demonstrated an improvement in overall survival, but the cost-effectiveness evaluation remains a major hurdle to reimbursement. However, there is hope as another ADC, ‘Enhertu (trastuzumab deruxtecan),’ which was reimbursed in April, was recognized for innovativeness and applied a beneficial ICER from the government. In fact, Trodelvy is known to satisfy the government’s innovativeness standards. The criteria for innovativeness are drugs that satisfy all of the following three conditions: ▲ there is no substitute or therapeutically equivalent product or treatment ▲ demonstrated clinically meaningful improvement, such as a significant extension in survival ▲ the new drug has been approved by the Ministry of Food and Drug Safety under Article 35(4)(2) of the Pharmaceutical Affairs Act (designation of priority review) and were approved through the fast-track (GIFT) or received a breakthrough therapy designation (BTD) by the US FDA or a priority review (PRIME) by the European Union’s EMA. A petition calling for Trodelvy's reimbursement had garnered 50,000 signatures, and as drugs for triple-negative breast cancer having difficulty gaining access into the reimbursement system, whether Trodelvy will be presented to DREC and its outcome is gaining increasing attention. Trodelvy’s clinical efficacy was confirmed through the Phase III ASCENT study. In the study, Trodelvy significantly reduced the risk of death by 49% compared with a treatment of physician’s choice (TPC) in patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease. Also, the Trodelvy arm showed a 57% improvement in progression-free survival (PFS). These effects were observed regardless of the patient’s brain metastasis status.
- Policy
- Keytruda’s reimb expansion under review by CDRC
- by Lee, Tak-Sun Apr 17, 2024 06:06am
- MDS Korea 'Keytruda (pembrolizumab, MSD),' a cancer immunotherapy drug, will be considered for review by the Cancer Disease Review Committee this afternoon to discuss its expanding reimbursement. Keytruda’s reimbursement expansion has been submitted to the Cancer Disease Review Committee three times, but it has received re-evaluation decisions each time. Attention is being drawn to whether at least some of Keytruda’s indications will set reimbursement criteria, as this round of the Cancer Disease Review Committee will discuss the measure of the pharmaceutical company’s financial contribution. According to industry sources on the 16th, Keytruda’s reimbursement expansion application will be reviewed by the 3rd Cancer Disease Review Committee in 2024, which is scheduled to be held on the 17th. In June of last year, MSD Korea submitted Keytruda’s reimbursement expansion application to the Health Insurance Review and Assessment Service (HIRA) for 13 indications with high unmet needs in medical fields in Korea. MSD's application includes 13 indications: ▲ Early-stage triple-negative breast cancer ▲ Metastatic or recurrent triple-negative breast cancer ▲ Metastatic or recurrent head and neck cancer ▲ Advanced or metastatic esophageal cancer ▲ Adjuvant therapy after renal cell carcinoma surgery ▲ Non-invasive bladder cancer ▲ Persistent, recurrent, or metastatic cervical cancer ▲ Advanced endometrial cancer ▲ Metastatic endometrial cancer with MSI-H or dMMR ▲ Metastatic rectal cancer with MSI-H or dMMR that cannot be removed with surgery ▲ Metastatic small intestine cancer with MSI-H or dMMR ▲ Metastatic ovarian cancer with MSI-H or dMMR ▲ Metastatic pancreatic cancer with MSI-H or dMMR . In October and November of last year, some indications were considered for review by the Cancer Disease Review Committee but received re-evaluation decisions. Keytruda’s six indications were considered for reimbursement expansion in the first Cancer Disease Review Committee in January 2024, but the committee decided to reconsider them. The Cancer Disease Review Committee will prioritize reviewing the medical validity and clinical necessity of multiple indications for reimbursement expansion. Pharmaceutical companies' financial contribution measures towards proven indications will be analyzed to establish reimbursement criteria. Attention is drawn to whether Keytruda’s indications will set reimbursement criteria, as this round of the Cancer Disease Review Committee will consider the Pharmaceutical companies' financial contribution measures. Keytruda is an immune checkpoint inhibitor that treats cancer by inhibiting the PD-1 protein on the surface of T cells, preventing its binding to the PD-L1 receptor, and activating the immune cells. Keytruda is currently reimbursed for seven indications, including non-small cell lung cancer as a first-line treatment, melanoma, urothelial carcinoma, and four cancer types of Hodgkin’s lymphoma. According to IQVIA, Keytruda is ranked as the top-selling drug in Korea, with sales reaching KRW 398.7 last year.
- Policy
- A Korean 4th gen NSCLC drug starts clinical trial
- by Lee, Hye-Kyung Apr 16, 2024 05:47am
- A Phase 1 clinical trial for a domestically developed 4th generation non-small cell lung cancer (NSCLC) drug has been approved in Korea. The Ministry of Food and Drug Safety approved the Phase I trial for Oncobix’s oral ALK/EGFR inhibitor 'OBX02-011' on patients with advanced NSCLC on the 12th. The trial will be conducted at the National Cancer Center and will include dose escalation and dose expansion testing in the first-in-human Phase 1 trial. According to Oncobix, epidermal growth factor receptor (EGFR) mutations are one of the leading causes of NSCLC that account for approximately 10-30% of NSCLC, which is why an urgent need remains for the development of therapies to address the situation. Epidermal growth factor receptor (EGFR) mutations are found as a cause of cancer in some patients with NSCLC. Currently, NSCLC is treated with three generations of drugs, and are used according to mutation. EGFR inhibitors used to treat EGFR mutations include first-generation drugs gefitinib and erlotinib, second-generation drugs afatinib and dacomitinib, and third-generation drug Tagrisso (Osimertinib). Oncobix’s OBX02-011 has shown promise in nonclinical trials as a potential agent that can overcome resistance, which has been a drawback in existing third-generation NSCLC therapies. The company plans to verify its anticancer effect through the Phase 1 trial. Meanwhile, Oncobix was selected as a participating company in the 'Bio-Pharmaceuticals' category of the 2021 'Industrial Innovation Technology Support Platform Construction Project' package support service organized by the Ministry of Trade, Industry, and Energy, and has received partial support for the R&D costs for conducting the clinical trial from MOTIE.
- Policy
- Merck withdraws Tepmetko’s reimb application
- by Lee, Tak-Sun Apr 16, 2024 05:47am
- #I1 Merck voluntarily withdrew its reimbursement application for its Tepmetko’s Tab (tepotinib) after failing to establish reimbursement standards at the Health Insurance Review and Assessment Service's Cancer Disease Review Committee meeting in March After two unsuccessful attempts, the industry’s eyes are on whether the company will reapply for reimbursement after reorganizing its application. According to industry sources on the 14th, Merck recently submitted a document to HIRA to voluntarily withdraw the reimbursement application it had submitted for Tepmetko’s reimbursement. Tepmetko is a treatment for locally advanced or metastatic non-small cell lung cancer with a confirmed MET exon 14 skipping mutation. The MET inhibitors Tepmetko and Tabrecta (capmatinib, Novartis) were approved in Korea in 2021. MET exon 14 skipping mutation is a rare type of cancer that is present in approximately 3-4% of patients with non-small-cell lung cancer (NSCLC). Due to the lack of suitable treatments, expectations had been high for anticancer drugs targeting the disease. However, both drugs are struggling to receive reimbursement listing in Korea. Novartis failed to establish reimbursement standards for Tabrecta at the Cancer Disease Deliberation Committee meeting in August 2022 and February 2023, and received a non-reimbursement decision at the Drug Reimbursement Evaluation Committee meeting in April 2023. The DREC cited a lack of evidence of clinical utility as the reasoning behind the non-reimbursement decision. There has been no news of the company’s reimbursement attempts for Tabrecta thereafter. Instead, the company is selling its drug without reimbursement, which passed the drug committee (DC) reviews at Big 5 tertiary hospitals, including Samsung Medical Center, Seoul National University Hospital, Seoul St. Mary's Hospital, Seoul Asan Medical Center, and Sinchon Severance Hospital. Tepmetko is in a similar situation. The drug’s application was presented to the CDDC in February 2023 and March this year but did not get the desired result. However, its non-reimbursement sales are ongoing in the Big 5 tertiary hospitals in Korea. It also offers a patient support program. Merck is supporting a portion of the drug’s cost for patients undergoing treatment with Tepmetko. After failing two attempts, the industry's eyes are on how Merck will continue on its reimbursement journey hereon. The expectations are that Tabrecta will continue to be sold without reimbursement, and that Tepmetko will also follow suit. This is because the bar for accepting clinical utility set by the CDDC is high. However, Tepmetko was recently fully approved by the U.S. FDA, Therefore, it will be interesting to see if this approval will serve as a basis for setting new reimbursement standards in Korea as well. The FDA’s full approval was reportedly based on 28-month follow-up results from the Phase II VISION study.
- Policy
- K-pharma industry added 480 new jobs in Q4 of last year
- by Lee, Hye-Kyung Apr 16, 2024 05:47am
- As of the fourth quarter of last year, 81,000 people were employed in the pharmaceutical industry, a 2.4% increase year-over-year (YoY). New jobs in the medical service area included 4,757 jobs (80.4% of the total count), including healthcare professionals, followed by 480 jobs in the pharmaceutical industry, 438 jobs in the medical devices, and 244 jobs in the cosmetics industry. The Korea Health Industry Development Institute (KHIDI, President: Cha, Soon-do) announced the analysis of employment trends in the healthcare industry for the fourth quarter of 2023. The healthcare industry employed 1,050,000 people, a 3.4% (+35,000 people) increase YoY. In Q4 2023, 480 new jobs were created in the pharmaceutical industry, down 14.6% YoY. Among the healthcare industry workers, 81,000 people worked in the pharmaceutical industry. The sector with the highest increase in the number of employees was the traditional Korean medicine manufacturing business, with a growth rate of 7.9%. After this, there was a 2.6% increase in finished product manufacturing and a 1.3% increase in both biological agent manufacturing and medicinal and antibacterial products manufacturing. Women's employment in healthcare (+3.6% YoY) grew at a higher rate than men's (+2.6%) due to increased women's economic participation across industries. The pharmaceutical industry’s growth rate of female employees (+4.2%) was relatively high. In the medical device industry and medical services sector, the increase in the number of male employees (+2.9%) was relatively higher. The 60-and-above age group had the most noticeable increase in the number of employees, with a growth rate of 9.4% compared to the previous year. This was followed by the 50s (+6.7%), 30s (+4.7%), and 40s (+3.4%), in descending order of growth rate. On the other hand, the number of employees in the youth group (aged 29 and under) decreased by 1.7% compared to the same period last year. This decline appears to be due to a decrease in the youth population and increased economic participation among older people. The proportion of employees with less than 5 years of consecutive years of service was the highest, at 71.1% (748,000 people). Compared to other industries, the healthcare service sector showed an exceptionally high percentage of employees with less than 5 years of consecutive years of service (73.4%). By occupation, the healthcare and medical professionals field had the highest number of new jobs, which totaled 2,496 jobs (42.2%). This was followed by nurses with 1,042 jobs (17.6%), manufacturing operatives with 395 jobs (6.7%), medical technicians·therapists·rehabilitation specialists with 267 jobs (4.5%), and administrative support staff with 266 jobs (4.5%). “The healthcare industry’s job growth in 2023 remains at 3% and shows an upward trend. However, the healthcare industry faces challenges this year, including uncertain foreign economic conditions and prolonged geopolitical risks,” Lee Byungkwan, KHIDI’s Biohealth Innovative Planning leader, said. “It is essential to closely monitor macro-environmental trends and changes in the healthcare industry while proactively exploring emerging markets to respond preemptively,” he added.
- Company
- New macular degeneration drug 'Vabysmo' now available
- by Eo, Yun-Ho Apr 16, 2024 05:47am
- Roche Korea’s Vabysmo (faricimab), the first bispecific antibody for ophthalmologic disease. The macular degeneration drug 'Vabysmo' is now available for prescription at general hospitals. According to industry sources, Roche Korea’s Vabysmo (faricimab), the first bispecific antibody for ophthalmologic disease, has passed the drug committee (DC) of Big 5 tertiary general hospitals, including Samsung Medical Center in Seoul, Seoul National University Hospital, Seoul Asan Hospital, and Severance Hospital. It is also available for prescription at medical centers specializing in ophthalmologic disease, including Konyang University Hospital, Kim’s Eye Hospital, Nune Eye Hospital, Inje University Busan Paik Hospital, and Chung-Ang University Healthcare System. Vabysmo is expanding its prescription areas after being listed for insurance reimbursement last October. Approved in January 2023, it has been covered by reimbursement since last October to treat patients with neovascular or wet age-related macular degeneration (nAMD)-associated subfoveal choroidal neovascularization and to treat diabetic macular edema (DME). Vabysmo is a new drug that targets both vascular endothelial growth factor (VEGF)-A and angiopoietin-2 (Ang-2), which are involved in major disease pathways. Its clinical research for approval was based on a new mechanism. As the first intravitreal injection administered every 4 months (16 weeks), it can alleviate the burden on patients with only a few doses of administration via injection. The recommended dose for Vabysmo is 6 mg (0.05 mL) administered by intravitreal injection every month (4 weeks) for the first four administrations. After the initial treatment, patients with Neovascular (Wet) Age-Related Macular Degeneration (nAMD) who do not show any disease activity receive injections once every 4 months (16 weeks). Patients with DME can be dosed every 4 weeks for up to 4 months (16 weeks) with a doctor’s recommendation. Meanwhile, Vabysmo demonstrated its efficacy through four Phase 3 clinical trials: TENAYA and LUCERNE for the treatment of neovascular age-related macular degeneration (nAMD), and YOSEMITE and RHINE for the treatment of diabetic macular edema (DME). Among these trials, TENAYA and LUCERNE are non-inferiority trials comparing Vabysmo to 'Eylea (aflibercept)' for the treatment of Neovascular (Wet) Age-Related Macular Degeneration (nAMD). The results demonstrated that Vabysmo treatment administered every 4 months (16 weeks) showed non-inferior vision improvements compared to Eylea treatment administered every 2 months (8 weeks) at 1 year of treatment. In particular, 80% of the Vabysmo treatment group maintained an administration interval of over 3 months (12 weeks). In 2-year studies, 60% of the patients maintained an administration interval of over 4 months (16 weeks). The drug is expected to provide clinical benefits consistently.
- Policy
- Will the COVID-19 drug Paxlovid be reimbursed in H1 2024?
- by Lee, Tak-Sun Apr 16, 2024 05:46am
- Whether the reimbursement of the COVID-19 drug Paxlovid (nirmatrelvir and ritonavir, Pfizer), which the government has been working to make part of Korea’s general healthcare system after the end of the COVID-19 pandemic, will be able to be listed within the originally planned date is gaining attention. The Korea Disease Control and Prevention Agency aimed to list the drug within the first half of this year, but in the current situation, it appears that the authorities may miss the target date. According to industry sources on the 15th, the Health Insurance Reimbursement and Assessment Service requested a supplemental response letter for Paxlovid to Pfizer. As a result, Paxlovid was not presented at the Drug Reimbursement Evaluation Committee’s April 4 meeting. At the very least, the DREC will need to recognize the adequacy of the reimbursement in May to list the drug within the first half of the year as targeted. Even if it passes the DREC in May, it will not be easy to list the drug for reimbursement in the first half of the year if the NHIS applies the 60-day negotiation period. Pfizer applied for Paxlovid’s reimbursement to HIRA in October last year. Since then, HIRA has requested Pfizer to submit a supplemental response letter 3 times. As the drug was introduced urgently due to COVID-19, the company seems to have needed some time to prepare the required clinical trial data and pharmacoeconomic evaluation data. Pfizer submitted its first supplemental response in November last year and its second supplemental response in February this year. However, HIRA has requested another supplemental response thereafter. In its 2024 Major Policy Plan Report, the KDCA stated plans to ease the COVID-19 crisis level and adjust the same level of quarantine measures and special support system for COVID-19 as influenza to fully recover to daily life. For this, the agency said it would list COVID-19 drugs in Korea’s health insurance system in the first half of this year to supply the drug through the general healthcare system. However, as the reimbursement of the COVID-19 drug Paxlovid is progressing slower than expected, it is unclear whether the KDCA will meet its targeted plan. The agency plans to stop providing COVID-19 drugs for free from the second half of the year. If the government support is discontinued and patients are required to purchase the drug without reimbursement, its cost of KRW 700,000 for a five-day supply, could bring a serious financial burden. However, if the drug passes DREC in May and the NHIS negotiates quickly in line with the government’s policy, the drug may dramatically be listed for reimbursement in June, making Paxlovid’s coverage with the national health insurance possible within the first half of the year as planned. An industry official said, "Paxlovid’s reimbursement is essential to incorporate COVID-19 into Korea’s daily healthcare system and treat high-risk patients. However, it will be difficult for insurance authorities to recognize the appropriateness of its reimbursement without complete data submission, as they need to uphold the principle of the positive list system."
