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- 2026-03-12 11:15:47
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- AstraZeneca focuses on improving competitiveness of NMOSD
- by Eo, Yun-Ho Apr 22, 2024 05:45am
- (From upper left) Soliris, Ultomiris. AstraZeneca focuses on improving the competitiveness of neuromyelitis optica spectrum disorder (NMOSD) treatments. The company aims to target the market as its new blockbuster drugs, 'Soliris (eculizumab),' which is used to treat paroxysmal nocturnal hemoglobinuria (PNH), and 'Ultomiris (ravulizumab),' which is a treatment for neuromyelitis optica spectrum disorder (NMOSD), expand indications. In 2021, Soliris received approval for an expanded indication for NMOSD in South Korea. After a prolonged discussion about its listing for insurance reimbursement, Soliris can now be reimbursed for insurance under expanded criteria starting this month (April). The specifics of reimbursement criteria include adult NMOSD patients aged 18 and above who test positive for anti-aquaporin-4 (AQP-4) antibodies, with at least two symptom relapses within the past year or at least three relapses within the past two years (including at least one relapse in the past year). Soliris can be prescribed when 'Mabther (Rituximab)' or ' Enspryng (satralizumab)' treatment cannot be continued due to relapses or side effects following administration. In terms of Ultomiris, after a failed attempt last September, it secured U.S. FDA approval for an additional indication last month. Ultomiris has a higher adherence rate than Soliris. While Soliris requires injections every two weeks, Ultomiris is administered every eight weeks, resulting in longer intervals between doses. The expansion of Ultomiris indications is based on the global Phase 3 CHAMPION-NMOSD study results. During the 73-week treatment period (median value), none of the patients who received Ultomiris relapsed, resulting in a reported 98.6% reduction in relapse risk compared to the control group. On average, NMOSD is a chronic autoimmune disorder that affects the central nervous system. It is estimated to impact approximately 200,000 people worldwide and is more commonly found in women aged 30 to 40. Initially recognized as a variant of multiple sclerosis, a chronic inflammatory demyelinating disease of the central nervous system, NMOSD was distinguished from multiple sclerosis upon the discovery of disease-specific antibodies (aquaporin-4 [AQP4]-IgG) in opticospinal myelitis patients' serum. According to the Korean Society of Neuroimmunology, as of 2017, about 3.56 individuals per 100,000 are estimated to be affected by NMOSD. It is estimated that there are over 1,000 NMOSD patients in South Korea. The average onset age of NMOSD in South Korea is reported to be 43 years old, with a prevalence that is 4.7 times higher in females than in males.
- Company
- Will Padcev be deemed cost-effective and receive DREC review
- by Eo, Yun-Ho Apr 22, 2024 05:45am
- Whether the reimbursement discussions for Padcev, a new antibody-drug conjugate for bladder cancer, will make progress is gaining attention. According to industry sources, Astellas Pharma Korea’s Padcev (enfortumab vedotin), which passed the Health Insurance Review and Assessment Service's Cancer Disease Review Committee in February, has completed pharmacoeconomic evaluations and is being reviewed by the subcommittee. Whether the agenda will pass the subcommittee review and be presented to the Drug Reimbursement Evaluation Committee remains to be seen. The drug is recommended as Category 1 in the National Comprehensive Cancer Network (NCCN) guidelines. It is a new treatment option for urothelial cancer patients whose cancer has progressed or recurred even after receiving treatment with immunotherapy drugs and platinum-based chemotherapy, for whom no standard of care has existed as of yet. The drug was approved in March in Korea for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have received prior treatment with PD-1 or PD-L1 inhibitors and platinum-based chemotherapy. The key to Padcev’s successful reimbursement is in receiving a beneficial ICER threshold from the government in recognition of its innovativeness, like Enhertu (trastuzumab deruxtecan), which was listed in April. Padcev is also known to meet the government's preferential treatment standards for innovative new drugs. The standards are ▲ 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. Padcev demonstrated its efficacy through the EV-301 study, an open-label, Phase III trial that was conducted on 608 patients with locally advanced or metastatic urothelial cancer who have previously been treated with platinum-based chemotherapy and PD-1 or PD-L1 inhibitors. Study results showed that Padcev reduced the risk of death by 30% compared to chemotherapy. The median overall survival (OS) of the Padcev group was 12.9 months, demonstrating a significant improvement in survival compared to chemotherapy's 9.0 months. In addition, Padcev significantly improved progression-free survival (PFS) with a 39% reduction in disease progression or death risk, with the median progression-free survival (PFS) for Padcev being 5.6 months and 3.7 months for the control group. Mi-so Kim, Professor of Oncology at Seoul National University Hospital, explained, “Urothelial cancer progresses quickly and requires continuous treatment, but patients were left to use chemotherapy for later line therapies after using immunotherapy in the second-line due to the lack of a standard later line treatment option. Padcev can be used in patients whose cancer had progressed or relapsed after chemotherapy (first-line therapy) and immunotherapy (second-line therapy or first-line maintenance therapy), and will open a new paradigm in the treatment of patients with locally advanced or metastatic urothelial cancer.”
- Company
- Global companies are affected by doctors’ resignation
- by Moon, sung-ho Apr 19, 2024 06:24am
- Two months have passed since the government announced its plan to raise the medical school quota by '2,000' students. Pharmaceutical companies are facing more marketing challenges amin the ongoing dispute between the medical community and the government. In particular, global pharmacies that launched new drugs after overcoming reimbursement hurdles face challenges as new patients decline. In addition to local pharmaceutical companies, global companies are also impacted by doctors’ strikes. According to industry sources on April 6th, the Ministry of Health and Welfare (MOHW) approved the new listing and reimbursement expansion of 18 drugs until April. Due to the new listing and reimbursement expansion, approximately KRW 434.2 billion from the annual health insurance budget will be allocated toward these items this year. Last year, approximately KRW 381.5 was spent in 32 reimbursed drugs (24 newly listed and 8 reimbursement expanded drugs), whereas this year’s expenditure has already surpassed last year’s even before the end of the first half of the year. Breaking down the pricing by drugs, there are items that have gathered attention in the clinical field in South Korea. For example, the list includes Tagrisso (osimertinib) and Leclaza (lazertinib, Yuhan), which competed for reimbursement expansion for the first-line treatment of non-small cell lung cancer (NSCLC). According to estimates from the MOHW, Tagrisso and Leclaza will receive KRW 204.6 billion and KRW 137.7 billion, respectively, in finances this year. Both drugs were approved for reimbursement expansion in January. Out of the total finance, the expected increase due to reimbursement expansion would be KRW 92 billion and KRW 88.1 billion for these two drugs, and 2634 patients are expected to benefit from coverage of the first-line treatment. For these two drugs, an increase in financial spending by KRW 180 billion is expected. Among the drugs newly listed up to April, the antibody-drug conjugate (ADC) 'Enhertu (trastuzumab deruxtecan, Daiichi Sankyo Korea, AstraZeneca)' accounted for the largest part of the financial spending. The MOHW has calculated the expected financial spending for Enhertu, which is reimbursed for breast cancer and gastric cancer, to be KRW 134.7 billion. Among the reimbursement expanded and newly listed drugs, this is the single item with the highest financial spending. In addition to anticancer drugs, drugs for chronic diseases, such as the 'chronic kidney disease' drug Kerendia (finerenone, Bayer), are among the drugs gaining attention. As it can be prescribed in endocrinology and nephrology departments within university hospitals, it is considered a notable new drug from a global pharmaceutical company. This is supported by the government’s estimate that 29,350 patients can benefit from the reimbursement listing. Since the announcement on February 6th of an increase in medical school quotas, there have been mass resignations extending beyond resident physicians to professors at nationwide university hospitals, resulting in continued disruptions in medical services. The pharmaceutical industry, which must actively engage in sales and marketing following successful new drug approvals or reimbursement expansion, is in a challenging environment. As a result, they remain cautiousness about holding medical symposiums after new drug launches. So far, challenges have primarily been experienced by suppliers of surgical materials, pharmaceuticals, medical devices, wholesalers, and domestic pharmaceutical companies. However, this situation could also impact global big pharma with new drugs. AstraZeneca and Yuhan have been proactively preparing through prior processes, such as clearing the Drug Committees (DC) at hospitals for Tagrisso and Leclaza in line with the reimbursement expansion in January. This effort was aimed at gaining an advantage in the non-small cell lung cancer market through medical institution coding work. As a result, by the end of March, AstraZeneca cleared the DC review of Tagrisso in 94 hospitals, and Yuhan cleared the DC review of Leclaza in 103 hospitals. However, university hospitals face difficulties treating new patients with prolonged medical service disruptions. As a result, the expansion of the field for these two treatments, Tagrisso and Leclaza, is unfolding differently than anticipated. Enhertu, which became reimbursed in April, may have faced similar circumstances in a clinical setting specializing in oncology. Daiichi Sankyo and AstraZeneca, in joint sales and marketing, have obtained approval from the DC in 60 hospitals for Enhertu. “Due to structural challenges, our focus is currently on existing patients, but we must see new patients,” a professor of Hematology-Oncology at Hospital A commented. He added, “Despite efforts to prioritize patient care as much as possible, there has been a decline in the number of new patient treatments, which may result in reduced drug usage.” “Because leukemia patients are still being accepted through the emergency room, new patient intake has not stopped. The problem is that it is now becoming a chronic situation,” another professor of Hematology at a different university hospital stated. He added, “Even if the range of treatments expands, it will be challenging for pharmaceutical companies due to the structural constraints in the clinical setting, making it difficult to utilize them effectively.” Global big pharma headquarters are now increasingly concerned about the consequences of the increase in medical school quotas for the clinical field in South Korea. At the same time, there is a sense of urgency to evaluate the extent of revenue decline in the first quarter of this year due to the controversy surrounding the expansion of medical school quotas. "The headquarters closely monitors the long-term treatment disruption issue in the domestic clinical field. This issue is a major topic in every video conference," an anonymous executive from the Korean subsidiary of a global pharmaceutical company stated. He added, "As we are in a situation where the introduction of new drugs or their reimbursement is at stake, we are proactively evaluating and communicating the potential consequences of this situation."
- Company
- Adcetris’s IPS requirement for reimb may be removed
- by Eo, Yun-Ho Apr 19, 2024 06:23am
- A green light has been given for the removal of the IPS score requirement for Adcetris, which had been a long-standing wish of the patients. According to industry sources, Takeda Pharmaceutical Korea’s reimbursement expansion application to remove the International Prognostic Score (IPS) score criteria for prescribing its Adcetris (brentuximab vedotin) in combination with chemotherapy (AVD, adriamycin+bleomycin+dacarbazine) in Hodgkin's lymphoma passed the Health Insurance Review and Assessment Service's Cancer Disease Review Committee review on the 17th. Adcetris )’ was granted reimbursement as a first-line treatment for Hodgkin’s lymphoma in 2021, but a restriction of "IPS score of 4" was applied, meaning that the drug was only reimbursable for patients with severe disease. As a result, patients with an IPS score of 2-3 have been prescribed an existing chemotherapy combination, ABVD (adriamycin+bleomycin+vinblastine+dacarbazine), instead of Adcetris. Even patients with stage IV disease were unable to benefit from Adcetris and its better efficacy if they had a low IPS score. However, when analyzing the results of the 1,344 patients in the ECHELON-1 trial, Adcetris demonstrated efficacy in high-risk patients who were Stage IV, male, younger, and had an IPS score of 4-7. The National Comprehensive Cancer Network (NCCN) guidelines recommend Adcetris+AVD for the treatment of patients with stage III and IV disease, and the European guidelines allow Stage IV patients to be treated with Adcetris regardless of the IPS score. Therefore, the medical community has been pushing for the removal of the IPS score requirement from Adcetris’s reimbursement criteria, and expectations are rising with its passage of the CDDC review this time. However, it remains to be seen if Adcetris can clear the remaining hurdles, including the Drug Reimbursement Evaluation Committee and drug price negotiations, and remove the IPS score requirement from its reimbursement criteria. In the Phase III ECHELON-1 trial, Adcetris demonstrated superior clinical efficacy compared to ABVD in previously untreated patients with stage III or IV classical Hodgkin lymphoma. Its three-year progression-free survival (PFS) analysis showed that the Adcetris combination therapy (PFS rate 83.1%) reduced the risk of disease progression by 30%, compared with ABVD (PFS rate 76%).
- Company
- Drug exports escape ‘COVID-19 endemic slumps’ with botox
- by Kim, Jin-Gu Apr 19, 2024 06:23am
- The export values of drugs developed by Korean pharmaceutical companies increased 16% year-over-year in Q1. Compared to other quarters, it is the highest amount two years after Q1 of 2022. The export performances of domestic drugs had stagnated after the announcement of the endemic. However, the pharmaceutical industry has a positive outlook, as exports have started to recover since Q3 last year. According to the Korea Customs Service, exports of domestic drugs amounted to US$1.72 billion (approximately KRW 2.38 trillion). This is an increase of 16.1% over a year, compared to US$1.4 billion in Q1 of 2023. Around the same period, drug imports amounted to US$2.24 billion (approximately KRW 3.1 trillion), down 6.7%. As exports increased while imports decreased, the trade balance improved from KRW 925.38 million at loss to KRW 527.21 million at loss. Domestic drug exports have skyrocketed during the prolonged COVID-19 pandemic. In Q4 of 2020 and Q1 and Q4 of 2021, export values increased to over US$2 billion. Domestically produced COVID-19 vaccines played a significant role in boosting the export performance at that time. Quarterly drug exports (Unit: US$1 million, Source: Korea Customs Service). After the announcement of the COVID-19 endemic, export values declined due to decreased exports of domestically produced vaccines. Since Q4 of 2022, the export value has been consistently around US$1.5 billion, gradually decreasing. However, it was KRW 1.27 billion in Q3 of last year, the lowest after the endemic, but rebounded. The export value increased to US$1.6 billion in Q4 last year and over US$1.7 billion in Q1 of this year. It is the highest quarterly value since Q1 of 2022. Among major items, Botolinum toxin exports increased while vaccine exports decreased. Botolinum toxin exports in Q1 amounted to US$87.95 million (approximately KRW 120 billion), up 16.3% compared to US$75.64 million in Q1 of last year. In terms of countries, the export of botulinum toxin to the United States increased by 16.4% from US$14.5 million to US$16.88 million. Exports to China doubled from US$7.26 million to US$14.65 million. Exports to Japan increased by 64.1% from US$4.11 million to US$6.74 million. However, exports to Brazil decreased by 31.1% from US$9.73 million to US$6.71 million, and exports to Thailand decreased by 18.2% from US$6.53 million to US$5.34 million. Quarterly export values of vaccines and botolinum toxin (Unit: KRW 100 million, Source: Korea Customs Service). Vaccine exports decreased by 40.5% from US$135.6 million in Q1 of last year to US$61.59 million (approximately KRW 85 billion) in Q1 this year. The last export of domestically produced COVID-19 vaccines was in Q1 last year. However, COVID-19 vaccine exports sharply declined, steadily decreasing until Q4 and rebounding in Q1 this year.
- Company
- Korean pharma companies accelerate global market entry
- by Heo, sung-kyu Apr 18, 2024 05:54am
- Domestic pharmaceutical companies are targeting the Southeast Asian and Latin American markets as a bridgehead to their entry into the global market. As these are still emerging markets, the companies believe that they can secure relative competitiveness in those markets. For this, the companies are exploring the market through various strategies such as seeking local approvals or indirect entry through agreements, among others. According to industry sources on the 15th, pharmaceutical companies in Korea have recently started to accelerate their efforts to enter the Southeast Asian and Latin American markets. The reason the companies are primarily targeting these emerging markets is due to their high growth potential, as they point of entry for the companies’ global expansion. As these markets show high growth potential, domestic pharmaceutical companies have been prioritizing entry into these regions as a starting point for their global expansion. To this end, domestic pharmaceutical companies have already confirmed their entry into various Southeast Asian countries such as Thailand, Vietnam, and Indonesia. The need for companies to enter emerging markets in addition to markets such as the U.S. and Europe have been rising, sparking interest in the so-called ‘pharmerging’ markets. Pharmerging is a new term that combines 'Pharma' and 'Emerging' and refers to emerging pharmaceutical markets such as the Middle East, Latin America, and Southeast Asia. Due to the companies’ continued interest in emerging markets, the entry of pharmaceutical companies – especially mid-sized pharmaceutical companies - into the Southeast Asian market has risen further. In fact, companies that have recently accelerated their entry into the Southeast Asian market include Yuyu Pharma and Jeil Pharmaceutical, which have been receiving marketing authorizations and signing related agreements. First of all, Yuyu Pharma has received approval for its ‘Yuhylys Soft Cap (dutasteride)’ from the Philippines Food and Drug Administration and the Myanmar Food and Drug Administration. Yuhylys is sold under the brand name ‘Armadart’ in the Philippines and the same as Yuhylys in Myanmar. Jeil Pharmaceutical recently signed a memorandum of understanding with Universiti Kebangsaan Malaysia (UKM) University Hospital for the exclusive supply of pharmaceuticals and R&D cooperation, and plans to promote technology transfer and local production with UKM through the agreement. In addition, companies that have already entered the market are also making further inroads. For example, LG Chem held a symposium on its 'Zemiglo Tab' at the Philippine College of Endocrinology, Diabetes & Metabolism conference. LG Chem has been working to penetrate the global market since 2017 and had already entered the Philippines in 2019. LG Chem plans to continue holding symposiums with Korean endocrinology professors in Thailand later this month and then in Latin America, including Mexico, in the second half of the year. As the company has already entered the markets of all these countries, the symposium held will help expand the company's presence in the exporting countries. In addition, Daewoong Pharmaceutical has recently applied for marketing authorization for its ‘Envlo Tab’ in Mexico. Daewoong's Envlo has already entered Southeast Asian markets such as Indonesia, the Philippines, Thailand, and Vietnam, and is expanding its area to Latin America, seeking approval in Brazil and Mexico. In addition, Hugel recently received marketing authorization for its PDO (polydioxanone) suture brand ‘Licellivi’ in Brazil and announced that it will establish a strategy for its rapid market settlement. Korean companies are entering the Southeast Asian and Latin American markets because they are expecting growth in these markets. According to an export support report released by the Korean Health Industry Development Institute, the pharmaceutical market in 6 major emerging countries (Indonesia, Vietnam, the Philippines, Thailand, Malaysia, and Singapore) is worth about USD 20 billion, or KRW 26 trillion. In particular, the per capita cost of drugs in the countries was about USD 36 last year, an increase of 6.6% YoY, and is expected to reach USD 46 by 2026 at an average annual growth rate of 7.4%. In addition, in Latin America, the pharmaceutical market is growing rapidly due to the high demand for products and high prevalence of hypertension and gastrointestinal diseases. The market is expected to grow at an average of 7% per year through 2023 to reach a total value of USD 76 billion. As such, more companies are also expected to take on the challenge of entering these emerging markets.
- Company
- 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.
- 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.
- 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.
