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- 2026-06-21 13:47:32
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- Expansion of newly launched Kerendia underway in KOR
- by Moon, sung-ho Aug 23, 2024 06:18am
- Since early this year, Kerendia has been covered by reimbursement in clinical practices in South Korea. Kerendia's indication may expand to hypertension as it becomes available for prescriptions at clinical practices. Product photos of Kerendia. According to the pharmaceutical industry on August 13th, Kerendia (finerenone) is now being used in clinical practices after obtaining reimbursement coverage in February for adult patients with chronic kidney disease who have type 2 diabetes. Kerendia is the first non-steroidal, selective mineralocorticoid receptor antagonist and a novel therapeutic approach targeting inflammation and fibrosis in adult chronic kidney disease patients with type 2 diabetes. As a result, Kerendia has been prescribed this year in the departments of internal medicine and nephrology at medical centers in South Korea. Sung Hee Choi, Professor of the Department of Internal Medicine at Seoul National University Bundang Hospital, said "There is no drug like Kerendia that could directly suppress chronic suppression or kidney fibrosis. New treatment options that can directly target should be welcomed, and this could be an important part of changing the therapeutic strategy." Professor Choi explained, "I think we must consider the possibility that the drug could slow the progression of kidney disease when used early in diabetes patients and try to use it as early as possible." However, Kerendia is not actively prescribed because it is still in the early stages of its launch in South Korea. According to the medical market research firm UBIST, Kerendia generated approximately KRW 1 billion in prescription sales in the first half of this year. Considering that the government assigned KRW 9.95 billion for finance expenses in a year during the reimbursement process, it is still too early to determine if Kerendia is established in the market. Based on UBIST, the prescription amount for Kerenia is on the rise monthly, which suggests that the drug is expanding in clinical practices. Additionally, Bayer recently added Kerendia to treat patients with reduced left ventricular ejection fraction (LVEF) or preserved ejection fraction (HFpEF). The results met the primary endpoint of the Phase 3 FINEARTS-HF clinical trial, which evaluated the efficacy and safety of the drug compared to placebo. In the Phase 3 FINEARTS-HF clinical trial, the composite endpoints of heart failure events (including initial and recurrent events), defined as cardiovascular death and hospitalizations or emergency visits due to cardiovascular deaths and heart failure, demonstrated statistically and clinically significant risk reduction. As a result, Bayer is preparing to submit market authorization and expand the indication based on the clinical study. If realized, this would expand prescriptions across all areas, including endocrinology, nephrology, and cardiology. At the same time, it is expected to enable Bayer to actively target the market alongside its existing heart failure treatment lineup, including Verquvo (vericiguat). JinA Lee, CEO of Bayer Korea, explained, "Kerendia, which is now used for treating chronic kidney disease accompanying type 2 diabetes, has been shown to suppress additional chronic kidney disease progression and to show cardiovascular benefits when used in combination with standard therapy. It is expected to provide effective management and treatments for patients who need the new treatment option." Lee said, "In addition to Kerendia's role in treating chronic kidney disease accompanied by type 2 diabetes in South Korea, we will strive to provide better treatment benefits for patients with hypertension who have limited treatment options."
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- Will the SGLT-2i Jardiance be reimb for CKD in 2H?
- by Eo, Yun-Ho Aug 23, 2024 06:18am
- Attention is focused on whether the SGLT-2 inhibitor Jardiance can settle as a reimbursed prescription option for chronic kidney disease in the second half of the year. According to industry sources, the Health Insurance Review and Assessment Service is currently reviewing the reimbursement expansion of Boehringer Ingelheim and Lilly Korea’s Jardiance (empagliflozin). After the pharmaceutical companies submitted their applications in the first half of the year, HIRA began discussions in earnest after collecting expert opinions from relevant academic societies. The drug is for reducing the risk of progression of kidney disease or death from cardiovascular disease, regardless of the presence of type 2 diabetes, and the drug was approved for additional indication in Korea in October last year. As a result, Jardiance is now approved as a treatment for 3 conditions - diabetes, chronic heart failure, and chronic kidney disease. Chronic kidney disease is estimated to affect one in every 9 adults in South Korea. Patients with CKD are known to have 7.2 times higher the risk of death than those without chronic kidney disease. If not treated appropriately in the early stages, patients can progress to end-stage kidney disease (ESKD), which increases the risk of death. This is why the treatment of CKD is primarily aimed at delaying the progression of the disease, ultimately reducing progression to end-stage kidney disease. Jardiance’s efficacy in CKD was demonstrated through the Phase III EMPA-KIDNEY study, a large-scale SGLT-2 inhibitor clinical trial that was conducted on a broad patient population. The EMPA-KIDNEY trial included 6,609 participants with chronic kidney disease, many with comorbidities across the spectrum of cardiovascular, kidney, or metabolic conditions, regardless of Type 2 diabetes. Unlike previous SGLT-2 inhibitor studies, which focused specifically on patients with urinary albumin-to-creatinine ratios (UACRs), this study included patients with low UACR as well. The study met its primary endpoint, demonstrating a significant 28% reduction in the relative risk of kidney disease or cardiovascular death compared with placebo, and the effect was consistent across subgroups stratified by UACR, confirming a consistent treatment effect in patients with and without albuminuria The results also showed a statistically significant reduction in all-cause hospitalizations (14%) compared with a placebo, which was one of the pre-specified key secondary confirmatory endpoints, reducing the burden of hospitalization for CKD patients. Overall safety results were similar to the previously recognized safety profile. Meanwhile, Jardiance is expected to become the only original SGLT-2 inhibitor produced by a multinational pharmaceutical company in the country. Following AstraZeneca Korea's decision to withdraw Forxiga (dapagliflozin) from the market last December, Astellas Pharma Korea also recently announced the discontinuation of Suglat (ipragliflozin) in Korea.
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- Yungjin applies for approval of its Ofev generic
- by Hwang, Byung-woo Aug 23, 2024 06:17am
- Pic of Boehringer Ingelheim Yungjin Pharmaceutical announced on the 22nd that it has completed the license application for a generic version of Boehringer Ingelheim's ‘Ofev Soft Cap (Ofev)’ that it had developed by changing the original drug’s soft capsule formulation into a tablet. As a global blockbuster product, Ofev (nintedanib) is widely used in combination with pirfenidone to delay the decline in lung function in patients with idiopathic pulmonary fibrosis. Despite being a non-reimbursed drug in Korea, Ofev generated sales of around KRW 6 billion last year and is in such high demand that a petition is underway for its reimbursement. Yungjin Pharmaceutical was the first Korean pharmaceutical company to complete bioequivalence testing administration of its generic version of Ofev in March and recently completed submitting an application for its marketing authorization with the Ministry of Food and Drug Safety. The company had made the quickest progress among domestic pharmaceutical companies involved in the development of Ofev generics. Unlike Ofev soft capsules, it was developed as a tablet formulation, and it has a reduced size compared to the original, improving the convenience of intake for the patients. In addition, Yungjin Pharmaceutical has also succeeded in synthesizing the nintedanib raw material and is expected to become the only Korean pharmaceutical company to produce a finished product with its raw material. “Yungjin Pharmaceutical exports finished and raw pharmaceutical products to Japan and overseas based on production technology and facilities that meet global GMP standards,” said Ki-Su Lee, CEO of Yungjin Pharmaceutical. “We look forward to becoming the first to launch an Ofev generic in Korea with excellent raw materials and formulation technology to help reduce the suffering of pulmonary fibrosis patients and improve their convenience of administration.”
- Company
- Yuhan’s Leclaza enters US 6yrs after signing licensing deal
- by Chon, Seung-Hyun Aug 22, 2024 05:50am
- Yuhan Corp’s new anticancer drug Leclaza has successfully entered the U.S. market. The drug has reached the commercialization stage 6 years after licensing out its technology to Janssen. As a result, the company will receive USD 60 million as a milestone payment with Leclaza’s approval in the U.S. The company has earned nearly KRW 300 billion in technology fees since licensing out Leclaza’s technology. Yuhan Corp headquartersAccording to industry sources on the 21st, Yuhan Corp’s new anticancer drug Leclaza received marketing authorization from the U.S. Food and Drug Administration (FDA) on the 20th. The U.S. Food and Drug Administration (FDA) has approved Yuhan Corporation’s Leclaza in combination with Johnson & Johnson’s Rybrevant for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test. As a result, Leclaza became the first domestically developed cancer drug to receive U.S. approval. Leclaza, which was approved as the 31st domestically developed new drug in January 2021, is an NSCLC treatment. The company succeeded in entering the U.S. market 6 years after licensing out Leclaza to Janssen Biotech in November 2018. With the FDA approval of Leclaza, Yuhan secured additional milestone payments. The FDA approval milestone for Leclaza was set at USD 60 million (around KRW 80 billion). This is more than the company's operating profit of KRW 56.8 billion last year. In November 2018, the company received a USD 50 million upfront payment for Leclaza. In April 2020, the company received a USD 35 million milestone payment from Janssen. Johnson & Johnson paid the additional milestone to the company after initiating a clinical trial for the Rybrevant and Leclaza combination. In November 2020, Johnson & Johnson paid an additional milestone of USD 65 million to Yuhan Corp as it began recruiting subjects for the trial. Additional milestone payments followed upon successful completion of the trial and FDA approval. In total, Yuhan Corp has earned a total of USD 210 million in technology fees since licensing out Leclaza’s technology. Of the total technology fee revenue, 40% is to be paid to the original developer, Oscotec. In 2016, the company acquired the rights to develop the preclinical drug Leclaza from Oscotec and its subsidiary Genosco. The total value of the agreement had been KRW 1.5 billion. Of the amount, KRW 1 billion was set to be paid within 30 days of the signing of the agreement and KRW 500 million was to be paid after the approval of Phase I clinical trials. Since exporting Leclaza’s technology, the drug settled as Yuhan’s stable cash cow. From 2020 to Q2 this year, the company has recognized a total of KRW 253.8 billion as technology fee revenue. Quarterly saels of Leclaza (Unit: KRW 100 million, Source: IQVIA) Leclaza has already successfully settled in the domestic market. According to drug research institution IQVIA, sales of Leclaza reached KRW 22.6 billion last year, up 40.3% year-on-year. The year after its launch, Leclaza’s sales surpassed the KRW 10 billion mark and recorded KRW 16.1 billion, then exceeded KRW 20 billion last year. Demand in Korea has surged since the drug was granted first-line treatment status this year. Initially, Leclaza was approved for the second-line treatment of locally advanced or metastatic NSCLC with a specific gene (T790M) resistance after receiving first- or second-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs). In June last year, the MFDS approved the marketing authorization expansion for Leclaza to ‘first-line treatment of NSCLC.’ The MOHW approved the drug’s reimbursement expansion to first-line this year. In Q1, Leclaza reported sales of KRW 18.9 billion, up 269.9% year-on-year from the KRW 5.1 billion in Q1 the previous year. Leclaza’s revenues more than tripled in the first quarter compared to the previous quarter. Since its launch in South Korea, the company's cumulative sales of Leclaza through the first quarter totaled to KRW 61.7 billion. Together with the technology fee revenue, the company earned more than KRW 300 billion with Leclaza alone. According to MFDS, Leclaza's production performance was KRW 112.2 billion last year. Leclaza generated its first production revenue of KRW 9.8 billion in 2021, which soared to KRW 39.3 billion in 2022. Last year, the company's production scale exceeded KRW 100 billion for the first time. The increase in domestic sales and the acceleration of global clinical trials led to a rise in production performance. Leclaza, which is produced and supplied by Yuhan, is being used in global clinical trials. Therefore, the faster the global clinical trials progresses, the more the production of Leclaza increases. The MOHW analyzed that reimbursement of Lexarza as a first-line treatment will cost an additional KRW 88.1 billion. Based on Q1 sales of Leclaza and the reimbursement expansion, Leclaza’s sales will likely exceed KRW 100 billion this year.
- Company
- Bavencio shows clear benefit in urothelial cancer
- by Hwang, Byung-woo Aug 22, 2024 05:50am
- The treatment landscape for metastatic urothelial cell carcinoma has changed after Bavencio (avelumab) was granted reimbursement as a first-line maintenance therapy in Korea. Bavencio addressed the high unmet need that had remained for a maintenance therapy option on site, rapidly changing the prescribing pattern. (From the left) Inho Kim, Professor of Oncology at Seoul St. Mary Merck Biopharma Korea held a press conference celebrating the first anniversary of the reimbursed launch of its Bavencio in Korea, highlighting the changes in Korea’s prescribing environment and Bavencio’s clinical value. The indication for the anti-PD-L1 immuno-oncology drug was expanded in August 2021 to include first-line maintenance therapy for patients with metastatic urothelial cell carcinoma whose disease has not progressed following chemotherapy, then reimbursed for the indication in August last year. Bavencio’s reimbursement for first-line maintenance therapy was significant because it allowed the drug to be covered for patients who previously had no available treatment options following first-line therapy. For example, if there were 10 patients with urothelial carcinoma, 3-4 would progress to second-line treatment, while the remaining 6-7 whose disease had not progressed would maintain their state without receiving further treatment. In this regard, experts have positively evaluated Bavencio’s reimbursement expansion as later lines of therapy were only conducted if the prognosis worsened after 3-4 months of non-treatment. “Personally, I think it's useful because it treats patients well,” said Dr. Inho Kim, Professor of Oncology at Seoul St. Mary's Hospital. Kim explained that there is no reason not to proceed to maintenance therapy if the patient's condition does not worsen after chemotherapy. Kim added, “In Korea, reimbursement is always an important factor, so patients who respond to first-line treatment will likely use the reimbursement maintenance therapy with Bavencio. In terms of treatment convenience, patients have been experiencing the benefits of the immuno-oncology drug.” Bavencio’s efficacy was confirmed through the long-term follow-up Phase III JAVELIN Bladder 100 trial, which involved 700 patients with locally advanced or metastatic urothelial cancer in 29 countries, including Korea, for over 38 months. The trial results showed a median OS of 29.7 months with Bavencio+maintenance therapy, which was over 9 months longer than the 20.5 months found in the maintenance monotherapy arm. The drug has been increasing its presence after confirming its effect in the real world among Koreans through the early access program (EAP). Patients using Bavencio through the EAP showed a median progression-free survival (PFS) of 7.9 months after starting treatment with Bavencio, which is higher than the 5.5 months reported in the long-term follow-up of the global JAVELIN Bladder 100 (JB 100) trial. Min Jung Koh, Country Medical Director at Merck Biopharma Korea, said, “These results are the first real-world data (RWD) that confirms the clinical effectiveness and safety of Baevncio in the Korean population, demonstrating Bavencio’s consistent benefits in Korea as in global clinical trials.” However, the changing urothelial cancer treatment landscape remains a challenge on the company’s part. While not yet reimbursed, the growing number of first-line treatment options may change Bavencio’s position as a first-line maintenance therapy in the future. “Other drugs like Padcev have shown good results recently, and I think each drug has its pros and cons. Cost is also a consideration, and as we gain more prescription experience and accumulate more information on the patients’ conditions, we will be able to set guidelines for this.”
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- MET-targeting anticancer drug 'Tepmetko' prescribed at Big 5
- by Eo, Yun-Ho Aug 22, 2024 05:50am
- Product photo of The MET-targeting anticancer drug 'Tepmetko' is now available for prescription at general hospitals. Sources said that Merck Korea's Tepmetko (tepotinib), a treatment for patients with topically advanced or metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition factor gene exon 14 (METex14) skipping mutations, has passed the drug committees (DC) of 'Big 5' tertiary general hospitals, including Samsung Medical Center, Seoul University Hospital, Seoul St. Mary's Hospital, Asan Medical Center in Seoul, and Sinchon Severance Hospital, and 30 medical centers nationwide. However, Tepmetko is non-reimbursable. This drug failed to set the insurance reimbursement criteria twice, including the past Cancer Disease Review Committee review of the Health Insurance Review and Assessment Service (HIRA) in March. Afterward, the company voluntarily withdrew from the reimbursement process and reapplied for reimbursement last month. Tepmetko received domestic approval in 2021 at the same time as 'Tabrecta (capmatinib),' a drug with the same mechanism of action as Tepmetko, and proceeded with the reimbursement process. However, no MET anticancer drugs have yet been listed for reimbursement in South Korea. NSCLC accounts for 80% of all lung cancer diagnosis. METex14 skipping occurs in 3-4% of patients with NSCLC. Based on the diagnosis of 1020 patients with NSCLC in South Korea, 1.9% of patients were confirmed to have METex14 skipping. The effectiveness of Tepmetko was evaluated through the VISION study, which enrolled the largest number of participants than any other clinical trials that enrolled patients with NSCLC harboring METex14 skipping mutations. Based on the clinical results, patients treated with the drug had a median progression-free survival (PFS) of 15.3 months and an objective response rate (ORR) of 56.8%, demonstrating significant life extension effects. The median duration of response (DOR) was 46.4 months, and overall survival was 25.9 months, demonstrating long-term and continued anti-tumor activity. During the international conference of the Korean Association for Lung Cancer (KALC), Professor Han Ji-Youn, Division of Hemato-Oncology of the Center for Lung Cancer at the National Cancer Center, presented analysis outcomes of 79 Asian patients enrolled in the clinical trial for Tepmetko. Based on the results, the ORR was substantially high, with 66.7%. The second round of patients treated with the drug showed a 48.1% ORR. In the Phase 3 VISION follow-up study, Tepmetko also showed significant results in analyzing Asian patients. The analysis showed that Tepmetko-treated patients had an ORR of 56.6%, a median DOR of 18.5 months, a PFS of 13.8 months, and a median OS of 25.5 months. In particular, Asian patients with no prior therapy experience had an ORR of 64.0%, reconfirming the previous study results that the drug is effective in the first round of treatment. 39.6% of patients experienced adverse reactions over Grade 3, indicating that the safety-related issue has not been found.
- Company
- SCLC drug tarlatamab may soon be introduced in KOR
- by Eo, Yun-Ho Aug 21, 2024 05:48am
- Amgen is preparing to introduce its new small cell lung cancer drug tarlatamab in Korea. According to industry sources, Amgen Korea has submitted an application for tarlatamab, its bispecific antibody for small cell lung cancer, to the Ministry of Food and Drug Safety and is undergoing review. The drug was designated the first orphan drug of the new year in January and received accelerated approval from the U.S. FDA in May. Tarlatamab is a bispecific antibody that recognizes antigens in both tumor cells and T cells (immune cells). This allows for the drug to induce T cells to attack tumor cells even when the tumor cells try to avoid them. The drug’s efficacy was demonstrated in the Phase II DeLLphi-301 trial. The trial evaluated the efficacy of tarlatamab in patients with SCLC who had failed two or more prior lines of treatment. The patients that enrolled in the trial received tarlatamab 10 mg every two weeks. The team recruited and randomized 220 patients who had failed first-line treatment for small cell lung cancer at 56 centers in 17 countries around the world, with the goal of finding a new treatment strategy that would maximize the effectiveness of tarlatamab, which is currently under development, while maintaining patient safety. Results showed that the group of subjects who received tarlatamab 100 mg every two weeks achieved an objective response rate of 40%, with a median response duration of 9.7 months. The median overall survival was 14.3 months. The U.S. product label for tarlatamab also includes a boxed warning for neurotoxic adverse events, including cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS). Also, the label includes warnings and precautions for cytopenias, infections, hepatotoxicity, hypersensitivity, and embryo-fetal toxicity.
- Company
- Celltrion Pharm announces vision to become ‘Top 5'
- by Kim, Jin-Gu Aug 20, 2024 06:34am
- On the 19th, Celltrion Pharm announced its 'Vision 2030,’ which outlines the company’s vision to become one of the top five pharmaceutical companies in Korea by 2030. Until recently, Celltrion Pharm was promoting a merger with Celltrion, but the plan was reviewed again due to shareholder opposition, upon which the final decision was made not to merge on the 16th. Vision 2030 is the first mid- to long-term established for Celltrion Pharm since the cancellation of the merger. In Vision 2030, Celltrion Pharm presented detailed projects for each of the following sectors: ▲manufacturing, ▲R&D, and ▲sales as a comprehensive pharmaceutical company that manufactures and sells chemical and biological drugs. In manufacturing, the company will expand its production capacity around its core facility, its Cheongju Plant. The Cheongju plant is the company’s core production base for chemical drugs and has obtained GMP certification from international organizations including the United States, Europe, Japan, and Brazil. It also has an annual production capacity of 16 million prefilled syringes (PFS). The company plans to accelerate its growth by gradually increasing the proportion of PFS-type biopharmaceuticals that the company has started full-scale commercial production this year. To preemptively respond to the rapidly growing demand for PFS formulations, the company plans to build an additional production line utilizing its 13,500㎡ spare lands at its Cheongju plant. Upon completion of the expansion, the company’s production capacity will increase up to threefold. The company is also planning to expand its global CMO business. In the R&D sector, Celltrion Pharm plans to strengthen its capabilities by adding specialized personnel and developing ADC (antibody-drug conjugate) anticancer drugs and new drug platform technologies in earnest. To this end, Celltrion Pharm raised the status of its R&D organization in Cheongju last year to report directly to the CEO. It also expanded and reorganized the organization and relocated it to the Songdo Global Biotech Research Center in Songdo, Incheon. Through the reorganizations, Celltrion Pharm plans to become a drug development company that develops not only new drug platform technologies but also innovative new drugs to increase sales by licensing out technologies. In sales, the company will actively expand the range of its chemical and biological drug products. It plans to significantly expand the production of its biosimilar products, from the 6 it currently produces, including Celltrion's 'Remsima' and ‘Yuflyma,’ to a total of 22 products by 2030. The launch of its autoimmune disease treatment 'Stekima', eye disease treatment ‘Eydenzelt,’ and allergic asthma treatment ‘Omlyclo,’ which have received domestic approval, is also imminent. In the case of chemical drugs, the company's strategy is to secure additional high-value-added products through in-house development and active licensing-in activities and to expand its product portfolio to gain differentiated competitiveness. An official from Celltrion Pharm said, “We have achieved about twofold growth in sales over the past 5 years with even growth across all our business segments. As a comprehensive pharmaceutical company with a diversified portfolio and sales structure, we aim to continue this growth trend and do our best to achieve our goal of becoming one of the top five domestic companies by 2030.”
- Company
- 'Trodelvy' approved for prescription at general hospitals
- by Eo, Yun-Ho Aug 20, 2024 06:34am
- Product photo of Gilead Science Korea 'Trodelvy,' still not covered by reimbursement, has now been quickly approved for prescription in general hospitals. Sources said that Gilead Science Korea's Trodelvy (sacituzumab govitecan), a treatment for triple-negative breast cancer (TNBC), has cleared drug committees (DC) of 'Big 5' tertiary general hospitals, including Samsung Medical Center, Seoul National University Hospital, Seoul St. Mary's Hospital, Seoul Asan Medical Center, and Severance Hospital in Sinchon, and 34 medical centers nationwide. Although not covered by reimbursement, it has been approved for prescription at all medical centers with a prescription code issued. More prescriptions are anticipated if it succeeds in listing for insurance reimbursement. However, the reimbursement process for Trodelvy has not progressed since clearing the Cancer Disease Review Committee of the Health Insurance Review and Assessment Service (HIRA) in November last year. It was expected that Trodelvy would be considered for the Drug Reimbursement Evaluation Committee (DREC) review this month, but it was not. The upcoming DREC review is scheduled to be on September 5th. It is to be watched whether the first Trop-2 targeting Antibody-Drug Conjugate (ADC), Trodelvy, is to be considered for reimbursement listing. Triple-negative breast cancer is an aggressive form among breast cancer types that is more likely to recur and metastasize. Patients with triple-negative breast cancer who have progressed metastasis despite undergoing chemotherapy have a life expectancy of several months. However, chemotherapy has been used as the standard therapy for a long time because an effective method to target cancer cells has not been discovered. The current guidelines in the United States and Europe recommend Trodelvy as a priority treatment for patients with metastatic triple-negative breast cancer who have a treatment history. According to the Phase 3 study, patients treated with Trodelvy had an overall survival of 11.8 months, close to a year, whereas patients undergoing chemotherapy had 6.9 months. Furthermore, Trodelvy has been shown to be effective in regulating symptoms and pains associated with cancer and improving overall well-being, thereby improving patients' quality of life. Trodelvy received the highest score of 5 on the ESMO-MCBS, a value-evaluation tool for anticancer medicines rated by the European Society for Medical Oncology (ESMO). Drugs with Score of 5 are indicated to not only extend patient survival but also be effective in improving quality of life. Trodelvy is the only drug to receive a Score of 5 among triple-negative breast cancer treatments. In South Korea, several petitions requesting reimbursement listing of Trodelvy were posted on the website, and over 100,000 people agreed to the petition. However, despite these efforts by patients and caretakers, the petition was ended due to the session ending of the 21st National Assembly. Accordingly, the Korea Alliance of Patients Organization has submitted a statement to the Ministry of Health and Welfare (MOHW) requesting reimbursement review to be made quickly for drugs with high patient demand, such as Trodelvy, in May. Meanwhile, in the United Kingdom, Trodelvy was granted a preferential status on a cost-effectiveness analysis based on extending survival of the patient group, a population less than rare disease, who have a life expectancy of less than two years. As a result, it was approved for reimbursement after receiving a twofold higher incremental cost-effectiveness ratio (ICER) than other drugs.
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- Reimb remains an issue despite broadened options for UC
- by Moon, sung-ho Aug 20, 2024 06:34am
- Urothelial carcinoma, which is a type of bladder cancer, accounts for 90% of all bladder cancers and is considered a typical cancer type in the field. However, unlike other cancers like lung and breast cancer, where the standard of care changes quickly with the introduction of new drugs, UC has remained a barren area for decades, leaving a large unmet need for first-line treatment options. For the past 30 years, platinum-based chemotherapy has remained the first-line standard of care for UC. # Recently, new drugs, including immuno-oncology drugs and antibody-drug conjugates (ADCs), have been introduced for UC in Korea, shifting the treatment paradigm. However, until the health insurance reimbursement issue is resolved, their active use on-site seems unlikely. According to the medical and pharmaceutical industries on the 16th, platinum-based chemotherapy using gemcitabine, cisplatin, carboplatin, etc. had been used as a first-line treatment for UC. However, the median overall survival (OS) was only 12-15 months with their use due to toxicity, with patients often having to take a drug holiday from chemotherapy after 3-4 months of treatment, and disease progressing around 6-9 months after initiation. However, in the past year or two, the treatment paradigm for UC has been rapidly shifted with global pharmaceutical companies introducing treatments based on clinical research to Korea. One of the first treatments to receive attention is Merck's immuno-oncology drug Bavencio (avelumab). Bavencio is a fully human monoclonal antibody specific for PD-L1 and has demonstrated prolonged survival as a first-line maintenance therapy for UC. Since August last year, its use as first-line monotherapy has been reimbursed by Korea’s health insurance and is being used in practice. Bavencio’s efficacy was confirmed through the long-term follow-up Phase III JAVELIN Bladder 100 trial, which involved 700 patients with locally advanced or metastatic urothelial cancer in 29 countries, including Korea, for over 38 months. The trial results showed a median OS of 29.7 months with Bavencio+maintenance therapy. This is over 9 months longer than the 20.5 months found in the maintenance monotherapy arm. In July this year, the combination of the ADC cancer drug Padcev (enfortumab vedotin, Astellas) and the immuno-oncology drug Keytruda (pembrolizumab, MSD) was approved in Korea, marking another shift in the first-line UC treatment paradigm. The Phase III EV-302/KEYNOTE-A39 trial, which became the basis of its approval, showed a median OS of 31.5 months in the Padcev+Keytruda arm compared to 16.1 months in the control arm, which was a significant difference. Median progression-free survival (PFS) was 12.5 months in the Padcev+Keytruda arm versus 6.3 months in the control arm Around the same time the Padcev+Keytruda combination was approved, BMS and Ono Pharmaceutical’s immuno-oncology drug Opdivo (nivolumab) received approval in Korea as the first-line treatment for UC as well. The approval was based on results from the CheckMate 901 trial, which evaluated Opdivo versus the standard of care gemcitabine+cisplatin (GemCis) in 608 patients with metastatic UC. Results showed that at a median follow-up of 36 months, the primary endpoint, median OS, was 21.7 months with the addition of Opdivo versus 18.9 months in the control arm, resulting in improved treatment outcomes. The treatment paradigm for UC, which had remained unchanged for 30 years, has changed dramatically in the past 1-2 years after 30 years of unchanged treatment. Based on the results of the study, Padcev+Keytruda is expected to rise to the forefront among first-line treatment options on-site. “Based on the efficacy seen in the studies, the Padcev+Keytruda combination would be my first choice,” said In-Keun Park, Professor of Medical Oncology at Asan Medical Center in Seoul. ”The Opdivo+GemCis combination that has been approved at a similar period, has proven to be less effective. Also, we need to consider the availability of the cisplatin option and utilize drugs with caution, so I would consider using the Opdivo+GemCis option for patients with uncontrolled diabetes.” “The currently reimbursed Bavencio has fewer side effects and proven efficacy, but is indicated for patients who have not progressed after receiving platinum-based chemotherapy as a first-line treatment,” explained Professor Park. ”If Padcev+Keytruda or Opdivo+GemCis becomes a common first-line treatment option, Bavencio may lose more ground.” Now that the first-line treatment options for UC have been approved in Korea, attention is now focused on how quickly they will be available on-site. As Bavencio is covered as a maintenance therapy for first-line urothelial cancer, the industry is eyeing whether the Padcev+Keytruda combination will also be granted reimbursement. However, the Padcev+Keytruda combination presents a dilemma for pharmaceutical companies. This is because 2 different companies - Astellas and MSD - own the drugs that are included in the combination. In order for a combination therapy to be reimbursed, both companies must apply for reimbursement and participate in the process for the agenda to be discussed with the government. However, it is currently difficult for such discussions to take place due to the headquarters policies of global pharmaceutical companies and the possibility that discussions with other pharmaceutical companies may be judged as 'collusion' under domestic and international fair trade laws. In other words, both pharmaceutical companies must separately apply for reimbursement. If one of the companies is not interested in applying for reimbursement, reimbursement of the combination therapy is effectively off the table. This is the case for Padcev+Keytruda, and Astellas and MSD are known to be separately reviewing the need for reimbursement. However, the 2 companies are doing so at their discretion, as discussions between them could be regarded as collusion. As a result, the pharmaceutical industry has recently called for the need to establish regulations in the health insurance reimbursement process to address the combination therapy research being conducted between pharmaceutical companies. In other words, the industry has pointed out that a system needs to be established so that if one of the combination therapy developers applies for reimbursement, government agencies such as HIRA can notify the other companies so that the other companies can decide whether to participate in the reimbursement application process. A pharmaceutical industry official said, “If the developers of drugs used as combination therapies are different companies, the Fair Trade Act forbids the companies from discussing insurance reimbursement and insurance prices on their own. It is difficult for the government to proceed with the reimbursement process if one of the drug developers applies for health insurance benefits and the other does not show any willingness for its drug’s reimbursement.” This is why the industry sees it difficult for combination therapies to be applied reimbursement benefits. “Even though the number of first-line treatment options for UC has increased, it is difficult to actively utilize them on-site unless the cost issue is resolved,” said a professor of oncology at a tertiary hospital. ”It takes longer for combination therapies to be reimbursed. It may even be impossible if two separate pharmaceutical companies need to receive reimbursement together for one combination therapy regimen.”
