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- 2025-12-22 00:58:26
- Company
- Expanded reimbursement for 'Lorviqua' expected soon
- by Eo, Yun-Ho Apr 17, 2025 05:57am
- Product photo of Lorviqua The non-small cell lung cancer treatment 'Lorviqua' is expected to receive expanded insurance reimbursement after many attempts. According to industry sources, Pfizer Korea has recently signed an agreement with the National Health Insurance Service (NHIS) regarding drug pricing negotiations for the third generation ALK cancer drug Lorviqua (lorlatinib) as a first-line treatment of anaplastic lymphoma kinase (ALK)-positive metastatic NSCLC. Such accomplishment took 10 months since the breakdown of the drug price negotiations in May 2024, and then Pfizer had filed for reimbursement again. Pfizer immediately filed for general listing, which passed the last Drug Reimbursement Evaluation Committee (DREC) of the Health Insurance Review and Assessment Service (HIRA) last year. Even after reapplication, the reimbursement process has been slow. Analysis suggests that the government postponed the decision because Lorviqua was initially contracted as a total expenditure-capped RSA, then switched to a general listing. Earlier in January 2024, when the process for expanded reimbursement had been in process, Pfizer had filed for general medicine reimbursement. Of note, ALK cancer drugs, including the first-generation drug 'Xalkori (crizotinib)' and the second-generation drugs 'Alecensa (alectinib)' and 'Zykadia (ceritinib),' are all general listing medications. During the negotiations, Pfizer suggested switching to a general listing during the negotiation. However, the government insisted that "negotiations for the total expenditure-capped RSA must be completed before the company can move on to the next step." As a result, the negotiations ultimately failed. Meanwhile, Lorviqua is a drug designed to penetrate the blood-brain barrier (BBB). The drug has been assessed as having clinical significance based on the long-term follow-up results of the CROWN study, which was recently presented at the ASCO. The study results showed that Lorviqua reduced the disease progression and death risk by 81% compared to crizotinib, and 60% of treated patients were alive without disease progression even after five years. The risk of brain metastasis was reduced in 94% of the treated patients, with only 4 out of 114 patients who did not previously had brain metastasis developing it after being treated with Lorviqua.
- Company
- Lundbeck Korea appoints Brad Edwards as first foreign CEO
- by Whang, byung-woo Apr 17, 2025 05:57am
- Brad Edwards, new CEO of Lundbeck Korea On the 1st, Lundbeck, a global pharmaceutical company specializing in the treatment of brain diseases, announced on the 16th that it has appointed Brad Edwards as its first foreign CEO in 23 years since the establishment of its Korean subsidiary. The new CEO is a professional with extensive experience and expertise gained from 25 years of service at various multinational pharmaceutical companies, including Schering-Plough, Pfizer, Shire, and Takeda. Recently, he served as the Head of Plasma Derived Therapies (Growth and Emerging Markets) at Takeda in Singapore. Since joining Shire in 2014, Edwards has gained extensive experience through Shire's extensive rare disease portfolio. He has since served as the General Manager of Takeda Australia and New Zealand. Also, as a board member of Medicines Australia, he has contributed to shaping the external policy environment in Australia to improve patients' access to treatments for rare diseases. With the appointment of the new CEO, Lundbeck expects his extensive experience and in-depth knowledge in the field of rare diseases to play a crucial role in preparing Lundbeck Korea for its expansion into the field of neuro-rare diseases. CEO Brad Edwards said, “I am honored to have the opportunity to work in Korea by joining Lundbeck and am looking forward to joining Lundbeck's ‘Focused Innovator’ strategic journey.” He added, “I will work to reinforce Lundbeck Korea's position in the field of neuroscience and drive the company's expansion into other areas where there is an unmet medical need.” He added, “I am looking forward to learning more about the Korean culture, working closely with my colleagues at Lundbeck, and, above all, contributing to the development of treatments that have a real impact on Korean patients.” Lundbeck Korea is a multinational pharmaceutical company headquartered in Copenhagen, Denmark, and specializes in brain disease treatments, researching and developing treatments for neurological and psychiatric diseases. Representatively, the company owns the antidepressants Lexapro (escitalopram oxalate) and Brintellix (vortioxetine hydrobromide), Alzheimer's disease treatment Ebixa (memantine hydrochloride), and Parkinson's disease treatment Azilect (rasagiline mesylate).
- Company
- Vantive Korea to become kidney disease therapy leader
- by Whang, byung-woo Apr 17, 2025 05:57am
- Vantive, a spinoff of Baxter that was newly launched as an independent company, is embarking on a full-scale market penetration based on its manpower in the field of kidney treatment. In the long term, the company plans to provide solutions to become a company that provides life-sustaining organ therapy, beyond kidney treatment. Kwanghyuk Im, General Manager of Vantive Korea Vantive Korea held a meeting on the 16th to commemorate its launch in Korea and share the company's goals and strategies. Vantive was launched in February as a spin-off of Baxter's Renal Care and Acute Care Business Unit and seeks to be a company focusing on “Vital Organ Therapy.” The spin-off was made to establish a clearer business strategy by responding quickly to rapidly changing healthcare needs and focusing on innovation in each company's area of expertise. Vantive plans to present its business direction based on its legacy of leading innovation in kidney care for the past 70 years, with its mission “Extending lives, expanding possibilities.” Kwanghyuk Im, General Manager of Vantive Korea, said, “Vantive is a vital organ therapy company that aims to raise the standards of kidney and life-sustaining organ treatment,” Im added, “We will not only provide disease treatment solutions but also strive to remove obstacles in the treatment process from the beginning to the end as a companion in our patient’s treatment journey.” However, at the time of the spinoff, Vantive's business activities were not much different from those of Baxter's existing renal business unit. Some argue that the direction of a long-term plan is important for a company to differentiate itself as a standalone company. In this regard, Im said, “Baxter's business structure was diverse, so it was not easy for the company to invest in or conduct research and development (R&D) in a particular business under such circumstances. As Vantive has a major mission of long-term treatment for life support, we expect to be able to make more focused and differentiated investments." Im added, “We cannot reveal specific plans for new products, but we are soliciting various R&D ideas on a global scale to improve products and services. We fully expect there to be new innovations.” Vantive plans to provide innovative products, digital-enhanced solutions, and advanced services to support dialysis at home and in hospitals, as well as treatment options to support the kidney and vital organ functions of critically ill patients. In addition, the company aims to combine an automated peritoneal dialysis (APD) system with a digital patient management platform in the field of peritoneal dialysis to enable healthcare professionals to make patient-specific decisions quickly and accurately based on automatically transmitted data. “Vantive is working to improve the patient's treatment experience and reduce the inconvenience experienced during the treatment process,” said Im. ”We want to reduce the burden of treatment through patient-centric services such as a 24-hour consultation service for peritoneal dialysis patients and direct delivery of dialysis fluid to their homes.” In addition, Vantive plans to lead the advancement of critical care through multi-organ treatment, including continuous renal replacement therapy (CRRT). In the future, the company plans to pursue innovations that can be applied to the treatment of sepsis and organ failure, such as lung and liver failure. “We plan to expand our activities to raise awareness of end-stage renal disease and improve the dialysis environment, as well as sponsor the Kidney Camp for Children and other various social contribution programs,” said Im. ”We will work to provide better treatment experience at various points of contact between patients and healthcare professionals, fulfill our corporate social responsibility, and create sustainable change.”
- Company
- Expanded indication for Iclusig as a first-line treatment
- by Whang, byung-woo Apr 17, 2025 05:57am
- Product photo of Iclusig On the 16th, Korea Otsuka Pharmaceutical (CEO Sung-ho Moon) announced that Iclusig (ingredient name: ponatinib) can now be used in combination with chemotherapy for treating adult patients with Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ ALL). This expanded indication has expanded Iclusig's use of scope from a third-line or higher treatment for Ph+ ALL to Ph+ ALL first-line treatment. Previously, Iclusig was approved for the treatment of adult patients with chronic, accelerated, or blast phase chronic myeloid leukemia (CML) or Ph+ ALL who were refractory to other tyrosine kinase inhibitors (TKIs), as well as for the treatment of adult patients with T315I-positive chronic, accelerated, or blast phase CML or T315I-positive Ph+ ALL. This expansion of indications follows the expedited approval by the U.S. FDA in March 2024 for combining therapy comprised of Iclusig and chemotherapy to treat newly diagnosed Ph+ ALL patients. It has also led to an expansion of its indications in South Korea. Through this, Iclusig can now be used in Korea as a first-line treatment for adult Ph+ ALL patients in combination with chemotherapy for up to 20 cycles. The PhALLCON trial, which served as the basis for this approval, was a Phase 3 trial (randomized, open-label) conducted at 77 institutions across 17 countries. The study evaluated the efficacy and safety of the combination of ponatinib (brand name: Iclusig) with low-intensity chemotherapy versus the combination of the first-generation TKI imatinib (brand name Glivec) with low-intensity chemotherapy in 245 newly diagnosed adult Ph+ ALL patients. Study results showed that the primary evaluation endpoint, the MRD-negative complete remission (MRD-neg CR) rate at the end of induction therapy (12 weeks), was 34.4% in the Iclusig group, approximately twice as high as the 16.7% observed in the imatinib group. Furthermore, the median progression-free survival (PFS) was significantly longer in the Iclusig group at 20.0 months compared to 7.9 months in the imatinib group. In terms of safety, Iclusig demonstrated manageable tolerability. The treatment discontinuation rate due to adverse events was reported to be 12% (n=20/164) patients in the Iclusig group and 12% (n=10/81) in the imatinib group. The incidence of treatment-related serious adverse events was 20.9% (n=34/163) in the Iclusig group and 19.8% (n=16/81) in the imatinib group. Korea Otsuka Pharmaceutical representative stated, "Iclusig demonstrated superior MRD-neg CR and stable drug tolerability compared to the conventional therapy, such as the first-generation TKI, when used as a first-line treatment for patients with Ph+ ALL," and added, "Based on this expansion of indication, Iclusig, which was used for three or more line of treatments, is available as a first-line treatment option."
- Company
- ‘Should consider early use of effective new drugs for CML’
- by Son, Hyung Min Apr 17, 2025 05:57am
- Timothy Hughes, Professor of Hematology, South Australian Health and Medical Research Institute “Although various treatment options have emerged for chronic myeloid leukemia (CML), there is still unmet demand, as more than half of patients are intolerant. As CML treatment strategies are shifting to inducing a strong response in the early phase, it is important to prioritize the use of effective drugs.” Timothy Hughes, Professor of Hematology at the South Australian Health and Medical Research Institute, recently gave this assessment regarding CML treatment strategies during an interview with Dailypharm. The development of various tyrosine kinase inhibitors (TKIs), starting with Novartis' Gleevec, a first-generation targeted anticancer drug, in 2006, then the second-generation treatment options BMS' Sprycel, Novartis' Tasigna, Pfizer’s Bosulif, Il-Yang Pharmaceutical’s Supect, and the third-generation TKI Otsuka's Iclusig, has dramatically improved survival rates. However, since the existing first- to third-generation TKIs target the ATP binding site, there is a high possibility of developing resistance to mutations, which limits long-term treatment sustainability. In addition, as treatment options are limited for patients at risk of cardiovascular disease, there is a need for effective switching strategies and new treatment options in the third-line treatment space. Unlike existing treatment options, the fourth-generation TKI Scemblix is approved and mainly used as a third-line treatment for CML in Korea due to its specifically targeting the ABL myristoyl pocket t (STAMP) inhibition mechanism. Recently, it has been approved as a first-line treatment in Korea, the United States, and Europe, expanding its scope of use. Professor Hughes said, “We have seen a dramatic improvement in survival since the advent of TKI-based treatments, but many patients still experience treatment failure due to drug intolerance or resistance.” He added, “In particular, Scemblix is becoming an important alternative for patients who were contraindicated from using existing TKI treatment due to cardiovascular disease, etc.” Scemblix demonstrates superior efficacy in direct comparison studies with existing targeted therapies Scemblix has demonstrated its therapeutic improvement effect through a head-to-head study with existing targeted therapies. The clinical trial, ASC4FIRST, was the first study to compare Scemblix with standard first-line treatments currently available for newly diagnosed CML patients. The trial randomly assigned adult CML patients to the Scemblix group and the standard TKI treatment group and compared the major molecular response (MMR) rate at week 48. The results of the study showed that the MMR achievement rate at week 48 was 67.7% in the Scemblix-treated group and 49.0% in the standard TKI-treated group, showing an 18.9% difference. In terms of safety, the Scemblix-treated group showed a relatively low incidence of Grade 3 or higher adverse reactions, discontinuation rate due to adverse reactions, and dose adjustment and discontinuation rate for adverse reaction management compared to the control group. The biggest concern for TKI treatments, including Iclusig, which had been mainly used as a third-line therapy, was cardiovascular toxicity. Iclusig is known to have a tendency to increase the incidence of arterial occlusion depending on the dose. According to Professor Hughes, Iclusig should be used only in patients with no other treatment option because there have been many serious arterial system adverse reactions observed even at the standard dose of 45 mg per day. STAMP inhibitors have high target specificity as they act on the myristoyl pocket of the BCR-ABL1 protein, not the ATP binding site. Through this differentiated mechanism of action, Scemblix offers the advantage of maintaining a strong therapeutic effect while minimizing side effects. Professor Hughes commented, “Through the ASC4FIRST trial, Scemblix has demonstrated both efficacy and safety profiles superior to those of Gleevec, Tasigna, and Sprycel, which are currently used as first-line treatments for CML.” He went on to say, “In particular, Scemblix showed a higher MMR compared to Gleevec and also showed excellent results in terms of safety. The treatment discontinuation rate due to toxicity was also only half that of Gleevec. In addition, Scemblix also demonstrated higher treatment response rates and safety in the patient group compared to second-generation TKIs.” Potential rises for Scemblix as a first-line treatment option... “One step closer to treatment-free remission” #EB Professor Hughes believes that while CML treatment strategies have focused on improving survival in the past, it is now important to enable patients to achieve treatment-free remission and enjoy a 'life without need for treatment.' According to Professor Hughes, recent CML treatments tend to focus on inducing a strong response early, in the first-line treatment phase. This is because a fast and strong response induced by intensive treatment from the beginning can lead to a positive prognosis in the long term and ultimately increase the likelihood of achieving a treatment-free remission. Professor Hughes said, “Another notable agenda is that the treatment goal of patients is shifting to treatment-free remission. In fact, when patients are asked what treatment goal they most desire, most of them want to ‘no longer take medication.’ To date, the proportion of patients who have reached treatment-free remission is about 30%, but we expect that the figure will rise to more than 50% in the future through the use of STAMP inhibitors.” Professor Hughes believes that Scemblix has a high potential for use as a first-line treatment for CML. The ASCEND study, led by Professor Hughes, was the first Scemblix monotherapy clinical trial, involving approximately 100 patients. Professor Hughes explained that the results of the study were similar to those of the pivotal Scemblix clinical trial. “In Australia, ASCEND is currently undergoing a follow-up clinical trial. Patients who meet the criteria for participation are mostly enrolled in the study and receiving Scemblix as a first-line treatment,” added Professor Hughes. “For patients who are unable to participate in the trial, we are treating them with the best available option.” He went on to say, “Currently, the most important goal of first-line treatment is for patients to achieve a deep molecular response early and ultimately achieve a treatment-free remission. However, for patients who need to receive third line of treatment, the treatment goals will inevitably vary depending on the course and situation.” He said, “Scemblix has shown high safety and efficacy from the early stages of clinical trials. It is a drug that has shown the potential to be used not only as third-line treatment but also as first-line treatment.” He also emphasized, “We expect a strong therapeutic effect when Scemblix is used as a first-line treatment. If there were no restrictions set in our clinical trials, more than 90% of the patients may use Scemblix as a first-line treatment.”
- Company
- Vyndamax may be prescribed at tertiary hospitals in KOR
- by Eo, Yun-Ho Apr 16, 2025 05:55am
- Vyndamax, which was finally granted insurance reimbursement after 5 attempts, may now be prescribed in general hospitals. According to industry sources, Pfizer Korea's treatment for ATTR-CM (Tafamidis 61mg) passed the drug committees of 26 medical institutions nationwide, including the ‘Big 5’ major hospitals (Samsung Medical Center, Seoul National University Hospital, Asan Medical Center, Seoul St. Mary's Hospital, and Severance Hospital). Vyndamax was approved in Korea in August 2020 and has been granted reimbursement since March this year after a series of twists and turns. It failed its first reimbursement challenge in early 2021, Vyndamax failed to be designated as an essential drug at the time. In the first half of the same year, the company evaluated the drug’s cost-effectiveness and took on the second challenge through the risk-sharing agreement (RSA) track, just to meet the same results. In April 2022, it again failed to pass the Health Insurance Review and Assessment Service's Reimbursement Standard Subcommittee, but in July of the same year, it passed the subcommittee but was later judged non-reimbursable by the Drug Reimbursement Evaluation Committee 9 months later. At the time, the government and the pharmaceutical company were unable to reach an agreement on the risk-sharing plan. Pfizer again submitted a reimbursement application in June last year, passed the DREC review in October of the same year, and concluded a drug price negotiation with the National Health Insurance Service last month. The maximum insurance price ceiling for Vyndamax was set at KRW 100,000. Vyndamax is a separately licensed product that contains a different dose of the same ingredient as Vyndaqel, a treatment for familial amyloidotic polyneuropathy. Some view this as a strategy adopted by the pharmaceutical company to differentiate the drug price. However, it is encouraging that the drug was approved after 5 attempts over four years. Now, patients will only have to pay 10% of the drug price if the special calculation system is applied. The efficacy of Vyndamax was demonstrated through the Phase III ATTR-ACT study, where the drug reduced the incidence of cardiovascular events in patients with CM and showed an improvement in the six-minute walk test. In the ATTR-ACT study, 441 patients were randomly assigned in a 2:1:2 ratio to receive 80 mg of tafamidis, 20 mg of tafamidis, and placebo, respectively, and the primary endpoints of the study were hierarchical evaluation of all-cause mortality and frequency of cardiovascular-related hospitalization. The key secondary endpoints were the change from baseline to month 30 for the 6-minute walk test and the score on the Kansas City Cardiomyopathy Questionnaire–Overall Summary (KCCQ-OS), in which higher scores indicate better health status. Study results showed that tafamidis demonstrated a statistically significant reduction in all-cause mortality and frequency of cardiovascular-related hospitalizations compared to placebo.
- Opinion
- [Reporter's View] The MOHW’s contradiction
- by Lee, Jeong-Hwan Apr 16, 2025 05:55am
- The Ministry of Health and Welfare cited the 'non-face-to-face medical treatment pilot project' as an excellent administrative example last year. The reason for its excellence is that the non-face-to-face treatment, which was urgently and temporarily permitted in February 2020 in response to the COVID-19 pandemic, was converted into a pilot project in June 2023, 3 years later, and has been operated stably, with the pilot project model being supplemented and developed to improve the quality of medical services for the public. However, the MOHW overlooked the fact that in the process of implementing the non-face-to-face treatment pilot project, it revised and modified the scope of its application and permission several times, causing confusion among patients, medical institutions, pharmacies, and intermediary platforms. In particular, the MOHW also cited the Framework Act on Health and Medical Services as it failed to secure legal grounds, such as amendments to the Medical Service Act, in the process of converting non-face-to-face medical care into a pilot project in line with the government's declaration of the end of the COVID-19 pandemic. The MOHW's rationale for the pilot project was Article 44 of the Framework Act on Health and Medical Services, which states that “the national and local governments may conduct a pilot project if necessary to implement a new health and medical care system.” With just one line of legal provision as support, the MOHW conducted a non-face-to-face treatment pilot project that breaks the principle of face-to-face medical care. This is the background to the criticism that the opposition party, led by the Democratic Party of Korea, has leveled at the ruling party for forcing an executive order through politics on non-face-to-face medical care, which is directly linked to the health and lives of the people and has a significant impact on the domestic healthcare delivery system and pharmacy ecosystem. In fact, the MOHW has revised the guidelines for the pilot project 5 times since June 2023, when it converted non-face-to-face treatment into a pilot project. The model of the first pilot project, which divided medical institutions into clinics and hospitals and patients into returning and first-time patients, was criticized by the public as being overly complicated. This was also the time when some speculated that the MOHW Minister and Deputy Minister were reprimanded because the pilot project did not fully reflect former President Suk-Yeol Yoon’s request to consider ways to foster non-face-to-face treatment as its industry. Maybe due to this issue, the project for non-face-to-face treatment was revised to effectively remove the criteria on primary and follow-up visits on December 15, 2023, less than 6 months after its implementation. The reason put forward for revising the pilot project was to reduce the inconvenience raised by some in society and to expand patient access to medical care. Afterward, the Yoon administration’s policy on increasing the medical school capacity by 2,000 students was announced in 2024, and the scope of the pilot non-face-to-face treatment project was expanded under the pretext of “responding to the medical gap caused by the collective resignation of residents.” As a result, non-face-to-face medical care was allowed for more than the temporarily allowed period and was revised several times throughout the pilot project period, causing inconvenience to the public, medical institutions, and pharmacies as they had to constantly familiarize themselves with the changed standards and implementation plans. Even amid this confusion, the MOHW itself stamped its own excellent administrative seal because it had advanced the model of the non-face-to-face treatment pilot project, which is like giving itself a report card disjunct from the social confusion it had caused. Won-Joon Cho, a senior policy advisor for health and welfare from the Democratic Party of Korea, criticized the MOHW's full-scale expansion of the non-face-to-face treatment pilot project, saying, “Serious illegal activities are continuing. I will bring to account the background and responsibility for the unending pilot project in the future legislative process.” This is a glimpse of how the MOHW's ‘excellent administrative activity’ evaluation on its non-face-to-face treatment pilot project may be criticized during the National Assembly's audit and the bill review for the revision of the Medical Services Act. Non-face-to-face treatment is still being allowed without any legal basis. As the 22nd National Assembly is about to be inaugurated in a year and the country has entered an early presidential election due to the impeachment of the president, the MOHW should not issue a report card that contrasts with public opinion and the evaluation of the opposition party, but should instead work hard to sort out the problems identified in the process of revising the guidelines for the pilot project and prepare a legislative bill that can minimize social confusion.
- Company
- Tepmetko targets rare lung cancer target with reimbursement
- by Whang, byung-woo Apr 16, 2025 05:55am
- Merck is seeking to increase the market influence of Tepmetko (tepotinib), which was granted reimbursement 3 years after its approval, by improving treatment access. Although the MET mutation is a rare mutation that occurs in 1.8-3.1% of non-small cell lung cancer patients in Korea, it is evaluated that the drug’s reimbursement will have a significant effect as it increases the success rate when early diagnosis and appropriate treatment are carried out. Ji-Youn Han, professor of Hemato-Oncology at the National Cancer Center, On the 15th, Merck Biopharma Korea held a press conference to shed light on the implications brought by Tepmetko’s reimbursement, a treatment for non-small cell lung cancer with MET exon 14 deletion mutation. In Korea, MET mutations in non-small cell lung cancer are known to cause resistance to other anticancer treatments and have a high rate of metastasis to bones, the brain, etc., which is associated with poor patient prognosis. In addition, most patients are elderly, which lowers the response rate to immuno-oncology drugs, and most patients relapse within 5 months. “MET-mutated non-small cell lung cancer has a poor prognosis, and brings threefold increased risk of death compared to those without mutations,” said Ji-Youn Han, a professor of Hemato-Oncology at the National Cancer Center, who presented at the press conference. ”Most patients are elderly, have a low response rate to immuno-oncology drugs, and have difficulty tolerating strong side effects, so there was a high unmet need for MET-mutation targeted therapies.” Tepmetko’s reimbursement was based on the Phase II VISION study in patients with MET-mutated NSCLC. In the 32.6-month follow-up of 313 patients diagnosed by liquid biopsy or tissue biopsy, Tepmetko showed an objective response rate (ORR) of 58.6%, median progression-free survival (PFS) of 15.9 months, median overall survival (OS) of 29.7 months, and median duration of response (DoR) of 46.4 months in patients diagnosed by tissue biopsy and with no previous treatment experience. These results were consistent regardless of treatment line, biopsy method, etc., and showed consistent efficacy in Asian patients, including Koreans. In a subgroup analysis of 106 Asian patients, the ORR of patients who were initially treated with Tepmetko was 64%, with a median PFS of 16.5 months, a median OS of 32.7 months, and a median DoR of 20.7. “The importance of personalized treatment based on MET mutations is being emphasized in the non-small cell lung cancer setting. Tepmetko has demonstrated consistent effects regardless of the treatment line in Asians,” said Professor Han. Although Tepmetko has demonstrated its effect through clinical results, the company had to jump over high hurdles to be included in the reimbursement list. After failing to set the reimbursement criteria twice, including during the Health Insurance Review and Assessment Service's Cancer Disease Review Committee meeting, the company voluntarily withdrew its reimbursement application, and submitted a new application in July last year, which led to the current result. As a result, Tepmetko became the first treatment option in the same class to be listed for reimbursement, ahead of Tabrecta (capmatinib), an anticancer drug that was approved in Korea at the same time in 2021. Currently, Tepmetko is expected to quickly settle into the prescription environment as it has passed the Drug Committees (DCs) of more than 30 medical institutions nationwide, including the Big 5 tertiary hospitals such as Samsung Medical Center and Seoul National University Hospital. “From the perspective of a doctor treating patients in the clinical setting, we need more treatment options to keep patients alive and improve their quality of life,” said Professor Han. ”I think this coverage of Tepmetko is a positive step because it means patients can use it without financial burden.” “We hope that this reimbursement of Tepmetko will play an important role in the future treatment environment in Korea,” said Christoph Hamann, General Manager of Merck BioPharma Korea. ”Merck will continue to endeavor to drive innovation at the forefront in the field of cancer treatment and will continue to strive to improve the intractable cancer treatment environment.”
- Policy
- Will a 'Duodart' generic for prostatate drug be available?
- by Lee, Hye-Kyung Apr 16, 2025 05:55am
- Product photo of Duodart A generic version of GSK's benign prostatic hyperplasia (BPH) combination product 'Duodart Capsule (dutasteride·tamsulosin hydrochloride),' which drove the success of the combination drug market for urology in Korea, is now under development. On the 14th, the Ministry of Food and Drug Safety (MFDS) approved an open-label, randomized, two-group, two-period, fasting, single-dose, oral, crossover study in healthy adult male subjects for the biological equivalence evaluation of Aprogen Biologics' 'Dutatams Capsule' and the original 'Duodart Capsule.' Duodart is a fixed-dose combination of the 5α-reductase inhibitor dutasteride and the α‑blocker tamsulosin, which was first approved in Korea in 2021. It was subsequently listed on the reimbursement drug list the following year. According to market research firm UBIST, Duodart surpassed KRW 10 billion in outpatient prescription sales in its second year of market launch in 2023 and reached KRW 23.2 billion last year. Until earlier this year, before four fixed-dose combination products of dutasteride and tadalafil were released, the prostate hyperplasia combination market was considered unchallenged. Apart from Duodart, Hanmi Pharmaceuticals had launched 'Gugutams,' a product combining tamsulosin and tadalafil. Despite various ingredients such as tamsulosin·finasteride·dutasteride for prostate hyperplasia treatment; mirabegron·solifenacin for overactive bladder treatment; and sildenafil·tadalafil for erectile dysfunction having lost their patents, there had been no updates to new fixed-dose combinations launches. Among these, only Duodart was performing well. Duodart is designed for the treatment of moderate to severe BPH and is administered orally once daily as a single capsule. Combining the two active ingredients into one capsule achieves rapid symptom improvement and reduces the long-term risks associated with disease progression. Furthermore, it minimizes dosing frequency, improves patient adherence, such as the likelihood of missed doses, and simplifies treatment regimens.
- Policy
- Global pharma proposes 'indication-based pricing system'
- by Lee, Jeong-Hwan Apr 16, 2025 05:55am
- Overseas global pharmaceutical companies with subsidiaries in Korea are currently voicing the adoption of policies aimed at resolving 'reimbursement inequities' for therapies for severe and rare diseases and implementing an 'indication-based pricing system' amid an early presidential election. While the Korean government maintains that an indication-based pricing system should be carefully reviewed over the long term due to various potential challenges, global pharmaceutical companies have begun gathering public opinion on the issue at a parliamentary forum. On the 15th, Rep. Seo Mi-hwa of the Democratic Party, a National Assembly's Public Healthcare Committee member, is preparing to hold a 'Discussion Forum on Resolving Inequalities in Innovative New Drugs and Regulatory Reforms.' It is intended to highlight that only 22% of innovative new drugs, such as those changing the treatment paradigm for severe and refractory diseases like cancer drugs, are reimbursed in Korea, leaving patients without timely access to therapies. In particular, the forum will also discuss measures to introduce an indication-based pricing system in Korea to expand reimbursement for new drugs. The introduction of an indication-based pricing system was an issue raised by the Korea Research-Based Pharma Industry Association (KRPIA), which requested a pilot project from the Ministry of Health and Welfare (MOHW) and other government agencies overseeing national health insurance. The KRPIA requested that the government initiate a pilot project applying a 'weighted average price by indication' and 'differentiated reimbursement rates by indication' for drugs under risk-sharing agreements (RSA). Furthermore, KRPIA is reportedly planning to propose to the candidate camps of parties such as the Democratic Party and the People Power Party policies to expand patient treatment opportunities through the implementation of an indication-based pricing system during this early presidential election cycle. The request is based on the fact that some overseas countries, including Italy, France, and Switzerland, are already implementing policies that evaluate the therapeutic value of drugs with multiple indications separately by indication, by determining different insurance prices or applying differential discounts at reimbursement. The KRPIA is urging these measures to be adopted as a commitment to enhancing patient access to medications. The request aligns with a presidential policy proposal that will coincide with a parliamentary debate later this month. However, the MOHW has stated that the indication-based pricing system should be carefully reviewed from a long-term perspective. While they agree with the rationale for introducing the system, the MOHW believes that further long-term discussions are necessary, such as financial impact analysis, establishment of legal grounds, and development of billing and settlement systems to prevent circumvention and distorted prescribing practices among some patients, must be addressed first. The rep. office responsible for preparing for the forum stated, "At the discussion forum, we will look for solutions to the prolonged processing period following reimbursement listing and the delays in reimbursement payments occurring within the approved indications," and added, "We will review the regulatory improvement policy agenda from the perspective of treatment disparities among patients."
