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- 2026-04-03 19:52:00
- Policy
- Six of Keytruda's indications fail reimbursement
- by Lee, Tak-Sun Feb 14, 2025 05:58am
- After 5 failed attempts, MSD succeeded in receiving reimbursement standards for 11 additional indications of its immuno-oncology drug Keytruda in its 6th attempt. However, the company unfortunately has been denied reimbursement 6 indications. The six indications that have been denied reimbursement this time can only be reviewed if the company reapplies for reimbursement. On the 12th, the Health Insurance Review and Assessment Service's Cancer Disease Deliberation Committee set reimbursement standards for 11 additional indications of MSD's immuno-oncology drug Keytruda. As indications for which reimbursement standards have been set must undergo a drug price negotiation with the National Health Insurance Service after the Drug Reimbursement Evaluation Committee reviews the adequacy of their reimbursement, there are still many hurdles to overcome. Even so, the fact that the reimbursement standards for a single drug with a large number of indications were set and passed CDDC review is interpreted as a significant step in its reimbursement progress. Expanding the scope of reimbursement to 11 indications is expected to require a huge amount of health insurance finances. The 11 indications for which the salary criteria have been set this time are: ▲PD-L1 positive advanced or metastatic HER2-positive gastric cancer; ▲ advanced or metastatic HER2-negative gastric cancer; ▲ PD-L1 positive advanced or metastatic esophageal cancer ▲ MSI-H or dMMR advanced endometrial cancer; ▲ MSI-H or dMMR metastatic colorectal cancer; ▲ advanced or recurrent head and neck cancer with MSI-H or dMMR; ▲ metastatic or recurrent squamous cell carcinoma; ▲PD-L1-positive persistent, recurrent, or metastatic cervical cancer; ▲PD-L1-positive recurrent or metastatic triple-negative breast cancer ▲ MSI-H or dMMR Metastatic endometrial cancer; ▲ MSI-H or dMMR metastatic small intestine cancer; ▲ MSI-H or dMMR metstatic biliary tract cancer. MSD applied for reimbursement expansion for 13 indications in 2023 and added 4 indications last year. While the company succeeded in establishing reimbursement standards for 11 indications this time, it failed to do so for the remaining 6 indications. An official from HIRA explained, “The 11 indications for which the reimbursement criteria have been set this time have been pending for the past 2 years. The review of the financial sharing plan submitted by the pharmaceutical company has been completed, based on which the reimbursement criteria have been set during CDDC review.” “On the other hand, the results of the review showed that the 6 indications were not adequate for reimbursement without undergoing CDDC deliberations,” the official added. ”If the company applies for reimbursement again for the indications, it will be able to receive review.” The 6 indications for which the reimbursement standards have not been set are: ▲early triple-negative breast cancer, ▲adjuvant therapy after surgery for renal cell carcinoma, ▲non-invasive bladder cancer, ▲MSI-H or dMMR metastatic ovarian cancer, ▲MSI-H or dMMR metastatic pancreatic cancer, and ▲MSI-H gastric cancer. Currently, Keytruda is reimbursed for 7 indications in 4 cancer types, including as a first-line treatment for non-small cell lung cancer, melanoma, urothelial cancer, and Hodgkin's lymphoma, with annual claims amount reaching KRW 400 billion. Meanwhile, CDDC plans to reach a consensus on the need for a principle for the reimbursement of high-priced anticancer drugs and to establish detailed standards in the future, taking the review of this Keytruda as an opportunity. An official from the Health Insurance Review and Assessment Service said, “During CDDC review, there was a consensus on the need to establish a principle for the reimbursement of high-priced anticancer drugs and to review them as in some countries, such as the United States. We plan to discuss this in detail at the next CDDC meeting.”
- Product
- Distributors of Neurontin, Lyrica, and Celebrex to change
- by Kim JiEun Feb 14, 2025 05:58am
- With the transfer of sales rights between domestic pharmaceutical companies for major original products expected, the change is expected to affect not only the pharmaceutical and distribution industries but also front-line pharmacies. According to the pharmaceutical wholesale industry sources on the 13th, the transfer of rights to domestic pharmaceutical companies for some of Viatris and Takeda Pharmaceutical’s products is being confirmed or under discussion in the first quarter of this year. The products for which the recent transfer of rights has been confirmed and related notices are being issued to the pharmaceutical wholesale industry one after another are: Viatris' Neurontin Tab, Neurontin Cap, Lyrica Cap, Lyrica CR Tab, and Celebrex Cap. Their supplier will change from Jeil Pharmaceutical, the current supplier of these products, to a domestic pharmaceutical company on the 4th of next month. With less than a month left for the change of suppliers, some of these products are already in short supply. In the case of Neurontin, no new stock has been supplied to the distribution industry since last month, and the industry believes that the pharmaceutical company has adjusted its supply in anticipation of the change in sales channels. In the pharmaceutical and distribution industries, the change in the supplier of some of Takeda Pharmaceutical’s products is also rising as an issue. According to industry sources, information about the transfer of sales rights of Dexilant DR Cap and Lanston LFDT Tab, which have been supplied by Jeil Pharmaceutical, has spread throughout the industry, with the timing of the change expected around April 1. It is also reported that Dexilant's stock has been rapidly depleted recently. Jeil Pharmaceutical, which is at the center of the issue of changing suppliers, responded, “We are aware that relevant information is circulating in the industry, but it is difficult to confirm the details as it is a sensitive part of our contract.” The pharmaceutical and distribution industries believe that the market will be affected to some extent, as the products for which the change of suppliers is expected are major items. There may be some instability in the supply and demand of related items in the process of transferring sales rights, therefore, pharmacies that handle related items may need to manage their inventory. “Pharmaceutical companies and the distribution industry are keeping a close eye on the situation because the items under discussion are large,” said an official from the wholesale industry. “As the quantity of goods shipped may be adjusted during the process of changing suppliers, there may be temporary instability in the supply and demand of related items.”
- Policy
- MOHW "Why is HIRA concerned about substitute prescriptions?"
- by Lee, Tak-Sun Feb 14, 2025 05:58am
- The Ministry of Health and Welfare (MOHW) announced adding 'HIRA's Business Portal System' as part of the post-notification procedures for substitute prescriptions. However, an issue has been raised regarding differing opinions between the MOHW, which is responsible for the policy implementation, and the Health Insurance Review and Assessment Service (HIRA). On February 12, the MOHW team expressed discomfort regarding HIRA President Jung-Gu Kang's announcement of concerns to the press. The announcement highlighted that neither party had sufficiently discussed the agreement details during the revision of the Pharmaceutical Affairs Act guidelines and policies. The pharmacy industry deeply concerned about whether the revision can be effectively implemented given this ongoing dispute. HIRA, "We disagree with the inclusion of post-notification procedure…MOHW decided the portal service" According to industry sources, the MOHW was solely responsible deciding to include 'HIRA's Business Portal System' in the revised details of the Pharmaceutical Affairs Act guidelines and policies regarding post-notification procedures for substitute prescriptions. The HIRA did not mutually agree. It has been reported that HIRA expressed negative opinions towards utilizing either the DUR or the business portal system for post-notification procedures for substitute prescriptions. Before the notification of the implementation of the revision, the administrative team expressed concern about invading the system's intended role and potential incidents related to pharmaceuticals due to doctors not being aware of the updates. However, during the exchange of opinions, it has been reported that the party suggested the time it takes to develop a new system. After the MOHW announced the implementation of the revision to the Pharmaceutical Affairs Act on January 21, HIRA has not provided further opinion to the MOHW. The current post-notification procedure for substitute prescriptions is limited to 'telephone, fax, or computer network.' The MOHW announced the implementation of revision to the Pharmaceutical Affairs Act guidelines and policies on January 21 with details of including the 'HIRA's Business Portal System' as part of the notification method. Amid this situation, the HIRA president, who will be responsible for running the portal for substitute prescriptions, expressed concerns to the press. During the press conference the other day, Kang said, "Substitute prescriptions with the same active ingredient will not present significant issues for pharmaceuticals. However, we must be cautious because patients may have varying sensitivity for certain medicines." Kang added, "If the HIRA's portal is used, doctors must individually access the system and check the change. Thus they may be aware of the substitute prescription later or not at all in some cases." Kang also added, "We need to review ways to inform doctors about substitute prescription incidence immediately." MOHW, "Difficult to understand Kang's concerns…an agreement from doctors on the post-notification procedure is not necessary" Regarding this matter, the MOHW responds that it is difficult to understand why Kang announced a negative opinion towards the inclusion of the business portal for the post-notification procedure as part of the revision. Since the revision entails simply adding the business portal to existing methods, including phones, fax, and computer networks, the MOHW reportedly to disagree with Kang's argument that doctors' awareness and confirmation of substitute prescriptions will be delayed. During the meeting with the Korea Special Press Conference, a MOHW Bureau of Policy Planning representative said, "We did not revise the details to the guidelines to rely on the business portal system solely. We intended to add more notification channels." He added, "The intention is to add the business portal system to the existing methods, such as phones and fax, so it is difficult to understand why Kang expresses concerns." The representative added, "(If HIRA's system is used) Doctors checking the change could be delayed, but this is not intended to ask permission, but it is a notification. Adding another notification channel won't delay the check." He explained, "Technically, MOHW's adding a post-notification system to HIRA's portal is intended to support doctors and pharmacists' mutual access, and the HIRA's involvement is none." "If it (post-notification service for substitute prescriptions on the business portal) were HIRA's responsibility, Kang's concern would be important, but the HIRA does not play any role in this procedure. HIRA may be running the business portal system. However, MOHW is simply establishing the channel, and the HIRA is not responsible for mutual communication between doctors and pharmacists," the representative emphasized. "Because (HIRA) is a third party allowing the space, and does not play a specific role in the portal system, we are unclear about why (Kang) expresses opinions or whether it's his responsibility," the representative added.
- Company
- Reimb status of Keytruda for breast cancer treatment
- by Moon, sung-ho Feb 13, 2025 05:59am
- As Keytruda passed the Drug Reimbursement Evaluation Committee (DREC) review after another attempt, it is expected to be reimbursed within the first half of the year. According to the pharmaceutical industry on February 10, the Health Insurance Review and Assessment Service (HIRA) held the 2nd DREC for 2025 and approved reimbursement appropriateness for Gilead Sciences Korea's Trodelvy (sacituzumab govitecan). Product photos of Trodelvy and KeytrudaTrodelvy is an antibody-drug conjugate (ADC) that binds to Trop-2 protein, highly expressed in various cancer types, including breast cancer, and releases medication inside the tumor cells. It minimally affects healthy cells, and it can destroy not only tumor cells but also the tumor microenvironment (TME). Consequently, clinical practices in South Korea can now use the drug as a non-reimbursed treatment for triple-negative breast cancer (TNBC). However, using the drug without reimbursement costs over KRW 10 million per cycle (three weeks). Due to this cost burden, reimbursement is needed to improve patient access and more uses in clinical practices. Furthermore, Trodelvy is the only treatment approved by the MFDS as a second-line treatment for patients with metastatic TNBC, regardless of existing genetic mutation or biomarkers. Patients have high hopes for reimbursement of this medication. In response, the HIRA recognized the necessity of Trodelvy, which was reviewed for reimbursement appropriateness. HIRA stated that Trodelvy is the first case of a new drug being recognized for innovativeness. Last year, HIRA revised the details of the criteria for drugs submitted for negotiations and determined to offer new drugs a benefit from the government based on their ICER value. Innovative drugs are to meet the criteria of ▲If no products or therapy that can be replaced or have therapeutic equivalence ▲Final result index, such as overall survival extension, indicates significant clinical improvements ▲New drugs granted expedited review according to Article 35-4 Clause 2 of the Pharmaceutical Affairs Act or medicine determined to have equivalent value as determined by the committee. HIRA stated, "Trodelvy is the first case for which a revised system aimed at improving patient access to new drugs with innovativeness." Following this decision, Trodelvy is now closer to being reimbursed as the second new ADC drug, following Enhertu. If the company agrees to the drug price negotiations with the National Health Insurance Service (NHIS) without further issue, reimbursement can be applied within the first half of the year. Obtaining reimbursement will positively impact Gilead Sciences, which launched its oncology business division when launching Trodelvy in South Korea, to expand its presence in clinical practices. However, the status of Keytruda (pembrolizumab), used as a first-line treatment in combination with chemotherapy, is concerning as it remains non-reimbursed. Since Trodelvy is used as a second-line treatment, reimbursement approval of Keytruda is essential for use in clinical practices. MSD Korea has also applied for setting reimbursement criteria for Keytruda for up to 17 indications to treat cancers, including TNBC. Now, for metastatic TNBC treatments in clinical practices, chemotherapy, Keytruda or Tecentriq (atezolizumab) is used as first-line treatments, the PARP inhibitor Lynparza (olaparib) is used as a second-line treatment, and Trodevly is used after the second-line treatment. Professor Joohyuk Sohn at Yonsei Cancer Hospital (Department of Oncology) said, "Keytruda is not actually competing against Trodelvy. We hope reimbursement will be provided for drugs benefiting all patients." Sohn added, "Trodelvy extended the progression-free survival (PFS) by five months compared to chemotherapy. Five months is a significant time for patients. And, data indicate that patients who respond well to the treatment can extend up to 10-15 months, so the drug is clinically significant." Meanwhile, HIRA's DREC determined reimbursement appropriateness for Adempas (riociguat, Bayer Korea), a treatment for arterial pulmonary hypertension, in addition to Trodelvy during the second meeting. The committee determined that the plaque psoriasis treatment Bimzelx Autoinjector (bimekizumab, UCB Korea) and Ebglyss Autoinjector inj (lebrikizumab, Lily Korea) would be appropriate for expanded reimbursement scope if the companies accepted the drug price below the evaluated amount. Additionally, the committee determined that Cabometyx tab (cabozantinib, Ipsen Korea), a treatment for renal cell carcinoma (RCC), would be appropriate for expanded reimbursement scope if the company accepted the drug price below the evaluated amount.
- Opinion
- [Reporter’s View] Concerns over US drug tariffs
- by Kim, Jin-Gu Feb 13, 2025 05:58am
- The US President Donald Trump has hinted at the possibility of imposing tariffs on drugs imported into the country. Although he says he is still “reviewing” the matter, it would not be surprising if he signs a tariff declaration at any time. The United States has played a major role in the recent development of the Korean pharmaceutical and biopharmaceutical industries. Korean pharmaceutical and biopharmaceutical companies have steadily expanded their exports to the world's largest pharmaceutical market. Just a decade ago, the export value of domestically produced pharmaceuticals to the United States was only USD 33 million, but last year it increased more than 40-fold to USD 1.359 billion. The U.S. accounted for 18% of Korea's total pharmaceutical exports last year, the largest share of any country. The U.S. has now developed into an inseparable relationship with Korea's pharmaceutical and bio industries. In this situation, if tariffs are imposed on domestically produced drugs exported to the United States, it is expected that a considerable blow will be inevitable. For the time being, it is expected that there will be no major damage in the process of exporting existing orders, but if the situation is prolonged, the accumulated damage is expected to have a negative impact on pharmaceutical and biopharmaceutical companies. The unfortunate thing is that there is no government control tower to respond to the reality of the US tariff bomb. Since the state of emergency at the end of last year, there has been a long-term leadership vacuum. Sang-mok Choi, the acting president, has been filling the void, but it is clear that he has limitations as an acting president. It is difficult to expect measures such as a breakthrough through a summit with an acting president. If drug tariffs are imposed, we will have no choice but to suffer helplessly. Each pharmaceutical and biopharmaceutical company must fend for itself. With the absence of government leadership, the options for each company are limited. They can only set up production facilities in the US or find new markets. Even this is not a solution that can be solved immediately. Small and medium-sized pharmaceutical companies with insufficient financial resources are expected to face even greater difficulties. It is not just the pharmaceutical tariff. From the perspective of the pharmaceutical industry, there are many issues that the government needs to resolve. The conflict between the medical and pharmaceutical industries is a prime example. The conflict over the increase in the number of medical school admissions has continued for years. Its damage to the pharmaceutical industry is gradually accumulating. With the government lacking leadership, there is no sign of a solution. The shadow of crisis is looming over the pharmaceutical and bio-industry due to concerns over Trump’s imposition of tariffs on pharmaceutical products and the prolonged medical-political conflict. However, the bigger crisis is the current reality where pharmaceutical and bio companies are forced to fend for themselves due to the lack of government leadership.
- Company
- "Paradigm shift in follicular lymphoma treatment: CAR-T"
- by Whang, byung-woo Feb 13, 2025 05:58am
- "Although CAR-T cell therapy or bispecific antibody respectively offers an advantage for treating follicular lymphoma, CAR-T data demonstrating positive results over 10 years in 60% of patients indicate that it is an effective treatment option." As various treatment options are introduced to treat relapsed/refractory follicular lymphoma (FL) with a poor prognosis, how these treatments can be utilized is of great interest. In South Korea, Kymriah (tisagenlecleucel), which is known as the chief CAR-T therapy, was approved for expanded indications in 2023 to treat patients with relapsed/refractory FL who had previously undergone two or more treatments. After that, doctors are gaining treatment experiences with the drug. Dr. Stephen J. Schuster, Professor of the Department of Hematology/Oncology at the University of Pennsylvania Abramson Cancer CenterDuring a meeting with Daily Pharm, Dr. Stephen J. Schuster, Professor of the Department of Hematology/Oncology at the University of Pennsylvania Abramson Cancer Center, who has years of prescription experience in the United States, emphasized the necessity of CAR-T therapy for treating follicular lymphoma. Follicular lymphoma (hereafter, FL) is a type of non-Hodgkin Lymphoma (NHL) that occurs when cells in the lymph system turn malignant. Because the symptoms of the disease progress slowly, about 80% of the cases are identified at stage III or Stage IV after the disease progresses. The prognosis for patients who relapse is poor. Dr. Schuster said, "The prevalence of FL seems to be increasing in Asia." He added, "As FL progresses in various ways, clinical characteristics significantly vary by patient." Dr. Schuster explains that considering the characteristics of FL, characterized by low-risk disease cases and slow disease progression, most diseases can be managed through proactive treatments. The disease becomes problematic if a disease has a poor prognosis requiring more than one treatment due to relapses. According to Dr. Schuster, data from patients with FL who need more than one treatment indicate that the remission period shortens as patients repeatedly receive treatment. "About 20% of the patients with FL relapse after two years following the initial treatment. Even after further treatment, the remission period shortens, and patients have a poor prognosis, thereby needing strong treatments, including CAR-T cell therapy," Dr. Schuster said. "Despite increased overall survival, patients repeatedly need treatments, and the disease can become fatal, ultimately leading to death." There are several treatment options for FL, but Dr. Schuster highlights the clinical benefits of CAR-T cell therapy because CAR-T cell therapy does not require further treatment after the initial therapy. The clinical effect of Kymriah (tisagenlecleucel) has been proven through the ELARA clinical study regarding relapsed/refractory FL. The four-year long-term follow-up results of the study were presented at the American Society of Hematology (ASH) conference held in December 2024. The four-year long-term assessment results of the ELARA study (median follow-up period at 53 months) showed that patients with relapsed/refractory FL treated with Kymriah had consistent treatment response over 4 years and a favorable safety profile. The median progression-free survival (PFS) of all patients was 53.3 months. At 48 months, 50% PFS was reported in all patients, and 66% of patients were reported to have gained complete remission (CR). "The follow-up on patients who participated in the 2014 study has been about 10 years, and the data indicate that the overall response rate (ORR) is about 80%, similar to the recently presented ELARA clinical study result," Dr. Schuster said. "In contrast to FL requiring repeated blood tests, various scans, and drug administration for additional therapy, CAR-T cell therapy can lessen the physical and mental burden." Will the introduction of bispecific antibody change the treatment paradigm?..."CAR-T cell therapy's advantage" Kymriah received expanded indication in April 2023 in South Korea to treat FL, broadening treatment options. (모네투주맙)However, there are even more options available at clinical practices. For instance, the bispecific antibody Lunsumio (mosunetuzumab) has been introduced. Regarding this, Dr. Schuster acknowledges the role of bispecific antibodies but favors CAR-T cell therapy, which demonstrates positive long-term results over 10 years. "Each CAR-T cell therapy and bispecific antibody has an advantage, and there are no concrete answers to the treatment sequence. The CAR-T data demonstrating positive results over 10 years in 60% of patients is unbeatable," Dr. Schuster said. In particular, Dr. Schuster highlights that antigen can be easily lost during the treatment course of bispecific treatments, like MabThera or mosunetuzumab, that target CD20. "The biopsy results from patients treated with bispecific antibody drugs showed that 5.5-6% of patients had losses of CD20. However, CD19-targeting CAR-T cell therapy rarely led to losses of CD19," Dr. Schuster remarked. Dr. Schuster views that bispecific antibody drugs are important but may not replace CAR-T cell therapy. Long-term follow-up data on the remission period and response rate are needed for bispecific antibody treatment outcomes. Dr. Schuster mentions that drug tolerance is an advantage for Kymriah. The most common adverse event (AE) of CAR-T cell therapy is cytokine release syndrome (CRS). Kymriah has a relatively low AE rate and low severity. Dr. Schuster also emphasized, "In the past, there have been cases where FL patients received therapies repeatedly, but ultimately, the disease led to death. However, Kymriah offers a single treatment that can help maintain a remission state. It is also a cost-effective treatment option compared to previous therapies." Lastly, Dr. Schuster said, "Even if FL patients experience relapse after treatments, they may receive CAR-T cell therapy and maintain remission state for about 10 years, as well as having improved quality of life." He added, "Because an index for predicting survival varies by disease and disease shows characteristics, making a treatment choice through clinical follow-up assessment is important."
- Company
- Celltrion wins, Samsung loses Eylea patent trial
- by Kim, Jin-Gu Feb 13, 2025 05:58am
- Companies have seen mixed results regarding the preliminary injunction applications over the biosimilar version of the macular degeneration drug Eylea (aflibercept). While Samsung Bioepis lost the preliminary injunction application for patent infringement filed by Bayer, Celltrion won its case. The conflicting results have also led to conflicting reports on whether or not the Eylea biosimilar will be sold in Korea. Sales of Samsung Bioepis and Samil Pharmaceutical's Afilivu will be discontinued in Korea after the existing inventory. On the other hand, Celltrion and Kukje Pharm will be able to continue selling Eydenzelt as before. According to industry sources on the 12th, the Seoul Central District Court's 60th Civil Division recently reached conflicting conclusions in the preliminary injunction applications for patent infringement filed by Bayer and Regeneron against Samsung Bioepis and Celltrion. On July 30, 2019, Bayer filed a petition with the court for a preliminary injunction against Samsung Biologics, Samsung Bioepis, and Samil Pharmaceutical for infringement of the patent on the composition of Eylea along with Regeneron. On the same day, Bayer also filed a petition with the court for a preliminary injunction against Celltrion and Kukje Pharm. Their request was to discontinue sales of Samsung Bioepis and Celltrion’s Eyelea generics as they infringe on Eylea’s unlisted patents. On the 7th, the court made a decision. It decided to “acknowledge” Bayer's claims in the petition for a preliminary injunction against Samsung Bioepis. On the other hand, it decided to “dismiss” the petition for a preliminary injunction against Celltrion. The conflicting court decisions have rendered sales of the two companies biosimilars in Korea in opposite positions. Furthermore, Samil Pharmaceutical and Kukje Pharm, which have signed joint sales contracts with the two companies, are also experiencing mixed fortunes. Samsung Bioepis has been jointly selling Afilivu with Samil Pharmaceutical. Celltrion has been jointly selling Eydenzelt with Kukje Pharm. Due to the court’s decision, sales of Samsung Bioepis and Samil Pharmaceutical's Afilivu will be discontinued. Samsung Bioepis received approval for Afilivu in February last year and began joint sales with Samil Pharmaceutical in May. However, the company explained that the remaining stock can be prescribed to patients. “We will file an objection to the preliminary injunction,” said an official at Samsung Bioepis. ‘We cannot carry out any additional sales activities, but the stock that is already in circulation in the market can be prescribed to patients.’ On the other hand, Celltrion and Kukje’s Eydenzelt from Kukje Pharmaceutical can continue to be sold. Celltrion received approval for Eydenzelt in May last year. Kukje Pharm signed a joint sales agreement with Celltrion in April last year. It then began full-scale sales in September last year. The industry estimates that Samsung Bioepis and Samil Pharmaceutical, which launched their products one step ahead, have gained an advantage in the competition. However, the court's decision to grant a preliminary injunction is expected to accelerate the pace of the latecomers, Celltrion and Kukje Pharm’s product, in their pursuit.
- Company
- Officially launched Vantive Korea targets renal care market
- by Whang, byung-woo Feb 13, 2025 05:58am
- As Baxter's 'Renal Care and Acute Therapies Businesses' launches as an independent global company completes, it has begun officially operating under a new company name. Vantive LogoAccording to medical devices industry on February 5, a fund managed by global investment firm the Carlyle Group has completed the acquisition of Baxter International’s Renal Care business, finalizing the spin-off of the division. As a result, the 'Renal Care and Acute Therapies Businesses' newly launched as Vantive, a company specializing in Vital Organ Therapy. The decision to spin off the business aims to enhance agility in responding to rapidly evolving healthcare needs, establish more precise business strategies, and focus on innovation within each company's specialized division. Vantive has set its mission as 'Extending Life, Expanding Possibilities.' The company plans to set its business strategy based upon its 70-year legacy of pioneering innovations in renal care. As the company's spin-off is completed globally, the spin-off process has also been finalized in South Korea. While business registration updates remain completed, Baxter and Vantive have already been operating as separate entities. Before the launch of Vantive Korea, Baxter relocated its office to the Samil Building on Cheonggyecheon-ro last year. The move was a strategic decision to create a more efficient work environment in the heart of Cheonggyecheon. The global renal care market is currently valued at US$ 15 billion, with an anticipated annual growth rate of 3–4% over the next three years. As of 2021, the 'Renal Care and Acute Therapies Businesses,' which has now been spun off into Vantive, generated approximately US$ 5 billion (KRW 6.4895 trillion) in sales under Baxter, holding a significant share of the company's business. Based on the audit report, Baxter's sales for the past four years were reported to be ▲KRW 242.6 billion for 2020 ▲KRW 244.9 billion for 2021 ▲KRW 192.7 billion for 2022 ▲KRW 188.1 billion for 2023. During the same period, operating profits were reported as ▲KRW 11.9 billion for 2020 ▲KRW 12 billion in 2021 ▲KRW 5.8 billion in 2022 ▲KRW 5.6 billion in 2023. Baxter Korea Apart from the spinoff, the company already needed a turnaround opportunity to rebound its revenue. Following the separation, Vantive Korea is expected to focus on maintaining and expanding its domestic market presence. In December 2023, during a general meeting of shareholders, the company established Baxter Korea as a new entity through a corporate spinoff. As a result, Baxter Korea will now handle pharmaceutical imports and distribution, excluding the renal business. Vantive will remain the surviving company, responsible for all remaining business segments, including the renal care division. High hopes for Vantive Korea's future directions after a parallel company shift Vantive's 'Renal Care and Acute Therapies Businesses' aims to strengthen leadership in renal disease and vital organ therapy. Even regarding employee distribution, Vantive remains the primary entity after spinoff. According to Baxter Korea's 2023 audit report, the company had 267 employees. After the spinoff, Vantive Korea retained approximately 200 employees, while Baxter Korea downsized to about 50 employees. Based on its 70-year legacy, Vantive Korea plans to differentiate itself by integrating innovative technology and digital connectivity services. At the end of last year, before the launch of Vantive Korea, Baxter relocated its office to the Samil Building on Cheonggyecheon-ro. The move was a strategic decision to create a more efficient work environment in the heart of Cheonggyecheon. During announcing the company name Vantive, Lim Kwang-hyuk, CEO of Baxter Korea, said, "The renal care expertise accumulated over the past 70 years will be further expanded under Vantive. We will continue investing in innovative treatments and vital organ therapy to extend and improve patient lives." The company's logo also reflects its future strategy. The "V" in Vantive's logo is divided into three sections, representing innovative therapies, digital solutions, and advanced services. As peritoneal dialysis and home dialysis are encouraged, the 'digital patient management platform' is becoming increasingly significant. Vantive is expected to enhance its market share by integrating digital innovations into dialysis equipment. Kieran Gallagher, Chairman of Vantive's Board, said, "The launch of Vantive will be a significant milestone in the ongoing advancement of renal care and life-sustaining vital organ therapy. Vantive is committed to providing enhanced connectivity, visibility, and insights across the entire patient treatment journey."
- Company
- ‘Employees work long-term at Daiichi Sankyo for a reason'
- by Eo, Yun-Ho Feb 13, 2025 05:58am
- To survive and develop, we need to change and adapt to change. This is easy to say, but never easy to do. Daiichi Sankyo is a master of adaptation. The company has established itself in the domestic market by supplying drugs for chronic diseases, mainly cardiovascular diseases. Starting with hypertension drugs such as Olmetec, Sevikar, and Sevikar HCT, the company has launched the antiplatelet drug Effient and anticoagulant Lixiana and has achieved continuous growth by launching new leading products in crisis, such as patent expiry. Maybe it's the products, but it's also the strategy. The story of how Daiichi Sankyo stopped promoting its antibiotic Kravit independently when Olmetec’s patent expired and focused on its circulatory system pipeline through co-promotion with a Korean company is still much talked about. Now, Daiichi Sankyo is looking to take a new leap forward with its oncology business. Last year, Enhertu, an antibody-drug conjugate (ADC) that was listed for reimbursement in Korea, began to gain popularity in the anticancer field, supported by its excellent clinical results. With an average annual growth rate of 15% from 2014 to date, Dailypharm sought to learn more about the talents behind the company's growth. Daily Pharm met with Mr. Hyundong Ryu (50), Managing Director of Management Headquarters at Daiichi Sankyo to learn more about the people behind the company’s growth. Hyundong Ryu, Managing Director of Management Headquarters, Daiichi Sankyo Korea-Tell us about the company's organizational structure. What does the Management Headquarters do? Daiichi Sankyo Korea has 4 headquarters. The Primary Business Unit, responsible for chronic diseases and specialty drugs; the Oncology Business Unit, is responsible for anti-cancer drugs; the Development Medical Headquarters, which is responsible for clinical development, licensing, and follow-up; and the Business Management Headquarters, which is responsible for the overall management and operation of the company. I am currently in charge of the entire Business Management Headquarters, which includes human resources, general affairs, finance, distribution, IT, business planning, and external relations. -Daiichi Sankyo is very good at coming up with products that are needed at the time and achieving good results with those products. This cannot be done without the right “people.” Daiichi Sankyo is known for its job longevity, especially in the industry. What is the secret behind this? We have our own management philosophy and values with regard to human resources, on how to develop talent and treat them at Daiichi Sankyo. We don't just run a company for business, for sales, but for people to come together and work together. The mindset of not using people as tools is something that has been passed down as part of our culture. I think the sincerity of the management in valuing talent and caring to not make employees feel like they are being used as a tool is one of the important reasons behind our employees’ job longevity. -Regarding the new Oncology BU, it’s not easy to create a business unit that didn't exist before, get it up and running, and then have it drive the company's future strategy. What did you focus on and what difficulties did you face in creating the Oncology BU? When you create a new business unit (BU), you're bringing in new people, and the success of the business depends on them. We've been through this process twice in the past where new people come in, intertwine with existing employees, and grow. The company has learned from these experiences how to integrate and resolve cultural conflicts that can arise when bringing in new businesses and bringing in a lot of new talent. We believe that it is best to provide as many opportunities for communication as possible to help people understand the value of the organization's values of 'together' and 'togetherness' rather than trying to artificially seal conflicts. #SB-You seem to have a good internal mindset to deal with change. What does Daiichi Sankyo look for in its employees? Daiichi Sankyo Korea has created new business units and recruited new talents, so in Korea, since the 2020s, we have emphasized and valued “Collaborate & Trust” the most. We don't look at a candidate's experience or specifications but rather how they want to contribute to our organization. For example, we try to select candidates who value work and take responsibility for their work, rather than candidates who emphasize the resonance of “I did it” or “I am the best” or those who want to prioritize their career path. - Interest in multinational pharmaceutical companies has been rising these days. There aren't many new hires at each company, but in the overall framework of multinational companies, this seems to be happening to some extent. Does Daiichi Sankyo have any procedures or requirements for hiring new employees? We hire new employees on a case-by-case basis. It's not a regular program, but we have an intern program that has been up and running for more than 10 years. We hire people who have a good work attitude and understand the value of “working together” as marketing representatives (MRs). We don't look for any specific qualifications. Unless we need a pharmacy professional, we look for a 4-year graduate with some language level, etc., and their attitude towards work and contribution to the team and organization's goals is important. -What programs do you offer to foster talent after they join the company? In terms of fostering talent, the company has a systemic roadmap in place for overall talent growth and support. When you first join the company, we spend 2-3 days training you on the company's systems and other things you need to learn. At the one-year mark, we have a week-long training session at a separate location with other new hires and experienced employees. This is called the first-year onboarding training, which focuses on improving your understanding of the company's mission, values, and culture. In the second year, we hold a reminder training (vision training) where employees reflect on the goals and visions they set in the first year and what they want to achieve within the company. In the third year, you go to the headquarters in Japan for a week of training. When it comes to work-level job training, some parts cannot be fully covered in-house, so we offer training support without a specific budget limit for all training needs. Individuals can request individualized competency training, which they discuss with their manager and then receive support from the company. At the manager level, we offer an annual 360-degree, multi-faceted assessment to identify strengths and weaknesses and provide one-on-one coaching on how to overcome them. Key talent, such as potential next-generation leaders, is developed separately by HR. For example, we support MBA and pharmacy-related graduate programs. There is also a program called STDP (Short-Term Development Program) to help employees gain a global perspective. This program is mainly offered at our Japanese headquarters but has recently been expanded to include offices in the ASCA region (Asia and South America). -Is there a system in place that encourages employees to move between departments? Many programs in the pharmaceutical industry allow people to experience different roles. We have a very active job posting program. When we have a vacancy, we encourage job posting, preferably among existing employees. It is difficult to verify the potential and capabilities of people who have specialized experience from outside the company. On the other hand, we have expectations that people with sufficient internal potential can perform well if they are given time to develop their careers, and this has proven to be true in many cases. -How are employees and executives evaluated? We perform two main types of evaluations: Performance Evaluation and Competency Evaluation. First, in performance evaluation, the basic framework is performance-based relative evaluation for sales and absolute evaluation for internal employees. However, for both sales and internal employees, we make sure that the attitude and effort in the process of performance are fully reflected, not just the arithmetic results. After setting goals, we conduct feedback interviews about four times a year. Midterm feedback is used to correct the direction and track the process of achieving goals. -I'm also curious about the company’s reward system such as incentives. There are two types of performance pay: individual performance pay and management performance pay. Individual performance pay is based on the achievement of individual or team goals. For the base salary, many multinational companies adopt the merit increase system and set the increase rate according to performance, but Daiichi Sankyo does not differentiate the base salary increase rate by performance. We set the same base salary increase for all employees, reflecting the inflation rate of the previous year, and top it up with a performance bonus based on the performance of the organization. This is because cross-functional collaboration between teams and departments is of utmost importance. -Do you have annual longevity awards in addition to incentives? There are 5-yearly awards for 10, 15, 20, and 25 years of service. No one has reached 30 years of service yet, but there will be rewards when they do. For 10 years of service, you get a 10-day sabbatical. It's a valuable reward for contributing to the growth and development of the company over a long period of time, and in fact, long-term service is not uncommon in our company compared to other foreign companies. - The slogan “Cooperation” seems to be at the core of the company's foundation. That's right. At Daiichi Sankyo, individual achievement is important, but the performance of the underlying organization is also important, and this permeates the entire company as a corporate culture. The company takes its time and encourages individuals to develop their capabilities over time. The company focuses on “steadiness” rather than chasing short-term goals. We are creating a corporate culture where each person is not engrossed in their own role but rather has a company-wide perspective, that naturally leads to cooperation and trust.
- Product
- Non-face-to-face treatment takes another hit
- by Jung, Heung-Jun Feb 12, 2025 06:13am
- Following obesity treatments such as Wegovy, the medical community is now raising voices to restrict non-face-to-face artificial tears prescriptions. Following the restriction of Wegovy prescriptions through non-face-to-face medical care, voices are rising on the need to regulate the prescription of artificial tears as well. The platform industry believes that overprescription is an issue that occurs regardless of whether the patient receives face-to-face or non-face-to-face care. The Korean Ophthalmologists Association believes that prescriptions should be managed so that they are only given to appropriate patients, regardless of the route of care. During a press conference on the 9th, the Korean Ophthalmological Association argued on the need to increase restrictions due to the increase in non-face-to-face prescriptions of artificial tears. The purpose is to establish standards for non-face-to-face treatment of artificial tears and to develop a reasonable plan for the operation of non-reimbursed medical services. Due to an increase in non-face-to-face prescription of obesity drugs such as Wegogy, non-face-to-face prescription of such drugs has been restricted since December last year. A platform official said, “I understand that it should be prescribed appropriately to those who meet the indications. However, this problem is not only seen in non-face-to-face medical care but also in face-to-face medical care. We plan to communicate further to address the concerns that the medical community has.” Pharmacists have pointed out that in non-face-to-face medical care, artificial tears are prescribed in non-ophthalmic departments, increasing the possibility of overprescription. Pharmacist A from Seoul said, “Artificial tears are often overprescribed during face-to-face medical care. Of course, we cannot know how much a patient needs when we are not face-to-face, so there is a high possibility that they will be overprescribed according to patient demand.” Pharmacist B said, “Artificial tears are also being prescribed in non-ophthalmic departments. The reality is that it is not a problem for gynecologists to treat patients with hair loss during non-face-to-face medical care.” According to the ratio of patients by disease among non-face-to-face patients announced by the Telehealth Industry Council last year, artificial tears account for 4% of the total population. However, the industry explained that the ratio may be even lower if the total non-face-to-face patients are included, as only 4% of the patients that use the platform were counted. “4% of patients using the platform have been prescribed artificial tears, and 11 million cases are all non-face-to-face patients,” said a platform official. ”If all non-face-to-face patients are included, the number of chronic diseases will increase, so the rate of artificial tear prescriptions will be lower.”
