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- 2026-06-22 01:09:01
- Opinion
- [Reporter’s View] Trodelvy makes way to reimb in KOR
- by Eo, Yun-Ho Feb 10, 2025 05:51am
- The wait was worth it. The triple-negative breast cancer (TNBC) treatment Trodelvy (sacituzumab govitecan-hziy) has passed the Drug Reimbursement Evaluation Committee review, nearly 15 months after passing the Health Insurance Review and Assessment Service’s Cancer Disease Review Committee review. The most promising aspect of the news is that the drug met the new drug requirement that was revised in August last year (the detailed evaluation criteria for negotiated drugs, including new drugs) and was the first to receive a flexible application of the incremental cost-effectiveness ratio (ICER) threshold. Of course, another antibody-drug conjugate (ADC), Enhertu (trastuzumab deruxtecan) had previously been applied as an exceptional ICER threshold. However, Trodelvy is the first drug to pass DREC review after the amendments were implemented to define the exact criteria for an innovative new drug. The fact that a drug that is so good that it costs as much for the pharmaceutical company as well has passed DREC review, suggests that the ICER threshold has increased for innovative new drugs. Although there is no documented figure, it is generally accepted that the maximum ICER threshold for insurance coverage in Korea is KRW 50 million. And even the KRW 50 million threshold has been recognized for only a rare few cases. Raising the ICER threshold has been a long-standing desire of the pharmaceutical industry. In a study published last year in the online edition of the medical journal Springer, “Survey of Unmet Needs in the New Drug Registration System,” the ICER was the number one improvement that market access managers in the industry desired. 93% of respondents had selected the response. The ICER threshold was also the most anticipated element of the government's proposed innovative drug pricing incentives, and this is the first time it has been implemented. The criteria for innovativeness are drugs that satisfy all of the following three conditions: ▲ there is no substitute or therapeutically equivalent product or treatment ▲ demonstrated clinically meaningful improvement, such as a significant extension in survival ▲ the new drug has been approved by the Ministry of Food and Drug Safety under Article 35(4)(2) of the Pharmaceutical Affairs Act (designation of priority review) and were approved through the fast-track (GIFT) or is deemed equivalent by the committee. Now that there is a more concrete definition, new drugs that meet the requirements will surely line up. Regardless of the speed, it is the reporter’s hope that more promising new drugs will be able to pass review, enabling better access for patients.
- Company
- OliX licenses out RNA-based MASH drug technology to Lilly
- by Feb 10, 2025 05:50am
- OliX, a company developing RNA-based new drugs, has transferred its metabolic dysfunction-associated steatohepatitis (MASH) and obesity drug candidate to the multinational pharmaceutical company Eli Lilly. On the 7th, OliX announced that it had signed a joint development and technology export agreement with Lilly for its MASH and obesity drug candidate 'OLX75016 (OLX702A)'. The total contract size is USD 630 million (about KRW 911.7 billion). The amount is the sum of the upfront payment and the development and commercialization milestones based on clinical progress. Details such as the proportion of the upfront payment were not disclosed. Under the agreement, OliX will continue with the Phase 1 clinical trial of OLX75016. Lilly will be responsible for other research, development, and commercialization. The agreement includes a provision that, upon signing, OliX will grant an exclusive license to Lilly. Specifically, if OliX develops a treatment that targets the 'MARC1' gene and one or more other genes involved in MASH simultaneously, Lilly will have priority rights to that treatment. The company explained that the total size of the contract could increase or exclusive negotiations could be conducted according to the clinical progress. OLX75016 is a candidate for the treatment of obesity and MASH, which is based on double-stranded small interfering RNAs (siRNA) technology. OLX702A is being developed as a subcutaneous injection formulation for the treatment of obesity that is administered once every 3 months. Results of OLX702A in obese animal model (Source: OliX) OliX is currently conducting a Phase I trial in Australia for OLX75016. It began administering the first patient for the Phase I trial in February last year. In May of the same year, it completed a change in the clinical trial protocol to add patients with nonalcoholic fatty liver disease (NAFLD) to the trial subjects to ensure safety and preliminary efficacy. The company aims to complete the first phase of clinical trials this year. OliX previously confirmed the effects of OLX702A on improving fatty liver and liver fibrosis and weight loss in preclinical studies. OliX also confirmed the weight loss synergistic effect when OLX702A in combination with Lilly's ‘Zepbound’ in a high-fat diet obesity mouse model. Zepbound is a dual agonist that simultaneously activates the glucagon-like peptide-1 (GLP-1) receptor and the Glucose-dependent insulinotropic polypeptide (GIP) receptor.
- Company
- Bayer Korea marks 70th year, preparing for 100-yr milestone
- by Whang, byung-woo Feb 10, 2025 05:50am
- Bayer Korea, celebrating its 70th year in business in the Korean market, is preparing for the next leap toward the 100th year. The company plans to enhance the capacity of treatments already launched in the market and its new growth driver pipeline, aiming for long-term and continuous business growth. Additionally, as the importance of the ESG business has been stressed, the company pursues sustainable business by setting specific directions. Bayer launched in South Korea after the Korean war…Bayer known for Aspirin Bayer Korea, the South Korean subsidiary of the global life sciences company Bayer, entered the Korean market in 1955, starting with its crop protection business. In the 1950s, during the post-Korean War period when food shortages were severe, Bayer Korea collaborated with Dongbu Farm Hannong (previously, Korean Agricultural Association) to enhance agricultural productivity. The company’s primary focus was providing various crop protection products to improve crop yields. In the 1960s, Bayer products began manufacturing in South Korea through a technology partnership with Hanil Pharmaceutical. This period marks the introduction of Bayer products into the Korean market. The representative product at the time was aspirin, a widely used pain reliever with over 120 years of history. Historical records also indicate that Bayer contraceptives were distributed to public health centers in South Korea. Bayer's full-scale business expansion took place in 1972 with the establishment of Bayer Pharmaceuticals Korea. The company acquired 30 locally produced products from Hanil Pharmaceutical, including Bayer Aspirin, extending its business into the healthcare sector. In 1989, Bayer Korea was officially established as a corporation. Entering the 2000s, the company expanded its portfolio through successive mergers and acquisitions, including Aventis CropScience, Roche's OTC division, Schering Korea, MSD Consumer Care, and Monsanto. These acquisitions solidified Bayer Korea's position as a leading global life sciences company with a broader and more advanced product lineup. Bayer As of February 2025, Bayer Korea holds a total of 62 pharmaceutical products, including prescription and over-the-counter (OTC) medications. One of Bayer Korea's key products in recent years is Eylea (aflibercept), a treatment for age-related macular degeneration (AMD). In 2023, Eylea is a blockbuster medication that generated KRW 96.8 billion in sales in South Korea. However, the company faces increasing competition from next-generation therapies and biosimilars that challenge Eylea's market dominance. Expanding sales growth remains one of Bayer Korea's concerns. Based on the company report, Bayer's sales for the past four years amounted to ▲ KRW 332.6 billion in 2020 ▲ KRW 340.1 billion in 2021 ▲KRW 358.0 billion in 2022 ▲ KRW 347.6 billion in 2023. Bayer Korea entered the Korean market in 1955 and its current corporation was established in 1989 Bayer in need of a new growth driver…prepares for a new generation of pharmaceuticals As the pharmaceutical landscape continues to evolve rapidly, Bayer has been transitioning into a more agile organization since last year to adapt to environmental changes quickly. An agile organization breaks down departmental barriers, forming multifunctional teams integrating marketing·sales·operations within the same division. This structure enables greater flexibility and responsiveness to meet the demands of a fast-changing market environment. A Bayer Korea representative said, "Bayer Korea has been focusing on strengthening the foundation for collaboration among employees to build a better future together." One of the most significant changes for Bayer Korea is the appointment of JinA Lee as the company’s first Korean CEO since its entry into the Korean market. Lee's appointment highlights the increasing importance of the Korean market and its strong R&D ecosystem, including early- and late-stage clinical trials and real-world data (RWD) studies. Bayer Korea A notable achievement under Lee's leadership is Kerendia, ranked second in outpatient prescription sales among products that received reimbursement in 2024, making a strong debut in its first year as a reimbursed drug. Additionally, high-dose Eylea (8mg), which extends dosing intervals to 20 weeks, entered the reimbursement list earlier than expected in October last year, helping Bayer maintain its influence in the retinal disease market. Also, Verquvo, a heart failure treatment, is established as part of a new generation of therapies, securing Bayer's future growth. This year, Bayer Korea plans to address unmet medical needs in the Korean market and improve patient access to innovative drugs, such as Nubeqa, which has strong market potential. A Bayer Korea representative stated, "In the healthcare sector, Bayer is committed to delivering innovative products and services through research and development that spans disease diagnosis to prevention and treatment. We are strengthening our expertise in cardiovascular, renal, and oncology treatments while expanding into new therapeutic areas with novel treatment options to ensure continuous growth." Bayer Korea aims for the next leap, focusing on 'sustainable mangagement' Bayer Korea, as it celebrates its 70th anniversary, focuses on 'sustainability' for long-term success. In addition to corporate social responsibility activities, the company is committed to sustainable organizational growth, driven by employee-led campaigns. According to Bayer Korea’s report released in December, the company is actively engaged in activities aligned with its four sustainable development goals: ▲Ending hunger ▲Healthcare ▲Climate change response ▲Gender equality and diversity. For instance, the company pursues hunger relief efforts through a partnership with World Vision, supporting underprivileged children through the "Love Lunchbox" volunteer program. This initiative has been expanded into a year-long challenge, where a team of seven employees participates monthly in preparing meal ingredients, cooking, packaging, and cleaning up. Bayer Korea Additionally, volunteer activities such as an art contest for individuals with developmental disabilities, the Unity Marathon with visually impaired participants, and the Proper Disposal of Expired Medicines Campaign were conducted last year. Lee stated, "Bayer Korea's sustainability report holds the greatest significance not in the scale of its outcomes but in our employees' voluntary and active participation. Through this initiative, we have collectively shared Bayer's vision and goals across the company, systematically organized our achievements, and laid the groundwork for developing more advanced strategies in the future." Lee added, "Bayer Korea is undergoing a transitional phase as we introduce a new generation of pipeline products. We aim to successfully establish these new treatments in the market to improve patients' lives while building a strong foundation to develop further innovative therapies."
- Company
- New TED drug 'Tepezza' under review for marketing approval
- by Eo, Yun-Ho Feb 10, 2025 05:50am
- Product photo of The commercialization of 'Tepezza,' a targeted treatment for Thyroid Eye Disease, is expected. According to industry sources, the Ministry of Food and Drug Safety (MFDS) is reviewing the approval of the Thyroid Eye Disease (TED) treatment, Tepezza (teprotumumab). This drug was designated as an orphan drug in South Korea in August 2024. Tepezza is indicated for the 'treatment of adult patients with moderate to severe TED.' Tepezza is a monoclonal antibody that is designed to target insulin-like growth factor (IGF-1) receptor. It is an antibody drug administered once every three weeks (total of eight doses). Tepezza was approved by the US Food and Drug Administration (FDA) through the fast track program in January 2020. It was approved in Japan recently. This drug was initially developed by the Irish pharmaceutical company, Horizon Therapeutics. Then, Amgen acquired Horizon Therapeutics in 2022 and secured the sales right of the drug. The patients with TED who participated in the Tepezza clinical trial received an infusion of Tepezza or a placebo every three weeks for a total of eight infusions. In the OPTIC Phase 2 clinical trial, a total of 121 patients with chronic TED who have Clinical Activity Score (CAS) of greater than 4 and duration of illness under 9 months. Among the study participants, the number of patients of age greater than 40 was 99, and the average age was 54.5 years. Female participants over 40 accounted for 72.7% and diplopia was identified as 74.7%. The number of patients aged under 40 was 22, and the average age was 32.8 years. Female participants less than 40 accounted for 59.1%, and diplopia was identified in 68.2%. Based on the results analyzing the treatment response of Tepezza in chronic TED patients, the proportion of those who showed treatment response of improvements in exophthalmos by over 2 mm following 24-weeks treatment was 86.4% for the 40s or below group and 79.8% for the 40s or higher group. There was no statistical difference between these two groups. Meanwhile, Tepezza is regarded as having changed the treatment of TED. Before the introduction of Tepezza, steroids and orbital decompression surgery were the only options for the TED treatment. While steroids may reduce inflammation, they also pose concerns regarding adverse responses and the risk of relapse if patients discontinue the treatment. Orbital decompression surgery may result in complications.
- Policy
- Pricing negotiations complete for Pfizer’s Vyndamax
- by Lee, Tak-Sun Feb 10, 2025 05:50am
- Pfizer has completed pricing negotiations with the National Health Insurance Service for its cardiomyopathy drug, Vyndamax Cap (tafamidis). As a result, the drug is soon expected to be listed for reimbursement benefits in Korea. Four and a half years after its approval in August 2020, the drug is finally being included in Korea’s health insurance system. According to industry sources on the 7th, the National Health Insurance Service and Pfizer Korea recently agreed on the insurance price of Vyndamax Cap 61 mg, for which the pricing negotiations began in December last year. The NHIS and Pfizer reportedly reached an agreement through a risk-sharing agreement. Vyndamax has gained attention as the only treatment option for ATTR amyloidosis with cardiomyopathy (ATTR-CM). ATTR-CM is a devastating disease with a median survival of 2 to 3.5 years without adequate treatment but has been poorly treated, either because it is mistaken for simple heart failure or because there are no other treatments available. In this area with a dire need, Vyndamax has demonstrated its efficacy in reducing the incidence of cardiovascular events and improving the 6-minute walk test in CM patients through the Phase 3 ATTR-ACT study. Although it is the only treatment for the disease, its approval process has not been smooth. After receiving domestic approval in 2021, the company began to pursue reimbursement in earnest but was stuck in HIRA’s evaluation phase. In April 2022, the drug failed to pass HIRA’s Drug Reimbursement Subcommittee in April 2022, and then was presented to the Drug Reimbursement Evaluation Committee (DREC) review in April 2023, the last stage of HIRA’s review, but was not deemed adequate for reimbursement. However, in October of last year, it finally passed the DREC review and has been negotiating with the NHIS since early December by the Ministry of Health and Welfare's negotiation order. By completing negotiations with the NHIS, the reimbursement listing process has now been virtually completed. The only remaining procedures are the report to the Ministry of Health and Welfare’s Health Insurance Policy Deliberation Committee (HIPDC) and notification. It is expected that the report will be presented to the HIPDC as early as this month and will be listed for reimbursement on March 1. As the only treatment for ATTR-CM, Vyndamax’s reimbursement will provide patients with much better access to treatment. As of 2021, there are 75 patients with ATTR-CM in Korea.
- Company
- Will Keytruda’s reimbursement standards be set this time?
- by Whang, byung-woo Feb 07, 2025 05:52am
- Keytruda, for which MSD had submitted reimbursement applications to extend its coverage to 17 indications, is gaining industry attention as it is expected to be presented to the Cancer Disease Deliberation Committee for the first time this year. Pic of Keytruda According to industry sources, MSD Korea's Keytruda (pembrolizumab) will be presented to the Korea Health Insurance Review and Assessment Service's Cancer Disease Deliberation Committee (CDDC) on the 12th. Keytruda received a redeliberation decision for the two indications of gastric cancer at the 9th CDDC meeting in December. There were hopes that a conclusion could be reached last October when MSD Korea submitted a new financial sharing proposal to expand coverage to 17 indications, including gastric cancer, but the year had passed with no solid results. In particular, there were various interpretations of the fact that only the 2 additional gastric cancer indications were discussed at the CDDC meeting, as the company applied for coverage of 17 indications. However, with Keytruda expected to be presented at the first CDDC meeting this year, industry eyes are on whether the tables will turn this time. Keytruda is currently approved in 33 indications for 17 different cancers and has applied for reimbursement for 17 of those indications. After applying for reimbursement for 13 indications in 2023, the company added four more indications last year: ▲ MSI-H gastric cancer, ▲MSI-H biliary tract cancer, ▲HER2-positive gastric cancer, and ▲HER2-negative gastric cancer. The issue is how CDDC will view MSD's proposed fiscal sharing plan. It is understood that the agency has asked MSD to provide additional data beyond its financial sharing plan. Given that the last review only discussed gastric cancer, it will be interesting to see how the government will regard the cost burden of applying the additional reimbursement to the 17 indications. At this point, it is unlikely that the CDDC will pass or fail review for individual indications. The CDDC had reviewed all indications at the same time, with the exception of the gastric cancer indication, which was added last December after MSD filed for Keytruda's reimbursement in bulk. This means that the decision is likely to be an all-or-nothing proposition. This has led some to speculate that MSD may take on a different strategy if Keytruda's reimbursement extension is not approved in this CDDC review. While there are advantages to applying for reimbursement extensions for many indications at once, the downside is that it is difficult to get feedback on individual indications. Considering how even if the application passes CDDC review, there are still procedures such as the Drug Reimbursement Evaluation Committee and the National Health Insurance Service’s drug pricing negotiations, MSD may well worry about the lack of progress if there is no change in its third year of application. “As it has been three years since MSD applied for the reimbursement extension, MSD would be contemplating on setting a specific strategy to overcome the current situation,” said an industry official. ”As MSD has stated that it submitted the reimbursement for multiple indications at once to not marginalize certain cancer types, I expect there will be discussions on various strategies depending on the results of the upcoming CDDC review.”
- Company
- Will the non-reimb status of 'Padcev' change this year?
- by Eo, Yun-Ho Feb 07, 2025 05:51am
- Product photo of PadcevThe industry is paying attention to the progress of reimbursing monotherapy·combination therapy of 'Padcev,' the new ADC drug for bladder cancer. Astellas Korea's Antibody-Drug Conjugates (ADC) Padcev (enfortumab) is expected to be considered for the Cancer Disease Review Committee of the Health Insurance Review and Assessment Service (HIRA) in February. At the end of last year, Astellas applied for reimbursement of Padcev for the monotherapy of adult patients with locally advanced or metastatic urothelial carcinoma who had previous experience with platinum-containing chemotherapy or PD-1 or PD-L1 inhibitors, and also applied for reimbursement of Padcev in combination with Keytruda (pembrolizumab), a PD-1 inhibitor, as a first-line treatment of advanced or metastatic urothelial carcinoma. The monotherapy passed the Cancer Disease Review Committee in February 2024 but after the economic evaluation, its reimbursement is being postponed due to disagreement between the government and the pharmaceutical company over the cost-effectiveness. Astellas plans to submit a supplement of the monotherapy while applying for reimbursement of the combination therapy. Padcev is recommended as a Category 1 preferred treatment option in the National Comprehensive Cancer Network (NCCN), and a novel treatment option for patients with urothelial cancer who have disease progression or relapsed following cancer immunotherapy and platinum-containing chemotherapy and are not eligible for previous standard-of-care treatment options. In South Korea, Padcev was approved in March 2023 as a monotherapy for patients with locally advanced or metastatic urothelial cancer who had previous experience with platinum-containing chemotherapy or PD-1 or PD-L1 inhibitors. Consequently, the industry is closely monitoring whether the status of Padcev, which remained a non-reimbursed drug for two years following its domestic approval, will change. Astellas representative stated, "Padcev combination therapy has changed the paradigm of the first-line treatment of metastatic urothelial carcinoma after 30 years and a demonstrated therapy with superior clinical benefits. We will strive to closely talk with the government and interested parties so that Korean patients with metastatic urothelial carcinoma receive benefits." The efficacy of Padcev monotherapy was demonstrated through the global EV-301 Phase 3 clinical study, which compared Padcev to existing chemotherapy in 608 patients with locally advanced or metastatic urothelial cancer who had previous experience with platinum-containing chemotherapy or PD-1 or PD-L1 inhibitors. The study results have shown that Padcev treatment lowered the death risk by approximately 30% compared to the existing chemotherapy, and the Padcev treatment group had a median overall survival (OS) of 12.9 months, significantly improving the OS compared to the 9.0 months of those treated with chemotherapy. The efficacy of Keytruda combination therapy was demonstrated through the EV-302 clinical study presented during the 2023 Congress of the European Society for Medical Oncology (ESMO Congress 2023). EV-302 is a randomized Phase 3 clinical study evaluating the effectiveness of Padcev+Keytruda combination therapy compared to platinum-based chemotherapy in 886 patients in 25 countries. Based on the study, at the median follow-up of 17.2 months, the patients had a median OS of 31.5 months, extending the OS by approximately twofold compared to the platinum-based chemotherapy group, and reduced death risk by 53%.
- Company
- CKD to distribute·sell Bayer's 'Nexavar'·'Stivarga' in KOR
- by Kim, Jin-Gu Feb 07, 2025 05:51am
- Product photo of Stivarga Chong Kun Dang Pharm announced on February 6 that it has signed an exclusive sales agreement with Bayer Korea for the advanced hepatocellular carcinoma treatments 'Nexavar (sorafenib)'·'Stivarga (regorafenib).' Based on this contract, Chong Kun Dang Pharm will be responsible for exclusive distribution·sales·marketing of Nexavar and Stivarga at hospitals and clinics, starting in February. Nexavar and Stivarga are targeted treatments for hepatocellular carcinoma. The effectiveness and safety of these drugs were demonstrated through various clinical trials. In 2018, insurance reimbursement for Stivarga was expanded, allowing it to be used as a second-line treatment for hepatocellular carcinoma in South Korea. Consequently, using Nexavar as a first-line treatment followed by Stivarga as a second-line treatment is now established as a reimbursable consecutive treatment option. Young-Joo Kim, CEO at Chong Kun Dang Pharm, said, "Chong Kun Dang Pharm has been enhancing its expertise in anticancer drugs, recently establishing a dedicated anticancer drug division." Kim added, "With a stronger portfolio that includes the exclusive distribution of Nexavar and Stivarga, we expect further to expand our presence in the domestic anticancer market." JinA Lee, CEO at Bayer Korea, said, "Based on long-established trust between both companies, we are pleased to distribute the Bayer products with Chong Kun Dang Pharm with distinguished competitiveness in the anticancer drug area." Lee added, "Based on the partnership, we hope to contribute to improving the quality of life of Korean patients with liver cancer by efficiently providing treatment options, such as Nexavar and Stivarga." Chong Kun Dang Pharm and Bayer Korea have been co-selling the antibiotics, 'Ciprobay' and 'Avelox' since 2005 and 'Kerendia,' a treatment for chronic kidney disease in adults with type 2 diabetes, since 2024. Also, they have established a successful partnership with Chong Kun Dang Pharm, which exclusively distributes Bayer Korea's 'Aspirin Protect' and 'Adalat OROS SR Tab,' which are treatments for cardiovascular diseases.
- Company
- ‘Leqvio reduces LDL-C with twice-yearly dose’
- by Son, Hyung Min Feb 07, 2025 05:51am
- While the “the lower, the better” mantra in LDL-cholesterol (LDL-C) treatment is gaining traction around the world, achieving and maintaining target levels is challenging due to the patients’ poor adherence to existing therapies. In the United States, 50% of patients who are prescribed statins stop taking them within one year, and only 5% remain on treatment after 5 years. Long-term management of LDL-C is crucial, but the burden of traditional oral medications has been leading to poor patient adherence, which is why demand has been rising for new treatment options that can address this unmet need. Dr. Michael D. Shapiro. Profesosr of Cardiology at Wake Forest University School of Medicine Michael D. Shapiro. Professor of Cardiology at Wake Forest University School of Medicine explained that the siRNA therapy Leqvio could serve as an alternative in this aspect, at a recent meeting with Dailypharm. Leqvio uses siRNAs that are naturally present in the body to reduce LDL-C in the blood by inhibiting the production of the PCSK9 protein, which raises LDL-C. SiRNAs work by binding in a sequence-specific manner to messenger ribonucleic acids (mRNAs) that make disease-causing proteins and then degrade them to block the underlying cause of the disease. Through RNA interference, siRNA causes the degradation of PCSK9 mRNA, which inhibits protein production. When PCSK9 is inhibited, increased low-density lipoprotein receptors (LDLRs) on the cell surface bind LDL-C and reduce LDL-C levels in the blood. Leqvio was approved in the U.S. in December 2021 and has been available since 2022. In Korea, it was approved last year for the treatment of heterozygous familial hypercholesterolemia (HeFH) in patients with atherosclerotic cardiovascular disease (ASCVD) or at risk of ASCVD and has been gradually being used in the field. Leqvio’s greatest strength is its ease of administration. Leqvio can be administered twice a year for effective LDL-C control, compared to daily oral medications or biweekly injections. Professor Shapiro believes that Leqvio will allow more patients to benefit from effective LDL-C reduction. High LDL-C levels are associated with increased cardiovascular risk...“Expectations rise on the use of Leqvio” Cardiovascular disease is the number one cause of death worldwide, and LDL-C management has become an important goal in ASCVD as lowering LDL-C is associated with a lower risk of cardiovascular disease. However, only 24.4% of Korean patients with ASCVD achieved their LDL-C goal, and about 78% of Korean patients with acute myocardial infarction did not achieve their LDL-C goal within 1 year after myocardial infarction. Adherence is also one of the challenges of LDL-C treatment. Patients need to take medication for the rest of their lives to treat LDL-C, but adherence is difficult to maintain. U.S. data shows that 50% of patients stop taking statins within 1 year of being prescribed them, and only 5% remain on treatment at 5 years. “There has been rising hope that siRNA therapies may address the unmet need for adherence in patients with dyslipidemia,” said Professor Shapiro. In particular, Leqvio has the potential to change the landscape of LDL-C treatment with its ability to effectively lower LDL-C and maintain lower levels for longer with twice-yearly dosing.” In three Phase III studies in patients diagnosed with primary hypercholesterolemia, mixed dyslipidemia, or at-risk or heterozygous familial hypercholesterolemia, Leqvio demonstrated LDL-C reductions of up to 52% compared to placebo. In particular, the drug demonstrated 60.5% lower LDL-C compared to placebo in the ORION-18 study in Asian patients, 24% of which were Koreans. “Leqvio may be considered for patients who are not achieving adequate LDL-C control with the maximum tolerated dose of statin,” said Professor Shapiro. “The efficacy and safety of Leqvio in clinical studies have been consistent in real-world practice. The LDL-C reduction effect has been high, around 50%.“ Twice-yearly dosing a major strength...”We need to improve patient access” Leqvio’s twice-yearly dosing regimen dramatically increases the interval between doses compared to oral statins, ezetimibe, and other injectables that require daily dosing. The next hurdle is reimbursement. Novartis, Leqvio’s developer, has reportedly begun reimbursement discussions with the government. “It's not just about lowering LDL-C, it's about maintaining lower LDL-C levels for a longer period of time,” said Professor Shapiro. As LDL-C increases, the risk of cardiovascular disease increases, so we need to improve the care setting to allow consideration of aggressive treatment early on.” However, the burden of cardiovascular disease is underestimated in general due to a lack of understanding of its risk. For example, once a patient suffers a heart attack, there is a high likelihood of heart failure, and the prognosis is much worse than cancer, yet there is a lack of awareness of the seriousness of the disease. “It is important to actively manage LDL-C with drugs as soon as possible,” said Professor Shapiro. In Korea, cardiovascular disease is the second leading cause of death, but it can change to take the lead anytime, so we want to create an environment where people can manage their disease more actively,” said Dr. Shapiro. “Patients with familial hypercholesterolemia have very high cholesterol levels from birth, and if not diagnosed and treated early, they can experience cardiovascular disease at a young age. Statin and ezetimibe therapy alone is not enough, so Leqvio’s effect in achieving and maintaining stable LDL-C reductions renders the drug a quite significant treatment option.”
- Policy
- HIRA to develop RWE guidelines for post-listing drug evals
- by Lee, Tak-Sun Feb 07, 2025 05:51am
- The Health Insurance Review and Assessment Service (HIRA) has begun developing real-world evidence (RWE) guidelines for the evaluation of drugs listed under the post-listing drug control condition, with the goal of resolving uncertainties in the reimbursement decision-making process On the 5th, HIRA announced a request for proposals for research on guidelines for generating real-world evidence (RWE) for drug performance evaluations.” “Recently listed high-priced treatments for serious diseases have high uncertainty in terms of the level of evidence, but they are listed under the condition of post-listing control to improve patient access,” said the agency. ”Real-world data (RWD) and real-world evidence (RWE), which are the main sources of drug performance evaluation for post-listing control, are at risk of bias, so it is necessary to improve the reliability of RWE generations.” Drugs listed under the post-listing control condition are those that have only short-term, single-arm, small-patient trial results or have been exempted from submitting pharmacoeconomic evaluation data. HIRA plans to conduct post-listing evaluations to resolve the uncertainty of reimbursement of such drugs. RWE data is used for this purpose, but there is an urgent need for guidelines to improve reliability. Major countries such as the United Kingdom and Canada have developed and utilized their own RWE guidelines to better accommodate their decision-making process. The study aims to ▲ review the current status of RWE utilization for drug performance evaluations make recommendations and ▲ prepare guidelines for generating real-world evidence (RWE) for drug performance evaluations. The study is expected to improve the transparency and quality of domestic RWD collection, secure patient access and safety by generating reliable RWE, and establish an evidence-based expenditure management system. For example, post-listing control using RWE is expected to reduce uncertainties in clinical utility, cost-effectiveness, and financial impact of listed drugs, while strengthening patient access and safety with RWE-based post-listing control. It is also expected that the submission of standardized data prepared according to the guidelines will improve the predictability of pharmaceutical companies and shorten the review period for drug performance evaluation upon listing. The study will be conducted for 9 months from the date of selection and signing of the contract. The total budget for the study is KRW 100 million.
