- LOGIN
- MemberShip
- 2026-04-03 19:52:00
- Company
- "Increasing role of Kisqali in breast cancer therapy"
- by Whang, byung-woo Feb 24, 2025 05:51am
- The introduction of CDK 4/6 inhibitors has changed the treatment paradigm for metastatic breast cancer, addressing previously unmet needs. The introduction of a new treatment option has been positively evaluated because the existing endocrine therapy, which is used as first-line treatment for HR+/HER2 advanced and metastatic breast cancer, accompanies specific adverse responses, such as thrombosis and musculoskeletal adverse reactions associated with estrogen deprivation. Dr. Jae Ho Jeong, Professor of the Department of Oncology at Asan Medical Center located in SeoulAs CDK4/6 inhibitors have been approved in South Korea, the impact of new treatment options is gradually expanding. During the meeting with Daily Pharm, Dr. Jae Ho Jeong, Professor of the Department of Oncology at Asan Medical Center located in Seoul, stressed the importance of strengthening new drug access to improve treatment settings for HR+/HER2- advanced∙metastatic breast cancer in South Korea. The number of breast cancer patients in South Korea has been increasing for the past five years, from 2018 to 2023. HR+/HER2- breast cancer type accounts for approximately 60-70% of all metastatic breast cancer. Currently, the five-year survival rate of patients with early breast cancer is high, at over 90%, but the survival rate of patients with metastatic breast cancer is reported to be very low. Dr. Jeong said, "Despite the high overall survival rate for breast cancer, the five-year survival rate is only 32% when diagnosed as advanced‧metastatic breast cancer." Adding, "Difficult-to-treat cases often include existing multiple metastasis from diagnosis. When patients show resistance to first-line treatment, cancer progression becomes rapid, and patients have poor prognosis." "Advanced‧metastatic breast cancer has difficult remission and can easily relapse. Thus, the treatment goal is to consider the tumor characteristics, minimize side effects, and extend the progression-free survival (PFS) and overall survival," Dr. Jeong Said. "When establishing a treatment strategy, menopause, cancer progression, internal organ metastasis, and patient's overall health status must be considered." According to Dr. Jeong, the global guidelines (NCCN, ASCO, ESMO) recommend combination therapy containing endocrine therapy and CDK4/6 inhibitor as a first-line treatment for HR+/HER2- advanced breast cancer. A therapy with CDK4/6 inhibitor is recommended first instead of a cytotoxic anticancer agent for aggressive disease type." "The introduction of CDK4/6 inhibitors changed a paradigm for HR+/HER2- breast cancer" Data on CDK4/6 inhibitors for HR+/HER2- breast cancer have been competitively presented. Kisqali (ribociclib)'s 'RIGHT Choic subgroup study' results presented at the San Antonio Breast Cancer Symposium (SAVCS 2024) have gained attention. Based on the RIGHT Choice clinical study and the subgroup study, the clinical utility of Kisqali has been confirmed for HR+/HER2- breast cancer patients with internal organ metastasis and aggressive characteristics. In the study, endocrine therapy in combination with Kisqali demonstrated improved the median progression-free survival (mPFS) in various subtypes of HR+/HER2- advanced metastatic‧breast cancer than a combination therapy with chemotherapy. Dr. Jeong mentioned regarding this, "When a disease shows aggressive characteristics, chemotherapy, rather than endocrine therapy, is typically widely used in clinical practices. Thus, the results of the RIGHT Choice study hold significant importance." "Breast cancer is not a single type of disease and includes different tumors with various clinical characteristics and show different responses to disease progression and treatments. Depending on these groups, the analysis of the RIGHT Choice study showed that long PFS in the Kisqali combination therapy group," Dr. Jeong said. Dr. Jeong believes that more studies like these will enable customized treatments, allowing patients to receive appropriate treatment. Based on three Phase 3 clinical studies, including the NALEESA-2,3,7 study, Kisqali was confirmed to have consistent improvement to overall survival regardless of menopause status, treatment number, and combined treatment in advanced‧metastasis breast cancer patients. These study results will likely yield synergy. "Kisqali demonstrated benefits in OS survival through three clinical studies, where the quality of life was maintained and improved, regardless of the existence of combined treatments, the number of treatments, menopause status, metastasis location and number," Dr. Jeong said. "The effectiveness of Kisqali was confirmed in premenopausal patients, extending the treatment paradigm." "Changes to breast cancer treatment option…time to consider patient access" In addition to the global clinical study, the efficacy result of Kisqali from the real-world setting in South Korea was presented at the 2024 ESMO ASIA. Likewise, Kisqali's effect has been demonstrated in clinical settings. Dr. Jeong explains that no significant safety-related issues have not been reported for Kisqali, other than general side effects like fatigue and rashes, when prescribed. Compared to clinical studies, these side effects are manageable. "Considering a high percentage of premenopausal patients, Kisqali offers a benefit for use regardless of the menopause status. Effects and safety of Kisqali were demonstrated in these patient groups, and it has become a new standard therapy," Dr. Jeong said. "Furthermore, Kisqali has the advantage of increasing patient adherence because it offers convenience in dosage changes and administration guidance," Dr. Jeong said. "It is possible to change the dosage with the same formulation by changing the number of tablets. Given that a system to reduce re-purchase burden when changing a dosage has been introduced, the drug is gaining a positive review in clinical settings." However, Dr. Jeong says that expanded reimbursement standard is crucial to ensure patients to benefit from these new drugs. The introduction of CDK4/6 inhibitors has robustly changed the treatment paradigm for HR+/HER2- advanced‧metastatic breast cancer treatment. Thus, it is necessary to strengthen new drug access. Dr. Jeong said, "As better treatment options are available for not only HR+/HER2- metastatic breast cancer but also other types of metastatic breast cancer, positive changes have been brought. To improve treatment settings for HR+/HER2- advanced‧ metastatic breast cancer in South Korea, expanded National Health Insurance reimbursement standard and strengthened new drug access are needed." Ultimately, Dr. Jeong said, "It is important to improve patient access to new treatment options through securing medical facilities and expanding clinical study participation." "Accumulating clinical data that reflects the characteristics of Korean patients is important for establishing a foundation that can influence global guidelines."
- Company
- Will Prevnar 20 be included in NIP in 1H 2025?
- by Whang, byung-woo Feb 24, 2025 05:51am
- Pfizer is seeking to release Pfizer’s new pneumococcal vaccine, Prevenar 20, in the first half of this year with its inclusion in the National Immunization Program (NIP) for children. Pic of Prevnar20 According to industry sources, the Korea Disease Control and Prevention Agency and Pfizer have made progress in discussions on whether Prevnar20 should be included in the NIP. Prevenar 20 is a new pneumococcal vaccine that Pfizer has introduced in 14 years, and it is a vaccine that adds 7 serotypes (serotypes 8, 10A, 11A, 12F, 15B, 22F, and 33F) to the previously supplied Prevenar13. It can be administered to infants, children, and adolescents aged 6 weeks to 18 years and adults aged 18 years or older, according to the indications set by the Ministry of Food and Drug Safety. Initially, it was widely believed that the entry of Prevenar 20 into the NIP would be delayed until next year. This is because, in January, the Public Procurement Service announced a plan to execute a tender for the purchase of goods worth approximately KRW 120.2 billion, for a total of 163 cases, including the demand of the Korea Disease Control and Prevention Agency for “13-valent pneumococcal conjugate vaccine for children (PCV13) in 2024.” With the current situation where Prevenar 13 has entered the NIP, there is no reason for the KDCA to rush to include Prevnar20 into the NIP, and with the Public Procurement Service announcing its bidding plan, the industry expected Prevnar20’s inclusion into the NIP will be further delayed. However, as discussions on the NIP for Prevenar 20 have progressed since then, it is expected that it will be included in the NIP as early as the first half of this year. In this process, the view that Pfizer has found a compromise for Prevnar20’s price with the government. Nevertheless, there are still many processes to go through, including discussions with the Korea Expert Committee on Immunization Practices. If there is an issue, the is whether the NIP for Prevenar13 will be maintained and administered simultaneously with Prevnar20, or whether it will be completely switched to Prevnar20, and whether there will be cross-inoculation with Vaxneuvance, a vaccine that entered the NIP last year. However, considering how Prevnar20 is already recommended in major guidelines overseas, there is no major hurdle to Prevnar20's entry into the NIP if there is no cost issue. The infant and child sales for Prevnar20 will be maintained by Korea Vaccine, which was previously in charge of the sales of Prevenar13. In January, Pfizer Korea and Korea Vaccine signed a new strategic partnership for Prevnar20, which will be launched in Korea, following the partnership they signed in 2013. Prevnar20 is expected to be launched in Korea as early as April. As with Vaxneuvance, it will be able to take advantage of the favorable conditions of entering the NIP as soon as it is launched, depending on the results of the NIP discussion. In this case, Prevnar20 will likely be used as a sales strategy to naturally absorb the share of Prevenar13. A Pfizer official said, “We are doing our best internally to ensure that Prevnar20 is quickly introduced into NIP. We are working closely with relevant departments to prepare the necessary procedures.”
- Company
- Primary biliary cholangitis drug Iqirvo to land in Korea
- by Eo, Yun-Ho Feb 24, 2025 05:51am
- The new drug for primary biliary cholangitis Iqirvo may soon be launched in Korea. According to industry sources, Ipssen Korea is in the process of obtaining marketing authorization from the Ministry of Food and Drug Safety for Iqirvo (elafibranor), a dual peroxisome proliferator-activated receptor (PPAR) alpha/delta (PPAR α, δ) agonist. The drug was also designated as a rare drug in Korea in June last year. Iqirvo obtained accelerated approval from the US FDA in June last year for the indication of primary biliary cholangitis. Specifically, the drug is indicated for the treatment of adult patients with primary biliary cholangitis (PBC) who have shown an insufficient response to ursodeoxycholic acid (UDCA) or who cannot use UDCA monotherapy due to tolerability issues. The FDA's accelerated approval was based on the Phase III ELATIVE study's alkaline phosphatase (ALP) reduction data, and it has not been proven to improve survival or prevent liver function deterioration. Ipssen is currently conducting the confirmatory clinical trial, ELFIDENCE. The results of this trial will determine whether the drug’s approval will stand further. In the study, elafibranor demonstrated that it is an effective second-line treatment for PBC that has favorable benefit and risk data. Meanwhile, at last year's European Association for the Study of the Liver Annual Meeting (EASL 2024), two additional analyses of the Phase III ELATIVE clinical trial, which is evaluating the safety and efficacy of elafibranor in 161 patients with primary biliary cholangitis who do not respond adequately to ursodeoxycholic acid (UDCA) or are intolerant of it, were released in one after another. Additionally, the results of the open-label study were analyzed at week 72, and 30 of the 108 patients (28%) were assigned to the elafibranor group and 13 of the 53 patients (25%) were assigned to the placebo group maintained treatment through week 72.
- Company
- Pricing negotiations for Vocabria+Rekambys combo complete
- by Eo, Yun-Ho Feb 24, 2025 05:51am
- The long-acting HIV drug Vocabria+Rekambys combination therapy is on the verge of being reimbursed in Korea, 2 years after its approval. According to industry sources, GSK Korea recently concluded drug price negotiations with the National Health Insurance Service for the combination therapy of the new HIV drugs Vocabria (cabotegravir) and Rekambys (rilpivirine). Rekambys is Janssen Korea’s product, and GSK was responsible for its reimbursement process. Accordingly, the combination therapy of the 2 drugs is expected to be reimbursed soon if it passes the Health Insurance Policy Deliberation Committee review. The two drugs were approved by the Ministry of Food and Drug Safety in February 2022 as a combination therapy for the treatment of HIV-1 infection in adult patients who are virologically suppressed, have no history of virological failure, and have no known or suspected resistance to cabotegravir or rilpivirine. The advantage of this combination therapy is undoubtedly its convenience in administration. While existing HIV treatments require patients to take a tablet formulation once a day, the two injectable drugs will reduce the frequency of administration to once a month or once every two months with intramuscular injections, increasing satisfaction and reducing the burden on patients. The 2 drugs were originally developed as oral medications and then were developed into injectable drugs. While this long-acting injectable drug cannot cure HIV infection, it is a treatment that targets white blood cells to help lower and maintain the level of the AIDS virus. Meanwhile, the efficacy and safety of the Vocabria+Rekambys combination therapy was demonstrated in clinical trials in groups that received the drug once every four weeks or once every eight weeks. The combination was approved in Europe in December 2020. In the clinical trial, the most frequently observed adverse reactions in the group that received the Vocabria+Rekambys combination were injection site reactions, headache, fever, nausea, fatigue, asthenia, and myalgia. In addition, the indication for combination therapy has been expanded to include adolescent patients in Europe.
- Policy
- PMS of Rekovelle shows ovarian hyperstimulation
- by Lee, Hye-Kyung Feb 21, 2025 05:56am
- The reevaluation of Ferring Korea’s fertility drug ‘Rekovelle Prefilled Pen (follitropin delta)’ revealed that 0.65% of patients experienced ovarian hyperstimulation syndrome, which is expected to be added as an adverse event. The Ministry of Food and Drug Safety announced on the 20th the proposed changes to the licensed conditions following the re-examination of new drugs. A post-marketing surveillance was conducted on 611 patients over 4 years for the re-examination of Rekovelle in Korea. As a result, the incidence of adverse events reported was 17.84% (109/611, 137 cases in total), regardless of causality. Among them, ovarian hyperstimulation syndrome occurred in 4 (0.65%) of 611 patients with serious adverse drug reactions whose casualties cannot be ruled out. Unexpected adverse drug reactions were reported in 9 out of 611 patients (1.47%), including ovarian cysts, pelvic fluid accumulation, vulvar itching, acne, hair loss, cold sweats, pain at the injection site, erythema at the injection site, and palpitations. The Ministry of Food and Drug Safety will give advance notice by the 27th to add more cases of adverse reactions to the post-marketing surveillance and plans to change the label on the 28th. If there are disagreements during the opinion survey, the scheduled date for the label change order may be postponed. Since its domestic approval on December 27, 2019, Rekovelle has been prescribed at domestic infertility hospitals. Rekovelle increases the possibility of collecting the optimal number of eggs, 8 to 14, regardless of AMH levels, with a dosage that is delicately adjusted according to the patient's condition. At the time of its initial approval, the drug was only eligible for reimbursement as monotherapy, but From May 2022, controlled ovarian stimulation to mature multiple oocytes in women undergoing assisted reproductive technology such as IVF (in vitro fertilization) or ICSI (intracytoplasmic sperm injection) in combination with human menopausal gonadotropin (hMG) therapy was also covered by the National Health Insurance. The expansion of the health insurance reimbursement to the combination of Rekovelle and hMG has provided even patients with low pregnancy success rates due to age or ovarian dysfunction with an option that meets the goal of being the optimal treatment. Rekovelle’s reimbursement standard was extended based on the MARCS study, a multicenter, open-label, single-cohort clinical trial that evaluated the efficacy and safety profile of Rekovelle and hMG combination in 110 infertile patients who underwent in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI).
- Policy
- Ocrevus, DM Duo reimbursed from March
- by Lee, Jeong-Hwan Feb 21, 2025 05:56am
- Roche's new multiple sclerosis drug Ocrevus (ocrelizumab) and Hyundai Pharm’s first dementia combination drug DM Duo (donepezil + memantine) will be reimbursed by Korea’s national health insurance starting next month. Amgen's osteoporosis drug Prolia will see some changes to its reimbursement standard as Celltrion's biosimilar Stoboclo is soon to be listed on the National Health Insurance reimbursement list. The Ministry of Health and Welfare announced on the 20th that it has issued a pre-announcement of administration regarding the details of the application criteria and methods for the reimbursement of pharmaceuticals. The new multiple sclerosis drug, Ocrevus (ocrelizumab), will be reimbursed from March 1. Reimbursement for the drug is granted for patients with relapsing-remitting multiple sclerosis (RRMS) who meet the McDonald ('17) diagnostic criteria and can exclude the occurrence of other similar diseases who have failed or are intolerant of first-line treatment (Interferon β-1b, etc.) and is ambulatory (able to walk). In patients with secondary progressive multiple sclerosis (SPMS), treatment should be discontinued when the EDSS score evaluated every six months from the first dose is 7.0 or higher. The treatment method is monotherapy. Hyundai Pharm’s DM Duo (donepezil + memantine), the first dementia combination drug in Korea, will also be reimbursed in March. Patients with moderate to severe dementia of the Alzheimer's type who meet the criteria for both the Mini-Mental State Examination (MMSE) score of 20 or less and the Dementia Scale Examination are eligible for reimbursement. Re-evaluation is conducted every 6 to 12 months to determine whether to continue administration, and continued administration is granted even if the MMSE score exceeds 20 during re-evaluations. However, when concurrently using DM Duo, Tanamin Tab, and Ginexin F Tab, the patient must pay the full cost of one of the drugs with the lowest cost of treatment within the scope of the drugs’ indications. Prolia’s reimbursement standard will change as the Celltrion biosimilar Stoboclo Prefilled Syringe’s imminent reimbursement listing. The standard change is to apply the same standards for the denosumab injection and add 'etc.' to the name of the product category in the notice.
- Company
- Asthma drug Tezspire ready for launch
- by Whang, byung-woo Feb 21, 2025 05:56am
- Tezspire (tezepelumab), an anti-TSLP therapy for the treatment of severe asthma, is entering the market with its effectiveness regardless of biomarker status. Although the drug still faces reimbursement hurdle, clinical practices have high hopes. They expect that Tezspire's versatility can change the current treatment paradigm in which drugs are preferentially prescribed to patients with severe asthma. During a February 18 press conference hosted by AstraZeneca Korea to celebrate the launch of Tezspire, Dr. Heung-Woo Park, Professor of the Institute of Allergy and Clinical Immunology at Seoul National University Hospital, anticipated that unmet needs for asthma treatment would be resolved. Tezspire is the first and only drug to treat severe asthma by inhibiting 'thymic stromal lymphopoietin (TSLP).' By inhibiting TSLP, which is one of the factors associated with the pathology of asthma, the drug shows effectiveness in modulating symptoms in a wide range of patients with severe asthma regardless of asthma subtype. Dr. Heung-Woo Park, Professor of the Institute of Allergy and Clinical Immunology at Seoul National University HospitalIn December 2023, Tezspire was approved by the Ministry of Food and Drug Safety (MFDS) as an "Add-on maintenance treatment in adults and adolescents 12 years and older with severe asthma not adequately controlled by previous treatments." AstraZeneca plans to launch Tezspire in the first half of the year. The industry closely watches Tezspire for overcoming biomarker limitations and expanding treatment opportunities for patients with severe asthma. One of the difficulties in diagnosing asthma and its treatments is the wide range of manifestations of the disease. An accurate diagnosis is difficult because a clear biomarker for each asthma subtype is lacking. In other words, this causes a significant challenge in establishing a customized treatment strategy. Treatment options for non-Type-2 inflammation are still limited. Dr. Park said, "The introduction of biological agents improved the prognosis of patients with severe asthma, but unmet needs are yet to be addressed." Adding, "Severe asthma is a disease that causes not only decreased individual patient's quality of life but a societal burden. We are desperately in need of more effective treatment alternatives." The industry analysis suggests that Tezspire's unique mechanism of inhibiting TSLP, which drives asthma inflammatory cascade responses, will likely give distinction. Based on Phase 2 PATHWAY study and Phase 3 NAVIGATOR study, Tezspire was effective in demonstrating clinically significant improvement in asthma exacerbation rate regardless of asthma subtypes or biomarker status. Dr. Hwa Young Lee, Professor of Seoul St. Mary's Hospital, said, "This drug has brought a paradigm shift to the treatment of a wide range of patients with severe asthma since it can be used regardless of biomarker status, such as treating patients with low blood eosinophil or fractional exhaled nitric oxide (FeNO). Dr. Lee said, "It has shown effectiveness in reducing asthma exacerbation regardless of weather or accompanying diseases. Therefore, it is expected to expand treatment opportunities for patients with severe asthma significantly." Tezspire targets the standard therapy of severe asthma…"We will consider priority treatment" However, the indication of Tezspire is limited to cases where patients are not responding to previous treatments. It also has a limitation of not reimbursement by the National Health Insurance. Dr. Hwa Young Lee, Professor of Seoul St. Mary HospitalTezspire can be used regardless of type-2 inflammation and non-type-2 inflammation. It was expected that the use of the drug in clinical practices will gradually increase for patients with severe asthma whose biomarker status is difficult to identify. Dr. Park stated, "The drug can be expanded for use in both type-2 inflammation and non-type-2 inflammation. Clinicians may choose to use a treatment effective for a wider range of conditions first, and then select a treatment with a narrower range." Dr. Lee also emphasized that "For pneumonia treatment, doctors may use broader-spectrum antibiotics when identifying bacteria is difficult. In severe asthma, Tezspire can be effectively used if diagnosing type-2 inflammation proves difficult." However, due to limitations in reimbursement, only 10-20% of severe asthma patients are likely to receive the treatment readily. Ultimately, it will be up to the company to make efforts to obtain reimbursement. Regarding this, Ji-Young Kim, executive director of AstraZeneca Korea's Respiratory·Inflammatory Division, stated, "We acknowledge that severe asthma poses an economic burden." Kim added, "We are carefully considering patient support programs to reduce patient's economic burden."
- Policy
- 'JAK inh-biological agent' switching will be reimb in March
- by Lee, Jeong-Hwan Feb 21, 2025 05:56am
- The National Health Insurance reimbursement standard for severe atopic dermatitis treatments will be extended starting March 1. The key change is reimbursement coverage for switching between JAK inhibitor and biological agent. The Ministry of Health and Welfare (MOHW) announced on February 20 that it gave administrative notice of 'Partial revision to the pharmaceutical long-term care reimbursement.' In South Korea, the atopic dermatitis treatments that gained marketing authorization include JAK inhibitors such as AbbVie's Rinvoq (upadacitinib), Lilly's Olumiant (baricitinib), Pfizer's Cibinqo (abrocitinib), as well as biological agents such as Sanofi's Dupixent (dupilumab), and LEO Pharma's Adtralza (tralokinumab). According to this administrative notice, the MOHW improved the standard so that reimbursement coverage is provided for switching to JAK inhibitor if atopic diseases are not adequately responded to or a patient lacks tolerability to initial treatment with a biological agent. If a patient does not respond to a JAK inhibitor or no longer continues treatment due to side effects (recommended to stay on the switched drug for at least 6 months), one can switch to a biological agent. In this case, doctors must file a doctor's note. However, reimbursement has not been approved for switching between JAK inhibitors. Switching to a JAK inhibitor is possible if treatment with a biological agent is not effective or a patient cannot continue treatment due to side effects. Yet, Dupixent and Adtralza switching treatment has not been approved for reimbursement. Meanwhile, previously, JAK inhibitors were excluded from the list of allowed drugs for switching because approval is specified for 'patients over 65 years and older whose initial treatment has failed.' Once the switching is approved, this patient group can receive treatment.
- Will the dyslipidemia drug Leqvio be reimbursed for ASCVD?
- by Eo, Yun-Ho Feb 21, 2025 05:56am
- The industry’s attention is focused on whether progress will be made in the discussion of insurance reimbursement coverage for the new dyslipidemia drug Leqvio. Novartis' siRNA drug Leqvio (inclisiran) applied for a new drug reimbursement listing at the same time as it obtained approval from the Ministry of Food and Drug Safety in June last year, but there are significant differences of opinion on the scope of its reimbursement standard set during the review process. Dailypharm coverage found that Leqvio’s reimbursement agenda will be submitted to the Drug Reimbursement Subcommittee today (21st). The core of the discussion on the reimbursement criteria for Leqvio is whether it will be recognized for the reduction of cardiovascular events in patients with atherosclerotic cardiovascular disease (ASCVD), which has not yet been officially approved. Leqvio is only currently indicated for the treatment of the rare condition, familial hypercholesterolemia. The PCSK9 inhibitor 'Repatha (evolocumab)', which can be considered Leqvio’s competitor, was also approved for reimbursement only for familial hypercholesterolemia at the time of its initial listing, but its reimbursement criteria were expanded thereafter. Since the government has already granted reimbursement for its competitor that has the same therapeutic position, it is possible that the government has decided that it would not be a problem to delay the reimbursement of Leqvio for the same indication as much as possible. Currently, Repatha is already reimbursed in 41 countries, including major countries, and Leqvio is already reimbursed in 39 countries. However, it is worth considering whether Leqvio’s convenience in administration, being administered twice a year by medical staff directly at the hospital, has not been taken into account. Not only is the number of doses reduced, but the advantage is that the injection is administered by medical staff at the hospital rather than by the patient. 78.4% of the target patient population, including patients with atherosclerotic cardiovascular disease (ASCVD) who have been administered Leqvio for up to 6.8 years or more, have reached the target LDL-C level. In a real-world study in the United States, the group with high medication adherence (fully adherent) among patients with ASCVD, including myocardial infarction, had a 27% lower risk of major adverse cardiovascular events (MACE) compared to the low-adherence group. In addition, it was found that patients with ASCVD who were highly compliant with their medication had lower annual medical costs than those with low compliance, which reduced the risk of recurrent cardiovascular disease and the economic burden of ASCVD patients. In other words, the convenience of taking the drug provided by Leqvio has clear therapeutic benefits. If Leqvio’s reimbursement standard for ASCVD is not approved this time, the company will have to wait for the results of the CVOT (Cardiovascular Outcome Trial) and wait for official approval, which would take several years. The market for statins and ezetimibe combination drugs alone is worth KRW 1 trillion, and if we add the funds spent on statins and PCSK9 inhibitors, the funds spent on lowering LDL-C alone are estimated to be between KRW 1.5 trillion to KRW 2 trillion. However, the LDL-C target achievement rate for ASCVD patients in Korea is only 24%. “In the case of high-risk patients, medication adherence is especially important for lipid-lowering treatment. In reality, medication adherence to current treatment options is low, and only 3 out of 10 patients still achieve the target LDL-C level. This is proof that new treatment options are urgently needed for lipid-lowering therapy,” said Jon Suh, Secretary of the Insurance Committee of the Korean Society of Cardiology and a member of the Insurance Committee of the Korean Society of Cardiology. He added, “If patients are not benefiting from the coverage of the treatment benefits of Leqvio, which can be used to manage LDL-C and prevent or delay the occurrence of cardiovascular events, this could lead to national losses due to an increase in cardiovascular disease mortality in the long term.”
- Policy
- Pfizer 'Vyndamax' reimbursed from March…KRW 100,000/cap
- by Lee, Tak-Sun Feb 21, 2025 05:56am
- Product photo of Vyndamax About 20% of the non-reimbursed price…significantly reduces patient with a special exemption of calculation provisions The completion of negotiations with the National Health Insurance Service (NHIS) has been reported, so the reimbursement listing was a matter of time. The ceiling price is reported to be KRW 100,000 per capsule. According to industry sources on February 19, Vyndamax Cap was the only treatment for ATTR amyloidosis with cardiomyopathy (ATTR-CM). As Vyndamax Cap becomes added to the reimbursement list in March, the ceiling price is reported to be set as KRW 100,000. The survival time for ATTR-CM is 2 to 3.5 years when it is not adequately treated. It is a disease mistaken for simply heart failure, but the treatment outcome is poor due to the unavailability of treatment. The efficacy of Vyndamax was demonstrated through the Phase 3 ATTR-ACT study, which showed Vyndamax reduced cardiovascular-related events and improved the 6-minute walking test in CM patients. However, after domestic approval in 2020, it faced difficulty in listing reimbursement. In April 2022, the drug was considered for the Health Insurance Review and Assessment Service (HIRA)'s Drug Reimbursement Evaluation Committee (DREC), but reimbursement appropriateness was not approved. Ultimately, high drug price was the problem. Vyndamax costs US$ 225,000 (approximately KRW 300 million) annually, and in South Korea, non-reimbursed treatment is reported to cost KRW 150 million (KRW 410,000 per capsule) annually. If the ceiling price is KRW 100,000 per capsule, it costs 20% less than when it was non-reimbursed. Patients only pay a co-payment of 10% with a special exemption of calculation provisions, so the economic burden is expected to be less. If the company has reached a risk-sharing agreement (RSA), drug cost is expected to decrease even more. The number of ATTR-CM patients in South Korea is reported to be 75 as of 2021.
