- LOGIN
- MemberShip
- 2026-04-07 09:51:39
- Policy
- Ceprotin Inj passes reimbursement committee’s review
- by Lee, Tak-Sun Jun 18, 2024 05:48am
- The congenital protein C deficiency treatment ‘Ceprotin Inj’ was recognized as adequate for reimbursement by the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee (DREC). As a result, its final reimbursement will be determined through pricing negotiations with the National Health Insurance Service. The committee decided so at its 6th 2024 meeting that was held on the 13th. Takeda Pharmaceutical’s Ceprotin Inj (human protein C) is the first human protein C concentrate drug to treat congenital protein C deficiency. The drug, which was approved in Korea in 2022, treats venous thrombosis and fulminant purpura in patients with congenital protein C deficiency. Congenital protein C deficiency is a rare genetic disorder in which a lack of protein C causes a fatal defect in blood clotting control. It affects about 1 in 4 million newborns. The committee determined the drug’s reimbursement was adequate. As a result, the reimbursement listing process will now move past the DREC stage and enter the negotiation stage with the National Health Insurance Service. On the other hand, the new drug for symptomatic obstructive hypertrophic cardiomyopathy, Camzyos Cap received a redeliberation decision. As a result, the drug’s reimbursement is expected to be discussed again at the DREC meeting. Camzyos is the first treatment for symptomatic obstructive hypertrophic cardiomyopathy, and its mechanism of action dissociates myosin from actin and relaxes the over-contracted heart muscle, thereby improving the enlarged left ventricular structure and improving left ventricular outflow tract obstruction. Meanwhile, the adequacy of Zejula Cap’s reimbursement extension as a monotherapy maintenance treatment for patients with advanced ovarian cancer following first-line treatment with platinum-based chemotherapy was also determined to be adequate at the meeting.
- Company
- Eisai’s JAK inhibitor, 'Jyseleca,' has landed at hospitals
- by Eo, Yun-Ho Jun 18, 2024 05:48am
- Eisai Korea’s Eisai Korea’s 'Jyseleca,' a JAK inhibitor, is now available for prescription at general hospitals in South Korea. According to industry sources, Jyseleca, which is the fifth JAK inhibitor in South Korea, has passed the drug committee (DC) of Big 5 tertiary general hospitals, including Seoul National University, Seoul Asan Hospital, and Sinchon Severance Hospital, and national hospitals in major cities. It has expanded prescription areas after being listed for insurance reimbursement in November of last year. Jyseleca’s initial indication for reimbursement was for the treatment of rheumatoid arthritis and moderately to severely active ulcerative colitis. The reimbursement criteria are set for individuals who have had an inadequate response to conventional therapies or have no drug tolerance to each disease. For those who are over 65 years old, the criteria are set for individuals who have had an inadequate response to TNF-α inhibitors or have no drug tolerance. In July of last year, Jyseleca received conditional approval for reimbursement from the Drug Reimbursement Evaluation Committee (DREC) of the Health Insurance Review and Assessment Service (HIRA). It is indicated for the treatment of rheumatoid arthritis and ulcerative colitis. For the approval, Eisai accepted a price 90% below the actual average, exempted from the HIRA ceiling price negotiations, and quickly became reimbursable. In South Korea, JAK inhibitors, such as 'Xeljanz (tofacitinib),' 'Olumiant (baricitinib),' and 'Rinvoq (upadacitinib),' are being prescribed. It is to be watched whether Jyseleca would have a competitive advantage over these drugs. Since their launch, these drugs have been expanding indications and reimbursement criteria. Xeljanz additionally secured indications for ulcerative colitis and psoriatic arthritis, and latecomers, such as Rinvoq, are also expanding prescription areas in autoimmune diseases, including atopic dermatitis, Chron’s disease, and ankylosing spondylitis. Meanwhile, Jyseleca is a selective ATP-competitive and reversible JAK1 inhibitor. JAK1 transmits signals from a cytokine, and it is regarded as the key target for the treatment of rheumatoid arthritis. Recently launched treatments inhibit JAK2 or JAK3, depending on their mechanism. However, there are concerns that adverse reactions may occur, as two signaling pathways are involved in regulating immune cell proliferation and homeostasis. The FINCH1, FINCH2, and FINCH3 Phase 3 trials demonstrated the effectiveness of Jyseleca. In the FINCH1 trial, Jyseleca 200 mg treatment in patients with moderately to severely active rheumatoid arthritis reached ACR20 at 20 weeks more quickly despite continued treatment with MTX.
- Policy
- Fasenra·Xpovio reimb from July…Jardiance price cut
- by Lee, Tak-Sun Jun 18, 2024 05:47am
- Pic of Fasenra and Xpovio The severe asthma treatment Fasenra Prefilled Syringe 30 mg (benralizumab, AZ) and multiple myeloma treatment Xpovio Tab 20 mg (selinexor, Antengene) may be reimbursed as early as July. The companies that own the two products have completed drug pricing negotiations with the National Health Insurance Service, and are waiting for them to be reported to the Ministry of Health and Welfare’s Health Insurance Policy Review Committee. According to industry sources on the 17th, the companies reached an agreement in the latest round of drug price negotiations for Fasenra and Xpovio. Fasenra is a treatment for severe eosinophilic asthma and will be reimbursed through the Risk-sharing agreement track (Refund type, Expenditure Cap type). Although it is not an anticancer or orphan drug, it fell into the expanded scope and was applied RSA as a drug that threatens the patients’ quality of life. It is also rare for a latecomer to be reimbursed through the RSA track, as Nucala (mepolizumab, GSK) was the first drug in its class to receive reimbursement through RSA last October. Also, another drug, Cinqair (reslizumab, Teva-Handok), which also has the same mechanism of action, was reimbursed through the general track, making Fasenra’s RSA reimbursement the more rare. As a result, all 3 monoclonal antibody treatments for severe asthma will soon be reimbursed in Korea. Xpovio is a treatment for multiple myeloma developed by the Chinese pharmaceutical company Antengene. The drug is up for reimbursement 3 years after its approval in 2021. The drug was approved for two indications: ▲ for use in combination with dexamethasone for the treatment of adult patients with relapsed and/or refractory multiple myeloma who have received at least 4 prior therapies and whose disease is refractory to at least 2 proteasome inhibitors (PI), at least two immunomodulatory medicinal products (IMiD), and an anti-CD38 monoclonal antibody (mAb); and ▲ as a monotherapy for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma (rrDLBCL) who have received at least two prior lines of treatment. Of these, only the multiple myeloma indication was approved as adequate for reimbursement. Xpovio is also applied the refund type and expenditure cap type RSA. Meanwhile, the insurance price ceiling of the SGLT-2 inhibitor class diabetes treatment ‘Jardiance 10mg, 25mg (empagliflozin, Boehringer Ingelheim) will be cut through the PVA system. Jardiance’s price had also been cut last year due to its increased usage. With SGLT2 inhibitors such as Forxiga and Suglat recently withdrawing from the market, Jardiance is expected to reap reflective interest.
- Company
- Noh will retire from Amgen after 9 years since its inception
- by Eo, Yun-Ho Jun 17, 2024 05:46am
- Noh Sang-kyung, Amgen Korea general manager Noh Sang-kyung (61), general manger of Amgen Korea, who led Amgen’s Korean office since its inception is set to retire from the company. According to industry sources, Noh has recently confirmed his retirement from the company. He has served in this role for nine years since the company’s inception in South Korea in 2015. His successor has recently been appointed. Noh has been recognized for contributing to the stable establishment of Amgen in Korea and for delivering Amgen’s innovative products to Korean patients. Under Noh’s management, Amgen’s Korean office was able to list six launched products, including 'Prolia (denosumab),' 'Evenity (romosozumab),' 'Xgeva (denosumab),' 'Repatha (evolocumab),' 'BLINCYTO (blinatumomab),' and 'Kyprolis (carfilzomib),' in health insurance reimbursement listing. Meanwhile, Noh graduated from Sogang University with a degree from the Department of Life Sciences and worked at Lilly Korea, Roche Korea, and BMS. After working at Bayer Schering Pharma in 2007, he was appointed as the CEO of Bayer Schering Pharma Philippines office and the Head of Pharmaceuticals Business unit of Bayer Korea. In May 2015, Noh was appointed as the first general manager of Amgen’s affiliate.
- Policy
- Multiple myeloma drug Elrexfio receives conditional approval
- by Lee, Hye-Kyung Jun 17, 2024 05:46am
- The orphan drug ‘Elrexfio (elranatamab)' that is being imported by Pfizer Korea, has been approved subject to the submission of therapeutic confirmatory clinical trial data. Elrexfio is an orphan drug indicated as monotherapy to treat adult patients with relapsed or refractory multiple myeloma who have received three or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody Being a subcutaneously delivered B-cell maturation antigen (BCMA)-CD3-directed bispecific antibody (BsAb) immunotherapy, it owns the advantage of being able to be administered immediately compared to CAR-T cell therapy. After receiving accelerated approval from the U.S. FDA in August last year as a fifth-line therapy for multiple myeloma, the European EMA granted conditional approval in December of the same year. In Korea, the drug was approved on the 30th of last month, and according to the minutes of the Central Pharmaceutical Affairs Council meeting disclosed by the Ministry of Food and Drug Safety on the 12th, the approval was conditional, and the council requested the company to submit Phase III results after the approval. Results from the Phase II trial showed that 84% of 63 patients who received Elrexfio as a fourth-line treatment, including with the standard B-cell mature antigen therapy, maintained a response for up to 9 months. Of those who achieved a response, 72% maintained it for 15 months. By targeting B-cell maturation antigen (BCMA), which is found on multiple myeloma cancer cells, and CD3, which is found on immune T cells, Elrexfio Inj binds bispecifically to both cells, triggering an immune response that destroys multiple myeloma cancer cells. A CPAC member said, "Based on the safety, efficacy, and regulatory aspects of the submission, and considering its overseas approval status, it is reasonable to grant approval under the condition that the company submits the final results of a therapeutic confirmatory clinical trial.” Another member added, “Elrexfio monotherapy is already approved in the US and EU based on existing studies. The toxicity data reported in the literature is sufficient to support a conditional marketing authorization." Meanwhile, Elrexfio’s competitor is Janssen's ‘Tecvayli(talquetamab).’ In Korea, a Phase III trial comparing Talquetamab Plus Pomalidomide (Tal-P), Talquetamab Plus Teclistamab (Tal-Tec), and Elotuzumab, Pomalidomide, and Dexamethasone (EPd) or Pomalidomide, Bortezomib, and Dexamethasone(PVd) in Participants With Relapsed or Refractory Myeloma Who Have Received 1 to 4 Prior Lines of Therapy Including an Anti-CD38 Antibody and Lenalidomide’ was approved in November last year.
- Company
- Elafibranor receives orphan drug designation in Korea
- by Eo, Yun-Ho Jun 17, 2024 05:46am
- The biliary cholangitis drug 'elafibranor' has been designated as an orphan drug in Korea. The Ministry of Food and Drug Safety (MFDS) recently announced the designation through an announcement. Elafibranor, a dual peroxisome-activated peroxisome receptor alpha/delta (PPAR α,δ) agonist that is being developed by Ipsen, received accelerated approval from the U.S. FDA for the primary biliary cholangitis indication on Nov. 10. More specifically, the drug is indicated for the treatment of adult patients with primary biliary cholangitis who have had an inadequate response to ursodeoxycholic acid (UDCA) or who cannot tolerate UDCA monotherapy due to tolerability issues. The FDA’s accelerated approval is based on data from the Phase III ELATIVE trial, which did not demonstrate improved survival or prevention of liver function decline. Ipsen is currently conducting the ELFIDENCE trial, a confirmatory clinical trial. The results of this study will determine whether the authorities will maintain the authorization. The ELATIVE trial demonstrated that elafibranor is an effective second-line treatment for patients with PBC with favorable benefit and risk data. Meanwhile, at the European Association for the Study of the Liver (EASL) 2024 Annual Congress, 2 additional analyses from the Phase 3 ELATIVE study, which evaluated the safety and efficacy of elafibranor in 161 primary biliary cholangitis patients with inadequate response or intolerance to ursodeoxycholic acid (UDCA), were presented one after another. The presented results were from Week 72 analysis, which showed that 30 of 108 patients (28%) in the elafibranor arm and 13 of 53 patients (25%) in the placebo arm remained on treatment through Week 72. Among these patients, 70% achieved biochemical response in the elafibranor arm, whereas no patients achieved biochemical response in the placebo arm.
- Policy
- External reference pricing reevaluations are nearly ready
- by Lee, Tak-Sun Jun 17, 2024 05:46am
- The external reference pricing reevaluation system is expected to be soon launched by the Korean government. At the 9th meeting held on the 10th of this month, there were disagreements over the specific details, but no change had been made in the big picture. The health authorities are reportedly planning to finalize the discussions within this month. According to industry sources on the 14th, the health authorities are expected to hold another meeting with the pharmaceutical industry within the month and conclude the opinion-gathering process. At this pace, the reevaluations may begin as early as the second half of the year. An industry insider said, "I can't share specific details due to confidentiality, but the government seems to be firm in its intention to end the discussion within this month. A meeting will be held soon to coordinate the details, after which HIRA will start reviewing its initiation. The external reference pricing reevaluation involves adjusting the domestic insurance ceiling price of patent-expired same-ingredient drugs in comparison with the highest price in the A8 countries - Japan, France, Germany, Italy, Switzerland, the United Kingdom, and Canada. The government plans to conduct the re-evaluations by comparing the weighted average price excluding the highest and lowest prices among the A8 countries to the domestic ceiling price. The pharmaceutical industry is concerned that this method will result in large losses due to the large drug price cut rates. With the revaluations coming near, the industry has reportedly been proposing slightly more favorable options to the government. For example, in the case of combination drugs, the company requested that the total price of each single-agent drug be guaranteed even after the reevaluations. The government will divide drugs into 3 groups and reassess them every 3 years. The industry is predicting that high-costing drugs (those with a high claims amount) such as hypertension and digestive system drugs will be the first to be reevaluated.
- Policy
- CKD speeds up developing Duvie+Jardiance+metformin therapy
- by Lee, Hye-Kyung Jun 14, 2024 05:47am
- Photo of Chong Kun Dang Chong Kun Dang is conducting a clinical trial to develop a triple combination therapy, aiming to strengthen its competitiveness in the diabetes treatment market. On June 12th, the Ministry of Food and Drug Safety (MFDS) approved Chong Kun Dang’s application for a phase 1 trial for the “Evaluation of the Impact of Dietary Intake on Pharmacokinetic Profiles and Safety of CKD-383 in healthy adults.” CKD-383 is a triple combination therapy with CKD’s 'Duvie (lobeglitazone),' Boehringer Ingelheim Korea's 'Jardiance (empagliflozin),' and 'metformin,' which is used for the first-line treatment of type 2 diabetes. Chong Kun Dang has been conducting a phase 1 trial related to CKD-383 from February 2021 to develop a triple combination therapy. CKD-383 is under development with a combination of lobeglitazone 0.5 mg, empagliflozin 25 mg, and metformin 1000 mg. The company has completed a phase 1 trial, evaluating the safety and pharmacokinetic profiles of ▲CKD-501, D745, D150 combination therapy ▲CKD-501, D744, D150 combination therapy ▲CKD-501, D745, D150, D029 combination therapy, and ▲CKD-383 monotherapy and CKD-501, D745 ,D150 combination therapy in healthy adults. The ongoing phase 1 trial evaluates pharmacokinetics related to dietary intake, and its successful completion is anticipated to lead to approval. Chong Kun Dang has a line-up of 'Duvie,' the 20th Korea’s new drug, and 'Duvimet-S XR Tab,' a triple combination therapy containing lobeglitazone, metformin, and sitagliptin for the treatment of diabetes. Furthermore, the company has a completed line-up of various pharmaceuticals, including 'Duvie tab,' a lobeglitazone monotherapy, 'Duvimet XR Tab,' containing metformin plus lobeglitazone, 'Duvie S Tab,' containing sitagliptin plus lobeglitazone, and 'Exiglu M XR Tab,' containing dapagliflozin plus metformin. Since July, CKD acquired the license for 'Januvia' series from MSD Korea for exclusive marketing. According to the 'Korean Diabetes Fact Sheet (DFS 2022)' presented by the Korea Diabetes Association, the number of patients with diabetes who are over 30 years old has increased every year since 2018, recording 5,700,000 patients in 2020. Type 2 diabetes accounts for 90% of all diabetes patients. According to a medical market research firm UBIST, the market size for type 2 diabetes in Korea has seen a steady growth, with a sales of approximately KRW 1.5 trillion .
- Policy
- Yuhan’s NSCLC new drug earns approval for clinical trial
- by Lee, Hye-Kyung Jun 14, 2024 05:47am
- Yuhan Pharmaceutical receives approval to conduct a first-in-human phase ½ trial of YH42946. Yuhan Pharmaceutical has initiated the development of a new drug, 'YH42946,' a HER2 TKI, for the treatment of non-small cell lung cancer (NSCLC) in South Korea. On June 11th, the Ministry of Food and Drug Safety (MFDS) approved “A first-in-human 1/2 clinical trial to assess YH42946 treatment in patients with locally advanced or metastatic solid cancer harboring HER2 mutations and epidermal growth factor receptor (EGFR) exon 20 insertion mutations.” The clinical trial will be conducted in Severance Hospital. Yuhan Pharmaceutical has acquired new drug pipeline technology involving YH42946, which was at the preclinical stage, from J INTS BIO. Before receiving approval for a clinical trial in South Korea, the company received approval to conduct a phase ½ trial of YH42946 from the U.S. Food and Drug Administration (FDA) on May 30. YH42946 is a HER targeting TKI, and during a preclinical trial, it showed anti-tumor effects on exon 20 insertion commonly found in NSCLC and mutations in the HER 2 tyrosine kinase domain (TKD). Additionally, YH42946 has demonstrated anti-tumor effects on mutation subtypes found in major solid cancers, including breast cancer and colorectal cancer. As a result, the company is considering expanding its indication goal. NSCLC, which accounts for 85% of all lung cancer patients, is a cancer type with frequent occurrence of HER2 or EGFR mutation. Especially for NSCLC harboring HER2 exon 20 insertion mutations, there are unmet medical needs due to the lack of approved oral treatments. The upcoming study is a first-in-human phase ½ trial of YH42946. It will assess the safety, drug tolerance, pharmacokinetics, and anti-tumor activation following oral administration of YH42946 in patients with locally advanced or metastatic solid cancers harboring HER2 mutation and EGFR exon 20 insertion mutations.
- Company
- Pfizer immediately reapplies to extend reimb for Lorviqua
- by Eo, Yun-Ho Jun 14, 2024 05:47am
- Pfizer Korea has quickly reapplied for reimbursement of Lorviqua, its third-generation ALK anticancer drug whose reimbursement review process recently broke down at the drug pricing negotiation stage. According to Dailypharm’s coverage, Pfizer Korea submitted an application to expand insurance reimbursement for the ALK-positive non-small-cell lung cancer (NSCLC) treatment Lorviqua (lorlatinib) to the first-line treatment on the 12th. The drug's drug pricing negotiations with the National Health Insurance Service broke down in late May. It remains to be seen whether Lorviqua will be able to secure reimbursement in its second attempt and how quickly the discussions will move forward. In January, Pfizer submitted an application to convert the drug’s reimbursement status to general listing. At the time, its reimbursement expansion process was already underway, and given that Lorviqua has already undergone a pharmacoeconomic evaluation in the first-line setting and has completed the Health Insurance Review and Assessment Service review, the drug’s conversion to general reimbursement listing status is expected to be discussed in conjunction with the first-line reimbursement expansion Regardless of whether reimbursement is expanded or not, the pharmaceutical company’s will and the government’s flexible administration will be required to achieve a quick result. Lorviqua was specifically designed to penetrate the blood brain barrier (BBB). The drug’s high clinical value as a first-line treatment was recognized in the 5-year long-term follow-up results of the CROWN study that was presented at ASCO. Study results showed that Lorviqua reduced the risk of disease progression or death by 81% compared to crizotinib, with 60% of patients surviving without disease progression at 5 years. The risk of brain metastasis progression was reduced in 94% of patients, with only 4 of 114 Lorviqua-treated patients without brain metastases developing brain metastases. The reason the drug pricing negotiations broke down the last time is believed to be related to the ‘expenditure cap amount’ rather than 'drug price'. Lorviqua was granted pharmacoeconomic evaluation exemptions when it was first listed for reimbursement. PE exemption drugs are required to be reimbursed through the RSA Expenditure Cap type scheme. As such, a new cap amount would have been derived to account for the increased usage due to the expanded reimbursement during negotiations, which Pfizer was likely unable to accept. Press conference in front of the main gate of the National Assembly on the 13th
