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- 2025-12-20 01:25:25
- Policy
- Samjin and Korea Pharma’s first generics are reimb in KOR
- by Lee, Tak-Sun Jul 25, 2024 05:51am
- Samjin Pharmaceutical and Korea Pharma have launched first generics in Korea. Samjin Pharmaceutical will launch the first generic of Sanofi's atrial fibrillation drug Multaq Tab, while Korea Pharma will launch the first generic of Pfizer's antidepressant Pristiq ER Tab. According to industry sources, Samjin Pharmaceutical's ‘Samjin Dron Tab as (dronedarone)’ will be listed at KRW 808 per tablet in Korea. The drug is indicated for the management of atrial fibrillation (AF) in patients in sinus rhythm with a history of paroxysmal or persistent AF to reduce the risk of hospitalization. Adults may take 1 tablet (dronedarone 400 mg) twice daily with breakfast and dinner. The original generic version of dronedarone is Sanofi's Multaq Tab. It was approved in Korea in February 2010. The product patent for Multaq expired in 2022. According to UBIST, its last year's outpatient prescriptions amounted to KRW 10.9 billion, exceeding KRW 10 billion for the first time last year. As Samjin already owns a high market share in the field of cardiovascular disease withPlatless (clopidogrel) among others, Samjin Dron Tab is expected to settle in the market in the short term. In particular, sales growth will further accelerate as there are no generic competitors in the market. Korea Pharma will launch the first generic version of Pfizer's Pristiq 100mg. Pristiq’s generics are already available in the market. In 2020, 4 domestic pharmaceutical companies entered the market with salt-modified drugs that evaded the patents. Therefore, the currently available follow-on drugs have different ingredients from the original product. Whereas Pfizer's Pristiq contains desvenlafaxine succinate monohydrate, the salt-modified drugs contain desvenlafaxine benzoate or desvenlafaxine. Korea Pharma’s ‘Pharma Desvenlafaxine ER Tab. 100mg’ is a first generic that uses the same salt as the original. Desvenlafaxine is a serotonin-norepinephrine reuptake inhibitor (SNRI), which is characterized by its low risk of drug interactions and a low risk of side effects such as hypertension and sexual dysfunction. Last year, Pristiq generated sales of KRW 7.2 billion according to IQVIA. Its sales have been declining with newer generics gradually gaining influence in the market. A representative from Korea Pharma said, "Pharma Desvenlafaxine ER Tab is a competitive product that was first approved with the same salt formulation as the original Pristiq ER Tab. We plan to quickly land and expand our market share through active sales activities." Samjin Pharmaceutical and Hankook Pharma's products received an insurance price of 59.5% of the original’s insurance ceiling price instead of 53.55% because the two companies have listed the first and only first generics. As a result, Samjin Dron Tab was listed at KRW 808 and Pharma Desvenlafaxine ER Tab at KRW 742 in Korea. Their original versions, Multaq Tab and Pristiq ER Tab are priced at KRW 1,357 and KRW 1,247, respectively.
- Policy
- Gvt commences 'Machine Learning AI Project' for new drug dev
- by Lee, Jeong-Hwan Jul 24, 2024 05:51am
- The government will actively pursue a project for faster new drug discovery. It will fund KRW 34.8 billion over 5 years, from 2024 to 2028, and conduct a project utilizing federated learning of new drug discovery data owned by pharmaceutical companies, university hospitals, research institutes, and corporations. The Ministry of Health and Welfare (MOHW) and Ministry of Science and ICT (MSIT) announced on July 23rd that 26 projects have been selected for the 'Machine Learning Ledger Orchestration for Drug Discovery (K-MELLODY)' project. The MOHW and MSIT are jointly promoting the MELLODDY project, which aims to reduce the cost and time for new drug discovery using a federated learning-based AI model that can safely protect data while exploring. Federated learning is a decentralized learning approach that enables machine learning to be trained internally on data from multiple locations, such as private and institutes, without directly sharing. Analyzed data are sent to a central server. The government has commenced this project and designated the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA) to run the project. The project group has selected 26 subprojects and research institutes for each project through a public survey and evaluation. The selected subprojects are categorized into three fields: ▲Establishing Federated Drug Discovery (FDD) platform, ▲Utilizing new drug discovery data and quality management, and ▲Developing AI solution. First, for 'Establishing Federated Drug Discovery (FDD) platform,' project has been selected to establish FDD platform to enable machine learning safely without sharing data between institutes and keeping privacy. As a supervision agency, Evident Inc. has been chosen. Also, 20 institutes have been selected as supervision agencies for AI-driven drug discovery. They will share new data from the fields of drug metabolism·toxicity testing and pharmacoepidemiology. Pharmaceutical companies, universities·hospitals, research centers, and corporations are included. Eight pharmaceutical companies have been selected, including Daewoong Pharmaceutical, Dong-wha Pharm, Samjin Pharm, Yuhan Pharm, Jeil Pharm, Hanmi Pharm, Huons, and JW Pharmaceutical. Universities·hospitals include Gachon University, Catholic University of Korea, Kyungpook National University, Seoul National University, and Seoul National University Hospital. Participating research centers·foundations include Daegu Gyeongbuk Advanced Medical Industry Promotion Foundation, KRIBB, Institut Pasteur Korea, and KRICT. Selected corporations include CIMPLRX and Apace. For 'developing AI solution,' five institutes, including GIST, Mogam Institute for Biomedical Research, AIGEN Sciences, Chonbuk National University Industrial Cooperation Foundation, and KAIST. They will develop the 'Federated ADMET Model (FAM)' to aid in drug candidate discovery, using experimental data from all stages of new drug discovery. The MOHW and MSIT will allocate KRW 34.8 billion to these selected projects over a five year period, from 2024 to 2028. They anticipate establishing an AI-driven new drug discovery infrastructure by collaborating with the government, pharmaceutical companies, research centers, and universities. "By developing machine learning with a federated learning approach that safely shares and uses data, previously challenging large-scale data analysis and use will be enabled, accelerating drug discovery," Ko Hyeongu, MOHW's Advanced Healthcare Support Officer, said. Ko said, "We will strengthen the data usage system and support AI‧Data R&D. We will also strive to lead future healthcare and pharmaceutical innovation and promote citizen's welfare." "The federated learning approach will enable the safe utilization of high-quality drug discovery data accumulated from multiple institutes to develop an AI-driven drug discovery platform and machine-learning solution," Kwon Hyeonjun, MSIT's R&D Policy Director, said. "We will support the R&D of digital bio-health businesses, which converges digital technology, and creating value so that South Korea emerges as a hub for cutting-edge biotechnology."
- Policy
- Roche’s Phesgo is applied RSA for reimb in Korea
- by Lee, Tak-Sun Jul 24, 2024 05:51am
- Korea’s insurance authorities are introducing various measures to reduce drug costs. The government is applying risk-sharing agreements to precalculation drugs and requiring submission of follow-up data for drugs that are exempt from sumitting pharmacoeconomic evaluation data. The drugs subject to the authorities’ measures are Phesgo SC Inj (pertuzumab/trastuzumab) and Ilaris Solution (canakinumab). Phesgo is a biobetter that was developed as a fixed-dose subcutaneous injection formulation of the intravenous injected Herceptin and Perjeta to improve dosing convenience and reduce treatment time for breast cancer patients. Since it is approved as an improved biologic, its insurance price was automatically set at 110% of the upper limit of its targeted products. As a result, Phesgo SC Inj 600/600mg will be listed at KRW 3,490,410, and Phesgo SC Inj 1200/600mg at KRW 5,914,418. According to IQVIA, sales of Herceptin and Perjeta in Korea amounted to KRW 56.5 billion and KRW 111.3 billion, respectively, last year. As an improved version of the two drugs, Phesgo is also expected to record high sales. However, its impact on insurance finances is also expected to be significant. This is why the insurance authorities decided to apply RSA to Phesgo and save insurance finances. The decision was influenced by the fact that Phesgo’s development target, Perjeta, is currently reimbursed through RSA. Like Perjeta, Phesgo is applied the refund-type RSA, under which the company refunds a certain percentage of the claims. "Considering that Phesgo’s target product is an RSA drug, we decided to apply RSA to Phesgo through negotiations with the National Health Insurance Service," explained the insurance authorities. “The product has improved the administration route of the target product, which is convenient for patients to administer, and we expect it to bring financial savings when it replaces the target product." Phesgo passed the Health Insurance Review and Assessment Service’s Cancer Disease Review Committee in August last year, but it took more than a year for it to be listed for reimbursement, the delay which can be explained by the cost-saving measure. Ilaris, which is being reimbursed after 9 years of approval in Korea, also has a number of safeguards in place to reduce costs. It is applied to the refund-type and expenditure cap-type RSA, and conditional follow-up is also required as a PE exemption drug. Its list price is KRW 11,029,469 Ilaris is a rare disease drug for which there are no alternatives and is being publicly reimbursed in over 3 of the A8 countries, allowing the drug to omit submission of pharmacoeconomic evaluation data. However, HIRA’s panel determined that the drug needs to be followed up in the future, including reevaluation of clinical effectiveness and cost-effectiveness, given the uncertainty of its improvement in clinical utility and high cost. Therefore, HIRA imposed a condition on the pharmaceutical company to conduct a prospective clinical study (observation period of 2 years for each patient and submission of observation data and results in 1-year increments) and submit clinical utility and cost-effectiveness data at the end of the RSA term. For example, the pharmaceutical company is required to conduct relevant prospective clinical studies, in an objective, cross-sectional survey format, with at least 2 years of observation per patient, and submit observations and results on a yearly basis. For the NOMID (neonatal onset multisystemic inflammatory disease)/CINCA (chronic infantile neurocutaneous joint syndrome) indication, the company needs to submit efficacy comparison data with existing treatments and cost-effectiveness data at the end of the RSA term. In addition, details such as plans to conduct prospective clinical studies for follow-up management and measures to be taken in case of failure to conduct such studies are required in the RSA. "In the future, drugs that are exempted from economic evaluation, but whose clinical usefulness is unclear, will be thoroughly reevaluated through follow-up management measures," explained a HIRA official.
- Policy
- Breast cancer drug Phesgo will be reimb next month
- by Lee, Tak-Sun Jul 22, 2024 05:51am
- Roche Korea’s breast cancer drug ‘Phesgo SC Inj (pertuzumab, trastuzumab),’ is expected to be reimbursed next month. The drug was approved in September 2021, and in August last year, the Health Insurance Review and Assessment Service's Cancer Disease Review Committee (CDDC) set the standards for its reimbursement, but no news on its progress has been heard of since. According to industry sources on the 19th, Roche has completed negotiations with the National Health Insurance Service on supply and quality control obligations, and Phesgo will be listed on the payroll next month after being reported to the Health Insurance Policy Review Committee. The drug is a fixed-dose subcutaneous injection formulation that combines the company’s existing breast cancer treatments, Perjecta and Herceptin. Phesgo was recognized for its innovation in improving patient convenience and reducing treatment time by changing the IV-injected Herceptin and Perjeta into a fixed-dose subcutaneous injection and was named the first biobetter approved for cancer in Korea. Considering how biobetters are more difficult to develop compared to incrementally modified drugs (chemical drugs), the government decided to set the overall price of biobetters at the 100-120% range of the original drug. Phesgo’s price is known to have been set at 110% of its target drug. Phesgo was expected to be quickly reimbursed when it passed CDDC review in August last year. As it is a data submission drug that has already an established drug price for calculation, the industry expected that it would be able to skip DREC review and NHIS pricing negotiations once its reimbursement standard is established. However, there was no news of the drug's reimbursement until 11 months after the CDDC review, when the news of the completion of the negotiations with the NHIS was announced. "Due to the drug's large potential impact on healthcare finances, it is said that the company was in a tug-of-war with HIRA over the additional conditions," said an industry insider. Based on IQVIA sales last year, Herceptin and Perjeta sold KRW 56.5 billion and KRW 111.3 billion, respectively. Phesgo is expected to dominate the market in the short term by addressing two drugs' drawbacks of being injected intravenously while reducing dosing time. According to the company, metastatic HER2-positive breast cancer patients who had received maintenance therapy with IV Herceptin and Perjeta injections every three weeks may reduce their administration and monitoring time by 90% from 270 minutes (90min+180min) to 20 minutes (5min+15min) when switching to Phesgo. In addition, the drug can reduce the risk of vascular and nerve damage caused by repeated intravenous injections. Based on these advantages, although it is expected to be used a lot upon its launch, it is also expected to cost as much as a new drug.
- Policy
- Ilaris·Latuda newly reimb…Dupixent’s reimb extended
- by Lee, Jeong-Hwan Jul 22, 2024 05:51am
- New insurance reimbursement standards will be established for Novartis Korea’s Novartis' Ilaris (canakinumab), which is used to treat hereditary recurrent fever syndrome, and Bukwang Pharmaceutical’s imported drug Latuda (lurasidone HCI), which is used to treat schizophrenia and bipolar I depression. Also, the scope of reimbursement for Sanofi's severe atopic dermatitis treatment Dupixent (dupilumab) will be extended to cover infants and children 6 months to 5 years of age. On the 19th, the Ministry of Health and Welfare made a preannouncement of an administrative notice on the 'Partial Amendment to the Details on the Standards and Methods for Applying Medical Care Benefits’ and implemented the new standards starting on August 1st. ◆Ilaris Inj=Among its indications, the drug’s indications for Cryopyrin-Associated Periodic Syndromes (CAPS), Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS), and Familial Mediterranean Fever (FMF) were deemed eligible for reimbursement. Otherwise, it is non-covered and the patient is responsible for the full cost of the drug. For CAPS, pediatric and adult patients 2 years of age and older with a confirmed NLRP3 gene mutation are eligible for reimbursement. Patients must meet both criteria for reimbursement: confirmed moderate-to-severe disease activity, and C-reactive protein (CRP) or serum amyloid A protein (SAA) >10 mg/L. In addition, the patient has to satisfy one of the following conditions: patients with Familial Cold Autoinflammatory Syndrome (FCAS)/Familial Cold Urticaria (FCU), Muckle-Wells Syndromes (MWS), who are unable to perform activities of daily living; or have a confirmed diagnosis of Neonatal-Onset Multisystem Inflammatory Disease (NOMID)/ Chronic Infantile Neurologic, Cutaneous, and Articular Syndrome (CINCA). In TRAPS, children and adults 2 years of age and older with a confirmed TNFRSF1A gene mutation will be eligible. The patient needs to meet both of the following criteria: confirmed moderate-to-severe disease activity and a C-reactive protein (CRP) or serum amyloid A protein (SAA) level of 10 mg/L or greater. IN FMF, children and adults 2 years of age and older with a confirmed MEFV gene mutation are eligible. These patients also need to satisfy all of the following three conditions for reimbursement: confirmation of moderate-to-severe disease activity; C-reactive protein (CRP) or serum amyloid A protein (SAA) of 10 mg/L or higher; and inadequate response to colchicine after 3 months of treatment, or inability to receive colchicine due to contraindications or side effects. ◆Latuda Tab= A new reimbursement standard will be set for oral lurasidone HCI 20mg. In principle, it is reimbursable when administered within the scope of its indication. When used for depression in individuals 24 years of age or younger, careful consideration should be given to whether the clinical benefit outweighs the risk, as indicated by the labeling (warnings, adverse reactions, general precautions, etc.) ◆Dupixent Inj=THe reimbursed indications for Dupilumab Prefilled Inj 300 mg will be extended. Currently available in children 6 to 11 years of age, its reimbursement will be extended to cover patients with chronic severe atopic dermatitis 6 months to 5 years of age. Patients must meet both of the following conditions for reimbursement: the condition has not been adequately controlled with first-line topical therapy (moderate-or-stronger corticosteroids or calcineurin inhibitors) for at least 4 weeks or is unable to use such due to side effects; EASI 21 or higher prior to initiation of treatment.
- Policy
- Was AZ's plan to maintain Forxiga’s drug price all along?
- by Lee, Tak-Sun Jul 19, 2024 05:47am
- With the market withdrawal for the diabetes drug ‘Forxiga Tab,' which retained its insurance price ceiling, already decided upon, AstraZeneca’s decision to withdraw its relevant lawsuit has been gaining much attention. AstraZeneca had filed a lawsuit against the ex-officio reduction in the price of Forxiga and Xigduo that was imposed on May 1 last year upon the emergence of their generics. The lawsuit enabled the company to retain Forxiga’s insurance price. On the 17th, the Ministry of Health and Welfare announced that AstraZeneca had withdrawn its lawsuit filed to cancel the reduction in the insurance ceiling price of Forxiga and Xigduo, ending the lawsuit and lifting the suspension of execution previously made on the price cut for Xigduo. As a result, the price of Xigduo XR 10/1000mg will be reduced from KRW 717 to KRW 512, and Xigduo XR 10/500mg will be reduced from KRW 717 to KRW 473. Dapagliflozin is a diabetes combination drug that contains dapagliflozin and metformin. The price of the single-agent dapagliflozin Forxiga Tab will not be reduced because Forxiga Tab has already been removed from the reimbursement list. Fosiga was removed from the reimbursement list on June 1, following the withdrawal of its domestic marketing authorization on April 25. With its removal, its final insurance ceiling price remains the same at KRW 734. AstraZeneca has made tireless efforts to retain this KRW 734 price. In April last year, when the Ministry of Health and Welfare announced an ex-officio adjustment to its price to KRW 514 due to the introduction of generics, AstraZeneca immediately filed a lawsuit to cancel and suspend the administrative disposition. As the first trial dragged on, the suspension of execution remained in effect. Eventually, the company was able to maintain its KRW 734 price until it was removed from the reimbursement list. Industry officials believe that AstraZeneca defended the price cut in order to sell Forxiga at a higher price in other countries that reference Korea’s drug prices. However, Forxiga almost underwent price cuts not just from ex-officio adjustments but due to post-marketing control measures - the Price-Volume Agreement negotiations. The National Health Insurance Service and AstraZeneca had been in PVA negotiations before June when Forxiga was removed from the reimbursement list. After the first round of negotiations broke down, the parties renegotiated until the end of May, when they decided to leave the price as is without changing the insurance ceiling price. This has led to speculation in the industry that the Ministry of Health and Welfare and AstraZeneca had some sort of agreement within. AstraZeneca would have had to make a counterpayment for the government to allow Forxiga to withdraw from the market at its original price. The news of the litigation withdrawal came a month after Forxiga’s removal from the reimbursement list was finalized. While the price cut of Xigduo was inevitable, AstraZeneca still chose to drop the lawsuit. AstraZeneca could have delayed the price reduction of Xigduo by waiting for the outcome of the first lawsuit. This has led some to speculate that AstraZeneca's withdrawal of the lawsuit was a trade-off for Forxiga’s PVA negotiations. There are also rumors that the Ministry of Health and Welfare was very dissatisfied with AstraZeneca filing the lawsuit. In any case, the withdrawal of the lawsuit reinforces the idea that AstraZeneca's original goal was to maintain the cap on Forxiga, not Xigduo. Unlike Forxiga, Xigduo will continue to be sold in the domestic market. In January, AstraZeneca Korea signed a co-marketing agreement with HK Inno.N for Xigduo. However, some distribution industry insiders have speculated that the company may be abandoning Xigduo as well because of the lack of notification on returns and settlements following the price reduction. However, it seems unlikely that the company would abruptly abandon Xigduo, given how Forxiga has been in the process of market withdrawal for half a year. Last year, Xigduo generated KRW 47.2 billion in outpatient prescriptions, according to UBIST.
- Policy
- MOHW imposes 'CSO Reporting & Training' duty to copromoters
- by Lee, Jeong-Hwan Jul 19, 2024 05:47am
- The government announced on the 18th an amendment to the Enforcement Rules of the Pharmaceutical Affairs Act that imposes the same level of local government reporting and employee training obligations on pharmaceutical companies that have signed co-promotion agreements with drug companies that have obtained the official marketing authorization. Initially, the government considered adjusting the reporting and training obligations for co-marketing pharmaceutical companies to a reasonable level in the amendment to the Enforcement Rules, but ultimately decided it would be difficult to exempt co-marketing pharmaceutical companies from the CSO reporting and education obligations in a subordinate law without changing the parent law, the Pharmaceutical Affairs Act. In order for CSOs to register their business with local governments and perform the contract pharmaceutical sales and promotion services for pharmaceutical companies, the CSO company’s representatives and employees must complete 24 hours of new training. In addition, the employees need to receive 8 hours of refresher training every year from the date of completing the initial training. The training covers order in the distribution of medicines, writing economic benefits and expenditure reports, and CSO compliance. If CSOs file false or fraudulent business reports to the local governments, they will be subject to closure, and if they fail to file a change report or file a false or fraudulent change report, they will be subject to a 3-day business suspension for the first offense, 7 days for the second offense, 15 days for the third offense, and 1 month for the fourth offense. If a CSO engages in drug sales promotion activities using employees who have not received mandatory training, the CSO will be suspended for 15 days for the first offense, 1 month for the second offense, 3 months for the third offense, and 6 months for the fourth offense. On the same day, the Ministry of Health and Welfare made a pre-announcement of legislation on the partial amendments to the Enforcement Rules of the Pharmaceutical Affairs Act and will collect opinions until the 27th. The amendment to the enforcement rules is being promoted to set detailed regulations for the revised Pharmaceutical Affairs Act, which will introduce a CSO reporting system and impose training obligations. The revised Pharmaceutical Affairs Act is scheduled to take effect on October 19th. First, a procedure for reporting new, changes, closure, suspension, and succession of CSO status has been established. CSOs are required to complete 24 hours of new training when registering with local governments to fulfill the notification criteria. Requirements for CSO training and standards for administrative penalties were also established. CSOs are required to receive 24 hours of initial training on the order of drug sales order and 8 hours of refresher training every year starting from the year following the date of initial training completion. The contents of the CSO consignment contract and notification of re-consignment were also stipulated. The amended rule specifies the contents that should be included in the CSO contract, such as the name of the consigned drug, the commission rate for each item, and the matters that require compliance of the consignee and requires written notification to the CSO supplier within 30 days of re-consigning its sales promotion business. The scope of allowable economic benefits has also been clarified. The amended regulation clarified the scope of business activities allowed by drug promoters, such as product presentations, and improved some deficiencies such as by specifying the food and beverage standards that can be provided at product presentations conducted by CSOs at individual nursing institutions. Specifically, in the product presentation category, CSOs are allowed to provide economic benefits within the scope of the law. The previous food and beverage standards at individual care organizations that allowed "food and beverages of KRW 100,000 or less per day (limited to 4 times per month)" were clarified to "food and beverages (excluding taxes and service charges) of KRW 100,000 or less per day, limited to 4 times per month. Meanwhile, from this year, CSOs will also be subject to submit and disclose economic benefit expenditure reports. Active CSOs are required to submit last year's expenditure report to the Health Insurance Review and Assessment Service by the 20th of this month. The implementation of this reporting system is expected to be an opportunity to identify the current status of CSOs in Korea.
- Policy
- MSD begins cervical cancer trials for its drug candidate
- by Lee, Hye-Kyung Jul 18, 2024 05:48am
- The phase 3 clinical trials for MSD’s new drug candidate 'MK-2870 (sacituzumab tirumotecan)' for the second-line treatment of patients with cervical cancer are being conducted in South Korea. This drug is an antibody-drug conjugate (ADC) currently being studied in multi-national clinical trials for various cancer types, including cervical cancer. On July 16th, the Ministry of Food and Drug Safety (MFDS) approved 'The Phase 3 Randomized, Active-controlled, Open-label, Multicenter Study to Compare the Efficacy and Safety of MK-2870 Monotherapy versus Treatment of Physician's Choice as Second-line Treatment for Participants with Recurrent or Metastatic Cervical Cancer (TroFuse-020/GOG-3101/ENGOT-cx20).' MK-2870 is an ADC for which MSD acquired global rights, excluding China, from Kelun-Biotech. The deal size for this acquisition was US$1.41 billion. It targets TROP-2 (tumor-associated calcium signal transducer 2), which is overexpressed in over 80% of triple-negative breast cancer patients. TROP-2 is associated with growth, transformation, regeneration, and proliferation processes. Notably, in South Korea, 11 clinical trials have been approved, including those recently approved for the treatment of cervical cancer. Phase 3 clinical trials for MK-2870 have been approved since February. The clinical trials are recruiting ▲Patients with endometrial cancer who have previously received platinum-based chemotherapy and immunotherapy ▲Patients with advanced or metastatic non-squamous NSCLC who have previously been treated and have EGFR mutations or other genomic alterations, and ▲Patients with advanced or metastatic esophageal cancer (esophageal adenocarcinoma and esophagogastric junction adenocarcinoma) in third-line or later treatment settings. Since the patent of MSD's leading product, 'Keytruda,' used in cancer immunotherapy, will expire in 2028, MSD is focusing on developing ADC treatments that can substitute for Keytruda. In South Korea, clinical trials for drugs in combination with Keytruda were approved. For instance, the following clinical trials for monotherapies or treatments in combination with Keytruda have been approved: ▲Participants with resectable stage II-IIIB (N2) NSCLC who underwent surgery after platinum-based doublet chemotherapy plus Keytruda adjuvant therapy but did not achieve pathologic complete response (pCR) ▲Participants with EGFR mutation-positive advanced non-squamous NSCLC progressing on prior EGFR tyrosine kinase inhibitor therapy ▲First-line treatment in metastatic NSCLC patients with PD-L1 TPS ≥ 50% using Keytruda combination therapy, and ▲Monotherapy or Keytruda combination therapy in participants with HR+/HER2- inoperable locally advanced or metastatic breast cancer. Meanwhile, global pharmaceutical companies have developed ADCs that have demonstrated effects in various breast cancer types, including triple-negative breast cancer and hormone-positive·HER2-negative breast cancer. ADC is a new anticancer drug that combines an antibody targeting a specific antigen on cancer cell surfaces with a cell death-inducing drug (payload) linked via a linker molecule. ADC has the advantage of increasing treatment effects while minimizing adverse reactions. The drug selectively targets cancer cells using targeted antibody selectivity and cell death-activation.
- Policy
- Ilaris, Orkedia, Latuda will likely be reimbursed next month
- by Lee, Tak-Sun Jul 17, 2024 05:50am
- Novartis The companies of the rare disease treatment ‘Ilaris Inj.,’ secondary hyperparathyroidism treatment ‘Orkedia Tab,’ and schizophrenia treatment ‘Latuda Tab’ have reached an agreement with the National Health Insurance Service on the drugs’ insurance drug prices. Accordingly, if no specific issue arises, the 3 new drugs are expected to be reimbursed from August after passing the Health Insurance Policy Review Committee this month. According to the NHIS on the 16th, it has negotiated and agreed on the insurance drug prices and expected claims amounts with the drugmakers of Ilaris, Orkedia, and Latuda. Novartis Korea's Ilaris (canakinumab) is a rare disease drug used to treat Cryopyrin-Associated Periodic Syndromes (CAPS), Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS), Hyper IgD Syndrome or Mevalonate Kinase Deficiency (HIDS/MKD), Familial Mediterranean Fever (FMF), and Systemic Juvenile Idiopathic Arthritis (SJIA). Of these, HIRA determined that its indications for CAPS, TRAPS, and FMF were eligible for reimbursement. However, the agency requested Novartis to submit supporting data afterward. Novartis did not accept the data submission condition after the first Drug Reimbursement Evaluation Committee review but accepted the condition after the second review. Novartis has since negotiated Ilaris’s insurance drug price with the NHIS and completed reimbursement preparations. Orkedia Tab (1·2mg, evocalcet) is Kyowa Kirin Korea’s secondary hyperparathyroidism treatment. .It was approved adequate for reimbursement alongside Ilaris in April .As an oral calcimimetics agent, it suppresses excessive parathyroid hormone (PTH) secretion by acting on the calcium receptors in parathyroid gland cells .Secondary hyperparathyroidism is a condition in which excessive secretion of parathyroid hormone persists due to hypocalcemia caused by decreased kidney function .If the condition continues, it can lead to complications such as bone fractures .Latuda (20·40·60·80·120mg, lurasidone HCI) is a new drug used to treat schizophrenia and Type 1 bipolar depression .It works by binding to dopamine and serotonin receptors in the central nervous system and blocking the action of brain neurotransmitters .It was developed by Japan's Sumitomo Pharma and is exclusively developed and distributed in Korea by Bukwang Pharmaceutical .In May, DREC ruled the reimbursement of Latuda adequate if the company accepts a price less than the evaluated amount, and Bukwang Pharmaceutical agreed on the condition and started pricing negotiations with the NHIS .To launch Latuda, Bukwang plans to establish a CNS business unit directly under the CEO, consisting of 25 people dedicated to sales and marketing ."We have started pre-marketing in May and plan to conduct marketing activities in all psychiatry and neurology clinics and hospitals," said a company official ."We aim to sell over KRW 30 billion in 3 years."
- Policy
- AbbVie renews RSA for leukemia drug 'Venclexta'
- by Lee, Tak-Sun Jul 17, 2024 05:50am
- Product photo of AbbVie Korea Sources said Abbvie Korea has signed a risk-sharing agreement (RSA) renewal agreement for its 'Venclexta Tab (Venetoclax).' Consequently, Venclexta Tab will be reimbursable for five years under the RSA agreement. According to sources on July 16th, AbbVie and the National Health Insurance Service (NHIS) have reached an agreement to sign RSA renewal for Venclexta. When it became reimbursement listed in April 2020, Venclexta was approved for the RSA agreement. The type was a total expenditure cap model. Venclexta can be reimbursed for use as monotherapy for the third-line treatment or more in patients with Chronic Lymphocytic Leukemia (CLL) who have relapsed or refractory to previous chemo-immunotherapy and inhibitors of B-cell receptor signaling and also for the second-line combination treatment of patients with relapsed or refractory CLL who have had previously undergone at least one or more chemotherapies. Since February last year, Venclexta can be reimbursed when used in combination with decitabine or azacytidine for the first-line treatment of adult patients over 75 years and above with newly diagnosed acute myeloid leukemia (AML) who are inadequate to receive induction chemotherapy. Due to expanded use, the price of the 10 mg product was reduced from KRW 4,299 to KRW 3,755, 50 mg product from KRW 21,492 to KRW 18,870, and 100 mg product reduced from KRW 42,984 to KRW 37,740. At that time, the company entered a negotiation for resigning RSA. The initial RSA agreement was set to end on March 31st of last year, but the company continued to negotiate by a temporary contract. Then, sources said that they had signed the final agreement this time. The RSA contracts are valid for five years. "Since Venclexta is a pharmacoeconomic evaluation exemption drug, it has a total expenditure cap. This might have been the focus of negotiations for the total expected claim amount resulting from expanded usage," an industry official said. In 2023, Venclexta's sales totaled KRW 7.5 billion, according to IQVIA data.
