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- 2025-12-21 05:15:48
- Policy
- Impurity detected in single-agent entacapones
- by Kang, Shin-Kook Apr 19, 2024 06:24am
- t has been confirmed that impurities have been detected in entacapone, a single-agent drug used to treat symptoms of Parkinson's disease. According to medical and pharmaceutical organizations on the 18th, the Ministry of Food and Drug Safety began reviewing safety measures, including setting necessary temporary permissible limits based on the submitted test and inspection results, following a company report that nitrosamine impurities (NDEA, N-nitrosodiethylamine) were detected in its entacapone-containing drugs. In other words, if there is a medical need for the drug or there is a concern about supply interruptions (shortage), the government plans to apply a temporary permissible limits for the drugs’ distributions for a certain period of time. For this, the MFDS is collecting opinions from doctors to prepare for the possibility of unstable supply and demand of entacapone-containing drugs if recall measures or suspension of production and import measures are applied due to necessity until impurities are reduced. This is a preliminary investigation into the medical necessity of entacapone, the impact on patient care in the event of a supply interruption (shortage) of entacapone single-agent drugs, the current status of substitute drugs, and the establishment of temporary permissible limits. The entacapone single tablets currently approved in Korea include Comtan Tab 200 mg, Myungin Entacapone Tab 200 mg, and Entapone Tab 200 mg.
- Policy
- Four Otezla generics were authorized simultaneously in Korea
- by Lee, Hye-Kyung Apr 19, 2024 06:24am
- Amgen Four generic versions of Amgen's oral psoriasis drug Otezla (Apremilast) have been approved simultaneously in Korea. With the resolution of Otezla’s 'use patent' issue, which had served as an obstacle to the launch of generics, domestic pharmaceutical companies that have previously succeeded in avoiding the drug’s composition patent seem to have applied for approval of their generic versions at once. On the 17th, the Ministry of Food and Drug Safety approved four apremilast-based formulations, including Dong-A ST's ‘Otelia Tab,’ Daewoong Pharmaceutical's ‘Apsola Tab,’ Dongkoo Biopharm’s ‘Otemila Tab,’ and Chong Kun Dang’s ‘Otebell Tab.’ Otezla, the original apremilast formulation of these generics, was the first oral psoriasis treatment to be approved by the MFDS in November 2017, but the company voluntarily withdrew the drug’s license in June 2022 after failing to cross the reimbursement threshold. In the process, domestic pharmaceutical companies began filing patent suits to launch their generic versions of Otezla. Otezla has 3 registered patents, including a use patent (10-0997001) and two formulation patents (10-2035362 and 10-2232154). In the case of the 2 formulation patents, 7 companies, including Daewoong Pharmaceutical, Dong-A ST, DongKoo Bio&Pharma, Huons, Chong Kun Dang, Mothers Pharm, and Cosmax, filed to confirm the passive scope of rights in May 2021 and November 2022 and succeeded in avoiding the patents. However, the companies still had to overcome the use of patents to launch their generic versions. Otezla’s use patent was set to expire on March 18, 2028. The companies must invalidate the use patent as well to launch their generic versions, and on August 24 last year, the court decided to ‘partially reject and dismiss’ the use patent’s invalidation trial. Despite withdrawing from the Korean market, Amgen appeared to be vigorously defending its patent rights, leading to criticism that it was blocking the entry of generics that were preparing to launch in Korea. And with no further news of the domestic pharmaceutical companies filing appeals to evade the use of patents since August last year, the news of the 4 generic Otezla approvals drew attention to their background. A representative from a relevant Korean pharmaceutical company said, "We have been continuously making an agreement with Amgen regarding the use of the patent. Amgen withdrew its license for Otezla in 2022 and had no intention of launching it in the future, so there was no reason to prevent generics from entering the market." "Amgen said that it didn't want to continue litigating a product that they had no intention of launching in the country. They agreed that the patent would not be a barrier to generic entry in the future, which is why we went through the process." Currently, the legal status of Otezla's use patent, (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione, and methods of synthesis and compositions thereof" is indicated as “revoked," according to Korea’s Intellectual Property Trial and Appeal Board bulletin. An industry official said, "The Otezla generics have not been jointly developed by the companies, but seem to have been approved at the same time upon the resolution of the patent issue. We plan to apply for reimbursement immediately upon approval and start drug price negotiations."
- Policy
- PVA exemptions expanded to drugs below KRW 3 billion
- by Lee, Tak-Sun Apr 18, 2024 05:54am
- Effective this year, the price-volume agreement (PVA) criteria will be expanded to provide an exemption to products with a claim amount below KRW 3 billion. This amount represents an increase from the previous criteria, which was below KRW 2 billion. Also, any product that has undergone more than two price reductions in the last five years will receive a 30% cuts. The reduction rate will be differentially applied depending on the claimed amount. Since April 15th, the National Health Insurance Service (NHIS) has been collecting opinions regarding the partial revision of the 'Detailed Matters regarding PVA negotiation’s operational guidelines.' The revised program will be implemented starting on May 1st. ◆Expansion of drugs eligible for exemption·Addition of drugs eligible for reduction =Exempted drugs from negotiations will be expanded from same-class products with an annual claim amount of less than KRW 2 billion to less than KRW 3 billion. If a product has undergone more than two price reductions in the last five years before the end of the analysis period, it will be eligible for a reduction. However, drugs that have already received a reduction rate during the two negotiations with agreements before the end of the analysis period will not be eligible for the reduction. Drugs eligible for reduction will include those developed by innovative pharmaceutical companies or companies with R&D expenses to sales as of the year preceding the end of the analysis period, with a ratio of 10% or more and recognized by NHIS. The reduction rate is set to 30%. ◆Differential reduction rate based on claimed amounts = A formula for reference price for negotiation will be differentially calculated based on the claim amount. A higher reduction rate will be applied to drugs with a larger claim amount. For example, if the claim amount of 'Drug-type Ga' during the analysis period is more than KRW 3 billion and less than KRW 5 billion, the formula will be 'Reference price for negotiation = 0.95×(Price ceiling)+(1-0.95)×{Price ceiling×(Expected claim amount/Claimed amount by same-class product during the analysis period)}'. If the claim amount is more than KRW 5 billion and less than KRW 30 billion, the formula of 'Reference price for negotiation = 0.9×(Price ceiling)+(1-0.9)×{Price ceiling×(Expected claim amount/Claimed amount by same-class product during the analysis period)}' will be applied. If the claim amount is more than KRW 30 billion, the formula of 'Reference price for negotiation = 0.85×(Price ceiling)+(1-0.85)×{Price ceiling×(Expected claim amount/Claimed amount by same-class product during the analysis period)}' will be applied. The differential formula will be used for 'Drug-type Na' and 'Drug-type Da'. If the claim amount is more than KRW 3 billion and less than KRW 5 billion, the formula of 'Reference price for negotiation = 0.9×(Price ceiling)+(1-0.9)×{Price ceiling×(Claimed amount by same-class product during the analysis period)}' will be applied. If the claim amount is more than KRW 5 billion and less than KRW 30 billion, the formula of 'Reference price for negotiation = 0.85×(Price ceiling)+(1-0.85)×{Price ceiling×(Claimed amount by same-class product during the analysis period)}' will be applied. If the claim amount is more than KRW 30 billion, the formula of 'Reference price for negotiation = 0.8×(Price ceiling)+(1-0.8)×{Price ceiling×(Claimed amount by same-class product during the analysis period)}' will be applied. ◆Expanded refund contracted drugs = Drugs eligible for a refund contract instead of a drug reduction will be expanded. Drugs with multiple indications for the initial listing will be eligible for a refund contract. A one-time refund contract is also possible. The NHIS can enter into a one-time refund contract with a company instead of adjusting the reference price for negotiation when there is a temporary increase in the volume and upon the company’s request. The new guidelines will be implemented starting on May 1st, 2024. Drugs undergoing PVA monitoring or negotiations will be applied first. Therefore, any drugs subjected to this year’s 'Drug-type Da' monitoring will be eligible for the new guidelines.
- Policy
- KRW 10 Bil antiemetic drug Akynzeo seeks reimb for injection
- by Lee, Tak-Sun Apr 18, 2024 05:54am
- Akynzeo Inj has applied for reimbursement. HK inno.N is expanding the lineup of 'Akynzeo,' a medicine used to prevent vomiting in cancer patients. In addition to the capsule formulation currently covered by health insurance, the company has applied for reimbursement to the Health Insurance Review and Assessment Service (HIRA) for Akynzeo inj. According to industry sources on the 17th, Akynzeo inj, approved in October 2022, has applied for HIRA review. Akynzeo was introduced to South Korea by HK inno.N from the Swiss pharmaceutical company Helsinn. It is used for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately and highly emetogenic cancer chemotherapy. It is a combination of netupitant and palonosetron hydrochloride, with a mechanism of action inhibiting the nerve pathway associated with causing nausea and vomiting. According to analysis, the two active ingredients have a long plasma half-life, which makes them effective antiemetics. The capsule formulation was already available in South Korea. Akynzeo cap was approved in 2018 and listed for reimbursement in December of the same year. After the listing, the sales of the drug have skyrocketed. According to IQVIA, its sales of KRW 1.8 billion in 2019 increased to KRW 4.5 billion in 2020, KRW 6.4 billion in 2021, KRW 7.3 billion in 2022, and recorded KRW 9.8 billion last year (KRW 2 billion shy of KRW 10 billion). Akynzeo cap usage was expanded after the approval of reimbursement expansion in June 2022. Before the expansion, it could be used as a combination therapy with corticosteroids in patients who fell into the high-risk group (over 90%). After the reimbursement expansion, it can now be administered to severe patient groups (30~90%) without combination with corticosteroids. Akynzeo Inj, which has applied for reimbursement, is an IV injection. It is expected to benefit cancer patients who have difficulty ingesting oral medicines. Akynzeo Inj will undergo HIRA review for reimbursement appropriateness and seek health insurance listing.
- Policy
- Will Fasenra be applied RSA for reimbursement in KOR?
- by Lee, Tak-Sun Apr 18, 2024 05:54am
- AstraZeneca has entered into drug price negotiations with the National Health Insurance Service for its ‘Fasenra Prefilled Syringe Inj (benralizumab, AZ),’ a severe eosinophilic asthma treatment that passed the Health Insurance Review and Assessment Service's Drug Reimbursement Evaluation Committee review in March. With other drugs with the same mechanism of action such as Cinqair and Nucala already listed for reimbursement in Korea, whether Fasenra will also be granted reimbursement in Korea is gaining attention. According to an industry source on the 16th, the National Health Insurance Service is in drug price negotiations with AstraZeneca for Fasenra. In particular, Fasenra’s reimbursement is receiving attention in particular for the fact that 2 other drugs with the same mechanism of action – Cinqair (reslizumab, Teva-Handok) and Nucala (mepolizumab, GSK) - have already been approved in Korea. In October last year, the 2 interleukin (IL)-5 antagonists were granted reimbursement at the same time. However, Cinqair was approved through the regular reimbursement process, and Nucala was approved through the RSA process. This was the first time a drug in the same class had been approved through two different reimbursement schemes. Fasenra is also seeking reimbursement through the RSA track, which is likely to rise as a new case. In principle, it is possible for latecomers to be listed through the RSA track, but there have been almost no cases of drugs being listed through RSA after a same-class drug was listed through the general track. Moreover, as RSA was limitedly applied to anticancer drugs and rare diseases, Fasenra is regarded as an example of its expanded application, being a treatment for severe asthma. Meanwhile, the Health Insurance Review and Assessment Service is also conducting drug pricing negotiations for ‘Idelvion Inj (CSL Behring),’ which is used to treat hemophilia B.
- Policy
- Keytruda’s reimb expansion under review by CDRC
- by Lee, Tak-Sun Apr 17, 2024 06:06am
- MDS Korea 'Keytruda (pembrolizumab, MSD),' a cancer immunotherapy drug, will be considered for review by the Cancer Disease Review Committee this afternoon to discuss its expanding reimbursement. Keytruda’s reimbursement expansion has been submitted to the Cancer Disease Review Committee three times, but it has received re-evaluation decisions each time. Attention is being drawn to whether at least some of Keytruda’s indications will set reimbursement criteria, as this round of the Cancer Disease Review Committee will discuss the measure of the pharmaceutical company’s financial contribution. According to industry sources on the 16th, Keytruda’s reimbursement expansion application will be reviewed by the 3rd Cancer Disease Review Committee in 2024, which is scheduled to be held on the 17th. In June of last year, MSD Korea submitted Keytruda’s reimbursement expansion application to the Health Insurance Review and Assessment Service (HIRA) for 13 indications with high unmet needs in medical fields in Korea. MSD's application includes 13 indications: ▲ Early-stage triple-negative breast cancer ▲ Metastatic or recurrent triple-negative breast cancer ▲ Metastatic or recurrent head and neck cancer ▲ Advanced or metastatic esophageal cancer ▲ Adjuvant therapy after renal cell carcinoma surgery ▲ Non-invasive bladder cancer ▲ Persistent, recurrent, or metastatic cervical cancer ▲ Advanced endometrial cancer ▲ Metastatic endometrial cancer with MSI-H or dMMR ▲ Metastatic rectal cancer with MSI-H or dMMR that cannot be removed with surgery ▲ Metastatic small intestine cancer with MSI-H or dMMR ▲ Metastatic ovarian cancer with MSI-H or dMMR ▲ Metastatic pancreatic cancer with MSI-H or dMMR . In October and November of last year, some indications were considered for review by the Cancer Disease Review Committee but received re-evaluation decisions. Keytruda’s six indications were considered for reimbursement expansion in the first Cancer Disease Review Committee in January 2024, but the committee decided to reconsider them. The Cancer Disease Review Committee will prioritize reviewing the medical validity and clinical necessity of multiple indications for reimbursement expansion. Pharmaceutical companies' financial contribution measures towards proven indications will be analyzed to establish reimbursement criteria. Attention is drawn to whether Keytruda’s indications will set reimbursement criteria, as this round of the Cancer Disease Review Committee will consider the Pharmaceutical companies' financial contribution measures. Keytruda is an immune checkpoint inhibitor that treats cancer by inhibiting the PD-1 protein on the surface of T cells, preventing its binding to the PD-L1 receptor, and activating the immune cells. Keytruda is currently reimbursed for seven indications, including non-small cell lung cancer as a first-line treatment, melanoma, urothelial carcinoma, and four cancer types of Hodgkin’s lymphoma. According to IQVIA, Keytruda is ranked as the top-selling drug in Korea, with sales reaching KRW 398.7 last year.
- Policy
- A Korean 4th gen NSCLC drug starts clinical trial
- by Lee, Hye-Kyung Apr 16, 2024 05:47am
- A Phase 1 clinical trial for a domestically developed 4th generation non-small cell lung cancer (NSCLC) drug has been approved in Korea. The Ministry of Food and Drug Safety approved the Phase I trial for Oncobix’s oral ALK/EGFR inhibitor 'OBX02-011' on patients with advanced NSCLC on the 12th. The trial will be conducted at the National Cancer Center and will include dose escalation and dose expansion testing in the first-in-human Phase 1 trial. According to Oncobix, epidermal growth factor receptor (EGFR) mutations are one of the leading causes of NSCLC that account for approximately 10-30% of NSCLC, which is why an urgent need remains for the development of therapies to address the situation. Epidermal growth factor receptor (EGFR) mutations are found as a cause of cancer in some patients with NSCLC. Currently, NSCLC is treated with three generations of drugs, and are used according to mutation. EGFR inhibitors used to treat EGFR mutations include first-generation drugs gefitinib and erlotinib, second-generation drugs afatinib and dacomitinib, and third-generation drug Tagrisso (Osimertinib). Oncobix’s OBX02-011 has shown promise in nonclinical trials as a potential agent that can overcome resistance, which has been a drawback in existing third-generation NSCLC therapies. The company plans to verify its anticancer effect through the Phase 1 trial. Meanwhile, Oncobix was selected as a participating company in the 'Bio-Pharmaceuticals' category of the 2021 'Industrial Innovation Technology Support Platform Construction Project' package support service organized by the Ministry of Trade, Industry, and Energy, and has received partial support for the R&D costs for conducting the clinical trial from MOTIE.
- Policy
- Merck withdraws Tepmetko’s reimb application
- by Lee, Tak-Sun Apr 16, 2024 05:47am
- #I1 Merck voluntarily withdrew its reimbursement application for its Tepmetko’s Tab (tepotinib) after failing to establish reimbursement standards at the Health Insurance Review and Assessment Service's Cancer Disease Review Committee meeting in March After two unsuccessful attempts, the industry’s eyes are on whether the company will reapply for reimbursement after reorganizing its application. According to industry sources on the 14th, Merck recently submitted a document to HIRA to voluntarily withdraw the reimbursement application it had submitted for Tepmetko’s reimbursement. Tepmetko is a treatment for locally advanced or metastatic non-small cell lung cancer with a confirmed MET exon 14 skipping mutation. The MET inhibitors Tepmetko and Tabrecta (capmatinib, Novartis) were approved in Korea in 2021. MET exon 14 skipping mutation is a rare type of cancer that is present in approximately 3-4% of patients with non-small-cell lung cancer (NSCLC). Due to the lack of suitable treatments, expectations had been high for anticancer drugs targeting the disease. However, both drugs are struggling to receive reimbursement listing in Korea. Novartis failed to establish reimbursement standards for Tabrecta at the Cancer Disease Deliberation Committee meeting in August 2022 and February 2023, and received a non-reimbursement decision at the Drug Reimbursement Evaluation Committee meeting in April 2023. The DREC cited a lack of evidence of clinical utility as the reasoning behind the non-reimbursement decision. There has been no news of the company’s reimbursement attempts for Tabrecta thereafter. Instead, the company is selling its drug without reimbursement, which passed the drug committee (DC) reviews at Big 5 tertiary hospitals, including Samsung Medical Center, Seoul National University Hospital, Seoul St. Mary's Hospital, Seoul Asan Medical Center, and Sinchon Severance Hospital. Tepmetko is in a similar situation. The drug’s application was presented to the CDDC in February 2023 and March this year but did not get the desired result. However, its non-reimbursement sales are ongoing in the Big 5 tertiary hospitals in Korea. It also offers a patient support program. Merck is supporting a portion of the drug’s cost for patients undergoing treatment with Tepmetko. After failing two attempts, the industry's eyes are on how Merck will continue on its reimbursement journey hereon. The expectations are that Tabrecta will continue to be sold without reimbursement, and that Tepmetko will also follow suit. This is because the bar for accepting clinical utility set by the CDDC is high. However, Tepmetko was recently fully approved by the U.S. FDA, Therefore, it will be interesting to see if this approval will serve as a basis for setting new reimbursement standards in Korea as well. The FDA’s full approval was reportedly based on 28-month follow-up results from the Phase II VISION study.
- Policy
- K-pharma industry added 480 new jobs in Q4 of last year
- by Lee, Hye-Kyung Apr 16, 2024 05:47am
- As of the fourth quarter of last year, 81,000 people were employed in the pharmaceutical industry, a 2.4% increase year-over-year (YoY). New jobs in the medical service area included 4,757 jobs (80.4% of the total count), including healthcare professionals, followed by 480 jobs in the pharmaceutical industry, 438 jobs in the medical devices, and 244 jobs in the cosmetics industry. The Korea Health Industry Development Institute (KHIDI, President: Cha, Soon-do) announced the analysis of employment trends in the healthcare industry for the fourth quarter of 2023. The healthcare industry employed 1,050,000 people, a 3.4% (+35,000 people) increase YoY. In Q4 2023, 480 new jobs were created in the pharmaceutical industry, down 14.6% YoY. Among the healthcare industry workers, 81,000 people worked in the pharmaceutical industry. The sector with the highest increase in the number of employees was the traditional Korean medicine manufacturing business, with a growth rate of 7.9%. After this, there was a 2.6% increase in finished product manufacturing and a 1.3% increase in both biological agent manufacturing and medicinal and antibacterial products manufacturing. Women's employment in healthcare (+3.6% YoY) grew at a higher rate than men's (+2.6%) due to increased women's economic participation across industries. The pharmaceutical industry’s growth rate of female employees (+4.2%) was relatively high. In the medical device industry and medical services sector, the increase in the number of male employees (+2.9%) was relatively higher. The 60-and-above age group had the most noticeable increase in the number of employees, with a growth rate of 9.4% compared to the previous year. This was followed by the 50s (+6.7%), 30s (+4.7%), and 40s (+3.4%), in descending order of growth rate. On the other hand, the number of employees in the youth group (aged 29 and under) decreased by 1.7% compared to the same period last year. This decline appears to be due to a decrease in the youth population and increased economic participation among older people. The proportion of employees with less than 5 years of consecutive years of service was the highest, at 71.1% (748,000 people). Compared to other industries, the healthcare service sector showed an exceptionally high percentage of employees with less than 5 years of consecutive years of service (73.4%). By occupation, the healthcare and medical professionals field had the highest number of new jobs, which totaled 2,496 jobs (42.2%). This was followed by nurses with 1,042 jobs (17.6%), manufacturing operatives with 395 jobs (6.7%), medical technicians·therapists·rehabilitation specialists with 267 jobs (4.5%), and administrative support staff with 266 jobs (4.5%). “The healthcare industry’s job growth in 2023 remains at 3% and shows an upward trend. However, the healthcare industry faces challenges this year, including uncertain foreign economic conditions and prolonged geopolitical risks,” Lee Byungkwan, KHIDI’s Biohealth Innovative Planning leader, said. “It is essential to closely monitor macro-environmental trends and changes in the healthcare industry while proactively exploring emerging markets to respond preemptively,” he added.
- Policy
- Will the COVID-19 drug Paxlovid be reimbursed in H1 2024?
- by Lee, Tak-Sun Apr 16, 2024 05:46am
- Whether the reimbursement of the COVID-19 drug Paxlovid (nirmatrelvir and ritonavir, Pfizer), which the government has been working to make part of Korea’s general healthcare system after the end of the COVID-19 pandemic, will be able to be listed within the originally planned date is gaining attention. The Korea Disease Control and Prevention Agency aimed to list the drug within the first half of this year, but in the current situation, it appears that the authorities may miss the target date. According to industry sources on the 15th, the Health Insurance Reimbursement and Assessment Service requested a supplemental response letter for Paxlovid to Pfizer. As a result, Paxlovid was not presented at the Drug Reimbursement Evaluation Committee’s April 4 meeting. At the very least, the DREC will need to recognize the adequacy of the reimbursement in May to list the drug within the first half of the year as targeted. Even if it passes the DREC in May, it will not be easy to list the drug for reimbursement in the first half of the year if the NHIS applies the 60-day negotiation period. Pfizer applied for Paxlovid’s reimbursement to HIRA in October last year. Since then, HIRA has requested Pfizer to submit a supplemental response letter 3 times. As the drug was introduced urgently due to COVID-19, the company seems to have needed some time to prepare the required clinical trial data and pharmacoeconomic evaluation data. Pfizer submitted its first supplemental response in November last year and its second supplemental response in February this year. However, HIRA has requested another supplemental response thereafter. In its 2024 Major Policy Plan Report, the KDCA stated plans to ease the COVID-19 crisis level and adjust the same level of quarantine measures and special support system for COVID-19 as influenza to fully recover to daily life. For this, the agency said it would list COVID-19 drugs in Korea’s health insurance system in the first half of this year to supply the drug through the general healthcare system. However, as the reimbursement of the COVID-19 drug Paxlovid is progressing slower than expected, it is unclear whether the KDCA will meet its targeted plan. The agency plans to stop providing COVID-19 drugs for free from the second half of the year. If the government support is discontinued and patients are required to purchase the drug without reimbursement, its cost of KRW 700,000 for a five-day supply, could bring a serious financial burden. However, if the drug passes DREC in May and the NHIS negotiates quickly in line with the government’s policy, the drug may dramatically be listed for reimbursement in June, making Paxlovid’s coverage with the national health insurance possible within the first half of the year as planned. An industry official said, "Paxlovid’s reimbursement is essential to incorporate COVID-19 into Korea’s daily healthcare system and treat high-risk patients. However, it will be difficult for insurance authorities to recognize the appropriateness of its reimbursement without complete data submission, as they need to uphold the principle of the positive list system."
