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- 2026-03-11 21:57:56
- Policy
- Chinese immunotherapy tislelizumab to soon arrive in KOR
- by Lee, Hye-Kyung Nov 15, 2023 05:39am
- A PD-1 cancer immunotherapy developed in China is soon expected to receive marketing approval in Korea. According to industry sources on the 14th, the Ministry of Food and Drug Safety has completed the drug safety and efficacy review for BeiGene Korea’s ‘Tevimbra 100mg (tislelizumab).’ If no issues were found during the safety and efficacy review, the authorities can immediately grant marketing authorization for the drug. If approved, the Chinese immunotherapy drug will be competing with MSD’s ‘Keytruda (pembrolizumab),’ and BMS’s ‘Opdivo (nivolumab).’ BeiGene Korea has been conducting Phase II and III trials in Korea since 2020. The company completed a Phase III clinical trial on patients with locally advanced unresectable NSCLC whose disease had not progressed after concomitant chemotherapy who were selected based on the PD-L1 expression status, to compare the ‘ociperlimab ((BGB-A1217)+tislelizumab (BGB-A317)’ combination with durvalumab. BeiGene had previously signed a collaboration and license agreement with Novartis worth USD 2.2 billion (approx. KRW 2.942 trillion) for the drug in June 2021 but mutually agreed to terminate the agreement in September this year. On the same day of the agreement termination, the European Commission (EC) approved tislelizumab as monotherapy for the treatment of adult patients with unresectable, locally advanced, or metastatic esophageal squamous cell carcinoma (ESCC) after prior platinum-based chemotherapy. BeiGene completed over 20 clinical trials for Tevimbra’s approval and secured positive results for 10 Phase III randomized trials and 4 Phase II trials. In China, the drug has 12 indications including non-small cell lung cancer, small cell lung cancer, liver cancer, stomach cancer, nasopharyngeal cancer, and bladder cancer.
- Policy
- Drug price lawsuit recovery & refund, effective on the 20th
- by Lee, Jeong-Hwan Nov 15, 2023 05:39am
- Pharmaceutical company to reduce drug price, abusing lawsuit to reduce 'term profit' strategy In order to recover or refund the loss of drug costs as a result of the drug price-down lawsuit, the NHIS must notify the pharmaceutical company of the details such as the amount of refund, method, and the deadline for submitting opinions. The Corporation of Public Security shall refund the amount of the amount of loss to the pharmaceutical company within one year from the date of the administrative trial or administrative lawsuit's citation review, or judgment is confirmed. The amount of loss is calculated as 100% of the difference in the drug price in the case of a reduction, 40% of the difference in the drug price in case of suspension or exclusion, or reduction. On the 14th, the Ministry of Health and Welfare issued a partial revision of the Enforcement Rules of the National Health Insurance Act. The revised enforcement rules will take effect on the 20th, when the Drug Refund and Refund Act comes into effect. Specifically, the Ministry of Health and Welfare has established a new provision in the Enforcement Regulations of the Health Care Act, such as 'Collection and payment procedures for equivalent losses when disputes 60-2 drugs'. The relevant provision stipulated the matters that should be notified in advance when the Korea Medical Security Corporation collects or pays the amount of losses caused by the suspension or cancellation of drug price in accordance with paragraphs 1 and 2 of the health and 2 of the health security Act, which stipulates the Drug Expenses Repayment and Refund Act. In addition, the attached details such as the standard for calculating the amount of loss and the standard for calculating the added money corresponding to interest have been specified. The Corporation shall include in the notice the name (name or business name of the corporation), address, etc. of the pharmaceutical manufacturer, from the reduction of the upper limit on the cost of the drug care benefits, that is, the drug price is, but the title of the suspension or adjustment of the application of medical care benefits, and the drug manufacturer's name and address. Details such as the amount of loss caused by the drug price-down lawsuit, the calculation of the increase, the method of loss payment and payment, and the deadline must be notified in advance, and if you do not submit the opinion of the target pharmaceutical company, you must also present the processing law. At this time, the period for pharmaceutical companies subject to drug recovery should be 10 days or more from the date of receipt of notice from the Corporation. After the opinion submission period, the Corporation must send a payment notice when collecting (refunding) the loss, and a document stating the reason for payment, payment amount, payment method, and expected payment date at the time of payment (refund) to the target pharmaceutical company. The Corporation shall pay the loss to the pharmaceutical company within one year from the date the citation decision or judgment of the administrative trial or administrative lawsuit is finalized. The criteria for calculating losses and extra money are in accordance with Schedule 82 of the Enforcement Regulations, and other details related to recovery and refunds can be determined by the chairman of the Corporation after approval of the Minister of Welfare. According to Table 82, which stipulates the criteria for calculating the loss and the added money, 100% of the drug price difference that occurred during the period when the drug price was stopped due to the administrative trial committee or the court's suspension of execution in the case of the dispute over the drug price drop disposition, and 100% of the drug price difference that occurred during the period when the administrative trial or administrative lawsuit decision is finalized from the time of drug price. In the event of a dispute over suspension, exclusion, or reduction, 40% of the approximate price difference is a loss. With the promulgation of the revised enforcement rules of the Ministry of Welfare, all the work on sub-laws related to the drug price recovery and refund system scheduled to be implemented on the 20th has been completed. The Ministry of Health and Welfare expects that the implementation of the drug price reduction and refund system will reduce the number of indiscriminate suspension and cancellation lawsuits of drug price reduction, significantly reducing the amount of health insurance finances.
- Policy
- Enforcement rules for the recovery of drug price
- by Lee, Jeong-Hwan Nov 14, 2023 05:49am
- The amendment to the enforcement rules of the 'Refund and Refund Act', which was legislatively announced by the Ministry of Health and Welfare, was judged to be important in the preliminary review of the Regulatory Reform Commission, leaving only the procedure for confirming the enforcement rules as announced in the near future. According to the Ministry of Health and Welfare on the 10th, the sub-enforcement ordinance of the National Health Insurance Act, which stipulates the drug price recovery and refund law, was amended and promulgated on the 7th, followed by the enforcement rules soon. The main contents of the amendment to the Enforcement Rules of the Health Care Act previously announced by the Ministry of Health and Welfare are as follows. First, when the Health Insurance Corporation wins the drug administration dispute, the pharmaceutical company's refund will be set as the amount of 'the drug cost paid by the Health Insurance Corporation to the drug' minus the 'drug cost that the Corporation will pay if there was no decision to stop the execution of the court'. Conversely, when the pharmaceutical company wins, the Corporation's refund is the amount of 'the drug cost that the Corporation will pay if there is no adjustment such as drug price adjustment' minus 'the drug cost already paid by the Corporation'. Interest on the amount of loss (refund amount) due to drug disputes is subject to the interest rate of the national tax refund addition under the Enforcement Decree of the National Tax Collection Act. In addition to the matters specified in the amendment, the details necessary for collection and payment, such as the collection and payment procedures for losses, calculation criteria and periods, were determined by the Corporation. It decided that the enforcement rules of the Ministry of Welfare were not important enough to receive the main regulatory review, and passed the Ministry of Welfare with only a preliminary examination, and it went through the procedure of the Ministry of Legislation to be confirmed.
- Policy
- Discussions on external drug price referencing reevals begin
- by Lee, Tak-Sun Nov 14, 2023 05:49am
- The National Health Insurance Review and Assessment Service will start collecting industry opinions for the external pricing reference system reevaluations next year. At the first meeting, the pharmaceutical industry is said to have expressed disapproval, complaining of fatigue accumulated from successive reevaluations. At the meeting on the 10th, the Ministry of Health and Welfare, HIRA, Korea Pharmaceutical and Bio-Pharma Manufacturers Association, Korea Research-based Pharmaceutical Industry Association, and working group members of pharmaceutical companies gathered to share opinions. At the meeting, the government reportedly explained the legitimacy and necessity of conducting reevaluations through external reference pricing. However, the pharmaceutical industry is said to have expressed resistance to the external reference pricing reevaluation itself due to difficulties experienced due to the accumulated burden from successive reassessments conducted this year, including the price ceiling standard requirement reevaluations, drug reimbursement adequacy reevaluations, actual transaction price survey, etc. At the meeting, the government only announced the principle of sequentially re-evaluating drugs for chronic diseases whose patents have expired starting next year was expressed, and did not share specific plans. However, it has been reported that reevaluations will be carried out by calculating the highest price of each country based on the adjusted price calculation standards of the A8 countries (US, UK, Germany, France, Italy, Switzerland, Japan, and Canada) that were newly set by through revised regulations this year and comparing it with the highest price in Korea. However, it has not been decided whether to adjust the average price using the highest prices of the A8 countries, the median price, or the average price excluding the highest and lowest price, and the government is said to be planning to decide this based on industry opinion. Accordingly, the pharmaceutical industry is expected to begin collecting opinions on adjusting the price method starting this week. An industry official explained, “We plan to run a simulation to see which of the four proposed methods, including using the adjusted average price, median price, and adjusted average price excluding the maximum and minimum prices, is more advantageous.” Industry officials said that too many agendas remain in need of review, such as details on subjects for drug price cuts, and that it would be difficult to complete collecting opinions on the remaining agendas in just one or two meetings. However, the government plans to make no change in its plan of finalizing its plan this year and starting reevaluations next year. As a result, is expected that the pharmaceutical industry meeting scheduled for this month will be held, and if necessary, additional meetings will be held to complete opinion collection and report the reevaluation plan at the Health Insurance Policy Deliberative Committee meeting scheduled for next month.
- Policy
- Drug pricing adjustment guidelines to be established soon
- by Lee, Tak-Sun Nov 14, 2023 05:49am
- With the rise of drugs that show unstable supply and the consequent rise in drugs requesting pricing adjustments, the National Health Insurance Service plans to establish a guideline for smooth pricing adjustment negotiations and disclose it soon. The NHIS recently completed expert consultations and is currently revising the final draft. According to industry sources on the 13th, the NHIS had started establishing a guideline for the pricing adjustment negotiations to simplify materials requiring submissions and ensure accurate cost analysis. Also, the authorities had collected opinions from the industry after establishing a consultative body with the Korea Pharmaceutical and Bio-Pharma Manufacturers Association. Since October, the body has started to consult with experts to establish a guideline. Currently, the NHIS completed expert consultations, and final preparations to release the final draft are said to be in progress. An NHIS official explained, “We plan to release the pricing adjustment negotiation guidelines before the end of the year. Final work is currently in progress.” Due to the rise in the number of drugs with unstable supply and demand requesting pricing adjustments, the need for a clear pricing adjustment negotiation guideline has been increasing. Moreover, the drug subject to negotiations has also increased with the NHIS’s expansion of drugs subject to adjustment applications in 2021. Previously, only drugs that did not have alternative drugs or were necessary for medical treatment were able to apply for pricing adjustments, but from 2021, drugs with an administration cost lower than their alternatives and are necessary for medical treatment and drugs that only one other company owns a drug with the same administration route and ingredient can also apply for pricing adjustments. Recently, resolving the supply and demand instability has emerged as a government task, and drugs subject to pricing adjustment are being interpreted broadly. Starting with acetaminophen at the end of last year, prices of magnesium hydroxide and pseudoephedrine were also increased through pricing adjustment negotiations, and the application for the pricing adjustment of budesonide passed the Drug Reimbursement Review Committee, and will soon begin full-scale negotiations. The adjustment negotiations aim to facilitate a stable supply of drugs by conserving drug costs. However, there was much criticism around the large amount of data submissions required, as most of the data required aligns with those required for the Drug Shortage Prevention Program. In addition, there was an opinion that an accurate cost analysis is needed by setting a fixed ratio for the general management cost and profit. NHIS plans to comprehensively collect these opinions and reflect them in the guidelines. Once the guidelines are created, it is expected to simplify the required data submissions, clarify cost analysis, and facilitate smoother drug pricing negotiations. However, drugs with an unstable supply and demand that are currently undergoing drug negotiations undergo rapid negotiations within a month through prior consultation between the public and private sectors under the condition of increasing their supply, so attention is being paid to whether these will also be able to reach an agreement within the set guidelines.
- Policy
- Regeneron enters Phase 3 in Korea
- by Lee, Hye-Kyung Nov 13, 2023 05:23am
- FDA and EMA review begins in the second half of this year for CD20 and CD3 targeted treatments. Phase 3 clinical trials for Regeneron's new lymphoma treatment drug Odronextamab are being conducted in Korea. The Ministry of Food and Drug Safety recently submitted an application from ICON Clinical Research Korea for the efficacy and safety of Odronextamab (REGN1979), an anti-CD20/anti-CD3 bispecific antibody used in combination with Lenalidomide in subjects with relapsed/refractory follicular lymphoma and marginal zone lymphoma. A phase 3, open-label, randomized clinical trial (OLYMPIA-5) was approved to compare rituximab in combination with lenalidomide. It can be viewed as a clinical trial for approval of a wide range of indications as an initial treatment for lymphoma and additional treatment for B-cell non-Hodgkin lymphoma. Odronextamab is a type of CD20 Follicular lymphoma and diffuse large B-cell lymphoma are the most frequently occurring subtypes of B-cell non-Hodgkin lymphoma. The European Medicines Agency (EMA) received PanMAA in August for the treatment of adult patients with relapsed or refractory follicular lymphoma or relapsed or refractory diffuse large B-cell lymphoma that has progressed after at least two prior systemic treatments. Subsequently, the US FDA accepted the application for priority review approval as a third-line therapy for the same indication in September. The target date for final approval is reportedly March 31 next year. It is expected to be the fourth dual antibody treatment targeting CD20·CD3 to receive FDA approval, following Roche's 'Lunsumio', AbbVie's Epkinly, and Roche's Columvi. Lunsumio', the first CD20·CD3 targeting dual antibody treatment approved by the FDA, received product approval in Korea on the 3rd. Following Epkinly and Columvi, if Odronextamab receives FDA approval, it is expected to take steps for domestic approval.
- Policy
- Looking at the review date for GIFT No. 1 Lunsumio
- by Lee, Hye-Kyung Nov 13, 2023 05:23am
- "The goal of the GIFT program is to shorten the general review period by 25%. The statutory review period is 120 days for chemical drugs and 115 days for biopharmaceuticals, but GIFT items In the case of, the goal is to complete the review within 90 days.” Park Jae-Hyeon, head of the rapid review division of the Ministry of Food and Drug Safety, announced on the 3rd that the actual review period for Roche Korea's Lunsumio Injection, the first GIFT product to receive domestic product approval, took 86 working days. GIFT's goal was to shorten the general review period by at least 25%. However, if you look at the period from the expedited review designation on November 29th of last year to the actual approval, it took 11 months. At first glance, you may question whether the expedited review is appropriate. Manager Park said in a recent interview with Dailypharm, "Lunsumio was reviewed for about 86 working days. As it is GIFT's first product, the licensing manager worked together to process it quickly," adding, "It took 11 months from designation to approval. “When I looked at the reason why it took, it took about 7 months to supplement the new application’s data,” he explained. According to the 'Drug Rapid Review Report' published by the Ministry of Food and Drug Safety this year, the time taken for rapid review during the drug review period, which generally takes 120 days, was 26.9 days for COVID-19 vaccines and treatments, and 81.5 days for other products. However, this statutory review period does not include the data supplementation period. The Ministry of Food and Drug Safety does not include the supplementation period in the approval review period under the current legal system. Therefore, the Ministry of Food and Drug Safety's shortened expedited review period refers to the pure review period excluding the data supplementation period. Manager Park said, “Shortening the review period is not an easy task,” and added, “The key is how well the applicant understands the supplementary matters and prepares the materials.” In particular, this year's expedited review designation has more than tripled compared to last year, and Manager Park said, "The pharmaceutical industry is interested and is applying for expedited review designation." He added, "It officially takes 30 days to review the expedited review designation, but the current employees' “Through our efforts, we are completing the designation without completing 30 days,” he said. These days, it is said that an increasing number of pharmaceutical companies do not immediately submit applications for approval even after receiving expedited review designation. This is because each company has its own circumstances, such as taking the licensing step after understanding the global market. Manager Park said, “After being designated for expedited review, the applicant must submit all documents related to the permit to the permit general manager before they are forwarded to the expedited review department.” “It’s going on,” he said. As of November 6, there were 19 items designated as GIFT brands, but the rapid review department was newly established in 2020 and the number of items designated for rapid review is 44. Once designated as expedited review, the Ministry of Food and Drug Safety shares the overall review schedule and holds product information sessions and supplementary information information sessions. In addition, the review period will be shortened through 'rolling review', which reviews materials prepared through prior review. Manager Park said, "It is meaningful that Runsumio was the first to receive approval under the GIFT name. However, shortening the review period also requires efforts from the industry. When the Ministry of Food and Drug Safety delivered the first review opinion, the parts that were not understood were discussed with the person in charge. “I think it will be helpful if we communicate with each other to understand clearly and prepare materials,” he said. Currently, items subject to GIFT are ▲medicines intended to treat serious or rare diseases such as life-threatening cancer, ▲intended for the prevention or treatment of infectious diseases that are likely to cause serious harm to public health, such as bioterrorism infectious diseases or infectious disease pandemics. It is limited to ▲ new drugs developed by innovative pharmaceutical companies designated and announced by the Ministry of Health and Welfare ▲ combinations of drugs and medical devices subject to rapid review ▲ cases where there is no existing treatment or showing clinically meaningful improvement in effectiveness, etc. compared to existing treatments. Manager Park added, “We are receiving a request to expand the GIFT target as an industry suggestion,” and added, “It is not easy as we are conducting screening work with limited manpower, but we are making efforts.” .
- Policy
- Korean researchers develop 1st new substance for Alzheimer's
- by Lee, Hye-Kyung Nov 09, 2023 05:43am
- A Korean research team has developed a new substance (ALT001) that promotes mitophagy, and the recycling of damaged mitochondria, and presented a new door to treating Alzheimer's type dementia. The Korea Health Industry Development Institute (President: Soon-Do Cho) announced that a joint research team that consists of Jin-ho Yoon (College of Medicine, Dong-A University), Jong-Hyun Cho (Department of Medicinal Biotechnology, College of Health Sciences, Dong-A University), Ji-Hoon Jo (Chonnam National University), and Alt Medical (CEO: Eun-Hee Yoo) has succeeded in developing a new mitophagy promoting substance (ALT001) that can treat Alzheimer's type dementia. Summary of ALT001 ALT001 demonstrated low toxicity and safety that does not interfere with cell growth. Also, animal testing in vivo showed that the substance effectively improved damaged cognitive function, proving its value as a clinically applicable treatment substance for dementia. Previously, most studies for the treatment of Alzheimer's type dementia had focused on amyloid beta and tau proteins, but recent study results showed that mitochondrial dysfunction plays an important role in the development of dementia by interacting with amyloid beta, and promoting the mitophagy process that maintains mitochondrial function has been attracting attention as a new treatment strategy. However, due to the absence of mitophagy-promoting substances with proven clinical applicability, dementia treatment through mitophagy has not been implemented in practice. To improve this situation, the joint research team conducted a chemical library screening using an in-house mitophagy activity analysis system. Through the screening, the research team identified an isoquinolium scaffold for mitophagy induction and generated ALT001 through chemical optimization of the isoquinolium scaffold. ALT001 effectively promotes mitophagy and is safe as it does not interfere with cell growth, demonstrating its clinical applicability. The result of an experiment conducted to evaluate the learning and memory ability when using ALT001 for Alzheimer's type dementia in mouse models showed surprising results, where the learning and memory ability of the dementia mouse model was restored, and this therapeutic effect was also identified in a mouse model widely used in other dementia research. Professor Jin-ho Yoon, who led the research, said, “Thanks to the national support and helping hands, we researchers in Korea were able to develop a dementia treatment substance that can be clinically applied in the highly competitive mitophagy-based treatment development field. We are very grateful for the support. Our research will allow the development of a mitophagy-based dementia treatment that has been difficult to commercialize due to the lack of a drug with defined molecular mechanisms. We will devote ourselves to follow-up research with the goal of commercializing a dementia treatment using the results of this research.” The study was conducted with the support of the Korea Dementia Research Center, and its results were published in Theranostics, a world-renowned academic journal ranked among the top 5.8% in the field of medical research.
- Policy
- Drug pricing nego start in earnest for Tagrisso·Leclaza
- by Lee, Tak-Sun Nov 09, 2023 05:43am
- With drug pricing negotiations ongoing for the reimbursement of Tagrisso (AZ, osimertinib) and Leclaza (Yuhan, lasertinib) as a first-line treatment for non-small cell lung cancer, whether the two drugs will be applied the initial treatment refund-type RSA (risk-sharing agreement system) remains a variable. Leclaza, which is being supplied for free through the early access program (EAP), is not applied to the initial treatment refund type RSA and the National Health Insurance Service is conducting negotiations in consideration of this. According to industry sources on the 8th, Leclaza began drug pricing negotiations with the National Health Insurance Service at the end of last month. Leclaza was previously recognized as adequate for reimbursement in the first line at the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee meeting that was held on the 12th. Tagrisso had been conducting negotiations with the corporation since the end of September. Given that drug price negotiations are carried out within a 60-day deadline, Tagrisso and Leclaza are expected to complete negotiations in December at the earliest receive reimbursement listing in January. However, a tense tug-of-war between the government and companies is expected over the RSA refund rate. In particular, in the case of Leclaza, as the initial treatment refund type is not included in its RSA, the government is expected to adjust the other refund rates while taking this into account. The initial treatment reimbursement type RSA takes into account uncertainties in effect among others for the initial treatment period. The initial treatment reimbursement type RSA was not applied for Leclaza because the full amount is being supported without limit to patients until its reimbursement listing through the Early Access Program (EAP). However, from the NHIS’s perspective, the authorities would need to adjust the other refund rates as it has no choice but to consider treatment uncertainty and the required finances. Moreover, they also must consider equity with Tagrisso, which is also under negotiation. Due to high interest in the reimbursement of the two drugs, including the National Assembly, the NHIS is expected to speed up negotiations. However, it remains to be seen whether both drugs will succeed in receiving reimbursement together or whether only one drug will be listed for reimbursement. An industry official said, “Their reimbursement depends on how much the pharmaceutical company is willing to give up on the RSA refund rate. Since the government and pharmaceutical companies are all willing to reimburse both drugs, it is highly likely that negotiations will be concluded at an appropriate level.”
- Policy
- MFDS approves P3T for talquetamab in MM patients
- by Lee, Hye-Kyung Nov 08, 2023 05:37am
- Janssen Korea Janssen Korea received approval to initiate a Phase III trial for its first-in-class investigational bispecific antibody ‘talquetamab’ for multiple myeloma in Korea. The drug is ‘Talvey,’ which was approved by the US FDA in August. The FDA granted accelerated approval to Talvey based on its overall response rate and duration of response. Its continued approval will depend on the results of the Phase III confirmatory trial. The phase 3 drug trial approved in Korea this time is for the indication approved by the FDA. The FDA approved Talvay for the treatment of adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. The randomized Phase III conducted in Korea will enroll adults patients with relapsed or refractory multiple myeloma who have received one to four prior lines of therapy, and compare the effect of talquetamab+pomalidomide, talquetamab+ teclistamab, and investigator’s choice of elotuzumab combined with pomalidomide dexamethasone(EPd) or pomalidomide, bortezomib, and dexamethasone (PVd). The trial will be conducted at seven sites, including Seoul National University Hospital, Samsung Medical Center Chonnam National University Hwasun Hospital, Ulsan University Hospital, Seoul St. Mary's Hospital, and Pusan National University Hospital. Talvay is a bispecific T-cell engaging antibody that binds to the CD3 receptor on the surface of T cells and G protein-coupled receptor class C group 5 member D (GPRC5D) expressed on the surface of multiple myeloma cells, non-malignant plasma cells and healthy tissue such as epithelial cells in keratinized tissues of the skin and tongue. The Phase 2 MonumenTAL-1 study, which became the basis for its accelerated approval, was conducted on 187 patients who had received at least four prior lines of therapy and who were not exposed to prior T-cell redirection therapy Results showed that patients who received a biweekly dose of Talvay 0.8 mg/kg, 73.6% of patients achieved an ORR. At a median follow-up of nearly 6 months from the first response among responders, 58% of patients achieved a very good partial response (VGPR) or better, including 33% of patients achieving a complete response (CR) or better 73.0% of patients who received a once-weekly subcutaneous injection (0.4mg/kg) of Talvay also achieved an ORR, but their CR rate was 35%, lower than the biweekly arm. The duration of response was also favorable for the biweekly arm, which was why the drug was approved as a biweekly subcutaneous injection.
