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- 2025-12-21 23:26:11
- Policy
- MFDS cautious about strengthening regulations
- by Lee, Jeong-Hwan Jun 22, 2023 05:40am
- The Ministry of Food and Drug Safety explained that although the MFDS with the purpose of the legislation to strengthen regulations on drugs that have been conditionally approved for expedited marketing authorizations before completing Phase III clinical trials from the current guideline level to the Pharmaceutical Affairs Act level, its application will require ample collection of opinions from stakeholders. In other words, the MFDS has a cautious stance regarding the reinforcement of related regulations. However, there was also the opinion that mandating all matters related to conditional expedited approval drugs to be decided through the Central Pharmaceutical Affairs Committee could lead to delay and overload of work in practice. Regarding the bill, the Korean Pharmacists Association for a Healthy Society expressed its support for its legislation while Korean Research-based Pharmaceutical Industry Association (KRPIA) took an opposing stance. On the 20th, the Ministry of Health and Welfare's position was included in the review report on the proposal for the amendment to the Pharmaceutical Affairs Act, which included reinforcing regulations of conditionally approved drugs, that was presented by the Democratic Party of Korea Rep. Jong-Yoon Choi. Choi’s bill stipulates that if a pharmaceutical company that has received conditional approval for a Phase III trial wants to extend the data submission period, including those for clinical trial data, it must apply for the extension to the Minister of Food and Drug Safety in advance and the minister shall listen to the opinions of the CPAC and decide whether to extend the period. It also contains a mandatory provision for pharmaceutical companies that have received conditional approval for items shall report their plans to submit data, such as clinical trial data of its users, to the Minister of Food and Drug Safety within 3 months from the date of approval. Also, the report on the implementation status of the reported plan, such as the status of clinical trials, was increased from the current once a year to semi-annually, that is, twice a year, to the Minister of Food and Drug Safety. However, no separate provisions for punishment were prepared for their non-compliance. To the bill, the Expert Committee of the National Assembly's Health and Welfare Committee judged that when considering the characteristics of conditionally approved drugs, there is a need to stipulate provisions in the current management guidelines to check whether the conditions to submit clinical data have been fulfilled. Specifically, to extend the deadline for submitting clinical trial data for currently conditionally licensed drugs, the MFDS first conducts an internal feasibility review, and then, if necessary, consults with the CPAC or external advisors before finally deciding whether to adjust the conditions for approval, such as by extending the submission deadline. The expert committee members agreed that a stricter review of the data submission obligation may be needed so that companies do not neglect the data submission obligation or abuse the extension system. On the part, the experts agreed with the purpose of the amendment, which will stipulate the procedure for extending the data submission period by law rather than just a guideline as in the current state and require CPAC advice when deciding on allowing the extensions. However, the committee also added that the opinion that MFDS’s compulsory consultation with the Central Pharmacy on all matters regardless of the severity of the case, could cause work delay. Regarding the provision to report the clinical trial plan to the Minister of Food and Drug Safety within 3 months from the date of approval of conditional approval drugs, the expert committee said that the provision does not conform to the reality of the situation as a clinical trial of some drugs are not approved at the time the conditional approval is granted. Also, the expert committee diagnosed that increasing the number of reports to the MFDS on the progress of clinical trials from the current once a year to twice a year would be beneficial for management as it will allow the authorities to quickly be known of changes made in clinical trials. At the same time, the expert committee asked for the authorities to comprehensively review the opinion that it may increase the risk of administrative burden on the pharmaceutical industry. Regarding the bill, the Ministry of Food and Drug Safety took a neutral stance, saying, “We will need to sufficiently collect industry opinion,” stating the need to minimize resistance from the pharmaceutical industry and secure receptivity for the regulations. The MFDS said, “We agree with the purpose of the amendment to strengthen the management and supervision of conditional approval drugs. However, further review will be needed in consideration of the working-level business process. "We need to sufficiently collect opinions from the industry to secure regulatory acceptance.” The Korean Pharmacists Association for a Healthy Society agreed to the bill, saying, “The bill strengthens the safety verification of conditionally licensed drugs. We agree with the purpose of the amendment to strengthen the responsibility of the MFDS in verifying drug safety, by requiring CPAC review when deciding whether to extend the submission period for clinical data for conditionally approved drugs." However, the Korean Research-based Pharmaceutical Industry Association opposed the bill. “In the case of conditionally licensed drugs, 6 months is generally too short to report any significant changes that require MFDS attention to the authorities. Semi-annual submission of reports will increase the burden of time and labor for companies."
- Policy
- Imported orphan drug specimen storage standards
- by Lee, Hye-Kyung Jun 22, 2023 05:40am
- The Ministry of Food and Drug Safety (Minister Oh Yoo-gyeong) announces a legislative announcement on the 21st of the amendment to the 'Rules on Safety of Pharmaceuticals, Etc. and, comments are accepted until August 21st. The main contents of this revision are ▲ rationalization of sample storage standards for importers of imported orphan drugs ▲ allowing companies applying for national release approval to directly collect and submit samples for testing ▲ operation of the number of samples approved for national release, processing deadlines, and inspection items in the form of public notice. Currently, all pharmaceuticals must keep a sample volume that can test the test items specified for each product more than twice. Importers may only keep samples for product identification. When applying for national shipment approval for pharmaceuticals such as vaccines, current public officials visit the drug storage facility to collect and collect samples and seal the rest. In order to increase the flexibility and promptness of the operation of the national lot release approval system, ▲the national lot release processing period ▲quantity of test samples ▲approval items, which were regulated by the Ministry of Food and Drug Safety*, will be improved so that the Minister of Food and Drug Safety can announce them in the future. The Ministry of Food and Drug Safety said it would continue to strive for a stable supply of medicines to ensure patient treatment opportunities, and to support the revitalization of the domestic pharmaceutical industry by rationally improving regulations within the scope of ensuring safety. Details on this amendment can be found on the Ministry of Food and Drug Safety website (mfds.go.kr) → Laws and Materials → Administrative Notice.
- Policy
- 85% of the public requests more coverage for severe diseases
- by Lee, Jeong-Hwan Jun 21, 2023 05:52am
- A survey found that more than 8 of 10 Koreans are in favor of increasing health insurance spending on new health technologies and new drugs to treat severe diseases such as cancer and rare diseases. Also, over 80% of the respondents agreed that the proportion of new drugs in total health insurance pharmaceutical spending should be increased and that health insurance should promptly cover new drugs. On the 19th, the Future Health Network (representative Ok-Ryun Moon, Professor Emeritus at Seoul National University), a think tank in the field of healthcare, unveiled the survey results that contained the results above at a ‘Policy Debate for Health Insurance Reform that the People Want’ that was hosted by Rep. Lee Jong-Seong of People Power Party. The survey, which was commissioned to Gallup Korea, researched 5,039 people aged 19 to 65 across the country last April. In the survey, 85% of the respondents agreed (21% strongly agree, 21% strongly agree, 64% agreed) that ‘expanding the coverage of essential healthcare from now on, should focus on severe diseases rather than mild diseases.’ On which requires priority coverage – essential healthcare for severe diseases or frequently occurring mild diseases, 73% responded in favor of severe diseases, which was more than four times higher than the 17% that choose mild diseases. To the question that how a (presumable) KRW 10 million of Korea’s health insurance finances should be allocated, respondents allocated KRW 6,615,000 to severe diseases and KRW 3,385,000 won to mild diseases. When asked would be better to preferentially spend the funds secured by reducing health insurance drug expenses on covering severe disease or mild disease, 72% chose severe diseases, which was 54%p higher than the proportion of those who chose mild disease. Also, 81% agreed with the plan to increase expenditures on new drugs or new health technologies out of the total health insurance budget. 83.8% agreed on the need to increase the proportion of new drugs in Korea’s total health insurance pharmaceutical expenditures. On the reason why the government should strengthen coverage of new drugs and new health technologies, respondents showed a strong agreement of 91.2% to the reason that ‘Those can save the people's lives or guarantee their quality of life.’ Also, 87.1% agreed to the claim that it was 'because it can prevent losses that may arise from non-coverage, such as other medical expenses, care expenses, and social and economic burdens.’ 87.9% of the respondents agreed that the government should promptly apply health insurance coverage when new drugs for severe diseases such as cancer and rare diseases are developed in Korea and abroad. As its measure, 80.0% of the respondents agreed that a pre-listing post-evaluation system should be applied to new drugs and new health technologies that have been approved for their efficacy and safety by overseas health authorities. As for the reason for consent, 45.3% said 'because this will allow timely coverage of new drugs and new health technologies for the patients’, and 25.5 said 'because patients cannot receive sufficient treatment with private insurance alone for severe or rare diseases.' 80.5% of the respondents agreed that the government should further expand its financial support for the national health insurance finances and create a separate medical expense fund. 82.4% of respondents agreed on the need to create a separate medical expense fund for those with severe or rare diseases and the vulnerable with government subsidies. 83.2% of respondents agreed that the pharmaceutical companies' health insurance contributions should fund the catastrophic medical expense support project to support the use of new drugs and new health technologies. Based on the results above, Professor Jin-Hyoung Kang, who was in charge of the presentation, suggested a policy that shifts the principle of health insurance coverage to give priority to severe diseases and essential healthcare, and that it is necessary to create and operate a medical safety net fund. Pressor Kang also suggested promoting a pilot project in the form of a pre-listing and post-evaluation system to promptly apply coverage to new drugs and new health technologies, and devise ways to expedite review such as integrated operation of the HIRA-NHIS committees or parallel review. In addition, Professor Kang out the need to comply with the government's statutory support rate for health insurance to ease the public burden of national insurance premiums. His argument was that the government should take measures such as increasing the government subsidization rate from the current 14% of the expected revenue of health insurance to 20%, in compliance with the legal rate. Meanwhile, the government plans to establish and announce the 2nd Comprehensive National Health Insurance Plan, which will contain the health insurance policy direction for the next 5 years (2024-2028) in the second half of the year.
- Policy
- Mandatory benefit for Erleada impact?
- by Lee, Tak-Sun Jun 20, 2023 05:36am
- As Erleada, a prostate cancer treatment, has received mandatory reimbursement since last April, attention is focusing on whether the co-payment ratio for Xtandi and Zytiga in the same class will be reduced. Currently, Erleada receives mandatory benefits with a co-payment of 5%, and Xtandi·Zytiga receives 30% screening benefits. The Cancer Disease Review Committee of the Health Insurance Review and Assessment Service held the 4th meeting in 2023 on the 14th and decided to reduce the co-payment rate for Xtandi and Zytiga. Earlier in April, Janssen Korea's Erleada was listed as a mandatory benefit with a co-payment rate of 5% for the first time in the Androgen receptor targeted agent series. Accordingly, the same family of drugs, such as Xtandi and Zytiga, which receive screening benefits of 30% of the co-payment rate, applied for the expansion of mandatory coverage. The review committee recommends androgen deprivation therapy (ADT) in combination with Xtandi for the treatment of patients with hormone-responsive metastatic prostate cancer (mHSPC) and Zytiga for the treatment of patients with hormone-responsive high-risk metastatic prostate cancer (mHSPC). ) and combination therapy (combination with prednisolone), it was decided to change the rate of co-payment. On the same day, the review committee also set the reimbursement standards for the new reimbursement application drugs, Jemperli for endometrial cancer treatment and Xpovio for multiple myeloma treatment. On the other hand, Gavreto and Vyxeos Liposomal failed to set reimbursement standards.
- Policy
- Negotiations between Verquvo and Retevmo begin
- by Lee, Tak-Sun Jun 20, 2023 05:36am
- Retevmo, an anticancer drug with mutations in RET, and Verquvo, a treatment for chronic heart failure, have entered into drug price negotiations with the NHIS. It is said that negotiations are still underway for Cibinqo, which started negotiations on drug prices in March, and Onureg, which started negotiations with the company last month. The NHIS recently updated its new drug price negotiation target through its website. The newly updated information is that Verquvo 2.5, 5, and 10mg and Retevmo 40, 80mg were included in the drug price negotiations in June. The two drugs were recognized for their reimbursement adequacy at the 2023 5th Pharmaceutical Reimbursement Evaluation Committee held on the 4th of last month. Verquvo is effective for chronic heart failure, and Retevmo is effective for RET fusion-positive non-small cell lung cancer, RET-mutated medullary thyroid cancer, and RET fusion-positive thyroid cancer. Verquvo is the world's first sGC accelerator to be approved for the treatment of chronic heart failure, and clinical trials have shown that it reduces deaths or hospitalizations due to heart failure by 10% compared to the placebo group. Retevmo was the first RET gene mutation anticancer drug to pass the evaluation committee in Korea. It has become official that drug price negotiations are underway for Onureg 200 and 300mg, which passed the committee last April. This drug is approved for maintenance therapy after induction therapy in adult patients with acute myeloid leukemia. It is understood that the atopic dermatitis treatment Cibinqo 50, 100, and 200mg, which passed the committee in February, is still under negotiation even after 60 days of negotiations. In particular, it was analyzed that this drug would shorten the time until it was listed as reimbursement, as it was known to have accepted the drug price suggested by the committee, but the NHIS negotiations are sluggish.
- Policy
- Rationalization of expedited review of new pharmaceuticals
- by Lee, Hye-Kyung Jun 20, 2023 05:35am
- In the case of a new drug developed by a first-in-class pharmaceutical company, a priority review request can be made to the rapid review division of the Ministry of Food and Drug Safety. The Ministry of Food and Drug Safety recently prepared detailed procedures, such as the method of requesting designation from the Minister of Health and Welfare, when prioritizing new drugs developed by innovative pharmaceutical companies. According to Article 35, Paragraph 4 of the Pharmaceutical Affairs Act, which was revised in July 2021, 'drugs for which the Minister of Health and Welfare has requested designation among new drugs developed by innovative pharmaceutical companies pursuant to Article 2, Subparagraph 3 of the Special Act on the Promotion and Support of the Pharmaceutical Industry' may be designated for priority review. This means that even for a new drug developed by a first-in-class company, the Ministry of Health and Welfare must request designation before the Ministry of Food and Drug Safety can proceed with an expedited review. If this continues, innovative pharmaceutical companies will have to request a request for support from the Ministry of Health and Welfare, and after that, the Ministry of Health and Welfare will request designation, and the Ministry of Food and Drug Safety will have to go through the process of reviewing the rapid review. The Ministry of Food and Drug Safety said, "In order to quickly resolve the difficulties of first-in-class companies, we have prepared a procedure so that an official letter requesting designation can be sent from the Ministry of Health and Welfare's Health Industry Promotion Division to the Ministry of Food and Drug Safety's Rapid Review Division without establishing a separate procedure." When an innovative pharmaceutical company proceeds with a request for review of priority review designation to the Ministry of Food and Drug Safety's rapid review department, the rapid review department requests confirmation of the innovative pharmaceutical company's certification from the Ministry of Health and Welfare and receives a reply and a request for priority review designation directly from the Ministry of Health and Welfare. Therefore, first-in-class companies only need to contact the Ministry of Food and Drug Safety to apply for expedited review, and then apply for product approval. Meanwhile, not only new drugs developed by innovative pharmaceutical companies but also drugs prescribed by the Prime Minister Ordinance that is used for the purpose of treating serious severe diseases or rare diseases under Article 2, Subparagraph 1 of the Rare Disease Management Act are subject to expedited review. The Ministry of Food and Drug Safety shall decide whether to designate the drug within 30 days of receiving the application for priority review and notify the applicant of the result.
- Policy
- 100 billion won more for new drug 500 billion won megafund
- by Lee, Hye-Kyung Jun 19, 2023 06:00am
- The government plans to create an additional fund of 100 billion won this year following the creation of a 500 billion won 'mega fund' last year to strengthen investment and export support for the pharmaceutical and bio industries. However, since a proper drug price valuation must necessarily accompany first-in-class development support, it was suggested that the system should be improved for this purpose. Kim Yong-woo, head of the Korea Health Industry Development Institute, explained the 3rd 5-year comprehensive plan to nurture and support the pharmaceutical and bio industries in a session on 'Government Policy and Industrial Strategy for Creating a New Bio-Health Market' held at the KFDC Spring Conference held on the 16th. Director Kim said, "The Ministry of Health and Welfare created two investment institutions at the end of last year to create a mega fund worth 500 billion won." The creation of the megafund is part of the 3rd plan to nurture and support the pharmaceutical and bio industries from this year to 2027 and was prepared to strengthen financial support and support start-ups in the pharmaceutical and bio sectors. Director Kim said, "We are paying attention to infrastructure creation so that we can bring in a lot of money to the biopharmaceutical field by creating mega funds and strengthening policy finance investment links." prepared,” he explained. In addition to mega funds, financial support such as technology guarantee funds, preferential loans to expand private investment and attraction support, and incentives to attract domestic and foreign investments were included in the 3rd comprehensive plan. Looking at the 3rd Comprehensive Plan in detail, 10 key tasks (investment in global blockbuster R&D, R&D investment in response to health security and social needs, AI promotion of new drug development, digital conversion support, finance and start-up support, export industrialization, core talent cultivation, human resources development ecosystem, support for innovative new drug development system, support for strategy to achieve global No. 3 in clinical trials, and strengthening of infrastructure by pharmaceutical value chain). Looking at the investment strategy for creating global blockbuster new drugs, support is provided for expanding public and private investment in new drug development, establishing a first-mover strategy to secure super-gap technologies, and investing in vitalizing open innovation. Director Kim explained, "In order to support the first-in-class development system, it is necessary to improve the system for proper drug price evaluation." He emphasized, “Efforts must be made to shorten the period of new drug development through an expedited approval system and simultaneous reimbursement review for each drug characteristic.”
- Policy
- Awareness of Korean pharmaceuticals, ranked 7th out of 13
- by Lee, Hye-Kyung Jun 16, 2023 05:55am
- In an awareness survey conducted on overseas consumers in countries leading the world's bio-health industry, they ranked 7th out of 13 countries in the pharmaceutical sector, 7th out of 15 countries in the medical device sector, 3rd out of 12 countries in the cosmetics sector, and 3rd out of 12 countries in the medical service sector. It was ranked 5th out of 14 countries. In the case of pharmaceutical respondents, 75.3% were aware of Samsung Biologics. Daewoong Pharmaceutical 34.2%, Hanmi Pharmaceutical 33.8%, GC Pharma 31.7%, Celltrion 30.3%, SK Bioscience 29.9%, Yuhan Corporation 26%, Hugel 23.5%, Seegene 18.2%, Donga ST 15.1%. All companies in each sector were selected as the top companies in terms of manufacturing exports in 2021, and it is a figure that confirms whether or not they are each company, rather than selecting companies known to them in terms of ranking. On the 14th, the Korea Health Industry Development Institute (President Cha Soon-do) announced the '2022 Korean Bio-Health Industry (Manufacturing and Medical Service) Overseas Awareness Survey' with these contents. The countries surveyed were 19 countries (25 cities), including the United States, China, Japan, India, and Germany, with a focus on countries where Korea's health products are exported a lot. the survey was conducted on the subject. As a result of the survey, awareness of Korea as a manufacturer of health products was 75.1%, up 3.5%p from 2021 (71.6%). Specifically, the awareness rate in the pharmaceutical sector was 68.6% (▲4.8%) and the medical device sector was 68.6% (▲3.9%), and awareness rose significantly in Japan, Australia, and France. Among Korean bio-health products, the number of consumers who are aware of a specific product stood at 67.1%, a slight increase from 65.8% in 2021. The proportion of people who are aware of specific medical device products in Korea was 63.8%, an increase of 4.2%p compared to 2021. When using Korean bio-health products for the first time, about 8 out of 10 (82.2%) knew that they were Korean products and used them, a slight increase compared to 2021 (81.5%). As a result of asking 507 respondents who later recognized that it was a Korean bio-health product, the degree of change in perception after brand recognition, the average score of 100 was 67.2 points. Respondents who used it for the first time before (67.1 points) before the outbreak of COVID-19 (67.2 points) had a higher opinion that 'positive changes' had taken place, and South America (76.9 points), Southeast Asia (72.7 points), and medical devices (69.1 points) The average score of 100 users was high. By country, in Thailand, India, and France, Korean brand awareness before using the product was relatively low, while in Brazil, Kazakhstan, and Vietnam, there was a high change in positive awareness among post-recognizers. After using Korean biohealth products, the overall satisfaction rate was 75.3 points, a decrease of 0.3 points compared to 2021. By factor, quality, and efficacy satisfaction was the highest at 75.8 points, and the positive evaluation for product diversity (75.0 points) increased compared to the previous year. In the field of medical devices, it was found that satisfaction with the diversity of Korean medical devices increased. As a result of asking about the intention to recommend Korean bio-health products regardless of experience, active recommendation (voluntarily recommended) was 61.4 points and passive recommendation (not voluntarily, but recommended if someone asks) was 62.8 points, indicating active and passive recommendation. All intentions increased year-on-year. As for the reason for recommendation, the opinion that the efficacy of the product was ranked first (87.7%). The willingness to recommend Korean bio-health products by 265 foreign experts was high at 60.1%, and cosmetics experts showed a willingness to recommend 83.3%, and the entire bio-health product industry showed a high willingness to recommend. General consumers' overseas awareness of Korea's first medical service was 61.3%, and awareness was high in countries with many foreign patients visiting Korea, such as Vietnam, China, and Mongolia. In addition, after Corona 19, the national brand and power awareness of Korean medical services has been strengthened, and it was high in countries such as Vietnam, Indonesia, UAE, and Saudi Arabia. As a result of analyzing perceptions between Korean bio-health products and medical services, Vietnam, China, Thailand, and Indonesia all showed high awareness of manufacturing and medical services, while Kazakhstan, UAE, and Russia had higher awareness of Korean medical services than manufacturing. investigated. As a result of a correlation analysis between foreign patient attraction performance and medical service awareness by country, Korean medical services in China (1st place, 83.3%), Mongolia (5th place, 80.8%), and Vietnam (7th place, 91.7%) ranked high in foreign patient attraction. Awareness of the service was very high. In the Middle East, the UAE (10th, 74.2%) and Saudi Arabia (14th, 71.7%) showed a high level of awareness of Korean medical services compared to the performance of attracting foreign patients. Han Dong-woo, head of the Health Industry Innovation Planning Division at the Promotion Agency, said, "This survey is significant in that it has been expanded not only to Korea's bio products, but also to the medical service sector, such as attracting foreign patients." Director Han said, "It is possible to objectively grasp overseas consumers' perceptions of our products and services in major bio health-related exporting countries and to analyze the differences and causes of awareness between our bio health products and medical services in the same country. It is expected that our bio health industry will be highly utilized in establishing strategies for overseas expansion tailored to each foreign country."
- Policy
- RMP evaluation cycle Up to 3 yrs What items can be changed?
- by Lee, Hye-Kyung Jun 16, 2023 05:55am
- Items that can change the risk management plan (RMP) cycle up to three years have been determined. The Ministry of Food and Drug Safety recently enacted an amendment (draft) to the 'drug risk management plan guidelines and specifically included the targets for changing the RMP reporting cycle, related documents, and procedures for reviewing the feasibility of the change. In the case of RMP-submitted drugs, safety evaluation or benefit/risk evaluation, such as clue analysis, is conducted every 6 months from item approval until 2 years, and every 1 year after 2 years have elapsed, and the results are submitted after the expiration of the relevant period. It must be reported to the Ministry of Food and Drug Safety within one month. However, in the future ▲Items that have completed re-examination in accordance with Article 32 of the Pharmaceutical Affairs Act ▲Items for which additional pharmaceutical surveillance activities (post-marketing surveillance) have been completed ▲Items for which 4 years have elapsed since marketing if other pharmaceutical surveillance activities are not established ▲RMP after product approval In the case of drugs designated for submission, the RPM evaluation cycle can be changed to a maximum of 3 years or less for items for which 4 years have elapsed since the date of change of approval following the RMP submission. However, the plan may be changed if essential changes have occurred to the relevant item, such as the addition of new indications or changes in usage and dosage, or if evaluation and reporting of RMP implementation results are required at a shorter cycle than the changed cycle due to pharmacovigilance, etc. If it is judged that it is necessary to shorten the evaluation cycle due to issues such as safety, the RMP plan can be changed. In the case of drugs with high safety concerns, such as anticancer drugs, antibiotics, drugs for the nervous system, narcotics, orphan drugs, and biological products, whether they fall under the review of changing the evaluation cycle and the need for the change must be separately considered. The Ministry of Food and Drug Safety ▲occurrence or change of important clue information, benefit/risk analysis/evaluation results, etc. ▲clinical characteristics of established safety review items and types and characteristics of bad information ▲deletion or change of safety review items and additional risk mitigation measures ▲ The RMP cycle can be changed by reviewing the appropriateness of the implementation of the risk management plan that has been implemented so far ▲ the characteristics of formulations with low risk of safety problems ▲ consideration of the overseas safety information evaluation cycle and differences. When changing the periodic reporting period, the change of evaluation start point is not applicable except in unavoidable circumstances. The Ministry of Food and Drug Safety said, "The change in the evaluation cycle of the RMP is to review the feasibility of the target item and change the implementation result evaluation cycle period to a maximum of three years or less." "he said.
- Policy
- Why Vyndamax and Tabrecta’s reimb were unable to pass DREC
- by Lee, Tak-Sun Jun 15, 2023 05:38am
- # i1 The reasons why Vyndamax and Tabrecta, the two drugs that had high reimbursement demand, were unable to pass the Health Insurance Review and Assessment Service’s review were revealed. The two drugs were determined to be ineligible for reimbursement by HIRA’s Drug Reimbursement Evaluation Committee (DREC) at its meeting that was held in April, and the results of the relevant meeting were disclosed recently. According to the industry sources on the 14th, Vyndamax and Tabrecta were reviewed by the DREC on April 6. Vyndamax Capsule (tafamidis, Pfizer), a treatment for transthyretin amyloid cardiomyopathy (ATTR-CM), was reviewed by the DREC in April, 9 months after passing the Drug Reimbursement Standard Subcommittee deliberations in July last year. The drug was deemed to be eligible for the Risk-Sharing Agreement scheme due to its lack of alternative treatment options, disease severity, social impact, and impact on public healthcare. However, the authorities failed to close the gap with the pharmaceutical company on the terms of the RSA. DREC requested the refund plan proposed by the subcommittee, ‘full refund for the initial treatment through a Refund-type RSA, then and simple refund rate Refund-type RSA and Expenditure Cap-type RSA,’ should be applied for Vyndamax’s reimbursement to reflect the uncertainties including its effect during the initial treatment period. However, as the suggested refund plan was not implemented, and the pharmacoeconomic evaluation results were deemed to be cost-ineffective, the committee decided on its non-reimbursement. Regarding its clinical efficacy, the committee pointed out that the drug had reduced all-cause mortality and frequency of cardiovascular-related hospitalizations compared to placebo in adult patients with hereditary or wild-type ATTR-CM, but the degree of clinical improvement varied depending on the type and stage of the disease, and there are limitations in that there is no study with a sufficient number of patients or observation period to analyze the varying effect. In the case of Tabrecta (capmatinib, Novartis), the lack of evidence to judge its clinical usefulness acted as an obstacle to its reimbursement. DREC determined the drug to be non-reimbursable as the drug is approved drug for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer with MET exon 14 skipping mutations, but there is insufficient evidence to determine its clinical usefulness, and the cost required is higher than its alternative drugs. DREC selected the pembrolizumab+pemetrexed+platinum therapy and pemetrexed+platinum therapy as alternatives to Tabrecta. For patients who have previously used immune checkpoint inhibitors and failed first-line platinum-based therapy, DREC selected docetaxel monotherapy as the alternative option. Based on these selections, the 3-week administration cost required for Tabrecta was higher than its alternative therapies. The survival period of patients with ATTR-CM is only 2 to 3.5 years if not treated properly, and known for its poor treatment results due to a lack of treatment options. Tabrecta is the only treatment for ATTR-CM, which brought out the high demand for its insurance reimbursement. However, due to the large number of expenses required, the industry opinion is that it will be difficult to receive reimbursement if the pharmaceutical company lets go of its terms for risk-sharing in the future. Tabrecta also drew attention as the first NSCLC treatment that confirmed the MET exon 14 deletion mutation. In addition to Tabrecta, Tepmetko (Tepotinib, Merck), which is in the same class, is also undergoing a reimbursement review, with no progress. Therefore, without providing more evidence to support its clinical usefulness, it seems unlikely that Tabrecta will be covered and reimbursed in Korea.
