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- 2025-12-21 07:38:40
- Policy
- Novavax’s COVID-19 vaccine receives EUA in KOR
- by Lee, Hye-Kyung Dec 01, 2023 05:35am
- The Ministry of Food and Drug Safety (Minister Yu-Kyoung Oh) announced that it had granted emergency use authorization (EUA) for Novavax’s ‘Novavax COVID-19 Vaccine 2023-2024’ to respond to the Omicron subvariant (XBB.1.5). The Minister of Food and Drug Safety grants emergency use authorization when the head of relevant central administrative agencies requests a medical product that is not approved in Korea to appropriately respond to public health crises such as infectious disease pandemics, and allows the manufacturer or importer to manufacture or import medical products not approved in Korea. The EUA was granted after a review of the clinical and quality data submitted by the company, consultation with experts in various fields, then deliberation and resolution by the Medical Product Safety Management and Supply Committee. The Korea Disease Control and Prevention Agency had requested the use of Novavax’s vaccine in accordance with its national vaccination plan to prevent COVID-19 in the 2023-2024 winter season which is imported and supplied by SK Chemicals in Korea. Novavax's vaccine directly injects an antigenic protein made by genetic recombinant technology into the body to induce the production of antibodies that eliminate the virus The Pfizer and Moderna vaccines that are currently available are mRNA-based vaccines that express antigenic proteins to induce the body’s immune response. The Novavax vaccine has been granted EUA in the United States and is being used with formal approval in Europe. The Ministry of Food and Drug Safety said, "The introduction of Novavax’s vaccine in Korea holds significance as it expands the types of vaccines that can be used in the field. We will continue to strengthen the safe management of COVID-19 vaccines by carrying out thorough quality control measures and collection of adverse event reports to ensure that the public can receive the vaccination with peace of mind.”
- Policy
- Imfinzi's 3-drug combo burden reduced despite nonreimb
- by Lee, Tak-Sun Nov 30, 2023 05:55am
- An unprecedented decision was made at the Cancer Disease Review Committee meeting that was held on the 22nd. At the meeting, AstraZeneca failed to establish reimbursement standards for its Imfinzi Inj (durvalumab) as part of a three-drug combination therapy for biliary tract cancer, but the CDDC decided to grant reimbursement for the gemcitabine and cisplatin used in the combination. Accordingly, the economic burden of the non-reimbursed Imfinzi + gemcitabine + cisplatin combination as first-line treatment for biliary tract cancer will be reduced to some extent with partial reimbursement approval. A HIRA official explained, "The CDDC decided to recognize part of the patient's out-of-pocket cost spent on gemcitabine and cisplatin that is used in combination with durvalumab. We plan to weigh the cost-effectiveness and report the results to the Ministry of Health and Welfare." If the MOHW recognizes the cost-effectiveness, it will amend the anticancer drug reimbursement standards so that only 5% of the drug cost for gemcitabine and cisplatin will have to be borne by the patient when used in combination with durvalumab. Gemcitabine’s insurance price ceiling is set at KRW 200,000 per vial, and cisplatin is also not expensive, costing less than KRW 20,000 per vial, so it seems likely that the reimbursement standards will be revised without complicated procedures. However, because Imfinzi, which is priced at KRW 3.34 million per vial, is non-reimbursed, the burden borne by the patients has not been completely resolved. Imfinzi’s biliary tract cancer indication was approved by the Ministry of Food and Drug Safety in November last year, as a first-line treatment for locally advanced or metastatic biliary tract cancer in combination with gemcitabine and cisplatin. With the approval, Imfinzi became the first new standard therapy introduced to the field of biliary tract cancer in 12 years. The approval was demonstrated through Phase III TOPAZ-1 which was conducted on 685 treatment naïve patients with unresectable locally advanced or metastatic biliary tract cancer. The Phase III trial results showed that the Imfinzi arm (Imfinzi+gemcitabine+cisplatin) showed a survival rate in the Imfinzi arm was 24.9% compared with 10.4% in the placebo arm at 2 years. The median progression-free survival (PFS) was 7.2 months for the Imfinzi arm, which was a 25% improvement compared to the 5.7 months in the placebo arm. Since obtaining the indication, the non-reimbursed three-drug regimen has been widely used in the field for the primary treatment of biliary tract cancer. AstraZeneca applied for extended reimbursement in August in consideration of the burden borne by the patients, but failed at the first gate to reimbursement, at the CDDC level. However, the CDDC accepted the reimbursement for the other two drugs used in the combination in consideration of the patient burden and the high frequency of their use. An AstraZeneca official said, “We would like to express our gratitude to the government for showing the will to ease the burden of treatment costs for patients with biliary tract cancer, who are relatively elderly, have a poor prognosis, and have a progressive disease. Regarding the CDDC results, we have been conducting internal discussions to devise a measure to extend Imfinzi’s reimbursement to patients suffering from biliary tract cancer and the medical staff who work tirelessly day and night for their treatment.” “Considering the many HCPs and patients waiting to use Imfinzi, the first new standard treatment option and immunotherapy for biliary tract cancer that was introduced in 12 years, the company will continue to work with health authorities to expand its reimbursement in the future.” AstraZeneca is now left to decide whether to be content with the results or to reorganize the data and apply for reimbursement again.
- Policy
- External ref price reevals will be carried out as planned
- by Lee, Tak-Sun Nov 30, 2023 05:55am
- The Health Insurance Review and Assessment Service decided to thoroughly discuss its external reference price reevaluation plan with the industry. Although the government’s original plan of preparing a final draft by December is also expected to be postponed somewhat due to the prolonged discussions, HIRA explained that there is no change to its policy in starting the reevaluations next year. According to industry sources on the 29th, at the 2nd meeting on the external reference price reevaluation held on the 24th, HIRA accepted the pharmaceutical industry's opinion to continue working-level discussions until February next year when the final plan is set. Due to prolonged discussions, the final plan is expected to be prepared after February next year. Initially, HIRA planned to prepare final guidelines by December after several discussions with the industry. An industry official said, "At the meeting, the industry raised the opinion that more time was needed, so we decided to continue discussions until February. Specific details will likely come out after further meetings are held." Although the preparation of the final plan has been delayed, the government has confirmed that its policy of starting reevaluations next year remains unchanged. A HIRA official explained, “If we prepare well while gathering industry opinion, there will likely be no problem in conducting the first evaluation next year even if the final reevaluation plan is released after February.” Starting next year, HIRA plans to sequentially conduct reevaluations on the price of listed off-patent drugs, mainly chronic disease drugs, based on their overseas drug price. The price adjustments made through the reevaluations are planned to be applied from January of the following year. At the first meeting, the government had only disclosed the principle of comparing the highest price of each drug in the A8 countries (USA, UK, Germany, France, Italy, Switzerland, Japan, Canada) with the highest price in Korea, and decided to discuss further details in further meetings. The HIRA official added, “We plan to decide on subject drugs for the first year and other specifics after discussing with the industry. Internally, HIRA has already prepared a plan.”
- Policy
- BeiGene applies for reimb of its 2nd new drug after Brukinsa
- by Lee, Tak-Sun Nov 29, 2023 05:50am
- The Chinese new drug developer BeiGene is working to quickly receive reimbursement for its 2nd new drug, Tevimbra (tislelizumab) following its first new drug, Brukinsa (zanubrutinib). According to industry sources, the company had immediately applied for reimbursement listing of its Tevimbra upon its approval on the 20th. Tevimbra is a PD-1 class immuno-oncology drug that received marketing authorization from the Ministry of Food and Drug Safety on the 20th as monotherapy for the treatment of adult patients with unresectable, relapsed, locally advanced or metastatic oesophageal squamous cell carcinoma after prior platinum-based chemotherapy. The drug was also approved by the European Commission in September for the same indication. BeiGene had previously received approval for its 1st new drug, ‘Brukinsa’ in February last year. Brukinsa is the first drug developed by a Chinese company that received US FDA approval based on clinical trials in conducted China in November 2019. Brukinsa is indicated ▲as monotherapy for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy and ▲as monotherapy for the treatment of adult patients with Waldenström’s macroglobulinemia (WM) who have received at least one prior therapy. The company had taken rapid steps for its reimbursement upon approval and was granted reimbursement in May, a year and 2 months since approval, as a ‘monotherapy for the treatment of adult patients with Waldenström’s macroglobulinemia (WM) who have received at least one prior therapy.’ It was the moment when a new drug developed by a Chinese pharmaceutical company first entered the Korean market. Its insurance price ceiling was set at KRW 34,100 per capsule and was applied to an expenditure cap type risk-sharing agreement (RSA). At HIRA’s Cancer Diseae Deliberation Committee meeting that was held on the 22nd, Brukinsa’s reimbursement standards were set as ▲monotherapy for adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy, ▲ monotherapy for adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least one prior therapy, and ▲ monotherapy for adult patients 65 years and older or adult patients below 65 years of age with comorbidities with naïve CLL or SLL previously treated with at least one prior therapy. The three indications that passed the CDDC review will become eligible for reimbursement once they pass HIRA’s Drug Reimbursement Evaluation Committee and the NHIS’s drug pricing negotiations. BeiGene has long been preparing to enter the Korean market, establishing a Korean branch in October 2019. Its entry is raising expectations as its immune-oncology drug may be distributed at a lower price than those sold by existing multinational pharmaceutical companies. However, it remains to be seen whether the second new drug, Tevimbra, will also succeed in promptly receiving reimbursement.
- Policy
- HIRA starts preparing for RWE-based reimb reevaluations
- by Lee, Tak-Sun Nov 29, 2023 05:50am
- The Health Insurance Review and Assessment Service are accelerating the establishment of a plan to reevaluate Korea’s reimbursed drugs based on RWD (Real World Data)/RWE (Real World Evidence). The idea of RWD/RWE-based reimbursement reevaluations took shape at the public hearing for the ‘Performance-based reimbursement management plan for drugs using RWD/RWE’ that was held on the 21st. The plan is to reevaluate high-priced drugs or those that did not undergo pharmacoeconomic evaluations using RWD/RWE data. According to the industry on the 28th, HIRA's working-level officials will go on a business trip to Taiwan early next month as part of establishing the plan for RWD/RWE-based reimbursement reevaluations in Korea. Taiwan has been conducting RWD/RWE-based reimbursement reevaluations. Therefore, HIRA’s working-level officials plan to visit Taiwan's Ministry of Health and Welfare and benchmark Taiwan's RWE-based reevaluation system. RWD refers to a patient’s actual clinical data that is collected after reimbursement, such as health insurance claims data, hospital medical records, surveys, and post-marketing surveillance data. The clinical evidence based on such data is referred to as RWE (Real-World Evidence). At a public hearing that was held on the 21st, Ji-Hye Byun, associate researcher at HIRA presented the ‘Use RWE: reimbursement listing to reevaluation.’ Byun said, “For high-cost drugs that have submitted pharmacoeconomic evaluation data but have great uncertainty in its cost-effectiveness evaluation results (ICER), or for drugs that did not or cannot submit pharmacoeconomic evaluation data, we can conduct reevaluations after listing the drugs with RWD.” Associate researcher Byun is also known to be participating in the Taiwan business trip. Insurance authorities believe that there is a rising need for RWE-based reimbursement management based on RWD analysis due to the rising number of reimbursed high-priced drugs that have unclear treatment effects. Mi-Young Yoo, Director-General of the Pharmaceutical Benefits at HIRA, said, “Since the introduction of the positive listing system in 2006, many drugs have been listed for reimbursement through various systems including the PE exemption system to enable better patient access. So this is now the time a post-listing measure needs to be implemented. Although social consensus should be made on its need, such a management system can be a way to ensure an appropriate level of financial soundness within limited insurance.” Chang-Hyun Oh, Director of Pharmaceutical Benefits at MOHW, added, “Addressing the uncertainty that follows the listing of high-priced drugs reimbursed with PE exemption is a pending task for all. As a tool, I expect RWD to become a good way to cover the uncertainties that remain in the area,” and expressed a positive attitude towards the introduction. The number of drugs that are exempt from submitting pharmacoeconomic evaluation data has been on the rise ever since the system was implemented in 2015. Last year, 87.5% of anticancer drugs and rare disease treatments reimbursed as new drugs were drugs that were exempt from submitting pharmacoeconomic evaluation data. In this context, RWE is rising as an alternative and appropriate follow-up management tool to verify cost-effectiveness. As HIRA held public hearings and has set out to conduct field surveys, an RWE-based reevaluation system is expected to surface soon in Korea as well.
- Policy
- DPM Choo ‘will finalize telemedicine plans this year'
- by Kang, Shin-Kook Nov 28, 2023 05:42am
- The direction of the government's policy to institutionalize non-face-to-face treatment has been set to institutionalize non-face-to-face treatment for overseas Korean nationals and prepare an improvement plan for the domestic non-face-to-face treatment pilot project within the year. Deputy Prime Minister Kyung-Ho Choo presided over the Emergency Economy-related Ministers' Meeting and Export Investment Measures Meeting on the 27th and finalized the regulatory innovation measures for new industries. Deputy Prime Minister Kyung-Ho Choo presides over the Emergency Economy-related Ministers Among the projects, the 4 regulatory innovation tasks in the field of bio healthcare field are ▲clarification of non-medical standards to foster the healthcare service industry; ▲institutionalization of non-face-to-face treatment; ▲allowing joint establishment and use of living modified organism (LMO) research facilities; and ▲expansion of subjects for rapid processing of advanced regenerative biopharmaceuticals. ◆Non-face-to-face treatment = The government plans to institutionalize non-face-to-face treatment for overseas Korean residents and improve the domestic pilot project for non-face-to-face treatment within the year. The government has decided to promote revision of the Medical Service Act to include Korean nationals residing abroad into the scope of eligible patients. The bill to amend the Medical Service Act (presented by Rep. Jong-Seong Lee) is pending at the National Assembly’s Health and Welfare Legislative subcommittee level. Furthermore, to resolve public inconvenience and improve access to medical care, the ministers decided to supplement and promote the pilot project by comprehensively reflecting opinions from various sectors, through discussion with the pilot project advisory panel, public hearings, etc. The goal is to contribute to improving medical accessibility and public health by improving and institutionalizing the pilot project for non-face-to-face treatment. Deputy Prime Minister Kyung-Ho Choo said, "We will institutionalize non-face-to-face treatment for Korean residents residing above, whose safety has been verified through the regulatory sandbox, and will improve the domestic pilot project for non-face-to-face treatment within the year." ◆Healthcare service = Due to the diversification of healthcare services, the government saw the need to clarify the uncertainties as to whether each service constitutes a medical practice (can only be performed by medical personnel) under the Medical Service Act. Accordingly, the government decided to clearly define whether certain medical services should be included or excluded from medical practice and expand the scope so that various healthcare services using new digital devices can be launched in line with technological developments. The goal is to create a foundation for revitalizing the development of new services by resolving uncertainty among non-medical healthcare service companies. The government decided to revise the 'Non-medical healthcare service guidelines and casebook' next year after conducting a pilot demand survey and collecting opinions in Q1 next year. ◆ LMO research facility = Companies had been burdened with high facility construction costs because the establishment and use of living modified organism (LMO) research facilities were prohibited. It was decided that a bill to amend to the ‘LMO Act' will be presented next year to improve this and allow joint establishment and use of research facilities to develop and test LMOs. The government predicted that this would contribute to revitalizing research by alleviating the cost burden of establishing separate facilities for relevant companies. ◆Advanced regenerative biopharmaceuticals = An expedited processing system (that reduces the review period from 115 days to 90 days) is in place for the accelerated approval and review of advanced regenerative biopharmaceuticals, but its scope of application was limited. Accordingly, the government decided to expand the scope of interpretation for 'cases where there is no alternative treatment' subject to expedited review. In other words, the scope will then include everything from ‘cases where there are no domestically approved drugs’ to ‘cases where the drug demonstrated improved safety and efficacy over existing drugs.’ The goal is to reduce the burden of approval and review on advanced regenerative biopharmaceuticals by reducing the time required for approval and improving public access to drugs.
- Policy
- Enspryng and Jemperli will be reimbursed through RSA
- by Lee, Tak-Sun Nov 22, 2023 05:30am
- The new Neuromyelitis optica spectrum disorder (NMOSD) drug Enspryng Prefilled Syringe Inj (satralizumab, Roche) and new PD-1 inhibitor immune-oncology drug ‘Jemperli Inj (dostarlimab, GSK) will be reimbursed in Korea from December 1st this year. Also, the insurance price ceiling for Xeljanz Tab 5mg, for which reimbursement has been extended to cover ankylosing spondylitis, will be reduced. According to industry sources on the 21st, Enspryng will be reimbursed through the expenditure cap type RSA, and Jemperli through the expenditure cap type and refund type RSA from December 1st. The price ceilings set for the drugs are KRW 7,823,456/syringe for Enspryng and KRW 3,868,840 for Jemperli. Enspryng is reimbursed for the treatment of f neuromyelitis optica spectrum disorders (NMOSD) in adult patients over 18 years of age who are anti-aquaporin-4 IgG (AQP4-IgG) seropositive and satisfy all of the following conditions: ▲2 or more symptom relapses in the last 2 years (including ≥1 relapse in last year, were viable for reimbursed use of rituximab injections and had used the drug for over 3 months but experienced relapse or cannot continue rituximab due to side effects, and ▲has a 6.5 or lower Extended Disability Status Scale (EDSS) score upon administration of satralizumab. Jemperli is indicated for the treatment of adult patients with dMMR recurrent or advanced endometrial cancer. The drug is the 3rd PD-1 inhibitor immune-oncology drug introduced to the field following Opdivo (nivolumab, Ono·BMS) and Keytruda (pembrolizumab, MSD). Meanwhile, with its reimbursement standards extended to severe cover active ankylosing spondylitis Xeljanz’s insurance price ceiling will be adjusted from KRW 11,085 to KRW 10,996. In addition, the prices of Taltz Prefilled Syringe Inj and Taltz Autoinjector Inj which also received reimbursement extensions to active ankylosing spondylitis will be adjusted from KRW 802,800 to KRW 798,786. Also, Cosentyx Sensoready Pen’s insurance ceiling price will be reduced from KRW 633,084 to KRW 629,308, and Cosentyx Unoready Pen 300mg/2mL from KRW 1,202,860 to KRW 1,195,643.
- Policy
- Will PE exemption drugs be reevaluated based on RWD?
- by Lee, Tak-Sun Nov 22, 2023 05:30am
- A public hearing on measures for performance-based reimbursement management of drugs that was held on the afternoon of the 20th at the main auditorium of the Catholic University of Korea’s Institute of Biomedical Industry Will ultra-high-priced drugs or drugs exempted from receiving pharmacoeconomic evaluations be reevaluated based on actual patient administration data after being listed for reimbursement? Starting with Kymriah first last year, as drugs were applied a performance-based refund type RSA for reimbursement, an interpretation that it would now be possible to reevaluate the price of high-priced drugs or drugs that are waived PE evaluations based on real-world data has been proposed. The ‘Public hearing on measures for performance-based reimbursement management of drugs’ that was held on the 20th at the main auditorium of the Catholic University of Korea’s Institute of Biomedical Industry is likely to serve as the starting point for re-evaluation using RWD on high-priced drugs or PE exemption drugs. RWD refers to actual patient clinical data collected post-reimbursement, such as health insurance claims data, hospital medical records, surveys, and post-marketing drug survey data. Real-world evidence (RWE) is actual clinical grounds derived from RWD. The public hearing was prepared to share the results of RWD/RWE research conducted by the Korea Cancer Study Group and HIRA for the past 5 years and to collect various opinions on the use of RWD/RWE-based drug reimbursement management guidelines. On the day, Chi-Hoon Maeng, Professor of Kyung Hee University’s School of Medicine, announced the results of his study that evaluated the efficacy and safety of paclitaxel-ramucirumab combination therapy through RWD data in patients with advanced gastric cancer. In addition, Jung-hoon Ahn, Professor of Health Convergence at Ewha Womans University Graduate School, prepared a pharmacoeconomic evaluation result based on the RWE data of the paclitaxel-ramucirumab combination therapy based on Professor Maeng's interpretation of the results. The two results have significance in that the post-marketing evaluation was conducted based on RWE. Ji-Hye Byun, associate researcher at HIRA followed the two presentations with an announcement of the RWE guidelines for reimbursement management through drug performance evaluation, which contained a whole RWE utilization plan from Step 1:reimbursement plan to Step 4: reevaluations. Steps 1 and 2 contain measures identical to what has been applied to Kymriah and Zolgensma – the current performance-based refund type RSA. The plan is to reimburse drugs based on the pharmaceutical company’s RWE evaluation, and then when the medical institutions submit RWD data, the authorities evaluate the drug’s performance and receive a refund from the company for patients who fail treatment. Steps 3 and 4 evolve further from current plans. HIRA plans to work with external experts to analyze RWD data for reimbursement reevaluations. If implemented, high-cost drugs that have submitted PE data but have a highly uncertain Incremental Cost-Effective Ratio (ICER) or drugs for which PE evaluation data were not or could be submitted can be reevaluated after reimbursement with RWD. The ‘PE evaluation data waiver system,’ or ‘PE exemption system’ had been applied in 2015 to benefit rare disease drugs or anticancer drugs with no alternatives. This year, subjects were expanded to benefit drugs for pediatric patients that demonstrate an improvement in quality of life. Managing reimbursement through RWD allows for post-marketing evaluation of drugs that have unclear cost-effectiveness rather than prior evaluations, thereby offering an advantage in being able to shorten the reimbursement listing process, and strengthening access to high-priced drugs for severe and rare diseases. Also, post-marketing evaluations can help improve the financial soundness of health insurance and offer transparent management of reimbursement as decisions are made based on real-world data. On the other hand, RWD collection adds a burden to the various other parties involved, such as the burden of data collection posed on the doctors and the risk of refunding the drug cost of patients who fail treatment on the companies’ part. However, the measures presented at the public hearing are not specific guidelines and will require serious opinion-gathering processes to be implemented as an actual policy. Dong-Churl Suh, Director of the Pharmaceutical Policy Research Institute, who participated at the hearing as a panelist, pointed out, "RWD data analysis presents rise to transparency issues. The results can vary depending on the data source, so many considerations would need to be made for its implementation, including on how to secure data transparency.” However, the government was more for the use of RWD as a way to reduce uncertainties in financial management regarding high-priced drugs and PE exemption drugs. Mi-Young Yoo, Director-General of the Pharmaceutical Benefits at HIRA, said, “Since the introduction of the positive listing system in 2006, many drugs have been listed for reimbursement through various systems including the PE exemption system to enable better patient access. So this is now the time a post-marketing measure needs to be implemented. Although social consensus should be made on its need, such a management system can be a way to ensure an appropriate level of financial soundness within limited insurance.” Chang-Hyun Oh, Director of Pharmaceutical Benefits at MOHW, added, “Addressing the uncertainty that follows the listing of high-priced drugs reimbursed with PE exemption is a pending task for all. As a tool, I expect RWD to become a good way to cover the uncertainties that remain in the area.”
- Policy
- Global bioleaders gather in Seoul for World Bio Summit
- by Lee, Jeong-Hwan Nov 21, 2023 05:48am
- Vaccine and bio leaders from around the world will gather in Seoul, Korea to discuss response strategies for the next global pandemic that may come after COVID-19. On the 19th, the Ministry of Health and Welfare and the World Health Organization (WHO) announced they will hold the '2023 World Bio Summit' from the 20th to the 21st at the Conrad Seoul Hotel in Yeongdeungpo-gu, Seoul, under the theme of 'Strengthening capacities for pandemic response: Preparation of Workforce, Business, and Civil Society.’ The World Bio Summit is an annual global event where the Korean government invites leaders in the bio field from various countries, companies, and international organizations around the world to discuss measures and seek international cooperation. The event celebrates its 2nd year this year. Last year, 'The Seoul Declaration' was announced, which declares the need to strengthen measures for response to infectious diseases such as vaccines and treatments, and guarantee equal access to such responses. This year, international organizations that played a pivotal role in responding to the COVID-19 pandemic in the vaccine and bio fields, namely, the Asian Development Bank (ADB), Coalition for Epidemic Preparedness Innovation (CEPI), the International Vaccine Institute (IVI), and the Foundation for Innovative New Diagnostics (FIND) and the Korea Disease Control and Prevention Agency are contributing as partner organizations and cooperating in organizing detailed programs, garnering high anticipation for more professional presentations and discussions. Also, Kenya's Minister of Health, India's Minister of Livestock and Dairy Affairs, and the Acting Director-General of the EU Health Emergency Preparedness and Response Authority will visit Korea to attend the event. After the opening ceremony, the regulatory session will be held. The session will focus on discussing ways to bolster vaccine, pharmaceutical, and diagnostics manufacturing and regulatory oversight to strengthen capacities for pandemic response under the theme of 'Regulatory Oversight to Build Capacities for Pandemic Response', with the participation of the Asian Development Bank (ADB) as a partner organization. The session is expected to provide implications for low- and middle-income countries striving to institute a pharmaceutical regulatory system or to make major strides toward an advanced regulatory system, and serve as an opportunity to explore the development of safe and effective local vaccines. In the therapeutics session that is held the next day, under the theme of 'Accelerating Pandemic Therapeutics Development and Manufacturing to Respond to Future Pandemics', the Korea Disease Control and Prevention Agency will serve as a partner organization to share global strategies for therapeutics development and find ways to maximize each country's capacities through regional cooperation at each stage of therapeutics research and development. In the diagnostics session, under the theme of ‘Accelerating pandemic diagnostics development and manufacturing’, the Foundation for Innovative New Diagnostics (FIND) will partake as a partner to discuss future diagnostic market trends, ways to strengthen future diagnostic capacities, and collaborative approaches in South Korea to enhance diagnostic accessibility in low- and middle-income countries. Lastly, at the vaccine session, the Coalition for Epidemic Preparedness Innovations (CEPI) will introduce CEPI’s 100-day mission, CEPI’s collaboration with International Vaccine Institute(IVI), collaboration with industry and engagement with academia, and the achievements of the KDCA’s National Institute of Health Center for Vaccine Research (KVRC) under the theme, ‘Strengthening Global Preparedness Through CEPI’s 100-Day Mission.’ Various other side events such as luncheons, seminars, and business networking will also be held during the event. In addition to workshops and seminars sponsored and partnered by CEPI and ADB each, a ‘Global Business Lounge’ will be set up to foster and facilitate cooperation between international organizations, global companies, overseas health ministries, and domestic bio companies In addition, the 2nd Vice-Minister of Health and Welfare Minsoo Park will have a meeting with WHO Assistant Director-General of External Relations and Governance Catharina Boehme and resume the Korea-WHO policy dialogue, which had been on hold since it was first held in 2019 and discuss various measures to strengthen cooperation between the Korean government and WHO. Also, the MOHW will have a meeting with Saudi Arabia’s Vice Minister of Health for Planning and Development Abdulaziz bin Hamad bin Saleh Al-Ramaih, Ukraine’s Deputy Minister of Health Ihor Kuzin, Laos’ Vice Minister of Health Phayvanh Keopaseuth, and Chair of CEPI Board Jane Halton to proceed with discussions on key issues of mutual interest of both sides.
- Policy
- Results of the 2nd price ceiling reevals to be released soon
- by Lee, Tak-Sun Nov 20, 2023 05:50am
- The National Health Insurance Service plans to hold a preliminary briefing session before starting its main negotiations for the 2nd drug price ceiling re-evaluations. The authorities decided upon this measure to inform companies in advance about the documents that would need to be submitted for negotiations due to the tight 10-day negotiation deadlines. According to industry sources on the 17th, the NHIS will be conducting an online briefing session for the 2nd drug price ceiling re-evaluation negotiations on the 23rd. The NHIS said, “Due to our tight schedule, including the Drug Reimbursement Evaluation Committee meeting expected in early December, we expect the negotiation period for the companies to be limited to 10 days or so. Although the drugs subject to negotiations have not been finalized yet, the briefing session will be held for all pharmaceutical companies to minimize the burden work burden on the NHIS and companies.” Also, the NHIS asked for the companies to prepare and submit their negotiation documents in advance to complete the negotiations in the set period. Also, for the convenience of negotiation administrations and simplification of documents, the process will be completely converted and conducted electronically. Currently, 6,700 items are subject to the 2nd insurance price ceiling reevaluations. These are some of the oral and sterile preparations ETCs the Ministry of Food and Drug Safety included as in need of bioequivalence verifications. Following re-evaluations, the prices of the subject drugs will be reduced according to the standard requirements. The requirements are ▲ completion of in-house bioequivalence tests or clinical trials ▲ using raw drugs registered with the MFDS when manufacturing finished drugs. The price of those that only meet one of the requirements is adjusted to 85%, and those that meet none are adjusted to 72.25% of the previous price HIRA has been conducting reevaluations after receiving data from pharmaceutical companies until July this year. The NHIS will start the main negotiations in mid-December after the results are deliberated by DREC at its meeting on December 7th. Then the results will be reported to the Health Insurance Policy Deliberative Committee and pricing adjustments applied from January next year. Meanwhile, the price ceiling of 7,675 items had been adjusted in September through the 1st drug price ceiling re-evaluation negotiations.
