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- 2026-05-01 14:44:57
- 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.
- Policy
- Takeda Obizur accepts results of the drug rating
- by Lee, Tak-Sun Nov 17, 2023 05:59am
- If the alternative drug was accepted less than 90%, the drug price negotiation was omitted. It was confirmed which was conditionally approved by the Pharmaceutical benefit evaluation committee in October, accepted the results and moved to the stage of negotiation. This drug is used to treat bleeding in patients with adult acquired hemophilia A.l According to the industry on the 16th, Obizur was recognized for its salary suitability by accepting less than the evaluation amount of the weak level. The Pharmaceutical Review Committee, held on October 12, determined that there is a suitable salary for Obijour if it is accepted below the assessed amount. It is interpreted as a condition that the weighted average of alternative drugs is below. If Takeda accepts less than 90% of the weighted average price, drug price negotiations will be omitted, and only the expected amount of use will be negotiated, so it will be possible to make a faster registration. The drug has been undergoing a rapid payroll process since obtaining an item permit last March. Unlike conventional bypass drugs, it is a treatment that replaces the 8th person of blood clotting with AHA (accent hemophilia A) adaptation, and it has the advantage of being the only AHA treatment that can reliably monitor blood clotting factor 8 through standard analysis and treat individual doses. Takeda Pharmaceuticals Korea explained, "This drug is a gene recombinant made by removing B-domain from liver-like pig blood clotting 8 people, and it can replace inactivated human blood clotting 8 because it is not easily recognized by autoimmune antibodies to help blood clotting and help control bleeding." Good results were also found in clinical trials. An open-label phase 22/3 study evaluating the efficacy of Obijour in 28 patients with acquired hemophilia A found that all patients treated with Obzur had a positive response to all early episodes of bleeding at a 24-hour assessment after the first dose. Takeda are said to be preparing related materials before the full-scale negotiations.
- Policy
- Abbvie’s Skyrizi is approved for Crohn's disease in Korea
- by Lee, Hye-Kyung Nov 16, 2023 05:46am
- Abbvie’s ‘Skyrizi,’ which was first introduced to Korea as a psoriasis treatment, has received additional marketing authorization for its Crohn's disease indication The Ministry of Drug and Safety approved Abbvie Korea’s ‘Skyrizi Inj (risankizumab)’ and ‘Skyrizi Cartridge Inj (risankizumab)’ on the 15th. The products, which contain 600mg and 360mg doses of risankizumab, are indicated ’ for the treatment of moderately to severely active Crohn's disease in adults who have had an inadequate response to, lost response to, or were intolerant to conventional therapy or biologic therapy. Skyrizi Cartridge Inj is a self-injectable product that contains a prefilled cartridge and an electric drug injection pump (on-body injector) as an administration device, improving the convenience of administration for patients. In Korea, Abbvie had received approval for different doses of its risankizumab ingredient as ‘Skyrizi Prefilled Syringe Inj,’ ‘Skyrizi Prefilled Syringe Inj 150mg/mL,’ and ‘Skyrizi Prefilled Pen Inj 150mg/mL.,’ for plaque psoriasis and psoriatic arthritis. The European Commission approved Skyrizi as a treatment for adult patients with moderately to severely active Crohn's disease in November 2022. Skyrizi is the first interleukin-23 (IL-23) inhibitor approved to treat moderately to severely active Crohn's disease. The European Commission’s approval of Skyrizi in Crohn's disease was supported by results from the 3 global Phase III programs. Interleukin inhibitors are biological agents and are mainly used to treat moderate to severe adult plaque psoriasis, and can largely be divided into IL-17 inhibitors and IL-23 inhibitors. The IL-17 inhibitors approved in Korea include Janssen’s ‘Stelara (ustekinumab),’ Lilly’s ‘Taltz (ixekizumab),’ and Novartis’s ‘Cosentyx (secukinumab).’ In the case of IL-23 inhibitors, they include Janssen’s ‘Tremfya (guselkumab),’ and Abbvie’s ‘Skyrizi.’ According to the market research institution IQVIA, the size interleukin inhibitor market rose 30% YoY to exceed KRW 100 billion last year. In particular, Janssen’s Stelara is the first interleukin inhibitor approved for Crohn's disease. Therefore, if Abbvie releases Skyrizi for Crohn's disease in Korea, it is expected to compete with Stelara.
- 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.
