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- 2026-04-09 03:05:55
- Policy
- Preferential pricing plan will be further discussed by HIPDC
- by Lee, Tak-Sun Dec 04, 2023 05:12am
- The government’s announcement of the plan to improve Korea’s drug pricing system to properly compensate for the innovation value of new drugs (hereinafter referred to as the New Drug Preference Pricing Plan) is expected to be made around the end of this month. The plan was originally set to be presented for deliberation at the general meeting of the Health Insurance Policy Deliberation Committee (HIPDC) on the 8th of this month, but the Health Insurance Policy Deliberation Subcommittee decided that the agenda requires further discussion. According to the industry on the 3rd, the New drug preference pricing plan had been presented as an agenda for deliberation on the 22nd, but the subcommittee decided to continue further discussions. As such, another subcommittee meeting is expected to be held around the middle of this month. Prior to this, the contents of the New drug preference pricing plan will be shared at a meeting with the pharmaceutical industry. This is also expected to be held in the middle of this month, ahead of the subcommittee meeting. The New drug preference pricing plan has been discussed with the pharmaceutical industry since January this year. The government has been working on a plan since the end of last year to strengthen the competitiveness of homegrown new drugs and foster the pharmaceutical and bio industries. The industry has also consistently called for drug pricing incentives for homegrown new drugs that have proven non-inferiority to existing drugs, saying that more practical measures are needed to encourage innovative pharmaceutical companies. As such, the ministry held 5 public-private consultative body meetings and 6 working-group level meetings with the Korea Pharmaceutical and Bio-Pharma Manufacturers Association, the Korea Biomedicine Industry Association, and the Korean Research-based Pharmaceutical Industry Association until June this year. Since then, the Ministry of Health and Welfare has taken time to organize the final draft, collecting opinions from related organizations in consideration of the financial soundness of insurance finances and feasibility. In addition, the MOHW had added other measures, such as adding drug price preservation plans for drugs with unstable supply and demand. Currently, the most promising plans include ▲ Flexible application of ICER thresholds by prioritizing innovation for pharmacoeconomic evaluation of innovative new drugs ▲ Preferential drug pricing for domestically developed innovative new drugs (apply highest price among alternative drugs) ▲ Preferential drug pricing for natural drugs at the same level as cell therapies ▲ Expansion of drugs for severe diseases that deteriorate the quality of life to be allowed exemption from pharmacoeconomic evaluative and applied RSA ▲ Application of RSA (dual drug pricing) for homegrown new drugs planned for exports. If the plan is finalized, the industry expects that the preferential pricing of homegrown new drugs and eased post-marketing management will improve the competitiveness of the drugs overseas and allow faster listing of innovative new drugs developed abroad that are urgently needed for patient treatment.
- Company
- Pharma companies fiercely compete to develop ADC drugs
- by Son, Hyung-Min Dec 01, 2023 05:35am
- Competition among domestic pharmaceutical companies to secure new antibody-drug conjugate (ADC) technology has been intensifying in Korea. With ADC drugs recently demonstrating an effect on various cancer types, there is an analysis that the industry is making active measures to secure new ADC technologies. According to the pharmaceutical industry on the 29th, not only pharmaceutical companies such as Samjin Pharm and Chong Kun Dang, but also bio companies such as LegoChem Biosciences, ABL Bio, PinotBio, AIMed Bio, Celltrion, Samsung Biologics, and Lotte BioLogics have entered the ADC market. ADCs are drugs made by connecting antibodies that bind to specific target antigens on the surface of tumor cells to cytotoxic payloads with a linker. ADC has the advantage of increasing the treatment effect while minimizing side effects due to the target selectivity of the antibody and the apoptosis activity of the drug, which induces the drug to work selectively to target cancer cells. Domestic pharma and bio companies start developing ADC candidates through open innovation… is seeking promising ADC candidates The domestic pharmaceutical and bio industry joined in the ADC development game through open innovation. Accordingly, an overall platform technology has been implemented in all stages of development from early-stage candidate discovery to preclinical trials. To date, LegoChem Biosciences has successfully licensed-out 9 contracts in the field of ADC. Starting with technology transfer to China's Fosun Pharmaceutical Group in 2015, the company has licensed-out 5 pipeline platform technologies to Amgen in December last year. LegoChem Biosciences owns 2 proprietary platform technologies, ‘ConjuAll’ and ‘LegoChemistry.’ ABL Bio is developing ABL201, an ADC candidate targeting blood cancer, and ABL202, targeting solid cancer. ABL Bio also successfully licensed-out ABL201 to bio venture TSD Life Sciences. Also, ABL202 is being developed by incorporating LegoChem Biosciences linker technology. PinotBio is developing PINOT-ADC, which was developed by changing the chemical structure of camptothecin, a topoisomerase class anticancer drug. The candidate substance that linked PINOT-ADC to the HER2 targeting antibody was confirmed to have an anti-tumor effect in a preclinical mouse model. , Ahn-Gook Pharmaceutical, Celltrion, and Lotte Biologics, who eyed PinotBio’s technological capabilities, have made equity investments. AIMed Bio is developing its solid cancer-targeted ADC candidate, AMB302. AMB302 is a novel drug candidate targeting FGFR3 for glioblastoma and bladder cancer. Its first clinical trial is scheduled to begin next year. AIMed Bio received an equity investment from a Life Science Fund created by Samsung C&T, Samsung Biologics, and Samsung Bioepis last September. Samjin Pharm started ADC development in earnest after signing an agreement for joint R&D with an ADC specialist, Novelty Nobility. Under the agreement, the partners will be investigating the use of Samjin Pharm’s new payload with Novelty Nobility’s linker technology. The company is known to be developing differentiated payloads, unlike existing ADC new drug development companies. Chong Kun Dang will begin exploring candidate substances using the Dutch ADC company Synaffix’s ADC technology. Chong Kun Dang plans to secure the rights to use Synaffix’s 3 ADC platform technologies, GlycoConnect, HydraSpace, and an undisclosed linker-payload from the toxSYN platform, to develop ADC anticancer drugs. Samsung Biologics, Celltrion, and Lotte BioLogics are also expanding their ADC contract development and manufacturing (CDMO) business in addition to investing in new drug development companies. ADC development difficult…only around 10 candidates became commercialized Daiichi Sankyo and AstraZeneca’s ADC drug Enhertu Domestic pharmaceutical and bio companies are eager to develop ADC drugs because of the excellent effect demonstrated by ADC drugs developed to date. In particular, relatively recently released drugs are attracting attention as they have secured superior data over existing treatments for various cancer types. However, due to its difficulty in development, only a handful of drugs have been commercialized as of now. Since Pifzer’s Mylotarg (gemtuzumab ozogamicin) was released in early 2000s, Takeda’s Adcetris (Brentuximab vedotin), Roche’s Kadcyla (Trastuzumab emtansine), Pfizer’s Besponsa(Inotuzumab ozogamicin), and Roche’s Polivy (Polatuzumab vedotin-piiq) were successfully commercialized. Recently, Astellas’ Padcev (enfortumab vedotin), Gilead’s Trodelvy (sacituzumab govitecan), and Daiichi Sankyo and AstraZeneca’s Enhertu (trastuzumab deruxtecan) were also released into the market. The relatively recently released drugs have been demonstrating their efficacy in areas with a high unmet need or where existing treatments were ineffective, and have been scoring various therapeutic indications like immune-oncology drugs. In the case of Enhertu, it is currently approved as a treatment for HER2-positive breast cancer and gastric cancer in Korea but has also shown effectiveness in areas that lack treatment options, such as triple-negative breast cancer and non-small-cell lung cancer. Trodelvy is also looking to secure various indications. Currently, it has been approved as a treatment for triple-negative breast cancer in Korea, but its efficacy and safety are also evaluated for HR+/HER2- breast cancer and non-small-cell lung cancer.
- 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.”
- Company
- AstraZeneca appoints Sewhan Chon as new Country President
- by Eo, Yun-Ho Dec 01, 2023 05:35am
- Sewhan Chon, new Country President of AstraZeneca Korea. Sewhan Chon (49), former Country President of AstraZeneca Indonesia, has been appointed the new Country President of AstraZeneca Korea. According to industry sources, Sewhan Chon has officially taken office as the Country President of AstraZeneca Korea as of the 1st. With the appointment, the former Country President, Kim Sang-pyo (53), has resigned. Kim has had led AstraZeneca Korea for 5 years since being appointed in 2018. The new Country President Chon had previously served as the Business Unit Director of the Cardiovascular, Renal, and Metabolic Disease BU until August 2020, then was promoted to lead the Indonesian subsidiary in September of the same year. Chon had also served as the Interim Country President of AstraZeneca Korea after Liz Chatwin, former Country President of the Korean subsidiary, was appointed to head the Australia and New Zealand subsidiary from September 2017 until Kim’s appointment. Chon graduated with a BA in Business Administration from Korea University and received an MBA from the Wharton School of the University of Pennsylvania. Before joining the pharmaceutical industry, he worked as a financial expert at global accounting consulting companies including Price Waterhouse Coopers (PWC), Afterward, he entered the pharmaceutical industry as a finance manager at Abbott Laboratories and continued to build his career at Novartis headquarters, its US subsidiary, and AstraZeneca Korea, building capabilities not only in finance but also in R&D and BD, to rise to the position of Country President.
- 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.
- Company
- Demand for ADC Enhertu rise despite nonreimbursement
- by Kim, Jin-Gu Nov 30, 2023 05:55am
- Cumulative sales of Daiichi Sankyo’s HER2-positive breast cancer treatment ‘Enhertu (trastuzumab-deruxtecan)’ have exceeded KRW 10 billion even without reimbursement. According to the market research institution IQVIA on the 27th, Enhertu's cumulative sales were KRW 13.8 billion by Q3 this year. Sales steadily increased from KRW 2.2 billion in Q1, to KRW 5.2 billion in Q2, then to 6.4 billion in Q3 this year. In other words, the drug has posted cumulative sales of more than KRW 10 billion without insurance reimbursement. The non-reimbursed administration cost of Enhertu is known to be around KRW 7 million for each cycle that consists of 3 doses. For patients who participate in the company's Patient Assistant Program (PAP), the price drops to the high KRW 5 million range, which still poses quite a burden to the patient. Sales show that quite a few patients are in need of the drug. Voices calling for Enhertu's reimbursement were even raised during the National Assembly audit. At the NA audit on the National Health Insurance Service and Health Insurance Review and Assessment Service, Rep. Ki-Yoon Kang of the People Power Party, said, “I do not understand why Enhertu, which is undergoing pharmacoeconomic evaluations, cannot be reimbursed even though its global clinical trials are complete. Please review its reimbursement so no patients are left to die due to a lack of treatment.” Enhertu is a treatment for HER2-positive breast cancer. It is an antibody-drug conjugate (ADC) that has recently attracted attention and was approved by the Ministry of Food and Drug Safety in September last year. It is indicated for ▲unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens (third-line or higher treatment), and ▲locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received two or more prior therapies including an anti-HER2-based regimen. It further expanded indications in December and can be used in patients with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2-based regimens. However, it has been making less progress in receiving insurance reimbursement. Although the agenda had passed HIRA’s Cancer Disease Deliberation Committee review after redeliberation in May, it remains pending without being presented for review at the Drug Reimbursement Evaluation Committee level. The company had recently submitted supplementary pharmacoeconomic evaluation data to HIRA and is again awaiting DREC review. However, the company and the government are having difficulty reaching a consensus regarding Enhertu’s pharmacoeconomic evaluation results. The industry analysis is that Enhertu's superior effect is hindering economic evaluations. For pharmacoeconomic evaluations, Enhertu’s cost-effectiveness is being compared to that of Kadcyla. Enhertu demonstrated an extension in median progression-free survival (mPFS) by more than 22 months compared to existing drugs. The prolonged survival leads to an increased administration period. However, the current economic evaluation system is known to have difficulty reflecting this. Enhertu demonstrated a significant improvement in progression-free survival (PFS) in the DESTINY-Breast03 trial that compared Enhertu with trastuzumab emtansine (T-DM1) in patients with HER2-positive unresectable or metastatic breast cancer previously treated with one or more anti-HER2 therapy. The median PFS for patients in the Enhertu arm was 28.8 months compared with 6.8 months for the T-DM1 arm. Also, in terms of OS, the key secondary endpoint in the trial, Enhertu demonstrated a statistically significant 36% reduction in risk of death versus T-DM1. Also, in the DESTINY-Breast01 trial, Enhertu demonstrated continued anticancer effect in patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens that include T-DM1, trastuzumab, and pertuzumab. Results showed that Enhertu met its main efficacy outcome with a confirmed objective response rate (ORR) of 60.9% % (95% CI, 53.4-68.0) and a mPFS of 16.4 months.
- 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.
- Company
- Samsung Biologics’ CMO orders exceed KRW 3 trillion this yr
- by Chon, Seung-Hyun Nov 29, 2023 05:50am
- Samsung Biologics Samsung Biologics announced on the 28th that its contract manufacturing organization (CMO) orders this year will exceed KRW 3 trillion. On the day, the company publicly announced that it signed 1 new and 4 expanded CMO deals. Samsung Biologics signed a CMO deal worth KRW 588.8 billion with Asian pharmaceutical companies. In addition, the CMO order amount increased by KRW 171.9 billion with the 4 expanded contracts, As a result, the company's cumulative annual CMO order amount has reached KRW 3.4867 trillion, surpassing KRW 3 trillion for the first time since its establishment. The company explained, “Based on the solid trust we have built with our customers, large multinational pharmacuetical companies. that have initially signed agreements with us have all expanded the contracted line of products or increased the production scale of previously contracted quantities, strengthening partnerships thereafter.” The company’s fourth plant, which began full operations in June, is the world's largest facility with a production capacity of 240,000 liters. The plant has been continuously recording a high utilization rate due to the increase in large-scale orders from large multinational pharmacuetical companies. Samsung Biologics is currently operating 4 biopharmaceutical manufacturing plants. The company further strengthened its CMO capacity by starting its fourth factory 23 months after construction in October last year, which has the world's largest production capacity (240,000 liters) for a single plant. Samsung Biologics has secured a total production capacity of 618,000 liters along with the existing 3 factories (Plant 1 30,000 liters, Plant 2 152,000 liters, Plant 3 180,000 liters). In order to preemptively respond to market demand, Samsung Biologics began construction of a fifth plant with a 180,000 capacity last April with the goal of completion in April 2025. When the fifth factory is completed, Samsung Biologics' total production capacity will be expanded to 784,000 liters.
- 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.
