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- 2026-04-11 04:27:22
- Policy
- Reimb of antidiabetic SGLT-2+DPP-4 combo near
- by Kim, Jung-Ju Dec 07, 2022 05:55am
- Reimbursement of antidiabetic SGLT-2+DPP-4 class combinations near Expanding reimbursement to the combined use of SGLT-2 inhibitors and DPP-4 inhibitors as treatment for diabetes has entered its final stages. As the reimbursement will be carried out through voluntary price cuts by pharmaceutical companies as intended by the government, the process may proceed faster than when companies take the drug price negotiation track. However, the fiscal burden on NHI finances, which remains the biggest issue, depends on the size of the voluntary price cuts that will be made by pharmaceutical companies. Therefore, agreeing on the amount of the price cuts may continue for several months. Extending reimbursement to the combined use of three ingredients including SGLT-2 inhibitor class and DPP-4 inhibitor class drugs had been deferred several years due to various reviews and procedures, such as integrating the opinions of the Korean Diabetes Association, analyzing their fiscal impacts, and revising phrases for reimbursement standards. Chang-Hyun Oh, Director of the Pharmaceutical Benefits Division of the Ministry of Health and Welfare explained to the multinational pharmaceutical company press corps, “We have completed analysis on the fiscal impact and selected drugs that will be sharing finances with the reimbursement expansion, and explained to the 10 companies that will be affected on how they will be required to share finances. We are currently collecting opinions from the companies.” As the reimbursement requires changes in the drug price, both the payer and the supplier must agree on the price cut. According to MOHW, all the companies have agreed on making voluntary price cuts and will be subject to voluntary price cuts rather than drug pricing negotiations. The time required for reimbursement can be shortened with voluntary price cuts, as it is a sort of fast track system that allows the omittance of pricing negotiations. This is beneficial for both the government and the payers as it can reduce the financial burden on NHI finances and the company can also raise more sales with extended reimbursement standards. However, the government and the companies still need to reach an agreement after comparing the scale of voluntary price cuts and the amount of NHI finances the government is willing to share. Even afterward, the agenda needs to undergo remaining administrative procedures including signing the quality supply contract and making reports to Health Insurance Policy Deliberation Committee. Therefore, the government explained that it is unsure how long it would take for reimbursements to be extended. Director Oh said, “I can't guarantee that the remaining procedures (such as the opinion collection from companies and other follow-up procedures) will be completed within the month. All companies must sign quality supply contracts with NHIS and complete other procedures. The reimbursement extension can be implemented quicker if its fiscal impact is not so large, but if the parties involved do not reach a complete agreement, the implementation may be further delayed.
- Company
- Oral Exon20 targeted Exkivity to apply for reimb in Korea
- by Eo, Yun-Ho Dec 06, 2022 07:55pm
- The EGFR Exon20 insertion mutation targeted oral therapy ‘Exkivity’ is attempting reimbursement listing in Korea. According to industry sources, Takeda Pharmaceuticals Korea is preparing to apply for reimbursement of ‘Exkivity (mobocertinib), its treatment for non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations. Although the drug targets the same biomarker as Janssen Korea’s ‘Ryvrevant (amivantamab),’ Exkivity is different as an oral formulation. EGFR Exon20 insertion mutation is a new biomarker that is newly receiving attention in the field of NSCLC. Targeted anticancer therapies that are currently available for prescriptions include those that target the Exon19 deletion or Exon21 L858R substitution mutations that are commonly found in EGFR mutations, but an unmet need had existed for EGFR Exon20 insertion mutations. Therefore, the industry’s eyes are on whether Exkivity will succeed in reimbursement listing with Ryvrevant failing to pass deliberations by the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee. Meanwhile, Exkivity demonstrated its efficacy through a Phase I/II trial which enrolled 114 patients with EGFR Exon20 insertion-positive NSCLC who received prior platinum-based therapy. In the trial, patients who were treated with a 160 mg dose of Exkivity showed an objective response rate (ORR) of 28% as well as a median duration of response (DoR) of 17.5 months per independent review committee (IRC). In particular, the median time to response after Exkivity treatment was 1.9 months, demonstrating the rapid effect it shows from the beginning of treatment. The median progression-free survival (mPFS) was 7.3 months, and the median overall survival (mOS) 24.0 months. The safety profile was also manageable. The most common adverse reactions were diarrhea, rash, fatigue, etc, and were manageable through dosage adjustments.
- Policy
- One-shot Zolgensma fulfills terms of its RSA contract
- by Kim, Jung-Ju Dec 06, 2022 05:57am
- Zolgensma (onasemnogene abeparvovec), the ultra-high-priced ‘one-shot treatment’ that succeeded in receiving reimbursement in Korea in May this year, will start fulfilling the terms of its risk-sharing agreements (RSA) contract. If the drug was administered at the time its reimbursement was approved in Korea, the medical institutions that administered Zolgensma would need to prepare a report on the effectiveness of the drug every 6 months and submit it to the Health Insurance Review and Assessment Service for 5 years. HIRA’s New Drug Performance Management Division issued a notice to the hospital community that contains the ‘Operation Plan for the Performance Management of Zolgensma inj’ to inform the medical institutions that use the drugs on the need to carry out the RSA contract. Zolgensma is a new treatment for spinal muscular atrophy (SMA) that had attracted social attention in the long term for being an ‘ultra-high-priced new drug.’ Despite being a one-shot treatment that can provide a transformative effect with a single administration, its insurance reimbursement listing had remained a challenge due to its very high price. In Korea, only 7 patients are expected to be eligible for its use, but the expected pharmaceutical expense for the 7 patients amounted to KRW 13.87 billion. The drug was applied for reimbursement in August. Its insurance ceiling price in Korea had been agreed on at KRW 1.98 billion under RSA after pricing negotiations with the National Health Insurance Service. The terms of the RSA contract were built around the financial-based RSA with an added outcome-based RSA. Zolgensma was applied the Refund type, Expenditure Cap type, and Patient-unit performance-based type RSA in its reimbursement. The refund type mandates the company to refund a certain rate (refund rate) of the claims amount, the Expenditure Cap type mandates the company to refund an amount that exceeds a prespecified amount (Cap), and the Patient-unit performance-based type where the pharmaceutical company refunds a certain proportion of the expenditures when treatment fails after following up on the treatment outcome of each patient. Therefore, to fulfill its patient-unit performance-based RSA, long-term follow-up evaluation data must be prepared and submitted to HIRA. Data must be submitted to HIRA on the progress of patients who have been administered Zolgensma every 6 months for a total of 5 years by the attending physician and the affiliated medical institution that signed an agreement to conduct the long-term follow-up study for administering Zolgensma. The attending physician can evaluate the treatment response and effect in line with the evaluation period after dividing the period into 10 terms. In addition, the patient's motor function evaluation result sheet and progress record sheet, etc., can be submitted to the system on the medical institution’s work portal by the end of the month of each evaluation period. However, HIRA’s system for the submission is in development, so the data must be submitted via notified email until the development is complete. HIRA plans to distribute related manuals in the future.
- Company
- ImmuneOncia targets niche market in cancer immunotherapy
- by Dec 06, 2022 05:57am
- “NK/T-cell lymphoma is a niche market that has no approved immunotherapy. After completing the trial in Q2 next year, we plan to promptly receive approval and extend our indication if we see good results.“ Heung Tae Kim, CEO of ImmuneOncia Therapeutics Inc On the 3rd (local time), Heung Tae Kim, CEO of ImmuneOncia Therapeutics, expressed his aspirations at the ‘ESMO Asia Congress 2022’ that was held in Singapore. ImmuneOncia is a new cancer immunotherapy drug-developing company that was established as a joint venture company between Yuhan Corp and the US bio-company Sorrento. The company owns various pipelines including the PD-L1 antibody IMC-001 and the CD47 antibody IMC-002, etc. The results that were presented were interim analysis results of a domestic Phase II trial that enrolled 13 patients with relapsed or refractory NK/T cell lymphoma who failed to see an effect with ‘L- asparaginase,’ the standard therapy. Professor Won-Seog Kim of the Hemato-Oncology Department at Samsung Medical Center presented the findings at the Mini Oral session on Haematological malignancies. Interim analysis efficacy results of Phase II IMC-001 trial (Source: ESMO Asia) Interim analysis results showed that of the 10 evaluable patients, 6 showed a response (ORR=60%), and all patients that showed a response had a complete response (CR=100%). 4 of the patients have continued treatment for at least 1 year. Based on the results, the evaluation was that the drug produced excellent results in terms of drug safety and continued response. The drug also was acceptable in terms of safety. No cytokine release syndrome hematologic toxicity that commonly arises with the use of immuno-oncology drugs was observed. Only 1 patient was observed with Grade 3 uveitis. During the clinical trial, 3 patients adjusted the medication period due to side effects, and 1 patient was delayed due to COVID-19 infection. The major adverse reactions were fatigue, headache, skin rash, and itching, most of which were mild and manageable. Interim analysis safety results of Phase II IMC-001 trial (Source: ESMO Asia) Professor Kim said, “Due to the small number of patients that were analyzed, we cannot conclude that IMC-001 is a far superior treatment, but I think it is at least similar or slightly superior (compared to existing immuno-oncology drugs). Although the survival period of recurrent patients is only 4-6 months, 4 out of 6 patients that responded to IMC-001 have survived long-term, receiving treatment for over a year. IMC-001 is a PD-L1 immunotherapy. Other drugs with the same mechanism of action include the global blockbuster ‘Keytruda (pembrolizumab)’ which sold over KRW 2.1 trillion and ‘Opdivo (nivolumab)’ which sold KRW 1 trillion globally. However, the two drugs do not indicate NK/T-cell lymphoma, the disease IMC-001 is being studied for. Professor Won-Seog Kim, Samsung Medical Center NK/T-cell lymphoma is a rare EBV-associated lymphoma. 90% of Asians are infected with the virus. Although an ordinary person would have no problem when infected, when immunocompromised, the dormant virus is activated and causes cancer. The current treatment option mainly consists of radiation and chemotherapy, but the 2-year recurrence rate is 75%. The company plans to start the approval process immediately after completing the clinical trial by Q2 next year and receiving the final data. ImmuneOncia will also actively promote the technical export of IMC-001 for its global entry. CEO Kim said, “We plan to first preoccupy the niche market through rapid domestic commercialization, then gradually expand its scope of indications. Also, we plan to promote technology exports to Asian regions including China, where many patients remain. We plan to reapply for the technical evaluation around Q3 next year."
- Company
- Concerns over Leclaza's sluggish secondary indicators
- by Dec 06, 2022 05:57am
- This is in contrast to the significant improvement in the primary indicator, the progression-free survival period (PFS). We cannot rule out the possibility that a similar situation to Tagrisso, whose effectiveness was questioned by the Asian OS, will be reproduced. The global clinical director (PI) explains that it is not easy to secure statistical significance due to the relatively high ratio of crossover converted to third-generation treatments due to confirmed resistance mutations among control patients. Cho Byung-chul, a professor of oncology at Yonsei Severance Hospital, who oversees LASER301 clinical trials, said at a press conference held in Singapore on the 3rd (local time), "Leclaza failed to meet the statistical significance of OS improvement because there was a high crossover rate of about 40 percent," adding, "There is no room for resistance change now." Professor Cho Byung-chul (left) and Professor Ross Su (right) explain the clinical results of phase 3 of Leclaza LASER301 is a global study that confirmed the effectiveness and safety of the first-generation treatment "Iressa" when Leclaza was used as the first treatment for EGFR-mutated non-small cell lung cancer patients. The first evaluation index was the progression-free survival period (PFS), and Leclaza recorded a 20.6-month PFS, which reduced the risk of disease progression and death by 55% compared to the control group, demonstrating high improvement. OS, the secondary indicator, has 29% data maturity, and sufficient data has not been collected. However, the survival rate of Leclaza at 18 months after administration was not statistically significant compared to the control group (p=0.116). At the time of 29% of data collection, 25% (49) of the Leclaza group died, and 32% (64) of the control group died. Looking at the trend of the graph of the total survival period released on this day, the survival rate of the Leclaza group and the control group becomes almost similar from 27 months after administration. The final OS data will be released at the end of next year. Leclaza phase 3 clinical overall survival graph (29% maturity). (Source: ESMO) Professor Cho explained that the high rate of crossover in the control group that received the first-generation treatment affected Leclaza's OS. Crossover refers to allowing patients classified as control groups to take other treatments at an ethical level if they do not see treatment effects due to resistance during the administration of control drugs. In phase 3 clinical trials, 24% (47) of 197 control groups changed the treatment to Leclaza through crossover. 12% (24) stopped clinical trials and administered other treatments. A total of 71 people (36%) stopped administering control drugs and switched to third-generation treatments. Tagrisso, the first 3rd generation EGFR formulation conducted earlier, was also affected by the OS by allowing crossover at the time of phase 3 clinical trials. Tagrisso Japan Real World Data The 40.9-month OS dispelled concerns caused by phase 3 data (Source: ESMO) Tagrisso demonstrated OS improvement over controls but failed to improve OS in Asian subgroups (HR=0.995). At that time, 85 (31%) of 277 patients in the clinical control group stopped administering first and second-generation treatments and received Tagrisso as a follow-up treatment, which caused "data bias." Because of this, Tagrisso's effectiveness was questioned by Asians. Concerns have been raised that Tagrisso's OS benefits are unclear in Asians. Tagrisso has also been pointed out as the main reason why it has not been listed on the domestic primary benefit so far. The effectiveness of Tagrisso is being proven in clinical practice. According to the recently released Real World data in Japan, Tagrisso recorded an OS of 40.9 months for more than three years. About 90% of EGFR-mutated non-small cell lung cancer patients in the United States and Europe as well as Japan are being treated with Tagrisso in the first round. Leclaza was also influenced by the clinical environment where the diagnosis of T790M mutations, the first and second generations of resistant mutations, became active. Professor Cho said, "At the time of phase 3 of Tagrisso, the T790M mutation itself was unfamiliar. Naturally, the diagnosis was not active. However, now, follow-up treatments have emerged and T790M tests are being actively conducted. Because of this, nearly 40% of patients were crossover. In other words, as resistance diagnosis was actively conducted, more patients were found to receive follow-up treatment. He added, "Leclaza's higher OS effect was observed when analyzed by applying the IPCW (Inverse Probability of Sensing Weight) technique." The IPCW technique refers to an analysis that minimizes "bias" by correcting crossover patient data. Professor Cho said, "I don't think the failure of OS to secure statistical significance will lead to concerns over the Leclaza effect." Ross A. Soo, a professor at the National Cancer Center in Singapore, also said, "It is still too early to evaluate OS, and the effectiveness of individual drugs can be confirmed by PFS indicators, and OS is an indicator of the entire treatment, including follow-up treatment."
- Policy
- The government is conducting six studies on drug prices
- by Kim, Jung-Ju Dec 06, 2022 05:57am
- With a number of drug price systems in operation within the positive list system, the government is conducting six studies on drug price policies related to insurance benefit entry permits and follow-up management, drawing attention to how the results will be reflected next year. According to the Ministry of Health and Welfare, this year, the insurance authorities are conducting six studies on the ▲ actual transaction price system, ▲ low-priced purchase incentive system, ▲ PVA improvement, ▲ RSA performance evaluation and future improvement, ▲ drug price adjustment system, and ▲ plasma raw materials. These studies are expected to be an important basis for the reorganization or improvement of the government's drug price policy because the main goal is to check the need for policy improvement and present improvement plans. In fact, Oh Chang-hyun, head of the insurance drug division at the Ministry of Health and Welfare, said, "These studies, which started this year, will be completed by early next year. Although improvement plans for the systems may be drawn, it is not known at present whether they can all lead to implementation, he said. "There will be some that can lead to improvement of the system next year and some that will be delayed further." The Ministry of Health and Welfare said that even if the foundation of these studies was to improve spending efficiency, they did not include any new drug price reduction measures. In other words, this also means that the Ministry of Health and Welfare will maintain the existing policy among the Trade-Offs that have been used as the keynote for recent years in next year's policy projects. Manager Oh said, "We have not discovered a new system (to do next year). Since the drug price system has changed a lot in 2020, we are working on follow-up work to make it well realized, he said. "We will continue to maintain this stance because we need to increase drug access for severely rare and intractable patients with reduced costs."
- Company
- Rozlytrek can be prescribed at Big 5 hospitals
- by Eo, Yun-Ho Dec 06, 2022 05:57am
- Rozlytrek can be prescribed in big 5. According to related industries, Rozlytrek, a target anticancer drug for NTRK in Roche, Korea, passed the DC of Big 5, including Samsung Medical Center, Seoul National University Hospital, Seoul St. Mary's Hospital, and Sinchon Severance Hospital. Bayer Korea's Vitrakvi has already entered the Big 5 hospitals, and both drugs have been covered by insurance benefits since April this month, so competition for full-fledged prescriptions has begun. The two drugs can actually be applied to most carcinomas where the NTRK gene has been identified. However, there are restrictions on standards. The subjects of salary administration of the two drugs were limited to cancer types mentioned in the NCCN guidelines. Rozlytrek, approved in Korea as a rare drug in April 2020, can be prescribed for solid cancer in adults and children aged 12 or older with NTRK gene fusion without acquisition-resistant mutations, and local progressive or metastatic non-small cell lung cancer, which is positive for ROS1 in adults. Rozlytrek's permission was determined based on clinical Phase 1/2 STARTRK-NG trials in pediatric patients and data from STARTRK-2, a major phase 2 clinical trial, and STARTRK-1 and ALKA-372-001 trials in clinical phase 1. In the STARTRK-2 study, Rozlytrek reduced tumors in more than half to 56.9% of patients with solid cancer positive for NTRK fusion genes. Patients were conducted on 10 different solid cancer patients, and the response duration was observed to be 10.4 months. At the International Conference of the World Lung Cancer Society in August, the results of an additional integrated analysis of Rozlytrek's major clinical studies conducted on patients were released. In this integrated analysis, Rozlytrek's objective response rate (ORR) was 67.4% in all patients, 63.3% in patients with cerebral metastasis, 69.6% in patients with non-brain metastasis, and 68.7% in patients with first-treatment. The progression-free survival (PFS) and overall survival (OS) were 16.8 months and 44.1 months, respectively, but there was no significant difference between the first-treatment patient group and the entire patient group.
- Policy
- "A9 countries not used for drug pricing reevals next year"
- by Kim, Jung-Ju Dec 05, 2022 05:53am
- The government announced that it will not immediately apply its plan to increase the number of foreign drug price reference countries by 2 in its reevaluations next year. The foreign reference drug pricing system is essentially used to evaluate the price of reimbursed drugs in Korea. Also, regarding the pharma-bio industry’s concern, the government firmly said using the A9 price as a reference for unilateral drug price cuts in the future does not fit the purpose or objective of the system. At a recent meeting with the multinational pharmaceutical company press corp, Oh Chang-Hyun, Director of Pharmaceutical Benefits at the Ministry of Health and Welfare, said so regarding questions on the MOHW’s plan to expand the number of foreign drug price referencing countries. According to the government, the currently used drug price decision method has an unclear reference basis, so the MOHW commissioned a research service for 'Measures for Improving Foreign Drug Price Reference Standards' in 2019, based on which it prepared the revision plan. The plan was part of the 1st Comprehensive Plan of National Health Insurance. The research service results proposed the inclusion of Taiwan, Australia, and Canada in the current A7 (US, UK, France, Germany, Italy, Switzerland, and Japan). The government decided to amend the current standards by including Canada and Australia, countries that have similar or slightly smaller economic levels and pharmacuetical industry scales, and review the price calculation formula. Director Oh said, “We included the two countries that evaluate the economic feasibility of public health insurance through HTA (health technology assessment) as these countries assess drug price based on clinical usefulness.” The government and the Health Insurance Review and Assessment Service are collecting industry and expert opinions on systemic reform. According to Director Oh, the industry opinion inquiry that is set until the 11th is the first official external opinion inquiry being issued for the system. The industry’s concerns are clear. Australia and Canada’s drug prices are generally lower as they are not new drug developing countries, therefore referring to the price of these countries will naturally lower Korea’s price level and reduce the drive for new drug development. The area that the industry worries the new system may soon be applied was in the reevaluation of patent-expired drugs next year. Also, the industry expressed concerns about how the system may be further applied to unilateral drug price cuts in the future. Adding on to the concerns, the possibility remains that applying the steeped pricing system may further reduce the drug price. Regarding concerns over reevaluations, Director Oh clearly stated that it is physically impossible for the revision to be applied next year for patent-expired drug reevaluations. Director Oh said, “We need to prepare around 1 year in advance to conduct such reevaluations, In other words, we need to make announcements a year in advance. As we have not made any announcement until now, it is impossible to conduct reevaluations next year.” Also, another reason is that the government nor HIRA has the resources to conduct the reevaluation as large-scale reassessments on reimbursement adequacy of drugs are already set to be conducted next year. Director Oh said, “We are not ready to conduct foreign drug price reevaluations next year as the reevaluation of drugs that have submitted bioequivalence data (reevaluation of reimbursed drug prices for already-listed bioequivalence test subjects) and reevaluation of reimbursement for 8 ingredients are in progress." Also, Oh added that applying the A9 countries for unilateral drug price cuts will not be feasible as it does not meet the purpose or objective of the revision. "Using our plan to reevaluate the foreign drug reference system and applying it to unilateral price cuts does not fit the purpose of our reform. The government never mentioned that it will be used for unilateral price cuts.”
- Policy
- Implementation of projects linked to permission evaluation
- by Kim, Jung-Ju Dec 05, 2022 05:53am
- The government will conduct a pilot project of the "Permission Evaluation Negotiation Linkage System" in the first half of next year, which will simultaneously carry out three tracks of the drug market-wage hurdles, including the Ministry of Food and Drug Safety's item license safety and efficacy evaluation and the NHIS drug price negotiation. Although detailed standards or appropriate drug candidates have not yet been set, the pharmaceutical industry is showing interest, and the process will be created as soon as possible and applied as soon as appropriate drugs appear in the first half of the year. The Ministry of Health and Welfare recently announced the business plan when asked about pending insurance drug issues by the Korea Special Press Association. The government is currently operating the drug approval-patent linkage system to strengthen accessibility to patients. The drug approval-patent linkage system is a system that allows insurance benefits to be applied quickly by drastically reducing the time required by the Ministry of Food and Drug Safety's product approval and the HIRA benefit adequacy evaluation stage. Usually, the Ministry of Food and Drug Safety's review of the safety and effectiveness of drugs must be passed and item permission must be obtained to apply for insurance registration by the Korea Appraisal Board. If the salary adequacy is determined here, it will be reported to the Health Insurance Policy Review Committee immediately after the drug price negotiation of the industrial complex or if the salary is confirmed by formula, the final registration will be decided. Negotiations have been added to the permit evaluation linkage system, one of the "fast tracks" listed in the drug, which reduces the time further as a total of three tracks are conducted in parallel at the same time. The target is a drug that has a short life expectancy of ▲ from 6 months to less than 1 year, meets ▲the number of patients with cancer, and rare diseases, and has ▲ sufficient improvement effects instead of alternative drugs. Judging from what pharmaceutical companies are inquiring about, Oh seems to have drugs included in the target category. He added, "We will start a pilot project next year, we will organize the process as soon as possible and start it as soon as possible." He said, "I think it's the first half of the year, but I haven't decided on the candidate group or the details yet." He said, "We can set up a candidate group for pharmaceutical companies. "We will start in the first half of the year," he said. The government plans to effectively operate the Drug Approval-Patent Linkage System, which is currently in operation. This is because the existing system has also proven effective in improving drug accessibility. Manager Oh added, "Even if the Drug Approval-Patent Linkage System is introduced, the existing Drug Approval-Patent Linkage System will be taken as it is."
- Policy
- MOHW “reasonably decide on using A9 countries as reference"
- by Kim, Jung-Ju Dec 05, 2022 05:53am
- # i1 Regarding criticism from the industry on how the systemic reform of adding Australia and Canada to the existing A7 countries as drug price reference countries that are used for new drug insurance reimbursement evaluations, the government said it would make a reasonable decision after collecting industry and expert opinion. The Ministry of Health and Welfare released an explanation on the afternoon of the 2nd and emphasized that the revised plan was made as a result of lengthy discussions with the pharmaceutical industry and working-level consultative bodies. On November 21st, the Health Insurance Review and Assessment Service made a preannouncement of its revision plan to officially expand the number of reference countries used to evaluate new drugs from 7 to 9 (US, UK, Germany, France, Italy, Switzerland, Japan, Canada, Australia·A9) through the ‘Proposal for the Amendment to the Regulations on the Evaluation Standards and Procedures to Determine Eligibility for Reimbursement Benefits.’ Until now, the government had referred to the insured drug price of A7 countries when negotiating, agreeing, or designating insurance drug prices in Korea to not exceed the level set in A7 countries. Following the announcement, concerns and criticisms from interested parties arose on how adding Australia and Canada, which are not strong new drug developers, to the reference countries will decrease the price of insured drug prices in Korea and adversely affect the domestic pharmaceutical and bio-industry. On this, the MOHW explained that “The currently used drug price decision-making method has an unclear reference basis, so the MOHW organized a working-level consultative body with the pharmaceutical industry for 4 months from May this year based on the results of the policy research conducted in 2019 and expert consultation.” The MOHW added, “We will reasonably review various opinions that are submitted during the opinion inquiry period according to relevant procedures until the 11th, and then collect expert opinions to make a final decision." Meanwhile, the MOHW said that no specific plan has yet been set for the reevaluation of listed generics based on the revisited A9 plan and that it will provide information on the issue after collecting relevant opinions from the pharmaceutical industry.
