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- 2026-04-30 04:35:45
- Opinion
- [Reporter’s view] WLA Registration
- by Lee, Hye-Kyung Nov 03, 2023 05:32am
- WHO announced on October 26 that the Ministry of Food and Drug Safety was listed on the WHO Listed Authorities. The news became known in Korea on the afternoon of the 30th, when WHO posted a list of WLA-registered countries on its website and then suddenly deleted it. It was confirmed that the error was due to detailed coordination, and it was on the afternoon of the 31st that the Ministry of Food and Drug Safety officially heard the news of WLA registration. WHO also officially distributed a press release and announced that Korea was listed in the WLA. The good news about the Ministry of Food and Drug Safety's WLA is that although Korea is a full member of the ICH, it has not been listed on the WHO's SRA (Stringent Regulatory Authority), which means that the domestic pharmaceutical and bio industries have not been able to receive incentives in bidding for the procurement of medicines and vaccines from UN-affiliated organizations. In particular, in 2021, when COVID-19 was prevalent, Hong Kong limited the scope of countries recognizing vaccination certificates to countries listed in the SRA, raising controversy over the reliability of the regulatory level of domestic pharmaceuticals. This is a happening that occurred as the WHO has not been operating the SRA registration application process since 2015. WHO has been promoting WLA, in which WHO directly evaluates regulatory agencies, since 2016 to replace SRA, which is based on ICH membership requirements. Korea had no choice but to wait for an evaluation system to replace SRA since 2016, and submitted its first letter of intent for registration in 2021, when WHO began accepting letters of intention to register WLA. The news of the Ministry of Food and Drug Safety's WLA registration is a great achievement after two years. However, the specific incentives that the domestic pharmaceutical and bio-industry will experience once WLA registration is achieved are unknown. The Ministry of Food and Drug Safety also provides advantageous conditions by applying exceptions to WHO quality certification (Pre-qualification (PQ)) when SRA countries bid for the procurement of medicines and vaccines from UN-affiliated organizations, and WHO provides equivalent standards to countries listed in the WLA. The only announcement was that they expected to implement support measures. The pharmaceutical bio-industry is expecting WHO's PQ exception to be applied through this WLA listing. Although WHO is not a regulatory agency, it conducts PQ when procuring medicines and vaccines from UN-affiliated organizations, which includes data review, testing, and on-site inspection. In the end, it seems that domestic sites will only be able to realize the Ministry of Food and Drug Safety's WLA registration if they are able to receive exceptions to WHO's PQ. We hope that the Ministry of Food and Drug Safety will be able to announce in detail WHO's incentives for WLA registration as soon as possible.
- Opinion
- [Reporter’s View] Asthma drugs reimb through diff tracks
- by Eo, Yun-Ho Oct 25, 2023 05:24am
- An unusual case has emerged where drugs for the same indication were listed through different tracks for reimbursement in Korea. The interleukin-5 antagonists for asthma, ‘Cinquair (reslizumab)’ and GSK Korea’s ‘Nucala (mepolizumab)’ have been simultaneously listed for reimbursement in Korea through different reimbursement tracks. Cinquair was listed through the standard reimbursement listing process whereas Nucala received reimbursement listing through the Risk Sharing Agreement (RSA) scheme. This is a situation that has been virtually unheard of. If a drug is listed through the regular reimbursement listing process, no latecomer drugs can enter Korea’s insurance system through the RSA track. Nucala's application for RSA itself was not impossible as Cinquair had not been yet listed. However, with Teva taking active steps to list Cinquair (in the drug pricing calculation phase), it was not at all easy for GSK, which wanted dual pricing, to enter the system. AstraZeneca Korea, which sought to list its drug Fasenra (benralizumab) with Nucala, was unable to pass the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee review in September. Nucala’s listing can be said to be the fruition of GSK's determination for reimbursement in Korea. With Cinquair already undergoing drug pricing negotiations through the general listing process, the government's willingness to leave open the possibility of securing additional treatment options also stands out. On the other hand, AstraZeneca's failure to overcome the same situation remains a disappointment. AstraZeneca’s drug was also an interleukin (IL)-5 antagonist that reduces the level of blood eosinophils, a type of white blood cell that is involved in the development of asthma exacerbation. At the time of their approval, it also received attention for being an effective treatment option that had not been available before However, no other drug has been reimbursed since the reimbursement approval of Novartis Korea’s ‘Xolair (omalizumab)’ in 2020. Although the three drugs all treat the same disease, ‘asthma,’ the three drugs and Xolair’s indication differ. However, the government had compared the drugs with Xolair, and therefore, the set price was difficult for the three new biological drugs to bear, which led to the discontinuation of their reimbursement listing process. And then, AstraZeneca was the only company to not join in the efforts the companies had reignited in 2023, which had led to the different results for the three asthma drugs.
- Opinion
- [Reporter's view]Skill is more important than trends
- by Oct 20, 2023 05:31am
- Recently, antibody-drug conjugates (ADCs) have emerged rapidly in the pharmaceutical industry. ADC is a biopharmaceutical that combines an antibody that binds to a specific target antigen on the surface of cancer cells and a drug (payload) with a powerful cell-killing function. Unlike Roche Kadcyla, which is classified as a first-generation ADC anticancer drug, which only secured indications for breast cancer, the recently launched Enhertu is proving its effectiveness by showing effectiveness in various indications, including breast cancer, stomach cancer, non-small cell lung cancer, and colon cancer. In line with this, the domestic biopharmaceutical industry is also challenging the ADC anticancer drug market. Traditional pharmaceutical companies and the bio industry have expressed their intention to participate in ADC development. This is not much different from the previous situation where cancer immunotherapy drug development was popular due to Keytruda. Keytruda, a third-generation anti-cancer immunotherapy drug, is a drug that the domestic biopharmaceutical industry was committed to developing before ADC. It is similar to ADC in that it has fewer side effects and can secure a variety of indications. Many domestic pharmaceutical and bio companies are competing to promote that they are developing anti-cancer immunotherapy drugs such as Keytruda or confirming the effectiveness of new drug candidates by conducting clinical trials in combination with Keytruda. To date, there are numerous stories of confirmed efficacy in preclinical or early clinical trials. However, there is no news that it has entered late-stage clinical trials and is close to commercialization or has achieved notable technology exports. The prevailing assessment is that the domestic biopharmaceutical industry has not yet demonstrated the ability to develop new drugs as much as its willingness to follow trends. Most anticancer drugs from domestic companies, including Leclaza, have failed miserably in the market. It is true that the domestic biopharmaceutical industry, which had not succeeded in developing such a notable anticancer drug, was following the trend and starting to develop ADCs, so it was more focused on whether it was possible than expected. Currently, the industry is following the latest trends not only in ADCs and anti-cancer drugs but also in various areas such as NASH treatments and obesity treatments. It cannot be denied that the research and development (R&D) costs of the domestic biopharmaceutical industry are relatively high compared to global pharmaceutical companies. Accordingly, the industry should not blindly follow trends but rather distinguish between what it can do well, what areas it should challenge, and when it should collaborate. I hope that the true capabilities of the domestic pharmaceutical and bio-industry will be demonstrated, rather than just raising expectations.
- Opinion
- [Reporter's view]Promotion of pharmaceutical & bio-industry
- by Lee, Jeong-Hwan Oct 19, 2023 05:30am
- In the audit conducted by the National Assembly Health and Welfare Committee for the Ministry of Health and Welfare and the Ministry of Food and Drug Safety this year, it was difficult to find policy questions to foster the domestic pharmaceutical and bio-industry. There are still audits from the National Health Insurance Corporation, the Health Insurance Review and Assessment Service, the Health Industry Promotion Agency, and a general audit, but it seems that there is not enough time to deal with issues related to the pharmaceutical industry with weight. The Yoon Seok-yeol government has shown a blueprint for creating two global blockbuster-class new drugs and nurturing more than three global-level pharmaceutical bio companies by 2027 while showing its willingness to record 16 billion in drug exports, but the National Assembly's willingness to verify this was weak. On the second day of the Ministry of Health and Welfare's national audit and the day of the Ministry of Food and Drug Safety's national audit, the problem of vulnerability to the self-sufficiency rate of domestic raw materials and drugs was pointed out, but even this was only proposed as a solution to solve the problem of supply and demand unstable medicines that suffer from long-term out of stock. There were no questions related to the Prime Minister's BioHealth Innovation Committee, which will serve as a control tower to foster the pharmaceutical bio-industry, pointed out the direction of operating the pharmaceutical bio-industry megafund, and no concerns about the reduction of the budget to support the development of the pharmaceutical industry next year. It was difficult to look at the expression of the National Assembly, which is considering the reform of the innovation value compensation drug price system, which is a hot topic for domestic pharmaceutical companies and global pharmaceutical companies, preferential treatment for domestic raw materials, and ways to foster new domestic drugs. It was a pity that it was hard to find a reference to the agenda related to the pharmaceutical and bio-industry in the National Assembly's audit day of the Ministry of Appreciation Day between the Ministry of Welfare and the Ministry of Food and Drug Safety, which are in charge of nurturing the pharmaceutical and bio-industry. I feel that I have lost the opportunity to look into whether the Ministry of Health and Welfare and the Ministry of Food and Drug Safety are currently putting into practice their policy vision regarding the development of the domestic pharmaceutical and bio-industry. This national audit is the last audit of the 21st term of the National Assembly. The 21st National Assembly experienced the COVID-19 pandemic and felt the need and importance of securing domestic pharmaceutical, bio, and vaccine sovereignty more deeply than anyone else. During the three years following the pandemic, we continued our national activities, seeing that the pharmaceutical and bio-industry is an industry directly related to national security and a field that needs to be intensively nurtured for the future of the country. The National Assembly's interest in creating an R&D, drug price, and regulatory environment where domestic pharmaceutical bio companies can demonstrate sufficient capabilities in the global market is directly related to fostering domestic industry through policy improvement by government ministries. It's time to encourage the government's measures to foster the domestic pharmaceutical and bio-industry, which have unlimited growth potential during the rest of the national audit period, and to show a level of active interest and expertise that can monitor whether the administration is being carried out according to the promised blueprint.
- Opinion
- [Reporter’s View] KRPIA pulls out ‘structural reform' card
- by Eo, Yun-Ho Oct 12, 2023 05:37am
- The Korean Research-based Pharmaceutical Industry Association (KRPIA) has pulled out the ‘expenditure structure reform’ card as a solution to finance new drug expenditures. Although the message seems somewhat familiar, it is a new and unprecedented request. On the 4th, KPRIA released the results of 'A study on the analysis and rationalization of drug expenditures for new drugs in Korea' conducted by Professor Jong-Hyuk Lee from Chung-Ang University’s College of Pharmacy. Study results showed that the expenditures spent on new drugs from the national health insurance finances accounted for 8.5% of total drug costs and 2.1% of the total national health insurance medical costs. In particular, the financial impact made by new drugs on national health insurance finances was among the lowest when compared with other OECD countries. More specifically, the annual drug expenditure spent on each new drug amounted to KRW 6.1 billion whilst the total drug expenditure spent in Korea over the past 10 years amounted to KRW 164.2 trillion. In this analysis, the financial expenditures spent on items that were waived pharmacoeconomic evaluation data submissions and were subject to RSA, which account for most of the new drugs used to treat serious diseases such as cancer and rare diseases, were low, accounting for 0.3% and 2.7%, respectively, of the total drug cost. In addition, the financial impact of new drugs according to their serious disease classification status showed that drug expenditures spent on new drugs for severe and rare diseases (cancer, rare diseases) were found to only account for 3.3% of the total drug costs, suggesting the low treatment access available for domestic patients with severe and rare diseases. If so, why are studies and claims that should have been made a long time ago being raised and regarded as unusual now? The fact that new drugs account for a small portion of drug expenditures means that drug costs of existing drugs, not new drugs, account for a sizable portion of the expenditures. In other words, Korea spends 91.5% of its drug expenditures on drugs that are not new. The direction of improving the expenditure structure, which the KRPIA has suggested, is to increase the proportion of new drugs and to reduce the proportion of drug expenditures spent on drugs that are not new. It is an agenda that is bound to bring conflict of interest between new drug developers and non-developer pharmaceutical companies. However, there is no doubt that new drugs are important to Korea’s society as a whole. Prior to pointing out the limitations and reliability of the research published this time; it is necessary to consider Korea’s current expenditure structure. However, the number of expensive drugs is indeed increasing, and the number of drugs that remain non-reimbursed due to their potential financial impact is also rising. Korea has been known for its strong health insurance coverage supported by the national health insurance system framework. Even if the government had been a little insensitive to the changes in trends in related industries, new drugs have now surely become mainstream. Therefore, it is now time to consider adapting and evolving Korea’s expenditure structure and priorities accordingly.
- Opinion
- [Reporter's view] Paid-in capital increase & bio ventures
- by Lee, Seok-Jun Sep 26, 2023 05:49am
- Bio ventures have recently begun to raise funds through paid-in capital increases allotted to shareholders as promised. This is a phenomenon that has recently emerged as the bio market is not doing well, making it difficult to attract investment from institutional investors such as VCs (venture capitals) or specific third parties. Shareholders express the current situation as a ‘crying train’. Even though there is a high possibility that the stock price will fall, it is because of the worry. Just looking at the past three to four months, there are numerous bio ventures that have completed or are in the process of capital increase. CJ Bioscience, PCL, SCM Life Science, Cellid, Voronoi, SD Biosensor, and Noul have completed the paid-in capital increase. MedPacto, Micobiomed, Lunit, EDGC, Kangstem, Vaxcell-bio, Medi-post, etc. are in progress. Among them, SD Biosensor (10.4 billion won), Lunit (201.9 billion won), Medi-post (120 billion won), MedPacto (115.9 billion won), and Vaxcell Bio (100.6 billion won) decided to increase paid-in capital on a large scale of more than 100 billion won. Honestly, it is difficult to identify bio ventures. This is because it is virtually impossible to judge technological capabilities. We only rely on the data disclosed by the company and judge its value by referring to technology exports, partners, research team history, etc. While watching the paid-in capital increase trend, we believe that it may be possible to separate bio ventures in other ways. For example, it is possible to understand valuation through ▲how often financing is raised, ▲how well the fund use plan matches reality, and ▲whether the financing plan announced through IR, etc. has been reversed. In addition, ▲how often management changes, ▲whether the securities report at the time of IPO is implemented, ▲the largest shareholder's participation in bequests, etc. can be objective factors. Of course, financing is also an important element of corporate management. However, the problem is that even as the years go by, more and more companies rely on financing rather than their own ability to survive. In a time where paid-in capital increases are rampant, why not try creating an opportunity for bio ventures to separate the pros and cons? There are not many factors that can determine a company's valuation as much as financing issues. This is especially true for bio ventures where liquidity is vital.
- Opinion
- [Reporter’s View] Biobetters to prosper with better prices
- by Eo, Yun-Ho Sep 21, 2023 05:23am
- A series of cases where preferential pricing has been applied to biobetter drugs are being introduced to Korea. In 2016, the government announced a plan to provide preferential pricing for biosimilars and biobetters, which are improved versions of already approved biopharmaceuticals, that have contributed to the improvement of Korea’s healthcare. Considering how biobetters are more difficult to develop compared to incrementally modified drugs (chemical drugs), the government decided to set the overall price of biobetters at the 100-120% range of the original drug. However, no drug had reaped the benefit until recently. And then in September, Sanofi-Aventis Korea’s Nexviazyme (avalglucosidase alfa-ngpt) made the start. Nexviazyme is an improved biological drug that offers improved dosing and administration compared to Myozyme (alglucosidase alfa), a recombinant human acid alpha-glucosidase (rhGAA), that is developed by the same company, Sanofi. The drug has increased the amount of M6P, which plays an important role in the intracellular uptake of drugs, by about 15-fold compared to Myozyme through the glycol-engineering technology. Nexviazyme’s increased M6P increases drug uptake over Myozyme and GAA activity to enable more effective glycogenolysis and less damage to muscle cells. Also, the increase in surface M6P contributes to improved immunogenicity, providing benefits in terms of safety. And another drug is soon to be added to the list. The second to benefit is expected to be Roche Korea’s subcutaneous fixed-dose combination injection Phesgo (pertuzumab, trastuzumab), which combines the company’s ‘Perjeta’ and ‘Herceptin.’ The drug passed the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee review last month. If listed, Phesgo will become the first anticancer drug and the second drug to benefit from the biobetter preferential treatment plan. Phesgo was recognized for its innovation in improving patient convenience and reducing treatment time by changing the IV-injected Herceptin and Perjeta into a fixed-dose subcutaneous injection and was named as the first biobetter approved for cancer in Korea. Metastatic HER2-positive breast cancer patients who had received maintenance therapy with IV Herceptin and Perjeta injections every three weeks may reduce their administration and monitoring time by 90% from 270 minutes (90min+180min) to 20 minutes (5min+15min) when switching to Phesgo. Also, as Phesgo is a subcutaneous formulation injected in the thigh rather than into the veins, it can reduce blood vessel and nerve damage that can be caused by repeated intravenous injections. Biobetters are much more difficult to develop than IMDs. It mainly offers improved convenience over the existing original drugs, but the improvement in convenience of injectable drugs has a greater impact on patients compared to orally administered synthetic drugs. Although the first case had been implemented so late, it is encouraging that more cases are starting to emerge. In addition, domestic companies are also developing biobetters. As the likelihood of success is higher for biobetters than new drugs, we expect more to benefit in the future. Amid the many imminent patent expiries of blockbuster drugs, this is now the time for companies to take the opportunity.
- Opinion
- [Reporter’s View] Industry suffers from ‘Re-eval Neurosis'
- by Kim, Jin-Gu Sep 20, 2023 05:36am
- The era of reevaluations has dawned on Korea. Reevaluation of reimbursement adequacy, clinical reevaluations, and generic drug pricing reevaluations are being carried out simultaneously. The Ministry of Health and Welfare and its affiliated organizations appear to be scrambling to reevaluate and reduce drug pricing expenditures as if they have received orders from somewhere. The reevaluation of the reimbursement adequacy began with choline alfoscerate preparations in 2020, and then reviewed 4 ingredients including silymarin and avocado-soya in 2021, then 7 ingredients including streptokinase in 2022, and then 8 ingredients including hyaluronic acid eye drops, and rebamipide this year. In addition, the reimbursement adequacy of 7 ingredients, including sarpogrelate and mosapride will be reevaluated next year. At the same time, the Ministry of Food and Drug Safety is conducting its clinical reevaluations. Clinical safety and efficacy reevaluation of choline alfoscerate, acetyl L-carnitine, oxiracetam, streptokinase, and streptodornase has been conducted or is in progress. Not long ago, reevaluations on the reimbursement ceiling price of drugs, also known as the reevaluation of generic drug prices, had been carried out. This reevaluation was conducted to apply the new drug pricing system implemented in July 2020 to already listed generics. More than 20,000 items were subject to reevaluation. As a result, as of the 5th of this month, the prices of 7,355 generic drugs were reduced by up to 28%. Due to so many items being reevaluated at the same time, much confusion has been occurring in the field. The biggest problem pointed out was the redundancy of reevaluation targets. Choline alfoscerate, streptokinase, streptodornase, acetyl L-carnitine, and oxiracetam were selected simultaneously as subjects for clinical reevaluation and the reevaluation of reimbursement adequacy. As a result, acetyl L-carnitine and oxiracetam were withdrawn from the market after failing to prove clinical utility and were naturally excluded from receiving reevaluation on their reimbursement adequacy. In the case of streptokinase, some indications that failed to prove clinical usefulness were removed, and there is a high possibility that the remaining indications will also be deleted following the other reevaluations. Employees in charge of related affairs express extreme fatigue caused by the excessive and redundant reevaluations. Although the government claims that the legal basis and purpose of each reassessment are clearly different, the pharmaceutical industry's criticism is that there is no significant difference in the methods each uses to select subject drugs, assess the adequacy of reimbursement, and prove clinical usefulness. In addition, the officials had to painstakingly reevaluate the prices of 20,000 generic drugs. Even though these drugs were legally approved and listed for reimbursement, the pharmaceutical industry had no choice but to conduct bioequivalence tests for the sole purpose of maintaining drug prices. Even though the generic drug pricing re-evaluation is not complete, pharmaceutical industry officials say they have no time to rest. This is because a bigger wave of ‘overseas drug price comparison reevaluation’ is expected to land soon. The MOHW had announced that it will conduct a reevaluation and compare the price of listed drugs with their overseas prices next year. The MOHW plans to finalize the reevaluation criteria within the year, report it to the Health Insurance Policy Deliberation Committee, and implement it in earnest next year. This means that next year, in addition to the ongoing reimbursement adequacy reevaluations and clinical reevaluations, a reevaluation for comparison with overseas drug prices will also be carried out simultaneously. In particular, anxiety appears to be rising as the scope and range of drug price cuts are expected to be larger than that made by the existing reevaluations. In addition to anxiety, uncertainty is also rising due to repeated reevaluations every year and the various accompanying measures that follow. But above all, constant reevaluations are serving as the largest barrier. Complaints are rising constantly on how so many reevaluations are taking place simultaneously. The data that must be submitted amounts to hundreds or thousands of pages. Some have been cynically joking that a department dedicated to reevaluation should be established. And so it seems fair to say that the pharmaceutical industry is indeed suffering from reevaluation neurosis.
- Opinion
- [Reporter’s View] MFDS makes changes ahead PIC/S reeval
- by Lee, Hye-Kyung Sep 13, 2023 05:28am
- The Ministry of Food and Drug Safety will be amending the ‘Regulations for Good Manufacturing Practices for Medicinal Products’ as preannounced ahead of PIC/S re-evaluations. The main point of the amendment is to amend the GMP for sterile medicinal products to align with those of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S). This includes the establishment of a contamination control strategy through quality risk management and the establishment of management standards for the latest aseptic manufacturing equipment and technology. The main purpose of the amendment is for the MFDS to prepare for the PIC/S reevaluations that will be held next year. This is because member countries are obligated to implement the PIC/S’s GMP regulations to maintain their member status. PIC/S is the only organization worldwide that promotes the international harmonization of GMP and inspection procedures. Since its establishment in 1995, 56 regulatory agencies from 53 countries, including the US FDA, the UK, France, Germany, and Japan, have joined as members. Korea became the 42nd country to join in 2014 but will be subject to reevaluation of its PIC/S member state requirements starting in H2 of this year. As part of the reevaluation process, the PIC/S will visit Korea in H1 next year. In order to receive a good evaluation, the latest revisions to PIC/S GMP regulations must be reflected in Korea’s regulations as well. This is why the MFDS prepared ‘Regulations for Good Manufacturing Practices for Medicinal Products (Plan) that reflect the latest PIC/S GMP regulations that include improvements to the GMP for sterile medicinal products. PIC/S member countries can receive benefits such as the waiver of some procedures including on-site GMP inspections when exporting pharmaceutical products to other member countries. Therefore, the membership status can strengthen the competitiveness of domestic pharmaceutical companies seeking to export products to other countries. Therefore, the MFDS has been preparing to amend the regulations since 2021 ahead of the PIC/S reevaluations. The Ministry of Food and Drug Safety expects that there will be no difficulties in implementing the amended regulations, as it has set a sufficient grace period for its enforcement in consideration of industry opinion on their need for ample time to prepare for regulatory implementation. However, there are bound to be difficulties following the introduction of new systems, due to the addition of new personnel or new facilities such as lyophilizers and sterilization equipment. At the information session MFDS will be holding for managers of domestic sterile medicinal product manufacturing plants from the 19th to the 20th, the reporter hopes that the authorities will hold an ear out to the voices in the industry and make efforts to reflect the opinions into the system.
- Opinion
- [Reporter's view] What is the solution
- by Eo, Yun-Ho Sep 13, 2023 05:28am
- A drug is so effective that it is difficult to discuss listing it for insurance benefits. Although it has proven a very large improvement in survival rate compared to existing drugs, this actually increases uncertainty in health insurance, making it difficult to estimate cost-effectiveness. Since no patients die in clinical trials, costs increase. The important point is effect estimation. OS can only be counted when the patient dies, but since no one dies, calculating OS becomes difficult. Paradoxically, if the effect of the drug is too good, the cost will definitely increase, but the problem of not knowing how much the effect will increase arises. However, the clinical results are excellent. Drugs that are truly the best of all time are emerging right now. So what is the solution to these drugs? Currently, the government is requesting a financial sharing plan, but this is not a regular regulation. I think it is time to consider establishing a fundamental evaluation system for the value of social requirements themselves. Decisions related to healthcare are a process of compromise between many complex and conflicting factors. Multiple-criteria decision analysis (MCDA) is a type of decision analysis designed to transparently integrate multiple considerations in decision-making situations where multiple criteria act simultaneously. Using such a structured and explicit approach can improve the quality of decision-making, and its application in the medical field has recently been increasing. There is an increasing discussion on the introduction of MCDA as a decision-making support tool related to pharmaceutical reimbursement in countries other than these countries. In Spain, MCDA is referred to as a method of systematic evaluation procedure that helps consistent decision-making and ensures equity in access to medicines when evaluating early access to medicines and indications before approval and reimbursement. MCDA faced opposition domestically. However, on the other hand, it is already being used domestically. In accordance with the National Health Insurance Comprehensive Plan, the Ministry of Health and Welfare is conducting a reevaluation of drug coverage adequacy every year, starting with Choline alfoscerate, a brain function improvement drug, in 2020. At this time, clinical usefulness, cost-effectiveness, and social needs are used as criteria to evaluate the adequacy of benefits. Comprehensive evaluations such as MCDA may have interpretation difficulties depending on the weights and methodology, but the reality is that the current new drug registration method relies too much on cost-effectiveness and does not reflect the characteristics of each drug. Now is the time to take action.
