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- 2026-04-30 19:05:29
- 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.
- Opinion
- [Reporter's view] Obesity-themed stocks
- by Lee, Seok-Jun Sep 11, 2023 05:29am
- The theme stock craze is happening again. This time it is related to obesity treatment. Companies that ride on theme stocks easily hit the upper price limit. There is also a bio venture that recorded the upper limit three times, ‘up, up, up’ on the full moon. It is easy to find companies whose market capitalization has doubled in just a few months. As obesity treatment has recently become a global issue, the corporate value of related theme stocks is also increasing. In fact, Eli Lilly ranked first in market capitalization among global pharmaceutical companies as its diabetes treatment (Maunjaro) showed effectiveness in treating obesity. It can be seen as ‘theme stock = future growth potential’. The possibility leads to a rise in ransom prices. Everyone can understand the upper price limit phenomenon to some extent. However, we need to take a closer look. Above all, attention should be paid to the feasibility of realization (commercialization). This is because most of the theme companies only discovered the possibility of treating obesity in the early stages of clinical trials. These are materials that have potential but still require time and money to create substance. Hanmi Pharmaceuticals, which is preparing for phase 3, is only in late-stage clinical trials for some products, including 'Efpeglenatide'. Even if it is developed, it must be checked whether it is the first in class, the best new drug (best in class), or simply a drug in the same class. You should also look at the development status of other competitors. Only then can you truly know the corporate value of theme stocks. Some companies launch large-scale promotions related to themed stocks. “We discovered the potential for an innovative new drug in preclinical trials,” “We are negotiating with a number of global companies for technology transfer,” and “We have overcome the limitations of the world’s No. 1 obesity formulation.” Just looking at the press release, it appears that it has already achieved innovative new drug status. At this time, stock prices fluctuate. Some even feel pressured to promote even the slightest possibility in order to belong to a themed stock. In reality, Pharmaceutical Company A is under pressure from its owner. Bio ventures that need financing are also active. Companies under put option pressure are busy riding theme stocks. Raising the stock price makes it easier to raise funds and avoid put option pressure. “It is safe to say that corporate value is based on theme stocks. Objective figures such as performance do not apply. I believe rapid fluctuations are determined simply by whether influence is brought in or not. This is why companies related to theme stocks are excessively promoting them. In particular, to raise funds, etc. “Bio ventures that need to raise their stock prices sometimes throw unreasonable numbers.” This is not an unconditional criticism of the theme stock craze. In the case of a company, it must make its value known. However, what is unfortunate is that companies are often found to focus on increasing market capitalization by riding the bandwagon of theme stocks rather than the company's original value. It is also unfortunate that the market trend is ‘theme stocks, power = market cap’ rather than ‘performance, potential = market cap’. On the other side the surge in theme stock prices is a bitter reality.
- Opinion
- [Reporter's view] Massive drug price cuts
- by Kim, Jin-Gu Sep 06, 2023 05:36am
- Generic proliferation. It is the root of all evil. At least that's the case from the government's perspective. When the valsartan incident occurred in 2018 and the ranitidine incident the following year, everyone knew that the essence of the incident was impurities, but the government continued to point out that the proliferation of generics was the problem. The government said it would reduce the proliferation of generic drugs. A new drug pricing system was proposed in July 2020. The new rule set by the government was that the drug price would be reduced if one of the two was not done, whether it was conducting an in-house BA test or using registered raw drug products. It is an ambitious plan by the government to prevent the proliferation of generics. Finally, the time has come to reevaluate already registered generics. The government proposed qualifications such as its own BA testing and use of registered raw drug substances. They said they would reduce the price of drugs by up to 27% for drugs that do not have these two pieces of data. Approximately 23,000 generics suddenly underwent this qualification verification. Pharmaceutical companies face a moment of choice. More than 7,000 generic drugs accepted the fate of lower drug prices. As of September 5, the government lowered the prices of 7,355 generic products. The pharmaceutical industry is expected to lose more than 300 billion won per year. Can the government, which seeks to resolve the proliferation of generic drugs and further secure the financial soundness of health insurance, be free? Initially, the government proposed a new drug pricing system, saying it would solve the proliferation of generics, and at the same time gave a grace period of nearly two years. During the grace period, pharmaceutical companies approved generics as if it were their last chance. Pharmaceutical companies received approval for insurance use of drugs they had no intention of selling, and these products became the subject of this reevaluation of generic drug prices. It is time for generics to be sorted out. Many of the targets of this drug price cut were for insurance purposes, not for sales. The government is required to take a more responsible attitude. A sufficient explanation is needed to resolve the issue caused by incorrect policy judgment using a different logic. It is difficult to look at the direct and indirect losses to the pharmaceutical industry, distribution industry, and pharmacy prices resulting from the price reduction of 7,000 generic drugs as if it were someone else's problem.
- Opinion
- [Desk’s View] Compensate for the value of novel drugs
- by Lee, Tak-Sun Sep 06, 2023 05:36am
- The Ministry of Health of Welfare plans to soon announce an appropriate compensation plan for the innovative value of new drugs, including novel homegrown drugs. The health authorities’ plan is to deliberate its plan by the Health Insurance Policy Review Committee within the month and release the results to the public soon. The domestic pharmaceutical industry is hoping that this measure will provide additional points to non-inferior new drugs. Non-inferior new drugs contain new active ingredients and have proven to be non-inferior to existing drugs. Most new drugs developed in the domestic pharmaceutical industry fall into this category. The novel homegrown drugs, No. 36 'Envlo Tab,' No. 34 'Fexuclue Tab,' and No. 30 'K-CAB' have all demonstrated their noninferiority to existing drugs in clinical trials. However, the insurance price ceiling for these drugs had been set below the weighted average price of their alternatives because they were unable to demonstrate superiority over existing drugs. As a result, the price of Envlo Tab was set below 90% of previously released SGLT-2 inhibitors in the same class, and Fexuclue Tab was priced below the weighted average price of previously released P-CAB class drugs and PPI class drugs. K-CAB, which was listed with reimbursement in March 2019, was able to receive a relatively high price as it had benefitted from the ‘global innovative new drug pricing premium’ that was applied at the time. However, the preferential pricing plan for global innovative new drugs arose as a discriminatory element during the Korea-US FTA negotiations and was nearly non-existent at the time. The pharmaceutical industry has been criticizing how the current price calculation method for domestically produced new drugs is not sufficient to compensate for the industry’s new drug development efforts. The MOHW’s compensation plan for the innovative value of new drugs under review this time is the result of the continuous efforts of the domestic industry that has continuously raised the need to provide preferential pricing for domestically produced new drugs. In 2013, the MOHW reported to the National Assembly that the development of a domestic new drug costs an average of KRW 22.2 billion and takes 9 years and 8 months. As these results were from 10 years ago, the average cost of new drug development would have only increased further since then. In Korea, where drugs are covered by health insurance, companies need to receive a high insurance drug price to make up for the enormous costs of developing new drugs. The companies can determine when they could retrieve their investment according to drug price. Moreover, as the companies that developed the homegrown new drugs seek to expand overseas after initial release into the domestic market, it is beneficial for the companies to receive a high insurance price for their drugs in Korea, as it will serve as a future reference price for their price abroad as well. Above all, if the government wants to foster and improve the competitiveness of Korea’s pharmaceutical industry, it has to provide preferential treatment to these homegrown new drugs. The profit margins of the domestic pharmaceutical industry have been dropping significantly as generic drugs, which had been the main driver of the industry until now, are not making enough profit as they are constantly subject to price cuts to ensure the financial soundness of the National Health Insurance. The losses arising from the price ceiling reevaluations that were conducted this time are expected to amount to KRW 300 billion. In this environment, who would want to develop a new drug and suffer the huge amount of costs incurred? If lowering the price of generic drugs, which companies depend on to fund new drug development, is inevitable, the value of new drugs must be recognized to create a virtuous cycle that encourages new drug development. In addition to providing preferential drug pricing at the time of initial listing, the government should fully compensate for the value of homegrown new drugs by ensuring that the prices are not later reduced through post-marketing control measures such as price-volume agreements. We need new drugs to raise the competitiveness of the Korean pharmaceutical industry in overseas markets. If the government has set its sights on fostering homegrown new drugs, it should focus on what it needs to support and stop being indecisive.
- Opinion
- [Reporter’s View] Disclose PVA results in advance as well
- by Lee, Tak-Sun Sep 04, 2023 05:04am
- The government announced the 7,000 drug items whose insurance price ceiling will be lowered according to the reevaluations that were conducted in advance. This preemptive measure was made out of concern over the large settlement of price differences and returns that may occur with the price adjustment. The product list and upper limit price were released on the 23rd of last month and were publicly notified on the 1st. The price adjustment will be applied in the field from the 5th. The public health authorities accepted the opinion of the Korea Pharmaceutical Association and others who requested sufficient time to prepare for returns and settlement of differences before the price adjustments. However, there remains some to be desired. In addition to those that were adjusted post-reevaluations, the insurance price ceiling of 134 other items had also been adjusted through the PVA (price-volume agreement) system. The adjusted price for the PVA price cuts will also become effective as of the 5th. Among the PVA price cut items, the prices of some have been further reduced due to the reassessment of the price ceiling, so the implementation of the PVA price adjustments was changed to match the price ceiling reevaluation schedule to prevent confusion in the field and reduce administrative costs. 18 items have undergone both PVA and price ceiling reevaluations. If the PVA price cuts were first implemented on the 1st of this month as scheduled, then the price ceiling reevaluation adjustments implemented on the 5th, these drugs would have had to change their price twice in one month. In this sense, setting the same implementation date for the two was reasonable and correct. However, it would have been better if the government had disclosed the PVA-adjusted drug items in advance as well. The price ceiling reevaluation results were released on the 23rd of last month, but the PVA list was released only on the 31st, after completing the Health Insurance Policy Deliberative Committee (HIPDC) review. Wholesalers and pharmacies have expressed the opinion that more preparations were needed for items on the PVA list, due to the high volume of returns necessary for some of the frequently used items. However, unlike the price ceiling reevaluations, the adjusted insurance prices were not announced in advance for the PVA items, increasing inconvenience in the field. Why the PVA list was not disclosed in advance, unlike the price ceiling reevaluation results, remains a question, as the effective date for the price ceiling adjustment for the two drugs was set at the same date, on the 5th. It is interpreted this may have been in line with the principle of non-disclosure before HIPDC review, but it is regrettable that the government was unable to show some flexibility, given that the price ceiling reevaluation results that were disclosed were also yet to receive HIPDC review at the time of disclosure. As a result, while 14 days were given to prepare for the return of items that underwent price ceiling reevaluations, only 6 days were given to prepare for the return of the PVA items. Another problem is that the prices of some items that are on the price ceiling reevaluation list will further be reduced due to PVA. If companies had prepared to settle their accounts based on the prices indicated in the price ceiling reevaluation list that was disclosed on the 23rd, they would have had to make re-readjustments to their accounts. In this sense, the imperfect data that was disclosed to prevent on-site confusion has burdened the site. This too could have been prevented if the PVA results had been transparently disclosed on the 23rd. The government's pre-release of the list of drug price cuts and postponement of the PVA implementation date are commendable in that they considered the confusion that will be caused by returns and balance settlements after the price adjustments. However, the measure should have been more well thought out. It would be best if the Ministry of Health and Welfare, which is in charge of the price ceiling reevaluations and PVA, put some more considerations into its measures.
- Opinion
- [Reporter’s View] M&A storm blows through industry
- by Lee, Seok-Jun Aug 30, 2023 05:32am
- At a dinner party with a second-generation owner in his 40s, I asked what the company’s goal is for the second half of the year. It was sort of an icebreaker question to warm up the party atmosphere. What I expected was a routine response, such as 'we will be building growth engines by investing in R&D or facilities', ‘we will promptly develop new products into blockbusters’, 'We will maximize profitability by reducing costs', or 'We will increase efficiency in management through the integration of the organization and personnel relocation.’ But the response he gave was completely unexpected. “We plan to prepare for an M&A.” The simple response indicated how the industry has changed over the years. The perception of M&As in the pharmaceutical industry has changed in line with the generation shift in its management, which has been passed on from the founder to second or third generation owners. The plan was also specific. The owner knew the characteristics of the business structure, the stake of the largest shareholder, and the market cap of the companies he was eyeing. He said, “There are many old pharmaceutical companies with weak governance structures. If they can create synergy with our company, there is no reason not to consider an M&A. We are considering several candidates. Our company has a lot of cash, so we can buy companies whose largest shareholder's stake is around 10-15%. The era of selling generics to grow the company is now in the past. Instead of paying commissions for CSO sales, M&A is more cost-effective.” ' I also asked another second-generation owner in his mid-50s whether he had plans for M&As as well. ‘Of course’ was the answer. He said, "If the need for M&A was recognized in the past, this is now the time to act on it." Citing the case of GC Pharma and Ildong Pharmaceutical, he emphasized that being tied to past relationships will only hinder efficient business management. “Whether the owner can lead his/her employees well is a core competency required for owners. You may miss opportunities if you give up M&As because you have known each other for a long time. If GC Pharma and Ildong Pharmaceutical's big deal had occurred, it would have been another milestone for the pharmaceutical industry. At that time, the deal was criticized as a hostile takeover, but the view on M&As has now changed. It has now become one of the pillars of business management." To collect a more collective opinion of the industry, I continued to ask the same question to second and third generation owners on their opinion of M&As. Most of the owners had a positive attitude towards M&As. Some also hinted at specific plans, such as a specific pharmaceutical company and accompanying financing plans. However, a conservative mindset regarding M&As remains in the industry still. There are cases where companies acquire bioventures, cosmetics, and functional health food companies as a means of business diversification, but large-scale M&As between pharmaceutical companies are rare. PharmaResearch and CTC Bio, which have been fighting over shares, is the M&A possibility that currently exists in the field. The change is palpable. Following the attitude of its second and third generation owners, the companies’ attitude towards M&A has changed to take on a more pro-M&A stance. Times have changed, and things that seemed impossible in the past are now being taken for granted. In this context, could it be that an M&A storm is blowing through the industry? At least, the second and third generation owners' perspectives are more pro-M&A for sure. Although M&As are not the answer for everything, if it can be considered as a means of business management and used wisely, it has ample potential to bring another boom in the pharmaceutical industry.
- Opinion
- [Reporter's view] Hemophilia drug war of nerves
- by Kim, Jin-Gu Aug 24, 2023 05:46am
- GC Pharma snipes JW Pharmaceutical. Hemlibra, a hemophilia treatment that JW Pharmaceutical is introducing and selling in Korea, became the target. GC Pharma distributed a press release on the 21st. It is a press release titled, 'The report rate of abnormal blood clots in Hemlibra was 2.8 times higher than Factor XIII.' This press release was written based on the information presented at the American Society for Bleeding Disorders Conference. Based on the U.S. Food and Drug Administration (FDA) adverse event reporting system, JW Pharma's Hemlibra and GC Pharma's XIII formulation were compared. As a result, Hemlibra's thrombotic adverse event reporting rate was 4.07%, which was 2.83 times higher than Factor XIII's 1.44%. it was the content. It is unusual. It is true that cases of sending a press release directly mentioning and comparing competing drugs to the company's official e-mail address were rare, except for a few biopharmaceutical companies. In the biopharmaceutical industry, rather than directly mentioning the product name of a competing drug, it used to be expressed in terms of ingredient names. It was read with the intention of highlighting the side effects of competing drugs and finding fault with them, rather than revealing the advantages of the company's products and comparing them with competing drugs. Moreover, it was completely omitted from the press release that GC Pharma's Factor XIII drug showed a higher number of total adverse event reports and serious adverse event reports in the same data. There are many cases in which the pharmaceutical industry directly compares two drugs. However, this is based on the results obtained through elaborately designed clinical trials. This is because there are many external variables to evaluate the superiority or inferiority of the two drugs based on the simple reporting rate, as in the GC Pharma press release. JW Pharma expressed strong displeasure. In a separate statement, he said, "I am very sorry for the act of officially disparaging a competitor's drug." GC Pharma responded, saying, “There is no intention to disparage,” and that it was “to monitor the side effects of blood clots.” The dominant evaluation is that GC Pharma did something useless over the untimely war of nerves between the two companies. GC Pharma already dominates the domestic hemophilia treatment market through the Korea Hemophilia Foundation. There is no need to distribute press releases with poor comparison results. You just need to confidently compete with clinical data and sales power. Rather, there are opinions that this press release had an adverse effect. This is because the awareness of Hemlibra has increased as a result of this nerve war. At the same time, with Hemlibra accelerating its pursuit, GC Pharma has admitted to being nervous.
- Opinion
- [Reporter's view] There should be no recurrence of the Champ
- by Lee, Hye-Kyung Aug 17, 2023 05:29am
- On the 10th, the Ministry of Food and Drug Safety lifted the suspension of manufacturing and sales of Dong-A Pharmaceutical's Champ Syrup and Daewon Pharmaceutical's Coldaewon Kidsfen Syrup. Champ Syrup, which represents children's antipyretics containing acetaminophen, was produced and distributed again in 128 days, and Coldaewon Kidsfen Syrup in 85 days. Dong-A issued a recall order four times on April 25th, April 28th, and May 31st, starting with the recall of commercially distributed products due to 'concern about unsuitable quality (characteristics, microbial limit) on April 4th. On the other hand, Daewon Pharmaceutical recalled business operators for commercially available products as a precautionary measure following the phase separation phenomenon (concern) on May 18. Although the reasons for the recall of the two items are different, it is unknown when and how the order to recall and destroy the drug will occur. First, Champ Syrup, which had been recalled, went through the return and refund process through pharmacies and online. In addition, when a customer brings a product to a pharmacy, even in the case of products purchased at other pharmacies, normal product exchange or return and refund measures are to be carried out first. Suffering from the Champ Syrup recall process became the pharmacy distributing the product. Perhaps for this reason, Daewon Pharmaceutical, which was advised to recall the business operator, went through the process of returning and refunding the drug directly to the pharmaceutical company without going through the pharmacy. Of course, there was also Coldaewon Kidsfen Syrup, which was confused with Champ Syrup and brought to pharmacies, but pharmacies did not have to accept the product. Champ Syrup and Coldaewon Kidsfen Syrup, which had been discontinued for nearly three months, were canceled at the same time, and it was the pharmacy that was confused again. This is because it was not easy to order antipyretics for children whose production was resumed due to sales at specific hours and restrictions on the number of purchases per pharmacy. As Champ Syrup and Coldaewon Kidsfen Syrup went through a series of incidents such as manufacturing, suspension, and cancellation, pharmaceutical companies were insufficiently prepared to resume distribution due to inconsistent recall procedures and the Ministry of Food and Drug Safety's unilateral cancellation of manufacturing/suspension. Looking at this process, there is a need for support measures such as preparing a consistent procedure for recalls of business operators rather than compulsory recalls in the future and providing time to prepare for preparations such as pre-announcement by pharmaceutical companies in case of the lifting of manufacturing or suspension of drugs with issues such as supply and demand instability. seems to be
- Opinion
- [Reporter's view] Fight between AZ/Janssen
- by Jung, Sae-Im Aug 17, 2023 05:29am
- Since the discovery of EGFR gene mutation in non-small cell lung cancer patients in 2004, EGFR-targeted anti-cancer drugs have made remarkable progress over the past 20 years. Tyrosine kinase inhibitors (TKIs) targeting this genetic mutation have been established as standard therapy through the first generation (Iressa), second generation (Giotrif ·Vizimpro), and third generation (Tagrisso). Among them, Tagrisso is currently the only third-generation EGFR-TKI in the global market and has maintained its top position for more than five years without any competing drugs. The strength of Tagrisso is that it shows better effects than the first and second generations, especially in brain metastasis, which lung cancer patients often experience. Lung cancer is one of the most diagnosed cancers in the world, and EGFR is a major mutation in lung cancer, so global pharmaceutical companies are interested in it. For this reason, pharmaceutical companies have measured the effect of EGFR mutations with various new drugs, and immuno-anticancer drugs are representative. Immunotherapy has changed the paradigm of lung cancer treatment and brought about groundbreaking results. However, even this was not as effective as expected in patients with EGFR mutations. Only the recognition that EGFR-mutated lung cancer should be treated with targeted anticancer drugs has become more solid. Since then, the attention of pharmaceutical companies has been focused on 'Next Tagrisso'. AstraZeneca is betting on combination therapy using Tagrisso to protect its status, while competitors are betting on a combination therapy that has developed a new drug with a new mechanism. In the second half of this year, a true swordsman battle will unfold between those who want to protect and those who challenge. AstraZeneca plans to present the results of the FLAURA2 study, a phase 3 clinical trial comparing Tagrisso with chemotherapy alone, at the World Lung Cancer Society in September. In October, Janssen will present at the European Society of Oncology (ESMO) the results of a phase 3 clinical MARIPOSA study comparing Rybrevant, an anti-cancer drug targeting EGFR exon 20 insertion mutation, and Leclaza, an EGFR-targeting anti-cancer drug introduced from Yuhan Corporation, compared to Tagrisso. Currently, the two clinical trials that are directly compared with Tagrisso, the global first-line standard therapy, are both trying to change the standard treatment. Of course, it was Janssen who had a greater ripple effect in case of success. This is because it combines a TKI with a new mechanism called Rybrevant and a TKI similar to Tagrisso. Global market research firm 'Evaluate Vantage' explained the market value of the two studies earlier this year, "The MARIPOSA study has two chances to beat Tagrisso by comparing Rybrevant + Leclaza combination therapy and Leclaza monotherapy, respectively, with Tagrisso." did. The market research firm also commented, "Given the advantages MARIPOSA holds, the results of the FLAURA2 study may reduce the threat of Leclaza, but may not completely eliminate it." While AstraZeneca has already announced that it has demonstrated improvement in the primary endpoint in the FLAURA2 study, the market is paying keen attention to how much improvement Tagrisso + chemotherapy would have shown, and how the results of the MARIPOSA study, which are still veiled, will come out. It is very likely that standard treatment options will increase in EGFR-mutated lung cancer. This means that the patient's prognosis will be further improved. In addition, within EGFR, customized treatment may be possible depending on the subtype and health condition. This is good news for Korea, which has a high proportion of EGFR mutations. So, the results of the second half are expected.
- Opinion
- [Reporter's view] Prompt benefit registration
- by Eo, Yun-Ho Aug 10, 2023 05:33am
- These days, the word 'expedited' appears frequently in the reform of the insurance benefit system. The plan is to speed up the listing of necessary new drugs by linking approval, and evaluation, and shortening the listing period at each stage. This is a good intention to quickly expand drug coverage for patients who are waiting. Shortening the insurance benefit registration period for pharmaceuticals has been discussed almost every year, and in fact, the regulatory period is getting shorter and shorter. Both the HIRA and the NHIS' evaluation and negotiation phases are similar. However, it is only a deadline for pharmaceutical companies to apply and review them. First of all, not a few pharmaceutical companies spend a considerable amount of time in the process of obtaining approval from the head office and requesting actual reimbursement. In other words, they are thoroughly flirting with an idea. If the registration process of drugs that have long passed the review period is traced back, there are many cases in which the Subcommittee on Drug Reimbursement Standards voluntarily withdraws after the decision to delay the review. However, there are many cases where this voluntary withdrawal is not 'voluntary'. In drug price negotiations between the NHIS and pharmaceutical companies, delayed decisions are made as if they were eating rice. The 60-day negotiation period is a promise. While announcing a proposal to shorten the deadline for domestically produced new drugs, is called a 'benefit'. However, there is no transparency in this whole process of the NHIS and the HIRA. Before simply promoting 'speed', concerns about transparency should be added. Just as the results of the Pharmaceutical Reimbursement Evaluation Committee and the Cancer Disease Review Committee were switched from non-disclosure to disclosure, discussions on the disclosure of information as much as possible in the new drug reimbursement process are now necessary. If drug price negotiations break down and additional disclosure of drugs that have been delayed after the application for reimbursement is made, the predictability of those waiting and watching will increase, which will lead to the establishment of effectiveness in shortening the evaluation period.
