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- 2025-12-19 19:06:32
- Opinion
- [Reporter’s View] Still no news on SGLT-2 combo reimb.
- by Eo, Yun-Ho Apr 06, 2022 06:06am
- Still no news nor progress has been made on the discussions regarding reimbursement of combination therapies using SGLT-2 inhibitors. After a long three years, the Health Insurance Review and Assessment Service called for a diabetes expert meeting to discuss expanding reimbursement of SGLTL-2 inhibitors in September last year. At the meeting, the experts saw consensus on integrating and accepting the ‘class effect’ of DPP-4 and SGLT-2 inhibitor combinations as well as three-drug combinations for reimbursement. Such results had sparked hope that the non-reimbursed combination drugs would also be finally listed for reimbursement. But that was the last spark of hope. The year has passed and April has come with no news on the reimbursement of SGLT-2 combos that is now subject to formal review by the Health Insurance Review and Assessment Service. Recognizing the expected efficacy of drugs with the same mechanism of action is an issue that requires consideration. However, with the interests of various experts and pharmaceutical companies clashing, and the opinions of the experts divided, the issue was dealt with case-by-case. However, consistency was the issue for the reimbursement deliberation of SGLT-2 inhibitors. The authorities recognized the class effect of some drugs are recognized regardless of their indication and applied the same reimbursement standard, while other cases of reimbursement for some classes differ by each drug. In 2013, the diabetes society played a leading role in discussing the reimbursement extension of DPP-4 inhibitors and TZD class combos and claimed the need and justification for the extension. The society emphasized the importance of clinical experience and expert judgment over fiscal impact, and the government accepted the expert’s decision based on disease characteristics and drug use experience. What has changed since then? The academic society changed its position on the reimbursement of SGLT-2 inhibitors in 2018 and pushed back the plans for the proposed improvement. Many drugs were expected to be affected by the plan, not only SGLT-2 inhibitors such as ‘Jardiance (empagliflozin),’ ‘Forxiga (empagliflozin),’ ‘Suglat (ipragliflozin),’ ‘Steglatro (ertugliflozin)’ but DPP-4 inhibitors such as ‘Januvia (sitagliptin),’ ‘Galvus (vildagliptin),’ ‘Trajenta (linagliptin),’ ‘Zemiblo (gemigliptin)’ were affected. However, the amendments that were made thereon were encouraging. The society had reached a consensus and submitted an opinion that reimbursement should be extended to combination therapies, which was accepted by the Ministry of Food and Drug Safety. The MFDS then announced it would ‘simplify’ the diabetes treatment indications in August of the same year, from listing the ingredients to ▲monotherapy or ▲combination therapy, adding momentum. The various movements made had borne fruit. And then the baton was handed over to the government. The SGLT-2 inhibitors are now also subject to PMS. Most of the drugs are required to submit their PMS results between 2023-2024. In other words, the companies only have around a year or two left. For the PMS study, hundreds to thousands of patients need to be recruited and registered. However, due to the characteristic of the diabetes market, it is hard to secure a stable proportion of prescriptions for a non-reimbursed drug. Unless the reimbursement issue is resolved, the companies will not be able to recruit the necessary amount of patients required by the MFDS. Now is the time to conclude this issue once and for all, and decide on extending reimbursement for SGLF-2 inhibitors.
- Opinion
- [Reporter's view] Commercialization of innovative new drugs
- by Lee, Tak-Sun Apr 05, 2022 05:58am
- #iLast month, immuno-cancer drug Keytruda was listed as the primary treatment for non-small cell lung cancer patients, and this month, the first chemical antigen receptor-T cell therapy (CAR-T) Kymirah received insurance benefits. Innovative treatments using patient immunity have succeeded in commercializing them in Korea one after another. The registration of the two drugs is significant. In terms of health insurance finance, the entry of ultra-high-priced drugs became a reality, leaving homework on rational financial management. From the perspective of medical staff and patients, the emergence of new paradigm drugs that go beyond the limits of existing treatments is raising expectations to increase the treatment effect. Immuno-cancer drugs such as Keytruda block the interaction of certain proteins that deactivate immune cells (T cells), making T cells more aware of cancer cells. CAR-T collects the patient's immune cells, mounts special receptors, puts them back into the patient's body, and finds and kills cancer cells that avoid attacks from T cells. While existing anticancer drugs directly attack cancer cells, there is a big difference in that immuno-cancer drugs or CAR-T treat cancer using the immune system. Moreover, it is in the spotlight as a next-generation drug that will lead chemotherapy in the future as it proves its high therapeutic effect in certain areas. Although next-generation drugs with such high therapeutic effects are expensive, it is encouraging that they have been commercialized in Korea. It is very unfortunate that the technology gap with the global market is gradually widening when looking back on the domestic pharmaceutical industry, which the state promotes as a future growth engine. Domestic pharmaceutical and bio companies are also developing immuno-cancer drugs and CAR-T, but they are still in the stage of seeking commercialization success. There is a big difference in level from Big Pharma, which has already completed commercialization and has grown into the highest-ranked drug. Contrary to investors' expectations, which are driven to pharmaceutical and bio stocks only by the possibility of development, it is necessary to calmly realize that the domestic pharmaceutical and bio industries are falling further behind. The new government also intends to actively invest in the pharmaceutical and bio industries. However, there seems to be no specific way to invest in an industry with any competitiveness. The current government and the new government also seem to focus solely on finding domestic pharmaceutical companies as a consignment production destination for overseas development COVID-19 vaccines, with biosimilars jumping into large companies. The government's diagnosis of the domestic pharmaceutical industry is to realize that it lacks thorough reflection than cheers and expectations for short-term performance. If there were mid- to long-term support for cell therapy when the world's first cell therapy was born in the early 2000s, wouldn't it have imitated CAR-T?
- Opinion
- [Reporter’s View] Regrets in GOV's COVID-19 responses
- by Mar 30, 2022 06:09am
- “Gullmoosae” is a newly coined Korean word commonly used by stock investors to refer to investors who have lingering buy/sell regrets. The word is a combination of the Korean word ‘~halgul (should've)’ and the bird ‘engmossae (parrot),’ which describes the individual investor who regrets the past every time without buying or selling in advance. The government’s response to COVID-19 is not so different from these ‘Gullmoosae’ investors. Korea has already suffered two out-of-stock crises - the lack of COVID-19 self-diagnosis kits in January followed by the lack of respiratory disease treatments such as cold medicine and antipyretics in March – due to the surge in demand that arose due to the government’s policy change to ‘With-COVID-19’ earlier on this year. The government had urgently requested companies to expand their productions after the issues arose, but this was not the kind of problem that could be resolved in a matter of days. Just take the COVID-19 self-diagnostic kits as an example. The government had shown reluctance in using the tests until last year, citing the low reliability of the tests. As a result, the kits were approved, but rarely sold in the pharmacies and were considered a nuisance. This was why the companies had minimized the production of domestic products and increased exports. And then, the companies received this request for mass production from the government after a sudden policy change. The companies were barely able to meet the requested amount by changing the export products to domestic use and temporarily including value-pack products. However, most were taken by the government, and It was difficult to find kits on the market. Also, the front-line pharmacies experienced chaos due to the work of subdividing kits and fluctuating prices. Consumers also had to go from pharmacy to pharmacy and convenience stores to purchase the kits. The situation caused by the shortage of respiratory disease treatments is more severe. Not many companies specialize in treating respiratory diseases, and the companies had reduced their target manufacturing goal compared to the previous years. However, with the rapid surge in the number of COVID-19 cases, companies were suddenly hit with the sold-out bomb. It was only at this time around that the government hurriedly called on the pharmaceutical companies to and visited production plants to request supply expansions. However still, with large amounts of the urgently produced supplies taken by the government, customers are still having trouble finding the drug at pharmacies. The government’s complacent policy judgment was what caused this confusion throughout the industry. Due to the unplanned increased supply of cold medicines, pharmaceutical companies are unable to produce the other medicines. Eventually, the out-of-stock situation that was limited to cold medicines has spread to other unrelated medicines. And the pharmacists and pharmaceutical company employees were left to deal with the numerous inquiries that arose. The government had started considering transitioning to the With-COVID-19 around mid-last year. Although the period of the transition was adjusted due to various variables including the spread of the Omicron variant if the government had simulated the various situations that could arise when switching to the With-COVID-19 era, they could have stockpiled a sufficient amount in advance. It is not difficult to predict that the demand for self-diagnostic kits would increase if people who are not in the high-risk group are first tested with self-diagnostic kits, and the increase in patients with mild symptoms would increase the demand for cold medicines and antipyretics. In this sense, the journalist hopes that the government leaves no more regrets behind in the making of its measures for COVID-19.
- Opinion
- [Reporter’s View] Specific healthcare plans are required
- by Lee, Jeong-Hwan Mar 24, 2022 05:54am
- President-elect Suk-Yeol Yoon’s transition committee has officially started working. Due to the COVID-19 pandemic, Yoon’s transition committee has opted to separately establish a special committee for COVID-19 response and operate the healthcare sector through the subcommittee for social affairs, welfare and culture. Therefore, policies on COVID-19 control, domestic health, and welfare, as well as pharmaceutical and bio-industry will be jointly established by the special COVID-19 committee and the social affairs, welfare, and culture. subcommittee. After the 20th presidential election ended with Yoon’s victory, the domestic healthcare and pharmaceutical-bio industry officials keenly eyed the composition and direction taken by Yoon’s transition committee, as it would become the basis of the next administration. The policy guidelines that the special COVID-19 committee and the social affairs, welfare, and culture subcommittee establish will greatly affect the direction of work of those in the industry. The return of the transition committee is special in that it is the first committee of its form in 10 years and that it works to identify the organization and function of the government and sets a policy base for the new government. Therefore, the committee needs to prepare specific measures and plans for funding to realize the pledges that were made by Yoon. The committees would need to design a more detailed action plan that goes beyond the implementation plan and fiscal measures that Yoon had set as a candidate to promote policies that minimize uncertainty. The direction Yoon takes to implement his pledge acts as an important reference point for pharmaceutical companies in Korea and abroad in developing new drugs and devising business strategies. The healthcare, pharmaceutical, and legal community all began to revisit Yoon's healthcare pledges while working to identify the transition committee’s direction of work in realizing Yoon’s pledges. In addition, government affairs officials in every industry are also starting to work under the table to lead the policy operation direction of the next government to their benefit. Therefore, the responsibility of the transition committee to devise a specific implementation plan for the inauguration of the next government has also grown. Yoon had defined the current government's COVID-19 response measures as a failure and said that he will implement completely different disease control and prevention measures within 100 days of taking office. Along with bold investments to promote the domestic biopharmaceutical industry, Yoon had pledged to prepare various mechanisms to strengthen patient access to relatively expensive innovative new drugs. Based on the expansion of government R&D in the fields of vaccines, treatments, and advanced medical care, Yoon had also pledged to establish a Pharma-Bio Innovation Committee directly under the Prime Minister and promised to strengthen NHI coverage for disease, establish a separate severe disease fund, and industrialize non-face-to-face treatment. Yoon’s transition committee needs to speed up its drawing up a concrete blueprint to bring the promised health care and biopharmaceutical pledges into reality. Yoon’s fulfillment of his pledges will directly translate to the policy management score of the next government. When and how the science-based COVID-19 management and control system, government R&D support for vaccine sovereignty and the establishment of the global vaccine hub, the establishment of a pharma-bio committee, and fostering key talents in the pharmaceutical and bio-industry, and job creation will be implemented or realized in the pharmaceutical and bio sector will be reflected in Yoon’s grades. The committee will receive reports from each ministry until the 29th and then select the final list of tasks for the new administration for a public announcement in early May. With the kick-off of the transition committee, Yoon’s administration has put to the test its ability to fulfill its pledges and manage state affairs. Since his victory to the kick-off of the transition committee, Yoon had repeatedly stated that he “will not hide behind the public and staff, and will communicate sincerely with the public.” Therefore, expectations rise for the transition committee and on how it will present a clear vision to change and develop the paradigm of the healthcare and pharmaceutical, and bio-industry.
- Opinion
- [Reporter's view] Our attitude toward personalized txs
- by Eo, Yun-Ho Mar 23, 2022 05:51am
- These drugs such as HER2, ALK, EGFR, and ROS1 are keywords that appear more frequently in recent articles related to anticancer drugs Effective treatments for patients vary depending on what genetic mutations the patient has. Starting with treatment HER2, ALK, EGFR, etc., which show excellence in patients in certain conditions, drugs targeting gene mutations such as ROS, NTRK, and RET are now emerging. Advances in precision medicine now herald a shift in prescription standards for drugs from disease to genetic. The era of customized medical care has arrived. Can the Korean system handle these drugs that are effective if genetic mutations are identified regardless of cancer species? It is not easy to expand salaries for target anticancer drugs and cancer immunotherapy that have already been registered. Although drug prices are expensive, valuation should be carried out again as the use increases. This is also the basis for supporting health insurance system. One of the characteristics of these new drugs is that the number of patients corresponding is very small. In other words, there are not many subjects who can prescribe new drugs. The rare type of patient is less than 1%, and the diagnostic efficiency is less than 200. Moreover, doctors explain that this type of patient does not work well with typical standard treatment (existing drugs). The time has come to think about benefit track based on precision medicine. It does not seem to ignore our system, but it seems necessary to prepare a situation-appropriate benefit screening standard for the benefits of treatments regardless of cancer. One more goal of precision medicine is to realize personalized treatment for patients. For customized treatment, tests that can apply the latest research are essential. To this end, it is time to reconsider whether it is necessary to expand essential genes for patient treatment, and to consider improving NGS-based panel tests.
- Opinion
- [Reporter's view] Consistency in the post evaluation
- by Lee, Tak-Sun Mar 07, 2022 05:49am
- Re-evaluation of drugs is underway. The move is aimed at preventing waste of health insurance benefits due to insufficient drugs to verify efficacy. Accordingly, the MFDS is playing a leading role in re-evaluating clinical trials and the HIRA is playing a leading role in re-evaluating the adequacy of benefits. The problem is that there is no consistency in selecting the target drug as the re-evaluation is carried out separately. The MFDS goes through clinical re-evaluation procedures if it fails to prove that it is currently not used in developed countries, the United States, the United Kingdom, France, Italy, Japan, Germany, Switzerland, and Canada, called A8 during the license renewal process. The HIRA is also based on the benefit performance of A8 countries. However, compared to the MFDS, it is excluded from the re-evaluation only if there are two or more countries' performance. However, the HIRA started re-evaluating the adequacy of benefits from the 2020 Choline alfoscerate, a brain function improvement drug. In addition, it targets ingredients worth more than 0.1% of the annual claims and about 20 billion won, so there are not many ingredients subject to revaluation per year. Six ingredients were selected this year and eight next year. The agency in charge of drug approval and registration conducted re-evaluation on different criteria, making it impossible to ensure consistency in the results. Of course, the MFDS verifies the efficacy and the HIRA evaluates the appropriateness of benefits, but basically, it is the same to determine whether the drug is effective or not. The verification of 'clinical usefulness' is the most important indicator for both institutions. Enteron, which went through a re-evaluation last year, was recognized for its appropriateness in treating ophthalmic disorders such as retinal and choroid circulation. The MFDS is also conducting a clinical re-evaluation of the indications, and in the process, the efficacy and effect were limited due to eye disorders in diabetic patients. Streptokinase and Streptodornase, which are subject to revaluation this year, are expected to produce clinical revaluation results next year. This is also a situation where we cannot guarantee the results of this year and next year. Basically, if the MFDS grants a drug license, the HIRA will establish standard based on the license. However, this basic procedure is ignored in the revaluation. Whether the MFDS verifies its efficacy through clinical re-evaluation or not, the re-evaluation will be conducted separately. Conversely, clinical re-evaluation proceeds regardless of clinical usefulness in re-evaluation. It is meaningless for drugs that have not been recognized for their clinical usefulness in revaluation and have been expelled from benefit to be recognized for their efficacy in clinical revaluation. Pharmaceutical companies with Streptokinase and Streptodornase, which are undergoing clinical re-evaluation, are worried about this. Some think that the HIRA is an affiliated organization of the MOHW, and the MFDS is a different independent ministry, so each of them tried to demonstrate their capabilities in the re-evaluation. It is unlikely that the problem will be solved because there is no ministry to adjust this. Anyway, drug licensing and benefit evaluation should be done by an independent institution to be a better choice for national health. The important thing is to keep the basics. The MFDS determines the exact efficacy of the drug, and the HIRA determines whether to pay based on this and applies it to post-reevaluation.
- Opinion
- [Reporter’s View] Why Big Pharmas 'select and focus'
- by Mar 02, 2022 05:54am
- In the famous TV show ‘Backstreet,’ CEO Baek Jong-won’s main advice and solution for small eateries suffering from slow business was to ‘reduce menus.’ Paik tells the restaurant owners to concentrate on their main menus instead of trying everything. Due to his consistent act of reducing menus in every restaurant he consults, he was fondly dubbed ‘BBunos,’ a combination of his nickname ‘BBu the homemaker’ and the ‘Avengers’ villain ‘Thanos’ who eradicated half of all life in the universe. Global big pharmas are also busy ‘reducing their menus.’ The companies are letting go of their main sources of income, in particular, products in their Consumer Health care units that are mainly consumer goods. In this sense, Johnson & Johnson’s announcement of its plan to spin off its consumer division had received much attention. The spin-off will not only transfer the baby powder product that imprinted the J&J brand on the public, but also many familiar brands including Aveeno, Neutrogena, Listerine, etc. The company had also said that the planned separation was a “momentous event” and the “biggest change in direction in J&J's 135-year history.” GSK is also spinning off its consumer healthcare unit. The spin-off, newly named ‘Haleon’ does not contain the GSK name. GSK Consumer Healthcare had been in charge of OTC drugs and consumer goods including popular products such as Sensodyne, Otrivin, and Theraflu. GSK Consumer Healthcare, which had been formed as a joint venture with Novartis, increased its size by adding Pfizer’s Consumer Healthcare business in 2018. However, the company seems to have intended to separate from the business. The company announced its plans to sell the business last year and is known to be considering its acquisition offers. The same trend is evident in other big pharmas as well. Sanofi had transferred all of its OTC drugs to its newly established spin-off of its Healthcare ‘Opella Healthcare.’ Going further, MSD had even transferred its off-patent chronic disease business to its spin-off, Organon. The global pharmaceutical companies are making such decisions to 'select and focus' on their specialty drugs, especially those in the field of oncology, immunology, and rare diseases. Of course, J&J’s decision is being suspected as a sort of ‘sham’ to pass on its responsibility for compensation for its baby powder product, which caused controversy due to the detection of carcinogens. However, the global perception in the industry is that they may survive only by focusing on severe and rare diseases. Also, it has been evaluated the industry reached a limit in growing using OTC drugs and consumer goods. On the other hand, once commercialized, innovative new drugs for severe and rare diseases bring big profit to companies. This is because these drugs may be sold at a high price due to little or no competition and the use of next-generation technology. Such restructuring of businesses through reorganizations of their business units has recently begun in earnest. J&J promised to strengthen its pharmaceutical division at the JP Morgan Health Care Conference in January and aims to achieve sales of ₩70 trillion in its pharmaceutical division by 2025 with next-generation new drugs such as anticancer drugs and CAR-T therapies. GSK also plans to focus on developing innovative new drugs and vaccines. Sanofi also stopped investing in chronic diseases and is broadening its autoimmune diseases and vaccines portfolio. For this, the company bought several early-stage research biotechs rather than those that can generate immediate sales. Last year alone, the company carried out 6 M&As with biotechs. The domestic pharmaceutical industry should eye this trend and movement of global pharmaceutical companies. Although it is impossible to directly compare companies due to the different size and focus areas, domestic pharmaceutical companies are still mainly pursuing the business strategy of providing 'many generics' rather than a single ‘wise drug'. Cash cows are necessary to develop new drugs as this costs an astronomical amount of resources, but everyone knows that it cannot be a long-term survival strategy. It's time for Korean companies to devise their own differentiation strategy on what and which areas to ‘select and focus.'
- Opinion
- [Reporter's view]Will it be different this time?
- by Kim, Jin-Gu Feb 23, 2022 05:49am
- Earlier this month, the government announced "Comprehensive Measures for Stable Supply of National Essential Drugs." In the wake of the COVID-19 crisis, the importance of stockpiling and supplying essential medicines has increased, and the government has stepped up. National essential drugs refer to drugs that are essential for health care, but are difficult to supply stably only with market functions. It will be designated by the MOHW and the MFDS through consultation. Currently, 511 items are designated as national essential medicines. The government announced a comprehensive measure of the same name in 2016. At that time, instead of COVID-19, MERS served as a catalyst for establishing countermeasures. Even then, the government said that a stable supply of national essential medicines is important to cope with the public health crisis. After the announcement of comprehensive measures in 2016, did the stockpiling and supply of national essential drugs improve? The prevailing assessment is that this is not the case. Rather, the suspension of supply of essential national drugs is expanding every year. After the establishment of comprehensive measures, the "Lipiodol incident" occurred in 2018. The reason for repeated supply interruptions is simple. This is because pharmaceutical companies no longer supply them. Currently, the government is compensating pharmaceutical companies that produce and import national essential drugs at the "cost" level. However, the pharmaceutical industry argues that this alone is not enough. Who will step up for the public interest in a structure in which the more they produce, the more damage they incur. The government seems to be fully aware of this reality. In fact, the measures announced in 2016 included contents such as "support for the supply of essential medicines for stockpiling" and "establishment of support measures when the supply is suspended." However, adequate support has not been provided, and the national essential medicine system has been lax and has reached this day. Similar information is included in the measures announced this time. The government said it will support production costs for drugs that have been suspended due to poor profitability. In addition, the government said it would purchase all of its production in the case of rare disease treatments that have less domestic demand than the minimum production. The pharmaceutical industry's response is not positive. It has not yet been decided how much production costs will be supported, but the pharmaceutical industry believes that the scope of support is limited to "production costs," which will be far from appealing to companies. Appropriate compensation is an essential solution for a stable supply of national essential drugs. If a company is judged to make any physiological profits, it will jump into the production of national essential medicines even if the government stops them. You cannot forever appeal to the pharmaceutical industry only for the "public interest." We hope that the details of this measure will include reasonable and appropriate compensation.
- Opinion
- [Reporter’s View] Why set deadlines in pricing negotiations
- by Eo, Yun-Ho Feb 17, 2022 05:53am
- A deadline is a pre-determined set amount of period. If this period is extended frequently, what meaning would setting a ‘deadline’ have? This question arises with the uprise of deadline extensions being made in the drug pricing negotiations between the National Health Insurance Service and pharmaceutical companies for reimbursement listing or reimbursed indication extensions. Simply put, too many ‘exceptions’ are being made. When the drug pricing negotiation period for the 3rd generation lung cancer treatment ‘Tagrisso (Osimertinib)’ was extended five years ago, the media had described the extension as ‘exceptional’ or ‘unprecedented.’ However, so many drugs, especially anticancer drugs, have recently failed to reach negotiations or completed negotiations after the deadline. Even now, more than 3 drugs are in negations past their deadlines. This is why pharmaceutical officials awaiting negotiations sometimes make jokes that “We wouldn’t be able to complete negotiations at once, but maybe during the extended period.” With the introduction of the effective but high-priced drugs, the increased extensions, and exceptions may be implying that the ’60 day’ negotiation period is now not sufficient time for the government pharmaceutical companies to reach an agreement. However still, a deadline is a deadline. Moreover, the reduction of the negotiation period is being used as an incentive and a benefit. In other words, the period was set to accelerate listing and limit the final period of negotiations and allow predictability of listings. However, no either party is fully accountable. The common period extensions, the introduction of more expensive and difficult-to-negotiate drugs, and the lack of determination to produce results within the deadline have led to a repetition of such ‘exceptions.’ Also, the companies’ dragging out negotiations due to delay in communication with its headquarters, and the administrative department’s complacency in postponing the immediate breakdown of negotiations fearing the rush of complaints from patients, undermines the purpose of the system. If discussions became difficult, strengthen the conditions for initiating negotiations. The required documentation should be reviewed and discussed with the NHIS in advance at the HIRA review stage, and the parties should be pressed to complete the negotiations within the set period. Do it “for the patients,’ that both parties have frequently referred to. Frequent exceptions are no longer exceptions.
- Opinion
- [Reporter's view]Predictability should be increased
- by Lee, Tak-Sun Feb 14, 2022 05:54am
- Starting with Choline Alfoscerate, a brain function improving agent, the benefit reassessment, which has been in full swing since last year, has risen again this year. On the 11th, HIRA's Drug Reimbursement Evaluation Committee confirmed the items subject to salary revaluation in 2022 and 2023. Detailed items will be released through the Health Insurance Policy Committee. However, despite the HIRA notice, the target item was released to the media a few hours later. Six drugs, including Godex, were included in 2022 and eight drugs, including Hyaluronic acid eye drops, in 2023. Since media reports, the HIRA has not made any opinions on this. Perhaps this is because the items subject to re-evaluation match. Rather, they seem to be more curious about how the target item was delivered to the media. The exposure of items is due to the constant intelligence activities of the pharmaceutical industry to know the subject of re-evaluation in advance. No matter how much the HIRA cracks down on subcommittees or groups of experts in the committee that deliberate on revaluation targets, it is interpreted that it has not overcome the pharmaceutical industry's desire to predict revaluation projects in advance. This is because the benefit revaluation project is piled up in the veil. When The HIRA announced its five-year revaluation plan last year, it said it would use ▲ 0.1% of claims, or more than 20 billion won ▲ less than one of A8 countries, ▲ policy and social demands, insufficient intellectual drugs ▲ other committees. On top of that, there is an opinion that the registration date may have been considered. However, it is difficult to predict target items based on these criteria. Rather, looking at the selected drugs, most of them have undergone clinical re-evaluation by the MFDS or controversy over their socially usefulness. In fact, it is difficult to predict the order of re-evaluation. From a pharmaceutical company's point of view, if they knew the order of re-evaluation of benefits a few years ago, they would decide whether to maintain the business of the item and develop a new business to replace it. However, if it is announced so suddenly, companies cannot afford to prepare. Therefore, it may be a natural choice for companies to continue lawsuits such as suspension of execution. In order to increase predictability, the HIRA plans to disclose items subject to re-evaluation not only this year but also next year. Accordingly, the items subject to next year's re-evaluation have gained time to prepare for now. However, there is a limit to enhancing the predictability of the business by disclosing only the target items for next year. For now, it is not known whether the project will continue in the long run or end up with five years. If it is carried out regularly, how about applying a renewal system like the MFDS to determine whether or not to reevaluate benefits according to the order of registration date? In addition, if it was a five-year temporary project, the predictability of pharmaceutical companies would have increased if it had been divided by disease in the first place. The revaluation in this way is much more unilateral. Rather, the predictability of the business should be increased, giving the company more time to prove the clinical usefulness of the drug. Although it is a burden on health insurance finances, it is still important that drugs necessary for patients are not expelled due to lack of data evidence. It is questionable whether this will be properly filtered out by a short-term re-evaluation.
