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- 2026-03-10 07:55:27
- Opinion
- [Reporter's View] Pharmas rethink bio venture investments
- by Lee, Seok-Jun Jul 30, 2024 05:51am
- Multiple pharmaceutical companies have made significant investments in promising bio ventures, spending a substantial amount to acquire shares. Some have become the largest shareholder, and those holding over 5% of the share are involved in the management. Through the investment, companies anticipate sharing R&D results in the future. However, such expectations pose challenges. First, ventures require regular funding. Venture pipelines are mostly in early clinical stages. They must secure costs for the later phase of clinical trials. However, it is uncommon for ventures to generate sales regularly. As they advance to later phases of clinical trials, they may quickly need funds. Listed ventures depend on exterior funds, such as recapitalization and convertible bonds (CB). This process works by issuing new stock to raise funds. Pharmaceutical companies investing in ventures want to secure liquidity through clinical trials. However, the percentage of shares owned by pharmaceutical companies decreases with new stocks. Some companies have complained that unnotified funding disrupts their business plans. Pharmaceutical company A owner complained, "We have invested in Venture A by acquiring over 5%. However, our stock share reduced to 3% after Venture A received multiple funding. Frequent funding of Venture A caused a market liquidation signal, leading to decreased stock prices. Unnotified funding has resulted in a setback for our business plan. We are reconsidering whether to hold the share." Moreover, pharmaceutical companies are also concerned about the gap between the venture's plan for clinical trials before going public and the present. In this case, a decrease in stock prices could result in a reduction in stock share value. In the fifth year of listing, most pipelines of TiumBio did not reach the originally planned clinical stage or achieve technology transfers. Their accumulated net loss is over KRW 100 billion. Before being listed on the KOSDAQ at the end of 2019, TiumBio expected to turn a net profit from 2022, anticipating generating a net profit of KRW 54.1 billion by 2023. However, the company has been in deficit. The company also expected to raise operating revenue of KRW 81.5 billion in 2023 but realized operating revenue amounted to KRW 4.9 billion instead. During this time, TiumBio's market capitalism plunged by one-fourth over three years and a half. Consequently, pharmaceutical companies are withdrawing their venture investment shares because of frequent funding and differences in their investment plan compared to the venture's listing. Companies like D and W have retrieved their principal, leaving only the rest of the shares, and another company sold the entire second-quarter stock. Of course, pharmaceutical companies invest in ventures at high-risk and high return because they have invested in the potential R&D of those ventures. However, ventures must also take some responsibility. Ventures must not defend that frequent funding is prerequisite for clinical trials. They must notify all investment partners before raising funds. Additionally, ventures must explain the differences between expected gain and realized loss. They should not argue that delays in earning profits are anticipated outcomes of clinical studies. Many venture companies receive frequent funding, and their outcomes are different from their initial plan before going public. Pharmaceutical companies that have invested in these venture companies are reconsidering their investments. If this trend continues, it may disrupt the virtuous circle of investment between pharmaceutical companies and venture technology.
- Opinion
- [Reporter's View] Keeping up with the Chinese bio industry
- by Son, Hyung-Min Jul 24, 2024 05:51am
- The research and development (R&D) capabilities of Chinese pharmaceutical companies are going from strength to strength year after year. Last year, the immuno-oncology drug Loqtorzi, developed by Junshi Biosciences, was approved in the United States. It became the first Chinese immuno-oncology drug to be approved by the U.S. Food and Drug Administration (FDA). While Chinese anti-PD-L1/PD-1-targeted immuno-oncology drugs have been approved within China, this is the first time they have crossed the FDA approval threshold. This year, BeiGene’s immuno-oncology drug Tevimbra was approved by the FDA. Another Chinese drugmaker, Innovent, is also seeking FDA approval for its own immuno-oncology drug sintilimab in partnership with Eli Lilly. The domestic pharma and biotech industry has also launched a number of immuno-oncology drugs, but most of them are still in the pre-Phase II stage. This is in contrast to Chinese companies, which have completed Phase III trials and are closer to global commercialization. China is leading the way in global commercialization not only of immuno-oncology drugs but also of next-generation therapies such as targeted anti-cancer drugs, gene therapies, and nucleic acid therapeutics. On the other hand, Korea has not been able to make a significant impression in the global market outside of biosimilars. In fact, the number of global new drug approvals by Korean pharmaceutical companies is incomparable, far less than that of Chinese pharmaceutical companies. The number of global new drug approvals by Chinese pharmaceutical companies in countries other than the US has also been steadily increasing, receiving approvals for 44 new drugs in 2020, 40 in 2022, and 14 last year. In the United States, 11 Chinese-made drugs have been approved in the past 3 years. In the case of Korean pharmaceutical companies, only 8 new drugs have been approved so far. In terms of clinical trials, China's share grew by 6.1% from 2019 to 2023, while Korea's share grew by only 0.3% during the same period. Government support has played a major role in raising the Chinese pharmaceutical industry's R&D capabilities. The Chinese government has deisgnated the pharma-bio industry as its economic growth engine and has shortened the approval time for drugs by innovating the CFDA’s review system. Examples include priority review drugs, expanding the number of Centers for Drug Evaluation (CDEs), and accepting overseas clinical data. As a result, China's clinical and new drug review time has been reduced by about one-third compared to before 2015. The expansion of China’s insurance reimbursement that increased the number of drugs on the reimbursement list has also worked in favor of Chinese pharmaceutical companies. The Chinese government continues to expand insurance reimbursement coverage of new drugs, and the revenues are being channeled into R&D investments. Korea, on the other hand, has been less successful in supporting R&D. The Yoon Suk-Yeol's government pledged to support bio R&D from the beginning of his administration, pledging to ‘establish a pharma-bio control tower’ to integrate, foster, and support the pharma-bio industry. However, to date, cooperation between the government and the industry has not been active, as the control tower, the Biohealth Innovation Committee, has not been fully operationalized, and regulations restricting the pharmaceutical industry, such as the drug price reduction system and reimbursement adequacy reevaluations, continue to increase. In order to create new global drugs, Korea needs to establish specific regulations and support systems for innovative drug development. It is illogical to expect good drugs to be made while investing less. Only more investment can lay the foundation for the development and launch of new global medicines. The government has budgeted KRW 2.9 trillion for fundamental R&D next year, which is the largest amount ever allocated. It is this reporter’s hope that this will spur the biotech industry to invest in challenging research areas and develop innovative new drugs.
- Opinion
- [Reporter’s View] ‘Cool time’ too short for price cuts
- by Kim, Jin-Gu Jul 19, 2024 05:47am
- There is a gaming term called 'cool time.’ It refers to the cooling down time a character in a game needs to wait before reusing a certain skill. Looking at the government's recent drug price reduction measures, its ‘cool time’ seems to be too short. The price cuts have been imposed on generic drugs continuously since around the 2020 drug price reform. In July 2020, the government revived the 'tiered drug price system'. If a generic drug meets the requirements of conducting a self-bioequivalence test and registering a domestic active pharmaceutical ingredient, the price of the generic drugs listed on the 21st and later were cut by 15%. The government retroactively applied the new system to previously listed generics. Twenty thousand listed generics were subject to price reevaluations, and the prices of more than 7,000 generics were lowered simultaneously last year. Earlier this year, a second round of reevaluations was conducted on listed generics, resulting in additional price cuts of more than 1,000 items. In July this year, the price cuts on actual transaction price that is conducted every 2 years were conducted. The prices of more than 4,000 drugs that were supplied and billed at lower prices than the upper limit were reduced. In addition, since 2020, the annualized reimbursement reevaluation has been repeatedly eliminating reimbursements, reducing the scope of reimbursement, and forcing voluntary drug price reductions. Drug prices have also been repeatedly reduced due to price-volume agreement negotiations. Since the end of last year, the government has been discussing comparative reevaluation of overseas drug prices (external reference pricing reevaluations). The plan is to reduce the price of generic drugs in Korea by comparing their price with A8 countries, which are Korea’s drug price referencing countries. The repeated drug price cuts have caused much confusion in the pharmaceutical industry. Pharmaceutical companies are bearing losses due to price cuts, and pharmacies are experiencing confusion due to the monthly changes in drug prices. Some pharmaceutical companies challenge the drug price cut measure through lawsuits. The confusion on the front lines is amplified when courts issue and lift injunctions. This is not to say that price reductions have not happened before, but the pharmaceutical industry has had plenty of time to adapt at the time. Historically, major generic pricing policies have typically been in place for 6-7 years upon implementation. The tiered pricing system, introduced in 2007, operated until 2012. After the 2012 generic price cuts, the system of equal pricing for identical ingredients was implemented until 2020. However, since the revival of the tiered drug price system in 2020, various price reduction measures have been operated simultaneously. And another huge wave of reevaluations is set to hit the field, with the imminent implementation of the external reference pricing system. Games have a ‘cool time’ because the overuse of a specific skill can put off the balance of the entire game. The same goes for the drug price reduction measures. Too many repetitive drug reductions will unbalance the entire pharma-bio industry. The current ‘cool time’ is too short.
- Opinion
- [Reporter’s view] public-private consultative body
- by Lee, Jeong-Hwan Jul 17, 2024 05:50am
- During the swine flu pandemic, South Korea had a challenging time due to the Tamiflu shortage. Then, during the COVID-19 pandemic, the government spent national finances to import vaccines from the U.S., Europe, and even Russia due to the absence of local mRNA vaccines. During the COVID-19 pandemic, countries worldwide focused on locally distributing medicines and active pharmaceutical ingredients (API), and strengthened the trade hurdle, maintaining a closed economy. Therefore, South Korea acknowledged the importance of the pharmaceutical and biotech industry as a national security industry. The World Health Organization (WHO) announced the end of the COVID-19 pandemic in May of last year. However, the pharmaceutical sector is still affected by its aftermath. There are shortages of basic essential drugs, such as antipyretic analgesic agents containing acetaminophen. Fortunately, the government department responsible for the sector actively meets with a public-private consultative body for drug shortages to resolve the issue. The Ministry of Health and Welfare (MOHW) and the Ministry of Food and Drug Safety (MFDS) regularly host meetings with officials from the Health Insurance Review and Assessment Service (HIRA), Korea Pharmaceutical Association, the Korean Medical Association, and the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA) to review current drug shortages list and possible causes and discuss solutions. Consequently, out-of-stock medicine issues have been resolved with updated policies, such as maintaining production cost and conditional drug price increase, to encourage the volume of production by the pharmaceutical companies that are manufacturing out-of-stock medicines, and administrative measures to simplify the distribution stage. For these effective administrative measures to continue producing positive results, we need to institutionalize them through legislation. In other words, this must be submitted for an item to the National Assembly to specify running a public-private consultative body for drug shortages in the Pharmaceutical Affairs Act. The "public-private consultative body for drug shortages" bill was passed by consensus in the relevant standing committee, the Health and Welfare Committee, in the 21st National Assembly and submitted to the Legislation & Judiciary Committee. However, it was not enacted due to the expiration of the legislative term, resulting in legislative failure. Fortunately, the same bill was reintroduced in the early stages of the 22nd National Assembly and will be considered for review. Drug shortages, which occur frequently and suddenly, disrupt pharmacies and pose a threat to public health. The National Assembly must prioritize and address this pressing national issue with total effort for the well-being of the citizens. Establishing a management committee involving both public and private sectors is crucial to supervising drug shortage distribution and implementing a drug shortage management system. Additionally, legislative measures should ensure the authority to issue emergency production and import orders for drugs in short supply. Establishing this will be essential for effectively addressing drug shortages without delays in an upcoming pandemic. We hope the new National Assembly is aware that the previous legislative term ended without passing this bill, and we hope they will promptly resolve issues through swift legislation.
- Opinion
- [Reporter's View] Aspirations for Indication-based pricing
- by Eo, Yun-Ho Jul 17, 2024 05:50am
- The government doesn't seem to be considering it, but talks keep rising. At a recent media briefing held by the Korean Research-based Pharmaceutical Industry Association, Dong-Cheol Seo, Director of the Korea Institute for Pharmaceutical Policy Affairs (former professor at Chung-Ang University College of Pharmacy), emphasized the need for Korea to introduce Indication-based Pricing (IBP). Director Seo explained that domestic drugs are initially given a set price, which is reduced as the number of indications for the drug increases. However, the introduction of new drugs with many uses is increasing cases where reimbursement is often not expanded. What should we make of the existence of 'drugs that some people can use and others cannot' and the discussion over 'indication-based pricing' that comes with it? 'Indication-based pricing’ is a method of setting a drug price separately according to the innovativeness of each indication. It reflects the increasing number of cases where a single drug is approved for various indications. KRPIA, a representative organization of multinational pharmaceutical companies, has been calling for the introduction of indication-based pricing for several years. The government's response was more of a strong "No" than a "We will consider its review," but the industry is once again voicing a strong opinion on indication-based pricing. However, there are two main barriers to its adoption. “Can the billing system disaggregate prescription data by indication?,” and “Can patients accept paying different prices for the same drug?” The questions certainly pose a serious issue. However, administrative issues can be overcome with 'effort' if necessary. Also, the differentiated coinsurance rates by indication would require public acceptance. However, it is also true that drugs that have a clear use are currently unavailable for the right patients. Patients will obviously accept paying the different copayment price rather than have the drug remain nonreimbursed. The industry trend of having a single drug with multiple indications has been ongoing for at least 5 years, even if we base the timing on the drugs’ introduction in Korea. Indication-based pricing is currently being adopted by countries such as Australia, Switzerland, and the United States, and in many countries, the practice is to adjust the reimbursement rates while leaving the list price unchanged. We do not know whether indication-based pricing is the only answer. However, in just 3-5 more years, the issue of expanding indications and access to new drugs will be even more pressing than it is today. If we continue to put off addressing the piling up of off-label indications, the accessibility score of Korea’s reimbursement system will drop significantly.
- Opinion
- [Desk’s View] Respect Korea's generic drug industry
- by Lee, Tak-Sun Jul 16, 2024 05:46am
- The Korean pharmaceutical industry is characterized by generic competition upon the original drug’s patent expiry. When a new drug's patent expires, companies develop products that contain the ingredients for marketing. Combination drugs, reformulated drugs, and generic drugs containing patent-expired drug ingredients are the weapons of domestic pharmaceutical companies. With more than 200 finished drug pharmaceutical companies focusing on the market for patent-expired drugs, it is indeed an inefficient industry. If 10 of these pharmaceutical companies devoted to new drug development, the industry would have been bigger with be less excessive competition. However, in the 100-year history of Korea’s pharmaceutical industry, the industry’s focus has always been on the development of generic drugs, not new drugs. With global pharmaceutical companies such as Pfizer, Novartis, and Roche dominating the new drug market, it is unlikely that the Korean pharmaceutical industry will be reorganized into a new drug-oriented industry in the near or even distant future. However, it is a self-evident fact that the generic drug industry is increasing Korea’s self-sufficiency in finished drugs. According to the Korea Food and Drug Statistical Yearbook, as of 2022, the self-sufficiency rate of finished drugs in Korea was 68.7%, and the self-sufficiency rate of API was 11.9%. Although we are highly dependent on foreign countries for APIs, a high proportion of the finished drugs are made in Korean factories and supplied to domestic patients. The self-sufficiency of finished drugs is also high because of Korea’s generics industry foundation. This is a factor that gives us a sense of stability in terms of market supply and demand. If Korea’s generic industry had been dominated by foreign companies, the Korean drug market would have been unstable, being fully dependent on imports. However, the excessive competition in the generic industry needs to be addressed as it leads to inefficient market conditions. Illegal rebates and substandard quality are among the issues that hinder the competitiveness of the Korean pharmaceutical industry. Furthermore, the inability of competition to drive down prices in the state-controlled insurance market also plays a role in the inability of this bad practice to be corrected In this regard, the key to the proper growth of the Korean generics industry depends on the creation of a normal competition system that does not break the current high degree of self-sufficiency. However, it is unclear whether the state’s recent drug price reduction policies reflect this situation, especially as the government's recent external reference pricing reevaluation disregards Korea’s situation. The very idea of comparing generic drug prices in 8 developed countries that have different pharmaceutical industry structures seems to be a misunderstanding or complete disregard of the Korean generic industry. A unilateral drug price reduction policy will kill the domestic generic industry. This is a problem that could lead to the retreat of the Korean pharmaceutical industry, which is built on generics. There is no guarantee that killing the generics industry will lead to the growth of the new drug industry. The recent 'Study on Improving the Drug Price System for Generic Drugs' that the government conducted to implement the generic drug price reduction policy also suggests that it is necessary to strengthen policies to encourage the use of low-priced products in the early stages. If the government doesn't intend to kill the generic industry, it should prepare measures to encourage the use of low-priced generics before unconditionally lowering drug prices. Korea's generic drug industry may look less sophisticated than those of developed countries that develop new drugs, but is not something to disregard.
- Opinion
- [Reporter’s View] MFDS provides support for drug shortages
- by Lee, Hye-Kyung Jul 15, 2024 05:47am
- A thyroid cancer treatment ‘Theracap’ was once listed on a “Drug Shortages Database,” where suspension of the supply or shortages are listed as current, of the Ministry of Food and Drug Safety (MFDS)’s Drug Safety website and then removed. Saehan Industry expected the drug shortage and notified the MFDS of its suspension in accordance with the ‘Regulation on Safety of Pharmaceuticals (Ordinance of the Prime Minister), which states that when a marketing authorization holder of medicinal product discontinues production, importation, or supply of drug products, they must report to the MFDS the reasons no later than 60 days before the suspension day. Shortly after the notification, Theracap was removed from the Drug Shortages Database. Saehan Industry said reduced demand and an increase in raw materials produced in a manufacturing plant in Braunschweig, Germany, are the causes of drug shortages. After the MFDS let the company know that it would review possible administrative supports, the company likely withdrew reports of suspension of the drugs. Saehan Industry said, “We are internally reviewing alternative measures to produce the products instead of approval cancellation.” The MFDS anticipated that because 'Sodium Iodide(131I),' the active ingredient of Theracap, has been designated as an essential medicine, approval cancellation of the product due to a raw material issue would, in turn, affect patients. The MFDS already has various administrative support measures to resolve drug shortages after experiencing acetaminophen shortages during COVID-19. However, many small pharmaceutical companies are not aware of the administrative support provided by the MFDS. This year, the MFDS established a pharmaceutical management and support team and enhanced the management of items of drug shortages. Suppose other companies have difficulties manufacturing pharmaceuticals, such as National Essential Drugs, similar to the case of Saehan Industry. They may knock on the MFDS’ pharmaceutical management and support team. For instance, Bukwang Pharm’s ‘Synthyroid’ was a similar case. Synthyroid is designated as a National Essential Drug, containing ‘levothyroxine’ as the active ingredient used to treat hypothyroidism. Due to a recent increase in demand, it was sold out in pharmacies. After multiple press coverages of drug shortages, the MFDS sent an official request to Bukwang Pharm to contact the MFDS for the administrative support they needed. Bukwang Pharm needed support in relaxing the 52-hour working week for workers at the plant. Consequently, the MFDS is close to negotiating with the Ministry of Employment and Labor. Although the government is preparing various support measures to address drug shortages, this approach may not completely solve the shortages in clinical settings. However, we hope the government’s various support measures, such as the national essential drugs, will help stabilize the supply of medicinal products.
- Opinion
- [Reporter’s View] 'all-comers' with strict criteria
- by Eo, Yun-Ho Jul 02, 2024 05:48am
- Drugs that are intended for use regardless of any conditions are strictly regulated. In the pharmaceutical industry, 'all-comers' refers to a drug indication that can be prescribed at any treatment stage, regardless of conditions. Drugs with all-comers indications have demonstrated their efficacy regardless of receptors or genetic mutations. This is appealing and interesting. Yet, the Korean government has a firm stance towards these all-comers’ indications. It is certainly reasonable. Drugs with many uses, in other words, mean an increased volume of use, which then leads to financial consideration. However, the government’s discretion towards a drug seems to suggest another hurdle besides finance. Drugs with all-comers indication have proven records and gained the Ministry of Food and Drug Safety (MFDS) approval, yet a difference in efficacy exists. When reviewing reimbursement of all-comers that target particular genes, considering the mechanisms of drugs, but the basis of concluding effectiveness is irrelevant to those genes, the government stands by the guideline, 'limiting to originally targeted genetic mutations.' Such discretion is considered reasonable and to be considered with time. However, time hasn’t been helpful when we consider past cases. In the case of the PD-L1 inhibitor 'Optivo (nivolumab),' an immunotherapy medication for the treatment of non-small cell lung cancer (NSCLC) that was approved for all-comers indication, experts at the time agreed that 'PD-L1 expression rate' was not a marker. However, due to untimeliness of the drug’s release, Optivo was granted reimbursement in 2017 with a conditional criteria. Since then, numerous new drugs with all-comers indications have been released. Yet, these drugs are still applied with limited reimbursement criteria during the review for reimbursement listing. It suggests that the government must consider patients and propose a compromise along with carefulness. If pharmaceutical companies make unreasonable requests during the reimbursement discussion of a drug with approval, the government cannot accept them, especially since even the physicians oppose them due to financial issues. However, the government must provide reasons rather than just saying "difficult." Instead, the government must continue the discussion based on data evidence.
- Opinion
- [Reporter’s View] No innovation without failure
- by Son, Hyung-Min Jul 01, 2024 05:47am
- Korean biopharmaceutical companies are exchanging joy and sorrow over out-licensing agreements. Last month, three companies, including HK inno.N, have successfully signed agreements to out-licensing of their new drug candidates in addition to AprilBio and ISU Abxis. In contrast, there are instances where new drug candidates that have been successfully out-licensing are later returned. GC Cell announced that a collaborative R&D agreement with Artiva Biotherapeutic, its U.S. subsidiary, for three treatments for CAR-NK solid tumors in 2021 has terminated. Furthermore, Olix Pharmaceuticals and Curacle received notifications of contract terminations from France’s Thea Open Innovation last month. In April, Voronoi terminated the out-licensing agreement made in 2022 with METiS Therapeutics, a biotech company in the United States, for its solid tumor treatment VRN14. Yet, it is too early to be disappointed about the termination of out-licensing agreements. There are instances where companies can succeed by developing drugs for new indications. For instance, last year, Hanmi Pharmaceutical confirmed the potential of Poseltinib for the treatment for recurrent or diffuse large B-cell lymphoma (DLBCL). The licensing of Poseltinib, a BTK inhibitor under development by Hanmi Pharmaceutical, was returned from Lily in January 2019 because the efficacy of the drug was not confirmed in a phase 2 trial involving patients with rheumatoid arthritis. Additionally, Hanmi Pharmaceutical is showing a process in clinical trials for efpeglenatide, a new drug candidate for obesity. Efpeglenatide is a product that initially struck a licensing agreement with Sanofi in 2015 to treat diabetes and later returned to Hanmi Pharmaceutical. Then, Hanmi Pharmaceutical changed its development strategy for this drug to a Korean-focused obesity treatment. Based on recent clinical results, Efpeglenatide demonstrated weight loss effects. During the new drug development process, selecting and focusing are necessary steps. The company’s R&D strategy can be changed, and instances of new drug candidates that fail to demonstrate efficacy can occur. Out-licensing returns are common practice in the pharmaceutical industry. Fortunately, none of the four returned new drug candidates had significant issues regarding their efficacy. Companies with returned technologies plan to proceed with later phases of clinical trials without delays. Now is the time for companies to clearly announce their potential development directions to seek future investment opportunities. When clear directions are suggested, they could seek opportunities to out-license their new drug candidates again. There is no innovation without failure. If a company firmly believes in a pipeline item (new drug candidate), it may not worry about each case of returned licensing or the success of out-licensing. Only the companies that are not discouraged or give up are poised to survive.
- Opinion
- [Reporter's View] No more exemptions, just deferrals
- by Eo, Yun-Ho Jun 24, 2024 05:47am
- The Korean government has set out to fix the pharmacoeconomic evaluation exemption system. Although the authorities coined it as an “improvement,” the direction seems to be near a “reduction.” A report on a study commissioned by the Health Insurance Review and Assessment Service was released at the end of last year. The study, titled 'Study on Preparing a Plan to Improve the System for Exemption from Submission of Pharmacoeconomic Evaluation Data,' analyzed the current status and issues of Korea’s pharmacoeconomic evaluation exemption system, which was introduced in 2015, and proposed measures for its improvement. The report claims that the core of the improvement plan is to change the exemption system into a deferral system. The report pointed out that the core of the positive-listing system is the cost-effectiveness evaluation, therefore, Korea should not exempt drugs from evaluations when other countries do conduct evaluations. Based on the research results, HIRA proposed a revision of the current PE exemption system. To this end, the HIRA and the Korean Research-based Pharmaceutical Industry Association (KRPIA) recently held their first meeting. The industry's reaction to this is understandably grim. The PE Exemption System is literally the only way out for drugs that are difficult to evaluate but deemed necessary. It contains various financial control devices and has embraced an "expenditure cap" design since its inception. In fact, the industry has been constantly claiming that the current system has too high a threshold and has consistently emphasized the need for its expansion. Of course, the contents of the recent report will not be reflected 100%. However, the proposed measures in the report will hardly be satisfactory for the industry. Even now, it is not easy for companies to apply for the PE exemption system, and the number of eligible drugs will be significantly reduced if the reform is implemented. For example, contrary to how the current 200 patients or fewer (the usual threshold required to be eligible for the PE exemption) requirement refers to the number of patients that fall within the drug's scope of use, the proposed reforms refer to a stand-alone disease, meaning that a drug that would have been eligible if it met the 200 patients or fewer requirement based on its genotype or line of therapy indication must now have 200 or fewer patients affected by the disease itself. The fundamental purpose of deferring the PE exemption is more difficult to understand. The pharmaceutical industry has constantly requested the application of a flexible ICER threshold. And we have heard endlessly about how Korea’s ICER threshold is too strict for drugs to be reimbursed. It is doubtful whether drugs that would not have been listed if not for the PE exemption system will be able to remain reimbursed when evaluated after the deferred period. If some regulations are tightened, some need to be loosened as well. The government is already planning to save national health insurance finances by implementing bold drug price reduction mechanisms such as external reference pricing reevaluations and revision of the price-volume linkage system. It may be that the number of applicable drugs has increased since the implementation of the system, rendering improvements necessary. However, it is also true that this system has served as a 'breathing hole' in Korea's listing system, we need to devise other ways out before closing that hole.
