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- 2026-06-13 22:42:39
- Opinion
- [Reporter’s View] Conglomerates expanding into the pharma
- by Kim, Jin-Gu Jan 26, 2024 05:51am
- M&A activities have made headlines in the pharmaceutical and biotechnology (pharma and biotech) industries in early 2024. Hanmi Pharmaceutical, a leader in the Korean pharmaceutical industry, has officially confirmed its merger with OCI group, a chemical company. Additionally, Orion has acquired LegoChem Biosciences, a globally recognized bioventure company. Major conglomerate companies are expanding their scopes into the pharma and biotech industries. In the previous year, Hanwha Group entered the biotechnology materials, components, and equipment sector, while in 2022, Lotte Group launched Lotte Biologics. CJ CheilJedang also made a comeback to the industry by acquiring the microbiome company Cheonlab, three years after selling HK Inno.N. The pharma and biotech companies such as Samsung, SK, and LG have announced their plan for increased investments. This trend reflects the pharma and biotech industries as a favored choice for business expansion among many conglomerate companies. It is expected that these conglomerate companies will play a central role in shaping the future of the Korean pharma and biotech industries. Currently, there are varying opinions on the industry outlook. However, a prevailing positive analysis is emerging concerning the increased investment in the Korean pharma and biotech industries. Until now, one of the significant differences between the Korean pharma and biotech industries and global big pharma has been investment size. Korean companies’ business model of licensing out potential candidate products to global big pharma is prevalent because Korean companies often struggle to manage the substantial costs associated with completing the clinical process. The entry of conglomerate companies with substantial available funds into the pharma and biotech industries has the potential to bolster R&D capacity. At the same time, concerns are emerging regarding the current trend, given the distinctive nature of the pharma and biotech industries. In the industry, drug development entails costs and time. Enormous investments and enduring patience until the final product is achieved are prerequisites. Typically, it takes around 10 years to identify a candidate product and bring it to market following clinical trials. Even if efforts to expedite development through open innovations, a waiting period of at least 4-5 years may be necessary. According to the report from the Biotechnology Innovation Organization (BIO), the average success rate of new drug development projects to obtain FDA approval for marketing between 2011 to 2020 stands at 7.9%. Even if a company secure FDA approval, it does not guarantee a business success. Successful commercialization and achieving business success in the global market are distinct processes. Korean industry giants have frequently achieved success through a method referred to as, ‘compressed growth’ in their respective fields. The question now arises whether the pharma and biotech industries will experience a similar period of compressed growth. These industry giants must endure extended periods of efforts until they reach success, while recognizing the possibility of commercialization failure. "Some employees from other subsidiaries seem to view the pharma and biotech industries as resembling a 'money pit,’ characterizing it as a sector that demands substantial financial resources but lags in delivering outcomes,” staff member from the pharma and biotech industries said. "From their perspective, our sector appears to require substantial investments, yet immediate returns are not apparent. However, this viewpoint may not be entirely fair." Conglomerate corporations entering the pharma and biotech industries with substantial investments is a positive development. However, more than financial investment is needed. Equally crucial, alongside these significant investments, is patience. It remains to be seen whether these large corporations can withstand a long and challenging journey through clinical trials, coupled with the weight of potential setbacks and failures.
- Opinion
- [Reporter’s View] KRPIA's new BOD signifies fresh starts
- by Eo, Yun-Ho Jan 25, 2024 05:49am
- Following its fresh start with new staff members and a restructured board of directors, KRPIA is stabilizing its operations. Previously, Korean Research-based Pharmaceutical Industry Association (KRPIA) faced increasing concerns regarding its operations, primarily involving leadership vacancy. The decrease in the number of board members can be explained by reassignments of CEOs in multinational companies, but the frequent resignations of high-ranking officials, including the Head of Policy Business, Kim Min-Young, have sparked inquiries into the association's responsibilities and functions, resulting in criticisms. KRPIA's operations in the New Year signals a new beginning. Beginning in February, Choi In-Hwa, currently serving as the Access & Policy Cluster lead at Roche Korea, will assume the role of KRPIA’s Head of Policy Business, which has remained vacant for a year. Choi graduated from the College of Pharmacy at Ewha University and began her career as a public pharmacist at the Central Pharmaceutical Affairs Council (CPAC) within the Ministry of Food and Drug Safety (MFDS). Following this role, Choi held positions at Boryung Pharmaceutical, Taejoon Pharmaceutical, and Roche since 2001, accumulating over 20 years of experience in managing policy-related responsibilities, including Market Access (MA) and Regulatory Affairs (RA). Among the MA managers, Choi is called the ‘big sister.’ KRPIA's board of directors currently consists primarily of Korean nationals. Out of the 13 members, which includes KRPIA chairman Dong-Wook Oh, who is the CEO of Pfizer Korea, only two are foreign nationals, resulting in Korean members making up 85% of the board. This trend can be attributed to multinational pharmaceutical companies appointing Koreans as CEOs for their Korean branches instead of foreign nationals, consequently shaping the board of directors as Korean members in the majority. Junil Kim (CEO of Astellas Pharma Korea), JinA Lee (CEO of Bayer Korea), and Albert Kim (CEO of MSD Korea) are Koreans who were newly appointed last year. Among them, Albert Kim holds Canadian nationality. Two new members, Maurizio Borgatta (CEO of GSK Korea) and Christoph Hamann (Merck Korea), are the only foreign nationals. The growing presence of Korean leadership within KRPIA does not necessarily imply that it is the best approach. However, it is worth noting that KRPIA is currently navigating a crucial and significant period in its history. It is reasonable for the KRPIA CEO position to be held by a Korean national, especially considering that multinational pharmaceutical companies are involved in the distribution of new drugs. The CEO's primary responsibility often involves communication with departments responsible for overseeing the drug pricing system in Korea. Especially now, multinational pharmaceutical companies tend to focus on high-priced drug pipelines, and the successful listing of these drugs often hinges on effective communication skills with the government. Additionally, departments within the Ministry of Health and Welfare (MOHW) often favor communication with Korean leaders, further emphasizing the importance of having a Korean national in key positions. Choi's appointment is indeed promising. As she prepares to step down from her role at Roche Korea at the end of this month, her status as a high-ranking official places her in a prominent position for effective communication. She will play a crucial role in engaging not only with association members but also with government departments across various aspects of the pharmaceutical industry. KRPIA is entering a new era of operation, and there is a hope that it will focus on ‘enhancing patient access’ through rational and innovative negotiations with the MOHW, in addition to its role in managing drug pricing.
- Opinion
- [Reporter’s View] Supply disruptions disclosed in real-time
- by Lee, Hye-Kyung Jan 24, 2024 05:46am
- As of January 10, it became possible to view the list of medicines that are at risk of short shortages or interruptions in real time. The Ministry of Food and Drug Safety (MFDS) has improved the quarterly drug manufacture, import, and supply interruption information system on the Nedrug webpage to allow real-time updates. As a result, not only the status of supply interruption and shortage of drugs, but also the expected date of supply normalization, the reason for the interruption, and alternative drug items are transparently disclosed. Previously, the Ministry of Food and Drug Safety disclosed manufacture, import, and supply interruptions reported by pharmaceutical companies up to 60 days in advance every quarter, leaving the information checked through the website ‘outdated.’ As a result, medical institutions and pharmacies have been checking the list of shortage and discontinued drugs through their wholesalers. However, it has been difficult to determine when and for what reason the shortage occurs for drugs that they do not deal with. Also, consumers who did not know the status of drug supply had no way of knowing which drugs were in short supply in the field. However, after the MFDS released the list of drug supply interruptions, we learned that the brain function enhancer Semion (nicergoline) had experienced a supply interruption due to facility issues and that the shortage of asthma treatment drug ‘Montelukan ODT 10mg (montelukast sodium)’ was due to a surge in sales and will be normalized around January 26. The MFDS’s decision to expand the disclosure of drug-related information is not only helpful for the consumers but also for those in the clinical and pharmaceutical field. The MFDS, which had been reluctant to disclose various information, has changed its stance and started to actively disclose information in 2022. The contact information for each department in the organizational chart, which was previously kept private, is now available on the website, and new drug approval information is released in real time through a press release. The status of approvals for each medical product every week and the status of drugs subject to information disclosure are also disclosed every month. The real-time reporting of drug supply interruptions is considered a positive change that MFDS MInister Yu-Kyung Oh has been making toward an 'open MFDS' since her appointment in 2022. The general election is coming up on April 10. There is a lot of talk about her resignation from the MFDS due to the ‘general election shake-up' that always occurs during the general election season. It is this reporter’s hope that the positive changes that have been made so far will not be reversed regardless of who is appointed.
- Opinion
- [Reporter’s View] Forxiga withdrawal raises concern
- by Son, Hyung-Min Jan 19, 2024 05:44am
- AstraZeneca, the UK-based global pharmaceutical company, is withdrawing its diabetes treatment Forxiga (ingredient: dapagliflozin) from the Korean market, ten years since its approval in 2013 in Korea. Initially approved as SGLT-2 inhibitor-class diabetes treatment, Forxiga achieved success as its indications were expanded to include conditions like heart failure and kidney disease. Forxiga generated sales of 55 billion won in the previous year. However, AstraZeneca has decided to withdraw Forxiga from the Korean market, giving up annual sales of 50 million won. This decision entails not only the supply halt, but also the withdrawal of approval and reimbursement. What factors have influenced AstraZeneca to make such a decision? The prevailing analysis suggests that reduction in drug pricing was a significant factor in Forxiga’s withdrawal. The primary reason for the withdrawal of Forxiga is widely attributed to the price reduction resulting from the expiration of its patent. AstraZeneca Korea contested the government’s price reduction measure and initiated administrative litigation against them. Having granted suspension of the measure, Forxiga’s current drug price will be maintained through February. However, there is no guarantee that the price of Forxiga will remain at its current level after February. Forxiga’s price could be adjusted to 53.55% of its current price, which is around 730 won, due to patent expiration. Additionally, further reductions in the drug price may be possible due to expanded reimbursement criteria and the price-volume agreement program (PVAP). The drug price of Forxiga in Korea is currently less than 1/30th of the price in the United States. Further price reductions could potentially lead to complications in manufacturing. Furthermore, the cost for conducting clinical trials to expand its indications to include heart failure and kidney disease is substantial. Another factor that may have influenced Forxiga’s withdrawal is that price reductions in Korea can affect drug pricing in neighboring countries. East Asian countries, including China, Japan, Taiwan, and others, may demand drug price reductions referencing the price in Korea. As a global pharmaceutical company, the company needs to consider the potential impact on drug prices beyond Korea. Furthermore, factors such as commission expenses from joint marketing agreements and heightened competition resulting from generic releases may have influenced this decision. The concern is that the current withdrawal of Forxiga could be the beginning of the phenomenon known as ‘Korea Passing’ by global pharmaceutical companies. Entering the Korean market can be challenging for global pharmaceutical companies seeking to establish a presence in East Asia. The reductions in drug pricing and insurance reimbursement policies applied to innovative drugs make the Korean market less attractive to global headquarters. While it's understandable that the government seeks to implement fiscal measures to improve savings in a single national healthcare system like Korea's, global pharmaceutical companies cannot create a 'special drug pricing' exclusively for Korea. Furthermore, Korea employs various methods to reduce drug prices, including reevaluations of reimbursement adequacy, clinical reevaluations, price-volume agreements, and overseas price comparisons. Technology advancement is expected to result in the continuous development of innovative new drugs. Survival rates for diseases that were once life-threatening have improved for patients, and there is hope for recovery in the case of rare and incurable diseases. If these innovative new drugs cannot enter the domestic market in the future, Korean patients may have to seek medical treatment abroad. For patients to access innovative new drugs, there needs to be more communication between the government and pharmaceutical companies. It should not be a unilateral announcement, but an open approach aimed at improving patients’ access to innovative new drugs.
- Opinion
- [Reporter’s View] HIRA's role in managing high-priced drugs
- by Kim, Jin-Gu Jan 15, 2024 05:36am
- In 2012, Soliris, a treatment for paroxysmal nocturnal hemoglobinuria (PNH), was listed for reimbursement in Korea. The drug, which cost more than KRW 5 million per vial and up to KRW 500 million for a year's supply, sparked controversy over "ultra-high-priced drugs” at the time. Since then, drugs more expensive than Soliris were introduced and reimbursed one after another. Novartis' Kymriah and Zolgensma were two representative examples. Zolgensma is listed at KRW 1.982 billion per kit, and Kymriah at KRW 360 million per treatment. Although the number of doses required per drug varies, as of the end of last year, a total of 26 drugs cost more per unit than Soliris. Among them, Biogen's ‘Spinraza,’ Novartis' ‘Lutathera,’ AstraZeneca's ‘Ultomiris,’ BMS' ‘Yervoy,’ Anterogen’s 'Cupistem,’ JW Pharmaceutical's ‘Hemlibra,’ Pfizer's ‘Besponsa,’ Anterogen’s ‘Remodulin,’ and Sanofi-Aventis' ‘Lemtrada’ cost more than KRW 10 million per unit. Truly, the era of ultra-high-priced drugs has arrived. Moreover, drugs that far exceed the price of Zolgensma are awaiting entry in Korea. Lyfgenia, a treatment for sickle cell anemia that was approved by the U.S. Food and Drug Administration (FDA) in December last year, has a price tag of USD 3.1 million (KRW 4.1 billion). ‘Casgevy’ and ‘Exa-cel,’ which were approved around the same time, cost $USD 2.2 million (around KRW 2.9 billion) each. And many other drugs that cost more than USD 1 million are yet to be introduced to Korea. The hemophilia B treatment ‘Hemgenix’ costs USD 3.5 million, the cerebral adrenoleukodystropha treatment ‘Skysona’ costs USD 3 million, the beta-thalassemia treatment ‘Zynteglo’ costs USD 2.8 million, the leptin deficiency treatment ‘Myalept’ costs USD 1.26 million, and Hutchinson-Gilford progeria syndrome treatment Zokinvy costs USD 1.07 million. Most of these are 'one-shot drugs' that treat diseases caused by genetic abnormalities. Given the development speed and recent advances in gene editing technology, industry experts say it is only a matter of time before more expensive drugs appear. The annual cost of KRW 500 million, which was astronomical at the time of Soliris’s introduction, now falls in the ‘modest’ range among ultra-high-priced drugs. The government is also expressing significant concerns over the issue. Earlier this year, the Health Insurance Review and Assessment Service set up a ‘Pharmaceutical Performance Evaluation Department’ dedicated to the post-listing management of high-priced drugs. It took over the duties of the New Drug Performance Management Division, which was established as a temporary organization under the Office of Benefits Management in September 2022. For now, the office is in charge of evaluating the performance of high-priced drugs such as Kymriah and Zolgensma but will expand its responsibilities to include post-listing management of drugs that are exempt from submitting pharmacoeconomic evaluation data. This seems to be a timely move in the era of ultra-high-priced drugs. It's time to prepare for the next step. Given that drugs even more expensive than Zolgensma are expected to be introduced into Korea in the future, one single department, however, dedicated, may not be enough to take on the responsibility of managing all of the listed high-priced drugs. The changes to come call for a more fundamental reorganization of the system. The number of drugs listed through tracks that do not require pharmacoeconomic evaluation, which is the basis of Korea’s health insurance reimbursement system, is increasing every year. However, due to limited health insurance finances, it is impossible to blindly allow the listing of all ultra-high-priced drugs. We need to prepare for the entry of another wave of ultra-high-priced drugs, including the establishment of a separate fund, which is just beginning to be discussed. Korea eagerly awaits the establishment of a new system that can receive public consensus.
- Opinion
- [Reporter's View] GOV takes measures to stabilize supply
- by Lee, Hye-Kyung Jan 11, 2024 05:45am
- To resolve the issue of medicines supply instability, the government has announced a plan to conduct a field investigation of pharmacies and hospitals that engage in stockpiling of drugs, in collaboration with a local government starting in January. This is the government’s first active involvement in checking nursing homes and taking administrative measures. In March of last year, a public-private consultative body was established, comprised of the Ministry of Health and Welfare (MOHW), the Ministry of Food and Drug Safety (MFDS), the Korean Disease Control and Prevention Agency (KDCA), the Korean Medical Association, Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA), the Korea Pharmaceutical Distribution Association (KPDA), the Korean Society of Health-system Pharmacists. The decision to investigate stockpiling in nursing homes was made during a meeting held in September last year. The items to be investigated include Sam Il’s ‘Sudafed tab.’ and Sama Pharm’s ‘Setopen suspension,’ and the criteria for categorizing purchases as stockpiling have been defined as cases where the claimed amount (usage) was less than 25% after purchasing. Notably, there have been 40 instances where medical institutions have acquired cold medicines with 0% recorded usage. In response, the government has chosen to examine these cases during the field investigation to see if indeed they were stockpiling. However, a few pharmacies have criticized the government for intervening with purchasing practices ahead of prescription. According to the government, drug shortages have historically been a recurring issue in many countries, regardless of their income levels. However, when addressing medicines of supply instability, such as common cold medicines, which are non-essential but can cause inconvenience when unavailable during the simultaneous outbreak of various respiratory diseases, even with increased production by pharmaceutical companies, government intervention may become necessary. Until now, several measures have been implemented to address the supply shortage. For six ingredients such as 'acetaminophen' and 'pseudoephedrine,' the government raised drug prices conditionally, and for twelve ingredients such as 'mifepristone' and 'cefpodoxime proxetil,' pharmaceutical companies were encouraged for production and provided with administrative support for raw materials. Following their request for cooperation in prescribing alternative medications to enhance demand management and minimize distribution disparities while ensuring fair access to drugs, the government has launched an investigation into stockpiling practices. In November last year, the list of national essential medicines was expanded to include seven products with six ingredients for pediatric drugs, including acetaminophen syrup. Over the past year, various measures, including the establishment of a public-private consultative body, have been prepared for drug supply stabilization. This year, taking suggestions from the meeting, it is crucial to establish a system aimed at preventing drug shortages. In addition, there should be a discussion about a follow-up plan. Waiting until major disruptions in drug supply occur would be too late. It appears that frequent surveys of supply shortages of drugs may be needed. Starting this year, the government plans to raise the prices of unprofitable drugs, extending a measure that was initially introduced last year for supply shortages of drugs. There is an expectation that these various measures will function effectively to address the drug supply issue. This year, we should see a decrease in instances where people ‘hop from one pharmacy to another in search of medicines.’
- Opinion
- [Reporter’s View] Be generous and provide tangible benefits
- by Eo, Yun-Ho Jan 10, 2024 05:42am
- Expectations of pharmaceutical companies that own new drugs have been rising in the light of the new year. The reason for this is the ‘Plan for Appropriate Compensation of the Innovative Value of New Drugs' that the government announced at the end of last year. According to the announcement, the government will grant reimbursement for innovative new drugs that have recognized innovativeness even if their economic feasibility exceeds that of the ICER threshold, an economic evaluation indicator. The criteria for innovativeness are those that satisfy all of the following conditions: a drug ▲ with no substitute or therapeutically equivalent product or treatment ▲ that demonstrated clinically meaningful improvement, such as a significant extension in survival, and ▲ has been approved by the Ministry of Food and Drug Safety through GIFT or received a breakthrough therapy designation (BTD) by the US FDA or a priority review (PRIME) by the European Union’s EMA. All three conditions must be met to qualify as an innovative drug. Although there is no documented figure, it is generally accepted that the ICER threshold for insurance reimbursement is KRW 50 million in Korea. Even drugs whose ICER value is KRW 50 million are rarely listed. In other words, the government announced that it will apply a flexible ICER threshold for drugs designated as an innovative new drug and satisfy all the conditions above, allowing such drugs an easy pass across the economic evaluation hurdle. This flexible application of the ICER threshold has been the industry’s greatest desire for some time. But there are also concerns over the large disappointment the high expectations may bring. If the actual increase in the threshold is less than expected, the pharmacoeconomic evaluations will still be a serious hurdle. If the KRW 50 million threshold, which was rarely applied, just becomes the norm, or the threshold is only increased by around KRW 5 million to KRW 10 million, their actual benefit will be minimal. This is not for all drugs, but just the innovative new drugs that meet all of the three conditions above. In fact, even if the threshold is raised by KRW 20 to KRW 30 million, the pharmaceutical industry may still long for a larger benefit. This will be especially true for drugs that have shown too much clinical improvement compared to existing drugs to demonstrate cost-effectiveness, i.e., drugs that are likely to be designated an innovative new drug. And these drugs will only increase in the future. As the government has already expressed its willingness to provide benefits, it would have devised a practical system to implement this year. All this reporter would like to ask of is, to be generous when giving out benefits. We know that the government is devising measures to cut costs along with measures that provide preferential treatment, therefore, all we ask is for the government to provide clear and generous benefits in areas it already decided to do so.
- Opinion
- [Reporter's View] No regulatory innovation, no future
- by Son, Hyung-Min Jan 08, 2024 06:09am
- The importance of Decentralized Clinical Trials (DCT) through digital biomarkers in developing digital therapeutics (DTx) is gaining attention. Biomarkers are usually indicators used to detect changes within one’s body, using proteins, DNA, RNA, metabolites, etc. Digital biomarkers are an extension of this concept and refer to biomarkers collected using digital technologies. Digital biomarkers are used for DCT, as they enable remote monitoring and treatment of patients. It offers the advantage of enabling patient recruitment via website and mobile channels in addition to the traditional offline recruitment, to maximize recruitment speed and participation rates in clinical trials. Unlike how DCT is being more and more widely used around the world, it is relatively less used in Korea. From 2019 to 2022, only 1.1% of multinational clinical studies conducted in Korea utilized DCT. In the UK, the rate was 14.6% during the same period. It's no secret why DCT is underutilized in Korea. This is due to the strict regulations set on the use of personal information for telemedicine and access to electronic medical records (EMR) in Korea. Although the pharmaceutical and IT industries and clinical trial-related organizations agree on the need to use DCT, they are having difficulty with its implementation due to the strict regulations. There are already DCT guidelines established in Europe and the United States. Since 2021, some countries in Europe have issued DCT guidelines, and in 2023, the U.S. Food and Drug Administration (FDA) released its draft guidance, called ‘Decentralized Clinical Trials for Drugs, Biological Products, and Devices.’ As such, countries overseas have already been creating an environment where patients may participate in clinical trials without visiting medical institutions. The pharmaceutical and bio industry invests astronomical amounts of money in clinical trials despite its little probability of success. The longer the clinical trial process takes, the more expensive the new drug development becomes. It's not as if the industry can just wait for new technologies to emerge without making changes. The shift from randomized controlled trials (RCTs) to DCTs will not only provide accurate medical information but also reduce costs. To foster an advanced medical environment, clear guidelines will need to be set for clinical trials, including the use of digital therapeutics. Only bold regulatory innovations made by the government will be able to advance the development of the digital healthcare industry to the next level.
- Opinion
- [Reporter’s view] Expanded catastrophic medical expenses
- by Lee, Hye-Kyung Dec 22, 2023 05:47am
- Among foreigners, the saying, "If you are ill, you should go to Korea," had once become a trend. Foreigners that stay in the country for over 6 months are eligible for the National Health Insurance subscription as a local subscriber, allowing them to receive reimbursement benefits. This issue has been a topic of heated debate during the annual National Assembly audit. As a result, the National Health Insurance Service (NHIS) has been implementing safety measures every year to prevent foreigners from freeloading on Korea's National Health Insurance. For foreigners, the National Health Insurance is a cost-effective benefit, but there are Korean citizens who cannot afford medical bills even with the National Health Insurance coverage. In the past, when the cost coverage was not high enough, medical bills used to be one of the top three causes of household bankruptcy. In Korea, many citizens still subscribe to private health insurance. Starting in the early 2000s, there was a movement with the initiative "Single-payer healthcare: all medical fees to be covered by National Health Insurance," but it was often seen as an empty slogan. In response, the government introduced measures to alleviate the financial burden on the people. These measures included the introduction of the copayment maximum in 2004, the special assessment for cancer, cerebrovascular disease, and heart disease in 2005, and the implementation of the Catastrophic Medical Expenses Support Program in 2013. The Catastrophic Medical Expenses Support Program is designed to alleviate the burden of medical fees on households facing excessive expenses, and its insurance coverage is expanding. At a recent cabinet meeting, the partial amendment to the "Enforcement Decree for the Catastrophic Medical Expenses Support Program," was approved. Starting on January 1st, 2024, the Catastrophic Medical Expenses Support Program will be expanded to include all medical conditions that occurred within one year prior to the final inpatient or outpatient treatment. Prior to the revision, the previous system combined all medical expenses for inpatient care, but for outpatient care, it only considered expenses for the same disease, and application was restricted to the six major severe diseases. Even if the total medical expenses for the entire year reached the standard for the Catastrophic Medical Expenses Support Program, there were situations where support could not be provided because the standard was not met for the same diseases alone. Starting next year, with the expansion that includes all diseases, reimbursement for catastrophic medical expenses can be claimed if the total medical expenses for all conditions exceed 4.1 million won. Previously, a four-person household earning 100% of the median income could only apply for support if medical expenses for the same condition exceeded 5.9 million won. However, lowering the standard means that more people will be able to benefit from catastrophic medical expense support. The Catastrophic Medical Expenses Support Program is designed to prevent households from facing financial disaster due to medical expenses. Questions have arisen regarding the implementation of reimbursement for all types of diseases, including non-reimbursement and total copay, selective reimbursement, implants for those aged 65 and older, double and triple room hospitalization fees, Chuna manual therapy, and senior dentures, based on income levels. The National Health Insurance system was established to enhance the quality of national healthcare and improve social security. To ensure that people do not have to worry about medical expenses, catastrophic medical expenses coverage should be expanded to include all diseases could serve as a significant step toward the establishment of a single-payer healthcare system.
- Opinion
- [Reporter’s view] Dilemma of compassionate use
- by Son, Hyung-Min Dec 20, 2023 05:41am
- Recently, certain global pharmaceutical companies have decided to discontinue compassionate use of its drugs, which permits patients access to investigational drugs, following the official approval of these drugs in Korea.. Consequently, patients without alternative treatment options are left with no choice but to obtain the drugs at a non-reimbursed price, despite the effectiveness of the treatment. The Ministry of Food and Drug Safety (MFDS) permits an ‘approval system for compassionate use of investigational drugs,’ which is intended for patients with a serious or life-threatening disease or condition, particularly in cases where no alternative treatment options is available. The system is designed to allow patients to access therapeutic drugs, often referred to as “off-label” (prior to receiving official approval for prescription) drugs, typically in situations where there are no other treatment options available. However, there are cases where pharmaceutical companies discontinue compassionate use of drugs once the drugs are officially approved or receive expanded indications. Recently, Norvatis announced that they are discontinuing the supply of two drugs, Rafinlar (dabrafenib) and Meqsel (trametinib), on a compassionate basis for patients with BRAF-positive solid tumors excluding lung cancer. The two drugs were granted approval for the treatment of BRAF-mutation positive malignant melanoma and non-small cell lung cancer. Until now, the two drugs were provided on a compassionate basis to patients with BRAF-mutation positive solid tumors that had no comparable or alternative treatment options available. On the 15th of last month, the combination therapy of Rafinlar and Meqsel received an expanded indication for the treatment of unresectable or metastatic BRAF V600 mutation-positive melanoma. Novartis has stated that due to this updated indication, they are no longer able to supply the drugs for compassionate use. In response, some medical professionals have strongly lodged a complaint against Novartis. Novartis has recently extended the supply of the drug for an additional 6 months, but they have not provided any information regarding the supply of the drug after the specified period ends. There are more cases like Novartis’s. Pfizer, for example, tried to discontinue compassionate use of Lorviqua (lorlatinib), which has shown effectiveness in ALK and ROS1 mutation-positive non-small cell lung cancer, following official approval in Korea in 2021. However, in response to the continued requests from medical professionals, Pfizer reversed its decision to discontinue compassionate supply of the medication. Medical professionals argue that it is unethical to stop supplying compassionate use of drugs to patients without alternative treatment options. Since global pharmaceutical companies put emphasis on social responsibility and on serving the community’s best interests, they should continue providing these drugs as a moral obligation. It's not entirely unreasonable from the pharmaceutical company's perspective. Since pharmaceutical companies have provided the medication off-label, it's understandable that once the treatment is officially approved, patients should follow the approved procedures. However, instead of abruptly transitioning to non-reimbursed administration, it might be more appropriate to establish a grace period through mutual agreement. Corporate social responsibility to serve their community doesn't always involve grand gestures. It's the behind-the-scenes efforts that can make a significant impact on fulfilling the needs of the patients.
