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- 2025-12-19 14:20:39
- Opinion
- [Reporter’s View] Potential drawbacks of expanding RSAs
- by Lee, Tak-Sun Mar 12, 2024 05:49am
- It has been announced that more drugs will be added to the Risk Sharing Agreements (RSAs) track, which will help to improve patient access and reduce uncertainties. In December, the ‘Improvement of the Drug Pricing System to Ensure Fair-value Compensation for Innovative New Drugs and Healthcare Security’ was announced. Under this system, drugs to treat ‘Irreversible Chronic and Severe Diseases’ will be eligible for the RSAs track. The current RSAs only applies to anticancer and orphan drugs, which treat life-threatening and severe diseases that cannot be treated with substitute drugs. In the future, the RSAs will cover drugs that are used to treat chronic and severe diseases that cannot be treated with substitute drugs and result in irreversible deterioration in the quality of life. For example, RSAs will provide coverage for treatments for generalized pustular psoriasis, interstitial lung disease, hereditary angioedema, and severe asthma. The improvement in the drug pricing system will also likely include implementing a dual price system through RSAS to support the export of domestically developed new drugs. The plan is for new drugs granted preferential pricing due to domestic clinical trial status to be listed for the RSAs with essential reimbursement pricing if confirmed to be intended for foreign market distribution and technology export. The RSAs were introduced to South Korea ten years ago. Starting in December 2013, RSAs became available for orphan drugs or anti-cancer drugs without substitutes. Since then, the scope of RSAs has continued to expand through revisions and amendments. In 2020, the coverage was extended to include tuberculosis treatments, antibiotics, and emergency antidotes. Additionally, RSAs were made applicable to subsequent therapeutically equivalent and cost-effective drugs. The advantages of the RSAs are evident. Pharmaceutical companies and insurance authorities can expedite reimbursement inclusion by sharing the uncertainty of drug efficacy and the financial risk burden on health insurance. Expedited listing enables patients to access new treatments. Pharmaceutical companies can overcome the disadvantage of information disclosure in international drug price negotiations by differentiating between the list price and the actual price. However, implementing a dual price system may negatively affect price transparency, potentially disadvantaging patients. For example, patients who paid the total cost of drugs under the RSAs or those who receive selective reimbursement may be eligible for a refund of a portion of the drug cost from pharmaceutical companies, but only if they apply. Patients who are not properly informed may miss out on reimbursement. If the contract renegotiations fail, the drug may be transitioned to non-reimbursable status, potentially increasing the financial burden on patients who were previously covered. The issue of price transparency is being raised internationally. Recently, in Spain, a citizens' group filed a lawsuit demanding the disclosure of actual drug prices under a risk-sharing scheme, and the court accepted the case. Administrative burden is also a concern. Regarding patient refunds, the National Health Insurance Service (NHIS) directly handles the process. For example, a patient was charged KRW 1 million for a cancer drug, and they paid a 5% co-payment rate, which was KRW 50,000. In this case, if a refund rate of 30% is applied according to the contract, and the NHIS receives KRW 300,000 from the pharmaceutical company, the final burden on the patient is not just KRW 50,000, but 5% of KRW 700,000, which is KRW 35,000. Therefore, the NHIS should refund the difference of KRW 15,000. The issue is that the government bears the total burden of this administrative process. With increasing medications subject to RSAs, the workload is only getting heavier. The situation is worsened by the shortage of officials with pharmaceutical expertise due to the drug department's relocation to local areas. It is reported that in advanced countries such as France, medications subject to RSAs are not refunded at all. Because Korea’s initial system included patient refunds, administrative burdens have yet to be relieved in South Korea. While hiring dedicated personnel could help minimize administrative burdens, it would result in additional costs. Experts say expanding RSAs should be handled delicately due to administrative costs and price transparency issues. However, recent government policies appear to be focusing on improving patients' access to new drugs without considering the administrative burden, leading to an increase in drugs subject to RSAs. The government should strengthen the review process to ensure RSAs are applied only to essential drugs. It is important to establish measures to minimize administrative burden to create sustainable policies.
- Opinion
- [Reporter’s View] On MFDS’s new drug management team
- by Lee, Hye-Kyung Mar 06, 2024 06:03am
- A new drug management support team will be established under the Ministry of Food and Drug Safety’s Pharmaceutical Safety Bureau. According to the 'Partial Amendment of the Enforcement Rules of the Ministry of Food and Drug Safety and its Affiliated Institutions' that was released by the MFDS on February 7, the MFDS will newly establish a drug safety management team using the total payroll costs system. As such, the MFDS is expected to reorganize and make personnel appointments to reflect the amendments in the near future. The role of the Pharmaceutical Management Support Team will focus on managing items with unstable supply and demand. The duties of the head of the Pharmaceutical Management Support Team include overseeing the procurement policies for medical products in response to public health crises, operating the Safety Management and Supply Committee, establishing and operating information systems, approving emergency use of drugs, designating, managing, and stabilizing the supply of national essential medicines, operating the drug supply forecast system, managing the targets for reporting production and supply interruptions, and managing Korea Orphan & Essential Drug Center projects. The Pharmaceutical Management Support Team will also take over some of the tasks currently handled by the Pharmaceutical Policy Division. The team will also represent the MFDS at the public-private consultative meetings held to respond to unstable drug supply and demand, which have been held 13 times so far. The imbalance in the supply and demand of medicines has intensified since COVID-19, and through the public-private consultative meeting, measures for distribution management and administration are being explored. The MFDS monitors the unstable supply and demand items and simultaneously requests pharmaceutical companies to cooperate with production while seeking measures to support drugs that have supply disruptions due to problems such as unavailability. As such, there is consensus on the need to separately manage drug supply and demand instabilities. It is a positive sign that the MFDS plans to separate the Pharmaceutical Management Support Team from the Pharmaceutical Policy Division to manage items with unstable supply and demand. However, unlike the Narcotics Prevention and Rehabilitation Team, whose team leader is appointed from 4th Grade or above, the head of the Pharmaceutical Management Support Team can be a 5th Grade official. The team is supposed to be in charge of encouraging pharmaceutical companies to manufacture and provide administrative support to stabilize the supply of medical products to respond to public crises, but instead of a Director with a Grade 4 clearance or higher, a Grade 5 Deputy Director would be in charge. Although they can manage, it would have been nice to have a Deputy Director take charge of the team and make viable promises to pharmaceutical companies. In addition, the Pharmaceutical Management Support Team will have a set term and will end on January 31, 2027. After the term, the team’s tasks will be reassigned to the Pharmaceutical Policy Division. However, when looking at the roles taken by the Pharmaceutical Management Support Team, the team seems to be an indispensable department that has a close relationship with medical institutions, pharmacies, and pharmaceutical companies. The MFDS’s decision to reorganize its structure to manage the unstable supply and demand of drugs is laudable, but thoughts are required on whether a 3-year temporary team with a team leader at the level of a 5th-grade official will be able to function as intended.
- Opinion
- [Reporter’s View] Long-awaited, but not prescribed?
- by Eo, Yun-Ho Feb 08, 2024 05:49am
- Even though the only existing treatment on the planet has finally been approved for reimbursement in Korea, prescribers are hesitant to introduce the drug to their institutions due to concerns over incurring losses if the costly drugs are not used. These are drugs that have gained much attention since approval. The drugs showed outstanding efficacy in diseases with no or limited treatment options, but are expensive. Upon their entry into Korea, patients and their families had been desperately arising for their insurance reimbursement. In every stage of the process, from when the pharmaceutical company applied for reimbursement benefits to the Health Insurance Review and Assessment Service, to every step of the listing process by the National Health Insurance Service, attention was gained and petitions were filed, prompting its listing. However, to the public’s disappointment, the approval process for new drugs that bring heavy financial burdens on national health insurance is usually not smooth and takes a long time. But often, these new drugs that passed this rough and difficult reimbursement process are not being prescribed at most hospitals. And these aren’t all gene therapies that require specific facilities for their prescription. One drug, which was listed almost half a year ago, has only landed in a handful of medical centers in the country despite being an unprecedented and reimbursable treatment. This is because hospitals are reluctant to bear the loss that may occur if the government orders insurance cuts after the drugs are prescribed at the discretion of their physicians. The same is true for the distributors. If they incur a loss in the process of distributing these drugs, they lose a lot of money. The same goes for drugs that require preapproval. The preapproval system is a system established to review whether or not to reimburse expensive rare disease drugs for each patient in advance and is designed to improve patient access to treatments while protecting health insurance finances. It has two functions: prior review, which determines the eligibility of the patients before treatment, and concurrent review, which determines whether the patient may continue treatment with reimbursement after the preapproval. In other words, because the drug is so expensive, the authorities are using prior review to determine whether or not the drug can be reimbursed, case-by-case. The drugs that require prior review can also prescribed when there is an emergency at the doctors’ discretion. The problem lies in when the drug is prescribed but the authorities decided to reject its coverage. It’s not right to ask the hospitals and distributors to just bear the losses. But we all need to remember that much yearning and hard work went into reimbursing the drugs. Hospitals and distributors need to work with the industry and authorities to fulfill the purpose of the ‘risk-sharing’ scheme. This is not the time to be reluctant, it is rather the time to take a proactive step forward. The government also needs to understand this hesitation on-site in using drugs that have entered the system. ‘Landing’ shouldn't become one more barrier that contributes to ‘drugs that exist but can't be taken or administered’ in addition to reimbursement.
- Opinion
- [Reporter’s View] Handling AI-collected ‘cancer info’
- by Kim, Jin-Gu Feb 06, 2024 06:10am
- Medical AI company Lunit announced on the 5th that it will be participating in the establishment of an internet-only bank. Lunit will join the U-BANK consortium, including Lendit, Jobis & Villains, Travel Wallet, and Hyundai Marine & Fire Insurance, to establish Korea’s fourth internet-only bank. An interesting part of the information is the Lunit’s role within the consortium. “The company aims to develop insurance services personalized to individuals and accurate,” Lunit announced. Lunit plans to utilize the data gathered from its ‘Lunit INSIGHT,’ the company’s primary product of artificial intelligence (AI)-enabled cancer detection, to develop insurance products with exceptional accuracy. It is expected that Lunit’s business operations will expand. Previously, Lunit’s business model involved receiving patients’ medical files containing cancer-diagnosis information. The company then uses artificial intelligence to analyze this Big Data, allowing them to determine whether a patient has a cancer from a single MRI image. With a current approach to expanding their business into developing insurance services and sales, companies involved in the consortium will likely take on different roles. The consortium is expected to operate the business by Lunit gathering an enormous amount of data from media files of cancer diagnoses and relaying those data to the consortium’s insurance company (Hyundai Marine & Fire Insurance), which will utilize the data to develop insurance products. Then, the consortium’s newly established internet-only bank will sell those products in a Banccasurance-like manner. There are concerns regarding the possibility of leaks when sensitive cancer personal information is utilized as an ingredient to develop insurance product. Under the current privacy protection law, consortiums like Lunit must obtain consent from each patient to develop and sell insurance products, clearly specifying the purpose and duration of use. The collected information must go through a separate processing step to ensure it cannot identify individuals. To transfer the data collected by Lunit to insurance companies or banks, they must also obtain third-party data-sharing consent. Lunit appears to be prepared to obtain consent. “When we receive patient data, personal information is anonymized. If we actively pursue business, we will properly manage to obtain patient consent related to utilizing personal information,” a Lunit representative stated. “Currently, we have only decided to invest, and we do not plan to change article of association to include insurance business at this time.” Even though Lunit provided these explanations, a feeling of uneasiness persists. This is because incidents of patient data leaks continue to occur in Korea. In July of last year, 17 university hospitals in Korea leaked sensitive patient information. Between April 2018 and January 2020, the hospitals leaked 185,271 cases of patient information. It was discovered that hospital staff or employees of pharmaceutical companies accessed the hospital system and took pictures or downloaded patient prescription information. Several years ago, there was a large-scale data leak in which IMS Health Korea and Korea Pharmaceutical Information Center (KIPIS) leaked patients’ personal information. At that time, the personal information of 43.99 million patients was leaked, amounting to 4.7 billion cases. In the era of Big Data, information is equivalent to goods. If a company decides to transform information into goods, like ‘alchemy,’ it must establish a safety net to protect individuals or patients who own personal data. This does not entail distrusting the corporation’s security policy of handling personal information or criticizing the company’s business model. However, companies must be highly cautious when collecting and utilizing patient information.
- Opinion
- [Desk’s View] New principles rouse moral responsibility
- by Lee, Tak-Sun Feb 06, 2024 06:10am
- The government’s reevaluation of approved and listed drugs is in full swing. The stated purpose is to filter out ineffective drugs and provide coverage to better ones. As this is very necessary for the public, it is the government's responsibility to fulfill this task. The reevaluation is being conducted omnidirectionally by the Ministry of Food and Drug Safety (MFDS), which conducts the approval review, and the Health Insurance Review and Assessment Service (HIRA), which conducts the reimbursement evaluations. MFDS is in charge of conducting the bioequivalence reevaluations for generic drugs and clinical reevaluations for drugs with little evidence literature. HIRA is conducting a reevaluation of the reimbursement adequacy of drugs that lack clinical utility. Last year, it also conducted a reevaluation of the insurance ceiling price, lowering the ceiling price of generic drugs that did not conduct direct bioequivalence tests. Once the authorities create the standards, the evaluation itself progresses at lightning speed. The problem is that the evaluation standards that are being applied after approval and listing this time are different from what had been applied before. For example, in the case of generic versions of natural product-derived drugs, the MFDS requires a comparative disintegration test (a test that compares the disintegration rate under the same conditions for two solid dosage forms with the same active ingredient and route of administration before approval but requires more than a just a bioequivalence test during the post-marketing reevaluations. Similarly, in the price ceiling reevaluations, companies were required to submit direct bioequivalence test results regardless of the criteria that had been applied before. As a result, most generic versions of natural product-derived drugs such as Stillen and Layla were unable to pass reevaluations. One company is said to be preparing a lawsuit against the unilateral price ceiling reevaluation standards that were applied, as it does not reflect the characteristics of each drug. The MFDS is also expected to set ‘comparative clinical trials’ as the standard for natural product-derived drugs. Since bioequivalence tests cannot be applied to natural product-derived drugs, the government is considering applying a higher standard of comparative trials. Comparative clinical trials are more expensive and time-consuming than comparative disintegration tests or bioequivalence tests, and it is not easy to demonstrate equivalence through such trials, therefore, there is analysis that many companies will fail to pass reevaluation if the MFDS applies the comparative clinical trial card. It is rumored that HIRA’s reimbursement adequacy reevaluations in 2025 will also include natural product-derived drugs such as Stillen and Joins. In the case of Stillen, it is questionable whether it will be subject to reevaluations as it was judged to be clinically useful in the 2006 drug list reorganization project. No one can object to the idea of conducting post-evaluation to weed out ineffective drugs. However, if the criteria for pre- and post-evaluation are different, it would be unfair to those who already received the evaluations. In that case, the government owes it to the company to at least explain why the standards have changed and why it was right then but wrong now. Also, when a drug passed pre-evaluations and was taken with confidence by patients, but the post-evaluations showed opposite results, the government should at least express regrets, if not an apology, to the patients who may be unable to use the drug in the future. Various reasons may lead to the same results, such as a lack of scientific evaluation methods at the time, or the fact that clinical utility can only be determined after their release, but this does not eliminate the moral responsibility of the state that is responsible for verifying the safety of the drugs for the public. Therefore, the government should at least express their regrets at the least. This is not something that can be passed over.
- Opinion
- [Reporter’s View] Restructuring in pharmaceutical industry
- by Son, Hyung-Min Feb 05, 2024 07:27pm
- Korea’s biopharmaceutical industry is facing corporate restructuring. Both global and Korean pharmaceutical companies are undergoing aggressive employee reductions. AstraZeneca Korea is implementing a voluntary resignation as a follow-up measure related to the withdrawal of Forxiga, a diabetes treatment, from the Korean market. The company is reducing its employees and offering an Early Retirement Plan (ERP) compensation package. Pfizer Korea is also planning to implement a voluntary resignation program. Since Pfizer’s headquarters in the United States is reducing employees as part of its cost realignment program, the extent of the staff reduction for the Korean subsidiary of Pfizer is under discussion. Korean pharmaceutical companies are also considering implementing employee reduction. GC Biopharma is reducing its employee by 10%. Ildong Pharmaceuticals began a restructuring process in May of last year, including voluntary retirement, which led to a 20% reduction in its employee. Moreover, companies such as Kyung Dong Pharmaceutical, Aprogen, YuYu Pharma, and Genome & Company also implemented restructuring measures last year. In light of the recent economic downturn, many pharmaceutical companies face challenges, and there is a growing concern that this restructuring trend may continue throughout the industry. Moreover, the timing of these restructuring efforts, which coincides with the typical employee reshuffling season at the beginning of the year, is worsening these concerns. According to a spokesperson overseeing the restructuring measures, the internal atmosphere is depressing despite the provision of appealing compensation packages. There are concerns that the biopharmaceutical industry may be entering another challenging period. Even during the Covid-19 pandemic, when face-to-face marketing was not feasible and shortages of essential drugs occurred, the pharmaceutical industry successfully implemented countermeasures tailored to the circumstances. The pharmaceutical industry is selecting and focusing on business as if choosing a candidate product. Each pharmaceutical company focuses on what it is best at, chooses an area to focus on, and develops an R&D plan. The industry anticipates that restructuring in the pharmaceutical industry could serve as an opportunity for advancement. Some global pharmaceutical companies have achieved success in corporate improvement via aggressive restructuring. Pfizer underwent significant restructuring in 2007 and 2015. The company successfully revamped its portfolio, focusing on cancer drugs and developing new drugs such as Ibrance and Lorbrena. Pfizer also achieved success in vaccine development during the Covid-19 pandemic. GSK has undergone multiple restructuring efforts to successfully reshape its portfolio. The company has focused on respiratory drugs, cancer treatments, and vaccines, which have led to the development of several blockbuster drugs. The company's growth has been attributed to employee optimizations to increase profits. Government and industry experts have suggested that the industry should transition from a generic-centered approach to new drug development. Many pharmaceutical companies have invested heavily in new drug development. Certain pharmaceutical companies are actively undergoing R&D despite having to endure operating losses. However, investing beyond their limit would be risky. It is wise to come up with an effective investment strategy and employee optimizations. Hopefully, Korean biopharmaceutical companies will achieve success similar to global pharmaceutical companies that have successfully developed new drugs by revamping their portfolios after corporate restructuring.
- 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.
