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- 2026-05-03 18:19:08
- Policy
- 'Preferential drug pricing for K-made new drugs' revision
- by Lee, Jeong-Hwan Oct 24, 2024 05:52am
- Rep. Baek Jong-heon It was pointed out that upon receiving criticism that the recently announced amendment plan for drug pricing system lacked provision to provide preferential drug pricing for new drugs made by Korean pharmaceutical companies, the Ministry of Health and Welfare (MOHW) posted an administrative notice detailing amendment to be made for 'Pharmaceutical Approval and Adjustment Criteria.' Previously, the amendment plan had been criticized for making a reverse discrimination against Korean pharmaceutical companies. According to the MOHW's notice, the amendment plan included implementing a 68% drug pricing increase applied to national essential medicines for up to 10 years (5+5 years), preferential drug pricing of new drugs manufactured by pharmaceutical companies with significant R&D contribution, and a double pricing system to support exports. On October 23rd, Rep. Baek Jong-heon, a member of the People Power Party, stated that during the parliamentary audit held on October 8th, he raised an issue with the Health Insurance Review and Assessment Service (HIRA)'s amendment plan for the pharmaceutical pricing system. The criticism concerned that the amendment plan excluded the core clause to benefit Korean pharmaceutical companies. Baek emphasized that the amendment plan could reverse discrimination against Korean pharmaceutical companies because most of the revision details for the drug pricing system favored multinational companies. In response to this criticism, the MOHW's Pharmaceutical Benefits division proceeded with revising the drug pricing system, aiming to reflect the new drug's innovative value and public health security. They have notified an administrative action for 'Pharmaceutical Approval and Adjustment Criteria.' MOHW's plan will be officially announced in 2025 after being reviewed by the Ministry of Government Legislation and evaluated by the Regulatory Reform Committee. Earilier, Baek questioned Cho Kyoo-hong, Minister of Health and Welfare, about the rationale for excluding a measure that provides practical benefits to Korean pharmaceutical companies from the revised plan, despite Korean pharmaceutical companies requesting improvements to the current policy related to new drug development and exports. "As part of the 120th national agenda, the Yoon Suk Yeol government has decided to foster bio-health business as the core export business, aiming to leap as a leading global country in the bio·digital health field," Baek said. "However, the MOHW announced the revised plan without considering practical supporting measures." "MOHW's role is to lead the growth and development of the Korean biopharmaceutical industry and enhance international competitiveness, thereby contributing to the nation's health and welfare improvement," Beak emphasized.
- Policy
- Will non-face-to-face prescriptions of Wegovy be banned?
- by Lee, Jeong-Hwan Oct 24, 2024 05:51am
- Yu-Kyoung Oh, Minister of the Ministry of Food and Drug Safety, said the ministry will discuss the issue of Wegovy, a new obesity drug, being prescribed through non-face-to-face treatment with the Ministry of Health and Welfare. The MOHW Minister Kyoo-hong Cho also responded that he would actively engage in Oh's request for discussions. On the 23rd, Rep. Joo Young Lee, a lawmaker from the Reform Party, asked Oh about the misuse of obesity drugs through non-face-to-face prescriptions. Rep Lee said, ‘The anticipated concerns regarding obesity treatment have become a reality. After the release of Wegovy on the 15th, in addition to the illegal sales and advertisements of the drug online, but also the issue of the drug being prescribed through non-face-to-face treatment platforms even if they are normal or underweight arose. The MFDS’s promotion is not enough, and I believe it is necessary to make it institutionally difficult to make the inappropriate access itself.” “There is a precedent of post-partum contraceptives being excluded from the list of possible prescriptions from non-face-to-face treatment platforms,” said Lee, adding, “Obesity management should start with lifestyle improvement. Adding Wegovy prescriptions to the list of allowed non-face-to-face prescription servrequiresquire more sensitivity and expertise. Bad practices such as using them in smaller doses are arising. Is there a countermeasure?” Oh replied that the ministry would seek measures to address the misuse of Wegovy and limit non-face-to-face treatment prescriptions. “The purchase of Wegovy online is a problem, and the cyber investigation team has been intensively monitoring this for a month,’ Oh said, adding, ’Overseas direct sales are also a concern due to poor temperature control. Since yesterday, we have been cooperating with the Korea Customs Service to block overseas direct sales and purchases of Wegovy.’ “Non-face-to-face treatment prescriptions are also a problem. We sent a letter asking them to refrain from excessively advertising the prescription of obesity drugs,” said Oh, adding, ’We will discuss whether to include prescriptions for non-face-to-face treatment (such as Wigobi) as it is the responsibility of the Ministry of Welfare.’ Minister Cho Kyu-hong also briefly responded to Oh's comment, saying that the MOHW would “cooperate.”
- Policy
- Overseas direct purchases of GLP-1 obesity drugs banned
- by Lee, Hye-Kyung Oct 23, 2024 05:50am
- The government has begun blocking direct purchases of GLP-1 obesity drugs overseas in the wake of the ‘Wegovy’ craze. The Ministry of Food and Drug Safety (Minister: Yu-Kyung Oh) and Korea Customs Service (Comissioner: Kwanghyo Ko) announced on the 22nd that they would block the direct purchase of recently launched GLP-1-based obesity drugs via overseas online platforms and bringing them into Korea. They also said they are actively cracking down on illegal sales and advertisements online and via social media. The MFDS has asked major online shopping malls to set ‘Wegovy,’ ‘Saxenda,’ ‘diet pills,’ and ‘slimming pills’ as prohibited words and requested their cooperation in self-monitoring and regulating the illegal imports. GLP-1-class obesity drugs such as Wegovy must be administered following a doctor’s prescription at a hospital and dispensing and medication guidance of a pharmacist at a pharmacy, according to the set dosage and administration method. If purchased directly from overseas, it is difficult to check the authenticity of the drug due to unclear manufacturing and distribution routes, and if it is an illegal counterfeit product, its safety cannot be guaranteed as it may contain harmful ingredients and is dangerous due to the possibility of misuse. The Ministry of Food and Drug Safety has requested major online shopping malls to prohibit the sales of obesity treatment drugs and conduct self-monitoring and requested the Korea Communications Commission to block access to posts on social media and online shopping malls that illegally promote or advertise sales of such drugs. Since Wegovy was released on the 15th to the 21st of this month, 12 violative posts were detected and taken action against. The Ministry of Food and Drug Safety and the Korea Customs Service will continue to share relevant information to prevent consumer damage caused by illegal direct purchases and advertisement of obesity treatment drugs overseas. They also warned that the obesity drugs sold on online platforms should never be purchased or administered and that they will do their best to strengthen the monitoring system for illegal sales and bait advertising in the future for the safe use of drugs by people in Korea.
- Company
- Moderna’s keyword for post-COVID vaccination is ‘RWE’
- by Whang, byung-woo Oct 23, 2024 05:50am
- With the COVID-19 pandemic transitioning to the post-COVID-19 era, Moderna is putting forward ‘real-world evidence (RWE)’ as the keyword for its vaccines. As the seasonal vaccination of COVID-19 vaccines has become the norm, the company has been promoting the accumulated effectiveness and safety of its vaccines. (from the left) Jae-Kap Lee, Professor of Infectious Disease at Hallym University Kangnam Sacred Heart Hospital, Piyali Mukherjee, Executive Vice President, Medical Affairs, Moderna Asia Pacific Since the pandemic, the Korea Disease Control and Prevention Agency (KDCA) has designated COVID-19 as an infectious disease that requires annual vaccination along with influenza (flu). As a result, this year, as in previous years, the KDCA is recommending people aged 65 and older, who are at higher risk of both COVID-19 and influenza, receive both vaccines at the same time. However, there is still a lack of awareness of the disease compared to the flu. According to a survey of 1,003 adults in Korea, only 14.5% of the respondents perceived COVID-19 vaccination as important to protect their health, which is over 3 times lower than the 54.2% for the flu. COVID-19 awareness lower than flu, emphasizing the need for vaccination At a conference hosted by Moderna Korea on the 22nd, Jae-Kap Lee, Professor of Infectious Disease at Hallym University Kangnam Sacred Heart Hospital, emphasized the lingering dangers of COVID-19. “COVID-19 is a dangerous disease that causes higher hospitalization and mortality rates than influenza due to the constant rise of new variants,” said Professor Lee. “Among elderly patients, hospitalization rates for COVID-19 were 5 times higher than influenza, and in-hospital mortality rates were 3 times higher for COVID-19 than influenza among those with underlying medical conditions.’ Given this, Lee believes high-risk groups, including those aged 65 and older, should be vaccinated against COVID-19 alongside the flu to protect them from health deterioration and disease burden. Moderna is supplying the COVID-19 vaccine, ‘Spikevax JN,’ in line with the government's 2024-2025 seasonal vaccination plan, which began on the 11th of this month. Jae-Kap Lee, Professor of Infectious Disease at Hallym University Kangnam Sacred Heart Hospital In Korea, there are currently 7.55 million doses of COVID-19 vaccine available in the country for this season, including 5.23 million doses of Pfizer, 2 million doses of Moderna, and 320,000 doses of Novavax vaccines. With multiple COVID-19 vaccine options, Moderna emphasized the accumulation of real-world experience (RWE) as its vaccine’s strength. ‘With more than 1 billion doses of Moderna's COVID-19 vaccine supplied, its RWE continues to confirm its effectiveness and safety. In a real-world study evaluating its COVID-19 prevention effect, the Moderna vaccine booster arm reduced hospitalization rates by 89%,’ said Piyali Mukherjee, Executive Vice President, Medical Affairs, Moderna Asia Pacific. She added, “Moderna’s Spikevax is available in single-dose vials to help both healthcare providers and patients in the country, increasing the likelihood of required dose administration and reducing the chance of contamination. Moderna's vaccine is the only mRNA vaccine manufactured in Korea in partnership with Samsung Biologics.” Most importantly, Vice President Mukherjee said, Moderna's vaccine has proven its value in the current situation where concurrent vaccination for COVID-19 and flu is recommended. “In a Phase III study evaluating the combination of a quadrivalent influenza vaccine and Moderna's COVID-19 vaccine, the combination resulted in a high immune response and a tolerable safety profile.” ‘Flu+COVID-19’ combo vaccine is on the horizon...domestic clinical trials to start next March Another hot topic related to COVID-19 vaccination at the event was the rise of a ‘combo vaccine’ that protects against both flu and COVID-19. Moderna has completed clinical trials on the combo vaccine and plans to submit data to regulatory authorities in Europe and the United States, which is expected to be a game changer in the future. In Korea, the company plans to start enrolling patients for a bridging trial in March next year. “The combo vaccine will first be approved abroad, and patient enrolment in Korea will start in March next year. We expect discussions on approval will take place after 2-3 years of clinical trials,” said Professor Lee. “Many companies are conducting clinical trials on mechanisms that prevent both COVID-19 and influenza at the same time with interest.” While cost remains an issue in the long term, there is no doubt that a combo vaccine that protects against both COVID-19 and flu would be a game-changer, said Lee. “Currently, two doses are administered separately, but the combo vaccine is only one dose. When you look at the cases of children, the market share changes when the combo vaccine comes out,’ he said, adding, ’If the price of the combo vaccine becomes affordable for the government to supply, I don't think there will be much of a problem with its marketability.”
- Policy
- New drug expenditure is 13.5% of NHI finance's drug spending
- by Whang, byung-woo Oct 23, 2024 05:49am
- It was found that the total expenditure on new drugs listed in the past six years since the Positive List System policy was implemented amounted to 13.5% of the National Health Insurance pharmaceutical spending, which is the lowest compared to the averages of A8 countries and OECD countries. The Korean Research-based Pharmaceutical Industry Association (KRPIA) announced the research outcome of 'Analysis of pharmaceutical spending on new drugs by disease,' conducted by Seung-Rae Yu, a Professor at Dongduk Women's University's College of Pharmacy, on October 22nd. The research evaluated new drugs listed from 2007 to 2022 when the Positive List System policy was implemented to allocate financial resources to drugs. The document compared the performance to 25 OECD countries besides South Korea. The research aimed to set the analysis period to the past 6 years (2017-2022) and to investigate financial analysis reflecting the outcome of the government's policy implementation to strengthen patient access to new drugs. It researched disease types contributing to patient deaths and compared domestic and overseas new drug expenditures in diseases with the highest financial burden, by analyzing pharmaceutical costs by disease. The percentage of new drug expenditures in South Korea (red), OECD countries (green), and A8 countries (blue). The percentage of new drug expenditure in South Korea Based on the research, the percentage of new drug expenditure in South Korea's total pharmaceutical cost amounted to 13.5%, which was below half of those in A8 countries, 38.0% on average, and in OECD countries, 33.9% on average. The analysis suggests that the figure would be the lowest among 26 countries. The analysis of the trend in the percentage of new drug expenditure from 2017 to 2022 indicates that the differences between Korea and the average for A8 countries grew significantly, amounting to almost a threefold difference in 2022. In particular, the total expenditure on new drugs was merely 15-25% of those in A8 countries, including the U.K., France, Italy, and Canada, which are similar in population and GDP per capita. The research analyzed the financial cost of disease by comparing a weighted index of disease·injury·risk factor, including death·disorder, by country, and new drug expenditure through the analysis of pharmaceutical cost by disease. The percentage of expenditure on new drugs for treating tumors was 46.2% for South Korea, not significantly different from 54.4% in the OECD on average. However, the percentage of expenditure on new drugs for treating cardiovascular diseases was 20.2% for the OECD on average and 2.4% for South Korea. Furthermore, the neurological disease category was 30.1% and 4%, respectively. The respiratory system category was 43% and 6.7%, respectively. They showed that Korea's percentages were merely 1/10th of the OECD countries' average, indicating relatively poor patient access to treatments. In other words, Korea showed significantly lower expenditures in the top-costing disease category, including the cardiovascular system, neurological system, and respiratory system, compared to those of the OECD and A8 countries. The analysis of the trend in the percentage of new drug expenditures in South Korea (red) and the average for A8 countries (blue). The research pointed out that despite a continuous increase in National Health Insurance reimbursement in the past, reimbursement for severe·high cost diseases started to decrease since 2022. The expenditure index of the number of new drugs and pharmaceutical cost by reimbursement category shows that the number of new drugs listed under the economic evaluation exemption program or essential program amounts to merely 11.6% and 3.6%, respectively. These drugs are needed to enhance patient access to severe disease treatments. The percentages of these drugs in the total pharmaceutical cost were 0.6% and 0.3%, which is relatively low. Additionally, the percentage of new drugs listed after undergoing economic evaluation out of the total number of listed new drugs was 26.8%. Excluding drugs in the antitumor category, it is merely 14.5%, indicating that the percentage of listed new drugs that are found to have values for improving clinical effectiveness is relatively small. "After implementing the Positive List System policy, the percentage of pharmaceutical cost in the total medical cost was aimed at about 24%, and it has been maintained. However, it seems that setting the new drug expenditure in the total pharmaceutical cost lacked specific aim and direction," said Yu. "From a financial viewpoint, we need to consider differences in the percentage of new drugs in Korea to other major countries and set the priority to strengthen reimbursement of treatments, including reimbursement of innovative new drugs, for diseases with high cost." "The percentage of new drugs in National Health Insurance-supported pharmaceutical cost is significantly lower than those of overseas, indicating that Korean patients are not fully benefiting from new drug treatments," Lee Young-shin, vice chairman of the KRPIA, said. "The system may need improvements, including the economic evaluation and expanding economic evaluation exemption and risk sharing agreement system, to enhance patient access to innovative new drugs and to allow them to have a better lifestyle."
- Product
- Stockpiled COVID-19 drugs soon to expire in KOR
- by Kim JiEun Oct 23, 2024 05:49am
- A corona drug that caused a crisis due to its shortage has become a nuisance, an inventory glut, in just 3-4 months. In August, the government additionally distributed large quantities of the treatments, but the number of confirmed COVID-19 cases plummeted. The expiry date of the supply is approaching, raising the possibility of mass discarding of the high-priced drugs. As of the 23rd, the drug distribution industry and pharmacies are closely monitoring the change in the supply of COVID-19 drugs such as Paxlovid Tab and Veklury Inj, as these will be reimbursed through national health insurance from the 25th. It has been confirmed that there are still some stocks of Paxlovid and Lagevrio that were supplied to pharmacies by the government in late August. The issue is that the expiry date of the government’s additional supply is nearing. The extra supply was provided via an emergency purchase by the government and is due to expire in January next year. This means that the stockpiles of COVID-19 drugs in COVID-19 dedicated pharmacies have less than 3 months left. In some pharmacy communities, pharmacy-to-pharmacy exchanges are being attempted, but there is currently no demand. “The demand was so high that the dedicated pharmacies had taken as much extra supply as they could, which coincidentally coincided with the drop in confirmed COVID-19 cases, which has left them with excess stock,” said a local pharmacist. “I think it's safe to say that there has been virtually no prescribing since September. We've had very little response to posts on our local dedicated pharmacy group chat for pharmacies in need of stock.” The pharmacist added, ”‘The extra supplies have a short expiration date, set to expire in less than two to three months, so if the outbreak doesn't resurface in November or December, the expiration date of the drugs will either have to be extended or be discarded.” The distribution industry believes that despite the change in the supply system from government supply to commercial distribution upon reimbursement of COVID-19 drugs with national health insurance finances, it would not be easy to commercially distribute the drug immediately. This is because the government is reportedly aiming to first exhaust the existing supply from the market. A pharmaceutical wholesaler said, “There is no set date for the commercial distribution of COVID-19 drugs. Drug distributors are also checking with interest due to their reimbursement listing, but I heard that the KDCA recently requested pharmaceutical companies to delay the release of the general distribution as much as possible. I know that there is a lot of stock left in existing pharmacies, so using it up first is being discussed. The current stock on the market has an expiration date of only about 3 months, which is why the government has decided to use it up first.” The wholesaler added, “I believe the drugs for commercial distribution will be released when the current stock is exhausted. When I asked the pharmaceutical company, they said that the timing is not clear and that they need to see the trend, such as whether the existing stock is exhausted. We can't rule out the possibility of the existing stock being mixed up with the commercially distributed items.”
- Product
- Illegal errand companies deliver Wegovy for ₩10,000
- by Jung, Heung-Jun Oct 22, 2024 05:52am
- Amid the craze for obesity treatment drug Wegovy, errand companies are also thriving by offering pharmacy proxy pick-up and delivery services. These are illegal businesses that take advantage of the fact that consumers are looking for a low-priced source of the non-reimbursed drug, as the price varies greatly depending on the pharmacy. There are posts on diet communities that claim to have purchased Wegovy at a low price in the KRW 400,000 range. Some people said that they called the pharmacy to check the price, while others said that they found a lower price through non-face-to-face treatment venues. Some people also wrote that they received Wegovy packaged in a cooler from another region. When the reporter checked with the pharmacy that offered Wegovy delivery, they were using an errand delivery service. The pharmacy representative said, ‘We don't offer delivery services for Wegovy,” but gave me the contact details of a courier service. They explained that the pharmacy has been contacted repeatedly due to the courier service’s promotion. Although the pharmacy does not deliver directly, they are tacitly allowing the act. “They charge KRW 10,000 for 1-2 pens and KRW 12,000 for 3-5 pens,” said A, who introduced himself as an errand-running company. If you use non-face-to-face treatment services, you can send the prescription to the pharmacy and then contact them for us to receive and deliver the medicine,” A explained. After submitting the prescription to the pharmacy, the customer can exchange the detailed address and account number for the Wegovy delivery through A. A also added a condition that the customer should leave a review on online cafes and communities. “I don’t make much with the deliveries. To make a profit, we need multiple delivery orders,’ said A, adding, ’Please leave your reviews online.’ Meanwhile, pharmacies are also focusing on stocking up and selling Wegovy in line with shifting attention from Saxenda to Wegovy. Low doses are selling out quickly. Lawmakers are also posting reviews of Wegovy use on social media to promote in-patient prescriptions. The selling price of the drug, which can be checked through non-face-to-face treatment websites, varied greatly on the first day of its release, but as of today (21st), the drug’s price is set in the KRW 500,000 range.
- Policy
- Dongkook receives reimb for s-amlodipine triple-drug combo
- by Lee, Tak-Sun Oct 22, 2024 05:52am
- Olmevikar, a combination of s-amlodipine and olmesartan currently sold by Dongguk. The company will sell Olmevikar HCT from November, which contains Olmevikar and hydrochlorothiazide Dongkook Pharmaceutical has succeeded in becoming the first Korean company to receive reimbursement for a three-drug combination drug for hypertension that combines the CCB ‘s-amlodipine,’ ARB ‘olmesartan’ and diuretic ‘hydrochlorothiazide’. The combination therapy is expected to be useful for patients whose blood pressure is not adequately controlled with the company's combination product, s-amlodipine+olmesartan. Only Dongkook Pharmaceutical and Ahngook Pharm owns an s-amlodipine+olmesartan combination drug. According to industry sources on the 21st, Dongkook Pharmaceutical will start selling three types of Olmevikar HCT Tab beginning November, 1 with reimbursement. Olmevikar HCT Tab is a three-drug combination of S-Amlodipine Besylate 2.5 Hydrate, Olmesartan Medoxomil, and Hydrochlorothiazide. Compared to Daiichi Sankyo's existing Sevikar HCT, the only difference is the amlodipine and s-amlodipine ingredients. S-amlodipine is a component derived from only the S-enantiomer of amlodipine, which is the active isomer of amlodipine. Therefore, it is equally effective with half the dose of amlodipine with no difference in terms of stability. In Korea, there are 28 amlodipine 3-drug combination drugs like Sevikar HCT. However, Dongkook Pharmaceutical is the first to develop a 3-drug combination containing s-amlodipine. Olmevikar HCT is a combination of s-amlodipine besylate 2.5 hydrate and olmesartan medoxomil that was approved in late May for the treatment of essential hypertension, a condition in which blood pressure is not adequately controlled. It is indicated as a second-line treatment following amlodipine+olmesartan combination therapy as well as s-amlodipine+olmesartan. There are only two as s-amlodipine+Olmesartan combination drugs on the market, Dongkook Pharmaceutical ‘Olmevikar Tab’ and Ahngook Pharm’s ‘Levomos Tab.’ Last year, Olmevikar generated KRW 3.8 billion in outpatient prescriptions and Levomos KRW 1.2 billion, according to UBIST. “Looking at the indications, Olmevikar HCT tablets are expected to be useful for patients who are not sufficiently treated with Olmevikar Tab,” said a pharmaceutical industry insider. “Dongkook’s product competitivity by strengthening its hypertension combination product lineup.” The price has been set in line with the original Sevikar HCT. The company has applied for the 5 (s-amlodipine)/40 (olmesartan)/12.5 mg (hydrochlorothiazide) dose at KRW 821 per tablet, the 2.5/40/12.5 mg dose at KRW 765, and 2.5/20/12.5 mg dose at KRW 703 for, which is lower than the calculated price. This is the same as the price of the same dose Sevikar HCT.
- Company
- "Multiple myeloma dynamics require changes to reimb strategy
- by Whang, byung-woo Oct 22, 2024 05:51am
- Youngil Koh, Professor of the Department of Hemato-Oncology at Seoul National University Hospital "Multiple myeloma is a cancer type that has a great ripple effect depending on new drugs provided in a certain environment. Reimbursement of multiple myeloma treatment requires discussion following a thorough evaluation of the impact of the treatment depending on the treatment environment." Multiple myeloma is one of the cancer types with increased treatment options following new drug entries. There are concerns about extending the relapse period and progression-free survival (PFS) as the number of treatments increases due to relapses. However, the discussion for reimbursement is hindered by cost issues. Youngil Koh, Professor of the Department of Hemato-Oncology at Seoul National University Hospital, emphasizes the importance of discussing appropriate disease-specific environments. According to Koh, the development of new drugs for blood cancers is active because of disease characteristics. Because cancer cells tend to exist in the blood and it is easy to obtain samples, the research is relatively simple. Understanding of blood cancer yields significant results compared to solid cancers. "Almost all new drugs begin from blood cancers, including TKI, therapeutic antibody, bispecific antibody, and ADC, and expand to solid cancers. Bispecific antibodies and ADCs are used as the standard treatment for blood cancers and expand their indications to solid cancers," Koh said. In South Korea, a bispecific antibody treatment, Tecvayli (teclistamab), is available for treating multiple myeloma. This drug was approved in July. The use of Tecvayli is limited because it is not reimbursed, but the expansion of market presence is expected following the announcement of long-term follow-up research results of the drug's clinical trial, MajesTEC-1, at the American Society of Clinical Oncology (ASCO 2024) meeting. The results of evaluating the efficacy of Tecvayli in 165 study participants at 30.4 months interim follow-up showed that Tecvayli reduced tumor sizes by 63% (overall response rate, ORR) in patients who had failed or were non-responsive to third-line treatments or higher. 46.1% of the patients reached complete remission (CR). The study confirmed consistent, long-term clinical effectiveness and positive safety profile. "The 30-month follow-up outcome did not differ from the data presented in 2022; therefore, it is significant that we have confirmed the anticipated outcome," Koh said. "Specifically, 4 out of 10 patients showed great responses and maintained response over two years." "We have observed that the real effects observed in 30-50 patients administered with the drug at the Seoul National University Hospital did not differ greatly from the research," added Koh. "1/3 of the patients benefited from the treatment, and close to half experienced great responses." In conclusion, Koh says that the result should be highly regarded because Tecvayli's long-term follow-up data demonstrated that patients showed a significantly long response period after almost two-years of treatment. Will Tecvayli, demonstrating its long-term effects, be adminstered earlier in the treatment course? Based on the assumption that there are no differing opinions about the effect of Tecvayli, the question is 'when' to use the drug. There are concerns about using the good drug first or last, regardless of disease. However, multiple myeloma requires a more careful approach because the treatment order is particularly important. Koh says it is difficult to determine at this point, but Tecvayli is likely to be placed earlier in order since the data supporting its use of Tecvayli in earlier treatment course are now available. "Tecvayli is the only bispecific antibody to be used for the treatment of multiple myeloma in South Korea and it targets BCMA, which the conventional treatments haven't targeted," Koh said. "Based on the clinical data of Tecvayli used in combination with already effective treatments that are currently used, Tecvayli is likely to be employed earlier in the treatment and will be able to extend overall survival," Koh said. However, Koh assessed that it is too early to mention whether bispecific antibody, known as the next-generation treatment, or CAR-T therapy should be placed earlier. "The positions of bispecific antibody and CAR-T for treating multiple myeloma have not been established yet. We now know that two treatments successfully treat multiple myeloma, but it is early to determine which one is superior. Upcoming clinical data will determine their positions," Koh emphasized. "Multiple myeloma is highly dynamic…changes to reimbursement strategy should be considered" Besides the Tecvayli effect, the dilemma for new drugs is the cost. Patient burden increases when high-cost drugs are not covered by reimbursement. Since multiple myeloma treatment tends to use 2-3 treatments in combination, the government is hesitant to opening the door to reimbursement. Regarding this issue, Koh advises that rather than simply comparing the cost of the drug, a reimbursement strategy reflecting the characteristics of multiple myeloma should be discussed. "The dynamic of treatments for multiple myeloma is changing due to new drugs, and the disease is greatly influenced by the type of new drugs and the type of reimbursement. We need to discuss reimbursement after anticipating the potential impact of reimbursement on overall treatment outcomes," Koh explained. "The landscape of multiple myeloma is diverse and constantly changing; therefore, instead of simply comparing costs, the government can strategize better reimbursement plan taking into account various outcomes," Koh said. Koh stated that we need to discuss patient access to clinical trials while reimbursement for new drugs is limited. "New drugs are being developed faster than the reimbursement process. It is inevitable that patients cannot benefit from new drugs because reimbursement cannot cover all," Koh said. "In other words, drugs are available at clinical stages, so we could discuss increasing patient access to new drugs."
- Policy
- MFDS grants EUA to COVID-19 variant vaccine for infants
- by Lee, Hye-Kyung Oct 22, 2024 05:51am
- The Ministry of Food and Drug Safety (MFDS) announces. The Ministry of Food and Drug Safety (Minister Oh Yu-kyoung, MFDS) announced on October 21st that it has granted Emergency Use Authorization for 'Comirnaty JN.1 Inj 0.033 mg/mL (bretovameran),' a SARS-coV variant (JN.1) vaccine for infants aged 6 months-4 years. Emergency Use Authorization is a system designed to respond appropriately to a public health crisis, including infectious disease pandemics. In this system, the MFDS minister enables the supply of medical products that do not have domestic approval by ordering manufacturers and importers to manufacture or import upon requests from the central administrative agency. The Korea Disease Control and Prevention Agency (KDCA) requested the Emergency Use Authorization to provide immunization for infants (6 months-4 years old), and the MFDS quickly reviewed it and granted approval. For Emergency Use Authorization, MFDS gathers expert opinions by reviewing company's submitted clinical and quality documents through the official posting of the emergency use authorization upon request from the central administrative agency. Then, after review and voting from the committee for the 'Public Health Emergency Preparedness and Responses for a Medicinal Product,' the MFDS makes a final decision. "We will continue to put efforts in enhancing public health by quickly supplying medical products that are effective in overcoming COVID-19, based on our scientific knowledge and regulatory expertise," the MFDS stated.
