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- 2026-04-10 23:45:48
- Opinion
- [Reporter’s View] CDDC continues to raise controversy
- by Eo, Yun-Ho Feb 01, 2023 05:54am
- The Cancer Disease Deliberation Committee has settled as the highest threshold in reimbursement for anticancer drugs in Korea. This expert committee, which is a mandatory step for reimbursement in Korea, has put many anticancer drugs through an ordeal, to the extent that it was coined the ‘wailing wall’ to reimbursement in Korea. The committee, which had originally been launched for the purpose of evaluating the clinical usefulness of anticancer drugs that applied for reimbursement listing, had become ridden with issues after additionally starting a review on each drug’s fiscal impact. Questions were raised on what grounds the CDDC had to analyze the drug’s fiscal impact, and the fairness and objectivity of the review results were also criticized. However, the Health Insurance Review and Assessment Service only disclosed the meeting results and made no other significant change in the operation of the committee. As a result, the CDDC’s power grew stronger, empowering the government with the justification that ‘the doctors that use the drugs said no,’ and the doctors that were selected as members have become priority targets for management by pharmaceutical companies. Recently, controversy arose over the composition of the committee itself. The criticism was that the blood cancer drugs were not properly evaluated due to the high proportion of solid cancer experts in the committee. In other words, it was pointed out that the large proportion of solid cancer specialists with low expertise in hematologic malignancies in the committee made the committee unfit for proper evaluation of blood cancer drugs. In fact, the Korean Society of Hematology and The Korean Society of Blood and Marrow Transplantation had asked HIRA to organize a separate deliberation committee to review blood cancer drugs, but HIRA has been conservative in their response. This is not the first time an issue was raised on the expertise of the committee’s review. The CDDC had excluded direct stakeholders from deliberations in last year’s committee. In other words, doctors who participated in the clinical study of the subject drug were not allowed to attend the committee on the day of the drug’s deliberation. In terms of the purpose itself, the measure was made to secure transparency. However, as the scope of “direct stakeholders” included doctors who participated in PMS – or Phase IV studies – the composition of the committee itself was at a point where the expertise on the drug could not be ensured. Doctors are not financial experts. They are word by word, a medical expert. This is why the government had to explain that financial experts and healthcare experts were added to the CDDC to support the legitimacy of CDDC in evaluating the financial impact made by anticancer drugs. If so, the key role of the doctor in CDDC is to inform the committee of the medical necessity of the drug and the significance of its clinical trial results. An expert committee can no longer function as an expert committee without expertise. CDDC deliberates not any drug, it evaluates long-awaited new drugs for cancer patients. Neither exclusion for transparency nor the proportion of hematological and solid cancer experts should lead to a lack of expertise. With so many voicing the need for change, when will the government continue to argue that there is “no problem?”
- Company
- Sales of statin-ezetimibe combo rise threefold in 3 yrs
- by Chon, Seung-Hyun Feb 01, 2023 05:54am
- Statin-ezetimibe combination drugs greatly expanded their influence in Korea’s dyslipidemia treatment market. Their total prescription amount increased by over threefold in the past 5 years, and its annual market size exceeds KRW 750 billion. In the market, rosuvastatin-ezetimibe combinations drove market growth, and the bulk of generic atorvastatin-ezetimibe combination drugs that were recently released also supported the strong growth. ◆Sales of statin-ezetimibe combos rise from KRW 228.4 billion to KRW 750.4 billion in 5 yrs According to the market research institution UBIST on the 31st, outpatient prescriptions of statin-ezetimibe combination drugs reached KRW 750.4 billion last year, recording a 23.0% YoY increase. Its market size had increased 51.5% in two years from KRW 495.3 billion in 2020. The prescription market for statin-ezetimibe combination drugs had recorded KRW 228.4 billion in 2017 and then expanded over threefold in just 5 years. This analysis is that the increased preference for statin-ezetimibe combinations due to its excellent effect in lowering LDL-C and cost, which is not greater than taking the two drugs separately, has attributed to market growth. Currently, four types of statin-ezetimibe combinations that combine four types of statin - simvastatin, rosuvastatin, atorvastatin, and pitavastatin - with ezetimibe have been introduced to the market. ◆Rosuvastatin·ezetimibe combo occupies 65% of market...atorvastatin·ezetimibe combo expands market In the statin-ezetimibe combination market, rosuvastatin·ezetimibe combinations occupy the greatest share of the market. Last year, rosuvastatin·ezetimibe combination drugs raised KRW 488.5 billion last year, recording a 12.0% YoY increase. This is a 33.1% increase in 2 years from KRW 367.1 billion in 2020. Compared to the KRW 136.6 billion the combination had made in 2017, its market size has increased 257.8% in 5 years. Last year, the rosuvastatin·ezetimibe combination occupied 65.1% of the statin-ezetimibe combination market. Hanmi Pharmaceutical’s Rosuzet was the first product to enter the rosuvastatin·ezetimibe combination market. Hanmi Pharmaceutical entered the market earlier than its competitors by securing the right to use ezetimibe from its patent holder, MSD. Prescription sales of Rosuzet last year recorded KRW 123.2 billion, a 17.4 increase YoY. Among all combinations, the product made the second-most sales for two consecutive years, led only by Lipitor. Rosuzet’s prescriptions rose over threefold in 5 years from KRW 41.5 billion in 2017. Since 2020, sales exceeded KRW 100 billion for 3 consecutive years and showed off its status as the flagship statin-ezetimibe combination drug product. Yuhan Corp’s Rosuvamibe had shown prominence in the rosuvastatin-ezetimibe combination market. Rosuvamibe’s sales recorded KRW 66.8 billion last year, showing a 7.7% YoY increase. Rosuvamibe’s sales rose over twofold in 5 years from the KRW 23.7 billion it had made in 2017. Recently, atorvastatin·ezetimibe combination drugs have shown explosive growth in the market. Prescription of atorvastatin·ezetimibe combination drugs had recorded KRW 197.5 billion last year, which is a 53.4% YoY increase. Also, its market size expanded over fourfold in only 5 years from the KRW 44.2 billion it had made in 2017. The bulk of Atozet generics that entered the market rapidly expanded the market in a short period of time. Until 2020, the only atorvastatin-ezetimibe combination drug available was Organon Korea's Atozet. Then, the market size started to increase with around 100 companies in Korea simultaneously entering the atorvastatin-ezetimibe combination market with their generic versions in 2021. In October 2020, Chong Kun Dang received approval for ‘Lipilouzet’, a combination drug that contains the same ingredients as Atozet. During the same period, 22 companies received approval for their authorized generics of Lipilouzet and were listed for reimbursement from April 2021. Then, 88 more pharmaceutical companies received approvals for their Atozet generics from February 2021 and were reimbursed in May, one month after the reimbursement listing of authorized generics of Lipilouzet. In June 2021, 2 more companies have additionally received approval for their Atozet generics, raising the count of Korean companies that entered the Atozet market to 113. The atorvastatin-ezetimibe combination market had recorded KRW 82.8 billion in 2020 with only Atozet in the market, then grew 138.6% in 2 years after a load of generic drugs entered the market. Atorvastatin-ezetimibe combinations, which had only occupied 19.3% of the total statin-ezetimibe combination market in 2017, rose to 26.3% last year. On the other hand, sales of simvastatin-ezetimibe combinations have somewhat slowed down. Prescription sales of simvastatin-ezetimibe combinations had recorded KRW 35.9 billion last year, which is a 16.6% YoY decrease. Its sales fell for two consecutive years after recording KRW 45.4 billion in 2020. Prescription of simvastatin-ezetimibe combinations last year had decreased 21.0% compared with 2 years ago. Organon Korea’s Vytorin was the original drug to entered the simvastatin-ezetimibe combination market. However, the prescription market gradually shrunk compared to other combinations. In the statin-ezetimibe combination market, the share of the simvastatin-ezetimibe combination had shrunk to 4.8% last year from the 20.9% in 2017. In 2021, JW Pharmaceutical's first pitavastatin and ezetimibe combination, Livalozet, has recently shown good momentum. Pitavastatin is the main active pharmaceutical ingredient used in JW Pharmaceutical's flagship hyperlipidemia treatment, Livalo. Livaloaet was released in October 2021, and the drug made a successful debut raising prescriptions to KRW 28.5 billion last year in the first year of its release.
- Policy
- KMA·MOHW discusses essential healthcare at 1st meeting
- by Lee, Jeong-Hwan Jan 31, 2023 05:59am
- The medical community and the Ministry of Health and Welfare held the first meeting of the Pending Medical Issues Council under the agenda of essential healthcare support measures and reached a mutual consensus. On the 30th, the Korean Medical Association (President: Pil-Soo Lee) and the Ministry of Health and Welfare (Minister: Kyu-Hong Cho) held the first meeting at Conference House Dalgaebi (located in Jung-gu, Seoul) at 4:00 pm. From KMA, Kwang-Rae Lee (President, Incheon Medical Association), Sang-Woon Lee (Vice President, KMA ), Jin-Kyu Park Lee (Vice President, KMA ), and Min-Gu Kang (President, Korean Intern Resident Association) attended the meeting. On the government’s side Hyung-Hoon Lee (Director-General, Bureau of Healthcare Policy at MOHW), Jeon-Kyung Cha (Director, Division of Healthcare Policy at MOHW), Joon Kang (Director, Division of Healthcare Security Innovation), Gang-Sup Lim (Director, Division of Nursing Policy) attended the meeting. The Pending Medical Issues Council was organized for the academic society and the government to discuss major medical issues necessary for promoting public health and developing healthcare in Korea. At the first meeting, the two parties agreed that the objective of operating the consultative body should be to 'strengthen essential healthcare and improve Korea’s medical system'. In addition, the parties agreed to actively discuss various tasks at hand and shared their opinions on how to implement the measures for support that the medical community and MOHW collectively built to support essential healthcare. Also, the KMA and MOHW agreed to continue discussing key tasks that should be implemented to strengthen essential healthcare and local healthcare even after the measures to support essential healthcare are announced. Meanwhile, the second Pending Medical Issues Council is set to be held at 3:00 pm on February 9th.
- Company
- Merck makes large investments in Korea’s science tech
- by Jan 31, 2023 05:59am
- With President Suk Yeol Yoon prioritizing fostering talent in science and technology as the government’s key task, one global company has attracted attention for being committed to strengthening domestic talent in science and technology in Korea. According to industry sources on the 31st, Merck Life Sciences, a global life science company, has long been investing in Korea’s science and technology through awards, researchers and academic society support, and talent development programs. Science and technology directly translate to national competitiveness. This is why countries around the world make efforts to further their competitiveness in science and technology. The US Biden administration emphasized that the development of science and technology will become a 'game changer' in the field of healthcare, and the medical and pharmaceutical industry will become indispensable for national security over the next 10 years. The Korean government has also been prioritizing science and technology in all its policies. At a recent meeting with senior secretaries, President Yoon stressed that growth can only be achieved through scientific and technological innovation, saying, "science and technology are important to ensure sustainable growth of the country." President Yoon also emphasized the importance of science and technology in the past, saying, "This is an era where science and technology are directly linked not only to the nation's future but our survival.” Merck Life Science has shown interest in strengthening Korea’s science and technology from early on. It has been supporting the research of Korean scientists for over 20 years and striving to cultivate pharmaceutical and bio talent with leading universities in Korea. This is a rare case where a global company has taken the initiative to invest in the development of science and technology in Korea. ◆Full support to foster talents that will lead the development of science and technology in the future SNUH Bio-day Specifically, the company signed an academic-industry cooperation and exchange agreement with the Jeonbuk National University College of Pharmacy in 2020. Through the program, Merck provided support for scholarships and mentoring, business development to establish a safe laboratory environment, to foster industry leaders and life-respecting pharmaceutical care experts. The company also supported human and material resources necessary for the research and development of new bio drugs. Since 2021, at Sungkyunkwan University’s Institute of Quantum Biophysics, the company has been collaborating with the school, cooperating in the research and development of diagnosis and disease treatments based on quantum biophysical theory and phenomena. For this, the company has been providing seminars and training programs for knowledge and information exchange, as well as scholarship support and internship programs to procure talent in the life sciences sector. Also, the company has provided opportunities for students to experience the industry and provided information on the pharmaceutical and bio industry. Last year, Merck Life Science participated in the ‘SNU Bio-Day’ hosted by Seoul National University’s Bio-MAX Institute and introduced how the technology of the global company Merck is applied in the field to derive scientific results. Also, the company hosted a field trip to Merck Life Science’s Custom Synthesis Lab as part of the Kiuri Project workshop program run by Seoul National University’s Bio-MAX Institute. ◆Has awarded outstanding scientists in Korea for 20 years...promoting active research Also, the company has been supporting the research activities of scientists in Korea in partnership with prestigious academic societies in Korea through awards. The Sigma-Aldrich Chemist Award that Merck Life Science held with the Korean Chemical Society has celebrated its 20th year this year. The award is given every year to 2 chemists with outstanding research achievements and outstanding creativity in the field of chemistry. This traditional award has a long history and has been given even before the merger of Merck and Sigma Aldrich. The award is presented every year at KCA’s regular autumn conference. Merck The ‘350 Future Researcher Award’ was co-established by Merck and the Korean Society for Molecular and Cellular Biology in celebration of Merck’s 350th anniversary in 2018 to continue supporting research for the next-generation bio-industry. Every year, three first authors (research professors) and postdoctoral researchers that performed outstanding research achievements related to molecular cell biology are selected for the award. The award ceremony is held at the Autumn Conference of the Korean Molecular Cell Biology Association, with lectures by the awardees. For objectivity and transparency, candidates are nominated by regular members of KSMCB, and the awardee is selected through a strict review by the Academic Research Award Committee, without any involvement on Merck Life Science’s part. ◆Merck’s science journal issued a special feature on Korea...shed light on domestic science and technology research Korean Scientist Feature of Material Matters, Merck Merck’s interest in Korean science and technology research can also be seen in its scientific journal. Recently, in its global science journal ‘Material Matters,’ Merck issued a special feature on Korean scientists, introducing 4 renowned professors in Korea and their research Material Matters is a scientific journal prepared to provide information on material science and nanotechnology necessary for scientific research. The journal reviews technologies and their applications by world scholars on a specific subject, and is distributed to research institutes around the world. Korea’s special edition of Material Matters featured:▲Seoul National University Professor Yung-Eun Sung’s discussion on ‘PGM and PGM-free Catalysts for Polymer Electrolyte Membrane Fuel Cells’, ▲Korea Advanced Institute of Science and Technology (KAIST) Professor Byeong-Soo Bae’s review of Sol-Gel Derived Siloxane-Encapsulated Luminescent Nanocrystal Composites for Optoelectronics and Display,’ ▲ Yonsei University Professor Woo-Dong Jang’s research on ‘Poly (2-isopropyl-2-oxazoline)-based Multimodal Stimuli-responsive Functional Materials,’ and ▲Yonsei University Professor Wooyoung Shim’s research on ‘Phyllosilicate Clay Minerals: Principles and Applications’
- Company
- MSD Korea to replace its leader for the first time in 2 yrs
- by Jan 31, 2023 05:59am
- Kevin Peters, president of MSD KoreaThe head of MSD Korea will be replaced for the first time in about two years. Kevin Peters, the current president, will leave Korea at the end of this month. According to the pharmaceutical industry on the 28th, Kevin Peters, CEO of MSD Korea, will be appointed as the general representative of the German branch from February. It has been two years and three months since he became the representative of MSD Korea. He recently reportedly had a farewell ceremony with Korean MSD employees. Kevin Peters has led MSD Korea since November 2020, succeeding former president Avi BenShoshan. It is evaluated that he actively communicated with employees even in a situation where he was converted to telecommuting due to COVID-19. After Kevin Peters took office as president, MSD Korea signed its first collective agreement since the establishment of the labor union. This is considered to be a result of mutual cooperation between labor and management ahead of the corporate division of Organon Korea. At the time of the replacement of the president, MSD Korea was at odds with the union in the process of spin-on. Immediately after taking office, Kevin Peters traveled around the country to communicate directly with employees and actively accepted employees' opinions to lead labor-management cooperation. He also succeeded in expanding the primary benefit for Keytruda lung cancer, which had not crossed the threshold for four years. Keytruda had a very good effect in terminal non-small cell lung cancer without major mutations, but discussions on salary have not progressed for four years due to a large number of patients and expensive new drugs. President Kevin Peters drew the primary benefit for lung cancer in Kitruda with an unconventional proposal of a 'trade-off'. Instead of expanding Keytruda's benefit, the plan calls for lowering drug prices for 15 items, including the "Januvia," a diabetes treatment with large domestic sales. At the time, Kevin Peters, president of the company, said in an interview with Dailypharm, "We presented an unprecedented level of sharing to the Cancer Disease Deliberation Committee of the Health Insurance Review and Assessment Service." Since then, the benefit has expanded in March last year as discussions on Keytruda's benefit have accelerated. It also contributed to the rapid approval and supply of Lagevrio, a COVID-19 treatment developed by MSD. Peters also appealed, "Lagevrio can be supplied from the day of approval." Kevin Peters was scheduled to continue his term as president of MSD Korea this year, but the sudden resignation of the German branch representative led to Peters serving as the German general representative. The successor to MSD Korea has not been decided. For the time being, David Peacock, president of MSD Asia-Pacific, is expected to temporarily work on MSD in Korea. Kevin Peters joined MSD in the UK in 1996 and performed various tasks at the relevant national/regional and global levels in the Asia-Pacific, China, and Europe. He served as vice president of MSD in China, chief marketing officer (CMO), and CEO of MSD in Thailand.
- Policy
- The legislation of cold chain improvement plan is announced
- by Lee, Hye-Kyung Jan 30, 2023 05:55am
- Following biological agents such as insulin, the cold chain regulations for refrigerated and frozen medicines such as eye drops will be eased. The Ministry of Food and Drug Safety announced today (26th) a revision to the "Prime Ministerial Decree on Safety of Drugs," which includes reasonable improvement in temperature management methods to be observed when transporting refrigerated and frozen drugs, and will receive opinions by March 27. The revision to the Prime Minister's Decree calls for dividing the refrigerated and frozen storage products into the current refrigerated and frozen storage products and the allowed products to be stored at temperatures other than refrigerated and frozen for a certain period of time. Transportation facilities equipped with automatic temperature recording devices should be used for all refrigerated and frozen medicines, but in the future, transportation facility standards will be rationalized for products that are allowed to be stored at temperatures other than refrigerated and frozen for a certain period. Products that are allowed to be stored at temperatures other than refrigeration and freezing for a certain period of time can be installed in transportation facilities instead of automatic temperature recorders if the temperature meets the permitted storage conditions when entering and leaving. The Ministry of Food and Drug Safety strengthened drug distribution safety and management standards in January last year, requiring importers and drug wholesalers to have automatic temperature recorders when transporting drugs (including biological products) that require refrigeration and freezing storage. As complaints have been filed at the site, including biological products such as insulin, non-refrigerated products that can be stored at room temperature are excluded from mandatory applications such as automatic temperature recording devices and automatic calibration records. In order to prevent supply instability due to rising costs for temperature management when transporting refrigerated and frozen medicines, the Ministry of Food and Drug Safety discussed with industries such as KDPA, the Korean Pharmaceutical Association, and pharmaceutical companies to improve the cold chain. Earlier in December last year, it was deliberated by the Active Administration Committee to quickly implement drugs for a stable supply of drugs, and measures to improve the transportation management system for refrigerated and frozen medicines will be implemented first from the pre-announcement of the Prime Minister's Decree. Among refrigerated and frozen medicines, a list of products that may not be refrigerated or frozen for a certain period of time when used can be found on the notification board of the representative website of the Ministry of Food and Drug Safety (www.mfds.go.kr). Opinions on this amendment can be submitted to the Ministry of Food and Drug Safety or the Public Participation Legislative Center by March 27.
- Company
- HKinno.N exports new drug K-CAB technology to Brazil
- by Chon, Seung-Hyun Jan 30, 2023 05:54am
- K-CABHKinno.N announced on the 26th that it has signed a technology export contract with Brazilian pharmaceutical company Eurofarma for the new drug K-CAB for gastroesophageal reflux disease. HKinno.N will transfer the manufacturing technology of K-CAB to Eurofarma, and Eurofarma will develop and sell K-CAB in Brazil. Along with the down payment, HKinno.N receives technical fees step by step, such as permission and release, and royalties according to sales. The contract period is 10 years after the launch of the product in Brazil. Eurofarma is the third-largest pharmaceutical company in the region with sales power throughout Latin America, mainly in Brazil. Brazil's digestive ulcer solvent market is the largest market in Latin America with an annual amount of about 800 billion won as of 2020. K-CAB announced its entry into the Americas with this Brazilian technology transfer following the US and Canada technology transfer. K-CAB, a Tegoprazan ingredient released in Korea in March 2019, is an anti-allergic drug based on P-CAB). It shows an action mechanism that inhibits gastric acid secretion by competitively combining a proton pump located in the final stage of acid secretion and potassium ions in gastric wall cells. K-CAB has entered a total of 35 countries and has recently been released in the Philippines following China. Twenty-seven countries, including Mexico, have been approved for permission in Mongolia, Indonesia, and Singapore, and are currently reviewing or preparing for permission. Development is underway in three countries, the United States, Canada, and Brazil. Kwak Dal-won, CEO of HKinno.N, said, "Recently, K-CAB's export contracts, follow-up clinical trials, item permits, and local launches are progressing at a rapid pace in the global market, and we will further accelerate our global business with the goal of entering 100 countries by 2028."
- Company
- SK Bioscience proposes building a vaccine hub in Middle East
- by Jan 30, 2023 05:54am
- Jae-Yong Ahn, CEO of SK Bioscience SK Bioscience announced on the 27th that the company’s CEO, Jae-Yong Ahn, participated in the ‘2023 Riyadh Global Medical Biotechnology Summit’ that was held in Riyadh, the capital of the Kingdom of Saudi Arabia, and proposed a partnership for vaccine supply on the 25th (local time). The Riyadh Summit, which celebrated its second event this year, is a national bio event where major bio-industry officials from the US and Europe gather to share future R&D prospects and investment strategies for the bio industry. At the event, CEO Ahn gave a session presentation on the theme, 'Preparing for Next Pandemic through Global Partnership'. During presentations, CEO Ahn shared his company’s experience in successfully developing Korea’s first homegrown COVID-19 vaccine and proposed a partnership that builds on the company’s R&D and manufacturing capabilities. CEO Ahn said, “We can establish a bilateral partnership if the country is willing to provide funds, human resources, and an overall pharmaceutical manufacturing environment based on global initiatives. Then, building on the partnership, the country can stably supply necessary vaccines within the region during Peace Time, which can also switch to a pandemic vaccine production system during Pandemic Time.” He added, “Having already experienced the human casualties, economic loss, and crises in national systems with the COVID-19 pandemic, we all know that this is the time to consider ensuring self-sufficiency of vaccines for national security. The cooperation model we are proposing requires strong will and commitment from each government and can only be achieved when reasonable compensation is provided to participating institutions." SK Bioscience has been pursuing a ‘Glocalization’ business based on its R&D capabilities, global partnerships, and its Ahndong Plant’s manufacturing capacity. The project is expected to contribute to addressing the inequity in access to vaccines in countries that lack technology and infrastructure and further create social and economic values by pioneering new markets for its vaccine. SK Bioscience is currently conducting specific discussions with various countries in the Middle East, and Southeast Asia including Saudi Arabia, and plans to expand the project to other countries and regions in the future.
- Company
- Practice manual issued for COVID-19 treatments in Korea
- by Jan 30, 2023 05:54am
- Doctors have issued a ‘Practice Manual’ to provide an understanding of how to use the COVID-19 treatment in one glance. The manual was prepared to directly address difficulties HCPs experienced prescribing COVID-19 treatments in the field due to a large number of contraindicated drugs. The Korean Society for Antimicrobial Therapy (KSAT) recently distributed a manual for the actual prescription of Paxlovid, Pfizer's oral COVID-19 treatment. The manual was designed to allow easier understanding for HCPs on whether to refrain prescription of Paxlovid or make dosage adjustments according to a patient's medication status. Paxlovid is the first oral COVID-19 treatment that was approved in Korea. The drug was granted Emergency Use Authorization in December 2021 and was indicated for moderate-to-severe COVID-19 patients at high risk of progressing to severe disease. At the time the authorities initiated the supply of Paxlovid, the authorities had also issued treatment prescription guidelines, however, the guidelines issued then were more than 100 pages long and were not easy to use in the field. un-Joo Choo, Professor of Infection, Soonchunhyang University College of Medicine, The Guidelines on Paxlovid use that was recently announced by KSAT is a practice manual that addresses such difficulties experienced in the field. The KSAT collected the main areas of consideration of up to 100 drugs that require attention so that they could be applied to practice right away. The manual summarized the cautions that do not appear in the Drug Utilization Review (DUR) program. The guidelines also contain, a list of over-the-counter drug products that contain ingredients that require special attention. In an interview with Daily Pharm, Eun-Joo Choo, Director of the Insurance Committee at KSAT and Professor of Soonchunhyang University College of Medicine, who contributed to the preparation of the guidelines for Paxlovid, said, “The existing guidelines were too detailed to identify what precautions apply for each patient's medication. We hope that the guideline can contribute to increasing the practical prescription rate of oral COVID-19 treatments that lower disease severity rate,” stressing the importance of prescribing the COVID-19 treatment. The full interview transcript of Daily Pharm’s interview with Professor Choo is as follows. - A Paxlovid prescription guideline that the government issued already exists. Why did KSAT see a need to prepare a separate guideline?? =KSAT’s practice guideline is more of a ‘practical manual' that allows healthcare professionals to understand contraindicated drugs and dose adjustment at a glance in the field during prescriptions. The Paxlovid prescription guidelines issued by the government are over 100 pages long. It contains too much detail for HCPs to immediately absorb and apply in the field. This is why HCPs had difficulty prescribing the drug in the field, being an unfamiliar drug that is difficult to use. Paxlovid KDCA’s guideline categorizes the list of drug-drug interactions as ▲ 7 contraindicated drugs ▲21 drugs that can be temporarily discontinued or substituted to a different drug during Paxlovid use, ▲List of OTC drugs that contain the ‘St. John’s Wort’ substances that are contraindicated, ▲drugs that require use with caution when co-administered, etc. In particular, the drug substances that require caution in the use and key recommendations were summarized in a table format so that they can be applied immediately in practice. -I first thought the contraindicated drugs will be easy to identify as they immediately show up in the DUR database, but it seems that I was wrong. In particular, it seems that it would have been difficult to identify all the products that contain St. John’s Wort, as the substance is commonly used in OTC drugs and health functional foods. =That’s right. Only the 7 contraindicated drugs that must not be prescribed together pop up on the DUR, which includes epilepsy substances such as St. John's Wort. Substances commonly used by patients for hyperlipidemia, heart failure, gout, etc., that can be temporarily discontinued or substituted to administer Paxlovid, but such information is not reflected in the DUR. In addition, there are about 100 drugs that require attention, such as dose reductions, etc. It's not easy for doctors to know all this during prescriptions. In particular, the St. John's Wort substance is contraindicated, regardless of whether it is a prescription drug, general OTC drug, or health functional food. Since doctors need to check directly with the patient on whether or not they use the substance, a list of the OTC drugs was prepared that specifies the product and company names. The self-checklist also asks patients once more to confirm whether they are taking OTCs or health functional foods. Fortunately, St. John's Wort is mainly used in women, but the rate of those taking it at the age of over 60 is not that high. Patient self survey to identify patient -The prescription rate of oral COVID-19 treatments has remained in the 30% range for several weeks. What do you believe is the reason behind this? = During our webinar, one of the most common concerns that the doctors had was ‘Whether they should use COVID-19 treatments in mild COVID-19 patients with few symptoms.’ Being a drug that the doctor hasn’t used before, in addition to the fact that the drug has many drug-drug interactions, and the treatments for COVID-19 are mainly conducted non-face-to-face, it is natural that doctors may be hesitant in using such unfamiliar drugs. The part I want to emphasize is that oral COVID-19 treatments prevent patients with mild symptoms from progressing to severe diseases. Patients may have minor symptoms at first, but if they do not take the right medicine at the right period, their disease can progress to severe disease, in particular in patients that are over the age of 60 or have underlying diseases. In fact, quite a lot of inpatients who had COVID-19 were sent to the intensive care unit when there were no available vaccines or treatments. However, this number decreased significantly after the introduction of COVID-19 vaccines and oral treatments. Real-world data also showed that the rate of progressing to severe disease was reduced by about 50% with the prescription of Paxlovid. I believe prescriptions will naturally increase after such data on Paxlovid’s actual effect and HCP prescriptions increase and accumulate. -The majority of Korean people have been vaccinated several times. Also, with so many having a history of COVID-19 infections, not many are concerned about reinfections. Do you believe these people also should receive vaccinations with booster shots? If they are high-risk groups, would they need to be prescribed oral COVID-19 treatments when reinfected? If you look at the government’s reinfection rate data, the age-standardized risk of death in case of reinfection is 1.58 times higher than that at initial infection. Just as people receive vaccination for the flu every year and then use Tamiflu when infected, COVID-19 also requires regular vaccination and treatment. In fact, COVID-19 requires more caution as it has a higher rate of complications and disease progression than the flu. Patients who have pneumonia due to COVID-19 suffer complications such as difficulty in breathing due to pulmonary fibrosis even after completing treatment. Some people describe COVID-19 as a 'highly contagious cold', but I do not agree, as no one dies of a simple cold. Also, the experience of the patient that receives the treatment is as important as the HCP that prescribes Paxlovid. There is little positive feedback yet because not many patients have experienced the treatment. However, the treatment has been proven to be effective, and in particular, it is more beneficial for patients that opt for at-home treatments. Because of the definite benefits, I hope that patients do not worry too much and take their prescribed oral COVID-19 treatment as indicated.
- Policy
- Price of Dutasteride has fallen to the 200 won range
- by Lee, Tak-Sun Jan 30, 2023 05:54am
- Original AvodartThe upper limit of Dutasteride products used for prostatic hypertrophy and hair loss has fallen to around 200 won. The effect of cascading drug prices is large, and it is expected to affect the hair loss treatment market. According to industries on the 27th, TELCON RF PHARMACEUTICAL's Durid 0.5mg will be listed at the upper limit of 267 won on the 1st of next month. More than 20 of the same system were applied, 85% of the existing lowest price of the same system (315 won). Dutasteride tablets are evaluated as more convenient formulations than conventional capsule formulations. All 37 currently paid drugs are from domestic pharmaceutical companies. Domestic companies have put forward tablets as a differentiation strategy from Avodart, the original drug containing Dutasteride. Analysts say that it is easier to split and swallow than capsule formulation. As more than 20 are listed at once, the upper limit is gradually falling due to the cascaded drug prices implemented by late pharmaceutical companies since July 2020. The lowest price of 267 won is only 38% of the highest price (709 won). The lowest price for a month on the 30th is 8,010 won, while the highest price is 21,270, a difference of more than 10,000 won. The original Avodart is also 709 won per capsule, the highest price. As such, the falling upper limit of Dutasteride is expected to affect the non-reimbursed hair loss treatment market. This is because low prices are advantageous in the non-reimbursed market. If pharmaceutical companies supply products to nursing institutions in line with the upper limit, hospitals and pharmacies will put a margin based on the upper limit. Therefore, the lower the upper limit, the cheaper the non-reimbursed amount when prescribed for hair loss. Hair loss patients also visit hospitals and clinics that prescribe inexpensive products on purpose, so the lowest price is also helpful for market competition. As a result, it is understood that there are pharmaceutical companies that want to register salaries for competitiveness in the hair loss treatment market even if the upper limit is lowered due to cascaded drug prices. Since Dutasteride drugs are covered by benefits for prostate hypertrophy, most pharmaceutical companies have fewer factors to lower the upper limit. Currently, 28 out of 37 Dutasteride tablets are listed at 709 won, the highest price. It is said that a few pharmaceutical companies deliberately lower the upper limit and sell it as a non-payment for hair loss treatment because supplying it cheaper than the upper limit of the actual transaction price could be lowered. Ten of the same products currently licensed remain non-reimbursed.
