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- 2026-04-14 23:24:31
- Policy
- Results of HIRA’s preemptive response to COVID-19
- by Lee, Hye-Kyung Apr 27, 2021 06:05am
- In the ‘2020 sustainable management report’ published by the Health Insurance Review and Assessment Service (HIRA), the institution cited its preemptive COVID-19 response as one of its achievements last year. HIRA, which had organized a COVID-19 Countermeasure Promotion Committee in response to the COVID-19 pandemic, evaluated its performance to conclude that it had monitored 68,652 cases of international arrivals, sold 2.5 trillion won's worth of K-diagnostic agents as exports to 170 countries and supported 939.9 billion won in compensation to hospitals and small businesses impacted with COVID-19. In particular, the 'identification system for repeated mask purchases’ played a key role in resolving the ‘mask shortage crisis’ that arose in the early COVID-19 period. According to HIRA, the five-part mask supply system was implemented within 5 days of the mask shortage crisis. During the early stages of its implementation, pharmacies and post offices were designated sellers of the public face masks. HIRA ran an emergency response team 24/7, and disclosed inventory information regarding the public masks every five minutes. HIRA then implemented the identification system for repeated mask purchases. The authorities ordered pharmacies and mask sellers to log the mask sale information of each individual on the portal service for medical institutions, then compared and inspected the sales and cumulative purchasing information to prevent repeated purchases. HIRA’s report states that the identification system for repeated mask purchases helped resolve the public's inconvenience of having to wait in line at pharmacies and other stores to purchase the masks. In February of this year, upon request by the Korea Disease Control and Prevention Agency (KDCA), HIRA had completed the development of a treatment (remdesivir, legdanbimab) management system. In addition, HIRA had dispatched 216 epidemiological investigators to institutions and medical sites including the Central Disaster and Safety Countermeasures Headquarters, Central Disease Control Headquarters, screening clinics, and quarantine centers. This year, HIRA plans to work with KDCA and continue to align its infectious disease response support system by automating the provision of epidemiological data. To accommodate the government's request for the development of patient-specific treatment status and statistical information system for each COVID-19 confirmed case in each city and province, HIRA organized a temporary organization and started to provide the requested service to KDCA, cities and provinces, and quarantine institutions (health centers, medical institutions, etc.) from March last year. Meanwhile, HIRA has provided 3.94 million cases of infectious disease information to medical institutions by advancing the Drug Utilization Review (DUR) service and International Traveler Information System (ITS). Also, HIRA monitored the appearance of symptoms through a phone survey on all incoming international travelers (Korean and foreigners, 68,652 cases) to detect the inflow of COVID-19 cases in advance. Also, HIRA self-acclaimed its achievements, stating that its efforts in allowing rapid entry of COVID-19 diagnostic tests into Korea's health insurance system and establishing a follow-up management system had contributed to the establishment of the world-class K-disease control and prevention system. HIRA said, “We have conducted 203 times more tests than the number of patient occurrences, and 17 diagnostic reagent products from 15 Korean companies were listed, achieving 2.5. trillion dollars in overseas exports."
- Company
- MSD virtually prohibits one-on-one product presentations
- by Apr 27, 2021 06:04am
- MSD Korea has proposed new rules for one-on-one product presentations with doctors. Product presentations that are not for business purposes are minimized, and the limit for meals is lowered from ₩100,000 per person to a maximum of ₩70,000. It is expected that the labor-management conflict will intensify as a counter-argument has been raised within the business that it is a'substantially banned rule'. On the 23rd, MSD Korea announced the reorganized guidelines for product presentations to its employees. According to this, from this coming May ▲Meetings with speakers scheduled to lecture ▲Details that require a lot of time, such as changes in new drugs, indications, and guideline changes ▲One-on-one products under the approval of NSM only when in-depth details are needed for important business purposes. The pre-lecture meeting with the speaker is when in-depth discussions about products and diseases are necessary to determine and prepare the contents of the lecture. Details that take a lot of time include new drug launches, new indications, adverse reaction issues, supply-related, insurance benefits, and important clinical data updates. An important business purpose refers to business-related discussions after product presentations and Q&A, or when additional discussions on other business-related topics such as marketing, insurance benefits, supply, etc. are necessary in relation to products or diseases.If this is not the case above, one-on-one product presentations must be approved by the business unit director (BUD). The limit on food and beverages that can be provided at product presentations has also been lowered. From ₩100,000 per person, lunch is limited to ₩40,000 and dinner is ₩70,000 (excluding VAT). The company said, "We hope that the product briefing sessions conducted one-on-one with the doctor will be conducted as a simple PRE. When a product briefing with meals is absolutely necessary, it is conducted with the approval of the executive, and the approval authority carefully reviews the reason why this activity must be conducted as a general briefing rather than a simple product briefing, and additional reasons are recognized..” Simple product presentations refer to light meals that are less than ₩10,000, such as coffee or sandwiches. There is a backlash from inside the business that it is a measure that effectively bans one-on-one product presentations. This is because the scope of the provisions allowed by the company is narrow and ambiguous. An official from the MSD Korea union said, "The speakers scheduled to lecture are only for some professors at general hospitals, and there are few new drugs available." "Because the important business purpose is ambiguous, there is a difference in the position between the field staff and the company. It is expected to be large.” He added, "In the end, the three provisions proposed by the company seem to be in most cases that are not possible in the field, so it is actually interpreted to mean that one-on-one meetings should not be held." Employees pointed out that the company is pushing for a unilateral change of regulations that does not take into account the business environment, which is a stronger measure than that of the pharmaceutical affairs law and the KRPIA. Earlier, MSD Korea said, "We regularly review whether the communication method with customers is appropriate and update internal regulations if necessary." It said that it will derive an appropriate plan by collecting opinions from employees
- Policy
- The industry is paying attention to the review of generics
- by Lee, Jeong-Hwan Apr 27, 2021 06:04am
- Following the generic joint bioequivalence test '1+3 Restriction Act', the Drugs for Data-Based Re-evaluation (IMD) clinical data '1+3 Restriction Act' will be submitted to the National Assembly's Health and Welfare committee (Legislative Subcommittee) to be held next week. The two bills initiated by Democratic Party of Korea Rep. Seo Young-suk and People Power Party Rep. Seo Jeong-sook, respectively, have strengthened their influence on the pharmaceutical industry if passed as a merger review was decided. A bill to upgrade the CMA (Conditional Marketing Authorization) system for clinical trials operated by the MFDS to the pharmaceutical affairs law has also been newly added as an agenda for review of the legislation. On the 21st, Kim Min-seok, chairman of the Welfare Committee, and the secretaries of the ruling and opposition parties discussed the agenda of the subcommittee on the bill. Earlier, after the plenary meeting on the 26th, the Welfare Committee confirmed the schedule of the 2nd Subcommittee on the 27th and the 1st Subcommittee on the 28th. In the Legislative Subcommittee, which will be held this time, a law under the jurisdiction of the MFDS, which was not reviewed in February, will be first reviewed. In particular, the pharmaceutical affairs law, which has a great influence on the pharmaceutical industry and pharmacy, was included. The most representative bill is the combined review of the bioequivalence test 1+3 regulatory bill (by Seo Young Seok), which aims to prevent the overrun of generic drugs, and the law limiting the number of joint use of IMD clinical trial data to four pharmaceutical companies (by Seo Jeong-sook). The generic joint bioequivalence test 1+3 regulatory bill was put forward in February, but it did not have an opportunity for review. IMD's 1+3 regulation bill, which was proposed afterwards, was newly added as an agenda, and the Welfare Committee decided to review the two bills together. If the bill passes the deliberation of the welfare committee, the impact on the pharmaceutical industry and pharmacies will be greatly increased. In particular, there are opinions that generic and IMD licensing regulations should be strengthened in preparation for the past as illegal cases of voluntarily manufacturing pharmaceuticals in violation of the GMP regulations of the Pharmaceutical Affairs Act are discovered one after another. The merged review of the 1+3 bills for IMD Next week, the Legislative Subcommittee confirms the evaluation. Including bills for vitalization of generic substitution and mandatory CSO expenditure reports Following the generic joint bioequivalence test '1+3 Restriction Act', the Drugs for Data-Based Re-evaluation (IMD) clinical data '1+3 Restriction Act' will be submitted to the National Assembly's health welfare committee (Legislative Subcommittee) to be held next week. In particular, the two bills initiated by Democratic Party of Korea Rep. Seo Young-suk and People Power Party Rep. Seo Jeong-suk, respectively, have strengthened their influence on the pharmaceutical industry if passed as a merger review was decided. A bill to upgrade the CMA (Conditional Marketing Authorization) system for clinical trials operated by the MFDS to the pharmaceutical affairs law has also been newly added as an agenda for review of the legislation. On the 21st, Kim Min-seok, chairman of the Welfare Committee, and the secretaries of the ruling and opposition parties discussed the agenda of the subcommittee on the bill. Earlier, after the plenary meeting on the 26th, the Welfare Committee confirmed the schedule of the 2nd Subcommittee on the 27th and the 1st Subcommittee on the 28th. In the Legislative Subcommittee, which will be held this time, a law under the jurisdiction of the MFDS, which was not reviewed in February, will be first reviewed. In particular, the pharmaceutical affairs law, which has a great influence on the pharmaceutical industry and pharmacy, was included. The most representative bill is the combined review of the bioequivalence test 1+3 regulatory bill (by Seo Young Seok), which aims to prevent the overrun of generic drugs, and the law limiting the number of joint use of IMD clinical trial data to four pharmaceutical companies (by Seo Jeong-sook). The generic joint bioequivalence test 1+3 regulatory bill was put forward in February, but it did not have an opportunity for review. IMD's 1+3 regulation bill, which was proposed afterwards, was newly added as an agenda, and the Welfare Committee decided to review the two bills together. If the bill passes the deliberation of the welfare committee, the impact on the pharmaceutical industry and pharmacies will be greatly increased. There are opinions that generic and IMD licensing regulations should be strengthened in preparation for the past as illegal cases of voluntarily manufacturing pharmaceuticals in violation of the GMP regulations of the Pharmaceutical Affairs Act are discovered one after another. Rep. Young-Seok Seo, who initiated the generic regulation bill, argued that it would be possible to prevent the recurrence of the BINEX incident by regulating the 1+3 joint bioequivalence test at the time of the BINEX incident. Rep. Seo Jeong-suk has also initiated a bill to regulate the IMD. The MFDS’ phase 3 clinical conditional expedited approval bill is also being reviewed by the Act Subcommittee. The bill was initiated by Democratic Party Rep. Nam In-soon, along with Rep. Jong-heon Paik, the Power of the People, and the merger was decided. The main goal is to upgrade the system for marketing approval for drugs for treatment of severe intractable diseases such as rare cancers to the pharmaceutical affairs law from the existing notification, subject to the submission of the results of phase 3 clinical trials. It strengthens the management and operation of conditional permits, and contains provisions that clearly stipulate the subject of conditional permits, conditions for granting, and reasons for cancellation of permits. An amendment to the pharmaceutical affairs law (by Seo Yeong Suk) was also on the agenda, in which the name of generic substitution was changed to the same ingredient preparation, and the doctor who prescribed for follow-up notification at the pharmacy added and expanded it to the HIRA to activate the generic substitution. Pharmacy notified the physician who prescribed it afterwards, but the amendment to the pharmaceutical affairs law (by Seo Young Seok) was also on the agenda to activate the alternative preparation to be added or expanded to the HIRA. In addition to pharmaceutical companies that manufacture and sell drugs, bills that require physicians and pharmacists to report on expenditures for CSOs (pharmaceutical sales agencies) entrusted with sales promotion tasks (by Seo Young-seok, Jung Chun-suk, and Go Young-in) are also under review. Drug day is designated as a national anniversary (by In Jae-geun), strengthened management of raw material drug and national lot release (by Kim Sang-hee), increased the penalty for drugs for false and illegal national lot releases (by Kang Byung won, and mandatory braille markings and voice codes for medicines (by Hye-young Choi and Ye-ji Kim), punishment for illegal purchasers of Rx drug's (by Seo Jeong-suk and Lee Sang-heon), and obligatory guidance for pharmacists to take medicine for drug waste (by Yeon-sook Choi) were also proposed for this bill review agenda.
- Policy
- Generics for Pradaxa · Xarelto are scheduled to be released
- by Lee, Tak-Sun Apr 26, 2021 05:52am
- Xarelto (top) and Pradaxa (bottom) Due to the failure of the patent challenge, sales of the domestic NOAC (oral anticoagulant drug), generic for Eliquis (Apixaban) product, will be suspended for the time being. But within this year Pradaxa (Dabigatran Etexilate Mesylate) and Xarelto (Rivaroxaban), other types of NOAC generics are expected to be released, so domestic pharmaceutical companies' NOAC challenges are expected to continue. According to the industry on the 25th, product patents for Pradaxa and Xarelto are expected to expire this year. The product patent expires on July 17 for Pradaxa and October 3 for Xarelto. Pradaxa and Xarelto, along with Eliquis and Lixiana, are representative drugs of NOAC called post Warfarin. All of these are imported drugs, and domestic pharmaceutical companies are waiting for generic for exclusivity for Pradaxa and Xarelto to expire. Pradaxa recorded an outpatient prescription (UBIST) of ₩14.3 billion last year and Xarelto, ₩50 billion, establishing itself as a trend in the anticoagulant market. However, since these products have a high proportion of prescriptions in general hospitals, domestic pharmaceutical companies are expecting to expand to clinics when they release generics. As soon as the prodcut patent is terminated, generic drugs will be available to market. 21 pharmaceutical companies have already obtained product licenses for generics. 8 generics (Dabigatran Etexilate Mesylate) acquired generic for exclusivity, and the same drug will be banned from July 18 to April 17 next year. However, most of the already approved products are salt-modified products, so they are not subject to the ban on the sale of the same drug according to the generic for exclusivity. There are 160 Xarelto's generics. Since the original Xarelto is licensed in 4 doses, there are also a large number of generic items. Hanmi's Riroxban 2.5mg and SK Chemical's SK Rivaroxaban 2.5mg acquired generic for exclusivity from October 4 to July 3, next year. Xarelto 10mg, 15mg, and 20mg are not listed as generic for exclusivity, so most generics are expected to be released after the expiration of the product patent. However, in the case of Chong Kun Dang, it depends on the result of a trial to confirm the scope of rights requested to avoid a product patent. Chong Kun Dang's Riroxia15mg and 20mg will be listed next month. According to the patent results, there is a possibility that Chong Kun Dang will dominate the market. In the case of generics for Eliquis, the KIPO and the Patent Court of Korea accepted the claim of the generic company's patent invalidation, but the Supreme Court recently returned the case. Accordingly, generic companies recently stopped selling. generics for Eliquis were the first NOAC products sold by Korean pharmaceutical companies.
- InterView
- KRPIA will introduce advanced new drugs and seek co-growth
- by Eo, Yun-Ho Apr 26, 2021 05:52am
- Dong-Wook Oh, Chairman of KRPIA The Korean Research-based Pharmaceutical Industry Association (KRPIA), which represents the multinational pharmaceutical companies that are considered the key source for the supply of new drugs, welcomed a new leader last February. KRPIA’s newly appointed Chairman Dong-Wook Oh (51) has been leading Pfizer Pharmaceuticals Korea since 2015. Oh's appointment has brought on various changes within the organization. For the first time in three years, KPRIA has appointed a Korean to head its organization. Demand for the appointment of a Korean leader had been rising as it would enable better communication with relevant ministries, as the access and supply of new drugs is the primary objective of multinational pharmaceutical companies Moreover, with the pipeline of multinational companies weighing towards high-priced drugs, the ability to communicate with the government and list such drugs is being emphasized. In fact, related ministries, such as the Ministry of Health and Welfare (MoHW ) also tend to prefer Korean leaders. Former chairman Avi BenShoshan (former CEO of MSD Korea) was the first foreigner to be elected in 7 years since 2011, after the appointment of the former CEO of Pfizer Dong-Soo Lee (58), former CEO of GSK Korea Jin-Ho Kim (70), and former CEO of Janssen Korea Ok-Yeon Kim. The rise of the dominance of Korean leaders cannot be welcomed without reservations. However, from KRPIA’s perspective, there is no doubt that now is more important than ever. With Oh’s appointment, a new board of directors (BOD) has launched, including a new Vice-Chair and Director. Also, Min-Young Kim (51) joined KRPIA as a policy executive, a position that was left vacant for 6 months after executive director Seong-Ho Kim (63) resigned from his post last April. Dailypharm Korea met with Chairman Dong-Wook Oh, who is leading the change at KRPIA, to hear about the assosication's future direction and challenges. -Regardless of rights and wrongs, a difference certainly exists between companies led by a Korean and a foreigner. As the new chairman, how are you planning to run KRPIA? The trend these days is to pursue a win-win model in which Korean society, Korean patients, and business companies can coexist. In special circumstances like the current COVID-19 outbreak, promptly introducing vaccines to Korea was an extremely difficult task as the whole world needed vaccines. However, KRPIA and branch offices of multinational pharmaceutical companies were dedicated to securing a stable supply of the vaccine, persuading their headquarters, and cooperating with the government. The COVID-19 vaccine case is a perfect example of the efforts made by pharmaceutical companies to support the local community by persuading their headquarters and cooperating with the government. The win-win model is also important in terms of economic contribution. In the age of the 4th industrial revolution, barriers to entering the biopharma industry are higher than in other industries because the know-how and technology transfer of leading global companies is very extremely important. KRPIA has been acting as the bridge connecting domestic companies to form partnerships with global pharmaceutical companies through open innovation so that these companies may grow to establish themselves as leaders in the field by developing their own know-how and capabilities based on partnerships with the global companies. - As you have mentioned, it is encouraging that multinational companies were able to persuade their headquarters to improve Korea’s treatment and prevention environment. However, advanced new drugs that ㅊcannot be properly handled under Korea’s current healthcare system are pouring in right now. Persuading company headquarters may get more and more difficult in this aspect. That is true. With the development of advanced technology, ‘cures’ are now emerging. In other words, ‘one-shot treatment’ technologies that can fundamentally treat diseases caused by genetic defects are currently being developed. The key issue is whether the insurance models established in the past may embrace these innovative treatments. Although the drugs are good news for the patients, as it is an unprecedented technological advance, new financing methods and insurance models need to be introduced to allow the innovative drugs to be included in Korea's systems and policies. The government has also made much effort to deal with this challenge, such as by implementing the ‘Safety and Support Act for Advanced Regenerative Medicine and Advanced Biopharmaceuticals.' From now on, it will be important to bring together the relevant organizations, government, and various stakeholders to create an appropriate model for the introduction of advanced treatments. At this stage, it is too early to decisively point to a certain model and follow its direction. With no precedents available, I believe much social discussion will be needed in the future. - More countries, including the U.S. and China, have been referencing Korea's drug prices for more than just advanced new drugs. It seems ironic that the transparency of our system, which has led to more companies referencing Korea's prices, may ultimately cause supply difficulties in Korea. The phenomenon may seem positive. in terms of sharing information and in verifying that Korea's position in the global market has risen to the level where other countries wish to refer to Korea's prices. However, considering that Korea's drug prices are referenced in large overseas markets such as the US and China, and the influence power of Korea's price will continue to increases gradually, the dreaded situation of drugs being not released at all in Korea may really become a reality. In other words, I am very concerned about the 'Korea passing phenomenon,' in which the introduction of new drugs to Korea becomes delayed due to Korea's reference pricing system. KRPIA feels grateful the government made the decision to implement systems like RSA (Risk Sharing Agreement) as a means to overcome such situations. Currently, drugs eligible for RSA are limited, therefore continuous support is required for the system to expand flexibly and to allow more drugs to overcome such difficulties by devising various models. -‘Clinical investment’ cannot be left out when discussing the contributions made by multinational pharmaceutical companies. However, research investment in Korea is undoubtedly concentrated on Phase 3 research. Does KRPIA have plans to expand its funding to basic research? The association has been actively promoting and taking interest in domestic clinical trials and investment, as well as in the investment trend in the high value-added Phase 1 and 2 research. According to an annual R&D investment status survey conducted by KRPIA, in addition to the overall size of the field, the field of basic research has also been growing continuously recently. Discussions have been held to attract more early-phase clinical trials, and we encourage our members to also do so. KRPIA expects to expand investment to basic clinical studies and will continue to make further efforts in the future. - WIth regards to the direction discussed for KRPIA in the future, What is KPRIA's top priority challenge? Tackling challenges in the drug pricing system to allow the smoother introduction of new drugs is a priority. Also, our key objective is to find ways to transparently and reasonably improve various systems to allow the approval, distribution, and introduction of new drugs. More specifically, we need to find reasonable methods to flexibly expand the application of beneficial systems like the RSA and to utilize the scope, methodology, and real-world data in the PE exemption system.
- Company
- Hankook Korus Pharm is preparing for Sputnik V
- by Kim, Jin-Gu Apr 26, 2021 05:51am
- Hankook Korus Pharm announced on the 23rd that it has begun preliminary work for domestic approval of Sputnik V, COVID-19 vaccine developed by Russia. According to Hankook Korus Pharm, the company has recently requested documents related to the permit from the Russian Direct Investment Fund (RDIF) and is preparing the necessary materials for the permit. An official from Hankook Korus Pharm said, "We have inquired the MFDS for other domestic permits and necessary matters. We are preparing for it as the recent discussion on the introduction of Sputnik V in Korea has progressed." In particular, President Moon Jae-in ordered the inspection. There are steps that must be taken to introduce Sputnik V in Korea. First, it is a contract with the Russian Direct Investment Fund (RDIF). As with other vaccines, the amount and timing of introduction should be negotiated with the supplier. Formal approval from the MFDS is also required. The approval of the MFDS is expected to be the key to approval by the European Medicines Agency (EMA). Currently, the EMA is undergoing formal review of Sputnik V. It is expected that the evaluation results will be announced as early as May. If the EMA approves Sputnik V, it is expected to speed up domestic introduction. In Korea, Hankook Korus Pharm and Huons Global each have signed a contract for consignment production of Sputnik V. Hankook Korus Pharm has decided to produce 500 million doses. Huons decided to build a facility capable of producing more than 100 million doses per month.
- Policy
- The authorities is monitoring Sputnik V's overseas data
- by Kim, Jung-Ju Apr 26, 2021 05:51am
- Regarding the information that Cheongwadae and the licensing authorities are trying to introduce Russia's COVID-19 vaccine, Sputnik V, the Central Disease Control Headquarters said, "It is still in the stage of collecting and monitoring foreign data," and that no application for permission has been received from the company. The Central Disease Control Headquarters explained the current situation in connection with the review of the introduction of the Russian vaccine Sputnik V at the' COVID-19 Regular Briefing' today (22nd). Recently, President Moon Jae-in agreed with his staff that there is a need to review the introduction of COVID-19 vaccine in Russia. Prior to this, the National Security Council (NSC) also reportedly included the introduction of Russian vaccines in the process of discussing the need to secure additional vaccines at a standing committee meeting on the 15th. People's Power Rep. Jongheon Paik sent an official letter to the Ministry of Foreign Affairs on the 15th, asking the government to collect relevant safety information for 12 countries, including Russia, Algeria, and Mexico, which are vaccinating Sputnik V. Regarding this, the Central Disease Control Headquarters said, “Sputnik V's safety data is being collected mainly by the MFDS and the Ministry of Foreign Affairs. The current stage for Sputnik V is data collection and various overseas monitoring stages." However, the authorities revealed that it is not in the process of applying for a permit yet in relation to the company's permission application process. The Central Disease Control Headquarters added, "The company has not applied for permission from the MFDS at this time. We are collecting data from various channels to secure data and understand foreign trends."
- Policy
- Price cuts for Lixiana and Lenvima due to increased usage
- by Kim, Jung-Ju Apr 26, 2021 05:51am
- Prices of Daiichi Sankyo Korea’s Lixiana tab. (edoxaban tosylate hydrate), Eisai Korea’s Lenvima cap. (Lenvatinib mesilate), and Janssen Korea’s Trenfya Pre-filled Syringe inj. (guselkumab_genetic recombination) are expected to fall by 2.5% to 4.5% due to their increased usage. Prices of 10 products including Han Wha Pharma’s Hanwha Topiramate Tablet, Hanwha Donepezil Tablet, and Yooyoung Pharmaceutical’s Cnoxane Injection will also fall by 5.8% to 28.8% at most, following voluntary price cut requests by the companies. Also due to an expansion in the scope of usage, prices of Sanofi-Aventis Korea’s Eloxatin inj., and Lilly Korea’s Alimta inj. will be cut by 1.5% and 2.6% in advance. According to industry officials, the Ministry of Health and Welfare (MOHW) will make amendments to its drug reimbursement list on May 1st that contains the abovementioned changes. ◆Price-volume agreement type ‘A’ = Next month, three products will be applied type ‘A’ of the Price-Volume Agreement (PVA), a system used to manage prices of post-listed drugs. PVA Type A is applied to new drugs that were through drug pricing negotiations for which the actual claims amount of the same drug exceeds over 30% of the expected volume discussed during the negotiation; in which case the National Health Insurance Service (NHIS) and the pharmaceutical company undergo further negotiation to reduce the price. Accordingly, the prices of Eisai Korea’s Lenvima cap. 4mg and 10mg will be cut by 2.5% each, and Janssen Korea’s Trenfya Pre-filled Syringe inj. by 4.5%. ◆Price-volume agreement type ‘B’ = In addition, three products that fall under PVA type 'B’ will be listed next month after negotiations. PVA Type B is applied to new drugs that have been listed for 4 years that did not receive pricing adjustments under Type A, but the actual claims amount of the same drug exceeds over 30% of the expected claims amount and requires adjustment of its ceiling price. From the eligible drugs, NHIS negotiates with the pharmaceutical companies whose claims amount ▲increased over 60% from the previous year or ▲increased by 10% but the amount exceeds 5 billion won. Under PVA Type B, prices of Daiichi Sankyo Korea’s Lixiana Tablet 15mg, 30mg, and 60mg will be each reduced by 2.7%. ◆Products that applied for voluntary price cuts = When a pharmaceutical company applies to lower the drug price of its listed drug to an amount lower than the set ceiling price, the government adjusts the insurance drug price of the product to the requested amount. Among 10 products that voluntarily requested price cuts, 8 are Han Wha Pharma’s products. Price of Hanwha Topiramate tab. 100mg will fall by 10.1%; Hanwha Quetiapine tab. 25mg by 8.4% and 100mg by 14.1%; Hanwha Escitalopram tab. 5mg by 19.5% and 10mg by 22.3%; and Hanwha Donepezil tab. 10mg by 11.9% and 5mg by 28.8%. Price of YooYoung Pharm’s Cnoxane inj. 60mg will also be reduced by 5.8%, and 80mg by 11%. ◆Price cuts in advance for expanded scope of use = Also, the government reduces prices of drugs taking into account the expected increase in the claims amount and rate of increase of drugs that received approval for expanded scope of usage through additional indications, etc. According to the price-cut formula, drugs with an expected additional claims amount of 7.5 billion won to 10 billion won will undergo price cuts between 3.6% to 5%, according to the rate of increase in their claims amount. 4 products will undergo price cuts in advance due to the expanded scope of usage. The price of Sanofi-Aventis Korea’s Eloxatin inj. 5mg/mL will be cut by 1.5% for each strength, and Lilly Korea’s Alimta Injection will be cut by 2.6% for each strength.
- Opinion
- [Reporter’s View] Interest in the role and vision of GAs
- by Eo, Yun-Ho Apr 26, 2021 05:51am
- Multinational pharmaceutical companies have been eagerly hiring employees for Government Affairs (GA). Even companies that originally had no such position have newly created the position. Until now, the distinction between areas covered by Market Access (MA) and GA was unclear, and GA's target 'government institutions’ were limited to directly relevant ministries such as the Ministry of Health and Welfare (MOHW), Health and Insurance Review & Assessment Service (HIRA), and National Health Insurance Service (NHIS). This was why in quite many companies, the MA managers also took care of GA. However, such industry practices have changed much over the past few years. Many multinational pharmaceutical companies including Novartis, Takeda Pharmaceuticals, Roche, AstraZeneca, Pfizer, BMS, and MSD have been reinforcing their policy area. Also, other companies including Boehringer Ingelheim, Viatris, and Organon have hired or are in the process of hiring GAs. This change is largely due to the trend of new drugs. With the advent of the ‘'high-priced drug era,' the government and pharmaceutical companies are finding it increasingly difficult to see eye to eye on the price of such drugs. As a result, whether and when the government would list a drug for reimbursement became the determinant that makes or breaks the success of a new drug. However, as issues that cannot be resolved through communication with only ‘directly related ministries’ began to accumulate, the pharmaceutical companies started to seek new solutions such as the National Assembly. This raised the need for experts from various backgrounds including the National Assembly, the government, and the media. The Korean Research-based Pharmaceutical Industry Association (KRPIA) has also been paying more attention to strengthen its GA-focused HC Policy committee. However, internal and external conflict regarding this increased interest in GAs exists. Contrary to MAs who are typical pharmaceutical industry experts that have a high understanding of drugs and drug pricing systems, GAs are often not from the industry. Therefore, the perception that ‘GAs do not know the industry well' does exist within the industry. Externally, although MAs and GAs both deal with government authorities, the specific authority targeted by each is different. For example, from the MOHW’s perspective, it is natural that it would feel uncomfortable if a drug-related issue is raised by the National Assembly. In such situations, if MA represents the MOHW and GA represents the National Assembly, friction is due to arise. Therefore, only companies that achieve synergy between MAs and GAs may succeed in using GAs. The internal message needs to be integrated first before taking further steps. However, one warning to bear in mind is that companies should not simply use GAs for the generation of profit in the ‘‘'high-priced drug era.’ Publicizing drug issues is like a double-edged sword. Bear in mind how the COVID-19 vaccine issue became embroiled in a political battle.
- Company
- Ninlaro can be prescribed at general hospitals
- by Eo, Yun-Ho Apr 26, 2021 01:34am
- Ninlaro, an oral multiple myeloma treatment that solves the problem of insurance benefits, is prescribed at general hospitals. According to related industries, Ninlaro (Ixazomib), an oral medication option in the field of multiple myeloma (MM), is used in Korea, including Samsung Medical Center, Seoul National University Hospital, the Catholic University of Korea Seoul St. Mary's Hospital, Hwasun Chonnam National University Hospital, Kyungpook National University Hospital, Pusan National University Hospital, and Chungnam National University Hospital. it has passed the drug commitee (DC) of major medical institutions nationwide. Ninlaro was designated as an orphan drug in May 2017 and was listed last month. This is because the risk sharing agreement (RSA) could not be used due to the selection of competing drugs. Takeda Korea, a supplier, has also provided free domestic supply since October 2019. This drug, a proteasome inhibitor, proved its efficacy in the TOURMALINE-MM1 study, a phase 3 clinical trial in 722 patients with relapsed or refractory multiple myeloma. According to the results of the study, Ninlaro, Revlimid (Lenalidomide), and Dexamethasone therapy had an average progression-free survival (PFS) of 20.6 months, which was higher than that of placebo, Lenalidomide and dexamethasone combination therapy at 14.7 months. Meanwhile, three-drug therapy including Revlimid for multiple myeloma is recommended as a major treatment option in the NCCN guidelines and ESMO. Reblimide's 'R' is the backbone of these three-drug therapies. Amgen's Kyprolis (Carfilzomib) is used as KRd (Kyprolis, Revlimid, dexamethasone) therapy, BMS' Empliciti (Elotuzumab) is used as ERd therapy, Ninlaro is used as IRd therapy, Janssen's Darzalex (Daratumumab) is used as DRd therapy. Deok-Hyun Yoon, professor of oncology at Asan Medical Center, said, "Multiple myeloma with many elderly patients and frequent recurrence will gradually increase in number of patients and increase the socioeconomic burden as the population ages. In the treatment of relapsed and refractory multiple myeloma patients for a long period of time," "The treatment strategy that keeps this from progressing is important, and one of the factors to consider for this is patient compliance." He added, “The combination therapy of oral three-drugs through Ninlaro is a treatment option that lowers the patient's treatment burden for outpatient and administration time and increases medication convenience. It is recommended for patients first.”
