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- 2025-12-23 20:01:58
- Policy
- Six more Arcoxia generics acquire generic exclusivity
- by Lee, Tak-Sun Apr 29, 2021 06:09am
- Six generic products of Arcoxia that received belated approval acquired generic exclusivity. Other Arcoxia generics that were previously approved will go on sale next month. On the 27th, the Ministry of Food and Drug Safety approved the generic etoricoxib products of 6 pharmaceutical companies - Theragen Etex, Guju Pham, Union Korea Pharm, Aju Pharm, Hana Pharm, Hutecs Korea Pharmaceutical. The products also obtained generic marketing exclusivity, applicable from the day after (28th) to December 25th. The 6 products will be produced by Theragen Etex under a consignment manufacturing agreement. Generics of Arcoxia from Arlico Pharm, Boryung Pharmaceutical, Reyon Pharmaceutical, and Samil Pharmaceutical was first approved last month. These companies also acquired generic exclusivity for their products until December 25th of this year. During this period, drugs of the same substances are not allowed to be sold in the market. Like the 4 products previously approved, the 6 products approved today also succeeded in avoiding Arcoxia’s patent by filing a defensive confirmation trial for the scope of right for Arcoxia’s crystalline patent. Applications for approval were submitted on December 22nd, at the time of the original PMS expiry. However, due to a delay in the review, the 6 products produced by Theragen Etex received approval a month later than the 4 products produced by Arlico Pharm. Thus, the release of the 6 products is expected to be delayed by a month. The 4 products produced by Arlico Pharm will be sold from the 1st of next month after completing the listing process. Being generic exclusivity products, the listing process for the said products was completed a month faster than general generics. According to UBIST, Arcoxia recorded outpatient prescription sales of 3.3 billion won last year. Arcoxia is a competitor to ‘Celebrex,’ which dominates the nonsteroidal anti-inflammatory analgesic market. As most of the pharmaceutical companies that will be releasing the Arcoxia generics also own their own generic versions of Celebrex, the industry expects the approval to create a synergistic effect of diversifying the prescription options in the analgesic market. Accordingly, further attention is being paid to whether the introduction of these Arcoxia generics may impact the Celebrex-dominant market.
- Policy
- AZ vaccine vaccination is being reviewed in the 2nd quarter
- by Kim, Jung-Ju Apr 29, 2021 06:09am
- The quarantine authorities are considering expanding the age range for AstraZeneca COVID-19 vaccine. Although it is currently impossible to select a product, it will be reviewed after sufficiently diversifying the quantity while changing the inoculation institution for each product characteristic in the future. Thr KCDA Commissioner Jeong Eun-kyung responded in this way during the inquiry time for the COVID-19 Central Disease Control Headquarters Regular Briefing' during the day on the 26th. The quarantine authorities are considering expanding the possibility of a second quarter vaccination plan. The authorities currently supply 3.87 million doses of AstraZeneca and Pfizer vaccines, and are expected to supply a total of 18.09 million doses by the second quarter. She said, "Currently, we are considering expanding the age target to under the age of 65 as a plan to review changes to the vaccination plan for the second quarter including AstraZeneca to be additionally introduced through COVAX and AZ vaccination of 65-74 years old, including the amount of vaccination plan for under 30s ." In order to increase the vaccination rate of chronically ill and socially indispensable personnel, including health care workers, she said, "We will provide vaccination guidance through each institution and organization and strengthen the guidance so that vaccination can be administered." She suggested that although it is difficult at present as to the possibility that the public can choose and inoculate a vaccine, it is possible to some extent if the quantity is sufficiently diversified and expanded. She said, "It will be difficult in the third quarter to ensure that people can get the vaccine they want by guaranteeing the right to choose a vaccine." "However, in the third quarter, more vaccines such as Pfizer, Moderna, and Novavax will be available, so we are working on a vaccination plan accordingly." She added, "In this case, the medical institution will be different so that the vaccine can be vaccinated according to the characteristics of the vaccine. Because the vaccination is carried out through a consignment medical institution or a private primary medical institution, and as an alternative method, the vaccination center or a hospital of a certain size can be different, so the most suitable vaccine type, inoculation institution, and characteristics. We will proceed to guide the vaccination by matching the appropriate vaccination targets.”
- Policy
- First retinoid acne treatment in 20 years comes to Korea
- by Lee, Tak-Sun Apr 28, 2021 05:17pm
- Galderma’s Aklief cream (trifaortene), the first new retinoid molecule to receive U.S. FDA approval for the topical treatment of acne in more than 20 years, has finally set foot in Korea. On the 27th, the Ministry of Food and Drug Safety (MFDS) approved Galderma Korea’s ‘Aklief cream 0.005%’ as a new drug. The new drug is indicated for the topical (facial and truncal) treatment of moderate acne vulgaris that is characterized by comedones, papules, and pustules. In particular, Aklief cream is the only topical retinoid that selectively targets retinoic acid receptor (RAR) gamma, the most common RAR found in the skin. By stimulating RAR, the drug modulates target genes that are associated with various processes, including cell differentiation and mediation of inflammation. Retinoid is a vitamin A compound that is used to treat acne. For the first time in 20 years, the U.S. FDA had approved the new retinoid product, Aklief cream, in September 2019. Alief cream showed an improved effect on acne compared to existing creams in clinical studies. In a clinical trial on patients with moderate facial and truncal acne, 1,214 subjects who were treated with Aklief cream showed over 10% improvement in IGA (Investigator’s Global Assessment) for the face and PGA (Physician’s Global Assessment) for the trunk compared to the 1,206 subjects treated with vehicle cream. Galderma Korea has been leading the topical acne treatment market in Korea with its products, including its Epiduo gel. The Epiduo brand has recorded 2.3 billion won in sales last year according to IQVIA. With the approval of Aklief cream bringing a new treatment option into the acne market, Galderma Korea's influence in the market is expected to increase.
- Policy
- The government signed an additional 40 million doses
- by Kim, Jung-Ju Apr 28, 2021 06:05am
- The government has signed an additional 40 million doses of Pfizer's COVID-19 vaccine product. As a result, Korea has secured twice the amount of vaccine vaccination in the country, enabling it to achieve the goal of forming collective immunity in November. Pan-government vaccine introduction TF (Team Leader Kwon Deok-cheol, Minister of Health and Welfare) announced that an additional purchase contract for 40 million Pfizer COVID-19 vaccines (for 20 million people) was signed by holding an emergency briefing during the day on the 24th. The government explained that after forming a pan-government vaccine introduction TF to stably supply COVID-19 vaccine on the 1st, it has mobilized all of its government-wide capabilities, including diplomatic efforts, by consistently meeting with each vaccine pharmaceutical company. This contract is the result of ongoing negotiations by discussing the supply of vaccines through video conferences with Pfizer with Kwon Deok-cheol, head of the Pan-Government Vaccine Introduction Task Force on the 9th and 23rd of this month. ◆Signed an additional purchase contract for Pfizer vaccine= This year, a total of 66 million doses of Pfizer vaccine, which was originally 26 million doses and 40 million doses contracted, were supplied, resulting in a total of 33 million Pfizer vaccines. Pfizer's vaccine has been supplied in 1.75 million doses so far, including 7 million doses by the end of June, and plans to supply 59 million doses sequentially from the third quarter. Pfizer vaccines have been supplied regularly every week since the start of supply on March 24th. With the signing of an additional purchase contract this time, the foundation for a more stable supply of COVID-19 vaccine has been laid. ◆COVID-19 Vaccine Supply Status and Plan The total number of COVID-19 vaccines secured by Korea this year amounted to 192 million doses, a total of 99 million. This is the amount that can be vaccinated for about 1.9 times of the total population in Korea and 2.75 times for the 36 million vaccination targets for the formation of collective immunity. The vaccine contracted for this year was for 79 million people, enough to secure collective immunity, but additional purchases laid the foundation to accelerate the time to achieve collective immunity. It is possible to prepare for additional demands that may arise in the future, such as the 3rd vaccination (called booster shot) to cope with the mutant virus and the expansion of the target age for vaccinations under the age of 18 to prepare for the uncertainty in the international vaccine supply and demand. First of all, the government plans to do its best to achieve the target inoculation for 12 million people with the 18.09 million doses confirmed by the end of June. AstraZeneca and Pfizer vaccines, which are currently being vaccinated, have already supplied 3.87 million doses of vaccine, and a total of 18.09 million doses will be supplied by the second quarter. The government plans to closely monitor the vaccine supply situation on a full-cycle basis to ensure that 18.09 million doses will be supplied without disruption, while additionally introducing some of the Novavax, Moderna and Janssen vaccines within the first half of the year, so that up to 20.8 million doses can be supplied. The government said, "By the end of June, 12 million people are vaccinated to prevent infection in high-risk groups such as nursing hospitals, facility admissions, and residents, thereby preventing severe and death, and through vaccinations for COVID-19 treatment, response personnel, and health care workers. We expected to be able to contribute to the maintenance of the quarantine system." From July, AstraZeneca and Pfizer, as well as Novavax, Moderna, and Janssen vaccines are expected to be supplied in earnest. Accordingly, a total of 100 million vaccines are planned to be supplied by the end of September. The total amount negotiated by the end of September is about 80 million doses of AZ, Pfizer, Novavax, Moderna, and Janssen, and when added to the supply in the first half, about 100 million doses of vaccine will be supplied by the end of September. This is an amount that can be vaccinated to more than 50 million people, and if the supply is smooth, it will be possible to inoculate all 44 million people over the age of 18 with only the amount until the end of September. In order to form collective immunity, vaccination of about 36 million people, or 70% of 52 million people, is necessary. The government said, "Through this additional purchase contract, it is possible to secure a sufficient amount of vaccine and achieve early achievement even after meeting the goal of forming population immunity in November." This is the result of specifying the supply schedule of vaccines, which were scheduled to be supplied in the second half of the year, by pursuing additional contracts through the pan-government vaccine introduction TF and expanding the volume of existing contracted vaccines in the third quarter. Although the supply and demand of vaccines worldwide is uncertain, the government said that through additional purchase contracts and quarterly consultations on supply, the government laid the foundation for more stable and rapid vaccination. About 90 million doses to be supplied in the fourth quarter will be used to respond to a variety of situations in a relaxed manner, and to actively utilize additional vaccinations if necessary. The government said, "In the future, we plan to actively cope with various situations that may arise during the vaccine supply and demand process through comprehensive support such as approval of COVID-19 vaccine, release of national lots, and supply of raw and subsidiary materials. By the end of June, 12 million people will be vaccinated and all government-wide capabilities will be mobilized to achieve collective immunity in November." Minister Kwon Deok-cheol said, "The government will do its best to prevent quarantine, introduce vaccines, and vaccinations so that the people's precious daily lives can be restored. I sincerely ask the people to believe in and actively cooperate with the government's plans and guidance for securing vaccines and vaccinations." The government plans to continue meticulous efforts on vaccine safety. The KCDA Commissioner Jeong Eun-kyeong said, "The vaccines contracted by our government are products that have been approved for safety, and the benefits of vaccination outweigh the risks. I hope you will actively participate in the order of vaccination."
- 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."
- 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.
- 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.
- Policy
- Rucalo & Xeljanz are subject to usage monitoring in 2Q
- by Lee, Hye-Kyung Apr 26, 2021 01:32am
- Yooyoung Pharmaceutical's chronic constipation treatment Rucalo(Prucalopride Succinate) 1mg and 2mg were included in the price volume agreement monitoring. Pfizer Korea's Xeljanz (Tofacitinib Citrate) 5-10mg, Novartis Korea's Revolade (Eltrombopag) 25-50mg also decreases in price due to drug price negotiations as the usage increases. The NHIS recently unveiled the drugs subject to monitoring in the second quarter of 2021 price volume agreement negotiations (Type Ka and Na) on the website. The targets for monitoring in the second quarter of this year are 187 items in 89 drug groups. The price volume agreement negotiation system is a method in which the NHIS and pharmaceutical companies share the risk to health insurance finances. In the case of drugs with a sharp increase in usage, drug prices are reduced through negotiations with the NHIS. Type Ka under price volume agreement negotiations is a case in which the amount of the same product group claim that has been agreed upon by the NHIS for drug price negotiations, estimated billing amount negotiations, drug price increase adjustment negotiations, and scope expansion negotiations has increased by more than 30% from the expected billing amount. For Type Na, in the case of the same product group that has been negotiated with Type Ka or that has not been negotiated with Type Ka and has passed 4 years from the date of initial listing, the previous type will increase by 60% or more or 10% or more from the previous year's bill every year from the day after the end of the analysis target period. This applies to cases of more than ₩5 billion. Meanwhile, drugs with an annual billing amount of less than ₩1.5 billion, drugs with an upper limit price lower than the arithmetic average price of the same ingredient, low-cost drugs, and shortage prevention drugs are excluded from the price volume agreement. The drug groups included this time include Sanofia Ventis Korea's Dupixent Prefilled Inj.(Dupilumab) 300mg, Jeil's' Apydamole ER Cap, and Hyundai's Dipyanox ER.
