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- 2025-12-23 23:28:48
- Policy
- Drug exempt from economic evaluation,cut to the lowest price
- by Lee, Hye-Kyung Feb 15, 2021 06:16am
- The NHIS continues to monitor foreign drug prices after signing and listing a drug price reduction contract linked to foreign prices for drugs exempt from economic evaluation in accordance with the drug price negotiation guidelines. In the past three years from 2018 to 2020, after 30 items of 14 pharmaceutical companies were listed on the list, they signed a contract stating that drug prices would be reduced if foreign prices lower than the domestic upper limit were confirmed. Among them, 6 items in 2018 and 15 items in 2019 received the lowest price. In particular, from 2019, the number of countries subject to foreign drug price linkages has been expanded from the lowest price of the newly listed country to the lowest price of all countries, and the price fluctuations of not only newly listed foreign drugs but also existing listed drugs have affected the domestic market. Japan, one of the A7 countries, implemented an ICER re-evaluation for registered drugs in April 2019, and drug price adjustments were made. If the price of the registered drugs fell to the lowest A7 due to drug price cuts, it is reflected in Korea,too. The NHIS uses the upper limit price in Taiwan, Singapore, and countries affiliated with the Organization for Economic Development Cooperation (OECD) as a reference price for drug price negotiation in accordance with Article 7 of the Drug Price Negotiation Guidelines. In the case of drugs exempt from economic evaluation, agreements have been made on drug price reductions, such as adjusting the upper limit in conjunction with the lower amount when it is confirmed that the adjusted price is lower than the upper limit for each A7 country. Foreign drug prices referenced by The NHIS can be checked on the website. The NHIS has created a bulletin board for foreign drug price inquiry guidelines since 2019, and has released sites in 38 countries, including OECD member countries and Taiwan and Singapore, which are referring to drug price negotiations.
- Policy
- AstraZeneca vaccine authorized for use in Korea on Feb. 10
- by Lee, Tak-Sun Feb 15, 2021 06:16am
- The COVID-19 vaccine developed by AstraZeneca was finally approved by the South Korean health authority on Feb. 10. The approval is valid for the age group over 18, including elders older than 65. On Feb. 10, South Korea’s Ministry of Food and Drug Safety (MFDS) convened a Final Inspection Committee to make a decision on authorizing AstraZeneca’s COVID-19 vaccine, and officially announced the result. Similar to Celltrion’s anti-COVID-19 monoclonal antibody treatment, the Final Inspection Committee gathered and agreed on a final decision for the vaccine on the same day. Expert Committee meetings were held twice prior to the final meeting and gave a positive result. Previously, the Central Pharmaceutical Affairs Deliberation Committee recommended the vaccine should be given to adults over the age of 18, and the Korea Advisory Committee on Immunization Practices (KACIP), associated under the Korea Disease Control and Prevention Agency (KDCA), should discuss the inoculation for elders aged over 65 due insufficient clinical data. Agreeing to the committees’ recommendation, the Final Inspection Committee authorized the vaccination for the age group over 65. However, the committee also decided to label a warning stating ‘a vaccine user aged over 65 should carefully consider on using the vaccine.’ According to the decision, AstraZeneca’s vaccine became the first COVID-19 vaccine to be officially authorized in South Korea.
- Policy
- On-site judgment is important
- by Lee, Tak-Sun Feb 09, 2021 06:04am
- COVID-19 vaccine by AZ, along with CMA, recommended that those over 65 years of age should review it by the Vaccination Specialist Committee, the Central Pharmaceutical Affairs Review Committee of the MFDS said it was because on-site judgment was important. In a briefing held on the 5th, Chairman Il-Hwan Oh said, "Because the data on the elderly are relatively limited, the MFDS has made a decision to carefully judge the benefits of vaccination and the risks that may occur if not." He said, "The clinical trial results so far are not statistically verifiable because the number of cases has been small. But it doesn't mean that this doesn't work or put a decision on hold" On this day, the Central Pharmaceutical Affairs Review Committee recommended CMA to be used for AstraZeneca’s vaccines over the age of 18, but suggested that vaccinations over 65 years of age should be discussed later at the Korea Advisory Committee on Immunization Practices (KACIP). Accordingly, vaccination for the elderly over 65 will be confirmed by the KACIP after final item approval. Chairman Oh said that the announcement of the results was delayed by one day. He said, “In consideration of the phenomenon that some European countries have various opinions on the administration of the elderly, it was delayed because there were many discussions to verify the level that all the people can understand.”
- Policy
- The Committee recommended AZ vaccine approval
- by Lee, Tak-Sun Feb 09, 2021 06:04am
- The Central Pharmaceutical Affairs Review Committee of the MFDS, which consulted on AstraZeneca's approval of the COVID-19 vaccine, recommended item approval, subject to the submission of ongoing clinical results. In addition, for vaccinations over 65 years of age, it was gathered that opinions should be made carefully in the matters of approval, and that it is recommended to be discussed later in the Korea Advisory Committee on Immunization Practices. The Central Pharmaceutical Affairs Review Committee held a meeting at the Osong headquarters of the MFDS on the 4th and made this decision. According to the MFDS, The Central Pharmaceutical Affairs Review Committee recognizes the need for the domestic COVID-19 prevention purpose of the applied item, and submits the results of clinical trials currently in progress when synthesizing the consultation results of the COVID-19 vaccine safety and effectiveness verification advisory group. It advised that item approval is possible on the condition of that. The dose and interval should be judged based on scientific verification, and it was possible to administer twice the applied dose at intervals of 4 to 12 weeks whose efficacy was confirmed, considering the standard dose and administration interval and two doses planned in the clinical trial. As for vaccination of elderly patients 65 years of age or older, the same as in Europe, they should be 18 years of age or older. It was also recommended to submit analysis data on the results of US clinical trials later. At the same time, and it is recommended to be discussed at the KACIP later. Regarding the safety of the vaccine, the safety profile (trend), such as adverse events that occurred in clinical trials, is acceptable, but the opinion that the occurrence of nervous system-related adverse events, including transverse myelitis, should be monitored after approval. Inoculation for pregnant women is not recommended, and for nursing mothers, it is appropriate to state in the precautions for use that'it is not known whether this drug is secreted into breast milk', he said. At the Central Pharmaceutical Affairs Review Committee meeting, 12 standing members of the Subcommittee on Biological Medicines, 5 verification advisors, 1 expert recommended by the Korea Medical Association, 7 members of the Vaccine Review Team, Clinical Review Team, and Quality Review Team attended the COVID-19 Crisis Response Support Division inside the MFDS. Previously, a verification advisory group composed of experts supported the approval of the AstraZeneca's COVID-19 vaccine, and recommended that elderly patients not be restricted. The Central Pharmaceutical Affairs Review Committee allows the administration of the elderly, but takes a more cautious approach and delays the decision to the Korea Advisory Committee on Immunization Practices in the future. Based on this consultation, the MFDS is planning to convene a final inspection committee to make a final decision on whether to approve AstraZeneca's COVID-19 vaccine.
- Policy
- Will the Committee allow AZ vaccine in the elderly?
- by Lee, Tak-Sun Feb 08, 2021 06:08am
- This is because the Central Pharmaceutical Affairs Review Committee, a specialized advisory body for the MFDS, determines the adequacy of the approval from 2pm. While it is expected that the Central Pharmaceutical Affairs Review Committee has decided on item approval, it is noteworthy how it will decide on the administration of the elderly. Earlier, the 1st expert meeting, Verification Advisory Group, suggested the use of the vaccine, saying, "There is no reason to exclude the administration of AstraZeneca’s vaccine to the elderly." The MFDS will hold an advisory meeting on the Central Pharmaceutical Affairs Review Committee for AZ Vaccine in a conference room at the headquarters in Osong, Chungbuk at 2 pm on the 4th. The MFDS is holding expert meetings three times in the case of COVID-19 vaccines and treatments. Final approval is decided through the first verification advisory group, the second Central Pharmaceutical Affairs Review Committee, and the third final review committee. In general, the agenda has been decided mostly through the Central Pharmaceutical Affairs Review Committee. In consideration of public interest and securing trust in screening for COVID-19 vaccines and treatments, the expert meeting was increased three times. However, since the committee has made a final decision, it seems that the approval of AZ vaccine will be decided through this meeting. The number of participants in AZ's COVID-19 vaccine clinical trial (UK and Brazil) was 8,895 adults over the age of 18 (4,440 vaccine groups, 4,455 control subjects). The average age was 42.2 years old, and 7.4% (660 people) of the elderly over 65 years old verified the effectiveness. Some European countries have recommended vaccination restrictions due to the fact that there are fewer seniors in clinical trials. Authorities in Germany, France, Sweden, Austria, Poland, Italy and Belgium recommended that older people should limit vaccination. However, the European Medicines Agency (EMA), which oversees drug approval in EU countries, did not place any restrictions on the administration of AZ vaccine to the elderly. The verification advisory group, who first consulted on whether or not to obtain permission in Korea, also stated that there was no reason to exclude the administration of the elderly. At the verification advisory meeting held on January 31 of last month (including 8 infectious internal medicine specialists, clinical statistics specialists, etc.), a number of experts said, "It is impossible to rule out administration to the elderly just because the number of elderly persons among the participants is small." However, some opinions suggested that the administration of the elderly aged 65 or older should be decided through additional clinical trials. A number of experts from the advisory group said, "In the clinical trial of the AstraZeneca’s vaccine, the prevention effect was confirmed in all subjects, including over 65 years of age, and the immune response after white administration is similar to that of adults and the safety profile is good." A small number of experts say that the preventive effect has not been proven due to lack of data, and that the antibody titer is lower than that of adults under the age of 65 and that the correlation between the immunogenic response and the preventive effect has not been established. In the end, according to the majority opinion, the verification advisory group recommended that vaccination is possible even for elderly people over 65 years of age. The meeting is expected to involve more experts than the verification advisory group. Earlier, a total of 18 people, including members of the verification advisory group, attended the Central Pharmaceutical Affairs Review Committee of Celltrion's COVID-19 treatment Rekirona. The results of the Central Pharmaceutical Affairs Review Committee meeting in Rekirona were different from that of the Verification Advisory Board. While the verification advisory group determined that it could be used for all mild patients, the Central Pharmaceutical Affairs Review Committee recommended that only high-risk patients be allowed among mild patients. Therefore, even at the Central Pharmaceutical Affairs Review Committee meeting of AZ’s vaccine, the possibility of results contrary to the previous verification advisory's position to allow the administration of the elderly cannot be excluded. It is analyzed that there is a high probability that a similar decision will be made in Korea as the European EMA, the agency most trusted by the MFDS, has not placed restrictions on vaccination for the elderly. If AZ vaccine is limited to the administration of elderly people, the vaccination plan should be changed. This is because most of the vaccines vaccinated in the first quarter are AZ vaccine. In particular, elderly people in nursing hospitals have difficulty in getting the Pfizer vaccine, which is introduced in mid-February because of their mobility. Pfizer vaccines require frozen storage and can only be inoculated at specific centers.
- Policy
- Government-pharmaceutical organizations discuss measures
- by Lee, Jeong-Hwan Feb 08, 2021 06:07am
- The MOHW and medical groups discussed COVID-19 vaccination plan and comprehensive measures to strengthen health insurance non-reimbursement management. The operation plan of the Health and Medical Personnel Policy Deliberation Committee was also on the agenda of the meeting. On the 3rd, the MOHW (Minister Kwon Deok-cheol) held the 4th working-level meeting with pharmaceutical organizations at the Korea Health Promotion Institute. It was attended by Health and Medical Policy Officer Lee Chang-joon of the Ministry of Welfare, Health and Medical Policy Manager Kim Kook-il, Medical Personnel Policy Manager Kim Hyun-sook, Medical Security Management Manager Gong In Sik, and Health Care Innovation Team Leader Jeong-min Yoo. The KHA Vice Chairman Song Jae-chan, the KDA Vice Chairman Hong Soo-Yeon, the AKOM Vice Chairman Lee Jin-ho, the Korean Pharmaceutical Association Vice Chairman Kim Dong-geun , and the Korean Nurses Association Vice Chairman Kwak Wol-hee were seated. The agenda of the meeting includes comprehensive measures to strengthen health insurance non-reimbursement management, organization and operation plan of health care personnel policy deliberation committee, operation plan of health care personnel support agency, progress of mid- to long-term health care personnel supply and demand estimate, and COVID-19 vaccination implementation plan (draft). Lee Chang-joon said, "We will provide necessary information to patients for effective non-reimbursement management, while discussing ways to minimize the burden on medical institutions and medical personnel, and continue to collect opinions from the medical community and related organizations." said. He explained, "The Health and Medical Personnel Policy Deliberation Committee was organized to reflect the opinions of various roles and classes." This policy officer said, “We will closely discuss the training and supply and demand management of health care personnel, measures to improve the treatment environment, etc. with related ministries, related organizations, and experts. To secure medical personnel necessary for COVID-19 vaccination, education, and designation of a consigned medical institution, etc., Active cooperation with organizations is necessary. The Health and Medical Development Council will actively discuss tasks that are difficult to resolve due to conflicts of interest between the direct sectors and produce results of the operation of the consultative body."
- Policy
- Phase III fast track for Leclaza·Lynparza was approved
- by Lee, Jeong-Hwan Feb 05, 2021 05:54am
- While a bill was proposed to upgrade the fast track system in phase III to the pharmaceutical affairs law from the public announcement, 62 new drugs were counted to have taken the fast track so far. Most of domestic and overseas anticancer drugs such as Leclaza (Lasertinib) developed by Yuhan, AstraZeneca's Lynparza, Tagrisso (Osimertinib), and Pfizer's Ibrance (Palbociclib), are fast tracked. Biosolution's CartiLife and Tego Science’s Rosmir were also included. On the 4th, the drugs approved by the MFDS for Phase III clinical trial, including drugs related to rare diseases and intractable diseases, as well as anticancer drugs and cell therapy drugs, received special cases of fast track. The CMA system is currently being operated by the MFDS with notice and internal guidelines (guidelines). In particular, the MFDS recently announced a revision of the licensing and management guidelines to improve the predictability of the CMA system in phase III clinical trial. It specifies the target of the fast track in detail, includes the evidence when setting the deadline for submission of the clinical plan, and describes whether or not the Central Pharmaceutical Affairs Review Committee needs consultation. When item approval, the conditions of permission were to be described in the permission details. In addition, the National Assembly is also pursuing a legislation (People Power Party, Jongheon Paik) to upgrade the CMA system of the MFDS to the pharmaceutical affairs law. Among 62 new drugs that followed the CMA track, Leclaza is the 31st domestic drug. Non-small cell lung cancer Leclaza 80mg is the 62nd CMA drug. Leclaza has been transferred to Janssen, a global pharmaceutical company, and is undergoing licensing procedures in other countries such as the United States. AstraZeneca’s ovarian cancer drug Lynparza, Novartis’ metastatic breast cancer drug Kisqali, and Biosolution’s osteoarthritis drug CartiLife were also approved for CMA. Lynparza, Kisqali and CartiLife, excluding Leclaza, were approved on January 18 this year, were CMA in 2019. Takeda Pharm's ALK-positive non-small cell lung cancer drug Alunbrig (Brigatinib), Tego science's sub-eye wrinkle improvement cell therapy Rosmir, soft tissue sarcoma drug Lartruvo (Olaratumab), Roche immune anticancer drug Tecentriq (Atezolizumab) and ALK-positive non-small cell lung cancer drug Alecensa (Alectinib), Pfizer's breast cancer drug Ibrance (Palbociclib) is also conditionally approved for phase III clinical trial. Hanmi’s Olita (Olmutinib), which was decided to discontinue marketing on September 30, 2016 due to a side effect of severe skin disease, also took the CMA track, and clinical trials are in progress even when the market is suspended. Eisai's Symbenda 25mg and 100mg are selected as treatments for which indications have been deleted due to failure to meet conditions such as submission of data for phase III clinical trials after CMA. Symbenda did not fulfill the condition and the indication was removed. GemVax & KAEL’s pancreatic cancer treatment Riavax was also delayed in submitting the result report for phase III clinical trials, so the MFDS decided to cancel its license. However, Samsung Pharm, who took over Riavax, objected to the disposition of the MFDS and applied for suspension of administrative disposition. Ilyang’s Supect (Radotinib) 100mg/200mg were also administered administratively. Pharmaceuticals that fulfilled the conditions for data submission in phase III include Boehringer Ingelheim's non-small cell lung cancer drug Giotrif (Afatinib) 20/30/40 mg, Amgen's bone giant cell tumor treatment Xgeva (Denosumab), Chong Kun Dang's CamTOBELL (Belotecan). For CMA drugs that have not completed the submission of data for phase III clinical trial, they are expected to submit final clinical results within the deadline reported to the MFDS. The MFDS is planning to actively approve the advancement of the CMA system by revising the internal guidelines and the handling of the CMA upgrade bill initiated by Jong-Heon Paik.
- Policy
- Special authorization requested for COVAX-Pfizer vaccine
- by Kim, Jung-Ju Feb 05, 2021 05:50am
- The South Korean disease control authority is requesting the health authority to grant a special approval on 117,000 doses of Pfizer vaccines to be supplied to the country by COVAX Facility. Under the supply agreement with COVAX Facility, the vaccines would be promptly introduced to South Korea for inoculation starting from this month. On February 2, Korea Disease Control and Prevention Agency (KDCA) announced it applied for a special import authorization to the Ministry of Food and Drug Safety (MFDS) for the vaccines. The action is based on the results of the COVID-19 Vaccine Expert Council meeting convened by MFDS and KDCA and the Article 85 of the Pharmaceutical Affairs Act. In accordance to the Pharmaceutical Affairs Act, manufacturing and importing preventive drug or treatments without market authorization in South Korea may be possible as requested by a head of related ministry and agency amid pandemic or state emergency. Previously at the council meeting, the experts agreed on the need of special import authorization of COVAX Facility-supplied Pfizer vaccine considering WHO and the U.S. Food and Drug Administration (FDA) have approved of it and also as South Korea’s MFDS has participated in the collaborative review by WHO safety, efficacy and quality evaluation. MFDS accepted KDCA’s special import authorization application on Feb. 2, so the agency could ink the supply contract with Pfizer to immediately bring in the vaccine as soon as the ministry’s authorization is granted. Also the administrative procedure related to UNICEF shipping contract and customs clearance would be processed promptly as well. KDCA official said, “We would fully prepare all processes to initiate the inoculation as soon as the vaccines arrive in South Korea.”
- Policy
- The approval of Atozet’s generics was also difficult
- by Lee, Tak-Sun Feb 04, 2021 06:09am
- It has become difficult for generic companies of MSD's hyperlipidemia complex Atozet to approve items in January. If the approval was obtained in January, the drug for data-based re-evaluation commissioned by Chong Kun Dang and the timing of the registration were the same, so that within 20 drugs could be applied. However, it is known that the time of completion was held in early March, and drug price cuts due to the cascade system became inevitable. According to the industry on the 3rd, generics for Atozet, which had completed the preliminary review, was applied for permission on January 23, the day after the end of PMS. Accordingly, it is known that some companies expected to complete the approval in January. This is because most items have already been reviewed through preliminary review. An official from a pharmaceutical company said, "Since there was an examination period of about 5 days after the 23rd, I was hoping. However, the time was short and since several companies applied, it was difficult to obtain approval in January from the standpoint of equity." If it was approved in January, it was possible to apply the drug price standard of up to 20 same active ingredients. This is because Chong Kun Dang's Drug for data-based re-evaluation was approved on the 8th. Drugs that apply for benefits for the same month are recognized in the same order. Generics for Atozet applied a working day on the 25th, and it was reported that the completion time of the permit review was set in early March. Another pharmaceutical company official said, "Through a preliminary review, we have completed the review of safety, effectiveness, standards and test methods, but if there is no supplementation by applying Working Day according to the existing regulations, the review will be completed in early March." He also said, "It was impossible to get approval in January." With 24 Generics for Atozet, generics licensed after February are subject to a stepped drug price, which is about 15% lower than the existing lowest price. Compared to the already approved Chong Kun Dang products and their consignment products, the launch time is also slow.
- Policy
- Re-evaluation of benefits, scheduled to be conducted annuall
- by Kim, Jung-Ju Feb 03, 2021 06:09am
- At the end of last year, the government is about to begin the main evaluation of the five active ingredients following the pilot project of reevaluation of the adequacy of registered drugs for Choline alfoscerate (reevaluation of the benefits of registered drugs). It seems to have taken into account the time taken for the procedure, such as review and re-evaluation, review of the Pharmaceutical Benefits Advisory Committee, and report to the Health Insurance Policy Review Committee. The government (insurer) plans to prepare a system for recovering drug costs for damages in the first half of the first half of the first half of the year in relation to the increase in administrative litigation, which has become more controversial due to the suspension of execution of choline alfoscerate. Yang Yoon-seok, head of the health insurance department of the Ministry of Health and Welfare, reported the reevaluation plan as a negative agenda at the 2nd plenary meeting of the 2021 the Health Insurance Policy Review Committeeon the afternoon of the 29th, and then met with the Korea Special Press Association to explain the government's position. He said, "I know the pharmaceutical bio industry is struggling with the re-evaluation of registered drug benefits," and "It will be conducted on an annual basis, but in the long term, we are also seeking a plan to evaluate it every 4 to 5 years (regularly). " The following is the contents of questions and answers with Yang. ▶ It is understood that it reported to the Health Insurance Policy Review Committee that a plan to compensate for financial losses due to suspension of execution was prepared in the first half of the year. Please explain this. “The government is aware of the problem of benefits due to the suspension of execution. Last year, the National Assembly also pointed out this issue. Measures to improve the system (which allow the reimbursement of drug costs, etc. paid during the suspension of execution) is being reviewed internally. We are not in the process of making any specific disclosures yet.” ▶ The contract to redeem the Choline alfoscerate drug has not been negotiated since 56 pharmaceutical companies filed lawsuits. The deadline is until the 10th of this month, are there any plans to extend the negotiation deadline in consideration of the litigation situation? "The negotiation period has not been completed yet. I think the NHIS will proceed with the negotiations as much as possible within the deadline. It will report the status of the negotiations after the negotiation period is over, and I will review the details and review again. " ▶ If the system is improved, is it a premise to amend the law? "Improving the system doesn't mean amendment of the law." ▶ Last year, the NHIS conducted a research on this. Do you proceed based on the result? "I'll refer to that, but how to actually legislate is a matter for the government to review and decide." ▶ Does it mean to proceed with government legislation? "The form of legislation has not yet been decided." ▶ This is a question about the reevaluation of the five ingredients that will be notified to the pharmaceutical company this month. The re-evaluation plan has been reported to the committee, please tell me the direction of the future. "It seems that the third quarter will have to go through the process of re-evaluating all five ingredients. Eventually, the re-evaluation will not be able to proceed in an annual cycle. Therefore, it can be considered that the process is being carried out in an annual plan." ▶ Do you have anything else to comment? "Last year, I had a lot of motivation and ambition as the head of the insurance drug department, but I had a lot of difficulties with COVID-19. Re-evaluation of benefits would be an inconvenient issue for the pharmaceutical industry. However, when applying benefits, it is correct to provide effective medicines to the public when applying benefits. Although it is currently undergoing annual evaluation, it is also seeking a plan for a long-term evaluation for the next four to five years, and a series of lawsuits filed by companies are guaranteed rights under the constitution, that's why a full legal review will be needed for the (under review) redemption bill."
