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- 2025-12-23 02:31:40
- Policy
- BA-linked listed drugs are about to be re-evaluated
- by Lee, Tak-Sun Jun 20, 2022 06:03am
- Aseptic formulations will be included in the re-evaluation of the registered drug for BA test from October With the re-evaluation of listed drugs subject to the BA test scheduled to begin in October, attention is being reimbursed to whether some procedural problems will be resolved in advance. The MOHW announced that it would directly conduct BA tests and re-evaluate the price of listed drugs in July 2023 after a three-year grace period. Accordingly, the HIRA will receive data from pharmaceutical companies to prove whether they meet the standard requirements from October to February next year. The question is whether the item will be able to submit related data by the deadline as it has expanded to the aseptic formulation for BA test since October this year. The HIRA plans to consult with the MFDS on necessary measures such as the selection of control drugs for data submission. According to the industry on the 16th, the HIRA will hold a briefing session from 1:30 p.m. on the 22nd at the White Veil located in Seocho-gu, Seoul. It is expected that the number of pharmaceutical companies related to the re-evaluation of the listed drug, which is a face-to-face explanation circuit that takes place for the first time in a long time, will exceed the capacity of the place. The HIRA plans to re-evaluate listed drugs with the aim of applying them in July 2023 as scheduled. Accordingly, pharmaceutical companies are requesting to submit data to prove whether they meet the standard requirements from October to February next year. The core of the data is whether to prove equivalence through BA and others. Most of the requirements for using registered raw materials drugs are expected to be met. To this end, pharmaceutical companies have conducted BA tests by converting consigned manufactured items that have not undergone BA tests into their own production items. The problem is that the drugs will also be subject to the BA test from October, when the data is submitted. The health authorities say these aseptic drugs are subject to re-evaluation of drug prices. After October, the equivalence must be demonstrated through the BA test for aseptic drugs such as injections or the chemical equivalence test that replaces them. The problem is that comparators for tests will not be announced until after October. The pharmaceutical industry believes that it may be difficult to submit data by February next year if the process of selecting a contrast agent is delayed. An official from a pharmaceutical company pointed out, "It is unlikely that companies with many items will be able to manage their schedules," adding, "Aseptic drugs subject to BA tests in October need to extend the deadline for submitting data or hurry to announce control drugs." The MFDS is aware of this. Accordingly, the government plans to apply for and announce the control group drug from time to time, and improve the recognition process. At a meeting with the Korea Special Press Association on the 14th, Kim Ae-ryeon, head of the HIRA drug management office, said, "There is a need for consultation with the MFDS regarding the designation of contrast agents." In March, the HIRA unveiled 3,372 product groups of control drugs and first-time registered products that are excluded from revaluation among 33,618 listed items. As a result, it is expected that items subject to re-evaluation, including aseptic drugs, will be clearly disclosed at the briefing session on the 22nd.
- Policy
- Limited indications of JAKI for high-risk groups
- by Lee, Hye-Kyung Jun 20, 2022 06:02am
- The MFDS (Director Oh Yoo-kyung) announced on the 15th that it will change the efficacy, and indication precautions of "JAK Inhibitor", which is used as a treatment for inflammatory diseases. Patients can be used the same as before, but high-risk patients such as those aged 65 or older, high-risk cardiovascular groups, and risk of malignancy will be available only if the effect is insufficient with the existing treatment. JAK Inhibitor is used to treat various inflammatory diseases such as rheumatoid arthritis by blocking the action of JAK, an enzyme that controls immunity and inflammation, and 65 items of Tofacitinib, Baricitinib, Upacitinib, Abrocitinib, and Filgotinib are licensed in Korea. This measure is a follow-up measure to the results of the safety review conducted after the MFDS distributed the drug dear healthcare professional letter in September last year, and plans to order the permission to be changed in July. The MFDS received advice from the Central Pharmaceutical Affairs Review Committee and the Professional Association after a post-marketing survey of Tofacitinib and Baricitinib drugs conducted in the U.S. and Europe, and reviewed the results of a recent domestic anomaly analysis. Detailed permission changes (drafts) can be found at nedrug.mfds.go.kr.
- Policy
- The KDCA is pushing for the introduction of Tecovirimat
- by Lee, Jeong-Hwan Jun 20, 2022 06:02am
- The KDCA announced on the 14th that it will hold a joint meeting of related ministries to introduce 500 people of the antiviral drug Tecovirimat in July to respond to monkeypox. Kwon Joon-wook, head of the National Institute of Health, made this announcement at a briefing on COVID-19. The KDCA plans to hold a meeting of the monkeypox task force jointly with related ministries later in the day. The meeting will discuss detailed plans to introduce 500 antiviral drugs to Korea in July compared to monkeypox. The antiviral drug to be introduced is Tecovirimat, the only product licensed as a monkeypox treatment overseas. Specifically, the product name Tpoxx (Tecovirimat), has been officially approved by the US FDA, Europe EMA, and Canada. Although it is a relatively high-priced drug, the need to secure Korea is also being raised due to mass stockpiling overseas. In the future, if a monkeypox patient occurs in Korea, the patient will be treated in isolation at the National Medical Center until the point of loss of infectious power. Contacts are classified in three stages, and the KDCA is considering quarantining high-risk contacts for 21 days.
- Policy
- Limited indications of JAKI for high-risk groups
- by Lee, Hye-Kyung Jun 16, 2022 05:58am
- It was confirmed that the opinions of the Central Pharmaceutical Affairs Council members were also mixed over the limited use of Janus kinase Inhibitors, which is used as a treatment for inflammatory diseases. The MFDS announced on the 15th that high-risk patients aged 65 or older, high-risk cardiovascular groups, and malignant tumors will be able to use them only when they are insufficient with existing treatments. 65 items of JAK inhibitors (Tofacitinib, Baricitinib, Upacitinib, Abrocitinib, and Filgotinib) were licensed in Korea. According to the minutes of the Central Pharmaceutical Affairs Council held last month, the committee members gathered opinions on the current status of foreign countries, related studies, and the need to manage JAK inhibitors. As a result, there were three members who did not need to change their efficacy, and only one member said that the effectiveness of all JAK inhibitors needed to be changed. Seven members agreed to change the efficacy effect of Tofacitinib and Baricitinib, which have clear grounds in the United States and Europe. However, it was pointed out by the chairman that if the efficacy is changed only for Tofacitinib and Baricitinib, the prescriptions for other ingredients of the same indication, such as Upacitinib and Filgotinib, are expected to increase at the clinics. It is due to concerns that measures to change the effectiveness of obtaining sufficient data on side effects by obtaining permission first could instill a perception that other ingredients approved late are safer ingredients. "Considering various issues, further discussions are needed on the range of ingredients that change efficacy, such as the application of all JAK inhibitors or two ingredients," the chairman said. A member of the committee said, "It is said to be the same category, but it is known that the mechanism of action is slightly different," adding, "It would be good to maintain restrictions on efficacy based on the evidence so far and apply precautions for use to all drugs." The MFDS said, "We will push for a change in usage precautions that describe major cardiovascular risks for all JAK inhibitors." The MFDS added, "We will change the permission for Tofacitinib and Baricitinib in consideration of confusion from clinics, but we will take further measures to include the remaining three ingredients." Meanwhile, after distributing dear healthcare professional letter in September last year, the MFDS confirmed that patients with cardiovascular risk factors administered Tofacitinib and Baricitinib increased their risk of cardiovascular abnormalities compared to the TNF inhibitor group. The United States restricts all JAK inhibitors to use only in patients who do not respond appropriately to other treatments, such as one or more TNF inhibitors, as well as in high-risk patients. For Tofacitinib, Europe restricts the use of high-risk groups only when there is no appropriate treatment alternative, and considers the need for additional measures for other JAK inhibitors. The MFDS plans to order the change of permission in July through procedures such as inquiry of permission change (proposal) opinion and advance notice.
- Policy
- Listing period for new drugs to be reduced up to 60 days
- by Kim, Jung-Ju Jun 16, 2022 05:57am
- The government will reduce the new drug reimbursement listing procedures by up to 60 days to reinforce accessibility to new drugs. Also, the government plans to expand pharmacoeconomic evaluation (PE) exemptions, a mechanism that plays a key role in the deliberations made on the reimbursement adequacy of new drugs. This is a specified plan set by the Ministry of Health and Welfare based on the national pledge that was presented by the Yoon administration to reinforce access to new drugs using the Risk-sharing Assessment (RSA) system. Based on the specificities that were planned, relevant regulations of the Health Insurance Review and Assessment Service (HIRA) and National Health Insurance Service (NHIS) will be revised within the 3rd quarter of this year. In the case of the reimbursement adequacy reassessment that will be conducted on listed drugs, the contents of their assessment will be first notified to subject companies within the next month, then be conducted sequentially after collecting opinions in the following August. Chang-Hyun Oh (53·Chung Ang University College of Pharmacy, Technical Secretary), Director of Pharmaceutical Benefits at MOHW, had answered so to the questions raised by the MOHW press corp on the 14th regarding the present state of affairs. Director Oh, who has now served as director for 4 months in MOHW’s Division of Pharmaceutical Benefits, is in charge of effectively promoting the pharmaceutical policy tasks that remain for the First Comprehensive Plan of National Health Insurance that was implemented in 2019 while performing the national tasks set by the new administration. Oh said, “The new administration’s task of reinforcing coverage of severe and rare diseases is an agenda we need to continuously pursue. We are also working to prevent a significant rise in the spending of national health insurance finances by rationalizing the pharmaceutical expenses through the better operation of the post-management mechanisms that are already in place.” The following are questions and responses provided by Director Oh. The new government’s task on improving drug accessibility ▶Accelerating reimbursement listing of pharmaceuticals is one of the national tasks proposed by President Suk-Yeol Yoon’s administration. How is MOHW planning to effectively implement this task? “The national tasks related to drug pricing that was set by the new government can largely be divided into two parts - accelerating listing of anticancer and severe disease treatments and expanding application of the RSA scheme. To accelerate listing, the HIRA and NHIS’s administrative procedures need to be improved to reduce the authorities' review period, and the application of the RSA scheme needs to be expanded. As a working-level official, reducing the reimbursement period and expanding eligibility of PE exemptions seem to be the most pressing matters at hand as expanding eligibility of PE exemptions will also expand RSA. The current PE exemption regulations in place are more often applied to rare diseases that severely deteriorate the patients’ quality of life rather than severe, life-threatening diseases, therefore, we are considering expanding this system to align with the purpose of the national task. We can improve the reimbursement review procedure so that drugs that may skip PE evaluations need not undergo review by the Pharmacoeconomic Evaluation Subcommittee. This can reduce the period required by around a month at HIRA’s level. Also, we can reduce another month from NHIS’s drug pricing negotiations by submitting the data necessary for negotiations to the NHIS in advance when HIRA’s evaluations are nearly complete. By reducing 30 days each from HIRA and NHIS, we can expect to save up to 60 days from the evaluation period and promote the faster listing of drugs." ▶Among the many kind of rare diseases, to what scope will the RSA PE exemption be applied to? “RSA PE exemptions are generally applied to anticancer or rare disease treatments. The rare disease treatments here are defined under a different concept from the orphan drugs designated by the MFDS. It refers to rare disease treatments that are used for drugs that receive a special exemption of calculation in the reimbursement process. We are considering applying the same standards for RSA PE exemptions. To implement this, we need to first revise both HIRA and NHIS’s regulations, which would be possible by the third quarter this year before September. Also, we would need to issue an administrative pre-announcement on the new drug negotiation guidelines, for which we will be fixing the operational guidelines. I believe we will be able to attempt this in the second half of the year. This would include changes made to data provision, data submission exemptions, drugs eligible for PE exemption, additional drugs, etc. In the case of PE exemptions, we would need to reform the ‘Regulations on Evaluation Standard Procedure for Pharmaceuticals Eligible for Reimbursement.’ I believe we will be able to apply the changes by the end of this year at the latest.” ▶Does this mean that the expanded scope of PE exemptions may be applied immediately from early next year? By saying that the specifics changes needed may be applied within the third quarter, do you mean that the standards and subjects for the expanded PE exemption have been at least roughly outlined already? “Expanding PE exemptions will accelerate the reimbursement process of drugs, and products that apply for reimbursement after the regulations are revised will all be eligible for PE exemptions and be more easily reimbursed. The standard will be set to ‘MFDS-approved products that have high social need. Therefore, we are trying to select items that have a clear clinically stated need in literature. A standard for eligible drugs has not been set year, but we will be able to prepare the specific standards soon.” ▶Will the accelerated reimbursement listing process only be applied to drugs eligible for PE exemptions? “It would have to be so for the time being. An accelerated reimbursement listing procedure is currently used in the approval-assessment linkage system. And we would need to newly add what I have previously mentioned to the approval-assessment linkage system, PE exemption system, and drug pricing negotiation exemptions.” ▶If the PE exemption drugs are listed through expediated pathways, the overall pharmaceutical expense spent by the government has to increase. How do you plan to manage this?. "I don’t think the expenses would increase to a great extent just because of the expanded PE exemption standards due to the limited use of the PE exemption system. The RSA scheme has been implemented since 2014, and then expanded in 2019 and 2020. The PE exemption has been implemented in 2015, then expanded in 2020. The scope of its application cannot be expanded much due to its limited and exceptional use and will be applied to areas that may not be life-threatening but greatly deteriorates the patients' quality of life. Also, these drugs will be exempt from receiving PE exemptions but be applied to the RSA scheme. We aim to match the cost-effectiveness of high-priced new drugs that are being listed recently, such as ‘one-shot’ treatments or cancer immunotherapies, through the RSA scheme. For ultra-high priced new drugs, 3 types of RSA – the refund type, expenditure cap type, and performance-based type-are being applied. We may also add a condition to require pre-approval before use. For new drugs, their fiscal uncertainty will be negotiated as much as possible upon entry, and then the conditions for RSA will be applied in the Drug Reimbursement Evaluation Committee's stage for reimbursement. The finances required would naturally increase with an increase in new drug listings. This is why we carried out reevaluations to rationalize the total amount of expenditures spent on existing drugs. We aimed to reduce the drug price to some extent through post-management of existing drugs. Also, through post-management processes such as the clinical usefulness reevaluations, the premium pricing reevaluations that were already completed, and the prescription reduction incentive system, usage-drug price linkage systems, etc., we will see to it that an appropriate amount of expenses are spent on already listed drugs. These cost-saving measures will allow the increase in NHI spending to be kept to a normal level as much as possible." ▶What percentage would be considered an appropriate level in terms of pharmaceutical expenditures?. “We do not have a cap set on expenditures, but history shows that the proportion of pharmaceutical expenditures accounted for 27 to 28% of NHI finances after the government made special measures to unanimously cut drug prices in 2012. So this would be considered a warning signal and is when social demand for reform starts rising. Currently, the level is around 23-24%, but the problem is that the total amount of expenditures are increasing by 1 trillion won every year.” ▶The Working Group for the improvement of the foreign drug price reference standard (A7 weighted average price) is being operated until next month. I heard the plan was to expand the number of reference countries by 2-3 countries. If the standards are made, can they be immediately applied next year for the foreign drug price comparison evaluations? "When assessing the adequacy of reimbursement on new drugs, we usually refer to A7 or A8 countries, and this system has been established quite a long time ago. Referencing foreign drug prices is important in new drug listings. Therefore, we sought to seek rationality and improve the older regulations. Fortunately, the research service that was carried out by Professor Seon-mi Jang was completed then, based on which we organized a Working Group. The MOHW, HIRA, and NHIS are involved in the group. The formula shows that there is a set standard for the exchange rate, the percentage set to calculate the ex-factory price (EXP), and a ‘distribution margin’ of the 7 reference countries. How to proceed afterward is an issue. The reevaluation is already scheduled in the Comprehensive Health Insurance Plan. So the formula will be used when it is derived. However, whether reevaluation will be solely based on the formula or will consider other areas for revision will be decided upon when we issue the reevaluation notice. In particular, the price of generics, which is set at 53.55% of the original price in Korea, is set at a lower level abroad. We will use this when looking at foreign reference standards for original drugs. The new formula will be used for reevaluations, but when this will be has not been confirmed yet.” Pharma industry requests regarding Price-Volume Linkage system, etc. ▶What is your opinion regarding the pharmaceutical companies’ request to be exempted from being subject to the Price-volume agreement due to COVID-19? “The pharmaceutical industry had made some requests seeking understanding on our part due to realistic difficulties faced with COVID-19. One was to exclude PVA for drugs that were prescribed under the COVID-19 disease code. Although this didn’t happen with the Delta variant, the Omicron variant had led to a shortage in stock of cold medicines, and the MFDS had encouraged its manufacture at the time. Under the PVA guidelines, if a certain drug’s reference price for negotiations may be adjusted if its use has increased temporarily in response to an infectious disease crisis for the treatment of the infectious disease. We cannot disregard the increase in sales completely, but as this increase in sales was made in response to COVID-19, we told the companies that the MOHW will make adjustments for this during negotiations, and so will the NHIS. This is applied to drugs under the price-volume linkage-type 'C', but the production of cold medicine did not increase in 2021. Production of the drugs increased and the drugs ran out of stock at the beginning of this year, but the 175 drugs subject to type 'C' in 2021, which compares the subject drugs’ sales in 2021 to those in 2020 do not contain cold medicines. However, the companies' requests will be reflected in our 2022 review, when we compare sales in 2022 with 2021 for negotiations next year. Also, there are some data that the industry needs to submit by the end of February next year with the 3-year grace period set for the generic drug pricing reform. During the period, the companies were required to conduct self-bioequivalence tests and satisfy the conditions for the use of raw materials and submit the data by February 28th next year. The companies have been asking the MOHW to extend this deadline, as the COVID-19 crisis had rendered companies difficult to recruit healthy subjects for bioequivalence tests due to the increase in infected patients. For injection-type drugs that cannot undergo bioequivalence tests, the products were required to conduct physicochemical tests in laboratories. This data also needs to be submitted by February next year, but the Korea Pharmaceutical and Bio-Pharma Manufacturers Association had held a meeting with the MFDS on postponing the deadline due to delays made in the selection of reference drugs. We plan to set a more flexible deadline for data submission in consideration of the ongoing COVID-19 situation. Also, the opinion has been raised that some companies have conducted self-bioequivalence tests but do not own evidentiary data because the tests were conducted before the regulation was changed. The MFDS regulations only indicate tests conducted after 2015, so we replied that we will accept such cases if the MFDS provides an authoritative interpretation. However, in the case of reassessments made for standard requirements, this data should be submitted by February 28th next year so that we could complete evaluations by end of July. Items that cannot verify that it had satisfied standards will receive a price cut of 15 to 30%. But I believe we should understand if submissions are delayed due to inevitable reasons. Therefore, we plan to accept plausible requests along with the MFDS and NHIS." Other issues ▶The Anti-Corruption and Civil Rights Commission had recommended on introducing a pre-listing post-evaluation system for pharmaceuticals directly related to life. What is your opinion on this? “This has been continuously proposed by patient groups and multinational pharmaceutical companies, but I believe it cannot be implemented in Korea’s reality. Evaluations are a must to be listed for initial reimbursement. For post-evaluation to happen, an agreement needs to be first made between the government and each company that states that the ‘actual review will be conducted at a certain level, and the company will accept the evaluation result as is,’ but I doubt that the companies will be willing accept the results ‘as is.’ Therefore, when considering various aspects, it would not be realistically easy. A similar system that is currently in place is the system for the urgent introduction of pharmaceuticals, which is not approved by the MFDS but is sought and introduced by the Korea Orphan & Essential Drug Center from abroad. Around 20 drugs are applied for reimbursement under the system. However, the process for the official import and reimbursement process for these drugs had not been as negotiable as other products as there are patients that are already using the drugs at a certain price level. It was difficult to lower the price to an appropriate level during negotiations. Although the situation may not be the same, drugs that are already listed are not negotiated to the level desired by the government, and this is why the working-level officials believe it would be difficult to implement a pre-listing post-evaluation system. We will be receiving data from the multinational pharmaceutical industry on its implementation cases abroad, and although we are waiting for the data, it would be difficult to implement the data soon. It would be easier to expedite the reimbursement listing of the drugs. Even from the practical point of view, even if a pre-listing post-evaluation system is introduced, it would have to undergo procedures similar to the current one in place, and will not be cost-effective."
- Policy
- Phase 2 of Shinpoong's Pyramax will be conducted again
- by Lee, Hye-Kyung Jun 16, 2022 05:57am
- Shinpoong will conduct phase 2 clinical trials of Pyramax again to prove its safety and effectiveness as a treatment for COVID-19. On the 13th, the MFDS approved a clinical trial to explore the safety and effectiveness of Pyramax in patients with mild or moderate COVID-19. Exploratory clinical trials are clinical trials conducted for the purpose of collecting initial safety and validity information of drugs, designing subsequent clinical trials, providing evidence for evaluation items, and evaluation methods, and are conducted over a relatively short period of time for a few subjects. Since June 2020, Shinpoong has conducted randomized, double-blind, parallel, placebo-controlled, and phase 2 to compare and evaluate the efficacy and safety of Pyramax in mild or moderate COVID-19 patients. The MFDS approved the phase 3 clinical trial plan on August 17 last year by synthesizing the results of the phase 2 clinical trial at the time, and Shinpoong is currently recruiting 1,420 target clinical trials. As a result of phase 2 in Korea, it was pointed out that the clinical significance as a variable for evaluating the effectiveness of the treatment was low. Shinpoong is expected to try to calm the controversy and secure the safety and effectiveness of phase 2 clinical trials for the purpose of commercializing as a treatment for COVID-19.
- Policy
- HIRA to review metformin+SGLT2+DPP4 reimb at last
- by Lee, Tak-Sun Jun 15, 2022 05:51am
- Ae-Ryun Kim, Deputy Minister of HIRA The Health Insurance Review and Assessment Service entered the final steps of its reimbursement review for a 3-drug combination therapy that contains metformin, an SLGT-2 inhibitor, and a DPP-4 inhibitor. Reimbursement of the combined use of SGLT-2 and DPP-4 class oral antidiabetic drugs had been continuously raised as an issue by academic societies including the Korean Diabetes Association as well as the pharmaceutical industry since 2016. Therefore, whether HIRA will newly establish a reimbursement standard and finally bring an end to this discussion is gaining industry attention. At the press conference with the Korea Special Press Association on the 14th, Deputy Minister Ae-Ryun Kim of the HIRA's Pharmaceutical Management Office announced that the ministry is conducting a fiscal impact analysis on the three-drug therapy that contains metformin+SGLT-2i+DPP-4i after reviewing its reimbursement standards. HIRA plans to complete evaluations on changing the reimbursement standards and drug price after analyzing its fiscal impact, reviewing expert opinion from academic societies., and deliberations by the Drug Reimbursement Evaluation Committee during the review period. However, Kim said “it is difficult to say” exactly when the reimbursement standards will be changed following the completion of evaluations. Two three-drug combinations are currently being analyzed on their fiscal impact after receiving reimbursement standard reviews: ▲metformin+SGLT-2i+DPP-4i, and ▲metformin+SGLT-2i(except ertugliflozin)+TZD. Also, applying reimbursement to some SGLT-2 inhibitors in combination with sulfonylurea or insulin is being reviewed. Currently, two-drug combination therapies for SGLT-2 inhibitors that are allowed reimbursement include SGLT-2 inhibitor+metformin and dapagliflozin+sulfonylurea. For DPP-4 inhibitors, its combination with metformin, sulfonylurea, and TZD (Thiazoli-dinedione) is allowed reimbursement. The reimbursement standards under review will be applied to combination drugs as well. Therefore, SGLT-2+DPP-4 combination drugs that are awaiting reimbursement after receiving approval are also expected to receive reimbursement benefits if reimbursement standards are newly added for the drugs. In addition, the new reimbursement standards widely allow combination between classes within the indications approved by the MFDS and is expected to increase the scope of use of applicable drugs. Of course, the increase of available combinations will also diversify prescription options for HCPs and ultimately result in improving the treatment effect for patients. However, on what the result will be remains unknown as the reimbursement in discussion is expected significantly affect NHI finances. However, as the discussion has been ongoing for over 6 years now and PMS of SGLT2+DPP4 combination is being imminent, the conclusion is expected to be made within this year one way or another.
- Policy
- Policies at a standstill due to absence of MFDS minister
- by Lee, Jeong-Hwan Jun 15, 2022 05:50am
- With the ruling and opposition parties having difficulty coming to an agreement on the composition of the NA leadership, the prolonged policy gap in national disease control and prevention and the pharma-bio industry is intensifying due to the absence of the Minister of Health and Welfare. President Suk-Yeol Yoon’s administration had set out to promote a roadmap for an emergency response to COVID-19 within 100 days of his inauguration and establish a Pharma-Bio Innovation Committee, but the position of the Minister of Health and Welfare that is required to perform both tasks has remained vacant since President Yoon’s inauguration. On the 13th, the ruling and opposition party is butting head over the appointment of the National Assembly’s Legislative and Judiciary Committee chair and NA leadership. In the prolonged absence of a head in the Ministry of Health and Welfare, the new administration has been deciding on national COVID-19 control and prevention policies without a minister, and the decisions are being by its two vice ministers. The Ministry of Health and Welfare is reviewing whether to lift the mandatory quarantine measures that were imposed on confirmed COVID-19 patients after lowering the statutory infectious disease class of COVID-19 from Class 1 to Class 2 last month. Regarding the removal of indoor masks, the Ministry of Health and Welfare has decided to keep the current measure as is and continue the existing measures for COVID-19 prevention and control. Although the Ministry of Health and Welfare advocates the scientific evidence-based quarantine, even veteran civil servants are burdened by the fact that they must make decisions on COVID 19-related policies every day in the absence of a minister. This gap in the appointment of the MOHW Minister has left various tasks including the addition of emergency treatment beds for COVID-19 and the antibody positivity rate survey on 10,000 citizens that were included in the 100-day roadmap for an emergency response to COVID-19 by the new administration at a standstill. In particular, the Pharma-Bio industry awaiting on specific plans for the establishment of a Pharma-Bio Innovation Committee that is to be directly operated by the Prime Minister that President Suk-Yeol Yoon had selected as a national task. The multi-ministry Pharma-Bio Innovation Committee is being established with the participation of the Ministry of Trade, Industry and Energy; the Ministry of Science and Technology; the Ministry of Education; and the Ministry of Food and Drug Safety. Officials from relevant ministries that were involved in the establishment will likely be dispatched to the committee under the Prime Minister’s Office, and the industry’s eyes are on how the committee will be constructed, its vision, role, and date of its launch, but the fact that no specific plan has been presented yet has left much to be desired on the industry’s part. President Suk-Yeol Yoon’s administration had only presented the course of direction that the government would take with the Innovation Committee, that it will establish integrated governance that encompasses industry, technology, and healthcare to foster a biohealth innovation ecosystem and become a pharma-bio powerhouse. Therefore, on when the Minister of Health and Welfare position will be filled after a series of procedures including the composition of the National Assembly members and the personnel hearing on the MFDS minister candidate Seung-hee Kim, is expected to directly affect the creation of national disease control policies and the specificities on the establishment of the Innovation Committee. The deadline for MFDS minister candidate Kim's personnel hearing is the 19th, and if no hearing is held by the deadline, President Yoon may directly appoint Kim as minister. However, it is unclear whether the appointment will be carried out without a hearing due to the many controversies surrounding candidate Kim, such as expedient real estate donations, violations of the Political Funds Act, and the abused ‘mom chance,’ etc.
- Policy
- Lorviqua is about to be reimbursed
- by Lee, Tak-Sun Jun 15, 2022 05:50am
- Pfizer ALK-Inhibiting Non-Small Cell Lung Cancer Treatment It is known that Lorviqua, a third-generation ALK-inhibiting non-small cell lung cancer treatment, is on the verge of insurance benefits through drug price negotiations. As a result, new treatment options are expected to be created for patients who have not seen any effect even if they use first and second-generation treatments. The drug was recognized for its benefit adequacy by the NHIS in April, which recently disclosed the progress of drug price negotiations on the drug. According to the industry on the 10th, the NHIS recently announced on its website that the NHIS is negotiating prices of Lorviqua 25mg, Lorviqua100mg and Dopa check. The two drugs passed the HIRA on April 7. Pfizer's Lorlatinib judged that there was an appropriateness for the treatment of adult patients with ALK-positive progressive non-small cell lung cancer. Dopa check considered that there is an appropriate benefit when accepting less than the evaluation amount for positron emission tomography. Drugs that pass the committee will be negotiated with the NHIS within 60 days. If the drug price negotiation is passed, it will be on the health insurance benefit list after being approved by the Health Insurance Policy Review Committee of the MOHW. It is observed that the two drugs passed the committee in April and immediately negotiated drug prices with the NHIS. Therefore, if the negotiations are completed within 60 days, it is likely to be submitted to the Health Insurance Policy Review Committee this month and listed from next month. It is interpreted that the fact of the negotiations was posted on the NHIS website because the negotiations were at the end or settled. The NHIS has been disclosing drugs on the progress of drug price negotiations since May 2019. After notifying the pharmaceutical company of the disclosure of information, it is released on the website through a procedure prescribed by law, but the drug information is limited due to the risk of exposure of the drug company's trade secrets. As a result, most of the drugs released on the website have been negotiated smoothly. Lorviqua is a third-generation drug that ALK-positive non-small cell carcinoma patients can use if it does not work using first-generation Xalkori, second-generation Zykadia, and Alecensa. Accordingly, if Lorviqua is reimbursed, it will be a new alternative for patients who have used second-generation drugs but have developed resistance. Duchembio's Dopa check is a radioactive drug used for tumor and neuroendocrine tumor testing.
- Policy
- MFDS reviews EUA of COVID-19 prevention drug Evusheld
- by Lee, Hye-Kyung Jun 14, 2022 06:04am
- The emergency use authorization review for AstraZeneca’s COVID-19 preventive antibody therapy ‘Evusheld’ has begun in Korea. The Ministry of Food and Drug Safety (Minister Yu-Kyoung Oh) announced on the 10th that the ministry has started reviewing the emergency use authorization of Evusheld per request by the Korea Disease Control and Prevention Agency. The MFDS will make a decision after reviewing the clinical trial and quality data that were submitted, followed by an expert advisory meeting and deliberation by the Public Health Emergency Response Medical Device Safety Management and Supply Committee. Evusheld is an antibody treatment that is directly administered to immunocompromised patients(blood cancer patients, patients receiving immunosuppressant therapy after organ transplantation, etc.) who may not mount an adequate immune response to COVID-19 vaccinations as preventive therapy. The MFDS said, “We will continue making our most effort to promptly supply safe and effective treatments to our people for the overall improvement of public health."
