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- 2026-04-12 05:55:23
- 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.
- Company
- GC Pharma leads 300 billion flu vaccine market
- by Nho, Byung Chul Jun 15, 2022 07:48pm
- SK Chemicals and GC Pharma are competing in the private 4-valent influenza (flu) vaccine market with an external banding of 200 billion won, the survey showed. SK Chemical's SKY Cellflu Quardrient and GC Flu Quardrient ranked first and second in the private distribution flu vaccine for the past three years (2018, 2019, 2020), with performances of "11.3 billion won, 13.1 billion won, and 63.8 billion won," "7.7 billion won, 12.4 billion won, and 51.5 billion won," respectively. However, in the case of last year, it is difficult to compare sales absolutely because SK Chemical placed seasonal flu production as a subordinate priority due to CMO issues of the COVID-19 vaccine. The growth of Boryung Biopharma FluV Tetra and Flu8 Tetra is also noteworthy. The total performance of the two products in 2018, 2019, 2020, and 2021 is 6.3 billion won, 7.1 billion won, 37.9 billion won, and 34.4 billion won, securing the third place. Ilyang's Teratect rose sharply from 970 million won in 2018 to 20.4 billion won in 2021, and the Korean vaccine Kovax flu quadrivalent also achieved a quantum jump in sales from 990 million won to 13.2 billion won during the same period. The overall performance increase of flu vaccine products can be attributed to temporary strategic production issues of SKY Cellflu quardrient, increased demand due to twin-demic concerns, and cold chain issues in 2020. Among foreign companies, Sanofi's Vaxigriptetra and GSK's Fluarix Tetra are supplied to the private sector. Vaxigcriptetra's sales were 4.4 billion won, 4.6 billion won, 12.7billion won, and 13 billion won while Fluarix Tetra's sales were 11.6 billion won, 7.8 billion won, 13.6 billion won, and 5.1 billion won. The size of the trivalent flu vaccine market has been reduced from 53.3 billion won in 2019 to 1.9 billion won in 2021. GC Pharma's trivalent flu vaccine GC Flu also posted sales of 12.4 billion won in 2018, but it has reduced its portion to 8 million won in 1Q in 2022 and is focusing its efforts on the quardrivalent vaccine. What should be noted is the opening of the quardrivalent vaccine era, and LG Chem has no sales of its only three-valent flu vaccine, Flu Plus TF. This product showed a performance of between 2 billion won and 5.6 billion won between 2018 and 2019, but it was the last time it sold 400 million won in 2020. In the bidding market for influenza vaccines between 2022 and 2023, Korea Vaccine and Boryung Biopharma, which bid 10,433 won(2.2 million doses), 10,670 won and 10,687 won respectively, will supply 1.7 million to 1.8 million doses to the KCDA. GC Pharma (6 million doses) and Ilyang Pharmaceutical (1.9 million doses) offered 10,700 won in the same bid. Ilyang Pharmaceutical fell from the KCDA's bid due to a bidding rule that selects companies with large quantities at the same price. Regarding the supply and demand of the flu vaccine in the open bidding market for the Nara Market of the Public Procurement Service, the KCDA amount is about 11 million doses, which is about 90 billion won in amount. The NIP market is formed in the range of 7,000 won to 10,000 won, which is lower than the private supply price, making it difficult for pharmaceutical companies to secure margins, raising public opinion on the realization of bidding prices. The flu vaccine vaccination price, which is supplied to the private sector, is around 20,000 won to 45,000 won, and the vaccination rate is increasing through various events. In the case of clinic A, it is promoting that the price has been reduced from 35,000 won to 27,000 won for a single vaccination of tetravalent influenza vaccine. The tetravalent influenza vaccine + shingles vaccine is discounted from 205,000 won to 180,000 won, and the tetravalent influenza vaccine + pneumococcal vaccine is discounted from 165,000 won to 140,000 won. Regarding the overall situation, Pharmaceutical B said, "It is also unusual that some companies are not very interested in NIP open competitive bidding due to the mismatch of realistic procurement prices in the vaccine bidding market." An employee of this pharmaceutical company said, "We are focusing our production and marketing capabilities on private supplies with a relatively high margin." The procurement agency's bidding has been held by wholesalers, a distributor, but it has been directly participating in the manufacturing and import mission since last year due to the issue of exposure to room temperature of the flu vaccine in 2020.
- 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.
- Company
- Samsung Bioepis Announces Phase 3 Results of Soliris Similar
- by Kim, Jin-Gu Jun 15, 2022 05:50am
- Samsung Bioepis announced on the 13th that it has unveiled the results of phase 3 clinical trials of Soliris (Eculizumab) biosimilar SB12 through the EHA annual academic conference held in Austria from the 9th to the 12th. SB12 is the seventh biosimilar developed by Samsung Bioepis. It is the first blood disease treatment. The original Soliris is a treatment for incurable rare diseases such as PNH and aHUS developed by Alexion in the U.S. Last year, global sales amounted to $1.874 billion (approximately 2.3 trillion won). Samsung Bioepis conducted a comparative study between SB12 and the original (ECU) in PNH patients from July 2019 to October 2021. At this conference, the results were announced in the form of an e-poster. Samsung Bioepis conducted clinical trials by comparing and evaluating efficacy, safety, pharmacology, and immunogenicity between the two products. Among PNH patients who were first prescribed drugs, 50 patients aged 18 or older whose LDH level was measured to be 1.5 times or more of the normal ULN were randomly assigned. Samsung Bioepis administered SB12 or original every week for the first four weeks, 900 mg at the fifth week, and 900 mg every two weeks during the subsequent maintenance period. It then conducted research until 50 weeks while switching the two products at the 26th week. The primary efficacy evaluation index for this clinical trial was set as the "LDH level at the 26th week of drug administration" and the "AUEC (Area Under Effect Curve) of the time-adjusted LDH from 14th to 26th weeks and 40th to 52nd weeks. As a result of the study, 46 out of 50 patients completed clinical trials, and the primary efficacy evaluation index met the predefined clinical equivalence range. The difference in mean LDH values at week 26 (SB12-ECU=34.48) between SB12 and the original drug was found to have a 95% confidence interval (-47.66, 116.62) in the predefined equivalence range. For SB12/ECU: 1.08) between SB12 and the original drug, it was included in the predefined equivalence range in the 90% confidence interval (0.95, 1.23). Similar results were found in the LDH values for the entire clinical trial period, one of the secondary efficacy evaluation indicators. For TEAs, SB12 was 72.3% and original drugs were 68.1%. All three serious post-treatment adverse events in SB12 prescribed patients were unrelated to treatment. Oh Yoon-seok, executive director of PE (Product Evaluation), the clinical director of Samsung Bioepis, said, "SB12 is a product that has the essential meaning of biosimilar development to improve patient accessibility of ultra-high-priced bio-medicine." He said, "We confirmed safety and efficacy compared to original drugs through clinical trials." Soliris is an expensive biopharmaceutical that costs hundreds of millions of won a year for adult-based medication, and Samsung Bioepis provides SB12 free of charge for up to two years to domestic and foreign patients who participate in clinical trials.
- 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.
- Company
- Sales of topical minoxidil rise with interest in hair loss
- by Jun 14, 2022 06:04am
- (From the left) Rogaine, Mynoxyl, Dongsung Minoxidil The market for minoxidil topical solutions that are applied directly to the scalp continued on its strong growth, with marked growth shown by the foam-type Rogaine Foam among the three major products in the market. According to the market research institution IQVIA on the 14th, the minoxidil topical solution market had raised ₩4.6 billion in 4 months from January to April this year, a 36% YoY increase from the ₩3.4 billion made in the same period last year. The minoxidil market expanded rapidly with the rise in younger hair loss patients and the increasing perception that the condition needs to be managed in its early stages. Minoxidil, a topical medication that is directly applied to the scalp, expands the blood vessels to facilitate a smoother supply of nutrients to the hair. The market size, which had been below ₩1 billion from January to August last year, has increased to ₩1.5 billion this year along with the rising interest in hair loss. The total sales of minoxidil products in the market last year amounted to ₩12.5 billion, a 22% increase from the ₩10.2 billion of the previous year. Three products – Hyundai Pharm’s Minoxyl., Johnson&Johnson’s Rogaine Foam, and Dongsung Minoxidil – are leading the minoxidil topical solutions market. Among the three drugs, Hyundai Pharm’s Minoxyl has a 33% share of the market, followed by Dongsung Minoxidil (25%), then Rogaine Foam(24%). Recently, Rogaine Foam has been making the most marked growth. Rogaine Foam, which was released in 2017, has only accounted for 15% of the total market, bringing in an annual sales of ₩1.6 billion in 2020. However, its sales rose 89% last year to record ₩3 billion. Its market share had also grown 9%p to reach 24%. After chasing the runner-up Dongsung Minoxidil to the brim last year, Rogaine Foam beat Dongsung Minoxidil this year and took second place in the market. Its cumulative sales by April this year were ₩1.4 billion, a 119% increase YoY. Rogaine Foam’s market share had even exceeded that of the market leader Minoxyl in April this year. Rogaine Foam currently occupies 30% of the market, just a 1%p difference from the No.1 leader Minoxyl. This year’s market growth is analyzed to have been driven by Rogaine Foam. Sales of Minoxyl and Dongsung Minoxidil have also increased, but only by 18% and 12% each. By April, cumulative sales made by Minoxyl amounted to ₩1.4 billion, and Dongsung Minoxidil to ₩1 billion. Rogaine Foam’s contribution to the growth of the minoxidil topical solution market was 61% this year. It is interpreted that Rogaine’s foam type made this success by differentiating itself from the existing liquid-type products. As Korea’s first foam-type hair loss treatment, it minimized the dripping and stickiness associated with the gel-type formulation. Also, it does not contain propylene glycol (PG), which can cause skin irritation such as itching and stinging. In fact, a consumer survey on hair loss patients that was conducted by Johnson&Johnson shows that people who purchased Rogaine Foam selected its convenience in use and verified effect as the product’s top strengths. Also, the company believes its marketing campaign that related well to the minds of its consumers had brought a synergistic effect along with its product power. Junghwa Cha, brand manager at Johnson & Johnson Korea, said, “Our original foam type minoxidil topical solution shows the optimal effect when used in combination with oral finasteride, and is therefore commonly prescribed by specialists at hair loss clinics. Our efforts to highlight the product’s efficacy and effect while preparing a solid ecosystem so that consumers can appreciate the value of Rogaine Foam from every aspect, in addition to the support shown by pharmacists in the field, have driven the rapid growth of the product this year."
- Company
- Lilly Korea has entered into negotiations on Emgality
- by Eo, Yun-Ho Jun 14, 2022 06:04am
- CGRP target migraine drug Emgality is in the final stage for insurance benefit registration. According to related industries, Emgality, a target migraine treatment for CGRP (Calcitoninogen-related peptide) by Lilly Korea, recently began negotiations with the NHIS on drug prices. Considering the deadline for negotiations, a conclusion is expected within next month. If Emgality is reimbursed, it will be the first new drug in the system. Emgality passed the Drug Reimbursment Evaluation Committee on the 12th of last month after submitting a benefit application in March 2021. Handok Teva's Ajovy, which is currently a competitive drug, is also in the process of registration. These drugs are humanized monoclonal antibody drugs that bind to CGRP molecules that play a major role in causing migraine symptoms to block binding to receptors. Although the two drugs are of the same series, there are differences in doses, so patients with severe migraine are approaching with another expectation. Emgality was based on the EVOLVE-1 and EVOLVE-2 studies in which 1773 Episodic Migrain patients (4-14 days per month) participated for 6 months, and the REGAIN study in which 1,113 patients (15 days per month) participated in the average headache and 8 days or more. In particular, in the EVOLVE-2 clinical study involving Koreans, the average number of days of migraines per month for six months in the Emgality group (226 patients) decreased by two more days compared to the placebo group (450 patients) (4.3 days in the Emgality group and 2.3 days in the placebo group), the number of patients administered by Emgality, whose number of migraine days decreased by 50% over 6 months, was 59% (36% in the placebo group), 34% (18% in the placebo group) which decreased by more than 75%, and patients who decreased by 100% were 12% (6% of placebo group). Min Ju-kyung, a neurology professor at Sinchon Severance Hospital, said, "Migrain headaches are more painful than imagined and hinder the quality of life of patients. Patients who experience migraines more than 4 to 5 days a month can expect to improve their quality of life through preventive treatment," she explained.
- 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."
