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- 2026-05-16 03:41:27
- Company
- Ilaris reattempts reimb for its 13 patients in Korea
- by Eo, Yun-Ho May 23, 2022 06:06am
- ‘Ilaris,’ an ultra-orphan drug indicated for only 13 patients in Korea, is reattempting to be listed for insurance benefit. According to industry sources, Novartis Korea recently submitted an application to receive insurance benefits for its hereditary periodic fever syndrome treatment ‘Ilaris (canakinumab). This is the first attempt made by the company since it was denied reimbursement by the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee in 2017. Among the various Hereditary Periodic Fever Syndrome conditions, the drug was approved in 2015 in Korea for the treatment of ▲Cryopyrin-Associated Periodic Syndromes (CAPS), ▲Tumor Necrosis Factor-Receptor Associated Periodic Syndrome (TRAPS), and ▲Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD) and ▲Familial Mediterranean Fever (FMF) in patients who are unable to use colchicine (due to contraindication, intolerance or lack of efficacy). The drug demonstrated an improvement in quality of life and convenience in administration in CAPS patients (a type of Hereditary Periodic Fever Syndrome) with 6 doses a year but was unable to prove its cost-efficiency, being a drug for an ultra-rare disease. In fact, Novartis had first applied for its reimbursement in 2017 after the drug was approved in 2015, and the company did not make any further attempts at listing until now. With this delay, the dire need for a reimbursed treatment option has intensified among patients. An alternative option exists, but just for one phenotype of the Hereditary Periodic Fever Syndrome - the chronic infantile neurological, cutaneous and articular (CINCA) syndrome – that patients can receive through the Korea Orphan & Essential Drug Center. With expectations rising on increased coverage for severe and rare disease drugs with the inauguration of the new administration, whether Ilaris will see different results this time remains to be seen. Dae Chul Jeong, Professor of Pediatrics at Seoul St. Mary's Hospital, said, “We need to improve accessibility to rare disease treatments so that Hereditary Periodic Fever Syndrome patients are guaranteed the same treatment benefits as other rare disease patients in Korea.” He added, “We also need to provide social attention and support so that patients diagnosed with Hereditary Periodic Fever Syndrome could continue on their difficult treatment journey while maintaining the quality of life with their families.”
- Company
- Keytruda became a new breakthrough in the tx
- by May 23, 2022 06:06am
- MSD's Keytruda succeeded in applying Hodgkin's lymphoma benefit for the second time as an immuno-cancer drug. Takeda is considered the best option for Hodgkin's lymphoma treatment. It is evaluated as suitable as a new option by proving superiority through comparative clinical trials with Takeda's Adcetris. As of March 1, Keytruda was reimbursed as a second or more treatment if it recurred or progressed after self-hematopoietic stem cell transplantation (ASCT) in typical Hodgkin lymphoma, and a third or more treatment if self-hematopoietic stem cell transplantation is impossible. Yoon Deok-hyun, a professor of oncology at Asan Medical Center in Seoul, commented on the expansion of the benefit, "Keytruda showed superior effect than Adcetris in most Hodgkin lymphoma patients, so Keytruda will be used first unless it is an exception." Hodgkin's lymphoma is mostly young patients, with people in their 20s and 30s accounting for 80% of the total. Lymphoma can occur in T lymphocytes, which play an important role in regulating the immune system and fighting viral infections, and in B lymphocytes, which produce antibodies essential to fighting some infections. Hodgkin's lymphoma is a type of lymphoma that is believed to have originated from B lymphocytes. In Korea, it accounts for about 5% of all lymphoma. Hodgkin's lymphoma has a high cure rate. In the case of local weapons, more than 95% of them are completely cured. However, about half of the high-risk groups of advanced stage patients suffer recurrence. Overall, it shows a recurrence rate of more than 20%. Patients who recur or fail to comply with treatment with cocktail therapy represented by ABVD consider autologous hematopoietic stem cell transplantation. The cure rate during transplantation is reported to be about 50%. However, the treatment of patients who cannot be transplanted or recur after transplantation still remains a homework. Professor Yoon said, "Self-hematopoietic stem cell transplantation is like high-dose chemotherapy, so patients who do not respond to chemotherapy cannot try it. This is one in three. In addition, about 20% of all patients are elderly or in poor systemic condition, so they cannot withstand transplants. The homework was how to treat these patients and those who recur after transplantation. Adcetris is the drug that contributed to improving their survival rate. It was a drug that combined strong anticancer drugs with antibodies targeting cancer, and it was effective not only in recurrent patients, but also in post-transplantation maintenance therapy and first-line treatment in high-risk groups." Although Adcetris has become the most effective drug for treating recurrence patients, many patients still experience recurrence with a 5-year progression-free survival rate of 20%, Professor Yoon said. At this time, Keytruda emerged as a new option by expanding the indication to Hodgkin's lymphoma. In particular, Keytruda first demonstrated superiority through a direct head-to-head comparison with Adcetris in phase 3 KEYNOTE-204. In this clinical trial, the risk of disease progression and death in the Keytruda group was 35% lower than that of the Adcetris group, and the median duration of progression-free survival was 13.2 months, showing a significant improvement compared to the control group (8.3 months). The objective reaction rate of the Keytruda group was 65.6%, and one in four showed complete remission. The median value and quality of life of the reaction duration were also significantly improved compared to the Adcetris group. Professor Yoon said, "When I used Keytruda at the treatment site, the quality of life of the patient increased due to its resistance, and it was convenient for patients as they only had to come once every three weeks without hospitalization. There was little hematological toxicity, he said. "Keytruda recorded a progression-free survival rate of 30-40% at the time of three years, which was higher than any other treatment." Since March, Keytruda benefits have been applied to Hodgkin's lymphoma, and treatment patterns at the treatment site have also changed. Professor Yoon said, "Based on the comparative clinical results, Keytruda can be considered first in almost all patients. If it is not an exceptional case, such as accompanying autoimmune diseases, we will use Keytruda first, he said. "Keytruda can be an important breakthrough in recurrent patients." Of course, Keytruda is not the perfect solution. Due to clinical design, Keytruda treatment is difficult to exceed two years. The reaction rate is high, but the rate of complete remission is 25%, which is also limited to achieving the goal of "complete recovery." However, Professor Yoon highly predicted the possibility of immuno-cancer drugs in Hodgkin's lymphoma, given that various clinical trials are underway beyond the effects of existing treatments. He said, "It is clear that immuno-cancer drugs will play a more role in the future as several clinical trials are currently underway in Hodgkin's lymphoma, including post-transplantation maintenance therapy and primary treatment therapy, including Keytruda."
- Company
- Keytruda leads sales for the 9th consecutive quarter
- by Chon, Seung-Hyun May 23, 2022 06:06am
- MDS’s cancer immunotherapy Keytruda has again topped the rank in pharmaceutical sales this year. Its increase in sales has been reduced somewhat due to the price cut disposition that followed Keytruda's reimbursement expansion, still, the drug was able to maintain its lead for the 9th consecutive quarter. Also, new drugs from multinational pharmaceutical companies, such as Plavix, Opdivo, Prolia, and Dupixent showed strength this quarter. According to the market research institution IQVIA on the 20th, Keytruda made the most among pharmaceuticals in Korea in the first quarter of this year, recording sales of ₩40.4 billion. Although the amount has decreased 8.4% YoY, still, the drug was able to maintain its overall lead. Keytruda is an immune checkpoint inhibitor that inhibits PD-1 (programmed death 1) proteins expressed at the surface of activated T cells, thereby inhibiting its binding to PD-L1 and activating the immune system to treat cancer. The drug, which was first released in March 2015, is currently approved for 18 indications in 14 cancer types in Korea, including melanoma, lung cancer, and head and neck cancer. Keytruda’s sales had first remained in the ₩3 billion range but started soaring after the drug was approved for insurance benefit as a second-line treatment for non-small cell lung cancer. Its sales exceeded ₩10 billion in Q1 2018 and then exceeded ₩30 billion in Q2 2019. In Q1 2020, the drug outsold the then-lead Lipitor and rose to the top that it maintained for 9 consecutive quarters until now. The reduction in sales of Keytruda this year is considered to be due to Keytruda’s price cut. Keytruda’s insurance ceiling price had fallen 25.6% with its reimbursement expansion to first-line treatment of NSCLC in March this year. Although sales had reduced somewhat due to the price cut, its rise in sales is expected to continue to surge due to the expanded scope of reimbursement. Sales of the hyperlipidemia treatment Lipitor recorded 2nd place with ₩38.5 billion in Q1 this year, making a 9.7% YoY increase. The sales gap between Keytruda and Lipitor had been nearly ₩9 billion in Q1 last year, but this gap was reduced to ₩1.9 billion with the slower rise in Keytruda’s overall sales this year. Lipitor (atorvastatin) is a hyperlipidemia treatment that was released by Pfizer Korea in 1999. Although its insurance price fell to half after patent expiry and the fierce competition created by the 100 or more generics, the drug continues to exert its strong influence in the prescription drug market. Viatris Korea, which was launched in November 2020 through a merger between Global Pfizer’s business division Upjohn and the global healthcare company Mylan, is in charge of its sales. Sanofi’s antiplatelet Plavix recorded 3rd place with its sales increasing 37.7% YoY to record ₩26.8 billion in Q1 this year. Plavix’s patent had also expired in 2007, despite the 100 or more generics that entered its market in the past decade, the drug is still recording high growth. Also, new drugs released by multinational pharmaceutical companies have made the ranks and have shown high growth. Sales of Sanofi’s atopic dermatitis treatment Dupixent rose 77.0% YoY to record ₩23.9 billion in Q1 this year and newly entered the Top 10. Dupixent is the first targeted biologic for the treatment of moderate-to-severe atopic dermatitis that is not well controlled with prescription topical therapies or cannot use topical therapies. It selectively inhibits interleukin-3 and interleukin-4 proteins, which are known causes of adult atopic dermatitis. Sanofi Genzyme received marketing authorization for Dupixent in March 2018 for the treatment of moderate-to-severe atopic dermatitis in adults and released the drug in August of the same year. Although its initial performance was not up to par, its sales surged with its reimbursement approval for severe atopic dermatitis in January 2020. Dupixent’s sales, which had been only ₩3.3 billion in Q1 2020, increased over fourfold in a single year to record ₩13.5 billion in Q1 last year and exceeded quarterly sales of ₩10 billion. The drug has been recording sales in the ₩20 billion range since Q3 last year. Sales of Ono Pharmaceutical’s cancer immunotherapy Opdivo (nivolumab) also increased 43.5% YoY to record ₩25.1 billion in Q1 this year. Amgen’s osteoporosis treatment Prolia and MSD’s HPV vaccine Gardasil 9 also showed high growth with a 25.9% and 39.2% respective YoY increase in sales. Among new homegrown drugs, HK Inno.N’s gastroesophageal reflux disease (GERD) drug K-CAB’s sales rose 25.2% YoY to record 25.1 billion in Q1 this year and ranked 5th among the most-sold prescription drugs in Korea this quarter.
- Company
- The global competitiveness of new drugs depends on
- by Nho, Byung Chul May 23, 2022 06:06am
- Public opinion on the realization of the preference for new drugs developed in Korea is rising ahead of the announcement of the results of research services on drug prices support policies for innovative pharmaceutical companies in line with the international trade order. The research service, which took place for five months from December last year to this month, is handled by Professor Park Mi-hye of Sungkyunkwan University with the order of the KHIDI, and is scheduled to be published as a report in June and July. The background of the research is due to the feasibility review of the MOHW's written inquiry of last year's parliamentary audit in the absence of subordinate laws due to trade issues, although the Pharmaceutical Industry Promotion Act was revised ('18.12). While positive results are expected, the core background and contents of the research service are expected to present support measures consistent with pharmaceutical company innovation and insurance finances, establish enforcement ordinances related to Article 17-2 of the Pharmaceutical Industry Promotion Act, and raise and resolve trade issues. New drug price preferential treatment at the new drug registration evaluation stage As a preference for drug prices for innovative pharmaceutical companies that can avoid trade issues demanded by the industry, first, a new drug price preference target (a new drug performed in phase 3 clinical trials in Korea) is established at the new drug registration evaluation stage. In the negotiation stage, innovative pharmaceutical companies are raising the current weighted average price of 90% to 100% for new drugs developed through phase 3 clinical trials in Korea, focusing on promoting R&D will and securing predictable marketability. Other preferential measures include improving the selection criteria for alternative drugs (excluding patent expired drugs from alternative drugs), accumulating a discount on drug prices during the patent period (deferred application), applying it after patent expiration, and reflecting the cost data of innovative pharmaceutical companies in Korea at the negotiation stage. The global innovative drug preferential treatment system was introduced temporarily between 2016 and 2018, and K-Cab and Olita have benefited from the suspension of development, but it has been virtually private due to the issue of non-compliance. Preferential conditions were the world's first domestic licensed or domestic production, joint development or social contribution between domestic and foreign companies, domestic clinical performance (phase 1), innovative pharmaceutical companies, or equivalent companies. Since 2018, all five requirements such as proving clinical usefulness, such as new mechanisms or substances, alternative treatments, extension of survival, rapid licensing in the United States or Europe, and rare disease treatments or anticancer drugs have been met, causing reverse discrimination against domestic history. Therefore, the industry believes that if innovative pharmaceutical companies omit ▲ economic evaluation, the highest A7 adjustment price or the highest alternative drug price will be reasonable, ▲ ICER when submitting PE data, and ▲ if PE data are not submitted, the maximum price of alternative drugs will be added by 10%. For new drugs similar to clinical usefulness, the lower of the amount between the weighted average price of substitute drugs and the weighted average price of substitute drugs × (100/53.55) (but in the case of new drugs, the highest price of substitute drugs can be recognized). The KPBMA said, "We plan to adopt the Pharmaceutical Bio Innovation Committee's policy, which will be established in the future, to encourage R&D, as well as secure new drug powerhouses and global entry points."
- Company
- COVID-19 exports to Australia↑123 times in a year
- by Kim, Jin-Gu May 23, 2022 06:06am
- In the January-April period, exports of medicines to Australia surged more than 100 times compared to the same period last year-on-year. In the pharmaceutical bio industry, it is interpreted that the moderna vaccine produced by Samsung BioLogics was exported to Australia in earnest, leading to an increase in total exports. Exports to Germany, which was previously the largest exporter, fell by one-fifth in a year. Exports to China and Japan also fell sharply. As the COVID-19 crisis enters a calming phase, analysts say changes are coming to major drug exporters. ◆Export to Australia 3.4 billion → 420 billion won in a year, 95% of them are vaccines According to the Korea Customs Service on the 17th, exports of medicines from Korea to Australia from January to April this year were 325.1 million dollars. Compared to $2.65 million (about 3.4 billion won) between January and April last year, it increased 123 times in a year. Until the middle of last year, Korea did not export much medicine to Australia. Before August last year, it was around 2 million dollars per month. It was in September last year that there were signs of full-fledged change. It exported 6.5 million dollars (about 8.3 billion won), more than three times more than usual. In November, it increased further to $12.74 million (approximately 16.3 billion won) in November. From December last year to February this year, it recorded more than 90 million dollars per month. In particular, in March, it reached its highest point by exporting 130.21 million dollars over a month. Exports in March were higher than annual exports of $126 million last year. Monthly exports in April have fallen again to $349 million. The pharmaceutical bio industry is paying attention to the fact that exports of medicines to Australia are concentrated in vaccines. Exports of vaccines (HS code 3002.41) to Australia from January to April amounted to $314.36 million, accounting for 97% of all drug exports to Australia. For the rest, it is maintained at the previous year's. It is explained that Moderna vaccines produced by Samsung BioLogics were exported to Australia. Yeonsu-gu, Incheon, is the only region in the country where vaccine exports have soared during this period. It is the area where Samsung BioLogics is located. ◆81% of Germany, the largest pharmaceutical export country in the past. "The base effect of panic buying" Exports of medicines to Germany plunged by one-fifth compared to the same period last year. In the January-April period of this year, exports of medicines to Germany amounted to 192.91 million dollars, down 81% from 1.010.27 billion dollars during the same period last year. Until last year, Germany was Korea's largest exporter of medicines for the past three years. Last year alone, 1.76922 billion dollars of medicines were exported to Germany. The pharmaceutical industry interprets that the rapid spread of COVID-19 in Europe has led to a decrease in drug exports to Germany. In the early days of the spread of COVID-19, exports of medicines increased as Germany and other European countries competed to stock up on essential drugs, and the opposite situation is taking place this year when COVID-19 calms down. Exports of medicines to Germany, which were $521.31 million in 2019, increased 3.5 times to $1.856.97 billion in 2020, the first year of COVID-19. Last year, it recorded a slight decrease of $1.76922 billion. In the process, the proportion of drug exports to Germany also increased significantly. Germany accounted for 14.1% of all drug exports in 2019, but soared to 26.9% in 2020. It decreased slightly to 21.8% last year, and fell to 8.8% from January to April this year. ◆47% decrease in China and 15% decrease in Japan In addition to Germany, exports of medicines to China and Japan also decreased significantly in a year. In the January-April period, exports of medicines to China amounted to $45.31 million, nearly half of $84.77 million in the same period last year. Exports to Japan also fell 15.2% from 161.25 million dollars to 136.68 million dollars in a year. In the case of the two countries, it is analyzed that the decrease in local demand for medicines has affected the decrease in exports.
- Policy
- Fexclu priced at 90% of the weighted average of K-CAB+PPIs
- by Lee, Tak-Sun May 20, 2022 06:12am
- The price of ‘Fexclu Tab (fexuprazan), the potassium-competitive acid blocker (P-CAB) class gastroesophageal reflux disease (GERD) treatment developed by Daewoong Pharmaceutical was set at 90% of the weighted average price of the same class drug ‘K-CAB (tegoprazan, HK Inno.N) and PPI (proton-pump inhibitors) drugs. On the 12th, the Drug Reimbursement Evaluation Committee of the Health Insurance Review and Assessment Service had deemed that reimbursement for the drug was adequate if the company accepts a price below the appraised amount. The appraised amount was set at 90% of the price of ‘K-CAB+PPI’ after classifying the alternative of Fexuclu as 'K-Cap + PPI’ in the calculation formula. According to industry sources on the 19th, HIRA delivered its appraised amount to Daewoong Pharmaceutical. Daewoong Pharmaceutical, which had been hoping to be appraised using only K-CAB’s price, received the results with some disappointment. The price of K-CAB had been set at a more expensive level than others, being applied the 'preferential treatment for new drugs that entered the global market’ system that does not exist anymore. The current price ceiling for K-CAB is set at ₩1,300, but as most PPIs are now off-patent and have received significant price discounts, the weighted average price that includes PPIs as alternatives will widen the price gap between Fexclu and K-Cab. The current ceiling price of major PPIs are Nexium 40mg (esomeprazole) ₩1,015, Lanston LFDT tab 30mg (lansoprazole) ₩829, Noltec tab 10mg (ilaprazole) ₩1,131. If a drug’s price is set low in Korea, other countries that reference Korea’s price would also set a lower price for the drug, ultimately creating an unfavorable environment for overseas expansion of drugs. This is why the domestic pharmaceutical industry had requested a preferential clause be added for new homegrown drugs. An industry official pointed out, "In some cases, domestic prices are what impedes overseas penetration of the drugs, and the current drug price calculation standards do not properly reflect the efforts invested by the companies in developing new drugs." However, it is expected that Daewoong Pharmaceutical will accept the given price and proceed to conduct pricing negotiations with the NHIS, as the company has been conducting pre-marketing activities with the aim to release the drug in July, and the low possibility that the decision will be overturned even if the company raises an objection to HIRA’s appraised price. Therefore, Fexclu is expected to engage in a one-on-one competition with K-CAB in Korea with its lower price. K-CAB had raised ₩109.6 billion in outpatient prescriptions (source:UBSIT) last year.
- Policy
- The MFDS will gradually disclose the results of GMP survey
- by Lee, Hye-Kyung May 20, 2022 06:11am
- The MFDS has decided to disclose the results of the drug GMP survey on its website in the future. The MFDS has prepared a plan to disclose information on the results of the drug GMP survey based on the discussions discussed through the Public-Private Consultative Body on the Results of the GMP Survey. As a PIC/S member country, the results of the survey will be disclosed at the level of the U.S. and Europe, but in consideration of the need to prepare legal grounds, it will gradually disclose detailed information after the revision of the Pharmaceutical Affairs Act in the first stage. Subject to the disclosure are pharmaceuticals and herbal medicines under the jurisdiction of the Drug Safety Bureau, and the results of a survey on the status of the licensing stage, regular monitoring, and overseas manufacturing plants. Advanced biopharmaceuticals such as biological drugs are excluded. As a result of the fact-finding survey, the disclosure time is within 6 months after the approval and report of the item, the regular monitoring of the post-authorization stage is within 6 months after the issuance of the GMP conformity report, and the overseas manufacturing plant survey is within 6 months after the report. The MFDS will go through the process of inquiring opinions of the company and disclose it on the website only for summary information. If the company does not agree to disclose the results of the survey, the survey related to the company among the disclosure contents will be shaded. The scope of disclosure is a level that summarizes the outline and points of the fact-finding survey by referring to the current status of the United States and Europe, and is limited to item information in the case of the fact-finding survey. The MFDS is planning to expedite the disclosure of the results of the GMP test in May in line with the current evaluation for WLA registration.
- Policy
- Green light to Sprycel's reimb with indication expansion
- by Lee, Tak-Sun May 20, 2022 06:11am
- The chronic myeloid leukemia treatment ‘Sprycel tab (dasatinib, BMS Korea)’ has received the green light to expand its reimbursement. The Health Insurance Review and Assessment Service announced that it had set the reimbursement standards for Sprycel in pediatric patients with acute lymphoblastic leukemia (ALL) at the 5th Cancer Disease Deliberation Committee meeting that was held on the 18th. Based on the set standards, Sprycel can now progress to the next step in expanding its reimbursement to the indication set above. The drug will now undergo Drug Reimbursement Evaluation Committee review, drug pricing negotiation with the National Health Insurance Service, then receive final deliberations for reimbursement. The specific indication for Sprycel that was approved in the reimbursement standard is for ‘the treatment of pediatric patients 1 year of age and older with newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) in combination with chemotherapy.’ Deliberation results of HIRA CDDC that was held on the 18th The other 3 drugs failed to establish reimbursement standards on the same day. Lilly Korea’s ‘Retevmo capsule (selpercatinib)’ that is gaining attention as a tumor-agnostic anticancer drug, Pfizer Korea's ‘Mylotarg injection (gemtuzumab ozogamicin),’ and Novartis Korea's ‘Jakabi tablet (ruxolitinib) all failed to establish reimbursement standards. Retvmo’s reimbursement standards were failed to be set for all its indications: ▲treatment of advanced or metastatic RET-mutated medullary thyroid cancer who require systemic therapy; ▲ treatment of patients who are refractory to radioactive iodine therapy and who have prior sorafenib and/or Lenvatinib treatment experience, with advanced or metastatic RET-fusion benign thyroid cancer who require systemic therapy; and ▲ treatment of metastatic RET fusion-positive non-small cell lung cancer (NSCLC). In the case of Mylotarg, which had failed to expand reimbursement to newly diagnosed CD33-positive acute myeloid leukemia (AML) in adults, and Jakabi which failed to expand its reimbursement standard to the treatment of patients with intermediate or high-risk myelofibrosis, the drugs are now left to reattempt reimbursement expansions at this stage.
- Opinion
- The Minister should be appointed to lead policy continuity
- by Lee, Hye-Kyung May 20, 2022 06:11am
- On the 13th, the Yoon Seok-yeol government announced the appointment of vice ministers, ministries, and commissioners. However, as the head of the Ministry of Food and Drug Safety was excluded from the list of appointments, many talks were exchanged about the background. The most credible argument was that the appointment of the head of the affiliated agency would not have been easy at a time when the appointment of the MOHW was not made. Candidate for Minister of Health and Welfare Chung Ho-young has yet to be appointed since the personnel hearing. Some say they are trying to trade for the confirmation of Prime Minister nominee Han Duck-soo and the resignation of Minister of Health and Welfare candidate Chung Ho-young. In this situation, attention is also being paid to who will become the head of the regulatory agency, the MFDS. Oh Yoo-kyung, dean of Seoul National University College of Pharmacy, Kim In-kyu, former head of Gyeongin Office, Yoon Hyung-joo, and Seo Kyung-won, head of safety evaluation, were mentioned as candidates for his successor. All candidates seem to have the advantage of being able to maintain policy continuity and consistency as internal personnel of the MFDS. It is unclear whether the head of the MFDS, who is first appointed by the Yoon Seok-yeol government, will also be able to exceed the average tenure. The MFDS is a regulatory agency for pharmaceutical and food safety management, and frequent replacement of the head of the MFDS does not seem desirable to maintain continuity and consistency. Yoon Seok-yeol, the first head of the government's MFDS, who will be appointed soon, should be empowered to lead policies such as rapid approval of medical products such as medicines and support the development of COVID-19 treatments.
- Policy
- HIRA plans to improve the overall management system
- by Lee, Tak-Sun May 20, 2022 06:11am
- Lee Jin-soo, chairman of HIRAWith the launch of Zolgensma, the HIRA plans to improve the overall management system of the pre-approval system. Accordingly, it has been confirmed that internal research is being carried out. The HIRA allows benefits for ultra-high-priced drugs such as Soliris and Spinraza or some medical procedures through a pre-approval system. However, some items have been pre-approved for a long time, and as ultra-high-priced drugs subject to pre-approval are expected to increase in the future, they are reportedly considering adjusting the target items. Lee Jin-soo, chairman of the HIRA Medical Review and Assessment Committee, made the announcement at a meeting with the Korea Special Press Association on the 17th. Chairman Lee explained, "Recently, demands for higher-priced drugs have continued to increase, and medical institutions are also expected to actively use the pre-approval system," adding, "We will improve the overall management system of the pre-approval system." Currently, hematopoietic stem cell transplantation, Soliris (subject to PNH, aHUS diseases) 'ICD&CRT, VAD, and Spinraza are allowed to administer or perform pre-approval systems. Among them, hematopoietic stem cell transplantation is under consideration. Chairman Lee said, "In the case of hematopoietic stem cell transplantation, the pre-approval system has been applied since 1992. At the beginning, it was a high-risk and high-cost act, but now it is cheaper than other expensive drugs, so I think we can go to a post-examination." However, in the medical community, there is a high opinion that it should be maintained. Hematopoietic stem cell transplantation benefited 3,323 people through preliminary screening last year, costing a total of 127.6 billion won. This is a much higher cost than other items. Soliris, an ultra-high-priced drug, cost 36.7 billion won and Spinraza 41.6 billion won last year. The number of people subject to approval is also higher. Chairman Lee said, "Hematopoietic stem cell transplantation has been a learning training for medical institutions since pre-examination was introduced for 30 years, so the approval rate is far higher than other items. However, we are considering withdrawing internally in consideration of manpower and screening capacity." The new drug to which the pre-approval system will be applied is Zolgensma, a treatment for spinal muscular dystrophy. Zolgensma was recognized of benefits on the condition of prior approval of medical care benefits at a review of the Drug Benefit Evaluation Committee held on the 12th. The Medical Review and Assessment Committee is currently considering coordinating the Spinraza review division with the same indication if Zolgensma is confirmed to be subject to the pre-approval system. "In order to improve the system, the review and evaluation laboratory is conducting internal research on the systematic operation of the pre-approval system," Chairman Lee said. "We will analyze the operation status and collect domestic and foreign cases to come up with specific improvement measures." The preliminary review department of the Medical Review and Assessment Committee plans to expand the application of the pre-approval system for severely incurable diseases who need high-risk and high-cost medical services and strengthen management. Chairman Lee said, "Last year, the number of pre-approval items increased from eight to nine, and we received about 280 billion won in medical expenses."
