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- 2025-12-21 13:28:17
- Policy
- Mifegyne, inadequate national essential drug system
- by Lee, Jeong-Hwan Sep 25, 2023 05:34am
- Rep. Nam In-soon applies as a reference to the Pharmaceutical Society for a Healthy Society Anticipation of questions such as transparency of essential medicines. Problems with the national essential drug designation system and the issue of the miscarriage inducer Mifegyne not being designated as a national essential drug are expected to be discussed at this year's Ministry of Food and Drug Safety inspection. On the 22nd, after examining the final list of applications for witnesses and references for the National Assembly's Health and Welfare Committee of the National Assembly, Nam In-soon, a member of the Democratic Party of Korea, applied for Lee Dong-Geun, secretary general of the Pharmaceutical Association for a Healthy Society, as a reference. Rep. Nam's reason for applying as a reference is to inquire about problems with the national essential drug system. The Pharmaceutical Association for a Healthy Society has been pointing out problems with the Ministry of Food and Drug Safety's national essential drug designation system for several years now. The biggest problem that the Pharmaceutical Association for a Healthy Society is looking at is that the purpose and standards for reorganizing the national list of essential drugs are unclear, and that “miscarriage-inducing drugs,” which civil society has been continuously demanding, are not designated as essential drugs. Due to the decision in 2019 to make the abortion law unconstitutional, many women are receiving abortion procedures at medical institutions starting in 2021, but abortion through medication is still not performed in Korea, and the reason for this is the non-designation of Mifegyne as an essential drug. The Ministry of Food and Drug Safety has not designated Mifegyne as a national essential drug. Although the Ministry of Food and Drug Safety's failure to designate Mifegyne as an essential drug cannot necessarily be viewed as faulty administration, it has been pointed out that the national essential drug designation system must be disclosed more transparently in order to examine whether it is proper administration. This is also the reason why the Pharmaceutical Association for a Healthy Society is demanding that the Ministry of Food and Drug Safety reveal the standards for designating nationally essential drugs. In addition, the Pharmaceutical Association for a Healthy Society pointed out that it was a problem that nine items for the treatment of acquired immunodeficiency syndrome (HIV) were included in the list of drugs that can be de-designated as essential drugs. Acquired immunodeficiency requires a variety of medicines due to the nature of the disease, and it is unreasonable for the Ministry of Food and Drug Safety to consider lifting the designation even though there is a precedent in the past where multinational pharmaceutical companies unilaterally stopped supply for economic reasons. An official from the Pharmaceutical Society for a Healthy Society explained, “We plan to respond to questions from the National Inspector General regarding the non-designation of miscarriage inducers such as Mifegyne as essential drugs and urge that the standards for designation as national essential drugs be disclosed more transparently than they are now.” He explained, “Even if a lactic acid inducing drug is not approved for domestic marketing, it is possible to designate it as an essential drug, but the Ministry of Food and Drug Safety is holding on by refusing to respond.”
- Policy
- Vabysmo·Evrysdi will be reimbursed in October
- by Lee, Jeong-Hwan Sep 25, 2023 05:34am
- New reimbursement standards for Vabysmo, SMA treatment Evrysdi, and hemophilia A treatment Jivi (Damoctocog Alfa Pegol) will be established from the 1st of next month. The scope of reimbursement for Spinraza, a cure for spinal muscular atrophy, will be expanded, and the reimbursement standard for the emergency introduction drug Ivexproglycem Suspension will be established within the range recognized by the Minister of Food and Drug Safety. The Ministry of Health and Welfare recently announced some revisions to the details of the standards and methods for applying such nursing care benefits. We plan to implement it from the 1st of next month after collecting opinions on the 25th. ◆Vabysmo=Vabysmo, an ophthalmic medication, is newly approved for neovascular (wet) age-related macular degeneration and diabetic macular edema. If the medication is replaced with Vabysmo with an administration opinion attached, and the treatment effect does not appear after 3 administrations, subsequent administration will not be reimbursed. In addition, for diabetic macular edema, reimbursement is recognized up to 14 times in total, including the number of administrations of Aflibercept and Ranibizumab. ◆Evrysdi=Evrysdi is newly reimbursed when administered to patients with 5q spinal muscular atrophy with a confirmed genetic diagnosis of deletion or mutation of the 5q SMN-1 gene. ▲If the SMN2 gene copy number is 3 or less even before the onset of symptoms and the start of treatment is less than 6 months old, or ▲Patients who have developed SMA-related clinical symptoms and signs and are Type 1 to Type 3 and are not using a permanent ventilator are eligible for the benefit. Reimbursement is not recognized for replacement or co-administration between Evrysdi and spinal muscular atrophy treatment. However, if improvement is confirmed during Spinraza administration and does not meet the discontinuation criteria, but the committee determines that there are clinical reasons for replacement with Evrysdi, one replacement administration is permitted. In addition, in-hospital prescriptions are the principle, but for long-term prescriptions, the dosage per prescription is limited to 2 bottles for discharge and outpatient use. ◆Jivi = Hemophilia A treatment Jivi is approved for reimbursement when administered to adult and adolescent (age 12 or older) hemophilia A patients with a previous treatment history (exposure for more than 150 days). The single administration dose (one serving) is 20-25 IU/kg. However, in case of moderate or higher bleeding, up to 30 IU/kg is allowed depending on the doctor's medical judgment. ◆Spinraza = Spinraza's benefits range is expanded based on the same standards as Evrysdi. Patients with 5q Spinal Muscular Atrophy (SMA) with a confirmed genetic diagnosis of deletion or mutation of the 5q SMN-1 gene are eligible for administration. Eligibility for coverage is ▲ SMN2 gene copy number of 3 or less even before symptom onset and less than 6 months of age at the start of treatment, or ▲ Type 1 to Type 3 with SMA-related clinical symptoms and signs and not using a permanent respirator. In addition, both Spinraza and Evrysdi will be added to the list of expensive drugs. The management period is 1 year, and those eligible for management are those who are over 18 years old at the time of first administration and have an HFMSE score of less than 5 points. ◆Other= Ivexproglycem Suspension is within the scope recognized by the Minister of Food and Drug Safety, that is, inoperable pancreatic islet cell adenoma, pancreatic islet cell carcinoma, or extrapancreatic malignant tumor in adults, leucine sensitivity, pancreatic islet cell hyperplasia, extrapancreatic malignant tumor, and islet cell in infants and children. Reimbursement is recognized for the treatment of hyperinsulinemia related to adenoma or pancreatic islet adenomatosis. It can be used not only as a temporary measure before surgery but also when hypoglycemia persists after surgery. Preda and Progynova, which are estradiol preparations, are approved for use not only within the scope of approval, such as prevention of menopausal disorders and postmenopausal osteoporosis, but also for hypoestrogenism (for women over 11 years of age) due to decreased gonadal function and ovarian dysfunction, and assisted reproductive technology.
- Policy
- How Samsung’s biosimilar became covered in the US
- by Lee, Hye-Kyung Sep 22, 2023 05:41am
- Language barriers, insufficient handling of administrative issues related to regulations and visas, difficulties in recruiting and managing local personnel, and lack of a network infrastructure were pointed to as barriers to the Korean pharmaceutical companies’ entry into the U.S. Entry into the U.S. market holds significance in the industry as it is the world's largest pharmaceutical market that leads global technological standards. However, due to the various risk factors that exist, thorough preliminary research and simulation are necessary before making an attempt. The '2023 Global Pharmaceutical-Bio Market Export Support Report' that was issued by the Korea Health Industry Development Institute on the 21st published the difficulties and entry strategies for domestic companies seeking to enter the US market. First, the report said that companies should consider a strategy of being listed in the private insurance market through pricing, like Celltrion Healthcare and Samsung Bioepis. Celltrion Healthcare's Humira biosimilar’ Yuflyma’ was listed on the formulary of OptumRx, which is a subsidiary of one of the top 3 PBMs in the US, United Healthcare. The company pursued a high price strategy of setting the price at USD 6,576, which is only 5% cheaper than the original Humira. It is said that the high drug price allows room for much margin, increasing rebate resources and being advantageous in negotiations with PBMs. Samsung Bioepis’s Humira biosimilar ‘Hadlima’ was listed as a preferred drug in the formulary of Cigna Healthcare, a major private insurance company. The company had set the Wholesale Acquisition Cost (WAC) of its drug at USD 1,038, which was the lowest among all Humira biosimilars in competition in Korea, and 85% lower than that of the original. On the other hand, SK Biopharmaceuticals had prepared a direct sales approach due to a lack of network infrastructure. When using a direct sales system, profitability increases as the number of products sold increases, but initially, it imposes a huge fixed cost burden as the company needs to establish a local corporate body and hire professional sales and marketing personnel. SK Biopharmaceuticals explained that its SG&A expenses have continued to rise for the company since 2019 when it began preparing for a direct sales system. According to KAPAL (Korean-American Professional Association in Life Sciences), difficulties faced by Korean companies entering the US include language barriers, poor administrative management related to regulations/visas, difficulties in recruiting and managing local personnel, and lack of a network infrastructure. It also advised that preliminary research, thorough simulation, and advice from local experts and the experienced should be used to address the difficulties. In other words, companies need to understand and overcome local environmental and cultural differences, including by thorough localization of personnel and business operations, understanding and accepting the high wages and flexible working conditions, and taking a long-term approach based on an understanding of the relatively slow business progress and invest the time for information collection and networking to continuously develop its technology and intelligence property to successfully enter the US market. Although the CDMO infrastructure in the US is saturated, the government announced a policy to strengthen manufacturing. This is expected to expand medical and pharmaceutical production facilities and bases in the US, and the situation could be used in favor of the Korean companies as it would allow the companies to receive incentives and secure leadership in local production. New investment in the field of new drug development and clinical trials has been increasing in the US, and the government has been investing particularly in cancer treatment. Anticancer drug development and clinical trials account for 40% of all clinical trials conducted in the US, therefore, companies can seek entry into relevant fields through licensing out, technology transfers, and M&A with companies related to anticancer drug development.
- Policy
- Vabysmo·Evrysdi, listed as reimbursement
- by Lee, Tak-Sun Sep 22, 2023 05:41am
- It is reported that Vabysmo and Spinal Muscular Atrophy Evrysdi Dry Syrup 0.75mg/mL will be listed on the benefit in October. Additionally, the upper limit for 2 Jardiance items and 2 Ninlaro items is expected to be reduced due to PVA. It is reported that the upper limit price of pseudoephedrine ingredient preparations that have completed negotiations will be adjusted to 29 to 32 won as a condition of supply expansion. According to the industry on the 21st, the government is pushing for such revisions to the drug list. It is expected to take effect as early as September 1. Vabysmo passed the HIRA Pharmaceutical Reimbursement Evaluation Committee last July. It is said that at the time of passage, the upper limit of the drug price negotiation standard was accepted and the NHIS only negotiated the estimated billing amount. This drug is used to treat nAMD and vision impairment caused by DME. In particular, it is attracting attention because it is a new drug that targets both VEGF-A and Ang-2, which are major disease pathogenesis. Evrysdi is used for symptomatic SMA patients under the age of 18. Along with the listing of Evrysdi, the existing SMA treatment Spinraza will also have expanded coverage. Only patients under the age of 3 with symptoms could be administered, but with the expansion of coverage, it is expected that patients under the age of 18 with symptoms, like Evrysdi, will also be able to use it. The upper limit for SGLT-2 inhibitory diabetes drugs Jardiance 10mg and Jardiance 25mg will be adjusted due to increased usage. PVA type Na standard was applied. The upper limit price for Takeda's multiple myeloma treatments Ninlaro 2.3mg, Ninlaro 3mg, and Ninlaro 4mg will be reduced based on the type price standard. Pfizer's acute lymphoblastic leukemia treatment Besponsa and Takeda's ovarian cancer treatment Zejula 100mg successfully renewed their RSA contracts. For the four single-drug pseudoephedrine products (Samil Pseudoephedrine Tablets, SamA Schdafen, Kolon Cosue, and Shinil Shinil Pseudoephedrine Tablets) for which price increases have been confirmed due to supply shortages, the upper limit price will range from 29 won to 32 won depending on the amount of supply expansion stipulated as a condition. It is applied differentially. Currently, one item is 20 won and the remaining three items are 23 won.
- Policy
- Bioequivalence reevals speed up in line with drug price reev
- by Lee, Hye-Kyung Sep 21, 2023 05:24am
- With the number of items requiring equivalence tests expanded as such, the Ministry of Food and Drug Safety is also accelerating the reevaluation of those that were previously approved. In particular, it is said that the review is being further accelerated this year as its timing overlaps with the reevaluation of the insurance price ceiling amount, which requires self-bioequivalence tests. So-Hee Kim, Director of the Bioequivalence Evaluation Division at the Ministry of Food and Drug Safety's National Institute of Food and Drug Safety Evaluation, said so at a press briefing it had held together with the Drug Evaluation Department. Director Kim explained, "The initial results of the Ministry of Health and Welfare's 'insurance price ceiling reevaluations (standard requirements)' have come out, and pharmaceutical companies are showing mixed responses based on their results. At the time of the drug pricing reevaluations that were conducted, the MFDS reviewed the equivalence reevaluation of many items in a short period of time, and have completed the first review and are reviewing the data again,” The MFDS has expanded the scope of equivalence reevaluations to include all prescription drug generics, starting with oral tablets (uncoated tablets) this year, tablets (film-coated tablets) in 2024, and capsules, granules, and syrups in 2025. For the equivalence reevaluation, subject companies would have to submit a bioequivalence testing result or plan by March of every year. If the companies find it difficult to submit the test result report by then, they may first submit a plan, and submit the results by December after completing the test according to plan. The reevaluation results will be released around February of the following year. The problem was the drug price reevaluations that took place this year. Generic drugs subject to drug price reevaluations had to satisfy both requirements - conducting bioequivalence tests and using registered raw drug substances - to receive the highest insurance price. For items that are subject to both equivalence reevaluations and drug price reevaluations, it was difficult for the companies to submit a notice of completion of their bioequivalence tests in accordance with the drug pricing reevaluation schedule under the Ministry of Food and Drug Safety’s plan. Kim explained, “ The MFDS also had to conduct many equivalence reevaluations in a short period to meet the pricing reevaluation schedule. The review of the items subject to drug price re-evaluation has been completed, and we are now reviewing the remaining equivalence re-evaluation data.” For companies to receive the highest price, the MFDS had to submit a notice of completion of the equivalence reevaluation review to HIRA within the drug pricing reevaluation period, which forced the MFDS to also accelerate its review. Kim said, “Pharmaceutical companies have been expressing difficulties. We have been guiding ways to resolve their issues to help them follow the government’s policies.” (from the left) Sang-Ae Park, Director of the Advanced Drug Quality Division, Mi-Jung Kim, Director of the Pharmaceutical Standardization Division, Young-Rim Kim, Director-General of the Drug Evaluation Department, Ho-Jung Oh, Director of the Oncology and Antimicrobial Products Division, So-Hee Kim, Director of the Pharmaceutical Standardization Division Regarding the need to engage in continuous communication with the pharmaceutical industry to respond to various issues including the recent reevaluations, Young-Rim Kim, Director-General of the Drug Evaluation Department, explained the plan. Director-General Kim said, "Last March, we launched CHORUS (CHannel On RegUlatory Submission & Review) to discover two-way agendas between the industry and the MFDS industry, and we are forming and have been operating five branches to allow various companies to cooperate with working-level members that directly carry out the actual work.” He added that CHORUS plans to announce the performance of each branch this year and establish a plan for next year at the H2 CHORUS workshop. In addition to related associations and industry meetings, it plans to strengthen communication with companies that directly meet reviewers. Director-General Kim said, “We have procedures in place so that companies can officially request a supplementary meeting or in-person consultation when applying for marketing authorizations. The temporary restrictions made on phone consultations for relevant departments due to COVID-19 have been lifted. Now, companies can call for consultation without any time limit.” However, as only 124 review personnel are available in the Institute which needs 135, the institute lacks the manpower to address the absolute number of civil complaints. For example, the U.S. FDA has 8,000 review personnel. Director-General Kim said, “We will take the domestic pharmaceutical industry environment into consideration, adjust the timing, and approach it step by step to ensure that the policy is well established and implemented, and we will fully listen to the industry’s opinions during the process.”
- Policy
- Pseudoephedrine price negotiations have been concluded
- by Lee, Tak-Sun Sep 21, 2023 05:24am
- Quick agreement reached after a week of negotiations, likely to be implemented in October It appears that the single agent for colds, Pseudoephedrine, will be subject to increased drug prices starting in October. There is news that drug price adjustment negotiations with the NHIS, which have been ongoing since last week, have been concluded. Attention is being paid to whether this drug price increase will increase the supply of products from pharmaceutical companies and alleviate supply and demand difficulties. According to the industry on the 19th, the corporation and pharmaceutical companies agreed to increase the price of 60mg of single drug Pseudoephedrine HCl. It is said that negotiations were concluded around 30 won, an increase from the current 23 won. Pseudoephedrine HCl 60mg products are sold as Cosue by Kolon, Schdafen by Sam-A, Sudafed by Samil, and Pseudoephedrine by Shinil. Among these, Pseudoephedrine is worth 20 won, and the rest are worth 23 won. This ingredient has been in short supply since last year. This is because, as the number of respiratory patients as well as COVID-19 increases, prescriptions for medications containing Pseudoephedrine, which are used for colds, sinusitis, and upper respiratory allergies, have increased. Accordingly, pharmacies have requested increased supply. Last May, the Pharmaceutical Association supplied one bottle of 500 tablets to each pharmacy to solve the supply shortage. Supply shortages continued, and recently, the ‘Public-Private Response Consultative Group on Instability in Pharmaceutical Supply and Demand’ composed of the Ministry of Health and Welfare, the Ministry of Food and Drug Safety, the Pharmaceutical Association, the Pharmaceutical and Biopharmaceutical Association, and the Pharmaceutical Distribution Association decided to push for an increase in drug prices. After the drug price increase agenda passed the HIRA on the 6th, the NHIS began drug price negotiations last week and announced a settlement within a week. Accordingly, the agenda for increasing the price of pseudoephedrine will be reported to the Health Policy Review Committee of the Ministry of Health and Welfare, which will be held soon, and the adjusted drug price is expected to be applied from October 1. The NHIS appears to have received confirmation from pharmaceutical companies regarding drug price increases as well as supply expansion. Accordingly, it is expected that the problem of a supply shortage of Pseudoephedrine single drugs will be resolved.
- Policy
- ‘Introduce a Korean Cancer Moonshot Plan for patients'
- by Lee, Jeong-Hwan Sep 21, 2023 05:24am
- It has been pointed out that Korea also needs a policy that can improve the quality of life of cancer patients by providing reasonable compensation for cancer treatment technologies such as robot-assisted surgery and advanced radiation therapy to improve the quality of life of cancer patients in Korea, like in the case of the U.S. Cancer Moonshot Initiative or the EU’s Beating Cancer Plan. On the 20th, the AI law, regulation, and policy platform CODIT’s (Jeong Ji-eun Chung) Global Policy Empirical Research Institute pointed out in an issue paper called 'Implications of the development of advanced cancer treatment technology - Focusing on improving the quality of life of cancer patients.’.' According to the issue paper, countries around the world have been making national efforts with the explicit goal of improving the quality of life of cancer patients and their families, with plans such as U.S. President Biden's 'Cancer Moonshot Initiative' and the EU's ‘Beating Cancer Plan.’ On the other hand, the paper criticized that in Korea, improving the quality of life of cancer patients is being pushed back from the priority list of health authorities due to frequent transfers of officials from the relevant ministries and seasonal changes in national health issues. The issue paper introduced examples of advanced treatment technologies that have a significant impact on improving the quality of life of cancer patients and emphasized the need for the government to contemplate on an institutional level on improving the quality of life of cancer patients. The paper pointed to robot-assisted surgery reducing bleeding and complications by enabling sophisticated surgery based on hand tremor correction, wide joint range of motion, and delicate joint movements, as well as advanced radiation that maximizes effectiveness through customized radiation therapy using artificial intelligence (AI) as examples. Such advanced treatment technology can greatly contribute to improving the quality of life of patients during the treatment process by increasing the likelihood of their successful return to society after surgery. However, in the current healthcare system, it is not easy for people to receive the benefits of advanced treatment technologies due to cost issues, and the paper stressed that the government needs to actively make considerations on that aspect. In addition, the issue paper emphasized that the government needs to improve social and emotional awareness to prevent having been or being a cancer patient or from acting as an invisible stigma in this society, which is ranked among the Top 10 in regards to its economic achievement in the world, while at the same time actively improving healthcare policies to build a healthcare system that allows patients to enjoy a better quality of life physically.
- Policy
- Generics for Janumet competition begins in earnest in Oct.
- by Lee, Tak-Sun Sep 21, 2023 05:23am
- MSD DPP-4 inhibitory diabetes treatment The diabetes treatment market is expected to remain active in October. This is because salt-modifying complex drugs that were not registered in September are hitting the market all at once. According to the industry on the 20th, generics of MSD's DPP-4 inhibitory diabetes combination drug 'Janumet and Janumet XR' will be listed in large numbers next month. These are salt-modifying drugs, and due to the calculation criteria, they were not released when the patent expired on September 2nd. This is because salt-modified complex drugs can only be calculated if a single salt-modified drug with the same ingredient is registered first. Sitagliptin hydrochloride hydrate complex drugs are scheduled to be registered in October. On the 2nd of this month, 134 single products were registered. There are 304 combination drugs on the approved list that combine Sitagliptin HCl and Metformin. If there are no production issues, most of these are expected to be registered in October. A combination drug combining Sitagliptin phosphate and Metformin is expected to be released in October. Accordingly, the follow-up drugs of Janumet and Janumet XR are expected to enter into full-scale competition starting in October. Looking at last year's outpatient prescriptions based on UBIST, Januvia's single drug was 40.5 billion won, Janumet and Janumet XR combination drugs were 68.9 billion won and 48.2 billion won, respectively, totaling 117.1 billion won, forming a much larger market than single drugs. The key appears to be the speed with which Hanmi Pharmaceutical and Chong Kun Dang can dominate the market. Both companies were the only ones to list Janumet and Janumet XR generics on September 2nd. This was possible because only both companies obtained generic for exclusivity as a generic with the same ingredient. The entry speed of other generics is expected to be determined by how well the two companies with large sales forces dominate the market within a month. An official in the pharmaceutical industry said, "In the Janumet and Janumet XR generics market, only Hanmi and Chong Kun Dang had the opportunity to dominate the market due to the salary standards, and other generic companies entered the market a month late." He explained, “The key for other generic companies is how much of the overall market share the two companies that released a month early have taken.”
- Policy
- High-priced drugs need adjustment from the approval stage
- by Lee, Tak-Sun Sep 20, 2023 05:36am
- He also explained that he would conduct a pilot project to curb multi-drug prescriptions to reduce usage. Chairman Jeong made this announcement at a press conference for a health magazine held at a restaurant in Gwanghwamun, Seoul on the 15th. He said, “It is true that as income increases, prescriptions switch to more expensive drugs even if they have similar efficacy.” He said, “Moreover, doctors prefer original drugs with extensive research rather than generic drugs that have only received BA evaluation.” He said, "The authorities are continuing to set prices for generic drugs and are using a savings policy of refunding half of the money after verifying the efficacy of expensive drugs for a year, but I personally believe that the trend of rising drug prices is inevitable." Accordingly, as a policy to suppress drug prices, he emphasized that adjustments must be made from the start of approval. Chairman Jeong explained, “In the past, there were many high blood pressure medicines priced at 5 won, but now the old, cheap medicines that are no longer used are naturally being eliminated, and their place is being filled by expensive medicines.” He emphasized, “Therefore, there must be coordination from the start of approval with the Ministry of Food and Drug Safety and HIRA.” This was also said to be the reason for participating in the HIRA Pharmaceutical Reimbursement Evaluation Committee. Chairman Jeong said, "If NHIS participates in the drug evaluation committee, the listing period can be shortened through prompt negotiations linked to evaluation, and insurance finances can be reduced by preemptively reviewing the financial impact." He added, "Patient groups also believe that NHIS is for this reason. “I understand that they expressed the opinion that there is a need to participate in the committee,” he explained. “Although NHIS did not participate in this 9th committee, we will continue to discuss this issue with HIRA and the Ministry of Health and Welfare for the benefit of the public,” he said. “We will strengthen the public’s access to medicines through smooth communication and mutual cooperation, including data sharing with related organizations.” “We will strive to manage drug costs more efficiently,” he emphasized. Chairman Jeong emphasized that he will make various efforts to ensure the sustainability of health insurance and that he will pay particular attention to encouraging appropriate treatment. He said, "The Ministry of Health and Welfare, NHIS, and HIRA will cooperate to reduce medical expenses by establishing 'standard treatment guidelines' to prevent citizens from receiving unnecessary excessive tests or treatment," and added, "In order to prevent leakage of health insurance funds, a special judicial police officer system will be introduced in NHIS." “We will strengthen the detection of illegally opened institutions.” In addition, in order to prevent foreign dependents from entering the country for medical purposes, the plan is to strengthen subscription criteria, such as stipulating a 'required period of stay (6 months)' for health insurance applications. Chairman Jeong emphasized, "We will fundamentally work to normalize the fee structure and establish a proper medical delivery system to address the shortage of doctors and improve the labor intensity of medical staff." Chairman Jeong was inaugurated as the 10th Chairman of NHIS last July. He graduated from Seoul National University and served as Chairman of the Academic Research Committee of Hallym University Medical Center, Director of Hallym University Sacred Heart Hospital, and Director of Hallym University Medical Center. He also served as Director of the Korea Centers for Disease Control and Prevention. In this administration, he served as the head of the COVID-19 Special Response Team and contributed to the transition to routine management of COVID-19.
- Policy
- The NHIS begins negotiations to increase the size of PSE
- by Lee, Tak-Sun Sep 20, 2023 05:36am
- The NHIS has started negotiations to adjust the drug price increase for the ingredient formulation of the nose cold medicine Pseudoephedrine (PSE), which is struggling with supply and demand. The deadline for this negotiation is 60 days, but it is said to be targeting an agreement this month. If this month's negotiations are signed, it is highly likely that the drug prices raised from next month will be applied. According to the NHIS and the industry on the 18th, the NHIS has been negotiating a drug price adjustment with manufacturers of 60 mg of Pseudoephedrine HCl since last week. This ingredient was recognized for the validity of the adjustment of the drug price increase by the Pharmaceutical Benefits Evaluation Committee of the HIRA held on the 6th. Soon after that, the Ministry of Health and Welfare reportedly issued a negotiating order. The deadline for negotiations is 60 days. However, the government aims to speed up adjustment negotiations like acetaminophen, which was a drug price increase last year. The Acetaminophen adjustment negotiations were completed in about 20 days. If this month's negotiations is completed as targeted and a resolution from the Ministry of Health Insurance Policy Review Committee at the end of the month is received, the adjusted drug price will be applied from the 1st of next month. Currently, manufacturers are said to want to double the current drug price. Currently, the upper limit is 20 won for one item, and the remaining 3 items are all 23 won. Kolon , Sam-A , Samil, and Shinil are selling it. The key to negotiating speed is a cost analysis. It is analyzed that if the two opinions differ in the cost analysis, the negotiation is likely to be longer. Pharmaceutical companies are reportedly doing a cost analysis using the cost of production opportunities early in the negotiations. However, the NHIS is of the opinion that cost analysis should be done through more practical data. Pseudoephedrine HCl formulation has been a supply problem since last year due to COVID-19. Therefore, in May, the Pharmaceutical Society also provided an equal supply of one bottle per pharmacy to solve the supply and demand instability. The industry argues that a drug price increase is essential for additional production power.
