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- 2026-04-13 17:39:02
- Company
- K-mRNA Consortium support group to gain momentum
- by Nho, Byung Chul Sep 13, 2021 05:57am
- The research and development move of the K-mRNA Consortium formed to develop the next-generation COVID-19 vaccine is expected to gain further momentum. The consortium consisting of Hanmi, ST Pharm, GC Pharma and KIMCo announced on the 9th that Dong-A ST, a major pharmaceutical company in the development and production of specialized drugs in Korea, and E-Cell, a company specializing in bio-original materials, participated in the consortium. Since the launch of the consortium in June, the progress of the project has accelerated, and material companies and others seem to be joining as partners. Dong-A ST is one of the representative pharmaceutical R&D companies in the domestic pharmaceutical bio industry, and will actively support the consortium's future application for approval of mRNA vaccines, clinical development, and licensing based on its rich experience and capabilities. E-Cell is Korea's first leading bio-materials, parts, and equipment company that developed disposable bio-processing equipment and consumables such as disposable cell culture devices and disposable mixer bags. At the time of launch, the consortium, which announced that it would expand additional participation from raw and subsidiary materials companies, universities, and research institutes, plans to open the door to companies that can play a role in the rapid implementation of the successful model of the entire cycle. Currently, the consortium is developing the COVID-19 mRNA vaccine candidate STP2104 with the aim of entering phase 1 clinical trial within the year and commercializing it following conditional permission in the first half of next year. The consortium is managing its schedule without a hitch, such as regularly sharing information and consulting with the MFDS every month for rapid clinical implementation. In addition, it is preparing to establish a production system of 100 million doses of mRNA vaccine, which is the national vaccination volume, by the end of 2022. In addition, a separate COVID-19 vaccine is being developed to respond to the delta mutation virus. In this regard, ST Pharm, which is in charge of the consortium's clinical part, is conducting a preclinical efficacy evaluation after selecting an additional mRNA vaccine candidate, STP2130.
- Company
- Pharma companies speed up delivery of urology combo drugs
- by Kim, Jin-Gu Sep 13, 2021 05:56am
- Korean pharmaceutical companies have been rushing to develop combination treatments for various urologic diseases, such as those for prostatic hypertrophy+erectile dysfunction or benign prostatic hyperplasia+overactive bladder. Many patients with urogenital disorders suffer various conditions at once, including enlarged prostate, erectile dysfunction, overactive bladder, etc. The market size for the single-therapy agents that treat each separate condition is considerable. With no other combination therapy than Hanmi’s ‘Gugutams’ authorized in Korea, the industry’s interest in the combo drug market has been rising. Pic of Hanmi Pharm As of the 13th, the only drug approved as a combination therapy for hypertrophy+erectile dysfunction in Korea by the Ministry of Food and Drug Safety is Hanmi Pharmaceutical's ‘Gugutams.’ Gugutams is a combination of the prostate treatment ‘tamsulosin’ and erectile dysfunction treatment ‘tadalafil.’ At the time of its release in 2016, Gugutam’s performance did not meet expectations, due to low awareness of the urogenital disease in general. However, with increased awareness, the product became a steady seller, reaching ₩2.1 billion in sales last year. On this, Dongkook Pharmaceutical and Yuyu Pharma have jumped in to compete in the combination treatment market for benign prostatic hyperplasia+erectile dysfunction that combines tadalafil with ‘dutasteride,’ which is another ingredient used for benign prostatic hyperplasia. No combination treatment has yet been approved for this combination in Korea. Dongkook Pharmaceutical has started Phase III clinical trials on its dutasteride+tadalfil combo, ‘DKF-313,’ earlier this month at the Seoul Asan Medical Center. The company expects the Phase III trials to be complete by the end of next year. Yuyu Pharma is also developing a combination therapy using the same two ingredients. The company received approval for the Phase III trial in 2018, however, before starting the Phase III trial, a need to change the formulation was raised, and the company decided to start over from Phase I. Also, the development of combination treatments for benign prostatic hyperplasia+overactive bladder is actively underway. KyungDong Pharm and Dongkoo Bio&Pharma are competing to develop the combo treatment. In March this year, KyungDong Pharm received approval to start Phase III trials for its ‘KDF1905,’ which combines the benign prostatic treatment tamsulosin with overactive bladder treatment ‘mirabegron.’ Dongkoo Bio&Pharma had also previously received approval for the Phase III trial of its tamsulosin+mirabegron combination in January last year. Ildong Pharmaceutical and Jeil Pharmaceutical had also developed combinations using tamsulosin and another overactive bladder treatment ‘solifenacin.’ The two companies have completed Phase III trials for their combinations. However, Ildong Pharmaceutical decided to discontinue the development of its drug last year. Jeil Pharmaceutical had not applied for the marketing authorization of its drug for over 2 years since the completion of its Phase III trial. Also, CTC Bio’s development of its combination treatment for premature ejaculation+ erectile dysfunction is in its final stages. It is a combination of the premature ejaculation treatment ‘clomipramine’ and the erectile dysfunction treatment sildenafil. The company plans to apply for marketing authorization of its combination drug after completing its Phase III trial within this year.
- Opinion
- [Reporter's view] A manual has been established
- by Lee, Tak-Sun Sep 13, 2021 05:55am
- The recovery of hypertension treatments containing excess impurity Sartans is significant in that it has established a new manual for drug recovery. All items were banned and recovered, making it difficult for manufacturing, sellers, and medical institutions to do additional work due to collection. However, since only excess Sartan items have been recovered this time, the loss of pharmaceutical companies is expected to be minimized, and the inconvenience caused by the recovery of medical institutions such as pharmacies is expected to be reduced. All of these measures were not perfect. In particular, the MFDS explained that the risk of impurity-containing drugs is low, but that patients with health concerns can be exchanged for normal products. In order for consumers to exchange them for normal products, pharmacies must exchange medicines to open pt's medicine packet. The question was who should pay the additional fees and additional work costs incurred by this. The government wants pharmaceutical companies to pay health insurance premiums, saying it is difficult to pay. Pharmacies are also not willing to volunteer for free. In this situation, the MFDS mediated to discuss settlement issues between pharmaceutical companies and pharmacists. The consultation was satisfactory. Two pharmaceutical companies have agreed to pay 110% of the existing formulation, which has become a guideline for other pharmaceutical companies. As the recovery has been delayed for more than a week, there is no separate suspension of sales, so the response is too late. Another problem is that it is not easy for consumers to put it into practice. Since this recovery only applies to the product number in question, consumers need to know the product name and manufacturing number to request an exchange. However, most patients often do not know the name. It is not easy for many elderly people to know this through the internet. Most patients do not know about this recovery. Therefore, it is necessary to establish a system so that minimal information can be delivered, even if it is difficult to actively communicate the recall to consumers, as in the case of automobile recall. With this voluntary recovery, the government should create a manual and take measures to enable consumers to actually recover so that they do not suffer damage.
- Policy
- Hanmi pushes for Champix follow-on despite hardships
- by Lee, Tak-Sun Sep 13, 2021 05:55am
- One pharmaceutical company is determined to develop a follow-on of the smoking cessation drug, ‘Champix’ (Pfizer, varenicline tartrate), and it is Hanmi Pharmaceuticals. Hanmi Pharmaceuticals had succeeded in the early release of its drug as a salt-modified drug, but had lost the patent challenge failed to enter the market. After the original's patent expiry, the company had attempted to set foot in the market again with a CMO product but faced hardships due to an impurity issue. On the 7th, the company voluntarily recalled its products due to an excess amount of N-nitroso-varenicline (NNV) impurities. With perseverance, Hanmi Pharmaceuticals attempted once more with a self-developed salt-modified drug. This is the company’s third attempt at a varenicline product. According to industry sources on the 9th, Hanmi Pharmaceuticals had recently applied for the approval of its smoking cessation treatment, ‘varenicline oxalate hydrate,’ to the Ministry of Food and Drug Safety. Industry experts observed that the product was prepared to replace the ‘Nokotine S tablet' that was partially recalled due to excess NNV detection. ▲ Smoking cessation treatment being sold by Hanmi Pharmaceuticals, Nokotine S is a Varenicline salicylate substance that is being produced on consignment by CTC Bio. The drug was released by Hanmi Pharmaceuticals after the original Champix’s substance patent was expired in July last year. Hanmi Pharmaceuticals had released a varenicline product before Nokotine S called ‘Nokotine,’ a varenicline oxalate hydrate that was originally developed by Hanmi Pharmaceuticals. However, the item was withdrawn after the company lost the patent challenge. Hanmi Pharmaceuticals had released Nokotine in November 2018 before the original's substance patent expiry, using the logic that the extended substance patent duration does not apply to salt-modified drugs. The claim, which was accepted by the Intellectual Property Trial and Appeal Board, was then rejected at the Patent Court. Due to the ruling, the product was taken off the market. To make matters worse, the Ministry of Food and Drug Safety revoked the license of ‘Nokotine’ with the reason of its sale before patent expiry. This was why the company had released the CMO product ‘Nokotine S,’ as an alternative. But the impurity issue put a hold on Hanmi’s path. Excess amounts of N-nitroso-varenicline were detected in products produced by Hanmi’s CMO, CTC Bio. The company recalled 16 lots of Nokotine S that was produced by CTC Bio. The fact that Hanmi Pharmaceuticals, whose credibility had suffered due to the impurity issue, was preparing a new product was found last month. The company filed an application to revive the canceled license for the varenicline oxalate hydrate product. In fact, many pharmaceutical companies have been wrapping up their Champix’s follow-on business due to the downtrend of the smoking cessation treatment market. Based on IQVIA, Champix sold ₩8.8 billion and NoKotine sold ₩715 million in the second half of last year. However still, Hanmi Pharmaceuticals is still intent on making it in the market. The company had entered the smoking cessation treatment market with ‘Nicopion,’ which was rare using bupropion products., and also lead the patent challenge against Champix after the development of its salt-modified drug. The company had filed for an invalidation trial of a patent after its appeal had failed. The company also runs a smoking cessation program involving all of its employees every time it launched a new product. Will the company be able to reap the rewards for its sincere efforts some day? Whether Hanmi Pharmaceuticals’ new smoking cessation treatment market will be able to break the sole lead held by Pfizer is gaining attention.
- Policy
- Voluntary recovery of 73 drugs with excess impurities
- by Lee, Tak-Sun Sep 13, 2021 05:55am
- 73 items from about 36 companies with blood pressure exceeding impurities will be recovered. Patients can also be exchanged for normal products at pharmacies. However, the MFDS explained that concerns about human harm are very low, and that it is not a situation to stop taking them arbitrarily. It announced on the 9th that some of the drugs containing Sartans, which are treatments for hypertension, have exceeded the daily intake allowance of AZBT (1.5//day) (1.51 to 7.67//day). AZBT (5-(4'-(azidomethyl)-[1,1'-biphenyl]-2yl)-1H-tetrazole) is a substance with mutant properties (genetic mutations). The MFDS explained that the pharmaceutical company is voluntarily collecting 183 Sartan drugs from 73 items from 36 companies that exceeded the daily intake allowance among the items subject to safety investigation. It also added that only sartan drugs with AZBT less than the daily intake allowance have been shipped since September. The MFDS ordered the AZBT test results for 819 items from 125 companies with production and import records to be submitted by the end of August and received test results for 751 items from 117 companies. The MFDS said that patients taking the drug should not stop taking it, but should decide whether to continue taking it after consulting with a pharmacist, but can exchange it for a lot number below the standard if necessary. It explained that it consulted the Central Pharmaceutical Review Committee to set the daily intake capacity of AZBT, and that it was set at 1.5㎍/day by applying the ICHM7. ICHM7 sets a daily intake allowance of mutagenic impurities that do not have data such as toxicity values as 1.5//day, which is a "negligible level" when consumed daily for life (70 years). This means that the possibility of additional cancer is less than 1 in 100,000 people. The MFDS evaluated the health effects of most patients who took Sartan drugs with excessive daily intake of AZBT, and found that the possibility of additional cancer was very low. The human impact assessment of patients taking Sartan drugs with excess detection of AZBT was conducted in accordance with ICHM7, considering the results of the daily maximum dose of Sartan drugs in circulation in Korea. As a result, the possibility of additional cancer is 0.008 to 0.224 out of 100,000 "Losartan containing drugs", 0.010 to 0.298 out of 100,000 "Valsartan-containing drugs", " It is explained that 0.004 to 0.804 out of 100,000 Irbesartan-containing drugs were very low, which was "negligible" according to the ICHM7 standard. The MFDS said that it will announce additional final results after completing the ongoing AZBT test and review of the results as soon as possible, and that it will strictly manage AZBT to supply and distribute only Sartan drugs that are less than permitted to consume on the market.
- Company
- Jardiance marks new milestone in heart failure treatment
- by Whang, byung-woo Sep 13, 2021 05:55am
- With the SGLT-2 inhibitor, Jardiance (empagliflozin), proving its efficacy in heart failure with preserved ejection fraction (HFpEF), on how it will affect the domestic prescription market for heart failure is gaining attention. As another SGLT-2 inhibitor, Forxiga (dapagliflozin), was the first to receive approval for heart failure with reduced ejection fraction (HFrEF) indication, whether Jardiance’s study results could become the solid blow that could overturn the drugs' positions is gaining industry interest. The competition among SGLT-2is that are expanding their indications from their existing diabetes indications to heart failure as well as chronic diseases is also a special point of interest. The full results of the EMPEROR-Preserved clinical trial that demonstrated Jardiance’s effect on heart failure were presented recently at the ESC Congress 2021. The study showed a 21% reduction in the relative risk of cardiovascular death or hospitalization using Jardiance in HFpEF patients with or without diabetes compared to placebo, meeting its composite primary outcome. Also, in the analysis of its major secondary endpoint, Jardiance reduced the relative risk of first and recurrent heart failure hospitalization by 27%, and significantly delayed kidney function decline. On this, Jung-Woo Son, Professor of Cardiology at Wonju Severance Hospital, said, “It is encouraging that a treatment had been able to meet its primary outcome in HFpEF, in the midst of all other trials failing development for the condition. The outcomes with regards to cardiovascular deaths were a little disappointing, but the results showed enough benefit in other areas.” Dong-Ju Choi, President of the Korean Society of Heart Failure who participated as the head coordinator in the trial, stressed that the study reflected Korea’s heart failure treatment environment as 13 Korean medical institutions participated in EMPEROR-Preserved trial. With such strengths, the sentiment in the field is that there is no reason not to prescribe Jardiance after its approval as the clinical benefits are clear. However, how the prescription patterns will change will need to be observed in comparison to Forxiga, which was approved for HFrEF. A cardiology professor from a tertiary hospital in Korea who requested animosity said, “The good performance shown by Forxiga and Jardiance, has even raised discussions on their class effect. Since we have already been using Forxiga for HFrEF, doctors will be preferring Forxiga for the time being, however, there is a possibility that Jardiance will attract attention due to its versatility.” In particular, the professor predicted prescription of Jardiance would increase for patients whose diagnosis between HFrEF and HFpEF is unclear. He said, “There are heart failure patients who belong in the range between HFrEF and HFpEF, and Jardiance will have an advantage in preoccupying this market as it has presented results for both HFrEF and HFpEF. However, I know Forxiga is also conducting studies to cover the relevant areas, so on how the results will be remain to be seen.” As such, the majority of the HCPs in Korea are positive about the performance and expandability of SGLT-2is in heart failure. Therefore, the only barrier is in the drugs' progress in receiving approval and reimbursement. Forxiga is currently approved for HFrEF but is not reimbursed yet. And Jardiance is aiming to gain approval for its HFpEF indication based on its EMPEROR-Reduced trial within this year. Some industry experts have cautiously anticipated that the two drugs may be concurrently approved for reimbursement after Jardiance is approved for its HFpEF indication. Also, Boehringer Ingelheim and Lilly plan to submit the HFpEF results from their clinical trial to regulatory authorities within the year, but considering the domestic situation in which approval for drugs is processed only after FDA approval, it is unclear whether the drug will immediately be approved for prescriptions. Another variable that exists is Entresto. Novartis has applied for approval to expand the drug’s indication to the HFpEF indication.
- Policy
- Financial savings should be given for new domestic drugs
- by Lee, Jeong-Hwan Sep 10, 2021 05:58am
- The domestic pharmaceutical industry argued that new domestic development drugs, which contributed to improving the financial soundness of health insurance through steady R&D investment, should be excluded from the list of "The Price-Volume Agreement (PVA)" or introduced a system that limits the number of applications. Even after the registration of new domestic drugs, additional clinical trials to enter overseas markets, and improve drug convenience have dampened the willingness to innovate management due to drug prices under the PVA system. According to the pharmaceutical industry on the 9th, multiple pharmaceutical companies that succeeded in developing new drugs in Korea plan to point out the irrationality of the drug price follow-up management system centered on the PVA system and urge policy improvement. Pharmaceutical companies that have succeeded in developing new domestic drugs or are preparing for development are demanding that domestic new drugs that contributed to health insurance finances be excluded from PVA. The reason why domestic pharmaceutical companies are making such demands is due to the specificity and PVA of domestic new drugs. In particular, domestic companies pointed out the problem of Type Da of PVA. Type Da of PVA calculation drugs are subject to negotiation from the fourth year after the registration. Drugs with an increase of more than 60% this year or an increase of more than 5 billion won compared to last year and an increase of more than 10% are subject to negotiations. Domestic companies explain that the clause is pushing ahead with a collective reduction in drug prices between domestic and global new drugs. Specifically, in the case of global new pharmaceutical companies that enter the domestic market, it is common to release them after fully equipped with treatment indications and full contents at the time of domestic marketing approval. Even after its launch on the market, R&D expenses will continue to be spent to allow overseas marketing, add indications, develop complex drugs, increase convenience in taking them, and reduce drug prices even though sales will rise in earnest from the fourth year. The drug price negotiation guidelines say that domestic R&D investment costs are considered when negotiating, but it is not known whether R&D costs are also considered in PVA negotiations. Domestic companies said that exceptions to the PVA system for new domestic drugs, which contributed to the effect of reducing health insurance finances, are also needed. Domestic companies are taking the lead in developing complexes based on new domestic drugs in line with the characteristics of chronic diseases such as general diabetes, high blood pressure, and hyperlipidemia,, and in the case of these complexes, they are asked to be excluded from PVA negotiations or limit the PVA negotiations. An official from a domestic pharmaceutical company A said, "The PVA system is applied repeatedly only to new domestic drugs that continue to invest in R&D to expand indications or add complex drugs. Drugs that are burdensome to health insurance finances should be selected as targets for PVA negotiations." He said, "The more drugs are used in the market, the more positive they are for drug spending. These drugs need to be excluded from PVA or limited the number of applications."
- Company
- Key 3 mRNA vaccine techs are not Moderna's nor Pfizer's
- by Kim, Jin-Gu Sep 10, 2021 05:58am
- The three key technologies required for developing mRNA vaccines were revealed. These are technologies related to antigen optimization, mRNA syntehsis·modification, and manufacture of lipid nanoparticles (LNP) that correspond to steps 1, 2, and 4 of the 5-step vaccine manufacturing process. The explanation was that a biopharmaceutical company aiming to develop COVID-19 vaccines or anticancer treatments using mRNA must secure the technologies mentioned above. Even Pfizer and Modera, which produce the mRNA COVID-19 vaccines, are said to have secured patents related to the abovementioned technology through a licensing agreement. On the 8th, the Korean Intellectual Property Office (KIPO) published an ‘mRNA Vaccine Patent Analysis Report' and introduced the key technologies required for the production of mRNA vaccines. According to the report, a total of 691 mRNA vaccine-related patent applications have been filed globally. Moderna had filed for the most with 211, followed by CureVac’s 108, TranslateBio’s 67, Pfizer·BioNTech’s 60, and GSK’s 25 applications. However, the report showed that the core patent required for the production of mRNA vaccines is not owned by Pfizer nor Moderna. mRNA vaccines are produced in five steps: ▲antigen optimization ▲mRNA synthesis and modification ▲ Separation & Purification ▲LNP production ▲formulation. Among these, technologies for antigen optimization, mRNA synthesis and modification, and LNP production are the key technologies required for vaccine production. Map of COVID-19 mRNA vaccine technology relationships between companies (Source: KIPO) The technology for antigen optimization is owned by the US National Institute of Health (NIH). NIH had applied for 3 patents on ‘COVID-19 spike protein antigens,’ and one of the three has been registered in the US. Companies that develop mRNA COVID-19 vaccines like Pfizer·BioNTech, Sanofi, and GSK have signed licensing agreements with the NIH for the relevant patent. It is not confirmed whether Moderna, which had jointly developed a COVID-19 vaccine with NIH, had signed a licensing agreement for the said patent. In mRNA syntehsis·modification, patents on the ‘modified nucleic acid’ is key. Cellscript owns the patent on ‘the method reducing immunogenicity using pseudouridine.’ The patent, which had previously been owned by the University of Pennsylvania, was transferred to Cellscript. Moderna and BioNTech secured the technology through a licensing agreement with Cellscript. Two companies have the key technology related to lipid nanoparticles as patents- ‘Arbutus’ and ‘Acuitas.’ Arbutus owns multiple patents on “lipid-nucleic acid particle composition containing cationic lipids,’ and Acuitas owns multiple patents related to ‘lipid-nucleic acid particles containing cationic lipids and PEG-Lipid.’ Both play a vital role in the manufacturing of lipid nanoparticles. Pfizer·BioNTech had signed a license agreement with both companies to secure the technology. On the other hand, Moderna only signed a license agreement with Acuitas Therapeutics and is in a patent dispute with Arbutus in the US and Europe with regards to the technology. KIPO said, “Korean pharmaceutical companies and research institutions wishing to develop mRNA vaccines would need to acquire or evade the license of these patents. However, only 17% of the 691 patents related to mRNA are registered in Korea, therefore, Korean mRNA vaccine developers are less likely to get embroiled in patent dispute compared to those in the US or Europe.”
- Policy
- The evaluation criteria's determination for reimbursed drugs
- by Lee, Hye-Kyung Sep 10, 2021 05:58am
- If the administration cost is lower than that of alternative drugs, it is possible to apply for adjustment to raise the upper limit of the drug. However, it should be the case where the number of companies in the formulation with the same administration route or component is one. The HIRA recently guided the pharmaceutical industry to answer questions and comparison tables before and after the change of evaluation criteria containing "change of evaluation criteria for adjusting the upper limit amount of drugs." The evaluation criteria for this mediation application were deliberated and resolved through the Drug Reimbursement evaluation committee on the 2nd, and will be applied from September 1st. Items for adjustment application may be applied if the upper limit amount of drugs announced pursuant to Article 3 (1) 1 of the Drug Decision and Adjustment Standards is deemed remarkably unreasonable. Previously, it was possible to apply for an increase in the upper limit of drugs only if there was no replaceable drug or if there was a drug that was essential for treatment. However, due to the change in the evaluation criteria, if the number of companies in the drug with the same route or component is one, it is possible to apply for adjustment to raise the upper limit of the drug if the drug is cheaper than the alternative drug. If there is no record of production, import, or claim over the past two years, it shall be excluded when determining the number of replaceable drugs or companies. However, it falls under one of the three requirements, but excludes drugs that have been fined for violating Article 47(2) of the Pharmaceutical Affairs Act in accordance with regulations related to the National Health Insurance Act. It refers to all drugs that have been disposed of in relation to rebates. It is impossible to apply for mediation by including all rebate dispositions under the relevant regulations regardless of the period. Compared to the previous one, additional documents to be submitted have been specified, and submission documents must be submitted according to the cost calculation method of shortage-preventive drugs.
- Policy
- Will it be possible to expand the benefit of Prolia?
- by Lee, Jeong-Hwan Sep 10, 2021 05:58am
- Attention is focusing on whether the criticism that biopharmaceuticals that treat osteoporosis by preventing bone absorption or activating bone formation are not fully enjoyed due to restrictions on Korea's benefit standards can be resolved. This is directly related to Amgen's Prolia (Denosumab) and Evenity (Romosumab) access to patients, as experts argued the need every year and the National Assembly also agreed, the government said it would consider reflecting it after collecting opinions. On the 7th, the MOHW promised to improve the benefit standards reflecting the latest treatment guidelines at the "policy discussion on improving the treatment environment for osteoporosis" hosted by Rep. Lee Jong-sung of the People Power Party (YouTube). Although the MOHW has made some prospective opinions on the benefit criteria for osteoporosis drugs, it remains to be seen whether it will actually lead to an improvement in the actual standards. There are two reasons why critics say that domestic benefit standards are holding back biopharmaceuticals that treat osteoporosis. First, if the osteoporosis drug benefit period exceeds the bone density level of T-Score -2.5, it is recognized only for one year. The standard is applied to biopharmaceuticals, Prolia, including synthetic drugs such as bisphosphonate drugs, SERM drugs, and Zoledronic acid, and specialists are demanding improvement. Another critical factor is that the "ultra-risk group for osteoporosis" drug benefit standard can only be used when fractures using bone absorption inhibitors occur for more than a year. This is the standard applied to Evenity, a biopharmaceutical that promotes bone formation, and it is pointed out that evenness benefits are recognized only after bone absorption inhibitors are administered. Specifically, Prolia obtained the first treatment benefit as of April 1, 2019. If the bone density level (T-Score) is -2.5 or less, it will be applied twice a year, and if osteoporosis fractures are confirmed on radiography, it will be applied six times a year. Despite the acquisition of primary benefits, experts are calling for an improvement in the benefit standard for osteoporosis treatments such as Prolia because of the current standard for suddenly converting the benefit drug to non-reimbursement a year later if the bone density level exceeds -2.5. This is because patients' access to medicines is blocked by suspending their benefit if the drug is partially effective, even though fractures can be prevented by continuous administration of treatments. Evenity is receiving the second treatment benefit as of December 1, 2020. It is recognized only when additional conditions are satisfied based on the criteria that at least one of the existing bisphosphonate formulations is ineffective or unavailable. An additional condition for Evenness Secondary benefit is ▲ postmenopausal women aged 65 or older,▲ Bone density test results measured by Dual-Energy X-ray Absorptiometry (DEXA) in the central bone (excluding lumbar spine and femur)] showed that the bone density test was less than T-score -2.5 SD, ▲When two or more osteoporosis fractures occur (data on osteoporosis fractures must be attached for fractures that have occurred in the past). The administration period is recognized only up to 12 times every one month in a lifetime. Professor Lee Yoo-mi of Endocrinology at Severance Hospital, who attended a policy debate hosted by Rep. Lee Jong-sung, stressed that it should be improved and expanded to middle-aged people. In fact, international guidelines recommend Evenity, a bone formation promoter, as the primary drug in the ultra-high risk group. Ultra-high-risk groups, such as the elderly who have already experienced fractures, first use bone formation promoters to increase bone mass, and then prevent bone density and fracture by preventing absorption of increased bone mass with bone absorption inhibitors. This means that Korea's benefit standards are the opposite of international guidelines. At a policy debate hosted by Rep. Lee Jong-sung, both irrationalities of the domestic osteoporosis benefit standard were a hot topic. Experts pointed out all the problems of the innovation of bio-new drugs and domestic salary standards from disease risks and social costs caused by osteoporosis. The MOHW, which attended the debate, plans to collect expert criticism and review international guidelines to improve and expand the standards. Choi Kyung-ho, secretary of the insurance drug department, explained, "I agree with the pain of elderly patients due to osteoporosis and fractures and the burden of social and economic costs." He said, "We will try to improve access to new drugs so that the standards meet the latest medical guidelines, but we will also carefully review the soundness of sustainable health insurance finances."
