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- 2025-12-22 02:42:34
- Policy
- Taiwanese new drug receives reimb in only 1 yr since release
- by Lee, Tak-Sun Jul 07, 2023 05:43am
- The Nephoxil Cap (ferric citrate hydrate) that was granted reimbursement at KRW 377 per capsule from the 1st of this month is actually a Taiwanese new drug. The drug, which is being imported and sold by the Japanese pharmaceutical company Kyowa Kirin’s Korean subsidiary in Korea, was developed by a Taiwanese pharmaceutical company. In other words, Nephoxil marks a rare case where a new drug developed in Taiwan was imported and reimbursed in Korea. Although the drug has not been listed in any of Korea’s A7 reference countries, it only took 14 months for the company to complete the listing process from approval to reimbursement, at a lower price than its substitute. In 2017, Kyowa Kirin Korea signed a domestic licensing agreement for Nephoxil with the Taiwanese pharmaceutical company, Panion & BF Biotech. Nephoxil was developed by Panion & BF Biotech in 2015. The agreement drew attention at the time as the Korean subsidiary of Kyowa Kirin had independently promoted and signed the agreement, not its Japanese headquarters. Nephoxil is used to improve hyperphosphatemia in patients with chronic renal disease on hemodialysis. As an iron-based phosphate binder, the drug has been assessed to reduce the risk of adverse events that commonly arise in calcium-based phosphate binders such as hypercalcemia and vascular calcification. Non-calcium class drugs currently available in Korea are Sanofi’s Renvela Tab, SK Chemical’s Invela, JW Pharmaceutical’s Fosrenol, among others. Also, same-ingredient generics versions of Renvela have recently joined in on the competition in Korea’s market. In Korea, Kyowa Kirin Korea has been positioning itself as a company that sells treatments for chronic renal disease patients. The company had achieved high sales performance n the field with its anemia treatment 'Nesp' and 'Regpara', a treatment for secondary hyperparathyroidism in patients with chronic renal disease. The company had once excelled in the hyperphosphatemia treatment market as well. Its product, Renagel Tab, which contains the same ingredient as Lenvela, has once led the market, however, its supply was discontinued in 2015 due to a contract with its developer. The company had lacked a product for hyperphosphatemia ever since. In this context, Nephoxil was a relief to the company. Regarding the use of Nepoxil, the Korean Society of Nephrology recommended restricting the administration of calcium-based phosphorus binders to avoid hypercalcemia and favorably recommended ferric citrate as it is useful and has an additional effect on correcting anemia as it contains iron compared to general phosphorus binders. However, the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee reviewed that it is difficult to determine whether Nephoxil has a different effect over existing non-calcium-based binders. Moreover, none of the A7 countries (USA, Germany, Switzerland, UK, Italy, Japan, France) have listed the same product. Only different strengths of ferric citrate were available in the United States and Japan. Despite such criticism, the company overcame the barriers with its low price. Kyowa Kirin Korea accepted the drug’s price of KRW 377, which is 90% of the weighted average price of its alteratives, and was able to skip the drug price negotiation process. Nephoxil received approval from the Ministry of Food and Drug Safety on May 9 last year. After passing DREC review in only one year of its approval in April this year, it was swiftly applied reimbursement in July. The industry analysis is that the company’s low price strategy also had some influence on Nephoxil’s speedy reimbursement.
- Policy
- Evaluation different after Kymriah·Zolgensma benefits?
- by Lee, Tak-Sun Jul 07, 2023 05:43am
- The ultra-expensive treatments Zolgensma and Kymriah are supposed to go through a performance evaluation, but whether or not they are disclosed is different. As a pre-approved drug, Zolgensma, which is subject to review by an expert review committee, has performance evaluation results disclosed to the public, whereas Kymriah does not. Therefore, unlike Zolgensma, Kymriah, which received a benefit earlier than Zolgensma, does not disclose performance evaluation results. According to the industry on the 5th, The HIRA recently disclosed the first performance evaluation of Zolgensma on its website. Zolgensma requires clinical evaluation before administration and every 6 months after administration for up to 5 years, and objective data such as medical records for clinical evaluation must be submitted. In addition, ▲ permanent respiratory use or death, ▲ CHOP-INTEND score not improved by 4 points or more compared to the baseline before drug administration, ▲ even if the previous items were improved, CHOP-INTEND 4 points or more in two consecutive times in the subsequent response evaluation Or, if it falls under any of the cases of a decrease of 3 points or more on the HFMSE, it is defined as drug administration failure. Reflecting this, as a result of the first performance evaluation, clinically meaningful improvement was confirmed in 5 out of 6 cases and marked as successful. The remaining case was judged to be a failure because a patient with respiratory problems due to SMA died of suspected acute respiratory failure. 5 out of 6 were successful reviews. Then, how was Kymriah, which was listed for benefit in April last year, 4 months ahead of Zolgensma, evaluated? Zolgensma is an ultra-expensive new drug worth 2 billion won and Kymriah is about 360 million won, and the Ministry of Health and Welfare is managing the performance of both. However, Kymriah cannot know the results of the evaluation. Because there are no disclosure rules. An official from the HIRA said, "Zolgensma is a pre-approved drug that goes through an expert review committee, so the review results are disclosed according to regulations, but Kymriah has no disclosure regulations." “At this time, we are not considering making it public,” he explained. Kymriah was not subject to the prior approval system because the patient's condition could deteriorate due to medication delay. For this reason, performance evaluations are not made public. Regarding this, an industry insider pointed out, "It is appropriate to disclose the results of the performance evaluation to the outside in order to enhance transparency and reliability in the context of the decision to evaluate the performance as part of the management of super-expensive drugs." The HIRA went through a professional review committee and disclosed two cases of the recognition of Kymriah's benefits in May, but both cases were rejected because they did not meet the standards. If the reimbursement is rejected, the patient has no choice but to pay 360 million won for non-reimbursement drugs. If benefits are applied, the drug price will be reduced to 6 million won. For this reason, some are suggesting that a plan to reduce the burden on patients should be prepared in the event of a post-reimbursement issue by reflecting the characteristics of an ultra-expensive new drug. Regarding this, Novartis said, "The reduction in benefit is a problem that occurs between the nursing institution and the patient and has nothing to do with the manufacturer. There is no separate patient support program."
- Policy
- Pres. Yoon urges swift legislation for remote treatment
- by Kang, Shin-Kook Jul 06, 2023 05:39am
- President Yoon Suk-yeol has instructed the Ministry of Health and Welfare to make every effort to pass the amendment of the Medical Service Act for the introduction of non-face-to-face treatment, which is currently under discussion in the National Assembly, raising hopes for its rapid legislation. President Yoon made these remarks on the 4th while leading the 18th Emergency Meeting on Economic Affairs on the direction of economic policies for the second half of 2023 at the Yeongbingwan in Cheong Wa Dae. President Yoon stated, "Many bills aimed at improving the economic constitution and ensuring stable public welfare - such as the National Finance Act for the introduction of fiscal rules, the Housing Act for easing residency obligations, and the Medical Service Act for establishing the basis for non-face-to-face treatments - are being impeded by the National Assembly, disappointing many citizens." To this, President Yoon urged, "Ministers of each department should focus solely on the people and make every effort to ensure the swift passage of essential economic and public welfare bills." As President Yoon personally directed the amendment of the Medical Service Act, it is anticipated that the government will expedite the legislation for the non-face-to-face treatment system. Currently, the amendment of the Medical Service Act related to non-face-to-face treatment is pending in the Legislative Review Subcommittee of the NA’s Health and Welfare Committee. The direction of the legislation has taken shape to closely align with the current pilot project for non-face-to-face treatment. The legislative direction being discussed and promoted by the government in cooperation with the National Assembly is as follows: Allowing non-face-to-face treatment only for follow-up visits, with initial consultations primarily in clinic-level medical institutions as exceptions. If patients are not eligible for home-delivered medication, the patient (or their representative) may obtain the prescribed medication directly from a pharmacy after receiving face-to-face medication counseling from a pharmacist. While the method of delivering medication is still an issue, the matter will not be a major point of contention during the National Assembly discussions, as the aspect falls under the amendment of the Pharmaceutical Affairs Act and not the Medical Service Act.
- Policy
- Roche Korea, "No decision has been made to resupply Madopar
- by Lee, Tak-Sun Jul 06, 2023 05:39am
- Roche Korea recently announced that it has no plans to resupply Madopar, a Parkinson's disease treatment for which the grace period for the deletion of benefits was recently extended. It is explained that the headquarters did not make a decision to resupply, and that no agreement was signed with any organization for resupply. The extension of the grace period for deletion of benefits was carried out in consultation with the Ministry of Health and Welfare, and it is explained that there is no plan to resupply Madopar during that period. An official from Roche Korea said in a phone call on the 4th. announced its withdrawal from the country in January by voluntarily withdrawing Madopar's license. Patients with Parkinson's disease are urging the resupply of Madopar, urging Myungdopar, which is the only generic drug with the same drug, to have significant side effects. The Ministry of Health and Welfare has also opened the door to resupply, saying that it is possible to negotiate a price increase through the upper limit adjustment system, and some have reported that the Parkinson's Association and Roche Korea have agreed to resupply Madopar. Roche Korea said that the agreement for Madopar was not true. A company official explained, "The head office has not made any decision regarding the resupply of Madopar." However, he explained that the reason why the grace period for deleting benefits was extended was because there was a consultation with the Ministry of Health and Welfare. The official explained, "After checking the Madopar inventory, we found that there was still a lot left, and in consultation with the Ministry of Health and Welfare, we extended the grace period for the deletion of benefits to prevent patients from suffering economic damage." The grace period for deleting Madopar benefits was extended by 4 months to a total of 10 months. Normally, the grace period for deleting benefits is up to six months, but it was extended by four months under the authority of the Ministry of Health and Welfare. As a grace period was granted, some said that the Ministry of Health and Welfare and Roche had confirmed the resupply of Madopar and extended the grace period. There is criticism that it is giving preferential treatment to original drugs that have voluntarily withdrawn from the market. In addition, the generic industry argues that if the government follows the issue of resupplying the original, the reliability of generics will decrease.
- Policy
- Will AZ/Kolon succeed in challenging COPD combi benefit?
- by Lee, Tak-Sun Jul 05, 2023 05:45am
- Two COPD 3 drugs combi inhalers that are competing for reimbursement are not easily able to get out of the HIRA stage. AstraZeneca's 'Breztri Aerosphere' also requested a re-evaluation of the committee's results, while Kolon Pharmaceutical's 'Trimbow Inhaler' took on a re-challenge for reimbursement despite the drug evaluation committee's conditional decision. According to the industry on the 4th, Breztri Aerosphere, which was notified of the conditional determination of the adequacy of benefits when accepting less than the appraised amount at the 5th committee last May, recently applied for re-evaluation. According to the drug reimbursement evaluation regulations, drug manufacturers, etc. may apply for re-evaluation within 30 days of being notified of the evaluation results. It is interpreted that AstraZeneca's action is based on the judgment that it is difficult to accept less than the appraised amount. If the re-evaluation results remain unchanged, AstraZeneca is likely to consider whether to reapply for benefits. Similar to Breztri Aerosphere, Kolon Pharmaceuticals Trimbow, which received a conditional judgment that benefits are appropriate when accepted below the appraisal amount, has not accepted the committee's decision and is currently reapplying for benefits. Currently, it is known that the second supplementary data submission has been completed and the society's opinions are being listened to. The reason why these drugs are having difficulty receiving reimbursement seems to be that GSK's 3-dose combination COPD inhaler Trelegy Ellipta, which was listed first, was listed at a relatively low price. Trelegy Ellipta, which was listed as a benefit in 2021, costs 45,602 won for a 30-day supply, similar to the price of a two-drug combination drug. Given that alternative drugs are cheap, there seems to be a large gap between the HIRA valuation and the management's expectations. The 3 drugs combination is expected as an alternative treatment for COPD patients who do not respond well to the existing ICS-LABA and LABA-LAMA combination therapy. While GSK products are currently listed, it is noteworthy whether AstraZeneca and Kolon Pharmaceuticals will be able to find a solution to the insurance coverage.
- Policy
- AZ Capivasertib, designated GIFT No. 8
- by Lee, Hye-Kyung Jul 05, 2023 05:45am
- On the 4th, the Ministry of Food and Drug Safety designated AstraZeneca Korea's breast cancer treatment Capivasertib as the 8th "Global Innovation Product Rapid Review (GIFT)." Starting with Lunsumio, a lymphoma treatment in Roche Korea, which was designated as GIFT No. 1 in November last year, it has been designated up to No. 8 recently, but none of the items have been officially approved yet. In this regard, Park Jae-hyun, head of the rapid review division of the Ministry of Food and Drug Safety, said in a briefing for reporters on the 4th, "Even if it is designated as GIFT, it may not apply for permission for each item." However, since a total of eight items have been designated starting with Lunsumio, the GIFT No. 1, Park explained that GIFT designated items are expected to be linked to permits in the second half of this year. Since the establishment of the GIFT system, a total of 13 items have been applied for rapid review, and eight of them have been designated as targets. In the end, it means that the designation rate is not as high as 61%. This is because GITF items are limited to ▲ drugs aimed at treating serious or rare diseases such as life-threatening cancer, ▲ drugs aimed at preventing or treating infectious diseases such as bioterrorism or infectious diseases, ▲ new drugs developed by innovative pharmaceutical companies designated by the Ministry of Welfare, ▲ rapid screening, and medical devices or ▲ if there is no existing treatment or if there is a clinically significant improvement in effectiveness compared to the existing treatment Park said, "When I meet with the pharmaceutical industry, I receive many suggestions to expand the scope of rapid review." "Among them, we are sometimes asked to include improved new drugs in the rapid review, and although it is difficult due to a lack of manpower, we plan to review them in the mid- to long-term," he said. The hurdles are high, but if designated as GITF targets, ▲ the screening period will be reduced by at least 25% (e.g., 120 working days→90 working days), ▲ close communication between reviewers and developers, such as item briefings and supplementary briefings, or ▲ regulatory-related consulting. The GIFT system is a branding of the rapid review program that has been operated since the establishment of the rapid review and has been in full force since September last year to revitalize the two-year rapid review and strengthen support for rapid commercialization of innovative products. Starting with frequent screening of COVID-19 vaccines and treatments, the rapid screening of drugs is Daewoong Pharmaceutical's Envlo 0.3mg and AstraZeneca's Koselugo 25mg. With the introduction of rapid screening in Korea, items such as the COVID-19 treatment Regkirona, COVID-19 AstraZeneca vaccine, Pfizer vaccine, Janssen vaccine, Moderna vaccine, etc. were approved in 2021. Manager Park explained, "Since the rapid examination department was established in August 2020 and the rapid examination began, a total of 33 items have been designated for rapid examination, and 28 items have been approved, and about 85% have been approved." "Over the past three years, the average number of days required for rapid review of designated items has been 65 working days, and in the case of the COVID-19 vaccine, 28.7 working days, less than 30 days on average," he explained. Among them, Daewoong Pharmaceutical's Envlo reduced the screening period by 59% compared to 120 working days, and reduced the screening period by more than 100 days compared to the average new drug screening period from 353 days, including the data supplement period. Manager Park said, "GIFT designated items aim to be reduced to 75% of the general screening period, and it is difficult to calculate and answer the entire screening date because there are no items that have been approved yet." "For reference, you can refer to the overall average screening date of items subject to rapid screening over the past three years by the rapid screening department," he said. Regarding the criticism that the GIFT system seems to have focused only on foreign pharmaceutical companies, Park explained, "When the Pharmaceutical Affairs Act is revised for rapid review, the law has been revised to support the development of the domestic pharmaceutical industry." "Since February, we have been operating GIFT Kiwoom, a 1:1 consultative body with developers, focusing on domestic innovative pharmaceutical companies to support commercialization such as item permits," he said. Currently, there are 48 innovative pharmaceutical companies certified by the Ministry of Health and Welfare, of which 46 are domestic pharmaceutical companies, so it is expected to help designate new drugs developed by domestic pharmaceutical companies as GIFT.
- Policy
- Mounjaro, a weight loss effect for DM pts, has been approved
- by Lee, Hye-Kyung Jul 03, 2023 05:47am
- Eli Lilly's 'Mounjaro PFS', known overseas as a game changer for obesity treatment, has been approved in Korea. In Korea, it has been approved as a treatment for diabetes. Mounjaro is a synthetic peptide with a mechanism that can selectively bind to both the GIP and GLP-1 receptors for the first time in Korea. The Ministry of Food and Drug Safety (Ministry of Food and Drug Safety, Minister Oh Yu-Kyoung) has tested the content of 6 Mounjaro (2.5, 5, 7.5, 10, 12.5, 15mg/0.5ml) used as an adjuvant for diet and exercise therapy to control blood sugar in adult type 2 diabetic patients. It was confirmed on the 28th. This drug selectively binds to the GIP receptor and the GLP-1 receptor to induce insulin secretion promotion, insulin resistance improvement, and glucagon secretion reduction, thereby causing pre- and postprandial blood glucose reduction. GLP-1 agonists act on GLP-1, a hormone that makes you feel full by acting on the brain's hypothalamus, activates incretin, an intestinal hormone, and promotes insulin production to lower blood sugar levels. It slows down the movement of food from the stomach to the small intestine, increases satiety, and has proven its effectiveness, becoming a very popular obesity treatment in the United States. Mounjaro is a successor to Lilly's blockbuster diabetes treatment Trulicity and was approved by the US FDA in May of last year as a dietary and exercise supplement to improve blood sugar control in patients with type 2 diabetes. It can be used as a monotherapy or as a combination therapy with Metformin, SGLT2 inhibitor, Sulfonylurea, and Insulin glargine. The Ministry of Food and Drug Safety said, “We will continue to do our best to expand treatment opportunities for patients by making efforts to promptly supply treatments whose safety and effectiveness are sufficiently confirmed based on regulatory science expertise.”
- Policy
- Drug price negotiations such as Roche Evrysdi begin
- by Lee, Tak-Sun Jul 03, 2023 05:47am
- Roche's 5q spinal muscular dystrophy treatment Evrysdi Dry Syrup began negotiations with the NHIS as soon as it passed the Drug Benefit Evaluation Committee of the HIRA. Ace Pharma and H&O Pharm's multiple myeloma treatments Megval Inj. and Melpspal Inj. have also entered negotiations. The NHIS added oEvrysdi Dry Syrup 0.75 mg/mL, Melpspal Inj. 50 mg and Megval Inj. 50 mg to the negotiation list for new drug prices on the 30th. As a result, six items are currently under negotiation, including these three items, Lilly Retevmo Cap, Bayer Verquvo, and BMS Onureg. When the drug price negotiations are concluded, the benefits will be applied through a report by the Health Insurance Policy Review Committee of the Ministry of Health and Welfare. Evrysdi Dry Syrup, Megval Inj., and Melpspal Inj. were recognized for their adequacy of benefit at the Drug Benefit Evaluation Committee of the HIRA on June 1 and moved on to the negotiation stage of the industrial complex. Usually, when the MOHW orders the negotiation, the NHIS sets up a negotiation team to conduct full-fledged negotiations on the upper limit and expected usage. Evrysdi Dry Syrup is a liquid formulation that is taken PO QD and is characterized by being applicable to patients who have difficulty in treating spinal cord cavities. Motor function improvement and safety profiles were confirmed in patients of a wide range of diseases, including patients of a wide age range from 2.2 to 25 months old and patients with experience in scoliosis-related surgery. Since self-administration is possible at home, it is expected to reduce insurance financial and socioeconomic burdens by reducing the burden of indirect medical expenses such as academic, workplace interruption, transportation, and nursing. Megval and Melpspal are forms of injections with Melphalan as the main active ingredient and are national essential drugs. In Korea, Samil Pharmaceutical's Alkeran has been reported, but currently, the KODC has stopped importing and only the KODC supplies inventory as unlicensed drugs in Korea. Accordingly, Megval and Melpspal are expected to have much better accessibility to patients with multiple myeloma if they are paid.
- Policy
- Eval period for HCV treatment shortened to 12 weeks from 24
- by Lee, Hye-Kyung Jun 30, 2023 06:01am
- The evaluation period used to determine the efficacy of chronic hepatitis C treatments has been reduced in Korea. The Ministry of Food and Drug Safety (Minister Yu-Kyoung Oh) revised the 'Clinical Trial Evaluation Guidelines for Chronic Hepatitis C Treatments' on June 29 to align Korea’s clinical trial efficacy evaluation standards with the international standards and reflect the standard treatment method for chronic hepatitis C treatments. The main revisions included ▲changing the evaluation period of major efficacy evaluation indices, ▲setting toxicity test exemption standards for combination drugs, and ▲reflecting the latest chronic hepatitis C standard of care to the guidelines. Through the revision, the sustained virologic response (SVR) period that was used to evaluate the efficacy of HCV treatments will be reduced from 24 weeks to 12 weeks. The authorities had analyzed the clinical trial results of approved drugs and confirmed a correlation (98-100%) between the 12- and 24-week treatment results, and also considered its coherence with those of health agencies abroad. Also, the guidelines presented a clear standard for companies developing combination drugs to waive toxicity tests. Companies can submit their non-clinical or clinical data of the individual composite drugs and be exempt from toxicity tests if no serious toxicological concerns are present in the submitted data of each ingredient. Since the standard treatment for HCV was changed from the use of peginterferon in combination with ribavirin to direct-acting antivirals, the information on the new standard of care was also reflected in the guideline. The MFDS said, “We hope that the revised guidelines will support the development of HCV treatments, and will continue to provide information to support the development of treatments based on our expertise in regulatory science.”
- Policy
- Tx for combi of dementia/hyperlipidemia have increased
- by Lee, Tak-Sun Jun 30, 2023 06:01am
- The amount of claims for dementia treatment and hyperlipidemia has increased by more than 50% in the past two years. In the case of dementia treatment, it seems to have increased significantly as the elderly patients' visits to medical institutions decreased in 2020 due to COVID-19. The hyperlipidemia complex is interpreted as the amount of charge has also increased as the post-drugs of statin + edetimive came out all at once. In the '2022 payroll drug claim status' disclosed by the Health Insurance Review and Assessment Service on the 26th, the claim status by ATC code was compared to 2020. The drug with the largest claim in the ACT Code is the treatment for peptic ulcer and gastroesophageal reflux disease, and 1.155.8 trillion won was charged in 2022. Compared to the past 2020, this is an increase of 25.1%. However, the number of listed items decreased by 170 from 1510 to 1340. This formulation is interpreted as a significant increase in claims due to the overlap of the emergence of domestic new drug K-cap, the growth of PPI+ sodium bicarbonate formulation, and the balloon effect after the expulsion of ranitidine. Of course, the decrease in medical use due to COVID-19 in 2020 is also a major increase.. In the case of dementia treatment, such a underlying effect was more prominent. Dementia treatment claims increased by a whopping 58.4% when compared to 2020 and 2022, reflecting the decline in visits to medical institutions for the elderly in 2020. In fact, 2019 before COVID-19 had higher dementia treatment claims than in 2020. As visits to medical institutions have gradually normalized since 2021, the demand for dementia treatment has turned to an increasing trend, surpassing 400 billion won last year. During this period, the number of subsympathetic nervous system, which contains choline-alpocerate formulation, increased by 17.4%. This ingredient formulation has been judged as a selection benefit due to salary re-evaluation, but the notice is being delayed due to the suspension of execution, and the marketing of pharmaceutical companies is strengthening, so it seems that the claim is ahead of the dementia treatment. However, the number of listed items has decreased by 109 in two years. The hyperlipidemia complex also increased claims by 56% as 323 items were added in two years. Atojet generics have been pouring out since 2021, and the sales of improved new drugs from domestic companies have grown to 1 trillion won last year. The 16 top ATC code classifications for claims have all grown compared to 2020. However, direct-acting antiviral drugs, which include hepatitis B treatment and hepatitis C treatment, grew only 0.8%, making a contrast. This is interpreted because there are drugs that have a high therapeutic effect, so the number of patients does not increase. In the second year, the number of listed items has also decreased by 199.
