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- 2026-03-12 04:51:04
- Policy
- Enhertu passed the cancer dz review board after a retrial
- by Lee, Tak-Sun Jul 14, 2023 05:39am
- After a retrial in the first half of last year, the anticancer drug Enhertu, which passed the Cancer Disease Review Committee, met another hurdle: passing the Pharmaceutical Reimbursement Evaluation Committee. Enhertu, which succeeded in setting reimbursement standards at the end of the review committee's reexamination in May, was not presented to the Pharmaceutical Reimbursement Evaluation Committee, which was held three times afterward. According to the industry on the 11th, Enhertu's Daiichi Sankyo submitted data to HIRA a day late, which requested PE supplementary data earlier this month. Currently, Enhertu is in PE, and it is expected to be submitted to the committee by taking steps such as the RSA sub-committee. The PE data was submitted on the 5th and is currently awaiting deliberation. Accordingly, it is expected that Enhertu's submission to the Pharmaceutical Reimbursement Evaluation Committee will be decided according to the deliberation results. Currently, it is difficult to estimate when the drug benefit evaluation committee will be presented. Enhertu, which applied for reimbursement in November last year, began reviewing patients' prompt reimbursement. In February, through a national consent petition, 50,000 people agreed to the demand for the benefit, and it was referred to the National Assembly. It is indicated for the treatment of patients with unresectable or metastatic HER2-positive breast cancer who have previously received one or more anti-HER2-based therapies. It is also indicated for the treatment of locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have previously received two or more therapies, including anti-HER2 therapy. The petitioner for Enhertu reimbursement strongly requested health insurance approval, saying that Enhertu is called the last hope for breast cancer patients and that it is difficult to use because it is an expensive drug that costs about 5 million won per injection. The HIRA reviewed the reimbursement standards for Enhertu for the first time in March. However, in the case of gastric cancer indications, the cancer disease review committee decided to re-deliberate without reaching a conclusion due to the weak evidence and the high price of the applied drug. Still, it was not that the salary standard setting failed, but that it was re-examined, so I was able to continue my hopes. Afterward, Daiichi Sankyo submitted supplementary data and managed to set the salary standard at the cancer screening meeting held in May. In order for the reimbursement to be applied, there are still procedures, such as passing through the Drug Evaluation Committee and then negotiating with NHIS. In many cases, it took a long time to pass the drug evaluation committee after the reimbursement standard was established. In the case of Keytruda, an immuno-oncology drug, it was presented to the Drug Evaluation Committee within six months. Accordingly, there is an opinion that the reimbursement review process for anti-cancer drugs, which must pass through two consecutive committees, should be improved to expedite reimbursement. However, the HIRA draws a line against this argument, saying that the cancer disease review committee, which sets reimbursement standards, and the drug evaluation committee, which determines the adequacy of reimbursement, have distinctly different functions. However, given that Enhertu's petition for expedited reimbursement is a drug that has been referred to the National Assembly, there is a prospect that it will not take long for Enhertu to be presented to the Drug Evaluation Committee. The rare re-discussion by the Cancer Disease Review Committee is an interpretation that the insurance authorities are also conscious of the speed of reimbursement. Daiichi Sankyo also said, "We are actively discussing with the government authorities for the prompt reimbursement of Enhertu, putting the patient's wishes first." Attention is focusing on whether Enhertu, which is facing the drug evaluation committee, will quickly go through the reimbursement process as patients wish.
- Policy
- HIRA declines NHIS and KPBMA's request
- by Lee, Tak-Sun Jul 14, 2023 05:39am
- The National Health Insurance Service and the Korea Pharmaceutical and Bio-Pharma Manufacturers Association have requested to participate in the Drug Reimbursement Evaluation Committee, but the Health Insurance Review and Assessment Service announced plans to amend its operational regulations without reflecting their requests. The NHIS has been strongly pushing to take part in the Drug Reimbursement Evaluation Committee since earlier this year, which drew attention to the recent amendment of the operational regulations. According to HIRA on the 13th, the amendment to the operational regulations for the Drug Reimbursement Evaluation Committee will be officially announced soon and will incorporate the contents pre-announced last month. The pre-announced contents of the amendment included increasing the committee's member pool from 100 to 105 and increasing the number of experts recommended by academic societies from 65 to 70. HIRA will reorganize the specific departments for specialized experts among those recommended by the Korean Medical Association by removing the Korean Society of Gastrointestinal Cancer Research and adding 4 specialized departments including the Korean Orthopedic Association, the Korean Society of Coloproctology, the Korean Society of Medical Oncology, and the Korean Society of Surgical Oncology, HIRA made a pre-announcement of its administrative decision on the 21st of last month and has collected opinions until the 27th of the same month. After the announcement, the NHIS immediately offered to take part in the Drug Reimbursement Evaluation Committee. The NHIS has been emphasizing the need for their participation in the committee to enable smooth operation of tasks related to drug reimbursement.since earlier this year. While NHIS participated in the 3rd Drug Reimbursement Evaluation Committee, they were not given voting rights due to a conflict of interest and are now no longer involved in the committee. In March, Sang-Il Lee, Executive Director for Benefit at NHIS, argued for NHIS’s participation in the Drug Benefit Evaluation Committee during a briefing with the Korea Special Press Association. He said, "NHIS’s participation in the Drug Reimbursement Evaluation Committee is necessary to ensure the appropriateness of reimbursement, secure consistency of financial impacts when listing new drugs, and serve as an organic link between the evaluation and negotiation conducted on the uncertainty of new drugs under the risk-sharing agreement. We will further discuss this matter with relevant organizations, such as MOHW and HIRA.” Subsequently, the National Health Insurance Trade Union and the Korea Alliance of Patients Organization also supported the participation of NHIS in the Drug Reimbursement Evaluation Committee. The Korea Alliance of Patients Organization submitted a letter of opinion in favor of NHIS’s participation when the amendment to the operating regulations for the Drug Reimbursement Evaluation Committee had been pre-announced. However, HIRA showed a negative stance toward NHIS’s participation in the Drug Reimbursement Evaluation Committee. Mi-Young Yoo, Head of the Department of Drug Management at HIRA stated during a briefing in March that “As an insurer, NHIS directly negotiates with pharmaceutical companies on the ceiling price for new drugs, etc. Concerns may arise about fairness and objectivity if the negotiating party participates in the decision-making process,” essentially rejecting their opinions. In addition to the NHIS, the Korea Pharmaceutical and Bio-Pharma Manufacturers Association also submitted their opinion for its participation in the Drug Reimbursement Evaluation Committee during the pre-announcement period, with the aim of ensuring transparency in the process of reimbursement decisions. However, their opinions to take part in the Drug Reimbursement Evaluation Committee were not accepted. The official announcement is expected to align with the pre-announced contents. Thus, NHIS and KPBMA representatives will not be part of the 9th Drug Reimbursement Evaluation Committee that is set to commence in October.
- Policy
- Approval of phase 3 for Retatrutide
- by Lee, Hye-Kyung Jul 14, 2023 05:38am
- Eli Lilly's anti-obesity drug Ly3437943 is undergoing phase 3 clinical trials in Korea. The Ministry of Food and Drug Safety recently approved a phase 3 clinical trial to study the efficacy and safety of once-weekly administration of Retatrutide in obese or overweight type 2 diabetic subjects. Seoul National University Hospital, Severance Hospital, Ulsan University Hospital, Hanyang University Guri Hospital, Korea University Ansan Hospital, and Yeungnam University Hospital participate in the phase 3 clinical trial conducted worldwide. Retatrutide is a triple agonist of Lilly's GIP/GLP-1/glucagon (GCG) receptor, which is famous as an obesity treatment following Mounjaro. Mounjaro was clinically confirmed to have a 22.5% weight loss effect when administered at the highest dose of 15mg/0.5ml for 72 weeks in obese patients without diabetes. approved as an adjuvant in therapy. The indication for obesity treatment plans to receive approval from the FDA within the next year. On the other hand, Retatrutide showed a weight loss effect of 24.2% after 48 weeks in the 12mg group, the highest dose group, in phase 2 clinical trial conducted on 281 adults aged 18 to 75 years at the recently opened ADA. It is evaluated that the combination of glucagon receptor action with glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor action led to the weight loss effect of Retatrutide. GLP-1 was developed as a diabetes treatment because it promotes insulin secretion and lowers blood sugar levels, but as the side weight loss effect was confirmed, it is being used as an obesity treatment. Meanwhile, representative drugs such as GLP-1 agonists include Novo Nordisk's Saxenda and Wegovy.
- Policy
- HIRA is reviewing reimb of Korea’s first donepezil 3mg
- by Lee, Tak-Sun Jul 14, 2023 05:38am
- Donepezil Powder released by Hyundai Pharmaceutical last year The 3mg donepezil tablet that was developed by Hyundai Pharmaceutical is being reviewed by the health authorities for reimbursement in Korea. No other tablet formulation of donepezil 3mg currently exists in Korea’s reimbursement list. Therefore, the Health Insurance Review and Assessment Service is seeking for the most appropriate development target product to determine its price. Hyundai Pharmaceutical received approval for Hipezil Tab 3mg (Donepezil hydrochloride monohydrate) on the 28th of last month. Hipezil Tab 3mg is indicated to slow the progression of symptoms of dementia associated with Alzheimer's disease and is the first 3mg donepezil formulation introduced to the market. Although the 3mg dose is being used abroad, Hyundai is the first in Korea to receive approval for the specific dose. Currently, 5mg, 10mg, and 23mg formulations of donepezil are listed for reimbursement in Korea. The 3mg donepezil tablet has a specific use. Its dosing schedule indicates that an initial dose of 3mg once daily can be used for the purpose of reducing gastrointestinal adverse reactions. However, the use of the 3mg dose is conditional and limited to 1-2 weeks. Also, the dosage for underweight female patients aged 85 or older is not allowed to exceed 5mg, therefore are allowed the use of the 3mg formulation. Hyundai Pharmaceutical is thought to have adopted the strategy of receiving approval for Hipezil Tab 3mg to target a less attended spot in the highly competitive donepezil market. Hyundai Pharmaceutical has also released a powder-type formulation of donepezil, Hipezil Powder, that offers better convenience in intake. In the domestic donepezil market, competition among pharmaceutical companies is so fierce that 121 10mg tablets are on the reimbursement list. According to HIRA, the amount of claims submitted for dementia (ATC code N06D) in Korea amounted to KRW 414.9 billion in 2022, up 58.4% compared to 2020. The market is growing due to the increasing number of dementia patients and the normalization of hospital visits by the elderly with COVID-19 becoming endemic. Therefore, whether Hyundai Pharmaceutical’s strategy will show an effect is receiving industrywide attention.
- Policy
- ‘Refer to Japan’s half-price policy for generic's price'
- by Lee, Tak-Sun Jul 13, 2023 05:35am
- The Health Insurance Research Institute, a research institution under the National Health Insurance Service, stressed the need to refer to Japan’s generic drug price reduction policies in its recently published ‘Issue & View June 2023.’ Hyun-Ok Lee, Associate Research Fellow of the Health Insurance Research Institute, and her fellow researchers published an article containing the need above in the June issue of Issue & View under the title of 'Recent Changes in Japan's Drug Pricing System and Implications'. The authors argued that it is necessary to refer to and reflect on Japan’s generic drug pricing system in the paper’s conclusion and implications. The research team said, “Korea’s elderly population continues to increase, and the country is expected to enter a super-aged society by 2025. Therefore, various reforms need to be made to Korea’s current pricing system in preparation for a super-aged society, and we should refer to Japan's revised drug pricing system in the process.” As its background, the paper pointed to the rise in drug expenditures that followed the rise in multiple chronic diseases caused by population aging. The medical expenditures in Korea’s national health insurance from KRW 43.6 trillion in 2010 to KRW 86 trillion in 2019, and health insurance drug expenditures increased from KRW 12.7 trillion in 2010 to KRW 19.4 trillion in 2019. In other words, drug expenditures accounted for 24.1% of the total medical expense in 2019. “In Korea, an equal price policy between original and generic drugs was implemented in 2012. Based on the system, the upper limit of insurance listing price for generic drugs was set at 59% of the initial original drug price in the first year, then at 53.55% from the second year. In Japan, generic drug prices are set at 50% of the original drug price, and generic drugs that are listed thereafter are set at the same price as the lowest price of previously listed generics.” Japan also has a drug price system where if 10 or more generic drugs are listed, their price is set at 40% of the original price, and at 90% of the lowest price when 20 or more are listed. Unlike Korea, Japan implemented a claim addition system to encourage the use of generic drugs. Japan's first generic drug price (50%) is lower than that of Korea (53.55%). The method of lowering drug prices according to the number of generics introduced has also been introduced in Korea, but the difference is that Japan applies the standard from 10 or more, and Korea from 20 or more. The authors explained, "Korea has conducted drug price reevaluations for already-listed drugs in 2012 and unilaterally adjusted drug prices in 2012, but has not been regularly conducting drug price reevaluations thereafter. However, Korea has a post-marketing Price-Volume Agreement system in place that lowers prices as a drug’s use volume increases. “On the other hand, Japan has been conducting an annual drug price survey on all items since 2020 to adjust its drug prices to reflect actual market prices. Korea should also refer to Japan’s drug price adjustment policy that reflects actual transaction price and generic price decision method to improve Korea’s drug pricing policy in the future, ahead of the surge in pharmaceutical expenses that may occur in line with the rapidly aging population.” In other words, the paper stressed the need to periodically make price adjustments to generic drugs in Korea. The paper is expected to serve as a basis for raising the legitimacy of generic drug price cuts at a time when the government has recently started measures to improve the drug price cut investigation system and reform the generic drug price system.
- Policy
- Will the number of generics decrease?
- by Lee, Tak-Sun Jul 13, 2023 05:35am
- Analysts say that the government has begun strengthening the standard for cascading drug pricing in order to reduce the number of generics. A plan to reduce the existing list of 20 items, which is currently used as the standard for lowering the upper limit of new items, to 10 seems promising. However, the industry points out that there is a limit to reducing the number of large generics even if the tiered drug pricing standard is strengthened. Rather, it is predicted that it will only encourage development. The Ministry of Health and Welfare recently entrusted a research service to Kongju University professor Kim Dong-sook's team on the subject of 'preparation of measures to improve the drug price system for generic drugs'. In this study, the appropriateness of 20 products, which is the standard for the number of products to which differential price is applied, will be addressed. The 20 baselines were introduced in 2020 with the reorganization of the drug pricing system. If a generic enters the market with more than 20 identical products already listed, the upper limit will be set at 85% of the lower price between the lowest price of the same product and 38.69%. Unfortunately, the NHIS-affiliated Health Insurance Research Institute recently introduced the Japanese generic drug pricing system through a publication in the June 2023 issue and View, arguing that it needs to be reflected in the domestic system. In particular, when the number of generics is 10 or more, the generic price is calculated at 40% of the original price, and when there are 20 or more, the system is set at 90% of the lowest price. There was an atmosphere that the current baseline of 20 needs to be reduced to 10 like Japan. It is known that the Ministry of Health and Welfare, NHIS, and HIRA have also mentioned the plan to have a strict baseline for generic drug price cuts. Accordingly, the industry is of the opinion that it is not possible to further strengthen the cascading drug pricing system by creating a clear basis through research services. However, it is pointed out that there is a limit to reducing the number of large generics no matter how low the baseline for cascading drug pricing is. The cascading drug pricing system will be applied from the month after the first generic is listed. Therefore, in the first month, there is no penalty even if the number of entries exceeds 20. In the case of Forxiga's generic 10mg, which served as an opportunity for insurance authorities to pursue a plan to reduce the number of generics, 57 were listed in the first month of April alone. Most of the generic companies tried to register their products according to the patent expiry schedule to avoid the cascading drug pricing system. For the next two months, only one of Forxiga's generic 10mg was listed. Industry analysts say that generics with a large market size, such as Forxiga's generic, are highly likely to be listed on a large scale in the first month regardless of the cascading drug pricing baseline. The same is true for Januvia generics scheduled to be listed in September. Therefore, in Korea where generic competition is fierce, even if the price cut baseline is reduced from 20 to 10, the number of large generics will not change significantly. Rather, it is pointed out that generic companies can only waste social costs by trying to develop without asking regardless of expected performance in order not to be late for entering the insurance coverage. An official from the pharmaceutical industry explained, "There is a possibility that generic companies will flock to patent challenges at once to get reimbursed early." However, if the baseline is set from 20 to 10, the effect of not increasing the number of listed generics will be more significant. However, it is also pointed out that there is a limit to reducing the total number of generics. Another official in the pharmaceutical industry said, “Although Japan has generally reduced the price of generic drugs, it is different from Korea in that it is simultaneously promoting generic incentives, such as actively granting incentives to doctors and pharmacists for generic prescriptions.” He criticized, "Our insurance authorities are only concentrating on lowering the price of generic drugs and seem to have no interest in encouraging their use."
- Policy
- 2 Tylenol products stopped production will be decided in 2Q
- by Lee, Jeong-Hwan Jul 13, 2023 05:35am
- In the second half of this year, the Ministry of Health and Welfare plans to discuss the cancellation of the safety household medicine designation and the designation of additional alternative medicines for two Tylenol items, which have stopped production due to the sale of Janssen Korea's Hyangnam plant. On the 11th, the Ministry of Health and Welfare Ministry of Health and Welfare's Pharmaceutical Affairs Policy Division announced through a press briefing on media reports that the response to Tylenol, a safe and household medicine that has been suspended for more than a year, was insufficient. Some items, such as Tylenol 80mg for children and Tylenol 160mg, were withdrawn in March 2022 due to the relocation of the Tylenol manufacturer's factory overseas. A media company reported a critical article claiming that the government was neglecting the two items even though they had not been supplied for a year and four months due to a halt in production. In response, the Ministry of Health and Welfare explained that there is a considerable amount of inventory that has already been produced and that there are items that are trying to re-permit after relocating the factory, so they are examining the situation in consideration of the use of inventory and the possibility of re-permission. In particular, it also announced that it would make a decision within the second half of the year on the cancellation of the designation of safety and emergency medicines for two items that have been discontinued and the designation of additional alternative medicines. Regarding the suspension of supply, the Pharmaceutical Affairs Policy Division said, “It is not that the supply to convenience stores has stopped because the stock that has already been produced is being distributed.” The Pharmacy Policy Division continued, "Tylenol tablets for children 80mg and Tylenol tablets 160mg are alternative items such as children's Ibuprofen syrup and children's Tylenol suspension." "We will quickly discuss and decide on the need to cancel the designation of safe household medicines for the two items that have been discontinued and the need to additionally designate alternative drugs. According to the safety and household medicine system, the designation decision is made in consideration of the ingredients, side effects, content, dosage form, awareness, and convenience of purchase of the item," the Pharmaceutical Affairs Policy Division said.
- Policy
- Gov’s halts price cut discussions on generics
- by Lee, Jeong-Hwan Jul 10, 2023 05:21am
- Pharmaceutical companies in Korea are carefully monitoring the government's direction in improving the pricing system of generic drugs, including the government's insurance ceiling price policy. The Ministry of Health and Welfare was known to be contemplating a system with the health insurance authorities to further reduce the price of generic drugs after 3 years through a stepped pricing system. However, with no specific movement being observed in that direction for several months, there have been speculations that the government has temporarily halted the pursuit of additional price cuts on generic drugs. On the 7th, the pharmaceutical industry began to assess the atmosphere surrounding MoHW’s drug pricing policy on generics. Previously, MOHW, centering around the 2nd Vice-Minister of Health and Welfare Park Min-Soo, started exploring improvement measures to prevent the mushrooming of generics in the market. One measure mentioned was to further the price reduction imposed on generic drugs. As MOHW’s drug pricing policy aimed to expand accessibility for patients with severe and rare diseases who require high-cost drugs and rationalize the prices of generic drugs that lead to excessive competition in distribution, there was speculation that the upper price limit of 53.55% that was set for generic drugs could be adjusted or the number of differential price reductions for listed drugs with the same ingredients be reduced. However, no progress in the area has been made for several months since the internal meeting was conducted between the MOHW, the Health Insurance Review and Assessment Service, and the National Health Insurance Service regarding the drug pricing policy on generics in April. Therefore, the speculation is that the MOHW is controlling the speed of price reduction of generic drugs. MOHW may have felt it burdensome to create additional measures for the price reduction of generic drugs ahead of the reevaluation of the ceiling price (criteria) that will be held for listed generic drugs. This speculation has been supported by the fact that the scheduled TFT meeting between the MOHW, HIRA, and NHIS for drug pricing policies of generics in June was postponed. However, MOHW has not proclaimed a specific stance regarding the pricing system of generics. This means that it is difficult to hastily judge whether the government has halted its pursuit to impose price cuts on generic drugs. Given the situation, pharmaceutical companies are focusing on the actions of MOHW to formulate countermeasures in line with the administrative direction. An official from a pharmaceutical company stated, “For now, MOHW has halted the scheduled meetings on drug pricing policy on generics with HIRA and NHIS. With the reevaluation of the standards for listed drugs scheduled in the second half of the year, there are speculations that the MOHW may have slowed down its pace in pursuing additional revisions in drug pricing policies on generics. However, some expect partial differential price cuts may be imposed on generic drugs, even if the ceiling price is not adjusted" An official in charge of drug pricing from another pharmaceutical company said, "For the pharmaceutical industry, the news that MOHW has halted additional drug price reductions is a significant development. However, we cannot be at ease until the MOHW presents specific policy directions regarding drug price cuts. Many pharmaceutical companies are preparing various arguments and evidence against drug price cuts." In addition, with the upcoming announcement of the final version of the Second Comprehensive Plan of National Health Insurance this year, pharmaceutical companies are demanding a clearer policy direction from MOHW so that they can increase predictability in order to respond to government policies. A representative from another pharmaceutical company said, “In addition to the drug pricing policies on generics, MOHW has not yet released the final version of its policy on preferential pricing for breakthrough therapies after their discussions with private-public consultative bodies in the first half of the year. As this coincides with the formulation of the Second Comprehensive Plan of the National Health Insurance, pharmaceutical companies are contemplating on how to strategize their management policies accordingly. It would be desirable for the government to gather a wide range of opinions and take actions to prioritize predictability for companies and provide support for future management decisions, rather than being solely driven by political considerations.”
- 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."
