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- 2026-05-01 13:09:09
- Policy
- High-strength Ebixa generics start receiving approval again
- by Lee, Hye-Kyung Mar 07, 2024 07:16am
- Approvals for generic versions of the high-strength Ebixa 20mg (memantine hydrochloride), a treatment for severe Alzheimer's, that had been slowing down lately, have begun to gain momentum again. On March 5, the Ministry of Food and Drug Safety approved Dongkook Pharmaceuticals 'Memantine Tab 20mg.' Eighteen years after the 10mg formulation of the original memantine drug Ebixa (company: Lundbeck Korea) was approved in September 2003, the 20mg formulation that offers improved patient convenience had been released in November 2021. Unlike how patients had to take the 10mg formulation twice daily, the higher-strength 20mg tablet formulation can be taken only once a day, significantly improving dosing convenience. In particular, the release of such high-strength products by the market leader Eisai Korea’s ‘Aricept (donepezil hydrochloride)’ and the runner-up Ebixa has attracted the attention of domestic pharmaceutical companies. According to UBIST, outpatient prescription sales of Aricept were KRW 86.1 billion and Ebixa KRW 16.9 billion in 2021. Eleven months after the approval of Ebixa 20mg, Hyundai Pharm’s ‘Dimantine Tab’ became the first high-strength generic to receive approval in Korea. Launching the first 20mg generic version in addition to the existing Dimantine 5mg and 10mg, the company promoted the release of a new treatment option. Last year, 3 Korean pharmaceutical companies made a bid into the high-strength Ebixa market: Myung In Pharmaceutical’s ‘Fello OD Tab,’ Korean Drug Co’s ‘Admed Tab,’ and Huons’ ‘Easymantine Tab.’ In particular, only Whan In Pharm and Myung In Pharmaceutical had approvals for low-strength oral disintegrating tablet formulations of Ebixa. Orally disintegrating tablets are more convenient than capsules or tablets, and in the case of memantine, which is used to treat dementia, it was evaluated to be more effective as many patients have swallowing disorders. Due to this, Myung In Pharmaceutical first gained competitiveness with its high-strength Fello OD. With Dongkook Pharmaceutical also waiting to enter Ebixa’s high-strength generic market, which has been sluggish since Huons received approval for its Easymantine Tab 20mg in October last year, 6 companies are set to compete in the market from now on. Use of high-dose memantine must be initiated by a physician experienced in the diagnosis and treatment of Alzheimer's disease, and only if a caregiver is available to regularly check the patient's compliance with the medication. The drug is administered orally once daily, and the recommended dose is 20 mg per day in elderly patients over the age of 65.
- Policy
- Once-weekly growth hormone Sogroya is approved in Korea
- by Lee, Hye-Kyung Mar 07, 2024 07:16am
- A growth hormone that can be administered once weekly was approved in Korea. The Ministry of Food and Drug Safety approved Novo Nordisk’s ‘Sogroya Prefilled Pen (somapacitan-beco)’ 5mg, 10mg, and 15mg on June 6. Sogroya is a once-weekly treatment for adult hormone deficiency and is indicated for the replacement of endogenous growth hormone (GH) in children aged 3 years and above, and in adults with growth hormone deficiency (adult GHD) in Korea. As a type of human growth hormone analogue that is injected subcutaneously once a week, Sogroya offers better dosage convenience over existing growth hormone formulations that require daily dosing. The drug was approved by the US FDA in 2020 based on results from a comprehensive clinical development program, including those from the REAL 1 trial. The Real 1 trial was a Phase III, randomized, parallel-group, double-blind, placebo-controlled trial that was conducted on treatment-naïve patients with adult GHD for 35 weeks. In the trial, a total of 300 adult patients with adult GHD were recruited and randomized to treatment with once-weekly Sogroya, once-weekly placebo, or once-daily somatropin. Results showed that patients treated with Sogroya demonstrated a mean reduction of 1.06% in truncal fat at week 34, a significant difference compared with the 0.47% increase found with the use of placebo. Patients treated with daily somatropin achieved a change in truncal fat % of -2.23% after 34 weeks. Sogroya was approved and released in Japan in 2021, at a price of JPY 26,107 for the 5mg vial and JPY 52,214 for the 10mg vial.
- Policy
- The RSA track to include drugs for chronic diseases, asthma
- by Lee, Tak-Sun Mar 07, 2024 07:15am
- The Risk Sharing Agreement (RSA) will cover chronic and severe diseases that cannot be treated with substitute drugs and result in irreversible deterioration in the quality of life. It was announced last year as part of ‘The drug pricing system to ensure fair-value compensation for innovative new drugs.’ Since the announcement, the RSA has covered several drugs to treat chronic and severe disorders. The committee will now develop detailed guidelines to ensure the implementation of these measures. The Drug Reimbursement Evaluation Committee (DREC) of the Health Insurance Review and Assessment Service (HIRA) will hold a meeting on the 7th to review the guidelines, according to the industry sources on the 6th. The current RSA only applies to anticancer and orphan drugs treating life-threatening severe diseases without substitute drugs. However, there were cases where the RSA covered other severe diseases besides orphan drugs. For instance, ‘Dupixent inj,’ a drug used to treat severe atopic dermatitis, and the severe asthma drug ‘Nucala’ have been covered by health insurance reimbursement via RSA. The government will additionally apply RSA to drugs treating chronic and severe diseases to provide better patient insurance benefits. The government will promptly implement this measure because RSA has already covered several drugs for treating severe diseases, and the administrative work only includes developing detailed guidelines. This is the first measure to implement ‘The drug pricing system to ensure fair-value compensation for innovative new drugs,’ announced last year. Therefore, once the DREC reaches an agreement, it is expected that drugs for treating chronic and severe diseases causing irreversible deterioration in the quality of life, including generalized pustular psoriasis, interstitial lung disease, hereditary angioedema, and severe asthma, will be covered by RSA and later, those drugs will likely be reimbursement listed. The DREC, which will be held on the 7th, will also review the reimbursement appropriateness of Fasenra Pre-filled Syringe Inj. (benralizumab, AZ), used for treating severe eosinophilic asthma. Fasenra Pre-filled Syringe Inj. received a reimbursement status via RSA at the DREC last September. However, it did not receive a non-reimbursement decision. On the other hand, Nucala (mepolizumab, GSK), a severe eosinophilic asthma treatment similar to Fasenra, was successfully listed for reimbursement via RSA. Whether Fasenra will clear the reimbursement appropriateness and the expansion of the RSA measure is to be watched.
- Policy
- Will Ferinject be reimbursed this time?
- by Lee, Tak-Sun Mar 05, 2024 05:48am
- Reimbursement for JW Pharmaceutical’s high-dose iron injection ‘Ferinject Inj’ is imminent in Korea. Although the company failed to pass the pricing negotiation stage once in 2020, analysts are seeing a true possibility for its reimbursement this time, as the company's willingness for its reimbursement is stronger than ever. According to industry sources on the 4th, the reimbursement application for Ferinject passed the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee meeting in January and is currently in the drug pricing negotiation stage with the National Health Insurance Service. The 60-day drug pricing negotiation period will end at the end of this month. Therefore, depending on the speed of the negotiations, Ferinject can be reimbursed in Korea as early as next month. However, given the short period left to report to the Health Insurance Policy Review Committee this month, it is likely that the drug will be included in the reimbursement list in May. The drug, which was introduced by JW Pharmaceuticals from the Swiss company Vifor and released in Korea in 2011, is a high-dose iron injection that has the advantage of supplementing iron with just a single injection. On January 11, the Ministry of Food and Drug Safety determined that the drug was adequate for reimbursement in treating iron deficiency. This is the 4th time the company attempted reimbursement listing for Ferinject. In 2014 and 2018, the drug failed to pass the DREC review, and in 2020, the drug was recognized as adequate for reimbursement at the DREC level but filed to complete negotiations. Despite such setbacks, the company has been posting strong sales in the non-reimbursement market. In 2022, the company's consolidated annual sales reached KRW 20.5 billion. While conventional intravenous iron injections take more than 40 minutes per dose and require multiple hospital visits, Ferinject can quickly replenish iron in the body with up to 1,000 mg of iron per day in 15 minutes, making it an effective alternative to blood transfusions for surgical patients who need to raise their hemoglobin levels in a short period of time, and for mothers who experience hemorrhage due to childbirth. Its high efficacy and convenience have made it popular in the non-reimbursement market, and its market has been growing strongly every year. However, its cost, which is around KRW250,000 per injection, is posing a financial burden for the patients. According to the company, it needs to be reimbursed to make it more affordable for more patients. The problem is if the drug is reimbursed, its price has to become lower than its non-reimbursed price. Therefore, JW Pharmaceuticals is expected to struggle over the change in profit margin and balance the increased usage and price difference during drug price negotiations. However, as it is the second drug price negotiation, the industry believes that there is a higher chance of the NHIS and the company reaching an agreement than in the last negotiation in 2020. This is because if the negotiations fall through again, it will be difficult to attempt reimbursement again. An industry official said, “The deadline for negotiations is the end of March, but it will take a while for the two to reach an agreement. Depending on the progress, the drug may be listed in April, but I don't think the company will deliberately speed up the process."
- Policy
- Guideline to be revised to prevent unintentional impurities
- by Lee, Hye-Kyung Mar 04, 2024 05:52am
- Amid the recent recall of sitagliptin combination products due to excess detection of impurities, the Ministry of Food and Drug Safety appears to be busy preparing a system to manage unintentional impurities at all times. The MFDS aims to revise the 'Guideline for Safety Management of Impurities in Drug Products’ within June to establish and advance a permanent pharmaceutical industry-led system for managing unintentional impurities in drugs. The revised guidelines will reflect the latest advances in Korea and abroad such as new impurity tolerance standards, causes, and reduction strategies, and measures such as information collection, risk assessment, testing, and reduction. Unintentional impurities have continued to occur, including those in the hypertension drug valsartan in 2018, gastrointestinal drugs ranitidine and nizatidine in 2019, and the diabetes drug metformin in 2020. In addition, last year, due to the detection of nitrosamine impurities, the government implemented safety measures such as submission of test results and recalls were implemented on domestically distributed drugs such as ‘perindopril,’ ‘tamsulosin,’ ‘nortriptyline,’ and ‘sitagliptin’ based on the evaluation results. In particular, in the case of sitagliptin, a number of sales recalls have recently been carried out by the companies as a precautionary measure due to concerns over the detection of excess impurities (NTTP). In January, Kyung Dong Pharma’s anti-ulcer drug ‘Zanitin Tab 150mg' was recalled due to concern over the detection of impurities, and in February, Alvogen Korea's ‘Genxiga S Tab 10/100mg', Hutecs Korea Pharmaceutical's ‘Nanudangxiga Tablet 10/100mg', KyungBo Pharmaceutical's ‘Janustin Duo Tab 10/100mg', Ahn-Gook Pharm’s ‘Adapasita Duo Tablet 10/100mg', and Nex Pharm Korea's 'Flosita Tab 10/100mg' were also recalled. An MFDS official, said, “We will strengthen drug quality control and contribute to public safety through preemptive management of impurities that may be unintentionally mixed into drugs."
- Policy
- Will the novel anticancer drug Enhertu be reimb in April?
- by Lee, Tak-Sun Mar 04, 2024 05:52am
- After going through two Cancer Disease Deliberation Committee meetings and two Drug Reimbursement Evaluation Committee meetings, the anticancer drug ‘Enhertu’ has finally started drug pricing negotiations with the National Health Insurance Service. As the drug has passed drug evaluations after repeated revisions, the negotiations are expected to go smoothly. In particular, it will be interesting to see if the government grants reimbursement within April, as there are analysts who believe that the government is using the scenario of coverage before the parliamentary election. According to the industry on the 28th, the Health and Welfare Ministry recently issued a drug pricing negotiation order to the NHIS for Enhertu, after which the NHIS has begun full-scale negotiations. Enhertu 100mg Inj (fam-trastuzumab deruxtecan-nxki, Daiichi Sankyo Korea) was granted marketing approval in Korea in September 2022. The company applied for reimbursement coverage in December of the same year. In Korea, Enhertu is indicated to treat ▲ unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting and ▲ locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen. .As a HER2-targeted antibody-drug conjugate (ADC), Enhertu demonstrated clinical efficacy over existing agents .HER2-targeted antibody-drug conjugate (ADC) Enhertu reduced the risk of disease progression or death by nearly 50% compared with conventional chemotherapy, with an mOS of 23.4 months, which was a 6.6-month extension from the 16.8 months in the chemotherapy group .However, this high effect rather posed a hurdle during drug pricing evaluations .Due to the high survival rate, the duration of its use was expected to increase, making it difficult for the drug to pass the economic evaluation threshold .If the ICER value (incremental cost-effectiveness ratio) of a drug, which is used as an indicator for economic evaluation, exceeds the threshold, it makes it difficult for reviewers to recognize the adequacy of the drug’s reimbursement .Due to this, the Cancer Disease Deliberation Committee was held twice last year to set the reimbursement standard for the drug, and the Drug Reimbursement Evaluation Committee meeting, which makes the final judgment on the adequacy of reimbursements appropriateness of drugs, was held twice in January and February this year .Although the ICER value of Enhertu exceeded the threshold of KRW 50 million set for anticancer drugs, the threshold was reportedly lowered to a reasonable level after discussion with the authorities .The company is analyzed to have conceded a lot in terms of drug price .As the drug price and financial sharing have been somewhat clarified during the evaluation process, negotiations are expected to go more smoothly .This raises the possibility that the deal could be finalized earlier than the 60-day negotiation period and listed in April .As there is talk that the government may list Enhertu and promote it as an innovative new drug listing achievement before the general elections, this is expected to speed up the negotiation process .However, there is also an analysis that the MOHW’s negotiation order came later than expected, leaving insufficient physical time to complete negotiations before the Health Insurance Policy Review Committee meeting commences in March.
- Policy
- Patients bear 100% of Imfinzi cost for biliary tract cancer
- by Lee, Tak-Sun Feb 28, 2024 05:50am
- Reimbursement standards have been prepared for the use of combination therapy in biliary tract cancer in Korea. However, in consideration of health insurance finances, patients are required to the full cost of the high-priced immuno-oncology drugs. The Health Insurance Review and Assessment Service recently added the combination of immuno-oncology Imfinzi (durvalumab) with gemcitabine and cisplatin to the biliary tract cancer reimbursement standards after an opinion survey on the amendment to the notification on medicines prescribed and administered to cancer patients. This is the first time an immuno-oncology drug regimen has been added for biliary tract cancer. HIRA said that the cost of the Imfinzi+gemcitabine+cisplatin combination is too high relative to its clinical benefit to cover the entire regimen, therefore patients will need to bear a 100% copayment rate for Imfinzi and a 5% copayment rate for the other drugs, gemcitabine + cisplatin. In terms of eligibility, reimbursement standards are limited to histologically confirmed adenocarcinoma and exclude ampulla of Vater cancer. Currently, the drug price (upper limit) of Imfinzi is set at KRW 3,347,202 per vial (10 ml). The use of immuno-oncology drugs, which attack cancer cells by activating the body's immune system, is being applied to various cancer types. In Korea, it is being used in lung, head and neck, stomach, breast, and cervical cancers, and the use has now been extended to biliary tract cancer. In addition, the immuno-oncology drug Keytruda applied for reimbursement extensions to 13 cancer indications last year. Meanwhile, in the amendment to reimbursement standards for anticancer drugs, the use of FOLFIRINOX (oxaliplatin+irinotecan+leucovorin+5-FU) therapy (neoadjuvant chemotherapy) was newly added for pancreatic cancer and capecitabine monotherapy (adjuvant therapy) for biliary tract cancer. In addition, the phrase that restricts the use of enzalutamide (Xtandi soft capsules)+ADT and abiraterone acetate (Zytiga)+ADT regimens for prostate cancer has been removed. In acute myeloid leukemia, reimbursement for Xostapa is now approved without limiting the duration of treatment, regardless of their eligibility for hematopoietic stem cell transplantation As a result of the negotiations with the NHIS, the expected claims amount for Xostapa was set at KRW 124.1 billion, and an additional KRW 83.8 billion was with the reimbursement extension. However, the actual financial expenditure is expected to be less than this when considering the risk-sharing agreement. Xostapa agreed to a drug price of KRW 190,704, a 6.2% reduction from the current upper limit, starting in March.
- Policy
- AbbVie Korea will discontinue supply of Kaletra
- by Lee, Tak-Sun Feb 27, 2024 05:45am
- The HIV drug Kaletra, which was used as a first-line antiviral treatment during the COVID-19 outbreak, will be withdrawn from the domestic market. The decline in domestic demand is cited as the reason. On the 23rd, AbbVie Korea reported to the Ministry of Food and Drug Safety that will stop supplying Kaletra Tab(lopinavir + ritonavir) in Korea. The company explained, "In light of the decrease in demand for Kaletra and the fact that improved substitute options are well in supply, we plan to discontinue its supply." The company added that the impact on patients is expected to be minimal as improved alternatives are already well-established in the market. In consideration of the available improved alternatives to Kaletra, AbbVie said it will work to ensure that patient care is not disrupted through notifications and guidance to long-term care organizations and their patients. With the notification, Kaletra will be available only until October of this year. Kaletra was used as an antiviral drug during the first outbreak of the COVID-19 virus in February 2020. However, in August of that year, the National Medical Center’s Central Clinical Committee for New Infectious Diseases removed Kaletra from recommendations in the clinical practice guideline for the antiviral treatment of COVID-19. Instead, remdesivir was added in its place. The reasoning was that Kaletra seemed to have no or limited effect against COVID-19. At the time, the committee explained, "HIV-protease inhibitors, including Kaletra, are not generally recommended for COVID-19 and may be considered cautiously in very limited circumstances, such as in clinical studies.” Kaletra gave up the rights to its patent in early 2020, allowing generics to be developed around the world, but no generic versions have been released in South Korea since. Currently, Pfizer's Paxlovid and MSD's Lagevrio are the only officially authorized COVID-19 treatments in Korea.
- Policy
- Expedited domestic supply of suspended essential medicines
- by Lee, Hye-Kyung Feb 27, 2024 05:45am
- The timelines for domestic distribution of supply-disrupted essential medicines will likely be shortened to two months from four months starting this year. The Korea Orphan & Essential Drug Center (KOEDC) announced on the 27th their plans to ensure a stable supply through monitoring the supply and demand of orphan drugs and essential medicines in Korea and overseas, according to its ‘2024 Business plan.’ If supply monitoring indicates medical needs and urgency of medicines, the center will shorten the timelines for domestic supply through a preliminary survey of overseas medicines for expedited supply. Previously, the Ministry of Food and Drug Safety (MFDS) was responsible for confirming the expedited supply of essential drugs that had been suspended, and the center handled business related to imports and distribution. The plan for expedited supply of suspended essential drugs: the center will be responsible for implementing preliminary measures of expedited supply, such as independently conducting surveys of overseas medicines and domestic demands. Then, the MFDS will undertake administrative management of the expedited supply. From now on, the center will conduct preliminary measures of expedited supply, such as independently conducting surveys of overseas medicines and domestic demands. Then, the MFDS will undertake administrative management of the expedited supply. Furthermore, the center aims to strengthen the domestic self-sufficiency of suspended essential medicines by expanding consignment manufacturing (a new item per year). If a stable supply of the previously ordered items is achieved, the production will be transferred to private companies. The center will diversify their sources for purchasing (manufacturer, overseas wholesale business) drugs, especially for orphan drugs, to improve the system of imports and distribution of orphan drugs and essential medicines that are not available domestically. Furthermore, the center plans to shorten import timelines and reduce drug prices by discussing estimated demands with a distributor beforehand and obtaining three months of stock. Besides these plans, the center will strengthen its supportive measures. This includes improving the environment related to safe use of medicines and reducing patients’ financial burden by adjusting drug prices. The center will continue to offer support related to regular surveys of overseas medicines and adjustment of drug prices by reducing importing costs, tariff refunds via tariff and tax exemption, low-income funding projects for purchasing medicines (90 million won), and patient support (free supply) programs. “KOEDC will continue to survey and provide information related to the development of orphan drugs and put our efforts into providing patients with medicines that are necessary but unavailable domestically,” KOEDC President Jinseok Kim stated
- Policy
- Delayed actual transaction price cuts slash expected savings
- by Lee, Tak-Sun Feb 26, 2024 05:25am
- The implementation of the actual transaction price system intended to reduce the drug price has been postponed. Since the system was initially scheduled to take effect in January, the price monitoring investigation reached conclusion. However, the price adjustments are being delayed for various reasons. Pharmaceutical companies may benefit from the delay, but it results in financial loss for the National Health Insurance Service (NHIS) due to reduced effects of financial savings. According to industry experts on the 22nd, the price cutting of the actual transaction prices of drugs has been repeatedly delayed. It is unlikely to be implemented in March as it has not been included in this year’s Health Insurance Policy Review Committee agenda. Since the post-listing price cuts following the re-evaluation of the upper price limit are scheduled to begin in March, price cutting of the actual transaction prices of drugs is expected to be postponed. This delay is intended to allow the payer to take effective management of returns and budgets into account. However, it is unclear whether the policy changes will take effect in April. Financial savings may be negatively affected due to the delay in policy implementation. The government implements an actual transaction price system biannually. This system investigates the actual prices of drugs distributed in hospitals, except for national and public hospitals. If a drug’s actual price distributed is lower than the upper limit price, it is subject to a discount rate of 10%. The investigations exclude low-priced drugs and drugs that have been listed as shortage prevention drugs (SPD). The NHIS can expect financial savings through the system. The 2019 actual transaction price investigation resulted in price cutting of 3900 drugs, leading to annual financial savings of 42.1 to 112.9 billion won in 2020 and 2021, according to ‘Research on the comprehensive improvement of the actual transaction price system based on the effectiveness evaluation (P.I: Professor Kim, Jinhyun of Seoul National University).’ According to government data, adjusting the upper limit price of 3829 drugs based on the actual transaction price investigation resulted in a net estimated financial savings of 79.6 billion won in 2022. Since a price cutting of drug prices based on the actual transaction price investigation saves a minimum of 40 billion won annually, 10 billion savings in the first quarter are estimated to be lost due to delays in the implementation. The Ministry of Health and Welfare (MOHW) stated that the price cuts of the actual transaction price have been delayed because their review of National Essential Drugs and drugs in short supply is incomplete. The implementation timeline will be decided later, according to the MOHW. Every month, the price of drugs on the drugs shortages list has been increasing. In March, The prices of 49 items of tulobuterol patch are expected to increase by an average of 13.9% of the upper limit price. An additional designation of National Essential Drugs is planned for the first half of the year. However, critics argue that the NHIS is causing financial losses by delaying the price cuts not only for drugs under investigation but also for those where investigations have already concluded. The point is that the drugs in short supply or National Essential Drugs represent only a small fraction of the items investigated for actual transaction prices, and these can be adjusted during post-management. Another point is that the government is refraining from taking risks before the upcoming general election. The government may proceed with implementation cautiously because price cutting of drugs in short supply may lead to public criticism. “Is the government reluctant to take risks before the upcoming general election, despite their goal of efficiently managing finances by assessing the financial structure of national insurance?” a pharmaceutical industry representative emphasized. “If the government continues to delay the implementation, their expected financial savings will be reduced,” a representative added.
