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- 2025-12-21 09:32:20
- Policy
- SR version of gabapentin enters Korean market
- by Lee, Tak-Sun Nov 02, 2023 05:35am
- The first sustained-release formulation of gabapentin, which is used for nerve pain, has been introduced to Korea. The drug is Alvogen Korea’s Gralise SR Tab. The drug will be reimbursed from November and is expected to improve the convenience of intake for patients. According to industry sources on the 1st, Gralise SR Tab 600mg will be listed at KRW 648/tablet. It has improved the dosage guidelines from the 3 times a day with existing immediate-release tablets to once a day. The drug may be taken once daily with dinner. The Gralise SR was recognized as a drug that offers a new dosing method and strength, and the drug price was calculated at 110% of the insurance price ceiling set for the development target products. Therefore, its listed price became 10% higher than the highest price of KRW 589 given to the existing gabapentin immediate-release tablet 600 mg. However, its scope of indication is narrower than those for existing immediate-release tablets. Gralise SR 600 mg is only indicated for pain associated with postherpetic neuralgia. The immediate-release versions were also allowed used for epilepsy and neuropathic pain. The original gabapentin is Neurontin from Viatris Korea. The drug was introduced to Korea in 2000, and 174 products are currently approved on the market, indicating the highly competitive market. Based on UBIST last year, the original Neurontin's outpatient prescriptions amounted to KRW 21.4 billion. In a clinical trial on 359 patients with postherpetic neuralgia, Gralise SR showed a higher Cmax (highest blood concentration after drug administration) and a lower steady-state AUC (blood drug concentration) than its immediate-release version. The time to reach maximum plasma concentration (Tmax) was 8 hours, about 4 to 6 hours longer than immediate-release gabapentin. Graliz SR is an imported product developed by the US pharmaceutical company Almatica Pharma. It was approved by the FDA in 2011. Attention is rising on whether this drug, which offers an improved convenience, will rise to become a rival to Neurontin.
- Policy
- There were more than 20 doses of Dapagliflozin 5mg
- by Lee, Tak-Sun Nov 02, 2023 05:35am
- Forxiga 5mg, it was withdrawn from the domestic market Even though there are 21 SGLT-2 series Dapagliflozin propanediol hydrate 5mg products listed for reimbursement, the stepped drug price was not applied to the newly listed items in November. Why? This is because all 21 products were viewed as first-time registered products. According to the industry on the 1st, Nexpharm Korea's 'Floga 5mg' met the standard requirements when it was listed for reimbursement in November, and was added to the 59.5% given to first generics to the existing highest price of the same drug, setting a price of 291 won per tablet. Even though there are already 21 generics on the benefit list, they were calculated using the highest price formula. The stepped drug price system implemented in 2020 is such that when generics enter the market with more than 20 already listed identical products, the price is capped at 85% of the lowest price for the same drug or 38.69%. However, this time, the stepped drug price was not applied. This is because, in the case of a first-registered product, multiple products are considered one. Dapagliflozin 5mg was listed for the first time in Korea on April 8. AstraZeneca's original drug, Forxiga 5mg, was listed on the reimbursement list in 2014 but was deleted in 2018, so there was no identical drug on the reimbursement list at the time of listing the generics. Therefore, all 21 products listed for reimbursement on April 8 were recognized as first-listed. However, for the same drug that will be registered in the future, a stepped drug price will be applied. From now on, drug prices will be calculated based on the total number of registered items, including the first listed products. Therefore, the next item listed for benefit is calculated at 85% of the lower of the lowest price for the same product or 38.69%, regardless of whether the standard requirements are met. Nexpharm Korea's Floga 5mg was listed for reimbursement 7 months later than competing drugs, but was fortunate enough to receive a high price. An industry official said, "The generic calculation standards themselves were complicated, so in the case of Dapagliflozin 5mg, it was not possible to know whether the stepped drug price would be applied in the field." He explained, “It was only later that I understood why Nexpharm products received the highest price plus extra.”
- Policy
- Complete deletion of Ranitidine from the list of benefits
- by Lee, Tak-Sun Nov 01, 2023 05:40am
- Most ranitidine products, which were suspended due to adulteration in September 2019, will be removed from the reimbursement list as of November. This is because there has been no production performance over the past three years or no insurance benefit claims over the past two years. There are only three Ranitidine products remaining on the November list. According to the industry on the 30th, unclaimed medicines were deleted and unproduced, and expired medicines were deleted from the November benefit list, leading to the expulsion of the majority of ranitidine preparations. Ranitidine preparations were suspended on September 26, 2019, after the impurity NDMA (N-nitrosodimethylamine) was detected. Although it has been on the benefits list with benefits suspended, it has been completely removed from the list due to the recent overhaul of unclaimed and unproduced medicines. In order to normalize the benefits, there is no choice but to apply for benefits again, but as it is analyzed that it will be difficult to maintain the license through renewal, it appears that it will virtually be permanently excluded from the market. Unclaimed medicines are those that have not been claimed for insurance benefits over the past two years (July 1, 2021 - June 30, 2023) and are subject to deletion from the benefits list. 125 items were deleted from the November list. Unproduced or expired medicines are medicines that have not been produced or imported for the past three years (January 1, 2020, to December 31, 2022) and are deleted from the benefit list if their expiration date or expiration date has expired. This time, 961 items were deleted. Ildong Pharmaceutical's Curan (5 products), which was the flagship product of a single ranitidine drug, was deleted due to non-production and expired expiration dates. Daewoong Pharmaceutical's Albis Tablet, which had the highest performance among combination drugs, was also removed from the benefits list due to non-production and expiration date. This time, 46 items identical to Alvis disappeared from the benefit list. Now, there are only three ranitidine products remaining on the payroll list. The combination drug is Anacid from Aju Pharmaceutical, and the single drug is Genupharma Latini Tablet and SCD Ranitidine 150mg. The three items were also suspended as of September 26, 2019.
- Policy
- Hanmi recieves 1st approval for aspirin+rabeprazole combo
- by Lee, Hye-Kyung Nov 01, 2023 05:40am
- With the development of aspirin and rabeprazole sodium combinations in active progress, Hanmi Pharmaceutical successfully obtained the first marketing authorization for its combination drug. The Ministry of Food and Drug Safety approved Hanmi Pharmaceutical's Raspirin Cap. 100/5mg (aspirin/rabeprazole) on the 30th. The combination of aspirin and rabeprazole is considered a way to minimize the side effects of aspirin and is proposed as an alternative to the combined use of low-dose PPI agents. The Ministry of Food and Drug Safety included the aspirin+rabeprazole combination as a subject for the new drug development support it provides for Korean incrementally modified drugs, which is expected to lead to continued approvals of such combinations in the future. The rabeprazole combination was developed to prevent the side effects of bleeding that follow the long-term use of aspirin in patients with gastric and duodenal ulcers who take aspirin to inhibit blood clot formation. Aspirin is indicated for patients with a history of gastric or duodenal ulcers who need to inhibit thrombus formation in myocardial infarction, cerebral infarction, and unstable angina; or inhibition of thrombus formation after coronary artery bypass graft (CABG) or percutaneous coronary coronary angioplasty (PTCA); or reduction of cardiovascular risk in high-risk patients (patients with complex risk factors such as family history of ischemic heart disease, hypertension, hypercholesterolemia, obesity, and diabetes) Rabeprazole is a proton pump inhibitor (PPI) that has a mechanism to suppress gastric acid secretion. The ingredient comes in various doses ranging from the lowest dose of 5 mg to 10-20 mg. Adults take 1 Raspirin capsule (aspirin/rabeprazole sodium 100/5mg) once a day. The total market for aspirin is worth about KRW 46 billion based on UBIST’s outpatient prescriptions last year. In addition to Hanmi Pharmaceutical, which received approval for the combination of aspirin and rabeprazole, domestic developers such as Youngjin Pharm and GL Pharm Tcch are preparing to receive approval for their drugs.
- Policy
- HIRA ‘Will advance CDDC result disclosure within the year'
- by Lee, Jeong-Hwan Oct 31, 2023 05:35am
- The Health Insurance Review and Assessment Service announced that it will pursue systemic advancement within the year so people can gain access to details such as the reasons for the evaluations made by the Cancer Disease Review Committee. HIRA also revealed plans to review the scope, method, and timing of disclosure of the details of the meeting results, on how they will only be disclosed when it has a ingsingificant impact on the Ministry of Health and Welfare's reimbursement policy or reimbursement order. In addition, the authorities announced that they will include experts recommended by consumer and patient groups as members in the next committee composition stage set for the end of the year. On the 27th, HIRA responded so to the criticism raised by the National Assembly’s Health and Welfare Committee at the NA audit. Rep. Jeoung-ae Han of the Democratic Party of Korea urged the committee to disclose the results of the CDDC meeting in more detail and prepare ways to better reflect patient opinion in the committee's decision-making process. HIRA responded that CDDC, which reviews the standards and methods to apply reimbursement to anticancer drugs prescribed and administered to seriously ill patients, has been disclosing the deliberation results on its website immediately after its meeting since 2021 in response to the rising social interest. However, the authorities also added that specific details are not being disclosed due to regulations that restrict their disclosure, including sensitive information such as the pharmaceutical company’s trade secrets or when follow-up procedures are in progress. Instead, HIRA promised to advance the system within the year to broaden the disclosed details such as specific evaluation stages and reasons for evaluation of applicants to improve the predictability of CDDC's review results. After advancing the system, HIRA will consult the MOHW to review ways to expand the disclosure of cancer information and improve it so that experts recommended by patient groups can participate in the committee. Regarding the composition of the committee, 4 experts recommended by consumer and patient groups can be added out of the total quota of 45, but only 1 expert is currently participating in the committee due to the insufficient number of recommendations made from related organizations when composing the current committee in 2021. So the improved system will seek to address this problem as well. HIRA said, “We will review the scope, method, and timing of disclosure of the meeting details, but only for those whose reimbursement standards have not been set, and their disclosure is met with a high level of social interest and has relatively little impact on the Ministry of Health and Welfare’s reimbursement policy or order. We will fill the quota of recommended experts by allowing consumer and patient groups to recommend cancer-related experts regardless of the relevant cancer type to fill the quota of recommended experts when forming the next committee.”
- Policy
- Roche Lunsumio, domestic approval imminent
- by Lee, Hye-Kyung Oct 31, 2023 05:35am
- According to the pharmaceutical industry on the 30th, the Ministry of Food and Drug Safety completed the safety and effectiveness review of Lunsumio. Completing this review means that the product approval process will soon begin. Lunsumio was designated as a GIFT item as the urgency of its introduction to expand patient treatment opportunities was recognized as the target disease is relapsed or refractory follicular lymphoma and is a drug for which there is no existing treatment. When designated as a GITF target, the review period is shortened by at least 25% (e.g. 120 → 90 working days), the rolling review is applied to review prepared materials first, close communication between reviewers and developers through product briefing sessions and supplementary briefing sessions, and regulatory-related expertise. You will receive a variety of support for rapid productization, including consulting. Lunsumio was designated as a GITF on November 29th of last year, and it is understood that it would take about 11 months from review to approval if the approval announcement is made as early as the end of this month or at the latest in early November. The Ministry of Food and Drug Safety emphasized that the time taken may vary from pharmaceutical company to pharmaceutical company when requesting supplementary data as the reason why it took longer than the originally targeted shortened review period. There are a total of 17 items designated as GIFT targets, and GIFT approvals are expected to continue one after another, starting with the first, Lunsumio. Lunsumio was approved by the U.S. FDA in December last year as a treatment for adult patients with relapsed or refractory follicular lymphoma (FL) after receiving two or more systemic treatments. This drug is a bispecific antibody that engages CD20xCD3 T cells and has a mechanism to connect immune cells and cancer cells by selectively binding to T cells and malignant B cells, which are immune cells that attack cancer cells. Lunsumio confirmed its potential through Lunsumio's phase 2 clinical trial GO29781 study conducted on patients with follicular lymphoma. The study found that Lunsumio's ORR was 80% (72/90), with the majority (57%) having responses that lasted at least 18 months. The proportion of patients who achieved a complete response was 60% (54/90), and the mDOR of response for patients who responded to treatment was 22.8 months.
- Policy
- Dupixent receives the green light for reimb extensions
- by Lee, Tak-Sun Oct 30, 2023 05:30am
- The insurance authorities showed a positive stance on expanding coverage of Dupixent (dupilumab, Sanofi), which is available for patients with severe atopic dermatitis from 6 years of age, to critically ill infants and toddlers from 6 months to 5 years of age. Depending on the cost-effective review results, the reimbursement process may gain momentum in the future. In addition, it appears that the authorities are also reviewing reimbursing the drug for another indication, asthma. The Health Insurance Review and Assessment Service recently revealed so in response to a written inquiry they received at the NA audit. Last April, Sanofi applied HIRA to expand reimbursement so that infants and young children with symptomatic atopic dermatitis from 6 months to 5 years of age can also receive reimbursement for the drug.”. Dupixent obtained the relevant indication from the Ministry of Food and Drug Safety on November 3 last year. The indication was approved based on the results of a Phase III clinical trial (LIBERTY AD PRESCHOOL) that was conducted on atopic dermatitis patients aged 6 months to 5 years of age, which confirmed a significant improvement in AD lesions compared to the placebo group. HIRA subsequently held an expert advisory meeting and reported the review plan to the Ministry of Health and Welfare to secure the feasibility of expanding Duppixent’s reimbursement to infants and toddlers. A full-scale cost-effectiveness evaluation will be conducted accordingly. Regarding the application of reimbursement for the asthma indication, the agenda is also expected to enter the cost-effectiveness evaluation stage soon. It is said that the reimbursement standards were set after two expert advisory meetings held to prepare the reimbursement standards. Dupixent is indicated for severe eosinophilic asthma and oral corticosteroid-dependent severe asthma in adults (aged 18 and older) and adolescents (aged 12 to 17). At the expert advisory committee that took place last July, the members decided that the reimbursement standards should be set, but undergo additional expert advice on the unification of terminology and detailed standards with other drugs in the process of being listed for reimbursement for the same indication. Additional expert advice and opinion collection were conducted thereafter. Based on this, if a reimbursement standard plan is prepared and reported to the Ministry of Health and Welfare, a cost-effectiveness evaluation for the indication will also begin, similar to the case of AD in infants and toddlers. As Cinqair Inj and Nucala Inj, which are biological asthma drugs, have recently succeeded in being reimbursed, the possibility of Dupixent's successful reimbursement expansion has also been increasing. Of course, it takes a considerable amount of time to evaluate cost-effectiveness and it is not easy to pass, so it is currently impossible to predict when the reimbursement expansion will take place. Nevertheless, as the feasibility of expanding the salary standard has been recognized, it is expected that the reimbursement process can accelerate if pharmaceutical companies are willing to present appropriate cost-sharing plans. In addition to the reimbursement extension, Dupixent is also in the process of renewing its risk-sharing contract. After the first round of RSA renewal negotiations broke down, it seems highly likely that a contract renewal will be agreed upon in the second round of negotiations. Attention is being paid to whether Dupixent's Sanofi will be able to kill two birds with one stone, by expanding reimbursement and renewing the risk-sharing agreement, remains to be seen. Based on IQVIA, Dupixent posted sales of KRW 105.2 billion in 2022. As claims are expected to increase further this year due to reimbursement extension to children and adolescents, there is a possibility that the pharmaceutical company's share of the burden will increase with the renewal of the risk-sharing system.
- Policy
- NA criticizes HIRA's low prior approval of specific drug
- by Lee, Tak-Sun Oct 30, 2023 05:29am
- In response to the criticism that the prior review approval rate of certain drugs is low, the Health Insurance Review and Assessment Service said that the low rate is due to a lack of understanding of the reimbursement standards and that it will maintain the current standards. The response was made regarding the low approval rate of Soliris for aHUS (atypical hemolytic uremic syndrome) disease. On the 18th, Rep. Sun-Woo Kang of the Democratic Party of Korea made a written inquiry about the low prior approval rate of certain drugs used for aHUS during the NA audit of the Health Insurance Review and Assessment Service. aHUS is a severe and rare hereditary disease in which 79% of patients die or require dialysis within 3 years of onset and suffer permanent renal failure. Also, patents with aHUS experience 'thrombotic microangiopathies (TMA)' (a condition in which blood clots and inflammation damage small blood vessels throughout the body), and major organs such as the kidneys, heart, and brain become damaged, bringing about various complications such as acute renal failure, heart failure, and stroke. In acute cases, the disease can tear internal organs within 1 week, especially the walls of the kidneys, which severe cases lead to death. The prior approval system was implemented in 1992 as a system that allows a prior review subcommittee, which consists of several experts, to decide whether or not to allow reimbursement for each case before treatment to allow patients in dire need of treatment with high-priced rare disease treatments. The system has been applied to pharmaceuticals since 2007. This is not the first time Soliris' low approval rate for aHUS has been raised as an issue. According to the data presented by Yong Kyun Won, Professor of Radiation Oncology at Soonchunhyang Univ. Cheonan Hospital, Soliris’s prior approval rate for aHUS was only 21.6%. None of the 6 new applications filed in July that were disclosed by the HIRA passed expert review. This is why experts in the field have expressed concerns saying, "If the prior review approval rate is low, the prescribing doctor may give up use of the drug in advance, impeding patient access to treatment." However, HIRA has been arguing that the low approval rate is not a concern, rather, it is due to a lack of understanding of the reimbursement standards. In a response to Rep Kang’s written inquiry, HIRA stated, "The approval rate for aHUS is low because medical institutions have been filing many applications to receive help from experts in the prior review subcommittee on determining the reimbursement adequacy of their patients or apply with a lack of knowledge about the reimbursement standards, rather than clearly determining the eligibility and exclusion criteria themselves based on each patient’s medical records. In addition, regarding the criticism about the strict reimbursement standards, HIRA answered, “A reimbursement t expansion request has been filed recently, asking for ‘'ease of the TMA requirements in the aHUS salary standards.’” After discussing the request at an advisory meeting, including experts from related societies such as the Korean Society of Nephrology, they concluded that the current standards should be maintained, as no new clinical evidence has been generated to warrant a change, and the prior review subcommittee has been reviewing the situation of each patient in consideration of the comprehensive situation of each patient for cases that require medical judgment.” Despite so, concerns have continued to rise in the field. In a survey conducted on relevant societies in the ‘Current Status and Improvement Plan for Medical Benefit Prior Approval System (2022)’ that was conducted by HIRA, the relevant societies said that the criteria for selecting target drugs for the prior review system have not been specified, and the varying composition of the expert committee members that discuss each reimbursement can bring different results. Related academic societies said, “Although the prior review application process in itself is complicated, there is a lack of sufficient explanation regarding the progress or reasons for disapproval. Patients miss out on the appropriate treatment period due to the prior review meeting schedule, which is held once or twice a month. Therefore, flexible operation may be necessary to review cases that arise by case." In addition to Rep Kang, Rep Chounsook Jung from the same party had also raised the issue of the prior review approval rate of a specific drug. Jung made a written inquiry to the health authorities regarding the cases of disapproval of Spinraza, which is used to treat spinal muscular atrophy (SMA), and the need for their improvement. Spinraza’s scope of administration has been expanded starting in October. Its subjects have been expanded from those under the age of 3 to those under the age of 18 who show onset of symptoms. Rep. Jung pointed out that measures are needed for patients who were not approved before the change of the standards. Regarding this, HIRA said, "Patients who were previously disapproved because they did not meet the existing age requirements may be able to receive reimbursement if they meet all the reimbursement requirements after evaluation through the prial approval process in line with to the expansion of the age requirement. However, patients who were disapproved while receiving other drugs after review would need to consider that their decision was made based on the expert opinion that ‘after a close and careful review of the medical records (progress record, test results, video, etc.), the members of the ‘prior review subcommittee’ that consist of many experts made the professional medical judgment that ‘it cannot be determined whether the motor function can be maintained or improved with administration of the medication.” HIRA added, “We also have a relief procedure that allows patients and caregivers to file an appeal to the prior review results, and committee members rediscuss the rejected cases based on the submitted explanatory material. If the patient or institution has an objection to the appealed results, they may seek relief for the patient’s rights through administrative adjudication by the Health Insurance Dispute Mediation Committee." HIRA added that 10 administrative adjudications have been filed, 8 of which were rejected, and 2 are under review.
- Policy
- New dug price reeval standards will be set within the year
- by Lee, Jeong-Hwan Oct 27, 2023 05:33am
- The Health Insurance Review and Assessment Service said, “We will prepare a final plan within this year” to an inquiry on the progress made on the reevaluation of off-patent drugs through a comparison of overseas drug prices. In particular, based on the established reevaluation standards, HIRA also expressed their intention to sequentially carry out reevaluations starting next year and reduce the prices of drugs listed at higher prices compared to overseas to secure the financial sustainability of Korea’s national health insurance. Such will were found in the response submitted to answer People Power Party Rep. Young-Hee Choi’s written inquiry during the NA audit on the 25th. Regarding the comparison of overseas drug prices, HIRA explained that it had improved the foreign drug price reference standard (foreign drug price conversion formula) through the operation of a working group with the pharmaceutical industry last year. HIRA is currently working with the Ministry of Health and Welfare to prepare a plan to compare and reevaluate overseas drug prices of listed drugs and announced that it will prepare a final plan within this year after gathering opinions through meetings with the pharmaceutical industry. HIRA said, “We plan to carry out the revaluations sequentially on an annual basis starting next year. We will secure the sustainability of health insurance finances by managing the expenditures spent on drugs listed at a higher price compared to foreign countries.”
- Policy
- Galvusmet generics released in all dosage forms in KOR
- by Lee, Tak-Sun Oct 27, 2023 05:33am
- Novartis Korea The second round of competitions is now on with the entry of Galvusmet generics. If the first round was held between generics before and after Galvusmet’s substance patent expiry, the second round this time expected this time is set to start with the release of Galvusmet generics that come in all dosage forms. According to the industry on the 26th, Daewoong Bio, Mothers Pharmaceutical, and Korea Hutex Pharmaceutical, led by the contracted CDMO Genuone Science, will launch all dosage forms of Galvusmet generics. Galvusmet is a combination of the DPP-4 inhibitor vildagliptin and metformin hydrochloride. Novartis Korea received approval for the drugs in 2008 in Korea. It had been offered in three doses, Galvusmet Tab 50/500mg, Galvusmet Tab 50/850mg, and Galvusmet Tab 50/1000mg. Five companies (United Pharma Korea, Shinpoong, Ahn-gook, Ahn-gook New Pharm, Samjin) had previously released a 50/500mg dosage of the same-ingredient generic. Only Hanmi Pharmaceutical’s Vildaglmet Tab and KyungBo Pharma’s Vildamet Tab offered all the dosage forms offered by Galvusmet, and were self-modified drugs. So this is the first time 50/850mg, and 50/1000mg same-ingredient generics are being released in Korea. Last year, Galvus (including single and combination drugs) posted outpatient prescription sales of KRW 14.5 billion (UBIST data). Among the amount, the original Galvus series posted KRW 32.4 billion in prescriptions, down 30% YoY due to the release of generics. Among the latecomers, Hanmi’s Vildagle series showed the highest performance of KRW 3.9 billion. The analysis is that the company succeeded in preoccupying the market by launching a variety of dosage options. The competition is expected to intensify further with the release of the generic versions in all dosages. In particular, these Galvus generics were released after the enforcement of patent avoidance and bioequivalence t sharing regulations 1 (consignee) + 3 (consignor) and therefore will have fewer competitors than Forxiga or Januvia, which will work in favor of the generic companies in terms of sales and marketing. Also, the fact that the market size for the combination drug Galvusmet is 5 times larger than that of its single-agent drug Galvus is also a factor that the generic companies are looking forward to. Last year, Galvus recorded outpatient prescriptions of KRW 5.4 billion, while Galvusmet recorded KRW 26.9 billion.
