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- 2025-12-25 02:54:34
- Policy
- HIRA rejects reimbursed use of Spinraza on 14-year-old
- by Lee, Hye-Kyung Dec 03, 2019 05:53am
- Approval on reimbursed use of Spinraza (nusinersen) on a 14-year-old male patient with 5q spinal muscular atrophy (SMA) was denied. The application submitted by the hospital was rejected as it did not clarify if the patient had developed clinical symptoms of SMA before 36 months. On Nov. 29, Health Insurance Review and Assessment (HIRA, President Kim Seung-taek) posted seven cases of Treatment Review and Evaluation Committee deliberation in October. Although Spinraza was listed on the Drug Reimbursement List from last April 8, a healthcare institute planning to use the treatment has to submit a preliminary drug use approval application due to the ultra-expensive maximum reimbursement price reaching 92,359,131 won per 5 ml vial. In last month, 15 preliminary drug use approval applications on Spinraza, including 13 first loading doses and two maintenance doses (application submitted once every four months), were submitted. But the committee disapproved only one case, which involved a 14-year-old boy. Other 11 first loading doses and two maintenance doses were approved, and one first loading dose was approved with conditions. The conditional approval was granted to a five-month-old female infant trying to get detached from ventilator. The committee approved of reimbursed use of Spinraza as long as the patient submits medical profession’s statement on use of ventilator prior to Spinraza administrations and medical record of respiratory function. Before the Spinraza review, the committee reviewed 34 preliminary applications on use of Soliris (eculizumab), including 23 cases of paroxysmal nocturnal hemoglobinuria (PNH) and 11 cases of atypical hemolytic uremic syndrome (aHUS). For the first loading dose, one PNH case was accepted and other one was rejected. Whereas three cases of aHUS patients were accepted and other three were rejected. Use of Soliris on a PNH case denied as the patient’s medical record was missing repetitive abdominal pain-induced hospital administration, but showed a recent increase in use of narcotic analgesic. The patient’s record did not meet scope of reimbursed use of the treatment. An aHUS case was rejected because the patient’s status was not clear cut as stated in the criteria. The patient’s symptom was considered as a secondary thrombotic microangiopahty induced from rheumarthritis and its treatment, and from multiple myeloma and its treatment. And also the patient showed rise of CEA level, delayed prothrombin time and activated partial thromboplastin time (PT/aPTT), and fall of fibrinogen level. The committee also decided the patient cannot expect positive effect from the treatment as the patient needs dialysis for end-stage renal disease. A preliminary approval review on reimbursed ventricular assist device (VAD) treatment was conducted as well. A male patient aged 64 years was registered on the heart implant waiting list with dilated cardiomyopathy (DCM), who was diagnosed with end-stage heart failure by an echocardiography with dobutamine substance and motor function test. The patient did not recover from medication treatment and is dependent on intravenous cardiotonic agent. HIRA approved reimbursement on the patient’s VAD treatment, because the case met the reimbursement standard of ‘indication for VAD implant on end-stage heart failure patient, who has been registered on heart implant waiting list as a makeshift treatment’. Also the patient not showing any contraindication helped the decision. Other details of the Treatment Review and Evaluation Committee’s October meeting can be found on HIRA website (www.hira.or.kr).
- Policy
- 'Ongentys' by SK Chemicals approved in Korea
- by Lee, Tak-Sun Dec 02, 2019 05:56am
- SK Chemicals obtained a domestic item approval for Parkinson's disease treatment,‘ Ongentys Capsule (Opicapone)’. This product is expected to be a new drug in the Parkinson's disease market after a long interval. The Ministry of Food and Drug Safety approved the marketing of SK Chemicals 'Ongentys Capsule 25mg, 50mg' on the 26th. This drug has been approved as an adjuvant therapy for levodopa/dopa decarboxylase inhibitors (DDCI) in patients with Parkinson's syndrome who have symptoms of locomotion that do not improve with levodopa/dopa decarboxylase inhibitor (DDCI) standard therapy. As a COMT inhibitor, it has a mechanism to improve the drug efficacy by increasing the plasma concentration of levodopa. Levodopa is a medicine that supplements dopamine, a brain neuron that Parkinson's patients lack. Ongentys has demonstrated efficacy and safety in a clinical trial in 1027 patients who are receiving Parkinson's treatment with levodopa/DDCI (alone or in combination with other anti-Parkinson medications) and who have symptoms of exercise fluctuations. Developed by BIAL, the largest pharmaceutical company in Portugal, SK Chemicals signed an exclusive sales contract with Bial in March 2018. Within a year since its first commercialization in Europe in 2016, the company is expanding its market rapidly, exceeding 10% market share in the same field market in Germany and Spain. The domestic Parkinson's disease drug market is estimated at ₩80 billion. As Ongentys is licensed as an adjuvant for levodopa, the market for product sales is expected to be smaller than the total market. Competitive drug 'Comtan' (ingredient name: Entacapone, Novartis Korea), which has a similar mechanism to Ongentys, recorded sales of 850 million won by IQVIA in last year. Comtan is also licensed as an adjunct to levodopa/dopa decarboxylase inhibitors, like Ongentys. An official of SK Chemicals said, "Ongentys will be a treatment alternative that will improve the motor agitation symptoms that are typical of Parkinson's patients". "We will strengthen our portfolio of central nervous system-related therapies to contribute to the establishment of a national health right," he said.
- Policy
- Generics for Galvus, focus on development strategy
- by Lee, Tak-Sun Dec 02, 2019 05:56am
- 노바티스 The development of generic drugs for Galvus (Vildagliptin by Novatis Korea), which is a DPP-4 inhibitor for diabetes mellitus is continuing. In particular, while Ahn-gook pharmaceuticals and Hanmi Pharmaceuticals have already completed their commercialization and anticipated market preoccupation, pharmaceutical companies' strategies to penetrate this gap and enter the market early on are drawing attention. According to the MFDS and the industry, pharmaceutical companies that are currently developing generics for Galvus include Ahn-gook Pharmaceuticals, Hanmi Pharmaceuticals, Korea United Pharm, inc, Kolmar Korea, and Alvogen Korea. The generic drug Angukvildaliptin tablets 50mg by Ahn-gook Pharmaceuticals approved on 22nd last month. Hanmi Pharmaceuticals also applied for a salt alteration drug in last July. Ahn-gook pharmaceuticals and Hanmi pharmaceuticals laid the groundwork for the market by the end of August 2021, citing a request for an extended trial invalidation filed in the Galvus material patent. In addition, both companies have a strong chance of obtaining a preferential selling license to monopolize the generic market for nine months. Both companies which have the rapid speed of patent challenge and commercialization has increased the likelihood to obtain benefit of first generics. Given this scenario, it is likely that other pharmaceutical companies except for Ahn-gook & Hanmi which are likely to get exclusivity for generic product , will enter the market late. But second-runners, Korea United Pharm, inc, Kolmar Korea, and Alvogen Korea. also have the opportunity to accelerate their time to market. They are developing generics for Galvus late for that niche market. In order to avoid the sale ban period under exclusivity for generic product of Ahn-guk and Hanmi, they must prevail over revised drugs such as salt changes, slow-release drugs, or through appeals of different nature. Korea United Pharm, inc, which received approval for the bioequivalence test plan last September, and filed a patent trial earlier last month, is conducting patent trials in a manner other than the successful patent challenge method of Ahn-guk and Hanmi. If Ahn-guk & Hanmi succeeded in the patent challenge through the extended period of invalidity trial, Korea United Pharm, inc raised the right to confirm the scope. There are different kinds of judgments, but there are similar aspects in attempts to neutralize extended durations. However, due to the different methods of patent challenge, if Korea United Pharm, inc wins the Scope of Rights Judgment, it could be a new exclusivity for generic product vendor. However, there is a premise that the company must win the referee. Alvogen Korea was approved last month on the bioequivalence protocol, which identified the drug as Vilagliptin sustained release tablets. In some cases, Galvus may be administered twice daily, and Vildaliptin sustained-release tablets appear to be a reduced version of the drug once daily. In any case, if sustained-release tablets are commercialized, they will be able to plan early market launches in their own way, regardless of previous generic patents. Kolmar Korea, who was approved for a bioequivalence test on the 25th of last month, has yet to disclose how to circumvent exclusivity for generic product because there is no patent challenge. However, there is an observation that it is asking for a passive jurisdiction judgment like Korea United Pharm, inc. What's important is that latecomers such as Korea United Pharm, inc, Kolmar Korea, and Alvogen Korea will have to succeed in product development and win a patent challenge in order to evade exclusivity for generic product and enable early release scenarios. So far, only scenarios have emerged, making it most likely that a licensed Ahn-guk will have a monopoly in the generic market. There are only nine new DPP-4 inhibitors, and competition among companies is fierce, but it is not open to generics. Among them, Vilagliptin formulations for Galvus are likely to become the first generic product in the DPP-4 inhibitor market.
- Policy
- “Cost-effectiveness review inevitable for high-cost drugs”
- by Lee, Jeong-Hwan Nov 30, 2019 05:51am
- Korean Minister of Health and Welfare Park Neung-hoo stated the ministry would approach the issue of National Health Insurance (NHI) coverage on super expensive drugs by evaluating cost-effectiveness of treatment and pharmaceutical opportunity cost. Particularly, Minister Park highlighted insurance covered drug pricing system in Korea is comparatively reasonable than other countries. At the recent annual audition session by National Assembly Health and Welfare Committee, Minister Park answered Lawmaker Chang Jung-sook’s questioning. Lawmaker Chang’s question was on the pharmaceutical benefit issue from the NHI coverage enhancement policy, the ‘Moon Jae-in Care.’ She argued patients with severe diseases are still struggling with insurance coverage on high-cost drugs, despite Ministry of Health and Welfare (MOHW) is positively evaluating Moon Care’s performance. The lawmaker specifically pointed out about increasing number of global pharmaceutical companies giving up on bringing in new treatment or immunotherapy for severe diseases to Korean market due to MOHW’s unreasonable pharmaceutical benefit policy for high-cost drugs. “I applaud the government’s endeavor in challenging negotiation to set favorable pricing for the NHI. However, the public would eventually reprehend the government for betting patients’ lives on the table if the government relentlessly press companies on to reduce drug price on severe disease treatment”, Lawmaker Chang claimed. “84 percent of the Citizen Council for NHI that formed last year agreed on providing insurance benefit on severe disease treatment with small patient size, and on removing mild health condition treatment from reimbursement listing. The government should urgently help those patients in severe condition and in desperate need for treatment access”, Lawmaker Chang added. Minister Park partially agreed with the lawmaker’s argument, but explained the reality of MOHW how it has no choice but to keep cost-effectiveness in mind when deciding on insurance benefit for high-cost drugs. “The lawmaker’s criticism is right, but partially. NHI coverage should be considered from all sides as there are extremely expensive drugs at an unbelievable price of over hundred million won. We need to ponder on whether to save one patient with hundred million won, or to save ten patients with cost-effective price”, the minister stated. Minister Park also elaborated, “The government is not neglecting patients with severe condition. But we are trying to balance out the cost-effectiveness. Recently I was in ministerial meetings with Dutch and Danish health ministers on the topic of medicine access. And they personally expressed gratitude towards Korean government for having a proper control over high-cost drugs. In some countries, the expensive drugs cost tenfold of price in Korea. Korea is actually keeping the balance in global market.” “Despite all, it is right for the NHI coverage to center treatments for severe condition. The government would continue to seek out for reasonable plan to expand coverage through discussion”, he added.
- Policy
- NHI billing soars and brings down Xeljanz price by 9%
- by Eo, Yun-Ho Nov 30, 2019 05:50am
- Starting from next month, reimbursed price of Pfizer Korea’s Janus kinase (JAK) inhibitor Xeljanz (5 mg) is to be lowered by 9 percent. The treatment is now included as subject for price-volume agreement (PVA), because the actual insurance billing amount was surged by 30 percent than the initially estimated amount. Also for Allergan Korea’s Pred Forte Eye Drop, its reimbursed price would be brought down by 1.7 percent as actual billing amount of the same class items was surged by 30% than the estimated amount. Human growth hormone injection Eutropin by LG Chem is now a subject for preliminary price reduction by 3.3 percent after securing an additional indication. According to pharmaceutical industry source on Nov. 22, the government is preparing an updated list of reimbursed drug price and upper limit price with the said changes. When the list is finalized, the updated prices would be in effect from Dec. 1. First, the weighted price of Myungmoon Pharm’s Taro Ammonium Lactate Cream (12 percent) is to be adjusted by discretionary arbitration from October, 2020. Its price would be brought down by 21.2 percent, from 16,650 won to 13,112 won. The treatment’s price is to be dropped when the discretionary price adjustment ends the weighted pricing period. The government provides weighted pricing at 70 percent of the original’s price to the first generic to get listed, which it lasts for a year. But if there are less than three manufacturers with the equivalent class of generics after a year, the weighted pricing can be maintained until the fourth one is listed. After negotiating with National Health Insurance Service (NHIS), three items now have PVA in type Ga (가) and Na (나). Their listed price would also fall and it would be reflected from next month. Categorized as type Ga, Allergan Korea’s Pred Forte Eye Drop was initially listed after pricing negotiation but actual NHI billing amount of other items in the same class surpassed the estimated amount by 30 percent since the point of negotiation. Pricing of the eye drop in 50 mg/5 mL vial and in 0.1 g/10 mL vial are to go down from 2,569 won to 2,525 won, and 5,138 won to 5,050 won, respectively, by 1.7 percent. Although not categorized as type Ga, Xeljanz tablet was categorized by PVA type Na after being listed for four years. The overall billing amount of other items in the same class has gone over the estimated amount by 30 percent, and the tablet was then included among the group of items in the same class with adjusted upper limit price. Xeljanz met the criteria of PVA type NA, which recognizes an item with actual insurance billing amount increased from the year before by either 60 or 10 percent, and by over 5 billion won. According to the negotiation result, the treatment price is to be reduced by 8.9 percent from 12,992 won to 11,836 won. Five items, including Pfizer’s Genotropin injections (16IU and 12 mg), LG Chem’s Eutropin Plus injection (24 mg), Eutropin injection and Eutropin Pen, are subject for preliminary drug price reduction with expanded indication. These drug items are to reduce prices beforehand considering additional estimated billing amount and increase rate based on expanded indications. Reimbursed prices of Genotropin injection 16IU and 12 mg vial are to get reduced by 2.6 percent, from 91,920 won to 89,530 won and 195,790 won to 190,699 won, respectively. All Eutropin injection prices are to get lowered by 3.3 percent each. Prices of Eutorpin Plus injection (24 mg), Eutropin injection, and Eutropin Pen are to be lowered from 172,626 won to 166,929 won, from 22,810 won to 22,057 won, and from 202,060 won to 195,392 won, respectively. Another item’s price was raised after a pricing negotiation with NHIS as its request for an adjustment on upper limit price was accepted. Access Pharma’s Tuberculin PPD RT 23 SSI/APC is a substance used for tuberculosis skin test, and the company submitted an application for upper limit price increase due to import price raised by privatization of its manufacturer. The substance price would be raised from 19,225 won to 24,000 won. Chong Kun Dang’s Raparobell tablet (2 mg) went through a discretionary adjustment last month as expected when the original Rapamune tablet’s price was voluntarily reduced in March, 2016. The reduction was made after negotiating with NHIS, as generics were getting listed. Raprobell’s current price, 3,018 won would be bumped up to 4,311 won. With the first generic getting listed, the price of Rapamune tablet (2 mg) was adjusted down to 70 percent at 4,438 won. Accordingly, the generic tablet’s price was increased up to 68 percent of the first-in class item’s price. Other three items’ prices are to be lowered by their companies, voluntarily. Il Yang Pharmaceutical is lowering Il Yang Choline Alfoscerate capsule price by 8.2 percent, from 523 won to 480 won. Whereas Nelson Korea is to reduce price of Nelson Donepezil tablet (5 mg) by 53.8 percent, from 1,300 won to 600 won, and Jinyang Pharm to reduce Tacromin capsule price by 16.9 percent, from 3,630 won to 3,015 won.
- Policy
- Price competition for Donepezil’s generics is high
- by Kim, Jung-Ju Nov 29, 2019 07:06am
- Pharmaceutical companies with Donepezil have lowered their reimubrsement premium caps and intensified price competition. This time, drugs that voluntarily lowered were dropped from 36% to 67% below the current price. This would be less than one-third of the highest price. LG Chem's three lines of Eutropin are expected to be subject to additional drug price cuts due to the expanded range of use. According to the industry on the 26th, the Ministry of Health and Welfare is pursuing the revision of the list of drug reimbursement and the cap. When confirmed as scheduled, most will apply on the 5th of next month. ◆Lowered the upper limit due to price-volume aggreement negotiations= First of all, there are a total of eight drugs, which are priced in the price-volume agreement linkage and negotiated with the National Health Insurance Service. Among the new drugs listed in the drug price negotiations, the same product group charges increased by more than 30% from the estimated bill at the time of negotiation. Each falls by 2-3% from the current price. In the case of Stivarga, the price dropped 3.2% from ₩378,18 to ₩36,608 from the 5th of next month, Lartruvo will be down 2.3% from ₩1,064,000 to ₩1,039,446 from February 1 2022. Of the new drugs that have not been included in the 'Ka' group for four years, the total number of claims for the same product group has increased by more than 30%. The new drug application date is the 5th of next month. In other words, the total number of products cut by 'Na' group is six LG Chem's three Eutropin line items fell 6.1% each. By item, Eutropin Plus 24mg will be cut from ₩172,626 to ₩162,096 , Eutropin will be reduced from ₩22,810 to ₩221,419, and Eutropin pen will be reduced from ₩202,060 to ₩189,734, respectively. In particular, these products have extended their scope of use, resulting in advance drug price reductions based on the results of price-volume aggreement negotiations. Trulicity 0.75ml by Lilly Korea, a genetically modified drug, has a 8.8% decrease from ₩21,722 to ₩10,981 and a Trulicity 1.5mg decrease from ₩34,289 to ₩38,014, down 9.8%. Tresiva Flex Touch 100 units / ml by Korea's Novo Nordisk Pharm's fell 6.5% from ₩16,876 to ₩15,780. ◆Advance price reduction of extending the scope of use = There are a total of 15 products for which the pre-lower price for the expansion of the scope of use is effective on the 5th of next month. In particular, LG Chem's Eutropin lines, which signed a price-volume aggreement, has expanded its scope of use and has been eligible for pre-price cuts. In other words, the result is an additional 2.6% reduction in the price-volume aggreement negotiation. By item, Eutrophin Plus 24mg ranges from ₩162,096 to ₩15,788,288, Eutrophin range from ₩21,419 to ₩28,620, and Eutropin pen range from ₩189,734 to ₩184,801. Each is lowered. Concerta OROS Tab lines by Jansen Korea also fell 1.5% each. Concerta 18mg Tab will be lowered from ₩1,226 to ₩1,208, and Concerta 36mg Tab will be lowered from ₩1,849 to ₩1,821. Lilly Korea, Strattera capsule line is also in ₩1,030 is by 3.6% lower to ₩993, Korea Pfizer, Genotropin 16IU to note to ₩89,530 from ₩91,920, as if notes Genotropin 12mg at ₩195,790, It drops 2.6% to ₩19,699 each. ◆Adjusted upper limit of voluntary price cut= 12 items have been lowered due to the drug maker's voluntary decision to lower its insurance price. The government calculates and re-adjusts a manufacturer, a consigned manufacturer, or an importer to apply for a price cut at a price lower than the listed maximum drug price. In general, it is a measure of cuts in line with its policies following market competition. Prominent among these is the product of four donepezil preparations. They decided to voluntarily cut from 31.6 percent to as high as 67.8 percent. Considering that the highest drug content is ₩2,060, the price is lowered by a third or more. Looking at the items, Hanpung Pharmaceutical's Doneil 5mg Tab voluntarily lowered from ₩2,060 to ₩675, and Doneil 10mg tab from ₩2,460 to ₩1,000. They were reduced 67.2% and 59.3%, respectively. Hwail Pharmaceutical's Donewon 5mg Tab decided to voluntarily cut from ₩980 to ₩670 and Donewon 10mg Tab from ₩1,480 to ₩950, 31.6% and 35.8%, respectively, were lowered by content. In addition, Paroxat 20mg of Hallim Pharmaceuticals, will fall 23.4% from ₩560 to ₩690. The Green Cross, Cansar 16mg tab will fall 16.3% from ₩824 to ₩690 , and the Cansarplus tablet will be reduced 15.6% from ₩853 to ₩720.
- Policy
- Lupus drug 'BENLYSTA' opened rehabilitation path
- by Lee, Tak-Sun Nov 29, 2019 06:33am
- There is now a way to recover the lupus drug, Benlysta, which is at risk of withdrawal due to failure to meet postmarketing (PMS) criteria. The MFDS decided to use the drug as a RMP (Risk Management Plan) after long discussion of the Central Pharmaceutical Affairs Council and continue to use it for patients to monitor side effects. According to the MFDS on November 28, Benlysta, which PMS expired in June, will be designated as an RMP target and managed. The new drug should submit a monitored use report for more than 3000 patients for six years after marketing. Failure to comply will result in administrative disposition in three stages, and the final product license will be revoked. Although Benlysta is the only biologic formulations used in lupus disease, it has not met the PMS standards due to its high price as a non-reimbursement drug. Moreover, the possibility of failing to fill more than 3000 patients even during the three administrative disposition periods was strong, and in the end, the cancellation of the product license was prominent. However, as the drug is undergoing a reimbursement discussion recently and voiced that the license should be maintained at the request of the patient and the seller, the MFDS discussed it through the Central Pharmaceutical Affairs on the 4th. As a result of the discussion, it was recognized that Benlysta's necessity to maintain licenses was secured in order to secure patient treatment opportunities. Therefore, it was suggested that new measures for safety and effectiveness should be prepared. There were also opinions that it is practically difficult to report 3000 cases of use report through existing drug review. Kyu-han Chae, director of Biopharmaceutical Quality Control department in MFDS, said, "Benlysta is the only biologics of lupus treatment, and the experts have agreed with the necessity of maintaining the license because of its usefulness in patients who have not responded to existing treatment." The MFDS will continue to monitor post-marketing and maintain permits through RMP instead of PMS. RMP is a submission of a risk management plan throughout the life cycle of a drug product, which requires the reporting of evaluation results every six months up to two years after the product approval and once a year after two years. The director, Chae said, "We plan to evaluate the safety and efficacy of post-marketing products according to the characteristics of drugs." Mr. Chae added “ We ordered the company to make a risk management plan so that it could be actively marketed and used to treat patients”. Mr. Chae added that the action was decided to be patient-centered in order to secure patient treatment opportunities. However, Benlysta's initial disposal cannot be avoided. If the new drug fails to submit a usability survey necessary for re-evaluation, the first administrative disposition will suspend the sale of the item for three months. Meanwhile, lupus disease is a chronic autoimmune disease that occurs mainly in young age, including women of childbearing age, and is an inflammatory reaction in the whole body such as skin, joints, kidneys, lungs, and nerves. Over time, symptoms worsen and relieve over time, greatly reducing the quality of life of patients. It is reported that there are about 10,000 lupus patients in Korea.
- Policy
- Dantrolene designated as emergency drug at KRW 95K
- by Kim, Jung-Ju Nov 28, 2019 09:39pm
- 20 mg injection of Dantrolen, used for malignant hyperthermia and neuroleptic malignant syndrome (NMS), was designated as an emergency treatment and its insurance reimbursed price would be maintained at around 95,000 won. According to pharmaceutical industry source on Nov. 26, Ministry of Health and Welfare (MOHW) is planning to update the lists of reimbursed drugs and their upper limit price with the said changes. When the update is finalized, the revised list would be in effect from December 1. When Korea Orphan & Essential Drug Center (KOEDC) requests for a deliberation on a drug, government refers to imported price and list the drug for insurance reimbursement with pricing set by Drug Reimbursement Evaluation Committee. Dantrolene secured approval on indication for treating malignant hyperthermia and NMS. Healthcare institute stocks the injection vial and use it for an emergency use only. KOEDC received import approval in May and has been supplying it ever since. But since then, the center designated 20 mg of Datrium IV as an emergency treatment and listed the item on Nov. 1. Before the listing removal, Dantrolene was given grace period until Nov. 30, and the market was going to end up with a lot of unused stock. The issue was reimbursed price. The upper limit prices of two items showed a huge price gap with 20-mg Dantrium IV at 137,628 won and 20-mg Dantrolene injection at 95,709 won. As the government predicted the switch in items would bring up the National Health Insurance expenditure by about 30 million won, it designated Dantrolene injection as emergency treatment and decided to maintain its reimbursed price. The maintained price before listing removal is 95,709 won per vial, which is also the current reimbursed price.
- Policy
- Gazyva applied Moon Care policy’s selective health benefits
- by Lee, Hye-Kyung Nov 27, 2019 11:06pm
- Roche's Gazyva(Obinutuzumab), a non-Hodgkin's lymphoma treatment, will be converted into a selective reimbursement benefit in accordance with Moon Jae-in Care's ‘Non-benefit’ policy. The implementation date is December 15. The Korea Health Insurance Review and Assessment Service announced that it would revise the details of the criteria and methods for applying medical care benefits to drugs prescribed and administered to cancer patients, and will hold an opinion inquiry by 28th. On the 26th, the amendment was made ▲ Gazyva(30/100) +Bendamustine(30/100) combination therapy (2nd or higher) and copayment for non-Hodgkin's lymphoma ▲Gazyva(30/100) Establishment of monotherapy (maintenance therapy) and self deduction rate ▲ Excludes the case where the primary site is the posterior intestine. Gazyva is approved as a monotherapy for maintenance therapy after coadministration with Bendamustine, or when does not respond to Rituximab monotherapy or combination therapy with Rituximab. On May 30 2018, the cancer disease review committee decided that the patient would pay the full amount of the drug within the scope of the permit for reasons such as lack of clinical efficacy and cost effectiveness, but the HIRA reviewed whether the benefits would be extended in accordance with the non-reimbursement benefit policy. After reviewing textbooks, guidelines, and clinical papers, no new additions have been made to the excluded countries' reimbursement standards, but in the additionally analyzed phase 3 study (GADOLIN 2018), the median progression-free survival (25.3 months vs. 14.0 months) compared to the control period until the next treatment (33.6 months vs. 18.0 months). However, there is a lack of evidence to determine the clinical efficacy of maintenance therapy, as further analysis does not provide a numerical value of the median overall survival of Gazyva’s maintenance therapy. In case of non-compliance, there was not enough alternative therapies, so they decided to pay 30% co-payment. Ipsen Korea's 120 mg of Somatuline autogel is approved for the treatment of non-resectable, highly differentiated or moderately differentiated local or metastatic gastric, intestinal and pancreatic neuroendocrine tumors. After reviewing textbooks, guidelines, and clinical papers on the elimination of primary site limitations, the NCCN guidelines recommends the drug as category 2A for gastrointestinal neuroendocrine tumors, and additional clinical studies on clearance studies (CLARINET). The progression-free survival for the posterior ulcer was reported to be 31.0 months in the lanleotide group and 24.4 months in the treatment conversion group. The Health Insurance Review and Assessment Service said, “The number of patients included in the study related to the licensed clinical literature and domestic research has a limitation that it is difficult to prove statistical significance. Given the limited need for medical care, we have decided to remove exclusions if the primary part is the posterior part of the current imbursement standards”.
- Policy
- Clinical trial coverage on standard therapy and IND
- by Lee, Hye-Kyung Nov 26, 2019 10:52pm
- Insurance coverage would be granted on both investigational new drug and standard treatment simultaneously used in an anticancer treatment clinical trial. Health Insurance Review and Assessment Service (HIRA) presented a revised standard of healthcare insurance reimbursement on anticancer treatment in clinical trial on Nov. 4. From last year, the government has been providing reimbursement within a typical reimbursement provision scope for public-good clinical trials. First, reimbursement would be provided for clinical trial serving the purpose of public good. And also other client-based clinical trials in a need of emergency healthcare reimbursement to counteract public health risk, or serving more public-good purpose focusing on rare disease related study, would be eligible for the reimbursement as well. But to this date, there has been a dispute over providing reimbursement on the existing standard treatment used for comparison arm in anticancer clinical trial. The Korean Cancer Association (KCA) proposed the government to provide healthcare insurance on standard anticancer treatment used during a span of clinical trial, when used to compare results with investigational new drug. At a Clinical Trial Reimbursement Evaluation Committee meeting convened on last Mar. 20, the committee members discussed the said issue, where HIRA decided to grant reimbursement for clinical trial comparing standard anticancer treatment to investigational drug based on Ministry of Health and Welfare’s authoritative interpretation. As a principle, healthcare reimbursement eligibility scope is defined by the standard and procedure of clinical trial healthcare reimbursement provision. When submitting an application for insurance reimbursement on a clinical trial for investigational anticancer treatment, a healthcare institute can now also submit another application to HIRA for reimbursement on standard anticancer treatment. When the application has been submitted, HIRA would report the details to Cancer and Severe Disease Deliberation Committee. The reimbursement decision on the standard treatment would be notified straight to the healthcare institute, separately from the clinical trial reimbursement. HIRA official said, “Clinical trial reimbursement application submitted after Mar. 20, but already has received a review result notice is also eligible, according to the Article 4 of Clinical Trial Reimbursement Standard and Regulation”.
