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- 2025-12-26 16:58:20
- Policy
- HIRA unveils listed drug reevaluation guideline
- by Kim, Jung-Ju Dec 05, 2019 06:14am
- Chief Park Eun-Young of Pharmaceutical Evaluation Improvement Team at HIRAThe government unveiled the details of the post-marketing reevaluation criteria and procedure of reimbursed drug. The scope of listed drug reevaluation mainly centers expensive drug items, such as anticancer and rare disease treatments, covered by insurance benefit despite their uncertainty in clinical efficacy. The evaluation borrows the previous reimbursed drug list adjustment procedure, but the criteria are to be set in more intricately to cover different kinds of pharmaceutical benefit provided now. Health Insurance Review and Assessment Service’ (HIRA) Chief Park Eun-Young of Pharmaceutical Evaluation Improvement Team under Pharmaceutical Department presented a post-marketing reevaluation plan on listed drug at a public hearing convened for the topic on Dec. 3 at the Ferrum Tower, Seoul. For the reevaluation, applicable items are to be selected from the pool of high-cost drugs treating cancer and rare disease with uncertainty in clinical efficacy. The selection procedure would take account of item’s insurance listing status in foreign countries, usage frequency, insurance billing ratio, namely pharmaceutical expenditure increase rate and billing amount. Also levels of pharmaceutical and medical importance and social interest could also affect the procedure. Initially selected list of drugs would then be evaluated by published literature, such as textbooks, guidelines and clinical literatures. Basically, the structure of the listed-drug post-evaluation is to follow the footsteps of the Moon Jae-in Care. Evaluation model the government used for adjusting reimbursed drug list from 2007 to 2011 ◆ Updating listed drug post-evaluation from 12 years back: Evaluation on clinical efficacy was a key evaluation model in the previous reimbursed drug list adjustment. Enforced from 2007 to 2011, the list adjustment procedure also made decisions on reimbursement listing cancellation or restriction based on literature review of related textbooks and guidelines, and verification of medically essential substances. The Level A clinical efficacy evaluation indicated an item is “clinically effective”, as long as it met at least one of criteria, including Health Technology Assessment (HTA), World Health Organization (WHO) Model List of Essential Medicines (EML), shortage prevention drug, orphan drug, basic parenteral solution, and other essential drug. Whereas, Level B evaluation indicated an item as “clinically effective” when it met all three criteria of confirming essential medicine recommendation by related academics, recognition by related committees, and usage status in foreign countries. In the past, the Korean government used to refer to the U.S. the U.K., France, Italy, Japan, Germany and Switzerland, also known as A7, for the status of reimbursement listing. For the evaluation, an item had to be listed in more than two countries from the list. A new drug developed from Korea or in Asia was considered ‘listed in two or more A7 countries.’ And now the government plans to apply the past experience in the reimbursed drug list adjustment procedure on to the new listed drug post-management. Considering the diversified pharmaceutical benefits since then, the new post-management system is expected to be segmentalized and tightened even more. New reimbursed drug post-marketing evaluation procedure model ◆ Evaluation details: From the overall list of reimbursed drug items, anticancer therapy, rare disease treatment and items with uncertainty in clinical efficacy would be selected as subjects for the evaluation. Further selection criteria consist of substances requiring clinical efficacy validation by reevaluating effectiveness, requiring tightened management due to change in population structure and increased usage volume, and requiring Post-marketing Drug Reevaluation Subcommittee’s evaluation considering impacts on the society and other healthcare issues. After the first phase of selection, HIRA would review foreign countries’ approval and reimbursement listing status on the subjects. Besides the list of seven foreign countries used for the past reimbursed drug list adjustment, Canada is newly added. Moreover, drug reimbursement billing amount, increased rate claims, billing frequency and its ratio are to be reviewed all around. Other factors like levels of pharmaceutical and medical importance and social interest would be added as the evaluation criteria. HIRA would then evaluate the filtered subjects with evenly chosen clinical literatures, such as related textbook, guidelines and HTA reports. The agency explained alternative treatment options and special property of substances would be considered as well. When choosing the textbooks and guidelines for the review, HIRA would extensively consider literature’s evidence basis, popularity, expertise, validity, publication period, language, and recognition based on academic society’s evidence evaluation. Currently, the government and HIRA have not finalized the detailed list of literatures, such as basic list of textbooks from major search database, list of basic guideline from foreign guideline search database, government-related or not-for-profit performance assessment report, and list of published Cochran Reviews and HTA report. In addition, HIRA is contemplating on taking account of substance demand from related academic societies, alternative feasibility based on available option with equivalent or different mechanisms, and special property of substance. Restrictive use for pediatric patient, treatment for special patients with HIV-like conditions, and emergent medicine are categorized as special property of substance. Clinical efficacy reevaluation procedure ◆ Procedure of clinical efficacy reevaluation: The government and HIRA are planning to select subject items with administrative review, Post-marketing Drug Reevaluation Subcommittee, and Drug Reimbursement Evaluation Committee (DREC), in the said order. The literature-based evaluation would follow the selection, and then the government agency is to officially notify respective pharmaceutical companies. The reevaluation can be repeated from the top, if need be, and the result is finalized after the second around. The government plans to subdivide the reevaluation procedure into finance-based and performance-based post-marketing evaluation, and further enhance the reevaluation procedure. Prospective plan for the reevaluation system
- Policy
- Opdivo label changes but reimbursed scope unchanged
- by Lee, Hye-Kyung Dec 03, 2019 05:55am
- Ono Pharmaceutical’s immunotherapy Opdivo’s (nivolumab) 240 mg dose secured an approval from the regulator and expanded scope of administration on the label, but apparently the treatment’s reimbursed level of dose would remain unchanged. Health Insurance Review and Assessment Service (HIRA) recently collected public comments on the revised ‘notice on medicine prescribed and used for cancer patients.’ The agency then clarified the insurance reimbursement would only be granted for Opdivo used to treat patients with non-small cell lung cancer or melanoma with dosing schedule of 3 mg/ kg every two weeks. It would be in effect from Dec. 9. After Ministry of Food and Drug Safety (MFDS) approved of Opdivo 240 mg in April, the immunotherapy received expanded approval on dosing schedule of ‘240 mg for every two weeks or 480 mg for every four weeks’ and added it to the label of Opdivo 20 mg, 100 mg and 240 mg, on Nov. 7. However, HIRA decided not to approve of reimbursement on the new dosing schedule as Opdivo’s clinical result did not demonstrate meaningful differences between several different doses. The agency explains because Opdivo 240 mg product is not listed for reimbursement, the cost-effectiveness of additional higher dose and administration is uncertain. “HIRA has decided to grant insurance reimbursement only for using the immunotherapy under the initial dosing schedule of ‘3 mg/ kg every two weeks’, as stated on the MFDS-approved label”, HIRA official said.
- Policy
- Hyperalgesia possibility if Fentanyl mucosa not control pain
- by Lee, Tak-Sun Dec 03, 2019 05:54am
- 대표적 펜타닐 점막투여제 Fentanyl mucosal drug, a typical narcotic analgesic used for the treatment of cancer patients, may not be controlled by hyperalgesia and resistance, will be reflected in the permit. This was done by the Agency by reviewing safety information from the European Medicines Agency (EMA). The permission change adds that fentanyl mucosal medications may cause hyperalgesia if pain is not controlled, and that dose reduction and discontinuation may be considered. In particular, new content is added to the usage and dosage located in the upper line of the permit. The additional phrase is, "If pain is not properly controlled, there is a possibility of hyperalgesia, tolerance and underlying disease progression, which should be taken into account." Hyperalgesia is an abnormally sensitive condition for a painful stimulus. In addition to the general precautions, "Optimal drug-induced hyperalgesia should be considered when there is a lack of pain control compared to increasing fentanyl doses, as with other opioids. Fentanyl dose reduction or discontinuation may be considered." Adverse events such as drug abuse and Synching Withdrawal Syndrome from postmarketing experience are also added. The MFDS asked for a review by December 12. Fentanyl mucosal drugs approved in Korea are 26 items in six companies, and the items are Narco Sublingual Tab. 200μg of BC World Pharmaceuticals, Actiq oral transmucosal tab of Hyundai Pharmaceuticals, Abstral sublingual tab of Menarini Korea, Daewoong Pharmaceutical's 'Instanyl Nasal Spray', Pharmbo’s Fentakhan sublingual tablet, Teve-handok’s Fentora Buccal tab. Of these, Fentora's sales amounted to ₩6.8 billion in 2018 and Abstral recorded ₩5.9 billion based on IQVIA.
- 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.
