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- 2025-12-24 23:30:07
- Policy
- ATP-based reduction on immunosuppressant Certican
- by Kim, Jung-Ju Jan 09, 2020 06:24am
- Price of Novartis’ immunosuppressant Certican (everolimus), still in prolonged pricing reduction cancellation litigation with the government, would be reduced based on actual transaction price (ATP) survey result. The pricing reduction on Certican would be enforced after the ongoing litigation reaches its final decision as it still has administrative suspension order in effect. According to pharmaceutical industry sources on Jan. 6, Korea's Ministry of Health and Welfare (MOHW) is planning to announce amended Pharmaceutical Reimbursement Listing and Maximum Reimbursed Price on Jan. 9. The ATP-based pricing reduction refers to the government lowering price of drugs by a rate within ten percent of weighted average value calculated according to the recently surveyed ATP. Previously, the government has decided to alter Certican's pricing as Chong Geun Dang Pharmaceutical exclusively launched a generic, Certirobel, with Preferential Sales Approval. Accordingly, MOHW authorized pricing reduction of Certican in four different doses, based on the principle automatically lowering price of the original when a first generic is listed. Opposing on the government's decision, Novartis filed an administrative litigation and requested suspension of pricing reduction enforcement, which the court accepted and sustained the original pricing. The suspension request has been accepted on Mar. 15, May 31 and June 28 last year for three times, and currently the court's decision to suspend the pricing reduction until 30 days after the final decision on the appeal has been maintained. Certican's pricing has been kept unchanged with the repeated suspension order, but the government has to adjust the original maximum reimbursed price before with the ATP survey result. However, if the pricing reduction is enforced as planned, before the court’s order of suspension, the ATP-based pricing reduction would not be necessary as the first reduction rate is steeper than the ATP-based reduction rate. The government was first planning to lower the drug pricing down to 1,592 won for 0.25 mg, 2,546 won for 0.5 mg, 3,180 won for 0.75 mg and 3,714 won for 1.0 mg.
- Policy
- Reevaluation to first review underperforming drug
- by Kim, Jung-Ju Jan 08, 2020 06:19am
- The government reaffirmed the listed drug reevaluation subject would prioritize drugs with clinical efficacy underperforming than initially expected. Gradually conducted on all subjected drugs, actions following up the reevaluation, such as pricing reduction or reimbursed indication revocation or reduction on drug not reaching expected efficacy agreed on during listed pricing negotiation, would be decided after the result is out. On Jan. 7, Korea’s Ministry of Health and Welfare (MOHW) announced listed drug reevaluation principles, as a part of the National Health Insurance (NHI) Comprehensive Plan, and briefed current status of severe disease treatment-centered insurance coverage enhancement. First, the ministry plans to differentiate reevaluation type and conduct in phases to accommodate diverse properties of various drugs. The drug properties would mean new drug or drug with underperforming efficacy listed for NHI reimbursement through selective reimbursement, high-cost and severe disease treatment, conditional approval or pharmacoeconomic evaluation (PE) exemption tracks. MOHW explained, “The reevaluation would first review drugs not demonstrating expected level of clinical efficacy, while detailed evaluation procedure, criteria and schedule would be open as much as possible to keep them transparent.” And noting on the public’s concern about the objective of the reevaluation, the ministry official stressed “Follow-up actions like resetting reimbursement criteria and pricing, maintaining reimbursement and others would be decided depending on the evaluation outcome. So it does not mean definite revocation of reimbursement.” The official elaborated that each item has a number of indications and actual effectiveness in the field, patient demand and necessity could be different and affect the decision accordingly. The official also added the NHI coverage has been expanded since the announcement of NHI Coverage Enhancement Policy, centering anticancer and rare disease treatment. Total 421 items, including anticancer and rare disease treatments, were listed within a year from the government’s announcement in July 2018 to July last year. For an instance, Biogen’s spinal muscular atrophy (SMA) treatment Spinraza was originally priced at 92.35 million won per vial (5 ml), but the patient copayment went down significantly as it was listed for reimbursement in April last year. According to the government, the treatment is an expensive drug costing a patient approximately 300 million won to 600 million won annually. But NHI reimbursement was granted and copayment ceiling system was applied, which dropped patient copayment to around 5.8 million won a year. The government also cleared reimbursement for Sanofi-Aventis’ novel treatment for severe atopic dermatitis, ‘Dupixent Prefilled Syringe 300 mg’, and brought down copayment to around 5.8 million won like Spinraza. The patient copayment was decreased steeply as it was a first drug to sign newly expanded risk sharing agreement and was applied with copayment ceiling system. When it was still non-reimbursed, a patient had to pay 26 million won annually per patient. MOHW explained, “The NHI coverage would expand but selectively based on feasibility of NHI reimbursement depending on the improvement in clinical efficacy, reimbursement criteria and basic principle of moderate pricing evaluation. Focusing on severe disease treatments with high social demand, the government would continue to expand insurance coverage.”
- Policy
- Generic pricing should be at original’s 40%-45%
- by Lee, Hye-Kyung Jan 08, 2020 06:17am
- The national insurer’s research result claims the volume of generic would increase up to 73 percent to 82 percent if the use of generic is promoted, if the present lump-sum generic pricing reduction is brought down to 40 percent or 45 percent of the original price before patent expiration. Currently, the lump-sum pricing reduction drops generic pricing to 53.55 percent of the initial pricing of the original. To improve pharmaceutical supply structure, the research report recommended three-step enforcement of distribution and new drug-related strategic policies, including; generic pricing reduction policy, generic use promotional policy and pharmaceutical distribution system improving policy. Korea’s National Health Insurance Service (NHIS) recently published a final report of a year-long cosigned study of improving drug supply and purchase program on All Public Information In-One (ALIO) conducted with Sungkyunkwan University’s academic-industry cooperation research team (Principal researcher: Professor Lee Sang-Won of Pharmaceutical Technology & Business Management Department at School of Pharmacy). Also known as ‘Pharmaceutical Product Life-cycle Research Report,’ the study was directly ordered by President Kim Yong-ik of NHIS, who spent 250 million won on the massive research project. According to the report on Jan. 6, the research team has laid down regulatory policy recommendations in categories of pharmaceutical supply structure, generic supply structure, pharmaceutical distribution structure, and Korean-made new drug supply structure. ◆ Pharmaceutical supply structure: The university research team suggested reforming pharmaceutical supply structure to secure financial health of National Health Insurance (NHI), to supply good quality drugs and to expand Korean generic items’ market share. To achieve the goal, the report recommended seven objectives in three categories; improving generic supply structure (generic quality standard strengthening policy, off-patent drug pricing reduction policy, generic use promoting incentive policy); distribution structure (distribution company competitiveness enhancing policy, fair trade order reinforcing policy); and new drug supply structure (corporate R&D investment expanding policy, technology commercialization supporting policies). The team predicted the seven objectives could be implemented in three steps. Starting from generic quality standard enhancing policy, Step 2 off-patent drug pricing reduction policy and generic use incentive policy and Step 3 distribution structure and new drug supply structure shifting policies should follow, the researchers claimed. The Step 1 objective, generic quality standard enhancing policy, was prioritized as it affects the three policy goals overall, which are ‘NHI financial health,’ ‘outstanding drug supply’ and ‘self-sustained medical technology.’ Policies targeting distribution and new drug supply have been assigned under Step 3 objective, because their importance level was apparently lower than that of generic policies. The researchers commented, “The importance of generic quality standard enhancing policy and generic drug pricing reduction policy are very high and they require intricate plan of action. Also they need to consider each interest group’s stance.” ◆ Generic supply structure: The research team stated the present volume of generic use in Korea (61.8 percent as of 2017) should meet the average level of OECD member countries (over 70 percent) to leverage generic supply structure and industry. To realize the goal, bringing down the generic pricing is essential. The report calculated the ratio of generic use in overall drug volume could be raised up to 73 percent to 82 percent, assuming generic use would soar when the price is dropped to 40 percent to 45 percent of the original’s initial price. Previously, the researchers mentioned of three policies—generic quality standard enhancing policy, off-patent drug pricing reduction policy and generic use incentive policy—to achieve the aim to reform pharmaceutical supply structure. The policy objectives of reforming generic supply structure is to lower pricing to the level of competitive market and increasing volume on par with advanced countries, while enhancing the quality of generic items. More detailed objectives of enhancing generic quality includes tightening management standard change after approving and conducting stringent Good Manufacturing Practice (GMP) due diligence. As for the mechanism of drug pricing reduction, the report recommended reforming actual transaction price (ATP)-based drug pricing reduction and lowering drug price on the level of competitive market. For the ATP-based pricing reduction, the study argued the existing system of calculating reduction rate by each item should be changed to calculate by same class medicine. The report elaborated the change would reduce not only a specific item’s pricing, but affect all items in a same class, which would enable supply of low-priced drugs. Then sales of a company with capacity to supply mass amount of low-priced products would surge and eventually push up the efficiency of NHI expenditure management, the researchers added. Moreover, the report said the equal drug pricing system should be abolished and should rather differentiate pricings of generic and original, bringing down the generic pricing from the current level of 53.55 percent of the original pricing to 40 percent to 45 percent level. Basically, the generic pricing would not reach the level of off-patent original pricing. The report added another recommendation to constantly monitor pricing of off-patent drug market and regulate pricing reduction on generic listed for a long time or with pricing unchanged despite multiple listed generics. After enhancing generic’s quality and lowering pricing, incentive policy is recommended to promote further active use of generic. Increasing demand for low-priced drug in the market would ultimately expand volume of generic use and promote price competition. To increase the demand for low-priced drug, the report proposed the following; providing incentive for using more generic to doctor and pharmacist; reforming payment system to adopt capitation; prescription budget cap; or diagnosis related group payment; and lowering patient copayment or providing incentive point. On the other hand, the report also proposed increasing generic use by the purchasing power of the insurer, NHIS. Apparently, the insurer could select and announce a generic item capable of supplying low-priced product among multiple generic items in equivalent class, or set and mandate alternative prescription goal for pharmacist on preferred generic item. ◆ Pharmaceutical distribution structure: The researchers claimed the currently convoluted distribution models should be better sorted out. Depending on a distributor’s business management and scale, the type of distributors should be divided into ‘Total Distributor (owning a nationwide sale network and dealing logistics and commercial distributor),’ and ‘General Distributor (commercial sales),’ and ‘Contract Sales Organization (CSO).’ And the researchers argued idealistic image of Korean drug distributor should be set forth by establishing distributor evaluation index and designating an Innovative Distribution Company based on ‘Special Act on Fostering and Support Pharmaceutical Industry,’ 한국의약품유통협회 회원사 527개 대상 의약품 유통 현황 및 선진화 방안을 위한 설문조사 For the changes to be made, approval management and post-management should be reinforced through distributor license renewal and capital reappraisal, all the while government due diligence and statute reform should follow to prevent expedient direct wholesale, such as abusing authoritative position of healthcare institute. Besides, the report presented tasks to reform structure, regulation and environment of the pharmaceutical supply by adopting ‘Pharmaceutical Purchasing Card’ to set straight wholesale profit margin inflated with unreasonable distribution cost; forming ‘Supply Chain Council’ with pharmaceutical company and distributor’s representative to talk about minimum profit margin; enhancing logistics and minimizing return through improved minimum packaging unit and labeling; and requiring aggregation; fostering distribution and marketing specialists to advance distribution industry. ◆ Korean-made new drug supply structure: The research team stated the supply structure of new drug developed in Korea should be strengthened in both quality and quantity by inducing innovativeness of new drug, and by setting a reasonable supply volume goal based on global level productivity of new drug. Average 19 new drugs are launched annually these days, but only 1.9 items or ten percent of them are made in Korea. To expand supply of Korean-made new drug and improve its innovativeness, the researchers proposed reinforcing Innovative Pharmaceutical Company support system, changing new drug R&D policy, supporting open innovation and fostering development and commercialization capability.
- Policy
- China's "New Law" tightens safety and quality management
- by Kim, Jung-Ju Jan 08, 2020 06:15am
- China is to reinforce overall pharmaceutical management and monitoring regulation covering from pharmaceutical production, launch, clinical trial to counterfeit drug. The so-called ‘New Drug Administration Law’ would mainly focus on safety and quality. China’s National Medical Products Administration (NMPA) had taken the revised law in effect from last month. Considering the time it needs to settle in with the entire system, the new law would be enforced from the beginning of this year. The revision consists of pharmaceutical marketing authorization holder system, clinical trial institute record management, Good Manufacturing Practice (GMP) and Good Storage Practice (GSP) management, review and approval on chemical ingredient, and tightened investigation and prosecution over illegal practice. First, the Drug Marketing Authorization Holder (MAH) system has been toughened stringently. The system stipulates a pharmaceutical company or manufacturer, with registration number-marked drug registration certificates and imported drug registration certificate, should strictly perform the MAH obligations. The authorization holder has liability for the entire life-cycle of a drug from development to production and management to ensure drug safety, efficacy and quality. The new law also tightened clinical trial institute’s record management. The Chinese regulator has adopted a form of pre-management system that would process clinical trial institute certification according the regulation, if it has not been completed before last December. The revised law would also strictly regulate GMP and GSP certification. A company cannot apply for the certification if charged with illegal practice in R&D, production or management, and the Chinese regulator would also conduct on-site audit as stated by the regulation. And the regulator’s review and approval for chemical ingredient manufacturer would be integrated within the existing registration procedure. Each regional regulatory authority has to ultimately enhance drug safety effectively by strictly following the said regulation and also by stringently imposing penalty on illegal practice. The Chinese government plans to promptly set and announce further details of the New Drug Administration Act.
- Policy
- Derazantinib-Tecentriq trial approved in Korea
- by Lee, Jeong-Hwan Jan 07, 2020 06:28am
- A global clinical trial to test a combination therapy of anticancer treatment derazantinib and immunotherapy Tecentriq (atezolizumab) was approved in Korea to treat patients with urothelial cancer. The clinical trial has been put together as derazantinib developer Basilea Pharmaceutica and Tecentriq developer Roche have signed a collaborative deal to investigate immunotherapy combination to treat urothelial cancer in January last year. On Jan. 3, Korea’s Ministry of Food and Drug Safety (MFDS) announced approval of a Phase 1b/2 multi-cohort open-label study to explore combination therapy of derazantinib and atezolizumab in patients with urothelial cancer with confirmed FGFR mutation. Apparently, National Cancer Center, Inje University Busan Paik Hospital, Seoul National University Hospital, Seoul Asan Medical Center, Korea University Hospital and Seoul National University Bundang Hospital are healthcare institutes executing the clinical trial in Korea. Derazantinib inhibits fibroblast growth factor receptor (FGFR) kinase that helps cell proliferation, differentiation and migration and demonstrates five to 30 percent gene alteration in liver, bladder, breast, liver and stomach cancers. An ongoing study approved earlier had announced interim data finding objective response rate (ORR) of 21 percent in 29 patients with intrahepatic cholangiocarcinoma (iCCA). Six of the patients demonstrated 83percent of disease control rate (DCR). Basilea in-licensed derazatinib from U.S.-based biopharmaceutical company ArQule in 2018. Meanwhile, Seattle Genetics is initiating a clinical trial in Korea as well with ladiratuzumab vedotin, an investigational antibody-drug conjugate (ADC), to treat breast cancer. The approved Phase 2 protocol aims to confirm efficacy of ladiratuzumab vedotin targeting unresectable locally advanced or metastatic solid cancer. The list of clinical trial centers consistsd of Seoul National University Boramae Medical Center, Ajou University Hospital, Seoul National University Hospital, Dong-a University Hospital, Seoul National University Bungdang Hospital, Catholic University Seoul St. Mary’s Hospital, Chonnam National University Hwasun Hospital and Korea University Guro Hospital.
- Policy
- Eliquis' price cut has been reserved
- by Kim, Jung-Ju Jan 06, 2020 11:00pm
- Against the government's lower policy price cut, the former drug price of BMS Eliquis (Apixaban), which is appealing to the court, will be temporarily held. Currently in progress at the Seoul High Court, if it is terminated, additional price cuts are scheduled for June 1st. The Seoul High Court's 9th Executive (2019-Ah1617) decided to temporarily suspend the price cuts related to this drug in “ the list of pharmaceutical benefits and the maximum reimbursement schedule”, which included a decision to lower the price of the Ministry of Health and Welfare. Earlier, the Ministry of Health and Welfare decided to drop the Eliquis’ price by 30% by content through some revisions. Eliquis was the target for lowering the maximum price of the most listed products and the same route, ingredients, and formulations. BMS disagreed with the objection and currently in progress in the Seoul High Court. There are 2.5mg and 5mg tablets, and the amount the Ministry of Health has decided to cut is ₩830 each. According to the court's decision, the drug will remain at the original upper limit of ₩1185 until 30 days after the sentence of judgment on the 3rd. On the other hand, on June 1, the Ministry of Health and Welfare plans to further reduce the price of drugs to ₩635 each.
- Policy
- Industry speculating on special clause for IMD
- by Lee, Jeong-Hwan Jan 06, 2020 06:22am
- While the government’s announcement on the revised drug pricing regulation has been delayed, the pharmaceutical industry is seemingly speculating on a possible new special clause of the regulation to exempt incrementally modified drug (IMD) with recognized non-obviousness. The industry predicts the government is more likely to make an exception for IMD, because Korea Pharmaceutical and Bio-pharma Manufacturers Association (KPBMA) and the pharmaceutical industry have been consistently voicing the necessity of maintaining weighted pricing benefit for IMD and National Assembly Health and Welfare Committee have also expressed concerns about the issue as well. According to sources from pharmaceutical industry and National Assembly on Jan. 5, companies dealing with IMDs are keeping their eye close to Ministry of Health and Welfare’s (MOHW) finalized drug pricing system revision. For now, the industry does not have much to complain about the government’s intention to lower generic pricing. As MOHW has shown its firm determination to strictly regulate drug pricing, the industry seems convinced about the need of shifting companies’ business focus. However, the industry is strongly urging the government to establish a special clause on the revised drug pricing regulation to exempt IMDs from the generic pricing reduction. Basically, the industry is expecting the government’s smart regulation to set a different regulation for IMD that protects industry’s willpower to develop pharmaceutical cash cow in the future. The industry’s voice has gotten even louder, because recently a court ruled against a generic challenging an original’s patent by changing its saline base. The Patent Court in last December has decided some of generic-makers’ strategy to change saline base of the original Champix (varenicline) is patent infringement. Prior to the Patent Court’s decision, the Supreme Court also did not concede with generics claiming to have evaded infringement of term-extended patent by changing the saline base of the original overactive bladder treatment Vesicare (solifenacin). Technically, it was the end of the saline-based patent evasion strategy. As a result, generic makers have lost its one of major income sources as they used to launch their generics after challenging and shortening an original’s patent term. Now that the saline-based patent evasion is not an option anymore, generic makers argue at least pricing benefit for IMDs with proven non-obviousness should be kept. A Korean pharmaceutical company insider commented, “We are quite curious about the finalized drug pricing regulation of MOHW, because IMD is the only technical strategy and cash cow business model in Korean pharmaceutical market saturated with excessive amount of generics. The government should set forth a special clause providing pricing benefit for IMDs, at least, regardless of tightened pricing regulation on simple generic or general combination drug.” Another company’s insider claimed, “Up to date, saline-based patent evasion strategy has been a legitimate and prominent means to push up generic launch date and generate profit. Without the strategy, pharmaceutical companies would struggle to develop any drug and generate profit from it. Only when the government recognizes pricing benefit for IMDs, more companies would endeavor to develop IMDs with non-obviousness.”
- Policy
- Early market entry of Gabsmet salt-modifying drugs are noted
- by Lee, Tak-Sun Jan 06, 2020 06:21am
- The salt-modifying drug 'Galvusmet', a DPP-4 inhibitory diabetes drug, applied for approval for the first time in Korea on the 24th of last month. It is therefore noteworthy whether it will be released to the market early. According to the MFDS on the 24th, Vildagliptin HCl-Metformin HCl combination was applied for the first time to the patent holder, Novartis. The salt is different from the original 'Galvus', which is a combination of Vilagliptin-Metformin HCl. Therefore, the industry has made an observation that Hanmi which has been developing Galvus salt modification drugs, has applied for a license. Hanmi also reportedly filed an application for a license for the Vildagliptin HCl formulation, a Galvus' monolithic salt change product, in July. However, it has not yet obtained a product license. On November 22, last year, Anguk received the first approval of generic drugs and obtained a exclusivity for generic product following the successful patent challenge. However, since the company succeeded in invalidating part of the extended period of the patent, the exclusivity for generic product of sale is not applied immediately, and it is enforced for nine months from August 30 2021. Galvusmet's salt-modifying drug, one of material patent is also likely to be on the market at this time. This is because Anguk and Hanmi have succeeded in invalidating patents that survive after August 29, 2021. Nevertheless, Galvusmet, a latecomer of DPP-4 diabetes, is expected to be the fastest case to enter the market. Galvus recorded outpatient prescriptions of ₩9 billion on UBIST basis in 2018, and Metformin-included Galvusmet is a blockbuster drug with a record earnings of ₩35.1 billion. If first-latecomers enter the market early through patent challenge, they will benefit from the preemptive effect.
- Policy
- Announcement of drug price reform is delayed
- by Kim, Jung-Ju Jan 04, 2020 08:47pm
- The reform of the drug price system, which the government plans to announce last month, is delayed somewhat. The pharmaceutical industry is all on edge because of the reorganization of generic drug prices, improved risk-sharing contract (RSA), economic exemption system, and insurance policy supplementary agreement (sub-contract). ◆Generic price restructuring= Among the many cases where drug price restructuring is expected, the focus of the industry is on the final revision of the 'Determination and Adjustment Criteria for Drug Price Revision', which contains the generic price restructuring. The government planned to announce the final announcement no later than last month, but it was slightly delayed, with some revisions to the earlier this month. It is essential to calculate this system by linking the MFDS' item permission to the Ministry of Health and Welfare’s drug price system. It is largely divided into generic cascade drug price reform and cut line system. The requirement for a cascading drug price reform is to conduct its own bioequivalence test and to meet the registered use of the Drug Master File (DMF). If both criteria are met, the price is estimated at 53.55% of the cost of the original drug (before generic listing). However, if one or not met, then the price is multiplied by 0.85 based on 53.55%, depending on the level of fulfillment of the criteria. They are cut by 15%. In addition, the 'cut line system' is a price condition that is lowered separately from the permit linkage. Starting from the 21st order of health insurance, the drug price is estimated at 85% of the lowest price regardless of whether the criteria are met. For example, the 21st generic is estimated at 85% of the lowest price in 20 products, while the 22nd generic is 85% of the 21st generic price. The government has announced that the drug price reform will be finalized by the middle of this month and planned to be implemented in July. ◆Completion of RSA, reimbursement decision, the economic evaluation exemption system and additional contract creation subjects=In the current drug price system, issues that require expansion or reorganization of the reimbursement gateway stage are also overhauled. The government has continually improved the drug price system without changing the fundamentals of the system since the implementation of the positive list system. However, as the groundbreaking reinforcement of security continued, the awareness of the need to reorganize and upgrade the positive list system continued. The improved drug price system can be divided into: ▲expanding the scope of RSA coverage ▲complementary details of reimbursement determination ▲complement of economic evaluation exemption system ▲expansion of generics for writing subsidies when reimbursement listed. First of all, in the case of RSA improvement, one of the new drug listing tracks, it is important to expand the gateway to be able to apply the RSA target criteria that could be applied only to the current selection drugs. In the meantime, drugs that have the same therapeutic position but have not been covered by RSA just because of late-release drugs will have a wider benefit opportunity. In addition, high-priced drugs that are subject to phase III conditional approval are considered to have greater uncertainty, and thus, improvements are made in the direction of raising benefits by reimbursed them within the framework of the RSA. In the case of reimbursement determination, some socially disturbing reimbursed priorities are supplemented. The government is currently making reimbursement in consideration of medically feasible or medically significant materiality and treatment effects, as well as patient costs and social benefits. In the future, it will be added to determine detailed principles or priorities in consideration of the financial status of health insurance. In other words, it reflects the decision of reimbursement to the financial level that health insurance can cover, along with the characteristics of pharmaceuticals and the necessity of the times. The economic evaluation exemption system will also be supplemented. The government plans to improve the system by adding antibiotics, tuberculosis treatment, and emergency detoxification drugs, which are difficult to evaluate, to reflect the voice of expanding the scope of drugs that are difficult to evaluate. Lastly, it is a revised plan that includes a generic agreement that is included when insurance is listed. The contracting parties are the Korea Health Insurance Corporation and pharmaceutical companies. The main contents of the contract are to fulfill supply obligations and accept price cuts when disposing of rebates. The government aimed to implement the midterm this year after outlined this month's reorganization plan based on improving the positive list system and promoting administrative notice. Evaluation adopted by the government during the maintenance of the list of registered agreements from 2007 to 2011 ◆Re-evaluation of listed drugs=The government is currently setting up a 'post-evaluation of pharmaceuticals', that is, a re-evaluation guideline for already listed reimbursed drugs and collecting expert opinion. The evaluation is based on the revised List of Contracts, which was carried out 12 years ago, but the standard is expected to be more detailed. Reevaluation targets are selected from anti-cancer drugs, rare disease drugs, and drugs of uncertain clinical usefulness. Of these, ▲drugs that need to confirm clinical usefulness through effects re-evaluation ▲drugs that need to be managed due to increase in population structure and usage ▲other drugs that require evaluation taking into account social impacts and other effects on health care at ex post evaluation Sub-committees become standards. The government plans to announce the final reassessment soon and finalize the system within the year.
- Policy
- Only 6 out of 9 reimbursed use of Spinraza approved
- by Lee, Hye-Kyung Jan 03, 2020 06:31am
- Only 66.6 percent of preliminary approval applications for reimbursement submitted last month was cleared for the use of spinal muscular atrophy (SMA) treatment Spinraza (nusinersen). Six out of nine applications were approved, and other three applications were rejected with conditional approval, disapproval and required supplementary data. On Dec. 31, Health Insurance Review and Assessment Service (HIRA, President Kim Seung-taek) officially disclosed outcomes of reimbursement review on four items—Spinraza, Soliris, ventricular assist device (VAD), and hematopoietic stem cell transplantation—deliberated by Healthcare Review & Assessment Committee in November 2019. Spinraza has been listed for reimbursement since last Apr. 8, but a healthcare institute intending to use super-high-cost treatment priced at 92.36 million won per 5 ml has to apply for a preliminary approval for reimbursement. For reimbursement on the treatment, a patient has to qualify for all conditions of lacking 5q SMN-1 gene or being diagnosed with gene mutation; SMA related clinical symptoms and signs onset from age younger than three; and not in use permanent ventilator. A well-known unapproved case was a 14-year-old male patient with SMA, who could not clearly prove his age of SMA-related symptom and sign onset was younger than 36-month-old according to the submitted data. The committee did not approve the application without proper objective data. A conditional approval was granted on 24-year-old female patient with a record of scoliosis surgery as her myelogram result proved she is able to take continuous administration into her dura mater with lumber puncture. However, the approval condition was submission of the confirmed number of SMN2 copy with the monitoring report. Soliris (eculizumab) was available for preliminary approval for reimbursement prior to Spinraza, and had six applications submitted for treating atypical hemolytic uremic syndrome (aHUS). But only one was approved out of all. A 49-year-old male patient was approved with reimbursed use of Soliris as he had recurrent thrombotic microangiopathy and kidney dysfunction, despite he had conservative treatment after ABO-incompatible kidney transplantation. Although HIRA found, reviewing his medical record, thrombotic microangiopathy has occurred after the kidney transplantation and using immunosuppressant, it approved of the reimbursed use because the patient had clinical symptoms of aHUS and also continued to show thrombotic microangiopathy symptoms with no apparent response to hemodialysis and therapeutic plasma exchange. But the patient has been ordered to submit genetic testing result and two-month monitoring report. His feasibility of maintained reimbursement would be deliberated depending on the clinical result.
