Balapiravir_690270-29-2_CoA_MedChemExpress

Naglazyme® (galsulfase)(Intravenous)Document Number: MH-0084 Last Review Date: 02/01/2022Date of Origin: 11/28/2011Dates Reviewed: 12/2011, 02/2013, 02/2014, 12/2014, 10/2015, 10/2016, 10/2017, 10/2018, 02/2019,02/2020, 02/2021, 02/2022I.Length of AuthorizationCoverage will be provided for 12 months and may be renewed.II.Dosing LimitsA.Quantity Limit (max daily dose) [NDC Unit]:•Naglazyme 5 mg vial: 23 vials per 7 daysB.Max Units (per dose and over time) [HCPCS Unit]:•115 billable units every 7 daysIII.Initial Approval Criteria 1Coverage is provided in the following conditions:•Patient is at least 5 years of age; AND•Documented baseline 12-minute walk test (12-MWT), 3-minute stair climb test (3-MSCT), and/or pulmonary function tests (e.g., FEV1, etc.); AND•Documented baseline value for urinary glycosaminoglycan (uGAG); ANDMucopolysaccharidosis VI (MPS VI, Maroteaux-Lamy syndrome) † Ф1,4,5•Patient has a definitive diagnosis of MPS VI as confirmed by the following:o Detection of pathogenic mutations in the ARSB gene by molecular genetic testing; ORo Arylsulfatase B (ASB) enzyme activity of <10% of the lower limit of normal in cultured fibroblasts or isolated leukocytes; AND▪Patient has normal enzyme activity of a different sulfatase (excluding patients with Multiple Sulfatase Deficiency [MSD]); AND▪Patient has an elevated urinary glycosaminoglycan (uGAG) level (i.e. dermatan sulfate or chondroitin sulfate) defined as being above the upper limit of normal bythe reference laboratory†FDA-approved indication(s); ‡Compendia recommended indication(s); ФOrphan DrugIV.Renewal Criteria 1,4,5Coverage can be renewed based on the following criteria:•Patient continues to meet indication-specific relevant criteria such as concomitant therapy requirements (not including prerequisite therapy), performance status, etc. identified insection III; AND•Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: anaphylaxis and hypersensitivity reactions, immune-mediated reactions, acute respiratorycomplications associated with administration, acute cardiorespiratory failure, severeinfusion reactions, spinal or cervical cord compression, etc.; AND•Disease response with treatment as defined by improvement or stability from pre-treatment baseline by the following:o Reduction in uGAG levels; AND▪Improvement in or stability of 12-minute walk test compared (12-MWT); OR▪Improvement in or stability of 3-minute stair climb test (3-MSCT); OR▪Improvement in or stability of pulmonary function testing (e.g., FEV1, etc.)V.Dosage/Administration 1Indication DoseMucopolysaccharidosis VI(MPS VI, Maroteaux-Lamy Syndrome) 1 mg/kg administered as an intravenous (IV) infusion oncea weekVI.Billing Code/Availability InformationHCPCS Code:•J1458 – Injection, galsulfase, 1 mg; 1 billable unit = 1 mgNDC:•Naglazyme 5 mg per 5 mL solution; single-use vial: 68135-0020-xxVII.References1.Naglazyme [package insert]. Novato, CA; BioMarin Pharmaceutical Inc.; December 2019.Accessed January 2022.2.Giugliani R, Harmatz P, Wraith JE. Management guidelines for mucopolysaccharidosis VI.Pediatrics. 2007 Aug;120(2):405-18.3.Giugliani R, Federhen A, Rojas MV, et al. Mucopolysaccharidosis I, II, and VI: Brief reviewand guidelines for treatment. Genet Mol Biol. 2010 Oct;33(4):589-604. Epub 2010 Dec 1.4.Vairo F, Federhen A, Baldo G, et al. Diagnostic and treatment strategies inmucopolysaccharidosis VI. Appl Clin Genet. 2015 Oct 30;8:245-55.5.Valaannopoulos V, Nicely H, Harmatz P, et al. Mucopolysaccharidosis VI. Orphanet J RareDis. 2010; 5: 5.6.Harmatz P, Giugliani R, Schwartz I, et al. Enzyme replacement therapy formucopolysaccharidosis VI: a phase 3, randomized, double-blind, placebo-controlled,multinational study of recombinant human N-acetylgalactosamine 4-sulfatase(recombinant human arylsulfatase B or rhASB) and follow-on, open-label extension study. JPediatr. 2006 Apr;148(4):533-539.Appendix 1 – Covered Diagnosis CodesICD-10 ICD-10 DescriptionE76.29 Other mucopolysaccharidosesAppendix 2 – Centers for Medicare and Medicaid Services (CMS)Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National CoverageDetermination (NCD), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs) may exist and compliance with these policies is required where applicable. They can be found at: https:///medicare-coverage-database/search.aspx. Additional indications may be covered at the discretion of the health plan.Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/LCA): N/AMedicare Part B Administrative Contractor (MAC) JurisdictionsJurisdiction Applicable State/US Territory ContractorE (1) CA, HI, NV, AS, GU, CNMI Noridian Healthcare Solutions, LLCF (2 & 3) AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ Noridian Healthcare Solutions, LLC5 KS, NE, IA, MO Wisconsin Physicians Service Insurance Corp (WPS)6 MN, WI, IL National Government Services, Inc. (NGS)H (4 & 7) LA, AR, MS, TX, OK, CO, NM Novitas Solutions, Inc.8 MI, IN Wisconsin Physicians Service Insurance Corp (WPS) N (9) FL, PR, VI First Coast Service Options, Inc.J (10) TN, GA, AL Palmetto GBA, LLCM (11) NC, SC, WV, VA (excluding below) Palmetto GBA, LLCNovitas Solutions, Inc.L (12) DE, MD, PA, NJ, DC (includes Arlington &Fairfax counties and the city of Alexandria in VA)K (13 & 14) NY, CT, MA, RI, VT, ME, NH National Government Services, Inc. (NGS)15 KY, OH CGS Administrators, LLC。

阿加曲班注射液【商品名】达贝【英文或拉丁名】Argatroban Injection【汉语拼音】Ajiaquban Zhusheye【主要成分】阿加曲班【化学名】（2R,4R）-4-甲基-1-[N2-（（R,S）-3-甲基-1,2,3,4-四氢-8-喹啉磺酰基）-L-精氨酰基]-2-哌啶羧酸一水合物【结构式及分子式、分子量】分子式:C23H36N6O5S·H2O分子量:【性状】本品为略带粘稠的无色或微黄色的澄明液体。

【药理毒理】药理作用阿加曲班是一种凝血酶抑制剂，可逆地与凝血酶活性位点结合。

阿加曲班的抗血栓作用不需要辅助因子抗凝血酶Ⅲ。

阿加曲班通过抑制凝血酶催化或诱导的反应，包括血纤维蛋白的形成，凝血因子Ⅴ、Ⅷ和ⅩⅢ的活化，蛋白酶C的活化，及血小板聚集发挥其抗凝血作用。

阿加曲班对凝血酶具有高度选择性。

治疗浓度时，阿加曲班对相关的丝氨酸蛋白酶（胰蛋白酶，因子Xa，血浆酶和激肽释放酶）几乎没有影响。

阿加曲班对游离的及与血凝块相联的凝血酶均具有抑制作用。

阿加曲班与肝素诱导的抗体间没有相互作用。

对接受多次给药的12名健康者和病人血清的评价，没有发现阿加曲班抗体的形成。

毒理研究遗传毒性：在Ames试验、中国仓鼠卵母细胞（CHO/HGRT）正相变突试验、中国仓鼠肺成纤维细胞染色体畸变试验、大鼠肝细胞及WI-38人肺细胞非程序DNA合成（UDS）试验，或者小鼠微核试验中，阿加曲班均没有显示有遗传毒性。

生殖毒性：阿加曲班静脉给予剂量达27mg/kg/d（以mg/m2计，为人最大推荐剂量的倍）对雄性和雌性大鼠的生育力及生殖行为没有影响。

大鼠静脉给予27mg/kg/d（以mg/m2计，为人最大推荐剂量的倍）及兔子静脉给予kg/d （以mg/m2计，为人最大推荐剂量的倍）的致畸研究没有发现对生育力及胎儿的损害。

但是，尚无充分和严格对照的孕妇研究。

由于动物生殖研究不能完全预测人体的反应，只有当明确需要时孕期才使用本品。

国家食品药品监督管理局进口药品注册标准标准号：JX20100263棕榈酸帕利哌酮注射液Zonglvsuan Palipaitong ZhusheyePaliperidone Palmitate Injection本品含棕榈酸帕利哌酮按帕利哌酮（C23H27FN4O4）计算，应为标示量90.0%~110.0%。

【性状】本品为白色至灰白色的混悬液。

【鉴别】（1）取本品1支，摇匀，取1滴至溴化钾片的表面。

照红外分光光度法（中国药典2010年版二部附录IV C）测定，其红外光吸收图谱在3200-2600cm-1,1800-1500cm-1和1200-750cm-1范围内应与对照品的红外光吸收图谱一致。

（2）在含量测定项下记录的色谱图中，供试品溶液主峰的保留时间应与对照品溶液主峰的保留时间一致。

【检查】重混悬性与抽针试验取本品3支，在10秒钟内振摇30次，振摇幅度约为25cm，振摇后溶液应均匀，不得检出可见异物或团块物。

用23号针头（蓝色针座）的注射器抽取，应顺利通过，不得阻塞。

pH值应为6.5~7.5（中国药典2010年版二部附录VI H）。

粒度分布取本品1支，加水稀释至250ml（1.5ml规格稀释至500ml），混匀后测试。

应用Malvern Mastersizer 2000 激光粒度仪，红光检测，泵速为1250转/分，颗粒折射率为1.56，颗粒吸收率为0.01，遮光度在6.8%-7.2%之间稳定1分钟后测试，测试时间为30秒。

d(0.1)应为0.3-0.6μm，d(0.5)应为0.9-1.4μm，d(0.9)应为2.0-4.4μm。

有关物质照含量测定项下的色谱条件，精密量取含量测定项下供试品溶液和对照品溶液各10μl注入液相色谱仪，记录色谱图。

供试品溶液色谱图中如有杂质峰，加校对因子校正后，按外标法以对照品溶液中主峰面积计算各杂质的含量，单个杂质峰面积不得过0.2%，各杂质的总和不得过0.4%。

单个杂质含量计算公式如下：式中G 为注射液的密度，1.037g/mlq s为供试品称样量，gP r为对照品纯度F r为棕榈酸帕利哌酮与帕利哌酮的换算因子1.56RRF为校正因子，杂质R130696为0.933（相对保留时间为0.70），其他杂质均为1.0 r i为供试品溶液中单个杂质色谱峰的峰面积Q th为标示含量，100mg/mlr r为对照品溶液色谱图中主峰的峰面积q r为对照品溶液中对照品的称样量，mg释放度取本品，照溶出度测定法（美国药典32版<711> 第二法），以0.489%聚山梨醇酯20的0.001mol/L盐酸溶液900ml为释放介质，介质温度为25 ︒C±0.5︒C，转速为每分钟50 转，依法操作，向每个溶出杯中加入相当于0.5ml±0.025ml的均匀混悬液样品【加样方式：取本品足够支数，摇匀，预先混合，量取0.5ml±0.025ml，置样品杯（规格为高14mm，内径14mm，壁厚1mm）中，精密称定，使样品杯悬于释放介质正上方，接近溶出杯的边沿，在桨转动时将样品投入；或将预先混合注射液约0.5ml±0.025ml，置1ml规格的带针头注射器内，精密称定，当桨转动时，将上述混悬液加入每个溶出杯中，精密称定带有针头的空注射器】。

1ml:1mg
Belcher Pharmaceuticals , LLC/BPI Labs, LLC
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增加持证商BPI Labs, LLC
23-197
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sanofi K.K./太陽ファルマ株式会社
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