IPSOS Healthcare Elements Deck

means that the patient does not sit on the sling. Instead, the sling provides support from the tailbone up to the shold-ers and under the legs. BasicSling is designed for use in most common lifting situations such as transfers from bed to wheelchair, etc.SystemRoMedic includes a wide range of functional, comfortable, high-quality slings that can be adapted for different types of lifting and for patients with different needs. The slings are available in several different materials and in sizes from XXS to XXL. All models are safe and very easy to use and are rated for lifting patients weighing up to 300 kg. The choice of model and material depends on the patient’s needs and the transfer situation.Visual and mechanical inspectionCheck the condition and function of the sling regularly. Always inspect the product after laundering. Check to ensure that seams and material are free from damage. Check to ensure that fabric is not worn or faded. Apply load to the device and check to ensure that clasps, handles, etc. withstand heavy load. If there are signs of wear, the product must be discarded.Always read the manuals for all assistive devices used during a transfer.Keep the manual where it is accessible to users of the product.Do not leave the patient unattended during a transfer situation.To prevent discomfort and the risk of the patient sliding out of the sling, trial fit the sling carefully. First, apply the sling’s back loops to the slingbar, and then apply the leg support loops. Use a slingbar that has been tested.The lowest allowable safe working load always determines the safe working load of the assembled system. Always check the safe working loads for the lift and accessories before use. Contact your dealer if you have any questions.Always read the manualManual - English1.Hold the sling in one hand and place your other hand in the pocket at the lower edge of the sling. This is easier if the patient leans forward or can be helped to lean forward slightly. Guide the sling down behind the patient’s back, by sliding it along the back of the chair/wheelchair or along the bed, ideally, to the tailbone. The mid-section of the slingshould follow the patient’s spine.2. Take care to guide the sling down to the patient’s hips. Do this by pushing the sling into the space in the back corners of the wheelchair seat.3. Pull the leg supports out along the outside of the thighs. Face the patient and pull the lower edge of the leg support, so that the sling slides into place around the hips. Light pressure against the patient’s knees prevents him/her from sliding forward in the chair.4. After checking to ensure that the leg sup-ports are of equal length on both sides, placethem under the patient’s thighs. Cross the leg supports and hook them to the slingbar.Start raising the lift, when the straps become taut, stop and check that everything is ok before proceeding with the lift.Application of the sling when the patient is sitting in a wheelchair/chair or in bed1. Fold the leg support and allow it to slide under itself when you pull it out at the outside of the thigh.2. Then, pull the sling up behind the patient’s back.Removal of the sling when the patient is sitting123412Application of the sling when the patient is lying in bed, on a stretcher or on the floor1. Turn the patient towards you. Place the sling so that the product label is fac-ing the underlying surface and the sling’s mid-section follows the spine. The upper edge of the sling’s back section should be at shoulder height and the lower edge level with the tailbone. Place the edgeof the sling as far in under the patient as possible. Push the back-section loop under, so that you can reach it once you have turned the patient back onto the sling.2. To reduce the number of application steps, you can fold the back section up against the patient’s back and place the leg supports between the patient’s knees when he/she is turned towards you, and then pull them forward when the patient is lying on the sling.3. Turn the patient back onto the sling and pull out the back section and leg support.4. Cross the leg supports and hook themto the slingbar.Start raising the lift, when the straps become taut, stop and check that everything is okbefore proceeding with the lift.1. Lay the leg supports between the patient’s knees.2. Turn the patient towards you and fold the sling in under the patient so that the fabric slides towards you when you pull it out after you have turned back thepatient.Removal of the sling when the patient is recumbent123412Alternative application of the sling’s leg supports1. In the standard application the leg supports are crossed before they are hooked to the slingbar.2. If it is desired to keep the legs of the patient together, for dignity or comfort the leg supports can also be overlapped under both legs.3. For more access to the perinea area of the patient. You can even choose not to cross the leg supports. Note, however, that this entails a risk that the patient might slide out of the sling.Material:Polyester: Durable material with low friction. Withstands high laundry temperatures.Polyester net: An airy material that can be left under the patient, if necessary. Withstands high laundry temperatures.Plasticized net fabric: Material intended for bathing and showering situations. The material can be disinfected with rubbing alcohol.Care of the product:Read the product label.Do not use rinsing agent. T o prolong product life, avoid tumble-drying.Size informationSlings can often be used for both 2 and 4-point suspension. It is essential to ensure that the width of the slingbar is appropriate for the sling size and the patient’s status and capacity. Use patient-specific slings to ensure safety and hygiene.Size XXS/Grey XS/Orange S/Red M/Yellow L/Green XL/Purple XXL/White Rec. user Ibs 22-55 44-77 77-121 99-176 165-242 220-331 308,5-441weight kg 10-25 20-35 35-55 45-80 75-110 100-150 140-200Sling overall inch 25 25,5 30 35 37,5 38,5 38,5height cm 63 65 77 89 959898Sling seat inch 8 10,5 14,5 19,5 23,5 25,5 29,5measurement cm 21 27 37 50 606575123。

《人诱导多能干细胞》团体标准
《人诱导多能干细胞》团体标准是指用来确定和规范人诱导多能干细胞（induced pluripotent stem cells，简称iPSCs）制备和应用过程中的各项要求和指导方针的标准。

该团体标准通常由国际科学组织、研究机构、领域专家和政府部门等共同制定，旨在推动该领域的科学研究和应用，并确保其安全性、质量和可靠性。

人诱导多能干细胞是通过将成熟的人体细胞重新编程，使其回到类似胚胎干细胞的状态，具有潜在的重要应用价值。

然而，其制备和应用过程中存在着一系列技术和伦理等方面的挑战与风险，因此需要制定相应的团体标准来进行规范和指导。

《人诱导多能干细胞》团体标准可能包括以下内容：
1. iPSCs制备的方法和技术要求：包括细胞重编程的方法、培养条件、质量控制等方面的要求，确保iPSCs制备的高效性、稳定性和可重复性；
2. iPSCs的质量标准和鉴定方法：包括iPSCs的遗传稳定性、表型特征和分化潜能等方面的鉴定和评估标准；
3. iPSCs的应用指导和安全评估：包括iPSCs在再生医学、疾病模型建立等方面的应用指导，以及相关的安全性评估和监测措施；
4. 伦理和法律问题的考虑：包括伦理审查、知情同意和数据共享等方面的规范和指导。

通过制定和实施《人诱导多能干细胞》团体标准，可以促进该领域的国际合作和交流，提高iPSCs的制备和应用水平，同时保障研究的可持续发展和社会的公共利益。

With Azurion, performance and superior care become oneAzurion 7Image Guided Therapy System17% reduction of procedure time with Philips Azurion at St. Antonius Hospital.1The ability to treat one more patient per day today, or in the futureAzurion enables you to provide superior careAzurion helps you optimize your lab performanceAn easy-to-use platform supports you in quickly and easily performing diverse proceduresThis is exemplified by our Image Guided Therapy System - Azurion 7. It allows you to easily and confidently perform a wide range of routine and complex procedures with a unique user experience, helping you optimize your lab performance and provide superior care. Azurion is powered by ConnectOS, a real-time multi-workspot technology designed specifically for the Azurion image guided therapy platform.As the interventional space evolves, we continue to integrate essential lab systems and tools onto the Azurion platform for a better user experience. The Azurion integrated lab offers a seamless user experience that gives you control of all compatible applications from a single touch screen at table side, to help make fast and informed decisions without breaking sterility.With Azurion’s industry leading image guided therapy platform, we reinforce our commitment to you and your patients. Our goal is to help you effectively meet today’s challenges so that you are ready for the future.Treating patients. It’s what you do.You strive every day to provide the best patient care, quickly and reliably, no matter which procedure you are performing.So try to imagine an increased number of procedures, for more patients, carried out consistently and efficiently with fewerpreparation errors. Workflow can be optimized and performed on an intuitive platform designed to make your day a lot easier.“ I t (Azurion) profited from the experienceprovided by the users and it’s for sure something which is incredible easy to use.”Prof. Laurent Spelle, Hospital Bicetre AP-HP, Paris, FranceFull control at table side to enhance decision making You can now control all compatible applications in the interventional lab via the central touch screen module and FlexVision Pro. Not only does this improve workflow within the exam room, it helps reduce the need for team members to leave the sterile area and walk to the control room during procedures. This can save time and help avoid delays.Gain advanced physiologic guidance to help improve treatment outcomesYou can access IntraSight, a comprehensive suite of clinically proven 2-6 imaging, physiology and co-registration 7 tools, via the central touch screen module. These tools allow you to go beyond the angiogram and complete your view of the target vessel, to help you make fast, informed clinical decisions.Azurion with FlexArm – more independent control for physiciansThe FlexArm option further evolves Azurion’s table side control with the intuitive Axsys controller to make procedures flow naturally and easily. When changes or complications occur, the physician can quickly and easily take action. This can also reduce the need to move in and out of the sterile field during a procedure.Designed around you and your procedureAll Azurion systems and interventional tools use the same standardized user interface to support training. Use has been further simplified through a sophisticated help function. You can access digital user guides with one click for on-the-spot assistance. Clear and simple to useOn screen, information clearly stands out against the distinctive black background where active applications are highlighted. Backlit icons and distinctly shaped buttons on the Control Module promote intuitive operation. All controls are designed for easy cleaning to meet stringent sterility requirements. Less clutter and faster workflowWith the Azurion integrated lab, controlling allcompatible applications at the touch screen module can reduce extra interfaces and controls table side. The FlexSpot works according to the same principle. It gives you access to all compatible applications in one compact, customizable workplace that can be placed in the control room or exam room where needed.Save time by setting the display to re-arrange and re-size as applications are opened and closed.At Philips, we are guided by you. With Azurion, we’ve brought the userexperience and simplicity of touch screen controls right where it’s needed to make a difference to lab workflow.Outstanding user experienceFlexSpot Touch screen module ProFlexVision Pro“ T he new integrated system saves us time, because we can control all applications via one user interface.”Dr. med. Peter Ong, Robert Bosch Hospital, Stuttgart, Germany.With Azurion we help you to optimize your lab performanceAzurion’s integrated approach can help you achieve measurable improvements in throughput, cost reduction and staff satisfaction.Do more at table sideWith our enhanced touch screen module, you will experience simpler, smoother procedures, based on familiar tablet interactions. For example, you can now easily mark relevant details on 2D images on the touch screen with your fingertip.Azurion allows you to run an entire case without breaking sterilityThe touch screen module offers total control within the sterile field. Run an entire case table side as you quickly diagnose, navigate, annotate and measure to your exact specifications, even when wearing gloves and under a sterile drape. Table side control saves you from having to go to the control room to access applications.Save time through Instant Parallel WorkingThe Azurion 7 image guided therapy system has been specifically designed to save time by enabling interventional team members to do two tasks at the same time in the exam room and control room - without interrupting each other. As an example, while fluoroscopy/exposure is taking place, a technologist in the control room can instantly review previous images from the same patient, prepare the next exam or finish reporting on another patient. This leads to higher throughput and faster exam turnover without compromising quality of care.Simplify workflowEnter patient information once and it is automatically transferred to connected applications to reduce data entry errors. To save time, IntelliSpace Cardiovascular 8 and IntelliSpace Portal launch automatically with the specific patient on the exam room monitor.Azurion’s full system automatic position control (APC) gives you more flexibility to recall the stored position of the C-arm, table and other parameters for a particular image to simplify positioning.Imagine an easier work dayYou can combine different user centric workspots (FlexVision Pro, FlexSpot and touch screen modules) to view, control and run applications where and when needed. At these workspots you can co-register 9 iFR or IVUS data with the angiogram, so you have the tools in hand to manage procedure quality and patient care. Together these flexible workspots allow you to customize your workflow to boost efficiency.Safeguard clinical performance and enhance lab security over time with Windows 10 platform The standard Windows 10 platform can help support compliance with the latest security and standards to protect patient data. It can also accommodate new software options to extend your system’s clinical relevance over time.Clinical demands are getting more specific. So are we. Our clinical suites are tailored to meet your specific challenges, while offering you the flexibility to carry out procedures in the easiest, most efficient way.We have a flexible portfolio of integrated technologies and services to support the full interventional spectrum. We also offer Hybrid OR solutions that create an innovative care environment for performing open and minimally invasive surgical procedures.Simplified set-up and operationThe Azurion 7 uses a range of ProcedureCards to help optimize and standardize system set-up for all your cases. The system will automatically select the appropriate ProcedureCard(s) based on the (CIS/RIS/HIS) code of the scheduled procedure from the information system. ProcedureCards can increase the consistency of exams by offering presets (e.g. most-frequently used, default protocols and user-specified settings) on the procedure, physician or department level.In addition, hospital checklists and/or protocols can be uploaded into the ProcedureCards to help safeguard the consistency of interventional procedures and reduce preparation errors.Enhance patient care with continuous monitoring The Philips Interventional Hemodynamic System is integrated with the IntelliVue X3 patient monitor, allowing continuous patient monitoring throughout procedures in the interventional workflow. There isno need to change cables, minimizing disruption to vulnerable patients and giving you more time to focus on them. Continuous patient monitoring also results in a gap-free patient record.Increase clinical confidence with 3D imagingThe clinical application software SmartCT enriches our exceptional 3D interventional tools for interventional procedures with step-by-step guidance that is designed to remove the barriers to acquiring 3D images in the interventional lab.Easily control advanced 3D visualization and measurements at table side on the touch screen module. Studies have shown that 3D CT-like imaging can enhance diagnostic accuracy 9,10,11 and support improved patient outcomes.Azurion enables you to provide superior careAs patient volumes rise and procedures become more complex, how do you maintain high standards of quality and safety in your healthcare facility?Clinical suites “ W e always stay in the angio suite because the ease of use has really improved and now we can control everything from the side of the patient in the angio lab itself.”Prof. Vincent Costalat, Centre Hospitalier Universitaire de Montpellier, FranceHigh quality images at low X-ray doseOur ClarityIQ imaging technology provides significantly lower dose across clinical areas, patients, and operators.12 In routine coronary procedures13, ClarityIQ technology reduces patient dose by 67% without affecting procedural performance while maintaining equivalent image quality, compared to a system without ClarityIQ.14,15 In interventional Neuro procedures, ClarityIQ technology reduces patient dose by 65%, compared to a system without ClarityIQ.16 Managing dose efficientlyDoseWise is integrated across the Philips image-guided therapy Azurion portfolio. DoseWise consists of a comprehensive range of radiation dose management tools, training, and integrated product technologies that aim to help you take control over patient care, staff safety, and regulatory compliance. Another feature is the Zero Dose Positioning function. It lets you pan the table, change table height or field-of-view on your Last Image Hold (LIH) image. This enables positioning without the use of radiation on previously recorded last image.Managing dose across your organizationPhilips DoseAware provides real-time feedback in the exam room It displays the invisible nature of radiation in real time, so that you and your staff can see it promptly, easily and simply – and rapidly understand the effect of behavior changes and work patterns.DoseAware Xtend is a dedicated solution for treatment rooms that builds on the capabilities of DoseAware and interfaces seamlessly with the Azurion image-guided therapy system. Thanks to this seamless integration, DoseAware Xtend can provide live individual dose rates (live screen) during procedures, and summarized procedure doses (review screen). It also reminds staffto better protect themselves by providing a warning symbol when the lead protection screen is not being used properly.Perform standardized quality assurance verifications in just 5 minutes17To make it easier for you to routinely perform consistent verification tests of radiation dose and image quality, only Philips offers the User Quality Control Mode (UQCM) tool on its Azurion system.With this option, you can independently verify and audit the radiation and image quality related factors of your Azurion system in a standardized way in just5 minutes, as well as carry out a range of validation and quality assurance tests.High standards of safety and low radiation exposureAs you look for new radiation dose management strategies to continue to enhance patient and staff safety, while maintaining and enhancing yourlevel of care, we can support you in meeting your goals.Azurion – a comprehensive image guided therapy platformThe Azurion 7 integrated lab brings together a range of sophisticated interventional tools, including clinically proven 2-6 imaging and physiology tools, advancedhemodynamic measurements and cardiac informatics to support clinical excellence during procedures.Azurion 7 C/F12With its 12" Flat Detector, the 7 Series provides high-resolution imaging over a large field-of-view with flexible projection capabilities, making it ideal for cardiac interventions. The entire coronary tree can be visualized in a single view with minimal table panning.Azurion 7 C/F20Enhance visibility for diverse cardiac and vascular procedures with the excellent image quality and broad coverage of the next generation 20" Flat Detector. This system supports head-to-toe imaging and patient access from all sides.Azurion 7 C20 with FlexArmCreate a Hybrid OR that provides unlimited imaging flexibility for diverse procedures and exceptional positioning freedom for medical teams with the Azurion 7 and the next generation 20" Flat Detector, combined with the ceiling-mounted FlexArm option. You get a highly cost-effective environment that is ready for the procedures of the future.Azurion 7 C20 with FlexMoveMove to a Hybrid OR with confidence, with the Azurion 7 and the next generation 20" Flat Detector, combined with the ceiling-mounted FlexMove option. FlexMove offers exceptional workflow flexibility to perform open and minimally invasive procedures in the same room.Azurion 7 B12/12The Azurion 7 biplane system with two 12" Flat Detectors provides high-resolution imaging and positioning flexibility to reveal critical anatomical information during congenital heart and electrophysiology procedures.Azurion 7 B20/12The Azurion 7 biplane system with a 20” and 12” Flat Detector provides exceptional clarity of detail and navigational precision to support a wide range of challenging cardiac and vascular interventions.Azurion 7 B20/15Enhance insight and certainty during neuro interventions with the Azurion 7 biplane system. It pairs a 20" frontal with a 15" lateral detector.information,pleasecontactyoursalesrepresentativeorsendanemailto:***************************High productivity combined with low cost of ownershipWith Philips, you get the best service performance which enables you totreat more patients, and professional support to help you deliver cost-efficient care.Best service performance18 enables you to treatmore patients19Staying on top of today’s complex healthcareenvironment is challenging enough without aconstant concern of keeping your systems up andrunning smoothly. With Philips, your operationsare protected by the best overall service engineerperformance for imaging systems according to IMVServiceTrak for 5 years in a row. Philips remotelyconnected systems provide 135 more hours ofoperational availability per year, enabling you totreat more patients.Professional support helps you delivercost-efficient careTo help you fully leverage your financial,technological and staffing resources and realizea high return on your investment, we offerprofessional support through our experiencednetwork of over 7,000 field service engineers, aswell as a flexible service offering that includes:• Innovative financing solutions tailored to meetthe needs of healthcare organizations• A broad range of healthcare consulting programsto help your organization further enhance theefficiency and efficacy of your care deliveryprocess• Philips Healthcare Education can help unlockthe full potential of your staff, technology andorganization to meet new challenges throughinnovative, meaningful and evidence-basedhealthcare education.Cost-effectively manage future upgrades withthe Technology Maximizer programTechnology Maximizer is a program that runs intandem with your Philips Service Agreement.20When you opt into the program, you receivethe latest available software and hardware21technology releases for a fraction of the cost ofpurchasing them individually. The TechnologyMaximizer Plus allows you to further tailorupgrades to reduce costs. No need to wait forbudget approval.No need to buy individual upgrades. Just a cost-effective way to manage ongoing technologyupgrades through your operational budget.Doing business responsibly and sustainablyWhen you choose Philips, you are choosing apartner committed to meet sustainability andcircular economy ambitions. As a leading healthtechnology company, our purpose is to improvepeople’s health and well-being through meaningfulinnovation, positively impacting 2.5 billion lives peryear by 2030.The Azurion is the result of our EcoDesign processand offers significant environmental improvements:• 100% product take-back after customers’acceptance of our trade-in offer.• 100% repurposing of the equipment that isreturned to Philips• Up to 90% of material weight is reused duringrefurbishing, depending on type and age ofproduct• At least 10% lower energy consumption over totalproduct life usage22Read more about our Environmental, Social andCorporate Governance (ESG) commitments here:https:///a-w/about/sustainability.html135 more hours of operational availability on average, per year,enabling you to treat more patients.19Philips remotely connected systems provide1.2.3.4.5.6.7.8.9. 10.11.12.13.14.15.16.17.18.20.22.**********************。

胰岛素样生长因子结合蛋白-7水平与2型糖尿病病人心血管风险的关系王蕊,王翠娟,尹福在,王锐,张萌萌,韩改玲,陆强,马春明,鲁娜,王佳美摘要目的:分析胰岛素样生长因子结合蛋白-7(IGFBP7)水平与2型糖尿病病人心血管风险的关系㊂方法:选取2018年12月 2019年12月于我院就诊的158例2型糖尿病病人,入院时测量病人基线IGFBP7水平,根据IGFBP7水平中位数分为高水平组和低水平组,各79例㊂治疗后通过门诊㊁电话等方式随访2年,记录两组主要不良心血管事件(MACE)发生情况㊂采用Kaplan-Meier 曲线分析两组2型糖尿病病人心血管风险,并将所有完成随访的病人根据是否发生MACE事件分为发生组和未发生组,采用多因素Logistic回归分析IGFBP7对2型糖尿病的影响,通过受试者工作特征(ROC)曲线分析IGFBP7对2型糖尿病病人发生MACE的预测效能㊂结果:截至末次随访时间2021年12月19日,实际纳入有效病例:高水平组73例,低水平组70例㊂Kaplan-Meier曲线分析显示,高水平组MACE发生风险高于低水平组(Log-Rankχ2=6.289,P=0.012)㊂多因素Logistic回归分析显示,基线IGFBP7水平(OR=1.428)㊁空腹血糖(OR=5.293)㊁糖化血红蛋白(OR=7.004)㊁餐后血糖(OR=2.037)㊁三酰甘油(OR=4.335)㊁总胆固醇(OR= 20.327)㊁低密度脂蛋白胆固醇(OR=4.731)是2型糖尿病病人发生MACE的独立危险因素㊂ROC分析显示,IGFBP7水平预测2型糖尿病病人MACE发生的ROC曲线下面积为0.920,高于空腹血糖(0.730)㊁糖化血红蛋白(0.696)㊁餐后血糖(0.760)㊁三酰甘油(0.798)㊁总胆固醇(0.770)㊁低密度脂蛋白胆固醇(0.727)㊂结论:高基线IGFBP7水平的2型糖尿病病人发生MACE风险升高,IGFBP7水平联合高血脂代谢指标(三酰甘油㊁总胆固醇㊁低密度脂蛋白胆固醇)及高血糖状态指标(空腹血糖㊁糖化血红蛋白㊁餐后血糖)建立的模型预测2型糖尿病病人MACE发生有较好的效能㊂关键词2型糖尿病;胰岛素样生长因子结合蛋白-7;心血管风险d o i:10.12102/j.i s s n.1672-1349.2023.20.0242型糖尿病是临床常见的代谢性疾病,也是当前严重的公共卫生疾病之一[1]㊂主要不良心血管事件(major adverse cardiovascular events,MACE)是2型糖尿病的严重并发症[2]㊂有研究显示,2型糖尿病病人罹患心血管疾病和死亡的风险较正常人高2~3倍,且年龄>40岁的群体预期寿命较未患2型糖尿病者短8年[3]㊂因此,早期预测2型糖尿病病人MACE发生并予以针对性干预具有重要的意义㊂循环生物标志物是具有吸引力的选择,然而,迄今为止报道的多数生物标志物预测2型糖尿病MACE发生或进展方面表现不佳,减轻2型糖尿病MACE发生或进展治疗益处的特定生物标志物尚未明确[4]㊂胰岛素样生长因子结合蛋白-7(insulin-like growth factor binding protein-7, IGFBP7)是一种29kDa的蛋白,是有多种体内作用的衰老相关分泌表型的成员[5]㊂既往研究已证实, IGFBP7水平与心功能及结构损伤关系密切[6]㊂目前基金项目河北省秦皇岛科学技术研究与发展计划项目(No. 202004A133,202301A204);河北省卫健委2020年度医学科学研究项目(No.20201512)作者单位秦皇岛市第一医院(河北秦皇岛066000)通讯作者王锐,E-mail:***************引用信息王蕊,王翠娟,尹福在,等.胰岛素样生长因子结合蛋白-7水平与2型糖尿病病人心血管风险的关系[J].中西医结合心脑血管病杂志,2023,21(20):3809-3813.IGFBP7水平与2型糖尿病病人发生MACE之间的相关性尚未明确㊂本研究通过收集病人基线IGFBP7并随访病人MACE发生情况,探讨其与2型糖尿病病人MACE的关系㊂1资料与方法1.1一般资料选取2018年12月 2019年12月于我院就诊的158例2型糖尿病病人,年龄45~75(63.54ʃ6.96)岁㊂纳入标准:符合‘中国2型糖尿病防治指南“[7]中2型糖尿病的诊断标准;估算肾小球滤过率(eGFR)>30 mL/(min㊃1.73m2)㊂排除标准:入院时已发生心血管事件;既往有酮症酸中毒史㊁脑梗死病史;合并器质性心脏病;依从性差㊂剔除标准:随访期内脱失㊂本研究经医学伦理委员会审核批准,所有病人均签署知情同意书㊂1.2资料收集1)基础资料包括病人性别㊁年龄㊁糖尿病病程㊁既往史等㊂2)实验室检查包括病人生化指标㊁肝功能㊁肾功能等指标及糖代谢指标㊂3)入院时采用乙二胺四乙酸(EDTA)管抽取病人肘静脉血5mL,常规离心处理(离心半径10cm,以3800r/min离心12min)分离上清液待测,使用电化学发光法(Elecsys)测量IGFBP7,试剂盒购自德国Roche Diagnostic,Penzberg㊂1.3随访通过门诊或电话随访2年,记录病人是否出现心源性死亡㊁心肌梗死㊁心力衰竭㊁心绞痛,或需经皮冠状动脉介入(PCI)㊁血运重建等,若出现上述事件即认定2型糖尿病病人发生MACE[8]㊂1.4方法根据2型糖尿病病人IGFBP7水平中位数分为高水平组和低水平组,治疗后随访2年,采用Kaplan-Meier 曲线分析两组2型糖尿病病人心血管风险㊂根据治疗后随访2年病人发生MACE情况分为发生组和未发生组,以发生组和未发生组的临床资料为协变量,通过多因素Logistic回归方程分析IGFBP7水平与2型糖尿病病人发生MACE的相关性,通过绘制受试者工作特征(ROC)曲线评估IGFBP7对2型糖尿病病人发生MACE的预测效能㊂所有数据收集及整理均由2名专职人员共同完成,在整理及数据过程中剔除不合格数据,均采用EpiData3.1软件进行平行双录入㊂1.5统计学处理采用SPSS25.0统计软件对数据进行分析,符合正态分布的定量资料以均数ʃ标准差(xʃs)表示,组间比较采用独立样本t检验;不符合正态分布的定量资料以中位数四分位数[M(P25,P75)]表示,组间比较采用Mann-Whitney U检验;定性资料以例数㊁百分比(%)表示,采用χ2检验;等级资料采用秩和检验㊂多因素采用Logistic回归方程分析;绘制ROC曲线评估预测效能㊂以P<0.05为差异有统计学意义㊂2结果2.1两组一般资料比较IGFBP7水平中位数为102.5ng/mL,据此分为高水平组和低水平组,每组79例㊂高水平组,男47例,女32例,年龄50~74(62.63ʃ6.85)岁;病程2~5 (3.32ʃ1.10)年㊂低水平组,男51例,女28例;年龄50~75(63.12ʃ6.94)岁;病程2~5(3.41ʃ1.07)年㊂两组一般资料比较,差异均无统计学意义(P>0.05),具有可比性㊂2.2随访结果及2型糖尿病病人心血管风险比较截至末次随访日期2021年12月19日,高水平组79例病人中73例病人完成随访,低水平组79例病人中70例完成随访㊂其中高水平组36例病人发生MACE,低水平组24例病人发生MACE㊂将60例发生MACE病人作为发生组,83例未发生MACE病人作为未发生组㊂Kaplan-Meier曲线分析显示高水平组MACE发生风险高于低水平组(Log-Rankχ2=6.289, P=0.012)㊂详见图1㊂图1两组2型糖尿病病人心血管风险比较2.3发生组和未发生组临床资料比较发生组空腹血糖㊁糖化血红蛋白㊁餐后血糖㊁三酰甘油㊁总胆固醇㊁低密度脂蛋白胆固醇㊁IGFBP7水平高于未发生组(P<0.05)㊂详见表1㊂表1发生组和未发生组临床资料比较项目发生组(n=60)未发生组(n=83)统计值P 年龄(岁)63.93ʃ6.1962.80ʃ6.01t=1.0900.278男性[例(%)]33(55.00)42(50.60)χ2=0.2700.603体质指数(kg/m2)25.33ʃ4.2524.69ʃ4.78t=0.8430.401吸烟史[例(%)]55(91.67)70(84.34)χ2=1.7000.192酗酒[例(%)]23(38.33)26(31.33)χ2=0.7590.384病程(年) 3.23ʃ1.01 3.49ʃ1.10t=-1.4630.146平均动脉压(mmHg)68.34ʃ5.4666.55ʃ5.92t=1.8570.064空腹血糖(mmol/L)8.02ʃ1.107.18ʃ0.88t=4.891<0.001糖化血红蛋白(%)7.15ʃ0.58 6.74ʃ0.51t=4.385<0.001餐后血糖(mmol/L)11.69ʃ1.529.94ʃ1.76t=6.355<0.001胰岛素剂量[U/(kg㊃d)]0.83ʃ0.130.86ʃ0.14t=-1.3180.190(续表)项目发生组(n=60)未发生组(n=83)统计值P eGFR[mL/(min㊃1.73m2)]49(40,62)52(40,67)Z=1.7460.083谷氨酸氨基转移酶(U/L)30.84ʃ2.9331.32ʃ3.09t=-0.9450.347 IGFBP7(ng/mL)112.47ʃ6.5499.06ʃ9.83t=10.972<0.001三酰甘油(mmol/L) 2.38ʃ0.45 1.95ʃ0.48t=3.0560.003总胆固醇(mmol/L) 6.56ʃ0.72 5.84ʃ0.72t=5.847<0.001低密度脂蛋白胆固醇(mmol/L) 3.71ʃ0.99 2.90ʃ0.91t=5.024<0.0012.42型糖尿病病人MACE发生的影响因素分析以表1中差异有统计学意义的指标作为自变量,是否发生MACE为因变量,并进行赋值(见表2)㊂多因素Logistic回归分析显示,空腹血糖(OR= 5.293)㊁糖化血红蛋白(OR=7.004)㊁餐后血糖(OR= 2.037)㊁三酰甘油(OR=4.335)㊁总胆固醇(OR= 20.327)㊁低密度脂蛋白胆固醇(OR=4.731)㊁IGFBP7水平(OR=1.428)是2型糖尿病病人发生MACE的危险因素(P<0.05)㊂详见表3㊂表2变量赋值情况变量命名赋值方式MACE Y是=1,否=0空腹血糖X1连续变量糖化血红蛋白X2连续变量餐后血糖X3连续变量IGFBP7X4连续变量三酰甘油X5连续变量总胆固醇X6连续变量低密度脂蛋白胆固醇X7连续变量表32型糖尿病病人MACE发生的影响因素分析指标回归系数标准误Waldχ2值P OR值95%CI空腹血糖 1.6660.676 6.0710.014 5.293[1.406,19.922]糖化血红蛋白 1.9470.939 4.2960.0387.004[1.112,44.139]餐后血糖0.7120.361 3.8870.049 2.037[1.004,4.132]IGFBP70.3560.09214.821<0.001 1.428[1.191,1.711]三酰甘油 1.4670.5407.3860.007 4.335[1.505,12.484]总胆固醇 3.0120.9759.5430.00220.327[3.007,137.392]低密度脂蛋白胆固醇 1.5540.5757.3010.007 4.731[1.532,14.604]常数-99.02724.31416.5882.52型糖尿病MACE发生的预测因素及预测效能ROC曲线分析显示:联合预测2型糖尿病病人MACE风险的ROC曲线下面积(AUC)为0.987, IGFBP7水平为0.920;Delong法比较结果显示,联合预测AUC高于IGFBP7水平,IGFBP7的AUC高于空腹血糖㊁糖化血红蛋白㊁餐后血糖㊁三酰甘油㊁总胆固醇㊁低密度脂蛋白胆固醇㊂详见表4㊁图2㊂表4预测2型糖尿病病人发生MACE的临床效能变量截断值AUC95%CI标准误敏感度(%)特异度(%)空腹血糖7.59mmol/L0.730[0.671,0.810]0.03864.9474.42糖化血红蛋白 6.58%0.696[0.613,0.770]0.04468.3363.86餐后血糖10.83mmol/L0.760[0.682,0.828]0.03973.3369.88 IGFBP7105.44ng/mL0.920[0.863,0.959]0.02286.6783.13三酰甘油 2.39mmol/L0.798[0.723,0.861]0.03853.3395.18总胆固醇 6.27mmol/L0.770[0.692,0.836]0.04070.0079.52低密度脂蛋白胆固醇 3.45mmol/L0.727[0.646,0.798]0.04295.0039.76联合指标0.987[0.952,0.999]0.00696.6795.18图2各预测因素预测2型糖尿病病人发生MACE的ROC曲线图3讨论MACE是2型糖尿病常见的严重并发症之一,据统计,约50%的2型糖尿病病人发生MACE,严重影响病人生存质量及生存期[9]㊂因此,早期防治2型糖尿病病人MACE发生是改善生存质量㊁延长生存期的关键㊂鉴于已有的减轻2型糖尿病MACE严重程度和相关并发症发生率的方法,预测发病和进展具有重要的意义㊂考虑到检测可能无法识别的疾病信号的潜力,循环生物标志物成为潜在选择㊂目前未找到早期预测2型糖尿病病人MACE发生的可靠生物标志物㊂有研究显示,IGFBP7是与衰老分泌表型相关的细胞周期停滞生物标志物,在急慢性心力衰竭㊁冠心病等发生发展中发挥着重要作用[10-11]㊂目前IGFBP7水平与2型糖尿病病人发生MACE的相关性尚未明确㊂鉴于此,本研究测量2型糖尿病病人基线IGFBP7水平,探讨IGFBP7水平与2型糖尿病病人MACE的相关性,评估IGFBP7对2型糖尿病病人MACE发生的预测效能㊂IGFBP7是胰岛素生长因子结合肽家族的成员,在体内具有多项作用[12]㊂IGFBP7是参与衰老的分泌表型,其在受损组织中可诱导细胞周期停滞,参与组织老化㊁细胞死亡和纤维化㊂IGFBP7的研究热点主要集中在心力衰竭病人的生物标志物方面,其中病情严重的病人IGFBP7浓度更高,且与心脏结构异常有关[13]㊂本研究观察到高IGFBP7水平的2型糖尿病病人发生MACE的风险更高,Logistic进一步分析显示, IGFBP7水平可预测2型糖尿病病人MACE发生,表明高IGFBP7水平可增加2型糖尿病病人发生MACE 的风险㊂分析认为:胰岛素样生长因子(IGF)通路是哺乳动物保守的通路㊂IGF-1和IGF-2与其同源受体的结合导致磷脂酰肌醇-3-激酶(PI3K)-蛋白激酶B (AKT)和Ras-Raf-丝裂原活化蛋白激酶(MAPK)信号传导的激活,调节新陈代谢㊁组织稳态[14]㊂2型糖尿病病人高水平IGFBP7通过抑制细胞外调节蛋白激酶(ERK)-1/2和激活p38MAPK和p53-p21通路抑制血管内皮细胞㊁心肌增殖,加速心肌㊁血管内皮细胞衰老,增加胶原蛋白沉积,导致心肌老化和心肌纤维化,加重心功能障碍[15]㊂IGFBP7对胰岛素有高亲和力,可干扰胰岛素的生物学反应,血液循环中较高的IGFBP7水平参与胰岛素受体磷酸化和胰岛素受体底物(IRS)-1磷酸化,降低胰岛素敏感性和脂联素,增加C反应蛋白和可溶性肿瘤坏死因子受体水平[16]㊂有研究表明,增加的IGFBP7可结合血清胰岛素,并显著降低血清游离胰岛素水平,竞争性抑制胰岛素和受体结合,减少或消除胰岛素的生物学效应[17]㊂Yan等[18]研究显示, IGFBP7可干扰胰岛素功能,IGFBP7水平升高可诱发胰岛素抵抗,参与糖尿病和心血管疾病进展㊂证实了高IGFBP7水平可增加2型糖尿病病人MACE的发生风险㊂本研究结果显示,空腹血糖㊁糖化血红蛋白㊁餐后血糖㊁三酰甘油㊁总胆固醇㊁低密度脂蛋白胆固醇与2型糖尿病病人MACE的发生相关㊂空腹血糖㊁糖化血红蛋白㊁餐后血糖过高可诱导高蛋白糖化率,形成高级糖基化终产物,可诱导转录因子的表达和激活,促进脂肪生成,导致血浆脂质谱改变,形成高三酰甘油㊁总胆固醇㊁低密度脂蛋白胆固醇状态㊂血浆脂质谱的改变可增加高级糖基化终产物降解酶的抗性,造成糖基化终产物累积,糖基化终产物过多累积影响了鞘脂代谢,导致神经酰胺和1-磷酸鞘氨醇的血浆水平升高,损伤心脏功能[19]㊂Hu等[20-21]研究显示,脂质和血糖含量高,神经酰胺和1-磷酸鞘氨醇合成增加,且与胰岛素敏感性降低有关㊂Borror等[22]研究显示,糖化血红蛋白每升高1%,心血管事件的危险性升高28%㊂Al Kury 等[23]研究显示,空腹血糖>7.8mmol/L㊁餐后血糖> 11.1mmol/L的病人发生心血管病变风险较正常群体高2~5倍㊂分析原因可能为在高血糖代谢状态下,代谢细胞对过量的营养和能量可激活核转录因子(NF)-κB 通路,表现出慢性炎症反应,损伤病人心血管系统功能,且与高血糖病人NOD样受体热蛋白结构域相关蛋白3(NLRP3)炎症小体复合物特定激活有关[24-25],通过抗糖尿病化合物选择性NLRP3抑制剂靶向炎症小体激活㊂证实高血脂及高血糖状态可影响病人心血管功能,增加2型糖尿病病人MACE的发生风险㊂本研究多因素Logistic回归分析显示,空腹血糖㊁糖化血红蛋白㊁餐后血糖㊁三酰甘油㊁总胆固醇㊁低密度脂蛋白胆固醇㊁IGFBP7水平均为2型糖尿病病人发生MACE的独立危险因素㊂本研究存在不足之处,仅纳入2型糖尿病病人外推性受限,同时炎症及氧化应激反应可能也参与2型糖尿病病人MACE发生过程,结果存在一定的偏倚,后期需大样本量㊁多地域研究,纳入病人炎症㊁氧化应激反应指标证实该观点㊂将各相关因素纳入多因素Logistic回归分析,进一步经ROC分析验证,结果显示,联合指标的AUC为0.987, IGFBP7的AUC为0.920,说明均具有较好的效能㊂Delong法比较结果显示,联合预测AUC高于IGFBP7水平,说明联合模型可预测2型糖尿病病人心血管事件发生风险,因此,建议早期监测相关因子并给予重点关注有助于临床医生高效地识别高危人群,提供有效预防和治疗方案㊂综上所述,高基线IGFBP7水平的2型糖尿病病人发生MACE风险升高,IGFBP7水平联合高血脂代谢指标(三酰甘油㊁总胆固醇㊁低密度脂蛋白胆固醇)及高血糖状态指标(空腹血糖㊁糖化血红蛋白㊁餐后血糖)建立的模型预测2型糖尿病病人MACE发生的效能较好㊂参考文献:[1]石瑞峰,郭晓蕙,章秋.我国成人2型糖尿病自我管理教育与支持的现状与展望[J].中华糖尿病杂志,2021,13(2):121-124. [2]刘杰,顾天伟,钟胜利,等.住院早发2型糖尿病患者代谢特征及慢性并发症情况[J].中华糖尿病杂志,2020,12(6):387-392. [3]VETRONE L M,ZACCARDI F,WEBB D R,et al.Cardiovascularand mortality events in type2diabetes cardiovascular outcomestrials:a systematic review with trend analysis[J].ActaDiabetologica,2019,56(3):331-339.[4]DAVIS T M E,DAVIS W A.The LEADER trial in type2diabetes:were the characteristics and outcomes of the participantsrepresentative?[J].Journal of Diabetes and Its Complications,2019,33(6):427-433.[5]JIN L,SHEN F,WEINFELD M,et al.Insulin growth factor bindingprotein7(IGFBP7)-related cancer and IGFBP3and IGFBP7crosstalk[J].Frontiers in Oncology,2020,10:727.[6]LISOWSKA A,SWIECKI P,KNAPP M,et al.Insulin-like growthfactor-binding protein7(IGFBP7)as a new biomarker incoronary heart disease[J].Advances in Medical Sciences,2019,64(1):195-201.[7]中华医学会糖尿病学分会.中国2型糖尿病防治指南(2013年版)[J].中华内分泌代谢杂志,2014,30(10):893-942.[8]SHARIF S,VISSEREN F L J,SPIERING W,et al.Arterial stiffnessas a risk factor for cardiovascular events and all-cause mortalityin people with type2diabetes[J].Diabetic Medicine,2019,36(9):1125-1132.[9]KRISTENSEN S L,RØRTH R,JHUND P S,et al.Cardiovascular,mortality,and kidney outcomes with GLP-1receptor agonists inpatients with type2diabetes:a systematic review and meta-analysis of cardiovascular outcome trials[J].The LancetDiabetes&Endocrinology,2019,7(10):776-785.[10]BLUM S,AESCHBACHER S,MEYRE P,et al.Insulin-like growthfactor-binding protein7and risk of congestive heart failurehospitalization in patients with atrial fibrillation[J].Heart Rhythm,2021,18(4):512-519.[11]JANUZZI J L,BUTLER J,SATTAR N,et al.Insulin-like growthfactor binding protein7predicts renal and cardiovascularoutcomes in the canagliflozin cardiovascular assessment study[J].Diabetes Care,2021,44(1):210-216.[12]JANUZZI J L,PACKER M,CLAGGETT B,et al.IGFBP7(insulin-like growth factor-binding protein-7)and neprilysin inhibition inpatients with heart failure[J].Circulation Heart Failure,2018,11(10):e005133.[13]KALAYCI A,PEACOCK W F,NAGURNEY J T,et al.Echocardiographic assessment of insulin-like growth factorbinding protein-7and early identification of acute heart failure[J].ESC Heart Failure,2020,7(4):1664-1675.[14]HAGE C,BJERRE M,FRYSTYK J,et parison of prognosticusefulness of serum insulin-like growth factor-binding protein7inpatients with heart failure and preserved versus reduced leftventricular ejection fraction[J].The American Journal ofCardiology,2018,121(12):1558-1566.[15]COULOURES K G,MARSENIC O.Can we use tissue inhibitormetalloproteinase-2and insulin-like growth factor bindingprotein-7levels to predict acute kidney injury in neonate andinfants undergoing cardiac surgery?[J].Pediatric Critical CareMedicine,2020,21(6):593-594.[16]PIEK A,DU W J,DE BOER R A,et al.Novel heart failurebiomarkers:why do we fail to exploit their potential?[J].CriticalReviews in Clinical Laboratory Sciences,2018,55(4):246-263. [17]LÓPEZ-BERMEJO A,KHOSRA VI J,FERNÁNDEZ-REAL J M,et al.Insulin resistance is associated with increased serumconcentration of IGF-binding protein-related protein1(IGFBP-rP1/MAC25)[J].Diabetes,2006,55(8):2333-2339.[18]YAN H,LI T,WANG Y T,et al.Insulin-like growth factor bindingprotein7accelerates hepatic steatosis and insulin resistance innon-alcoholic fatty liver disease[J].Clinical and ExperimentalPharmacology&Physiology,2019,46(12):1101-1110. [19]ARAGNO M,MASTROCOLA R.Dietary sugars and endogenousformation of advanced glycation endproducts:emergingmechanisms of disease[J].Nutrients,2017,9(4):385. [20]HU Q X,ZHANG H L,GUTI RREZ CORT S N,et al.IncreasedDrp1acetylation by lipid overload induces cardiomyocyte deathand heart dysfunction[J].Circulation Research,2020,126(4):456-470.[21]BELLIER J,NOKIN M J,LARDÉE,et al.Methylglyoxal,a potentinducer of AGEs,connects between diabetes and cancer[J].Diabetes Research and Clinical Practice,2019,148:200-211. [22]BORROR A,ZIEFF G,BATTAGLINI C,et al.The effects ofpostprandial exercise on glucose control in individuals with type2diabetes:a systematic review[J].Sports Medicine,2018,48(6):1479-1491.[23]AL KURY L,SMAIL M,QURESHI M A,et al.Calcium signaling inthe ventricular myocardium of the goto-kakizaki type2diabeticrat[J].Journal of Diabetes Research,2018,2018:1-15. [24]LI Q X,LENG K K,LIU Y Y,et al.The impact of hyperglycaemia onPKM2-mediated NLRP3inflammasome/stress granule signallingin macrophages and its correlation with plaque vulnerability:an invivo and in vitro study[J].Metabolism:Clinical and Experimental,2020,107:154231.[25]WANG S F,LI Y B,FAN J J,et al.Interleukin-22ameliorated renalinjury and fibrosis in diabetic nephropathy through inhibition ofNLRP3inflammasome activation[J].Cell Death&Disease,2017,8(7):e2937.(收稿日期:2022-06-29)(本文编辑薛妮)。

国家药监局关于发布仿制药参比制剂目录（第三十八批）的通告正文：----------------------------------------------------------------------------------------------------------------------------------------------------国家药品监督管理局通告2021年第18号国家药监局关于发布仿制药参比制剂目录（第三十八批）的通告经国家药品监督管理局仿制药质量和疗效一致性评价专家委员会审核确定，现发布仿制药参比制剂目录（第三十八批）。

特此通告。

附件：仿制药参比制剂目录（第三十八批）国家药监局2021年2月20日附件仿制药参比制剂目录（第三十八批）序号药品通用名称英文名称/商品名规格持证商备注1备注238-1噻托溴铵奥达特罗吸入喷雾剂Tiotropium Bromide and Olodaterol Hydrochloride Inhalation Spray/Spiolto（思合华）每瓶60喷，每喷含噻托铵2.5μg（相当于噻托溴铵一水合物3.124μg）和奥达特罗2.5μg（相当于盐酸奥达特罗2.736μg）Boehringer Ingelheim International GmbH国内上市的原研药品原研进口38-2噻托溴铵喷雾剂Tiotropium Bromide Spray每瓶60喷，每喷含噻托铵2.5μg，药液浓度含噻托铵0.2262mg/mlBoehringer Ingelheim International GmbH国内上市的原研药品原研进口38-3硝酸咪康唑阴道软胶囊Miconazole Nitrate Vaginal Soft Capsules/Gyno-Daktarin（达克宁）0.4gJanssen-Cilag N.V.国内上市的原研药品原研进口38-4硝酸咪康唑阴道软胶囊Miconazole Nitrate Vaginal Soft Capsules/Gyno-Daktarin（达克宁）1.2gJanssen-Cilag N.V.国内上市的原研药品原研进口38-5丁丙诺啡纳洛酮舌下片Buprenorphine Hydrochloride and Naloxone Hydrochloride Sublingual Tablets 丁丙诺啡2mg/纳洛酮0.5mg（均以碱基计）Indivior UK Limited国内上市的原研药品原研进口38-6丁丙诺啡纳洛酮舌下片Buprenorphine Hydrochloride and Naloxone Hydrochloride Sublingual Tablets 丁丙诺啡8mg/纳洛酮2mg（均以碱基计）Indivior UK Limited国内上市的原研药品原研进口38-7羧甲基纤维素钠滴眼液Carboxymethylcellulose Sodium Eye Drops0.4ml:2mgAllergan Pharmaceuticals Ireland国内上市的原研药品原研进口38-8复方倍他米松注射液Compound Betamethasone Injection/得宝松1ml：二丙酸倍他米松（以倍他米松计）5mg与倍他米松磷酸钠（以倍他米松计）2mg MSD Merck Sharp &amp; Dohme AG国内上市的原研药品原研进口38-9注射用全氟丁烷微球Perflubutane Microspheres for Injection/Sonazoid（示卓安）每瓶中含微球的体积为16μlGE Healthcare AS国内上市的原研药品原研进口38-10索磷维伏片Sofosbuvir，Velpatasvir and Voxilaprevir tablets/Vosevi（沃士韦）每片含 400mg 索磷布韦、100mg 维帕他韦和 100mg 伏西瑞韦Gilead Sciences Ireland UC国内上市的原研药品原研进口38-11复合维生素片Vitamin Complex Tablets/ Elevit Pronatal（爱乐维）复方制剂Bayer S.A.国内上市的原研药品原研进口38-12盐酸奥洛他定鼻喷雾剂Olopatadine Hydrochloride Nasal Spray/Patanase0.665mg/sprayNovartis Pharmaceuticals Corp未进口原研药品美国橙皮书38-13盐酸环丙沙星滴眼液Ciprofloxacin Ophthalmic Solution/Ciloxan0.30%Novartis Pharmaceuticals Corp未进口原研药品美国橙皮书38-14硫酸麻黄碱注射液Ephedrine Sulfate Injection/Akovaz50mg/mlExela Pharma Sciences LLC未进口原研药品美国橙皮书38-15艾考糊精腹膜透析液Icodextrin Peritoneal Dialysis Solution/Extraneal 含7.5%艾考糊精（2L/袋、2.5L/袋）Baxter Healthcare Corporation未进口原研药品美国橙皮书38-16艾考糊精腹膜透析液Icodextrin Peritoneal Dialysis Solution/Extraneal 含7.5%艾考糊精（1.5L/袋、2L/袋、2.5L/袋）Baxter A/S未进口原研药品欧盟上市38-17氨基酸（15）腹膜透析液Amino Acids （15） Peritoneal Dialysis Solution 2.0LBaxter Healthcare Ltd.未进口原研药品欧盟上市38-18氨基酸（15）腹膜透析液Amino Acids （15） Peritoneal Dialysis Solution 2.5LBaxter Healthcare Ltd.未进口原研药品欧盟上市38-19麦芽酚铁胶囊Ferric Maltol Capsules /Feraccru每片含铁30mgNorgine B.V.未进口原研药品欧盟上市38-20氯甲西泮注射液Lormetazepam Injection/ Sedalam10ml：2mgDr. Franz K?hler Chemie GmbH未进口原研药品欧盟上市38-21硝酸异康唑阴道片Isoconazole Nitrate Vaginal Tablets300mgバイエル薬品株式会社未进口原研药品日本上市38-22盐酸头孢卡品酯片Cefcapene Pivoxil Hydrochloride Tablet/Flomox 100mg塩野義製薬株式会社未进口原研药品日本上市38-23氧氟沙星滴耳液Ofloxacin Ear Drops0.30%アルフレッサファーマ株式会社/第一三共株式会社未进口原研药品日本上市38-24氟骨化三醇片Falecalcitriol Tablets/Fulstan0.15μg大日本住友製薬株式会社未进口原研药品日本上市38-25氟骨化三醇片Falecalcitriol Tablets/Fulstan0.3μg大日本住友製薬株式会社未进口原研药品日本上市38-26注射用盐酸吡柔比星Pirarubicin Hydrochloride for Injection/Pinorubin 10mg日本マイクロバイオファーマ株式会社未进口原研药品日本上市38-27注射用盐酸吡柔比星Pirarubicin Hydrochloride for Injection/Pinorubin 20mg日本マイクロバイオファーマ株式会社未进口原研药品日本上市38-28注射用盐酸吡柔比星Pirarubicin Hydrochloride for Injection/Pinorubin 30mg日本マイクロバイオファーマ株式会社未进口原研药品日本上市38-29注射用盐酸多柔比星Doxorubicin Hydrochloride for Injection /Adriacin 10mgアスペンジャパン株式会社未进口原研药品日本上市38-30美沙拉秦缓释颗粒Mesalazine Sustained-release Granules /Pentasa 1g，按美沙拉秦（C7H7NO3）计Ferring S.A.S未进口原研药品法国上市38-31美沙拉秦缓释颗粒Mesalazine Sustained-release Granules /Pentasa 2g，按美沙拉秦（C7H7NO3）计Ferring S.A.S未进口原研药品法国上市38-32富马酸伏诺拉生片Vonoprazan Fumarate Tablets /Vocinti（沃克）10mgTakeda Pharmaceutical Company Limited国内上市的原研药品原研进口38-33富马酸伏诺拉生片Vonoprazan Fumarate Tablets /Vocinti（沃克）20mgTakeda Pharmaceutical Company Limited国内上市的原研药品原研进口38-34碳酸镧颗粒Lanthanum Carbonate Oral Powder/ Fosrenol 1000mgShire Development LLC/Takeda Pharmmaceuticals USA INC 未进口原研药品美国橙皮书38-35尼莫地平口服溶液Nimodipine Oral Solution / Nymalize6mg/mlArbor Pharmaceuticals, LLC未进口原研药品美国橙皮书38-36氟尿嘧啶注射液Fluorouracil Injection/ Fluorouracil500mg/10mlAccord Healthcare, Inc国际公认的同种药品美国橙皮书38-37小儿复方氨基酸注射液（19AA-Ⅰ）10% Amino Acid Injection /Trophamine 10%10%（500ml）B Braun Medical Inc未进口原研药品美国橙皮书38-38氯化钾缓释片Potassium Chloride Extended Release Tablets/K-Tab20mEq（相当于1.5g氯化钾）Abbvie Inc未进口原研药品美国橙皮书38-39盐酸吡格列酮片Pioglitazone Hydrochloride Tablets/Actos45mgTakeda Pharmaceuticals USA Inc未进口原研药品美国橙皮书38-40盐酸丁螺环酮片Buspirone Hydrochloride Tablet15mgTeva Pharmaceuticals USA Inc.国际公认的同种药品美国橙皮书38-41盐酸罗匹尼罗缓释片Ropinirole Hydrochloride Sustained-release Tablets 8mgGLAXO SMITHKLINE/SmithKline Beecham Limited未进口原研药品欧盟上市38-42亚叶酸钙注射液Calcium Folinate Injection5ml：50mgHospira UK Ltd未进口原研药品欧盟上市38-43苯磺酸氨氯地平片Amlodipine Besylate Tablets10mg（以C20H25CLN2O5计）Pfizer未进口原研药品欧盟上市38-44甲氨蝶呤注射液Methotrexate Injection2ml：50mgPfizer Pharma Pfe GmbH未进口原研药品欧盟上市38-45多西他赛注射液Docetaxel Injection/Taxotere20mg/1mlSanofi Mature IP未进口原研药品欧盟上市38-46盐酸罗哌卡因注射液Ropivacaine Hydrochloride Injection/Naropin/Naropeine/Naropina20mg/10mlAspen Pharma Trading Limited未进口原研药品欧盟上市38-47盐酸坦索罗辛口崩缓释片Tamsulosin Hydrochloride Oral Dispersible Sustained Release Tablets0.2mgAstellas Pharma Inc/アステラス製薬株式会社未进口原研药品日本上市38-48钆特醇注射液Gadoteridol Injection/ ProHance10ml:2.793gブラッコスイス株式会社未进口原研药品日本上市38-49钆特醇注射液Gadoteridol Injection/ ProHance15ml:4.1895gブラッコスイス株式会社未进口原研药品日本上市38-50注射用头孢他啶Ceftazidime For Injection/Modacin1.0gグラクソ?スミスクライン株式会社未进口原研药品日本上市38-51注射用氨曲南Aztreonam For Injection1.0g日本エーザイ株式会社未进口原研药品日本上市5-19卡托普利片Captopril Tablets/Captopril12.5mgDaiichi Sankyo Espha Co., Ltd./アルフレッサファーマ株式会社日本橙皮书增加持证商アルフレッサファーマ株式会社5-20卡托普利片Captopril Tablets/Captopril25mgDaiichi Sankyo Espha Co., Ltd./アルフレッサファーマ株式会社日本橙皮书增加持证商アルフレッサファーマ株式会社21-102注射用环磷酰胺Cyclophosphamide for Injection/Endoxan（安道生）1gBaxter Oncology GmbH/Baxter Healthcare Ltd国内上市的原研药品增加持证商Baxter Healthcare Ltd23-48阿普司特片Apremilast Tablet /Otezla10mgCelgene Corp/Amgen Inc未进口原研药品增加持证商Amgen Inc23-49阿普司特片Apremilast Tablet /Otezla20mgCelgene Corp/Amgen Inc未进口原研药品增加持证商Amgen Inc27-412阿普司特片Apremilast Tablet /Otezla30mgCelgene Corp/Amgen Inc未进口原研药品增加持证商Amgen Inc27-372苯磺酸氨氯地平片Amlodipine Besylate Tablets5mg（以C20H25CLN2O5计）Pfizer Luxembourg Sarl/Pfizer Limited/Pfizer未进口原研药品增加持证商Pfizer Luxembourg Sarl/Pfizer；不限定商品名8-175盐酸齐拉西酮胶囊Ziprasidone Hydrochloride Capsules/Zeldox20mg（按齐拉西酮计）Pfizer Australia Pty Limited / Pfizer Pharma PFE GmbH原研进口持证商变更，增加变更后持证商Pfizer Pharma PFE GmbH8-225盐酸齐拉西酮胶囊Ziprasidone Hydrochloride Capsules/Zeldox40mg（按齐拉西酮计）Pfizer Australia Pty Limited / Pfizer Pharma PFE GmbH原研进口持证商变更，增加变更后持证商Pfizer Pharma PFE GmbH21-111沙美特罗替卡松吸入粉雾剂Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation/Seretide（舒利迭）50ug/100ug/泡Laboratoire GlaxoSmithKline国内上市的原研药品药品通用名称修订为“沙美特罗替卡松吸入粉雾剂”21-112沙美特罗替卡松吸入粉雾剂Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation/Seretide（舒利迭）50ug/250ug/泡Laboratoire GlaxoSmithKline国内上市的原研药品药品通用名称修订为“沙美特罗替卡松吸入粉雾剂”21-113沙美特罗替卡松吸入粉雾剂Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation/Seretide（舒利迭）50ug/500ug/泡Laboratoire GlaxoSmithKline国内上市的原研药品药品通用名称修订为“沙美特罗替卡松吸入粉雾剂”21-116沙美特罗替卡松吸入气雾剂Salmeterol Xinafoate and Fluticasone Propionate Aerosol/Seretide（舒利迭）25ug/125ug/揿Laboratoire GlaxoSmithKline国内上市的原研药品药品通用名称修订为“沙美特罗替卡松吸入气雾剂”22-122氟维司群注射液Fulvestrant Injection/Faslodex（芙仕得5ml:0.25gAstraZeneca UK Limited/AstraZeneca AB国内上市的原研药品持证商发生变更，增加变更后持证商AstraZeneca AB23-217中长链脂肪乳/氨基酸（16）/葡萄糖（36%）注射液Medium and Long Chain Fat Emulsion，Amino Acids（16）and Glucose（36％） Injection625mlB. Braun melsungen ag国际公认的同种药品英文名称修订为“Medium and Long Chain Fat Emulsion，Amino Acids（16）and Glucose（36％） Injection”23-218中长链脂肪乳/氨基酸（16）/葡萄糖（36%）注射液Medium and Long Chain Fat Emulsion，Amino Acids（16）and Glucose（36％） Injection1250mlB. Braun melsungen ag国际公认的同种药品英文名称修订为“Medium and Long Chain Fat Emulsion，Amino Acids（16）and Glucose（36％） Injection”27-326琥珀酸索利那新片Solifenacin Succinate Tablets/Vesicare5mgAstellas Pharma US Inc未进口原研药品更新持证商为Astellas Pharma US Inc27-327琥珀酸索利那新片Solifenacin Succinate Tablets/Vesicare10mgAstellas Pharma US Inc未进口原研药品更新持证商为Astellas Pharma US Inc备注1.未在国内上市品种，需参照原总局2015年第230号公告等的相关要求开展研究，通用名、剂型等经药典委核准后为准。

In today's world an "online branch" is a must even for a highly successful storeMarch 2020Consumers typically look first for the opening hours, services and products available in the online profile of a supplier before they go shopping. For that reason, offline purchasing is no longer conceivable without an online presence. Consumers are directed to their local eye care professional (ECP) by a clever use of online marketing and social media in the beginning of the so called “customer journey”.Is an elaborate shop window decoration enough to lure customers into the store? Are all consumers aware of how often an eye test is recommended or what solutions optometry can offer? Online marketing and the intelligent use of social media can help to inform consumers about everything to do with optometry. ZEISS provides ECPs with support along the entire customer journey.These days, it is a given that a large number of consumers will start searching online at an early stage. Where is the nearest optician? What are the opening times? What brands does it carry? Or perhaps the consumer is first made aware through news and advertising that it is now time for the next eye test or that there are new solutions available for one or the other of their visual challenges.Today, in the digital age, consumers are already familiar with the subject of optometry long before they enter the shop. The initial part of the customer journey is the first digital encounter. ECPs who are not on board tend to fall through the search grid. Potential customers are lost. All businesses are now well advised to also operate a "branch" online. As a partner to ECPs, ZEISS helps to reach consumers online and to raise awareness of the topic of optometry - and not just in the store but also in the digital world.What is the customer journey?The customer journey describes the route a consumer takes in purchasing a product. It starts with an awareness phase and goes far beyond customer loyalty programs. Particularly at the start, the customer journey is based on the motto: There are many roads leading to the ECP. There is generally no universal procedure. The media preferred by a consumer can be highly individual. That makes it all the more important for all businesses to engage with and be active on the most popular platforms. This is the only way to reach potential customers at the very start of their journey nowadays.Three digital areas - all linked:Learn more, search, find an ECP"I know what's out there"Visibility is the key. If a consumer does not know what products or what specific solutions may be available, it is difficult for them to search for them. With the help of personalized ads, ZEISS or the ECP themselves can draw attention to individual solutions via Facebook and Instagram. ZEISS offers support in three ways: ZEISS ads in Facebook and Instagram, ad templates for ECPs and training courses on how to use ads in a particularly effective and sustainable manner. There are 394 million active Facebook users in Europe.1 Just this figure alone demonstrates the importance of the ECP's presence in social media.As a customer, ZEISS is in direct, continuous contact with Facebook. ZEISS consequently understands the latest trends and consumer insights and always knows what to look out for. Everyone should be well aware that Facebook has also become a competitive advertising environment. Various companies work towards the greatest degree of visibility in their respective markets. This makes it all the more important to be able to stand out and to know exactly what images, videos and postings are required to reach a specific target group. This is where the ECP can rely on ZEISS expertise and advice."I have a problem and I'm looking for a solution""Tired eyes", "blurred vision", "dry eyes" - all of these are visual problems that consumers tend to Google - perhaps because they were alerted to them previously by an advertisement. Product searches can also be triggered by ads. The search results: include among other things the Better Vision portal from ZEISS, which provides comprehensive information on a wide range of consumer issues and reaches more than 1 million users worldwide every month. Or the consumer may search directly for "optician near me" and navigate to the local ECP's Google My Business profile2 or website. Data shows that every 20 to 30 seconds “optician near me” is searched via Google in the US alone3. This trend has become more important in the recent years in all countries, where Google can be used. Therefore, search engines obviously play a significant role for consumers before going to a local ECPs store. They are interested in what is on offer, what brands of frames are available and whether they can or must make an appointment.1https://allfacebook.de/toll/state-of-facebook2 This is typically the profile of a shop or service provider etc., which appears in Google Maps and includes information such as ratings, opening hours or pictures.3 Google Ads Keyword Stats 2020-02-24 - 2019-01-24 for term “optician near me” in the US and UK.The ZEISS Better Vision portal offers information on a range of relevant consumer issues.Google My Business as a digital business card on the web is a minimum for ECPs. Furthermore, personalized online advertising should refer to the ECP’s website to bring valuable traffic on his profile with the purpose of getting more consumer in-store. Regarding the website there are two important factors to consider. Firstly, the texts should be search engine optimized. Consequently, when creating the site, the ECP should ask whether, for example, terms are used which a consumer would also use when searching online. But even more important is to pay attention to the overall image of the website. Are the images significant? Do all links work? Can the site also be displayed well on the smartphone - i.e. optimized for mobile use? Is it designed to be easy to use? In the end, a poor website is just as discouraging as an awkward store layout.4 ZEISS invests a great deal of effort to fulfil precisely these requirements for its own web presence. For one thing is certain: Whereas ten years ago consumers relied mostly on recommendations from their friends and acquaintances, today they have access to a much larger network in the world of the Internet. An inviting website has meanwhile become part of the standard program for creating a professional appearance, which also conveys a sense of trustworthiness."I know where to go"With the growth of Google searches for “opticians near me” it gets more important for ECPs to own an optimized Google My Business profile, so consumer can find, engage and – at the end – visit them. Images, contact details and opening hours are inserted into Google in a very easy and uncomplicated process, and after a short, analogue verification procedure, the store appears in the local search results. Furthermore, today's consumers like to inform themselves online about products and services, for example via Google ratings, which can be viewed in this profile. These ratings, whether positive or negative, offer ECPs the opportunity to enter into a direct exchange with consumers or to identify potential for improvement.4 You can check your website performance with Google’s Grow My Store web app for free:https:///intl/en_ukConsumers can use the ZEISS Store Locator to find the ZEISS partner ECP in their area.The ZEISS website also connects ECPs directly with consumers. The so-called ZEISS Store Locator on the ZEISS website was developed in cooperation with Google. In January 2020, 77,000 search queries were recorded worldwide using the ZEISS Store Locator. It is directly linked to the Google My Business profiles of the ECPs: Some of the advantages of the ZEISS and Google cooperation are a modern appearance, targeted search, cross-platform benefits and the easy use. If a consumer is directed to the ZEISS website by Google or by an advertisement, they can find the nearest ZEISS partner ECP based on their address. The ZEISS Store Locator is connected with the Google My Business profile and therefore automatically shows images and opening hours which are part of that profile. The same happens when consumers have completed their ZEISS My Vision Profile. Ultimately, they receive personal lens recommendations, a QR code on their smartphone that the ECP can scan with the ZEISS VISUCONSULT app in the store and a redirection to the ZEISS Store Locator to find the nearest ZEISS ECP. Everything is linked.ZEISS My Vision Profile is just one element in a networked world of tools for the customer journey.Online presence - not an option, but a mustFacebook, Google, own websites, POS materials, apps, newsletters - all of these cannot be considered in isolation from one another. There are many ways on the digital customer journey and often a few twists and turns are made first or there is a back and forth for the first three quarters of the journey before finally entering the store. This is where the customer journey continues offline, for example with the ZEISS Vision Analysis.So it is clear that customers are not only attracted to the shop window, and not every target group can be reached via an advertisement in the regional press. In today's world, it must be a foregone conclusion for successful ECPs to use digital platforms and social media.5 Without a website and a Google My Business profile, your business will simply not be found in search results. Without maintained opening hours, customers would prefer to go to another store. If the offers are not advertised on Facebook and Instagram, the consumers will probably not use them. ZEISS will help to shape the customer journey at all stages so that both consumers and ECPs benefit. The ultimate goal of all activities is always the same: to guide consumers to the store where the experts are waiting.5 According to Facebook, at the start of 2020 there were 2.3 billion people who used a Facebook service (Instagram, Facebook, WhatsApp, etc.) on a daily basis. | https://allfacebook.de/toll/state-of-facebook。

UnitedHealthcare ® Community PlanMedicaSpevigo ® (Spesolimab-Sbzo)Policy Number: CS2023D00119CEffective Date: June 1, 2023Instructions for UseTable of Contents PageApplication ..................................................................................... 1 Coverage Rationale ....................................................................... 1 Applicable Codes .......................................................................... 2 Background .................................................................................... 3 Clinical Evidence ............................................................................ 3 U.S. Food and Drug Administration .............................................. 4 References ..................................................................................... 4 Policy History/Revision Information ............................................. 5 Instructions for Use ........................................................................ 5 This Medical Policy does not apply to the states listed below; refer to the state-specific policy/guideline, if noted: State Policy/Guideline IndianaSpevigo ® (Spesolimab-Sbzo) (for Indiana Only)KansasRefer to the state’s Medicaid clinical policy LouisianaSpevigo ® (Spesolimab-Sbzo) (for Louisiana Only)MississippiNone North CarolinaNone OhioNone PennsylvaniaRefer to the state’s Medicaid clinical policy TexasRefer to drug specific criteria found within the Texas Medicaid Provider Procedures ManualGeneralized Pustular Psoriasis (GPP)Spevigo is proven and medically necessary for the treatment of generalized pustular psoriasis flares when all of the following criteria are met:1,2,3Diagnosis of generalized pustular psoriasis (GPP) based on both of the following:2,3 o Presence of primary, sterile, macroscopically visible pustules on non-acral skin o Pustulation is not restricted to psoriatic plaques andOne of the following: o Patient has a moderate to severe GPP flare based on one of the following: ▪ Generalized Pustular Psoriasis Physician Global Assessment (GPPPGA) total score ≥ 3 (moderate)▪ Generalized Pustular Psoriasis Physician Global Assessment (GPPPGA) pustulation subscore ≥ 2 (mild)▪ Erythema and pustules cover ≥ 5% of body-surface areaCommercial Policy • Spevigo ® (Spesolimab-Sbzo)▪New appearance or worsening of pustulesoro All of the following:▪Patient has already received one initial dose of Spevigo for a current GPP flare; and▪Documentation that the patient requires a second dose of Spevigo in order to treat persistent GPP flare symptoms including one of the following:GPPPGA total score ≥ 2GPPPGA pustulation subscore ≥ 2FeverAstheniaMyalgiaElevated C-reactive proteinLeukocytosis with peripheral blood neutrophilia (above the upper limit of normal [ULN])and▪The second dose of Spevigo is to be administered no sooner than one week after the initial dose of Spevigo.andPatient is not receiving Spevigo in combination with any of the following:o Biologic disease-modifying antirheumatic drug (DMARD) [e.g., Enbrel (etanercept), Humira (adalimumab), Cosentyx (secukinumab), Stelara (ustekinumab)]o Janus kinase inhibitor [e.g., Xeljanz (tofacitinib)]o Phosphodiesterase 4 (PDE4) inhibitor [e.g., Otezla (apremilast)]andSpevigo is dosed according to U.S. Food and Drug Administration labeled dosing for GPP flares; andTotal dose of Spevigo does not exceed two doses per single GPP flare (Note: If the patient has been treated with Spevigofor a previous GPP flare, then a new (different) GPP flare may be treated with up to two doses of Spevigo); andPrescribed by a dermatologist; andAuthorization will be for no more than 21 days.Spevigo (Spesolimab-sbzo) is unproven and not medically necessary for the treatment of the following conditions and situations:Administration in excess of 2 doses per single GPP flareAtopic dermatitisCrohn’s diseaseHidradenitis suppurativaPalmoplantar pustulosisPlaque psoriasisPrevention of GPP flaresUlcerative colitisThe following list(s) of procedure and/or diagnosis codes is provided for reference purposes only and may not be all inclusive. Listing of a code in this policy does not imply that the service described by the code is a covered or non-covered health service. Benefit coverage for health services is determined by federal, state, or contractual requirements and applicable laws that may require coverage for a specific service. The inclusion of a code does not imply any right to reimbursement or guarantee claim payment. Other Policies and Guidelines may apply.HCPCS Code DescriptionJ1747 Injection, spesolimab-sbzo, 1 mgDiagnosis Code DescriptionL40.1 Generalized pustular psoriasisGeneralized pustular psoriasis is a severe skin disease characterized by the repeated occurrence of acute flares caused by systemic inflammation affecting the skin and internal organs.4,9 GPP is distinct from plaque psoriasis in clinical presentation, pathophysiology, histopathology, response to therapies, epidemiology and genetics.2 The clinical presentation of GPP is different from psoriasis vulgaris (PV) in its’ episodic nature, often with normal appearing skin between very acute and severe disease flares. GPP is clinically characterized by the preponderance of pustules as the primary lesion on an erythematous base rather than red plaques covered with silvery scales representing the primary lesion of typical plaque psoriasis. GPP may be associated with systemic symptoms (fever, increased CRP and neutrophilia) and severe extra-cutaneous organ manifestations (liver, kidney failure, CV shock). The European Rare And Severe Psoriasis Expert Network (ERASPEN) has defined consensus criteria that include as key diagnosis criteria for acute GPP the presence of primary, sterile, macroscopically visible pustules on non-acral skin (excluding cases where pustulation is restricted to psoriatic plaques), with or without systemic inflammation, with or without plaque-type psoriasis, either relapsing (> 1 episode) or persistent (> 3 months).3 Chronic GPP describes the state in between disease flares that may be characterized by the complete absence of symptoms or the persistence of residual skin symptoms such as erythema and scaling and minor pustulation.Spevigo is a humanized antagonistic monoclonal immunoglobulin G1 antibody that blocks the activation of the interleukin-36 receptor (IL-36R), a signaling pathway within the immune system that is involved in the pathogenesis of generalized pustular psoriasis (GPP).2 Binding of spesolimab-sbzo to IL36R prevents the subsequent activation of IL36R by cognate ligands (IL36 α, β and γ) and downstream activation of pro-inflammatory and pro-fibrotic pathways. IL36R signaling is differentiated from TNF-α, integrin and IL-23 inhibitory pathways by directly and simultaneously blocking both inflammatory and pro-fibrotic pathways. The role of the interleukin-36 pathway in GPP is supported by the finding of loss-of-function mutations in the interleukin-36 receptor antagonist gene (IL36RN) and associated genes (CARD14, AP1S3, SERPINA3, and MPO) and by the overexpression of interleukin-36 cytokines in GPP skin lesions.4-8ProvenGeneralized Pustular Psoriasis FlaresA phase 2, multicenter, randomized, double blind, placebo-controlled trial evaluated the safety and efficacy of spesolimab-sbzo in patients age 18 to 75 years who had generalized pustular psoriasis (GPP) and had a GPP flare of moderate-to-severe intensity.2 A GPP flare of moderate-to-severe intensity was defined as: a GPPGA total score of ≥ 3, new or worsening pustules, a GPPGA pustulation subscore of ≥ 2, and ≥ 5% of bodysurface area with erythema and the presence of pustules. Patients who presented with a GPP flare were randomly assigned in a 2:1 ratio to receive a single intravenous dose of 900 mg of spesolimab-sbzo or placebo. On day 8, patients from both groups were eligible to receive a single, open-label, intravenous dose of 900 mg of spesolimab-sbzo (which led to a crossover from placebo to open-label spesolimab-sbzo for some patients) if they had persistent symptoms, on the basis of a predefined threshold that consisted of a Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) total score of 2 or higher at the end of week 1 (range, 0 [clear skin] to 4 [severe disease]) and a clinician assessment of GPP severity based on a modified Physician Global Assessment and a GPPGA pustulation subscore of 2 or higher at week 1 (range, 0 [no visible pustules] to 4 [severe pustulation]). The GPPGA total score is the average of the subscores for pustulation, erythema, and scaling. After week 1, rescue treatment with a single intravenous dose of 900 mg of spesolimab-sbzo could be administered in case of reoccurrence of a flare (defined as an increase of ≥ 2 points in both the GPPGA total score and the pustulation subscore after a GPPGA total score of 0 or 1 had been reached). Escape treatment was defined as standard-of-care therapy, according to the treating physician’s choice, that was allowed for patients who had worsening of disease that warranted immediate treatment during week 1 and for patients with disease worsening who did not qualify for a rescue medication with open-label spesolimab-sbzo after week 1. The primary end point was a GPPGA pustulation subscore of 0 (no visible pustules) at the end of week 1. At the end of week 1, a total of 19 of the 35 patients (54%) who were assigned to the spesolimab-sbzo group and 1 of the 18 patients (6%) who were assigned to the placebo group had a GPPGA pustulation subscore of 0 (no visible pustules) (difference, 49 percentage points; 95% confidence interval [CI], 21 to 67; p < 0.001). A total of 15 patients (43%) who were assigned to the spesolimab-sbzo group and 2 patients (11%) who were assigned to the placebo group had a GPPGA total score of 0 or 1 (clear or almost clear skin) (difference, 32 percentage points; 95% CI, 2 to 53; p = 0.02). In Study Effisayil-1, subjects in either treatment group who continued to experience flare symptoms at Week 1were eligible to receive a single open-label intravenous dose of 900 mg of Spevigo (second dose and first dose for subjects in the Spevigo and placebo groups, respectively). At Week 1, 12 (34%) subjects and 15 subjects (83%) in the SPEVIGO and placebo groups, respectively, received open-label Spevigo. In subjects who were randomized to Spevigo and received an open-label dose of Spevigo at Week 1, 5 (42%) subjects had a GPPPGA pustulation sub score of 0 at Week 2 (one week after their second dose of Spevigo).Through the first week of treatment, adverse events were reported in 66% of the patients assigned to the spesolimab-sbzo group and 56% of those assigned to the placebo group. Pyrexia occurred in 6% of the patients who received spesolimab-sbzo and in 22% of those who received placebo; all pyrexia events occurred in the context of the underlying GPP flare, but pyrexia attributable to the drug cannot be ruled out. Infections were reported in 17% of the patients in the spesolimab-sbzo group and in 6% of those in the placebo group through the first week. At week 1, in the spesolimab-sbzo group, there were two cases of urinary tract infection and one case each of various other infections. Serious adverse events were reported in 6% of the patients who received spesolimab-sbzo and in none of the patients who received placebo in the first week. At week 12, a total of 82% of the patients who received at least one dose of spesolimab-sbzo (including those assigned to the placebo group who received open-label spesolimab-sbzo at day 8) had an adverse event, and 12% had a serious adverse event; in the spesolimab-sbzo group, the percentages of patients with adverse events remained unchanged or increased and the time-adjusted incidence rates decreased from week 1 to week 12. Infections were reported in 47% of the patients. There were three cases each of urinary tract infection and influenza; two cases each of folliculitis, otitis externa, upper respiratory tract infection, and pustule; and one case each of other infections. Symptoms that were observed in two patients who received spesolimab-sbzo were reported as a drug reaction with eosinophilia and systemic symptoms (DRESS) with RegiSCAR (European Registry of Severe Cutaneous Adverse Reactions) scores of 1 and 3.UnprovenPlaque PsoriasisGeneralized pustular psoriasis (GPP) is a rare neutrophilic skin disease and is distinct from plaque psoriasis. Key exclusion criteria in a phase 2 trial (Effisayil™ 1) evaluating spesolimab-sbzo for the treatment of GPP flares were plaque psoriasis without pustules or with pustules restricted to psoriatic plaques.2This section is to be used for informational purposes only. FDA approval alone is not a basis for coverage.Spevigo is a humanized anti–interleukin-36 receptor monoclonal antibody indicated for the treatment of generalized pustular psoriasis flares in adults.11.Spevigo [prescribing information]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc.; September 2022.2.Bachelez H, Choon SE, Marrakchi S, et al. Trial of Spesolimab-sbzo for Generalized Pustular Psoriasis. N Engl J Med.2021;385(26):2431-2440. doi:10.1056/NEJMoa2111563.3.Navarini AA, Burden AD, Capon F, et al. European consensus statement on phenotypes of pustular psoriasis. J Eur AcadDermatol Venereol. 2017;31(11):1792-1799. doi:10.1111/jdv.14386.4.Marrakchi S, Guigue P, Renshaw BR, et al. Interleukin-36–receptor antagonist deficiency and generalized pustularpsoriasis. N Engl J Med 2011;365:620-8.5.Berki DM, Liu L, Choon S-E, et al. Activating CARD14 mutations are associated with generalized pustular psoriasis butrarely account for familial recurrence in psoriasis vulgaris. J Invest Dermatol 2015; 135:2964-70.6.Setta-Kaffetzi N, Simpson MA, Navarini AA, et al. AP1S3 mutations are associated with pustular psoriasis and impaired Toll-like receptor 3 trafficking. Am J Hum Genet 2014;94:790-7.7.Frey S, Sticht H, Wilsmann-Theis D, et al. Rare loss-of-function mutation in SERPINA3 in generalized pustular psoriasis. JInvest Dermatol 2020;140(7):1451- 1455.e13.8.Vergnano M, Mockenhaupt M, Benzian-Olsson N, et al. Loss-of-function myeloperoxidase mutations are associated withincreased neutrophil counts and pustular skin disease. Am J Hum Genet 2020;107:539-43.9.Hussain S, Berki DM, Choon SE, et al. IL36RN mutations define a severe autoinflammatory phenotype of generalizedpustular psoriasis. J Allergy Clin Immunol. 2015;135(4):1067-1070.e9. doi:10.1016/j.jaci.2014.09.043.Date Summary of Changes06/01/2023 ApplicationLouisianaAdded reference link to the Medical Benefit Drug Policy titled Spevigo® (Spesolimab-Sbzo) (forLouisiana Only)TexasAdded language to indicate this Medical Benefit Drug Policy does not apply to the state of Texas;refer to the drug-specific criteria found within the Texas Medicaid Provider Procedures Manual Supporting InformationArchived previous policy version CS2023D00119BThis Medical Benefit Drug Policy provides assistance in interpreting UnitedHealthcare standard benefit plans. When deciding coverage, the federal, state or contractual requirements for benefit plan coverage must be referenced as the terms of the federal, state or contractual requirements for benefit plan coverage may differ from the standard benefit plan. In the event of a conflict, the federal, state or contractual requirements for benefit plan coverage govern. Before using this policy, please check the federal, state or contractual requirements for benefit plan coverage. UnitedHealthcare reserves the right to modify its Policies and Guidelines as necessary. This Medical Benefit Drug Policy is provided for informational purposes. It does not constitute medical advice.UnitedHealthcare may also use tools developed by third parties, such as the InterQual® criteria, to assist us in administering health benefits. The UnitedHealthcare Medical Benefit Drug Policies are intended to be used in connection with the independent professional medical judgment of a qualified health care provider and do not constitute the practice of medicine or medical advice.。

o o ST:ZIP:( )Fax:( )ST:ZIP:oo ( )Fax:( )Note: PLA size has been optimized based upon anthropometric studies relative to cushion width.Note: Optimal PLA sizing can help provide lower Ischial pressures, improved stability and comfort for the user.PLA INSERTFactory Filled (FF) Fluid PadField Variable (FV) Fluid Pad Note: Field Variable comes standard with the following supplement pads:PLA A = 2-Medium PLA B = 2-Large PLA C = 2-XlargeFF or FVSTEP 4Factory FilledField VariableSelectedComponent Select Part # Up-Charge o FF NC oFV $22For additional information, please refer to the J3 Cushion Quick Reference Guide. Part # 111903.Confirm Via:Fax EmailShip To Phone:The HCPCS CODES herein are based on PDAC verification or interpretation of Medicare definitions and guidelines. Non-Medicare payers may accept alternative HCPCS CODES , includingmisc. codes to ensure access for their enrollees. The use of HCPCS CODES does not ensure coverage or payment.JAY J3 CushionTo order a J3 Cushion, a J3 SMART Part Number must be built. Follow the steps below to build your own unique Smart Part #.ExampleSelected ComponentJ3 CUSHION BASESelect Part # Charge Dealer Contact:Ship To:Dealer Address:Attention:Dealer City:Address:Dealer Phone:Address:Confirmation Email:Ship To City:JAY ®J3 CushionE2622 / E2623 / E2624 / E2625February 2023Mark For:Submitting for:Quote OrderDate:PO#:Dealer Acct #:Dealer:ADDITIONAL SHIPPING INFORMATIONNot shown but available through Sun Parts Online:"Pelvic Obliquity Pads" - example part # J3CDCOLNC Move PLA location. PLA Size remains the same. Available to move up to 4" forward, 1" left or right in 1" increments NC Front of PLA is additionally cutaway to decrease the slope angle from the PLA to the femoral support area NC Note: Multiple combinations of these MODS are possible. Common example is Femoral Transition and Scrotal. Please contact customer service for combinations Note: If there is a modification that is not listed above, contact customer service and we will do our best to accommodate your needs.NOTESPOSITIONING COMPONENTS(If applicable)Note: Please contact customer service to discuss your modification options. 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o J3CS2424CFFME2623 JAY J3 CUSHION 2424 $685$794$685$794$685$794$685$794$685$794$685$794$685$794$685$794$685$794$685$794$685$794$685$794$685$794$685$794$685$794$685$794$685$794$685$794$685$794$685$794$685$794$685$794$685$794$685$794$685$794$685$794$685$794$685$794$685$794$685$794$685$794$685$794$685$794$685$794$685$794$685$794$685$794$685$794$685$794$685$794$685$794$685$794$685$794$685$794$685$794$685$685$685$685$685$685$685$685$685$685$68522" & Greater in Width$685$794$685$794$685$794$685$685$685$685o J3CS1412AFFIE2622 JAY J3 CUSHION 1412 o J3CS2120CFFIE2622 JAY J3 CUSHION 2120 o J3CS1414AFFIE2622 JAY J3 CUSHION 1414 o J3CS2121AFFIE2622 JAY J3 CUSHION 2121 o J3CS1416AFFIE2622 JAY J3 CUSHION 1416 o J3CS2121BFFIE2622 JAY J3 CUSHION 2121 oJ3CS1418AFFI E2622 JAY J3 CUSHION 1418 oJ3CS2121CFFI E2622 JAY J3 CUSHION 2121 o J3CS1515AFFIE2622 JAY J3 CUSHION 1515 o J3CS2122AFFIE2622 JAY J3 CUSHION 2122 o J3CS1516AFFIE2622 JAY J3 CUSHION 1516 o J3CS2122BFFIE2622 JAY J3 CUSHION 2122 o J3CS1517AFFIE2622 JAY J3 CUSHION 1517 o J3CS2122CFFIE2622 JAY J3 CUSHION 2122 o J3CS1615AFFIE2622 JAY J3 CUSHION 1615 o J3CS1615BFFIE2622 JAY J3 CUSHION 1615 o J3CS2218AFFIE2623 JAY J3 CUSHION 2218 o J3CS1616AFFIE2622 JAY J3 CUSHION 1616 o J3CS2218BFFIE2623 JAY J3 CUSHION 2218 o J3CS1616BFFIE2622 JAY J3 CUSHION 1616 o J3CS2218CFFIE2623 JAY J3 CUSHION 2218 o J3CS1617AFFIE2622 JAY J3 CUSHION 1617 o J3CS2219AFFIE2623 JAY J3 CUSHION 2219 o J3CS1617BFFIE2622 JAY J3 CUSHION 1617 o J3CS2219BFFIE2623 JAY J3 CUSHION 2219 o J3CS1618AFFIE2622 JAY J3 CUSHION 1618 o J3CS2219CFFIE2623 JAY J3 CUSHION 2219 o J3CS1618BFFIE2622 JAY J3 CUSHION 1618 o J3CS2220AFFIE2623 JAY J3 CUSHION 2220 o J3CS1620AFFIE2622 JAY J3 CUSHION 1620 o J3CS2220BFFIE2623 JAY J3 CUSHION 2220 o J3CS1620BFFIE2622 JAY J3 CUSHION 1620 o J3CS2220CFFIE2623 JAY J3 CUSHION 2220 o J3CS1715AFFIE2622 JAY J3 CUSHION 1715 o J3CS2221AFFIE2623 JAY J3 CUSHION 2221 o J3CS1715BFFIE2622 JAY J3 CUSHION 1715 o J3CS2221BFFIE2623 JAY J3 CUSHION 2221 o J3CS1716AFFIE2622 JAY J3 CUSHION 1716 o J3CS2221CFFIE2623 JAY J3 CUSHION 2221 o J3CS1716BFFIE2622 JAY J3 CUSHION 1716 o J3CS2222AFFIE2623 JAY J3 CUSHION 2222 oJ3CS1717AFFI E2622 JAY J3 CUSHION 1717 oJ3CS2222BFFI E2623 JAY J3 CUSHION 2222 o J3CS1717BFFIE2622 JAY J3 CUSHION 1717 o J3CS2222CFFIE2623 JAY J3 CUSHION 2222 o J3CS1718AFFIE2622 JAY J3 CUSHION 1718 o J3CS2318AFFIE2623 JAY J3 CUSHION 2318 o J3CS1718BFFIE2622 JAY J3 CUSHION 1718 o J3CS2318BFFIE2623 JAY J3 CUSHION 2318 o J3CS1816AFFIE2622 JAY J3 CUSHION 1816 o J3CS2318CFFIE2623 JAY J3 CUSHION 2318 o J3CS1816BFFIE2622 JAY J3 CUSHION 1816 o J3CS2319AFFIE2623 JAY J3 CUSHION 2319 o J3CS1817AFFIE2622 JAY J3 CUSHION 1817 o J3CS2319BFFIE2623 JAY J3 CUSHION 2319 o J3CS1817BFFIE2622 JAY J3 CUSHION 1817 o J3CS2319CFFIE2623 JAY J3 CUSHION 2319 o J3CS1818AFFIE2622 JAY J3 CUSHION 1818 o J3CS2320AFFIE2623 JAY J3 CUSHION 2320 o J3CS1818BFFIE2622 JAY J3 CUSHION 1818 o J3CS2320BFFIE2623 JAY J3 CUSHION 2320 o J3CS1820AFFIE2622 JAY J3 CUSHION 1820 o J3CS2320CFFIE2623 JAY J3 CUSHION 2320 o J3CS1820BFFIE2622 JAY J3 CUSHION 1820 o J3CS2321AFFIE2623 JAY J3 CUSHION 2321 o J3CS1916AFFIE2622 JAY J3 CUSHION 1916 o J3CS2321BFFIE2623 JAY J3 CUSHION 2321 o J3CS1916BFFIE2622 JAY J3 CUSHION 1916 o J3CS2321CFFIE2623 JAY J3 CUSHION 2321 oJ3CS1917AFFI E2622 JAY J3 CUSHION 1917 oJ3CS2322AFFI E2623 JAY J3 CUSHION 2322 o J3CS1917BFFIE2622 JAY J3 CUSHION 1917 o J3CS2322BFFIE2623 JAY J3 CUSHION 2322 o J3CS1918AFFIE2622 JAY J3 CUSHION 1918 o J3CS2322CFFIE2623 JAY J3 CUSHION 2322 o J3CS1918BFFIE2622 JAY J3 CUSHION 1918 o J3CS2418AFFIE2623 JAY J3 CUSHION 2418 o J3CS1920AFFIE2622 JAY J3 CUSHION 1920 o J3CS2418BFFIE2623 JAY J3 CUSHION 2418 o J3CS1920BFFIE2622 JAY J3 CUSHION 1920 o J3CS2418CFFIE2623 JAY J3 CUSHION 2418 o J3CS2016AFFIE2622 JAY J3 CUSHION 2016 o J3CS2419AFFIE2623 JAY J3 CUSHION 2419 o J3CS2016BFFIE2622 JAY J3 CUSHION 2016 o J3CS2419BFFIE2623 JAY J3 CUSHION 2419 o J3CS2016CFFIE2622 JAY J3 CUSHION 2016 o J3CS2419CFFIE2623 JAY J3 CUSHION 2419 o J3CS2018AFFIE2622 JAY J3 CUSHION 2018 o J3CS2420AFFIE2623 JAY J3 CUSHION 2420 o J3CS2018BFFIE2622 JAY J3 CUSHION 2018 o J3CS2420BFFIE2623 JAY J3 CUSHION 2420 o J3CS2018CFFIE2622 JAY J3 CUSHION 2018 o J3CS2420CFFIE2623 JAY J3 CUSHION 2420 o J3CS2020AFFIE2622 JAY J3 CUSHION 2020 o J3CS2421AFFIE2623 JAY J3 CUSHION 2421 o J3CS2020BFFIE2622 JAY J3 CUSHION 2020 o J3CS2421BFFIE2623 JAY J3 CUSHION 2421 o J3CS2020CFFIE2622 JAY J3 CUSHION 2020 o J3CS2421CFFIE2623 JAY J3 CUSHION 2421 o J3CS2118AFFIE2622 JAY J3 CUSHION 2118 o J3CS2422AFFIE2623 JAY J3 CUSHION 2422 o J3CS2118BFFIE2622 JAY J3 CUSHION 2118 o J3CS2422BFFIE2623 JAY J3 CUSHION 2422 o J3CS2118CFFIE2622 JAY J3 CUSHION 2118 o J3CS2422CFFIE2623 JAY J3 CUSHION 2422 oJ3CS2119AFFI E2622 JAY J3 CUSHION 2119 oJ3CS2424AFFI E2623 JAY J3 CUSHION 2424 o J3CS2119BFFIE2622 JAY J3 CUSHION 2119 o J3CS2424BFFIE2623 JAY J3 CUSHION 2424 o J3CS2119CFFIE2622 JAY J3 CUSHION 2119 o J3CS2424CFFIE2623 JAY J3 CUSHION 2424 $685$794$685$794$685$794$685$794$685$794$685$794$685$794$685$794$685$794$685$794$685$794$685$794$685$794$685$794$685$794$685$794$685$794$685$794$685$794$685$794$685$794$685$794$685$794$685$794$685$794$685$794$685$794$685$794$685$794$685$794$685$794$685$794$685$794$685$794$685$794$685$794$685$794$685$794$685$794$685$794$685$794$685$794$685$794$685$794$685$685$685$685$685$685$685$685$68522" & Greater in Width$685$794$685$794$685$794$685$794$685$685$685$685$685$685aHCPCSa HCPCSo J3CS1212AFFSPE2624 JAY J3 CUSHION 1212 o J3CS2120AFFSPE2624 JAY J3 CUSHION 2120 o J3CS1214AFFSPE2624 JAY J3 CUSHION 1214 o J3CS2120BFFSPE2624 JAY J3 CUSHION 2120 o J3CS1412AFFSPE2624 JAY J3 CUSHION 1412 o J3CS2120CFFSPE2624 JAY J3 CUSHION 2120 o J3CS1414AFFSPE2624 JAY J3 CUSHION 1414 o J3CS2121AFFSPE2624 JAY J3 CUSHION 2121 o J3CS1416AFFSPE2624 JAY J3 CUSHION 1416 o J3CS2121BFFSPE2624 JAY J3 CUSHION 2121 oJ3CS1418AFFSP E2624 JAY J3 CUSHION 1418 oJ3CS2121CFFSP E2624 JAY J3 CUSHION 2121 o J3CS1515AFFSPE2624 JAY J3 CUSHION 1515 o J3CS2122AFFSPE2624 JAY J3 CUSHION 2122 o J3CS1516AFFSPE2624 JAY J3 CUSHION 1516 o J3CS2122BFFSPE2624 JAY J3 CUSHION 2122 o J3CS1517AFFSPE2624 JAY J3 CUSHION 1517 o J3CS2122CFFSPE2624 JAY J3 CUSHION 2122 o J3CS1615AFFSPE2624 JAY J3 CUSHION 1615 o J3CS1615BFFSPE2624 JAY J3 CUSHION 1615 o J3CS2218AFFSPE2625 JAY J3 CUSHION 2218 o J3CS1616AFFSPE2624 JAY J3 CUSHION 1616 o J3CS2218BFFSPE2625 JAY J3 CUSHION 2218 o J3CS1616BFFSPE2624 JAY J3 CUSHION 1616 o J3CS2218CFFSPE2625 JAY J3 CUSHION 2218 o J3CS1617AFFSPE2624 JAY J3 CUSHION 1617 o J3CS2219AFFSPE2625 JAY J3 CUSHION 2219 o J3CS1617BFFSPE2624 JAY J3 CUSHION 1617 o J3CS2219BFFSPE2625 JAY J3 CUSHION 2219 o J3CS1618AFFSPE2624 JAY J3 CUSHION 1618 o J3CS2219CFFSPE2625 JAY J3 CUSHION 2219 o J3CS1618BFFSPE2624 JAY J3 CUSHION 1618 o J3CS2220AFFSPE2625 JAY J3 CUSHION 2220 o J3CS1620AFFSPE2624 JAY J3 CUSHION 1620 o J3CS2220BFFSPE2625 JAY J3 CUSHION 2220 o J3CS1620BFFSPE2624 JAY J3 CUSHION 1620 o J3CS2220CFFSPE2625 JAY J3 CUSHION 2220 o J3CS1715AFFSPE2624 JAY J3 CUSHION 1715 o J3CS2221AFFSPE2625 JAY J3 CUSHION 2221 o J3CS1715BFFSPE2624 JAY J3 CUSHION 1715 o J3CS2221BFFSPE2625 JAY J3 CUSHION 2221 o J3CS1716AFFSPE2624 JAY J3 CUSHION 1716 o J3CS2221CFFSPE2625 JAY J3 CUSHION 2221 o J3CS1716BFFSPE2624 JAY J3 CUSHION 1716 o J3CS2222AFFSPE2625 JAY J3 CUSHION 2222 oJ3CS1717AFFSP E2624 JAY J3 CUSHION 1717 oJ3CS2222BFFSP E2625 JAY J3 CUSHION 2222 o J3CS1717BFFSPE2624 JAY J3 CUSHION 1717 o J3CS2222CFFSPE2625 JAY J3 CUSHION 2222 o J3CS1718AFFSPE2624 JAY J3 CUSHION 1718 o J3CS2318AFFSPE2625 JAY J3 CUSHION 2318 o J3CS1718BFFSPE2624 JAY J3 CUSHION 1718 o J3CS2318BFFSPE2625 JAY J3 CUSHION 2318 o J3CS1816AFFSPE2624 JAY J3 CUSHION 1816 o J3CS2318CFFSPE2625 JAY J3 CUSHION 2318 o J3CS1816BFFSPE2624 JAY J3 CUSHION 1816 o J3CS2319AFFSPE2625 JAY J3 CUSHION 2319 o J3CS1817AFFSPE2624 JAY J3 CUSHION 1817 o J3CS2319BFFSPE2625 JAY J3 CUSHION 2319 o J3CS1817BFFSPE2624 JAY J3 CUSHION 1817 o J3CS2319CFFSPE2625 JAY J3 CUSHION 2319 o J3CS1818AFFSPE2624 JAY J3 CUSHION 1818 o J3CS2320AFFSPE2625 JAY J3 CUSHION 2320 o J3CS1818BFFSPE2624 JAY J3 CUSHION 1818 o J3CS2320BFFSPE2625 JAY J3 CUSHION 2320 o J3CS1820AFFSPE2624 JAY J3 CUSHION 1820 o J3CS2320CFFSPE2625 JAY J3 CUSHION 2320 o J3CS1820BFFSPE2624 JAY J3 CUSHION 1820 o J3CS2321AFFSPE2625 JAY J3 CUSHION 2321 o J3CS1916AFFSPE2624 JAY J3 CUSHION 1916 o J3CS2321BFFSPE2625 JAY J3 CUSHION 2321 o J3CS1916BFFSPE2624 JAY J3 CUSHION 1916 o J3CS2321CFFSPE2625 JAY J3 CUSHION 2321 oJ3CS1917AFFSP E2624 JAY J3 CUSHION 1917 oJ3CS2322AFFSP E2625 JAY J3 CUSHION 2322 o J3CS1917BFFSPE2624 JAY J3 CUSHION 1917 o J3CS2322BFFSPE2625 JAY J3 CUSHION 2322 o J3CS1918AFFSPE2624 JAY J3 CUSHION 1918 o J3CS2322CFFSPE2625 JAY J3 CUSHION 2322 o J3CS1918BFFSPE2624 JAY J3 CUSHION 1918 o J3CS2418AFFSPE2625 JAY J3 CUSHION 2418 o J3CS1920AFFSPE2624 JAY J3 CUSHION 1920 o J3CS2418BFFSPE2625 JAY J3 CUSHION 2418 o J3CS1920BFFSPE2624 JAY J3 CUSHION 1920 o J3CS2418CFFSPE2625 JAY J3 CUSHION 2418 o J3CS2016AFFSPE2624 JAY J3 CUSHION 2016 o J3CS2419AFFSPE2625 JAY J3 CUSHION 2419 o J3CS2016BFFSPE2624 JAY J3 CUSHION 2016 o J3CS2419BFFSPE2625 JAY J3 CUSHION 2419 o J3CS2016CFFSPE2624 JAY J3 CUSHION 2016 o J3CS2419CFFSPE2625 JAY J3 CUSHION 2419 o J3CS2018AFFSPE2624 JAY J3 CUSHION 2018 o J3CS2420AFFSPE2625 JAY J3 CUSHION 2420 o J3CS2018BFFSPE2624 JAY J3 CUSHION 2018 o J3CS2420BFFSPE2625 JAY J3 CUSHION 2420 o J3CS2018CFFSPE2624 JAY J3 CUSHION 2018 o J3CS2420CFFSPE2625 JAY J3 CUSHION 2420 o J3CS2020AFFSPE2624 JAY J3 CUSHION 2020 o J3CS2421AFFSPE2625 JAY J3 CUSHION 2421 o J3CS2020BFFSPE2624 JAY J3 CUSHION 2020 o J3CS2421BFFSPE2625 JAY J3 CUSHION 2421 o J3CS2020CFFSPE2624 JAY J3 CUSHION 2020 o J3CS2421CFFSPE2625 JAY J3 CUSHION 2421 o J3CS2118AFFSPE2624 JAY J3 CUSHION 2118 o J3CS2422AFFSPE2625 JAY J3 CUSHION 2422 o J3CS2118BFFSPE2624 JAY J3 CUSHION 2118 o J3CS2422BFFSPE2625 JAY J3 CUSHION 2422 o J3CS2118CFFSPE2624 JAY J3 CUSHION 2118 o J3CS2422CFFSPE2625 JAY J3 CUSHION 2422 oJ3CS2119AFFSP E2624 JAY J3 CUSHION 2119 oJ3CS2424AFFSP E2625 JAY J3 CUSHION 2424 o J3CS2119BFFSPE2624 JAY J3 CUSHION 2119 o J3CS2424BFFSPE2625 JAY J3 CUSHION 2424 o J3CS2119CFFSPE2624 JAY J3 CUSHION 2119 o J3CS2424CFFSPE2625 JAY J3 CUSHION 2424 $707$816$707$816$707$816$707$816$707$816$707$816$707$816$707$816$707$816$707$816$707$816$707$816$707$816$707$816$707$816$707$816$707$816$707$816$707$816$707$816$707$816$707$816$707$816$707$816$707$816$707$816$707$816$707$816$707$816$707$816$707$816$707$816$707$816$707$816$707$816$707$816$707$816$707$816$707$816$707$816$707$816$707$816$707$816$707$707$707$707$707$707$70722" & Greater in Width$707$816$707$816$707$816$707$816$707$816Option #DefinitionPriceOption #Definition Price$707$707$707$707$707$707$707$707$707$707$707$707JAY J3 Cushion Standard w/ Factory Filled Fluid Insert and Stretch Cover and Positioningo J3CS1412AFFMPE2624 JAY J3 CUSHION 1412 o J3CS2120CFFMPE2624 JAY J3 CUSHION 2120 o J3CS1414AFFMPE2624 JAY J3 CUSHION 1414 o J3CS2121AFFMPE2624 JAY J3 CUSHION 2121 o J3CS1416AFFMPE2624 JAY J3 CUSHION 1416 o J3CS2121BFFMPE2624 JAY J3 CUSHION 2121 oJ3CS1418AFFMP E2624 JAY J3 CUSHION 1418 oJ3CS2121CFFMP E2624 JAY J3 CUSHION 2121 o J3CS1515AFFMPE2624 JAY J3 CUSHION 1515 o J3CS2122AFFMPE2624 JAY J3 CUSHION 2122 o J3CS1516AFFMPE2624 JAY J3 CUSHION 1516 o J3CS2122BFFMPE2624 JAY J3 CUSHION 2122 o J3CS1517AFFMPE2624 JAY J3 CUSHION 1517 o J3CS2122CFFMPE2624 JAY J3 CUSHION 2122 o J3CS1645AFFMPE2624 JAY J3 CUSHION 1645 o J3CS1645BFFMPE2624 JAY J3 CUSHION 1645 o J3CS2218AFFMPE2625 JAY J3 CUSHION 2218 o J3CS1616AFFMPE2624 JAY J3 CUSHION 1616 o J3CS2218BFFMPE2625 JAY J3 CUSHION 2218 o J3CS1616BFFMPE2624 JAY J3 CUSHION 1616 o J3CS2218CFFMPE2625 JAY J3 CUSHION 2218 o J3CS1617AFFMPE2624 JAY J3 CUSHION 1617 o J3CS2219AFFMPE2625 JAY J3 CUSHION 2219 o J3CS1617BFFMPE2624 JAY J3 CUSHION 1617 o J3CS2219BFFMPE2625 JAY J3 CUSHION 2219 o J3CS1618AFFMPE2624 JAY J3 CUSHION 1618 o J3CS2219CFFMPE2625 JAY J3 CUSHION 2219 o J3CS1618BFFMPE2624 JAY J3 CUSHION 1618 o J3CS2220AFFMPE2625 JAY J3 CUSHION 2220 o J3CS1620AFFMPE2624 JAY J3 CUSHION 1620 o J3CS2220BFFMPE2625 JAY J3 CUSHION 2220 o J3CS1620BFFMPE2624 JAY J3 CUSHION 1620 o J3CS2220CFFMPE2625 JAY J3 CUSHION 2220 o J3CS1715AFFMPE2624 JAY J3 CUSHION 1715 o J3CS2221AFFMPE2625 JAY J3 CUSHION 2221 o J3CS1715BFFMPE2624 JAY J3 CUSHION 1715 o J3CS2221BFFMPE2625 JAY J3 CUSHION 2221 o J3CS1716AFFMPE2624 JAY J3 CUSHION 1716 o J3CS2221CFFMPE2625 JAY J3 CUSHION 2221 o J3CS1716BFFMPE2624 JAY J3 CUSHION 1716 o J3CS2222AFFMPE2625 JAY J3 CUSHION 2222 oJ3CS1717AFFMP E2624 JAY J3 CUSHION 1717 oJ3CS2222BFFMP E2625 JAY J3 CUSHION 2222 o J3CS1717BFFMPE2624 JAY J3 CUSHION 1717 o J3CS2222CFFMPE2625 JAY J3 CUSHION 2222 o J3CS1718AFFMPE2624 JAY J3 CUSHION 1718 o J3CS2318AFFMPE2625 JAY J3 CUSHION 2318 o J3CS1718BFFMPE2624 JAY J3 CUSHION 1718 o J3CS2318BFFMPE2625 JAY J3 CUSHION 2318 o J3CS1816AFFMPE2624 JAY J3 CUSHION 1816 o J3CS2318CFFMPE2625 JAY J3 CUSHION 2318 o J3CS1816BFFMPE2624 JAY J3 CUSHION 1816 o J3CS2319AFFMPE2625 JAY J3 CUSHION 2319 o J3CS1817AFFMPE2624 JAY J3 CUSHION 1817 o J3CS2319BFFMPE2625 JAY J3 CUSHION 2319 o J3CS1817BFFMPE2624 JAY J3 CUSHION 1817 o J3CS2319CFFMPE2625 JAY J3 CUSHION 2319 o J3CS1818AFFMPE2624 JAY J3 CUSHION 1818 o J3CS2320AFFMPE2625 JAY J3 CUSHION 2320 o J3CS1818BFFMPE2624 JAY J3 CUSHION 1818 o J3CS2320BFFMPE2625 JAY J3 CUSHION 2320 o J3CS1820AFFMPE2624 JAY J3 CUSHION 1820 o J3CS2320CFFMPE2625 JAY J3 CUSHION 2320 o J3CS1820BFFMPE2624 JAY J3 CUSHION 1820 o J3CS2321AFFMPE2625 JAY J3 CUSHION 2321 o J3CS1916AFFMPE2624 JAY J3 CUSHION 1916 o J3CS2321BFFMPE2625 JAY J3 CUSHION 2321 o J3CS1916BFFMPE2624 JAY J3 CUSHION 1916 o J3CS2321CFFMPE2625 JAY J3 CUSHION 2321 oJ3CS1917AFFMP E2624 JAY J3 CUSHION 1917 oJ3CS2322AFFMP E2625 JAY J3 CUSHION 2322 o J3CS1917BFFMPE2624 JAY J3 CUSHION 1917 o J3CS2322BFFMPE2625 JAY J3 CUSHION 2322 o J3CS1918AFFMPE2624 JAY J3 CUSHION 1918 o J3CS2322CFFMPE2625 JAY J3 CUSHION 2322 o J3CS1918BFFMPE2624 JAY J3 CUSHION 1918 o 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