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Real-world access is hindered by healthcare infrastructure limits, complex treatment workflows, and reimbursement issues, and clear best practices to shorten time to treatment remain insufficient. Autolus Inc convened an expert panel blending HSCT-center and payer expertise to identify operational barriers, propose cross-stakeholder solutions, and emphasize streamlined referrals, authorization, certification prerequisites, and time-efficient contracting approaches.",{"@graph":69,"@context":123},[70,84,106],{"@type":71,"itemListElement":72},"BreadcrumbList",[73,77,79,82],{"item":74,"name":75,"@type":76,"position":8},"https://docshare.wps.com","Home","ListItem",{"item":78,"name":9,"@type":76,"position":14},"https://docshare.wps.com/document/",{"item":80,"name":35,"@type":76,"position":81},"https://docshare.wps.com/document/healthcare/",3,{"item":83,"name":65,"@type":76,"position":19},"https://docshare.wps.com/document/operationalizing-access-for-chimeric-antigen-receptor-t-cell-therapies-a-cross-functional-perspective/411515/",{"url":83,"name":65,"@type":85,"image":86,"author":91,"headline":65,"publisher":94,"fileFormat":97,"inLanguage":63,"description":67,"dateModified":98,"datePublished":99,"encodingFormat":97,"isAccessibleForFree":100,"interactionStatistic":101},"DigitalDocument",{"url":87,"@type":88,"width":89,"height":90},"https://docshare.wps.com/thumbnails/operationalizing-access-for-chimeric-antigen-receptor-t-cell-therapies-a-cross-functional-perspective/411515.png","ImageObject",300,407,{"name":92,"@type":93},"Dipper","Person",{"url":74,"name":95,"@type":96},"DocShare","Organization","application/pdf","2026-11-01","2026-09-28",true,{"@type":102,"interactionType":103,"userInteractionCount":105},"InteractionCounter",{"@type":104},"ViewAction",11,{"@type":107,"mainEntity":108},"FAQPage",[109,115,119],{"name":110,"@type":111,"acceptedAnswer":112},"Why does timely CAR T infusion matter for outcomes?","Question",{"text":113,"@type":114},"CAR T efficacy is higher for patients who receive timely infusions. Mortality increases with each month of delay.","Answer",{"name":116,"@type":111,"acceptedAnswer":117},"What factors contribute to delays in accessing CAR T therapy?",{"text":118,"@type":114},"Delays stem from healthcare infrastructure constraints, intricate treatment processes, and reimbursement complexities that complicate authorization and contracting.",{"name":120,"@type":111,"acceptedAnswer":121},"How can stakeholders reduce time to treatment?",{"text":122,"@type":114},"The article highlights opportunities such as expanding treatment capacity by reducing redundant certification prerequisites, aligning clinical criteria to support prompt referral, and streamlining payer authorization. It also notes that faster financial arrangements and appropriate single-case agreements can facilitate timely care.","https://schema.org",{"og:url":83,"og:type":125,"og:title":65,"og:site_name":95,"og:description":67},"article",{"robots":127,"canonical":83},"index,follow",{"doc_id":129,"site_id":62},411515,1790876506,{"code":4,"msg":5,"data":132},{"doc_id":129,"user_id":133,"nickname":92,"user_avatar":134,"doc_module":4,"category_id":34,"category_name":35,"doc_title":65,"doc_description":67,"doc_content":135,"file_id":136,"file_url":137,"file_type":138,"file_size":139,"view_count":105,"is_deleted":4,"is_public":8,"is_downloadable":8,"audit_status":8,"page_count":140,"language":141,"language_code":63,"site_id":62,"html_lang":63,"table_of_contents":142,"faqs":143,"seo_title":144,"seo_description":67,"update_tm":145,"read_time":41,"preview_page_count":4},1374404997633,"https://ap-avatar.wpscdn.com/davatar_a8503ba1806abce46bf441b54a3ca4cd","SPECIAL ARTICLE  \nOperationalizing Access for Chimeric Antigen Receptor T cell Therapies: ACross-functional Perspective  \nSurya Singh, MD; Carol Greulich, MBA; Ariel Perez, MD; Kelly Terrell, MBA, BSN; Julie Walz-Jensen, BS, RN; and Michael D. Dalzell, BA  \nAbstract  \nChimeric antigen receptor T cell (CAR T) treatment efficacy has been shown to be greater in those who receive timely infusions, while mortality rates increase with each month’s delay in treatment. Yet healthcare infrastructure constraints, an intricate treatment process, and reimbursement complexities present challenges that affect timely patient access to CAR T therapy. Best practices for decreasing time to treatment are not well established. Autolus Inc convened an expert panel of 3 advisors from established hematopoietic stem-cell transplant centers and 3 advisors with extensive national or regional payer experience to identify operational barriers that contribute to treatment delays as well as potential means for addressing them. Opportunities exist to expand treatment capacity by reducing redundant prerequisites for treatment center certification and through collaboration between established centers and newer centers that need critical expertise to gain accreditation. Aligning clinical criteria are important for improving clinician understanding of the treatment process, facilitating timely referral to treatment centers, and streamlining payer authorization processes. Negotiating financial arrangements is the most time-consuming step of the process before CAR T manufacturing can begin; contracts between treatment centers and payers can help to facilitate timely care, but single-case agreements are necessary for treatment centers and payers without extensive CAR T experience. Single-case agreements should consider each side’s experience and financial exposure. In identifying obstacles to timely care and working through potential solutions, participants developed a genuine appreciation for the interdependence among stakeholders. Recognition of mutual interest is a starting point for cross-functional cooperation.  \n© 2025 THE AUTHORS. Published by Elsevier Inc on behalf of Mayo Foundation for Medical Education and Research. This is an open access article under the CC BY license ([http://creativecommons.org/licenses/by/4.0/](http://creativecommons.org/licenses/by/4.0/)) n Mayo Clin Proc Inn Qual Out 2026;10(1):100682  \nC  \nell and gene therapies (CGTs) compose a fast-growing area of cancer treatment and research. As of  \nthe end of 2024, more than a dozen of the 43 CGTs approved by the US Food and Drug Administration (FDA)―8 of them chimeric antigen receptor T cell (CAR T) therapies―had hematology or oncology indications.1-3 Approximately 300 additional CGTs were in late-stage clinical trials for oncologic use.3  \nThe rapid pace of approvals has led to predictions about widespread, data-driven adoption of CGT and CAR T therapies. However, capacity constraints and reimbursement complexities present challenges confounding these expectations. In 2024, ∼ 100 facilities  \nin the United States were certified to offer CAR T therapy.4 These centers absorb much of the patient volume, in part because the ever-increasing number of referrals exceeds the growth in certification of new centers of excellence (COE) . Moreover, the largest centers have at least some payer contracts in place for CAR T reimbursement, while other centers and payers are obliged to negotiate  \ntime-consuming single-case agreements.  \nInfrastructure and operational bottlenecks increase time to treatment in a patient population whose disease tends to progress rapidly, many of whom have relapsed or refractory disease, and therefore need care as quickly as possible to maximize outcomes. For example, median overall survival in  \nFrom InformedDNA, St. Petersburg, FL (S.S.); CGP Consulting, Cincinnati, OH (C.G.); Miami Cancer Institute, Baptist Health South Florida, Miami, FL (A.P.); Siteman Cancer Center, ","cbCailTtF7rWVNnb","https://ap.wps.com/l/cbCailTtF7rWVNnb","pdf",1849377,12,"English","# Background and Access Challenges\n## Capacity Constraints and Reimbursement Complexity\n# Operational Barriers and Time to Treatment\n## Disease Progression During Waiting Period\n# Expert Panel Approach and Solutions\n## Capacity Expansion and Streamlined Processes\n## Clinical Alignment and Payer Authorization\n## Financial Contracting and Single-Case Agreements","[{\"question\":\"Why does timely CAR T infusion matter for outcomes?\",\"answer\":\"CAR T efficacy is higher for patients who receive timely infusions. Mortality increases with each month of delay.\"},{\"question\":\"What factors contribute to delays in accessing CAR T therapy?\",\"answer\":\"Delays stem from healthcare infrastructure constraints, intricate treatment processes, and reimbursement complexities that complicate authorization and contracting.\"},{\"question\":\"How can stakeholders reduce time to treatment?\",\"answer\":\"The article highlights opportunities such as expanding treatment capacity by reducing redundant certification prerequisites, aligning clinical criteria to support prompt referral, and streamlining payer authorization. It also notes that faster financial arrangements and appropriate single-case agreements can facilitate timely care.\"}]","Operationalizing Access for Chimeric Antigen Receptor T cell Therapies: A Cross-functional Perspective | PDF",1790588781]