Resources

Resources & References

These are published materials from FDA, professional societies and cancer care organizations and grouped by the question they answer. Resources do not represent an endorsement or recommendation.  They are intended to be illustrative of available materials and to provide general guidance.

Resource Materials

Clinical

CAR-T Care After Treatment

ACCC's quick reference checklist for after care. This checklist covers everything from contact information, monitoring and support needs.

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FDA Labeling Update After the REMS Removal

FDA’s June 2025 notice removing the REMS for autologous CAR T therapies, with the monitoring, proximity and driving parameters that replaced it, and the 15-year follow-up that did not change.

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Financial

Addressing reimbursement with risk mitigation

Cell and gene therapies in managed care: US payer insights on coverage and financial risks

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Durability and reimbursement

Five-Year durability in cell and gene therapy: evidence review and implications for payer coverage.

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The Economics of CAR T-Cell Therapy

A 2024 ACCC brief on why CAR-T reimbursement falls short of cost, covering the NTAP and MS-DRG 018 history, prior authorization delays, Medicaid limits, and fixes like outpatient care.

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Operational

CAR-T Access Coalition Onboarding Guide

A manufacturer-agnostic guide to onboarding a CAR-T treatment center in six stages, from initiation to sustainment.

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Receiving, Storing and Administering CAR-T Product

The EBMT/EHA CAR-T Cell Handbook has a European focus. Product handling: reception, cryogenic storage, thaw timing, dispensing and administration, and the pharmacist’s role is universal.

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Cell and Gene Therapy

InspiroGene 2025 CGT Report

InspiroGene’s 2025 report covers a pipeline moving beyond oncology, a survey of 126 oncologists and interviews with 20 payers on access and reimbursement, and flat growth in treatment sites.

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McKesson 2024 CGT Report

McKesson’s 2024 report covers a late-stage CGT pipeline of 734 drugs moving beyond oncology, a survey of 124 oncologists on barriers to access, a map of treatment centers, and a call to action.

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Case Studies

ACCC CAR-T in Community Summary Article

“CAR T-Cell Therapy in Action: Successful Examples in Outpatient Settings” profiles outpatient CAR-T at City of Hope, Astera Cancer Care, and St Luke’s Cancer Institute.

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New York Oncology Hematology

"Advancing Outpatient CAR T-Cell Therapy in the Community: The NYOH Model" building a community outpatient CAR-T program with a hospital partner, covering infrastructure, staffing, product choice, payer contracting, and first 6 patients.

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Practice Profile: Billings Clinic Cancer Center

ACCC’s profile of how a rural health system stood up a CAR-T program, covering implementation, staff education and communication with referring providers.

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Practice Profile: Fox Chase Center

An ACCC profile of how Fox Chase Cancer Center works with community programs such as St. Luke’s to deliver CAR-T, covering onboarding, REMS, coverage, referrals, and patient support.

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Targeted Oncology Article

“Expanding CAR T-Cell Therapy in Community Oncology” Virginia Cancer Specialists built a community CAR-T program, covering leadership, care pathways, team, hospital partners, payers, and early cases.

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Transplantation and Cellular Therapy Abstract

Expanding Access to Life-Prolonging Cellular Therapies: A Case Series of the First Three CAR T-cell Recipients at an Urban Public Safety-Net Hospital

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External Resources & Organizations

There are many available resources that are reliable and can provide you and your patients with great guidance. Check out some of the available links below.

AABB Standards AABB publishes standards and runs an accreditation program for cellular therapy services, covering cell collection and processing.
Visit AABB Standards
ACCC Resources ACCC publishes community-focused CAR-T implementation guidance, practice profiles and care coordination tools, including Bringing CAR T-Cell Therapies to Community Oncology.
Visit ACCC Resources
American Journal of Managed Care A place to find health policy and healthcare news, including engaging with key opinion leaders around community expansion.
Visit American Journal of Managed Care
ASTCT CAR-T Education The American Society for Transplantation and Cellular Therapy publishes the consensus grading criteria for CRS and ICANS and the CAR-T coding and billing guide.
Visit ASTCT CAR-T Education
CAR-T Vision A global initiative on barriers to CAR-T access, led by an independent steering committee with industry funding. Publishes analysis of awareness, capacity and financing gaps.
Visit CAR-T Vision
CIBMTR CIBMTR is a resource for data collection to collect CAR-T outcomes data on standard forms and give the center staff who submit it manuals and guides.
Visit CIBMTR
City of Hope City of Hope published “How to build a successful outpatient CAR T cell therapy program” which speaks to considerations for community treatment.
Visit City of Hope
Community Oncology Alliance A national nonprofit that advocates for independent community oncology practices and the patients they serve.
Visit Community Oncology Alliance
FACT Standards The Foundation for the Accreditation of Cellular Therapy sets immune effector cell standards, including a Community IEC edition scaled for programs outside academic centers.
Visit FACT Standards
Manufacturer Resources FDA’s list of approved cellular and gene therapy products links through to every licensed CAR-T product. Use it to reach a developer’s own onboarding, ordering and reimbursement materials.
Visit Manufacturer Resources

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