National Landscape of Logistical and Nonmedical Requirements for Transplantation and Cellular Therapy.

BACKGROUND

New disease indications and supportive care advances have expanded the populations who may benefit from cellular therapies, including autologous or allogeneic hematopoietic cell transplant (HCT) and/or chimeric antigen receptor T-cell therapy (CAR T). However, nonmedical requirements for these therapies, such as caregiver and housing availability, may limit access. We sought a detailed national assessment of nonmedical requirements for HCT and CAR T-cell therapy to describe and quantify barriers.

OBJECTIVE

Describe the national landscape and implementation of logistical and nonmedical requirements for HCT and CAR T-cell therapy.

STUDY

DESIGN

We developed a web-based survey of HCT/CAR T-cell therapy requirements and obtained pilot feedback from 3 centers that regularly perform HCT/CAR T-cell therapy. We distributed the survey via the NCCN Best Practices Committee, which is composed of physician, nursing, and administrative leaders from 34 member institutions. We requested survey completion by an institutional content area expert.

RESULTS

The response rate was 91% (31/34). >80% of centers required a caregiver, local housing, and local transportation, but the number of days required, institutional supports, and acceptable distances varied widely. A subset of centers offered "all-outpatient" procedures and required more stringent logistical criteria, including autologous HCT by 13/19 centers (68%), allogeneic HCT by 4/8 centers (50%), and CAR T-cell therapy by 10/16 centers (63%). Many centers excluded patients with a history of medication nonadherence, substance use, or psychiatric comorbidity, but most did not employ formal adjudication or definition of patient eligibility. Institutions noted "soft" contraindications or case-by-case review for these patients and those experiencing homelessness, lack of insurance, or without citizenship. Overall, caregiving, housing, cost, and insurance coverage emerged as the top nonmedical barriers to HCT and CAR T-cell therapy.

CONCLUSIONS

Significant variability exists in nonmedical requirements for HCT and CAR T-cell therapy, with a lack of standard policies across institutions. We recommend that centers formally track reasons for noneligibility to identify nonmedical barriers to HCT and CAR T-cell therapy and develop targeted interventions to reduce the number of patients who are excluded for nonmedical reasons.