Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Review
. 2021 Aug;16(4):345-356.
doi: 10.1007/s11899-021-00635-3. Epub 2021 Jun 5.

Balancing Quality, Cost, and Access During Delivery of Newer Cellular and Immunotherapy Treatments

Affiliations
Review

Balancing Quality, Cost, and Access During Delivery of Newer Cellular and Immunotherapy Treatments

Praveen Ramakrishnan Geethakumari et al. Curr Hematol Malig Rep. 2021 Aug.

Abstract

Purpose of review: The chimeric antigen receptor (CAR) T-cell therapy is currently changing the landscape of hematologic malignancies with multiple FDA-approved cell therapy products in the USA. The current administration process of the CAR T-cell therapy is complicated, labor-intensive, and expensive.

Recent findings: The chimeric antigen receptor (CAR) T-cell therapy is currently changing the landscape of hematologic malignancies with multiple FDA-approved cell therapy products in the USA. The current administration process of the CAR T-cell therapy is complicated, labor-intensive, and expensive. This review article addresses the present-day challenges and discusses opportunities to optimize the access and affordability of the CAR T-cell therapy. The field of cellular immunotherapy is going to change the future of solid tumors and non-oncological diseases. However, this promising therapy poses challenges in the administration and management of quality in the current field of healthcare. We describe various novel approaches to manage challenges in improving access and improving widescale implementation of cellular therapies.

Keywords: Access; Acute lymphoblastic leukemia; Barriers; CAR T cell therapy; Cost-effectiveness; Immune-effector cell therapy; Immunotherapy; Lymphoma; Multiple myeloma; Quality.

PubMed Disclaimer

Conflict of interest statement

Praveen Ramakrishnan Geethakumari declares that he has no conflict of interest.

Dheepthi Perumal Ramasamy declares that she has no conflict of interest.

Bhagirathbhai Dholaria has received research funding from Takeda, Poseida Therapeutics, Janssen, and Angiocrine Bioscience, and has served on an advisory board for Jazz Pharmaceuticals.

Jesús Berdeja has received research funding (paid in his name to his institution) from AbbVie, Amgen, Acetylon, bluebird bio, Bristol-Myers Squibb, Celgene, Celularity, Constellation Pharmaceuticals, CRISPR Therapeutics, Curis, EMD Serono, Genentech, Glenmark Pharmaceuticals, Ichnos Sciences, Janssen, Kesios Therapeutics, Eli Lilly, Novartis, Poseida Therapeutics, Sanofi, Takeda, Teva, and Vivolux; and has served as a consultant for Amgen, Bioclinica, bluebird bio, Bristol-Myers Squibb, Celgene, CRISPR Therapeutics, Janssen, Karyopharm Therapeutics, Kite Pharma, Legend Biotech, Prothena, Secura Bio, and Laboratoires Servier, with all compensation made payable to his institution.

Ankit Kansagra has participated on advisory boards for Alnylam Pharmaceuticals, Bristol-Myers Squibb/Celgene, GlaxoSmithKline, Karyopharm Therapeutics, Oncopeptides, Pharmacyclics, Pfizer, Takeda, and Sanofi.

Figures

Fig. 1
Fig. 1
Patients CAR T cell therapy journey and associated barriers
Fig. 2
Fig. 2
Toolkit to overcomes hurdles in improving access to CAR T cell therapy

References

    1. Waldman AD, Fritz JM, Leonardo MJ. A guide to cancer immunotherapy: from T cell basic science to clinical practice. Nat Rev Immunol. 2020;20:651–668. doi: 10.1038/s41577-020-0306-5. - DOI - PMC - PubMed
    1. June CH, Sadelain M. Chimeric antigen receptor therapy. N Engl J Med. 2018;379(1):64–73. doi: 10.1056/NEJMra1706169. - DOI - PMC - PubMed
    1. Maude SL, Laetsch TW, Buechner J, et al. Tisagenlecleucel in children and young adults with B-cell lymphoblastic leukemia. N Engl J Med. 2018;378(5):439–448. doi: 10.1056/NEJMoa1709866. - DOI - PMC - PubMed
    1. • Neelapu SS, Locke FL, Bartlett NL, et al. Axicabtagene ciloleucel CAR T-cell therapy in refractory large B-cell lymphoma. N Engl J Med. 2017;377(26):2531–44. 10.1056/NEJMoa1707447. Pivotal study of CAR T-cell therapy in adults with relapsed/refractory Large Cell Lymphoma. - PMC - PubMed
    1. Schuster SJ, Bishop MR, Tam CS, Waller EK, Borchmann P, McGuirk JP, Jäger U, Jaglowski S, Andreadis C, Westin JR, Fleury I, Bachanova V, Foley SR, Ho PJ, Mielke S, Magenau JM, Holte H, Pantano S, Pacaud LB, Awasthi R, Chu J, Anak Ö, Salles G, Maziarz RT. Tisagenlecleucel in adult relapsed or refractory diffuse large B-cell lymphoma. N Engl J Med. 2019;380(1):45–56. doi: 10.1056/NEJMoa1804980. - DOI - PubMed