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Curated Papers > High-Impact Authoritative Literature on "CAR-T Therapy"

Chimeric Antigen Receptor T-Cell Therapies: Barriers and Solutions to Access. ​

Literature Information ​

DOI10.1200/OP.22.00315
PMID36130152
JournalJCO oncology practice
Impact Factor4.6
JCR QuartileQ1
Publication Year2022
Times Cited45
KeywordsChimeric Antigen Receptor T-Cell Therapy, Patient Access Barriers, Treatment Accessibility
Literature TypeReview, Journal Article
ISSN2688-1527
Pages800-807
Issue18(12)
AuthorsJoseph Mikhael, Jessica Fowler, Nina Shah

TL;DR ​

This review highlights the significant barriers to patient access for chimeric antigen receptor T-cell (CAR-T) therapies, which are vital for treating heavily pretreated hematologic malignancies but hindered by issues such as stringent clinical trial criteria, high costs, and logistical challenges exacerbated by the COVID-19 pandemic. It proposes innovative solutions and emphasizes the need for collaboration among stakeholders to improve access and expand treatment opportunities for patients.

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Chimeric Antigen Receptor T-Cell Therapy · Patient Access Barriers · Treatment Accessibility

Abstract ​

Chimeric antigen receptor T-cell (CAR-T) therapies are relatively new treatments for patients with heavily pretreated hematologic malignancies. Although these innovative therapies can offer substantial benefit to patients with limited alternative treatment options, patient-access barriers exist. Conventional clinical trials are time-consuming and may be limited by strict patient eligibility criteria, resources, and availability of enrollment slots. Because of the complexity of the CAR-T administration process, treatment delivery can be associated with additional burden for the patient, including requiring patients to reside close to treatment centers and remain with a caregiver after infusion. Manufacturing of CAR-T cells is completed in specialized facilities and depends on the availability of reagents, manufacturing workforce, and timely transportation. CAR-T therapy is costly, and many US health plans restrict coverage of cell and gene therapies. Several of the existing challenges because of these barriers have been exacerbated during the COVID-19 pandemic. This review discusses these barriers and proposes some potential solutions to improving patient access, including innovation in clinical trial design and manufacturing, location of treatment delivery, and key stakeholder opinions regarding treatment and reimbursement. We propose a call to action for key stakeholder groups to address these barriers to CAR-T therapy to expand treatment access for patients. Future collaboration between key stakeholders, including payers, regulatory agencies, and industry/academia, will be critical to continue to address these barriers and enhance patient access to these therapies.

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Primary Questions Addressed ​

  1. What alternative strategies can be implemented to streamline the clinical trial process for CAR-T therapies?
  2. How can patient education and support systems be improved to alleviate the burden associated with CAR-T treatment delivery?
  3. What role do insurance companies play in shaping access to CAR-T therapies, and how can their policies be reformed?
  4. In what ways can advancements in CAR-T cell manufacturing technologies reduce costs and improve accessibility for patients?
  5. How can collaboration among stakeholders, including healthcare providers and regulatory agencies, enhance the overall framework for CAR-T therapy access?

Key Findings ​

1. Research Background and Purpose ​

Chimeric antigen receptor T-cell (CAR-T) therapies represent a groundbreaking advancement in the treatment of hematologic malignancies, particularly for patients who have undergone extensive previous treatments with limited options left. Despite their potential to significantly improve outcomes for these patients, a range of barriers restrict access to CAR-T therapies. The purpose of this review is to identify these barriers—ranging from stringent clinical trial criteria to logistical challenges in treatment delivery—and to propose actionable solutions aimed at improving patient access to these innovative therapies.

2. Main Methods and Findings ​

The review synthesizes existing literature on the barriers to CAR-T therapy access, emphasizing challenges faced during the clinical trial process, treatment administration, and manufacturing logistics. Key findings highlight:

  • Clinical Trials: Traditional trial designs often limit participant eligibility due to strict criteria, which can exclude many patients who might benefit from CAR-T therapies. The processes are also time-consuming, compounding access issues.
  • Treatment Delivery: The complexity of CAR-T administration necessitates that patients live near treatment centers and have caregivers available post-infusion, creating logistical challenges.
  • Manufacturing Factors: The production of CAR-T cells occurs in specialized facilities and relies on a consistent supply of reagents and skilled personnel, which can be disrupted, particularly in light of recent global challenges like the COVID-19 pandemic.
  • Economic Barriers: The high cost of CAR-T therapies poses significant financial barriers, with many insurance plans imposing restrictions on coverage for these treatments.

3. Core Conclusions ​

The review concludes that addressing the barriers to CAR-T therapy access is imperative to broaden the reach of these treatments to eligible patients. It emphasizes the need for innovative strategies in clinical trial designs that accommodate a wider range of patient populations and streamline the manufacturing process. Furthermore, it highlights the importance of collaboration among stakeholders—including healthcare providers, payers, regulatory agencies, and industry—to develop solutions that enhance access.

4. Research Significance and Impact ​

This research holds significant implications for the future of CAR-T therapy accessibility, advocating for systemic changes that could lead to improved patient outcomes. By identifying barriers and proposing multifaceted solutions, the study aims to catalyze collaborative efforts among key stakeholders. The findings underscore the necessity for a unified approach to eliminate inequities in access to CAR-T therapies, ultimately paving the way for a more inclusive healthcare landscape where all eligible patients can benefit from these advanced therapies. The call to action serves as a framework for ongoing discussions about improving treatment access, with the potential to influence policy decisions and healthcare practices moving forward.

Literatures Citing This Work ​

  1. Innovation in BCMA CAR-T therapy: Building beyond the Model T. - Rahul Banerjee;Sarah S Lee;Andrew J Cowan - Frontiers in oncology (2022)
  2. Patient Perceptions of CAR-T Therapy in the USA: Findings from In-Depth Interviews. - Todd J Bixby;Christine J Brittle;Patricia A Mangan;Edward A Stadtmauer;Lisa R Kallenbach - Oncology and therapy (2023)
  3. Real-time semantic segmentation and anomaly detection of functional images for cell therapy manufacturing. - Rui Qi Chen;Benjamin Joffe;Paloma Casteleiro Costa;Caroline Filan;Bryan Wang;Stephen Balakirsky;Francisco Robles;Krishnendu Roy;Jing Li - Cytotherapy (2023)
  4. Recent advances in cellular immunotherapy for lymphoid malignancies. - Haerim Chung;Hyunsoo Cho - Blood research (2023)
  5. An updated cost-effectiveness analysis of axicabtagene ciloleucel in second-line large B-cell lymphoma patients in the United States. - Olalekan O Oluwole;Anik R Patel;Sachin Vadgama;Nathaniel J Smith;Rob Blissett;Chaoling Feng;Michael Dickinson;Patrick B Johnston;Miguel-Angel Perales - Journal of medical economics (2024)
  6. Mosunetuzumab with polatuzumab vedotin in relapsed or refractory aggressive large B cell lymphoma: a phase 1b/2 trial. - Lihua E Budde;Adam J Olszewski;Sarit Assouline;Izidore S Lossos;Catherine Diefenbach;Manali Kamdar;Nilanjan Ghosh;Dipenkumar Modi;Waleed Sabry;Seema Naik;Amitkumar Mehta;Shazia K Nakhoda;Stephen D Smith;Kathleen Dorritie;Ting Jia;Song Pham;Ling-Yuh Huw;Jing Jing;Hao Wu;Wahib S Ead;Iris To;Connie Lee Batlevi;Michael C Wei;Julio C Chavez - Nature medicine (2024)
  7. Circulating-tumor DNA Assessment in Diffuse Large B-cell Lymphoma to Determine Up-front Stem Cell Transplantation: A Pilot Study. - Juhyung Kim;Tan Minh LE;Donghyeon Lee;Hong Duc Thi Nguyen;Hee Jeong Cho;Sang Kyun Sohn;Jong Gwang Kim;Shin-Young Jeong;Ji Yeon Ham;Ji Yun Jeong;Hyung Soo Han;Joon Ho Moon;Dong Won Baek - In vivo (Athens, Greece) (2024)
  8. Cost-effectiveness of second-line lisocabtagene maraleucel in relapsed or refractory diffuse large B-cell lymphoma. - Jee H Choe;Tianzhou Yu;Jeremy S Abramson;Mohamed Abou-El-Enein - Blood advances (2024)
  9. Engineered Adoptive T-Cell Therapies for Breast Cancer: Current Progress, Challenges, and Potential. - Diego F Chamorro;Lauren K Somes;Valentina Hoyos - Cancers (2023)
  10. Autologous stem cell transplant in fit patients with refractory or early relapsed diffuse large B-cell lymphoma that responded to salvage chemotherapy. - Aung M Tun;Yucai Wang;Seth Maliske;Ivana Micallef;David J Inwards;Thomas M Habermann;Luis Porrata;Jonas Paludo;Jose Villasboas Bisneto;Allison Rosenthal;Mohamed A Kharfan-Dabaja;Stephen M Ansell;Grzegorz S Nowakowski;Umar Farooq;Patrick B Johnston - Haematologica (2024)

... (35 more literatures)

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