Over the past decade, cell and gene therapies (CGTs) have evolved from promising theoretical concepts into some of the most groundbreaking innovations in modern healthcare. These pioneering treatments are reshaping the field of medicine and providing new hope for patients with serious and life-threatening conditions.

Today there are more than 40 FDA-approved cell and gene therapies.¹ While a handful of products were approved in the early and mid-2000s, the current era of care began in earnest with the FDA approval of the first chimeric antigen receptor T-cell (CAR-T) therapies in 2017. Seven CAR T-cell therapies are currently available in the U.S., demonstrating profound and durable clinical responses in patients with relapsed or refractory blood cancers, including lymphomas and multiple myeloma.²

The potential expansion of CGTs into more prevalent conditions, including autoimmune disease, diabetes, and neurological disorders, could also markedly change health outcomes on an even broader scale. However, despite the thriving science and clinical advancements behind these therapies, real-world delivery struggles to keep pace. To meet the growing demand, the industry must navigate highly specialized and complex processes across logistical, economic, and infrastructural barriers.

The migration of CAR-T therapies into community treatment sites is a promising development that aims to expand access to these advanced treatments. Traditionally, CAR-T therapies have been concentrated in large academic medical centers (AMCs), where the necessary infrastructure and expertise are readily available. By moving beyond large AMCs, more patients can benefit from CAR-T therapies closer to home. However, determining the best approach to expanding access will require coordinated efforts across all stakeholders, including patients, payers, providers, and manufacturers. In this article, we will examine the multi-faceted challenges that are limiting CGT, with a specific focus on CAR-T therapy, discuss the role of community treatment sites in transforming CGT delivery, and explore collaborative pathways for overcoming access barriers.

Current challenges in CGT accessibility

Although CGTs have the potential to dramatically revolutionize disease treatment, the path from scientific breakthrough to widespread clinical use is fraught with complexities. Research indicates that roughly 7 to 8 in 10 patients who are eligible for CAR T therapy do not receive the treatment, demonstrating that adoption of CAR T-cell therapy has been slower than expected.³

Below we explore the broad array of patient barriers and provider-related challenges that are limiting access to these potentially transformative therapies.

Patient access barriers

While CAR-T therapies have been available in the United States for nearly eight years, several barriers continue to impede patient access. In a 2024 study of 124 oncologists, issued by McKesson, two-thirds of respondents agreed that CGTs are not easily accessible for patients who meet the labeled indications.⁴ Among the most significant barriers are lack of patient awareness and trust, and financial and geographic disparities.

Lack of patient awareness and trust: Although 99% of oncologists agree that CGTs are among the most important medical innovations of our time, research demonstrates a lack of patient awareness that CGTs are even a treatment option.⁴ In fact, 48% of oncologists from the aforementioned McKesson study noted that patients are rarely or never aware that a CGT is available for their condition; and 60% of oncologists reported that patients typically do not mention CGTs unless the healthcare provider initiates the conversation. Even when informed of CGTs as a treatment option, 45% of patients think CGTs are too experimental or risky, indicating a lack of patient understanding of the high efficacy and safety profiles of these therapies.

Financial burden: With the single dose price tag of CGTs ranging from $450,000 to $4.2 million,managing the high cost of these one-time therapies remains a considerable challenge, especially within a healthcare system that is designed for pay as-you-go treatments.^5,6 Three out of five physicians say that even when they do refer for CGTs, patients often receive alternative therapies; and oncologists cite insufficient insurance coverage and patient out-of-pocket costs as among the primary reasons for opting against the use of CGT.⁴ More than half of oncologists, and 80% of community cancer care providers, say that patient economic burden – out of pocket costs, missed work, caregiver and other costs –also pose a significant CGT access barrier for patients.

Geographic disparity: Another major socioeconomic roadblock to CGT care is geography. In October of 2024, McKesson research into qualified CGT centers identified a total of 512 named centers in the United States, located in 109 metropolitan regions.⁴ The challenge facing patients who live in more rural areas is clearly illustrated by the map in Figure 1: 66 million rural Americans, who comprise 20% of the country’s population, live in regions lacking CGT-qualified treatment centers, creating vast “CGT deserts.”⁷ These geographical barriers significantly impact access to care as research indicates that patients residing two to four hours away from their nearest treatment center have a 40% lower likelihood of receiving CAR T therapy.⁸

Geographical issues are not unique to CGT—advanced care is centered in urban areas across nearly all facets of medicine. However, many CGT patients encounter a distinct burden because they must often stay near a treatment center for weeks or even months following treatment for clinical monitoring and management of acute adverse events.

Provider-related challenges

As CGT continues to advance into broader clinical indications, both community treatment centers and AMCs grapple with streamlining the delivery of care across clinical, operational and financial frameworks.

• Clinical: Delivering CGT requires a highly trained multi-disciplinary team to manage complex infusion procedures, adhere to frequent follow-up protocols, and monitor patients for potentially life-threatening adverse events, often over an extended period of time.
• Operational: CGT requires coordinated logistics, including robust infrastructure, specialized equipment, standardized protocols and procedures, and capabilities for cell collection and handling. Even at AMCs which generally have the resources necessary to meet these requirements, capacity constraints and bottlenecks are extending patient wait times for CGTs, a fact supported by the 96% of 2024 McKesson survey respondents who said that expanding the capacity of CGT programs at AMCs is necessary to ensure broader access to patients.⁴
• Financial: CGTs come with staggering costs and significant financial risk, particularly as institutions bear the upfront expense while awaiting reimbursement from payers. Large hospital systems have traditionally been able to secure financial resources to support the cost of such treatments. However, financial risk will only intensify as more ultra-costly therapies enter the market, making it increasingly improbable that even the largest hospitals will be able to sustain these growing financial burdens.

Point: Community is the logical next step for CGT

As the CGT landscape continues to evolve into larger disease states and earlier treatment lines, a pivotal question emerges: how do we deliver these life-changing treatments at scale, with broader reach and long-term sustainability? Given today’s CGT access challenges, expanding CGT delivery into community-based settings presents a logical evolution.

• Improved Access and Awareness: Oncologists may have differing views on the changes needed to address accessibility issues, but 82% of respondents in the 2024 McKesson survey agreed that expanding CGTs into community hospitals is necessary to ensure broader access to patients – and 77% agreed that CGT should also be expanded to community clinics.⁴ Expanding local access into community settings helps address financial and geographic disparities by reducing travel burdens and associated costs for patients and caregivers, while also increasing patient awareness by making information and services more visible, accessible, and approachable within their own communities.
• System Efficiency and Meeting Growing Demand: Community hospitals and clinics also provide a viable option to help alleviate the patient access capacity issues faced by the AMCs, which are currently administering the lion’s share of CGT treatments. Expanding CGT delivery into well-prepared community treatment settings eases system pressures and enables AMCs to focus more on their core missions of innovation, research, and care of the most complex cases. Importantly, as physicians and patients eagerly await the development of new CGT advancements and indications, extending CGT access to community hospitals and clinics will expand the industry’s scale and build capacity to meet the expected increase in CGT demand.

Counterpoint: Barriers to expanding CGTs to the community

While many industry experts postulate that expanding CGT into community cancer care settings can be an effective strategy to access expansion, several barriers can complicate its implementation.

• Clinical Expertise and Experience: A common mindset among healthcare stakeholders is that CAR T patients should be treated in academic centers which have the clinical expertise, experience, and infrastructure to support complex CGT administration and monitoring. Historically, AMCs have been at the forefront of pioneering clinical research involving CGTs. There are concerns that broadening CGT administration into less-experienced community cancer hospitals and clinics may compromise quality and outcomes if not executed appropriately and could potentially impact the patient populations available for research at AMCs, negatively influencing the size of clinical trial cohorts.
• Hesitance on behalf of community providers: For community cancer hospitals and clinics to effectively administer CGTs, they must first be both willing and able to make sizeable financial and time investments to appropriately develop their staff, infrastructure and operational capacity. Community providers would need to hire additional nursing and administrative staff – which is in and of itself a challenge, considering that the Health Resources and Services Administration projects a shortage of nearly 208,000 registered nurses by 2037, with non-metro areas of the United States predicted to face even greater nurse shortages.⁹ Community cancer providers would also need to develop and implement staff training and education, and research and invest in cold-chain storage and logistics infrastructure – all of which require significant financial and time investment.
• Becoming a qualified and accredited treatment center for CGTs creates yet another burden for community providers. Accrediting bodies such as the Foundation for the Accreditation of Cellular Therapy (FACT) set rigorous guidelines for institutions delivering many types of CGTs, requiring extensive documentation, facility infrastructure, staff training, and compliance protocols.¹⁰ While these standards are critical to maintain quality, the time and resource-intensive nature of the accreditation process can introduce delays and complexities for emerging CGT programs. For community treatment centers with limited infrastructure and support, establishing a CGT program that meets these requirements can be prohibitively difficult, particularly because many payers mandate FACT accreditation as a prerequisite for reimbursement. Similarly, manufacturers often layer on their own extensive qualification process for their products which can also be a considerable burden for clinical sites. Each manufacturer has at least some unique requirements, resulting in a complex and often duplicative qualification process, which can take months to complete.
• Even in cases when community providers can hurdle logistical, infrastructure, and accreditation barriers, there is also a need to adeptly understand and implement case rate reimbursement models frequently utilized by payers for CAR T-cell therapy reimbursement––which differ significantly from average sales price (ASP)-based reimbursement models traditionally used by many community providers. Community providers may struggle to achieve the economies of scale that larger academic centers can leverage to make case rate reimbursement financially sustainable.

Rebuttal: Addressing barriers with innovative solutions

Although the centralization of CGT expertise in urban AMCs was a natural starting point, the current delivery model of CGT care is at risk of becoming overwhelmed particularly as CGTs move from treating rare diseases to more common conditions with larger patient populations. Expanding into community settings can help alleviate this pressure, particularly as confidence in the management and monitoring of these therapies continues to grow. This trend is especially evident in the FDA’s recent removal of Risk Evaluation and Mitigation Strategies (REMS) requirements and the easing of patient monitoring restrictions for CAR T-cell therapies.¹¹ In response, new innovative and scalable strategies are emerging that promise to reduce access barriers. The key is not to replicate the academic model, but to thoughtfully adapt processes to meet the unique needs and capabilities of high-performing community treatment sites.

Below are four practical examples and solutions that demonstrate strategies for building confidence, bridging capability gaps, and appropriately extending CGT access into community treatment sites without compromising quality or patient safety.

Demonstrated feasibility of community-based CGT administration.

In the growing movement to transition more CGT care into the community practice setting, advancements in clinical protocols, provider education, and infrastructure development are making it increasingly feasible to expand access into community-based treatment settings. The following sections showcase emerging evidence from clinical studies as well as real-world examples, demonstrating that CGT delivery in the community settings is not only achievable, but already underway.

The OUTREACH Study – Demonstrating that CAR-T therapies can be effectively administered in community cancer settings: In the United States, approximately 70% of patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL), a form of non-Hodgkin lymphoma, receive treatment at community cancer centers.¹²

The OUTREACH study evaluated the effectiveness and safety of administering lisocabtagene maraleucel (Liso-cel) to patients with R/R LBCL in community-based treatment facilities.¹² Efficacy and safety outcomes were robust and consistent to those observed in the pivotal TRANSCEND study. The study was the first and largest of its kind to prospectively evaluate CAR T-cell therapy in community outpatient practices and non-academic hospitals, representing a critical step toward democratizing CGT access. Ultimately, the study found that with appropriate standard operating procedures, patient selection criteria, and outpatient monitoring protocols, Liso-cel can be safely and effectively delivered in community treatment settings.

HCA Healthcare/Sarah Cannon Cancer Network (SCCN)––Partnering with community oncologists to expand CAR T-cell therapy access: The Transplant and Cellular Therapy Network of HCA / SCCN is the largest provider of hematological cancer treatment in the U.S., administering approximately 1,600 stem cell transplants and cell therapies in 2023 alone. To optimize efficiency and drive the strategic utilization of resources, SCCN employs a model that expands CAR T-cell therapy into community sites by partnering with community oncologists. This approach integrates local oncology practices and HCA hospitals into a single cell therapy program, fostering collaboration and comprehensive delivery of care.

For community oncology clinics that are unable to offer inpatient support, patients may be exposed to gaps in care when their needs exceed what can be managed in an outpatient setting. To address this gap, SCCN maintains a comprehensive CAR T-cell program that allows physicians and patients to choose the most appropriate care setting as inpatient or outpatient based on patients’ clinical parameters. Furthermore, this model provides an alternative path to treatment for patients whose insurance does not cover infusions in an outpatient setting, enabling a pathway to receive treatment in a hospital setting.

While this approach may not be feasible for every treatment site or practice, the model demonstrates that treatment of CAR T-cell therapy patients can be administered outside of AMCs, setting the stage for more community oncologists and hospitals to play a role in expanding access to these innovative therapies.

University of Pennsylvania– Hub-and-spoke model to expand CGT capacity: Penn Medicine has been at the forefront of CGT research and administration since the development of the first CAR-T therapies and continues to be one of the largest centers for CGT care.

To advance CGT access in community treatment sites, Penn Medicine is pioneering an innovative hub-and-spoke model for CAR T therapy delivery. The hub-and-spoke model is an emerging treatment framework that expands access to CGT, where large or specialized AMCs function as “hubs”, providing expertise, clinical oversight, and a guidelines for CGT protocols and procedures, while partnering with a network of community “spoke” centers that are equipped to administer therapies locally. Under this model, CGT treatment is decentralized and localized, enabling community sites to perform therapy administration under the guidance and support of the hub facility.

As the hub facility, Penn operationalizes its CAR T blueprint across community treatment centers, outlining standardized workflows, training and education, safety procedures, and logistics protocols. Penn’s guidance and expertise ultimately enable community “spoke” sites to deliver CAR T care for patients safely, efficiently and in alignment with best practices.

This model not only enhances patient access but also helps accelerate the overall adoption of CGT by distributing the burden of care more evenly across healthcare systems and bringing CGT into more local clinical settings.

Streamline accreditation and qualification standards: To accelerate CGT delivery, there is an urgent need to streamline and harmonize qualification and accreditation processes as there is often significant overlap which can lead to duplicated efforts in documentation, audits, and compliance protocols. Encouragingly, efforts to standardizing manufacturer expectations are underway. The American Society for Transplantation and Cellular Therapy (ASTCT) launched the “80/20 Task Force,” aiming to alleviate the administrative burden and speed up the qualification process.¹³ The Task Force is working to enhance consistency across manufacturers by standardizing 80% of manufacturer qualification requirements. Streamlining these processes is necessary to ensure that CGT care can be efficiently and sustainably delivered by a broader range of providers.

Collaborate to collect real-world datato enhance confidence in treatment outcomes.

As CGTs advance into broader clinical practice, the collection of real-world evidence (RWE) is essential to strengthen confidence in the safety and durability of CGT outcomes. Additionally, RWE can help identify variations in outcomes, uncover safety signals, and inform optimal patient selection and management strategies that might not otherwise be recognized in randomized trials. As an increasing number of innovators work to expand the administration of CGTs in community settings, the industry must also prioritize conducting real-world research to document the long-term efficacy and safety of CGT treatment in more diverse patient groups and community treatment settings.

Encourage innovative models to mitigate financial risk.

Given the high upfront costs and complex reimbursement associated with CGTs, healthcare providers are exploring the role that different distribution strategies can play in mitigating the financial risk. Specialty pharmacies are an emerging strategic model in the CGT landscape that can serve as intermediaries to manage the complex handling, logistics, and reimbursement processes for CGT. Rather than requiring centers to purchase and hold expensive therapies on site, specialty pharmacies can dispense the product just in time for the infusion, potentially reducing inventory costs and minimizing reimbursement risk for providers. As CGT continues to expand into more community treatment settings, partnerships with experienced specialty pharmacies can be an enabler for broader patient access.

Conclusion

In summary, both community and academic delivery models play essential and complementary roles in expanding CGT access. AMCs will continue to remain hubs for innovation and complex patient care, but to truly expand access and scalability, CGT must be made more available in the community setting. The barriers to community CGT delivery are significant but not insurmountable. With proper investments in infrastructure, clinical experience, and support, the community can become a viable next step for CGTs.

Solving accessibility challenges necessitates cooperation across all stakeholders: Patients to advocate for access; Providers to collaborate and share expertise; Payers to embrace new care networks; Manufacturers to invest in community readiness. There is no single solution, but a collective effort is necessary to enable scalability and unlock the transformative potential of CGTs. Progress will depend on a shared vision and a commitment to build a delivery model that makes CGTs a practical reality for all patients.

Sources

1. U.S. Food and Drug Administration. Approved Cellular and Gene Therapy Products. U.S. Department of Health and Human Services. Updated April 16, 2024. Accessed May 20, 2025. https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/approved-cellular-and-gene-therapy-products
2. National Cancer Institute. CAR T Cells: Engineering Patients’ Immune Cells to Treat Their Cancers. U.S. Department of Health and Human Services. Updated April 19, 2024. Accessed May 20, 2025. https://www.cancer.gov/about-cancer/treatment/research/car-t-cells
3. Perales MA, McGuirk JP, Fesen MR, et al. Real-World Treatment Patterns of Large B-Cell Lymphoma Patients over Time in a Post-CAR T Approval Era. Transplant and Cell Ther. 2025;31(2):Supplement
4. InspiroGene by McKesson. 2024 Cell and Gene Therapy Report: Advancing the Future of Medicine. McKesson Corporation. Published October 9, 2024. Accessed May 20, 2025.https://inspirogene.com/2024cgtreport/
5. Young CM, Quinn C, Trusheim MR. Durable cell and gene therapy potential patient and financial impact: US projections of product approvals, patients treated, and product revenues. Drug Discov Today. 2022;27(1):17-30. doi:10.1016/j.drudis.2021.09.001
6. Bansal A. Lenmeldy becomes world’s most expensive drug. Pharmaceutical Technology. April 2, 2024. Accessed May 21, 2025. https://www.pharmaceutical-technology.com/analyst-comment/lenmeldy-becomes-worlds-most-expensive-drug/
7. U.S. Department of Agriculture, Economic Research Service. What is Rural? Updated January 8, 2025. Accessed May 20, 2025. https://www.ers.usda.gov/topics/rural-economy-population/rural-classifications/what-is-rural
8. Ahmed N, Sun F, Teigland C, et al. Chimeric Antigen Receptor T-cell Access in Patients with Relapsed/Refractory Large B-Cell Lymphoma: Association of Access with Social Determinants of Health and Travel Time to Treatment Centers. Transplant Cell Ther. 2024;30(4):190-198. doi:10.1016/j.jtct.2024.01.011. Accessed September 9, 2024. https://www.astctjournal.org/article/S2666-6367(24)00370-1/pdf
9. Health Resources and Services Administration. Nurse Workforce Projections, 2020–2035. U.S. Department of Health and Human Services. Published November 2022. Accessed May 20, 2025. https://bhw.hrsa.gov/sites/default/files/bureau-health-workforce/Nursing-Workforce-Projections-Factsheet.pdf
10. Curran KJ, Nikiforow S, Bachier C, et al. A robust quality infrastructure is key to safe and effective delivery of immune effector cells: how FACT-finding can help. Blood Adv 8, 1053-1061 (2024).
11. U.S. Food and Drug Administration. (2025, June 27). FDA eliminates Risk Evaluation and Mitigation Strategies (REMS) for autologous chimeric antigen receptor CAR T cell immunotherapies. https://www.fda.gov/news-events/press-announcements/fda-eliminates-risk-evaluation-and-mitigation-strategies-rems-autologous-chimeric-antigen-receptor
12. Linhares Y, Freytes C, Cherry M, et al. OUTREACH: phase 2 study of lisocabtagene maraleucel as outpatient or inpatient treatment at community sites for R/R LBCL. Blood Adv 2024; 8 (23): 6114–6126.
13. Nikiforow S, Frigault M, Frey N et al. Paving the Road for Chimeric Antigen Receptor T Cells: American Society for Transplantation and Cellular Therapy 80/20 Task Force Consensus on Challenges and Solutions to Improving Efficiency of Clinical Center Certification and Maintenance of Operations for Commercially Approved Immune Effector Cell Therapies. Transplant Cell Ther. 2023 Apr;29(4):228-239.