An international steering committee launched earlier in 2025 to improve access to CAR T-cell therapies for cancer patients. A cell therapy research specialist shares her reasons why.
By The Medicine Maker
September 4, 2025 – CAR T Vision is guided by a Steering Committee of leaders from prominent patient advocacy groups across Europe and North America, medical societies, treatment centers, and other subject matter experts. The initiative launched in early 2025 with initial funding and support from Gilead and Kite.
Just in Europe and the US currently receive CAR T-cell therapy for certain rare and advanced blood cancers. CAR T Vision’s newly released roadmap report calls for urgent, coordinated efforts from across the healthcare ecosystem.
To date, over 10 influential stakeholder organizations – including the Lymphoma Coalition, International Myeloma Foundation, and the Leukemia & Lymphoma Society – have endorsed the CAR T Vision and roadmap. The initiative has also attracted over a dozen external requests to join, ranging from biotech companies and healthcare providers to researchers and other members of the CAR T-cell therapy community.
Clinical Hematologist Professor Anna Sureda, Cell Therapy Researcher and Steering Committee Co-Chair, discusses the hope and the hard work required to realize the vision.
How do you define the urgency behind the CAR T Vision, and why was now the right time to launch this initiative?
It stems from the transformative potential of CAR T-cell therapy to revolutionize cancer treatment, particularly for patients with limited or no remaining options. Despite its promise, access to CAR T therapies remains uneven, constrained by complex manufacturing, high costs, and logistical challenges. The increasing volume of clinical data, regulatory momentum, and scientific breakthroughs have converged to create a pivotal moment for accelerated action.
Launching the CAR T Vision now capitalizes on this momentum to address existing disparities and scale innovation across research, clinical practice, and infrastructure. With patient needs growing and the therapeutic pipeline expanding, any delay risks leaving behind those who could benefit most. The initiative aims to unify stakeholders – researchers, clinicians, regulators, and policymakers – around a shared strategic framework to drive equitable, sustainable implementation. By acting decisively at this inflection point, the CAR T Vision can shape a future where this life-saving therapy is accessible, effective, and embedded into standard oncology care.
What are the most significant clinical or systemic barriers currently preventing eligible patients from receiving CAR T-cell therapy?
In the clinic, patient referral delays, rapid disease progression, and strict eligibility criteria often prevent timely intervention. From a systemic perspective, limited availability of certified treatment centers, regional disparities in access, and workforce shortages contribute to inequitable care delivery.
The complex, individualized manufacturing process also leads to long turnaround times, which can be detrimental for patients with an aggressive form of their disease. Additionally, high upfront costs and reimbursement complexities pose financial barriers for both institutions and patients. A lack of streamlined care pathways and inter-institutional coordination further exacerbates these challenges.
Many community hematologists and oncologists may also lack familiarity with CAR T indications or referral processes, delaying patient entry into appropriate care networks. Addressing these multifaceted barriers is essential to ensure that advances in CAR T-cell therapy translate into real-world patient benefit across diverse populations.
What are the most effective strategies for improving early identification and referral of patients?
A multifaceted approach that integrates education, streamlined workflows, and data-driven tools is required. Enhancing awareness among community hematologists/oncologists through targeted education on eligibility criteria, clinical benefits, and referral timing is a critical first step. Embedding decision-support tools into electronic health records can prompt timely evaluations based on clinical markers and treatment history. Establishing standardized referral pathways and fostering stronger collaborations between academic centers and community practices can ensure smoother transitions and earlier interventions.
Multidisciplinary tumor boards, including CAR T specialists, can also aid in real-time decision-making. Additionally, leveraging predictive analytics and registries to identify at-risk patients earlier in their treatment journey can support proactive care planning. Ultimately, a coordinated, system-wide strategy is essential to bridge knowledge gaps and reduce delays, ensuring that eligible patients receive CAR T therapy at the optimal point in their disease course.
What role should community-based hematologists and oncologists play in increasing access, and how can we better support them?
The timely identification of eligible candidates and initiation of referrals to specialized centers is essential to ensuring optimal outcomes for patients. To better support providers to do this, tailored educational initiatives focused on CAR T indications, referral processes, and post-infusion care are critical. Providing clear clinical pathways, co-management protocols, and direct lines of communication with CAR T centers can foster more seamless collaboration.
Integrating community providers into multidisciplinary networks and tumor boards helps align care across institutions. Offering logistical support, including patient navigation and digital tools, can further ease the referral burden. By equipping community oncologists with the necessary resources and partnerships, we can significantly enhance equitable access to this transformative therapy.
How can decentralized models of care contribute to equitable access, especially in rural or underserved regions?
By extending key components of the care continuum – such as pre-treatment evaluation, apheresis, and post-treatment monitoring – to local or regional centers, patients can receive high-quality care closer to home, reducing the burden of travel and associated costs. Hub-and-spoke frameworks, where specialized CAR T centers serve as hubs supporting community-based “spoke” sites, enable shared responsibilities and streamlined referrals.
Telemedicine and remote monitoring tools further facilitate real-time collaboration between local providers and CAR T specialists. Training and certifying more regional centers for aspects of CAR T delivery can also alleviate pressure on major academic institutions and shorten wait times.
Importantly, decentralized models must be supported by standardized protocols, robust data-sharing systems, and equitable reimbursement strategies to ensure consistent quality and safety. With thoughtful implementation, decentralization can drive inclusivity and reach historically marginalized patient populations.
Can you discuss the importance of harmonizing treatment center qualifications and manufacturer requirements, and where you see progress happening?
It’s happening everywhere! The GoCART coalition, for example, launched a committee to work on the harmonization of existing center qualification schemes to reduce inspection burdens. In March 2022, a new initiative was announced to allow apheresis and cell therapy treatment centers accredited by JACIE to leverage their accreditation as part of site qualification processes for Bristol Myers Squibb, Johnson & Johnson, Gilead and Kite, and Novartis. Subject to marketing authorization holders’ agreement and obligations, centers holding JACIE accreditation will have the option of undergoing a reduced or remote audit focused on product-specific requirements for cell therapies.
In the US, the ASTCT 80/20 Task Force has proposed standardizing roughly 80 percent of manufacturer onboarding and operational requirements – streamlining accreditation, training, reporting, and IT workflows – to avoid duplication and promote efficiency across treatment centers. Additionally, the FACT Community CAR T Working Group, also launched in 2025, is actively defining clinical accreditation standards tailored to community-based providers, with participation from physicians, academic leaders, and insurer observers.
Progress is also emerging through the CGT Consortium, which aims to unify portals, data standards, and communication protocols across manufacturers and clinical sites for immune effector cell therapies. By aligning expectations around education, apheresis, chain-of-identity logistics, IT, and quality systems, these cross-sector collaborations are laying the groundwork for more predictable, scalable expansion of CAR T services.
As harmonization continues, treatment centers – whether academic or community-based – can onboard more efficiently, reduce redundant audits, and focus resources on patient care rather than on administrative complexity.
What can be done to ensure that patient and caregiver perspectives are truly integrated into policy and treatment planning?
It begins with actively involving patients and caregivers in advisory roles on clinical committees, policy working groups, and regulatory panels. Structured feedback mechanisms – such as patient-reported outcome measures, experience surveys, and focus groups – should be systematically collected and used to inform care delivery, access criteria, and support services. Policies must also reflect the logistical, emotional, and financial burdens caregivers face, incorporating their insights into wraparound care planning.
Transparent communication and culturally sensitive engagement strategies can ensure diverse voices are heard, especially from historically underserved communities. Collaborating with patient advocacy organizations can amplify lived experience in a scalable, policy-relevant way. Ultimately, embedding these perspectives as standard practice – not as a checkbox – will lead to more equitable, compassionate, and effective CAR T-cell therapy programmes.
How do you envision sustainable financing and reimbursement models evolving to support broader CAR T-cell therapy adoption?
As one-time, high-cost therapies, CAR T treatments challenge traditional fee-for-service structures. Innovative models such as outcomes-based agreements, bundled payments, and annuity-style reimbursements, are emerging to align cost with therapeutic value and real-world outcomes. Payors and manufacturers are increasingly collaborating to tie reimbursement to patient response and durability of effect, reducing financial risk.
Public payors can also explore value-based pricing frameworks that reflect clinical benefit and societal impact. Additionally, simplifying prior authorization processes and ensuring timely reimbursement for ancillary services can alleviate provider burden. Scaling these approaches will require robust data infrastructure, transparent metrics, and cross-sector coordination. As the CAR T landscape expands to earlier lines of therapy and new indications, adaptive and equitable financing mechanisms will be essential to ensuring patient access without overwhelming healthcare budgets.
The report highlights that many health technology assessment (HTA) bodies use standard evaluation models not tailored for advanced therapies. What changes would you advocate for in HTA assessment?
To accurately assess the value of CAR T-cell therapies, HTA bodies must adapt their methodologies beyond traditional models designed for chronic treatments. Standard cost-effectiveness frameworks often undervalue advanced therapies by failing to capture long-term remission, curative potential, and quality-of-life improvements. I would advocate for HTA models that incorporate broader value elements, such as patient-reported outcomes, caregiver burden reduction, and societal impact.
Flexible evidentiary standards should also be considered, acknowledging the challenges of randomized controlled trials in rare or refractory populations. Use of real-world evidence, conditional reimbursement pathways, and lifecycle assessments can help HTA bodies make more dynamic, data-informed decisions.
Additionally, greater alignment between regulatory and HTA processes could expedite access while maintaining rigorous evaluation. Tailoring HTA models to reflect the unique attributes of CAR T-cell therapy is essential for supporting fair pricing, sustainable adoption, and patient-centred decision-making.
As a clinician and researcher, what gives you hope that the CAR T Vision target of doubling patient access by 2030 is achievable?
I am encouraged by the unprecedented pace of innovation, collaboration, and commitment across the cell therapy ecosystem, all of which make the CAR T Vision target of doubling patient access by 2030 a realistic and achievable goal. Advances in manufacturing technologies, such as allogeneic platforms, and automation, are rapidly improving scalability and reducing turnaround times. At the same time, collaborative efforts among regulators, payors, clinicians, and industry are fostering more flexible, harmonized frameworks for delivery and reimbursement. The growing body of clinical evidence is expanding indications and solidifying CAR T’s role earlier in the treatment continuum.
Importantly, initiatives focused on decentralization, workforce development, and digital infrastructure are addressing systemic access barriers. Above all, the shared sense of purpose among stakeholders to prioritize patient equity and innovation gives me confidence that, with sustained effort and alignment, we can make CAR T-cell therapy accessible to all who need it.
