It’s Time to Reimagine Reimbursement for CAR T-Cell Therapy

Since their launch in 2017, chimeric antigen receptor T-cell therapies (CAR T) have revolutionized the treatment of certain blood cancers, offering hope for cure where traditional treatments have failed. Yet access remains low, even in countries where treatment is approved and reimbursed. For example, only 2 in 10 eligible patients with diffuse large B-cell lymphoma receive CAR T.¹

This represents one of the most significant access gaps in modern oncology. A complex web of barriers prevents access: from difficulty establishing and staffing new treatment centers, to patient-level factors such as geography, insurance type, and one’s ability to afford travel or time off work.

The CAR T Vision Steering Committee has set an ambitious goal: to double the proportion of eligible patients treated with CAR T by 2030.² Reimbursement challenges stand out as an area where significant progress can be made quickly to broaden access and close equity gaps.

This article examines the challenges in the US and Europeand proposes concrete solutions that can help transform access while maintaining financial sustainability for health care systems. While we recognize that access gaps are even wider in other geographies, the US and Europe can provide a blueprint for reimbursement approaches worldwide.

Switching the Focus From Cost to Value

The cost of treatment is often cited as the central challenge for reimbursement.^3,4 The high acquisition cost strains traditional payment frameworks and health technology assessments (HTAs), particularly as health care systems face unprecedented financial pressures.⁵

We have gained significant knowledge and experience in recent years, both with the therapies themselves and methods for assessing their value. Recent regulatory shifts, such as the FDA’s decision to lift Risk Evaluation and Mitigation Strategies requirements for CAR T,⁶ reflect growing experience and may help reduce administrative burdens and logistics for treatment centers.

The US Landscape: Navigating a Complex Patchwork

Public insurance challenges

In the US, CAR T reimbursement varies significantly by payer and treatment setting. This creates a fragmented landscape where access depends heavily on insurance type, with Medicare and Medicaid patients facing the greatest barriers, which inevitably have the greatest impact on those with lower socioeconomic status.⁷

The Medicare and Medicaid payment problem. For inpatient treatment, Centers for Medicare & Medicaid Services(CMS) uses a diagnosis-related group (DRG) system, assigning CAR T cases to DRG 018. The base payment will be $314,176 in fiscal year (FY) 2026, up from $269,139 in FY 2025.⁸ While this represents progress, the base payment often falls short of covering the full costs of treatment—even when factoring in new technology add-on payments (NTAPs) and outlier payments.⁹

This gap forces treatment centers, particularly those serving Medicare populations, into the unsustainable position of providing CAR T at a financial loss. The situation will likely exacerbate in 2026, when a CMS policy change, bundling preparatory procedures for tissue procurement into the product payment comes into force.¹⁰ ForMedicaid, reimbursement rates vary by state and by product, creating additional uncertainty and administrative complexity that further deters adoption in under-resourced settings.¹¹

Process complexity. The reimbursement process involving DRGs, NTAPs, and outlier payments is not only complex but administratively burdensome, requiring significant staff time from revenue cycle and finance teams. These delays and uncertainties leave treatment centers carrying financial liabilities while awaiting payment.¹² Simultaneously, patients may face significant out-of-pocket costs for travel, lodging, and lost income.¹³

While community settings are being explored to broaden access, the financial investment and the risks of payment delays – makes adoption challenging.¹⁴

In the outpatient setting, the “72-hour rule” requires outpatient costs to be moved into inpatient reimbursement if patients are admitted within 3 days of infusion, removing financial incentives for outpatient administration.¹⁴

Commercial insurance challenges

While most commercial insurers cover CAR T with generally higher reimbursement than Medicare or Medicaid, significant barriers remain.¹⁵ Prior authorization and single case agreements often lead to treatment delays of several weeks.⁹ During this time, the disease can progress, closing treatment windows. For providers, navigating these payer-specific requirements consumes considerable resources, with oncology practices devoting entire teams to insurance authorization and appeals. While patients with commercial insurance are more likely to receive CAR T than those with public insurance, they face longer waits between treatment decision and infusion —a paradox that underscores the administrative burden and unpredictability providers must manage on their patients’ behalf.^16,17

Europe: Fragmentation Limiting Potential

Access to CAR T is limited in several European countries, where infrastructure and reimbursement frameworks may not support these advanced therapies.¹⁸ The European Medicines Agency provides unified regulatory approval across all European Union (EU) member states, and standardized clinical assessments under the new Health Technology Assessment regulation could drive consistency across countries. However, national pricing and reimbursement decisions create disparities in coverage across the continent.

Innovation amid inconsistency

Several European countries have pioneered innovative pricing approaches for CAR T, demonstrating leadership in value-based reimbursement. Spain and Italy introduced staged payment models where initial payment occurs at treatment administration, with additional payments contingent on sustained patient response after 18 months.¹⁹ England and France have used Coverage with Evidence Development, tying reimbursement to additional data collection. There have also been efforts to harmonize pricing and reimbursement across countries through joint price negotiation, including the Beneluxa Initiative²⁰ and the Nordic Pharmaceutical Forum.²¹ However, limited coordination still means patients in different countries face different access scenarios.

Harmonization hopes and concerns

The EU Joint Clinical Assessment (JCA) represents an opportunity to create more harmonized and systematic evaluations across Europe, enabling broader and more equitable patient access.²² However, concerns persist about the JCA framework adequately capturing the unique characteristics and benefits of CAR T.²³

Better value assessment can open doors to new solutions

At the heart of the reimbursement challenges is the concept of value—for patients and payers alike. If payers, providers, manufacturers, cancer associations, and advocacy organizations can coordinate to better characterize and communicate the long-term clinical and societal value of CAR T, reimbursement becomes more evident.

Limited clinical trial data must be supplemented with real-world evidence from large, prospective registries and observational studies to better estimate long-term effectiveness, cost-effectiveness, and adverse events in diverse populations. Proven approaches for modeling long-term remission with CAR T, such as mixture cure models,²⁴ should be embraced. Broader value frameworks should be adopted to include factors such as patient and caregiver productivity gains, as well as other modifiers of value.

Recent data from an Association of Cancer Care Centers member survey underscore that barriers are not just theoretical²⁵: US cancer programs cite reimbursement complexity and inadequate payment rates as top factors limiting access to CAR T.

The value of CAR T should be reflected in innovative payment and contracting models through the application of performance- or outcome-based agreements, where manufacturers and payers share financial risk by linking reimbursement to meaningful patient outcomes over a defined period. This allows for staged payments, with each payment contingent on CAR T delivering a sustained benefit, encouraging a rigorous system for collecting data over time.

For the DRG system in the US, the full value of CAR T should be better reflected in the base rates to ensure adequate payment for treatment centers taking Medicare patients. The base rate should also better reflect the long-term value of patients receiving CAR T, including reductions in total care costs and adverse events such as posttreatment emergency department visits.²⁶ CMS should also maintain separate reimbursement for preparatory procedures, rather than bundling these into the product payment.

In the shorter term, encouraging appropriate outpatient administration,where clinically suitable and with proper support systems, may offer cost efficiencies while maintaining patient safety standards.²⁷ More consistent reimbursement models that reflect the long-term value of CAR T and address health care disparities remain essential. Moving from single case agreements to global case agreements, which are characterized by all-inclusive payments with health care providers for a predefined volume of CAR T cases, would increase patient access and reduce administrative delays. Commercial insurers should also commit to maximum authorization timeframes to prevent treatment delays that render therapy ineffective.

Across Europe, greater harmonization of assessment and reimbursement processes is also critical to ensure fair and timely access. The EU JCA framework should establish criteria that capture the unique benefits of products like CAR T so that regulatory approval translates into consistent coverage decisions across member states.

Every eligible patient should have the opportunity for cure with CAR T. By addressingthese reimbursement challengessystematically and implementing value-based payment models that reflect the true benefit of these treatments, we move closer to our goal of doubling the proportion of eligible patients treated with CAR T by 2030.

Read more about CAR T Vision here.

About the Authors

Anna Sureda, MD, PhD, is a clinical hematologist and cell therapy researcher. She is head of the Clinical Hematology Department of Institut Català d’Oncologia – Hospitalet, Barcelona, Spain.

Meagan O’Neill, MS, is executive director of the Association of Cancer Care Centers, which provides education, advocacy, and resources for the multidisciplinary cancer care community.

Brian O’Rourke, PharmD, OMM, is colonel commandant (honorary) with the Royal Canadian Medical Service. He served 11 years as president and CEO of the Canadian Agency for Drugs and Technologies in Health and is the current chair of the Health Technology Assessment Steering Committee at the Centre for Innovation in Regulatory Science in Ottawa, Canada. O’Rourke served as president of ISPOR for 2023-2024.

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