Mounting evidence supports the use of chimeric antigen receptor T-cell (CAR T) therapy for multiple hematologic malignancies. Unfortunately, in the United States, many eligible patients are unable to receive these therapies due to restrictions on CAR T administration centers. CAR T therapies are often administered at large academic hospitals as part of their hematopoietic cell transplant program infrastructure, and have historically also been limited to those accredited by the Foundation for the Accreditation of Cellular Therapy (FACT). With the rise in use of these therapies, this is becoming a barrier to access for many patients, since more than half of patients newly diagnosed with cancer in the US are treated in community oncology practices. In a JAMA Oncology Viewpoint article, Dr Michael Byrne and colleagues described key barriers in the community oncology setting and the need for expanding access to CAR T.
Currently, most community practices are not authorized to administer CAR T. To become a CAR T authorized treatment center (ATC), oncology practices must have substantial infrastructure and human resources. Those that can become an ATC may still face obstacles from commercial insurance plans and reimbursement hurdles. When CAR T is unavailable in the outpatient setting, patients in a community oncologist’s care are transitioned to another team for care, typically in a hospital setting. This transition of care can cause communication and care coordination challenges with potential for interruptions in care and poor outcomes, which have been reported recently for community oncologists trying to optimize the use of CAR T-cell therapies for their patients with non-Hodgkin lymphoma.
Dr Byrne and co-authors propose that increasing the ability for CAR T therapies to be administered in the outpatient setting could increase patients’ access to therapy, prolonging more patients’ lives and potentially lowering total costs of care. Additionally, there is no evidence to suggest that outcomes are better when CAR T administration is restricted only to centers that also perform hematopoietic stem cell transplants.
Another challenge noted by the authors is that commercial payor policies often limit coverage for CAR T therapies to FACT-accredited ATCs, further restricting access and contributing to higher costs of care. CAR T contracting often falls under national transplant networks rather than local market-driven contracts, leading to the creation of narrow centers-of-excellence networks and only single-case negotiations for coverage in community settings.
High level
The success of CAR T in the community oncology setting relies on a culture of innovation and simplification of processes. The growth in eligible and applicable populations for CAR T therapies will soon exceed the capacity of existing ATCs. Therefore, all stakeholders must consider ways to mitigate access barriers so that these therapies can be delivered to the patients who will most likely benefit from them. For instance, a more prominent role for community oncology practices in expanding access to CAR T therapy relies on private payors adapting to new therapy settings and working together with manufacturers to negotiate for similar therapy discounts to those afforded to the larger practices. Private payors are encouraged to consider alternate certification pathways when evaluating coverage for new sites of care.
Ground level
As development continues, CAR T products are expected to be increasingly conducive to administration in the community oncology setting with faster manufacturing times, off-the-shelf products that eliminate the need for apheresis, and safer constructs that diminish reliance on inpatient care. Expanding access to CAR T therapies will require the evolution of community practices to support delivery of these therapies. Monitoring CAR T research and new guidance for managing their associated adverse events will help to prepare smaller community centers for the expanding population of patients in whom CAR T therapy could be beneficial. Expansion into CAR T therapy administration could potentially increase the continuity of patients’ therapies and could offer a new revenue stream if practices in nearby communities are slower to expand their therapy repertoires to include CAR T therapy.