Debuting in human clinical trials just a decade ago, chimeric antigen receptor (CAR) T-cell therapy was quickly hailed as a breakthrough cancer treatment for certain hematologic cancers. Today, patients and providers have access to 22 U.S. Food and Drug Administration (FDA)–approved cellular and gene therapy products, and CAR T-cell therapy is available beyond large academic research centers.
The treatment is a complex process involving cell manufacture, tracking and shipping of apheresis products, and managing novel and severe toxicities. However, the payoff may be worth it: CAR T-cell therapy is a single infusion with short recovery times and long-lasting benefits. Two ONS members shared their experience of developing and implementing CAR T-cell therapy programs at their institutions.
Education Is Essential
ONS member Karen Anderson, MN, RN, OCN®, BMTCN®, CRNI, RN operations support specialist at the University of Arizona Cancer Center in Tucson and member of the Southern Arizona ONS Chapter, was on the interprofessional team that developed and implemented workflows for investigational and FDA-approved CAR T-cell products at Seattle Cancer Care Alliance in Washington. She transitioned to the University of Arizona Cancer Center in 2018 when it opened its CAR T-cell program.
“As the authorized CAR T-cell representative for our hematopoietic stem cell transplant (HSCT) program, I coordinate with the clinical team, operational leaders, and pharmaceutical companies to support implementation and ongoing management of program requirements like risk evaluation mitigation strategies (REMS), policies, procedures, and training,” Anderson said.
ONS member Alisha Ellis, MSN, RN, OCN®, CHPN, BMTCN®, clinical educator of bone marrow transplant and hematology at Franciscan Health in Indianapolis and member of the Central Indiana ONS Chapter, began her current role in 2020, when “our CAR T-cell volumes ballooned,” she said. “It became apparent big learning gaps existed among the staff.”
In response, Ellis developed and implemented an extensive training program, beginning with a literature review and borrowing ideas from existing programs.
“Once I better understood the learning needs for CAR T-cell therapy, I surveyed our nurses to understand what gaps existed,” she said. Her staff said they would benefit from a new orientation course, but her unit could not pull nurses out of rotation.
“This required some creativity. We implemented a mandatory self-study course that addressed one topic each month for five months,” Ellis said. “This ensured that both our new hires and existing staff had consistent knowledge that enabled them to expertly care for these unique patients.”
Identify Initial Requirements
Finances are one of the biggest barriers to implementing CAR T-cell programs. Average costs are estimated at $900,000, with outlays driven largely by personnel expenses. Medicare reimbursements for CAR T-cell therapies may be insufficient, and institutions’ reimbursement, authorization, and billing and coding processes may be intense and complex.
Conducting a financial needs assessment is important to identify a potential referral base before implementing a CAR T-cell program, Anderson said, and institutions should perform extensive assessments, including:
- Payor mix
- Payor coverage policies
- Potential patient volumes
- Prior authorization workflows
- Program cost and reimbursement projections
“Financial teams must familiarize themselves with current reimbursement approaches for CAR T-cell therapy to ensure program viability,” she said.
Anderson said that administrative, medical, and nurse leaders should ask:
- Do we have adequate apheresis, emergency department, intensive care, outpatient, and inpatient resources to manage toxicities?
- How will patients access or learn about the program?
- How will we deliver education to prepare staff and patients?
- What intake workflows are needed to ensure timely access to therapy for patients with relapsed and refractory cancers?
After addressing finances but before implementing a program, Ellis encouraged institutions to establish an interprofessional team to initiate practice changes and develop policies for managing reporting, quality, adverse events, and long-term side effects.
Every member of the interprofessional team requires education about their role, and Ellis advised designing a plan for ensuring REMS training at program initiation and for onboarding new staff. “Our interprofessional group still meets monthly and is driven by our pharmacy and physician teams,” she said.
And patients need extensive education, too: “Patients and caregivers need education at initial consultation, prior to T-cell collection, during the conditioning regimen and cell infusion, and in the follow-up phase,” Ellis said. “The team can also develop education and decide who is responsible for delivering it so that a uniform plan is in place and patients can receive a consistent message.”
Establish Your Program
After determining feasibility of and processes for a CAR T-cell therapy program, Anderson said to establish program leaders and identify or hire staff from key areas involved with implementation and ongoing support, including:
- Apheresis and cell therapy
- Financial services
- Information technology
- Physician and advanced practice providers
- Regulatory and compliance
“Establish relationships with CAR T-cell therapy manufacturers and work with the companies to obtain site certification to administer the products,” Anderson said. “Understand regulatory requirements from pharmaceutical companies and FDA and standards that inform how to build a quality CAR T-cell program, which are available through the Foundation for the Accreditation of Cell Therapy.”
Implement and Support Your Program
“CAR T-cell therapy is commonly offered at centers with existing HSCT programs. The nursing staff at these centers are accustomed to administering cellular products according to a uniform process,” Ellis said. “However, these products are both cellular and pharmaceutical. These ‘living drugs’ are a new type, and nurses cannot assume that each CAR T-cell therapy can be administered the same way.”
At Franciscan Health, all staff attend annual seminars where physicians discuss process changes or developments and present education on side effects like cytokine release syndrome (CRS) and immune effector cell–associated neurotoxicity syndrome. New hires also start administering CAR T-cell therapy with their preceptor.
“This gives the orientee an additional level of comfort,” Ellis said. “They know they won’t be alone the first time they take care of one of these special patients.”
Providing updates and education in real time can be challenging because of rapid developments in CAR T-cell products, Ellis said, but thorough and timely training is necessary for a sustainable program and ongoing communication is imperative for success. Industry partners are indispensable, she added: one pharmaceutical company flew out a representative to be present on site for her staff’s first outpatient infusion.
“Another product manufacturer is now sharing that clinicians can consider prophylactic steroids, which were previously avoided unless treating higher grades of CRS,” Ellis said. “Once the physician group decides if we implement this consideration, we will update the order sets and communicate that information to our nurses. We can’t wait a year for that kind of revision to go out.”
Ellis encouraged nurse educators to embed process updates into order sets, which gives staff a reference point they trust and mitigates communication gaps from missed emails or meetings.
“Nurses are reassured when they know that, if changes occur with existing products or different nuances apply to new CAR T-cell therapies, they will always find that information in the order set, as well as receive ongoing updates and education,” she said.
Sustain Your Resources and Logistics
Care for patients receiving CAR T-cell therapy can be demanding, Anderson said, and much of the constraints are caused by logistics, space, and staffing. She suggested using standardized templates or flowsheets for common toxicities like CRS to speed up assessment, reporting, and management.
“If initial program volumes are low, centers should assess whether their current resources can support the addition of CAR T-cell workflows while strategically planning for growth,” Anderson said.
Another challenge is that FDA’s risk evaluation and management strategies for CAR T-cell therapies require patients to have regular follow-up visits and stay within at least two hours of the center for four weeks after infusions.
“Institutions should explore affordable temporary housing options nearby,” Anderson said. “Travel and lodging programs may be available through patient support organizations, some payors, and pharmaceutical companies.”
The Susan Lang Pre–CAR T-Cell Therapy Travel Assistance program is one option for patients with hematologic cancers who have significant financial need.
“CAR T-cell therapy is so new that I think most of the discomfort comes from the unknown and lack of experience,” Ellis said, “not from therapy administration.”
“Don’t underestimate the time, commitment, and resources needed to build a program,” Anderson said. “However, expanding access to these therapies is important for patients with relapsed and refractory cancers who are in need of new treatment options.”