Take Early, Exploratory Steps

Karen Anderson, MN, RN, OCN^®, BMTCN^®, CRNI, RN operations support specialist at University of Arizona Cancer Center, and Lenise Taylor, MN, RN, AOCNS^®, BMTCN^®, clinical nurse specialist at Seattle Cancer Care Alliance–University of Washington Medical Center, said that one of the first, high-level steps in establishing a CAR T-cell program is determining where it belongs and the administrative and medical leadership for the program. For example, will it be a new service line or part of hematology or blood and marrow transplant services? Consider the sites of care involved (inpatient, outpatient, and emergency department), and develop goals and plans to measure outcomes.

Conduct a needs assessment to identify community requirements, referral networks, gaps in the facility’s infrastructure, and regulatory and accreditation requirements, then develop a business plan to address the findings.

“It takes organizational resources and commitment to take on a high-touch, complex program like this,” Anderson said. “Starting a CAR T-cell service requires alignment and coordination among many, many teams.”

Build a Team

Because almost every type of professional in a hospital system is involved, bring them in early. The financial team, for example, must research the payer mix and reimbursement models and develop processes for coding and billing. Information technology must evaluate portals to communicate with CAR T-cell manufacturers, establish secure platforms to store long-term follow-up data, and update the electronic medical record with order sets and documentation tools. The legal team must ensure compliance and review new contracts and consent forms.

Pharmacy staff may need to learn proper handling and storage of CAR T-cell products or establish mechanisms to maintain key inventory items (e.g., medications to help manage additional side effects of CAR T-cell therapy). Prescribers must learn how to order through portals and to recognize and manage unique side effects and toxicities.

Nursing training for CAR T-cell programs includes:

• Equipment usage
• Administration and monitoring
• Recognition of side effects, particularly cytokine release syndrome and neurotoxicity
• Documentation

Finally, a successful CAR T-cell program must involve and continually reinforce education of supportive staff, such as assistive personnel, rapid response teams, and staff in the intensive care unit and emergency department.

Consider Other Tasks

Additional tasks to establish a CAR T-cell service include:

• Completing the Risk Evaluation and Mitigation Strategies (REMS) program.
• Having manufacturers validate the infrastructure, policies, and procedures.
• Doing a “dry run” to evaluate how well a program preparation to order and store therapies, perform cell collection, and administer treatment.

The presenters also recommended building a library of documents for patient education, patient evaluation, informed consent, and reporting adverse events, such as cytokine release syndrome and neurotoxicity.

Assess and Plan Ahead

Patients receiving CAR T-cell therapy have long-term needs, and the U.S. Food and Drug Administration requires 15-year follow-up and reporting. After the program is in place, prepare to add staff for essential tasks such as collecting and reporting data collection, reviewing and reporting adverse events, conducting REMS audits, maintaining manufacturer partnerships, communicating with primary care providers, and more.

“This field is evolving rapidly, so stay nimble,” Taylor said. “Continue to pay attention to reimbursement, new payment models, and new agents on the horizon.”