NCCN Report on CAR T-Cell Therapy, Recommendations for Future Use

A recent report from the National Comprehensive Cancer Network (NCCN) investigated the current state of chimeric antigen receptor (CAR) T-cell therapy and future strategies to consider as the novel immunotherapy evolves and is used in the treatment of more patients.

There are 2 CAR T-cell therapies approved by the FDA and currently available on the market, tisagenlecleucel (Kymriah) and axicabtagene ciloleucel (Yescarta), sold at $475,000 and $373,000, respectively. According to the NCCN, most commercially insured patients have coverage for at least 1 of the approved products, but specific plans or employer-sponsored groups may have limitations on patient’s clinical eligibility. Due to the therapies only being commercially available for about a year, there are still not finalized policies around payment and reimbursement. NCCN has recommended that “improved standardized reimbursement structures are needed to enhance the use of CAR T-cell therapy in cancer management.”

Click here to read more about CAR T-cell therapies.

While there are several toxicities associated with CAR T-cell therapy, 2 of the most common found in patients with hematologic malignancies are cytokine release syndrome (CRS) and neurologic toxicity, which can also be referred to as CAR-related encephalopathy syndrome (CRES). Several studies have established toxicity grading criteria and management algorithms; however, NCCN notes that as the use of CAR T-cell therapy expands to treat multiple malignancies, there is a growing need for standardization in terms of management strategies, antimicrobial prophylaxis, and patient selection in order to minimize toxicities and maximize effectiveness of the treatment.

More recently, researchers have sought to identify the possible utilization of CAR T-cell therapies beyond hematologic malignancies, specifically in solid tumors. This has proved challenging “due to heterogeneous antigen expression, immunosuppressive networks in the tumor microenvironment limiting CAR T-cell function and persistence, and suboptimal trafficking to solid tumors.” Importantly, NCCN noted that standardized procedures for monitoring CAR T-cell persistence and disease surveillance are still needed to determine any potential long-term effects of the treatment.

Though the process of launching FDA-approved CAR T-cell products involves many critical components, it is equally as essential to have dedicated and trained personnel in each of the clinical and administrative departments that manage work associated with CAR T-cell therapy. Every organization looking to administer this therapy to patients also needs to consider the implementation of a variety of different support systems, such as program and infrastructure development, psychosocial support, institutional protocols, and cost and coverage considerations.

Specifically, in terms of program and infrastructure development, organizations need to determine whether current facilities have the capacity to scale production to predicted volume levels, or whether additional units may be required. Psychosocial support is also a critical function of the clinical team, as oncology social workers provide psychosocial assessments to determine a patient’s strengths and available resources, as well as identify any barriers that may affect treatment.

Finally, although NCCN recognizes a need to develop CAR T-cell therapy—specific guidelines, until there is a uniform approach to these treatments, creating standard guidelines remains a challenge. “As the data develop and mature, such guidelines will help stratify commonalities and differences in terms of product-specific management.”

Reference

Ogba N, Arwood N, Bartlett N, et al. Chimeric antigen receptor T-cell therapy. J Natl Compr Canc Netw. 2018; 16(9):1092-1106. doi: 10.6004/jnccn.2018.0073