T-46: An Analysis of Healthcare Plan CAR T Cell Coverage Criteria for Medicaid Beneficiaries

Poster Presenter

Landon Shupe

Pst-Doctoral Fellow
Rutgers University/Ernest Mario School of Pharmacy
United States

Objectives

This study analyzed the publicly available Medicaid healthcare plan CAR T cell coverage criteria of the two currently approved CAR T products in the United States to gain a better understanding of how CAR T cell treatment access is currently being managed.

Method

A comprehensive literature review was conducted to determine state Medicaid coverage criteria for approved CAR T cell therapies, tisagenlecleucel and axicabtagene ciloleucel. Policies were compared with National Comprehensive Cancer Network (NCCN) guidelines and registrational trial publications.

Results

Through a public literature search, CAR T cell coverage criteria for tisagenlecleucel and axicabtagene ciloleucel on 46 different Medicaid plans in 24 different states were collected. State Medicaid policies included different criteria that were required in order for the drug to be deemed medically necessary and reimbursed. The three most frequent coverage criteria from our literature search for both tisagenlecleucel and axicabtagene ciloleucel were: patients must not have an active infection-including HIV, Hepatitis B, and Hepatitis C (57%), patients must not have had a previous CAR T cell therapy (54%), and patients must not have a malignancy involving the central nervous system (50%). When comparing the collected healthcare plan coverage criteria to the FDA approved indication statement, we found that there was an average of 4.38 additional coverage criteria for tisagenlecleucel in the acute lymphoblastic leukemia (ALL) indication, 4.83 additional coverage criteria for tisagenlecleucel in the Diffuse Large B-Cell Lymphoma (DLBCL) indication, and 4.43 additional coverage criteria for axicabtagene ciloleucel in the DLBCL indication. Through analysis of the registrational trial for tisagenlecleucel and axicabtagene ciloleucel, many additional medical policy coverage criteria were similar to the trial inclusion and exclusion criteria. In comparison to the NCCN DLBCL guidelines for CAR T therapy patient selection, the state Medicaid healthcare plan coverage criteria were more restrictive.

Conclusion

There are additional Medicaid CAR T coverage criteria not included in the indication statement that were associated with the registrational trial inclusion/exclusion criteria which must be met in order for Medicaid beneficiaries to access the cellular therapies.