A hypothetical CAR-T therapy: determining the expenses involved in setting up managed entry agreement based on performance

Clearly outlined methodologies that quantify the adoption burden of Managed Entry Agreements (MEAs) do not exist in the public domain and are needed by market access stakeholders. This study aimed to determine at hospital level the expenses involved in setting up a performance-based MEA

Focusing on a theoretical single-use treatment for Acute Lymphoblastic Leukemia, information from five NHS Hospital Trusts was gathered that detailed expenses related to job roles, personnel hours, capital investments and tasks. The research aimed to compare, over a 10-year period, the implementation of the treatment with or without a managed entry agreement (MEA), with the administrative workload of the current standard of care (SoC).

There was variability in the expenses required to support the hospital payments for the target patient population over a 10-year period: for the SoC was £447,353, compared to £1,117,024 for the novel therapy with MEA, and £245,317 without MEA.

The higher frequency of infusions requiring payments and the associated mandatory data explains the higher costs associated with the SoC compared to the novel therapy without an MEA. The greatest financial burden is attributed to the novel therapy with MEA, given the higher frequency of monitoring in year one to make up for the higher uncertainty in clinical data, and informs the performance-based reimbursement.

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