Managed access agreement

A managed access agreement (MAA) is a type of conditional reimbursement arrangement. These agreements, co-ordinated by the National Institute for Health and Care Excellence (NICE), allow a new healthcare technology (typically a drug) to be made available for a limited time at a negotiated price, while additional data is collected to address significant evidence uncertainties identified during the initial health technology assessment.
The primary purpose of an MAA is to manage the uncertainty surrounding the evidence base of a new technology, particularly in areas of the greatest clinical or cost-effectiveness uncertainty. For oncology medicines, these agreements are specifically facilitated through the Cancer Drugs Fund. This process involves collaboration between the technology sponsor, NHS England, clinicians, and patient advocacy groups, aiming to balance early patient access with the need for robust evidence collection. MAA proposals include an agreed rationale and duration for the arrangement, populations covered (in particular, where they come in the care pathway), clear criteria for starting and stopping the new therapy, definition of outcomes, methods of data collection and frequency of reporting, together with a commercial proposition (price discount), financial risk management plans and an understanding of what will happen if reimbursement is eventually withdrawn.