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Managed Access Agreement (MAA)

Managed Access Agreements (MAAs) are a form of conditional reimbursement or coverage with evidence development used within the UK National Health Service (NHS). These agreements are established between NHS England and manufacturers of new technologies, typically drugs, allowing these interventions to be made available for a limited time period at a discounted price. The coordination of MAAs is managed by the National Institute for Health and Care Excellence (NICE), particularly through the Cancer Drugs Fund for oncology medicines.

MAAs involve various stakeholders, including clinicians, patient advocacy groups, and clinical representatives from NHS England. They are designed to address significant areas of uncertainty in the evidence base, as identified by the NICE technology evaluation Committee. MAAs are commonly used in single technology assessments (STAs) and are anticipated for most highly specialised technologies (HST).

Key components of an MAA include:

– Agreed Rationale and Duration: Clear justification and specified time period for the arrangement.

– Populations Covered: Definition of the patient groups included, particularly their place in the care pathway.

– Criteria for Starting and Stopping Therapy: Specific conditions under which the new therapy should be initiated or discontinued.

– Outcome Definitions: Clear metrics for assessing the effectiveness of the intervention.

– Data Collection Methods: Detailed plans for gathering and reporting data, including the frequency of reporting.

– Commercial Proposition: Price discount agreements and financial risk management plans.

– Post-Reimbursement Plans: Contingency plans outlining the steps if reimbursement is eventually withdrawn.

MAAs provide a structured approach to managing the introduction of new therapies while addressing uncertainties and ensuring that patients have timely access to potentially beneficial treatments.

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