A managed access agreement (MAA) is an agreement between the National Health Service (NHS) and a pharmaceutical company that sets out the terms and conditions for funding and access to a drug or medical device that is not yet widely available on the NHS.
The purpose of an MAA is to ensure that patients who need the drug or medical device are able to access it in a timely and equitable manner. It also allows the NHS to manage its budget by negotiating the price of the drug or medical device and ensuring that it is cost-effective.
MAAs are usually entered into for drugs and medical devices that are still being evaluated for their safety, efficacy, and cost-effectiveness. These drugs and medical devices are often part of clinical trials and have not yet been approved for general use by the regulatory authorities.
The process of negotiating an MAA typically involves several stages. Firstly, the pharmaceutical company will submit an application to the NHS detailing the drug or medical device, its intended use, and the evidence of its safety, efficacy, and cost-effectiveness. This application will then be reviewed by an independent committee, usually the National Institute for Health and Care Excellence (NICE), which will make a recommendation to the NHS.
If the recommendation is positive, the NHS will enter into negotiations with the pharmaceutical company to agree on the terms and conditions of the MAA. This will include the price of the drug or medical device, the patient criteria for access, and the monitoring and evaluation requirements.
Once an MAA has been agreed, patients who meet the eligibility criteria will be able to access the drug or medical device through the NHS. This may involve a specialist clinician making an application on behalf of the patient, or the patient themselves applying through a patient advocacy group.
MAAs are an important tool for ensuring that patients have access to new and innovative treatments. They allow the NHS to negotiate fair prices and ensure that scarce resources are used in the most effective way possible. However, they must be managed carefully to ensure that patients are not denied access to treatments that could benefit them.