UK authorities launch faster assessment pilot for new medicines

NICE and NHS England started a pilot program to shorten the initial evaluation process for promising new drugs in the United Kingdom.

This initiative, called the Streamlined Managed Access Route for Therapies (SMART), aims to reduce the time it takes for patients to receive new treatments from approximately one year to six months. The SMART pilot targets medicines that show highly promising early data and have clear plans to collect real-world evidence after they enter the health service.

Currently, medicines in managed access undergo two separate evaluations by NICE. The new pilot tests a shorter starting assessment, followed by a full evaluation once more evidence is gathered during a managed access period. This period allows the health service to monitor how the drugs perform in clinical practice while protecting the finances of both the NHS and pharmaceutical companies.

The Department of Health and Social Care says these changes and other pilot schemes could result in the approval of five additional medicines per year. These efforts follow a 10-week sprint process involving input from patient organizations. Other related pilots include new ways to account for productivity benefits, such as patients returning to work, and regional funding to ensure patients have equal access to therapies regardless of where they live.