Question to the Department of Health and Social Care:

To ask His Majesty's Government what equality impact assessment they have carried out in regard to the decision to end access to Brineura for patients diagnosed with neuronal ceroid lipofuscinosis type 2 after January 2026.

The Department has not undertaken any equality impact assessment.

The National Institute for Health and Care Excellence (NICE) is the independent body responsible for developing authoritative, evidence-based recommendations for the National Health Service on whether new medicines represent a clinically and cost-effective use of resources. Equality impact assessments are not undertaken for managed access agreements, but considerations of equality and health inequalities are integral to NICE’s guidance development process.

Managed access gives people faster access to promising new treatments which might otherwise not be recommended, because of uncertainties about their clinical or cost effectiveness.

The managed access agreement (MAA) for cerliponase alfa (Brineura) was put in place to allow eligible patients to be treated, while additional evidence was collected to address significant uncertainties identified by NICE’s independent committee. Without this agreement, the treatment could not be made available at all.

Patients who started treatment during the MAA will continue to be funded. However, if the committee ultimately concludes that the treatment is not a cost-effective use of NHS resources, it cannot be recommended for routine commissioning and new patients would not be eligible for NHS-funded access.