Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, if he will make an assessment of the the approval process of (a) high tariff drugs (b) the use of Obinutuzumab in patients with lupus who have experienced severe infusion reactions with rituximab.

The National Institute for Health and Care Excellence (NICE) is the independent body that makes recommendations on whether new licensed medicines, including high cost medicines, should be routinely funded by the National Health Service in England, based on the evidence of their costs and benefits. The NICE aims, wherever possible, to publish guidance close to the time of licensing, and the NHS in England is required to fund NICE recommended medicines, normally within three months of final guidance.

The NICE is in the early stages of evaluating obinutuzumab with immunosuppressive therapies for treating lupus nephritis. Its independent committee will meet to consider the evidence on 10 December 2025, and the NICE currently expects to publish final guidance in March 2026. The evaluation is currently on track to be published within 90 days of marketing authorisation.