Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what his planned timetable is for when patients with Myasthenia Gravis will have access to recently licenced products.

On 7 March 2024, the Medicines and Healthcare products Regulatory Agency (MHRA) approved the medicine rozanolixizumab, marketed as Rystiggo, to treat adults with generalised myasthenia gravis.

The National Institute for Health and Care Excellence (NICE) evaluates all new licensed medicines and makes recommendations for the National Health Service on whether they should be routinely funded by the NHS based on their clinical and cost effectiveness. NICE aims to publish guidance as close as possible to the time of licensing.

NICE published draft guidance on the use of rozanolixizumab for consultation in September 2024 and was unable to recommend it as a clinically and cost-effective use of NHS resources due to uncertainties in the long-term effectiveness of the treatment, as well as uncertainties in the economic model and the cost-effectiveness at the price proposed by the company. NICE has not yet published final guidance, and it will keep stakeholders informed about next steps as soon as possible.