Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, whether his Department plans to make Omaveloxolone available through the NHS.

The National Institute for Health and Care Excellence (NICE) is the independent body responsible for developing evidence-based recommendations for the National Health Service on whether new, licensed medicines represent a clinically and cost-effective use of NHS resources.

The NICE is unable to make a recommendation about the use of omaveloxolone for treating Friedreich's ataxia in people aged 16 years old and over, in the NHS. This is because the company, Biogen, withdrew its evidence submission. The NICE will review its decision if the company decides to make a new submission. Further information is available at the following link:

www.nice.org.uk/guidance/indevelopment/gid-ta11431

NHS England does not fund medicines where the company has not engaged with the NICE. This is to avoid a potential pathway for circumventing the NICE’s appraisal process.