Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, if he will take steps to introduce interim access to omaveloxolone for Friedreich’s Ataxia patients.

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.

NICE is unable to make a recommendation about the use in the NHS of omaveloxolone for treating Friedreich's ataxia in people aged 16 years old and over. This is because the company, Biogen, withdrew its evidence submission. NICE will review its decision if the company decides to make a new submission. Further information can be found 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 NICE. This is to avoid a potential pathway for circumventing the NICE appraisal process.