Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what recent discussions he has had with the National Institute for Health and Care Excellence on approval of Skyclarys; and if he will consider the urgent provision of Skyclarys for patients on an interim basis.

The National Institute for Health and Care Excellence (NICE) initiated the appraisal of Skyclarys (omaveloxolone) for the treatment of Friedrich’s Ataxia for people aged 16 years old and over in anticipation of a licence bring granted by the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA is the independent agency responsible for licensing medicines for use in the United Kingdom based on an assessment of their safety, quality, and efficacy.

Although now licensed, following an update from the company, Biogen, NICE has had to terminate its appraisal of this medicine as the company has withdrawn its evidence submission.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:

https://www.nice.org.uk/guidance/TA1061

To avoid the possibility of creating a way to circumvent the appraisal process, NHS England is unable to fund medicines where companies have not engaged with NICE.