Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what recent assessment his Department has made of the reasons for the difference in availability of Omaveloxolone (Skyclarys) as a treatment for Friedrich's ataxia in (a) Scotland and (b) England and Wales; and if he will make it his policy to require the National Institute for Health and Care Excellence to set out the reasons for which new drugs that (i) have been approved by the Medicines and Healthcare products Regulatory Agency and (ii) are available in Scotland are not available in England and Wales.

The Department has made no assessment of the reasons for the difference in the availability of omaveloxolone (Skyclarys) as a treatment for Friedrich's ataxia in Scotland, England, and Wales.

Decisions on the availability of medicines are taken by the respective health authorities in each nation of the United Kingdom. The National Institute for Health and Care Excellence (NICE) is responsible for making recommendations on the use of new medicines in England, while Scotland has its own processes through the Scottish Medicines Consortium (SMC).

NICE publishes the reasons for its decisions on its website, and the Department has no plans to require NICE to set out the reasons for differences between its recommendations and the SMC’s. NICE was unable to make a recommendation on the use of omaveloxolone for treating Friedreich's ataxia in people aged 16 years old and over because the manufacturing company, Biogen, withdrew its evidence submission. NICE will review this decision if Biogen decides to make a new submission.