Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, whether her Department has made an assessment of the potential merits of (a) early access use for NHS patients for Omaveloxolone (Skyclarys) and (b) making Omaveloxolone (Skyclarys) a candidate for the innovative medicines fund.

Further to the answer provided in the House of Lords on 19 October in response to Question HL3794, Biogen must confirm that it is willing to re-engage with the evaluation process before further action on access to Omaveloxolone for National Health Service patients can be considered.

The Early Access to Medicines Scheme and Innovative Licensing and Access Pathway exist to support the development of medicines before they are licensed, which is not applicable in this case. Nor can NHS England consider providing funding through the Innovative Medicines Fund, in a situation where a company has failed to engage with the National Institute for Health and Care Excellence, as doing so would circumvent and undermine the established and independent appraisal process in a damaging way.

Health is devolved, and decisions on access to medicines in Scotland and Wales are matters for the respective devolved administrations.