Question to the Department of Health and Social Care:

To ask the Secretary of State for Health, what steps his Department has taken to ensure that proposed delays to NICE's process for highly specialised technologies will not delay access to treatments for rare and ultra-rare diseases.

The National Institute for Health and Care Excellence (NICE) has advised that the proposed arrangements are intended to both speed up access to effective treatment and provide clarity about the level of cost effectiveness below which funding will be made available, automatically and without delay, for highly specialised technologies that receive positive recommendations from NICE speeding up access to the latest drugs.

Those products that have a value proposition of above £100,000 per quality-adjusted life year (QALY) would be provided with a further opportunity to be considered for use in the National Health Service, through NHS England’s annual process for deciding which new treatments and services will be routinely commissioned.

Furthermore, the proposed changes are intended to clarify NICE’s existing responsibility to determine the period within which funding for recommended products needs to be made available by commissioners of services. This clarity should allow companies and commissioners to work on commercial arrangements in advance of and in parallel with the development of NICE technology appraisal and highly specialised technology guidance. In circumstances where this may not be possible, specific requests from commissioners to vary the timescale for the funding requirement will be considered by NICE.