The Government is fully assessing how the United Kingdom’s decision to leave the European Union will impact medicines regulation in the UK, including the potential relocation of the European Medicines Agency (EMA). However, whatever the future relationship between the UK and EMA, the Government will ensure that patient access to medicines will not be adversely impacted.

We are committed to ensuring that patients with rare and ultra-rare diseases in England are able to access effective treatments.

The National Institute for Health and Care Excellence (NICE) has advised that the proposed arrangements are intended to 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.

Subject to the outcome of the current consultation exercise, those products that have a value proposition of above £100,000 per quality-adjusted life year will 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.

We are committed to ensuring that patients with rare and ultra-rare diseases in England are able to access effective treatments.

The National Institute for Health and Care Excellence (NICE) has advised that the proposed arrangements are intended to 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.

Subject to the outcome of the current consultation exercise, those products that have a value proposition of above £100,000 per quality-adjusted life year will 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.

We are committed to ensuring that patients with rare and ultra-rare diseases in England are able to access effective treatments.

The National Institute for Health and Care Excellence (NICE) has advised that the proposed arrangements are intended to 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.

Subject to the outcome of the current consultation exercise, those products that have a value proposition of above £100,000 per quality-adjusted life year will 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.

We are committed to ensuring that patients with rare and ultra-rare diseases in England are able to access effective treatments.

The National Institute for Health and Care Excellence (NICE) has advised that the proposed arrangements are intended to 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.

Subject to the outcome of the current consultation exercise, those products that have a value proposition of above £100,000 per quality-adjusted life year will 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.

The National Institute for Health and Care Excellence (NICE) has advised that it is currently reviewing its overall approach to patient and public involvement, including involvement in its technology appraisal process.

Initial proposals, based on the findings of a literature review, a stakeholder survey and meeting, and internal interviews, were presented to NICE’s public board meeting on 20 July 2016. Once approved by the Board, these proposals will go out for public consultation later this year.