NICE, the health technology appraisal institute, is delaying its consultation on changing its methods, in part because of changes in the UK regulatory and commercial landscape.
The six-week public consultation on the methods review is now expected to begin in November 2020. A separate consultation on changing NICE processes will follow in February 2020.
Originally one six week-consultation on both methods and processes had been scheduled for the summer of 2020.
(Also see "NICE Expands On Methods Review Details" - Pink Sheet, 24 Jul, 2019.) (Also see "UK NICE Review Needs To Be More Than A ‘Bureaucratic Exercise’" - Pink Sheet, 20 Jun, 2019.). NICE said there would be a “short delay” to the methods review consultation. “We also need to factor in due consideration of any process requirements needed to address ongoing changes across the United Kingdom regulatory and commercial landscape, and to align the methods and process review into a single programme manual,” it added.
NICE currently develops its product guidance in parallel with European Medicines Agency’s regulatory process and therefore needs to “consider any impact and consequences as a result of the end of the EU exit transition period,” it told the Pink Sheet.
The UK agency, the MHRA, will become a fully freestanding regulator for medicines and medical devices on 1 January 2021. It recently published numerous pieces of guidance for industry on arrangements following the end of the transition period. (Also see "How To Get A ‘Great Britain’ Drug Approval In 2021" - Pink Sheet, 2 Sep, 2020.)
NICE said it was collaborating with the MHRA in “key areas of interest” through the MHRA and NICE Core Strategic Group.
“Current work is focused on ensuring that new MHRA licensing arrangements and NICE’s Technology Appraisals and Highly Specialised Technologies processes and timelines align such that timely patient access to important medicines is maintained and enhanced,” it said.
Meanwhile, NICE also needs to take into account NHS England’s forthcoming commercial framework when it conducts its reviews. Publication of a final framework had been expected this year but has been delayed because NHS England staff have been redeployed to help respond to the COVID-19 crisis.
This framework was outlined in the UK’s 2019 voluntary pricing scheme for branded medicines and sets out more detail on commercial arrangements with the pharmaceutical industry. (Also see "Concerns Emerge Over England’s Desire For Even Lower Drug Prices " - Pink Sheet, 4 Dec, 2019.)
According to NICE, topics considered for the methods review are: cost minimization (also referred to as cost comparison); costs used in health technology assessment; discounting; decision-making; equality considerations in guidance development; health-related quality of life; modifiers; sources and synthesis of evidence; technology-specific issues; and exploring uncertainty.