NICE’s Changing Role: a win for NICE, if it can deliver

16/04/2021

NICE’s Changing Role: a win for NICE, if it can deliver

First in a series of articles considering the implications of NICE’s changing role for industry and patients.

NICE’s role and remit has grown and morphed over its twenty plus year history, but its purpose is largely unchanged since its inception in 1999. That is, to give advice, guidance and recommendations on the provision of NHS-related health services in England¹. With two decades under its belt, NICE has established itself as a global leader in health technology assessment (HTA). The recently launched three-part consultation into its methods and processes for health technology evaluation is the largest review of its kind to be undertaken by NICE². It will also be the last. Described as ‘evolution rather than revolution’, the consensus so far is that proposed changes to health technology evaluation are prudent; yet a closer reading of the consultation materials reveal profound implications for health technology evaluation in England, and NICE as an organisation. NICE is growing its role beyond its original purpose: from health technology assessment to health technology management; to make decisions on affordability; and by extension, on commercial agreements, data collection, and policy. These new functions may seem an organic evolution of NICE’s remit, but raise questions for stakeholders about its purpose, priorities and place in the access landscape. This series of articles will consider the implications of NICE’s changing role in three areas: capacity, affordability, and scope. In this first article, we consider capacity – NICE’s ability to deliver – against the backdrop of the coronavirus pandemic and NICE’s emerging role in health technology management.

NICE is a well-respected pioneer of health technology evaluation. It has an integral role in the life sciences ecosystem. Under its new vision, it aims to be better fulfil its commitment to expedite access to innovative medicines and medical devices. However, NICE is already facing mounting pressure to deliver timely appraisals of medicines, let alone delivering anything beyond this core remit. It is, in this sense, a victim of its own success. Previous commitments to review all new active substances entering the UK, as agreed in the 2019 Voluntary Scheme for Branded Medicine Pricing and Access (VPAS), would require a capacity increase at the best of times. Naturally, the coronavirus pandemic has piled on further pressures, disrupting NICE services and exposing cracks in NICE timeline and processes. Timelines have been unpredictable since April 2020, with some products facing severely delayed timelines and others being expedited, suggesting challenges in planning workload. There is also a concern that NICE is failing to follow the processes as they are set out, effectively ‘cutting corners’. With this in mind, the process consultation can be read as an attempt to carefully balance ‘resource incurring’ and ‘resource releasing’ proposals. NICE states it aims to ‘maximise resource’, optimise the use of committee capacity, and expedite assessments³.

This shift in thinking has not gone unnoticed. Industry has spent much of NICE’s 22-year history arguing for faster, and lately, more flexible processes for health technology evaluation; yet seeing NICE’s proposals to strip away parts of the HTA process has caused a rethink for many, who fear a negative impact on access and uptake. The balance is now tipping in favour of rigour, as stakeholders double down on the importance of NICE having robust and thorough appraisals. Most agree that it would be self-defeating for NICE to remove some of the parts of health technology evaluation, which set it apart as a world-leader, for the sake of efficiency. However, industry can’t have it both ways. In order to meet the ambition to issue guidance as close to marketing authorisation (MA) as possible, NICE must be able to keep up with recently introduced expedited regulatory processes (i.e. MHRA accelerated assessment procedure, rolling review procedure, and ILAP). Not doing so would set us back to the ‘NICE blight’ of the early 2000s, when “new products were being held up for too long while NICE studied them and the NHS refused, in the main, to fund them”⁴. Whether by increasing capacity or optimising its processes, (or a combination of the two), NICE will be increasingly required to deliver faster.

The question of speed of access, coupled with more rapid regulatory processes, poses another challenge for NICE – that is, if it is to be expected to issue guidance close to MA, but that MA is received earlier, based on less mature data, then NICE must also overhaul its expectations of evidence maturity. Whether NICE can reconcile these competing factors is yet to be seen.

Whether you agree with the changes proposed by NICE, the question remains whether a potential increase in income from its proposed changes will be sufficient for NICE to manage its growing workload. Indeed, NICE acknowledges that the scale and impact of the proposals on the capacity of its multitude of advisors, committees and staff is unclear⁵. It is no wonder, then, that the methods and process consultations focus on expedited assessments and driving efficiency. NICE’s recently published five-year strategy is also revealing; the organisation sees partnership as the key “to expand our skills, capacity and capabilities”, yet will need to approach collaboration carefully, so as to not sacrifice the quality or independence of health technology evaluation.

NICE’s changing role will undoubtedly raise its profile and influence over the UK life sciences ecosystem – yet it remains unclear whether it will be at the expense of its HTA programmes; will NICE successfully boost capacity through partnerships, or will it ‘brain drain’ existing programmes to deliver its new offerings? Industry and patients should carefully monitor whether health technology management becomes a distraction from, or actually contributes to, patient access to beneficial and cost-effective technologies.