Chris Whitehouse, a political consultant and expert on medical technology policy and regulation at Whitehouse Communications, reflects on the outcome of the recent Department of Health and Social Care consultation on amendments to the regulations governing the National Institute for Health and Care Excellence (NICE).
In December 2025, the Department of Health and Social Care launched a five-week consultation seeking views on proposed amendments to the NICE regulations.
The proposals explored whether ministers should be granted a limited power to direct NICE on the standard cost-effectiveness threshold used in its technology appraisal (TA) and highly specialised technology (HST) programmes. The consultation also examined whether NICE should continue to be required to consult when procedural changes result directly from a ministerial direction.
The consultation received 203 responses from professionals, organisations and individuals across the health and life sciences community. Several themes emerged from the responses, including the importance of maintaining NICE’s independence and the role of government in setting health policy priorities.
While many respondents raised concerns about potential political influence over NICE’s work, others noted that decisions about the cost-effectiveness threshold ultimately relate to how NHS resources are allocated and therefore fall within the remit of government policy.
In its response, the government acknowledged these concerns but emphasised that the cost-effectiveness threshold reflects broader decisions about how NHS resources are allocated and is therefore ultimately a matter of public policy.
On that basis, ministers will be granted a limited power of direction to set the threshold used by NICE when developing TA and HST recommendations, while NICE will continue to be responsible for its wider methodological framework and evidence-based appraisal processes.
The government also confirmed that NICE will no longer be required to consult on procedural changes arising from a ministerial direction, though it retains discretion to engage stakeholders on implementation.
For the MedTech sector, these changes introduce both opportunities and considerations for the future policy environment. The ability for ministers to set the cost-effectiveness threshold may provide clearer signals about the policy parameters within which new technologies are assessed. Greater alignment between health technology assessment and wider government priorities could support planning for innovation, investment and evidence generation.
At the same time, the practical impact will depend on how this new power is exercised. The cost-effectiveness threshold plays a central role in determining whether new technologies are considered a good use of NHS resources. Any future adjustments could therefore influence the pace at which new devices and technologies are adopted across the health system.
For patients, the implications may similarly be shaped by how the policy is applied in practice. A framework that remains responsive to innovation has the potential to support timely access to new technologies. However, maintaining confidence in the transparency and evidence base of decision-making will remain important to ensure that access decisions continue to reflect both clinical value and responsible use of NHS resources.
The consultation also highlights broader considerations for policymakers, NHS bodies and industry stakeholders. Balancing the need to encourage innovation with the pressures facing NHS budgets remains a central challenge. Changes to the way cost-effectiveness thresholds are determined may provide additional flexibility in responding to evolving health priorities, but they also reinforce the importance of maintaining a clear and reliable assessment framework.
Taken together, the outcome represents a targeted policy adjustment rather than a fundamental change to NICE’s role. The key question now will be how this new mechanism is used and how it shapes the relationship between government priorities, health technology assessment and access to innovation across the healthcare system.
For further details, the government’s consultation response is available here, and the statutory instrument can be accessed here.
The author used AI in preparing this article. Comments upon or questions about this article can be addressed to chris.whitehouse@whitehousecomms.com.
