Minister can set NICE cost thresholds from 24 March
A short set of regulations has changed how NICE can be steered. From 24 March 2026, the Secretary of State for Health and Social Care may direct NICE on the cost-effectiveness threshold it must apply to a technology under appraisal. The change sits in the National Institute for Health and Care Excellence (Amendment) Regulations 2026 (S.I. 2026/202), made on 2 March and laid on 3 March, and it applies in England and Wales, according to legislation.gov.uk.
What does that mean in practice? NICE runs technology appraisals for medicines, devices and diagnostics, and a separate route for highly specialised technologies used in very rare conditions. These processes weigh clinical benefit, cost and uncertainty to decide whether the NHS should routinely fund a product.
Think of the cost-effectiveness threshold as the yardstick. It can be a single figure or a range and is used to judge value for money when NICE weighs up the evidence. The Regulations write that concept into law for this change, so everyone is clear what the direction would cover.
Most appraisals use quality-adjusted life years, or QALYs, to bring time and quality of life onto the same scale. One QALY equals one year of life in perfect health. Half a year at half quality equals 0.25 QALYs; two extra years at 80% quality equals 1.6 QALYs. Cost per QALY then shows how much the NHS would pay for those gains.
Here is the new lever. The Secretary of State can now tell NICE what threshold to apply in a particular appraisal, including the highly specialised route. A direction is not advice; it is a formal instruction that NICE must follow under law.
The amendment also trims process. NICE normally consults stakeholders before changing its appraisal procedures. But if the only change is what's needed to put a ministerial threshold direction into effect, NICE does not have to consult first.
For patients, the bar set by a threshold can shape access. A higher threshold makes it easier for treatments with good but costly benefits to clear the line; a lower threshold does the opposite. If you're waiting for a new therapy, the chosen threshold can speed a decision by making the target explicit before NICE concludes.
For clinicians and NHS decision-makers, a direction could bring upfront clarity on the budget trade-off in a given case. It could also make outcomes less predictable across therapy areas if different thresholds are set case by case. The evidence review and committee discussion still happen; what changes is the value-for-money line those judgements are held against.
Highly specialised technologies are a particular focus. These are treatments for very rare, severe conditions where trials are small and per-patient costs are high. Historically, NICE has accepted higher cost-per-QALY figures in this route to reflect severity and rarity; a ministerial direction could raise or lower that bar for a specific appraisal.
A quick picture helps. Imagine a medicine that delivers 1.5 extra QALYs at a net cost of £40,000. Its cost per QALY is about £26,700. If the threshold applied is £30,000 per QALY, that looks acceptable; if the threshold is £20,000, it likely would not be recommended. The science is the same; the bar isn't.
Nothing in this instrument sets a number today. It creates a power the Secretary of State may use when an appraisal is under way. When you read a future NICE decision, look for three cues in the papers: whether a ministerial direction is cited, what threshold is named, and how the committee balanced benefits, uncertainty and opportunity costs.
Key dates and sources matter. The amendment takes effect on 24 March 2026 and updates the 2013 Regulations that set out NICE's constitution and functions. An impact assessment is available from the Department of Health and Social Care and on legislation.gov.uk alongside S.I. 2026/202.
The instrument is signed for the Department of Health and Social Care by Parliamentary Under Secretary of State Zubir Ahmed on 2 March 2026. That is the legal confirmation that turns policy intent into a binding rule for NICE.
As readers, we should watch for how ministers explain any future directions and how NICE records them in its papers. The test is simple to state and hard to deliver: fair access to effective care, careful use of NHS funds, and clear reasoning about why a particular threshold was chosen in a specific case.