The government has announced that it will increase the thresholds NICE uses in evaluations of new medicines to decide which are cost-effective for use in the NHS. 

This change is designed to improve the operating environment for pharmaceutical companies in the UK to maximise the government’s commitment to unlock innovation and support the sector. We are now working to introduce these changes fairly and swiftly to provide clarity for patients and industry. 

Q: When will this change come into effect?   

Government has indicated it would like the new thresholds to be in place in the Spring (April) 2026. 

Q: Will you have to consult to change the manual? 

The details of how this change will be made will be confirmed in due course. 

Q: What does this mean for those treatments already being assessed? (Will that cause delays?)  

NICE will apply threshold changes to new technology appraisals and those currently underway. We will work to ensure our current timetables remain on track.  

Where evaluations are already underway, these will continue through our normal process. If our independent committees decide a treatment is not cost effective using our current thresholds and applying the new thresholds may change that decision, then the topic will be paused until NICE has the power to apply the new thresholds. Those paused topics will then be considered against the new thresholds and proceed to publication. Companies will also need to do their part by submitting their evidence to us swiftly and pricing their products fairly.     

Q: Will you go back and re-appraise those you rejected on cost grounds?  

The change to the threshold will not be applied retrospectively. The change will only apply to new medicines appraisals and those already underway when the changes come into effect in April 2026. 

NICE does not routinely re-evaluate negative decisions. Companies can request a new appraisal where there is a good reason to do so, for instance if significant new evidence is available that is likely to have a material effect on the recommendations. 

Importantly, NICE makes its recommendations based on a number of factors – not just cost. The evidence on how well a treatment works is equally important. 

Q: What about Highly Specialised Technologies (HSTs) for ultra-rare diseases?  

The changes apply to NICE’s standard cost-effectiveness thresholds used to develop Technology Appraisal (TA) guidance. We are not aware of any government proposals to change NICE’s cost-effectiveness thresholds used to evaluate HSTs for ultra-rare diseases. 

Q: Are you changing the threshold for all NICE evaluations or just medicines?  (digital, medtech, guidelines) 

NICE proposes that in order to compare the cost effectiveness of different treatment options in a clear and consistent way, the increase in threshold is applied across all NICE guidance as appropriate.  

We await further detail from government on this point. 

Q: Will this increase the number of medicines NICE recommends? 

NICE currently recommends 91% of the treatments it evaluates, around 70 per year. The changes should allow NICE to approve 3-5 additional medicines a year.   

The scale of the benefits the treatment provides to people and to the health and care system, including any potential savings, are taken into consideration alongside price.  

We can, and do, already say yes to very expensive treatments if they work well and offer long term health benefit [e.g. CRISPR gene editing medicine for sickle cell disease].

Q: Why hasn’t the standard threshold changed before? 

In a health service funded through general taxation, it is right that government decides on the level of health spend.  

No government since NICE was created 26 years ago has decided to change the core cost effectiveness threshold range of £20,000 - £30,000 per quality-adjusted life year (QALY). But they have permitted NICE to introduce significant upwards price flexibility so that for diseases that are the most severe, or those with fewest possible treatments we can flex and adapt our methods to so that the NHS “pays” a higher price for those medicines than the base price.  

• For severe diseases, such as cystic fibrosis, prices can be 20-70% higher than base  

• For treatments than can cure, like a treatment for neuroblastoma - an aggressive childhood cancer we can use a different approach to valuing health costs and future health benefits which means the NHS will pay prices that are ~10% higher on average than base  

• For diseases where there are significant health inequalities, we can reflect that in a higher price, such as with the recent gene editing technology for sickle cell  

• For ultra-rare diseases, we can pay up to 10 times higher than base – using a £100,000 - £300,000 per QALY, to reflect the difficulty in creating medicines and generating evidence for very small patient populations.  

In combination, these flexibilities mean that in the 2024 EFPIA WAIT report England ranked 6th out of 36 European countries for the availability of medicines. 

Q: What is EQ-5D-5L and the new value set? Why is this important/good news? And when will this happen?  

As part of today’s announcement, we welcome the government’s support to introduce a new value set for valuing health-related quality of life to use alongside the EQ-5D-5L instrument. 

The EQ-5D-5L is a tool that measures health-related quality of life for health research and decisions about healthcare treatments. 

The tool asks people to rate themselves across five areas of daily life: mobility (moving around), self-care (washing, dressing), usual activities (work, study, housework), pain or discomfort, and anxiety or depression. For each area, you choose from five levels ranging from "no problems" to "extreme problems." 

These responses create a health profile that gets converted into a single number using a value set. The value set comes from asking thousands of people to judge how good or bad different health states would be.  

These are then used to help healthcare decision-makers compare different treatments and understand their impact on health-related quality of life, and on the cost effectiveness of a treatment.