Changes to NICE’s cost-effectiveness thresholds

Q: When will this change come into effect?

The NICE manual has been updated, and the new thresholds are now in place. 

Q: What does this mean for those treatments already being assessed?

The threshold changes now apply to both new technology appraisals and those currently underway.

Where evaluations are underway, these will continue through our normal process with the independent evaluation committees applying the new thresholds.  

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

NICE does not routinely re-evaluate negative decisions and so the change to the threshold will not be applied retrospectively. The change will only apply to new medicines appraisals and those currently underway.

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.

It is important to remember that NICE makes its recommendations based on a number of factors – and 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 (digital, healthtech, guidelines) or just medicines?

At this stage, the threshold change only applies to medicines and health technologies evaluated through a Technology Appraisal. We await further detail from government on whether this will be extended to cover all NICE guidance in the future.

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

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

Q: Will this lead to more expensive drugs being recommended?

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

Our committees already take into account the scale of the benefits the treatment provides to people and to the health and care system, including any potential savings, which are taken into consideration alongside price.

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. 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 treatments that 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 to £300,000 per QALY gained threshold – 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.

Find out more

You can read more in our news article 'Changes to NICE’s cost-effectiveness thresholds take effect'.